[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]


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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.

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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
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                                                                                                         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 http://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


