Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 31203 

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 


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31204 Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this proposed 

rulemaking, call or email LT Jared 

Stevens, Waterways Management 

Division, MSU Cleveland, U.S. Coast 

Guard; telephone 216–937–0124, email 

Jared.M.Stevens@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background, Purpose, and Legal 

Basis 

On January 28, 2022, Tall Ships 

America notified the Coast Guard that it 

will be conducting a Tall Ships 

fireworks display tri-annually in July. 

Hazards from the fireworks display may 

include accidental discharge of 

fireworks, dangerous projectiles, and 

falling hot embers or other debris. The 

event fireworks are to be launched from 

the Cleveland Port Authority Terminal 

adjacent to Lake Erie, Cleveland, Ohio. 

The Captain of the Port Buffalo (COTP) 

has determined that potential hazards 

associated with the fireworks to be used 

in this display would be a safety 

concern for anyone within a 420-foot 

radius of the Cleveland Port Authority 

during the fireworks display. 

The purpose of this rulemaking is to 

ensure the safety of vessels and the 

navigable waters within a 420 foot 

radius of the fireworks, before, during, 

and after the scheduled event. 

The Coast Guard is proposing this 

rulemaking under authority in 46 U.S.C. 

70034 (previously 33 U.S.C. 1231). 

III. Discussion of Proposed Rule 

The COTP is proposing to establish a 

safety zone tri-annually in July. This 

safety zone will cover all navigable 

waters within a 420-foot radius of the 

fireworks display, before, during, and 

after the scheduled event. The duration 

of the zone is intended to ensure the 

safety of vessels and these navigable 

waters during the scheduled Tall Ships 

fireworks display. 

No vessel or person would be 

permitted to enter the safety zone 

without obtaining permission from the 

COTP or a designated representative. 

The regulatory text we are proposing 

appears at the end of this document. 

IV. Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This NPRM has not been designated a 

‘‘significant regulatory action,’’ under 

Executive Order 12866. Accordingly, 

the NPRM has not been reviewed by the 

Office of Management and Budget 

(OMB). 

This regulatory action determination 

is based on the size, location, and 

duration of the proposed rule. This 

safety zone would restrict navigation 

around the Tall Ships fireworks display 

triannually with a limited radius from 

the fireworks launch point for a period 

not likely to exceed 6 hours. Vessel 

traffic will be able to safely transit 

around the safety zone. Moreover, the 

rule would allow vessels to seek 

permission to enter the zone. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this proposed rule would not 

have a significant economic impact on 

a substantial number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section IV.A above, 

this proposed rule would not have a 

significant economic impact on any 

vessel owner or operator. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this proposed rule would have 

a significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this proposed rule. If the 

proposed rule would affect your small 

business, organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. The Coast 

Guard will not retaliate against small 

entities that question or complain about 

this proposed rule or any policy or 

action of the Coast Guard. 

C. Collection of Information 

This proposed rule would not call for 

a new collection of information under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132 

(Federalism), if it has a substantial 

direct effect on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. We have analyzed 

this proposed rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this proposed rule does not have 

tribal implications under Executive 

Order 13175 (Consultation and 

Coordination with Indian Tribal 

Governments) because it would not 

have a substantial direct effect on one or 

more Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

If you believe this proposed rule has 

implications for federalism or Indian 

tribes, please call or email the person 

listed in the FOR FURTHER INFORMATION

CONTACT section. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this 

proposed rule would not result in such 

an expenditure, we do discuss the 

potential effects of this proposed rule 

elsewhere in this preamble. 


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Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 31205 

F. Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Directive 023–01, Rev. 1, 

associated implementing instructions, 

and Environmental Planning 

COMDTINST 5090.1 (series), which 

guide the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment. This proposed 

rule involves a triannual safety zone for 

a fireworks display that would prohibit 

vessel navigation within 420 feet of the 

Cleveland Port Authority before, during 

and after the display. 

Normally such actions are 

categorically excluded from further 

review under paragraph L60(a) of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

preliminary Record of Environmental 

Consideration supporting this 

determination is available in the docket. 

For instructions on locating the docket, 

see the ADDRESSES section of this 

preamble. We seek any comments or 

information that may lead to the 

discovery of a significant environmental 

impact from this proposed rule. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places, or vessels. 

V. Public Participation and Request for 

Comments 

We view public participation as 

essential to effective rulemaking, and 

will consider all comments and material 

received during the comment period. 

Your comment can help shape the 

outcome of this rulemaking. If you 

submit a comment, please include the 

docket number for this rulemaking, 

indicate the specific section of this 

document to which each comment 

applies, and provide a reason for each 

suggestion or recommendation. 

Submitting comments. We encourage 

you to submit comments through the 

Federal Decision Making Portal at 

https://www.regulations.gov. To do so, 

go to https://www.regulations.gov, type 

USCG–2022–0355 in the search box and 

click ‘‘Search.’’ Next, look for this 

document in the Search Results column, 

and click on it. Then click on the 

Comment option. If you cannot submit 

your material by using https://

www.regulations.gov, call or email the 

person in the FOR FURTHER INFORMATION

CONTACT section of this proposed rule 

for alternate instructions. 

Viewing material in docket. To view 

documents mentioned in this proposed 

rule as being available in the docket, 

find the docket as described in the 

previous paragraph, and then select 

‘‘Supporting & Related Material’’ in the 

Document Type column. Public 

comments will also be placed in our 

online docket and can be viewed by 

following instructions on the https://

www.regulations.gov Frequently Asked 

Questions web page. We review all 

comments received, but we will only 

post comments that address the topic of 

the proposed rule. We may choose not 

to post off-topic, inappropriate, or 

duplicate comments that we receive. 

Personal information. We accept 

anonymous comments. Comments we 

post to https://www.regulations.gov will 

include any personal information you 

have provided. For more about privacy 

and submissions to the docket in 

response to this document, see DHS’s 

eRulemaking System of Records notice 

(85 FR 14226, March 11, 2020). 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard is proposing 

to amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.9XX to read as follows: 

§ 165.9XX Safety Zone; Lake Erie, 

Cleveland, OH 

(a) Location. All navigable waters of 

Lake Erie adjacent to Cleveland, OH, 

within a 420-foot radius from the 

fireworks launch site located near Port 

of Cleveland Dock 20. 

(b) Definitions. Official Patrol Vessel 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

coxswain, petty officer, or other officer 

operating a Coast Guard vessel and a 

Federal, State, or local officer 

designated by or assisting the Captain of 

the Port Buffalo (COTP) in the 

enforcement of the regulations in this 

section. Participant means all persons 

and vessels attending the event. 

(c) Regulations. (1) The Coast Guard 

may patrol the event area under the 

direction of a designated Coast Guard 

Patrol Commander. The Patrol 

Commander may be contacted on 

Channel 16 VHF–FM (156.8 MHz) by 

the call sign ‘‘PATCOM.’’ 

(2) All persons and vessels not 

registered with the sponsor as 

participants or official patrol vessels are 

considered spectators. The ‘‘official 

patrol vessels’’ consist of any Coast 

Guard, state, or local law enforcement 

and sponsor provided vessels 

designated or assigned by the Captain of 

the Port Buffalo to patrol the event. 

(3) Spectator vessels desiring to 

transit the regulated area may do so only 

with prior approval of the Patrol 

Commander and when so directed by 

that officer and will be operated at a no 

wake speed in a manner which will not 

endanger participants in the event or 

any other craft. 

(4) No spectator shall anchor, block, 

loiter, or impede the through transit of 

official patrol vessels in the regulated 

area during the effective dates and 

times, unless cleared for entry by or 

through an official patrol vessel. 

(5) The Patrol Commander may forbid 

and control the movement of all vessels 

in the regulated area. When hailed or 

signaled by an official patrol vessel, a 

vessel shall come to an immediate stop 

and comply with the directions given. 

Failure to do so may result in expulsion 

from the area, citation for failure to 

comply, or both. 

(6) Any spectator vessel may anchor 

outside the regulated areas specified in 

this chapter, but may not anchor in, 

block, or loiter in a navigable channel. 

(7) The Patrol Commander may 

terminate the event or the operation of 

any vessel at any time it is deemed 

necessary for the protection of life or 

property. 

(8) The Patrol Commander will 

terminate enforcement of the special 

regulations at the conclusion of the 

event. 


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31206 Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Proposed Rules 

(d) Enforcement Period. This section 

will be enforced tri-annually in July. 

The Coast Guard will provide advance 

notice of the enforcement date and time 

of the safety zone by publishing a Notice 

of Enforcement in the Federal Register, 

as well as issuing a Broadcast Notice to 

Mariners. 

Dated: May 12, 2022. 

M.I. Kuperman, 

Captain, U.S. Coast Guard, Captain of the 

Port Buffalo. 

[FR Doc. 2022–10881 Filed 5–20–22; 8:45 am] 

BILLING CODE 9110–04–P 


lotter on DSK11XQN23PROD with PROPOSALS1