[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 [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: 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:
     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));
     revise the introductory text in Sec.  161.190(a)(5) 
thereby clarifying that use of a packing medium is optional;
     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;
     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);
     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);
     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;
     amend Sec.  161.190(a)(8)(vi) for clarity and consistency 
with other label declaration provisions in the Code of Federal 
Regulations (CFR);
     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;
     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));
     add paragraph (d) to Sec.  161.190 to update the 
incorporation by reference information (currently found in Sec.  
161.190(a)(7)); and
     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:
     base the standard of fill of container on the product's 
drained weight rather than the pressed cake weight;
     require that the net contents declaration include both the 
net weight and drained weight;
     provide that use of a packing medium is optional;
     permit the use of any flavoring;
     limit the amount of vegetable broth that may be added as a 
flavoring based on the dry weight of the vegetable extractives;
     provide that a label statement about added salt is 
optional; and
     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 https://www.fda.gov/food/food-labeling-nutrition/standards-identity-food). 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 https://www.dietaryguidelines.gov) 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 
https://academic.oup.com/aoac-publications/book/45491/chapter/392327291.

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 https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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 https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov 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.). 
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. 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. https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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  5[deg]F (or 24  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 www.archives.gov/federal-register/cfr/ibr-locations.html or email [email protected]. 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