82980 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

accordance with, European Union Aviation 

Safety Agency (EASA) AD 2020–0022R1, 

dated September 18, 2020 (EASA AD 2020– 

0022R1). 

(h) Exceptions to EASA AD 2020–0022R1 

(1) Where EASA AD 2020–0022R1 refers to 

March 30, 2018 (the effective date of EASA 

AD 2018–0066, dated March 23, 2018) or 

February 21, 2020 (the effective date of EASA 

AD 2020–0022, dated February 21, 2020), 

this AD requires using the effective date of 

this AD. 

(2) The ‘‘Remarks’’ section of EASA AD 

2020–0022R1 does not apply to this AD. 

(3) Where EASA AD 2020–0022R1 refers to 

flight hours (FH), this AD requires using 

hours time-in-service. 

(4) Where the service information referred 

to in paragraphs (5) and (6) of EASA AD 

2020–0022R1 specifies to perform a 

metallurgical analysis and contact the 

manufacturer if unsure about the 

characterization of the particles collected, 

this AD does not require contacting the 

manufacturer to determine the 

characterization of the particles collected. 

(5) Although the service information 

referred to in paragraph (6) of EASA AD 

2020–0022R1 specifies that if any 16NCD13 

particles are found send a 1-liter sample of 

oil to the manufacturer, this AD does not 

require that action. 

(6) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to discard certain parts, this AD 

does not include that requirement. 

(7) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies returning certain parts to the 

manufacturer, this AD does not require that 

action. 

(8) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to contact the manufacturer if 

certain specified criteria are exceeded, this 

AD does not include that requirement. 

(9) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to submit certain information to the 

manufacturer, this AD does not include that 

requirement. 

(10) Although the service information 

referenced in EASA AD 2020–0022R1 

specifies to watch a video for removing the 

grease from the FFMP, using a cleaning 

agent, and collecting particles, this AD does 

not include that requirement. 

(11) Where EASA AD 2020–0022R1 

requires actions after the last flight of the day 

or ‘‘ALF,’’ this AD requires those actions 

before the first flight of the day. 

(i) Special Flight Permit 

Special flight permits may be issued in 

accordance with 14 CFR 21.197 and 21.199 

to operate the helicopter to a location where 

the helicopter can be modified (if the 

operator elects to do so), provided no 

passengers are onboard. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Strategic Policy 

Rotorcraft Section, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the Strategic Policy 

Rotorcraft Section, send it to: Manager, 

Strategic Policy Rotorcraft Section, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone 817–222–5110; email 9- 

ASW-FTW-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(k) Related Information 

(1) For EASA AD 2020–0022R1, contact the 

EASA, Konrad-Adenauer-Ufer 3, 50668 

Cologne, Germany; telephone +49 221 8999 

000; email ADs@easa.europa.eu; internet 

www.easa.europa.eu. You may find this 

EASA AD on the EASA website at https://

ad.easa.europa.eu. You may view this 

material at the FAA, Office of the Regional 

Counsel, Southwest Region, 10101 Hillwood 

Pkwy., Room 6N–321, Fort Worth, TX 76177. 

For information on the availability of this 

material at the FAA, call 817–222–5110. This 

material may be found in the AD docket on 

the internet at https://www.regulations.gov 

by searching for and locating Docket No. 

FAA–2020–1136. 

(2) For more information about this AD, 

contact Mahmood Shah, Aviation Safety 

Engineer, Fort Worth ACO Branch, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone 817 222 5538; email 

mahmood.g.shah@faa.gov. 

Issued on December 15, 2020. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2020–28026 Filed 12–18–20; 8:45 am] 

BILLING CODE 4910–13–P 

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 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 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, 

82982 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

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 

§ 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). 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82983 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

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/year.

.................. .................. .................. .................. 7 

3 

From/To ............................................ From: To: 

Other Annualized .............................

Monetized $millions/year ..................

.................. .................. .................. .................. 7 

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] 

Item 

Primary 

estimate 

(7%) 

Lower 

estimate 

(7%) 

Upper 

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 

82984 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

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 

■ 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. 

§ 169.115 [Removed] 

■ 2. Remove § 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 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–542] 

Designation of 3,4-MDP-2-P Methyl 

Glycidate (PMK Glycidate), 3,4-MDP-2- 

P Methyl Glycidic Acid (PMK Glycidic 

Acid), and AlphaPhenylacetoacetamide (APAA) as List I 

Chemicals 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration is proposing to 

designate 3,4-MDP-2-P methyl glycidate 

(PMK glycidate), including its optical 

and geometric isomers; 3,4-MDP-2-P 

methyl glycidic acid (PMK glycidic 

acid), including its salts, optical and 

geometric isomers, and salts of isomers; 

and alpha-phenylacetoacetamide 

(APAA), including its optical isomers, 

as list I chemicals under the Controlled 

Substances Act (CSA). PMK glycidate 

and PMK glycidic acid are used in and 

are important to the manufacture of the 

schedule I controlled substance 3,4- 

methylenedioxymethamphetamine 

(MDMA) and other ‘‘ecstasy’’-type 

substances. APAA is used in and is 

important to the manufacture of the 

schedule II controlled substances 

amphetamine and methamphetamine. If 

finalized, this action would subject 

handlers (manufacturers, distributors, 

importers, and exporters) of PMK 

glycidate, PMK glycidic acid, and APAA 

to the chemical regulatory provisions of 

the CSA and its implementing 

regulations. This action does not 

propose the establishment of a threshold 

for domestic and international 

transactions of these chemicals. As 

such, all transactions involving any of 

these chemicals, regardless of size, 

would be regulated. In addition, this 

action proposes that chemical mixtures 

containing any of these three chemicals 

would not be exempt from regulatory 

requirements at any concentration. 

Therefore, all transactions of chemical 

mixtures containing any quantity of 

PMK glycidate, PMK glycidic acid, or 

APAA would be regulated. 

DATES: Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before February 

19, 2021. Commenters should be aware 

that the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–542’’ on all correspondence, 

including any attachments. 

Electronic comments: The Drug 

Enforcement Administration (DEA) 

encourages all comments be submitted 

electronically through the Federal 

eRulemaking Portal, which provides the 

ability to type short comments directly 

into the comment field on the web page 

or to attach a file for lengthier 

comments. Please go to http://

www.regulations.gov/ and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on http://www.regulations.gov/. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

Paper comments: Paper comments 

that duplicate the electronic submission 

are not necessary and are discouraged. 

Should you wish to mail a paper 

comment in lieu of an electronic 

comment, it should be sent via regular 

or express mail to: Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (571) 362–3249. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received are considered part of the 

public record. They will, unless 

reasonable cause is given, be made 

available by the Drug Enforcement 

Administration (DEA) for public 

inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as name, address, 

etc.) voluntarily submitted by the 

commenter. The Freedom of 

Information Act applies to all comments 

received. If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place