Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality, 82395-82399 [2020-27823]
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Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules
Dated: December 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
Dated: December 11, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–27829 Filed 12–17–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 152
[Docket No. FDA–2020–N–1690]
RIN 0910–AI17
Frozen Cherry Pie; Proposed
Revocation of a Standard of Identity
and a Standard of Quality
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or we) proposes to
revoke the standard of identity and the
standard of quality for frozen cherry pie.
This action, in part, responds to a
citizen petition submitted by the
American Bakers Association (ABA).
We tentatively conclude that these
standards are no longer necessary to
promote honesty and fair dealing in the
interest of consumers. We also
tentatively conclude that revoking the
standards of identity and quality for
frozen cherry pie would provide greater
flexibility in the product’s manufacture,
consistent with comparable,
nonstandardized foods available in the
marketplace.
DATES: Submit either electronic or
written comments on the proposed rule
by March 18, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 18,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 18, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–1690 for ‘‘Frozen Cherry Pie;
Proposed Revocation of a Standard of
Identity and a Standard of Quality.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
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will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
3719.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the
Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Background
III. ABA Citizen Petition and Grounds
IV. Description of the Proposed Rule
V. Preliminary Economic Analysis of Impacts
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Consultation and Coordination With
Indian Tribal Governments
IX. Federalism
X. Reference
I. Executive Summary
A. Purpose of the Proposed Rule
This proposed rule, if finalized,
would revoke the standards of identity
and quality for frozen cherry pie. This
action, in part, responds to a citizen
petition submitted by the American
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Bakers Association (ABA). We
tentatively conclude that the standards
of identity and quality for frozen cherry
pie are no longer necessary to promote
honesty and fair dealing in the interest
of consumers and revoking these
standards will provide greater flexibility
in the product’s manufacture, consistent
with comparable, nonstandardized
foods available in the marketplace.
B. Summary of the Major Provisions of
the Proposed Rule
This proposed rule, if finalized,
would revoke the standards of identity
and quality for frozen cherry pie.
C. Legal Authority
We are issuing this proposed rule to
revoke the standards of identity and
quality for frozen cherry pie consistent
with our authority under section 401 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 341),
which directs the Secretary of Health
and Human Services (Secretary) to issue
regulations fixing and establishing for
any food a reasonable definition and
standard of identity, quality, or fill of
container whenever, in the Secretary’s
judgment, such action will promote
honesty and fair dealing in the interest
of consumers.
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D. Costs and Benefits
The proposed rule would affect
manufacturers of frozen cherry pie and
would not require firms within the
frozen cherry pie industry to change
their manufacturing practices. Our
analysis of current food manufacturing
practices and the proposal to revoke the
standards indicate that the proposed
rule would provide benefits in terms of
additional flexibility and the
opportunity for innovation to the
manufacturers. Therefore, we tentatively
conclude that the proposed rule to
revoke the standards for frozen cherry
pie would, if finalized, provide social
benefits at no cost to the respective
industries.
II. Background
Section 401 of the FD&C Act directs
the Secretary to issue regulations fixing
and establishing for any food a
reasonable definition and standard of
identity, quality, or fill of container
whenever, in the Secretary’s judgment,
such action will promote honesty and
fair dealing in the interest of consumers.
The purpose of these standards is to
protect consumers against economic
adulteration and reflect consumers’
expectations about food.
We proposed the standards of identity
and quality for frozen cherry pie in the
Federal Register of November 1, 1967
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(32 FR 15116), and finalized them in the
Federal Register of February 23, 1971
(36 FR 3364); the requirements were
codified at 21 CFR 28.1 (‘‘Frozen cherry
pie; identity; label statement of optional
ingredients’’) and 21 CFR 28.2 (‘‘Frozen
cherry pie; quality; label statement of
substandard quality’’). We later
amended the standards of identity and
quality in the Federal Register of June
13, 1973 (38 FR 15504), by removing
minimum frozen cherry pie weight
requirements, aligning the definition of
blemished cherries with that in the
United States Department of
Agriculture’s U.S. Standards for Grades
of Frozen Red Tart Pitted Cherries, and
adding clarifying language. We
renumbered the two sections in the
Federal Register of March 15, 1977 (42
FR 14302 at 14449), and combined them
into § 152.126 (21 CFR 152.126), with
the new section covering both the
standards of identity and quality.
FDA received a citizen petition from
the ABA asking us, in part, to revoke the
frozen cherry pie standards of identity
and quality (Citizen Petition from the
American Bakers Association, dated
August 18, 2005, Docket No. FDA–
2005–P–0435 (‘‘petition’’)). We propose
to grant this request; our proposed
action is to revoke part 152 (21 CFR part
152 (‘‘Fruit pies’’)) in its entirety
because the standards for frozen cherry
pie are the only standards in part 152.
III. ABA Citizen Petition and Grounds
The petition asks us, in part, to revoke
the standards of identity and quality for
frozen cherry pie in 21 CFR 152.126
(petition at page 10).
The petition claims that the essential
elements of § 152.126 are the
requirements that the drained cherry
content of frozen cherry pies cannot be
less than 25 percent of the weight of the
pie and that no more than 15 percent by
count of the cherries in the pie can be
blemished (id. at page 9). The petition
asserts that the sole purpose of
§ 152.126 is to establish a standard of
quality, and not a standard of identity,
for frozen cherry pie products (id.). The
petition also opposes the use of any
food standards to establish quality
characteristics of foods and asserts that
food manufacturers and consumers
should determine food quality (id.).
Consumers would decide whether they
wish to spend more money on higherquality products or less money on
lower-quality products. The petition
further states that a product of
unacceptably low quality will not
survive in the marketplace (id.).
The petition also states that there is
no basis for singling out frozen cherry
pie for the imposition of standards of
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identity and quality (id. at page 10). The
petition observes that there are no
standards of identity and quality for any
other types of frozen fruit pies, or for
any non-frozen fruit pies, including
those filled with cherries (id.). The
petition further asserts that
nonstandardized fruit pies have been
sold throughout the country for many
years without any evidence of public
confusion (id.).
IV. Description of the Proposed Rule
We disagree with the petition’s
opposition to using standards to
establish quality characteristics of foods.
Congress has given us the authority to
promulgate regulations establishing a
reasonable standard of quality for any
food. We may exercise this authority to
promote honesty and fair dealing in the
interest of consumers. Congress has
placed few limitations on the foods for
which standards of quality may be
established, excluding only fresh or
dried fruits, fresh or dried vegetables,
and butter. Frozen cherry pie is not
among these foods, and therefore, we
have the authority to establish a
standard of quality for frozen cherry pie
if doing so promotes honesty and fair
dealing in the interest of consumers.
However, we tentatively conclude
that the frozen cherry pie standards of
identity and quality are no longer
needed to promote honesty and fair
dealing in the interest of consumers.
Consequently, the proposed rule would
revoke part 152 (‘‘Fruit pies’’) in its
entirety because the standards for frozen
cherry pie are the only standards in part
152.
As the petition notes, frozen cherry
pie is the only fruit pie, either frozen or
non-frozen, that is subject to standards
of identity and quality. This means that:
• Other cherry pies (i.e., baked,
frozen cherry pie, which § 152.126(a)(1)
expressly excludes from the standards,
and baked, non-frozen cherry pie) are
not subject to standards of identity or
quality and
• other fruit pies are not subject to
standards of identity or quality.
We are not aware of any evidence
suggesting that consumers have
different expectations for unbaked,
frozen cherry pies than for other cherry
pies. At the same time, no other cherry
pies are subject to a standard of identity
or a standard of quality, and we are
aware of no evidence indicating that
such standards are necessary to promote
honesty and fair dealing in the interest
of consumers or to ensure that those
cherry pies meet consumer
expectations. Similarly, other fruit pies
are not subject to standards of identity
or quality, and we are aware of no
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evidence indicating that such standards
are necessary to promote honesty and
fair dealing in the interest of consumers
or to ensure that the pies meet consumer
expectations.
Additionally, we tentatively conclude
that the prohibition of artificial
sweeteners in § 152.126(a)(2) does not
promote honesty and fair dealing in the
interest of consumers. Baked, frozen
cherry pie and baked, non-frozen cherry
pie may be made with artificial
sweeteners to produce reduced-sugar
varieties to accommodate consumer
preferences and dietary restrictions.
Other types of fruit pies are
manufactured with artificial sweeteners
to produce reduced-sugar varieties.
These varieties appear to cater to
consumer preferences and needs, and
we are aware of no evidence that they
create confusion or circumvent
consumer expectations. If the standard
of identity for frozen cherry pie is
revoked, manufacturers could use
artificial sweeteners to make unbaked,
frozen cherry pie products, consistent
with other reduced-sugar fruit pies
available in the marketplace.
Therefore, after considering the
petition and related information, we
tentatively conclude that the standards
of identity and quality for frozen cherry
pie are no longer needed to promote
honesty and fair dealing in the interest
of consumers consistent with section
401 of the FD&C Act. We are interested
in any information, including data and
studies, on consumer expectations
regarding unbaked, frozen cherry pies
and whether the specifications in
§ 152.126 are necessary to ensure that
frozen cherry pie meets these
expectations.
In addition, our proposal to revoke
the standards of identity and quality for
frozen cherry pie is consistent with
Executive Order 13771, ‘‘Reducing
Regulation and Controlling Regulatory
Costs’’ (January 30, 2017), and Executive
Order 13777, ‘‘Enforcing the Regulatory
Reform Agenda’’ (February 24, 2017).
Executive Order 13771 and Executive
Order 13777, taken together, direct
agencies to offset the number and cost
of new regulations by identifying prior
regulations that can be eliminated
because, for example, they are outdated,
unnecessary, or ineffective. Our
proposed revocation also is consistent
with section 6 of Executive Order
13563, ‘‘Improving Regulation and
Regulatory Review’’ (January 18, 2011),
which requires agencies to periodically
conduct retrospective analyses of
existing regulations to identify those
‘‘that might be outmoded, ineffective,
insufficient, or excessively burdensome,
and to modify, streamline, expand, or
repeal them’’ accordingly.
V. Preliminary Economic Analysis of
Impacts
We have examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563,
Executive Order 13771, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). Executive Order
13771 requires that the costs associated
with significant new regulations ‘‘shall,
to the extent permitted by law, be offset
by the elimination of existing costs
associated with at least two prior
regulations.’’ We believe that this
proposed rule is not a significant
regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
82397
Because we have tentatively concluded,
as set forth below, that this rule would
not generate significant compliance
costs, we propose to certify that the
proposed rule will not have a significant
economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before proposing
‘‘any rule that includes any Federal
mandate that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $156 million,
using the most current (2019) Implicit
Price Deflator for the Gross Domestic
Product. This proposed rule would not
result in an expenditure in any year that
meets or exceeds this amount.
The proposed rule would affect
manufacturers of unbaked, frozen cherry
pie. Our review of supermarket scanner
data for the year 2018 shows that a total
of 40 distinct frozen cherry pie products
sold that year were manufactured by 20
firms. The proposed rule would not
require any firms within the frozen
cherry pie industry to change their
manufacturing practices. Our analysis of
current food manufacturing practices
and the proposal to revoke the standards
indicate that the proposed rule would
provide benefits in terms of additional
flexibility to the manufacturers of frozen
cherry pie products. The proposed rule
would promote innovation and the
introduction of new unbaked, frozen
cherry pie products, providing benefits
to both consumers and industry.
Therefore, we tentatively conclude that
the proposed rule to revoke the
standards for frozen cherry pie would,
if finalized, provide social benefits at
little to no cost to the respective
industries (table 1).
TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE
Units
Primary
estimate
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Category
Benefits:
Annualized
year.
High
estimate
Year
dollars
$millions/
$0
$0
$0
2018
Annualized Quantified ....................
........................
........................
........................
........................
VerDate Sep<11>2014
Monetized
Low
estimate
19:58 Dec 17, 2020
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Discount
rate
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7%
3%
7%
3%
18DEP1
Period
covered
Notes
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TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE—Continued
Units
Category
Qualitative ......................................
Costs:
Annualized Monetized $millions/
year.
Annualized Quantified ....................
Qualitative.
Transfers:
Federal Annualized
$millions/year.
Monetized
Primary
estimate
Low
estimate
High
estimate
........................
........................
$0
Year
dollars
Discount
rate
Period
covered
Notes
........................
........................
........................
........................
Benefits to manufacturers would
be from additional flexibility
for, and the opportunity for innovation regarding,
frozen cherry pie
products.
$0
$0
2018
........................
........................
........................
........................
7%
3%
7%
3%
........................
........................
........................
........................
........................
........................
From/To ..........................................
From:
Other
Annualized
$millions/year.
........................
Monetized
From/To ..........................................
7%
3%
To:
From:
........................
7%
3%
To:
Effects:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:
In line with Executive Order 13771, in
table 2 we estimate present and
annualized values of costs and cost
savings over an infinite time horizon.
Based on these cost savings, this
proposed rule, if finalized, would be
considered a deregulatory action under
E.O. 13771.
TABLE 2—EXECUTIVE ORDER 13771 SUMMARY
[In $ millions 2016 dollars, over an infinite time horizon]
Primary
estimate
(7%)
Item
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Present Value of Costs ................................................................................................................
Present Value of Cost Savings ...................................................................................................
Present Value of Net Costs .........................................................................................................
Annualized Costs .........................................................................................................................
Annualized Cost Savings .............................................................................................................
Annualized Net Costs ..................................................................................................................
We have developed a comprehensive
Preliminary Economic Analysis of
Impacts that assesses the impacts of the
proposed rule. The full preliminary
analysis of economic impacts is
available in the docket for this proposed
rule (Ref. 1) and at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
VI. Analysis of Environmental Impact
We have tentatively determined under
21 CFR part 25.32(a) that this action, if
finalized, is of a type that does not
individually or cumulatively have a
significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
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Lower
estimate
(7%)
$0
0
0
0
0
0
Upper
estimate
(7%)
$0
0
0
0
0
0
$0
0
0
0
0
0
VIII. Consultation and Coordination
With Indian Tribal Governments
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.
Accordingly, we tentatively conclude
that the rule does not contain policies
that have tribal implications as defined
in the Executive Order and,
consequently, a tribal summary impact
statement is not required.
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13175. We
have tentatively concluded that the rule
does not contain policies that have
IX. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. We
have determined that the proposed rule
environmental impact statement is
required.
VII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
proposed rule contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
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Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules
does not contain policies that have
substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the Executive
order and, consequently, a federalism
summary impact statement is not
required.
X. Reference
The following reference is on display
at the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Frozen Cherry Pie; Proposed Revocation of
a Standard of Identity and a Standard of
Quality: Preliminary Regulatory Impact
Analysis, Initial Regulatory Flexibility
Analysis, Unfunded Mandates Reform
Act Analysis. Available at: https://
www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm.
List of Subjects in 21 CFR Part 152
Bakery products, Food grades and
standards, Frozen foods, Fruits.
PART 152—[REMOVED]
Therefore, consistent with our
authority under 21 U.S.C. 321, 341, 343,
348, 371, and 379e, under the Federal
Food, Drug, and Cosmetic Act, it is
proposed that 21 CFR part 152 be
removed.
■
Dated: December 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
Dated: December 14, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
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DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 38
RIN 2900–AR03
Referral for VA Administrative
Decision for Character of Discharge
Determinations
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) proposes to amend title 38
of the Code of Federal Regulations (CFR)
to clarify that, when determining
eligibility for interment or
memorialization benefits, the National
Cemetery Administration (NCA) will
refer cases involving other than
honorable (OTH) discharges, certain
other discharges, or potential statutory
or regulatory bars to benefits, to the
Veterans Benefits Administration (VBA)
for character of discharge
determinations. VA is merely updating
its regulations to conform with statute
and current practice.
DATES: Comments must be received by
VA on or before February 16, 2021.
ADDRESSES: Written comments may be
submitted through www.regulations.gov;
or by mail to Director, Legislative and
Regulatory Service (42E), Department of
Veterans Affairs, 810 Vermont Ave. NW,
Washington, DC 20420. Comments
should indicate that they are submitted
in response to ‘‘RIN 2900–AR03—
Referral for VA Administrative Decision
for Character of Discharge
Determinations.’’ Comments received
will be available for public inspection at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jerry
Sowders, Division Chief, Eligibility
Verification Division, National
Cemetery Administration (NCA),
Department of Veterans Affairs, 810
Vermont Avenue NW, Washington, DC
20420. Telephone: (314) 416–6369 (this
is not a toll-free number).
SUPPLEMENTARY INFORMATION: VA
proposes to amend § 38.620 to clarify
that, when determining eligibility for
interment or memorialization benefits,
NCA will refer cases involving other
than honorable (OTH) discharges or
other character of discharge issues to
VBA for an administrative decision.
Eligibility for NCA-administered
benefits, including interment in national
cemeteries, is tied to an individual
establishing veteran status or meeting
other specified conditions. See, e.g., 38
U.S.C. 2402(a)(1) (stating any ‘‘veteran’’
may be buried in any open national
cemetery); 112 (allowing VA to provide
SUMMARY:
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
82399
Presidential Memorial Certificates to
those eligible for national cemetery
burial); 2306(a) (authorizing VA to
provide a government-furnished
headstone or marker to those buried in
a national cemetery or who meet other
specified conditions); 2306(b)(2) (tying
eligibility for memorial headstones or
markers to ‘‘veteran’’ status); 2306(f)
(authorizing caskets or urns for burial of
deceased ‘‘veterans’’). Congress has
defined a veteran as ‘‘a person who
served in the active military, naval, or
air service, and who was discharged or
released therefrom under conditions
other than dishonorable.’’ 38 U.S.C.
101(2).
Applying the ‘‘veteran’’ definition to
the sections governing NCAadministered benefits, it is thus clear
that, unless other specified conditions
are met, a deceased individual must
have been discharged or released from
active service under conditions other
than dishonorable; and an adjudication
must sometimes be made as to an
individual’s ‘‘veteran’’ status in order to
determine eligibility for NCAadministered benefits. Some
characterizations of service on a DD–214
(such as honorable and general under
honorable conditions) allow for
relatively straightforward
determinations that the character of
discharge was other than dishonorable;
however, other types of
characterizations can be somewhat
complex and require in-depth
examination. For example, bad conduct
discharges, OTH discharges, discharges
upgraded from bad conduct or OTH,
and uncharacterized administrative
separations may require more extensive
character of discharge determinations,
including a review to determine
whether any of the statutory bars to
benefits contained in 38 U.S.C. 5303(a)
apply.
In this rulemaking, NCA clarifies that
cases involving potential character of
discharge bars will be referred to VBA
for an administrative decision under 38
CFR 3.12 (Character of discharge) or
other applicable sections. NCA makes
efficient use of VBA’s existing expertise
and established procedures to
adjudicate character of discharge and
other complex eligibility issues when
needed. Coordination with VBA for
adjudication on such issues helps to
ensure consistency in benefits
determinations and minimizes
confusion for claimants and
beneficiaries that would likely result
from VBA and NCA having differing
protocols. NCA provides funding
resources, equivalent to the amount
necessary for two full time employees,
to VBA to offset the additional workload
E:\FR\FM\18DEP1.SGM
18DEP1
]]>Agencies
[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Proposed Rules]
[Pages 82395-82399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 152
[Docket No. FDA-2020-N-1690]
RIN 0910-AI17
Frozen Cherry Pie; Proposed Revocation of a Standard of Identity
and a Standard of Quality
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) proposes to
revoke the standard of identity and the standard of quality for frozen
cherry pie. This action, in part, responds to a citizen petition
submitted by the American Bakers Association (ABA). We tentatively
conclude that these standards are no longer necessary to promote
honesty and fair dealing in the interest of consumers. We also
tentatively conclude that revoking the standards of identity and
quality for frozen cherry pie would provide greater flexibility in the
product's manufacture, consistent with comparable, nonstandardized
foods available in the marketplace.
DATES: Submit either electronic or written comments on the proposed
rule by March 18, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 18, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 18, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-N-1690 for ``Frozen Cherry Pie; Proposed Revocation of a
Standard of Identity and a Standard of Quality.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-3719.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Background
III. ABA Citizen Petition and Grounds
IV. Description of the Proposed Rule
V. Preliminary Economic Analysis of Impacts
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Consultation and Coordination With Indian Tribal Governments
IX. Federalism
X. Reference
I. Executive Summary
A. Purpose of the Proposed Rule
This proposed rule, if finalized, would revoke the standards of
identity and quality for frozen cherry pie. This action, in part,
responds to a citizen petition submitted by the American
[[Page 82396]]
Bakers Association (ABA). We tentatively conclude that the standards of
identity and quality for frozen cherry pie are no longer necessary to
promote honesty and fair dealing in the interest of consumers and
revoking these standards will provide greater flexibility in the
product's manufacture, consistent with comparable, nonstandardized
foods available in the marketplace.
B. Summary of the Major Provisions of the Proposed Rule
This proposed rule, if finalized, would revoke the standards of
identity and quality for frozen cherry pie.
C. Legal Authority
We are issuing this proposed rule to revoke the standards of
identity and quality for frozen cherry pie consistent with our
authority under section 401 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 341), which directs the Secretary of Health
and Human Services (Secretary) to issue regulations fixing and
establishing for any food a reasonable definition and standard of
identity, quality, or fill of container whenever, in the Secretary's
judgment, such action will promote honesty and fair dealing in the
interest of consumers.
D. Costs and Benefits
The proposed rule would affect manufacturers of frozen cherry pie
and would not require firms within the frozen cherry pie industry to
change their manufacturing practices. Our analysis of current food
manufacturing practices and the proposal to revoke the standards
indicate that the proposed rule would provide benefits in terms of
additional flexibility and the opportunity for innovation to the
manufacturers. Therefore, we tentatively conclude that the proposed
rule to revoke the standards for frozen cherry pie would, if finalized,
provide social benefits at no cost to the respective industries.
II. Background
Section 401 of the FD&C Act directs the Secretary to issue
regulations fixing and establishing for any food a reasonable
definition and standard of identity, quality, or fill of container
whenever, in the Secretary's judgment, such action will promote honesty
and fair dealing in the interest of consumers. The purpose of these
standards is to protect consumers against economic adulteration and
reflect consumers' expectations about food.
We proposed the standards of identity and quality for frozen cherry
pie in the Federal Register of November 1, 1967 (32 FR 15116), and
finalized them in the Federal Register of February 23, 1971 (36 FR
3364); the requirements were codified at 21 CFR 28.1 (``Frozen cherry
pie; identity; label statement of optional ingredients'') and 21 CFR
28.2 (``Frozen cherry pie; quality; label statement of substandard
quality''). We later amended the standards of identity and quality in
the Federal Register of June 13, 1973 (38 FR 15504), by removing
minimum frozen cherry pie weight requirements, aligning the definition
of blemished cherries with that in the United States Department of
Agriculture's U.S. Standards for Grades of Frozen Red Tart Pitted
Cherries, and adding clarifying language. We renumbered the two
sections in the Federal Register of March 15, 1977 (42 FR 14302 at
14449), and combined them into Sec. 152.126 (21 CFR 152.126), with the
new section covering both the standards of identity and quality.
FDA received a citizen petition from the ABA asking us, in part, to
revoke the frozen cherry pie standards of identity and quality (Citizen
Petition from the American Bakers Association, dated August 18, 2005,
Docket No. FDA-2005-P-0435 (``petition'')). We propose to grant this
request; our proposed action is to revoke part 152 (21 CFR part 152
(``Fruit pies'')) in its entirety because the standards for frozen
cherry pie are the only standards in part 152.
III. ABA Citizen Petition and Grounds
The petition asks us, in part, to revoke the standards of identity
and quality for frozen cherry pie in 21 CFR 152.126 (petition at page
10).
The petition claims that the essential elements of Sec. 152.126
are the requirements that the drained cherry content of frozen cherry
pies cannot be less than 25 percent of the weight of the pie and that
no more than 15 percent by count of the cherries in the pie can be
blemished (id. at page 9). The petition asserts that the sole purpose
of Sec. 152.126 is to establish a standard of quality, and not a
standard of identity, for frozen cherry pie products (id.). The
petition also opposes the use of any food standards to establish
quality characteristics of foods and asserts that food manufacturers
and consumers should determine food quality (id.). Consumers would
decide whether they wish to spend more money on higher-quality products
or less money on lower-quality products. The petition further states
that a product of unacceptably low quality will not survive in the
marketplace (id.).
The petition also states that there is no basis for singling out
frozen cherry pie for the imposition of standards of identity and
quality (id. at page 10). The petition observes that there are no
standards of identity and quality for any other types of frozen fruit
pies, or for any non-frozen fruit pies, including those filled with
cherries (id.). The petition further asserts that nonstandardized fruit
pies have been sold throughout the country for many years without any
evidence of public confusion (id.).
IV. Description of the Proposed Rule
We disagree with the petition's opposition to using standards to
establish quality characteristics of foods. Congress has given us the
authority to promulgate regulations establishing a reasonable standard
of quality for any food. We may exercise this authority to promote
honesty and fair dealing in the interest of consumers. Congress has
placed few limitations on the foods for which standards of quality may
be established, excluding only fresh or dried fruits, fresh or dried
vegetables, and butter. Frozen cherry pie is not among these foods, and
therefore, we have the authority to establish a standard of quality for
frozen cherry pie if doing so promotes honesty and fair dealing in the
interest of consumers.
However, we tentatively conclude that the frozen cherry pie
standards of identity and quality are no longer needed to promote
honesty and fair dealing in the interest of consumers. Consequently,
the proposed rule would revoke part 152 (``Fruit pies'') in its
entirety because the standards for frozen cherry pie are the only
standards in part 152.
As the petition notes, frozen cherry pie is the only fruit pie,
either frozen or non-frozen, that is subject to standards of identity
and quality. This means that:
Other cherry pies (i.e., baked, frozen cherry pie, which
Sec. 152.126(a)(1) expressly excludes from the standards, and baked,
non-frozen cherry pie) are not subject to standards of identity or
quality and
other fruit pies are not subject to standards of identity
or quality.
We are not aware of any evidence suggesting that consumers have
different expectations for unbaked, frozen cherry pies than for other
cherry pies. At the same time, no other cherry pies are subject to a
standard of identity or a standard of quality, and we are aware of no
evidence indicating that such standards are necessary to promote
honesty and fair dealing in the interest of consumers or to ensure that
those cherry pies meet consumer expectations. Similarly, other fruit
pies are not subject to standards of identity or quality, and we are
aware of no
[[Page 82397]]
evidence indicating that such standards are necessary to promote
honesty and fair dealing in the interest of consumers or to ensure that
the pies meet consumer expectations.
Additionally, we tentatively conclude that the prohibition of
artificial sweeteners in Sec. 152.126(a)(2) does not promote honesty
and fair dealing in the interest of consumers. Baked, frozen cherry pie
and baked, non-frozen cherry pie may be made with artificial sweeteners
to produce reduced-sugar varieties to accommodate consumer preferences
and dietary restrictions. Other types of fruit pies are manufactured
with artificial sweeteners to produce reduced-sugar varieties. These
varieties appear to cater to consumer preferences and needs, and we are
aware of no evidence that they create confusion or circumvent consumer
expectations. If the standard of identity for frozen cherry pie is
revoked, manufacturers could use artificial sweeteners to make unbaked,
frozen cherry pie products, consistent with other reduced-sugar fruit
pies available in the marketplace.
Therefore, after considering the petition and related information,
we tentatively conclude that the standards of identity and quality for
frozen cherry pie are no longer needed to promote honesty and fair
dealing in the interest of consumers consistent with section 401 of the
FD&C Act. We are interested in any information, including data and
studies, on consumer expectations regarding unbaked, frozen cherry pies
and whether the specifications in Sec. 152.126 are necessary to ensure
that frozen cherry pie meets these expectations.
In addition, our proposal to revoke the standards of identity and
quality for frozen cherry pie is consistent with Executive Order 13771,
``Reducing Regulation and Controlling Regulatory Costs'' (January 30,
2017), and Executive Order 13777, ``Enforcing the Regulatory Reform
Agenda'' (February 24, 2017). Executive Order 13771 and Executive Order
13777, taken together, direct agencies to offset the number and cost of
new regulations by identifying prior regulations that can be eliminated
because, for example, they are outdated, unnecessary, or ineffective.
Our proposed revocation also is consistent with section 6 of Executive
Order 13563, ``Improving Regulation and Regulatory Review'' (January
18, 2011), which requires agencies to periodically conduct
retrospective analyses of existing regulations to identify those ``that
might be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal them''
accordingly.
V. Preliminary Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because we have tentatively concluded, as set forth below,
that this rule would not generate significant compliance costs, we
propose to certify that the proposed rule will not have a significant
economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by private
sector, of $100,000,000 or more (adjusted annually for inflation) in
any one year.'' The current threshold after adjustment for inflation is
$156 million, using the most current (2019) Implicit Price Deflator for
the Gross Domestic Product. This proposed rule would not result in an
expenditure in any year that meets or exceeds this amount.
The proposed rule would affect manufacturers of unbaked, frozen
cherry pie. Our review of supermarket scanner data for the year 2018
shows that a total of 40 distinct frozen cherry pie products sold that
year were manufactured by 20 firms. The proposed rule would not require
any firms within the frozen cherry pie industry to change their
manufacturing practices. Our analysis of current food manufacturing
practices and the proposal to revoke the standards indicate that the
proposed rule would provide benefits in terms of additional flexibility
to the manufacturers of frozen cherry pie products. The proposed rule
would promote innovation and the introduction of new unbaked, frozen
cherry pie products, providing benefits to both consumers and industry.
Therefore, we tentatively conclude that the proposed rule to revoke the
standards for frozen cherry pie would, if finalized, provide social
benefits at little to no cost to the respective industries (table 1).
Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Category Primary Low estimate High estimate ------------------------------------------------ Notes
estimate Year dollars Discount rate Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/ $0 $0 $0 2018 7%
year. 3%
7%
Annualized Quantified......... .............. .............. .............. .............. 3%
[[Page 82398]]
Qualitative................... .............. .............. .............. .............. .............. .............. Benefits to
manufacturers would
be from additional
flexibility for,
and the opportunity
for innovation
regarding, frozen
cherry pie
products.
Costs:
Annualized Monetized $millions/ $0 $0 $0 2018 7%
year. 3%
Annualized Quantified......... .............. .............. .............. .............. 7%
3%
Qualitative...................
Transfers:
Federal Annualized Monetized .............. .............. .............. .............. 7%
$millions/year. 3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To....................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .............. .............. .............. .............. 7%
$millions/year. 3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To....................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------
In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. Based on these cost savings, this proposed rule, if finalized,
would be considered a deregulatory action under E.O. 13771.
Table 2--Executive Order 13771 Summary
[In $ millions 2016 dollars, over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
Primary Lower estimate Upper estimate
Item estimate (7%) (7%) (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs.......................................... $0 $0 $0
Present Value of Cost Savings................................... 0 0 0
Present Value of Net Costs...................................... 0 0 0
Annualized Costs................................................ 0 0 0
Annualized Cost Savings......................................... 0 0 0
Annualized Net Costs............................................ 0 0 0
----------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
VI. Analysis of Environmental Impact
We have tentatively determined under 21 CFR part 25.32(a) that this
action, if finalized, is of a type that does not individually or
cumulatively have a significant effect on the human environment.
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
VII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
VIII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
concluded that the rule does not contain policies 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. Accordingly, we tentatively conclude that
the rule does not contain policies that have tribal implications as
defined in the Executive Order and, consequently, a tribal summary
impact statement is not required.
IX. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule
[[Page 82399]]
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.
X. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. Frozen Cherry Pie; Proposed Revocation of a Standard of Identity
and a Standard of Quality: Preliminary Regulatory Impact Analysis,
Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform
Act Analysis. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
List of Subjects in 21 CFR Part 152
Bakery products, Food grades and standards, Frozen foods, Fruits.
PART 152--[REMOVED]
0
Therefore, consistent with our authority under 21 U.S.C. 321, 341, 343,
348, 371, and 379e, under the Federal Food, Drug, and Cosmetic Act, it
is proposed that 21 CFR part 152 be removed.
Dated: December 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
Dated: December 14, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-27823 Filed 12-17-20; 8:45 am]
BILLING CODE 4164-01-P
