944 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 

SUPPLEMENT NO. 1 TO PART 745—SCHEDULES OF CHEMICALS—Continued 

CAS 

registry No. 

16. Methyldiethanolamine ............................................................................................................................................................. 105–59–9 

17. Triethanolamine ...................................................................................................................................................................... 102–71–6 

Note to Supplement 1: The numerical 

sequence of the ‘‘Schedule 1’’ Toxic 

Chemicals and Precursors is not consecutive 

so as to align with the December 23, 2019, 

consolidated textual changes to ‘‘Schedule 1’’ 

of the Annex on Chemicals to the Chemical 

Weapons Convention (CWC), which reflect 

the decisions adopted by the CWC 

Conference of the States Parties in November 

2019. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2020–27759 Filed 1–6–21; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Parts 742 and 774 

[Docket No. 201208–0330] 

RIN 0694–AI09 

Commerce Control List: Clarifications 

to the Scope of Export Control 

Classification Number 1C991 To 

Reflect Decisions Adopted at the June 

2019 Australia Group Plenary Meeting 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: The Bureau of Industry and 

Security (BIS) publishes this final rule 

to amend the Export Administration 

Regulations (EAR) to clarify the scope of 

the export controls that apply to certain 

vaccines and medical products, 

consistent with the release (i.e., 

exclusion) notes contained in the 

Australia Group (AG) ‘‘Human and 

Animal Pathogens and Toxins for 

Export Control’’ common control list. 

DATES: This rule is effective January 7, 

2021. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Kimberly Orr, Chemical and Biological 

Controls Division, Office of 

Nonproliferation and Treaty 

Compliance, Bureau of Industry and 

Security, Telephone: (202) 482–4201, 

Email: Kimberly.Orr@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: The 

Bureau of Industry and Security (BIS) is 

amending the Export Administration 

Regulations (EAR) to clarify the scope of 

the export controls that apply to certain 

vaccines, consistent with the vaccine 

release (i.e., exclusion) note contained 

in the Australia Group (AG) ‘‘List of 

Human and Animal Pathogens and 

Toxins for Export Control’’ common 

control list, as updated by a decision 

made at the AG Plenary meeting held in 

Paris, France, in June 2019. The AG is 

a multilateral forum consisting of 42 

participating countries and the 

European Union that maintain export 

controls on a list of chemicals, 

biological agents, and related equipment 

and technology that could be used in a 

chemical or biological weapons 

program. The AG periodically reviews 

items on its control list to enhance the 

effectiveness of participating 

governments’ national controls and to 

achieve greater harmonization among 

these controls. 

The AG specifically excludes certain 

vaccines from control under its ‘‘List of 

Human and Animal Pathogens and 

Toxins for Export Control’’ and the 

associated Warning List. However, prior 

to the June 2019 Plenary changes to this 

AG common control list, it was not clear 

if the release note therein applied not 

only to vaccines containing those 

human and animal pathogens and 

toxins identified on the list, but also to 

vaccines containing the genetic 

elements and genetically modified 

organisms identified therein. Recent 

changes to this AG common control list, 

based in part on a decision made at the 

June 2019 Plenary meeting, clarify that 

this release note applies to vaccines 

containing the genetic elements and 

genetically modified organisms 

identified on this list, as well as 

vaccines containing the viruses, 

bacteria, and toxins identified on this 

list. 

Specifically, this rule amends Export 

Control Classification Number (ECCN) 

1C991 on the Commerce Control List 

(CCL) to indicate that it includes 

vaccines containing, or designed for use 

against, any of the items identified in 

ECCN 1C351, 1C353 or 1C354. Prior to 

the effective date of this final rule, 

ECCN 1C991 indicated that it controlled 

vaccines ‘‘against’’ such items, but was 

not specific about whether all vaccines 

‘‘containing’’ such items were 

controlled, irrespective of whether the 

vaccines were designed for use 

‘‘against’’ such items. 

This rule also expands the scope of 

medical products controlled under 

ECCN 1C991 to include those 

containing genetically modified 

organisms and genetic elements 

described in ECCN 1C353.a.3. In 

addition, this rule clarifies the 

definition of ‘immunotoxin’ that 

appears in ECCN 1C351 and ECCN 

1C991 and removes the definition of 

‘subunit’ from ECCN 1C351. 

Finally, this rule renumbers ECCN 

1C991.c and .d by listing medical 

products that are subject to chemical/ 

biological (CB) controls, as well as antiterrorism (AT) controls, under ECCN 

1C991.c and listing medical products 

that are subject only to AT controls 

under ECCN 1C991.d. A conforming 

amendment is made to § 742.2(a)(3) of 

the EAR to reflect this change in 

paragraph sequencing. 

ECCN 1C991 (Vaccines, Immunotoxins, 

Medical Products, Diagnostic and Food 

Testing Kits) 

This final rule amends ECCN 1C991 

on the Commerce Control List (CCL) 

(Supplement No. 1 to part 774 of the 

EAR) to make the description of the 

vaccines controlled by this ECCN more 

closely reflect the scope of the vaccine 

release note contained in the AG ‘‘List 

of Human and Animal Pathogens and 

Toxins for Export Control.’’ ECCN 

1C991 does not control any of the 

human and animal pathogens and 

toxins or genetic elements and 

genetically modified organisms 

identified on this AG list; however, it 

does control vaccines, immunotoxins, 

medical products, and diagnostic and 

food testing kits that contain certain of 

these AG-listed items. 

The amendments contained in this 

final rule are intended to clarify the 

scope of the vaccine controls described 

in ECCN 1C991. Prior to the effective 

date of this final rule, the control text 

for vaccines described in ECCN 1C991.a 

indicated that this ECCN controlled 

‘‘vaccines against items controlled by 

ECCN 1C351, 1C353 or 1C354.’’ The use 

of the term ‘‘against’’ in the control text 

created some uncertainty concerning the 

extent to which ECCN 1C991.a applied 

to vaccines that ‘‘contain’’ items 

controlled by ECCN 1C351, 1C353 or 


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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 945 

1C354, but that act against agents (or 

other disease causing organisms) that 

are not identified in any of these ECCNs. 

This uncertainty caused some concern 

among manufacturers and exporters 

about the correct classification and 

licensing policies for such vaccines. 

The clarifications in this rule to the 

scope of the vaccine controls in ECCN 

1C991.a are also in response to recent 

scientific and medical developments. 

For example, viruses controlled under 

ECCN 1C351 (e.g., vesicular stomatitis 

virus, yellow fever virus, and Newcastle 

disease virus) are being modified to 

express surface proteins of other target 

organisms or cells for stimulating 

immune response to the surface protein, 

thus acting as vaccines against those 

targets. These medical products can be 

designed for the following purposes: (1) 

Vaccination against agents controlled by 

ECCN 1C351 (e.g., Ebolavirus or 

Chikungunya virus); (2) to protect 

against uncontrolled agents; or (3) as 

oncolytic medical products for treating 

specific cancers (oncolytic virotherapy 

is an emerging treatment that uses 

replication competent viruses to destroy 

cancers). 

This final rule addresses industry’s 

concerns and the recent scientific and 

medical developments described above 

by revising ECCN 1C991.a to read as 

follows: ‘‘Vaccines containing, or 

designed for use against, items 

controlled by ECCN 1C351, 1C353 or 

1C354.’’ As a result of this change, 

ECCN 1C991.a now clearly indicates 

that it controls all vaccines that 

‘‘contain’’ items controlled by ECCN 

1C351, 1C353 or 1C354, as well as those 

vaccines that are designed for use 

‘‘against’’ these items. 

This rule also amends ECCN 1C991 by 

expanding the scope of medical 

products controlled under this ECCN, 

consistent with the release (i.e., 

exclusion) note for such products in the 

‘‘List of Human and Animal Pathogens 

and Toxins for Export Control,’’ to 

include medical products containing 

genetically modified organisms or 

genetic elements controlled under ECCN 

1C353.a.3. In addition, the control text 

for medical products in ECCN 1C991 is 

renumbered by listing medical products 

that are subject to chemical/biological 

(CB) controls, as well as anti-terrorism 

(AT) controls, under ECCN 1C991.c and 

listing medical products that are subject 

only to AT controls, under ECCN 

1C991.d. Prior to the effective date of 

this final rule, the former were listed 

under ECCN 1C991.d, while the latter 

were listed under ECCN 1C991.c. This 

change is intended to emphasize the 

more stringent controls that apply to the 

medical products now described in 

ECCN 1C991.c (i.e., CB controls, in 

addition to AT controls) and to clearly 

indicate that the CB controls that apply 

to most of the medical products 

controlled under this ECCN do not 

apply to the medical products now 

controlled under ECCN 1C991.d, which 

are subject only to AT controls (the 

controls that apply to items in ECCN 

1C991 are described in more detail, 

below). A conforming amendment is 

made to § 742.2(a)(3) of the EAR to 

reflect this change in paragraph 

sequencing. 

This rule also makes a technical 

correction to the definition of ‘medical 

products’ in the ‘‘Related Definitions’’ 

paragraph under the List of Items 

Controlled for ECCN 1C991 by adding 

the parenthetical phrase ‘‘(or 

veterinary)’’ to the criterion describing 

pharmaceutical formulations. The 

criterion, as corrected, reads as follows: 

‘‘(1) pharmaceutical formulations 

designed for testing and human (or 

veterinary) administration in the 

treatment of medical conditions.’’ In 

addition, the definition of 

‘immunotoxins’ in the ‘‘Related 

Definitions’’ paragraph of ECCN 1C351 

and ECCN 1C991 is clarified to read as 

follows: ‘‘immunotoxins are monoclonal 

antibodies linked to a toxin with the 

intention of destroying a specific target 

cell while leaving adjacent cells intact.’’ 

This rule also adds a Technical Note 

at the beginning of the ‘‘Items’’ 

paragraph in the List of Items Controlled 

under ECCN 1C991 to clarify that, for 

purposes of the controls described in 

this ECCN, ‘toxins’ means those toxins, 

or their subunits, controlled under 

ECCN 1C351.d. 

Note that all items controlled by 

ECCN 1C991, including the vaccines 

described in ECCN 1C991.a, require a 

license for AT reasons to the 

destinations indicated under AT 

Column 1 on the Commerce Country 

Chart in Supplement No. 1 to part 738 

of the EAR (also see the AT license 

requirements described in part 742 of 

the EAR that apply to Iran, North Korea, 

Sudan and Syria). In addition, the 

medical products now controlled by 

ECCN 1C991.c (as renumbered by this 

rule) require a license for CB reasons, as 

well as AT reasons, to the destinations 

indicated under CB Column 3 and AT 

Column 1, respectively, on the 

Commerce Country Chart. A license also 

is required to certain destinations in 

accordance with the embargoes and 

other special controls described in part 

746 of the EAR. 

Anticipated Impact of This Final Rule 

Prior to the publication of this final 

rule, paragraph (a) of ECCN 1C991 

included only those vaccines designed 

to protect against biological agents 

controlled under ECCN 1C351, 1C353 or 

1C354 on the CCL. For example, the 

vaccine for protection against Ebola was 

previously (and continues to be) 

classified for control under ECCN 

1C991, because Ebola, itself, is a 

controlled biological agent. The Ebola 

vaccine also contains genetic elements 

for recombinant vesicular stomatitis 

virus (VSV), a controlled virus, and a 

common vector for vaccine 

development. 

However, ECCN 1C991 did not 

previously include vaccines containing 

controlled biological agents that were 

not also designed to protect against a 

controlled agent. Other VSV-based 

vaccines against EAR99 agents (i.e., 

agents not controlled on the CCL), such 

as SARS-CoV–2, were controlled to all 

destinations under ECCN 1C353, 

because they did not act against a 

controlled agent as previously required 

by the ECCN 1C991 vaccine control text. 

This rule amends the vaccine controls 

in paragraph (a) of ECCN 1C991 to more 

accurately reflect the scope of the AG 

release note for vaccines, which 

exempts vaccines from control under 

the AG List of Human and Animal 

Pathogens and Toxins. Specifically, the 

AG release note exempts from control 

all vaccines containing one or more of 

the biological agents identified on this 

AG common control list. 

Although certain COVID vaccines are 

not affected by this rule, the 

development of an unknown number of 

other vaccines, COVID and otherwise, is 

expected to be greatly facilitated as a 

result of these amendments to the 

vaccine controls in ECCN 1C991. 

Effective with the publication of this 

rule, COVID vaccines containing genetic 

elements of items controlled by ECCN 

1C353 (such as VSV) are now controlled 

under ECCN 1C991, instead of ECCN 

1C353. Consequently, instead of 

requiring a license for export or reexport 

to all destinations, a license is required 

only to a much more limited number of 

destinations (i.e., countries of concern 

for anti-terrorism (AT) reasons). 

A specific example of the impact of 

this rule is a VSV–SARS-CoV–2 vaccine, 

which is a vesicular stomatitis virus 

modified by adding the gene for the 

coronavirus spike protein. Because this 

vaccine acts against SARS-CoV–2, 

which is not controlled under ECCN 

1C351, it was not classified as an ECCN 

1C991 vaccine, prior to the publication 

of this rule. Instead, it was controlled 

under ECCN 1C353, in spite of having 

received FDA approval and being 

packaged for patient use, because it 

contains genetic elements from VSV (a 


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946 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 

controlled virus). Consequently, this 

vaccine previously required a license to 

all destinations. Effective with the 

publication of this final rule, this 

vaccine is now controlled under ECCN 

1C991 and requires a license only to 

designated countries of concern for AT 

reasons. 

Saving Clause 

Shipments of items removed from 

eligibility for export, reexport or transfer 

(in-country) under a license exception 

or without a license (i.e., under the 

designator ‘‘NLR’’) as a result of this 

regulatory action that were on dock for 

loading, on lighter, laden aboard an 

exporting carrier, or en route aboard a 

carrier to a port of export, on January 7, 

2021, pursuant to actual orders for 

export, reexport or transfer (in-country) 

to a foreign destination, may proceed to 

that destination under the previously 

applicable license exception or without 

a license (NLR) so long as they are 

exported, reexported or transferred (incountry) before March 8, 2021. Any 

such items not actually exported, 

reexported or transferred (in-country) 

before midnight, on March 8, 2021, 

require a license in accordance with this 

regulation. 

‘‘Deemed’’ exports of ‘‘technology’’ 

and ‘‘source code’’ removed from 

eligibility for export under a license 

exception or without a license (under 

the designator ‘‘NLR’’) as a result of this 

regulatory action may continue to be 

made under the previously available 

license exception or without a license 

(NLR) before March 8, 2021. Beginning 

at midnight on March 8, 2021, such 

‘‘technology’’ and ‘‘source code’’ may no 

longer be released, without a license, to 

a foreign national subject to the 

‘‘deemed’’ export controls in the EAR 

when a license would be required to the 

home country of the foreign national in 

accordance with this regulation. 

Export Control Reform Act of 2018 

The Export Control Reform Act of 

2018 (ECRA), as amended, codified at 

50 U.S.C. 4801–4852, serves as the 

authority under which BIS issues this 

rule. 

Rulemaking Requirements 

1. Executive Orders 13563 and 12866 

direct 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). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits and 

of reducing costs, harmonizing rules, 

and promoting flexibility. This rule has 

been designated a ‘‘significant 

regulatory action,’’ although not 

economically significant, under section 

3(f) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

The cost-benefit analysis required 

pursuant to Executive Orders 13563 and 

12866, as described below, indicates 

that this rule is intended to improve 

national security as its primary direct 

benefit and that this benefit significantly 

outweighs the costs of this rule. 

Specifically, implementation, in a 

timely manner, of the Australia Group 

(AG) agreements described herein will 

enhance the national security of the 

United States by reducing the risk that 

international trade involving dual-use 

chemical and biological items would 

contribute to the proliferation of 

chemical and biological weapons of 

mass destruction. The principal 

objective of AG participating countries 

is to use licensing measures to ensure 

that exports of certain chemicals, 

biological agents, and dual-use chemical 

and biological manufacturing facilities 

and equipment, do not contribute to the 

proliferation of chemical and biological 

weapons of mass destruction, which has 

been identified as a threat to domestic 

and international peace and security. 

The AG achieves this objective by 

harmonizing participating countries’ 

national export licensing measures. 

These controls are essential, given that 

the international chemical and 

biotechnology industries are a target for 

proliferators as a source of materials for 

chemical and biological weapons 

programs. 

In calculating what costs (if any) will 

be imposed by this rule, BIS estimates 

that 10 fewer license applications will 

need to be submitted to BIS, annually, 

as a result of the implementation of the 

amendments described in this rule (see 

Rulemaking Requirements #2, below). 

By applying the cost-benefit analysis 

required under Executive Orders 13563 

and 12866 to this rule, as described 

herein, BIS has determined that the 

benefits of this rule (i.e., the 

enhancement of our national security 

through the fulfillment our multilateral 

obligations as an AG participating 

country, together with the anticipated 

reduction in the number of license 

applications that would have to be 

submitted to export certain items 

affected by this rule) significantly 

outweigh any potential costs (i.e., the 

incidental costs to exporters of adjusting 

their export control procedures for 

certain items affected by this rule). 

Furthermore, consistent with the stated 

purpose of the amendments to ECCN 

1C991 (i.e., to enhance the national 

security of the United States), this rule 

meets the requirements set forth in the 

April 5, 2017, Office of Management 

and Budget (OMB) guidance 

implementing Executive Order 13771 

(82 FR 9339, February 3, 2017), 

regarding what constitutes a regulation 

issued ‘‘with respect to a national 

security function of the United States,’’ 

and it is, therefore, exempt from the 

requirements of E.O. 13771. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to, nor shall any person be 

subject to a penalty for failure to comply 

with, a collection of information subject 

to the requirements of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.) (PRA), unless that collection of 

information displays a currently valid 

OMB Control Number. This rule 

contains the following collections of 

information subject to the requirements 

of the PRA. These collections have been 

approved by OMB under control 

numbers 0694–0088 (Simplified 

Network Application Processing 

System) and 0694–0096 (Five Year 

Records Retention Period). The 

approved information collection under 

OMB control number 0694–0088 

includes license applications, among 

other things, and carries a burden 

estimate of 29.6 minutes per manual or 

electronic submission for a total burden 

estimate of 31,833 hours. The approved 

information collection under OMB 

control number 0694–0096 includes 

recordkeeping requirements and carries 

a burden estimate of less than 1 minute 

per response for a total burden estimate 

of 248 hours. 

This rule contains minor clarifications 

to the EAR for certain vaccines 

controlled by ECCN 1C991.a for antiterrorism (AT) reasons. Specifically, BIS 

expects the burden hours associated 

with these collections will decrease by 

5 hours and 6 minutes (i.e., 10 

applications × 30.6 minutes per 

response) for a total estimated decrease 

in cost of $153 (i.e., 5 hours and 6 

minutes × $30 per hour). The $30 per 

hour cost estimate for OMB control 

numbers 0694–0088 and 0694–0096 is 

consistent with the salary data for 

export compliance specialists currently 

available through glassdoor.com 

(glassdoor.com estimates that an export 

compliance specialist makes $55,280 

annually, which computes to roughly 

$26.58 per hour). Consequently, the 

burden hours associated with exports of 

the items affected by this rule will 

remain within the range of the existing 


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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 947 

estimates currently associated with 

OMB control numbers 0694–0088 and 

0694–0096. 

Written comments and 

recommendations for the information 

collections referenced above should be 

sent within 30 days of the publication 

of this final rule to: www.reginfo.gov/ 

public/do/PRAMain. Find these 

particular information collections by 

selecting ‘‘Currently under 30-day 

Review—Open for Public Comments’’ or 

by using the search function. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined in Executive Order 

13132. 

4. Pursuant to section 1762 of the 

Export Control Reform Act of 2018 (50 

U.S.C. Sec. 4821), this action is exempt 

from the Administrative Procedure Act 

(APA) (5 U.S.C. 553) requirements for 

notice of proposed rulemaking, 

opportunity for public participation and 

delay in effective date. 

Because a notice of proposed 

rulemaking and an opportunity for 

public comment are not required to be 

given for this rule by the APA or any 

other law, the analytical requirements of 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.) are not applicable. 

Accordingly, no regulatory flexibility 

analysis is required, and none has been 

prepared. 

List of Subjects 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 774 

Exports, Reporting and recordkeeping 

requirements. 

For the reasons stated in the 

preamble, parts 742 and 774 of the 

Export Administration Regulations (15 

CFR parts 730–774) are amended as 

follows: 

PART 742—CONTROL POLICY—CCL 

BASED CONTROLS 

■ 1. The authority citation for 15 CFR 

part 742 continues to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 

3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 

et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 

108–11, 117 Stat. 559; E.O. 12058, 43 FR 

20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 

608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 

Comp., p. 950; E.O. 13026, 61 FR 58767, 3 

CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 

44025, 3 CFR, 2001 Comp., p. 783; 

Presidential Determination 2003–23, 68 FR 

26459, 3 CFR, 2004 Comp., p. 320; Notice of 

November 12, 2019, 84 FR 61817 (November 

13, 2019). 

■ 2. In § 742.2, paragraph (a)(3) is 

revised to read as follows: 

§ 742.2 Proliferation of chemical and 

biological weapons. 

(a) * * * 

(3) If CB Column 3 of the Country 

Chart (Supplement No. 1 to part 738 of 

the EAR) is indicated in the appropriate 

ECCN, a license is required to Country 

Group D:3 (see Supplement No. 1 to part 

740 of the EAR) for medical products 

identified in ECCN 1C991.c. 

* * * * * 

PART 774—THE COMMERCE 

CONTROL LIST 

■ 3. The authority citation for 15 CFR 

part 774 continues to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C. 

8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 

U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 

2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 

U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783. 

■ 4. In Supplement No. 1 to part 774, 

Category 1, ECCN 1C351 is revised to 

read as follows: 

Supplement No. 1 to Part 774—The 

Commerce Control List 

* * * * * 

1C351 Human and animal pathogens and 

‘‘toxins,’’ as follows (see List of Items 

Controlled). 

License Requirements 

Reason for Control: CB, CW, AT 

Control(s) 

Country chart 

(see supp. No. 1 to 

part 738) 

CB applies to entire 

entry.

CB Column 1. 

CW applies to 1C351.d.11 and d.12 and a 

license is required for CW reasons for all 

destinations, including Canada, as follows: 

CW applies to 1C351.d.11 for ricin in the 

form of (1) Ricinus communis AgglutininII 

(RCAII), also known as ricin D or Ricinus 

Communis LectinIII (RCLIII) and (2) Ricinus 

communis LectinIV (RCLIV), also known as 

ricin E. CW applies to 1C351.d.12 for 

saxitoxin identified by C.A.S. #35523–89–8. 

See § 742.18 of the EAR for licensing 

information pertaining to chemicals subject 

to restriction pursuant to the Chemical 

Weapons Convention (CWC). The Commerce 

Country Chart is not designed to determine 

licensing requirements for items controlled 

for CW reasons. 

Control(s) 

Country chart 

(see supp. No. 1 to 

part 738) 

AT applies to entire 

entry.

AT Column 1. 

License Requirement Notes: 1. All vaccines 

and ‘immunotoxins’ are excluded from the 

scope of this entry. Certain medical products 

and diagnostic and food testing kits that 

contain biological toxins controlled under 

paragraph (d) of this entry, with the 

exception of toxins controlled for CW reasons 

under d.11 and d.12, are excluded from the 

scope of this entry. Vaccines, 

‘immunotoxins,’ certain medical products, 

and diagnostic and food testing kits excluded 

from the scope of this entry are controlled 

under ECCN 1C991. 

2. For the purposes of this entry, only 

saxitoxin is controlled under paragraph d.12; 

other members of the paralytic shellfish 

poison family (e.g., neosaxitoxin) are 

designated EAR99. 

3. Clostridium perfringens strains, other 

than the epsilon toxin-producing strains of 

Clostridium perfringens described in c.12, are 

excluded from the scope of this entry, since 

they may be used as positive control cultures 

for food testing and quality control. 

4. Unless specified elsewhere in this ECCN 

1C351 (e.g., in License Requirement Notes 1– 

3), this ECCN controls all biological agents 

and ‘‘toxins,’’ regardless of quantity or 

attenuation, that are identified in the List of 

Items Controlled for this ECCN, including 

small quantities or attenuated strains of 

select biological agents or ‘‘toxins’’ that are 

excluded from the lists of select biological 

agents or ‘‘toxins’’ by the Animal and Plant 

Health Inspection Service (APHIS), U.S. 

Department of Agriculture (USDA), or the 

Centers for Disease Control and Prevention 

(CDC), U.S. Department of Health and 

Human Services (HHS), in accordance with 

their regulations in 9 CFR part 121 and 42 

CFR part 73, respectively. 

5. Biological agents and pathogens are 

controlled under this ECCN 1C351 when they 

are an isolated live culture of a pathogen 

agent, or a preparation of a toxin agent that 

has been isolated or extracted from any 

source or material, including living material 

that has been deliberately inoculated or 

contaminated with the agent. Isolated live 

cultures of a pathogen agent include live 

cultures in dormant form or in dried 

preparations, whether the agent is natural, 

enhanced or modified. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

Special Conditions for STA 

STA: (1) Paragraph (c)(1) of License 

Exception STA (§ 740.20(c)(1)) may be 

used for items in 1C351.d.1 through 

1C351.d.10 and 1C351.d.13 through 

1C351.d.18. See § 740.20(b)(2)(vi) for 

restrictions on the quantity of any one 

toxin that may be exported in a single 

shipment and the number of shipments 

that may be made to any one end user in 

a single calendar year. Also see the 

Automated Export System (AES) 

requirements in § 758.1(b)(4) of the EAR. 

(2) Paragraph (c)(2) of License Exception 

STA (§ 740.20(c)(2) of the EAR) may not be 

used for any items in 1C351. 


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948 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 

List of Items Controlled 

Related Controls: (1) Certain forms of ricin 

and saxitoxin in 1C351.d.11. and d.12 are 

CWC Schedule 1 chemicals (see § 742.18 of 

the EAR). The U.S. Government must 

provide advance notification and annual 

reports to the OPCW of all exports of 

Schedule 1 chemicals. See § 745.1 of the 

EAR for notification procedures. See 22 

CFR part 121, Category XIV and § 121.7 for 

CWC Schedule 1 chemicals that are 

‘‘subject to the ITAR.’’ (2) The Animal and 

Plant Health Inspection Service (APHIS), 

U.S. Department of Agriculture, and the 

Centers for Disease Control and Prevention 

(CDC), U.S. Department of Health and 

Human Services, maintain controls on the 

possession, use, and transfer within the 

United States of certain items controlled by 

this ECCN (for APHIS, see 7 CFR 331.3(b), 

9 CFR 121.3(b), and 9 CFR 121.4(b); for 

CDC, see 42 CFR 73.3(b) and 42 CFR 

73.4(b)). (3) See 22 CFR part 121, Category 

XIV(b), for modified biological agents and 

biologically derived substances that are 

‘‘subject to the ITAR.’’ 

Related Definitions: For the purposes of this 

entry, ‘immunotoxins’ are monoclonal 

antibodies linked to a toxin with the 

intention of destroying a specific target cell 

while leaving adjacent cells intact. 

Items: 

a. Viruses identified on the Australia 

Group (AG) ‘‘List of Human and Animal 

Pathogens and Toxins for Export Control,’’ as 

follows: 

a.1. African horse sickness virus; 

a.2. African swine fever virus; 

a.3. Andes virus; 

a.4. Avian influenza (AI) viruses identified 

as having high pathogenicity (HP), as follows: 

a.4.a. AI viruses that have an intravenous 

pathogenicity index (IVPI) in 6-week-old 

chickens greater than 1.2; or 

a.4.b. AI viruses that cause at least 75% 

mortality in 4- to 8-week-old chickens 

infected intravenously. 

Note: Avian influenza (AI) viruses of the 

H5 or H7 subtype that do not have either of 

the characteristics described in 1C351.a.4 

(specifically, 1C351.a.4.a or a.4.b) should be 

sequenced to determine whether multiple 

basic amino acids are present at the cleavage 

site of the haemagglutinin molecule (HA0). If 

the amino acid motif is similar to that 

observed for other HPAI isolates, then the 

isolate being tested should be considered as 

HPAI and the virus is controlled under 

1C351.a.4. 

a.5. Bluetongue virus; 

a.6. Chapare virus; 

a.7. Chikungunya virus; 

a.8. Choclo virus; 

a.9. Classical swine fever virus (Hog 

cholera virus); 

a.10. Crimean-Congo hemorrhagic fever 

virus; 

a.11. Dobrava-Belgrade virus; 

a.12. Eastern equine encephalitis virus; 

a.13. Ebolavirus (includes all members of 

the Ebolavirus genus); 

a.14. Foot-and-mouth disease virus; 

a.15. Goatpox virus; 

a.16. Guanarito virus; 

a.17. Hantaan virus; 

a.18. Hendra virus (Equine morbillivirus); 

a.19. Japanese encephalitis virus; 

a.20. Junin virus; 

a.21. Kyasanur Forest disease virus; 

a.22. Laguna Negra virus; 

a.23. Lassa virus; 

a.24. Louping ill virus; 

a.25. Lujo virus; 

a.26. Lumpy skin disease virus; 

a.27. Lymphocytic choriomeningitis virus; 

a.28. Machupo virus; 

a.29. Marburgvirus (includes all members 

of the Marburgvirus genus); 

a.30. Middle East respiratory syndromerelated coronavirus (MERS-related 

coronavirus); 

a.31. Monkeypox virus; 

a.32. Murray Valley encephalitis virus; 

a.33. Newcastle disease virus; 

a.34. Nipah virus; 

a.35. Omsk hemorrhagic fever virus; 

a.36. Oropouche virus; 

a.37. Peste-des-petits ruminants virus; 

a.38. Porcine Teschovirus; 

a.39. Powassan virus; 

a.40. Rabies virus and all other members of 

the Lyssavirus genus; 

a.41. Reconstructed 1918 influenza virus; 

Technical Note: 1C351.a.41 includes 

reconstructed replication competent forms of 

the 1918 pandemic influenza virus 

containing any portion of the coding regions 

of all eight gene segments. 

a.42. Rift Valley fever virus; 

a.43. Rinderpest virus; 

a.44. Rocio virus; 

a.45. Sabia virus; 

a.46. Seoul virus; 

a.47. Severe acute respiratory syndromerelated coronavirus (SARS-related 

coronavirus); 

a.48. Sheeppox virus; 

a.49. Sin Nombre virus; 

a.50. St. Louis encephalitis virus; 

a.51. Suid herpesvirus 1 (Pseudorabies 

virus; Aujeszky’s disease); 

a.52. Swine vesicular disease virus; 

a.53. Tick-borne encephalitis virus (Far 

Eastern subtype, formerly known as Russian 

Spring-Summer encephalitis virus—see 

1C351.b.3 for Siberian subtype); 

a.54. Variola virus; 

a.55. Venezuelan equine encephalitis virus; 

a.56. Vesicular stomatitis virus; 

a.57. Western equine encephalitis virus; or 

a.58. Yellow fever virus. 

b. Viruses identified on the APHIS/CDC 

‘‘select agents’’ lists (see Related Controls 

paragraph #2 for this ECCN), but not 

identified on the Australia Group (AG) ‘‘List 

of Human and Animal Pathogens and Toxins 

for Export Control,’’ as follows: 

b.1. [Reserved]; 

b.2. [Reserved]; or 

b.3. Tick-borne encephalitis virus (Siberian 

subtype, formerly West Siberian virus—see 

1C351.a.53 for Far Eastern subtype). 

c. Bacteria identified on the Australia 

Group (AG) ‘‘List of Human and Animal 

Pathogens and Toxins for Export Control,’’ as 

follows: 

c.1. Bacillus anthracis; 

c.2. Brucella abortus; 

c.3. Brucella melitensis; 

c.4. Brucella suis; 

c.5. Burkholderia mallei (Pseudomonas 

mallei); 

c.6. Burkholderia pseudomallei 

(Pseudomonas pseudomallei); 

c.7. Chlamydia psittaci (Chlamydophila 

psittaci); 

c.8. Clostriduim argentinense (formerly 

known as Clostridium botulinum Type G), 

botulinum neurotoxin producing strains; 

c.9. Clostridium baratii, botulinum 

neurotoxin producing strains; 

c.10. Clostridium botulinum; 

c.11. Clostridium butyricum, botulinum 

neurotoxin producing strains; 

c.12. Clostridium perfringens, epsilon 

toxin producing types; 

c.13. Coxiella burnetii; 

c.14. Francisella tularensis; 

c.15. Mycoplasma capricolum subspecies 

capripneumoniae (‘‘strain F38’’); 

c.16. Mycoplasma mycoides subspecies 

mycoides SC (small colony) (a.k.a. contagious 

bovine pleuropneumonia); 

c.17. Rickettsia prowazekii; 

c.18. Salmonella enterica subspecies 

enterica serovar Typhi (Salmonella typhi); 

c.19. Shiga toxin producing Escherichia 

coli (STEC) of serogroups O26, O45, O103, 

O104, O111, O121, O145, O157, and other 

shiga toxin producing serogroups; 

Note: Shiga toxin producing Escherichia 

coli (STEC) includes, inter alia, 

enterohaemorrhagic E. coli (EHEC), verotoxin 

producing E. coli (VTEC) or verocytotoxin 

producing E. coli (VTEC). 

c.20. Shigella dysenteriae; 

c.21. Vibrio cholerae; or 

c.22. Yersinia pestis. 

d. ‘‘Toxins’’ identified on the Australia 

Group (AG) ‘‘List of Human and Animal 

Pathogens and Toxins for Export Control,’’ as 

follows, or their subunits: 

d.1. Abrin; 

d.2. Aflatoxins; 

d.3. Botulinum toxins; 

d.4. Cholera toxin; 

d.5. Clostridium perfringens alpha, beta 1, 

beta 2, epsilon and iota toxins; 

d.6. Conotoxins; 

d.7. Diacetoxyscirpenol; 

d.8. HT-2 toxin; 

d.9. Microcystins (Cyanginosins); 

d.10. Modeccin; 

d.11. Ricin; 

d.12. Saxitoxin; 

d.13. Shiga toxins (shiga-like toxins, 

verotoxins, and verocytotoxins); 

d.14. Staphylococcus aureus enterotoxins, 

hemolysin alpha toxin, and toxic shock 

syndrome toxin (formerly known as 

Staphylococcus enterotoxin F); 

d.15. T-2 toxin; 

d.16. Tetrodotoxin; 

d.17. Viscumin (Viscum album lectin 1); or 

d.18. Volkensin. 

e. ‘‘Fungi’’, as follows: 

e.1. Coccidioides immitis; or 

e.2. Coccidioides posadasii. 

■ 5. In Supplement No. 1 to part 774, 

Category 1, ECCN 1C991 is revised to 

read as follows: 

1C991 Vaccines, immunotoxins, medical 

products, diagnostic and food testing 

kits, as follows (see List of Items 

Controlled). 

License Requirements 

Reason for Control: CB, AT 


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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 949 

Control(s) 

Country chart (see 

supp. No. 1 to part 

738) 

CB applies to 

1C991.c.

CB Column 3. 

AT applies to entire 

entry.

AT Column 1. 

List Based License Exceptions (See Part 740 

for a Description of All License Exceptions) 

LVS: N/A 

GBS: N/A 

List of Items Controlled 

Related Controls: (1) Medical products 

containing ricin or saxitoxin, as follows, 

are controlled for CW reasons under ECCN 

1C351: 

(a) Ricinus communis AgglutininII (RCAII), 

also known as ricin D, or Ricinus Communis 

LectinIII (RCLIII); 

(b) Ricinus communis LectinIV (RCLIV), 

also known as ricin E; or 

(c) Saxitoxin identified by C.A.S. #35523– 

89–8. 

(2) The export of a ‘‘medical product’’ that 

is an ‘‘Investigational New Drug’’ (IND), as 

defined in 21 CFR 312.3, is subject to certain 

U.S. Food and Drug Administration (FDA) 

requirements that are independent of the 

export requirements specified in this ECCN 

or elsewhere in the EAR. These FDA 

requirements are described in 21 CFR 

312.110 and must be satisfied in addition to 

any requirements specified in the EAR. 

(3) Also see 21 CFR 314.410 for FDA 

requirements concerning exports of new 

drugs and new drug substances. 

Related Definitions: For the purpose of this 

entry, ‘immunotoxins’ are monoclonal 

antibodies linked to a toxin with the 

intention of destroying a specific target cell 

while leaving adjacent cells intact. For the 

purpose of this entry, ‘medical products’ 

are: (1) Pharmaceutical formulations 

designed for testing and human (or 

veterinary) administration in the treatment 

of medical conditions, (2) prepackaged for 

distribution as clinical or medical 

products, and (3) approved by the U.S. 

Food and Drug Administration either to be 

marketed as clinical or medical products or 

for use as an ‘‘Investigational New Drug’’ 

(IND) (see 21 CFR part 312). For the 

purpose of this entry, ‘diagnostic and food 

testing kits’ are specifically developed, 

packaged and marketed for diagnostic or 

public health purposes. Biological toxins 

in any other configuration, including bulk 

shipments, or for any other end-uses are 

controlled by ECCN 1C351. For the 

purpose of this entry, ‘vaccine’ is defined 

as a medicinal (or veterinary) product in a 

pharmaceutical formulation, approved by 

the U.S. Food and Drug Administration or 

the U.S. Department of Agriculture to be 

marketed as a medical (or veterinary) 

product or for use in clinical trials, that is 

intended to stimulate a protective 

immunological response in humans or 

animals in order to prevent disease in 

those to whom or to which it is 

administered. 

Items: 

Technical Note: For purposes of the 

controls described in this ECCN, ‘toxins’ 

refers to those toxins, or their subunits, 

controlled under ECCN 1C351.d. 

a. Vaccines containing, or designed for use 

against, items controlled by ECCN 1C351, 

1C353 or 1C354. 

b. Immunotoxins containing toxins 

controlled by 1C351.d; 

c. Medical products that contain any of the 

following: 

c.1. Toxins controlled by ECCN 1C351.d 

(except for botulinum toxins controlled by 

ECCN 1C351.d.3, conotoxins controlled by 

ECCN 1C351.d.6, or items controlled for CW 

reasons under ECCN 1C351.d.11 or .d.12); or 

c.2. Genetically modified organisms or 

genetic elements controlled by ECCN 

1C353.a.3 (except for those that contain, or 

code for, botulinum toxins controlled by 

ECCN 1C351.d.3 or conotoxins controlled by 

ECCN 1C351.d.6); 

d. Medical products not controlled by 

1C991.c that contain any of the following: 

d.1. Botulinum toxins controlled by ECCN 

1C351.d.3; 

d.2. Conotoxins controlled by ECCN 

1C351.d.6; or 

d.3. Genetically modified organisms or 

genetic elements controlled by ECCN 

1C353.a.3 that contain, or code for, 

botulinum toxins controlled by ECCN 

1C351.d.3 or conotoxins controlled by ECCN 

1C351.d.6; 

e. Diagnostic and food testing kits 

containing toxins controlled by ECCN 

1C351.d (except for items controlled for CW 

reasons under ECCN 1C351.d.11 or .d.12). 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2020–27754 Filed 1–6–21; 8:45 am] 

BILLING CODE 3510–33–P 

COMMODITY FUTURES TRADING 

COMMISSION 

17 CFR Parts 39 and 140 

RIN 3038–AE65 

Exemption From Derivatives Clearing 

Organization Registration 

AGENCY: Commodity Futures Trading 

Commission. 

ACTION: Final rule. 

SUMMARY: The Commodity Futures 

Trading Commission (Commission) is 

adopting policies and procedures that 

the Commission will follow with 

respect to granting exemptions from 

registration as a derivatives clearing 

organization (DCO). In addition, the 

Commission is amending certain related 

delegation provisions in its regulations. 

DATES: Effective February 8, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Eileen A. Donovan, Deputy Director, 

202–418–5096, edonovan@cftc.gov; 

Parisa Nouri, Associate Director, 202– 

418–6620, pnouri@cftc.gov; Eileen R. 

Chotiner, Senior Compliance Analyst, 

202–418–5467, echotiner@cftc.gov; 

Brian Baum, Special Counsel, 202–418– 

5654, bbaum@cftc.gov; August A. 

Imholtz III, Special Counsel, 202–418– 

5140, aimholtz@cftc.gov; Abigail S. 

Knauff, Special Counsel, 202–418–5123, 

aknauff@cftc.gov; Division of Clearing 

and Risk, Commodity Futures Trading 

Commission, Three Lafayette Centre, 

1155 21st Street NW, Washington, DC 

20581; Theodore Z. Polley III, Associate 

Director, 312–596–0551, tpolley@

cftc.gov; Division of Clearing and Risk, 

Commodity Futures Trading 

Commission, 525 West Monroe Street, 

Chicago, Illinois 60661. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Introduction 

B. Existing Exempt DCO Orders 

II. Amendments to Part 39 

A. Regulation 39.1—Scope 

B. Regulation 39.2—Definitions 

C. Regulation 39.6—Exemption From DCO 

Registration 

D. Regulation 39.9—Scope 

III. Amendments to Part 140 

IV. Related Matters 

A. Regulatory Flexibility Act 

B. Paperwork Reduction Act 

C. Cost-Benefit Considerations 

D. Antitrust Considerations 


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