
[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]


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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.

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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 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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.
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[[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 http://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


