[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: [email protected].
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