Prior Label Approval System: Expansion of Generic Label Approval

 
CONTENT
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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:
Authority: 5 U.S.C. 3301, 3302; E.O.
10577, 3 CFR, 1954–1958 Comp., p. 218; 5
CFR 2.2(c).
Subpart C—Term Employment
2. Amend § 316.301 by adding
paragraph (c) to read as follows:
§ 316.301 Purpose and duration.
* * * * *
(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 time-
limited organizations which have a
specific statutory appropriation; or time-
limited 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
than 10 years from the date of the initial
appointment.
3. Amend § 316.302 by revising
paragraph (b)(7) to read as follows:
§ 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
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 http://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 http://
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
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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)].
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.
T
ABLE
1—S
UMMARY OF
A
NNUALIZED
C
OSTS AND
B
ENEFITS
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)).
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,
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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.
3
Available at: https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatory-compliance/labeling/
Labeling-Policies.
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.
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.
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
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Methodology available at: https://
www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/labeling/labeling-policies/
assessment-generically-approved-label.
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.
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.
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
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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-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.
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.
17
The audit report is available at: https://
www.usda.gov/oig/webdocs/24601-0002-23.pdf.
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 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.
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
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
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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)).
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.
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.
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
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.
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
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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.
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.
T
ABLE
2—L
ABEL
E
VALUATIONS AND
A
DJUDICATIONS
, FY 2016–2019
[Pre proposed rule]
FSIS labels 2016 2017 2018 2019
Labels FSIS Would Not have Evaluated Under the Proposed Rule ............... 8,534 5,812 6,025 5,229
Total Labels FSIS Evaluated * .................................................................. 22,846 17,958 17,635 15,459
Total Label Adjudications ** ...................................................................... 30,857 25,125 27,580 26,158
* This is the total number of labels FSIS evaluated, including the labels that would have been generically approved under the 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.
T
ABLE
3—E
STIMATED
I
NDUSTRY
C
OST
S
AVINGS
[2019 Dollars]
Total industry cost savings from reduced need for FSIS label evaluation Present value
cost savings at
7%
Present value
cost savings at
3%
Total over 10 years .................................................................................................................................................. $3,293,105 $3,999,505
Annualized total over 10 years ................................................................................................................................ 468,864 468,864
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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.
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.
T
ABLE
4—E
STIMATED
A
GENCY
C
OST
S
AVINGS
[2019 Dollars]
Total agency cost savings from reduced need for FSIS label evaluation Present value
cost savings at
7%
Present value
cost savings 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.
T
ABLE
5—E
STIMATED
A
GENCY
C
OST
S
AVINGS
[2019 Dollars]
Total agency and industry cost savings from reduced need for FSIS label evaluation Present value
cost savings at
7%
Present value
cost savings 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.
T
ABLE
6—R
EGULATORY
A
LTERNATIVES
C
ONSIDERED
Alternative Benefits Costs Net benefit
(1) Take No Action .......................... No Benefit .................................... No potential industry or Agency
cost savings. Net benefits are less than alter-
native 3.
(2) The Proposed Rule, Except In-
dustry Would Still Have the Op-
tion to Have LPDS Evaluate La-
bels that Would Otherwise be
Generically Approved.
Industry could benefit from addi-
tional FSIS evaluation. Potential for inefficient use of
Agency resources. Industry
would also incur costs of sub-
mitting the labels and waiting
for FSIS evaluation.
Net benefits are less than alter-
native 3. Although industry
could marginally benefit from
additional FSIS evaluation, suf-
ficient guidance is available for
labels that can be generically
approved. Also, industry and
the Agency would incur costs
from submitting and evaluating
such labels.
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PHIS is FSIS’s electronic data analytic system,
used to collect, consolidate, and analyze data in
order to improve public health.
T
ABLE
6—R
EGULATORY
A
LTERNATIVES
C
ONSIDERED
—Continued
Alternative Benefits Costs Net benefit
(3) The Proposed Rule ................... Potential industry cost savings of
$468,864 and Agency cost sav-
ings of $235,690, annualized at
the 7 percent discount rate
over 10 years.
No Cost ........................................ Net benefits are $704,554
annualized at the 7 percent dis-
count rate over 10 years.
(4) Allow All FSIS Labels to be Ge-
nerically Approved. The Agency and industry would
benefit from time savings by
eliminating FSIS label evalua-
tion.
Costs include potentially increas-
ing the number of misbranded
products.
Net benefits are less than alter-
native 3 as the potential costs
of misbranded products from
eliminating FSIS label evalua-
tion 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
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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
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 http://
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).
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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‘‘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: http://
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:
http://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
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:
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:
§ 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
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
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.
6. In § 412.1, remove and reserve
paragraph (c)(2) and revise paragraph (e)
to 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), 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.
* * * * *
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
AGENCY
: Nuclear Regulatory
Commission.
ACTION
: Preliminary proposed rule
language; notice of availability.
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