Document ID: FDA-2019-N-4750-0001
Agency: fda
Document Type: Proposed Rule
Title: Revocation of Uses of Partially Hydrogenated Oils in Foods; Companion Document to Direct Final Rule
Posted Date: 2023-08-09T04:00Z

[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Proposed Rules]
[Pages 53827-53836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16724]

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

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; 
Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
amend 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). We are 
proposing to remove PHOs as an optional ingredient in the standards of 
identity for peanut butter and canned tuna. We are also proposing to 
revise 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 delete the regulation affirming 
hydrogenated fish oil as GRAS as an indirect food substance. We are 
also proposing to revoke 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.

DATES: Either electronic or written comments on the proposed rule or 
its companion direct final rule must be submitted by October 23, 2023. 
If FDA receives any timely significant adverse comments on the direct 
final rule with which this proposed rule is associated, we will publish 
a document withdrawing the direct final rule within 30 days after the 
comment period ends and we will then proceed to respond to comments 
under this proposed rule using the usual notice and comment procedures.

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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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 http://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:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule

[[Page 53828]]

    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Companion Document to Direct Final Rulemaking
III. Table of Abbreviations/Acronyms Used in This Document
IV. Background
V. Legal Authority
VI. Description of the Proposed 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 Proposed Rule

    The purpose of this action is to propose amendments 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 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 proposing to remove 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 proposing to prohibit 
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 tentatively determined that the prior-sanctioned uses of PHOs 
may render food injurious to health. Consequently, we are proposing to 
revoke the prior-sanctioned uses of PHOs.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule if finalized, would remove PHOs as an optional 
ingredient in the standards of identity for peanut butter and canned 
tuna, revise the regulations affirming the use of menhaden oil and 
rapeseed oil as GRAS to delete language regarding partially 
hydrogenated forms of these oils, and revoke the regulation affirming 
hydrogenated fish oil as GRAS as an indirect food substance. We are 
also proposing to revoke 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

    We are proposing this rule 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 including those of 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 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. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule 
published in the rules section of this issue of the Federal Register. 
This companion proposed rule provides the procedural framework to 
finalize the rule in the event the direct final rule receives any 
significant adverse comment and is withdrawn. The comment period for 
this companion proposed rule runs concurrently with the comment period 
for the direct final rule. Any comments received in response to this 
companion proposed rule will also be considered as comments regarding 
the direct final rule. FDA is publishing the direct final rule because 
we believe the rule contains noncontroversial changes and there is 
little likelihood that there will be significant adverse comments 
opposing the rule.
    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 the direct final 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 to the direct final rule are 
received during the comment period, FDA will publish,

[[Page 53829]]

within 30 days after the comment period ends, a notice of significant 
adverse comment and withdraw the direct final rule. If we withdraw the 
direct final rule, any comments received will be considered comments on 
the proposed rule and will be considered in developing a final rule 
using the usual notice-and-comment procedure.
    If no significant adverse comment is received in response to the 
direct final rule during the comment period, no further action will be 
taken related to this proposed rule. Instead, we will publish a 
document confirming the effective date within 30 days after the comment 
period ends. Additional information about direct final rulemaking 
procedures is set forth in the document entitled ``Guidance for FDA and 
Industry: Direct Final Rule Procedures,'' announced and provided in the 
Federal Register of November 21, 1997 (62 FR 62466). The guidance may 
be accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

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.
USC.................................  United States Code.
USDA................................  United States Department of
                                       Agriculture.
------------------------------------------------------------------------

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 PHOs, we refer readers to the Order and to our tentative 
determination that PHOs are no longer GRAS for any use in food (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 proposed 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

[[Page 53830]]

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 Proposed Rule

    The proposed rule, if finalized, would:
     Amend 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;
     Amend 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;
     Revise Sec.  184.1472 to delete references to partially 
hydrogenated menhaden oil;
     Revise Sec.  184.1555 to delete references to partially 
hydrogenated LEAR oil;
     Revoke Sec.  186.1551, which permits the use of partially 
hydrogenated fish oil in cotton and cotton fabrics used for dry food 
packaging; and
     Revoke the prior sanctions for the use of PHOs in 
margarine, shortening, and bread, rolls, and buns.

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 proposed 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 proposed rule would delete 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'' would 
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 proposed rule would revise the standard of identity for peanut 
butter by deleting the reference to partially hydrogenated vegetable 
oil in Sec.  164.150(c). The proposed rule also would make 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 proposed rule would amend 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 proposed rule also would change 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 proposed 
rule also would make 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

[[Page 53831]]

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 proposed rule would delete Sec.  184.1555(c)(2) entirely, 
delete all mention of partially hydrogenated LEAR oil from Sec.  
184.1555(c)(3) and (4), and redesignate 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 proposed rule would delete 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 
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 tentatively 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 proposed rule 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 proposed revocation elsewhere in this 
proposed 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

[[Page 53832]]

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), 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 proposing to revoke the prior sanction for these uses.

VII. Revocation of Prior-Sanctioned Uses of PHOs

    We have tentatively 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 proposing to revoke the 
prior sanction for the uses of PHOs in margarine, shortening, and 
bread, rolls, and buns. Our tentative 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 proposed 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 would be 
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

[[Page 53833]]

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 references 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 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 proposed 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. 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 tentatively 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 proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 14094, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Orders 12866, 13563, and 14094 direct us to assess all 
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 proposed rule is not a 
significant regulatory action as defined by Executive Order 12866 
Section 3(f)(1).
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule may require some

[[Page 53834]]

small business entities to undertake costly reformulations, we find 
that the proposed 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 proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    The benefits of this proposed 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.
    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 the proposed 
rule.

                        Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed 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
    AnnualizedQuantified.....................  ..........  ..........  ..........  ..........           7  ..........
                                               ..........  ..........  ..........  ..........           3  ..........
    Qualitative..............................  ..........  ..........  ..........  ..........  ..........  ..........
Transfers:
    Federal Annualized Monetized millions/     ..........  ..........  ..........  ..........           7  ..........
     year.
                                               ..........  ..........  ..........  ..........           3  ..........
                                              ----------------------------------------------------------------------------------------------------------
    From/To..................................  From:
                                               To:
                                              ----------------------------------------------------------------------------------------------------------
    Other Annualized Monetized millions/year.  ..........  ..........  ..........  ..........           7  ..........
                                               ..........  ..........  ..........  ..........           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 Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed 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

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set

[[Page 53835]]

forth in Executive Order 13175. We have tentatively 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. 
We invite comments from tribal officials or other interested parties, 
on any potential impact on Indian tribes from this proposed action.

XIII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XIV. References

    The following references 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 (Feb. 15, 1940), reprinted in 
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, 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'' Preliminary Regulatory Impact Analysis, Initial 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, we propose 
to amend 21 CFR parts 161, 164, 184, and 186 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

[[Page 53836]]

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.

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 28, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-16724 Filed 8-8-23; 8:45 am]
BILLING CODE 4164-01-P