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 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82985 

1 21 U.S.C. 802(34) and 871(b). 

2 21 CFR 1310.02(c). 

3Table I and Table II are amended from time to 

time in accordance with Article 12 of the 1988 

Convention. 

4With this scheduling action, if finalized, DEA 

would control the same set of chemicals specified 

by the CND. However, DEA uses more precise terms 

that relate to the specific chemical and variations 

that can actually exist. 

all of the personal identifying 

information you do not want publicly 

available in the first paragraph of your 

comment and identify what information 

you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information and confidential 

business information identified as 

directed above will generally be made 

publicly available in redacted form. If a 

comment has so much confidential 

business information or personal 

identifying information that it cannot be 

effectively redacted, all or part of that 

comment may not be made publicly 

available. Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

directed above as confidential. 

An electronic copy of this document 

and supplemental information to this 

proposed rule are available at http://

www.regulations.gov for easy reference. 

Legal Authority 

The Controlled Substances Act (CSA) 

gives the Attorney General the authority 

to specify, by regulation, a chemical as 

a ‘‘list I chemical;’’ this term refers to a 

chemical that is used in manufacturing 

a controlled substance in violation of 

subchapter I (Control and Enforcement) 

of the CSA and is important to the 

manufacture of the controlled 

substance.1 Pursuant to 28 CFR 0.100(b), 

the Attorney General has delegated his 

authority to so designate list I chemicals 

to the Administrator of DEA 

(Administrator). CSA regulations permit 

the Administrator to add a substance as 

a listed chemical by publishing a final 

rule in the Federal Register following 

the publication of a notice of proposed 

rulemaking that has provided at least 30 

days for public comments.2 The current 

list of all list I chemicals is available in 

21 CFR 1310.02(a). 

In addition, the United States is a 

Party to the 1988 United Nations 

Convention against Illicit Traffic in 

Narcotic Drugs and Psychotropic 

Substances (1988 Convention), 

December 20, 1988, 1582 U.N.T.S. 95. 

Under Article 12 of the 1988 

Convention, when the United States 

receives notification that a chemical has 

been added to Table I or Table II (tables 

annexed to such Convention), the 

United States must take measures it 

deems appropriate to monitor the 

manufacture and distribution of that 

chemical within the United States and 

to prevent its diversion, including 

measures related to international trade. 

Background 

With the growing problem of illicit 

drug production, the issue of precursor 

chemical control has gained global 

attention. International efforts to 

prevent the illicit production of 

controlled substances and international 

control of precursors have made 

significant progress with this problem. 

Article 12 of the 1988 Convention 

established International controls on 

precursors. This Convention established 

two categories of controlled illicit drug 

precursor substances: Table I and Table 

II.3 Two international entities have 

played a crucial role in this effort: The 

United Nations Commission on Narcotic 

Drugs (CND) and the International 

Narcotics Control Board (INCB). 

In response to domestic and 

international controls on precursors to 

the schedule I substance 3,4- 

methylenedioxymethamphetamine 

(MDMA), and schedule II substances 

amphetamine and methamphetamine, 

clandestine laboratory operators have 

continued to explore alternate methods 

to produce these illicit drugs, including 

the development of their own 

immediate precursors (‘‘designer 

precursors’’) and diversion of other 

precursors (pre-precursors) to produce 

these designer precursors. These 

clandestine laboratory operators often 

use 3,4-MDP-2-P methyl glycidate (PMK 

glycidate) and 3,4-MDP-2-P methyl 

glycidic acid (PMK glycidic acid) as 

precursors to MDMA, and other 

‘‘ecstasy’’-type substances, and alphaphenylacetoacetamide (APAA) as a 

precursor to amphetamine and 

methamphetamine. 

‘‘Precursor chemicals’’ are generally 

defined as chemical substances that 

become incorporated, at the molecular 

level, into a final product (including a 

controlled substance); it is a building 

block used to manufacture the final 

product/controlled substance. PMK 

glycidate and PMK glycidic acid are 

building blocks for the manufacture of 

the schedule I controlled substance 

MDMA, while APAA serves as a 

building block for the manufacture of 

the schedule II substance Phenyl-2- 

propanone (P2P), and subsequent final 

manufacture of the schedule II 

substances amphetamine and 

methamphetamine. All these chemicals 

meet the definition of list I chemicals 

since they are important to the 

manufacture of these controlled 

substances. 

In a letter dated May 23, 2019, the 

Secretary-General of the United Nations, 

in accordance with Article 12, 

paragraph 6 of the 1988 Convention, 

informed the United States Secretary of 

State that the CND voted to place the 

chemicals PMK glycidate (and all 

stereoisomers), PMK glycidic acid (and 

all stereoisomers), and APAA (and all 

optical isomers) in Table I of the 1988 

Convention (CND Decisions 62/10, 62/ 

11, and 62/12, respectively) at its 62nd 

Session on March 19, 2019. As a Party 

to the 1988 Convention, the United 

States is obligated to control these 

substances pursuant to Article 12 of the 

1988 Convention, as described in the 

above Legal Authority section. By 

designating PMK glycidate (and its 

optical and geometric isomers), PMK 

glycidic acid (and its salts, optical and 

geometric isomers, and salts of isomers), 

and APAA (and its optical isomers) as 

list I chemicals, the United States will 

fulfill its obligations under the 1988 

Convention.4

PMK glycidate, PMK glycidic acid, 

and APAA are close chemical relatives 

of controlled list I precursor 3,4 

methylenedioxyphenyl-2-propanone 

(3,4-MDP-2-P), and have been made 

specifically to circumvent existing 

precursor controls. DEA has not 

identified any known legitimate uses for 

these chemicals, other than possible 

research purposes. The first two 

substances, PMK glycidate and PMK 

glycidic acid, are closely related in 

chemical structure to precursors of 

MDMA (schedule I) and other 

‘‘ecstasy’’-type substances in schedule I. 

APAA is a precursor of schedule II 

controlled substances amphetamine and 

methamphetamine. All three chemicals 

are used for the illicit manufacture of 

two precursors listed in Table I of the 

1988 Convention (3,4-MDP-2-P and 1- 

phenyl-2-propanone (P-2-P)). For years, 

countries have reported the illicit 

trafficking and use of these chemicals in 

manufacturing controlled substances, 

82986 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

5Precursors and Chemicals Frequently Used in 

the Illicit Manufacture of Narcotic Drugs and 

Psychotropic Substances: Report of the 

International Narcotics Control Board for 2018 on 

the Implementation of Article 12 of the United 

Nations Convention against Illicit Traffic in 

Narcotic Drugs and Psychotropic Substances of 

1988 (E/INCB/2018/4, Released March 5, 2019) 

6 21 CFR 1310.13 specifies that this chemical 

mixture is a chemical mixture consisting of two or 

more chemical components, at least one of which 

is a list I or list II chemical.. 

7 21 CFR 1309.21. 

8 21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) 

with separate registration requirements pertaining 

to manufacturing or distributing a list I chemical. 

9 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B). 

10See 21 CFR 1309.23(b)(1). 

with increasing frequency and amounts 

reported in recent years.5

In making its assessments pursuant to 

Article 12, paragraph 4, of the 1988 

Convention, the CND found that there 

was no known legitimate manufacture 

of, and trade in, any of the three 

substances, and that their use was 

limited in small amounts to research, 

development, and laboratory analytical 

purposes. The inclusion of these 

substances in Table I would require 

Governments, as parties to the 1988 

Convention, to establish pre-export 

notifications as a means of monitoring 

shipments entering their territories. 

Therefore, the CND voted to include 

PMK glycidate (all four stereoisomers), 

PMK glycidic acid (all four 

stereoisomers), and APAA (including its 

optical isomers) in Table I of the 1988 

Convention. 

Proposed Designation of PMK 

Glycidate, PMK Glycidic Acid, and 

APAA as List I Chemicals 

For the reasons discussed above, the 

Acting Administrator of DEA finds that 

PMK glycidate, PMK glycidic acid, and 

APAA are used in the manufacture of a 

controlled substance in violation of the 

CSA, and are important to the 

manufacture of these controlled 

substances. Therefore, the Acting 

Administrator proposes the designation 

of PMK glycidate, PMK glycidic acid, 

and APAA as list I chemicals. 

If finalized, handlers (manufacturers, 

distributors, importers, and exporters) of 

these chemicals would become subject 

to the chemical regulatory provisions of 

the CSA, including 21 CFR parts 1309, 

1310, 1313, and 1316. Since even a 

small amount of these chemicals can 

potentially yield a significant amount of 

controlled substances, this action does 

not propose the establishment of a 

threshold for domestic, import, or 

export transactions in accordance with 

the provisions of 21 CFR 1310.04(g). 

Rather, DEA is proposing that all 

transactions, regardless of size, will be 

regulated transactions as defined in 21 

CFR 1300.02(b). As such, if finalized, all 

PMK glycidate, PMK glycidic acid, and 

APAA transactions will be subject to 

recordkeeping, reporting, import and 

export controls, and other CSA chemical 

regulatory requirements. In addition, 

each regulated bulk manufacturer must 

submit manufacturing, inventory, and 

use data to DEA’s Diversion Control 

Division, Drug and Chemical Evaluation 

section on an annual basis, in 

accordance with 21 CFR 1310.05(d). 

Chemical Mixtures of PMK Glycidate, 

PMK Glycidic Acid or APAA 

This rulemaking also proposes that 

chemical mixtures containing any of 

these three chemicals are subject to 

regulatory requirements at any 

concentration unless a manufacturer 

submits to DEA an application for 

exemption of a chemical mixture, DEA 

accepts the application for filing, and 

DEA exempts the chemical mixture in 

accordance with 21 CFR 1310.13 

(Exemption of chemical mixtures; 

application). Since even a small amount 

of these three chemicals can potentially 

yield a significant amount of controlled 

substances, DEA believes that regulation 

of chemical mixtures containing any 

amount of these three chemicals is 

necessary to prevent their illicit 

extraction, isolation, and use. Therefore, 

all chemical mixtures containing any 

quantity of these three chemicals would 

be subject to CSA control. This rule 

proposes modification of the ‘‘Table of 

Concentration Limits’’ in 21 CFR 

1310.12(c) to reflect the fact that 

chemical mixtures containing any 

amount of these three chemicals are 

subject to CSA chemical control 

provisions. 

Application Process for Exemption of 

Chemical Mixtures 

DEA has implemented an application 

process to exempt certain chemical 

mixtures from the requirements of the 

CSA and its implementing regulations.6

Manufacturers may submit an 

application for exemption for those 

mixtures that do not meet the criteria set 

forth in 21 CFR 1310.12(d) for an 

automatic exemption. Pursuant to 21 

CFR 1310.12(a), DEA may grant an 

exemption of a chemical mixture, by 

publishing a final rule in the Federal 

Register, if DEA determines that: (1) The 

mixture is formulated in such a way that 

it cannot be easily used in the illicit 

production of a controlled substance, 

and (2) the listed chemical or chemicals 

cannot be readily recovered. 

Requirements for Handling List I 

Chemicals 

If finalized as proposed, the 

designation of these three chemicals as 

list I chemicals will subject handlers 

(manufacturers, distributors, importers, 

and exporters) and proposed handlers to 

all of the regulatory controls and 

administrative, civil, and criminal 

actions applicable to the manufacture, 

distribution, importation, and 

exportation of a list I chemical. Upon 

publication of a final rule, persons 

potentially handling these three 

chemicals, including regulated chemical 

mixtures containing any of these three 

chemicals, would be required to comply 

with the following list I chemical 

regulations: 

1. Registration. Any person who 

handles (manufactures, distributes, 

imports, or exports), or proposes to 

engage in such handling of, any of these 

three chemicals or a chemical mixture 

containing any of these three chemicals 

must obtain a registration pursuant to 21 

U.S.C. 822, 823, 957, and 958. 

Regulations describing registration for 

list I chemical handlers are set forth in 

21 CFR part 1309. DEA regulations 

require separate registrations for 

manufacturing, distributing, importing, 

and exporting of any of these three 

chemicals.7 Further, a separate 

registration is required for each 

principal place of business at one 

general physical location where list I 

chemicals are manufactured, 

distributed, imported, or exported by a 

person.8

DEA notes that under the CSA, 

‘‘warehousemen’’ are not required to 

register and may lawfully possess list I 

chemicals, if the possession of those 

chemicals is in the usual course of 

business or employment.9 Under DEA 

implementing regulations, the 

warehouse in question must receive the 

list I chemical from a DEA registrant, 

shall only distribute the list I chemical 

back to the DEA registrant, and 

registered location from which it was 

received.10 A warehouse that distributes 

list I chemicals to persons other than the 

registrant and registered location from 

which they were obtained is conducting 

distribution activities and is required to 

register as such. 

Upon publication of a final rule, any 

person manufacturing, distributing, 

importing, or exporting any of these 

three chemicals or a chemical mixture 

containing any of these three chemicals 

will become subject to the registration 

requirement under the CSA. DEA 

recognizes, however, that it is not 

possible for persons subject to the 

registration requirement to immediately 

complete and submit an application for 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82987 

11 21 CFR 1310.05(d). 12 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b). 

13Sec. 2(a). 

14Sec. 2(c). 

15OMB Guidance Implementing Executive Order 

13771 titled ‘‘Reducing Regulation and Controlling 

Regulatory Costs’’ (April 5, 2017). 

registration and for DEA to immediately 

issue registrations for those activities. 

Therefore, to allow continued legitimate 

commerce in these three chemicals, 

DEA is proposing to establish in 21 CFR 

1310.09 a temporary exemption from 

the registration requirement for persons 

desiring to engage in activities with any 

of these three chemicals, provided that 

DEA receives a properly completed 

application for registration on or before 

30 days after publication of a final rule 

implementing regulations regarding 

these three chemicals. The temporary 

exemption for such persons will remain 

in effect until DEA takes final action on 

their application for registration or 

application for exemption of a chemical 

mixture. 

The temporary exemption applies 

solely to the registration requirement; 

all other chemical control requirements, 

including recordkeeping and reporting, 

would become effective on the effective 

date of the final rule. Therefore, all 

transactions of these three chemicals 

and chemical mixtures containing any 

of these three chemicals will be 

regulated while an application for 

registration or exemption is pending. 

This is necessary because failing to 

regulate these transactions could result 

in increased diversion of chemicals 

desirable to drug traffickers. 

Additionally, the temporary 

exemption does not suspend applicable 

federal criminal laws relating to these 

three chemicals, nor does it supersede 

State or local laws or regulations. All 

handlers of any of these three chemicals 

must comply with applicable State and 

local requirements in addition to the 

CSA regulatory controls. 

2. Records and Reports. Every DEA 

registrant would be required to maintain 

records and submit reports to DEA with 

respect to these three chemicals 

pursuant to 21 U.S.C. 830(a) and (b)(1) 

and (2) and in accordance with 21 CFR 

1310.04 and 1310.05. Pursuant to 21 

CFR 1310.04(a), a record must be made 

and maintained for two years after the 

date of a transaction involving a listed 

chemical, provided the transaction is a 

regulated transaction. 

Each regulated bulk manufacturer of a 

listed chemical is required to submit 

manufacturing, inventory, and use data 

on an annual basis.11 Existing standard 

industry reports containing the required 

information will be acceptable, 

provided the information is separate or 

readily retrievable from the report. 

The CSA and its implementing 

regulations require that each regulated 

person must report to DEA any 

regulated transaction involving an 

extraordinary quantity of a listed 

chemical, an uncommon method of 

payment or delivery, or any other 

circumstance that the regulated person 

believes may indicate that the listed 

chemical will be used in violation of 

subchapter I of the CSA. In addition, 

regulated persons must report any 

proposed regulated transaction with a 

person whose description or other 

identifying characteristics DEA has 

previously furnished to the regulated 

person, any unusual or excessive loss or 

disappearance of a listed chemical 

under the control of the regulated 

person, and any in-transit loss in which 

the regulated person is the supplier.12

3. Importation and Exportation. All 

importation and exportation of these 

three chemicals would need to be in 

compliance with 21 U.S.C. 957, 958, 

and 971 and in accordance with 21 CFR 

part 1313. 

4. Security. All applicants and 

registrants would be required to provide 

effective controls against theft and 

diversion in accordance with 21 CFR 

1309.71–1309.73. 

5. Administrative Inspection. Places, 

including factories, warehouses, or 

other establishments and conveyances, 

where registrants or other regulated 

persons may lawfully hold, 

manufacture, distribute, or otherwise 

dispose of a list I chemical or where 

records relating to those activities are 

maintained, are controlled premises as 

defined in 21 U.S.C. 880(a) and 21 CFR 

1316.02(c). The CSA allows for 

administrative inspections of these 

controlled premises as provided in 21 

CFR part 1316, subpart A. 21 U.S.C. 88). 

6. Liability. Any activity involving 

these three chemicals not authorized by, 

or in violation of, the CSA would be 

unlawful, and may subject the person to 

administrative, civil, and/or criminal 

action. 

Regulatory Analyses 

Executive Orders 12866, 13563, and 

13771, Regulatory Planning and Review, 

Improving Regulation and Regulatory 

Review, and Reducing Regulation and 

Controlling Regulatory Costs 

This proposed rule was developed in 

accordance with the principles of 

Executive Orders (E.O.) 12866, 13563, 

and 13771. E.O. 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health, 

and safety effects; distributive impacts; 

and equity). E.O. 13563 is supplemental 

to and reaffirms the principles, 

structures, and definitions governing 

regulatory review as established in E.O. 

12866. E.O. 12866 classifies a 

‘‘significant regulatory action,’’ 

requiring review by the Office of 

Management and Budget (OMB), as any 

regulatory action that is likely to result 

in a rule that may: (1) Have an annual 

effect on the economy of $100 million 

or more or adversely affect in a material 

way the economy, a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the E.O. DEA 

has determined that this proposed rule 

is not a ‘‘significant regulatory action’’ 

under E.O. 12866, section 3(f). 

E.O. 13771 requires an agency, unless 

prohibited by law, to identify at least 

two existing regulations to be repealed 

when the agency publicly proposes for 

notice and comment or otherwise 

promulgates a new regulation.13 In 

furtherance of this requirement, E.O. 

13771 requires that the new incremental 

costs associated with new regulations, 

to the extent permitted by law, be offset 

by the elimination of existing costs 

associated with at least two prior 

regulations.14 According to guidance 

provided by OMB, the requirements of 

E.O. 13771 only apply to each new 

‘‘significant regulatory action that . . . 

imposes costs.’’ 15 This proposed rule is 

not expected to be an E.O. 13771 

regulatory action because this proposed 

rule is not significant under E.O. 12866. 

If finalized as proposed, PMK 

glycidate, PMK glycidic acid, and APAA 

will be subject to all of the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to the 

manufacture, distribution, importing, 

and exporting of list I chemicals. The 

first two chemicals, PMK glycidate and 

PMK glycidic acid, are closely related in 

chemical structure to precursors of 

MDMA and other ‘‘ecstasy’’-type 

substances, as discussed in the above 

background section. APAA is a 

82988 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

16 5 U.S.C. 601–612. 

precursor of amphetamine and 

methamphetamine. All three chemicals 

are highly suitable for the illicit 

manufacture of precursors listed in 

Table I of the 1988 Convention (3,4- 

methylenedioxyphenyl-2-propanone 

(3,4-MDP-2-P) and 1-phenyl-2- 

propanone (P-2-P)). As noted earlier, 

incidents of illicit manufacture and 

tracking of these three chemicals have 

been reported for many years to the 

INCB, with an increase in the frequency 

and amounts reported in recent years. 

In making its assessment pursuant to 

Article 12, paragraph 4 of the 1988 

Convention, the CND found that there 

was no known legitimate manufacture 

of and trade in any of the three 

chemicals and that their use was 

limited, in small amounts, to research, 

development, laboratory, and analytical 

purposes. DEA also searched 

information in the public domain for 

legitimate uses of these three chemicals, 

and likewise, did not identify any 

known legitimate use for any of these 

chemicals, other than possibly for 

research purposes. DEA evaluated the 

costs and benefits of this proposed 

action. 

DEA cannot rule out the possibility 

that minimal quantities of PMK 

glycidate, PMK glycidic, or APAA are 

used for the manufacturing of legitimate 

pharmaceutical substances. DEA 

welcomes any public comment on these 

quantities and their economic 

significance. 

Costs 

As stated above, the only use for PMK 

glycidate and PMK glycidic acid is as 

intermediaries for the manufacturing of 

MDMA and other ‘‘ecstasy’’-type 

substances. Similarly, the only use for 

APAA is as a precursor for 

amphetamine and methamphetamine. 

Any manufacturer, distributor, importer, 

or exporter of any of these three 

chemicals for legitimate pharmaceutical 

commerce, if they exist at all, would 

incur costs if this proposed rule were 

finalized. The primary costs associated 

with this proposed rule are the annual 

registration fees ($3,047 for 

manufacturers and $1,523 for 

distributors, importers, and exporters). 

Additionally, any manufacturer that 

uses any of these three chemicals for 

legitimate pharmaceutical purposes is 

likely to already be registered with DEA 

and have all security and other handling 

processes in place, resulting in minimal 

cost. 

DEA has identified ten domestic 

suppliers of one or more of these 

chemicals, PMK glycidate, PMK glycidic 

acid, and APAA; nine of these suppliers 

are not currently registered with DEA to 

handle list I chemicals. The amount of 

these three chemicals distributed by 

these suppliers is unknown. It is 

common for chemical distributors to 

have items on their catalog while not 

actually having any material level of 

sales. Based on the discussion above, 

DEA believes any quantity of sales from 

these distributors for legitimate 

pharmaceutical purposes is minimal. If 

this proposed rule is finalized, suppliers 

for the legitimate use of PMK glycidate, 

PMK glycidic acid, and APAA are 

expected to choose the least-cost option, 

and stop selling the minimal quantities, 

if any, of PMK glycidate, PMK glycidic 

acid, and APAA, rather than incur the 

registration cost. Therefore, DEA 

estimates that the cost of foregone sales 

is minimal; and thus, the cost of this 

proposed rule is minimal. DEA 

welcomes any public comment 

regarding this estimate. 

This analysis excludes consideration 

of any economic impact to those 

businesses that facilitate the 

manufacturing and distribution of PMK 

glycidate, PMK glycidic acid, or APAA 

for the illicit production of 

amphetamine, methamphetamine, 

MDMA, or other ‘‘ecstasy’’-type 

substances. 

Benefits 

Controlling PMK glycidate, PMK 

glycidic acid, and APAA is expected to 

prevent, curtail, and limit the unlawful 

manufacture and distribution of 

amphetamine, methamphetamine, and 

MDMA and other ‘‘ecstasy’’-type 

substances. This action is also expected 

to assist in the prevention of possible 

theft or diversion of PMK glycidate, 

PMK glycidic acid, and APAA from any 

legitimate firms. DEA also believes 

control is necessary to prevent 

unscrupulous chemists from 

synthesizing PMK glycidate, PMK 

glycidic acid, and APAA and selling it 

(as an unregulated material) through the 

internet and other channels to 

individuals who may wish to acquire 

unregulated intermediary chemicals for 

the purpose of manufacturing illicit 

amphetamine, methamphetamine, or 

MDMA or other ‘‘ecstasy’’-type 

substances. 

In summary, DEA conducted a 

qualitative analysis of costs and 

benefits. DEA believes this proposed 

action, if finalized, will minimize the 

diversion of PMK glycidate, PMK 

glycidic acid, and APAA. DEA believes 

the market for PMK glycidate, PMK 

glycidic acid, and APAA for the 

legitimate pharmaceutical purposes is 

minimal. Thus, any potential cost 

resulting from this regulation is 

minimal. Therefore, the estimated 

economic impact of this proposed rule 

is less than $100 million in any given 

year. 

Executive Order 12988, Civil Justice 

Reform 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of E.O. 12988 

to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This proposed rulemaking does not 

have federalism implications warranting 

the application of E.O. 13132. The 

proposed rule does not have substantial 

direct effects on the states, on the 

relationship between the national 

government and the states, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed rule does not have 

tribal implications warranting the 

application of E.O. 13175. It does not 

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. 

Regulatory Flexibility Act (RFA) 

The Acting Administrator, in 

accordance with the RFA,16 has 

reviewed this proposed rule, and by 

approving, it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

As discussed above, if finalized as 

proposed, PMK glycidate, PMK glycidic 

acid, and APAA will be subject to all of 

the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, importation, and 

exportation of list I chemicals. PMK 

glycidate and PMK glycidic acid are 

closely related in chemical structure to 

precursors of MDMA and other 

‘‘ecstasy’’-type substances. APAA is a 

precursor of amphetamine and 

methamphetamine. All three chemicals 

are highly suitable for the illicit 

manufacture of precursors listed in 

Table I of the 1988 Convention (3,4- 

methylenedioxyphenyl-2-propanone 

(3,4-MDP-2-P) and 1-phenyl-2- 

propanone (P-2-P)). DEA has not 

Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 82989 

identified any legitimate industrial use 

for PMK glycidate, PMK glycidic acid, 

or APAA, other than as intermediary 

chemicals in the production of 

amphetamine, methamphetamine, and 

MDMA or other ‘‘ecstasy’’-type 

substances. Therefore, DEA believes the 

vast majority, if not all, of PMK 

glycidate, PMK glycidic acid, and APAA 

is used for the illicit manufacturing of 

amphetamine, methamphetamine, and 

MDMA or other ‘‘ecstasy’’-type 

substances. The primary costs 

associated with this proposed rule are 

the annual registration fees ($3,047 for 

manufacturers and $1,523 for 

distributors, importers, and exporters). 

Additionally, any manufacturer that 

uses PMK glycidate, PMK glycidic acid, 

or APAA for legitimate pharmaceutical 

purposes is likely to be already 

registered with DEA and have all 

security and other handling processes in 

place, resulting in minimal cost. 

DEA has identified ten domestic 

suppliers of one or more of the 

chemicals, PMK glycidate, PMK glycidic 

acid, and APAA; nine of these suppliers 

are currently not registered with DEA to 

handle list I chemicals. All nine nonregistered domestic suppliers are 

affected, and all nine (94.5 percent, 

based on Small Business Administration 

size standard for chemical distributors 

and Statistics of U.S. Businesses data) 

are estimated to be small entities. The 

quantity of these three chemicals 

distributed by these suppliers is 

unknown. It is common for chemical 

distributors to have items on their 

catalog while not actually having any 

material level of sales. Based on the 

discussion above, DEA believes any 

quantity of sales from these distributors 

for legitimate pharmaceutical purposes 

is minimal. DEA estimates that this 

proposed rule, if promulgated, will not 

have a significant economic impact on 

a substantial number of small entities. 

DEA welcomes any public comment 

regarding this estimate. 

Unfunded Mandates Reform Act of 

1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA), 2 U.S.C. 

1501 et seq., DEA has determined and 

certifies that this proposed rule would 

not result in any Federal mandate that 

may result ‘‘in the expenditure by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more (adjusted annually 

for inflation) in any 1 year . . . .’’ 

Therefore, neither a Small Government 

Agency Plan nor any other action is 

required under the UMRA. 

Paperwork Reduction Act 

The proposed action does not impose 

a new collection of information 

requirement under the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521. 

This proposed action would not impose 

recordkeeping or reporting requirements 

on State or local governments, 

individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

List of Subjects 21 CFR Part 1310 

Drug traffic control, Exports, Imports, 

Reporting and recordkeeping 

requirements. 

Accordingly, for the reasons set forth 

in the preamble, DEA proposes to 

amend 21 CFR part 1310 as follows: 

PART 1310—RECORDS AND 

REPORTS OF LISTED CHEMICALS 

AND CERTAIN MACHINES; 

IMPORTATION AND EXPORTATION OF 

CERTAIN MACHINES 

■ 1. The authority citation for part 1310 

continues to read as follows: 

Authority: 21 U.S.C. 802, 827(h), 830, 

871(b), 890. 

■ 2. In § 1310.02 add paragraphs (a)(34) 

through (36) to read as follows: 

§ 1310.02 Substances covered. 

* * * * * 

(a) * * * 

(34) 3,4-MDP-2-P methyl glycidate 

(PMK glycidate) and its optical and 

geometric isomers 8535 

(35) 3,4-MDP-2-P methyl glycidic acid 

(PMK glycidic acid) and its salts, optical 

and geometric isomers, and salts of 

isomers 8525 

(36) alpha-phenylacetoacetamide 

(APAA) and its optical isomers 8515 

■ 3. In § 1310.04: 

■ a. Redesignate paragraphs (g)(1)(vii) 

through (xiii) as paragraphs (g)(1)(x) 

through (xvi), respectively; 

■ b. Redesignate paragraphs (g)(1)(i) 

through (vi) as paragraphs (g)(1)(ii) 

through (vii), respectively; and 

■ c. Add new paragraphs (g)(1)(i), (viii), 

and (ix). 

The additions read as follows: 

§ 1310.04 Maintenance of records. 

* * * * * 

(g) * * * 

(1) * * * 

(i) alpha-phenylacetoacetamide 

(APAA) and its optical isomers 

* * * * * 

(viii) 3,4-MDP-2-P methyl glycidate 

(PMK glycidate) and its optical and 

geometric isomers 

(ix) 3,4-MDP-2-P methyl glycidic acid 

(PMK glycidic acid) and its salts, optical 

and geometric isomers, and salts of 

isomers 

* * * * * 

■ 4. Amend § 1310.09 by adding 

paragraph (q) to read as follows: 

§ 1310.09 Temporary exemption from 

registration. 

* * * * * 

(q)(1) Each person required under 21 

U.S.C. 822 and 957 to obtain a 

registration to manufacture, distribute, 

import, or export regulated forms of 3,4- 

MDP-2-P methyl glycidate (PMK 

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

glycidate (PMK glycidate), and alphaphenylacetoacetamide (APAA), 

including regulated chemical mixtures 

pursuant to § 1310.12, is temporarily 

exempted from the registration 

requirement, provided that DEA 

receives a properly completed 

application for registration or 

application for exemption for a 

chemical mixture containing regulated 

forms of 3,4-MDP-2-P methyl glycidate 

(PMK glycidate), 3,4-MDP-2-P methyl 

glycidic acid (PMK glycidic acid), or 

alpha-phenylacetoacetamide (APAA) 

pursuant to § 1310.13 on or before (30 

days after publication of a rule 

implementing regulations regarding 

these three chemicals). The exemption 

will remain in effect for each person 

who has made such application until 

the Administration has approved or 

denied that application. This exemption 

applies only to registration; all other 

chemical control requirements set forth 

in the Act and parts 1309, 1310, 1313, 

and 1316 of this chapter remain in full 

force and effect. 

(2) Any person who manufactures, 

distributes, imports or exports a 

chemical mixture containing regulated 

forms of 3,4-MDP-2-P methyl glycidate 

(PMK glycidate), 3,4-MDP-2-P methyl 

glycidic acid (PMK glycidic acid), or 

alpha-phenylacetoacetamide (APAA) 

whose application for exemption is 

subsequently denied by DEA must 

obtain a registration with DEA. A 

temporary exemption from the 

registration requirement will also be 

provided for those persons whose 

applications for exemption are denied, 

provided that DEA receives a properly 

completed application for registration 

on or before 30 days following the date 

of official DEA notification that the 

application for exemption has been 

denied. The temporary exemption for 

such persons will remain in effect until 

DEA takes final action on their 

registration application. 

■ 5. Amend § 1310.12(c) by adding in 

alphabetical order entries for 3,4-MDPVerDate Sep<11>2014 21:22 Dec 18, 2020 Jkt 253001 PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 E:\FR\FM\21DEP1.SGM 21DEP1
82990 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules 

2-P methyl glycidate (PMK glycidate), 

3,4-MDP-2-P methyl glycidic acid (PMK 

glycidic acid), and alphaphenylacetoacetamide (APAA) in the 

table ‘‘Table of Concentration Limits’’ to 

read as follows: 

§ 1310.12 Exempt chemical mixtures. 

* * * * * 

(c) * * * 

TABLE OF CONCENTRATION LIMITS

DEA 

chemical 

code No. 

Concentration Special conditions 

*******

3,4-MDP-2-P methyl glycidate (PMK glycidate) and 

its optical and geometric isomers.

8535 Not exempt at any concentration.Chemical mixtures containing any amount of this 

chemical are not exempt. 

3,4-MDP-2-P methyl glycidic acid (PMK glycidic 

acid) and its salts, optical and geometric isomers, and salts of isomers.

8525 Not exempt at any concentration.Chemical mixtures containing any amount of this 

chemical are not exempt. 

alpha-phenylacetoacetamide (APAA) and its optical isomers.8515 Not exempt at any concentration.Chemical mixtures containing any amount of this 

chemical are not exempt. 

*******

* * * * * 

Timothy J. Shea, 

Acting Administrator. 

[FR Doc. 2020–26813 Filed 12–18–20; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 882 and 1270 

[Docket No. FDA–2020–N–1519] 

RIN 0910–AI41 

Revocation of the Regulations for 

Human Tissue Intended for 

Transplantation and Human Dura 

Mater 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to revoke the 

regulations for human tissue intended 

for transplantation and human dura 

mater recovered prior to May 25, 2005. 

The proposed revocation does not affect 

the regulations for human cells, tissues, 

and cellular and tissue-based products 

(HCT/Ps) recovered on or after May 25, 

2005. FDA is proposing this action 

because these regulations are obsolete or 

no longer necessary to achieve public 

health goals. This action is part of FDA’s 

implementation of Executive Orders 

13771 and 13777. Under these 

Executive Orders, FDA is 

comprehensively reviewing existing 

regulations to identify opportunities for 

repeal, replacement, or modification 

that will result in meaningful burden 

reduction, while allowing the Agency to 

achieve our public health mission and 

fulfill statutory obligations. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by March 8, 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 8, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 8, 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–1519 for ‘‘Revocation of the 

Regulations for Human Tissue Intended 

for Transplantation.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ will be 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