Revocation of Uses of Partially Hydrogenated Oils in Foods; Companion Document to Direct Final Rule
| Court | Food And Drug Administration |
| Citation | 88 FR 53827 |
| Published date | 09 August 2023 |
| Record Number | 2023-16724 |
Federal Register, Volume 88 Issue 152 (Wednesday, August 9, 2023)
[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]
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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;
Companion Document to Direct Final Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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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
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Abbreviation/acronym What it means
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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.
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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.
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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
