[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Proposed Rules]
[Pages 82980-82984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27822]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 169

[Docket No. FDA-2020-N-1807]
RIN 0910-AI16


French Dressing; Proposed Revocation of a Standard of Identity

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 for French dressing. This action, in 
part, responds to a citizen petition submitted by the Association for 
Dressings and Sauces (ADS). We tentatively conclude that this standard 
no longer promotes honesty and fair dealing in the interest of 
consumers. Revocation of the standard of identity for French dressing 
could 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 22, 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 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 22, 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

[[Page 82981]]

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-1807 for ``French Dressing; Proposed Revocation of a 
Standard of Identity.'' 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, 240-402-2371.

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. ADS Citizen Petition and Grounds
IV. Description of the Proposed Rule
V. Preliminary Economic Analysis of Impacts
VI. Paperwork Reduction Act of 1995
VII. Consultation and Coordination With Indian Tribal Governments
VIII. Federalism
IX. Analysis of Environmental Impact
X. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    This proposed rule, if finalized, would revoke the standard of 
identity for French dressing. This action, in part, responds to a 
citizen petition submitted by the Association for Dressings and Sauces 
(ADS) (petition). We tentatively conclude that the standard of identity 
for French dressing no longer promotes honesty and fair dealing in the 
interest of consumers and revoking the standard could provide greater 
flexibility in the product's manufacture, consistent with comparable, 
nonstandardized foods available in the marketplace.

B. Summary of the Major Provision of the Proposed Rule

    This proposed rule, if finalized, would revoke the standard of 
identity for French dressing.

C. Legal Authority

    We are issuing this proposed rule to revoke the standard of 
identity for French dressing consistent with our authority under of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act), 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 dressings for 
salad, and would not require any of the affected firms within the 
industry to change their manufacturing practices. Our analysis of 
current food manufacturing practices and the petition to revoke the 
standard indicate that revoking the standard of identity could provide 
benefits in terms of additional flexibility and the opportunity for 
innovation to manufacturers. The potential for innovation is evidenced 
by the growing variety of dressings for salads on the market that are 
formulated to meet consumers' preferences and needs. Therefore, we 
tentatively conclude that the proposed rule to revoke the standard of 
identity for French dressing would, if finalized, provide social 
benefits at no cost to the respective industries.

II. Background

    Section 401 of the FD&C Act (21 U.S.C. 341) 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.
    In the Federal Register of August 12, 1950 (15 FR 5227), we 
established a standard of identity for French dressing. We later 
amended that standard of identity in the Federal Registers of May 10, 
1961 (26 FR 4012), February 12, 1964 (29 FR 2382), February 1, 1967 (32 
FR 1127 at 1128), May 18, 1971 (36 FR 9010), and November 8, 1974 (39 
FR 39554) to allow the use of certain ingredients in French dressing. 
We also re-designated the French dressing standard of identity as 21 
CFR 169.115 (42 FR 14481, March 15, 1977).
    We received a citizen petition from the ADS asking us, in part, to 
revoke the standard of identity for French dressing (Citizen Petition 
from the Association for Dressings and Sauces, dated January 13,1998, 
submitted to the Division of Dockets Management, Food and Drug 
Administration, Docket No. FDA-1998-P-0669 (``petition'')). We are 
issuing this proposed rule, in part, in response to the petitioner's 
request.

III. ADS Citizen Petition and Grounds

    The petition asks us to revoke the standard of identity for French 
dressing (petition at page 1).
    The petition states that there has been a proliferation of 
nonstandardized pourable dressings for salads with respect to flavors 
(Italian, Ranch, cheese, fruit, peppercorn, varied vinegars, and other 
flavoring concepts) and composition (including a wide range of reduced 
fat, ``light,'' and fat-free dressings) (petition at page 3). The 
French dressing standard of identity,

[[Page 82982]]

according to the petition, no longer serves as a benchmark for other 
dressings because of the wide variation in composition to meet consumer 
interests (id.). Instead, the petition claims that the standard of 
identity has become marginalized and restricts innovation (id.). 
Therefore, the petition states that the French dressing standard of 
identity no longer promotes honesty and fair dealing in the interest of 
consumers (id.).

IV. Description of the Proposed Rule

    We have reviewed the petition and tentatively conclude that the 
standard of identity for French dressing no longer promotes honesty and 
fair dealing in the interest of consumers. Therefore, we propose to 
revoke the French dressing standard of identity at 21 CFR 169.115.
    When the standard of identity was established in 1950, French 
dressing was one of three types of dressings we identified (15 FR 
5227). We generally characterized the dressings as containing a fat 
ingredient, an acidifying ingredient, and seasoning ingredients. The 
French dressing standard allowed for certain flexibility in 
manufacturers' choice of oil, acidifying ingredients, and seasoning 
ingredients. Tomatoes or tomato-derived ingredients were among the 
seasoning ingredients permitted, but not required. Amendments to the 
standard since 1950 have permitted the use of additional ingredients, 
such as any safe and suitable color additives that impart the color 
traditionally expected (39 FR 39543 at 39554-39555).
    Most, if not all, products currently sold under the name ``French 
dressing'' contain tomatoes or tomato-derived ingredients and have a 
characteristic red or reddish-orange color. They also tend to have a 
sweet taste. Consumers appear to expect these characteristics when 
purchasing products represented as French dressing. Thus, it appears 
that, since the establishment of the standard of identity, French 
dressing has become a narrower category of products than prescribed by 
the standard. These products maintain the above characteristics without 
a standard of identity specifically requiring them.
    Additionally, French dressing products are manufactured and sold in 
lower-fat varieties that contain less than the minimum amount of 
vegetable oil (35% by weight) required by 21 CFR 169.115(a). We are 
unaware of any evidence that consumers are deceived or misled by the 
reduction in vegetable oil when these varieties are sold under names 
including terms such as ``fat free'' or ``low-fat.'' By contrast, these 
varieties appear to accommodate consumer preferences and dietary 
restrictions.
    Therefore, after considering the petition and related information, 
we tentatively conclude that the standard of identity for French 
dressing no longer promotes 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 French dressing and whether the specifications 
in Sec.  169.115 are necessary to ensure that French dressing meets 
these expectations.
    In addition, our proposal to revoke the standard of identity for 
French dressing 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. 
The 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 dressings for 
salad. Our review of supermarket scanner data for the year 2018 shows 
that a total of 227 distinct pourable products sold as ``French 
dressing'' that year were manufactured by 53 firms. The proposed rule 
would not require any of the affected firms to change their 
manufacturing practices. Our analysis of current food manufacturing 
practices and the petition to revoke the standard indicate that 
revoking the standard of identity could provide benefits in terms of 
additional flexibility to the manufacturers of French dressing 
products. Revoking the standard of identity could provide an 
opportunity for innovation and the introduction of new French dressing 
products, providing benefits to both consumers and industry. Therefore, 
we tentatively conclude that the proposed rule, if finalized, would 
provide social benefits at little to no cost to the respective 
industries (Table 1).

[[Page 82983]]



                                     Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                  Primary       Low        High    ------------------------------------
                   Category                      estimate    estimate    estimate      Year      Discount     Period                  Notes
                                                                                      dollars    rate  (%)    covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year.......          $0          $0          $0        2018           7
                                                                                                         3
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                                         3
    Qualitative...............................  ..........  ..........  ..........  ..........  ..........  ..........  Benefits to manufacturers would
                                                                                                                         be from additional flexibility,
                                                                                                                         and the opportunity for
                                                                                                                         innovation regarding, French
                                                                                                                         dressing products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.......           0           0           0        2018           7
                                                                                                         3
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                                         3
    Qualitative...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/     ..........  ..........  ..........  ..........           7
     year.                                                                                               3
                                               ---------------------------------------------------------------------------------------------------------
    From/To...................................  From:
                                                To:
                                               ---------------------------------------------------------------------------------------------------------
    Other Annualized..........................  ..........  ..........  ..........  ..........           7
    Monetized $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 lack of costs, this proposed rule would be considered 
a deregulatory action under E.O. 13771.

                                        Table 2--E.O. 13771 Summary Table
                           [in $ millions 2016 dollars, over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
                                                                      Primary          Lower           Upper
                              Item                                estimate  (7%)  estimate  (7%)  estimate  (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. 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.

VII. 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 
determined that the rule does not contain policies that would have a 
substantial direct effect 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. We solicit comments from tribal officials 
on any potential impact on Indian Tribes from this proposed action.

VIII. 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 does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or

[[Page 82984]]

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.

IX. 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.

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 address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

1. French Dressing; Proposed Revocation of a Standard of Identity: 
Preliminary Regulatory Impact Analysis, Initial Regulatory 
Flexibility Analysis, Unfunded Mandates Reform Act Analysis, 
available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 169

    Food grades and standards.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, it is 
proposed that 21 CFR part 169 be amended as follows:

PART 169--FOOD DRESSINGS AND FLAVORINGS

0
1. The authority citation for 21 CFR part 169 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.


Sec.  169.115  [Removed]

0
2. Remove Sec.  169.115.

    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. 2020-27822 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P


