[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]
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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.
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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,
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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).
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Table 1--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
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Units
Primary Low High ------------------------------------
Category estimate estimate estimate Year Discount Period Notes
dollars rate (%) covered
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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.
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Costs:
Annualized Monetized $millions/year....... 0 0 0 2018 7
3
Annualized Quantified..................... .......... .......... .......... .......... 7
3
Qualitative...............................
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Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7
year. 3
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From/To................................... From:
To:
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Other Annualized.......................... .......... .......... .......... .......... 7
Monetized $millions/year.................. 3
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From/To................................... From:
To:
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Effects:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:
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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]
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Primary Lower Upper
Item estimate (7%) estimate (7%) estimate (7%)
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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
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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
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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