Prior Label Approval System: Expansion of Generic Label Approval, 56538-56548 [2020-17340]
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Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Proposed Rules
to warrant preparation of a Federalism
Assessment.
E.O. 12988, Civil Justice Reform
This regulation meets the applicable
standard set forth in section 3(a) and
(b)(2) of Executive Order 12988.
Unfunded Mandates Reform Act of
1995
This rule will not result in the
expenditure by State, local, or tribal
governments of more than $100 million
annually. Thus, no written assessment
of unfunded mandates is required.
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35)
This regulatory action will not impose
any additional reporting or
recordkeeping requirements under the
Paperwork Reduction Act.
List of Subjects in 5 CFR Part 316
Employment, Government employees.
Office of Personnel Management.
Alexys Stanley,
Regulatory Affairs Analyst.
Accordingly, we propose to amend 5
CFR part 316 as follows:
PART 316—TEMPORARY AND TERM
EMPLOYMENT
1. Revise the authority citation for part
316 to read as follows:
than 10 years from the date of the initial
appointment.
■ 3. Amend § 316.302 by revising
paragraph (b)(7) to read as follows:
DEPARTMENT OF AGRICULTURE
to https://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
• Mail, including CD–ROMs, etc.:
Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and
Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758, Room 6065,
Washington, DC 20250–3700.
• Hand or Courier-Delivered
Submittals: Deliver to 1400
Independence Avenue SW, Room 6065,
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, Room 6065,
Washington, DC 20250–3700.
FOR FURTHER INFORMATION CONTACT:
Rachel Edelstein, Acting Assistant
Administrator, Office of Policy and
Program Development, by telephone at
(202) 720–0399.
SUPPLEMENTARY INFORMATION:
Food Safety and Inspection Service
Executive Summary
§ 316.302
Selection of term employees.
*
*
*
*
*
(b) * * *
(7) Reappointment on the basis of
having left a term appointment prior to
serving the 4-year maximum amount of
time allowed under the appointment per
§ 316.301(a), the maximum time
allowed for an appointment authorized
under this paragraph (b), or the 10-year
maximum amount of time allowed
under § 316.301(c). Reappointment must
be to a position in the same agency for
filling under the original term
appointment and for which the
individual qualifies. Combined service
under the original term appointment
and reappointment must not exceed the
4-year limit for positions pursuant to
§ 316.301(a), the maximum time
allowed for an appointment authorized
under § 316.301(b), or the 10-year limit
under § 316.301(c), as appropriate; or
*
*
*
*
*
[FR Doc. 2020–20038 Filed 9–11–20; 8:45 am]
BILLING CODE 6325–39–P
■
Authority: 5 U.S.C. 3301, 3302; E.O.
10577, 3 CFR, 1954–1958 Comp., p. 218; 5
CFR 2.2(c).
9 CFR Parts 352, 354, and 412
[Docket No. FSIS–2019–0019]
Subpart C—Term Employment
RIN 0583–AD78
2. Amend § 316.301 by adding
paragraph (c) to read as follows:
Prior Label Approval System:
Expansion of Generic Label Approval
§ 316.301
AGENCY:
■
Purpose and duration.
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*
*
*
*
*
(c) An agency may make a term
appointment for a period of more than
1 year but not more than 10 years to any
science, technology, engineering,
mathematics (STEM) position when the
need for an employee’s services is not
permanent; or for positions needed to
stand-up, operate, and close-out timelimited organizations which have a
specific statutory appropriation; or timelimited projects which have been
funded through specific congressional
appropriation. An agency may extend
an appointment made for more than 1
year but fewer than 10 years up to the
10-year limit in increments determined
by the agency. The vacancy
announcement must state that the
agency has the option of extending a
term appointment under this section up
to the 10-year limit. No appointment
made under this section may last longer
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Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
The Food Safety and
Inspection Service (FSIS) is proposing
to amend its inspection regulations to
expand the circumstances under which
FSIS will generically approve the labels
of meat, poultry, and egg products. FSIS
is also proposing to cease evaluating
generically approved labels submitted to
FSIS for review.
DATES: Submit comments on or before
November 13, 2020.
ADDRESSES: FSIS invites interested
persons to submit comments on this
document. Comments may be submitted
by one of the following methods:
• Federal eRulemaking Portal: This
website provides commenters the ability
to type short comments directly into the
comment field on the web page or to
attach a file for lengthier comments. Go
SUMMARY:
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Sfmt 4702
To prevent the introduction of
adulterated or misbranded products into
commerce, the Food Safety and
Inspection Service (FSIS) implements a
prior approval program for labels
intended to be used on federally
inspected meat, poultry, and egg
products (9 CFR part 412). Without
approved labels, these products may not
be sold, offered for sale, or otherwise
distributed in commerce.
Certain categories of labels or
renderings of such labels (sketch labels)
must be submitted to FSIS for review
and approval before use. However, FSIS
considers certain labels that comply
with the Agency’s labeling rules to be
‘‘generically’’ approved. Such labels are
not submitted to FSIS, because they are
deemed approved and may be applied
to product in commerce.
Generic label approval has been in
place in some form since 1983. FSIS has
previously expanded the categories of
labeling claims eligible for generic
approval, most recently in 2013 (78 FR
66826, November 7, 2013). FSIS has also
published a proposed rule that, if
finalized as proposed, would permit
generic approval for egg product labels
(83 FR 6314, February 13, 2018). FSIS
is now proposing to expand the
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Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Proposed Rules
categories of meat, poultry, and egg
product labels that it will deem
generically approved and thus not
required to be submitted to FSIS.
Specifically, under this proposal the
following labels would no longer need
to be submitted to FSIS for approval: (1)
Labels on products for export that
deviate from FSIS requirements; (2)
labels that list ingredients in the
ingredients statement as being certified
‘‘organic’’ (e.g., organic garlic) under the
Agricultural Marketing Service (AMS)
National Organic Program; (3) labels
that display geographic landmarks, such
as a foreign country’s flag, monument,
or map; (4) labels that make ‘‘negative’’
claims identifying the absence of certain
ingredients or types of ingredients (e.g.,
statements such as ‘‘No MSG Added,’’
‘‘Preservative Free,’’ ‘‘No Milk,’’ ‘‘No
Pork,’’ or ‘‘Made Without Soy’’); and (5)
labels of products that receive voluntary
FSIS inspection (e.g., exotic species
under 9 CFR part 352). Finally, FSIS is
proposing to cease evaluating labels
submitted to FSIS that are eligible for
generic approval.
These reforms would result in an
estimated 33.8 percent reduction in
label submissions (based on fiscal year
2019 data) and reduce Agency costs
expended to evaluate the labels (see
Table 1). There will not be any negative
food safety impacts from this proposal,
based on FSIS’s experience evaluating
56539
these types of labels and the ability of
inspection personnel to continue to
verify labeling requirements in the field.
There is no cost burden for the
industry or FSIS for the proposed rule.
This is shown in Table 1 below, which
summarizes the costs and benefits of the
proposed rule. Industry would
experience cost savings of $468,864,
annualized at the 7 percent discount
rate over 10 years, from the reduction in
preparing and submitting certain labels
for FSIS evaluation. FSIS would
experience cost savings of $235,690,
annualized at the 7 percent discount
rate over 10 years, from the reduction in
label evaluations.
TABLE 1—SUMMARY OF ANNUALIZED COSTS AND BENEFITS
Costs
Cost savings
Net benefits
Industry ........................................................................................................................................
Agency .........................................................................................................................................
$0
0
$468,864
235,690
$468,864
235,690
Total ......................................................................................................................................
0
704,554
704,554
Note: Estimates are annualized using a 7 percent discount rate over 10 years.
Table of Contents
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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I. Background
A. Current Label Regulations
B. Current Prior Label Approval System
C. Generic Label Approval
II. Proposed Rule
III. Surveillance and Enforcement
IV. Executive Orders 12866 and 13563
V. Regulatory Flexibility Act Assessment
VI. Executive Order 13771
VII. Paperwork Reduction Act
VIII. E-Government Act
IX. Executive Order 12988
X. Executive Order 13175
XI. USDA Non-Discrimination Statement
XII. Environmental Impact
XIII. Congressional Review Act
XIV. Additional Public Notification
A. Current Label Regulations
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.) 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 of these provisions is that
they require the Secretary or his or her
representative to approve all labels to be
used on federally inspected and passed,
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The meat, poultry, and egg products
labeling regulations require that meat,
poultry, and egg products are truthfully
labeled, and that the labeling provides
the necessary product information for
consumers to make informed
purchasing decisions.
There are up to eight features required
on meat, poultry, and egg product
labels. The required features include: (1)
The standardized, common or usual, or
descriptive name, of the product (9 CFR
317.2(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(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(g), 381.122, and
590.411(c)(2)); (4) an accurate statement
of the net quantity of contents (9 CFR
317.2(h), 381.121, and 590.411(c)(4)); (5)
the inspection legend, including the
number of the official establishment (9
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CFR 312.2(b), 317.2(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)); 1 and (8) safe handling
instructions if the meat or poultry
component of the product is not readyto-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)).
These required features must appear
on the immediate containers of
domestic products (9 CFR part 317,
subpart A, and part 381, subpart N) and
imported products (9 CFR part 327 and
part 381, subpart T; 590.411(c); and
590.950(a)). The meat inspection
regulations define an ‘‘immediate
container’’ as ‘‘the receptacle or other
covering in which any product is
directly contained or wholly or partially
enclosed’’ (9 CFR 301.2). The EPIA and
poultry products inspection regulations
define an ‘‘immediate container’’ as
‘‘any consumer package; or any other
container in which poultry products,
1 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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not consumer packaged, are packed’’ (21
U.S.C. 1033(d)(1) and 9 CFR 381.1(b)).
The principal display panel,
information panel, or other surface of
the product label must prominently
display the mandatory features. The first
six features described above, and the
labeling of country of origin for
imported products in accordance with 9
CFR 327.14 and 381.205, have been
required by the meat and poultry
inspection regulations for decades. FSIS
published regulations that require the
nutrition labeling of cooked or heattreated multi-ingredient meat and
poultry products and the display of safe
handling instructions in 1993 and 1994,
respectively. Given industry’s
familiarity with these requirements,
FSIS typically finds establishments in
compliance with its labeling
regulations.
The regulations contain other
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)). Pursuant to
the authority contained in section 7(e)
of the FMIA (21 U.S.C. 607(e)), section
8(d) of the PPIA (21 U.S.C. 457(d)), and
section 7(b) of the EPIA (21 U.S.C.
1036(b)), the Administrator of FSIS may
withhold the use of any marking or
labeling that is false or misleading,
within the meaning of the FMIA, PPIA,
and EPIA and their implementing
regulations.
B. Current Prior Label Approval System
Under the current regulations, FSIS
evaluates sketches of some labels for
approval, and approves others
generically, i.e., without submission to
FSIS for sketch approval. A sketch label
is a printer’s proof or other version that
clearly shows all required label features,
size, location, and indication of final
color (9 CFR 412.1(d)). To obtain sketch
label approval, domestic meat and
poultry establishments, egg product
plants, and certified foreign
establishments that are eligible to export
product to the United States, or their
representatives, are required to submit
sketch labels to FSIS for evaluation,
except when the label is generically
approved by the Agency under 9 CFR
412.2.
These firms submit sketch labels
accompanied by FSIS Form 7234–1 (11/
16/2011), ‘‘Application for Approval of
Labels, Marking or Device,’’ to the
Agency for evaluation. In addition to the
required label information, any special
claims or statements that the
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establishment intends to make (e.g.,
quality claims, animal production
raising claims, product origin claims, or
nutrient content claims) must be
included on the label, along with
documentation supporting the claim.
The label application must contain the
basic information about the
establishment and the product,
including:
1. Establishment number;
2. Product name;
3. Product formulation;
4. Processing procedures and
handling information;
5. Firm name and address;
6. Total available labeling space of the
container;
7. Size of the principal display panel;
and
8. The Hazard Analysis and Critical
Control Point category under which the
establishment is producing the meat or
poultry product.
FSIS’s Labeling and Program Delivery
Staff (LPDS), in the Office of Policy and
Program Development (OPPD), verifies
that sketch labels comply with the
applicable requirements. Since July 1,
1996, a final version of a verified sketch
label does not have to be submitted to
the Agency for evaluation and approval
(60 FR 67444, December 29, 1995).2 All
labels are subject to verification for
compliance with Agency regulations by
FSIS inspectors to ensure that they are
accurate, truthful, and not misleading.
C. Generic Label Approval
FSIS allows certain meat, poultry, and
egg product labels that bear all required
labeling features and that comply with
the Agency’s labeling regulations to be
generically approved (9 CFR
412.2(a)(1)). Generically approved labels
do not need to be submitted to FSIS for
sketch approval before they can be used
on products in commerce. Generic label
approval requires that all mandatory
label features are prominent and
conform to FSIS regulations. Although
such labels are not submitted to FSIS for
approval, they are deemed to be
approved and, therefore, may be applied
to product in accordance with the
Agency’s prior label approval system.
Generic label approval has been in
place in some form since 1983. That
year, FSIS promulgated regulations that
granted limited label approval authority
to Inspectors-In-Charge (IICs) at official
establishments and provided generic
approval to limited types of labels (e.g.,
labels for raw, single ingredient meat
2 On February 13, 2018 FSIS published the Egg
Products Inspection Regulations proposed rule (83
FR 6314). If the rule is finalized as proposed, FSIS
will also not require submission of final versions of
sketch labels for egg products.
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and poultry products) (48 FR 11410,
March 18, 1983). The rulemaking’s
intent was to reduce the number of
labels and other materials submitted for
FSIS evaluation and to ease the
paperwork burden on official
establishments.
Even with the changes made by the
rule, the number of labels submitted to
the Agency continued to grow. During
fiscal year 1991, the Agency processed
approximately 167,500 labels. Of these,
FSIS approved approximately 87,500
final labels and 60,000 sketch labels.
FSIS disapproved approximately 20,000
labels.
On December 29, 1995, FSIS
published a final rule that outlined the
types of labels and modifications to
labels that were deemed to be approved
without submission to FSIS, provided
that the label displayed all mandatory
label features in conformance with
applicable Federal regulations (60 FR
67444). The following labeling was
deemed generically approved in that
final rule: Labels on products with a
standard of identity specified in FSIS
regulations or Food Standards and
Labeling Policy Book 3 (‘‘Policy Book’’);
labels for raw, single-ingredient
products that do not bear special claims;
labels for containers of meat and poultry
products sold under contract
specifications to the Federal
Government; labels for shipping
containers that contain fully labeled
immediate containers; labels for
products not intended for human food
(e.g., for the pharmaceutical industry)
and for poultry heads and feet to be
exported for processing as human food,
provided specific regulatory
requirements are met; meat and poultry
inspection legends that comply with 9
CFR parts 312, 316, and 381, subpart M;
labeling on inserts, tags, liners, posters,
and like devices that are not misleading
and do not reference products; labels for
consumer test products not intended for
sale; and labels that were previously
sketch approved by FSIS and contain no
modifications or only certain listed
modifications.
The 1995 final rule also transferred
responsibility for maintaining labeling
records from IICs to official
establishments in the United States and
to foreign establishments certified as
meeting U.S. requirements under
foreign inspection systems. For labels
that still required FSIS review, the final
rule removed the requirement that firms
submit final labels for FSIS approval;
thus, today, firms must only submit
3 Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatory-compliance/labeling/
Labeling-Policies.
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sketch labels. In the preamble to the
1995 final rule, FSIS stated that it
intended to expand generic labeling
after it completed an assessment of the
modified system (60 FR 67444, 67448).
As explained in the preamble to the
2011 rule, FSIS completed this
assessment in 1998 (76 FR 75809,
December 5, 2011). FSIS surveyed
industry to measure the effects of the
generic approval program and sampled
1,513 labels for compliance with
Federal regulations and policies. FSIS
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.
In 2011, FSIS published a proposed
rule to replace the extensive list of
generically approved meat and poultry
labeling with a simpler set of label
categories required to be submitted for
Agency approval. FSIS proposed to
require submission of: Labels for
temporary approval, labels for products
produced under religious exemption,
labels for export with labeling
deviations, and labeling with special
statements and claims (76 FR 75809).
FSIS also proposed to combine the label
approval regulations for meat and
poultry products (9 CFR 317.4 and
381.132) into a new part, 9 CFR part
412.
FSIS finalized the 2011 proposed rule
on November 7, 2013 (78 FR 66826).
The final rule codified the labeling
categories and combined the meat and
poultry labeling regulations as
proposed. However, upon consideration
of comments, FSIS finalized the rule
with four changes (78 FR 66826, 66827).
First, FSIS decided to continue to
review generic labels that
establishments voluntarily submit for
approval; but, the Agency also made
clear that such labels would receive
lower review priority than non-generic
labels. Second, FSIS clarified that
special statements or claims (except for
‘‘natural’’ and negative claims) that are
defined in FSIS’s regulations or in the
Policy Book are deemed to be
generically approved. Third, FSIS
determined that a label bearing a childnutrition (CN) box will not be
considered to have a special statement
or claim on it that would require sketch
approval by FSIS because such
information was evaluated for approval
by AMS. Finally, the Agency stated that
it would no longer add new entries to
the Policy Book; however, already
existing entries may be revised or
removed.
In the regulatory text of the 2013 final
rule, FSIS stated that it would assess
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compliance by selecting samples of
generically approved labels from
establishments [9 CFR 412.2(a)(2)].
Additionally, after the final rule was
published, FSIS received questions
about the effectiveness of generic
approval. To address these concerns and
to establish a protocol for the future
national assessment, the FSIS Office of
Policy and Program Development
(OPPD) conducted a limited assessment
of labels.
OPPD conducted this assessment over
a three-week period in September
2016.4 Labeling policy experts traveled
to five Federal meat and poultry
establishments within the commuting
area of FSIS headquarters in
Washington, DC. Both large and small
establishments were visited, including
at least one corporation. In each
establishment, the labeling policy
experts assessed compliance of a
representative sample of the generically
approved label records on file. At the
close of each assessment, the labeling
policy experts held a closeout meeting
with the FSIS inspection personnel and
the establishment management. At this
meeting, the labeling policy experts
explained any deficiencies, determined
if temporary approval was needed for
deficient labels, and made
recommendations for changes in the
establishment’s generic label approval
and records management process. An
assessment summary letter of this
closeout meeting was provided to the
establishment, inspection personnel,
and the FSIS Office of Field Operations
District Manager.
This assessment found a high level of
compliance with the requirements.
During examination of 270 labels, FSIS
identified only three labels with
deficiencies necessitating label
revocation, and none of these
deficiencies involved food safety.
During the closing meetings with
establishments, inspection and industry
personnel determined that more
outreach would significantly improve
compliance. FSIS has initiated more
outreach regarding labeling
requirements, as discussed later in this
document.
On February 13, 2018, FSIS published
the proposed rule, Egg Products
Inspection Regulations (83 FR 6314).
This rule proposed several changes to
FSIS’s egg product inspection program,
one of which adopted by reference
FSIS’s generic label approval regulation
into the egg products regulations (9 CFR
4 Methodology available at: https://
www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/labeling/labeling-policies/
assessment-generically-approved-label.
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56541
590.412). If the rule is finalized as
proposed, egg products will be eligible
for generic approval of product labels on
the same basis as meat and poultry
product labels.
II. Proposed Rule
Since the 2013 rulemaking that
established the categories of labels
requiring sketch approval, FSIS has
gained significant, additional
experience evaluating labels required to
be submitted and approved. From that
experience, the Agency has 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. FSIS is therefore
proposing changes to its regulations to
reduce the number of labels submitted
for evaluation by FSIS and to lessen the
paperwork burden on official
establishments. The reduction in staff
time spent approving these labels would
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 inspection
program personnel (IPP) effectively
verify that establishments meet labeling
requirements. All labels used at official
establishments would still be subject to
FSIS verification activities in the field.
These activities are further described in
the section III. ‘‘Surveillance and
Enforcement’’ below.
First, FSIS is proposing to extend
generic label approval to products only
intended for export that deviate from
domestic labeling requirements, by
removing 9 CFR 412.1(c)(2). FSIS
maintains an Export Library that lists
requirements for exported products that
foreign authorities have officially
communicated to FSIS, including
labeling requirements.5 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’s domestic labeling
requirements in order to comply with
foreign country requirements or to be
marketed more easily in a foreign
country.6 FSIS IPP verify whether
product for export meets requirements
listed in the Export Library, including
5 The Export Library is available at: https://
www.fsis.usda.gov/wps/portal/fsis/topics/
international-affairs/exporting-products/exportlibrary-requirements-by-country.
6 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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labeling, when certifying products for
export. Verification of foreign
requirements is ultimately determined
by each foreign country’s competent
authority.
Second, FSIS is proposing to revise
the types of ‘‘special statements and
claims’’ requiring label submission by
providing for generic approval of three
additional types of claims. FSIS has
observed through its prior label
approval system that errors, omissions,
and misrepresentations are rare on these
types of labels. The proposed changes
are to be made by amending 9 CFR
412.1(e) and 412.2(b).
The following types of claims would
be generically approved:
a. ‘‘Organic’’ claims that appear in a
product label’s ingredients statement,
which designate an ingredient as
certified ‘‘organic’’ under AMS’s
National Organic Program. The
ingredients statement on these product
labels designates specific ingredients as
organic (e.g., organic garlic). FSIS would
no longer require the submission and
evaluation of supporting documentation
to verify that such ingredients are
indeed certified as organic by an AMSrecognized third-party certifier.
However, FSIS would continue to
require that labels certifying a total
product as organic to be submitted for
FSIS 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 would no longer
require sketch approval: 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
would 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 would continue to
be required.
Third, FSIS is proposing to permit
generic approval of the labels of
products that receive voluntary FSIS
inspection. FSIS provides several types
of voluntary inspection services under
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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
animals, such as elk, bison, and
migratory water fowl (9 CFR part 352,
subpart A, and 9 CFR part 362); and
products containing meat or poultry but
are not under FSIS jurisdiction, e.g.,
closed-faced sandwiches (9 CFR 350(c)).
At present, labels for some products
produced under these voluntary
inspection programs are not covered
under the Agency’s generic approval
regulations at 9 CFR 412. FSIS is
proposing to permit generic approval for
them on the same basis as amenable
meat, poultry, and egg products by
amending the relevant program
regulations where needed to include
references to 9 CFR part 412.7 For
clarity, FSIS will also modify 9 CFR
352.1 to update the section heading and
remove unnecessary language.
Finally, FSIS is proposing to cease
evaluating generically approved labels
submitted voluntarily to LPDS for
review. In the 2013 rulemaking that
expanded the categories of labels
eligible for generic approval,
commenters requested to be allowed to
continue submitting generic labels for
FSIS guidance, evaluation, and
approval. FSIS agreed to continue
evaluating generic labels that were
submitted, giving such labels secondary
priority after labels requiring evaluation.
Since the 2013 final rule, producers
have become more familiar with FSIS’s
generic labeling requirements, and FSIS
has provided additional guidance to
assist them in designing compliant
labels. Therefore, FSIS’s evaluation of
otherwise generic labels no longer
represents an efficient use of Agency
resources.
Comprehensive labeling guidance,
including the FSIS Compliance
Guideline for Label Approval,8 is
available at FSIS’s website.9 Information
available includes a PowerPoint
presentation titled ‘‘Labeling 101,’’ 10
7 The regulations providing for voluntary
inspection of non-FSIS-jurisdiction products that
contain meat or poultry (9 CFR 350(c)) and products
containing non-amenable species of poultry (9 CFR
part 362) already adopt 9 CFR part 412 by reference.
For this reason, FSIS does not need to make
additional regulatory changes to these parts in order
to permit generic approval of labels for products
receiving these services.
8 Available at: https://www.fsis.usda.gov/wps/
wcm/connect/bf170761-33e3-4a2d-8f86940c2698e2c5/Label-ApprovalGuide.pdf?MOD=AJPERES.
9 Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatory-compliance/labeling.
10 Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatory-compliance/labeling/
labeling-policies/basics-of-labeling/basics-labeling.
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which is used by the Agency as a
teaching tool at workshops on meat and
poultry label requirements. FSIS also
provides guidance on allergen labeling
and nutrition labeling,11 a Label
Submission Checklist,12 a glossary of
meat and poultry labeling terms,13 the
Policy Book, and questions and answers
on various topics, such as generic
approval, and the labeling of
ingredients.14
FSIS will continue to conduct
outreach to assist label submitters with
labeling compliance in the form of
webinars, industry group meetings,
training for inspectors, guidance
documents published on the FSIS
website, and archived public askFSIS
questions. Additionally, FSIS provides
significant resources to assist label
submitters on labels that require FSIS
approval prior to use. These include
askFSIS, a web portal that allows
industry, IPP, and other stakeholders to
submit technical and policy-related
questions directly to OPPD.15
Establishments may also contact FSIS
for assistance with labeling questions.
FSIS offers resources to assist small and
very small plants, including the Small
Plant Help Desk, which may be
contacted by phone or email and
answers questions on FSIS
requirements.16
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’’).17 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
11 Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatory-compliance/labeling/
labeling-policies/nutrition-labeling-policies/
nutrition-labeling.
12 Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatory-compliance/labeling/
labeling-procedures/label-submission-checklist.
13 Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/food-safety-education/getanswers/food-safety-fact-sheets/food-labeling/meatand-poultry-labeling-terms/meat-and-poultrylabeling-terms.
14 Available at: https://www.fsis.usda.gov/wps/
wcm/connect/bf170761-33e3-4a2d-8f86940c2698e2c5/Label-ApprovalGuide.pdf?MOD=AJPERES.
15 Available at: https://askfsis.custhelp.com/. See
also, FSIS Directive 5620.1 Rev. 1, Using askFSIS,
available at: https://www.fsis.usda.gov/wps/portal/
fsis/topics/regulations/directives.
16 The latest information on these resources is
available at: https://www.fsis.usda.gov/wps/portal/
fsis/topics/regulatory-compliance/haccp/resourcesand-information/svsp-brochure.
17 The audit report is available at: https://
www.usda.gov/oig/webdocs/24601-0002-23.pdf.
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labels. FSIS also agreed to update its
internal policies to improve IPP label
verification activities. Such verification
activities are described in section III.
‘‘Surveillance and Enforcement’’ below.
FSIS does not believe that the audit’s
findings or FSIS’s responses to the audit
affect this proposal.
III. Surveillance and Enforcement
Official establishments are required to
label meat, poultry, and egg products
with labels that are neither false nor
misleading and that comply with FSIS’s
regulations. This is true whether the
labels require sketch approval or may be
generically approved. Establishments
are required to keep records of all labels
in accordance with 9 CFR 320.1(b)(10)
for meat products, 9 CFR 381.175(b)(6)
for poultry products, and 9 CFR
590.200(c) for egg products. These
records must include a copy of the final
label, the product formulation,
processing procedures, and any
supporting documentation needed to
show that the label complies with the
Federal meat, poultry, and egg
regulations. Such records must be made
available to any duly authorized
representative of the Secretary upon
request (9 CFR 320.4 and 590.200(b)).
IPP periodically perform a General
Labeling Task assigned through FSIS’s
Public Health Inspection System (PHIS)
as part of their regular label verification
activities. This task is described in FSIS
Directive 7221.1, Prior Labeling
Approval. It includes verifying that
establishments maintain records of the
selected labels in accordance with 9
CFR 320.1(b)(10), 381.175(b)(6), and
590.200(c). IPP also verify that final
labels applied to product contain all
mandatory labeling features and are
otherwise in compliance with the
applicable regulations by evaluating
establishments’ labeling records and the
labels themselves (e.g., to verify that the
ingredients statement on the label
matches the product formula).
IPP document in PHIS any
noncompliance found, e.g., if a required
labeling feature is missing or if a label
requires LPDS evaluation but such
evaluation is not documented in the
records.18 Establishments may take
corrective action by obtaining label
approval through LPDS, bringing the
labels into compliance with a pressure
sensitive sticker, or by replacing the
noncompliant labels with labels that
18 If IPP are not performing the General Labeling
task but observe a product label that is not in
compliance with Federal meat and poultry
regulations, they will initiate a directed General
Labeling task, retain affected product, and
document the noncompliance in PHIS as described
above.
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have received prior approval and are in
compliance with FSIS’s regulations.
Final labels that are not in compliance
with the regulations may still be granted
temporary approval under the
conditions listed in 9 CFR 412.1(f). IPP
will retain any product bearing a label
not in compliance with regulatory
requirements as well as those that
require, but have not received, LPDS
approval. Pursuant to 9 CFR 500.8, FSIS
may rescind approval of any false or
misleading labels.19
FSIS relies on these verification tasks,
in addition to evaluation by LPDS, to
ensure that meat, poultry, and egg
product labels are truthful and not
misleading. Designating some product
labels as generically approved, while
maintaining inspection activities for all
labels, promotes the effective use of
Agency resources. This expansion of
generic label approval will not affect
consumer protection because FSIS will
continue to evaluate labeling that has
consumer safety or economic
implications, e.g., special statements
and claims and requests for temporary
approval. For example, FSIS will
continue to review labeling that claims
product is organic or all natural, makes
statements regarding the raising of the
animals from which products were
derived, displays nutrition factual
statements (e.g., 10 g protein per
serving) on the label, or includes
certified claims (e.g., ‘‘Certified Gluten
Free’’) on the label.20
FSIS invites public comment on these
proposed changes and requests data and
additional suggestions for ways to make
FSIS’s generic labeling program more
effective and efficient. FSIS considered
three alternatives to this proposal:
Taking no action; the proposed rule,
except industry would still have the
option to have LPDS evaluate labels that
would otherwise be generically
approved; and allowing all labels to be
generically approved. Although FSIS
ultimately decided on the current
proposal, the Agency will continue to
consider the alternatives described
below (under the section titled
‘‘Alternative Regulatory Approaches’’)
based on the information received.
19 If FSIS rescinds or refuses to approve a label,
it must explain its reasoning in a written notice,
provide an opportunity for the establishment to
modify the label, and advise the establishment of
its appeal rights (9 CFR 500.8(b)).
20 For an extensive list of labeling that requires
FSIS approval, see the FSIS Compliance Guideline
for Label Approval. Available at: https://
www.fsis.usda.gov/wps/wcm/connect/bf17076133e3-4a2d-8f86-940c2698e2c5/Label-ApprovalGuide.pdf?MOD=AJPERES.
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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
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 proposed rule has been
designated 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.
Need for the Rule
The proposed rule would expand the
types of meat, poultry and egg product
labels that can be generically approved
by FSIS. This would reduce the number
of labels evaluated by FSIS and reduce
the costs to industry. The labels
submitted for FSIS evaluation are
becoming more complex and more timeconsuming for industry to prepare and
for FSIS to evaluate. The proposed rule
would 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 proposed rule also
would enhance market efficiency by
promoting a faster introduction of new
products into the marketplace to meet
consumer demand.
Baseline
Based on FSIS’s Label Submission
and Approval System (LSAS) 21 data,
FSIS evaluated 15,459 unique labels
during the 2019 fiscal year (FY). Of
these, 5,229 (33.8 percent) would have
been generically approved under the
proposed rule. 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 primarily make other types
of corrections and then resubmitted for
FSIS evaluation. FSIS has observed
through its prior label approval system
that corrections on the types of claims
FSIS is proposing to generically approve
are rare. In FY 2019, there were 26,158
21 FSIS’s 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.
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label adjudications, which included
each time a label was evaluated. See
Table 2 below for additional details.
each time a label was evaluated. See
Table 2 below for additional details.
TABLE 2—LABEL EVALUATIONS AND ADJUDICATIONS, FY 2016–2019
[Pre proposed rule]
FSIS labels
2016
Labels FSIS Would Not have Evaluated Under the Proposed Rule ...............
Total Labels FSIS Evaluated * ..................................................................
Total Label Adjudications ** ......................................................................
2017
8,534
22,846
30,857
2018
5,812
17,958
25,125
6,025
17,635
27,580
2019
5,229
15,459
26,158
* This is the total number of labels FSIS evaluated, including the labels that would have been generically approved under the proposed rule.
** Label adjudications include some labels being revaluated.
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 proposed to
permit generic approval for certain egg
product labels in 2018 (83 FR 6314,
February, 13, 2018).
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 Proposed Rule
The proposed rule would not impose
any new cost on producers that submit
labels for FSIS evaluation. Instead, the
proposed rule would reduce the
regulatory burden on producers that
currently 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 Proposed Rule
Industry Impacts
Industry would realize cost savings
from the reduction in FSIS label
submissions under the proposed 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.22 FSIS estimates 15
minutes of the 75 minutes are dedicated
to recordkeeping. The recordkeeping
time is not included in the proposed
rule’s regulatory impact analysis
because the recordkeeping requirements
are not changing under the proposed
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¥15 minutes). FSIS also
assumed food scientists and
technologists would perform this work
at a mean hourly wage of $36.63.23 A
benefits and overhead factor of two 24
was applied to estimate the total labor
cost per label submission of $73.26.
To determine the annual reduction of
label submissions, FSIS relied on the
average number of labels that FSIS
would not have evaluated under the
proposed 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
proposed rule (6,400 * 10). As shown in
Table 3, FSIS estimates that industry
would realize a discounted cost savings
of $3,293,105 (at a 7 percent discount
rate) and $3,999,505 (at a 3 percent
discount rate) by FSIS generically
approving an additional 64,000 labels
over a 10-year period. The cost savings
would be $468,864 when annualized at
the 7 and 3 percent discount rate, over
10 years.
TABLE 3—ESTIMATED INDUSTRY COST SAVINGS
[2019 Dollars]
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Total industry cost savings from reduced need for FSIS label evaluation
Total over 10 years ..................................................................................................................................................
Annualized total over 10 years ................................................................................................................................
22 FSIS Form 7234–1 Application for Approval of
Labels, Marking or Device. Last modified 11/16/
2011. Available at: https://www.fsis.usda.gov/wps/
portal/fsis/forms/.
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23 BLS Occupational Employment Statistics,
Occupational Employment and Wages, May 2019.
19–1021 Food Scientists and Technologists.
<https://www.bls.gov/news.release/pdf/
ocwage.pdfoes/current/oes191012.htm#nat>
Accessed on 4/30/2020. Last Modified 03/30/2020.
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Present value
cost savings at
7%
Present value
cost savings at
3%
$3,293,105
468,864
$3,999,505
468,864
24 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.
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Agency Impacts
During FY 2019, FSIS employed 14
labeling analysts in LPDS with an
average hourly salary of $64.75 (($47.52
* 36.25%) + 47.52 = $64.75 for a GS–
13 step 1,25 with an adjusted benefits
factor of 36.25 percent).26 On average,
LPDS analysts evaluate labels four hours
per day, five days a week, at a cost of
$18,130 per week. If the proposed rule
is adopted, LPDS analysts would
evaluate labels for three hours per day,
five days a week, at a cost of $13,598 per
week, because of the reduction in labels
submitted to FSIS.
If this proposed rule is adopted, the
Agency would realize a discounted cost
savings of $1,655,388 (at a 7 percent
discount rate) and $2,010,484 (at a 3
percent discount rate) for adjudicating
fewer labels over a 10-year period. The
cost savings would be $235,690 when
annualized at the 7 and 3 percent
discount rate over 10 years. See Table 4
for additional details. However, this cost
savings from fewer staff hours dedicated
towards adjudicating labels would be
redirected towards other Agency
priority initiatives, such as developing
and updating policy and guidance
documents, answering questions from
askFSIS and other sources, and
performing outreach activities. We also
anticipate an overall faster label review
process from the decline in LPDS label
evaluations. This would allow new
labels to enter the market faster.
TABLE 4—ESTIMATED AGENCY COST SAVINGS
[2019 Dollars]
Total agency cost savings from reduced need for FSIS label evaluation
Total over 10 years ..................................................................................................................................................
Annualized total over 10 years ................................................................................................................................
Net Benefits
This proposed rule would be net
beneficial because it would reduce the
costs to establishments, from submitting
fewer labels for FSIS evaluation, while
imposing no additional cost burden.
The net benefit derived from the
proposed rule is estimated to be
$4,948,493 ($3,293,105 in establishment
savings plus $1,655,388 in Agency
savings) discounted at the 7 percent
Present value
cost savings at
7%
Present value
cost savings at
3%
$1,655,388
235,690
$2,010,484
235,690
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 $704,554. See
Table 5 for details.
TABLE 5—ESTIMATED AGENCY COST SAVINGS
[2019 Dollars]
Total agency and industry cost savings from reduced need for FSIS label evaluation
Total over 10 years ..................................................................................................................................................
Annualized total over 10 years ................................................................................................................................
proposed rule was chosen as the least
burdensome regulatory approach. The
summary of the costs and benefits for
Alternative Regulatory Approaches
The Agency considered three
alternatives to the proposed rule. The
Present value
cost savings at
7%
Present value
cost savings at
3%
$4,948,493
704,554
$6,009,989
704,554
the considered alternatives are outlined
in Table 6 below.
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TABLE 6—REGULATORY ALTERNATIVES CONSIDERED
Alternative
Benefits
Costs
Net benefit
(1) Take No Action ..........................
No Benefit ....................................
(2) The Proposed Rule, Except Industry Would Still Have the Option to Have LPDS Evaluate Labels that Would Otherwise be
Generically Approved.
Industry could benefit from additional FSIS evaluation.
No potential industry or Agency
cost savings.
Potential for inefficient use of
Agency resources. Industry
would also incur costs of submitting the labels and waiting
for FSIS evaluation.
Net benefits are less than alternative 3.
Net benefits are less than alternative 3. Although industry
could marginally benefit from
additional FSIS evaluation, sufficient guidance is available for
labels that can be generically
approved. Also, industry and
the Agency would incur costs
from submitting and evaluating
such labels.
25 Salary Table 2019–DCB for the locality pay area
of Washington-Baltimore-Arlington, DC-MD-VAWV-PA. Effective January 2019. Available at:
https://www.opm.gov/policy-data-oversight/pay-
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leave/salaries-wages/salary-tables/pdf/2019/DCB_
h.pdf.
26 Nussle, Jim. (2008). M–08–13:
MEMORANDUM FOR THE HEADS OF
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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.
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TABLE 6—REGULATORY ALTERNATIVES CONSIDERED—Continued
Alternative
Benefits
Costs
Net benefit
(3) The Proposed Rule ...................
Potential industry cost savings of
$468,864 and Agency cost savings of $235,690, annualized at
the 7 percent discount rate
over 10 years.
The Agency and industry would
benefit from time savings by
eliminating FSIS label evaluation.
No Cost ........................................
Net
benefits
are
$704,554
annualized at the 7 percent discount rate over 10 years.
Costs include potentially increasing the number of misbranded
products.
Net benefits are less than alternative 3 as the potential costs
of misbranded products from
eliminating FSIS label evaluation outweighs the time savings
benefit.
(4) Allow All FSIS Labels to be Generically Approved.
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
proposed 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 $468,864 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.
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Alternative 2—The Proposed Rule,
Except Industry Would Still Have the
Option To Have LPDS Evaluate Labels
That Would Otherwise be Generically
Approved
FSIS considered an alternative of
proposing the same generically
approved label categories except FSIS
would continue to evaluate those labels
that would otherwise be generically
approved. Currently, industry can
submit labels that can be generically
approved for voluntary FSIS evaluation,
although this evaluation is not needed
prior to entering the market. When
industry submits these types of labels
for voluntary FSIS evaluation, they are
reviewed with a lower priority than
other labels, and thus take 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 could 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 food
safety and policy related issues (e.g.,
concerning allergens). Industry would
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16:50 Sep 11, 2020
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also incur costs in preparing and
submitting the labels for FSIS
evaluation while they could get FSIS
help through other outlets without
incurring these expenses. For these
reasons, FSIS rejects this alternative.
Alternative 3—The Proposed Rule
The proposed rule yields cost savings
for both the industry and the Agency.
There is no additional cost burden from
the proposed rule. The potential cost
savings for industry is $468,864,
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
$235,690, annualized at the 7 percent
discount rate over 10 years. This covers
the time FSIS saves from not evaluating
the proposed generically approved
labels. Since there is no additional
burden for this proposed 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
suffer. Therefore, FSIS believes the
labels that would still require prior
evaluation under the proposed rule,
such as labels with animal raising or
natural claims, benefit from LPDS
evaluation due to the complex nature
and need for supporting documentation
of these claims.
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Fmt 4702
Sfmt 4702
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 has made a
preliminary determination that this
proposed rule would not have a
significant economic impact on a
substantial number of small entities in
the United States, as defined by the
Regulatory Flexibility Act (5 U.S.C.
601). This determination was made
because small producers would
experience costs savings from the
reduced number of label submissions
for FSIS evaluation.
Based on LSAS and the Public Health
Information System (PHIS) 27 data, FSIS
estimates 92.3 percent (4,825/5,229) of
the label submissions in 2019, which
would have been generically approved
under the proposed 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, would not be
disadvantaged because the proposed
27 PHIS is FSIS’s electronic data analytic system,
used to collect, consolidate, and analyze data in
order to improve public health.
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Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Proposed Rules
rule would 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 proposed 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 proposed rule may impact
their label courier business. However,
the impact on these firms is small as
their other business, such as label
consultations, would not be affected.
Therefore, this proposed rule would not
have a significant economic impact on
the small label consultant firms.
VI. Executive Order 13771
Consistent with E.O. 13771 (82 FR
9339, February 3, 2017), FSIS has
estimated that this proposed rule would
yield cost savings. Assuming a 7 percent
discount rate, a perpetual time horizon,
and a starting year of 2021, the proposed
rule, if finalized, is estimated to yield
approximately $502,337 (2016$) in
annual cost savings. Therefore, if
finalized as proposed, this rule would
be an E.O. 13771 deregulatory action.
VII. Paperwork Reduction Act
khammond on DSKJM1Z7X2PROD with PROPOSALS
FSIS has reviewed the paperwork and
recordkeeping requirements in this
proposed rule in accordance with the
Paperwork Reduction Act (44 U.S.C.
3501, et seq.). The Administrator has
determined that the proposed rule
would not create any additional
collection, paperwork, or recordkeeping
burdens.
FSIS is proposing to expand 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, will have a net
reduction of 6,400 burden hours
because of the increased use of generic
labeling.
VIII. E-Government Act
FSIS and USDA are committed to
achieving the purposes of the EGovernment 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
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16:50 Sep 11, 2020
Jkt 250001
56547
access to Government information and
services, and for other purposes.
Remedies and complaint filing
deadlines vary by program or incident.
IX. Executive Order 12988, Civil Justice
Reform
This proposed 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.
How To File a Complaint of
Discrimination
To file a complaint of discrimination,
complete the USDA Program
Discrimination Complaint Form, which
may be accessed online at https://
www.ocio.usda.gov/sites/default/files/
docs/2012/Complain_combined_6_8_
12.pdf, or write a letter signed by you
or your authorized representative.
Send your completed complaint form
or letter to USDA by mail, fax, or email:
Mail: U.S. Department of Agriculture,
Director, Office of Adjudication, 1400
Independence Avenue SW, Washington,
DC 20250–9410.
Fax: (202) 690–7442.
Email: program.intake@usda.gov.
Persons with disabilities who require
alternative means for communication
(Braille, large print, audiotape, etc.),
should contact USDA’s TARGET Center
at (202) 720–2600 (voice and TDD).
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 governmentto-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.
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. USDA Non-Discrimination
Statement
In accordance with Federal civil
rights law and U.S. Department of
Agriculture (USDA) civil rights
regulations and policies, the USDA, its
Agencies, offices, and 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).
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Fmt 4702
Sfmt 4702
XIII. 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
proposed rule, which would refine 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.
XIII. Congressional Review Act
Pursuant to the Congressional Review
Act at 5 U.S.C. 801 et seq., the Office of
Information and Regulatory Affairs has
determined that this document is not a
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Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Proposed Rules
‘‘major rule,’’ as defined by 5 U.S.C.
804(2).
XIV. 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
PART 354—VOLUNTARY INSPECTION
OF RABBITS AND EDIBLE PRODUCTS
THEREOF
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.
■
4. Revise § 354.60 to read as follows:
§ 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 412—LABEL APPROVAL
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 proposing to amend 9
CFR Chapter III as follows:
PART 352—EXOTIC ANIMALS AND
HORSES; VOLUNTARY INSPECTION
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.
2. In § 352.7:
Jkt 250001
6. In § 412.1, remove and reserve
paragraph (c)(2) and revise paragraph (e)
to read as follows:
■
Administrative practice and
procedure, Animal diseases, Food
labeling, Meat inspection, Rabbits and
rabbit products, Reporting and
recordkeeping requirements, Signs and
symbols.
khammond on DSKJM1Z7X2PROD with PROPOSALS
*
*
*
*
All labels intended for use on
inspected and passed exotic animal
products must be approved in
accordance with Part 412 of this
chapter.
*
*
*
*
*
Authority: 21 U.S.C. 451–470, 601–695; 7
CFR 218, 2.53.
9 CFR Part 354
16:50 Sep 11, 2020
*
5. The authority citation for part 412
continues to read as follows:
Food labeling, Meat inspection,
Reporting and recordkeeping
requirements.
VerDate Sep<11>2014
§ 352.7 Marking and labeling of inspected
products.
■
9 CFR Part 352
■
a. Revise the section heading;
b. Remove from the introductory text
the phrase ‘‘Wording and form of
inspection mark.’’; and
■ c. Add a sentence at the end of the
introductory text.
The revision and addition read as
follows:
■
■
§ 412.1
Label approval.
*
*
*
*
*
(e) ‘‘Special statements and claims’’
are statements, claims, logos,
trademarks, and other symbols on labels
as defined in this paragraph.
(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.
(iii) Health claims (including graphic
representations of hearts), ingredient
and processing method claims (e.g.,
high-pressure processing), structurefunction claims, claims regarding the
raising of animals (e.g., ‘‘no antibiotics
administered’’), products labeled as
organic (except for those where only
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
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 (i.e., ‘‘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.’’
(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,’’ or displays of geographic
landmarks, such as a foreign country’s
flag, monument, or map.
*
*
*
*
*
■ 7. Revise § 412.2(b) to read as follows:
§ 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
paragraph 412.1(e) of this part.
Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020–17340 Filed 9–11–20; 8:45 am]
BILLING CODE 3410–DM–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Parts 50, 52, and 73
[NRC–2017–0227]
RIN 3150–AK19
Physical Security for Advanced
Reactors
Nuclear Regulatory
Commission.
ACTION: Preliminary proposed rule
language; notice of availability.
AGENCY:
E:\FR\FM\14SEP1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Proposed Rules]
[Pages 56538-56548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17340]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 352, 354, 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, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend its inspection regulations to expand the circumstances under
which FSIS will generically approve the labels of meat, poultry, and
egg products. FSIS is also proposing to cease evaluating generically
approved labels submitted to FSIS for review.
DATES: Submit comments on or before November 13, 2020.
ADDRESSES: FSIS invites interested persons to submit comments on this
document. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This website provides
commenters the ability to type short comments directly into the comment
field on the web page or to attach a file for lengthier comments. Go to
https://www.regulations.gov. Follow the on-line instructions at that
site for submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, 1400
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
Hand or Courier-Delivered Submittals: Deliver to 1400
Independence Avenue SW, Room 6065, 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, Room 6065, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Acting Assistant
Administrator, Office of Policy and Program Development, by telephone
at (202) 720-0399.
SUPPLEMENTARY INFORMATION:
Executive Summary
To prevent the introduction of adulterated or misbranded products
into commerce, the Food Safety and Inspection Service (FSIS) implements
a prior approval program for labels intended to be used on federally
inspected meat, poultry, and egg products (9 CFR part 412). Without
approved labels, these products may not be sold, offered for sale, or
otherwise distributed in commerce.
Certain categories of labels or renderings of such labels (sketch
labels) must be submitted to FSIS for review and approval before use.
However, FSIS considers certain labels that comply with the Agency's
labeling rules to be ``generically'' approved. Such labels are not
submitted to FSIS, because they are deemed approved and may be applied
to product in commerce.
Generic label approval has been in place in some form since 1983.
FSIS has previously expanded the categories of labeling claims eligible
for generic approval, most recently in 2013 (78 FR 66826, November 7,
2013). FSIS has also published a proposed rule that, if finalized as
proposed, would permit generic approval for egg product labels (83 FR
6314, February 13, 2018). FSIS is now proposing to expand the
[[Page 56539]]
categories of meat, poultry, and egg product labels that it will deem
generically approved and thus not required to be submitted to FSIS.
Specifically, under this proposal the following labels would no longer
need to be submitted to FSIS for approval: (1) Labels on products for
export that deviate from FSIS requirements; (2) labels that list
ingredients in the ingredients statement as being certified ``organic''
(e.g., organic garlic) under the Agricultural Marketing Service (AMS)
National Organic Program; (3) labels that display geographic landmarks,
such as a foreign country's flag, monument, or map; (4) labels that
make ``negative'' claims identifying the absence of certain ingredients
or types of ingredients (e.g., statements such as ``No MSG Added,''
``Preservative Free,'' ``No Milk,'' ``No Pork,'' or ``Made Without
Soy''); and (5) labels of products that receive voluntary FSIS
inspection (e.g., exotic species under 9 CFR part 352). Finally, FSIS
is proposing to cease evaluating labels submitted to FSIS that are
eligible for generic approval.
These reforms would result in an estimated 33.8 percent reduction
in label submissions (based on fiscal year 2019 data) and reduce Agency
costs expended to evaluate the labels (see Table 1). There will not be
any negative food safety impacts from this proposal, based on FSIS's
experience evaluating these types of labels and the ability of
inspection personnel to continue to verify labeling requirements in the
field.
There is no cost burden for the industry or FSIS for the proposed
rule. This is shown in Table 1 below, which summarizes the costs and
benefits of the proposed rule. Industry would experience cost savings
of $468,864, annualized at the 7 percent discount rate over 10 years,
from the reduction in preparing and submitting certain labels for FSIS
evaluation. FSIS would experience cost savings of $235,690, annualized
at the 7 percent discount rate over 10 years, from the reduction in
label evaluations.
Table 1--Summary of Annualized Costs and Benefits
----------------------------------------------------------------------------------------------------------------
Costs Cost savings Net benefits
----------------------------------------------------------------------------------------------------------------
Industry........................................................ $0 $468,864 $468,864
Agency.......................................................... 0 235,690 235,690
-----------------------------------------------
Total....................................................... 0 704,554 704,554
----------------------------------------------------------------------------------------------------------------
Note: Estimates are annualized using a 7 percent discount rate over 10 years.
Table of Contents
I. Background
A. Current Label Regulations
B. Current Prior Label Approval System
C. Generic Label Approval
II. Proposed Rule
III. Surveillance and Enforcement
IV. Executive Orders 12866 and 13563
V. Regulatory Flexibility Act Assessment
VI. Executive Order 13771
VII. Paperwork Reduction Act
VIII. E-Government Act
IX. Executive Order 12988
X. Executive Order 13175
XI. USDA Non-Discrimination Statement
XII. Environmental Impact
XIII. Congressional Review Act
XIV. 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.) 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 of these provisions is that
they require the Secretary or his or her representative to 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.
A. Current Label Regulations
The meat, poultry, and egg products labeling regulations require
that meat, poultry, and egg products are truthfully labeled, and that
the labeling provides the necessary product information for consumers
to make informed purchasing decisions.
There are up to eight features required on meat, poultry, and egg
product labels. The required features include: (1) The standardized,
common or usual, or descriptive name, of the product (9 CFR 317.2(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(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(g), 381.122, and 590.411(c)(2));
(4) an accurate statement of the net quantity of contents (9 CFR
317.2(h), 381.121, and 590.411(c)(4)); (5) the inspection legend,
including the number of the official establishment (9 CFR 312.2(b),
317.2(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)); \1\ 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)).
---------------------------------------------------------------------------
\1\ 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)].
---------------------------------------------------------------------------
These required features must appear on the immediate containers of
domestic products (9 CFR part 317, subpart A, and part 381, subpart N)
and imported products (9 CFR part 327 and part 381, subpart T;
590.411(c); and 590.950(a)). The meat inspection regulations define an
``immediate container'' as ``the receptacle or other covering in which
any product is directly contained or wholly or partially enclosed'' (9
CFR 301.2). The EPIA and poultry products inspection regulations define
an ``immediate container'' as ``any consumer package; or any other
container in which poultry products,
[[Page 56540]]
not consumer packaged, are packed'' (21 U.S.C. 1033(d)(1) and 9 CFR
381.1(b)).
The principal display panel, information panel, or other surface of
the product label must prominently display the mandatory features. The
first six features described above, and the labeling of country of
origin for imported products in accordance with 9 CFR 327.14 and
381.205, have been required by the meat and poultry inspection
regulations for decades. FSIS published regulations that require the
nutrition labeling of cooked or heat-treated multi-ingredient meat and
poultry products and the display of safe handling instructions in 1993
and 1994, respectively. Given industry's familiarity with these
requirements, FSIS typically finds establishments in compliance with
its labeling regulations.
The regulations contain other 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)).
Pursuant to the authority contained in section 7(e) of the FMIA (21
U.S.C. 607(e)), section 8(d) of the PPIA (21 U.S.C. 457(d)), and
section 7(b) of the EPIA (21 U.S.C. 1036(b)), the Administrator of FSIS
may withhold the use of any marking or labeling that is false or
misleading, within the meaning of the FMIA, PPIA, and EPIA and their
implementing regulations.
B. Current Prior Label Approval System
Under the current regulations, FSIS evaluates sketches of some
labels for approval, and approves others generically, i.e., without
submission to FSIS for sketch approval. A sketch label is a printer's
proof or other version that clearly shows all required label features,
size, location, and indication of final color (9 CFR 412.1(d)). To
obtain sketch label approval, domestic meat and poultry establishments,
egg product plants, and certified foreign establishments that are
eligible to export product to the United States, or their
representatives, are required to submit sketch labels to FSIS for
evaluation, except when the label is generically approved by the Agency
under 9 CFR 412.2.
These firms submit sketch labels accompanied by FSIS Form 7234-1
(11/16/2011), ``Application for Approval of Labels, Marking or
Device,'' to the Agency for evaluation. In addition to the required
label information, any special claims or statements that the
establishment intends to make (e.g., quality claims, animal production
raising claims, product origin claims, or nutrient content claims) must
be included on the label, along with documentation supporting the
claim. The label application must contain the basic information about
the establishment and the product, including:
1. Establishment number;
2. Product name;
3. Product formulation;
4. Processing procedures and handling information;
5. Firm name and address;
6. Total available labeling space of the container;
7. Size of the principal display panel; and
8. The Hazard Analysis and Critical Control Point category under
which the establishment is producing the meat or poultry product.
FSIS's Labeling and Program Delivery Staff (LPDS), in the Office of
Policy and Program Development (OPPD), verifies that sketch labels
comply with the applicable requirements. Since July 1, 1996, a final
version of a verified sketch label does not have to be submitted to the
Agency for evaluation and approval (60 FR 67444, December 29, 1995).\2\
All labels are subject to verification for compliance with Agency
regulations by FSIS inspectors to ensure that they are accurate,
truthful, and not misleading.
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\2\ On February 13, 2018 FSIS published the Egg Products
Inspection Regulations proposed rule (83 FR 6314). If the rule is
finalized as proposed, FSIS will also not require submission of
final versions of sketch labels for egg products.
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C. Generic Label Approval
FSIS allows certain meat, poultry, and egg product labels that bear
all required labeling features and that comply with the Agency's
labeling regulations to be generically approved (9 CFR 412.2(a)(1)).
Generically approved labels do not need to be submitted to FSIS for
sketch approval before they can be used on products in commerce.
Generic label approval requires that all mandatory label features are
prominent and conform to FSIS regulations. Although such labels are not
submitted to FSIS for approval, they are deemed to be approved and,
therefore, may be applied to product in accordance with the Agency's
prior label approval system.
Generic label approval has been in place in some form since 1983.
That year, FSIS promulgated regulations that granted limited label
approval authority to Inspectors-In-Charge (IICs) at official
establishments and provided generic approval to limited types of labels
(e.g., labels for raw, single ingredient meat and poultry products) (48
FR 11410, March 18, 1983). The rulemaking's intent was to reduce the
number of labels and other materials submitted for FSIS evaluation and
to ease the paperwork burden on official establishments.
Even with the changes made by the rule, the number of labels
submitted to the Agency continued to grow. During fiscal year 1991, the
Agency processed approximately 167,500 labels. Of these, FSIS approved
approximately 87,500 final labels and 60,000 sketch labels. FSIS
disapproved approximately 20,000 labels.
On December 29, 1995, FSIS published a final rule that outlined the
types of labels and modifications to labels that were deemed to be
approved without submission to FSIS, provided that the label displayed
all mandatory label features in conformance with applicable Federal
regulations (60 FR 67444). The following labeling was deemed
generically approved in that final rule: Labels on products with a
standard of identity specified in FSIS regulations or Food Standards
and Labeling Policy Book \3\ (``Policy Book''); labels for raw, single-
ingredient products that do not bear special claims; labels for
containers of meat and poultry products sold under contract
specifications to the Federal Government; labels for shipping
containers that contain fully labeled immediate containers; labels for
products not intended for human food (e.g., for the pharmaceutical
industry) and for poultry heads and feet to be exported for processing
as human food, provided specific regulatory requirements are met; meat
and poultry inspection legends that comply with 9 CFR parts 312, 316,
and 381, subpart M; labeling on inserts, tags, liners, posters, and
like devices that are not misleading and do not reference products;
labels for consumer test products not intended for sale; and labels
that were previously sketch approved by FSIS and contain no
modifications or only certain listed modifications.
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\3\ Available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/Labeling-Policies.
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The 1995 final rule also transferred responsibility for maintaining
labeling records from IICs to official establishments in the United
States and to foreign establishments certified as meeting U.S.
requirements under foreign inspection systems. For labels that still
required FSIS review, the final rule removed the requirement that firms
submit final labels for FSIS approval; thus, today, firms must only
submit
[[Page 56541]]
sketch labels. In the preamble to the 1995 final rule, FSIS stated that
it intended to expand generic labeling after it completed an assessment
of the modified system (60 FR 67444, 67448).
As explained in the preamble to the 2011 rule, FSIS completed this
assessment in 1998 (76 FR 75809, December 5, 2011). FSIS surveyed
industry to measure the effects of the generic approval program and
sampled 1,513 labels for compliance with Federal regulations and
policies. FSIS 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.
In 2011, FSIS published a proposed rule to replace the extensive
list of generically approved meat and poultry labeling with a simpler
set of label categories required to be submitted for Agency approval.
FSIS proposed to require submission of: Labels for temporary approval,
labels for products produced under religious exemption, labels for
export with labeling deviations, and labeling with special statements
and claims (76 FR 75809). FSIS also proposed to combine the label
approval regulations for meat and poultry products (9 CFR 317.4 and
381.132) into a new part, 9 CFR part 412.
FSIS finalized the 2011 proposed rule on November 7, 2013 (78 FR
66826). The final rule codified the labeling categories and combined
the meat and poultry labeling regulations as proposed. However, upon
consideration of comments, FSIS finalized the rule with four changes
(78 FR 66826, 66827). First, FSIS decided to continue to review generic
labels that establishments voluntarily submit for approval; but, the
Agency also made clear that such labels would receive lower review
priority than non-generic labels. Second, FSIS clarified that special
statements or claims (except for ``natural'' and negative claims) that
are defined in FSIS's regulations or in the Policy Book are deemed to
be generically approved. Third, FSIS determined that a label bearing a
child-nutrition (CN) box will not be considered to have a special
statement or claim on it that would require sketch approval by FSIS
because such information was evaluated for approval by AMS. Finally,
the Agency stated that it would no longer add new entries to the Policy
Book; however, already existing entries may be revised or removed.
In the regulatory text of the 2013 final rule, FSIS stated that it
would assess compliance by selecting samples of generically approved
labels from establishments [9 CFR 412.2(a)(2)]. Additionally, after the
final rule was published, FSIS received questions about the
effectiveness of generic approval. To address these concerns and to
establish a protocol for the future national assessment, the FSIS
Office of Policy and Program Development (OPPD) conducted a limited
assessment of labels.
OPPD conducted this assessment over a three-week period in
September 2016.\4\ Labeling policy experts traveled to five Federal
meat and poultry establishments within the commuting area of FSIS
headquarters in Washington, DC. Both large and small establishments
were visited, including at least one corporation. In each
establishment, the labeling policy experts assessed compliance of a
representative sample of the generically approved label records on
file. At the close of each assessment, the labeling policy experts held
a closeout meeting with the FSIS inspection personnel and the
establishment management. At this meeting, the labeling policy experts
explained any deficiencies, determined if temporary approval was needed
for deficient labels, and made recommendations for changes in the
establishment's generic label approval and records management process.
An assessment summary letter of this closeout meeting was provided to
the establishment, inspection personnel, and the FSIS Office of Field
Operations District Manager.
---------------------------------------------------------------------------
\4\ Methodology available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/assessment-generically-approved-label.
---------------------------------------------------------------------------
This assessment found a high level of compliance with the
requirements. During examination of 270 labels, FSIS identified only
three labels with deficiencies necessitating label revocation, and none
of these deficiencies involved food safety. During the closing meetings
with establishments, inspection and industry personnel determined that
more outreach would significantly improve compliance. FSIS has
initiated more outreach regarding labeling requirements, as discussed
later in this document.
On February 13, 2018, FSIS published the proposed rule, Egg
Products Inspection Regulations (83 FR 6314). This rule proposed
several changes to FSIS's egg product inspection program, one of which
adopted by reference FSIS's generic label approval regulation into the
egg products regulations (9 CFR 590.412). If the rule is finalized as
proposed, egg products will be eligible for generic approval of product
labels on the same basis as meat and poultry product labels.
II. Proposed Rule
Since the 2013 rulemaking that established the categories of labels
requiring sketch approval, FSIS has gained significant, additional
experience evaluating labels required to be submitted and approved.
From that experience, the Agency has 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. FSIS is therefore proposing changes to its regulations to
reduce the number of labels submitted for evaluation by FSIS and to
lessen the paperwork burden on official establishments. The reduction
in staff time spent approving these labels would 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 inspection
program personnel (IPP) effectively verify that establishments meet
labeling requirements. All labels used at official establishments would
still be subject to FSIS verification activities in the field. These
activities are further described in the section III. ``Surveillance and
Enforcement'' below.
First, FSIS is proposing to extend generic label approval to
products only intended for export that deviate from domestic labeling
requirements, by removing 9 CFR 412.1(c)(2). FSIS maintains an Export
Library that lists requirements for exported products that foreign
authorities have officially communicated to FSIS, including labeling
requirements.\5\ 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's domestic
labeling requirements in order to comply with foreign country
requirements or to be marketed more easily in a foreign country.\6\
FSIS IPP verify whether product for export meets requirements listed in
the Export Library, including
[[Page 56542]]
labeling, when certifying products for export. Verification of foreign
requirements is ultimately determined by each foreign country's
competent authority.
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\5\ The Export Library is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/export-library-requirements-by-country.
\6\ 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, FSIS is proposing to revise the types of ``special
statements and claims'' requiring label submission by providing for
generic approval of three additional types of claims. FSIS has observed
through its prior label approval system that errors, omissions, and
misrepresentations are rare on these types of labels. The proposed
changes are to be made by amending 9 CFR 412.1(e) and 412.2(b).
The following types of claims would be generically approved:
a. ``Organic'' claims that appear in a product label's ingredients
statement, which designate an ingredient as certified ``organic'' under
AMS's National Organic Program. The ingredients statement on these
product labels designates specific ingredients as organic (e.g.,
organic garlic). FSIS would 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 would continue to require that labels
certifying a total product as organic to be submitted for FSIS
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 would no longer require sketch
approval: 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 would 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 would continue to be required.
Third, FSIS is proposing to 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 animals, such as elk, bison, and migratory
water fowl (9 CFR part 352, subpart A, and 9 CFR part 362); and
products containing meat or poultry but are not under FSIS
jurisdiction, e.g., closed-faced sandwiches (9 CFR 350(c)). At present,
labels for some products produced under these voluntary inspection
programs are not covered under the Agency's generic approval
regulations at 9 CFR 412. FSIS is proposing to permit generic approval
for them on the same basis as amenable meat, poultry, and egg products
by amending the relevant program regulations where needed to include
references to 9 CFR part 412.\7\ For clarity, FSIS will also modify 9
CFR 352.1 to update the section heading and remove unnecessary
language.
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\7\ The regulations providing for voluntary inspection of non-
FSIS-jurisdiction products that contain meat or poultry (9 CFR
350(c)) and products containing non-amenable species of poultry (9
CFR part 362) already adopt 9 CFR part 412 by reference. For this
reason, FSIS does not need to make additional regulatory changes to
these parts in order to permit generic approval of labels for
products receiving these services.
---------------------------------------------------------------------------
Finally, FSIS is proposing to cease evaluating generically approved
labels submitted voluntarily to LPDS for review. In the 2013 rulemaking
that expanded the categories of labels eligible for generic approval,
commenters requested to be allowed to continue submitting generic
labels for FSIS guidance, evaluation, and approval. FSIS agreed to
continue evaluating generic labels that were submitted, giving such
labels secondary priority after labels requiring evaluation. Since the
2013 final rule, producers have become more familiar with FSIS's
generic labeling requirements, and FSIS has provided additional
guidance to assist them in designing compliant labels. Therefore,
FSIS's evaluation of otherwise generic labels no longer represents an
efficient use of Agency resources.
Comprehensive labeling guidance, including the FSIS Compliance
Guideline for Label Approval,\8\ is available at FSIS's website.\9\
Information available includes a PowerPoint presentation titled
``Labeling 101,'' \10\ which is used by the Agency as a teaching tool
at workshops on meat and poultry label requirements. FSIS also provides
guidance on allergen labeling and nutrition labeling,\11\ a Label
Submission Checklist,\12\ a glossary of meat and poultry labeling
terms,\13\ the Policy Book, and questions and answers on various
topics, such as generic approval, and the labeling of ingredients.\14\
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\8\ Available at: https://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-4a2d-8f86-940c2698e2c5/Label-Approval-Guide.pdf?MOD=AJPERES.
\9\ Available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling.
\10\ Available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/basics-of-labeling/basics-labeling.
\11\ Available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/nutrition-labeling-policies/nutrition-labeling.
\12\ Available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-procedures/label-submission-checklist.
\13\ Available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/food-labeling/meat-and-poultry-labeling-terms/meat-and-poultry-labeling-terms.
\14\ Available at: https://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-4a2d-8f86-940c2698e2c5/Label-Approval-Guide.pdf?MOD=AJPERES.
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FSIS will continue to conduct outreach to assist label submitters
with labeling compliance in the form of webinars, industry group
meetings, training for inspectors, guidance documents published on the
FSIS website, and archived public askFSIS questions. Additionally, FSIS
provides significant resources to assist label submitters on labels
that require FSIS approval prior to use. These include askFSIS, a web
portal that allows industry, IPP, and other stakeholders to submit
technical and policy-related questions directly to OPPD.\15\
Establishments may also contact FSIS for assistance with labeling
questions. FSIS offers resources to assist small and very small plants,
including the Small Plant Help Desk, which may be contacted by phone or
email and answers questions on FSIS requirements.\16\
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\15\ Available at: https://askfsis.custhelp.com/. See also, FSIS
Directive 5620.1 Rev. 1, Using askFSIS, available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives.
\16\ The latest information on these resources is available at:
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/resources-and-information/svsp-brochure.
---------------------------------------------------------------------------
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'').\17\ 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
[[Page 56543]]
labels. FSIS also agreed to update its internal policies to improve IPP
label verification activities. Such verification activities are
described in section III. ``Surveillance and Enforcement'' below. FSIS
does not believe that the audit's findings or FSIS's responses to the
audit affect this proposal.
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\17\ The audit report is available at: https://www.usda.gov/oig/webdocs/24601-0002-23.pdf.
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III. Surveillance and Enforcement
Official establishments are required to label meat, poultry, and
egg products with labels that are neither false nor misleading and that
comply with FSIS's regulations. This is true whether the labels require
sketch approval or may be generically approved. Establishments are
required to keep records of all labels in accordance with 9 CFR
320.1(b)(10) for meat products, 9 CFR 381.175(b)(6) for poultry
products, and 9 CFR 590.200(c) for egg products. These records must
include a copy of the final label, the product formulation, processing
procedures, and any supporting documentation needed to show that the
label complies with the Federal meat, poultry, and egg regulations.
Such records must be made available to any duly authorized
representative of the Secretary upon request (9 CFR 320.4 and
590.200(b)).
IPP periodically perform a General Labeling Task assigned through
FSIS's Public Health Inspection System (PHIS) as part of their regular
label verification activities. This task is described in FSIS Directive
7221.1, Prior Labeling Approval. It includes verifying that
establishments maintain records of the selected labels in accordance
with 9 CFR 320.1(b)(10), 381.175(b)(6), and 590.200(c). IPP also verify
that final labels applied to product contain all mandatory labeling
features and are otherwise in compliance with the applicable
regulations by evaluating establishments' labeling records and the
labels themselves (e.g., to verify that the ingredients statement on
the label matches the product formula).
IPP document in PHIS any noncompliance found, e.g., if a required
labeling feature is missing or if a label requires LPDS evaluation but
such evaluation is not documented in the records.\18\ Establishments
may take corrective action by obtaining label approval through LPDS,
bringing the labels into compliance with a pressure sensitive sticker,
or by replacing the noncompliant labels with labels that have received
prior approval and are in compliance with FSIS's regulations. Final
labels that are not in compliance with the regulations may still be
granted temporary approval under the conditions listed in 9 CFR
412.1(f). IPP will retain any product bearing a label not in compliance
with regulatory requirements as well as those that require, but have
not received, LPDS approval. Pursuant to 9 CFR 500.8, FSIS may rescind
approval of any false or misleading labels.\19\
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\18\ If IPP are not performing the General Labeling task but
observe a product label that is not in compliance with Federal meat
and poultry regulations, they will initiate a directed General
Labeling task, retain affected product, and document the
noncompliance in PHIS as described above.
\19\ If FSIS rescinds or refuses to approve a label, it must
explain its reasoning in a written notice, provide an opportunity
for the establishment to modify the label, and advise the
establishment of its appeal rights (9 CFR 500.8(b)).
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FSIS relies on these verification tasks, in addition to evaluation
by LPDS, to ensure that meat, poultry, and egg product labels are
truthful and not misleading. Designating some product labels as
generically approved, while maintaining inspection activities for all
labels, promotes the effective use of Agency resources. This expansion
of generic label approval will not affect consumer protection because
FSIS will continue to evaluate labeling that has consumer safety or
economic implications, e.g., special statements and claims and requests
for temporary approval. For example, FSIS will continue to review
labeling that claims product is organic or all natural, makes
statements regarding the raising of the animals from which products
were derived, displays nutrition factual statements (e.g., 10 g protein
per serving) on the label, or includes certified claims (e.g.,
``Certified Gluten Free'') on the label.\20\
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\20\ For an extensive list of labeling that requires FSIS
approval, see the FSIS Compliance Guideline for Label Approval.
Available at: https://www.fsis.usda.gov/wps/wcm/connect/bf170761-33e3-4a2d-8f86-940c2698e2c5/Label-Approval-Guide.pdf?MOD=AJPERES.
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FSIS invites public comment on these proposed changes and requests
data and additional suggestions for ways to make FSIS's generic
labeling program more effective and efficient. FSIS considered three
alternatives to this proposal: Taking no action; the proposed rule,
except industry would still have the option to have LPDS evaluate
labels that would otherwise be generically approved; and allowing all
labels to be generically approved. Although FSIS ultimately decided on
the current proposal, the Agency will continue to consider the
alternatives described below (under the section titled ``Alternative
Regulatory Approaches'') based on the information received.
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 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 proposed rule has been designated 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.
Need for the Rule
The proposed rule would expand the types of meat, poultry and egg
product labels that can be generically approved by FSIS. This would
reduce the number of labels evaluated by FSIS and 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 proposed rule would 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 proposed rule
also would enhance market efficiency by promoting a faster introduction
of new products into the marketplace to meet consumer demand.
Baseline
Based on FSIS's Label Submission and Approval System (LSAS) \21\
data, FSIS evaluated 15,459 unique labels during the 2019 fiscal year
(FY). Of these, 5,229 (33.8 percent) would have been generically
approved under the proposed rule. 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
primarily make other types of corrections and then resubmitted for FSIS
evaluation. FSIS has observed through its prior label approval system
that corrections on the types of claims FSIS is proposing to
generically approve are rare. In FY 2019, there were 26,158
[[Page 56544]]
label adjudications, which included each time a label was evaluated.
See Table 2 below for additional details.
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\21\ FSIS's 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.
Table 2--Label Evaluations and Adjudications, FY 2016-2019
[Pre proposed rule]
----------------------------------------------------------------------------------------------------------------
FSIS labels 2016 2017 2018 2019
----------------------------------------------------------------------------------------------------------------
Labels FSIS Would Not have Evaluated Under the 8,534 5,812 6,025 5,229
Proposed Rule..................................
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 proposed rule.
** Label adjudications include some labels being revaluated.
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 proposed to permit generic approval for certain egg product labels
in 2018 (83 FR 6314, February, 13, 2018).
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 Proposed Rule
The proposed rule would not impose any new cost on producers that
submit labels for FSIS evaluation. Instead, the proposed rule would
reduce the regulatory burden on producers that currently 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 Proposed Rule Industry Impacts
Industry would realize cost savings from the reduction in FSIS
label submissions under the proposed 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.\22\ FSIS estimates 15 minutes of the 75 minutes are
dedicated to recordkeeping. The recordkeeping time is not included in
the proposed rule's regulatory impact analysis because the
recordkeeping requirements are not changing under the proposed 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-15
minutes). FSIS also assumed food scientists and technologists would
perform this work at a mean hourly wage of $36.63.\23\ A benefits and
overhead factor of two \24\ was applied to estimate the total labor
cost per label submission of $73.26.
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\22\ FSIS Form 7234-1 Application for Approval of Labels,
Marking or Device. Last modified 11/16/2011. Available at: https://www.fsis.usda.gov/wps/portal/fsis/forms/.
\23\ BLS Occupational Employment Statistics, Occupational
Employment and Wages, May 2019. 19-1021 Food Scientists and
Technologists. <https://www.bls.gov/news.release/pdf/ocwage.pdfoes/current/oes191012.htm#nat Accessed on 4/30/2020. Last
Modified 03/30/2020.
\24\ 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.
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To determine the annual reduction of label submissions, FSIS relied
on the average number of labels that FSIS would not have evaluated
under the proposed 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 proposed rule (6,400 * 10). As shown in Table 3, FSIS estimates
that industry would realize a discounted cost savings of $3,293,105 (at
a 7 percent discount rate) and $3,999,505 (at a 3 percent discount
rate) by FSIS generically approving an additional 64,000 labels over a
10-year period. The cost savings would be $468,864 when annualized at
the 7 and 3 percent discount rate, over 10 years.
Table 3--Estimated Industry Cost Savings
[2019 Dollars]
------------------------------------------------------------------------
Present value Present value
Total industry cost savings from reduced cost savings cost savings
need for FSIS label evaluation at 7% at 3%
------------------------------------------------------------------------
Total over 10 years..................... $3,293,105 $3,999,505
Annualized total over 10 years.......... 468,864 468,864
------------------------------------------------------------------------
[[Page 56545]]
Agency Impacts
During FY 2019, FSIS employed 14 labeling analysts in LPDS with an
average hourly salary of $64.75 (($47.52 * 36.25%) + 47.52 = $64.75 for
a GS-13 step 1,\25\ with an adjusted benefits factor of 36.25
percent).\26\ On average, LPDS analysts evaluate labels four hours per
day, five days a week, at a cost of $18,130 per week. If the proposed
rule is adopted, LPDS analysts would evaluate labels for three hours
per day, five days a week, at a cost of $13,598 per week, because of
the reduction in labels submitted to FSIS.
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\25\ Salary Table 2019-DCB for the locality pay area of
Washington-Baltimore-Arlington, DC-MD-VA-WV-PA. Effective January
2019. Available at: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2019/DCB_h.pdf.
\26\ 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.
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If this proposed rule is adopted, the Agency would realize a
discounted cost savings of $1,655,388 (at a 7 percent discount rate)
and $2,010,484 (at a 3 percent discount rate) for adjudicating fewer
labels over a 10-year period. The cost savings would be $235,690 when
annualized at the 7 and 3 percent discount rate over 10 years. See
Table 4 for additional details. However, this cost savings from fewer
staff hours dedicated towards adjudicating labels would be redirected
towards other Agency priority initiatives, such as developing and
updating policy and guidance documents, answering questions from
askFSIS and other sources, and performing outreach activities. We also
anticipate an overall faster label review process from the decline in
LPDS label evaluations. This would allow new labels to enter the market
faster.
Table 4--Estimated Agency Cost Savings
[2019 Dollars]
------------------------------------------------------------------------
Present value Present value
Total agency cost savings from reduced cost savings cost savings
need for FSIS label evaluation at 7% at 3%
------------------------------------------------------------------------
Total over 10 years..................... $1,655,388 $2,010,484
Annualized total over 10 years.......... 235,690 235,690
------------------------------------------------------------------------
Net Benefits
This proposed rule would be net beneficial because it would reduce
the costs to establishments, from submitting fewer labels for FSIS
evaluation, while imposing no additional cost burden. The net benefit
derived from the proposed rule is estimated to be $4,948,493
($3,293,105 in establishment savings plus $1,655,388 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 $704,554. See Table 5 for details.
Table 5--Estimated Agency Cost Savings
[2019 Dollars]
------------------------------------------------------------------------
Total agency and industry cost savings Present value Present value
from reduced need for FSIS label cost savings cost savings
evaluation at 7% at 3%
------------------------------------------------------------------------
Total over 10 years..................... $4,948,493 $6,009,989
Annualized total over 10 years.......... 704,554 704,554
------------------------------------------------------------------------
Alternative Regulatory Approaches
The Agency considered three alternatives to the proposed rule. The
proposed 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 or Net benefits are less
Agency cost savings. than alternative 3.
(2) The Proposed Rule, Except Industry could benefit Potential for Net benefits are less
Industry Would Still Have the from additional FSIS inefficient use of than alternative 3.
Option to Have LPDS Evaluate evaluation. Agency resources. Although industry could
Labels that Would Otherwise be Industry would also marginally benefit from
Generically Approved. incur costs of additional FSIS
submitting the labels evaluation, sufficient
and waiting for FSIS guidance is available
evaluation. for labels that can be
generically approved.
Also, industry and the
Agency would incur
costs from submitting
and evaluating such
labels.
[[Page 56546]]
(3) The Proposed Rule............ Potential industry cost No Cost................. Net benefits are
savings of $468,864 and $704,554 annualized at
Agency cost savings of the 7 percent discount
$235,690, annualized at rate over 10 years.
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 time potentially increasing than alternative 3 as
savings by eliminating the number of the potential costs of
FSIS label evaluation. misbranded products. misbranded products
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 proposed 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 $468,864
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 Proposed Rule, Except Industry Would Still Have the
Option To Have LPDS Evaluate Labels That Would Otherwise be Generically
Approved
FSIS considered an alternative of proposing the same generically
approved label categories except FSIS would continue to evaluate those
labels that would otherwise be generically approved. Currently,
industry can submit labels that can be generically approved for
voluntary FSIS evaluation, although this evaluation is not needed prior
to entering the market. When industry submits these types of labels for
voluntary FSIS evaluation, they are reviewed with a lower priority than
other labels, and thus take 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 could
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 food safety and policy related issues (e.g.,
concerning allergens). Industry would also incur costs in preparing and
submitting the labels for FSIS evaluation while they could get FSIS
help through other outlets without incurring these expenses. For these
reasons, FSIS rejects this alternative.
Alternative 3--The Proposed Rule
The proposed rule yields cost savings for both the industry and the
Agency. There is no additional cost burden from the proposed rule. The
potential cost savings for industry is $468,864, 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 $235,690, annualized at the
7 percent discount rate over 10 years. This covers the time FSIS saves
from not evaluating the proposed generically approved labels. Since
there is no additional burden for this proposed 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
suffer. Therefore, FSIS believes the labels that would still require
prior evaluation under the proposed rule, such as labels with animal
raising or natural 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 has made a preliminary determination that
this proposed rule would not have a significant economic impact on a
substantial number of small entities in the United States, as defined
by the Regulatory Flexibility Act (5 U.S.C. 601). This determination
was made because small producers would experience costs savings from
the reduced number of label submissions for FSIS evaluation.
Based on LSAS and the Public Health Information System (PHIS) \27\
data, FSIS estimates 92.3 percent (4,825/5,229) of the label
submissions in 2019, which would have been generically approved under
the proposed 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, would
not be disadvantaged because the proposed
[[Page 56547]]
rule would minimize the regulatory burden on all producers.
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\27\ PHIS is FSIS's electronic data analytic system, used to
collect, consolidate, and analyze data in order to improve public
health.
---------------------------------------------------------------------------
Based on 2019 LSAS data, about 12 percent (627/5,229) of labels
that would have been generically approved under the proposed 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 proposed rule may
impact their label courier business. However, the impact on these firms
is small as their other business, such as label consultations, would
not be affected. Therefore, this proposed rule would not have a
significant economic impact on the small label consultant firms.
VI. Executive Order 13771
Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS has
estimated that this proposed rule would yield cost savings. Assuming a
7 percent discount rate, a perpetual time horizon, and a starting year
of 2021, the proposed rule, if finalized, is estimated to yield
approximately $502,337 (2016$) in annual cost savings. Therefore, if
finalized as proposed, this rule would be an E.O. 13771 deregulatory
action.
VII. Paperwork Reduction Act
FSIS has reviewed the paperwork and recordkeeping requirements in
this proposed rule in accordance with the Paperwork Reduction Act (44
U.S.C. 3501, et seq.). The Administrator has determined that the
proposed rule would not create any additional collection, paperwork, or
recordkeeping burdens.
FSIS is proposing to expand 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, will have a net reduction of 6,400
burden hours because of the increased use of generic labeling.
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 proposed 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.
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. USDA Non-Discrimination Statement
In accordance with Federal civil rights law and U.S. Department of
Agriculture (USDA) civil rights regulations and policies, the USDA, its
Agencies, offices, and 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.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at https://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.), should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
XIII. 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 proposed rule, which would refine 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.
XIII. Congressional Review Act
Pursuant to the Congressional Review Act at 5 U.S.C. 801 et seq.,
the Office of Information and Regulatory Affairs has determined that
this document is not a
[[Page 56548]]
``major rule,'' as defined by 5 U.S.C. 804(2).
XIV. 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 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 proposing to
amend 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 from the introductory text the phrase ``Wording and form of
inspection mark.''; and
0
c. Add a sentence at 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 412--LABEL APPROVAL
0
5. The authority citation for part 412 continues to read as follows:
Authority: 21 U.S.C. 451-470, 601-695; 7 CFR 218, 2.53.
0
6. In Sec. 412.1, remove and reserve paragraph (c)(2) and revise
paragraph (e) to read 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.
(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.
(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 (i.e., ``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.''
(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,'' or displays of geographic landmarks, such as a foreign
country's flag, monument, or map.
* * * * *
0
7. Revise Sec. 412.2(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
paragraph 412.1(e) of this part.
Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-17340 Filed 9-11-20; 8:45 am]
BILLING CODE 3410-DM-P
