Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 31195 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of Federal Aviation 

Administration Order JO 7400.11F, 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ASO SC E5 Greenwood, SC [Amended] 

Greenwood County Airport, SC 

(Lat. 34°15′01′′ N, long. 82°9′28′′ W) 

That airspace extending upward from 700 

feet above the surface within a 7-mile radius 

of Greenwood County Airport, and within 2- 

miles each side of the 265° bearing of the 

airport extending to 9.1-miles west of the 

airport. 

Issued in College Park, Georgia, on May 16, 

2022. 

Andreese C. Davis, 

Manager, Airspace & Procedures Team South, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2022–10838 Filed 5–20–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Parts 740, 742 and 774 

[Docket No. 220516–0114] 

RIN 0694–AI21 

Commerce Control List: Controls on 

Certain Marine Toxins 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: The Bureau of Industry and 

Security (BIS), Department of 

Commerce, maintains controls on the 

export, reexport and transfer (incountry) of dual-use items and less 

sensitive military items through the 

Export Administration Regulations 

(EAR), including the Commerce Control 

List (CCL). This rule proposes new 

unilateral export controls on four 

naturally occurring, dual-use biological 

toxins (specifically, the marine toxins 

brevetoxin, gonyautoxin, nodularin and 

palytoxin), the synthesis and collection 

of which BIS has identified for 

evaluation according to the criteria in 

Section 1758 of the Export Control 

Reform Act of 2018 (ECRA) pertaining 

to emerging and foundational 

technologies. These toxins have the 

potential (through either accidental or 

deliberate release) to cause casualties in 

humans or animals, degrade equipment, 

or damage crops or the environment. As 

these toxins are now capable of being 

more easily isolated and purified due to 

novel synthesis methods and 

equipment, the absence of export 

controls on such toxins could be 

exploited for biological weapons 

purposes. To address this concern, BIS 

proposes to amend the CCL by adding 

these toxins to Export Control 

Classification Number (ECCN) 1C351. 

This rule also proposes several 

conforming changes to the EAR to 

reflect the proposed addition of these 

marine toxins to ECCN 1C351. In 

addition, this document requests public 

comments to ensure that the scope of 

these proposed controls will be effective 

and appropriate (with respect to their 

potential impact on legitimate 

commercial or scientific applications). 

DATES: Comments must be received by 

BIS no later than June 22, 2022. 

ADDRESSES: You may submit comments, 

identified by docket number BIS–2022– 

0013 or RIN 0694–AI21, through any of 

the following: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

You can find this proposed rule by 

searching for its regulations.gov docket 

number, which is BIS–2022–0013. 

• Email: PublicComments@

bis.doc.gov. Include RIN 0694–AI21 in 

the subject line of the message. 

All filers using the portal or email 

should use the name of the person or 

entity submitting the comments as the 

name of their files, in accordance with 

the instructions below. Anyone 

submitting business confidential 

information should clearly identify the 

business confidential portion at the time 

of submission, file a statement justifying 

nondisclosure and referring to the 

specific legal authority claimed, and 

provide a non-confidential submission. 

For comments submitted 

electronically containing business 

confidential information, the file name 

of the business confidential version 

should begin with the characters ‘‘BC.’’ 

Any page containing business 

confidential information must be clearly 

marked ‘‘BUSINESS CONFIDENTIAL’’ 

on the top of that page. The 

corresponding non-confidential version 

of those comments must be clearly 

marked ‘‘PUBLIC.’’ The file name of the 

non-confidential version should begin 

with the character ‘‘P.’’ The ‘‘BC’’ and 

‘‘P’’ should be followed by the name of 

the person or entity submitting the 

comments. Any submissions with file 

names that do not begin with a ‘‘P’’ or 

‘‘BC’’ will be assumed to be public and 

will be made publicly available through 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions on the chemical and 

biological (CB) controls that would 

apply to the marine toxins proposed for 

control under ECCN 1C351, contact Dr. 

Tara Gonzalez, Chemical and Biological 

Controls Division, Office of 

Nonproliferation and Treaty 

Compliance, Bureau of Industry and 

Security, Telephone: (202) 482–3343, 

Email: Tara.Gonzalez@bis.doc.gov. For 

questions on the submission of 

comments, contact Willard Fisher, 

Regulatory Policy Division, Office of 

Exporter Services, Bureau of Industry 

and Security, U.S. Department of 

Commerce, (202) 482–6057, Email: 

RPD2@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Identification of Section 1758 

Technologies 

As part of the National Defense 

Authorization Act (NDAA) for Fiscal 

Year 2019, Public Law 115–232, 

Congress enacted the Export Control 

Reform Act of 2018 (ECRA), 50 U.S.C. 

4801–4852. Section 1758 of ECRA (as 

codified under 50 U.S.C. 4817) 

authorizes the Bureau of Industry and 

Security (BIS) to establish appropriate 

controls on the export, reexport or 

transfer (in-country) of emerging and 

foundational technologies that are 

essential to the national security of the 

United States. 

Neither Section 1758 nor any other 

section of ECRA defines the terms 

‘‘emerging technology’’ or ‘‘foundational 

technology.’’ Further, ECRA does not 

provide guidance on how to 

differentiate between ‘‘emerging 

technology’’ and ‘‘foundational 

technology.’’ Since ECRA’s enactment, 

BIS has solicited public comment on 

these two terms with the idea that 

defining the terms would assist in the 

identification of the technologies. To 

that end, BIS published numerous rules 

adding technologies to the CCL 

pursuant to Section 1758 without 

defining either term. Notably, pursuant 

to Section 1758, on November 19, 2018, 

BIS published an advance notice of 

proposed rulemaking, ‘‘Review of 

Controls for Certain Emerging 

Technologies’’ (83 FR 58201) (November 

19 ANPRM). The November 19 ANPRM 

identified biotechnology in a 

representative list of fourteen 


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31196 Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 

technology categories concerning which 

BIS sought public comment to 

determine whether there are specific 

emerging technologies that are essential 

to U.S. national security and for which 

effective controls can be implemented. 

The biotechnology-related comments 

submitted to BIS in response to its 

November 19 ANPRM did not 

specifically address the question of 

export controls on marine toxins and, 

consequently, this proposed rule does 

not address those comments. Since the 

publication of the November 19 

ANPRM, BIS has published several 

rules imposing controls on emerging 

technologies and advance notices of 

proposed rulemaking that requested the 

public to comment on potential 

emerging technologies. Additionally, on 

August 27, 2020, BIS published an 

advance notice of proposed rulemaking 

(85 FR 52934) (August 27 ANPRM) that 

sought public comment on the 

definition of, and criteria for, 

identifying foundational technologies. 

BIS has found, however, that the 

categorization of the technologies has 

sometimes delayed the imposition of 

controls. Further, ECRA does not 

mandate that BIS define either term nor 

does ECRA require that either of the two 

categories be treated differently from the 

other. 

Distinguishing Between Emerging and 

Foundational Technologies 

Based on its prior experience with 

implementing the requirements of 

Section 1758 of ECRA, in making future 

determinations, BIS will not 

characterize a specific technology as 

‘‘emerging’’ or ‘‘foundational’’ for 

purposes of Section 1758 of ECRA. 

Instead, BIS will characterize all 

technologies identified pursuant to 

Section 1758 as ‘‘Section 1758 

technologies’’ without drawing a 

distinction between ‘‘emerging’’ or 

‘‘foundational’’ technologies. This 

characterization will not affect the 

designation of ‘‘critical technologies,’’ 

for purposes of Committee on Foreign 

Investment in the United States (CFIUS) 

screenings, because technologies 

identified pursuant to Section 1758 of 

ECRA are ‘‘critical technologies,’’ 

pursuant to 50 U.S.C. 4565(a)(6)(A)(vi), 

regardless of whether such technologies 

are characterized as ‘‘emerging’’ or 

‘‘foundational.’’ This characterization 

will also not affect the scope of controls 

on any technologies controlled 

consistent with Section 1758 of ECRA. 

BIS is adopting this approach based 

on, among other sources, consultations 

with its interagency partners and a 

review of certain comments submitted 

in response to the November 19 ANPRM 

and the August 27 ANPRM, which 

sought public comment on ‘‘emerging’’ 

and ‘‘foundational’’ technologies, 

respectively. 

One key consideration drawn from 

BIS and interagency experience is that 

technologies cannot always be readily 

categorized as either ‘‘emerging’’ or 

‘‘foundational’’ technologies. A 

technology may be ‘‘foundational’’ in 

the sense of constituting an iterative 

improvement on technology already in 

production and use by one company, 

but simultaneously be ‘‘emerging’’ if 

such technology is only in the 

‘‘development’’ stage (hence not in use) 

by other manufacturers. These 

challenges apply to the technologies 

that are the subject of this proposed 

rule. 

Specifically, the four marine toxins 

(brevetoxin, gonyautoxin, nodularin and 

palytoxin) addressed in this proposed 

rule are naturally occurring and are not 

necessarily considered, by themselves, 

to be ‘‘emerging’’ technologies. 

Consequently, they could be evaluated 

as ‘‘foundational,’’ rather than 

‘‘emerging’’ technologies. However, the 

synthesis and collection of these toxins 

could be evaluated as an ‘‘emerging’’ 

technology. Specifically, these toxins 

can now be more easily isolated and 

purified due to novel synthesis methods 

and equipment and, therefore, are 

capable of being more easily exploited 

for biological weapons purposes than in 

the past. 

This proposed rule demonstrates 

some of the difficulties in attempting to 

draw meaningful and functional 

distinctions between ‘‘emerging’’ and 

‘‘foundational’’ technologies, for the 

purpose of applying the criteria in 

‘‘Section 1758’’ of ECRA to identify 

technologies essential to the national 

security of the United States that fall 

within the scope of this section. Similar 

challenges have made it difficult to 

characterize other technologies that 

have been proposed for addition to the 

Commerce Control List (CCL), Supp. No. 

1 to part 774 of the EAR, pursuant to 

Section 1758 as ‘‘emerging’’ or 

‘‘foundational.’’ Rather than attempting 

to continue to distinguish which new 

controls implemented pursuant to 

Section 1758 are ‘‘emerging’’ or 

‘‘foundational,’’ BIS believes the 

government’s resources and the 

mandate from Congress are better served 

identifying the technologies essential to 

U.S. national security under Section 

1758. 

BIS received several comments in 

response to the August 27 ANPRM that 

specifically requested that BIS set 

specific parameters by which 

foundational technologies would be 

defined. However, BIS does not believe 

the proposed parameters provided a 

meaningful distinction from ‘‘emerging’’ 

technologies. While BIS will not specify 

that a particular item is either 

‘‘foundational’’ or ‘‘emerging’’ 

technology, it will continue to be 

informed by, among other things, the 

Statement of Policy in Section 1752 of 

ECRA (50 U.S.C. 4811), the reasons for 

control described in part 742 of the 

EAR, and relevant factors described in 

the November 19 and August 27 

ANPRMs. Additionally, the 

identification of such technologies will 

take into account the statutory criteria 

in Section 1758(a)(2)(B) of ECRA: (i) The 

development of the emerging and 

foundational technologies in foreign 

countries; (ii) the effect export controls 

imposed pursuant to this section may 

have on the development of such 

technologies in the United States; and 

(iii) the effectiveness of export controls 

imposed pursuant to this section on 

limiting the proliferation of the 

emerging and foundational technologies 

in foreign countries. 

Referring to these items as ‘‘Section 

1758 technologies’’ without attempting 

to categorize individual technologies as 

‘‘emerging’’ or ‘‘foundational’’ 

technology is consistent with the 

requirements of Section 1758, will 

facilitate more efficient interagency 

review of implementing regulations, and 

result in more timely implementation of 

such controls. As noted above, ECRA 

neither defines nor requires 

distinguishing between emerging and 

foundational technologies and there is 

no impact on the scope of controls on 

technologies whether they are described 

as emerging or foundational. 

The Secretary of Commerce must 

establish appropriate controls on the 

export, reexport or transfer (in-country) 

of technology identified pursuant to the 

Section 1758 process, and in doing so, 

must consider the potential end-uses 

and end-users of emerging and 

foundational technologies, and the 

countries to which exports from the 

United States are restricted (e.g., 

embargoed countries). While the 

Secretary has discretion to set the level 

of export controls, at a minimum a 

license must be required for the export 

of such technologies to countries subject 

to a U.S. embargo, including those 

countries subject to an arms embargo. 

In addition, Section 1758(a)(2)(C) of 

ECRA (50 U.S.C. 4817(a)(2)(C)) requires 

that the interagency process for 

identifying Section 1758 technologies 

include a notice and comment period. 

Consequently, this proposed rule seeks 

public comments concerning the 

application of the criteria set forth in 


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Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 31197 

1Shen, H.H., et al. ‘‘Profiling of Brevetoxin 

Metabolites Produced by Karenia Brevis 165 Based 

on Liquid Chromatography-Mass Spectrometry.’’ 

Toxins 13.5 (2021). 

2Per the NIH National Library of Medicine, 

National Center for Biotechnology Information. 

3 Visciano, P., et al. ‘‘Marine Biotoxins: 

Occurrence, Toxicity, Regulatory Limits and 

Reference Methods.’’ Frontiers in Microbiology 7 

(2016). 

4Clark, RF; Williams, SR; Nordt, SP; Manoguerra, 

AS (1999). ‘‘A review of selected seafood 

poisonings.’’ Undersea & Hyperbaric Medicine. 26 

(3): 175–84. 

5 Dawson, R.M. ‘‘The Toxicology of 

Microcystins.’’ Toxicon. 36 (7): 953–962. (1998) 

doi:10.1016/S0041–0101(97)00102–5. 

6 Gehringer, M., et al. Nodularin, a cyanobacterial 

toxin, is synthesized in planta by symbiotic Nostoc 

sp.. ISME J 6, 1834–1847 (2012). https://doi.org/ 

10.1038/ismej.2012.25. 

7Ramos V, et al. ‘‘Palytoxin and analogs: 

biological and ecological effects.’’ Marine Drugs. 8 

(7): 2021–37. (2010) doi:10.3390/md8072021. 

ECRA Section 1758(a)(2), as well as the 

factors described above, to the proposed 

controls on four marine toxins as 

described below. 

Proposed Section 1758 Controls on Four 

Marine Toxins 

The synthesis and collection of four 

marine toxins (brevetoxin, gonyautoxin, 

nodularin and palytoxin) has been 

identified for evaluation, consistent 

with the interagency process described 

in Section 1758 of ECRA. This 

identification is based on a finding that, 

although these toxins are naturally 

occurring, dual-use biological toxins, 

they have the potential (through either 

accidental or deliberate release) to cause 

casualties in humans or animals, 

degrade equipment, or damage crops or 

the environment. As these toxins can 

now be more easily isolated and 

purified due to novel synthesis methods 

and equipment, the absence of export 

controls on such toxins could be 

exploited for biological weapons 

purposes. 

Proposed Amendments to ECCN 1C351 

Consistent with BIS’s authority to 

evaluate the level of controls that would 

be appropriate for the export, reexport 

or transfer (in-country) of emerging 

technologies, this rule proposes to 

amend the CCL by adding the 

aforementioned marine toxins to ECCN 

1C351.d. These toxins are not currently 

included on any of the Australia Group 

(AG) Common Control Lists— 

consequently, the Chemical/Biological 

(CB) controls that would apply to these 

toxins, as proposed by this rule, would 

be unilateral, absent the adoption of 

comparable controls by the AG. The 

toxins also would be controlled by 

ECCN 1C351.d for anti-terrorism (AT) 

reasons. The four marine toxins 

proposed for control by this proposed 

rule are described below. 

Brevetoxins are neurotoxins produced 

by the marine dinoflagellate Karenia 

brevis 1 that bind to the voltage-gated 

sodium channels in nerve cells, leading 

to a disruption of normal neurological 

processes and causing neurotoxic 

shellfish poisoning. The potent 

neurotoxic and hemolytic properties of 

these neurotoxins can be fatal to fish, 

aquatic mammals, birds, and humans 

(although no fatalities have yet to be 

reported for humans 2). 

Gonyautoxins are part of the group of 

saxitoxins (currently controlled under 

ECCN 1C351.d.12) that are naturally 

produced in several marine 

dinoflagellates species.3 Certain forms 

are included under Schedule 1 of the 

Chemical Weapons Convention (CWC) 

Annex on Chemicals. Gonyautoxins can 

bind to the a-subunit of the voltage 

dependent sodium channels in the 

postsynaptic membrane, blocking 

synaptic function (the transmission of 

nerve impulses between neurons or 

between neurons and muscle cells) and 

causing paralytic shellfish poisoning. 

Paralytic shellfish poisoning includes 

symptoms such as nausea, vomiting, 

dizziness, limb weakness, paralysis, or 

respiratory failure and can result in 

death.4

Nodularins are potent toxins that may 

cause irreversible liver damage.5

Naturally produced in cyanobacteria, 

nodularin shares significant structural 

homology and, presumably, function 

with microcystins 6 (currently 

controlled under ECCN 1C351.d.9). 

Microcystins have been studied 

extensively, and due to the homology 

with nodularin, these data are often 

extended to nodularins. 

Palytoxins are naturally produced in 

certain corals and dinoflagellates. These 

toxins are among the most toxic nonprotein compounds and are of particular 

concern due to their thermostability and 

effective inhalation exposure route.7

Palytoxins target the sodium-potassium 

pump protein, which may lead to 

vasoconstriction (the constriction of 

blood vessels through tightening of the 

small muscles in their walls). The most 

frequently reported routes of exposure/ 

entry are through inhalation, ingestion, 

or via the cutaneous route (i.e., direct 

contact with the skin or eyes). The 

symptoms of palytoxin poisoning, 

which may vary according to the route 

of exposure, include nausea, vomiting, 

diarrhea, lethargy, numbness, muscle 

spasms, slow heart rate, respiratory 

distress or kidney failure and can result 

in death. In lethal cases, death is 

generally caused by cardiac arrest. 

This rule proposes to add these 

marine toxins, in alphabetical order, to 

ECCN 1C351.d and to amend the 

introductory text of 1C351.d by 

removing the reference to the AG 

control list (thereby reflecting the fact 

that these marine toxins would be 

subject to unilateral controls, absent the 

adoption of comparable controls by the 

AG). This rule also proposes to make 

conforming changes elsewhere in ECCN 

1C351 to update references to certain 

toxins (i.e., in the CW Reason for 

Control paragraph, License 

Requirements Notes 1 and 2, the License 

Exception STA eligibility paragraph and 

the Related Controls paragraph). The 

proposed conforming amendments to 

the Chemical Weapons Convention 

(CWC) and License Exception Strategic 

Trade Authorization (STA) provisions 

in the EAR are described below. 

Proposed Expansion of ECCN 1E001 

Controls 

Although this rule does not propose 

to amend ECCN 1E001 (which controls, 

inter alia, ‘‘technology’’ for the 

‘‘development’’ or ‘‘production’’ of the 

human and animal pathogens and 

‘‘toxins’’ described in ECCN 1C351), the 

heading of ECCN 1E001 indicates that, 

with limited exceptions, ECCN 1E001 

controls ‘‘technology for the 

‘‘development’’ or ‘‘production’’ of 

items listed under Category 1C of the 

CCL. Consequently, if the changes 

proposed in this rule were to go into 

effect, ECCN 1E001 would control 

‘‘technology’’ for the ‘‘development’’ or 

‘‘production’’ of the four marine toxins 

that would be added to ECCN 1C351. 

This expansion in the scope of ECCN 

1E001 would be unilateral in nature, 

absent the adoption of comparable 

controls by the AG. 

Other Conforming Amendments To 

Reflect the Proposed Reordering of 

Toxins in ECCN 1C351.d 

This rule proposes to amend 

§ 740.20—License Exception Strategic 

Trade Authorization (STA) to make 

conforming changes to the ECCN 

1C351.d references in paragraph 

(b)(2)(v) and paragraph (b)(2)(vi). 

Specifically, § 740.20(b)(2)(v) would be 

amended to reference the exclusion of 

ECCN 1C351.d.15 and d.16 items from 

License Exception STA eligibility, 

consistent with the proposed 

renumbering of ricin and saxitoxin 

(which are currently controlled under 

ECCN 1C351.d.11 and d.12, 

respectively). Similarly, 

§ 740.20(b)(2)(vi) would be amended, 

consistent with the proposed 

renumbering of the toxins in ECCN 

1C351.d, by revising the references to 


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31198 Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 

the ECCN 1C351.d toxins that are 

authorized (with certain limitations) 

under License Exception STA to 

destinations indicated in Country Group 

A:5 (see Supplement No. 1 to part 740 

of the EAR). 

This rule also proposes to make 

conforming changes to § 742.18— 

Chemical Weapons Convention (CWC) 

and ECCN 1C991 (Vaccines, 

immunotoxins, medical products, 

diagnostic and food testing kits) to 

reflect the proposed renumbering of the 

toxins in ECCN 1C351.d. Specifically, 

§ 742.18(a)(1), (b)(1)(i), and (b)(1)(ii) and 

(iii) would be amended to reference 

ECCN 1C351.d.15 and d.16, consistent 

with the proposed renumbering of ricin 

and saxitoxin described above. ECCN 

1C991.c through 1C991.e would be 

amended to make conforming changes 

to the references therein to ECCN 1C351 

that would be affected by the proposed 

renumbering of the toxins in ECCN 

1C351.d. 

None of the proposed conforming 

amendments described above would 

change the scope of the controls in the 

affected EAR provisions. 

Request for Comments 

BIS is publishing this proposed rule 

to obtain public comments on the 

proposed application of CB controls to 

the four marine toxins that are proposed 

for addition to ECCN 1C351 and to 

‘‘technology’’ for the ‘‘development’’ or 

‘‘production’’ of such toxins that would 

satisfy the control parameters described 

in ECCN 1E001. Consistent with Section 

1758(a)(2)(C) of ECRA (50 U.S.C. 

4817(a)(2)(C)), this proposed rule 

provides the public with notice and the 

opportunity to comment on controlling 

this technology as described herein. 

Specifically, BIS welcomes any 

comments on this proposed rule 

relevant to the following: 

(1) Whether the proposed controls are 

clear and adequately identify ‘‘emerging 

and foundational technologies’’ within 

the context of biological weaponsrelated capabilities and developments 

(to the extent that this is not the case, 

comments should include specific 

control text that would be more 

appropriate to these ends); 

(2) The current capability for the 

‘‘development’’ or ‘‘production’’ of such 

toxins in the United States and other 

countries, including the extent to which 

the proposed controls would affect 

current production or sales of such 

toxins, either within or outside the 

United States (e.g., whether the 

proposed controls would inadvertently 

control any toxins that are suitable 

almost exclusively for legitimate 

commercial or scientific applications); 

(3) The effect that implementation of 

the proposed controls would have on 

the future ‘‘development’’ or 

‘‘production’’ of such toxins and related 

‘‘technology’’ in the United States; and 

(4) The effectiveness of the proposed 

controls in terms of limiting the 

proliferation of such toxins and related 

‘‘technology’’ abroad. 

BIS also welcomes comments 

concerning whether these controls 

should be implemented multilaterally 

(rather than unilaterally), in the interest 

of increasing their effectiveness and 

minimizing their impact on U.S. 

industry. Several respondents who 

commented on BIS’s November 19 

ANPRM indicated their preference for 

multilateral export controls over 

unilateral export controls, because the 

former typically place U.S. industry on 

a more level playing field versus 

producers/suppliers in other countries. 

In this regard, note that Section 1758(c) 

of ECRA (50 U.S.C. 4817(c)) provides 

that ‘‘the Secretary of State, in 

consultation with the Secretary [of 

Commerce] and the Secretary of 

Defense, and the heads of other Federal 

agencies, as appropriate, shall propose 

that any technology identified pursuant 

to subsection (a) [of ECRA] [which 

addresses the interagency process for 

identifying emerging technologies] be 

added to the list of technologies 

controlled by the relevant multilateral 

export control regimes.’’ 

Public comments submitted to BIS in 

response to this proposed rule will help 

BIS and other U.S. Government agencies 

to apply the criteria set forth in Section 

1758 of ECRA and identify and assess 

the appropriate level of controls that 

should apply to the four marine toxins 

proposed for control under ECCN 1C351 

and ‘‘technology’’ for the 

‘‘development’’ or ‘‘production’’ of such 

toxins, as proposed for control under 

ECCN 1E001. 

Comments should address specific 

aspects of the proposed addition of 

these toxins to ECCN 1C351 on the CCL 

in relation to the criteria described 

above (e.g., identify the specific aspects 

in which the proposed controls would 

satisfy these criteria or fail to do so). 

Comments should be submitted to BIS 

as described in the ADDRESSES section of 

this proposed rule and must be received 

by BIS no later than June 22, 2022. 

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 

proposed 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 

proposed rule has been designated a 

‘‘significant regulatory action,’’ although 

not economically significant, under 

section 3(f) of Executive Order 12866. 

Accordingly, this proposed rule has 

been reviewed by the Office of 

Management and Budget (OMB). 

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 

Office of Management and Budget 

(OMB) Control Number. This proposed 

rule contains the following collections 

of information subject to the 

requirements of the PRA: 

• OMB control number 0694–0088 

(Simplified Network Application 

Processing System)—this collection 

includes license applications and 

carries a burden estimate of 29.6 

minutes per manual or electronic 

submission; 

• OMB Control Number 0694–0096 

(Five Year Records Retention Period)— 

this collection includes recordkeeping 

requirements and carries a burden 

estimate of less than 1 minute per 

response; 

• OMB Control Number 0607–0152 

(Automated Export System (AES) 

Program)—this collection carries a 

burden hour estimate of 3 minutes per 

electronic submission and contains the 

Electronic Export Information (EEI) 

filing requirements under the 

Automated Export System (AES). 

Although this proposed rule would 

make important changes to the EAR for 

items controlled for CB reasons, BIS 

believes that these increases would not 

greatly exceed existing estimates. BIS 

does believe the number of applications 

will increase by 15 because, although 

there are few (if any) commercial 

applications for these marine toxins, a 

small number of these toxins may be 

exported for use in research and 


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development activities. BIS requests 

comments concerning the anticipated 

increase in burden hours and costs as a 

result of the changes proposed by this 

rule. Comments on the methodology 

associated with calculating the cost or 

burden increases, or any other aspect of 

this collection, may be submitted via 

www.regulations.gov by searching for 

OMB Control Number 0694–0088. 

BIS expects the burden hours 

associated with OMB control numbers 

0694–0088 and 0694–0096 to increase 

by 7 hours and 39 minutes (i.e., 15 

applications × 30.6 minutes per 

response) for a total estimated cost 

increase of $230 (i.e., 7 hours and 39 

minutes × $30 per hour). The $30 per 

hour cost estimate for OMB control 

number 0694–0088 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). 

Note that any increase in the burden 

hours associated with OMB control 

number 0607–0152 would not 

necessarily be in direct correlation with 

any increase in the aforementioned 

OMB information collections, because 

there could be multiple shipments (and, 

hence, multiple EEI filings) associated 

with an individual export license. 

3. This proposed 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 

(ECRA) (50 U.S.C. 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. 

Notwithstanding, BIS believes this 

proposed rule would benefit from 

public comment prior to issuance. 

Consistent with the Regulatory 

Flexibility Act, as amended by the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (SBREFA) (5 U.S.C. 

601 et seq.), BIS has prepared the 

following initial regulatory flexibility 

analysis (IRFA) of the impact that this 

proposed rule, if adopted, would have 

on small businesses. 

Description of the Reasons Why Action 

Is Being Considered 

The policy reasons for issuing this 

proposed rule are discussed in the 

background section of the preamble of 

this document and, consequently, are 

not repeated here. 

Statement of the Objectives of, and 

Legal Basis for, the Proposed Rule; 

Identification of All Relevant Federal 

Rules Which May Duplicate, Overlap or 

Conflict With the Proposed Rule 

The objective of this proposed rule, 

and all other Section 1758 technology 

proposed rules published by BIS, is to 

control emerging and foundational 

technologies identified by BIS and its 

interagency partners as being essential 

to U.S. national security. The legal basis 

for this proposed rule is as follows: 50 

U.S.C. 4801–4852. 

No other Federal rules duplicate, 

overlap, or conflict with this proposed 

rule. 

Number and Description of Small 

Entities Regulated by the Proposed 

Action 

This proposed rule would apply to all 

persons engaged in the export, reexport 

or transfer (in-country) of the marine 

toxins proposed for control under ECCN 

1C351 and the related ‘‘technology’’ 

subject to the EAR. Presently, these 

toxins and related ‘‘technology’’ are 

used in research and development 

activities in the biotechnology field 

(e.g., U.S. university and military 

laboratories). Therefore, BIS anticipates 

that the proposed controls would result 

in ‘deemed’ export license applications 

(for the release of ‘‘technology’’ to 

foreign nationals located within the 

United States) to allow access to this 

‘‘technology’’ by foreign students and 

faculty at U.S. universities, as well as by 

non-U.S. employees of U.S. biochemical 

firms. There would most likely also be 

‘deemed’ reexport license applications 

for the release of this ‘‘technology’’ to 

third-country foreign nationals located 

in foreign countries who are engaged in 

research and development activities 

involving this ‘‘technology.’’ 

BIS does not collect or maintain the 

data necessary to determine how many 

of the affected persons are small entities 

as that term is used by the Small 

Business Administration. Prior to 

issuing this proposed rule, BIS received 

36 comments on biotechnology in 

response to its November 19 ANPRM. 

None of these commenters specifically 

identified themselves as small 

businesses, although small businesses 

may have chosen to provide input 

through larger entities, such as trade 

associations. 

However, BIS was able to estimate the 

number of license applications that the 

agency anticipates receiving as a result 

of this proposed rule and is using that 

estimate as a means of assessing the 

impact on small businesses. Using the 

North American Industry Classification 

System Codes (NAICS) 541714 

(Research and Technology in 

Biotechnology (except 

Nanobiotechnology)), BIS determined 

that the standard small business size in 

this industry is 1,000 employees. Using 

Table 1a of the Census Bureau’s 2019 

Exports by Company Type and 

Employment Size and extrapolating to 

1,000 employees, BIS then estimated 

that approximately 40% of all identified 

companies that export in this industry 

are small businesses. BIS also estimates 

that it will receive 15 license 

applications per year for the items 

described in this proposed rule (see the 

PRA estimates described in Rulemaking 

Requirements #2, above). Based on that 

information, BIS estimates that the 

agency will receive approximately 6 

license applications per year from small 

businesses, or roughly 40% of the 15 

estimated license applications. 

In addition, based on the burden 

estimate for OMB under control 

numbers 0694–0088 (Simplified 

Network Application Processing 

System) and 0694–0096 (Five Year 

Records Retention Period), BIS expects 

that the total burden hours for small 

businesses associated with these EARrelated collections would increase only 

slightly, by just under 3 hours and 4 

minutes (i.e., 6 applications × 30.6 

minutes per response), for a total 

estimated cost increase of just under $92 

(i.e., 3 hours and 4 minutes × $30 per 

hour). 

The amendments proposed in this 

rule, if implemented, also would trigger 

a small information collection burden 

under the U.S. Census Bureau’s Foreign 

Trade Regulations (FTR) (15 CFR part 

30), which contain the Electronic Export 

Information (EEI) filing requirements 

under the Automated Export System 

(AES). This FTR-related information 

collection has been approved by OMB 

under control number 0607–0152 

(Automated Export System (AES) 

Program) and carries a burden hour 

estimate of 3 minutes per electronic 

submission. This collection, together 

with the aforementioned EAR-related 

information collections, would result in 

a total estimated cost increase to small 

businesses of just under $94 (i.e., 3 

hours and 7 minutes × $30 per hour). 

Note that, for purposes of consistency, 

the $30 per hour cost estimate used for 

the EAR-related information collections 

described above is also applied to this 

FTR-related information collection 

(which also would involve work 

performed by export compliance 

specialists). 

Based on the analysis provided above, 

the amendments proposed in this rule 

would not impose a significant 


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economic impact on a substantial 

number of small businesses. 

Description of the Projected Reporting, 

Recordkeeping, and Other Compliance 

Requirements of the Proposed Rule 

The changes proposed in this rule, if 

adopted, would mean that certain items 

currently eligible for export, reexport or 

transfer (in-country) to most 

destinations under the No License 

Required (NLR) designation would 

require an EAR authorization (i.e., in 

accordance with the terms and 

conditions of an EAR license exception 

or a license issued by BIS). Adding 

these items to the CCL, to be controlled 

under ECCN 1C351, may also change 

the export clearance requirements under 

the FTR for certain exports of these 

items by triggering an EEI filing 

requirement in AES (note that the 

requirement generally does not apply to 

items below a certain value that are 

classified as EAR99, i.e., subject to the 

EAR, but not listed under an ECCN on 

the CCL). 

To the extent that compliance with 

the changes proposed in this rule would 

impose a burden on persons, including 

small businesses, BIS believes the 

burden would be minimal. The 

reclassification process would need to 

be done only once per license applicant 

for exports, reexports or transfers (incountry) of these emerging technology 

items and, consequently, would 

constitute a one-time burden for each 

applicant. Similarly, assessing the 

availability of license exceptions and/or 

applying for and using BIS licenses 

would impose some minimal burden on 

persons, including small businesses. 

However, it should be noted that 

these EAR requirements would likely 

have less impact than might otherwise 

be the case, because of the resources 

that BIS makes available to all exporters, 

including small businesses. Specifically, 

BIS’s website has free on-line training 

explaining export basics, including 

instructions on how to register for and 

use BIS’s online license application 

tool, and tips on how to complete a 

license application for chemical and 

biological items. BIS also provides free 

export counseling by telephone and 

email via both its Washington, DC and 

Western Regional offices. In addition, 

BIS accepts requests for commodity 

classifications and processes them 

without charge to assist those exporters 

who need assistance in classifying their 

items for the purpose of determining 

whether any CCL-based license 

requirements would apply. 

Significant Alternatives and Underlying 

Analysis 

As noted above, BIS does not believe 

that the amendments proposed in this 

rule, if published in a final rule, would 

have a significant economic impact on 

small businesses. Nevertheless, 

consistent with 5 U.S.C. 603(c), BIS 

considered significant alternatives to 

these proposed amendments to assess 

whether the alternatives would: (1) 

Accomplish the stated objectives of this 

proposed rule (consistent with the 

emerging technology requirements in 

ECRA); and (2) minimize any significant 

economic impact of this proposed rule 

on small entities. BIS could have 

proposed a much broader control on 

marine toxins controlled under ECCN 

1C351 that would have captured a 

greater number of such toxins. However, 

that option would have had a greater 

impact not only on small businesses, 

but also on research and development 

laboratories (both academic and 

corporate), which are involved in 

advancing biological technology. BIS 

has determined that proposing focused 

controls on those marine toxins capable 

of posing a greater risk to human/animal 

health and the environment (i.e., the 

four toxins proposed for control under 

ECCN 1C351 and corresponding 

‘‘development’’ and production 

‘‘technology’’ in ECCN 1E001) is the 

least disruptive alternative for 

implementing export controls in a 

manner consistent with controlling 

technology that has been determined, 

through the Section 1758 technology 

interagency process authorized under 

ECRA, to be essential to U.S. national 

security. 

BIS is not proposing different 

compliance or reporting requirements 

for small businesses. If a small business 

is subject to a compliance requirement 

for the export, reexport or transfer (incountry) of this ‘‘software’’ and related 

‘‘technology,’’ then it would submit a 

license application using the same 

process as any other company (i.e., 

electronically via SNAP–R). The license 

application process is free of charge to 

all entities, including small businesses. 

In addition, as noted above, the 

resources and other compliance tools 

made available by BIS typically serve to 

lessen the impact of any EAR license 

requirements on small businesses. 

Lastly, consistent with 5 U.S.C. 

603(c), BIS assessed the use of 

performance standards rather than 

design standards and also considered 

whether an exemption for small 

businesses was practical under the 

circumstances (i.e., within the context 

of the changes proposed in this rule). 

BIS determined that the use of design 

standards was the most appropriate 

approach for regulating exports/ 

reexports of these toxins. Although the 

marine toxins that warrant control 

under this proposed rule are naturally 

occurring, dual-use biological toxins, 

they can now be more easily isolated 

and purified due to novel synthesis 

methods and equipment. For this 

reason, the absence of export controls 

on such toxins could be exploited for 

biological weapons purposes. However, 

because these toxins and related 

‘‘technology’’ are dual-use items, they 

also have legitimate commercial and 

scientific applications. Consequently, 

controlling these toxins and the related 

‘‘technology’’ based on design standards 

is the most appropriate way to impose 

export controls in a manner that would 

enhance U.S. national security, but also 

consider the legitimate commercial and 

scientific applications for these toxins. 

This proposed rule does not contain 

an exemption for small businesses from 

this license requirement because BIS 

and its interagency partners are 

assessing whether these controls are 

essential to U.S. national security. 

Specifically, these toxins and related 

‘‘technology’’ could be used for 

biological weapons purposes and, as 

such, controlling these items on the CCL 

may be determined to be essential to 

U.S. national security pursuant to the 

interagency process for identifying 

emerging and foundational technologies 

that is described in Section 1758(a) of 

ECRA (50 U.S.C. 4817(a)). An 

exemption for small businesses would 

undermine the effectiveness of these 

proposed controls. 

Conclusion 

BIS has identified the synthesis and 

collection of the marine toxins and the 

related ‘‘technology’’ addressed in this 

proposed rule as a technology suitable 

for evaluation under Section 1758 of 

ECRA that warrants public notice and 

comment. Consequently, consistent 

with the Regulatory Flexibility Act, BIS 

has prepared this IRFA addressing the 

impact that this proposed rule, if 

adopted, would have on small entities. 

BIS’s assessment indicates that the 

amendments proposed in this rule 

would not have a significant economic 

impact on a substantial number of small 

entities. 

Please submit any comments 

concerning this IRFA in accordance 

with the instructions provided in the 

ADDRESSES section of this proposed rule. 


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List of Subjects 

15 CFR Part 740 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements, Terrorism. 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 774 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

For the reasons stated in the 

preamble, parts 740, 742 and 774 of the 

Export Administration Regulations (15 

CFR parts 730–774) are proposed to be 

amended as follows: 

PART 740—LICENSE EXCEPTIONS 

■ 1. The authority citation for part 740 

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. 

7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 

1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 

3 CFR, 2001 Comp., p. 783. 

■ 2. Section 740.20 is amended by 

revising paragraph (b)(2)(v) and 

paragraph (b)(2)(vi) introductory text to 

read as follows: 

§ 740.20 License Exception Strategic 

Trade Authorization (STA). 

* * * * * 

(b) * * * 

(2) * * * 

(v) License Exception STA may not be 

used for any item controlled by ECCN 

1C351.a, .b, .c, .d.15, .d.16 or .e, ECCNs 

1C353, 1C354, 1E001 (i.e., for 

technology, as specified in ECCN 1E001, 

for items controlled by ECCN 1C351.a, 

.b, .c, .d.15, .d.16 or .e or ECCNs 1C353 

or 1C354) or ECCN 1E351. 

(vi) Toxins controlled by ECCN 

1C351.d.1 through 1C351.d.14 and 

1C351.d.17 through 1C351.d.22 are 

authorized under License Exception 

STA to destinations indicated in 

Country Group A:5 (See supplement no. 

1 to part 740), subject to the following 

limits. For purposes of this paragraph 

(b)(2)(vi), all such toxins that are sent 

from one exporter, reexporter or 

transferor to a single end-user, on the 

same day, constitute one shipment. 

* * * * * 

PART 742—CONTROL POLICY—CCL 

BASED CONTROLS 

■ 3. The authority citation for 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 10, 2021, 86 FR 62891 (November 

12, 2021). 

■ 4. Section 742.18 is amended by 

revising paragraph (a)(1), paragraph 

(b)(1)(i) introductory text, and 

paragraphs (b)(1)(ii) and (iii) to read as 

follows: 

§ 742.18 Chemical Weapons Convention 

(CWC or Convention). 

* * * * * 

(a) * * * 

(1) Schedule 1 chemicals and 

mixtures controlled under ECCN 1C351. 

A license is required for CW reasons to 

export or reexport Schedule 1 chemicals 

controlled under ECCN 1C351.d.15 or 

.d.16 to all destinations including 

Canada. CW applies to 1C351.d.15 for 

ricin in the form of Ricinus Communis 

AgglutininII (RCAII), which is also 

known as ricin D or Ricinus Communis 

LectinIII (RCLIII), and Ricinus 

Communis LectinIV (RCLIV), which is 

also known as ricin E. CW applies to 

1C351.d.16 for saxitoxin identified by 

C.A.S. #35523–89–8. (Note that the 

advance notification procedures and 

annual reporting requirements 

described in § 745.1 of the EAR also 

apply to exports of Schedule 1 

chemicals.) 

* * * * * 

(b) * * * 

(1) * * * 

(i) Exports to States Parties to the 

CWC. Applications to export Schedule 1 

Chemicals controlled under ECCN 

1C351.d.15 or .d.16 to States Parties to 

the CWC (destinations listed in 

supplement no. 2 to part 745 of the 

EAR) generally will be denied, unless 

all of the following conditions are met: 

* * * * * 

(ii) Exports to States not party to the 

CWC. Applications to export Schedule 1 

chemicals controlled under ECCN 

1C351.d.15 or .d.16 to States not Party 

to the CWC (destinations not listed in 

supplement no. 2 to part 745 of the 

EAR) generally will be denied, 

consistent with U.S. obligations under 

the CWC to prohibit exports of these 

chemicals to States not Party to the 

CWC. 

(iii) Reexports. Applications to 

reexport Schedule 1 chemicals 

controlled under ECCN 1C351.d.15 or 

.d.16 generally will be denied to all 

destinations (including both States 

Parties to the CWC and States not Party 

to the CWC). 

* * * * * 

PART 774—THE COMMERCE 

CONTROL LIST 

■ 5. The authority citation for 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. 

■ 6. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 1, 

revise ECCNs 1C351 and 1C991 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.15 and .d.16 and a 

license is required for CW reasons for all 

destinations, including Canada, as follows: 

CW applies to 1C351.d.15 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.16 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 

1C351.d, with the exception of toxins 

controlled for CW reasons under 1C351.d.15 

or .d.16, 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. 


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2. For the purposes of this entry, only 

saxitoxin is controlled under 1C351.d.16; 

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 

1C351.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.14 and 1C351.d.17 through 

1C351.d.22. 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. 

List of Items Controlled 

Related Controls: (1) Certain forms of ricin 

and saxitoxin in 1C351.d.15 and .d.16 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. Clostridium 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; 


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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,’’ as follows, or their subunits: 

d.1. Abrin; 

d.2. Aflatoxins; 

d.3. Botulinum toxins; 

d.4. Brevetoxin; 

d.5. Cholera toxin; 

d.6. Clostridium perfringens alpha, beta 1, 

beta 2, epsilon and iota toxins; 

d.7. Conotoxins; 

d.8. Diacetoxyscirpenol; 

d.9. Gonyautoxin; 

d.10. HT–2 toxin; 

d.11. Microcystins (Cyanginosins); 

d.12. Modeccin; 

d.13. Nodularin; 

d.14. Palytoxin; 

d.15. Ricin; 

d.16. Saxitoxin; 

d.17. Shiga toxins (shiga-like toxins, 

verotoxins, and verocytotoxins); 

d.18. Staphylococcus aureus enterotoxins, 

hemolysin alpha toxin, and toxic shock 

syndrome toxin (formerly known as 

Staphylococcus enterotoxin F); 

d.19. T–2 toxin; 

d.20. Tetrodotoxin; 

d.21. Viscumin (Viscum album lectin 1); or 

d.22. Volkensin. 

e. ‘‘Fungi’’, as follows: 

e.1. Coccidioides immitis; or 

e.2. Coccidioides posadasii. 

* * * * * 

1C991 Vaccines, immunotoxins, medical 

products, diagnostic and food testing 

kits, as follows (see List of Items 

Controlled). 

License Requirements 

Reason for Control: CB, AT 

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.7, or items controlled for CW 

reasons under ECCN 1C351.d.15 or .d.16); 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.7); 

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.7; 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.7; 

e. Diagnostic and food testing kits 

containing toxins controlled by ECCN 

1C351.d (except for items controlled for CW 

reasons under ECCN 1C351.d.15 or .d.16). 

* * * * * 

Thea D. Rozman Kendler, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2022–10907 Filed 5–20–22; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0355] 

RIN 1625–AA00 

Safety Zone; Lake Erie, Cleveland, OH 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard is proposing 

to establish a temporary safety zone for 

certain waters of Lake Erie. This action 

is necessary to provide for the safety of 

life on these navigable waters near 

Cleveland, OH, during the Tall Ships 

Cleveland event fireworks display triannually in July. This proposed 

rulemaking would prohibit persons and 

vessels from being in the safety zone 

unless authorized by the Captain of the 

Port Buffalo or a designated 

representative. We invite your 

comments on this proposed rulemaking. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before June 22, 2022. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2022–0355 using the Federal 

eRulemaking Portal at https://

www.regulations.gov. See the ‘‘Public 


lotter on DSK11XQN23PROD with PROPOSALS1