Proposed Rule2023-17916
Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is proposing to amend the standard of identity and standard of fill of container for canned tuna. This action partially responds to a citizen petition submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC (doing business as Chicken of the Sea International). We tentatively conclude that this action, if finalized, will promote honesty and fair dealing in the interest of consumers.
Full Text
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<title>Federal Register, Volume 88 Issue 164 (Friday, August 25, 2023)</title>
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[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Proposed Rules]
[Pages 58157-58167]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17916]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 161
[Docket No. FDA-2016-P-0147]
RIN 0910-AI74
Fish and Shellfish; Canned Tuna Standard of Identity and Standard
of Fill of Container
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 the standard of identity and standard of fill of container for
canned tuna. This action partially responds to a citizen petition
submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union
Seafoods, LLC (doing business as Chicken of the Sea International). We
tentatively conclude that this action, if finalized, will promote
honesty and fair dealing in the interest of consumers.
DATES: Either electronic or written comments on the proposed rule must
be submitted by November 24, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 24, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, we will post your comment, as well as any
attachments, except for
[[Page 58158]]
information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-P-0147 for ``Fish and Shellfish; Canned Tuna Standard of
Identity and Standard of Fill of Container.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jennifer Shemansky, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-2371, or Holli
Kubicki, 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 and Coverage of the Proposed Rule
B. Legal Authority
C. Costs and Benefits
II. Background
A. Need for the Regulation--Citizen Petition and Temporary
Marketing Permits
B. FDA's Food Standards Modernization
C. Incorporation by Reference
III. Legal Authority
IV. Description of the Proposed Rule
A. Proposed Amendments to the Standard of Fill of Container
B. Proposed Amendments to the Standard of Identity
C. Proposed Update of Incorporation by Reference
D. Proposed Additional Revisions
V. Proposed Effective and Compliance Dates
VI. Request for Information
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose and Coverage of the Proposed Rule
FDA is proposing to revise the canned tuna standard of identity and
standard of fill of container established at Sec. 161.190 (21 CFR
161.190). The proposed rule, if finalized, will modernize and update
these food standards and is in partial response to a citizen petition
submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri Union
Seafoods, LLC (doing business as (dba) Chicken of the Sea
International) (the petitioners). The proposed rule would:
<bullet> replace the pressed cake weight method with the drained
weight method to determine the standard fill of container (see proposed
Sec. 161.190(a)(3)(ii) and (iii), (a)(7), and (c));
<bullet> revise the introductory text in Sec. 161.190(a)(5)
thereby clarifying that use of a packing medium is optional;
<bullet> remove provisions for specific flavorings and spices
(i.e., monosodium glutamate currently in Sec. 161.190(a)(6)(ii),
spices or spice oils or spice extracts currently in Sec.
161.190(a)(6)(iv), garlic currently in Sec. 161.190(a)(6)(vi), and
lemon flavoring currently in Sec. 161.190(a)(6)(vii)), which are
covered under Sec. 101.22(a) (21 CFR 101.22(a)), to avoid redundancy;
<bullet> revise Sec. 161.190(a)(6)(ii) to allow use of safe and
suitable optional ingredients in accordance with Sec. 101.22, and
remove the discussion of safe and suitable carriers, solubilizing, or
dispersing ingredients that may be used in combination with a flavoring
or spice ingredient currently in Sec. 161.190(a)(6)(vii);
<bullet> revise Sec. 161.190(a)(1) to move the optional ingredient
of sodium acid pyrophosphate to proposed Sec. 161.190(a)(6)(v) and
revise Sec. 161.190(a)(8)(vii) regarding the labeling of canned tuna
products containing sodium acid pyrophosphate to update the cross-
reference from paragraph (a)(1) to paragraph (a)(6)(v);
<bullet> revise the upper and lower limits of vegetable extractives
under Sec. 161.190(a)(6)(iii) pertaining to amount of vegetable broth
allowed to be used as an optional ingredient;
<bullet> amend Sec. 161.190(a)(8)(vi) for clarity and consistency
with other label declaration provisions in the Code of Federal
Regulations (CFR);
<bullet> add a provision at Sec. 161.190(a)(8)(x) for clarity and
consistency with food standards in 21 CFR parts 131 through 169, which
include a similar provision for label declaration information;
<bullet> revise Sec. 161.190(a)(7) to update the method for
determining the Munsell value and remove the incorporation by reference
text regarding the Journal of the Optical Society of America (in
current Sec. 161.190(a)(7)(iii));
<bullet> add paragraph (d) to Sec. 161.190 to update the
incorporation by reference information (currently found in Sec.
161.190(a)(7)); and
<bullet> revise language throughout the section to improve clarity
and readability.
B. Legal Authority
We are issuing this proposed rule under section 401 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341), which grants
FDA the authority to establish a reasonable definition and standard of
identity, a reasonable standard of quality, or reasonable standards of
fill of container if such actions will promote honesty and fair dealing
in the interest of consumers. There are already standards of identity
and fill of container in place for canned tuna (Sec. 161.190(a) and
(c), respectively). We tentatively conclude that revising these food
standards will promote honesty and fair dealing in the interest of
consumers. Allowing for
[[Page 58159]]
more flexibility and for the use of modern methods in the standards
will allow for production of a wider range of products to meet consumer
tastes and preferences.
C. Costs and Benefits
We estimate benefits of the proposed rule, if finalized. We
estimate ongoing annual cost savings ranging from approximately $4
million to $15.9 million at a 3 percent discount rate, and
approximately $3.9 million to $15.8 million at a 7 percent discount
rate. Our primary annualized estimates are approximately $7.9 million
at both the 3 percent and 7 percent discount rates. The primary
estimate of the present value of total cost savings in the 10 years
following any final rule that may be issued based on the proposed rule
is $67.6 million at a 3 percent rate of discount and $55.4 million at a
7 percent rate of discount. Manufacturers and consumers may benefit
from other provisions of the proposed rule, if finalized, but these
impacts are harder to quantify.
The costs of the proposed rule, if finalized, are associated with
costs to industry for reading and understanding the rule, training
employees on new requirements, and the purchase of new equipment. These
are one-time costs that industry incurs immediately after any final
rule that may be issued based on this proposed rule passes its
compliance date. When annualized over a period of 10 years, we estimate
these costs range from approximately $3,800 to $6,000 at a 3 percent
discount rate, and approximately $4,500 to $7,100 at a 7 percent
discount rate. Our primary annualized estimates are approximately
$4,900 at a 3 percent discount rate and $5,800 at a 7 percent discount
rate. The primary estimate of total costs in the 10 years following any
final rule that may be issued based on this proposed rule is $41,600 at
a 3 percent discount rate and $40,600 at a 7 percent discount rate.
II. Background
A. Need for the Regulation--Citizen Petition and Temporary Marketing
Permits
Bumble Bee Foods, LLC, StarKist Co., and Tri Union Seafoods, LLC
(dba Chicken of the Sea) submitted a citizen petition (FDA-2016-P-0147)
requesting that we amend Sec. 161.190 to:
<bullet> base the standard of fill of container on the product's
drained weight rather than the pressed cake weight;
<bullet> require that the net contents declaration include both the
net weight and drained weight;
<bullet> provide that use of a packing medium is optional;
<bullet> permit the use of any flavoring;
<bullet> limit the amount of vegetable broth that may be added as a
flavoring based on the dry weight of the vegetable extractives;
<bullet> provide that a label statement about added salt is
optional; and
<bullet> specify that canned tuna is packed in hermetically sealed
rigid metal cans to clarify that pouch tuna products are not covered by
the standard of identity.
(See Citizen Petition from Steven Mavity, Senior Vice President,
Technical Services & Corporate Quality, Bumble Bee Foods, LLC, Nabil
Salib, Vice President of Operations, StarKist Co., and John DeBeer,
Vice President, Tri-Union Seafoods, LLC (dba Chicken of the Sea
International), to Division of Dockets Management, Food and Drug
Administration, dated September 3, 2015 (``petition'') at page 1.) The
proposed rule would revise the canned tuna standard of fill of
container and standard of identity in partial response to the petition.
In addition to submitting a citizen petition, the petitioners
submitted applications for temporary marketing permits (TMP) to market
test products (designated as ``canned tuna'' products) that deviate
from the requirements in Sec. 161.190. We issued the temporary permits
to each applicant in accordance with 21 CFR 130.17 (see 79 FR 35362,
June 20, 2014). The temporary permits covered limited interstate
marketing tests of products identified as ``canned tuna.'' These test
products deviated from Sec. 161.190 in that they did not meet the
standard of fill of container and were not labeled with the statement
``Below Standard in Fill'' as required in Sec. 161.190(c)(4) and 21
CFR 130.14(b). The TMPs allowed applicants to test market canned tuna
products using a standard fill of container based on the drained weight
rather than the pressed cake weight. The TMPs also allowed applicants
to provide a net quantity of contents declaration that includes both
the net and drained weight. In the Federal Register of March 7, 2016
(81 FR 11813), we announced an extension of the temporary permits. The
extension allowed the applicants to continue to measure consumer
acceptance of the products and assess the commercial feasibility of the
products, in support of the petition to amend Sec. 161.190. The new
expiration date for the permits is either the effective date of a final
rule amending Sec. 161.190 that may result from the petition or 30
days after denial of the petition. All other conditions and terms of
the permits remained the same (see 81 FR 11813). In the March 7, 2016,
notice, we invited other interested parties to participate in the
market test (id.). To date, FDA has approved several firms to
participate in the market test. In the Federal Register of March 5,
2021 (86 FR 12954), we published a notice amending StarKist Co.'s
temporary permit to add three manufacturing locations and to increase
the amount of test product. More recently, in the Federal Register of
December 28, 2021 (86 FR 73789), we published a notice adding a
manufacturing location for both Bumble Bee Foods, LLC and StarKist Co.
and to increase the amount of test product that could be marketed by
StarKist Co. We also published a notice in the Federal Register of
December 21, 2022 (87 FR 78110), allowing StarKist Co. to manufacture
test product at one additional plant.
These active TMPs for canned tuna products allowed applicants to
deviate from Sec. 161.190 so the standard fill of container is based
on the drained weight method rather than the pressed cake weight
method. Based on input from the industry, we understand that use of the
pressed weight method is outdated. Products using the drained weight
method appear to have gained consumer acceptance since becoming
available. Our proposed amendments to Sec. 161.190 will modernize
multiple aspects and requirements of the standards, including allowing
use of the drained weight method.
B. FDA's Food Standards Modernization
Section 401 of the FD&C Act specifically states that standards are
meant to promote honesty and fair dealing in the interest of the
consumer. Food standards typically set forth permitted ingredients,
both mandatory and optional, and sometimes specify the amount or
proportion of each ingredient. Many food standards also designate the
method of production. Since we established many food standards decades
ago, various stakeholders have expressed concerns that many food
standards are out of date and may impede innovation. The goal in
updating or modernizing food standards is to maintain the basic nature
and essential characteristics of standardized foods, while permitting
flexibility for more modern methods, technologies, or new ingredients,
as well as continued innovations (see <a href="https://www.fda.gov/food/food-labeling-nutrition/standards-identity-food">https://www.fda.gov/food/food-labeling-nutrition/standards-identity-food</a>). We seek to modernize food
standards in a manner that will: (1) protect consumers against economic
adulteration; (2) maintain the food's basic nature, essential
characteristics, and nutritional integrity; and (3) promote industry
innovation and provide flexibility to encourage manufacturers to
produce more healthy
[[Page 58160]]
foods (see 84 FR 45497 at 45499, August 29, 2019).
Amending the canned tuna standards may help modernize these food
standards and may provide consumers with a wider variety of choices of
tuna products. Additional choices of tuna products could lead to
increased consumption. The 2020-2025 Dietary Guidelines for Americans
(Ref. 1 at page 34) (see also <a href="https://www.dietaryguidelines.gov">https://www.dietaryguidelines.gov</a>) notes
almost 90 percent of Americans do not meet the recommendation for
seafood intake.
C. Incorporation by Reference
The proposed rule, if finalized, would incorporate by reference
Definitions of Terms and Explanatory Notes from Table 1, Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series), in
Official Methods of AOAC INTERNATIONAL, 22nd Ed. (2023). The Office of
the Federal Register (OFR) has regulations concerning incorporation by
reference (see 1 CFR part 51). These regulations require that, for a
final rule, Agencies must discuss in the preamble to the rule the way
in which materials that the Agency incorporates by reference are
reasonably available to interested persons, and how interested parties
can obtain the materials. Additionally, the preamble to the rule must
summarize the material (see 1 CFR 51.5(b)).
In accordance with the OFR's requirements, the discussion in
section IV.C. of this document summarizes the required provisions of
the material that we propose to incorporate by reference. Interested
persons may purchase a copy of the material from AOAC INTERNATIONAL
(AOAC), 2275 Research Blvd., Suite 300, Rockville, MD 20850-3250, 1-
800-379-2622. You may inspect a copy at Dockets Management Staff (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday
through Friday. AOAC INTERNATIONAL provides access to table 1 at
<a href="https://academic.oup.com/aoac-publications/book/45491/chapter/392327291">https://academic.oup.com/aoac-publications/book/45491/chapter/392327291</a>.
III. Legal Authority
We are issuing this proposed rule under section 401 of the FD&C
Act, which grants FDA the authority to establish a reasonable
definition and standard of identity, a reasonable standard of quality,
or reasonable standards of fill of container if such actions will
promote honesty and fair dealing in the interest of consumers. Canned
tuna is among the foods that FDA has standardized under this authority
(see Sec. 161.190). Standards of identity and fill of container were
established for canned tuna in 1957 (see 22 FR 892, February 13, 1957).
Although the standards have been amended several times, certain
requirements appear to be outdated. We tentatively conclude that
amending these requirements in the standards will promote honesty and
fair dealing in the interest of consumers. Allowing for more
flexibility and for the use of modern methods in the standards will
allow for production of a wider range of products to meet consumer
tastes and preferences.
IV. Description of the Proposed Rule
We are proposing to amend our canned tuna standard of identity and
standard of fill of container (Sec. 161.190). The proposed rule would
allow industry to use the internationally accepted drained weight
method, further clarify the standards, and permit more flexibility. The
proposed rule also would further clarify whether certain ingredients
are optional within the standard of identity.
A. Proposed Amendments to the Standard of Fill of Container
The current standard of fill of container for canned tuna requires
that the pressed cake weight method be used (see Sec. 161.190(c)(1)).
The petition requested, in part, that the pressed cake weight method be
replaced with the drained weight method (petition at pages 1 and 9).
We agree that the pressed cake weight method should be replaced
with the drained weight method. We do not agree with the petitioners'
suggestion to base the drained weight method for canned tuna products
solely on the AOAC Official Method 968.30 Canned Vegetables: Drained
Weight Procedure (petition at page 7). This method is specific for
canned vegetables and requires modification for canned tuna. We propose
to use a drained weight method that is based on both the drained weight
method specified in the Codex standard for canned tuna and bonito
(CODEX STAN 70-1981) (Ref. 2) and the AOAC method 968.30 (Ref. 3).
Although both methods are very similar, the Codex standard helps to
provide necessary details to modify the AOAC method 968.30 for canned
tuna.
The proposed rule would delete the text in Sec. 161.190(c) ``Fill
of container'' and replace it with text on the drained weight method.
The proposed rule would, however, keep the provision currently at Sec.
161.190(c)(4) for canned tuna that falls below the applicable standard
of fill of container, but would redesignate it as Sec. 161.190(c)(3)
to be consistent with other proposed changes to the standard. The
proposed rule also would update certain provisions in the canned tuna
standard of identity to reflect the proposed change from the pressed
cake weight method to the drained weight method. Specifically, the
proposed rule would change the specifications for chunk and flake tuna
in Sec. 161.190(a)(3)(ii) and (iii), respectively, so they will be
based on the ``drained weight of the contents of the container''
instead of the ``pressed contents'' of the container. Additionally, the
proposed rule would amend Sec. 161.190(a)(7) so that portions of the
drained product are combined rather than starting with a pressed cake.
To maintain the structure of the standard, the proposed rule would
redesignate other sections of the current standard and replace the
pressed cake weight method with the drained weight method in the
redesignated paragraphs. Specifically, the proposed rule would
redesignate the determination of free flakes in Sec. 161.190(c)(2)(xi)
as Sec. 161.190(c)(2)(i) and revise the newly designated paragraph
(c)(2)(i). The proposed rule would redesignate determination of
particle size from Sec. 161.190(c)(2)(xii) to Sec. 161.190(c)(2)(ii)
and revise newly designated paragraph (c)(2)(ii). The redesignated
paragraphs in paragraphs (c)(2)(i) and (ii) would be revised to
incorporate the drained weight method. The proposed rule also would
redesignate the paragraph that describes a sieving device used for size
separation in Sec. 161.190(c)(3)(iv) as Sec. 161.190(c)(2)(iii).
We are proposing these changes because the pressed cake weight
method is only required in the U.S. canned tuna standards and does not
align with current industry practice in the United States. For example,
the pressed cake weight method relies upon using a 3-piece can, but the
current industry practice is to use a 2-piece can. In comparison, the
type of packaging is irrelevant when using the drained weight method.
The pressed cake weight method relies on more complex instrumentation
and requires more steps than the drained weight method, resulting in a
more costly procedure with a wider margin of error than the drained
weight method. The pressed cake weight method is therefore more
difficult to perform, more prone to human error, and may produce
inconsistent results compared with the drained weight method. The
drained weight method is used in the production of many other foods,
both
[[Page 58161]]
domestically and internationally. FDA food standards require the
drained weight method in production of canned fruit cocktail, canned
pineapple, canned green beans and canned wax beans, canned tomatoes,
canned mushrooms, and canned oysters (see 21 CFR 145.135, 145.180,
155.120, 155.190, 155.201, and 161.145, respectively). Compared to the
pressed cake weight method, the drained weight method is easier to
perform, and produces more consistent and reliable results. The drained
weight method can be performed using a balance or a food scale and a
sieve or strainer.
The proposed amendments to Sec. 161.190(c) differ from what the
petition requested because we describe the drained weight method for
use with canned tuna products in the standard. The proposed drained
weight method is based on both the Codex standard for canned tuna and
bonito (Ref. 2) and the AOAC drained weight method for canned
vegetables (Ref. 3). Both the proposed drained weight method and the
Codex standard contain more details than the AOAC drained weight method
requested in the petition. The Codex standard gives clear, easy-to-
follow instructions that are specific for canned tuna products. The
proposed drained weight method aims for clarity, readability, and ease
of implementation. As a result, the proposed canned tuna standard of
fill incorporates much of the Codex standard, except the units are
changed to include both the imperial system as well as the metric
system (for example, including temperature ranges in both Fahrenheit
and Celsius, and sieve sizes in inches and centimeters). However, we
propose to maintain some components of the current pressed cake weight
method, such as the temperature range. We are also proposing to
maintain using the average weight from 24 cans but modifying it to use
the average weight from a minimum of 24 containers to allow
manufacturers to adjust their sampling amount for larger production
volumes, if needed.
Additionally, we disagree with the petitioners' request to limit
the standard to rigid metal cans (petition at pages 1, 2, and 10). The
proposed drained weight method may be used for any type of hermetically
sealed container (e.g., can, pouch, jar), in contrast to the pressed
cake method, which required the use of rigid metal cans to meet the
requirements. Accordingly, we have not proposed any conforming changes
to limit the standard of identity to rigid metal containers in Sec.
161.190(a)(1) as the petition requested. In addition, to help make
clear that hermetically sealed containers in which canned tuna is
packed may include containers other than rigid metal cans, we are
proposing to revise Sec. 161.190(a)(3)(i) to consistently refer to
``container'' or ``containers'' rather than ``can'' or ``cans.''
Unlike the pressed cake weight method, the drained weight method is
simple enough that a consumer could check the amount of tuna at home if
they wanted to verify the amount of tuna in the package. The switch
from the pressed cake weight method to the drained weight method may
promote honesty and fair dealing in the interest of the consumer.
B. Proposed Amendments to the Standard of Identity
1. Clarification That a Packing Medium Is Optional
The petition requested that we provide that the use of a packing
medium is optional (petition at pages 1 and 9). Under our current
regulations, the use of packing media is optional (Sec.
161.190(a)(5)); however, to further clarify, the proposed rule would
revise the introductory paragraph of Sec. 161.190(a)(5) to read
``Optional packing media. Canned tuna may be in one or more of the
following optional packing media:''. We propose to add a paragraph
heading to help improve clarity of the section. We also propose a
conforming revision to paragraph (a)(1) to read, in relevant part, ``.
. . may be in one or more of the optional packing media specified in
paragraph (a)(5) of this section, . . .''.
2. Revocation of the Requirement That Canned Tuna Bear a Label
Statement When Salt Is Used as an Optional Ingredient
Under our current regulations, salt is an optional ingredient (see
Sec. 161.190(a)(6)(i)). If salt is used as an ingredient, the label of
canned tuna must bear the statement ``seasoned with salt'' (Sec.
161.190(a)(8)(vi)). Alternatively, the label may bear any of the
statements ``salted,'' ``with added salt,'' or ``salt added'' if salt
is the only seasoning ingredient used. The petition requested that we
make a label statement about added salt optional (petition at pages 1
and 10).
We agree that a label statement about salt should not be mandatory
given that salt must be declared on the label in the ingredient
statement (see section 403(i)(2) of the FD&C Act (21 U.S.C. 343(i)(2))
and Sec. 101.4 (21 CFR 101.4(a))). We also note that salt is not a
characterizing ingredient that differentiates canned tuna varieties
such as those seasoned with flavorings and spices, vegetable broth, or
vegetable oil(s). Consequently, we propose to amend Sec.
161.190(a)(8)(vi) to only apply to the characterizing ingredients in
Sec. 161.190(a)(6)(ii) through (iv) and not to salt.
In addition, the proposed rule would clarify Sec. 161.190(a)(6) so
it is easily understood that salt is an optional ingredient. The
proposed rule would amend the introductory paragraph in Sec.
161.190(a)(6) to include the heading ``Optional Ingredients. One or
more of the following safe and suitable optional ingredients may be
used:''. This proposed change also would make the format in the canned
tuna standard more consistent with other standards, such as the canned
Pacific salmon and canned wet pack shrimp standards (see Sec. Sec.
161.170 and 161.173, respectively).
3. Expand Optional Ingredients To Allow for Safe and Suitable
Flavorings and Spices in Accordance With Sec. 101.22
Our current regulations list seasonings and flavorings with which
canned tuna may be seasoned or flavored (Sec. 161.190(a)(6)). The
petition requested that FDA permit the use of any flavoring (petition
at pages 1 and 9).
We agree that the canned tuna standard is restrictive regarding the
use of flavorings. The proposed rule would amend Sec.
161.190(a)(6)(ii) to permit flavorings and spices in accordance with
Sec. 101.22 as optional ingredients. The proposed rule would make
corresponding revisions to Sec. 161.190(a)(1) by changing ``seasonings
and flavorings'' to ``safe and suitable optional ingredients.'' To
avoid redundancy, the proposed rule would remove monosodium glutamate
(currently listed in Sec. 161.190(a)(6)(ii)), spices or spice oils or
spice extracts (currently listed in Sec. 161.190(a)(6)(iv)), garlic
(currently listed in Sec. 161.190(a)(6)(vi)), and lemon flavoring
(currently listed in Sec. 161.190(a)(6)(vii)) because these
ingredients are covered under Sec. 101.22 (Foods; labeling of spices,
flavorings, colorings and chemical preservatives).
The proposed rule would remove spices or spice oils or spice
extracts from Sec. 161.190(a)(6)(iv) and would group them with
flavorings and spices in Sec. 161.190(a)(6)(ii). Spice oils and spice
extracts would still be permitted as optional ingredients in canned
tuna because they are covered under proposed Sec. 161.190(a)(6)(ii).
Spice oils and spice extracts are covered under natural flavorings as
defined in Sec. 101.22(a)(3).
The proposed rule also would remove hydrolyzed protein (currently
listed in Sec. 161.190(a)(6)(iii)) because hydrolyzed
[[Page 58162]]
protein is a flavor and a flavor enhancer (see Sec. 101.22(h)(7)) and
therefore is covered under proposed Sec. 161.190(a)(6)(ii).
The proposed rule would remove the text regarding sodium acid
pyrophosphate currently in Sec. 161.190(a)(1) and move it to proposed
Sec. 161.190(a)(6)(v). This revision would consolidate the optional
ingredients in the standard and better clarify that sodium acid
pyrophosphate is also an optional ingredient. The proposed rule would
also revise Sec. 161.190(a)(8)(vii) regarding labeling of canned tuna
products that contain sodium acid pyrophosphate to update the cross-
reference for the new location of the sodium acid phosphate optional
ingredient provision from paragraph (a)(1) to paragraph (a)(6)(v). As
for lemon flavoring, as stated earlier, the proposed rule would remove
the lemon flavoring paragraph in Sec. 161.190(a)(6)(vii), and it also
would remove the language specific to lemon flavoring in Sec.
161.190(a)(8)(vi) and (viii) and renumber the remaining paragraphs
accordingly.
To further effectuate the changes proposed in Sec.
161.190(a)(6)(ii) through (iv), the proposed rule would include
conforming changes to the label declaration provisions in proposed
Sec. 161.190(a)(8)(vi). Specifically, we propose revising Sec.
161.190(a)(8)(vi) to state that ``[i]f the canned tuna contains one or
more of the optional ingredients in paragraphs (a)(6)(ii) through (iv)
of this section, the label must appropriately declare the ingredients
by the common or usual name in accordance with Sec. 101.22. If the
ingredients designated in paragraph (a)(6)(iii) of this section are
used, the term `vegetable broth' must be declared.'' The proposed rule
would also add that the label statements declare the ingredients by the
common or usual name ``in accordance with 21 CFR 101.22'' for clarity
and consistency with our other regulations (proposed Sec.
161.190(a)(8)(vi)) (see, for example, 21 CFR 163.111(c)(3) (Chocolate
liquor) and 21 CFR 163.124(c) (White chocolate)). In addition, the
proposed rule would add a provision in Sec. 161.190(a)(8)(x) that
states that ``Each of the ingredients used in the food must be declared
on the label as required by the applicable sections of parts 101 and
130 of this chapter.'' The proposed revision would be consistent with
other food standards (see, for example, 21 CFR 145.175(a)(4)(iv)
(Canned pears) and 21 CFR 161.145(a)(4) (Canned oysters)).
Use of additional flavor profiles, along with the use of more
modern methods, may help industry in producing canned tuna products
that better meet evolving tastes and consumer preferences. This may
help encourage tuna consumption consistent with the seafood
recommendations outlined in the 2020-2025 Dietary Guidelines for
Americans (Ref. 1).
We note that a notice of proposed rulemaking, ``Use of Salt
Substitutes to Reduce the Sodium Content in Standardized Foods,''
proposes additional changes that would amend Sec. 161.190(a)(6)(i) to
allow the use of salt substitutes, if finalized (see 88 FR 21148, April
10, 2023). Additionally, we note that a direct final rule, ``Revocation
of Uses of Partially Hydrogenated Oil in Foods'' (see 88 FR 53764,
August 9, 2023), and companion notice of proposed rulemaking,
``Revocation of Uses of Partially Hydrogenated Oil in Foods; Companion
Document to Direct Final Rule'' (see 88 FR 53827, August 9, 2023),
revised Sec. 161.190(a)(6)(viii) to remove partially hydrogenated
vegetable oil. This proposed rulemaking would redesignate Sec.
161.190(a)(6)(viii) as Sec. 161.190(a)(6)(iv) to accommodate other
proposed changes to Sec. 161.190(a)(6) and proposes minor editorial
changes to the language in the paragraph.
4. Revise the Upper and Lower Limits of Vegetable Extractives for
Vegetable Broth Used as an Optional Flavoring Ingredient
Our current regulations state that canned tuna may be seasoned or
flavored with vegetable broth in an amount not in excess of 5 percent
of the volume capacity of the container, such broth to consist of a
minimum of 0.5 percent by weight of vegetable extractives and to be
prepared from two more of the following vegetables: beans, cabbage,
carrots, garlic, onions, parsley, peas, potatoes, green bell peppers,
red bell peppers, spinach, and tomatoes (see Sec. 161.190(a)(6)(v)).
The petition requested, among other things, that we revise this
paragraph to limit the amount of vegetable broth that may be added as a
flavoring based on the dry weight of the vegetable extractives, as well
as revise the wording to reflect current industry practices and
terminology (petition at pages 1, 3, and 10).
We generally agree with the petitioners' suggested rephrasing.
Vegetable broth is no longer added directly to the can; it is added as
extractives and water, separately. Shifting the range of permitted
vegetable extractives would result in a reduction in the concentration
of permitted vegetable broth in standardized canned tuna products.
We understand that the current upper limit of 5 percent vegetable
extractives is likely not used due to flavor and gelling issues. We
support lowering the upper limit of vegetable extractives to 2.5
percent as the petition requested (petition at page 3). However, we
seek additional information regarding the rationale for the lower limit
of 0.025 percent vegetable extractives requested in the petition (id.).
The proposed rule would revise the upper limit range of vegetable
extractives to 2.5 percent and remove the lower limit of vegetable
extractives. The petition's requested lower limit of 0.025 percent
vegetable extractives would add a small amount of vegetable
extractives, similar to tuna packed in water. If a firm adds any
vegetable extractives, regardless of the percentage, the firm must
disclose the ingredients on the label (Sec. 101.4). We invite comments
on the petitioners' request for a lower limit of 0.025 percent
vegetable extractives (petition at page 3).
The proposed rule also would redesignate Sec. 161.190(a)(6)(v) as
Sec. 161.190(a)(6)(iii) to accommodate other proposed changes to
paragraph (a)(6) regarding optional ingredients.
5. Revise and Update the Method for Color Determination
The proposed rule would revise and update the method for color
determination in Sec. 161.190(a)(7). Currently, the regulation
describes use of an optical comparator for determining the Munsell
values for the color designations for canned tuna in Sec.
161.190(a)(4). We propose removing the portions of Sec. 161.190(a)(7)
that are specific to the use of an optical comparator as this change
will accommodate the use of electronic color meters to determine the
Munsell values. Electronic color meters are likely faster, more widely
used, and more objective than using an optical comparator. These
proposed changes would align the level of detail for the canned tuna
method for color determination with other regulations that rely on
Munsell values (see, e.g., Canned tomatoes (21 CFR 155.190) and
Vegetable Juices (21 CFR part 156)).
Additionally, we propose to remove the incorporation by reference
in Sec. 161.190(a)(7)(iii) of the 1943 report regarding the spacing of
Munsell colors published in the Journal of the Optical Society of
America. Removing the 1943 Journal of the Optical Society of America
reference would be consistent with other U.S. food standards, which
refer to the Munsell value without citing
[[Page 58163]]
a source or otherwise incorporating an article by reference in support.
C. Proposed Update of Incorporation by Reference
To help with readability of the section, we propose to add a new
paragraph (d) ``Incorporation by reference.'' for the proposed updates
to the IBR paragraphs in Sec. 161.190(a)(7).
Currently, Sec. 161.190(a)(7) incorporates by reference the
``Official Methods of Analysis of the Association of Official
Analytical Chemists,'' 13th Edition (1980), Table 1, ``Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under
the heading ``Definitions of Terms and Explanatory Notes.'' We propose
to update the regulation to refer to the 22nd Edition of the same
table. Table 1 provides information about international and USA
standard sieve sizes, including sieve designations, the nominal sieve
opening (in inches), and the nominal wire diameter (in millimeters) for
each sieve.
We propose several updates to the contact information for access to
the IBR materials. Specifically, we propose updating the National
Archives and Records Administration's (NARA's) contact information by
removing the phone number, revising the URL, and adding an email
address. We propose adding FDA's Dockets Management Staff contact for
information regarding the availability of copies of the material
incorporated by reference in proposed Sec. 161.190(d). We also propose
to update the address and to add a phone number for AOAC INTERNATIONAL.
These proposed changes will ensure that the reference materials are
accessible, if needed, and in accordance with the specified
requirements for incorporation by reference in the CFR. We note that a
notice of proposed rulemaking, ``Use of Salt Substitutes to Reduce the
Sodium Content in Standardized Foods,'' proposes a new section (Sec.
161.10) for the incorporation by reference information for all of part
161 (see 88 FR 21148). There is no substantive difference between the
material we propose to incorporate by reference in this proposal and
the proposed material incorporated by reference in the salt substitutes
proposed rule.
D. Proposed Additional Revisions
We are proposing additional revisions throughout the section to
improve the clarity and readability of the section and to use plain
language. For example, we are proposing to add paragraph headings for
paragraphs (a)(1) through (8), and we are proposing editorial changes
to simplify phrasing and to use consistent terminology throughout the
section.
V. Proposed Effective and Compliance Dates
We propose that any final rule that may be issued based on this
proposed rule become effective 30 days after publication of the final
rule in the Federal Register. The final rule would apply to affected
products initially produced or initially delivered for introduction
into interstate commerce on or after the effective date. We propose
that the compliance date for any final rule that may be issued based on
this proposed rule be 1 year after publication of the final rule in the
Federal Register.
VI. Request for Information
The petition requested that we limit the amount of vegetable broth
that may be added as a flavoring based on the dry weight of the
vegetable extractives used (petition at page 1). The standard of
identity currently states the vegetable extractives are not to exceed 5
percent of the volume capacity of the container, with a minimum broth
consisting of 0.5 percent by weight of vegetable extractives (Sec.
161.190(a)(6)(v)). The petition requested that the dry weight of the
vegetable extractives in the aqueous broth is at least 0.025 percent
and not more than 2.5 percent of the labeled net weight of the
container (petition at pages 3 and 10).
The proposed rule would revise the upper limit range of vegetable
extractives to 2.5 percent but remove the lower limit of vegetable
extractives (see proposed Sec. 161.190(a)(6)(iii)). Thus, in addition
to comments on the proposed rule itself, we request comments on whether
there should be a lower limit of vegetable extractives and if so,
whether the lower limit should be 0.025 percent as the petition
requested (petition at page 3) or another percentage. Please provide
data to support a lower limit.
VII. Preliminary Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of [the Office of Information and Regulatory
Affairs (OIRA)] for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this proposed rule is not a
significant regulatory action under Executive Order 12866 Section
3(f)(1).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule would not significantly increase
costs to manufacturers, we propose to certify that the proposed rule
will not have a significant economic impact on a substantial number of
small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before proposing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $177
million, using the most current (2022) Implicit Price Deflator for the
Gross Domestic Product. This proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.
The proposed rule, if finalized, would amend existing requirements
for the canned tuna standard of identity and standard of fill of
container. These include changes to methods for determining the fill of
a container, expanding the list of optional flavorings and spices, and
reducing the maximum amount of vegetable broth that can be used as an
ingredient. The proposed rule is in partial response to a 2015 citizen
petition submitted by Bumble Bee Foods, LLC, StarKist Co., and Tri
Union Seafoods, LLC (dba Chicken of the Sea).
To estimate costs and benefits associated with the proposed rule,
we assume that the appropriate baseline is the state of the world with
the current standard of identity and standard of fill
[[Page 58164]]
of container for canned tuna. We then compare the likely impacts of the
proposed rule against this baseline. The quantifiable benefits of the
proposed rule accrue to canned tuna manufacturers. These firms benefit
from switching to a less costly method for determining the fill of a
container. We estimate ongoing annual cost savings ranging from
approximately $4 million to $15.9 million at a 3 percent discount rate,
and approximately $3.9 million to $15.8 million at a 7 percent discount
rate. Our primary annualized estimates are approximately $7.9 million
at both the 3 percent and 7 percent discount rates. The primary
estimate of the present value of total cost savings in the 10 years
following any final rule that may be issued based on the proposed rule
is $67.6 million at a 3 percent rate of discount and $55.4 million at a
7 percent rate of discount. Manufacturers and consumers may benefit
from other provisions of the proposed rule, if finalized, but these
impacts are harder to quantify. We summarize quantified benefits in
table 1.
The costs of the proposed rule, if finalized, are associated with
costs to industry for reading and understanding the rule, training
employees on new requirements, and the purchase of new equipment. These
are one-time costs that industry incurs immediately after any final
rule that may be issued based on the proposed rule passes its
compliance date. When annualized over a period of 10 years, we estimate
these costs range from approximately $3,800 to $6,000 at a 3 percent
discount rate, and approximately $4,500 to $7,100 at a 7 percent
discount rate. Our primary annualized estimates are approximately
$4,900 at a 3 percent discount rate and $5,800 at a 7 percent discount
rate. The primary estimate of the present value of total costs in the
10 years following any final rule that may be issued based on the
proposed rule is $41,600 at a 3 percent discount rate and $40,600 at a
7 percent discount rate.
Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
----------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
----------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $7.9 $3.9 $15.8 2022 7 10
$millions/year......... 7.9 4 15.9 2022 3 10
Annualized Quantified... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
-----------------------------------------------------------------------------------
Qualitative.............
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized 0.01 0.00 0.01 2022 7 10
$millions/year......... 0.00 0.00 0.01 2022 3 10
Annualized Quantified... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
-----------------------------------------------------------------------------------
Qualitative.............
----------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized .......... .......... .......... .......... 7 ..........
Monetized $millions/ .......... .......... .......... .......... 3 ..........
year...................
-----------------------------------------------------------------------------------
From/To................. From:
To:
-----------------------------------------------------------------------------------
Other Annualized .......... .......... .......... .......... 7
Monetized $millions/ .......... .......... .......... .......... 3
year...................
-----------------------------------------------------------------------------------
From/To................. From:
To:
----------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.....................................................................
Small Business: None........................................................................................
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. 4) and at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
VIII. Analysis of Environmental Impact
We have determined under 21 CFR 25.32(a) 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.
IX. Paperwork Reduction Act of 1995
While FDA tentatively concludes that this proposed rule contains no
collection of information, it does refer to previously approved FDA
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521) is not required. The previously approved
collections of information are
[[Page 58165]]
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 101 have been approved under OMB control number 0910-
0381.
X. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this 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 proposed 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.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the proposed 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. FDA solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available only at the Dockets
Management Staff. FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
* 1. U.S. Department of Agriculture and U.S. Department of Health
and Human Services. ``Dietary Guidelines of Americans, 2020-2025,''
9th ed.
* 2. Codex Alimentarius, International Food Standards, Codex
standard for canned tuna and bonito (CODEX STAN 70-1981, R (Adopted
in 1981. Revised in 1995. Amended in 2011, 2013, 2016, 2018.).
<a href="https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B70-1981%252FCXS_070e.pdf">https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B70-1981%252FCXS_070e.pdf</a>. Accessed June 8,
2023.
3. Official Methods of Analysis of AOAC INTERNATIONAL (2023. 22nd
ed., AOAC INTERNATIONAL, Rockville, MD, Official Method 968.30.
* 4. Fish and Shellfish; Amendments to the Canned Tuna Standard of
Identity and Standard of Fill of Container, Docket No. FDA-2016-P-
0147, Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, Unfunded Mandates Reform Act Analysis. <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
List of Subjects in 21 CFR Part 161
Food grades and standards, Frozen foods, Incorporation by
reference, Seafood.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, the FDA
proposes that 21 CFR part 161 be amended as follows:
PART 161--FISH AND SHELLFISH
0
1. The authority citation for part 161 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
0
2. In Sec. 161.190:
0
a. Revise paragraph (a)(1);
0
b. Add a heading to paragraph (a)(2);
0
c. Revise paragraph (a)(3);
0
d. Add a heading to paragraph (a)(4);
0
e. Revise paragraphs (a)(5) through (7);
0
f. Add a heading to paragraph (a)(8);
0
g. Revise paragraphs (a)(8)(i), (iii), and (v) through (ix);
0
h. Add paragraph (a)(8)(x);
0
i. Revise paragraph (c); and
0
j. Add paragraph (d).
The revisions and additions read as follows:
Sec. 161.190 Canned tuna.
(a) * * *
(1) Description. Canned tuna is the food consisting of processed
fish of the species listed in paragraph (a)(2) of this section,
prepared in one of the optional forms of pack specified in paragraph
(a)(3) of this section, conforming to one of the color designations
specified in paragraph (a)(4) of this section, may be in one or more of
the optional packing media specified in paragraph (a)(5) of this
section, and may contain one or more of the safe and suitable optional
ingredients specified in paragraph (a)(6) of this section. It is packed
in hermetically sealed containers and processed by heat to prevent
spoilage. It is labeled per paragraph (a)(8) of this section.
(2) Species. * * *
(3) Forms of pack. The optional forms of processed tuna consist of
loins and other striated muscular tissue of the fish. The loin is the
longitudinal quarter of the great lateral muscle freed from skin,
scales, visible blood clots, bones, gills, viscera and from the
nonstriated part of the muscle, which part (known anatomically as the
median superficial muscle) is highly vascular in structure, dark in
color because of the retained blood, and granular in form. Canned tuna
is prepared in one of the following forms of pack, determined following
the methods prescribed in paragraph (c)(2) of this section.
(i) Solid or solid pack consists of loins freed from any surface
tissue discolored by diffused hemolyzed blood, cut in transverse
segments to which no free fragments are added. In containers of 1 pound
or less of net contents, the segments are cut in lengths suitable for
packing in one layer. In containers of more than 1 pound net contents,
such segments may be cut in lengths suitable for packing in one or more
layers of equal thickness. Segments are placed in the container with
the planes of their transverse cut ends parallel to the ends of the
container. A piece of a segment may be added if necessary to fill a
container. The proportion of free flakes broken from loins in the
canning process must not exceed 18 percent.
(ii) Chunk, chunks, chunk style consists of a mixture of pieces of
tuna in which the original muscle structure is retained. The pieces may
vary in size, but not less than 50 percent of the drained weight of the
contents of the container is retained on a \1/2\-inch (or 12.5-
millimeter) mesh sieve.
(iii) Flake or flakes consist of a mixture of pieces of tuna in
which more than 50 percent of the drained weight of the contents of the
container will pass through a \1/2\-inch (or 12.5-millimeter) mesh
sieve, but in which the muscular structure of the flesh is retained.
(iv) Grated consists of a mixture of particles of tuna that have
been reduced to uniform size, that will pass through a \1/2\-inch (or
12.5-millimeter) mesh sieve, and in which the particles are discrete
and do not comprise a paste.
(v) Any of the specified forms of pack of canned tuna may be
smoked. Canned smoked tuna must be labeled per paragraph (a)(8)(v) of
this section.
(4) Colors of pack. * * *
[[Page 58166]]
(5) Optional packing media. Canned tuna may be in one or more of
the following optional packing media:
(i) Any edible vegetable oil other than olive oil, or any mixture
of such oils not containing olive oil;
(ii) Olive oil; or
(iii) Water.
(6) Optional ingredients. One or more of the following safe and
suitable optional ingredients may be used:
(i) Salt.
(ii) Flavorings and spices in accordance with Sec. 101.22 of this
chapter.
(iii) Vegetable broth added in an aqueous solution, such that the
dry weight of the vegetable extractives in the broth must not be more
than 2.5 percent of the labeled net weight of the container. The
vegetable broth must be prepared from two or more of the following
vegetables: Beans, cabbage, carrots, celery, garlic, onions, parsley,
peas, potatoes, green bell peppers, red bell peppers, spinach, and
tomatoes.
(iv) Edible vegetable oil, excluding olive oil. The amount of
edible vegetable oil must not exceed 5 percent of the volume capacity
of the container, with or without any suitable form of emulsifying and
suspending ingredients that are generally recognized as safe per Sec.
170.30 of this chapter or approved as a food additive to aid in
dispersion of the oil, as seasoning in canned tuna packed in water.
(v) Sodium acid pyrophosphate added for the purpose of inhibiting
the development of struvite crystals. Sodium acid pyrophosphate may be
added in a quantity that must not exceed 0.5 percent by weight of the
finished food.
(7) Method of color determination. For the color designations
specified in paragraph (a)(4) of this section, the following method
must be used: Recombine the separations of drained product resulting
from the method prescribed in paragraph (c)(2) of this section. Pass
the combined portions through a \1/4\-inch (or 6.3-millimeter) sieve
complying with the specifications set forth in ``Official Methods of
AOAC INTERNATIONAL,'' 22nd Ed. (2023), Table 1, ``Nominal Dimensions of
Standard Test Sieves (U.S.A. Standard Series),'' under the heading
``Definitions of Terms and Explanatory Notes,'' (incorporated by
reference, see paragraph (d) of this section). Mix the sieved material
and place a sufficient quantity into a 307 x 113 size container
(bearing a top seam and having a false bottom approximately \1/2\-inch
(or 1.3-centimeter) deep and painted flat black inside and outside) so
that after tamping and smoothing the surface of the sample the material
will be \1/8\-inch (or 0.3-centimeter) to \1/4\-inch (or 0.6-
centimeter) below the top of the container. Within 10 minutes after
draining through the \1/4\-inch (or 6.3-millimeter) sieve, determine
the Munsell value of sample surface.
(i) Determine the Munsell value of the sample. The standards with
which comparisons are made are essentially neutral matte-finish
standards, equivalent in luminous reflectance of light at a wavelength
of 555 nanometers and 33.7 percent of the luminous reflectance of
magnesium oxide (for Munsell value 6.3); 22.6 percent of the luminous
reflectance of magnesium oxide (for Munsell value 5.3). When examining
albacore designated as ``white'', conduct the procedure using standards
of Munsell value 6.3.
(ii) For blended tuna, vary the method by first separating the tuna
flakes into the different colors before passing them through the \1/4\-
inch (or 6.3-millimeter) sieve, then determining the color value of
each portion separately. If necessary, use a sample container with a
false bottom greater than \1/2\ -inch (or 1.3 centimeter) deep.
(8) Labeling. (i) The specified name of the canned tuna described
in this section, except for tuna packed in water or tuna that is
smoked, is formed by combining the designation of form of pack with the
color designation of the tuna; for example, ``Solid pack white tuna'',
``Grated dark tuna'', etc. For blended tuna, use both applicable color
designations of the blended flakes with the predominant portion of the
container first; for example, ``Blended white and dark tuna flakes'',
``Blended dark and light tuna flakes''.
* * * * *
(iii) For canned tuna packed in vegetable oil or olive oil, the
label must include the name of any optional packing medium used, as
specified in paragraph (a)(5) of this section, preceded by the word
``in'' or the words ``packed in''. If the tuna is packed in an optional
vegetable oil, as specified in paragraph (a)(5)(i) of this section, the
name or names of the oil or the general term ``vegetable oil'' may be
used.
* * * * *
(v) If any of the specified forms of canned tuna are smoked, the
word ``smoked'' must appear as a part of the name on the label, for
example, ``Smoked light tuna flakes''.
(vi) If the canned tuna contains one or more of the optional
ingredients in paragraph (a)(6)(ii) through (iv) of this section, the
label must appropriately declare the ingredients by the common or usual
name in accordance with Sec. 101.22 of this chapter. If the
ingredients designated in paragraph (a)(6)(iii) of this section are
used, the term ``vegetable broth'' must be declared.
(vii) If the canned tuna contains the optional ingredient sodium
acid pyrophosphate as provided in paragraph (a)(6)(v) of this section,
the label must bear the statement ``pyrophosphate added'' or ``with
added pyrophosphate''.
(viii) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the names of the optional ingredients used, as specified in
paragraphs (a)(8)(iii), (vi), and (vii) of this section, must
immediately and conspicuously precede or follow such name without
intervening, written, printed, or graphic matter except that the common
name of the species of tuna fish may so intervene, but the species name
``albacore'' may be used only for canned tuna of that species which
meets the color designation ``white'' as prescribed by paragraph
(a)(4)(i) of this section.
(ix) Statements of optional ingredients present required by
paragraph (a)(8)(vi) of this section, but not subject to the provisions
of paragraph (a)(8)(viii) of this section, must be included on the
label with such prominence and conspicuousness as to render them likely
to be read and understood by the ordinary individual under customary
conditions of purchase.
(x) Each of the ingredients used in the food must be declared on
the label as required by the applicable sections of parts 101 and 130
of this chapter.
* * * * *
(c) Fill of container. (1) The standard of fill of container for
canned tuna is a fill such that tuna must constitute at least 72
percent of the fill of the container. The general method for
determining the fill of containers is specified in Sec. 130.12(b) of
this chapter. The drained weight method, as specified in paragraph
(c)(2) of this section, must be used to verify the standard fill of
container for canned tuna products. The drained weight of each
container must be determined individually, and an average value must be
determined based on an average taken from a minimum of 24 containers.
(2) Determine the drained weight of the tuna using unopened canned
tuna containers left at 75 <plus-minus> 5[deg]F (or 24 <plus-minus> 3
[deg]C) for at least 12 hours immediately before testing. Empty the
contents of one individual tuna container onto a previously weighed
sieve and evenly distribute the contents across the bottom of the
sieve. Without shifting any tuna,
[[Page 58167]]
tilt the sieve at a 17- to 20-degree angle to help facilitate drainage.
Allow the tuna to drain for 2 minutes, starting when the product is
applied to the sieve. The sieve containing the drained tuna is then
reweighed, after excess packing media is gently removed from the bottom
of the sieve with a paper towel. The drained weight is calculated by
subtracting the difference in the weights as follows:
Final weight of sieve with tuna--Empty weight of sieve = Drained weight
of tuna
If the contents of the tuna container weigh less than 3 pounds
(1.36 kilograms), then a sieve with an 8-inch (20-centimeter) diameter
must be used. If the contents of the tuna container weigh 3 pounds
(1.36 kilograms) or more, then a sieve with a 12-inch (30-centimeter)
diameter must be used. The bottom of the sieve has a woven-wire cloth
mesh complying with the specifications set forth for the 2.80 mm (No.
7) sieve in the ``Official Methods of AOAC INTERNATIONAL,'' 22nd Ed.
(2023), Table 1, ``Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),'' under the heading ``Definitions of Terms and
Explanatory Notes,'' (incorporated by reference, see paragraph (d) of
this section).
(i) Determination of free flakes: If the optional form of tuna
ingredient is solid pack, determine the percent of free flakes. Any
flakes resulting from the drained weight procedure described in
paragraph (c)(2) of this section are to be weighed as free flakes. Only
fragments that were broken in the canning process are considered to be
free flakes. Using a spatula, scrape free flakes gently from the
outside of the drained tuna product. Weigh the aggregate free flakes
that were broken from the loin segments in the canning process and
calculate their percentage of the total drained weight.
(ii) Determination of particle size: If the optional form of tuna
ingredient is chunks, flakes, or grated, the drained tuna product
resulting from the drained weight procedure described in paragraph
(c)(2) of this section, is gently separated by hand, care being taken
to avoid breaking the pieces. The separated pieces are evenly
distributed over the top sieve of the screen separation equipment
described in paragraph (c)(2)(iii) of this section. Beginning with the
top sieve, lift and drop each sieve by its open edge three times. Each
time, the open edge of the sieve is lifted the full distance permitted
by the device. Combine and weigh the material remaining on the top
three sieves (1\1/4\-inch (or 37.5-millimeter), 1-inch (or 25.0-
millimeter), \1/2\-inch (or 12.5-millimeter) meshes) and determine the
combined percentage retention by weight in relation to the total
drained weight.
(iii) The sieving device referred to in paragraph (c)(2)(ii) of
this section consists of three sieves, each approximately 1 foot
square, loosely mounted, one above another, in a metal frame. The mesh
in the top sieve complies with the specifications for 1 \1/4\-inch (or
37.5-millimeter) woven-wire cloth mesh as prescribed in paragraph
(a)(7) of this section. The meshes in the sieve below comply with
similar specifications for 1-inch (or 25.0-millimeter) and \1/4\-inch
(or 12.5-millimeter) mesh as set forth in AOAC Official Methods, Table
1, ``Nominal Dimensions of Standard Test Sieves (U.S.A. Standard
Series)'' (incorporated by reference, see paragraph (d) of this
section). The sides of each sieve are formed, in a raised rim, from \3/
4\-inch (or 1.9-centimeters) x \1/8\-inch (or 0.3-centimeter) metal
strap. The frame has tracks made of \3/8\-inch (or 1.0-centimeter)
angle metal to support each sieve under each side. The tracks are
positioned to permit each sieve a free vertical travel of 1\3/4\-inches
(or 4.4-centimeters).
(3) If canned tuna falls below the applicable standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
must bear the general statement of substandard fill per Sec. 130.14(b)
of this chapter.
(d) Incorporation by reference. Table 1, Nominal Dimensions of
Standard Test Sieves (U.S.A. Standard Series), Definitions of Terms and
Explanatory Notes, Official Methods of Analysis of AOAC INTERNATIONAL,
22nd Ed., 2023 is incorporated by reference into this section with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. This incorporation by reference (IBR) material is
available for inspection at the Food and Drug Administration (FDA) and
at the National Archives and Records Administration (NARA). Contact
FDA's Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500. For information on the availability of this
material at NARA, visit <a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a> or email <a href="/cdn-cgi/l/email-protection#167064387f7865667375627f7978567877647738717960"><span class="__cf_email__" data-cfemail="bed8cc90d7d0cdcedbddcad7d1d0fed0dfccdf90d9d1c8">[email protected]</span></a>. The material may be
obtained from AOAC INTERNATIONAL, 2275 Research Blvd., Suite 300,
Rockville, MD 20850-3250; 1-800-379-2622.
Dated: August 14, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-17916 Filed 8-24-23; 8:45 am]
BILLING CODE 4164-01-P
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