Revocation of Uses of Partially Hydrogenated Oils in Foods, 53764-53774 [2023-16725]
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53764
Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Rules and Regulations
have Wipaire, Inc. Supplemental Type
Certificate (STC) No. SA01795CH installed.
(d) Subject
Joint Aircraft System Component (JASC)
Code 5510, Horizontal Stabilizer Structure;
5511 Horizontal stabilizer, Spar/Rib; 5514,
Horizontal Stabilizer Miscellaneous
Structure; 5530, Vertical Stabilizer Structure.
(e) Unsafe Condition
This AD was prompted by reports of cracks
found in at least one forward horizontal
stabilizer spar on 24 of the affected airplanes
where the vertical finlets tie to the forward
horizontal stabilizer spar. The FAA is issuing
this AD to prevent structural failure of the
forward horizontal stabilizer spars. The
unsafe condition, if not addressed, could
result in structural failure of the horizontal
tail with consequent loss of control of the
airplane.
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(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Required Actions
(1) At the compliance times in paragraphs
(g)(1)(i) through (iii) of this AD, as applicable,
and thereafter at intervals not to exceed 200
hours time-in-service (TIS), inspect the left
and right forward horizontal stabilizer spars
for cracks in accordance with Steps 1 through
9 of the Work Instructions of Wipaire, Inc.
Service Letter 253, Revision B, dated July 27,
2023.
(i) For STC configuration 7D1–4399–01:
Within 3 days or 24 hours TIS after the
effective date of this AD or before the
accumulation of 200 hours TIS since
installation of STC No. SA01795CH,
whichever occurs later.
(ii) For STC configuration 7D1–4399–02:
Within 5 days or 24 hours TIS after the
effective date of this AD or before the
accumulation of 300 hours TIS since
installation of STC No. SA01795CH,
whichever occurs later.
(iii) For STC configuration 7D1–4399–03:
Within 15 days or 24 hours TIS after the
effective date of this AD or before the
accumulation of 600 hours TIS since
installation of STC No. SA01795CH,
whichever occurs later.
(2) If any crack is found in a forward
horizontal stabilizer spar during any
inspection required by paragraph (g)(1) of
this AD, before further flight, replace the
cracked forward horizontal stabilizer spar.
Replacement of the cracked forward
horizontal stabilizer spar starts the initial and
repetitive inspections over.
(3) Within 10 days after each inspection
required by paragraph (g)(1) of this AD or
within 10 days after the effective date of this
AD, whichever occur later, report the
following to the FAA at the address in
paragraph (j)(1) of this AD. Report this
information regardless of whether cracks are
found.
(i) Model, engine configuration (with
horsepower limits), and propeller type;
(ii) Serial number and N number;
(iii) Total hours TIS on airframe;
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(iv) Total hours TIS operated with floats,
if known;
(v) STC configuration and total hours with
STC installed;
(vi) Crack location (right or left, upper/
lower caps inboard/outboard hole);
(vii) Crack size;
(viii) Photos of cracks found, if available;
and
(ix) Any additional operator/mechanic
comments
Administration (NARA). For information on
the availability of this material at NARA,
email: fr.inspection@nara.gov, or go to:
www.archives.gov/federal-register/cfr/ibrlocations.html.
(h) Credit for Previous Actions
You may take credit for the initial
inspection required by paragraph (g)(1) of
this AD if, before the effective date of this
AD, you complied with Wipaire, Inc. Service
Letter 253, Revision A, dated April 5, 2023.
[FR Doc. 2023–16964 Filed 8–7–23; 11:15 am]
(i) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Central Certification
Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the Certification Branch,
send it to the attention of the person
identified in paragraph (j)(1) of this AD.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(j) Related Information
(1) For more information about this AD,
contact Tim Eichor, Aviation Safety
Engineer, Central Certification Branch, FAA,
1801 S Airport Road, Wichita, KS 67209;
phone: (847) 294–7141; email: tim.d.eichor@
faa.gov.
(2) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.
(k) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
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 the AD specifies otherwise.
(i) Wipaire, Inc. Service Letter 253,
Revision B, dated July 27, 2023.
(ii) [Reserved]
(3) For service information identified in
this AD, contact Wipaire, Inc., 1700 Henry
Ave, Fleming Field (KSGS), South St. Paul,
MN 55075; phone: (651) 451–1205; email:
customerservice@wipaire.com; website:
wipaire.com.
(4) You may view this service information
at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on
the availability of this material at the FAA,
call (817) 222–5110.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
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Issued on July 28, 2023.
Ross Landes,
Deputy Director for Regulatory Operations,
Compliance & Airworthiness Division,
Aircraft Certification Service.
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 161, 164, 184, and 186
[Docket No. FDA–2019–N–4750]
RIN 0910–AI15
Revocation of Uses of Partially
Hydrogenated Oils in Foods
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Direct final rule.
The Food and Drug
Administration (FDA or we) is
amending our regulations that provide
for the use of partially hydrogenated oils
(PHOs) in food in light of our
determination that PHOs are no longer
generally recognized as safe (GRAS).
The rule removes PHOs as an optional
ingredient in the standards of identity
for peanut butter and canned tuna. It
revises FDA’s regulations affirming food
substances as GRAS pertaining to
menhaden oil and rapeseed oil to no
longer include partially hydrogenated
forms of these oils, and deletes the
regulation affirming hydrogenated fish
oil as GRAS as an indirect food
substance. We are also revoking prior
sanctions (i.e., pre-1958 authorization of
certain uses) for the use of PHOs in
margarine, shortening, and bread, rolls,
and buns based on our conclusion that
these uses of PHOs may be injurious to
health. We are issuing these
amendments directly as a final rule
because they are noncontroversial given
the public health risks associated with
PHOs and the increasing use of PHO
alternatives, and we anticipate no
significant adverse comments because
PHOs were declared no longer GRAS for
any use in human food in 2015.
DATES: This rule is effective December
22, 2023. Either electronic or written
comments on the direct final rule or its
companion proposed rule must be
submitted by October 23, 2023. If FDA
receives no significant adverse
SUMMARY:
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Rules and Regulations
comments within the specified
comment period, we intend to publish
a document confirming the effective
date of the final rule in the Federal
Register within 30 days after the
comment period on this direct final rule
ends. If timely significant adverse
comments are received, FDA will
publish a document in the Federal
Register withdrawing this direct final
rule within 30 days after the comment
period on this direct final rule ends.
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
October 23, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
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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
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information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–4750 for ‘‘Revocation of Uses of
Partially Hydrogenated Oils in Foods.’’
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-201509-18/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.
FOR FURTHER INFORMATION CONTACT:
Ellen Anderson, Center for Food Safety
and Applied Nutrition, Office of Food
Additive Safety (HFS–255), Food and
Drug Administration, 5001 Campus Dr.,
PO 00000
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College Park, MD 20740, 240–402–1309;
or Carrol Bascus, 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:
I. Executive Summary
A. Purpose of the Direct Final Rule
B. Summary of the Major Provisions of the
Direct Final Rule
C. Legal Authority
D. Costs and Benefits
II. Direct Final Rulemaking
III. Table of Abbreviations/Acronyms Used in
This Document
IV. Background
V. Legal Authority
VI. Description of the Direct Final Rule
A. Amendment of Standard of Identity
Regulations
B. Amendment/Revocation of GRAS
Affirmation Regulations
C. Comments on Prior-Sanctioned Uses of
PHOs
VII. Revocation of Prior-Sanctioned Uses of
PHOs
VIII. Trans Fat Consumption Health Effects
A. Updated Scientific Literature and Expert
Opinion Review
B. Estimated Exposure to Trans Fat From
Prior-Sanctioned Uses of PHOs
C. Risk Estimates Associated With PriorSanctioned Uses of PHOs
IX. Economic Analysis of Impacts
X. Analysis of Environmental Impact
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 Direct Final Rule
The purpose of this direct final rule
is to amend our regulations and revoke
prior-sanctioned uses of PHOs to
conform with the current state of
scientific knowledge regarding the
public health risks of PHOs. In June
2015, FDA published a declaratory
order (Order) setting forth our final
determination, based on the available
scientific evidence and the findings of
expert scientific panels, that there is no
longer a consensus among qualified
experts that PHOs, which are the
primary dietary source of industrially
produced trans fatty acids, are GRAS for
any use in human food. The Order
stated that we determined that this body
of evidence established the health risks
associated with the consumption of
trans fat. In the Order, we recognized
that there were some uses of PHOs in
foods that are expressly authorized by
GRAS affirmation regulations,
acknowledged that there could be some
uses recognized by ‘‘prior sanction’’
(and thus could not be regulated as a
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Rules and Regulations
food additive), and stated that we would
address such uses separate from the
final determination. We also stated that
we would consider taking further
action, including revising certain
standards of identity that list PHOs as
optional ingredients.
As explained in the Order, there is a
lack of convincing evidence that PHOs
are GRAS. FDA has not approved a food
additive petition for PHOs. Accordingly,
we are removing PHOs from our food
regulations in light of our determination
that PHOs are no longer GRAS.
Furthermore, based on our current
review of scientific data and
information, as well as previous safety
reviews performed to support various
FDA actions regarding trans fat, we are
prohibiting all prior-sanctioned uses of
PHOs. A prior sanction exempts a
specific use of a substance in food from
the definition of food additive and from
all related food additive provisions of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) if the use was
sanctioned or approved prior to
September 6, 1958. In accordance with
FDA’s general regulations regarding
prior sanctions, we may revoke a priorsanctioned use of a food ingredient
where scientific data or information
demonstrate that prior-sanctioned use of
the food ingredient may be injurious to
health. We have determined that the
prior-sanctioned uses of PHOs may
render food injurious to health.
Consequently, we are revoking the
prior-sanctioned uses of PHOs.
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B. Summary of the Major Provisions of
the Direct Final Rule
The rule removes PHOs as an optional
ingredient in the standards of identity
for peanut butter and canned tuna,
revises the regulations affirming the use
of menhaden oil and rapeseed oil as
GRAS to delete language regarding
partially hydrogenated forms of these
oils, and revokes the regulation
affirming hydrogenated fish oil as GRAS
as an indirect food substance. We are
revoking prior sanctions (i.e., pre-1958
authorization of certain uses) for the use
of PHOs in margarine, shortening, and
bread, rolls, and buns.
C. Legal Authority
This rule is consistent with our
authority in sections 201, 401, 402, 409,
and 701 of the FD&C Act (21 U.S.C. 321,
341, 342, 348, and 371). We discuss our
legal authority in greater detail in
section V of this document.
D. Costs and Benefits
We estimated the costs of removing
PHO-containing foods from the market,
which accrue from product
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reformulation, relabeling products,
changing food recipes, finding
substitute ingredients and changes in
functional and sensory product
properties, such as taste, texture, and
shelf life. The benefits of the rule accrue
from reduction of coronary heart
diseases. Discounted at 7 percent over a
20-year period, the annualized primary
cost estimate of the rule is $24.5 million
with a lower bound estimate of $20.8
million and an upper bound estimate of
$29.7 million. The annualized benefits
of this rule discounted at 7 percent over
a 20-year period is $61.5 million for the
primary estimate with a lower bound of
$20.1 million and an upper bound of
$120.7 million.
II. Direct Final Rulemaking
In the document titled ‘‘Guidance for
FDA and Industry: Direct Final Rule
Procedures,’’ announced and provided
in the Federal Register of November 21,
1997 (62 FR 62466), FDA described its
procedures on when and how we will
employ direct final rulemaking. The
guidance may be accessed at: https://
www.fda.gov/RegulatoryInformation/
Guidances/ucm125166.htm. We have
determined that this rule is appropriate
for direct final rulemaking because it
includes only noncontroversial
amendments, and we anticipate no
significant adverse comments.
Consistent with our procedures on
direct final rulemaking, we are also
publishing elsewhere in this issue of the
Federal Register a companion proposed
rule proposing to amend our regulations
and revoke prior-sanctioned uses of
PHOs to conform with the current state
of scientific knowledge regarding the
public health risks of PHOs. The
companion proposed rule provides a
procedural framework within which the
rule may be finalized if the direct final
rule is withdrawn because of any
significant adverse comments. The
comment period for the direct final rule
runs concurrently with the companion
proposed rule. Any comments received
in response to the companion proposed
rule will be considered as comments
regarding the direct final rule.
We are providing a comment period
on the direct final rule of 75 days after
the date of publication in the Federal
Register. If we receive any significant
adverse comments, we intend to
withdraw this direct final rule before its
effective date by publication of a notice
in the Federal Register. A significant
adverse comment is defined as a
comment that explains why the rule
would be inappropriate, including
challenges to the rule’s underlying
premise or approach, or would be
ineffective or unacceptable without a
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change. In determining whether an
adverse comment is significant and
warrants terminating a direct final
rulemaking, we will consider whether
the comment raises an issue serious
enough to warrant a substantive
response in a notice-and-comment
process.
Comments that are frivolous,
insubstantial, or outside the scope of the
rule will not be considered significant
or adverse under this procedure. A
comment recommending a regulation
change in addition to those in the direct
final rule would not be considered a
significant adverse comment unless the
comment states why the rule would be
ineffective without the additional
change. In addition, if a significant
adverse comment applies to a part of
this rule and that part can be severed
from the remainder of the rule, we may
adopt as final those provisions of the
rule that are not the subject of the
significant adverse comment.
If any significant adverse comments
are received during the comment
period, FDA will publish, before the
effective date of this direct final rule, a
notice of significant adverse comment
and withdraw the direct final rule. If we
withdraw the direct final rule, any
comments received will be applied to
the proposed rule and will be
considered in developing a final rule
using the usual notice-and-comment
procedure.
If FDA receives no significant adverse
comments during the specified
comment period, we intend to publish
a document confirming the effective
date within 30 days after the comment
period ends.
III. Table of Abbreviations/Acronyms
Used in This Document
Abbreviation/
acronym
What it means
CFR ...............
CHD ..............
CVD ..............
FD&C Act ......
Code of Federal Regulations.
Coronary heart disease.
Cardiovascular disease.
Federal Food, Drug, and
Cosmetic Act.
Food and Drug Administration.
Federal Register.
Generally Recognized as
Safe.
Industrially Produced Trans
Fatty Acid.
Low Erucic Acid Rapeseed
Oil.
Percentage of Total Energy
Intake per Day.
Partially Hydrogenated Oils.
United States Code.
United States Department of
Agriculture.
FDA ...............
FR .................
GRAS ............
IP–TFA ..........
LEAR oil ........
%en ...............
PHOs ............
U.S.C. ...........
USDA ............
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Rules and Regulations
IV. Background
In the Federal Register of November
8, 2013 (78 FR 67169), we announced
our tentative determination that, based
on currently available scientific
information, PHOs are no longer GRAS
under any condition of use in human
food and, therefore, are food additives.
Section 201(s) of the FD&C Act (21
U.S.C. 321(s)) defines a food additive, in
part, as a substance that is not GRAS,
and section 402(a)(2)(C) of the FD&C Act
(21 U.S.C. 342(a)(2)(C)) establishes that
food bearing or containing a food
additive that is unsafe within the
meaning of section 409 of the FD&C Act
(21 U.S.C. 348) is adulterated. Section
409 of the FD&C Act establishes that a
food additive is unsafe for the purposes
of section 402(a)(2)(C) of the FD&C Act
unless certain criteria are met, such as
conformance with a regulation
prescribing the conditions under which
the additive may be safely used. In the
Federal Register of June 17, 2015 (80 FR
34650), we published a declaratory
order (the Order) announcing our final
determination that there is no longer a
consensus among qualified experts that
PHOs, the primary dietary source of
industrially produced trans fatty acids
(IP–TFA), are GRAS for any use in
human food. For a discussion of the
science regarding the harms associated
with PHOs, we refer readers to the prior
administrative proceeding (see 78 FR
67169 at 67171).
The Order acknowledged (see 80 FR
34650 at 34651) that the regulations at
21 CFR part 184, ‘‘Direct Food
Substances Affirmed as Generally
Recognized as Safe,’’ (GRAS affirmation
regulations) include partially
hydrogenated versions of two oils: (1)
menhaden oil (§ 184.1472(b) (21 CFR
184.1472(b))) and (2) low erucic acid
rapeseed (LEAR) oil (§ 184.1555(c)(2)
(21 CFR 184.1555(c)(2))). Partially
hydrogenated menhaden oil was
affirmed as GRAS for use in food (54 FR
38219, September 15, 1989) on the basis
that the oil is chemically and
biologically comparable to commonly
used partially hydrogenated vegetable
oils such as corn and soybean oils.
Partially hydrogenated LEAR oil was
affirmed as GRAS for use in food (50 FR
3745, January 28, 1985) based on
published safety studies (i.e., scientific
procedures) (21 CFR 170.30). In the
Order, we stated that we would amend
the GRAS affirmation regulations for
menhaden oil and LEAR oil
(§§ 184.1472 and 184.1555) in a future
rulemaking (see 80 FR 34650 at 34651,
34655, and 34667).
In addition, our GRAS affirmation
regulation for hydrogenated fish oil at
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§ 186.1551 (21 CFR 186.1551) (44 FR
28323, May 15, 1979), provides for
partial hydrogenation of oils expressed
from fish, primarily menhaden, and
secondarily herring or tuna, used as a
constituent of cotton and cotton fabrics
used for dry food packaging.
Certain standard of identity
regulations include PHOs as an optional
ingredient. Since 1990, the standard of
identity for canned tuna at § 161.190 (21
CFR 161.190) has provided for the use
of PHOs as an optional seasoning or
flavoring ingredient in canned tuna in
water (55 FR 45795, October 31, 1990).
Since 1968, the standard of identity for
peanut butter at § 164.150 (21 CFR
164.150) has provided for the use of
PHOs as an optional stabilizing
ingredient (33 FR 10506, July 24, 1968).
In addition, based on a review of our
regulations and on comments submitted
in response to our tentative
determination, ‘‘prior sanctions’’ exist
for the use of PHOs in margarine,
shortening, and bread, rolls, and buns.
As discussed in more detail in section
VI of this document, a prior sanction
exempts a specific use of a substance in
food if the use was sanctioned or
approved prior to September 6, 1958,
from the definition of a food additive
under section 201(s)(4) of the FD&C Act
and from all related food additive
provisions of the FD&C Act.
V. Legal Authority
We are issuing this rule under the
legal authority of sections 201, 401, 402,
409, and 701 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 its becoming a
component of food, if such substance is
not generally recognized by experts as
safe under the conditions of its intended
use (section 201(s) of the FD&C Act).
The definition of ‘‘food additive’’
exempts any uses that are the subject of
a prior sanction (section 201(s)(4) of the
FD&C Act). Food additives are deemed
unsafe except to the extent that FDA
approves their use (section 409(a) of the
FD&C Act). Food is adulterated when it
contains an unapproved food additive
(section 402(a)(2)(C) of the FD&C Act).
In addition, we may establish standards
of identity for foods to promote honesty
and fair dealing in the interest of
consumers (section 401 of the FD&C
Act). Section 701(a) of the FD&C Act
provides the authority to issue
regulations for the efficient enforcement
of the FD&C Act.
With respect to prior sanctions,
section 201(s)(4) of the FD&C Act
exempts from the definition of a food
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53767
additive any substance used in
accordance with a sanction or approval
granted under the FD&C Act, the Meat
Inspection Act, or the Poultry Products
Inspection Act before the enactment of
the Food Additives Amendment of 1958
on September 6, 1958. This type of
sanction or approval is referred to as a
‘‘prior sanction.’’ Our regulation, at 21
CFR 170.3(l), defines this term as an
explicit approval granted with respect to
use of a substance in food before
September 6, 1958, under the FD&C Act,
the Meat Inspection Act, or the Poultry
Products Inspection Act. Another FDA
regulation (21 CFR 181.5(a)) states that
a prior sanction exists only for a specific
use(s) of a substance in food, i.e., the
level(s), condition(s), product(s), etc.,
for which there was explicit approval by
FDA or the U.S. Department of
Agriculture (USDA) before September 6,
1958. The ‘‘explicit approval’’ needed to
establish a prior sanction may be either
formal or informal. If a formal approval,
such as a food standard regulation
issued under the FD&C Act before 1958,
does not exist, correspondence issued
by authorized FDA officials can
constitute an informal prior sanction.
In accordance with FDA’s general
regulations regarding prior sanctions
found at 21 CFR 181.1(b) and 181.5(c),
we may revoke a prior-sanctioned use of
a food ingredient where scientific data
or information demonstrate that priorsanctioned use of the food ingredient
may be injurious to health and, thus,
adulterates the food under section 402
of the FD&C Act.
VI. Description of the Direct Final Rule
This rule:
• Amends the food standard for
canned tuna at § 161.190 to no longer
include partially hydrogenated
vegetable oil as an optional ingredient
for seasoning in canned tuna packed in
water;
• Amends the food standard for
peanut butter at § 164.150 to no longer
include partially hydrogenated
vegetable oil as an optional stabilizing
ingredient in peanut butter;
• Revises § 184.1472 to delete
references to partially hydrogenated
menhaden oil;
• Revises § 184.1555 to delete
references to partially hydrogenated
LEAR oil;
• Revokes § 186.1551, which permits
the use of partially hydrogenated fish oil
in cotton and cotton fabrics used for dry
food packaging; and
• Revokes the prior sanctions for the
use of PHOs in margarine, shortening,
and bread, rolls, and buns.
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A. Amendment of Standard of Identity
Regulations
Standard of identity regulations for
food are issued under section 401 of the
FD&C Act and do not provide either an
authorization or an exemption from
regulation as a food additive under
section 409 of the FD&C Act. FDA’s
standards of identity, among other
things, establish the common or usual
name for a food and define the basic
nature of the food, generally in terms of
the types of ingredients that it must
contain (i.e., mandatory ingredients)
and that it may contain (i.e., optional
ingredients). The purpose of food
standards is to promote honesty and fair
dealing in the interest of consumers.
Therefore, the inclusion of PHOs in
certain standards of identity does not
necessarily mean that their use is
permissible under section 409 of the
FD&C Act. As such, our changes to these
standard of identity regulations are
merely for clarification purposes.
1. Canned Tuna—§ 161.190
Since 1990, our regulations, at
§ 161.190(a) have described canned tuna
as processed flesh of fish of the species
enumerated in § 161.190(a)(2),
commonly known as tuna, in any of the
forms of pack specified in
§ 161.190(a)(3) (55 FR 45795). The
standard of identity for canned tuna
includes, as an optional ingredient,
edible vegetable oil or partially
hydrogenated vegetable oil, excluding
olive oil, to be used alone or in
combination, as seasoning in canned
tuna packed in water
(§ 161.190(a)(6)(viii)).
The rule deletes the words ‘‘or
partially hydrogenated vegetable oil’’
and ‘‘alone or in combination’’ from the
list of optional ingredients in canned
tuna (§ 161.190(a)(6)(viii)). The
remaining term ‘‘edible vegetable oil’’
does not include the use of any partially
hydrogenated oils in canned tuna. (See
Ref. 1.)
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2. Peanut Butter—§ 164.150
Since 1968, our regulations at
§ 164.150 have described standardized
peanut butter as a product prepared by
grinding one of the shelled and roasted
peanut ingredients provided for by
§ 164.150(b), to which may be added
safe and suitable seasoning and
stabilizing ingredients provided for by
§ 164.150(c), if such seasoning and
stabilizing ingredients do not, in the
aggregate, exceed 10 percent of the
weight of the finished food (33 FR
10506).
The standard of identity for peanut
butter, at § 164.150(c), includes oil
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products as optional stabilizing
ingredients, which must be
hydrogenated vegetable oils; for
purposes of § 164.150(c), hydrogenated
vegetable oil is considered to include
partially hydrogenated vegetable oil.
The rule revises the standard of
identity for peanut butter by deleting
the reference to partially hydrogenated
vegetable oil in § 164.150(c). The rule
also makes a minor editorial change by
replacing ‘‘shall’’ with ‘‘must.’’
B. Amendment/Revocation of GRAS
Affirmation Regulations
1. Menhaden Oil—§ 184.1472
Since 1997, our GRAS affirmation
regulations for menhaden oil at
§ 184.1472(a) have described menhaden
oil as being prepared from fish of the
genus Brevoortia, commonly known as
menhaden, by cooking and pressing (62
FR 30756, June 5, 1997). The resulting
crude oil is then refined using the
following steps: storage (winterization),
degumming (optional), neutralization,
bleaching, and deodorization.
Our regulations, at § 184.1472(b),
address the preparation of partially
hydrogenated and hydrogenated
menhaden oils (§ 184.1472(b)(1)), the
specifications for partially hydrogenated
and hydrogenated menhaden oils
(§ 184.1472(b)(2)), the uses of partially
hydrogenated and hydrogenated
menhaden oils (§ 184.1472(b)(3)), and
the name to be used on the product’s
label (§ 184.1472(b)(4)).
The rule amends the GRAS
affirmation regulation for menhaden oil
at § 184.1472 to delete references to
partially hydrogenated menhaden oil
from § 184.1472(b), (b)(1), (b)(2),
(b)(2)(iv), (b)(3), and (b)(4). The rule also
changes the iodine value specification
for hydrogenated menhaden oil from the
current specification of ‘‘not more than
10,’’ to ‘‘not more than 4.’’ This is
consistent with our definition of PHOs
in the Order. For the purposes of the
Order, we defined PHOs as fats and oils
that have been hydrogenated, but not to
complete or near complete saturation,
and with an iodine value greater than 4
(80 FR 34650 at 34651). The rule also
makes minor editorial changes, such as
referring to hydrogenated menhaden oil
(singular) rather than to hydrogenated
menhaden oils (plural) and substituting
‘‘is’’ for ‘‘are’’ to reflect that the rule
would refer to only hydrogenated
menhaden oil.
2. Low Erucic Acid Rapeseed Oil—
§ 184.1555
Since 1985, our GRAS affirmation
regulations for LEAR oil, at
§ 184.1555(c) have described LEAR oil,
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also known as canola oil, as the fully
refined, bleached, and deodorized
edible oil obtained from certain varieties
of Brassica napus or B. campestris of the
family Cruciferae (50 FR 3745 at 3755).
The plant varieties are those producing
oil-bearing seeds with a low erucic acid
content. Chemically, low erucic acid
rapeseed oil is a mixture of
triglycerides, composed of both
saturated and unsaturated fatty acids,
with an erucic acid content of no more
than 2 percent of the component fatty
acids. The regulation provides for the
partial hydrogenation of LEAR oil
(§ 184.1555(c)(2)) and discusses the oil’s
purity (§ 184.1555(c)(3)) and uses in
food (§ 184.1555(c)(4)).
The rule deletes § 184.1555(c)(2)
entirely, deletes all mention of partially
hydrogenated LEAR oil from
§ 184.1555(c)(3) and (4), and
redesignates current § 184.1555(c)(3)
and (4) as § 184.1555(c)(2) and (3),
respectively.
3. Hydrogenated Fish Oil—§ 186.1551
Since 1979, our GRAS affirmation
regulations for hydrogenated fish oil at
§ 186.1551 have described hydrogenated
fish oil as a class of oils produced by the
partial hydrogenation of oils expressed
from fish, primarily menhaden and
secondarily herring or tuna (44 FR
28323). The regulation allows the use of
this oil as a constituent of cotton and
cotton fabrics used for dry food
packaging. It was noted in the final rule
entitled ‘‘Substances Generally
Recognized as Safe and Indirect Food
Substances Affirmed as Generally
Recognized as Safe; Hydrogenated Fish
Oil’’ that no reports of a priorsanctioned use for hydrogenated fish oil
were submitted in response to the
proposed rule, and therefore, in
accordance with that proposal, any right
to assert a prior sanction for a use of
hydrogenated fish oil under conditions
different from those set forth in this
regulation had been waived (44 FR
28323). Prior sanctions for hydrogenated
fish oil that differ from the use set forth
in the GRAS affirmation regulations do
not exist or have been waived
(§ 186.1551(e)).
The rule deletes the GRAS affirmation
regulations for hydrogenated fish oil at
§ 186.1551 entirely. Our earlier
determination that there are no prior
sanctions for this ingredient different
from the use provided for in § 186.1551
or that any other prior sanctions have
been waived remains in effect.
C. Comments on Prior-Sanctioned Uses
of PHOs
We stated in our tentative
determination that we were not aware
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that FDA or USDA had granted any
explicit approval for any use of PHOs in
food before the 1958 Food Additives
Amendment to the FD&C Act (78 FR
67169 at 67171) and requested
comments on whether there was
knowledge of an applicable prior
sanction for the use of PHOs in food (78
FR 67169 at 67174). We discuss the
comments in this section. In addition,
we conclude that any prior sanctions for
other uses of PHOs in food different
from the uses discussed in sections
VI.C.1, 2, and 3 of this document do not
exist or have been waived.
1. GRAS Affirmation Regulations for
Menhaden Oil, LEAR Oil, and
Hydrogenated Fish Oil
As noted in the Order we
acknowledged that we had, in our
regulations, previously affirmed as
GRAS the use of PHOs in certain foods
or food contact substances (80 FR 34650
at 34651). We describe these regulations
and our revocation elsewhere in this
rule. Although some comments on our
tentative determination suggested that
these uses are prior-sanctioned, in each
case the regulation affirming the status
of the use as GRAS post-dates 1958. We
have no evidence that the uses affirmed
for menhaden oil (§ 184.1472) or LEAR
oil (§ 184.1555) are prior-sanctioned. In
the case of hydrogenated fish oil
(§ 186.1551), any prior sanctions for this
ingredient different from the use in the
GRAS affirmation regulation do not
exist or have been waived
(§ 186.1551(e)).
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2. Canned Tuna and Peanut Butter
Standards of Identity
Some comments identified the
standards of identity for canned tuna
(§ 161.190) and peanut butter
(§ 164.150) as providing proof of prior
sanction of PHOs because ‘‘partially
hydrogenated vegetable oil’’ is explicitly
listed as an optional ingredient in each
of those regulations. As discussed in
section VI.A of this document, the
standards of identity for canned tuna
and peanut butter both post-date 1958.
We have no evidence of any prior
sanctions for the use of PHOs as
described in the standards of identity
for canned tuna and peanut butter.
3. Mayonnaise, French Dressing, and
Salad Dressing Standards of Identity
Some comments identified the preSeptember 6, 1958, standards of identity
for mayonnaise (21 CFR 169.140), salad
dressing (21 CFR 169.150), and French
dressing (21 CFR 169.115 (revoked
effective February 14, 2022 (87 FR
2038))) and claimed that they
constituted prior sanctions for PHOs.
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The comments acknowledged that these
standards did not explicitly list PHOs
but argued that because the standards
allow use of ‘‘edible vegetable oil’’ in
the standardized products, they were
understood by both FDA and industry to
include PHOs because vegetable oil can
be hydrogenated.
We issued the standards of identity
for mayonnaise, French dressing, and
salad dressing in 1950 (15 FR 5227,
August 12, 1950). They permit use of
‘‘edible vegetable oil’’ in the
standardized products. No comments to
our tentative determination identified
any reference to hydrogenation of oils in
the rulemaking issuing these standards.
No comments suggested that industry
used PHOs in these products at the time
or that industry is currently using PHOs
in these products. We understand that,
since at least 1940, hydrogenation
changes the physical properties of an oil
and therefore, changes a product’s
identity (see Ref. 1, discussing labeling
for, among other things, ‘‘vegetable oils
which have not had their identity
changed through hydrogenation. . .’’).
Thus, the references to ‘‘edible vegetable
oil’’ in these standards, without mention
of hydrogenation or hardening, do not
include PHOs or fully hydrogenated
oils. Therefore, the evidence does not
provide an adequate basis on which to
establish a prior sanction.
4. Margarine, and Bread, Rolls, and
Buns Standards of Identity, and
Shortening
Some comments identified the preSeptember 6, 1958, standards of identity
for bread, rolls, and buns (§ 136.110 (21
CFR 136.110)), and margarine (§ 166.110
(21 CFR 166.110)), and claimed that
they constituted prior sanctions for
PHOs. The comments acknowledged
that these standards did not explicitly
list PHOs but argued that because the
standards allow use of ‘‘shortening’’
(bread, rolls, and buns), and ‘‘oil’’
(margarine) in the standardized
products, they were understood by both
FDA and industry to include PHOs
because shortening and oil can be
hydrogenated. Moreover, the comments
acknowledged that, while there is no
standard of identity for shortening that
mentions PHOs specifically, historical
evidence shows that shortening was
generally understood to contain PHOs
before 1958.
We issued the standard of identity for
margarine in 1941 (6 FR 2761, June 7,
1941). At that time, the standard of
identity stated that oleomargarine is
prepared with one or more of several
optional fat ingredients, including the
rendered fat, or oil, or stearin derived
therefrom (any or all of which may be
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hydrogenated), of cattle, sheep, swine,
or goats or any vegetable food fat or oil,
or oil or stearin derived therefrom (any
or all of which may be hydrogenated) (6
FR 2761 at 2762). The standard of
identity, as it existed in 1941, contained
no specific limitations on these
ingredients. The current standard of
identity (now codified at § 166.110)
states, in relevant part, that margarine
may include edible fats and/or oils from
animals, vegetables, or fish, or mixtures
of these, which may have been
subjected to an accepted process of
physico-chemical modification
(§ 166.110(a)(1)). The standard of
identity for margarine also states that
margarine ‘‘may contain small amounts
of other lipids, such as phosphatides or
unsaponifiable constituents, and of free
fatty acids naturally present in the fat or
oil’’ (id.).
We issued the standard of identity for
bread, rolls, and buns in 1952 (17 FR
4453, May 15, 1952). The standard of
identity, which is now codified at
§ 136.110, identifies ‘‘shortening’’ as an
optional ingredient. We initially
proposed a more detailed description of
the term ‘‘shortening’’ in 1941 that was
very similar to the term used in the
margarine standard issued that same
year; that description indicated that
shortening is composed of fat or oil from
animals, vegetables, or fish, any or all of
which may be hydrogenated, or of
butter, or any combination of two or
more such articles (6 FR 2771, June 7,
1941). However, the final rule that we
issued in 1952 simply referred to
‘‘shortening’’ and did not prescribe the
contents of or otherwise define
‘‘shortening’’ (17 FR 4453). Similarly,
the current standard of identity
mentions ‘‘shortening,’’ but does not
prescribe the contents of or otherwise
define ‘‘shortening’’ (see
§ 136.110(c)(5)). Additionally, the
standard of identity, as it existed in
1952, contained no specific limitations
on these ingredients.
In addition to identifying these
standards of identity, some comments to
our tentative determination stated that
the reference to hydrogenation in the
pre-September 6, 1958, standard of
identity for margarine was likely to have
meant partially hydrogenated oils as a
practical matter, based on the inherent
difference in the functional
characteristics of partially and fully
hydrogenated oils and the history of use
of PHOs in margarine products.
Other comments submitted historical
evidence relating to widespread use of
PHOs in margarine and shortening
before 1958. This evidence included a
1945 USDA publication, ‘‘Foods—
Enriched, Restored, Fortified’’ (Ref. 2),
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that described margarine by saying: ‘‘As
it is made by 41 manufacturing plants
in the United States, margarine contains
a mixture of animal fats and vegetable
oils or one or the other—fats that have
been used as food for centuries. These
are partially hydrogenated and blended
to give the right spreading consistency.’’
The comments also submitted two
patents, one from 1915 for ‘‘[a]
homogeneous lard-like food product
consisting of an incompletely
hydrogenized vegetable oil,’’ (Ref. 3)
and one from 1957 for ‘‘fluid
shortening,’’ stating ‘‘[s]hortenings
heretofore available for baking have
included . . . compounded or blended
shortenings, made from mixtures of
naturally hard fats or hydrogenated
vegetable oils with liquid, soft, or
partially hydrogenated vegetable oils’’
(Ref. 4). One comment cited a Supreme
Court decision regarding the
patentability of the product of partial
hydrogenation of vegetable oil for use as
shortening (Berlin Mills Co. v. Procter &
Gamble Co., 254 U.S. 156 (1920)). In
finding the 1915 patent invalid, the
Court held that ‘‘it was known before
[the patentee] took up the subject that a
vegetable oil could be changed into a
semi-solid, homogeneous, substance by
a process of hydrogenation arrested
before completion and that it might be
edible’’ (Berlin Mills, 254 U.S. at 165).
Some comments said that we
intended to include PHOs in the terms
‘‘shortening’’ and ‘‘oil . . . (any or all of
which may be hydrogenated)’’ used in
these pre-1958 standards of identity.
One comment said that we have, in
other contexts, used the term
‘‘hydrogenated oils’’ when we intended
to refer to PHOs (see, e.g., 68 FR 41434
at 41443, July 11, 2003 (‘‘trans fatty
acids provided by food sources of
hydrogenated oil’’)) and that the term
‘‘partially hydrogenated’’ did not appear
in our regulations until 1978 (43 FR
12856, March 28, 1978 (amending the
food labeling regulations by substituting
‘‘hydrogenated’’ and ‘‘partially
hydrogenated’’ for ‘‘saturated’’ and
‘‘partially saturated’’ when describing a
fat or oil ingredient)). Additionally, in
trade correspondence in 1940, we
described three general types of
shortening in response to a question
about ingredient labeling; we said that
the types of shortening were: ‘‘(1)
vegetable shortenings composed wholly
of mixtures of edible vegetable oils,
which have been subjected to a
chemical hardening process known as
hydrogenation; (2) mixtures of vegetable
oils with or without varying proportions
of hardened vegetable oils and with
edible animal fats; and (3) hydrogenated
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mixtures of vegetable oils and marine
animal oils (Ref. 1).’’ In addition, during
a rulemaking regarding oils and fats, we
used the phrase ‘‘oil . . . (any or all of
which may be hydrogenated)’’ and
acknowledged that this category
included PHOs (36 FR 11521, June 15,
1971). We proposed that, if the
vegetable fats or oils present are
hydrogenated, the ingredient
declaration should include the term
‘‘hydrogenated,’’ ‘‘partially
hydrogenated,’’ or ‘‘hardened,’’ and gave
an example of ‘‘partially hydrogenated
cottonseed oil’’ (36 FR 11521).
Thus, a prior sanction, as provided for
in section 201(s)(4) of the FD&C Act,
exists for the uses of PHOs in margarine,
shortening, and bread, rolls, and buns.
However, as discussed in the next
section, we are revoking the prior
sanction for these uses.
VII. Revocation of Prior-Sanctioned
Uses of PHOs
We have concluded that there are
prior-sanctioned uses of PHOs in
margarine, shortening, and bread, rolls,
and buns, and that these uses may be
injurious to health and may adulterate
food under section 402 of the FD&C Act.
Therefore, we are revoking the prior
sanction for the uses of PHOs in
margarine, shortening, and bread, rolls,
and buns. Our conclusion is based on
our current review of scientific data and
information, as well as previous safety
reviews performed in support of various
FDA actions regarding trans fat and
PHOs spanning 1999 to 2018 (see 64 FR
62746, November 17, 1999; 68 FR
41434, July 11, 2003; 78 FR 67169,
November 8, 2013; 80 FR 34650, June
17, 2015; 83 FR 23382, May 21, 2018).
In our review for this rule, we estimated
the dietary exposure for IP–TFA from
the prior-sanctioned uses of PHOs in
margarine, shortening, and bread, rolls,
and buns (Ref. 5) and conducted a
quantitative risk assessment for the
coronary heart disease (CHD) and
cardiovascular disease (CVD) risks
associated with this estimated exposure
to IP–TFA (Ref. 6). We also conducted
an updated scientific review of
published studies and evaluations by
expert panels on the safety of trans fat
(Ref. 7).
As for the standards of identity for
margarine and bread, rolls, and buns, no
corresponding revision to these
regulations are necessary. Each
standard, as currently written, is limited
so that only ‘‘safe and suitable’’
ingredients may be used, and neither
current standard expressly refers to
hydrogenation or partial hydrogenation
(see §§ 136.110(b) and 166.110(a)).
Moreover, our regulations provide that
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no provision of any regulation
prescribing a definition and standard of
identity is to be construed as affecting
the concurrent applicability of the
general provisions of the FD&C Act and
our regulations (see § 130.3(c) (21 CFR
130.3(c))). For example, all standard of
identity regulations contemplate that
the food and all articles used as
components or ingredients must not be
poisonous or deleterious (see § 130.3(c);
see also § 130.3(d) (further defining
‘‘safe and suitable’’)). As for shortening,
our standards of identity do not describe
the contents of or otherwise define
‘‘shortening,’’ so no amendment is
necessary.
VIII. Trans Fat Consumption Health
Effects
A. Updated Scientific Literature and
Expert Opinion Review
Our Order referenced three safety
memoranda prepared by FDA that
document our review of the available
scientific evidence regarding human
health effects of trans fat, focusing on
the adverse effects of trans fat on risk of
CHD (Refs. 8 to 10). In addition, we
previously reviewed the health effects of
IP–TFA and PHOs in 2013 in support of
our tentative determination regarding
the GRAS status of PHOs (78 FR 67169,
Docket No. FDA–2013–N–1317). Our
Order announced our final
determination that there is no longer a
consensus among qualified experts that
PHOs are GRAS for any use in human
food (80 FR 34650). The safety reviews
for the Order, together with the previous
safety reviews of IP–TFA and PHOs,
provided important scientific
background information for our review
and denial of a food additive petition for
certain uses of PHOs in 2018 (83 FR
23382).
We based our Order on the available
scientific evidence that included results
from controlled feeding studies on trans
fatty acid consumption in humans,
findings from long-term prospective
epidemiological studies, and the
opinions of expert panels that there is
no threshold intake level for IP–TFA
that would not increase an individual’s
risk of CHD. We also published a safety
review for specific uses of PHOs in a
notice denying a food additive petition
for certain uses of PHOs in food (83 FR
23382, Docket No. FDA–2015–F–3663).
This safety review reinforced our 2015
scientific review supporting the final
determination that PHOs are not GRAS
for use in human food. We denied the
food additive petition because we
determined that the petition did not
contain convincing evidence to support
the conclusion that the proposed uses of
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PHOs were safe (83 FR 23382 at 23391).
All the previously mentioned safety
reviews of IP–TFA and PHOs provide
important scientific background
information for review of the health
effects of the prior-sanctioned uses of
PHOs.
We are not aware of any new,
scientific literature on the safety of IP–
TFA and PHOs that would cause us to
reconsider our previous safety
conclusions. International and U.S.
expert panels, using additional
scientific evidence available since 2015,
have continued to recognize the positive
linear relationship between increased
trans fat intake and increased low
density lipoprotein cholesterol blood
levels associated with increased CHD
risk, have concluded that trans fats are
not essential nutrients in the diet, and
have recommended that trans fat
consumption be kept as low as possible.
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B. Estimated Exposure to Trans Fat
From Prior-Sanctioned Uses of PHOs
For this direct final rule, in order to
estimate the risks to CHD and CVD
associated with consumption of IP–TFA
from prior-sanctioned uses of PHOs, we
first had to estimate dietary exposure to
IP–TFA from these uses of PHOs. We
used two non-consecutive days of 24hour dietary recall data from the 2011–
2014 National Health and Nutrition
Examination Survey (NHANES) to
estimate dietary exposure to IP–TFA
from the use of PHOs in margarine and
shortening (which includes the priorsanctioned uses in bread, rolls, and
buns due to the use of margarine and/
or shortening in the food). We included
all foods reported in NHANES that
contained margarine or shortening as an
ingredient in our analysis. We applied
levels of trans fat commonly used in
margarine and shortening manufactured
before the publication of the tentative
determination in 2013. These use levels
reflect our conservative assumption that
manufacturers may revert back to using
PHOs at these higher use levels in
margarine and shortening if prior
sanctions are not revoked by this direct
final rule. For the U.S. population aged
2 years and older, we estimated a
cumulative mean dietary IP–TFA
exposure of 0.3 grams per person per
day for typical trans fat levels, for both
margarine and shortening, based on 53
percent of the population consuming
margarine or shortening (Ref. 5). The
mean IP–TFA exposure for the total
population (i.e., per capita intake) was
also determined (Ref. 7). Expressed as a
percentage of total energy intake per day
(%en) based on a 2000 calorie diet, the
mean per-capita IP–TFA exposure for
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typical IP–TFA levels in foods was
estimated to be 0.07%en (Ref. 7).
C. Risk Estimates Associated With PriorSanctioned Uses of PHOs
We used four risk methods to estimate
change in CHD and CVD risk associated
with 0.07%en IP–TFA exposure from
prior-sanctioned uses of PHOs (Ref. 6).
Our assessment methodology is
documented in our memorandum (Ref.
6).
Our quantitative risk assessments
demonstrate that there is a substantial
health risk associated with 0.07%en
from IP–TFA from prior-sanctioned uses
of PHOs (Ref. 6). Along with our Order,
our denial of the food additive petition
for certain uses of PHOs in food, and
our recent updated scientific literature
review on the safety of PHOs and trans
fat (Ref. 7), these analyses provide
further support for the revocation of the
prior-sanctioned uses of PHOs. The
scientific consensus is that there is no
threshold intake level of IP–TFA that
would not increase an individual’s risk
of CHD (Ref. 7). Thus, based on the
available data, we conclude that PHOs
used in food may cause the food to be
injurious to health and that the use of
PHOs as ingredients in margarine,
shortening, and bread, rolls, and buns
would adulterate these foods under
section 402(a)(1) of the FD&C Act.
IX. Economic Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, Executive Order
14094, the Regulatory Flexibility Act (5
U.S.C. 601–612), the Congressional
Review Act/Small Business Regulatory
Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104–121), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4).
Executive Orders 12866, 13563, and
14094 direct us to assess all costs,
benefits 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
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53771
safety, or State, local, territorial, or tribal
governments or communities.’’ OIRA
has determined that this final rule is not
a significant regulatory action as defined
by Executive Order 12866 Section
3(f)(1).
Because this rule is likely to result in
an annual effect on the economy of $100
million or more or meets other criteria
specified in the Congressional Review
Act/Small Business Regulatory
Enforcement Fairness Act, OIRA has
determined that this rule falls within
the scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because this rule may require some
small business entities to undertake
costly reformulations, we find that the
final rule will 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 an assessment of anticipated
costs and benefits, 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 final rule would not result
in an expenditure in any year that meets
or exceeds this amount.
The benefits of this rule are expected
to accrue from the number of coronary
heart diseases averted from
discontinued use of foods made with
PHOs. The removal of PHO containing
foods from the marketplace will limit
their access by most consumers. Such
action will protect the public by
reducing the health risk of developing
CHDs and improving population health
among those who would otherwise
consume products containing PHOs.
Continual use of PHOs is associated
with increased CHD and CVDs. Per
capita higher intake of PHOs can lead to
elevated risk of CHD and CVDs among
the U.S. population. Therefore, FDA
notes that the benefit of this rule relative
to baseline market conditions are
expected to decrease over time as PHO
containing products exit the
marketplace. The annualized benefits of
this rule at a 7 percent discount rate
over a 20-year period is $61.5 million
for the primary estimate with a lower
bound of $20.1 million and an upper
bound of $120.7 million.
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Rules and Regulations
The quantified costs of the rule are
from reformulating manufactured
products currently produced with
PHOs, relabeling products that contain
PHOs, changing recipes for some PHO
containing breads by retail bakeries,
$24.5 million with a lower bound
estimate of $20.8 million and an upper
bound estimate of $29.7 million.
Table 1 presents a summary of costs
and benefits of this rule.
finding substitute ingredients as well as
costs arising from functional and
sensory product properties such as taste
and texture. The annualized cost of the
rule at a 7 percent discount rate over a
20-year period has a primary estimate of
TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF FINAL RULE, IN 2020 MILLION DOLLARS
Units
Category
Benefits:
Annualized Monetized $millions/year .......................................
Annualized Quantified ..............................................................
Primary
estimate
Low
estimate
High
estimate
$61.5
58.3
..................
..................
$20.1
19.1
..................
..................
$120.7
114.3
..................
..................
2020
2020
..................
..................
7
3
7
3
20
20
24.5
20.2
..................
..................
20.8
17.1
..................
..................
29.7
33.2
..................
..................
2020
2020
..................
..................
7
3
7
3
20
20
..................
..................
..................
..................
..................
..................
..................
..................
7
3
Year
dollars
Discount
rate
(%)
Period
covered
(years)
Notes
Qualitative ................................................................................
Costs:
Annualized Monetized $millions/year .......................................
Annualized Quantified ..............................................................
Qualitative ................................................................................
Transfers:
Federal Annualized Monetized $millions/year .........................
From/To ....................................................................................
From:
Other Annualized .....................................................................
Monetized $millions/year ..........................................................
..................
..................
From/To ....................................................................................
From:
To:
..................
..................
..................
..................
..................
..................
7
3
To:
Effects:
State, Local or Tribal Government: None.
Small Business: Potential impact on small business entities that are currently continuing to use or produce PHOs and PHO containing ingredients in their products.
Wages: None.
Growth: None.
We have developed a comprehensive
Economic Analysis of Impacts that
assesses the impacts of the final rule.
The full analysis of economic impacts is
available in the docket for this final rule
(Ref. 11) and at https://www.fda.gov/
about-fda/reports/economic-impactanalyses-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.
lotter on DSK11XQN23PROD with RULES1
XI. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
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XII. Consultation and Coordination
With Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13175. We have
determined that the rule does not
contain policies that would have a
substantial direct effect on one or more
Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
federal government and Indian tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the
Executive Order and, consequently, a
tribal summary impact statement is not
required.
XIII. Federalism
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13132. We have
determined that the rule does not
contain policies that have substantial
direct effects on the states, on the
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Sfmt 4700
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 are on
display with 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 are also available
electronically at https://
www.regulations.gov. 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, Trade Correspondence TC–62
(February 15, 1940), reprinted in
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Kleinfeld, Vincent A. and Charles
Wesley Dunn, Federal Food, Drug, and
Cosmetic Act Judicial and
Administrative Record 1938–1949.
2. U.S. Bureau of Human Nutrition and Home
Economics (1945). Foods—Enriched,
Restored, Fortified. USDA at page 11,
available at https://naldc.nal.usda.gov/
download/5804422/PDF.
3. Serial No. 591,726, Record No. 1,135,351,
U.S. Patent Office, Official Gazette of the
U.S. Patent Office, April 13, 1915, at 492;
available at: https://www.uspto.gov/
learning-and-resources/official-gazette/
official-gazette-patents.
4. Serial No. 639,222, Record No. 2,909,432,
U.S. Patent Office, Official Gazette of the
U.S. Patent Office, October 20, 1959, at
697; available at: https://www.uspto.gov/
learning-and-resources/official-gazette/
official-gazette-patents.
5. FDA, Memorandum from D. Doell to E.
Anderson, Exposure to Trans Fat from
the Prior-Sanctioned Uses of Partially
Hydrogenated Oils (PHOs), October 23,
2019.
6. FDA, Memorandum from J. Park to E.
Anderson, Toxicology Prior Sanction
PHO Review Memo One: Agencyinitiated Quantitative Coronary Heart
and Cardiovascular Disease Risk
Assessment of Industrially-Produced
Trans Fatty Acids (IP–TFA) Exposure
from Prior-Sanctioned Uses of Partially
Hydrogenated Vegetable Oils (PHOs),
October 22, 2019.
7. FDA, Memorandum from J. Park to E.
Anderson, Toxicology Prior Sanction
PHO Review Memo Two: Scientific
Literature Review of Safety Information
Regarding Prior-Sanctioned Uses of
Partially Hydrogenated Oils (PHOs) in
Margarine and Shortenings, October 22,
2019.
8. FDA, Memorandum from J. Park to M.
Honigfort, Scientific Update on
Experimental and Observational Studies
of Trans Fat Intake and Coronary Heart
Disease Risk, June 11, 2015.
9. FDA, Memorandum from J. Park to M.
Honigfort, Literature Review, June 11,
2015.
10. FDA, Memorandum from J. Park to M.
Honigfort, Quantitative Estimate of
Industrial Trans Fat Intake and Coronary
Heart Disease Risk, June 11, 2015.
11. FDA, ‘‘Revocation of Uses of Partially
Hydrogenated Oils in Foods’’ Regulatory
Impact Analysis, Regulatory Flexibility
Analysis, Unfunded Mandates Reform
Analysis. Also available at: https://
www.fda.gov/about-fda/reports/
economic-impact-analyses-fdaregulations.
List of Subjects
lotter on DSK11XQN23PROD with RULES1
21 CFR Part 161
Food grades and standards, Frozen
foods, Seafood.
21 CFR Part 164
Food grades and standards, Nuts,
Peanuts.
21 CFR Part 184
Food additives.
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16:18 Aug 08, 2023
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21 CFR Part 186
Food additives, Food packaging.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 161,
164, 184, and 186 are amended as
follows:
PART 161—FISH AND SHELLFISH
1. The authority citation for part 161
continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 343, 348,
371, 379e.
2. In § 161.190, revise paragraph
(a)(6)(viii) to read as follows:
■
§ 161.190
Canned tuna.
(a) * * *
(6) * * *
(viii) Edible vegetable oil, excluding
olive oil, used in an amount not to
exceed 5 percent of the volume capacity
of the container, with or without any
suitable form of emulsifying and
suspending ingredients that has been
affirmed as GRAS or approved as a food
additive to aid in dispersion of the oil,
as seasoning in canned tuna packed in
water.
*
*
*
*
*
PART 164—TREE NUT AND PEANUT
PRODUCTS
3. The authority citation for part 164
continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 343, 348,
371, 379e.
4. In § 164.150, revise paragraph (c) to
read as follows:
■
§ 164.150
Peanut butter.
*
*
*
*
*
(c) The seasoning and stabilizing
ingredients referred to in paragraph (a)
of this section are suitable substances
which are not food additives as defined
in section 201(s) of the Federal Food,
Drug, and Cosmetic Act, or if they are
food additives as so defined, they are
used in conformity with regulations
established pursuant to section 409 of
the Federal Food, Drug, and Cosmetic
Act. Seasoning and stabilizing
ingredients that perform a useful
function are regarded as suitable, except
that artificial flavorings, artificial
sweeteners, chemical preservatives, and
color additives are not suitable
ingredients in peanut butter. Oil
products used as optional stabilizing
ingredients must be hydrogenated
vegetable oils.
*
*
*
*
*
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53773
PART 184—DIRECT FOOD
SUBSTANCES AFFIRMED AS
GENERALLY RECOGNIZED AS SAFE
5. The authority citation for part 184
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 371.
6. In § 184.1472, revise paragraph (b)
to read as follows:
■
§ 184.1472
Menhaden oil.
*
*
*
*
*
(b) Hydrogenated menhaden oil. (1)
Hydrogenated menhaden oil is prepared
by feeding hydrogen gas under pressure
to a converter containing crude
menhaden oil and a nickel catalyst. The
reaction is begun at 150 to 160 °C and
after 1 hour the temperature is raised to
180 °C until the menhaden oil is fully
hydrogenated.
(2) Hydrogenated menhaden oil meets
the following specifications:
(i) Color. Opaque white solid.
(ii) Odor. Odorless.
(iii) Saponification value. Between
180 and 200.
(iv) Iodine number. Not more than 4.
(v) Unsaponifiable matter. Not more
than 1.5 percent.
(vi) Free fatty acids. Not more than 0.1
percent.
(vii) Peroxide value. Not more than 5
milliequivalents per kilogram of oil.
(viii) Nickel. Not more than 0.5 part
per million.
(ix) Mercury. Not more than 0.5 part
per million.
(x) Arsenic (as As). Not more than 0.1
part per million.
(xi) Lead. Not more than 0.1 part per
million.
(3) Hydrogenated menhaden oil is
used as edible fat or oil, as defined in
§ 170.3(n)(12) of this chapter, in food at
levels not to exceed current good
manufacturing practice.
(4) The name to be used on the label
of a product containing hydrogenated
menhaden oil must include the term
‘‘hydrogenated,’’ in accordance with
§ 101.4(b)(14) of this chapter.
■ 7. In § 184.1555, revise paragraphs
(c)(2) and (3) and remove (c)(4) to read
as follows:
§ 184.1555
Rapeseed oil.
*
*
*
*
*
(c) * * *
(2) In addition to limiting the content
of erucic acid to a level not exceeding
2 percent of the component fatty acids,
low erucic acid rapeseed oil must be of
a purity suitable for its intended use.
(3) Low erucic acid rapeseed oil is
used as an edible fat and oil in food,
except in infant formula, at levels not to
exceed current good manufacturing
practice.
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Rules and Regulations
PART 186—INDIRECT FOOD
SUBSTANCES AFFIRMED AS
GENERALLY RECOGNIZED AS SAFE
8. The authority citation for part 186
continues to read as follows:
■
Authority: 21 U.S.C. 321, 342, 348, 371.
§ 186.1551
■
[Removed]
9. Remove § 186.1551.
Dated: July 29, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023–16725 Filed 8–8–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 2
[234A2100DD/AAKC001030/
A0A501010.999900]
RIN 1076–AF64
Appeals From Administrative Actions
Bureau of Indian Affairs,
Interior.
ACTION: Final rule.
AGENCY:
The Department of the
Interior (Department) is finalizing
updates to its regulations governing the
process for pursuing administrative
review of actions by Indian Affairs
officials. These updates provide greater
specificity and clarity to the
Department’s appeals process; and
reflect changes in the structure and
nomenclature within Indian Affairs.
DATES: This rule is effective on
September 8, 2023.
FOR FURTHER INFORMATION CONTACT:
Oliver Whaley, Director, Office of
Regulatory Affairs and Collaborative
Action (RACA), Office of the Assistant
Secretary—Indian Affairs; Department
of the Interior, telephone (202) 738–
6065, RACA@bia.gov.
SUPPLEMENTARY INFORMATION: This final
rule is published in exercise of authority
delegated by the Secretary of the Interior
to the Assistant Secretary—Indian
Affairs (Assistant Secretary; AS–IA) by
209 Departmental Manual (DM) 8.
SUMMARY:
lotter on DSK11XQN23PROD with RULES1
Table of Contents
I. Executive Summary
II. Background
A. Providing Mechanisms for Appealing
Decisions by Indian Affairs Officials
That Did Not Exist in 1989
B. Presenting the Regulations in Plain
English
C. Authorizing, Where Possible, the Filing
of Appeal Documents in Portable
Document Format (pdf) via Email
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Jkt 259001
D. Clarifying the Process by Which the
Assistant Secretary—Indian Affairs
Takes Jurisdiction of an Appeal to the
Interior Board of Indian Appeals (IBIA);
and the Process Employed Whenever the
Assistant Secretary—Indian Affairs
Exercises Appellate Authority
E. Making Certain Changes to the Process
for Appealing Inaction of an Official
F. To Establish a New Subpart To Expedite
the Effectiveness of a BIA Decision
Regarding Recognition of a Tribal
Representative
G. Establishing a New Subpart Providing
Holders of Trust Accounts a Mechanism
for Disputing the Accuracy of Statements
of Performance Issued by the Bureau of
Trust Funds Administration (BTFA)
H. Establishing a New Subpart Setting Out
the Process for Resolving Challenges to
Administrative Actions by Alternative
Dispute Resolution Instead of by Formal
Appeals
III. Comments on the Proposed Rule and
Responses to Comments
A. Summary of Subpart H
B. Written Comment
IV. Summary of the Final Rule and Changes
From Proposed Rule to Final Rule
A. Subpart A—Purpose, Definitions, and
Scope of This Part
B. Subpart B—Appealing Administrative
Decisions
C. Subpart C—Effectiveness and Finality of
Decisions
D. Subpart D—Appeal Bonds
E. Subpart E—Deciding Appeals
F. Subpart F—Appealing Inaction of an
Agency Official
G. Subpart G—Special Rules Regarding
Recognition of Tribal Representative
H. Subpart H—Appeals of Bureau of Trust
Funds Administration Statements of
Performance
I. Subpart I—Alternative Dispute
Resolution
V. Procedural Requirements
1. Regulatory Planning and Review (E.O.
12866)
2. Regulatory Flexibility Act
3. Congressional Review Act (CRA)
4. Unfunded Mandates Reform Act of 1995
5. Takings (E.O. 12630)
6. Federalism (E.O. 13132)
7. Civil Justice Reform (E.O. 12988)
8. Consultation With Indian Tribes (E.O.
13175)
9. Paperwork Reduction Act
10. National Environmental Policy Act
(NEPA)
11. Effects on the Energy Supply (E.O.
13211)
I. Executive Summary
This final rule revises the Department
of the Interior’s (Department)
regulations governing administrative
appeals of decisions by officials
subordinate to the Assistant SecretaryIndian Affairs (AS–IA). These
regulations, at 25 CFR part 2, have not
been updated since 1989. These
revisions, set out in plain English, will
facilitate the Secretary’s fulfillment of
fiduciary responsibilities to Tribes and
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individual Indians. This rule updates
the regulations to align the terminology
and processes with organizational
changes since 1989. Additionally, the
rule allows, where possible, the filing of
appeal documents in Portable Document
Format via email. The rule clarifies the
process by which the AS–IA takes
jurisdiction of an appeal to the Interior
Board of Indian Appeals and for
appealing inaction of an official. A new
subpart allows for expediting the
effectiveness of a Bureau of Indian
Affairs (BIA) decision regarding
recognition of a tribal representative.
Another addition is the establishment of
provisions allowing holders of trust
accounts a mechanism for disputing the
accuracy of statements of performance
issued by the Bureau of Trust Funds
Administration. Finally, there are
provisions to resolve disputes through
alternative dispute resolution. All of the
revisions clarify and standardize
Departmental policy.
II. Background
The regulations governing
administrative appeals of actions by
Indian Affairs officials are in title 25,
chapter I of the Code of Federal
Regulations (25 CFR part 2). The last
major revision of the part 2 regulations
was in 1989. See 54 FR 6478 (Feb. 10,
1989). The background of this
rulemaking and Section-by-Section
analysis are in the preamble to the
proposed rule published on December 1,
2022 (87 FR 73688). During the 90-day
comment period, the Department held
two consultation sessions directly with
Indian Tribes: February 17, 2022, via
webinar; and February 22, 2022, via
webinar. The public comment period on
the proposed rule ended on March 1,
2023.
The Department revised the appeals
regulations in a number of ways, as
explained below:
• Providing Mechanisms for Appealing
Decisions by Indian Affairs Officials
That Did Not Exist in 1989
A number of significant changes have
been made to the organization of Indian
Affairs since publication of the prior
part 2 regulations in 1989. In 2003, the
office of the Director of the Bureau of
Indian Affairs was created and charged
with some of the responsibilities
previously carried out by the
Commissioner of Indian Affairs and the
Deputy Commissioner of Indian Affairs.
130 DM 3 (Apr. 21, 2003). The Bureau
of Indian Education, formerly an agency
within the Bureau of Indian Affairs
(BIA), was established as a separate
Bureau. More recently, the Secretary
created the Bureau of Trust Funds
E:\FR\FM\09AUR1.SGM
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Agencies
[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Rules and Regulations]
[Pages 53764-53774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16725]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 161, 164, 184, and 186
[Docket No. FDA-2019-N-4750]
RIN 0910-AI15
Revocation of Uses of Partially Hydrogenated Oils in Foods
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending our
regulations that provide for the use of partially hydrogenated oils
(PHOs) in food in light of our determination that PHOs are no longer
generally recognized as safe (GRAS). The rule removes PHOs as an
optional ingredient in the standards of identity for peanut butter and
canned tuna. It revises FDA's regulations affirming food substances as
GRAS pertaining to menhaden oil and rapeseed oil to no longer include
partially hydrogenated forms of these oils, and deletes the regulation
affirming hydrogenated fish oil as GRAS as an indirect food substance.
We are also revoking prior sanctions (i.e., pre-1958 authorization of
certain uses) for the use of PHOs in margarine, shortening, and bread,
rolls, and buns based on our conclusion that these uses of PHOs may be
injurious to health. We are issuing these amendments directly as a
final rule because they are noncontroversial given the public health
risks associated with PHOs and the increasing use of PHO alternatives,
and we anticipate no significant adverse comments because PHOs were
declared no longer GRAS for any use in human food in 2015.
DATES: This rule is effective December 22, 2023. Either electronic or
written comments on the direct final rule or its companion proposed
rule must be submitted by October 23, 2023. If FDA receives no
significant adverse
[[Page 53765]]
comments within the specified comment period, we intend to publish a
document confirming the effective date of the final rule in the Federal
Register within 30 days after the comment period on this direct final
rule ends. If timely significant adverse comments are received, FDA
will publish a document in the Federal Register withdrawing this direct
final rule within 30 days after the comment period on this direct final
rule ends.
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 October 23, 2023. 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-2019-N-4750 for ``Revocation of Uses of Partially Hydrogenated Oils
in Foods.'' 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
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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.
FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety
and Applied Nutrition, Office of Food Additive Safety (HFS-255), Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1309; or Carrol Bascus, 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:
I. Executive Summary
A. Purpose of the Direct Final Rule
B. Summary of the Major Provisions of the Direct Final Rule
C. Legal Authority
D. Costs and Benefits
II. Direct Final Rulemaking
III. Table of Abbreviations/Acronyms Used in This Document
IV. Background
V. Legal Authority
VI. Description of the Direct Final Rule
A. Amendment of Standard of Identity Regulations
B. Amendment/Revocation of GRAS Affirmation Regulations
C. Comments on Prior-Sanctioned Uses of PHOs
VII. Revocation of Prior-Sanctioned Uses of PHOs
VIII. Trans Fat Consumption Health Effects
A. Updated Scientific Literature and Expert Opinion Review
B. Estimated Exposure to Trans Fat From Prior-Sanctioned Uses of
PHOs
C. Risk Estimates Associated With Prior-Sanctioned Uses of PHOs
IX. Economic Analysis of Impacts
X. Analysis of Environmental Impact
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 Direct Final Rule
The purpose of this direct final rule is to amend our regulations
and revoke prior-sanctioned uses of PHOs to conform with the current
state of scientific knowledge regarding the public health risks of
PHOs. In June 2015, FDA published a declaratory order (Order) setting
forth our final determination, based on the available scientific
evidence and the findings of expert scientific panels, that there is no
longer a consensus among qualified experts that PHOs, which are the
primary dietary source of industrially produced trans fatty acids, are
GRAS for any use in human food. The Order stated that we determined
that this body of evidence established the health risks associated with
the consumption of trans fat. In the Order, we recognized that there
were some uses of PHOs in foods that are expressly authorized by GRAS
affirmation regulations, acknowledged that there could be some uses
recognized by ``prior sanction'' (and thus could not be regulated as a
[[Page 53766]]
food additive), and stated that we would address such uses separate
from the final determination. We also stated that we would consider
taking further action, including revising certain standards of identity
that list PHOs as optional ingredients.
As explained in the Order, there is a lack of convincing evidence
that PHOs are GRAS. FDA has not approved a food additive petition for
PHOs. Accordingly, we are removing PHOs from our food regulations in
light of our determination that PHOs are no longer GRAS.
Furthermore, based on our current review of scientific data and
information, as well as previous safety reviews performed to support
various FDA actions regarding trans fat, we are prohibiting all prior-
sanctioned uses of PHOs. A prior sanction exempts a specific use of a
substance in food from the definition of food additive and from all
related food additive provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) if the use was sanctioned or approved prior to
September 6, 1958. In accordance with FDA's general regulations
regarding prior sanctions, we may revoke a prior-sanctioned use of a
food ingredient where scientific data or information demonstrate that
prior-sanctioned use of the food ingredient may be injurious to health.
We have determined that the prior-sanctioned uses of PHOs may render
food injurious to health. Consequently, we are revoking the prior-
sanctioned uses of PHOs.
B. Summary of the Major Provisions of the Direct Final Rule
The rule removes PHOs as an optional ingredient in the standards of
identity for peanut butter and canned tuna, revises the regulations
affirming the use of menhaden oil and rapeseed oil as GRAS to delete
language regarding partially hydrogenated forms of these oils, and
revokes the regulation affirming hydrogenated fish oil as GRAS as an
indirect food substance. We are revoking prior sanctions (i.e., pre-
1958 authorization of certain uses) for the use of PHOs in margarine,
shortening, and bread, rolls, and buns.
C. Legal Authority
This rule is consistent with our authority in sections 201, 401,
402, 409, and 701 of the FD&C Act (21 U.S.C. 321, 341, 342, 348, and
371). We discuss our legal authority in greater detail in section V of
this document.
D. Costs and Benefits
We estimated the costs of removing PHO-containing foods from the
market, which accrue from product reformulation, relabeling products,
changing food recipes, finding substitute ingredients and changes in
functional and sensory product properties, such as taste, texture, and
shelf life. The benefits of the rule accrue from reduction of coronary
heart diseases. Discounted at 7 percent over a 20-year period, the
annualized primary cost estimate of the rule is $24.5 million with a
lower bound estimate of $20.8 million and an upper bound estimate of
$29.7 million. The annualized benefits of this rule discounted at 7
percent over a 20-year period is $61.5 million for the primary estimate
with a lower bound of $20.1 million and an upper bound of $120.7
million.
II. Direct Final Rulemaking
In the document titled ``Guidance for FDA and Industry: Direct
Final Rule Procedures,'' announced and provided in the Federal Register
of November 21, 1997 (62 FR 62466), FDA described its procedures on
when and how we will employ direct final rulemaking. The guidance may
be accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm. We have determined that this rule is appropriate for
direct final rulemaking because it includes only noncontroversial
amendments, and we anticipate no significant adverse comments.
Consistent with our procedures on direct final rulemaking, we are also
publishing elsewhere in this issue of the Federal Register a companion
proposed rule proposing to amend our regulations and revoke prior-
sanctioned uses of PHOs to conform with the current state of scientific
knowledge regarding the public health risks of PHOs. The companion
proposed rule provides a procedural framework within which the rule may
be finalized if the direct final rule is withdrawn because of any
significant adverse comments. The comment period for the direct final
rule runs concurrently with the companion proposed rule. Any comments
received in response to the companion proposed rule will be considered
as comments regarding the direct final rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comments, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register. A significant adverse comment is defined as a
comment that explains why the rule would be inappropriate, including
challenges to the rule's underlying premise or approach, or would be
ineffective or unacceptable without a change. In determining whether an
adverse comment is significant and warrants terminating a direct final
rulemaking, we will consider whether the comment raises an issue
serious enough to warrant a substantive response in a notice-and-
comment process.
Comments that are frivolous, insubstantial, or outside the scope of
the rule will not be considered significant or adverse under this
procedure. A comment recommending a regulation change in addition to
those in the direct final rule would not be considered a significant
adverse comment unless the comment states why the rule would be
ineffective without the additional change. In addition, if a
significant adverse comment applies to a part of this rule and that
part can be severed from the remainder of the rule, we may adopt as
final those provisions of the rule that are not the subject of the
significant adverse comment.
If any significant adverse comments are received during the comment
period, FDA will publish, before the effective date of this direct
final rule, a notice of significant adverse comment and withdraw the
direct final rule. If we withdraw the direct final rule, any comments
received will be applied to the proposed rule and will be considered in
developing a final rule using the usual notice-and-comment procedure.
If FDA receives no significant adverse comments during the
specified comment period, we intend to publish a document confirming
the effective date within 30 days after the comment period ends.
III. Table of Abbreviations/Acronyms Used in This Document
------------------------------------------------------------------------
Abbreviation/acronym What it means
------------------------------------------------------------------------
CFR................................. Code of Federal Regulations.
CHD................................. Coronary heart disease.
CVD................................. Cardiovascular disease.
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act.
FDA................................. Food and Drug Administration.
FR.................................. Federal Register.
GRAS................................ Generally Recognized as Safe.
IP-TFA.............................. Industrially Produced Trans Fatty
Acid.
LEAR oil............................ Low Erucic Acid Rapeseed Oil.
%en................................. Percentage of Total Energy Intake
per Day.
PHOs................................ Partially Hydrogenated Oils.
U.S.C............................... United States Code.
USDA................................ United States Department of
Agriculture.
------------------------------------------------------------------------
[[Page 53767]]
IV. Background
In the Federal Register of November 8, 2013 (78 FR 67169), we
announced our tentative determination that, based on currently
available scientific information, PHOs are no longer GRAS under any
condition of use in human food and, therefore, are food additives.
Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a food
additive, in part, as a substance that is not GRAS, and section
402(a)(2)(C) of the FD&C Act (21 U.S.C. 342(a)(2)(C)) establishes that
food bearing or containing a food additive that is unsafe within the
meaning of section 409 of the FD&C Act (21 U.S.C. 348) is adulterated.
Section 409 of the FD&C Act establishes that a food additive is unsafe
for the purposes of section 402(a)(2)(C) of the FD&C Act unless certain
criteria are met, such as conformance with a regulation prescribing the
conditions under which the additive may be safely used. In the Federal
Register of June 17, 2015 (80 FR 34650), we published a declaratory
order (the Order) announcing our final determination that there is no
longer a consensus among qualified experts that PHOs, the primary
dietary source of industrially produced trans fatty acids (IP-TFA), are
GRAS for any use in human food. For a discussion of the science
regarding the harms associated with PHOs, we refer readers to the prior
administrative proceeding (see 78 FR 67169 at 67171).
The Order acknowledged (see 80 FR 34650 at 34651) that the
regulations at 21 CFR part 184, ``Direct Food Substances Affirmed as
Generally Recognized as Safe,'' (GRAS affirmation regulations) include
partially hydrogenated versions of two oils: (1) menhaden oil (Sec.
184.1472(b) (21 CFR 184.1472(b))) and (2) low erucic acid rapeseed
(LEAR) oil (Sec. 184.1555(c)(2) (21 CFR 184.1555(c)(2))). Partially
hydrogenated menhaden oil was affirmed as GRAS for use in food (54 FR
38219, September 15, 1989) on the basis that the oil is chemically and
biologically comparable to commonly used partially hydrogenated
vegetable oils such as corn and soybean oils. Partially hydrogenated
LEAR oil was affirmed as GRAS for use in food (50 FR 3745, January 28,
1985) based on published safety studies (i.e., scientific procedures)
(21 CFR 170.30). In the Order, we stated that we would amend the GRAS
affirmation regulations for menhaden oil and LEAR oil (Sec. Sec.
184.1472 and 184.1555) in a future rulemaking (see 80 FR 34650 at
34651, 34655, and 34667).
In addition, our GRAS affirmation regulation for hydrogenated fish
oil at Sec. 186.1551 (21 CFR 186.1551) (44 FR 28323, May 15, 1979),
provides for partial hydrogenation of oils expressed from fish,
primarily menhaden, and secondarily herring or tuna, used as a
constituent of cotton and cotton fabrics used for dry food packaging.
Certain standard of identity regulations include PHOs as an
optional ingredient. Since 1990, the standard of identity for canned
tuna at Sec. 161.190 (21 CFR 161.190) has provided for the use of PHOs
as an optional seasoning or flavoring ingredient in canned tuna in
water (55 FR 45795, October 31, 1990). Since 1968, the standard of
identity for peanut butter at Sec. 164.150 (21 CFR 164.150) has
provided for the use of PHOs as an optional stabilizing ingredient (33
FR 10506, July 24, 1968).
In addition, based on a review of our regulations and on comments
submitted in response to our tentative determination, ``prior
sanctions'' exist for the use of PHOs in margarine, shortening, and
bread, rolls, and buns. As discussed in more detail in section VI of
this document, a prior sanction exempts a specific use of a substance
in food if the use was sanctioned or approved prior to September 6,
1958, from the definition of a food additive under section 201(s)(4) of
the FD&C Act and from all related food additive provisions of the FD&C
Act.
V. Legal Authority
We are issuing this rule under the legal authority of sections 201,
401, 402, 409, and 701 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 its becoming a component of food, if such substance is
not generally recognized by experts as safe under the conditions of its
intended use (section 201(s) of the FD&C Act). The definition of ``food
additive'' exempts any uses that are the subject of a prior sanction
(section 201(s)(4) of the FD&C Act). Food additives are deemed unsafe
except to the extent that FDA approves their use (section 409(a) of the
FD&C Act). Food is adulterated when it contains an unapproved food
additive (section 402(a)(2)(C) of the FD&C Act). In addition, we may
establish standards of identity for foods to promote honesty and fair
dealing in the interest of consumers (section 401 of the FD&C Act).
Section 701(a) of the FD&C Act provides the authority to issue
regulations for the efficient enforcement of the FD&C Act.
With respect to prior sanctions, section 201(s)(4) of the FD&C Act
exempts from the definition of a food additive any substance used in
accordance with a sanction or approval granted under the FD&C Act, the
Meat Inspection Act, or the Poultry Products Inspection Act before the
enactment of the Food Additives Amendment of 1958 on September 6, 1958.
This type of sanction or approval is referred to as a ``prior
sanction.'' Our regulation, at 21 CFR 170.3(l), defines this term as an
explicit approval granted with respect to use of a substance in food
before September 6, 1958, under the FD&C Act, the Meat Inspection Act,
or the Poultry Products Inspection Act. Another FDA regulation (21 CFR
181.5(a)) states that a prior sanction exists only for a specific
use(s) of a substance in food, i.e., the level(s), condition(s),
product(s), etc., for which there was explicit approval by FDA or the
U.S. Department of Agriculture (USDA) before September 6, 1958. The
``explicit approval'' needed to establish a prior sanction may be
either formal or informal. If a formal approval, such as a food
standard regulation issued under the FD&C Act before 1958, does not
exist, correspondence issued by authorized FDA officials can constitute
an informal prior sanction.
In accordance with FDA's general regulations regarding prior
sanctions found at 21 CFR 181.1(b) and 181.5(c), we may revoke a prior-
sanctioned use of a food ingredient where scientific data or
information demonstrate that prior-sanctioned use of the food
ingredient may be injurious to health and, thus, adulterates the food
under section 402 of the FD&C Act.
VI. Description of the Direct Final Rule
This rule:
Amends the food standard for canned tuna at Sec. 161.190
to no longer include partially hydrogenated vegetable oil as an
optional ingredient for seasoning in canned tuna packed in water;
Amends the food standard for peanut butter at Sec.
164.150 to no longer include partially hydrogenated vegetable oil as an
optional stabilizing ingredient in peanut butter;
Revises Sec. 184.1472 to delete references to partially
hydrogenated menhaden oil;
Revises Sec. 184.1555 to delete references to partially
hydrogenated LEAR oil;
Revokes Sec. 186.1551, which permits the use of partially
hydrogenated fish oil in cotton and cotton fabrics used for dry food
packaging; and
Revokes the prior sanctions for the use of PHOs in
margarine, shortening, and bread, rolls, and buns.
[[Page 53768]]
A. Amendment of Standard of Identity Regulations
Standard of identity regulations for food are issued under section
401 of the FD&C Act and do not provide either an authorization or an
exemption from regulation as a food additive under section 409 of the
FD&C Act. FDA's standards of identity, among other things, establish
the common or usual name for a food and define the basic nature of the
food, generally in terms of the types of ingredients that it must
contain (i.e., mandatory ingredients) and that it may contain (i.e.,
optional ingredients). The purpose of food standards is to promote
honesty and fair dealing in the interest of consumers. Therefore, the
inclusion of PHOs in certain standards of identity does not necessarily
mean that their use is permissible under section 409 of the FD&C Act.
As such, our changes to these standard of identity regulations are
merely for clarification purposes.
1. Canned Tuna--Sec. 161.190
Since 1990, our regulations, at Sec. 161.190(a) have described
canned tuna as processed flesh of fish of the species enumerated in
Sec. 161.190(a)(2), commonly known as tuna, in any of the forms of
pack specified in Sec. 161.190(a)(3) (55 FR 45795). The standard of
identity for canned tuna includes, as an optional ingredient, edible
vegetable oil or partially hydrogenated vegetable oil, excluding olive
oil, to be used alone or in combination, as seasoning in canned tuna
packed in water (Sec. 161.190(a)(6)(viii)).
The rule deletes the words ``or partially hydrogenated vegetable
oil'' and ``alone or in combination'' from the list of optional
ingredients in canned tuna (Sec. 161.190(a)(6)(viii)). The remaining
term ``edible vegetable oil'' does not include the use of any partially
hydrogenated oils in canned tuna. (See Ref. 1.)
2. Peanut Butter--Sec. 164.150
Since 1968, our regulations at Sec. 164.150 have described
standardized peanut butter as a product prepared by grinding one of the
shelled and roasted peanut ingredients provided for by Sec.
164.150(b), to which may be added safe and suitable seasoning and
stabilizing ingredients provided for by Sec. 164.150(c), if such
seasoning and stabilizing ingredients do not, in the aggregate, exceed
10 percent of the weight of the finished food (33 FR 10506).
The standard of identity for peanut butter, at Sec. 164.150(c),
includes oil products as optional stabilizing ingredients, which must
be hydrogenated vegetable oils; for purposes of Sec. 164.150(c),
hydrogenated vegetable oil is considered to include partially
hydrogenated vegetable oil.
The rule revises the standard of identity for peanut butter by
deleting the reference to partially hydrogenated vegetable oil in Sec.
164.150(c). The rule also makes a minor editorial change by replacing
``shall'' with ``must.''
B. Amendment/Revocation of GRAS Affirmation Regulations
1. Menhaden Oil--Sec. 184.1472
Since 1997, our GRAS affirmation regulations for menhaden oil at
Sec. 184.1472(a) have described menhaden oil as being prepared from
fish of the genus Brevoortia, commonly known as menhaden, by cooking
and pressing (62 FR 30756, June 5, 1997). The resulting crude oil is
then refined using the following steps: storage (winterization),
degumming (optional), neutralization, bleaching, and deodorization.
Our regulations, at Sec. 184.1472(b), address the preparation of
partially hydrogenated and hydrogenated menhaden oils (Sec.
184.1472(b)(1)), the specifications for partially hydrogenated and
hydrogenated menhaden oils (Sec. 184.1472(b)(2)), the uses of
partially hydrogenated and hydrogenated menhaden oils (Sec.
184.1472(b)(3)), and the name to be used on the product's label (Sec.
184.1472(b)(4)).
The rule amends the GRAS affirmation regulation for menhaden oil at
Sec. 184.1472 to delete references to partially hydrogenated menhaden
oil from Sec. 184.1472(b), (b)(1), (b)(2), (b)(2)(iv), (b)(3), and
(b)(4). The rule also changes the iodine value specification for
hydrogenated menhaden oil from the current specification of ``not more
than 10,'' to ``not more than 4.'' This is consistent with our
definition of PHOs in the Order. For the purposes of the Order, we
defined PHOs as fats and oils that have been hydrogenated, but not to
complete or near complete saturation, and with an iodine value greater
than 4 (80 FR 34650 at 34651). The rule also makes minor editorial
changes, such as referring to hydrogenated menhaden oil (singular)
rather than to hydrogenated menhaden oils (plural) and substituting
``is'' for ``are'' to reflect that the rule would refer to only
hydrogenated menhaden oil.
2. Low Erucic Acid Rapeseed Oil--Sec. 184.1555
Since 1985, our GRAS affirmation regulations for LEAR oil, at Sec.
184.1555(c) have described LEAR oil, also known as canola oil, as the
fully refined, bleached, and deodorized edible oil obtained from
certain varieties of Brassica napus or B. campestris of the family
Cruciferae (50 FR 3745 at 3755). The plant varieties are those
producing oil-bearing seeds with a low erucic acid content. Chemically,
low erucic acid rapeseed oil is a mixture of triglycerides, composed of
both saturated and unsaturated fatty acids, with an erucic acid content
of no more than 2 percent of the component fatty acids. The regulation
provides for the partial hydrogenation of LEAR oil (Sec.
184.1555(c)(2)) and discusses the oil's purity (Sec. 184.1555(c)(3))
and uses in food (Sec. 184.1555(c)(4)).
The rule deletes Sec. 184.1555(c)(2) entirely, deletes all mention
of partially hydrogenated LEAR oil from Sec. 184.1555(c)(3) and (4),
and redesignates current Sec. 184.1555(c)(3) and (4) as Sec.
184.1555(c)(2) and (3), respectively.
3. Hydrogenated Fish Oil--Sec. 186.1551
Since 1979, our GRAS affirmation regulations for hydrogenated fish
oil at Sec. 186.1551 have described hydrogenated fish oil as a class
of oils produced by the partial hydrogenation of oils expressed from
fish, primarily menhaden and secondarily herring or tuna (44 FR 28323).
The regulation allows the use of this oil as a constituent of cotton
and cotton fabrics used for dry food packaging. It was noted in the
final rule entitled ``Substances Generally Recognized as Safe and
Indirect Food Substances Affirmed as Generally Recognized as Safe;
Hydrogenated Fish Oil'' that no reports of a prior-sanctioned use for
hydrogenated fish oil were submitted in response to the proposed rule,
and therefore, in accordance with that proposal, any right to assert a
prior sanction for a use of hydrogenated fish oil under conditions
different from those set forth in this regulation had been waived (44
FR 28323). Prior sanctions for hydrogenated fish oil that differ from
the use set forth in the GRAS affirmation regulations do not exist or
have been waived (Sec. 186.1551(e)).
The rule deletes the GRAS affirmation regulations for hydrogenated
fish oil at Sec. 186.1551 entirely. Our earlier determination that
there are no prior sanctions for this ingredient different from the use
provided for in Sec. 186.1551 or that any other prior sanctions have
been waived remains in effect.
C. Comments on Prior-Sanctioned Uses of PHOs
We stated in our tentative determination that we were not aware
[[Page 53769]]
that FDA or USDA had granted any explicit approval for any use of PHOs
in food before the 1958 Food Additives Amendment to the FD&C Act (78 FR
67169 at 67171) and requested comments on whether there was knowledge
of an applicable prior sanction for the use of PHOs in food (78 FR
67169 at 67174). We discuss the comments in this section. In addition,
we conclude that any prior sanctions for other uses of PHOs in food
different from the uses discussed in sections VI.C.1, 2, and 3 of this
document do not exist or have been waived.
1. GRAS Affirmation Regulations for Menhaden Oil, LEAR Oil, and
Hydrogenated Fish Oil
As noted in the Order we acknowledged that we had, in our
regulations, previously affirmed as GRAS the use of PHOs in certain
foods or food contact substances (80 FR 34650 at 34651). We describe
these regulations and our revocation elsewhere in this rule. Although
some comments on our tentative determination suggested that these uses
are prior-sanctioned, in each case the regulation affirming the status
of the use as GRAS post-dates 1958. We have no evidence that the uses
affirmed for menhaden oil (Sec. 184.1472) or LEAR oil (Sec. 184.1555)
are prior-sanctioned. In the case of hydrogenated fish oil (Sec.
186.1551), any prior sanctions for this ingredient different from the
use in the GRAS affirmation regulation do not exist or have been waived
(Sec. 186.1551(e)).
2. Canned Tuna and Peanut Butter Standards of Identity
Some comments identified the standards of identity for canned tuna
(Sec. 161.190) and peanut butter (Sec. 164.150) as providing proof of
prior sanction of PHOs because ``partially hydrogenated vegetable oil''
is explicitly listed as an optional ingredient in each of those
regulations. As discussed in section VI.A of this document, the
standards of identity for canned tuna and peanut butter both post-date
1958. We have no evidence of any prior sanctions for the use of PHOs as
described in the standards of identity for canned tuna and peanut
butter.
3. Mayonnaise, French Dressing, and Salad Dressing Standards of
Identity
Some comments identified the pre-September 6, 1958, standards of
identity for mayonnaise (21 CFR 169.140), salad dressing (21 CFR
169.150), and French dressing (21 CFR 169.115 (revoked effective
February 14, 2022 (87 FR 2038))) and claimed that they constituted
prior sanctions for PHOs. The comments acknowledged that these
standards did not explicitly list PHOs but argued that because the
standards allow use of ``edible vegetable oil'' in the standardized
products, they were understood by both FDA and industry to include PHOs
because vegetable oil can be hydrogenated.
We issued the standards of identity for mayonnaise, French
dressing, and salad dressing in 1950 (15 FR 5227, August 12, 1950).
They permit use of ``edible vegetable oil'' in the standardized
products. No comments to our tentative determination identified any
reference to hydrogenation of oils in the rulemaking issuing these
standards. No comments suggested that industry used PHOs in these
products at the time or that industry is currently using PHOs in these
products. We understand that, since at least 1940, hydrogenation
changes the physical properties of an oil and therefore, changes a
product's identity (see Ref. 1, discussing labeling for, among other
things, ``vegetable oils which have not had their identity changed
through hydrogenation. . .''). Thus, the references to ``edible
vegetable oil'' in these standards, without mention of hydrogenation or
hardening, do not include PHOs or fully hydrogenated oils. Therefore,
the evidence does not provide an adequate basis on which to establish a
prior sanction.
4. Margarine, and Bread, Rolls, and Buns Standards of Identity, and
Shortening
Some comments identified the pre-September 6, 1958, standards of
identity for bread, rolls, and buns (Sec. 136.110 (21 CFR 136.110)),
and margarine (Sec. 166.110 (21 CFR 166.110)), and claimed that they
constituted prior sanctions for PHOs. The comments acknowledged that
these standards did not explicitly list PHOs but argued that because
the standards allow use of ``shortening'' (bread, rolls, and buns), and
``oil'' (margarine) in the standardized products, they were understood
by both FDA and industry to include PHOs because shortening and oil can
be hydrogenated. Moreover, the comments acknowledged that, while there
is no standard of identity for shortening that mentions PHOs
specifically, historical evidence shows that shortening was generally
understood to contain PHOs before 1958.
We issued the standard of identity for margarine in 1941 (6 FR
2761, June 7, 1941). At that time, the standard of identity stated that
oleomargarine is prepared with one or more of several optional fat
ingredients, including the rendered fat, or oil, or stearin derived
therefrom (any or all of which may be hydrogenated), of cattle, sheep,
swine, or goats or any vegetable food fat or oil, or oil or stearin
derived therefrom (any or all of which may be hydrogenated) (6 FR 2761
at 2762). The standard of identity, as it existed in 1941, contained no
specific limitations on these ingredients. The current standard of
identity (now codified at Sec. 166.110) states, in relevant part, that
margarine may include edible fats and/or oils from animals, vegetables,
or fish, or mixtures of these, which may have been subjected to an
accepted process of physico-chemical modification (Sec.
166.110(a)(1)). The standard of identity for margarine also states that
margarine ``may contain small amounts of other lipids, such as
phosphatides or unsaponifiable constituents, and of free fatty acids
naturally present in the fat or oil'' (id.).
We issued the standard of identity for bread, rolls, and buns in
1952 (17 FR 4453, May 15, 1952). The standard of identity, which is now
codified at Sec. 136.110, identifies ``shortening'' as an optional
ingredient. We initially proposed a more detailed description of the
term ``shortening'' in 1941 that was very similar to the term used in
the margarine standard issued that same year; that description
indicated that shortening is composed of fat or oil from animals,
vegetables, or fish, any or all of which may be hydrogenated, or of
butter, or any combination of two or more such articles (6 FR 2771,
June 7, 1941). However, the final rule that we issued in 1952 simply
referred to ``shortening'' and did not prescribe the contents of or
otherwise define ``shortening'' (17 FR 4453). Similarly, the current
standard of identity mentions ``shortening,'' but does not prescribe
the contents of or otherwise define ``shortening'' (see Sec.
136.110(c)(5)). Additionally, the standard of identity, as it existed
in 1952, contained no specific limitations on these ingredients.
In addition to identifying these standards of identity, some
comments to our tentative determination stated that the reference to
hydrogenation in the pre-September 6, 1958, standard of identity for
margarine was likely to have meant partially hydrogenated oils as a
practical matter, based on the inherent difference in the functional
characteristics of partially and fully hydrogenated oils and the
history of use of PHOs in margarine products.
Other comments submitted historical evidence relating to widespread
use of PHOs in margarine and shortening before 1958. This evidence
included a 1945 USDA publication, ``Foods--Enriched, Restored,
Fortified'' (Ref. 2),
[[Page 53770]]
that described margarine by saying: ``As it is made by 41 manufacturing
plants in the United States, margarine contains a mixture of animal
fats and vegetable oils or one or the other--fats that have been used
as food for centuries. These are partially hydrogenated and blended to
give the right spreading consistency.'' The comments also submitted two
patents, one from 1915 for ``[a] homogeneous lard-like food product
consisting of an incompletely hydrogenized vegetable oil,'' (Ref. 3)
and one from 1957 for ``fluid shortening,'' stating ``[s]hortenings
heretofore available for baking have included . . . compounded or
blended shortenings, made from mixtures of naturally hard fats or
hydrogenated vegetable oils with liquid, soft, or partially
hydrogenated vegetable oils'' (Ref. 4). One comment cited a Supreme
Court decision regarding the patentability of the product of partial
hydrogenation of vegetable oil for use as shortening (Berlin Mills Co.
v. Procter & Gamble Co., 254 U.S. 156 (1920)). In finding the 1915
patent invalid, the Court held that ``it was known before [the
patentee] took up the subject that a vegetable oil could be changed
into a semi-solid, homogeneous, substance by a process of hydrogenation
arrested before completion and that it might be edible'' (Berlin Mills,
254 U.S. at 165).
Some comments said that we intended to include PHOs in the terms
``shortening'' and ``oil . . . (any or all of which may be
hydrogenated)'' used in these pre-1958 standards of identity. One
comment said that we have, in other contexts, used the term
``hydrogenated oils'' when we intended to refer to PHOs (see, e.g., 68
FR 41434 at 41443, July 11, 2003 (``trans fatty acids provided by food
sources of hydrogenated oil'')) and that the term ``partially
hydrogenated'' did not appear in our regulations until 1978 (43 FR
12856, March 28, 1978 (amending the food labeling regulations by
substituting ``hydrogenated'' and ``partially hydrogenated'' for
``saturated'' and ``partially saturated'' when describing a fat or oil
ingredient)). Additionally, in trade correspondence in 1940, we
described three general types of shortening in response to a question
about ingredient labeling; we said that the types of shortening were:
``(1) vegetable shortenings composed wholly of mixtures of edible
vegetable oils, which have been subjected to a chemical hardening
process known as hydrogenation; (2) mixtures of vegetable oils with or
without varying proportions of hardened vegetable oils and with edible
animal fats; and (3) hydrogenated mixtures of vegetable oils and marine
animal oils (Ref. 1).'' In addition, during a rulemaking regarding oils
and fats, we used the phrase ``oil . . . (any or all of which may be
hydrogenated)'' and acknowledged that this category included PHOs (36
FR 11521, June 15, 1971). We proposed that, if the vegetable fats or
oils present are hydrogenated, the ingredient declaration should
include the term ``hydrogenated,'' ``partially hydrogenated,'' or
``hardened,'' and gave an example of ``partially hydrogenated
cottonseed oil'' (36 FR 11521).
Thus, a prior sanction, as provided for in section 201(s)(4) of the
FD&C Act, exists for the uses of PHOs in margarine, shortening, and
bread, rolls, and buns. However, as discussed in the next section, we
are revoking the prior sanction for these uses.
VII. Revocation of Prior-Sanctioned Uses of PHOs
We have concluded that there are prior-sanctioned uses of PHOs in
margarine, shortening, and bread, rolls, and buns, and that these uses
may be injurious to health and may adulterate food under section 402 of
the FD&C Act. Therefore, we are revoking the prior sanction for the
uses of PHOs in margarine, shortening, and bread, rolls, and buns. Our
conclusion is based on our current review of scientific data and
information, as well as previous safety reviews performed in support of
various FDA actions regarding trans fat and PHOs spanning 1999 to 2018
(see 64 FR 62746, November 17, 1999; 68 FR 41434, July 11, 2003; 78 FR
67169, November 8, 2013; 80 FR 34650, June 17, 2015; 83 FR 23382, May
21, 2018). In our review for this rule, we estimated the dietary
exposure for IP-TFA from the prior-sanctioned uses of PHOs in
margarine, shortening, and bread, rolls, and buns (Ref. 5) and
conducted a quantitative risk assessment for the coronary heart disease
(CHD) and cardiovascular disease (CVD) risks associated with this
estimated exposure to IP-TFA (Ref. 6). We also conducted an updated
scientific review of published studies and evaluations by expert panels
on the safety of trans fat (Ref. 7).
As for the standards of identity for margarine and bread, rolls,
and buns, no corresponding revision to these regulations are necessary.
Each standard, as currently written, is limited so that only ``safe and
suitable'' ingredients may be used, and neither current standard
expressly refers to hydrogenation or partial hydrogenation (see
Sec. Sec. 136.110(b) and 166.110(a)). Moreover, our regulations
provide that no provision of any regulation prescribing a definition
and standard of identity is to be construed as affecting the concurrent
applicability of the general provisions of the FD&C Act and our
regulations (see Sec. 130.3(c) (21 CFR 130.3(c))). For example, all
standard of identity regulations contemplate that the food and all
articles used as components or ingredients must not be poisonous or
deleterious (see Sec. 130.3(c); see also Sec. 130.3(d) (further
defining ``safe and suitable'')). As for shortening, our standards of
identity do not describe the contents of or otherwise define
``shortening,'' so no amendment is necessary.
VIII. Trans Fat Consumption Health Effects
A. Updated Scientific Literature and Expert Opinion Review
Our Order referenced three safety memoranda prepared by FDA that
document our review of the available scientific evidence regarding
human health effects of trans fat, focusing on the adverse effects of
trans fat on risk of CHD (Refs. 8 to 10). In addition, we previously
reviewed the health effects of IP-TFA and PHOs in 2013 in support of
our tentative determination regarding the GRAS status of PHOs (78 FR
67169, Docket No. FDA-2013-N-1317). Our Order announced our final
determination that there is no longer a consensus among qualified
experts that PHOs are GRAS for any use in human food (80 FR 34650). The
safety reviews for the Order, together with the previous safety reviews
of IP-TFA and PHOs, provided important scientific background
information for our review and denial of a food additive petition for
certain uses of PHOs in 2018 (83 FR 23382).
We based our Order on the available scientific evidence that
included results from controlled feeding studies on trans fatty acid
consumption in humans, findings from long-term prospective
epidemiological studies, and the opinions of expert panels that there
is no threshold intake level for IP-TFA that would not increase an
individual's risk of CHD. We also published a safety review for
specific uses of PHOs in a notice denying a food additive petition for
certain uses of PHOs in food (83 FR 23382, Docket No. FDA-2015-F-3663).
This safety review reinforced our 2015 scientific review supporting the
final determination that PHOs are not GRAS for use in human food. We
denied the food additive petition because we determined that the
petition did not contain convincing evidence to support the conclusion
that the proposed uses of
[[Page 53771]]
PHOs were safe (83 FR 23382 at 23391). All the previously mentioned
safety reviews of IP-TFA and PHOs provide important scientific
background information for review of the health effects of the prior-
sanctioned uses of PHOs.
We are not aware of any new, scientific literature on the safety of
IP-TFA and PHOs that would cause us to reconsider our previous safety
conclusions. International and U.S. expert panels, using additional
scientific evidence available since 2015, have continued to recognize
the positive linear relationship between increased trans fat intake and
increased low density lipoprotein cholesterol blood levels associated
with increased CHD risk, have concluded that trans fats are not
essential nutrients in the diet, and have recommended that trans fat
consumption be kept as low as possible.
B. Estimated Exposure to Trans Fat From Prior-Sanctioned Uses of PHOs
For this direct final rule, in order to estimate the risks to CHD
and CVD associated with consumption of IP-TFA from prior-sanctioned
uses of PHOs, we first had to estimate dietary exposure to IP-TFA from
these uses of PHOs. We used two non-consecutive days of 24-hour dietary
recall data from the 2011-2014 National Health and Nutrition
Examination Survey (NHANES) to estimate dietary exposure to IP-TFA from
the use of PHOs in margarine and shortening (which includes the prior-
sanctioned uses in bread, rolls, and buns due to the use of margarine
and/or shortening in the food). We included all foods reported in
NHANES that contained margarine or shortening as an ingredient in our
analysis. We applied levels of trans fat commonly used in margarine and
shortening manufactured before the publication of the tentative
determination in 2013. These use levels reflect our conservative
assumption that manufacturers may revert back to using PHOs at these
higher use levels in margarine and shortening if prior sanctions are
not revoked by this direct final rule. For the U.S. population aged 2
years and older, we estimated a cumulative mean dietary IP-TFA exposure
of 0.3 grams per person per day for typical trans fat levels, for both
margarine and shortening, based on 53 percent of the population
consuming margarine or shortening (Ref. 5). The mean IP-TFA exposure
for the total population (i.e., per capita intake) was also determined
(Ref. 7). Expressed as a percentage of total energy intake per day
(%en) based on a 2000 calorie diet, the mean per-capita IP-TFA exposure
for typical IP-TFA levels in foods was estimated to be 0.07%en (Ref.
7).
C. Risk Estimates Associated With Prior-Sanctioned Uses of PHOs
We used four risk methods to estimate change in CHD and CVD risk
associated with 0.07%en IP-TFA exposure from prior-sanctioned uses of
PHOs (Ref. 6). Our assessment methodology is documented in our
memorandum (Ref. 6).
Our quantitative risk assessments demonstrate that there is a
substantial health risk associated with 0.07%en from IP-TFA from prior-
sanctioned uses of PHOs (Ref. 6). Along with our Order, our denial of
the food additive petition for certain uses of PHOs in food, and our
recent updated scientific literature review on the safety of PHOs and
trans fat (Ref. 7), these analyses provide further support for the
revocation of the prior-sanctioned uses of PHOs. The scientific
consensus is that there is no threshold intake level of IP-TFA that
would not increase an individual's risk of CHD (Ref. 7). Thus, based on
the available data, we conclude that PHOs used in food may cause the
food to be injurious to health and that the use of PHOs as ingredients
in margarine, shortening, and bread, rolls, and buns would adulterate
these foods under section 402(a)(1) of the FD&C Act.
IX. Economic Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review
Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801,
Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
costs, benefits and transfers of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of [the Office of Information and Regulatory
Affairs (OIRA)] for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this final rule is not a
significant regulatory action as defined by Executive Order 12866
Section 3(f)(1).
Because this rule is likely to result in an annual effect on the
economy of $100 million or more or meets other criteria specified in
the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule falls within the scope
of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule may require some small business entities to
undertake costly reformulations, we find that the final rule will 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 an assessment of
anticipated costs and benefits, 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 final rule would
not result in an expenditure in any year that meets or exceeds this
amount.
The benefits of this rule are expected to accrue from the number of
coronary heart diseases averted from discontinued use of foods made
with PHOs. The removal of PHO containing foods from the marketplace
will limit their access by most consumers. Such action will protect the
public by reducing the health risk of developing CHDs and improving
population health among those who would otherwise consume products
containing PHOs. Continual use of PHOs is associated with increased CHD
and CVDs. Per capita higher intake of PHOs can lead to elevated risk of
CHD and CVDs among the U.S. population. Therefore, FDA notes that the
benefit of this rule relative to baseline market conditions are
expected to decrease over time as PHO containing products exit the
marketplace. The annualized benefits of this rule at a 7 percent
discount rate over a 20-year period is $61.5 million for the primary
estimate with a lower bound of $20.1 million and an upper bound of
$120.7 million.
[[Page 53772]]
The quantified costs of the rule are from reformulating
manufactured products currently produced with PHOs, relabeling products
that contain PHOs, changing recipes for some PHO containing breads by
retail bakeries, finding substitute ingredients as well as costs
arising from functional and sensory product properties such as taste
and texture. The annualized cost of the rule at a 7 percent discount
rate over a 20-year period has a primary estimate of $24.5 million with
a lower bound estimate of $20.8 million and an upper bound estimate of
$29.7 million.
Table 1 presents a summary of costs and benefits of this rule.
Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule, in 2020 Million Dollars
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year...... $61.5 $20.1 $120.7 2020 7 20
58.3 19.1 114.3 2020 3 20
Annualized Quantified.................... .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
----------------------------------------------------------------------------------------------------------
Qualitative..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year...... 24.5 20.8 29.7 2020 7 20
20.2 17.1 33.2 2020 3 20
Annualized Quantified.................... .......... .......... .......... .......... 7
.......... .......... .......... .......... 3
----------------------------------------------------------------------------------------------------------
Qualitative..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7
year. .......... .......... .......... .......... 3
----------------------------------------------------------------------------------------------------------
From/To.................................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized......................... .......... .......... .......... .......... 7
Monetized $millions/year................. .......... .......... .......... .......... 3
----------------------------------------------------------------------------------------------------------
From/To.................................. From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: Potential impact on small business entities that are currently continuing to use or produce PHOs and PHO containing ingredients in
their products..
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 11) 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
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
XII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that would have a substantial direct effect on one
or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the federal government and Indian tribes.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.
XIII. Federalism
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13132. We have determined that the 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 are on display with 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 are also
available electronically at https://www.regulations.gov. 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, Trade Correspondence TC-62 (February 15, 1940), reprinted in
[[Page 53773]]
Kleinfeld, Vincent A. and Charles Wesley Dunn, Federal Food, Drug,
and Cosmetic Act Judicial and Administrative Record 1938-1949.
2. U.S. Bureau of Human Nutrition and Home Economics (1945). Foods--
Enriched, Restored, Fortified. USDA at page 11, available at https://naldc.nal.usda.gov/download/5804422/PDF.
3. Serial No. 591,726, Record No. 1,135,351, U.S. Patent Office,
Official Gazette of the U.S. Patent Office, April 13, 1915, at 492;
available at: https://www.uspto.gov/learning-and-resources/official-gazette/official-gazette-patents.
4. Serial No. 639,222, Record No. 2,909,432, U.S. Patent Office,
Official Gazette of the U.S. Patent Office, October 20, 1959, at
697; available at: https://www.uspto.gov/learning-and-resources/official-gazette/official-gazette-patents.
5. FDA, Memorandum from D. Doell to E. Anderson, Exposure to Trans
Fat from the Prior-Sanctioned Uses of Partially Hydrogenated Oils
(PHOs), October 23, 2019.
6. FDA, Memorandum from J. Park to E. Anderson, Toxicology Prior
Sanction PHO Review Memo One: Agency-initiated Quantitative Coronary
Heart and Cardiovascular Disease Risk Assessment of Industrially-
Produced Trans Fatty Acids (IP-TFA) Exposure from Prior-Sanctioned
Uses of Partially Hydrogenated Vegetable Oils (PHOs), October 22,
2019.
7. FDA, Memorandum from J. Park to E. Anderson, Toxicology Prior
Sanction PHO Review Memo Two: Scientific Literature Review of Safety
Information Regarding Prior-Sanctioned Uses of Partially
Hydrogenated Oils (PHOs) in Margarine and Shortenings, October 22,
2019.
8. FDA, Memorandum from J. Park to M. Honigfort, Scientific Update
on Experimental and Observational Studies of Trans Fat Intake and
Coronary Heart Disease Risk, June 11, 2015.
9. FDA, Memorandum from J. Park to M. Honigfort, Literature Review,
June 11, 2015.
10. FDA, Memorandum from J. Park to M. Honigfort, Quantitative
Estimate of Industrial Trans Fat Intake and Coronary Heart Disease
Risk, June 11, 2015.
11. FDA, ``Revocation of Uses of Partially Hydrogenated Oils in
Foods'' Regulatory Impact Analysis, Regulatory Flexibility Analysis,
Unfunded Mandates Reform Analysis. Also available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
List of Subjects
21 CFR Part 161
Food grades and standards, Frozen foods, Seafood.
21 CFR Part 164
Food grades and standards, Nuts, Peanuts.
21 CFR Part 184
Food additives.
21 CFR Part 186
Food additives, Food packaging.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
161, 164, 184, and 186 are amended as follows:
PART 161--FISH AND SHELLFISH
0
1. The authority citation for part 161 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
2. In Sec. 161.190, revise paragraph (a)(6)(viii) to read as follows:
Sec. 161.190 Canned tuna.
(a) * * *
(6) * * *
(viii) Edible vegetable oil, excluding olive oil, used in an amount
not to exceed 5 percent of the volume capacity of the container, with
or without any suitable form of emulsifying and suspending ingredients
that has been affirmed as GRAS or approved as a food additive to aid in
dispersion of the oil, as seasoning in canned tuna packed in water.
* * * * *
PART 164--TREE NUT AND PEANUT PRODUCTS
0
3. The authority citation for part 164 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
4. In Sec. 164.150, revise paragraph (c) to read as follows:
Sec. 164.150 Peanut butter.
* * * * *
(c) The seasoning and stabilizing ingredients referred to in
paragraph (a) of this section are suitable substances which are not
food additives as defined in section 201(s) of the Federal Food, Drug,
and Cosmetic Act, or if they are food additives as so defined, they are
used in conformity with regulations established pursuant to section 409
of the Federal Food, Drug, and Cosmetic Act. Seasoning and stabilizing
ingredients that perform a useful function are regarded as suitable,
except that artificial flavorings, artificial sweeteners, chemical
preservatives, and color additives are not suitable ingredients in
peanut butter. Oil products used as optional stabilizing ingredients
must be hydrogenated vegetable oils.
* * * * *
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
0
5. The authority citation for part 184 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
0
6. In Sec. 184.1472, revise paragraph (b) to read as follows:
Sec. 184.1472 Menhaden oil.
* * * * *
(b) Hydrogenated menhaden oil. (1) Hydrogenated menhaden oil is
prepared by feeding hydrogen gas under pressure to a converter
containing crude menhaden oil and a nickel catalyst. The reaction is
begun at 150 to 160 [deg]C and after 1 hour the temperature is raised
to 180 [deg]C until the menhaden oil is fully hydrogenated.
(2) Hydrogenated menhaden oil meets the following specifications:
(i) Color. Opaque white solid.
(ii) Odor. Odorless.
(iii) Saponification value. Between 180 and 200.
(iv) Iodine number. Not more than 4.
(v) Unsaponifiable matter. Not more than 1.5 percent.
(vi) Free fatty acids. Not more than 0.1 percent.
(vii) Peroxide value. Not more than 5 milliequivalents per kilogram
of oil.
(viii) Nickel. Not more than 0.5 part per million.
(ix) Mercury. Not more than 0.5 part per million.
(x) Arsenic (as As). Not more than 0.1 part per million.
(xi) Lead. Not more than 0.1 part per million.
(3) Hydrogenated menhaden oil is used as edible fat or oil, as
defined in Sec. 170.3(n)(12) of this chapter, in food at levels not to
exceed current good manufacturing practice.
(4) The name to be used on the label of a product containing
hydrogenated menhaden oil must include the term ``hydrogenated,'' in
accordance with Sec. 101.4(b)(14) of this chapter.
0
7. In Sec. 184.1555, revise paragraphs (c)(2) and (3) and remove
(c)(4) to read as follows:
Sec. 184.1555 Rapeseed oil.
* * * * *
(c) * * *
(2) In addition to limiting the content of erucic acid to a level
not exceeding 2 percent of the component fatty acids, low erucic acid
rapeseed oil must be of a purity suitable for its intended use.
(3) Low erucic acid rapeseed oil is used as an edible fat and oil
in food, except in infant formula, at levels not to exceed current good
manufacturing practice.
[[Page 53774]]
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
0
8. The authority citation for part 186 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
Sec. 186.1551 [Removed]
0
9. Remove Sec. 186.1551.
Dated: July 29, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-16725 Filed 8-8-23; 8:45 am]
BILLING CODE 4164-01-P