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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations estimates currently associated with OMB control numbers 06940088 and 06940096.
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 ReviewOpen 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.
15 CFR Part 742
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 730774 are amended as follows:
PART 742CONTROL POLICYCCL
BASED CONTROLS
1. The authority citation for 15 CFR
part 742 continues to read as follows:

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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 774THE COMMERCE
CONTROL LIST
3. The authority citation for 15 CFR
part 774 continues to read as follows:

Authority: 50 U.S.C. 48014852; 50 U.S.C.
4601 et seq.; 50 U.S.C. 1701 et seq.; 10 U.S.C.
8720; 10 U.S.C. 8730e; 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 774The Commerce Control List

License Requirements Reason for Control: CB, CW, AT

Exports, Terrorism.

Authority: 50 U.S.C. 48014852; 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.
10811, 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 200323, 68 FR
26459, 3 CFR, 2004 Comp., p. 320; Notice of November 12, 2019, 84 FR 61817 November 13, 2019.

16:55 Jan 06, 2021

742.2 Proliferation of chemical and biological weapons.

1C351 Human and animal pathogens and toxins, as follows see List of Items Controlled.

List of Subjects
VerDate Sep<11>2014

2. In 742.2, paragraph a3 is revised to read as follows:

Jkt 253001

Controls CB applies to entire entry.

Country chart see supp. No. 1 to part 738
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. 35523898.
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.
Controls AT applies to entire entry.

PO 00000

Frm 00015

Fmt 4700

Country chart see supp. No. 1 to part 738
AT Column 1.

Sfmt 4700

947

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 c1 of License Exception STA 740.20c1 may be used for items in 1C351.d.1 through 1C351.d.10 and 1C351.d.13 through 1C351.d.18. See 740.20b2vi 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 758.1b4 of the EAR.
2 Paragraph c2 of License Exception STA 740.20c2 of the EAR may not be used for any items in 1C351.

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