[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Rules and Regulations]
[Pages 944-949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27754]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 742 and 774

[Docket No. 201208-0330]
RIN 0694-AI09


Commerce Control List: Clarifications to the Scope of Export 
Control Classification Number 1C991 To Reflect Decisions Adopted at the 
June 2019 Australia Group Plenary Meeting

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) publishes this final 
rule to amend the Export Administration Regulations (EAR) to clarify 
the scope of the export controls that apply to certain vaccines and 
medical products, consistent with the release (i.e., exclusion) notes 
contained in the Australia Group (AG) ``Human and Animal Pathogens and 
Toxins for Export Control'' common control list.

DATES: This rule is effective January 7, 2021.

FOR FURTHER INFORMATION CONTACT: Dr. Kimberly Orr, Chemical and 
Biological Controls Division, Office of Nonproliferation and Treaty 
Compliance, Bureau of Industry and Security, Telephone: (202) 482-4201, 
Email: <a href="/cdn-cgi/l/email-protection#307b595d5255425c491e7f4242705259431e545f531e575f46"><span class="__cf_email__" data-cfemail="82c9ebefe0e7f0eefbaccdf0f0c2e0ebf1ace6ede1ace5edf4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security (BIS) is 
amending the Export Administration Regulations (EAR) to clarify the 
scope of the export controls that apply to certain vaccines, consistent 
with the vaccine release (i.e., exclusion) note contained in the 
Australia Group (AG) ``List of Human and Animal Pathogens and Toxins 
for Export Control'' common control list, as updated by a decision made 
at the AG Plenary meeting held in Paris, France, in June 2019. The AG 
is a multilateral forum consisting of 42 participating countries and 
the European Union that maintain export controls on a list of 
chemicals, biological agents, and related equipment and technology that 
could be used in a chemical or biological weapons program. The AG 
periodically reviews items on its control list to enhance the 
effectiveness of participating governments' national controls and to 
achieve greater harmonization among these controls.
    The AG specifically excludes certain vaccines from control under 
its ``List of Human and Animal Pathogens and Toxins for Export 
Control'' and the associated Warning List. However, prior to the June 
2019 Plenary changes to this AG common control list, it was not clear 
if the release note therein applied not only to vaccines containing 
those human and animal pathogens and toxins identified on the list, but 
also to vaccines containing the genetic elements and genetically 
modified organisms identified therein. Recent changes to this AG common 
control list, based in part on a decision made at the June 2019 Plenary 
meeting, clarify that this release note applies to vaccines containing 
the genetic elements and genetically modified organisms identified on 
this list, as well as vaccines containing the viruses, bacteria, and 
toxins identified on this list.
    Specifically, this rule amends Export Control Classification Number 
(ECCN) 1C991 on the Commerce Control List (CCL) to indicate that it 
includes vaccines containing, or designed for use against, any of the 
items identified in ECCN 1C351, 1C353 or 1C354. Prior to the effective 
date of this final rule, ECCN 1C991 indicated that it controlled 
vaccines ``against'' such items, but was not specific about whether all 
vaccines ``containing'' such items were controlled, irrespective of 
whether the vaccines were designed for use ``against'' such items.
    This rule also expands the scope of medical products controlled 
under ECCN 1C991 to include those containing genetically modified 
organisms and genetic elements described in ECCN 1C353.a.3. In 
addition, this rule clarifies the definition of `immunotoxin' that 
appears in ECCN 1C351 and ECCN 1C991 and removes the definition of 
`subunit' from ECCN 1C351.
    Finally, this rule renumbers ECCN 1C991.c and .d by listing medical 
products that are subject to chemical/biological (CB) controls, as well 
as anti-terrorism (AT) controls, under ECCN 1C991.c and listing medical 
products that are subject only to AT controls under ECCN 1C991.d. A 
conforming amendment is made to Sec.  742.2(a)(3) of the EAR to reflect 
this change in paragraph sequencing.

ECCN 1C991 (Vaccines, Immunotoxins, Medical Products, Diagnostic and 
Food Testing Kits)

    This final rule amends ECCN 1C991 on the Commerce Control List 
(CCL) (Supplement No. 1 to part 774 of the EAR) to make the description 
of the vaccines controlled by this ECCN more closely reflect the scope 
of the vaccine release note contained in the AG ``List of Human and 
Animal Pathogens and Toxins for Export Control.'' ECCN 1C991 does not 
control any of the human and animal pathogens and toxins or genetic 
elements and genetically modified organisms identified on this AG list; 
however, it does control vaccines, immunotoxins, medical products, and 
diagnostic and food testing kits that contain certain of these AG-
listed items.
    The amendments contained in this final rule are intended to clarify 
the scope of the vaccine controls described in ECCN 1C991. Prior to the 
effective date of this final rule, the control text for vaccines 
described in ECCN 1C991.a indicated that this ECCN controlled 
``vaccines against items controlled by ECCN 1C351, 1C353 or 1C354.'' 
The use of the term ``against'' in the control text created some 
uncertainty concerning the extent to which ECCN 1C991.a applied to 
vaccines that ``contain'' items controlled by ECCN 1C351, 1C353 or

[[Page 945]]

1C354, but that act against agents (or other disease causing organisms) 
that are not identified in any of these ECCNs. This uncertainty caused 
some concern among manufacturers and exporters about the correct 
classification and licensing policies for such vaccines.
    The clarifications in this rule to the scope of the vaccine 
controls in ECCN 1C991.a are also in response to recent scientific and 
medical developments. For example, viruses controlled under ECCN 1C351 
(e.g., vesicular stomatitis virus, yellow fever virus, and Newcastle 
disease virus) are being modified to express surface proteins of other 
target organisms or cells for stimulating immune response to the 
surface protein, thus acting as vaccines against those targets. These 
medical products can be designed for the following purposes: (1) 
Vaccination against agents controlled by ECCN 1C351 (e.g., Ebolavirus 
or Chikungunya virus); (2) to protect against uncontrolled agents; or 
(3) as oncolytic medical products for treating specific cancers 
(oncolytic virotherapy is an emerging treatment that uses replication 
competent viruses to destroy cancers).
    This final rule addresses industry's concerns and the recent 
scientific and medical developments described above by revising ECCN 
1C991.a to read as follows: ``Vaccines containing, or designed for use 
against, items controlled by ECCN 1C351, 1C353 or 1C354.'' As a result 
of this change, ECCN 1C991.a now clearly indicates that it controls all 
vaccines that ``contain'' items controlled by ECCN 1C351, 1C353 or 
1C354, as well as those vaccines that are designed for use ``against'' 
these items.
    This rule also amends ECCN 1C991 by expanding the scope of medical 
products controlled under this ECCN, consistent with the release (i.e., 
exclusion) note for such products in the ``List of Human and Animal 
Pathogens and Toxins for Export Control,'' to include medical products 
containing genetically modified organisms or genetic elements 
controlled under ECCN 1C353.a.3. In addition, the control text for 
medical products in ECCN 1C991 is renumbered by listing medical 
products that are subject to chemical/biological (CB) controls, as well 
as anti-terrorism (AT) controls, under ECCN 1C991.c and listing medical 
products that are subject only to AT controls, under ECCN 1C991.d. 
Prior to the effective date of this final rule, the former were listed 
under ECCN 1C991.d, while the latter were listed under ECCN 1C991.c. 
This change is intended to emphasize the more stringent controls that 
apply to the medical products now described in ECCN 1C991.c (i.e., CB 
controls, in addition to AT controls) and to clearly indicate that the 
CB controls that apply to most of the medical products controlled under 
this ECCN do not apply to the medical products now controlled under 
ECCN 1C991.d, which are subject only to AT controls (the controls that 
apply to items in ECCN 1C991 are described in more detail, below). A 
conforming amendment is made to Sec.  742.2(a)(3) of the EAR to reflect 
this change in paragraph sequencing.
    This rule also makes a technical correction to the definition of 
`medical products' in the ``Related Definitions'' paragraph under the 
List of Items Controlled for ECCN 1C991 by adding the parenthetical 
phrase ``(or veterinary)'' to the criterion describing pharmaceutical 
formulations. The criterion, as corrected, reads as follows: ``(1) 
pharmaceutical formulations designed for testing and human (or 
veterinary) administration in the treatment of medical conditions.'' In 
addition, the definition of `immunotoxins' in the ``Related 
Definitions'' paragraph of ECCN 1C351 and ECCN 1C991 is clarified to 
read as follows: ``immunotoxins are monoclonal antibodies linked to a 
toxin with the intention of destroying a specific target cell while 
leaving adjacent cells intact.''
    This rule also adds a Technical Note at the beginning of the 
``Items'' paragraph in the List of Items Controlled under ECCN 1C991 to 
clarify that, for purposes of the controls described in this ECCN, 
`toxins' means those toxins, or their subunits, controlled under ECCN 
1C351.d.
    Note that all items controlled by ECCN 1C991, including the 
vaccines described in ECCN 1C991.a, require a license for AT reasons to 
the destinations indicated under AT Column 1 on the Commerce Country 
Chart in Supplement No. 1 to part 738 of the EAR (also see the AT 
license requirements described in part 742 of the EAR that apply to 
Iran, North Korea, Sudan and Syria). In addition, the medical products 
now controlled by ECCN 1C991.c (as renumbered by this rule) require a 
license for CB reasons, as well as AT reasons, to the destinations 
indicated under CB Column 3 and AT Column 1, respectively, on the 
Commerce Country Chart. A license also is required to certain 
destinations in accordance with the embargoes and other special 
controls described in part 746 of the EAR.

Anticipated Impact of This Final Rule

    Prior to the publication of this final rule, paragraph (a) of ECCN 
1C991 included only those vaccines designed to protect against 
biological agents controlled under ECCN 1C351, 1C353 or 1C354 on the 
CCL. For example, the vaccine for protection against Ebola was 
previously (and continues to be) classified for control under ECCN 
1C991, because Ebola, itself, is a controlled biological agent. The 
Ebola vaccine also contains genetic elements for recombinant vesicular 
stomatitis virus (VSV), a controlled virus, and a common vector for 
vaccine development.
    However, ECCN 1C991 did not previously include vaccines containing 
controlled biological agents that were not also designed to protect 
against a controlled agent. Other VSV-based vaccines against EAR99 
agents (i.e., agents not controlled on the CCL), such as SARS-CoV-2, 
were controlled to all destinations under ECCN 1C353, because they did 
not act against a controlled agent as previously required by the ECCN 
1C991 vaccine control text.
    This rule amends the vaccine controls in paragraph (a) of ECCN 
1C991 to more accurately reflect the scope of the AG release note for 
vaccines, which exempts vaccines from control under the AG List of 
Human and Animal Pathogens and Toxins. Specifically, the AG release 
note exempts from control all vaccines containing one or more of the 
biological agents identified on this AG common control list.
    Although certain COVID vaccines are not affected by this rule, the 
development of an unknown number of other vaccines, COVID and 
otherwise, is expected to be greatly facilitated as a result of these 
amendments to the vaccine controls in ECCN 1C991.
    Effective with the publication of this rule, COVID vaccines 
containing genetic elements of items controlled by ECCN 1C353 (such as 
VSV) are now controlled under ECCN 1C991, instead of ECCN 1C353. 
Consequently, instead of requiring a license for export or reexport to 
all destinations, a license is required only to a much more limited 
number of destinations (i.e., countries of concern for anti-terrorism 
(AT) reasons).
    A specific example of the impact of this rule is a VSV-SARS-CoV-2 
vaccine, which is a vesicular stomatitis virus modified by adding the 
gene for the coronavirus spike protein. Because this vaccine acts 
against SARS-CoV-2, which is not controlled under ECCN 1C351, it was 
not classified as an ECCN 1C991 vaccine, prior to the publication of 
this rule. Instead, it was controlled under ECCN 1C353, in spite of 
having received FDA approval and being packaged for patient use, 
because it contains genetic elements from VSV (a

[[Page 946]]

controlled virus). Consequently, this vaccine previously required a 
license to all destinations. Effective with the publication of this 
final rule, this vaccine is now controlled under ECCN 1C991 and 
requires a license only to designated countries of concern for AT 
reasons.

Saving Clause

    Shipments of items removed from eligibility for export, reexport or 
transfer (in-country) under a license exception or without a license 
(i.e., under the designator ``NLR'') as a result of this regulatory 
action that were on dock for loading, on lighter, laden aboard an 
exporting carrier, or en route aboard a carrier to a port of export, on 
January 7, 2021, pursuant to actual orders for export, reexport or 
transfer (in-country) to a foreign destination, may proceed to that 
destination under the previously applicable license exception or 
without a license (NLR) so long as they are exported, reexported or 
transferred (in-country) before March 8, 2021. Any such items not 
actually exported, reexported or transferred (in-country) before 
midnight, on March 8, 2021, require a license in accordance with this 
regulation.
    ``Deemed'' exports of ``technology'' and ``source code'' removed 
from eligibility for export under a license exception or without a 
license (under the designator ``NLR'') as a result of this regulatory 
action may continue to be made under the previously available license 
exception or without a license (NLR) before March 8, 2021. Beginning at 
midnight on March 8, 2021, such ``technology'' and ``source code'' may 
no longer be released, without a license, to a foreign national subject 
to the ``deemed'' export controls in the EAR when a license would be 
required to the home country of the foreign national in accordance with 
this regulation.

Export Control Reform Act of 2018

    The Export Control Reform Act of 2018 (ECRA), as amended, codified 
at 50 U.S.C. 4801-4852, serves as the authority under which BIS issues 
this rule.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including: Potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits and of reducing costs, harmonizing rules, and promoting 
flexibility. This rule has been designated a ``significant regulatory 
action,'' although not economically significant, under section 3(f) of 
Executive Order 12866. Accordingly, the rule has been reviewed by the 
Office of Management and Budget.
    The cost-benefit analysis required pursuant to Executive Orders 
13563 and 12866, as described below, indicates that this rule is 
intended to improve national security as its primary direct benefit and 
that this benefit significantly outweighs the costs of this rule. 
Specifically, implementation, in a timely manner, of the Australia 
Group (AG) agreements described herein will enhance the national 
security of the United States by reducing the risk that international 
trade involving dual-use chemical and biological items would contribute 
to the proliferation of chemical and biological weapons of mass 
destruction. The principal objective of AG participating countries is 
to use licensing measures to ensure that exports of certain chemicals, 
biological agents, and dual-use chemical and biological manufacturing 
facilities and equipment, do not contribute to the proliferation of 
chemical and biological weapons of mass destruction, which has been 
identified as a threat to domestic and international peace and 
security. The AG achieves this objective by harmonizing participating 
countries' national export licensing measures. These controls are 
essential, given that the international chemical and biotechnology 
industries are a target for proliferators as a source of materials for 
chemical and biological weapons programs.
    In calculating what costs (if any) will be imposed by this rule, 
BIS estimates that 10 fewer license applications will need to be 
submitted to BIS, annually, as a result of the implementation of the 
amendments described in this rule (see Rulemaking Requirements #2, 
below). By applying the cost-benefit analysis required under Executive 
Orders 13563 and 12866 to this rule, as described herein, BIS has 
determined that the benefits of this rule (i.e., the enhancement of our 
national security through the fulfillment our multilateral obligations 
as an AG participating country, together with the anticipated reduction 
in the number of license applications that would have to be submitted 
to export certain items affected by this rule) significantly outweigh 
any potential costs (i.e., the incidental costs to exporters of 
adjusting their export control procedures for certain items affected by 
this rule). Furthermore, consistent with the stated purpose of the 
amendments to ECCN 1C991 (i.e., to enhance the national security of the 
United States), this rule meets the requirements set forth in the April 
5, 2017, Office of Management and Budget (OMB) guidance implementing 
Executive Order 13771 (82 FR 9339, February 3, 2017), regarding what 
constitutes a regulation issued ``with respect to a national security 
function of the United States,'' and it is, therefore, exempt from the 
requirements of E.O. 13771.
    2. Notwithstanding any other provision of law, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with, a collection of information subject to the 
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.) (PRA), unless that collection of information displays a currently 
valid OMB Control Number. This rule contains the following collections 
of information subject to the requirements of the PRA. These 
collections have been approved by OMB under control numbers 0694-0088 
(Simplified Network Application Processing System) and 0694-0096 (Five 
Year Records Retention Period). The approved information collection 
under OMB control number 0694-0088 includes license applications, among 
other things, and carries a burden estimate of 29.6 minutes per manual 
or electronic submission for a total burden estimate of 31,833 hours. 
The approved information collection under OMB control number 0694-0096 
includes recordkeeping requirements and carries a burden estimate of 
less than 1 minute per response for a total burden estimate of 248 
hours.
    This rule contains minor clarifications to the EAR for certain 
vaccines controlled by ECCN 1C991.a for anti-terrorism (AT) reasons. 
Specifically, BIS expects the burden hours associated with these 
collections will decrease by 5 hours and 6 minutes (i.e., 10 
applications x 30.6 minutes per response) for a total estimated 
decrease in cost of $153 (i.e., 5 hours and 6 minutes x $30 per hour). 
The $30 per hour cost estimate for OMB control numbers 0694-0088 and 
0694-0096 is consistent with the salary data for export compliance 
specialists currently available through glassdoor.com (glassdoor.com 
estimates that an export compliance specialist makes $55,280 annually, 
which computes to roughly $26.58 per hour). Consequently, the burden 
hours associated with exports of the items affected by this rule will 
remain within the range of the existing

[[Page 947]]

estimates currently associated with OMB control numbers 0694-0088 and 
0694-0096.
    Written comments and recommendations for the information 
collections referenced above should be sent within 30 days of the 
publication of this final rule to: www.reginfo.gov/public/do/PRAMain. 
Find these particular information collections by selecting ``Currently 
under 30-day Review--Open for Public Comments'' or by using the search 
function.
    3. This rule does not contain policies with Federalism implications 
as that term is defined in Executive Order 13132.
    4. Pursuant to section 1762 of the Export Control Reform Act of 
2018 (50 U.S.C. Sec. 4821), this action is exempt from the 
Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for 
notice of proposed rulemaking, opportunity for public participation and 
delay in effective date.
    Because a notice of proposed rulemaking and an opportunity for 
public comment are not required to be given for this rule by the APA or 
any other law, the analytical requirements of the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.) are not applicable. Accordingly, 
no regulatory flexibility analysis is required, and none has been 
prepared.

List of Subjects

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, parts 742 and 774 of the 
Export Administration Regulations (15 CFR parts 730-774) are amended as 
follows:

PART 742--CONTROL POLICY--CCL BASED CONTROLS

0
1. The authority citation for 15 CFR part 742 continues to read as 
follows:

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 
U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 
59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 
783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 
Comp., p. 320; Notice of November 12, 2019, 84 FR 61817 (November 
13, 2019).


0
2. In Sec.  742.2, paragraph (a)(3) is revised to read as follows:


Sec.  742.2   Proliferation of chemical and biological weapons.

    (a) * * *
    (3) If CB Column 3 of the Country Chart (Supplement No. 1 to part 
738 of the EAR) is indicated in the appropriate ECCN, a license is 
required to Country Group D:3 (see Supplement No. 1 to part 740 of the 
EAR) for medical products identified in ECCN 1C991.c.
* * * * *

PART 774--THE COMMERCE CONTROL LIST

0
3. The authority citation for 15 CFR part 774 continues to read as 
follows:

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 
287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 
U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 
FR 44025, 3 CFR, 2001 Comp., p. 783.


0
4. In Supplement No. 1 to part 774, Category 1, ECCN 1C351 is revised 
to read as follows:

Supplement No. 1 to Part 774--The Commerce Control List

* * * * *
1C351 Human and animal pathogens and ``toxins,'' as follows (see 
List of Items Controlled).

License Requirements

Reason for Control: CB, CW, AT

 
                                              Country chart  (see supp.
                Control(s)                       No. 1 to part 738)
 
CB applies to entire entry................  CB Column 1.
 

    CW applies to 1C351.d.11 and d.12 and a license is required for 
CW reasons for all destinations, including Canada, as follows: CW 
applies to 1C351.d.11 for ricin in the form of (1) Ricinus communis 
AgglutininII (RCAII), also known as ricin D or Ricinus Communis 
LectinIII (RCLIII) and (2) Ricinus communis LectinIV (RCLIV), also 
known as ricin E. CW applies to 1C351.d.12 for saxitoxin identified 
by C.A.S. #35523-89-8. See Sec.  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.

 
                                              Country chart  (see supp.
                Control(s)                       No. 1 to part 738)
 
AT applies to entire entry................  AT Column 1.
 

    License Requirement Notes: 1. All vaccines and `immunotoxins' 
are excluded from the scope of this entry. Certain medical products 
and diagnostic and food testing kits that contain biological toxins 
controlled under paragraph (d) of this entry, with the exception of 
toxins controlled for CW reasons under d.11 and d.12, are excluded 
from the scope of this entry. Vaccines, `immunotoxins,' certain 
medical products, and diagnostic and food testing kits excluded from 
the scope of this entry are controlled under ECCN 1C991.
    2. For the purposes of this entry, only saxitoxin is controlled 
under paragraph d.12; other members of the paralytic shellfish 
poison family (e.g., neosaxitoxin) are designated EAR99.
    3. Clostridium perfringens strains, other than the epsilon 
toxin-producing strains of Clostridium perfringens described in 
c.12, are excluded from the scope of this entry, since they may be 
used as positive control cultures for food testing and quality 
control.
    4. Unless specified elsewhere in this ECCN 1C351 (e.g., in 
License Requirement Notes 1-3), this ECCN controls all biological 
agents and ``toxins,'' regardless of quantity or attenuation, that 
are identified in the List of Items Controlled for this ECCN, 
including small quantities or attenuated strains of select 
biological agents or ``toxins'' that are excluded from the lists of 
select biological agents or ``toxins'' by the Animal and Plant 
Health Inspection Service (APHIS), U.S. Department of Agriculture 
(USDA), or the Centers for Disease Control and Prevention (CDC), 
U.S. Department of Health and Human Services (HHS), in accordance 
with their regulations in 9 CFR part 121 and 42 CFR part 73, 
respectively.
    5. Biological agents and pathogens are controlled under this 
ECCN 1C351 when they are an isolated live culture of a pathogen 
agent, or a preparation of a toxin agent that has been isolated or 
extracted from any source or material, including living material 
that has been deliberately inoculated or contaminated with the 
agent. Isolated live cultures of a pathogen agent include live 
cultures in dormant form or in dried preparations, whether the agent 
is natural, enhanced or modified.

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

Special Conditions for STA

STA: (1) Paragraph (c)(1) of License Exception STA (Sec.  
740.20(c)(1)) may be used for items in 1C351.d.1 through 1C351.d.10 
and 1C351.d.13 through 1C351.d.18. See Sec.  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 Sec.  758.1(b)(4) of the EAR. 
(2) Paragraph (c)(2) of License Exception STA (Sec.  740.20(c)(2) of 
the EAR) may not be used for any items in 1C351.

[[Page 948]]

List of Items Controlled

Related Controls: (1) Certain forms of ricin and saxitoxin in 
1C351.d.11. and d.12 are CWC Schedule 1 chemicals (see Sec.  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 Sec.  745.1 of the EAR for notification procedures. 
See 22 CFR part 121, Category XIV and Sec.  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 syndrome-related 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 syndrome-related coronavirus 
(SARS-related coronavirus);
    a.48. Sheeppox virus;
    a.49. Sin Nombre virus;
    a.50. St. Louis encephalitis virus;
    a.51. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky's 
disease);
    a.52. Swine vesicular disease virus;
    a.53. Tick-borne encephalitis virus (Far Eastern subtype, 
formerly known as Russian Spring-Summer encephalitis virus--see 
1C351.b.3 for Siberian subtype);
    a.54. Variola virus;
    a.55. Venezuelan equine encephalitis virus;
    a.56. Vesicular stomatitis virus;
    a.57. Western equine encephalitis virus; or
    a.58. Yellow fever virus.
    b. Viruses identified on the APHIS/CDC ``select agents'' lists 
(see Related Controls paragraph #2 for this ECCN), but not 
identified on the Australia Group (AG) ``List of Human and Animal 
Pathogens and Toxins for Export Control,'' as follows:
    b.1. [Reserved];
    b.2. [Reserved]; or
    b.3. Tick-borne encephalitis virus (Siberian subtype, formerly 
West Siberian virus--see 1C351.a.53 for Far Eastern subtype).
    c. Bacteria identified on the Australia Group (AG) ``List of 
Human and Animal Pathogens and Toxins for Export Control,'' as 
follows:
    c.1. Bacillus anthracis;
    c.2. Brucella abortus;
    c.3. Brucella melitensis;
    c.4. Brucella suis;
    c.5. Burkholderia mallei (Pseudomonas mallei);
    c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
    c.7. Chlamydia psittaci (Chlamydophila psittaci);
    c.8. Clostriduim argentinense (formerly known as Clostridium 
botulinum Type G), botulinum neurotoxin producing strains;
    c.9. Clostridium baratii, botulinum neurotoxin producing 
strains;
    c.10. Clostridium botulinum;
    c.11. Clostridium butyricum, botulinum neurotoxin producing 
strains;
    c.12. Clostridium perfringens, epsilon toxin producing types;
    c.13. Coxiella burnetii;
    c.14. Francisella tularensis;
    c.15. Mycoplasma capricolum subspecies capripneumoniae (``strain 
F38'');
    c.16. Mycoplasma mycoides subspecies mycoides SC (small colony) 
(a.k.a. contagious bovine pleuropneumonia);
    c.17. Rickettsia prowazekii;
    c.18. Salmonella enterica subspecies enterica serovar Typhi 
(Salmonella typhi);
    c.19. Shiga toxin producing Escherichia coli (STEC) of 
serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other 
shiga toxin producing serogroups;

    Note: Shiga toxin producing Escherichia coli (STEC) includes, 
inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing 
E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).

    c.20. Shigella dysenteriae;
    c.21. Vibrio cholerae; or
    c.22. Yersinia pestis.
    d. ``Toxins'' identified on the Australia Group (AG) ``List of 
Human and Animal Pathogens and Toxins for Export Control,'' as 
follows, or their subunits:
    d.1. Abrin;
    d.2. Aflatoxins;
    d.3. Botulinum toxins;
    d.4. Cholera toxin;
    d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and 
iota toxins;
    d.6. Conotoxins;
    d.7. Diacetoxyscirpenol;
    d.8. HT-2 toxin;
    d.9. Microcystins (Cyanginosins);
    d.10. Modeccin;
    d.11. Ricin;
    d.12. Saxitoxin;
    d.13. Shiga toxins (shiga-like toxins, verotoxins, and 
verocytotoxins);
    d.14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, 
and toxic shock syndrome toxin (formerly known as Staphylococcus 
enterotoxin F);
    d.15. T-2 toxin;
    d.16. Tetrodotoxin;
    d.17. Viscumin (Viscum album lectin 1); or
    d.18. Volkensin.
    e. ``Fungi'', as follows:
    e.1. Coccidioides immitis; or
    e.2. Coccidioides posadasii.

0
5. In Supplement No. 1 to part 774, Category 1, ECCN 1C991 is revised 
to read as follows:
1C991 Vaccines, immunotoxins, medical products, diagnostic and food 
testing kits, as follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

[[Page 949]]



 
                                            Country chart (see supp. No.
                Control(s)                         1 to part 738)
 
CB applies to 1C991.c.....................  CB Column 3.
AT applies to entire entry................  AT Column 1.
 

List Based License Exceptions (See Part 740 for a Description of All 
License Exceptions)

LVS: N/A
GBS: N/A

List of Items Controlled

Related Controls: (1) Medical products containing ricin or 
saxitoxin, as follows, are controlled for CW reasons under ECCN 
1C351:

    (a) Ricinus communis AgglutininII (RCAII), also known as ricin 
D, or Ricinus Communis LectinIII (RCLIII);
    (b) Ricinus communis LectinIV (RCLIV), also known as ricin E; or
    (c) Saxitoxin identified by C.A.S. #35523-89-8.
    (2) The export of a ``medical product'' that is an 
``Investigational New Drug'' (IND), as defined in 21 CFR 312.3, is 
subject to certain U.S. Food and Drug Administration (FDA) 
requirements that are independent of the export requirements 
specified in this ECCN or elsewhere in the EAR. These FDA 
requirements are described in 21 CFR 312.110 and must be satisfied 
in addition to any requirements specified in the EAR.
    (3) Also see 21 CFR 314.410 for FDA requirements concerning 
exports of new drugs and new drug substances.

Related Definitions: For the purpose of this entry, `immunotoxins' 
are monoclonal antibodies linked to a toxin with the intention of 
destroying a specific target cell while leaving adjacent cells 
intact. For the purpose of this entry, `medical products' are: (1) 
Pharmaceutical formulations designed for testing and human (or 
veterinary) administration in the treatment of medical conditions, 
(2) prepackaged for distribution as clinical or medical products, 
and (3) approved by the U.S. Food and Drug Administration either to 
be marketed as clinical or medical products or for use as an 
``Investigational New Drug'' (IND) (see 21 CFR part 312). For the 
purpose of this entry, `diagnostic and food testing kits' are 
specifically developed, packaged and marketed for diagnostic or 
public health purposes. Biological toxins in any other 
configuration, including bulk shipments, or for any other end-uses 
are controlled by ECCN 1C351. For the purpose of this entry, 
`vaccine' is defined as a medicinal (or veterinary) product in a 
pharmaceutical formulation, approved by the U.S. Food and Drug 
Administration or the U.S. Department of Agriculture to be marketed 
as a medical (or veterinary) product or for use in clinical trials, 
that is intended to stimulate a protective immunological response in 
humans or animals in order to prevent disease in those to whom or to 
which it is administered.
Items:

    Technical Note: For purposes of the controls described in this 
ECCN, `toxins' refers to those toxins, or their subunits, controlled 
under ECCN 1C351.d.

    a. Vaccines containing, or designed for use against, items 
controlled by ECCN 1C351, 1C353 or 1C354.
    b. Immunotoxins containing toxins controlled by 1C351.d;
    c. Medical products that contain any of the following:
    c.1. Toxins controlled by ECCN 1C351.d (except for botulinum 
toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 
1C351.d.6, or items controlled for CW reasons under ECCN 1C351.d.11 
or .d.12); or
    c.2. Genetically modified organisms or genetic elements 
controlled by ECCN 1C353.a.3 (except for those that contain, or code 
for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins 
controlled by ECCN 1C351.d.6);
    d. Medical products not controlled by 1C991.c that contain any 
of the following:
    d.1. Botulinum toxins controlled by ECCN 1C351.d.3;
    d.2. Conotoxins controlled by ECCN 1C351.d.6; or
    d.3. Genetically modified organisms or genetic elements 
controlled by ECCN 1C353.a.3 that contain, or code for, botulinum 
toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 
1C351.d.6;
    e. Diagnostic and food testing kits containing toxins controlled 
by ECCN 1C351.d (except for items controlled for CW reasons under 
ECCN 1C351.d.11 or .d.12).

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2020-27754 Filed 1-6-21; 8:45 am]
BILLING CODE 3510-33-P


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