[Federal Register Volume 88, Number 11 (Wednesday, January 18, 2023)]
[Rules and Regulations]
[Pages 2798-2812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00693]
[[Page 2798]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 352, 354, 362, and 412
[Docket No. FSIS-2019-0019]
RIN 0583-AD78
Prior Label Approval System: Expansion of Generic Label Approval
AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of
Agriculture (USDA).
ACTION: Final rule.
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SUMMARY: FSIS is amending its regulations to expand the circumstances
under which it will generically approve the labels of meat, poultry,
and egg products. Also, as of the effective date of this final rule,
FSIS will no longer evaluate generically approved labels that
establishments and egg products plants voluntarily submit for FSIS
review. FSIS is also announcing the availability of revised guidelines
on the types of labels that must be submitted to FSIS for approval.
DATES: This rule is effective March 20, 2023. Submit comments on the
revised FSIS Guideline for Label Approval on or before February 17,
2023.
ADDRESSES: A downloadable version of the revised FSIS Guideline for
Label Approval is available to view and print at https://www.fsis.usda.gov/inspection/compliance-guidance. No hard copies of the
guideline have been published.
FSIS invites interested persons to submit comment on the revised
FSIS Guideline for Label Approval. Comments may be submitted by one of
the following methods.
Federal eRulemaking Portal: This website provides the
ability to type short comments directly into the comment field on this
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
Hand- or Courier-Delivered Submittals: Deliver to 1400
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E,
Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2019-0019. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to https://www.regulations.gov.
Docket: For access to background documents or comments received,
call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at
1400 Independence Avenue SW, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development, by telephone
at (202) 205-0495.
SUPPLEMENTARY INFORMATION:
Executive Summary
FSIS is finalizing its September 14, 2020, proposal to expand the
circumstances in which FSIS will generically approve the labels of
meat, poultry, and egg products (85 FR 56538). This final rule will
expand generic approval to products only intended for export that
deviate from domestic labeling requirements and permit generic approval
of the labels of products that receive voluntary FSIS inspection. This
final rule will also expand generic approval to: (1) ``Organic'' claims
that appear in a product label's ingredients statement; (2)
``Geographic landmarks'' displayed on a product label; (3) ``Negative''
claims made on product labels that identify the absence of certain
ingredients or types of ingredients. Furthermore, as of the effective
date of this final rule, FSIS will no longer evaluate generically
approved labels voluntarily submitted to the Agency for review. FSIS
will, however, continue to provide industry with relevant resources,
including updated generic labeling guidance, and timely answers to
generic labeling questions via phone, askFSIS, and the Small Plant Help
Desk.
Considering these changes, FSIS has revised and reissued the FSIS
Guideline for Label Approval \1\ to provide the public with updated
information on the types of labels that must be submitted to FSIS for
approval consistent with this final rule.
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\1\ The latest revision of the FSIS Guideline for Label Approval
is available at: https://www.fsis.usda.gov/inspection/compliance-guidance.
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As is shown in Table 1, this final rule has net benefits of
$799,507, annualized at the 7 percent discount rate over 10 years. Of
which, industry will experience cost savings of $517,888, annualized at
the 7 percent discount rate over 10 years, from the reduction in
preparing and submitting certain labels for FSIS evaluation. FSIS will
experience cost savings of $281,619, annualized at the 7 percent
discount rate over 10 years, from the reduction in label evaluations.
This final rule does not create any new cost burden for industry or
FSIS.
Table 1--Net Benefits
[Cost savings]
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Annualized net
benefit (7% discount
rate, 10 years)
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Industry.......................................... $517,888
Agency............................................ 281,619
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Total......................................... 799,507
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Table of Contents
I. Background
II. Final Rule
III. Summary of Comments and Responses
A. Industry Compliance and Agency Oversight
B. Cost of Label Review
C. Increase in Deficient Labels
D. Organic Claims
E. Negative Claims
F. Certified Claims
G. Temporary Label Approval
H. Voluntary Submissions
I. Geographic Landmark Claims
J. Front of Pack Nutrition Statements
K. Miscellaneous Comments
IV. Executive Orders 12866 and 13563
V. Regulatory Flexibility Act Assessment
VI. Paperwork Reduction Act
VII. USDA Non-Discrimination Statement
VIII. E-Government Act
IX. Executive Order 12988, Civil Justice Reform
X. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments
XI. Environmental Impact
XII. Additional Public Notification
I. Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.),
Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and Egg
Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) (hereinafter,
``the Acts'') direct the Secretary of Agriculture to maintain
inspection programs designed to ensure that meat, poultry, and egg
products are safe, wholesome, not adulterated, and properly marked,
labeled, and packaged. These laws prohibit the sale of products under
any false or misleading name, marking, or labeling and require the
Secretary to approve product marking and labeling (21 U.S.C. 457(c),
607(d), and 1036(b)). The Department's longstanding interpretation \2\
of these provisions is that they require the Secretary or his or her
representative to
[[Page 2799]]
approve all labels to be used on federally inspected and passed,
domestic and imported, meat, poultry and egg products, before the
products may be distributed in commerce. To implement these provisions,
FSIS uses a prior approval program for labels on federally inspected
meat, poultry, and egg products (9 CFR part 412). Without approved
labels, meat, poultry, and egg products may not be sold, offered for
sale, or otherwise distributed in commerce.
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\2\ See, e.g., 60 FR 67444, December 29, 1995; 76 FR 75809,
75810, December 5, 2011; 78 FR 66826, November 7, 2013; 85 FR 56538,
56539, September 14, 2020.
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To receive FSIS approval, meat, poultry, and egg product labels
must comply with the Acts and the labeling regulations implemented
thereunder. As discussed in the proposed rule (85 FR 56538, 56539), the
regulations contain provisions to ensure that no statement, word,
picture, design, or device that is false or misleading in any
particular, or that conveys any false impression, or that gives any
false indication of origin, identity, or quality, appears in any
marking or other labeling (9 CFR 317.8, 381.129, and 590.411(f)(1)).
Also, as discussed in the proposed rule, FSIS regulations require that
meat, poultry, and egg product labels display up to eight features, to
ensure that consumers have the information necessary to make informed
purchasing decisions (85 FR 56538, 56539). The required features
include: (1) The standardized, common or usual, or descriptive name, of
the product (9 CFR 317.2(c)(1) and (e), 381.117, and 590.411(c)(1));
(2) an ingredients statement containing the common or usual name of
each ingredient of the product listed in descending order of
predominance (9 CFR 317.2(c)(2) and (f), 381.118, and 590.411(c)(1));
(3) the name and place of business of the manufacturer, packer, or
distributor (9 CFR 317.2(c)(3) and (g), 381.122, and 590.411(c)(2));
(4) an accurate statement of the net quantity of contents (9 CFR
317.2(c)(4) and (h), 381.121, and 590.411(c)(4)); (5) the inspection
legend, including the number of the official establishment \3\ (9 CFR
312.2(b), 317.2(c)(5) and (i), 381.96, 381.123, and 590.411(c)(5)); (6)
a handling statement if the product is perishable, e.g., ``Keep
Frozen'' or ``Keep Refrigerated'' (9 CFR 317.2(k), 381.125(a), and
590.410(a)(1)-(2)); (7) nutrition labeling for applicable meat and
poultry products (9 CFR part 317, subpart B; part 381, subpart Y; and
590.411(e)); \4\ and (8) safe handling instructions if the meat or
poultry component of the product is not ready-to-eat (9 CFR 317.2(l)
and 381.125(b)). In addition, imported meat, poultry, and egg products
must bear the country of origin under the product name (9 CFR
327.14(b)(1), 381.205(a), and 590.950(a)(2)).
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\3\ For purposes of this document, the term ``establishment''
includes official meat and poultry establishments and egg products
plants, unless otherwise indicated.
\4\ Nutrition labeling for egg products must comply with the
provisions of 21 CFR part 101, promogulated under the Federal Food,
Drug, and Cosmetic Act and the Fair Packaging and Labeling Act [9
CFR 590.411(e)].
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Under the prior label approval program, certain categories of
labels receive ``sketch approval,'' meaning they must be submitted to
FSIS for review and approval before use. However, FSIS regulations
allow some product labels that bear all required labeling features and
comply with the Agency's labeling regulations to be ``generically
approved'' (9 CFR 412.2(a)(1)), meaning they may be used in commerce
without prior FSIS review. Establishments, therefore, do not need to
submit generically approved labels to FSIS' Labeling and Program
Delivery Staff (LPDS) for evaluation. Instead, as discussed in the
proposed rule, Inspection Program Personnel (IPP) perform surveillance
and enforcement tasks in the field to verify that generically approved
labels comply with labeling requirements (85 FR 56538, 56543).
Generic label approval has been in place in some form since 1983
(48 FR 11410, March 18, 1983). FSIS previously expanded the categories
of labeling claims eligible for generic approval in 1995 (60 FR 67444,
December 29, 1995). FSIS completed an assessment of the modified system
in 1998 (76 FR 75809, December 5, 2011) and concluded that the great
majority of establishments effectively used generically approved labels
and that the gradual implementation of generic label provisions under
the 1995 final rule was effective. FSIS expanded generic approval again
in 2013 (78 FR 66826, November 7, 2013) and, in 2016, conducted a
limited assessment of generic labels under the modified system, which
found a high level of compliance with the requirements.
In June 2020, the USDA Office of Inspector General (OIG) concluded
an audit of FSIS product labeling oversight (OIG audit #24601-0002-23,
``Controls Over Meat, Poultry, and Egg Product Labels'').\5\ In
response to the audit recommendations concerning FSIS oversight of
generic labeling, the Agency agreed that it would continue to enhance
its outreach efforts to ensure establishments are aware of applicable
mandatory labeling features for generic labels. FSIS also agreed to
update its internal policies to improve IPP label verification
activities. FSIS took subsequent action to satisfy OIG's audit
recommendations and, based on such action, the USDA Office of the Chief
Financial Officer (OCFO) closed the audit on June 29, 2021.
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\5\ OIG's audit report is available at: https://www.usda.gov/sites/default/files/audit-reports/24601-0002-23.pdf.
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Since the 2013 rulemaking (78 FR 66826), FSIS has gained
significant, additional experience evaluating labels required to be
submitted and approved. From that experience, FSIS has observed through
its prior label approval system that most labels in the categories
discussed in this final rule are compliant and do not require changes.
Therefore, the Agency concluded that the current label regulations
continue to require industry to submit for approval a significant
number of labels that could successfully be generically approved.
Therefore, on September 14, 2020, FSIS published a proposed rule to
amend the meat and poultry products inspection regulations to expand
the circumstances under which labels of meat and poultry products would
be deemed to be generically approved by the Agency (85 FR 56538). FSIS
also proposed to cease evaluating generically approved labels submitted
to FSIS for review (85 FR 56538, 56542). FSIS proposed these changes to
its regulations to reduce the number of labels submitted for evaluation
by FSIS and to lessen the paperwork burden on official establishments
(85 FR 56538, 56541). As stated in the proposed rule, the reduction in
staff time spent approving these labels will allow the Agency to better
focus on other consumer protection and food safety activities, such as
developing guidance materials, answering labeling policy questions,
providing outreach to stakeholders, and ensuring IPP effectively verify
that establishments meet labeling requirements (85 FR 56538, 56541).
FSIS is now finalizing the proposed rule with minor changes to clarify
label approval requirements with respect to voluntarily inspected
poultry.
II. Final Rule
This final rule is consistent with the proposed rule. First, the
final rule will extend generic label approval to products only intended
for export that deviate from domestic labeling requirements, by
removing 9 CFR 412.1(c)(2). As explained in the proposed rule, FSIS
maintains an Export Library that lists requirements for exported
products that foreign authorities have officially communicated to FSIS,
including
[[Page 2800]]
labeling requirements.\6\ At times, foreign country labeling
requirements conflict with domestic requirements. FSIS regulations (9
CFR 317.7 and 381.128) permit export product labels to deviate from
FSIS' domestic labeling requirements in order to comply with foreign
country requirements or to be marketed more easily in a foreign
country.\7\ FSIS IPP verify whether product for export meets
requirements listed in the Export Library, including labeling, when
certifying products for export. Verification of foreign requirements is
ultimately determined by each foreign country's competent authority.
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\6\ The Export Library is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country.
\7\ Although there is no specific equivalent regulation for egg
products, FSIS follows the same policy because such products,
intended exclusively for export, must comply with foreign countries'
requirements and are therefore not considered misbranded.
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Second, the final rule will revise the types of ``special
statements and claims'' requiring label submission by providing for
generic approval of three additional types of claims. As explained in
the proposed rule, FSIS has, through its prior label approval system,
routinely evaluated these types of claims for several years. From that
experience, FSIS has observed that errors, omissions, and
misrepresentations are rare on these types of labels. FSIS has,
therefore, decided to expand generic approval to such claims. As with
all generically approved labels, IPP will continue to conduct routine
verification tasks in establishments to verify ongoing compliance with
labeling requirements. FSIS is amending 9 CFR 412.1(e) and 412.2(b) to
make these changes.
Under this final rule, the following types of claims will be
generically approved:
a. ``Organic'' claims that appear in a product label's ingredients
statement, which designate an ingredient as certified ``organic'' under
the Agricultural Marketing Service's (AMS's) National Organic Program.
The ingredients statement on these product labels designates specific
ingredients as ``organic'' (e.g., ``organic garlic''). Under this rule,
FSIS will no longer require the submission and evaluation of supporting
documentation to verify that such ingredients are indeed certified as
``organic'' by an AMS-recognized third-party certifier. However, FSIS
will continue to require establishments to submit labels certifying a
total product as organic to FSIS for evaluation.
b. ``Geographic landmarks'' displayed on a product label, such as a
foreign country's flag, monument, or map. For example, the following
claims displayed on a product label will no longer require FSIS review
prior to entering commerce: a Polish flag depicted on a Polish sausage
product label, or an outline of the State of Nevada depicted on a
product label for beef produced in Nevada.
c. ``Negative'' claims made on product labels that identify the
absence of certain ingredients or types of ingredients. For example,
statements such as ``No MSG Added,'' ``Preservative Free,'' ``No
Milk,'' ``No Pork,'' or ``Made Without Soy,'' on product labels that do
not list these ingredients in the ingredients statement will no longer
have to be evaluated by FSIS before use. However, FSIS evaluation of
labels that bear negative claims relating to the raising of the animal
from which the product is derived (e.g., ``no antibiotics
administered'') or negative claims relating to the use of genetically
modified ingredients will continue to be required.
Third, the final rule will permit generic approval of the labels of
products that receive voluntary FSIS inspection. FSIS provides several
types of voluntary inspection services under the authority of the
Agricultural Marketing Act (AMA) (7 U.S.C. 1621 et seq.), including
inspection for: rabbits (9 CFR part 354), certain non-amenable species
of livestock and poultry, such as elk, bison, and migratory waterfowl
(9 CFR part 352, subpart A, and 9 CFR part 362); and products that
contain meat or poultry but are not under FSIS jurisdiction, e.g.,
closed-faced sandwiches (9 CFR 350.3(c)and 362.2(a)). Before this final
rule, labels for some products produced under these voluntary
inspection programs were not covered under the Agency's generic
approval regulations at 9 CFR part 412. This final rule will permit
generic approval for them on the same basis as amenable meat, poultry,
and egg products by amending the relevant regulations where needed to
include references to 9 CFR part 412.\8\ For clarity, the final rule
will also modify 9 CFR 352.1 to update the section heading and remove
unnecessary language.
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\8\ Under existing regulations, non-FSIS-jurisdiction products
that contain meat or poultry (9 CFR 350.3(c)) and products
containing non-amenable species of poultry (9 CFR part 362), which
are voluntarily inspected, are already subject to the label approval
provisions of 9 CFR part 412. Nonetheless, this final rule adds
additional regulatory language to 9 CFR part 362 to further clarify
label approval requirements with respect to voluntarily inspected
poultry.
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Finally, under the final rule, FSIS will no longer evaluate
generically approved labels submitted voluntarily for FSIS review. Over
the years, producers have become more familiar with FSIS' generic
labeling requirements, and FSIS has provided additional guidance to
assist them in designing compliant labels. Because voluntarily
submitted labels receive a lower review priority than other labels,
industry can receive more timely labeling assistance by utilizing
Agency resources or contacting FSIS for help. Therefore, FSIS'
evaluation of otherwise generic labels no longer represents an
efficient use of Agency resources.
FSIS will, however, continue to provide industry with generic
labeling resources and assistance to help them comply with
requirements. For example, FSIS has revised and reissued the FSIS
Guideline for Label Approval \9\ to provide updated information on the
types of labels that must be submitted to FSIS for approval consistent
with this final rule. FSIS will also continue to assist industry with
generic labeling issues via phone, askFSIS, and the Small Plant Help
Desk.
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\9\ The latest revision of the FSIS Guideline for Label Approval
is available at: https://www.fsis.usda.gov/inspection/compliance-guidance.
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II. Summary of Comments and Responses
FSIS received 33 comments on the proposed rule from individuals,
trade associations, private businesses, non-profit organizations, a
consultant, a software company, the European Union (EU), and OIG.
Fourteen commenters supported the proposed rule; though, some
commenters requested revisions to or clarification on specific
provisions of the rule. Most of these commenters stated that they
supported the proposed rule because it will streamline the prior label
approval system, reduce the label approval backlog, result in a cost
savings for industry and government, and allow FSIS to utilize its
resources more effectively.
Four commenters opposed the proposed rule, generally citing
concerns over reduced oversight of meat, poultry, and egg product
labeling claims. Twelve comments expressed concerns regarding specific
provisions or language in the proposed rule but did not otherwise
express opposition or support for the remainder of the rule. The
remaining comments were outside the scope of the rule. A summary of the
relevant issues raised by commenters and the Agency's responses
follows.
[[Page 2801]]
A. Industry Compliance and Agency Oversight
Comment: OIG questioned FSIS' conclusion that its previous generic
labeling assessments found a high level of industry compliance with
requirements and its assertion in the proposed rule (85 FR 56538,
56543) that OIG's audit of FSIS' product labeling oversight (OIG audit
#24601-0002-23) does not affect the proposed expansion of generic
labeling eligibility. Unlike FSIS, OIG does not believe that the
assessments or the audit found a high level of industry compliance with
generic labeling requirements. As part of its audit, OIG reviewed 878
generic labels that industry voluntarily submitted to FSIS for review
and found that FSIS requested changes to 74 percent of these labels.
OIG also noted that three establishments OIG visited during its audit
did not make required modifications to their generic labeling records.
For these reasons, OIG recommended that FSIS consider performing a
statistically valid assessment, before publishing this final rule, to
ensure establishments have achieved a high level of compliance with
generic label requirements. OIG also asked FSIS to consider ensuring
that IPP select generic labels when performing General Labeling Tasks.
Response: As discussed in the proposed rule (85 FR 56538, 56541),
FSIS completed an assessment of its generic labeling system in 1998 (76
FR 75809, December 5, 2011). Of the 1,513 labels that FSIS reviewed
during its assessment, 1,434 (approximately 95 percent) were either in
complete compliance or had only minor labeling errors (e.g.,
insufficient spacing around the declaration of net weight or an error
in the name of the manufacturer, packer, or distributor) that were not
of public health or economic significance (76 FR 75813). As discussed
in the proposed rule (85 FR 56538, 56541), FSIS also conducted a
limited assessment in 2016, with similar results. Thus, FSIS maintains
its view that its previous assessments found a high level of compliance
from the labels reviewed.
In June 2020, OIG concluded an audit of FSIS' oversight of
generically approved and sketch approved labeling.\10\ In response to
the official draft of the audit, FSIS expressed concerns that the audit
was flawed in several areas, and that OIG misinterpreted specific
labeling regulations and how they are applied to the labeling review
process. FSIS also expressed concerns that OIG evaluated the label
approval program on a rigid set of standards that did not accurately
reflect FSIS regulations or consider FSIS' history and expertise in
implementing the regulations and review of labels. OIG addressed some,
but not all, of these concerns in its final audit report. Despite FSIS'
misgivings about the audit, the Agency generally agreed with OIG's
recommendations, and OIG accepted FSIS' decisions on all its
recommendations.
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\10\ Audit Report 24601-0002-23 available at https://www.usda.gov/sites/default/files/audit-reports/24601-0002-23.pdf.
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FSIS took subsequent action to satisfy OIG's recommendations and,
based on such action, OCFO closed the audit on June 29, 2021. For
example, on June 7, 2021, the Agency revised FSIS Directive 7221.1,
Prior Labeling Approval,\11\ to clarify that IPP are to routinely
select generically approved labels when performing General Labeling
Tasks.\12\ FSIS also documented internal Standard Operating Procedures
to assist LPDS analysts with the label evaluation process, including
formalizing a Quality Control program to randomly review label
adjudications.
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\11\ FSIS Directive 7221.1 is available at: https://www.fsis.usda.gov/policy/fsis-directives/7221.1.
\12\ The General Labeling Task is a set of surveillance
procedures that IPP use to verify the ongoing compliance of labels,
including generic labels, at establishments. FSIS Directive 7221.1,
Prior Labeling Approval, provides instructions to IPP for conducting
the General Labeling task.
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FSIS also took action to address OIG's finding that three
establishments it visited during its audit did not make required
modifications to their labeling records. Although this finding was only
based on a review of four labels, FSIS nonetheless published a
Constituent Update to remind all establishments that FSIS label
approval, including approval of voluntarily submitted generic labels,
is contingent on the establishment making the revisions noted by
FSIS.\13\ FSIS also recently updated FSIS Directive 7221.1 to clarify
that, as part of the General Labeling Task, IPP are to routinely verify
that establishments make required modifications to their labels.
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\13\ FSIS Constituent Update: Tips for Faster Label Approval
Process. August 9, 2019, available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-august-9-2019-0.
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FSIS acknowledges OIG's finding that FSIS requested changes to 74
percent of the generic labels voluntarily submitted to the Agency by
industry, which OIG reviewed during its audit. For a number of reasons,
however, this finding does not accurately reflect the overall
compliance of generically approved labels. First, industry typically
submits generically approved labels to FSIS to resolve questions about
some aspect of the label's compliance. Thus, the labels OIG audited
were, by their very nature, more likely to have minor deficiencies than
generically approved labels not voluntarily submitted to FSIS. Second,
nearly all the deficiencies identified were very minor and did not
require label revocation. Moreover, none of the identified deficiencies
created a health or safety concern or provided the establishment with
an economic advantage.
Based on the above, FSIS maintains its view that generic labels
typically comply with labeling regulations. The great majority of
errors that do occur are minor, do not require label revocation, and
are not of public health or economic significance. As such, FSIS did
not conduct another assessment prior to publication of this final rule.
However, as discussed, FSIS has already taken action to address OIG's
recommendations and successfully close the audit, such as reissuing
Directive 7221.1 to clarify that IPP are to include review of generic
labels as part of the General Labeling Task and verify that
establishments have made required modifications, if any, to such
labels. In addition, FSIS will continue to train and support IPP on
this issue via webinars, askFSIS, and other outreach including
participating in IPP training conducted by the FSIS Center for Learning
(CFL).
Comment: An individual commenter argued that the sample size of the
2016 assessment was not adequate to effectively gauge industry
compliance with generic labeling requirements. The commenter also noted
that FSIS did not provide a link to the results of that assessment in
the proposed rule. The commenter recommended that, moving forward, FSIS
perform additional generic labeling assessments.
Response: As discussed in the proposed rule, the 2016 assessment
was a limited assessment conducted to address concerns about the
effectiveness of generic labeling and establish protocols for a
potential future national assessment (85 FR 56538, 56541). Labeling
policy experts reviewed 270 labels for compliance with generic labeling
requirements.\14\ These 270 labels reflect a representative sample from
the five Federally regulated establishments subject to the assessment.
Thus, the sample size was adequate to gauge their compliance with
generic labeling requirements.
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\14\ Methodology available at: https://www.fsis.usda.gov/guidelines/2016-0019.
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FSIS did not produce a report outlining the comprehensive results
of the assessment. Instead, in line with the assessment's methodology,
FSIS drafted
[[Page 2802]]
an assessment summary letter for each individual establishment. FSIS
also discussed the overall results of the assessment in the proposed
rule, noting that the assessment found a high level of compliance with
the generic labeling requirements and identified only three labels with
deficiencies necessitating label revocation (85 FR 56538, 56541). None
of these deficiencies involved food safety.
FSIS may conduct future assessments, as needed, and as Agency time
and resources permit to gauge ongoing industry compliance with generic
labeling, including the provisions in this final rule. However, the
Agency determined that an assessment was not necessary prior to
publication of this final rule, given its previous assessments have
shown a high level of industry compliance with generic labeling
requirements.
B. Cost of Label Review
Comment: One individual stated that the proposed rule is not
necessary because the costs associated with FSIS' label review process
are already relatively low.
Response: FSIS disagrees. The cost of label submissions and
evaluations vary and is dependent on the complexity of the individual
label. FSIS estimates that the total industry and Agency net cost
savings under this rule from the reduction in FSIS label submissions to
be $5,615,403 discounted at the 7 percent discount rate over a 10-year
period, present value. FSIS is focused on making the label approval
process more efficient while ensuring food safety and preventing
misbranded products.
C. Increase in Deficient Labels
Comment: Several individuals expressed concerns that expanding
generic approval to other categories of labels will substantially
increase the number of deficient labels in commerce. Some individuals
also suggested that expanding generic labeling will encourage
establishments to intentionally abuse the labeling system. In addition,
some individuals stated that periodic IPP verification of generic
labels is insufficient to identify and prevent misbranded labels before
they cause harm to consumers.
Response: FSIS disagrees. First, FSIS' experience with generic
label approval does not support the assertion that expanding generic
approval will substantially increase the number of deficient labels in
commerce. Generic labeling has been in place in some form since 1983.
This final rule, like previous expansions of generic approval
eligibility, will continue to require that establishments comply with
FSIS' labeling regulations. Establishments have been required to
include the following features on their product labels for many years:
product name (9 CFR 317.2(c)(1) and (e), 381.117, and 590.411(c)(1));
inspection legend/establishment number (9 CFR 312.2(b), 317.2(c)(5) and
(i), 381.96, 381.123, and 590.411(c)(5)); handling statement (9 CFR
317.2(k), 381.125(a), and 590.410(a)(1)-(2)); net weight (9 CFR
317.2(c)(4) and (h), 381.121, and 590.411(c)(4)); ingredients statement
(9 CFR 317.2(c)(2) and (f), 381.118, and 590.411(c)(1)); signature line
(9 CFR 317.2(c)(3) and (g), 381.122, and 590.411(c)(2)); nutrition
facts panels (9 CFR part 317, subpart B; part 381, subpart Y; and
590.411(e)); and safe-handling instructions (9 CFR 317.2(l) and
381.125(b)). FSIS IPP will continue to verify that establishments'
labels include these features and otherwise comply with labeling
requirements. Moreover, as discussed above, FSIS has evaluated the
compliance of generically approved labels after previous expansions of
generic approval eligibility and found that they typically comply with
labeling regulations. FSIS expects that the categories of labels added
to generic approval by this rule will have a similarly high compliance
rate, and any increase in the number of deficient labels entering
commerce resulting from the expansion of generic label approval by this
rule will be minimal.
FSIS' experience with generic label approval also does not support
the assertion that expanding generic label approval will encourage
establishments to intentionally abuse the labeling system. Past
incidents of establishments intentionally misusing generic label
approval have been rare, and FSIS does not expect that to change with
this rule. IPP routinely perform labeling verification activities in
federally inspected establishments to identify and deter such activity.
Moreover, the costs associated with noncompliance, such as the costs to
replace deficient labels or the disruption of production, disincentive
such behavior. In addition, if any such activity does occur, FSIS may
take action to control misbranded products and take enforcement action
under the FSIS Rules of Practice (9 CFR part 500).
In addition, FSIS disagrees with the assertion that IPP
verification of generic labels is insufficient to identify and prevent
misbranded labels before they cause harm to consumers. IPP have
consistently demonstrated their ability to review generic labels and
ensure a high level of compliance with labeling requirements. FSIS will
revise and reissue instructions to IPP regarding the verification of
generic labels as necessary. For instance, FSIS recently reissued FSIS
Directive 7221.1 to provide IPP with updated instructions for
conducting the General Labeling task in the Public Health Information
System (PHIS) \15\ that are consistent with this final rule. As
discussed, the Agency has also updated the FSIS Guideline for Label
Approval to be consistent with this final rule. FSIS will also update
and administer generic labeling training webinars for IPP, as
necessary. Moreover, this rule is expected to reduce the number of
labels submitted to FSIS, freeing up resources that will allow the
Agency to better focus on providing labeling support to industry and
IPP. FSIS will focus its time and resources on preventing more non-
compliances through new and improved labeling guidance, outreach, and
other support services for its stakeholders, including via phone,
askFSIS, and the Small Plant Help Desk. In addition, IPP will continue
to verify generic labels for compliance on a routine basis and inform
establishments of the need to correct any deficiencies they identify.
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\15\ PHIS is FSIS' dynamic, comprehensive data analytic system,
which was launched as part of the Agency's effort to collect,
consolidate and analyze data in order to improve public health.
---------------------------------------------------------------------------
D. Organic Claims
Comment: A consulting firm and a trade association asked FSIS to
expand generic approval to all ``organic'' labeling on a product,
rather than limiting it to ``organic'' claims listed in the ingredients
statement.
Response: FSIS will not expand generic approval to all ``organic''
labeling at this time. There are additional requirements for labeling a
total product as ``organic'' as opposed to just a particular
ingredient. For example, approving an entire product as ``organic''
requires the review of supporting documentation on ``organic''
processing, including ``organic'' certificates. Such claims need to be
reviewed by LPDS staff that have expertise in the types of supporting
documentation needed to determine compliance. Such ``organic'' claims
are, therefore, not easily verifiable by IPP. Thus, FSIS will continue
to require prior approval for labels that display ``organic'' claims
outside the ingredients statement, including those certifying a total
product as ``organic.''
Comment: Several individuals stated that the rule will weaken
regulatory oversight of ``organic'' claims on meat,
[[Page 2803]]
poultry, and egg products. They also stated that allowing ``organic''
claims in the ingredients statement will mislead consumers into
believing they are buying certified organic products.
Response: The final rule will not weaken oversight of ``organic''
claims. FSIS regulations will continue to require that all ``organic''
claims be truthful and not misleading. LPDS analysts will continue to
evaluate and approve ``organic'' claims displayed outside of the
ingredients statement. IPP will verify the truthfulness of generically
approved ``organic'' ingredient claims made in the ingredients
statement. IPP verify, through record review and observation, that all
ingredients used in the production of the product are present on the
product formulation record and that all ingredients in the product
formulation are declared in the ingredients statement on the product
label by common or usual name in descending order of predominance. IPP
also verify, through record review and observation, that the
appropriate label is applied to the product. IPP directly observe that
all ingredients used in a product formulation are appropriately
declared on the final meat, poultry, or egg product labels. The AMS
National Organic Program will also continue to provide oversight of
organic claims.
FSIS also disagrees that listing some ingredients as ``organic'' in
the ingredients statement will mislead consumers. So long as they are
truthful, the AMS National Organic Program regulations,\16\ which were
first published in December 2000,\17\ permit ``organic'' claims to
appear in the ingredient statements of non-certified products. FSIS did
not propose to change those requirements.
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\16\ 7 CFR part 205.
\17\ 65 FR 80548, December 21, 2000.
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E. Negative Claims
Comment: One producer asked FSIS to clarify whether ``gluten free''
claims qualify for generic approval under the rule. Another individual
specifically opposed any action that would deregulate ``gluten free''
labeling.
Response: The term ``gluten free'' is considered a negative claim
and will receive generic approval under this final rule. However, the
final rule will not deregulate ``gluten free'' labeling or change
recordkeeping requirements. Such claims must still be truthful and not
misleading in accordance with 9 CFR 317.8, 381.1, and 381.129. As
discussed above, IPP will routinely verify the accuracy of generically
approved labels. Specifically, for ``gluten free'' claims, IPP will
verify that the product does not have any gluten containing ingredients
and that there is adequate support for the claims in the labeling
record.
Comment: Some individuals stated that the rule will increase the
likelihood that meat, poultry, and egg products in commerce contain
undeclared allergens or other ingredients that consumers must avoid for
health, ethical, or religious reasons. A few individuals also stated
that generic approval of ``negative'' claims would encourage producers
to publish fraudulent ingredients statements.
Response: FSIS disagrees that the expansion of generic labeling
will increase the likelihood that meat, poultry, or egg products will
contain undeclared ingredients or allergens. The final rule will not
change the requirement that ``negative'' claims must be truthful and
not misleading. This final rule also will not change any requirements
pertaining to product ingredient statements, which must continue to be
truthful and list all ingredients in the product formula (9 CFR 317.2
and 381.118).
When LPDS evaluates labels during prior label review, they ensure
that: the up to eight labeling features required by the meat, poultry,
and egg products inspection regulations are present on the label; any
claims are appropriately supported; and that any undefined claims, ad
copy, or other information that may be false or misleading is not
included on the label. As part of this process, LPDS compares written
product formulations provided by establishments to the ingredients
listed on their product labels. LPDS does not, however, physically
inspect products as they are being made to ensure that only the
ingredients listed on the label are used in final food products. IPP
conduct reviews of this kind in the establishment, after the relevant
label has been approved, whether generically or on a per-case basis by
LPDS analysts.\18\ IPP review labels and compare them to actual product
formulations to verify that the ingredients used in the production of
the product are listed accurately on the label, that the label is not
misleading, and that it is otherwise in compliance with all labeling
requirements. IPP will also continue to perform general labeling tasks
to verify the accuracy of ``negative'' claims.
---------------------------------------------------------------------------
\18\ See FSIS Directive 7221.1, Prior Labeling Approval and FSIS
Directive 7000.1, Verification of Non-Food Safety Consumer
Protection Regulatory Requirements.
---------------------------------------------------------------------------
IPP will also continue to verify that establishments accurately
control and label the most common food allergens. In accordance with
FSIS Directive 7230.1, Ongoing Verification of Product Formulation and
Labeling Targeting the Eight Most Common (``BIG 8'') Food Allergens,
IPP identify products that may contain allergens and routinely conduct
allergen formulation verification tasks at the establishment. These
tasks include a record review and direct observation component to
ensure that all ingredients, including allergens, used in a product
formulation are appropriately declared on the final meat, poultry, or
egg product labels.
Additionally, the final rule will not expand generic approval to
all types of ``negative'' claims (e.g., ``no antibiotics
administered''). FSIS is only expanding generic approval to
``negative'' claims that identify the absence of certain ingredients or
types of ingredients that are not listed in the ingredients statement
and are easily verifiable by IPP. In FSIS' experience, errors or
omissions for these types of claims are rare.
Comment: A trade association stated that some ``negative'' claims,
including ``preservative free,'' ``no artificial ingredients,'' and
``no MSG added,'' are difficult for IPP to verify. Thus, the commenter
asked that FSIS either provide updated guidance on these terms before
publication of the final rule or modify the rule to exclude problematic
claims from generic approval.
Response: FSIS disagrees that ``negative'' ingredient claims are
difficult for IPP to verify. IPP have access to product formulas for
all products produced at Federal establishments, including those
products with labeling bearing ``negative'' ingredient claims. The
General Labeling Task and ``Big 8'' Formulation Verification Task in
PHIS require IPP to compare the product formula with the ingredients
listed on the label. In doing so, IPP will also verify that
``negative'' ingredient claims are truthful and not misleading. In
addition, FSIS has updated and reissued FSIS Directive 7221.1 and the
FSIS Guideline for Label Approval to include additional guidance and
instructions pertaining to ``negative'' claims. FSIS will also continue
to answer questions and provide labeling support to IPP and industry
through askFSIS. In addition, FSIS will perform more outreach and
develop webinars about ``negative'' claims.
Comment: Some non-profit organizations and individual commenters
stated that FSIS should not
[[Page 2804]]
generically approve animal raising claims, including ``negative''
claims pertaining to the raising of the animal.
Response: FSIS agrees. As discussed in the proposed rule, some
claims, including animal raising claims, benefit from LPDS evaluation
due to their complex nature and need for supporting documentation (85
FR 56538, 56545). Therefore, this final rule does not revise any Agency
policy or regulation concerning animal raising claims. As stated in the
proposed rule (85 FR 56538, 56542), generic approval will not apply to
``negative'' claims relating to the raising of the animal from which
the product is derived, e.g., ``no antibiotics administered''.
F. Certified Claims
Comment: One trade association requested that FSIS allow generic
approval of any certified claims, e.g., ``certified non-GMO,'' that are
preapproved by a third-party certifier. In the alternative, the
commenter asked that FSIS develop specific standards for third-party
certifiers, approve certifiers based on those standards, and allow the
generic approval of certified claims where the certification was issued
by an approved certifier. The commenter argued that IPP can easily
verify such claims by reviewing the labeling record.
Response: FSIS will not expand generic approval to certified
claims, preapproved by a third-party certifier. FSIS will continue to
review such claims, including certified animal raising claims,
certified non-GMO claims, and other certifications issued by third
party certifiers. Certified claims include the specific claim,
identification of the certifying entity verifying the claim, and a web-
address for interested parties to obtain additional information on the
standards applied that are being certified. Evaluation of these claims
includes reviewing the claim, standards for the claim, as well as
certificates for applicable products and establishments. The labeling
record must include proof of current certification, accompanied by
certification criteria, which must be evaluated by labeling experts.
Therefore, certified claims are not easily verifiable by IPP.
G. Temporary Label Approval
Comment: A few trade associations requested that FSIS expand
generic approval to cover temporary label extensions for time sensitive
claims (e.g., ``new,'' ``now,'' or ``improved'').
Response: FSIS will not expand generic approval to extensions of
the use of time sensitive label claims (e.g., ``new,'' ``now'' or
``improved''). Temporary use of labels bearing a time sensitive claim
beyond six months may not extend longer than 180 days, as stated in the
Policy Book, unless FSIS LPDS grants an applicant's request for
additional time (9 CFR 412.1(f)). To receive such an extension, an
applicant must demonstrate that denial of the request would create
undue economic hardship and that extending use of the label would not
misrepresent the product, give the applicant an unfair competitive
advantage, or present any health, safety, or dietary problems to the
consumer (9 CFR 412.1(f)(1)). Furthermore, according to the Policy
Book, applicants seeking an extension for time sensitive claims must
demonstrate that production or distribution delays precluded the use of
the approved labeling as scheduled or that labeling inventory needs for
the 180-day period, were overestimated due to poor sales. The Policy
Book also allows the extended use of time sensitive claims in
situations where it is customary to distribute ``new'' products to
various geographical regions if the processor can assure adequate
controls over the segregation and distribution of the products. In
addition, the Policy Book allows FSIS to approve the extended use of
time sensitive claims in situations where the applicant is test
marketing a product, but only if it can demonstrate that just 15
percent or less of the total market is involved in the test marketing.
Because applicants must demonstrate compliance with several
detailed requirements in order to use time sensitive claims beyond 180
days, such extensions are not good candidates for generic approval. IPP
cannot easily verify compliance with such criteria and, thus, the
Agency is concerned that allowing the extension of time sensitive
claims on a generic basis would result in use of the labels well beyond
the 180-day limit. FSIS LPDS will continue to evaluate all extension
requests for the use of time-sensitive claims to ensure that applicants
have demonstrated compliance with pertinent regulations and policy.
Comment: One trade association requested that FSIS allow
establishments to submit temporary and permanent label approval
requests simultaneously. According to the commenter, companies
sometimes need to submit labels for a temporary label approval to
account for an alternate ingredient substitution that requires a change
to the ingredients statement, after which the labels are updated, or
the company reverts to the original ingredient. If the ingredient
substitution is made permanent and the label bears a special statement
or claim potentially affected by the ingredient change, the company
must again submit the same label to obtain sketch approval for the
special statement or claim affected by the ingredient substitution. The
result is that the company must submit--and FSIS must review--the same
label twice. The commenter states that FSIS should streamline this
process by allowing establishments to submit a combined temporary and
permanent approval request.
Response: Extending temporary label approval of labeling with
deficiencies to include a sketch approval of the corrected label is
outside the scope of this rule. Temporary approval of the use of
deficient labels requires that the label meets the criteria described
in 9 CFR 412.1(f)(1)(i-iv), which is a different set of criteria than
that used to evaluate the corrected label.
H. Voluntary Submissions
Comments: Several commenters, including a consulting firm and a few
trade associations, stated that FSIS should continue to evaluate
generically approved labels voluntarily submitted to the Agency,
because, according to the commenters, it is necessary to protect
establishments from legal liability. These commenters also noted that
the proposal to eliminate this review may lead to more non-compliant
labels and product recalls.
Response: FSIS' decision to no longer review generic labels
voluntarily submitted to the Agency will not likely lead to more non-
compliant labels and product recalls. FSIS remains committed to helping
its stakeholders navigate labeling requirements. However, evaluating
generic labels submitted for voluntary review is an inefficient use of
Agency resources as the labels may be applied to products entering
commerce without formal FSIS approval, provided they meet the
conditions in 9 CFR 412.2. Moreover, industry can receive more timely
assistance by utilizing Agency resources or contacting FSIS, given that
voluntarily submitted labels receive a lower review priority than other
labels. Thus, rather than review generically approved labels, FSIS will
focus its time and resources on preventing more non-compliances through
new and improved labeling guidance, outreach, and other support
services for its stakeholders, including via phone, askFSIS, and the
Small Plant Help Desk. In addition, IPP will continue to verify generic
labels for compliance on a routine basis and inform establishments of
the need to correct any deficiencies they identify.
In addition, FSIS review of generic labels was never intended to
protect
[[Page 2805]]
industry from legal liability. Ultimately, establishments bear full
legal responsibility for ensuring that their final product labels are
truthful, accurate, and otherwise in compliance with all applicable
regulations.
Comment: Some commenters, including a few trade associations,
stated that FSIS' review of generically approved labels is sometimes
necessary to help industry and IPP resolve labeling issues. The
commenters asked FSIS to clarify whether it will continue to assist
industry and IPP with generic labeling issues by other means. If
voluntary review is eliminated, the commenters requested that FSIS
develop additional generic labeling guidance and resources for industry
and IPP. One trade association also asked FSIS to establish a help desk
for rapid answers to generic labeling questions.
Response: Given voluntarily submitted labels are not prioritized
for review, submission of such labels is not an efficient means to
resolve labeling questions or other issues for IPP or industry. It is
more efficient for industry and IPP to resolve such issues by
referencing Agency resources, such as published labeling guidance and
webinars, or by contacting FSIS. FSIS will continue to provide IPP and
industry with generic labeling assistance and timely answers to generic
labeling questions via phone or askFSIS. Thus, there is no need for
FSIS to create a new help desk for answering questions or resolving
issues. Moreover, a benefit of the final rule is that staff hours that
were previously spent adjudicating generic labels, will be redirected
toward other Agency priority initiatives that better support IPP and
industry through, amongst other things, the development of new and
improved training for inspectors, updated instructions for IPP,
outreach, and guidance on labeling, including generic labeling.
Comment: Some trade associations and individual commenters stated
that the proposal to eliminate review of labels that can be generically
approved will hurt new or small producers who do not have the expertise
or resources to navigate complex labeling requirements. In addition,
one trade association stated the Agency must continue the practice of
reviewing generic labeling to fulfill its mission under the Small
Business Regulatory Enforcement Fairness Act (SBREFA).
Response: FSIS disagrees with these comments. Although FSIS will no
longer review generic labels, the Agency will continue to be responsive
to small business inquiries about compliance with the Agency's
regulations and otherwise fulfill its obligations under SBREFA. FSIS
will continue to answer inquiries by new or small producers seeking
information and advice on compliance with Agency statutes and
regulations and the interpretation and application of law to specific
sets of facts supplied by the producers. As discussed above, FSIS will
continue to provide many resources to help industry, including new and
small producers, comply with generic labeling requirements. For
example, such producers can directly contact LPDS, whose staff members
are readily available to provide detailed answers to their generic
labeling questions via phone or askFSIS. Small producers can also
utilize FSIS' Small Plant Help Desk to find answers to common questions
from small and very small plant owners and operators across the country
or submit a question to FSIS subject matter experts. In addition, new
and small producers can easily access FSIS' comprehensive labeling
guidance, which is readily available on its website.\19\ Moreover, FSIS
plans to develop additional generic labeling materials, training,
webinars, and other support services to assist new or small producers.
Thus, new or small producers should not need to hire experts or
additional staff to comply with FSIS' labeling requirements.
---------------------------------------------------------------------------
\19\ Website available at: https://www.fsis.usda.gov/inspection/compliance-guidance/labeling.
---------------------------------------------------------------------------
Comment: One trade association stated that FSIS has a legal duty to
continue reviewing any label submitted to the Agency, including
generically approved labels.
Response: FSIS disagrees. The Acts require that the labels be
``approved'' by the Secretary (21 U.S.C. 457(c), 607(d), and 1036(b));
however, they do not require that the approval system be centralized or
decentralized. They also do not prescribe any particular type of system
for the granting of label approvals. Therefore, the Acts permit the
Agency to classify certain types of labels and labeling features as
eligible for ``generic'' approval.
Comment: One individual asked FSIS to clarify whether it conducted
a cost-benefit analysis of its decision to stop reviewing voluntarily
submitted labels.
Response: The cost-benefit analysis that FSIS published in the
proposed rule (85 FR 56538, 56546) and the updated analysis in the
``Alternative Regulatory Approaches'' section of this final rule
considered the alternative of having LPDS continue to evaluate labels
that would otherwise be generically approved. FSIS rejected this
alternative because, among other things, these labels are reviewed at a
slower pace and industry could more quickly get FSIS assistance on
these types of labels via phone, askFSIS, the Small Plant Help Desk, or
other Agency resources. Additional information on the analysis of this
alternative is found below under the heading ``Alternative 2--The Final
Rule, Except Industry Would Still Have the Option to Have LPDS Evaluate
Labels that Would Otherwise be Generically Approved.''
I. Geographic Landmark Claims
Comment: Some trade associations, individual commenters, and the EU
opposed generic approval of geographic landmark claims. They are
concerned that the rule will eliminate regulatory oversight for such
claims, increase the prevalence of misbranded products, and allow
establishments to mislead consumers regarding the origin of their
products by, for example, using foreign flags on domestic product
labels. These commenters also stated that prior label approval of
geographic landmark claims is necessary to preempt violations of
international agreements.
Response: FSIS disagrees with these comments. This final rule does
not change current regulations pertaining to the use of geographic
landmarks, such as foreign flags, on product labels or the
recordkeeping requirements to support such claims. The Acts require all
labeling to be truthful and not misleading (21 U.S.C. 601(n)(1),
453(h)(1), and 1036(b)). Moreover, geographic landmark claims must
continue to specifically comply with 9 CFR 317.8(b)(1) and
381.129(b)(2). These regulations permit, under certain conditions, the
display of foreign flags on domestic products. As discussed in the
proposed rule, IPP will routinely conduct verification and enforcement
activities to verify that geographic landmark claims comply with all
requirements (85 FR 56538, 56543).
FSIS will also continue to conduct export certification activities
for FSIS-regulated products intended for export to foreign countries.
During this process, IPP verify that such products meet country-
specific requirements, including labeling requirements, that have been
officially communicated to FSIS by the importing country. Thus, the
Agency does not expect any issues with regards to obligations it may
have to its international trade partners.
Comment: A trade association and a non-profit organization stated
that allowing generic approval of geographic landmark claims may
weaken, delay, or otherwise conflict with future ``Product of USA''
rulemaking. Thus, they asked that FSIS delay any geographic landmark or
country of origin specific
[[Page 2806]]
label rule changes until after such rulemaking is complete. In
addition, the comments stated that this final rule may weaken the
oversight and integrity of ``Product of USA'' labels and similar
claims, such as ``local'' or ``regional.'' They therefore asked that
these geographic landmark labels continue to go through the prior label
review process.
Response: This final rule will not conflict or interfere with any
future ``Product of USA'' rulemaking. The rule simply modifies the
label approval process to allow for generic approval of graphical
representations of geographic landmarks displayed on a product label,
such as a foreign country's flag, monument, or map. It does not modify
the provisions of 9 CFR 317.8 and 381.129, which regulate the use of
geographic claims to prevent false or misleading labeling. It also does
not modify the label approval process for written claims related to
geographical significance or those that make a country of origin
statement on the label of any meat or poultry product ``covered
commodity.'' \20\ Such claims are already eligible for generic
approval.\21\ It likewise does not affect the current labeling
requirements or the label approval process for similar types of written
statements, such as ``local'' or ``regional.''
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\20\ See 9 CFR 317.8(b)(40) and 381.129(f).
\21\ See 9 CFR 412.2(b).
---------------------------------------------------------------------------
The final rule will also not weaken regulatory oversight of labels
that display geographic landmarks. Although geographic landmark claims
will now be generically approved, the rule does not change any labeling
requirements for such labels. The use of geographic landmarks must be
truthful and not misleading. Moreover, IPP will routinely verify the
accuracy of such labels.
J. Front-of-Package Nutrition Statements
Comment: A trade association requested that FSIS expand generic
approval to include front-of-package (FOP) statements that repeat
information from the nutrition facts panel.
Response: FSIS will not expand generic approval to include FOP
statements that repeat information from the nutrition facts panel. FSIS
considers certain FOP labeling statements, such as those highlighting
select nutrients from the nutrition facts panel placed on the principal
display panel, to be nutrient content claims. The requirements for
defined nutrient content claims are listed in the regulations. However,
unlike traditional nutrient content claims which are defined in FSIS
regulations and are eligible for generic approval, such as ``low fat,''
there are no guidelines for the multiple types of FOP labeling
statements on product labels. Therefore, FSIS needs to continue to
require prior evaluation by the Agency to ensure these statements are
truthful and not misleading.
K. Miscellaneous Comments
Comment: A non-profit organization requested that FSIS modify the
final rule to state that illustrations and depictions of farms, animals
grazing, and animals' living environments are animal raising claims
and, as such, are not eligible for generic approval. A few non-profit
organizations also asked FSIS to adopt uniform standards for common
animal raising claims and require third-party verification of all such
claims, whether made pictorially or textually.
Response: The purpose of this final rule is to expand eligibility
for generic approval to specific categories of labeling. The final rule
will not, and is not intended to, exclude certain types of labeling
from eligibility or to establish any new regulations or policies
regarding animal raising claims.
Comment: One trade association asked FSIS to engage with
stakeholders before it updates its labeling guidance to assure the
updated guidance meets the needs of end users. The commenter stated
that updating guidance without industry input, especially when
substantive changes are being made to the guidance, can cause confusion
and, in the case of labeling, delay bringing products to market.
Response: Consistent with its current practices for developing all
guidance, FSIS is committed to a public process for updating or
publishing new labeling guidance. The availability of all FSIS guidance
is announced in the Federal Register or elsewhere and made available
for public comment. FSIS considers all input received from its
stakeholders and makes changes, as appropriate, to any guidance
documents.
Comment: One individual and a software company stated that FSIS
should use existing software to automatically review labels. According
to the commenters, this would reduce the time spent by FSIS reviewing
labels and allow the Agency to concentrate on other priorities. The
software company also proposed that FSIS adopt a public-private label
review partnership much like AMS uses for organic certification.
Response: These comments are outside the scope of this rulemaking,
as they do not pertain to the Agency's proposed expansion of generic
labeling. Regardless, FSIS is not convinced that existing software can
adequately review labels for compliance with FSIS regulations and
policies. FSIS does, however, use an electronic label system to allow
for easier label submission. Using the Label Submission and Approval
System \22\ (LSAS), establishments can submit label applications,
supporting materials, and appeals to FSIS via the internet. While the
system will not check labels automatically for errors, it will scan
them for some common mistakes in the label submission process,
including illegibility, missing information on the transmittal form,
and missing supporting documentation. The system also includes a
feature that helps submitters determine whether a label can be
generically approved, or if it must be submitted to FSIS for prior
approval.
---------------------------------------------------------------------------
\22\ FSIS' Label Submission and Approval System (LSAS) is a web-
based software application that integrates and implements an
electronic label application process for establishments to submit
label applications to FSIS.
---------------------------------------------------------------------------
Comment: An individual recommended that FSIS take steps to improve
its generic labeling surveillance and enforcement program.
Response: IPP have consistently demonstrated their ability to
review generic labels and ensure a high level of compliance with
labeling requirements. Moreover, FSIS has already taken steps to
improve its verification system by reissuing FSIS Directive 7221.1 to
clarify that, as part of the General Labeling Task, IPP are to
routinely review generic labels and verify that establishments have
made required modifications to such labels. FSIS has also updated
Directive 7221.1 to be consistent with this final rule. In addition,
FSIS will continue to train and support IPP on generic labeling via
webinars, askFSIS, and other outreach, including having LPDS
participate in IPP training conducted by CFL. This final rule promotes
the effective use of Agency resources and will allow FSIS to devote
more time to better supporting IPP through the development of new and
improved training and guidance on, amongst other things, the
surveillance, enforcement, and verification activities related to
generic labeling.
IV. Executive Orders 12866 and 13563
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety
[[Page 2807]]
effects, distributive impacts, and equity). E.O. 13563 emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility. This final rule has
been designated by the Office of Information and Regulatory Affairs a
``significant'' regulatory action under section 3(f) of E.O. 12866.
Accordingly, the rule has been reviewed by the Office of Management and
Budget under E.O. 12866.
Economic Impact Analysis
FSIS has updated the benefits estimates in this final regulatory
impact analysis as compared to the preliminary regulatory impact
analysis published in the proposed rule. These changes include:
updating wage rates to 2021 dollars for food scientists and
technologists; updating wage rates to 2021 dollars for labeling
analysts in LPDS; and updating the number of labeling analysts in LPDS
during fiscal year 2021.
Need for the Rule
The final rule will expand the types of meat, poultry and egg
product labels that are generically approved by FSIS. Therefore, this
rule will reduce the number of labels evaluated by FSIS and will reduce
the costs to industry. The labels submitted for FSIS evaluation are
becoming more complex and more time-consuming for industry to prepare
and for FSIS to evaluate. The final rule will improve the efficiency of
the label approval system by expanding generic labeling and making the
system more convenient and cost efficient for the industry. This final
rule also will enhance market efficiency by promoting a faster
introduction of new products into the marketplace to meet consumer
demand.
Baseline
Based on FSIS' LSAS data, FSIS evaluated 15,459 unique labels
during the 2019 fiscal year (FY). Of these, 5,229 (approximately 34
percent) would have been generically approved if this final rule was in
place in 2019. This amount (5,229) includes 632 labels currently
eligible for generic approval, which firms voluntarily submitted for
FSIS review. Many of the 15,459 labels were evaluated by FSIS more than
once because they were returned to the producer to make corrections and
then resubmitted for FSIS evaluation. FSIS has observed through its
prior label approval system that corrections are rare on the types of
claims that can now be generically approved under this final rule. In
FY 2019, there were 26,158 label adjudications, which includes the
total number of evaluations and reevaluations of labels reviewed. See
Table 2 below for additional details.
Table 2--Label Evaluations and Adjudications, FY 2016-2019
----------------------------------------------------------------------------------------------------------------
FSIS labels 2016 2017 2018 2019
----------------------------------------------------------------------------------------------------------------
Labels FSIS Would Not have Evaluated Under the Final Rule... 8,534 5,812 6,025 5,229
---------------------------------------------------
Total Labels FSIS Evaluated *........................... 22,846 17,958 17,635 15,459
---------------------------------------------------
Total Label Adjudications **............................ 30,857 25,125 27,580 26,158
----------------------------------------------------------------------------------------------------------------
* This is the total number of labels FSIS evaluated, including the labels that would have been generically
approved under the final rule.
** Label adjudications include some labels being reevaluated.
FSIS expanded the types of labels and label changes that may be
generically approved several times, starting in 1983 when the Agency
evaluated 130,000 labels. In 1991, the number of labels evaluated
peaked at 167,500. The 1995 final rule (60 FR 67444) amended the prior
label approval process by expanding the types of labels and label
changes that may be generically approved. From 2003-2010, the number of
label adjudication per year averaged 57,457, with a minimum of 43,255
in 2003 and a maximum of 66,061 in 2010. The 2013 final rule (78 FR
66826, November 7, 2013) further expanded generic labeling, decreasing
the number of label adjudications to 30,857 in FY 2016 (Table 2). FSIS
also finalized a rule permitting generic approval for certain egg
product labels in 2020 (85 FR 68640, October 29, 2020).
The number of FSIS label adjudications decreased after the
expansions of generically approved labels. However, the remaining label
submissions after each expansion are more time-consuming for industry
to prepare and for FSIS to evaluate. This is because the labels
requiring submission after each expansion are generally more complex,
with special statements or claims that require FSIS to evaluate a
significant amount of supporting documentation.
Expected Costs of the Final Rule
The final rule will not impose any new quantifiable costs on
producers that submit labels for FSIS evaluation. Instead, the final
rule will reduce the regulatory burden on producers that submit labels
for evaluation and does not change the recordkeeping requirements.
Producers already are using generically approved labels and maintaining
all labeling records and thus are experienced in submitting labels for
FSIS evaluation.
Expected Benefits of the Final Rule
Industry Impacts
Industry will realize cost savings from the reduction in FSIS label
submissions under the final rule. Industry is required to use FSIS Form
7234-1 (OMB control number: 0583-0092) for the initial FSIS label
submission. The estimated time to complete this form is 75 minutes per
response, which includes reviewing instructions, searching existing
data sources, gathering and maintaining the data needed
(recordkeeping), and completing and reviewing the collection of
information.\23\ FSIS estimates 15 minutes of the 75 minutes are
dedicated to recordkeeping. The recordkeeping time is not included in
the final rule's regulatory impact analysis because the recordkeeping
requirements will not change under the final rule; that is, even if the
establishment does not need to submit the label to FSIS, the
establishment is still required to maintain records to support the
label. Therefore, the average industry time to prepare one label
submission for FSIS evaluation is 60 minutes (75 minutes minus 15
minutes). FSIS also assumed food scientists and technologists perform
this work at a mean hourly wage of $40.46.\24\ A benefits and
[[Page 2808]]
overhead factor of two \25\ was applied to estimate the total labor
cost per label submission of $80.92.
---------------------------------------------------------------------------
\23\ FSIS Form 7234-1 Application for Approval of Labels,
Marking or Device. Last modified 11/16/2011. Available at: https://www.fsis.usda.gov/sites/default/files/2020-08/FSIS_7234-1_Approval_of_Labels_2.pdf.
\24\ BLS Occupational Employment Statistics, Occupational
Employment and Wages, May 2021. 19-1021 Food Scientists and
Technologists. <https://www.bls.gov/news.release/pdf/ocwage.pdfoes/current/oes191012.htm#nat> Accessed on 9/16/2022. Last Modified 03/
31/2022.
\25\ To be consistent with analyses done by the Department of
Health and Human Services, this analysis accounts for fringe
benefits and overhead by multiplying wages by a factor of 2.
---------------------------------------------------------------------------
To determine the annual reduction of label submissions, FSIS relied
on the average number of labels that FSIS would not have evaluated
under the final rule from 2016 to 2019, which was 6,400 labels, ((8,534
+ 5,812 + 6,025 + 5,229)/4), Table 2. Accordingly, FSIS estimates a
decrease of 64,000 label evaluations over 10 years under the final rule
(6,400 * 10). As shown in Table 3, FSIS estimates that industry will
realize a discounted cost savings of $3,637,429 (at a 7 percent
discount rate) and $4,417,690 (at a 3 percent discount rate) by FSIS
generically approving an additional 64,000 labels over a 10-year
period. The cost savings is $517,888 when annualized at the 7 and 3
percent discount rate, over 10 years. The primary estimate is over 10
years, but for illustrative purposes, Table 3 shows the potential cost
savings at the 7 and 3 percent discount rate over 20 years.
Table 3--Estimated Industry Cost Savings
[2021 Dollars]
------------------------------------------------------------------------
Present value Present value
Total industry cost savings from cost savings at cost savings at
reduced need for FSIS label evaluation 7% 3%
------------------------------------------------------------------------
Total over 10 years................... $3,637,429 $4,417,690
Annualized total over 10 years........ 517,888 517,888
Total over 20 years................... 5,486,513 7,704,866
Annualized total over 20 years........ 517,888 517,888
------------------------------------------------------------------------
Agency Impacts
During FY 2021, FSIS employed 15 labeling analysts in LPDS with an
average hourly salary of $72.21 (($53.00 * 36.25%) + $53.00 = $72.21
for a GS-13 step 3,\26\ with an adjusted benefits factor of 36.25
percent).\27\ Prior to this final rule, on average, LPDS analysts
evaluated labels four hours per day, five days a week, at a cost of
$21,663 per week. Under the final rule, LPDS analysts will evaluate
labels for three hours per day, five days a week, at a cost of $16,247
per week, because of the reduction in labels submitted to FSIS.
---------------------------------------------------------------------------
\26\ Salary Table 2021-DCB for the locality pay area of
Washington-Baltimore-Arlington, DC-MD-VA-WV-PA. Effective January
2021. Available at: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/DCB_h.pdf.
\27\ Nussle, Jim. (2008). M-08-13: MEMORANDUM FOR THE HEADS OF
EXECUTIVE DEPARTMENTS AND AGENCIES. Executive Office of the
President. Available at: https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2008/m08-13.pdf.
---------------------------------------------------------------------------
Under the final rule, the Agency will realize a discounted cost
savings of $1,977,974 (at a 7 percent discount rate) and $2,402,267 (at
a 3 percent discount rate) for adjudicating fewer labels over a 10-year
period. The cost savings is $281,619 when annualized at the 7 and 3
percent discount rate over 10 years. The primary estimate is over 10
years, but for illustrative purposes, Table 4 shows the potential cost
savings at the 7 and 3 percent discount rate over 20 years. See Table 4
for additional details.
The Agency plans to utilize any resources made available by this
final rule to work on other Agency priority initiatives, such as
developing and updating policy and guidance documents, answering
questions from askFSIS and other sources, and performing outreach
activities. This change in Agency workload will result in more
resources for the industry, which improves efficiencies for the Agency
and industry alike.
FSIS also anticipates an overall faster label review process from
the decline in LPDS label evaluations. This will allow new labels to
enter the market faster.
Table 4--Estimated Agency Cost Savings
[2021 Dollars]
------------------------------------------------------------------------
Present value Present value
Total agency cost savings from reduced cost savings at cost savings at
need for FSIS label evaluation 7% 3%
------------------------------------------------------------------------
Total over 10 years................... $1,977,974 $2,402,267
Annualized total over 10 years........ 281,619 281,619
Total over 20 years................... 2,983,476 4,189,780
Annualized total over 20 years........ 281,619 281,619
------------------------------------------------------------------------
Net Benefits
This final rule will be net beneficial because it will reduce the
costs to establishments, from submitting fewer labels for FSIS
evaluation, while imposing no additional cost burden. The net benefit
derived from the final rule is estimated to be $5,615,403 ($3,637,429
in establishment savings plus $1,977,974 in Agency savings) discounted
at the 7 percent discount rate over a 10-year period. When annualized
at the 7 percent discount rate over 10 years, the net cost savings is
estimated to be $799,507. For illustrative purposes, we also included
the net cost savings over 20 years in Table 5. See Table 5 for details.
[[Page 2809]]
Table 5--Estimated Net Benefits
[2021 Dollars]
------------------------------------------------------------------------
Total agency and industry cost savings Present value Present value
from reduced need for FSIS label cost savings at cost savings at
evaluation 7% 3%
------------------------------------------------------------------------
Total over 10 years................... $5,615,403 $6,819,957
Annualized total over 10 years........ 799,507 799,507
Total over 20 years................... 8,469,989 11,894,645
Annualized total over 20 years........ 799,507 799,507
------------------------------------------------------------------------
Alternative Regulatory Approaches
The Agency considered three alternatives to the final rule. The
final rule was chosen as the least burdensome regulatory approach. The
summary of the costs and benefits for the considered alternatives are
outlined in Table 6 below.
Table 6--Regulatory Alternatives Considered
----------------------------------------------------------------------------------------------------------------
Alternative Benefits Costs Net benefit
----------------------------------------------------------------------------------------------------------------
(1) Take No Action................... No Benefit............. No potential industry Net benefits are less
or Agency cost savings. than alternative 3.
(2) The Final Rule, Except Industry Industry could benefit Potential for Net benefits are less
Would Still Have the Option to Have from additional FSIS inefficient use of than alternative 3.
LPDS Evaluate Labels that Would evaluation. Agency resources. Although industry
Otherwise be Generically Approved. Industry would also could marginally
incur costs of benefit from
submitting the labels additional FSIS
and waiting for FSIS evaluation, sufficient
evaluation. guidance is available
for labels that can be
generically approved.
Also, industry and the
Agency would incur
costs from submitting
and evaluating such
labels.
(3) The Final Rule................... Potential industry cost No quantifiable costs.. Net benefits are
savings of $517,888 $799,507 annualized at
and Agency cost the 7 percent discount
savings of $281,619, rate over 10 years.
annualized at the 7
percent discount rate
over 10 years.
(4) Allow All FSIS Labels to be The Agency and industry Costs include Net benefits are less
Generically Approved. would benefit from potentially increasing than alternative 3 as
time savings by the number of the potential costs of
eliminating FSIS label misbranded products. misbranded products
evaluation. from eliminating FSIS
label evaluation
outweighs the time
savings benefit.
----------------------------------------------------------------------------------------------------------------
Alternative 1--No Action (Baseline)
FSIS considered keeping the current regulations and taking no
action. Taking no action would mean that industry and the Agency would
not experience costs savings from the reduction of labels submitted for
FSIS evaluation under the final rule. Industry would therefore not
realize the estimated reduction of 64,000 label submissions over 10
years and would not experience an annualized cost savings of $517,888
at the 7 percent discount rate over 10 years. The Agency would not
experience time savings from the reduction of label evaluations.
Therefore, the Agency rejects this alternative.
Alternative 2--The Final Rule, Except Industry Would Still Have the
Option To Have LPDS Evaluate Labels That Would Otherwise Be Generically
Approved
FSIS considered an alternative of finalizing the same generically
approved label categories except FSIS would continue to evaluate those
labels that would otherwise be generically approved. Prior to the final
rule, industry could submit labels that could be generically approved
for voluntary FSIS evaluation, although this evaluation was not needed
prior to entering the market. When industry submitted these types of
labels for voluntary FSIS evaluation, they were reviewed with a lower
priority than other labels, and thus took more time for FSIS to
approve. Although industry may marginally benefit from the additional
FSIS evaluation, the process is inefficient and raises unnecessary
costs. Industry can more quickly get FSIS assistance on these types of
labels through other guidance, such as askFSIS.
In addition, FSIS would have to take the time to process and
evaluate these labels, when reviewer time could be spent on higher
priorities, such as policy related issues (e.g., updating priority
labeling regulations or labeling guidance). Industry would also incur
costs in preparing and submitting the labels for FSIS evaluation while
they can get FSIS help through other outlets without incurring these
expenses. For these reasons, FSIS rejects this alternative.
Alternative 3--The Final Rule
The final rule yields cost savings for both the industry and the
Agency. There is no additional cost burden from the final rule. The
potential cost savings for industry is $517,888, annualized at the 7
percent discount rate over 10 years. This covers the time industry
saves from not preparing and submitting the labels for FSIS evaluation.
The potential cost savings for FSIS is $281,619, annualized at the
7 percent discount rate over 10 years. This covers the time FSIS saves
from not evaluating the generically approved labels. Since there is no
additional burden for this final rule, FSIS determined this to be the
preferred alternative.
Alternative 4--All Labels Are Generically Approved
FSIS also considered an alternative that would allow all labels to
be generically approved, requiring no prior approval by FSIS. This
alternative may increase the number of misbranded products going into
commerce, as LPDS would no longer verify the information on complex
labels. An increase in misbranded products that contain incorrect,
false, or misleading information may result in a loss of consumer
confidence in information on food labels. There is also cost associated
with discarding and reprinting misbranded labels that the industry may
[[Page 2810]]
suffer. Therefore, FSIS believes the labels that will still require
prior evaluation under the final rule, such as labels with animal
raising, natural, or front of package nutrition labeling claims,
benefit from LPDS evaluation due to the complex nature and need for
supporting documentation of these claims.
This alternative would yield time savings for industry from no
longer preparing and submitting labels for FSIS evaluation. FSIS would
also experience time savings from no longer evaluating these labels.
However, the potential costs of misbranded products entering commerce,
resulting from the elimination of all LPDS label evaluation, would
outweigh the benefits of the time savings.
V. Regulatory Flexibility Act Assessment
The FSIS Administrator certifies that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-602), this final rule will not
have a significant economic impact on a substantial number of small
entities in the United States. This determination was made because
small producers will experience costs savings from the reduced number
of label submissions for FSIS evaluation.
Based on LSAS and PHIS data, FSIS estimates 92.3 percent (4,825/
5,229) of the label submissions in 2019, which would have been
generically approved under the final rule, are from small or very small
Hazard Analysis and Critical Control Point (HACCP) sized
establishments. Under the HACCP size definitions, large establishments
have 500 or more employees and small establishments have fewer than 500
but more than 10 employees. Very small establishments have fewer than
10 employees or annual sales of less than $2.5 million. Small and very
small establishments, like large establishments, follow the same
standards for generic and sketch approval of labels. Small and very
small producers, therefore, will not be disadvantaged because the final
rule will minimize the regulatory burden on all producers.
Based on 2019 LSAS data, about 12 percent (627/5,229) of labels
that would have been generically approved under the final rule, were
submitted from 19 label consultant firms. These firms are very small,
usually having one to four employees. Many of these firms provide a
range of services, including label courier services, label consultation
and regulatory compliance, or label design. This final rule may impact
their label courier business. However, the impact on these firms is
small as their other business, such as label consultations, will not be
affected. Therefore, this final rule will not have a significant
economic impact on the small label consultant firms.
VI. Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements have been submitted for approval to the
Office of Management and Budget (OMB).
FSIS is expanding the circumstances under which it will generically
approve the labels of meat, poultry, and processed egg products. Under
this final rule, more official and foreign establishments will be able
to use the generic approval of product labels. As a result, fewer
labels will need to be submitted and evaluated by FSIS. The relevant
information collection, 0583-0092, Marking, Labeling, and Packaging,
has a net reduction of 6,400 burden hours because of the increased use
of generic labeling.
VII. USDA Non-Discrimination Statement
In accordance with Federal civil rights law and USDA civil rights
regulations and policies, USDA, its Mission Areas, agencies, staff
offices, employees, and institutions participating in or administering
USDA programs are prohibited from discriminating based on race, color,
national origin, religion, sex, gender identity (including gender
expression), sexual orientation, disability, age, marital status,
family/parental status, income derived from a public assistance
program, political beliefs, or reprisal or retaliation for prior civil
rights activity, in any program or activity conducted or funded by USDA
(not all bases apply to all programs). Remedies and complaint filing
deadlines vary by program or incident.
Program information may be made available in languages other than
English. Persons with disabilities who require alternative means of
communication to obtain program information (e.g., Braille, large
print, audiotape, American Sign Language) should contact the
responsible Mission Area, agency, or staff office; the USDA TARGET
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service
at (800) 877-8339.
To file a program discrimination complaint, a complainant should
complete a Form AD-3027, USDA Program Discrimination Complaint Form,
which can be obtained online at https://www.ocio.usda.gov/document/ad-3027, from any USDA office, by calling (866) 632-9992, or by writing a
letter addressed to USDA. The letter must contain the complainant's
name, address, telephone number, and a written description of the
alleged discriminatory action in sufficient detail to inform the
Assistant Secretary for Civil Rights (ASCR) about the nature and date
of an alleged civil rights violation. The completed AD-3027 form or
letter must be submitted to USDA by:
(1) Mail: U.S. Department of Agriculture, Office of the Assistant
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC
20250-9410;
(2) Fax: (833) 256-1665 or (202) 690-7442; or
(3) Email: [email protected].
USDA is an equal opportunity provider, employer, and lender.
VIII. E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.
IX. Executive Order 12988, Civil Justice Reform
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this rule: (1) All State and local laws and
regulations that are inconsistent with this rule will be preempted; (2)
no retroactive effect will be given to this rule; and (3) no
administrative proceedings will be required before parties may file
suit in court challenging this rule.
X. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. Executive Order 13175 requires Federal agencies to consult
and coordinate with tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects 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.
[[Page 2811]]
The USDA's Office of Tribal Relations (OTR) has assessed the impact
of this rule on Indian tribes and determined that this rule does not,
to our knowledge, have tribal implications that require tribal
consultation. If a tribe requests consultation, FSIS will work with the
OTR to ensure meaningful consultation is provided where changes,
additions, and modifications identified herein are not expressly
mandated by Congress.
XI. Environmental Impact
Each USDA agency is required to comply with 7 CFR part 1b of the
Departmental regulations, which supplements the National Environmental
Policy Act regulations published by the Council on Environmental
Quality. Under these regulations, actions of certain USDA agencies and
agency units are categorically excluded from the preparation of an
Environmental Assessment (EA) or an Environmental Impact Statement
(EIS) unless the agency head determines that an action may have a
significant environmental effect (7 CFR 1b.4 (b)). FSIS is among the
agencies categorically excluded from the preparation of an EA or EIS (7
CFR 1b.4 (b)(6)).
FSIS has determined that this final rule, which refines the
Agency's existing label approval program, will not create any
extraordinary circumstances that would result in this normally excluded
action having a significant individual or cumulative effect on the
human environment. Therefore, this action is appropriately subject to
the categorical exclusion from the preparation of an environmental
assessment or environmental impact statement provided under 7 CFR
1b.4(6) of the U.S. Department of Agriculture regulations.
XII. Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS web page located at:
https://www.fsis.usda.gov/federal-register.
FSIS will also announce and provide a link to it through the FSIS
Constituent Update, which is used to provide information regarding FSIS
policies, procedures, regulations, Federal Register notices, FSIS
public meetings, and other types of information that could affect or
would be of interest to our constituents and stakeholders. The
Constituent Update is available on the FSIS web page. Through the web
page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves and have the option to password protect
their accounts.
List of Subjects
9 CFR Part 352
Food labeling, Meat inspection, Reporting and recordkeeping
requirements.
9 CFR Part 354
Administrative practice and procedure, Animal diseases, Food
labeling, Meat inspection, Rabbits and rabbit products, Reporting and
recordkeeping requirements, Signs and symbols.
9 CFR Part 362
Food labeling, Poultry and poultry products, Reporting and
recordkeeping requirements.
9 CFR Part 412
Food labeling, Food packaging, Meat and meat products, Meat
inspection, Poultry and poultry products, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, FSIS is amending 9 CFR
chapter III as follows:
PART 352--EXOTIC ANIMALS AND HORSES; VOLUNTARY INSPECTION
0
1. The authority citation for part 352 continues to read as follows:
Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17(g) and (i), 2.55.
0
2. In Sec. 352.7:
0
a. Revise the section heading;
0
b. Remove the first sentence of the introductory text;
0
c. Add a sentence to the end of the introductory text.
The revision and addition read as follows:
Sec. 352.7 Marking and labeling of inspected products.
* * * All labels intended for use on inspected and passed exotic
animal products must be approved in accordance with Part 412 of this
chapter.
* * * * *
PART 354--VOLUNTARY INSPECTION OF RABBITS AND EDIBLE PRODUCTS
THEREOF
0
3. The authority citation for part 354 continues to read as follows:
Authority: 7 U.S.C. 1622, 1624; 7 CFR 2.17(g) and (i), 2.55.
0
4. Revise Sec. 354.60 to read as follows:
Sec. 354.60 Approval of official identification.
All labels intended for use on inspected and passed rabbit products
which bear any official identification must be approved in accordance
with part 412 of this chapter.
PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS
0
5. The authority citation for part 362 continues to read as follows:
Authority: 7 U.S.C. 1622; 7 CFR 2.18(g) and (i) and 2.53.
0
6. In Sec. 362.2, revise the second sentence of paragraph (a) to read
as follows:
Sec. 362.2 Types and availability of service.
* * * * *
(a) * * * All provisions of Part 381, Part 412, and Sec. Sec.
416.1 through 416.6 of this chapter shall apply to the slaughter of
poultry, and the preparation, labeling, and certification of the
poultry and poultry products processed under this poultry inspection
service except for the following provisions: the definitions of
``Act,'' ``animal food manufacturer,'' ``Inspection Service,''
``inspector,'' ``Inspector in Charge,'' ``poultry,'' ``poultry
product,'' ``poultry food product,'' ``poultry products broker,''
``renderer,'' and ``U.S. Refused Entry'' in Sec. Sec. 381.1 b), 381.3
(a), 381.6, 381.10, 381.13 through 381.17, 381.21, 381.29, 381.39
through 381.42, 381.175(a)(2) and (3), 381.179, 381.185 through
381.187, 381.192, and 381.195 through 381.225.
* * * * *
PART 412--LABEL APPROVAL
0
7. The authority citation for part 412 continues to read as follows:
Authority: 21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53.
0
8. In Sec. 412.1, remove and reserve paragraph (c)(2) and revise
paragraph (e).
The revision reads as follows:
Sec. 412.1 Label approval.
* * * * *
(e) ``Special statements and claims'' are statements, claims,
logos, trademarks, and other symbols on labels as defined in this
paragraph (e).
[[Page 2812]]
(1) The following are considered special statements and claims:
(i) Those not defined in the Federal meat and poultry products
inspection regulations or the Food Standards and Labeling Policy Book;
(ii) ``Natural'' claims, regardless of whether they are defined in
the Food Standards and Labeling Policy Book; and
(iii) Health claims (including graphic representations of hearts),
ingredient and processing method claims (e.g., high-pressure
processing), structure-function claims, claims regarding the raising of
animals (e.g., ``no antibiotics administered''), products labeled as
organic (except for those where only individual ingredients are labeled
as organic), and instructional or disclaimer statements concerning
pathogens (e.g., ``for cooking only'' or ``not tested for E. coli
O157:H7'').
(2) The following are not considered special statements and claims:
(i) Allergen statements (e.g., ``contains soy'') applied in
accordance with the Food Allergen Labeling and Consumer Protection Act;
(ii) Negative claims regarding ingredients not listed in the
ingredients statement (e.g., ``No MSG Added,'' ``Preservative Free,''
``No Milk,'' ``No Pork,'' or ``Made Without Soy'');
(iii) Statements that characterize a product's nutrient content in
compliance with Title 9 of the CFR, such as ``low fat''; and
(iv) Claims related to geographical significance, such as ``German
Brand Made in the US,'' or those that make a country of origin
statement on the label of any meat or poultry product ``covered
commodity,'' \1\ or displays of geographic landmarks, such as a foreign
country's flag, monument, or map.
---------------------------------------------------------------------------
\1\ See 9 CFR 317.8(b)(40) and 381.129(f).
---------------------------------------------------------------------------
* * * * *
0
9. In Sec. 412.2, revise paragraph (b) to read as follows:
Sec. 412.2 Approval of generic labels.
* * * * *
(b) Generically approved labels are labels that bear all applicable
mandatory labeling features (i.e., product name, handling statement,
ingredients statement, the name and place of
business of the manufacturer, packer or distributor, net weight,
legend, safe handling instructions, and nutrition labeling) in
accordance with Federal regulations and do not bear special statements
and claims as defined in Sec. 412.1(e).
Done at Washington, DC.
Paul Kiecker
Administrator.
[FR Doc. 2023-00693 Filed 1-17-23; 8:45 am]
BILLING CODE 3410-DM-P