Document ID: BIS-2022-0013-0001
Agency: bis
Document Type: Proposed Rule
Title: Commerce Control List: Controls on Certain Marine Toxins
Posted Date: 2022-05-23T04:00Z

[Federal Register Volume 87, Number 99 (Monday, May 23, 2022)]
[Proposed Rules]
[Pages 31195-31203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10907]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 740, 742 and 774

[Docket No. 220516-0114]
RIN 0694-AI21

Commerce Control List: Controls on Certain Marine Toxins

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Proposed rule; request for comments.

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SUMMARY: The Bureau of Industry and Security (BIS), Department of 
Commerce, maintains controls on the export, reexport and transfer (in-
country) of dual-use items and less sensitive military items through 
the Export Administration Regulations (EAR), including the Commerce 
Control List (CCL). This rule proposes new unilateral export controls 
on four naturally occurring, dual-use biological toxins (specifically, 
the marine toxins brevetoxin, gonyautoxin, nodularin and palytoxin), 
the synthesis and collection of which BIS has identified for evaluation 
according to the criteria in Section 1758 of the Export Control Reform 
Act of 2018 (ECRA) pertaining to emerging and foundational 
technologies. These toxins have the potential (through either 
accidental or deliberate release) to cause casualties in humans or 
animals, degrade equipment, or damage crops or the environment. As 
these toxins are now capable of being more easily isolated and purified 
due to novel synthesis methods and equipment, the absence of export 
controls on such toxins could be exploited for biological weapons 
purposes. To address this concern, BIS proposes to amend the CCL by 
adding these toxins to Export Control Classification Number (ECCN) 
1C351. This rule also proposes several conforming changes to the EAR to 
reflect the proposed addition of these marine toxins to ECCN 1C351. In 
addition, this document requests public comments to ensure that the 
scope of these proposed controls will be effective and appropriate 
(with respect to their potential impact on legitimate commercial or 
scientific applications).

DATES: Comments must be received by BIS no later than June 22, 2022.

ADDRESSES: You may submit comments, identified by docket number BIS-
2022-0013 or RIN 0694-AI21, through any of the following:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. You can find this 
proposed rule by searching for its regulations.gov docket number, which 
is BIS-2022-0013.
     Email: [email protected]. Include RIN 0694-AI21 
in the subject line of the message.
    All filers using the portal or email should use the name of the 
person or entity submitting the comments as the name of their files, in 
accordance with the instructions below. Anyone submitting business 
confidential information should clearly identify the business 
confidential portion at the time of submission, file a statement 
justifying nondisclosure and referring to the specific legal authority 
claimed, and provide a non-confidential submission.
    For comments submitted electronically containing business 
confidential information, the file name of the business confidential 
version should begin with the characters ``BC.'' Any page containing 
business confidential information must be clearly marked ``BUSINESS 
CONFIDENTIAL'' on the top of that page. The corresponding non-
confidential version of those comments must be clearly marked 
``PUBLIC.'' The file name of the non-confidential version should begin 
with the character ``P.'' The ``BC'' and ``P'' should be followed by 
the name of the person or entity submitting the comments. Any 
submissions with file names that do not begin with a ``P'' or ``BC'' 
will be assumed to be public and will be made publicly available 
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions on the chemical and 
biological (CB) controls that would apply to the marine toxins proposed 
for control under ECCN 1C351, contact Dr. Tara Gonzalez, Chemical and 
Biological Controls Division, Office of Nonproliferation and Treaty 
Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343, 
Email: [email protected]. For questions on the submission of 
comments, contact Willard Fisher, Regulatory Policy Division, Office of 
Exporter Services, Bureau of Industry and Security, U.S. Department of 
Commerce, (202) 482-6057, Email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

Identification of Section 1758 Technologies

    As part of the National Defense Authorization Act (NDAA) for Fiscal 
Year 2019, Public Law 115-232, Congress enacted the Export Control 
Reform Act of 2018 (ECRA), 50 U.S.C. 4801-4852. Section 1758 of ECRA 
(as codified under 50 U.S.C. 4817) authorizes the Bureau of Industry 
and Security (BIS) to establish appropriate controls on the export, 
reexport or transfer (in-country) of emerging and foundational 
technologies that are essential to the national security of the United 
States.
    Neither Section 1758 nor any other section of ECRA defines the 
terms ``emerging technology'' or ``foundational technology.'' Further, 
ECRA does not provide guidance on how to differentiate between 
``emerging technology'' and ``foundational technology.'' Since ECRA's 
enactment, BIS has solicited public comment on these two terms with the 
idea that defining the terms would assist in the identification of the 
technologies. To that end, BIS published numerous rules adding 
technologies to the CCL pursuant to Section 1758 without defining 
either term. Notably, pursuant to Section 1758, on November 19, 2018, 
BIS published an advance notice of proposed rulemaking, ``Review of 
Controls for Certain Emerging Technologies'' (83 FR 58201) (November 19 
ANPRM). The November 19 ANPRM identified biotechnology in a 
representative list of fourteen

[[Page 31196]]

technology categories concerning which BIS sought public comment to 
determine whether there are specific emerging technologies that are 
essential to U.S. national security and for which effective controls 
can be implemented. The biotechnology-related comments submitted to BIS 
in response to its November 19 ANPRM did not specifically address the 
question of export controls on marine toxins and, consequently, this 
proposed rule does not address those comments. Since the publication of 
the November 19 ANPRM, BIS has published several rules imposing 
controls on emerging technologies and advance notices of proposed 
rulemaking that requested the public to comment on potential emerging 
technologies. Additionally, on August 27, 2020, BIS published an 
advance notice of proposed rulemaking (85 FR 52934) (August 27 ANPRM) 
that sought public comment on the definition of, and criteria for, 
identifying foundational technologies. BIS has found, however, that the 
categorization of the technologies has sometimes delayed the imposition 
of controls. Further, ECRA does not mandate that BIS define either term 
nor does ECRA require that either of the two categories be treated 
differently from the other.

Distinguishing Between Emerging and Foundational Technologies

    Based on its prior experience with implementing the requirements of 
Section 1758 of ECRA, in making future determinations, BIS will not 
characterize a specific technology as ``emerging'' or ``foundational'' 
for purposes of Section 1758 of ECRA. Instead, BIS will characterize 
all technologies identified pursuant to Section 1758 as ``Section 1758 
technologies'' without drawing a distinction between ``emerging'' or 
``foundational'' technologies. This characterization will not affect 
the designation of ``critical technologies,'' for purposes of Committee 
on Foreign Investment in the United States (CFIUS) screenings, because 
technologies identified pursuant to Section 1758 of ECRA are ``critical 
technologies,'' pursuant to 50 U.S.C. 4565(a)(6)(A)(vi), regardless of 
whether such technologies are characterized as ``emerging'' or 
``foundational.'' This characterization will also not affect the scope 
of controls on any technologies controlled consistent with Section 1758 
of ECRA.
    BIS is adopting this approach based on, among other sources, 
consultations with its interagency partners and a review of certain 
comments submitted in response to the November 19 ANPRM and the August 
27 ANPRM, which sought public comment on ``emerging'' and 
``foundational'' technologies, respectively.
    One key consideration drawn from BIS and interagency experience is 
that technologies cannot always be readily categorized as either 
``emerging'' or ``foundational'' technologies. A technology may be 
``foundational'' in the sense of constituting an iterative improvement 
on technology already in production and use by one company, but 
simultaneously be ``emerging'' if such technology is only in the 
``development'' stage (hence not in use) by other manufacturers. These 
challenges apply to the technologies that are the subject of this 
proposed rule.
    Specifically, the four marine toxins (brevetoxin, gonyautoxin, 
nodularin and palytoxin) addressed in this proposed rule are naturally 
occurring and are not necessarily considered, by themselves, to be 
``emerging'' technologies. Consequently, they could be evaluated as 
``foundational,'' rather than ``emerging'' technologies. However, the 
synthesis and collection of these toxins could be evaluated as an 
``emerging'' technology. Specifically, these toxins can now be more 
easily isolated and purified due to novel synthesis methods and 
equipment and, therefore, are capable of being more easily exploited 
for biological weapons purposes than in the past.
    This proposed rule demonstrates some of the difficulties in 
attempting to draw meaningful and functional distinctions between 
``emerging'' and ``foundational'' technologies, for the purpose of 
applying the criteria in ``Section 1758'' of ECRA to identify 
technologies essential to the national security of the United States 
that fall within the scope of this section. Similar challenges have 
made it difficult to characterize other technologies that have been 
proposed for addition to the Commerce Control List (CCL), Supp. No. 1 
to part 774 of the EAR, pursuant to Section 1758 as ``emerging'' or 
``foundational.'' Rather than attempting to continue to distinguish 
which new controls implemented pursuant to Section 1758 are 
``emerging'' or ``foundational,'' BIS believes the government's 
resources and the mandate from Congress are better served identifying 
the technologies essential to U.S. national security under Section 
1758.
    BIS received several comments in response to the August 27 ANPRM 
that specifically requested that BIS set specific parameters by which 
foundational technologies would be defined. However, BIS does not 
believe the proposed parameters provided a meaningful distinction from 
``emerging'' technologies. While BIS will not specify that a particular 
item is either ``foundational'' or ``emerging'' technology, it will 
continue to be informed by, among other things, the Statement of Policy 
in Section 1752 of ECRA (50 U.S.C. 4811), the reasons for control 
described in part 742 of the EAR, and relevant factors described in the 
November 19 and August 27 ANPRMs. Additionally, the identification of 
such technologies will take into account the statutory criteria in 
Section 1758(a)(2)(B) of ECRA: (i) The development of the emerging and 
foundational technologies in foreign countries; (ii) the effect export 
controls imposed pursuant to this section may have on the development 
of such technologies in the United States; and (iii) the effectiveness 
of export controls imposed pursuant to this section on limiting the 
proliferation of the emerging and foundational technologies in foreign 
countries.
    Referring to these items as ``Section 1758 technologies'' without 
attempting to categorize individual technologies as ``emerging'' or 
``foundational'' technology is consistent with the requirements of 
Section 1758, will facilitate more efficient interagency review of 
implementing regulations, and result in more timely implementation of 
such controls. As noted above, ECRA neither defines nor requires 
distinguishing between emerging and foundational technologies and there 
is no impact on the scope of controls on technologies whether they are 
described as emerging or foundational.
    The Secretary of Commerce must establish appropriate controls on 
the export, reexport or transfer (in-country) of technology identified 
pursuant to the Section 1758 process, and in doing so, must consider 
the potential end-uses and end-users of emerging and foundational 
technologies, and the countries to which exports from the United States 
are restricted (e.g., embargoed countries). While the Secretary has 
discretion to set the level of export controls, at a minimum a license 
must be required for the export of such technologies to countries 
subject to a U.S. embargo, including those countries subject to an arms 
embargo.
    In addition, Section 1758(a)(2)(C) of ECRA (50 U.S.C. 
4817(a)(2)(C)) requires that the interagency process for identifying 
Section 1758 technologies include a notice and comment period. 
Consequently, this proposed rule seeks public comments concerning the 
application of the criteria set forth in

[[Page 31197]]

ECRA Section 1758(a)(2), as well as the factors described above, to the 
proposed controls on four marine toxins as described below.

Proposed Section 1758 Controls on Four Marine Toxins

    The synthesis and collection of four marine toxins (brevetoxin, 
gonyautoxin, nodularin and palytoxin) has been identified for 
evaluation, consistent with the interagency process described in 
Section 1758 of ECRA. This identification is based on a finding that, 
although these toxins are naturally occurring, dual-use biological 
toxins, they have the potential (through either accidental or 
deliberate release) to cause casualties in humans or animals, degrade 
equipment, or damage crops or the environment. As these toxins can now 
be more easily isolated and purified due to novel synthesis methods and 
equipment, the absence of export controls on such toxins could be 
exploited for biological weapons purposes.
Proposed Amendments to ECCN 1C351
    Consistent with BIS's authority to evaluate the level of controls 
that would be appropriate for the export, reexport or transfer (in-
country) of emerging technologies, this rule proposes to amend the CCL 
by adding the aforementioned marine toxins to ECCN 1C351.d. These 
toxins are not currently included on any of the Australia Group (AG) 
Common Control Lists--consequently, the Chemical/Biological (CB) 
controls that would apply to these toxins, as proposed by this rule, 
would be unilateral, absent the adoption of comparable controls by the 
AG. The toxins also would be controlled by ECCN 1C351.d for anti-
terrorism (AT) reasons. The four marine toxins proposed for control by 
this proposed rule are described below.
    Brevetoxins are neurotoxins produced by the marine dinoflagellate 
Karenia brevis \1\ that bind to the voltage-gated sodium channels in 
nerve cells, leading to a disruption of normal neurological processes 
and causing neurotoxic shellfish poisoning. The potent neurotoxic and 
hemolytic properties of these neurotoxins can be fatal to fish, aquatic 
mammals, birds, and humans (although no fatalities have yet to be 
reported for humans \2\).
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    \1\ Shen, H.H., et al. ``Profiling of Brevetoxin Metabolites 
Produced by Karenia Brevis 165 Based on Liquid Chromatography-Mass 
Spectrometry.'' Toxins 13.5 (2021).
    \2\ Per the NIH National Library of Medicine, National Center 
for Biotechnology Information.
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    Gonyautoxins are part of the group of saxitoxins (currently 
controlled under ECCN 1C351.d.12) that are naturally produced in 
several marine dinoflagellates species.\3\ Certain forms are included 
under Schedule 1 of the Chemical Weapons Convention (CWC) Annex on 
Chemicals. Gonyautoxins can bind to the [alpha]-subunit of the voltage 
dependent sodium channels in the postsynaptic membrane, blocking 
synaptic function (the transmission of nerve impulses between neurons 
or between neurons and muscle cells) and causing paralytic shellfish 
poisoning. Paralytic shellfish poisoning includes symptoms such as 
nausea, vomiting, dizziness, limb weakness, paralysis, or respiratory 
failure and can result in death.\4\
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    \3\ Visciano, P., et al. ``Marine Biotoxins: Occurrence, 
Toxicity, Regulatory Limits and Reference Methods.'' Frontiers in 
Microbiology 7 (2016).
    \4\ Clark, RF; Williams, SR; Nordt, SP; Manoguerra, AS (1999). 
``A review of selected seafood poisonings.'' Undersea & Hyperbaric 
Medicine. 26 (3): 175-84.
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    Nodularins are potent toxins that may cause irreversible liver 
damage.\5\ Naturally produced in cyanobacteria, nodularin shares 
significant structural homology and, presumably, function with 
microcystins \6\ (currently controlled under ECCN 1C351.d.9). 
Microcystins have been studied extensively, and due to the homology 
with nodularin, these data are often extended to nodularins.
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    \5\ Dawson, R.M. ``The Toxicology of Microcystins.'' Toxicon. 36 
(7): 953-962. (1998) doi:10.1016/S0041-0101(97)00102-5.
    \6\ Gehringer, M., et al. Nodularin, a cyanobacterial toxin, is 
synthesized in planta by symbiotic Nostoc sp.. ISME J 6, 1834-1847 
(2012). https://doi.org/10.1038/ismej.2012.25.
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    Palytoxins are naturally produced in certain corals and 
dinoflagellates. These toxins are among the most toxic non-protein 
compounds and are of particular concern due to their thermostability 
and effective inhalation exposure route.\7\ Palytoxins target the 
sodium-potassium pump protein, which may lead to vasoconstriction (the 
constriction of blood vessels through tightening of the small muscles 
in their walls). The most frequently reported routes of exposure/entry 
are through inhalation, ingestion, or via the cutaneous route (i.e., 
direct contact with the skin or eyes). The symptoms of palytoxin 
poisoning, which may vary according to the route of exposure, include 
nausea, vomiting, diarrhea, lethargy, numbness, muscle spasms, slow 
heart rate, respiratory distress or kidney failure and can result in 
death. In lethal cases, death is generally caused by cardiac arrest.
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    \7\ Ramos V, et al. ``Palytoxin and analogs: biological and 
ecological effects.'' Marine Drugs. 8 (7): 2021-37. (2010) 
doi:10.3390/md8072021.
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    This rule proposes to add these marine toxins, in alphabetical 
order, to ECCN 1C351.d and to amend the introductory text of 1C351.d by 
removing the reference to the AG control list (thereby reflecting the 
fact that these marine toxins would be subject to unilateral controls, 
absent the adoption of comparable controls by the AG). This rule also 
proposes to make conforming changes elsewhere in ECCN 1C351 to update 
references to certain toxins (i.e., in the CW Reason for Control 
paragraph, License Requirements Notes 1 and 2, the License Exception 
STA eligibility paragraph and the Related Controls paragraph). The 
proposed conforming amendments to the Chemical Weapons Convention (CWC) 
and License Exception Strategic Trade Authorization (STA) provisions in 
the EAR are described below.
Proposed Expansion of ECCN 1E001 Controls
    Although this rule does not propose to amend ECCN 1E001 (which 
controls, inter alia, ``technology'' for the ``development'' or 
``production'' of the human and animal pathogens and ``toxins'' 
described in ECCN 1C351), the heading of ECCN 1E001 indicates that, 
with limited exceptions, ECCN 1E001 controls ``technology for the 
``development'' or ``production'' of items listed under Category 1C of 
the CCL. Consequently, if the changes proposed in this rule were to go 
into effect, ECCN 1E001 would control ``technology'' for the 
``development'' or ``production'' of the four marine toxins that would 
be added to ECCN 1C351. This expansion in the scope of ECCN 1E001 would 
be unilateral in nature, absent the adoption of comparable controls by 
the AG.
Other Conforming Amendments To Reflect the Proposed Reordering of 
Toxins in ECCN 1C351.d
    This rule proposes to amend Sec.  740.20--License Exception 
Strategic Trade Authorization (STA) to make conforming changes to the 
ECCN 1C351.d references in paragraph (b)(2)(v) and paragraph 
(b)(2)(vi). Specifically, Sec.  740.20(b)(2)(v) would be amended to 
reference the exclusion of ECCN 1C351.d.15 and d.16 items from License 
Exception STA eligibility, consistent with the proposed renumbering of 
ricin and saxitoxin (which are currently controlled under ECCN 
1C351.d.11 and d.12, respectively). Similarly, Sec.  740.20(b)(2)(vi) 
would be amended, consistent with the proposed renumbering of the 
toxins in ECCN 1C351.d, by revising the references to

[[Page 31198]]

the ECCN 1C351.d toxins that are authorized (with certain limitations) 
under License Exception STA to destinations indicated in Country Group 
A:5 (see Supplement No. 1 to part 740 of the EAR).
    This rule also proposes to make conforming changes to Sec.  
742.18--Chemical Weapons Convention (CWC) and ECCN 1C991 (Vaccines, 
immunotoxins, medical products, diagnostic and food testing kits) to 
reflect the proposed renumbering of the toxins in ECCN 1C351.d. 
Specifically, Sec.  742.18(a)(1), (b)(1)(i), and (b)(1)(ii) and (iii) 
would be amended to reference ECCN 1C351.d.15 and d.16, consistent with 
the proposed renumbering of ricin and saxitoxin described above. ECCN 
1C991.c through 1C991.e would be amended to make conforming changes to 
the references therein to ECCN 1C351 that would be affected by the 
proposed renumbering of the toxins in ECCN 1C351.d.
    None of the proposed conforming amendments described above would 
change the scope of the controls in the affected EAR provisions.

Request for Comments

    BIS is publishing this proposed rule to obtain public comments on 
the proposed application of CB controls to the four marine toxins that 
are proposed for addition to ECCN 1C351 and to ``technology'' for the 
``development'' or ``production'' of such toxins that would satisfy the 
control parameters described in ECCN 1E001. Consistent with Section 
1758(a)(2)(C) of ECRA (50 U.S.C. 4817(a)(2)(C)), this proposed rule 
provides the public with notice and the opportunity to comment on 
controlling this technology as described herein. Specifically, BIS 
welcomes any comments on this proposed rule relevant to the following:
    (1) Whether the proposed controls are clear and adequately identify 
``emerging and foundational technologies'' within the context of 
biological weapons-related capabilities and developments (to the extent 
that this is not the case, comments should include specific control 
text that would be more appropriate to these ends);
    (2) The current capability for the ``development'' or 
``production'' of such toxins in the United States and other countries, 
including the extent to which the proposed controls would affect 
current production or sales of such toxins, either within or outside 
the United States (e.g., whether the proposed controls would 
inadvertently control any toxins that are suitable almost exclusively 
for legitimate commercial or scientific applications);
    (3) The effect that implementation of the proposed controls would 
have on the future ``development'' or ``production'' of such toxins and 
related ``technology'' in the United States; and
    (4) The effectiveness of the proposed controls in terms of limiting 
the proliferation of such toxins and related ``technology'' abroad.
    BIS also welcomes comments concerning whether these controls should 
be implemented multilaterally (rather than unilaterally), in the 
interest of increasing their effectiveness and minimizing their impact 
on U.S. industry. Several respondents who commented on BIS's November 
19 ANPRM indicated their preference for multilateral export controls 
over unilateral export controls, because the former typically place 
U.S. industry on a more level playing field versus producers/suppliers 
in other countries. In this regard, note that Section 1758(c) of ECRA 
(50 U.S.C. 4817(c)) provides that ``the Secretary of State, in 
consultation with the Secretary [of Commerce] and the Secretary of 
Defense, and the heads of other Federal agencies, as appropriate, shall 
propose that any technology identified pursuant to subsection (a) [of 
ECRA] [which addresses the interagency process for identifying emerging 
technologies] be added to the list of technologies controlled by the 
relevant multilateral export control regimes.''
    Public comments submitted to BIS in response to this proposed rule 
will help BIS and other U.S. Government agencies to apply the criteria 
set forth in Section 1758 of ECRA and identify and assess the 
appropriate level of controls that should apply to the four marine 
toxins proposed for control under ECCN 1C351 and ``technology'' for the 
``development'' or ``production'' of such toxins, as proposed for 
control under ECCN 1E001.
    Comments should address specific aspects of the proposed addition 
of these toxins to ECCN 1C351 on the CCL in relation to the criteria 
described above (e.g., identify the specific aspects in which the 
proposed controls would satisfy these criteria or fail to do so). 
Comments should be submitted to BIS as described in the ADDRESSES 
section of this proposed rule and must be received by BIS no later than 
June 22, 2022.

Export Control Reform Act of 2018

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

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including: Potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits and of reducing costs, harmonizing rules, and promoting 
flexibility. This proposed rule has been designated a ``significant 
regulatory action,'' although not economically significant, under 
section 3(f) of Executive Order 12866. Accordingly, this proposed rule 
has been reviewed by the Office of Management and Budget (OMB).
    2. Notwithstanding any other provision of law, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with, a collection of information subject to the 
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.) (PRA), unless that collection of information displays a currently 
valid Office of Management and Budget (OMB) Control Number. This 
proposed rule contains the following collections of information subject 
to the requirements of the PRA:
     OMB control number 0694-0088 (Simplified Network 
Application Processing System)--this collection includes license 
applications and carries a burden estimate of 29.6 minutes per manual 
or electronic submission;
     OMB Control Number 0694-0096 (Five Year Records Retention 
Period)--this collection includes recordkeeping requirements and 
carries a burden estimate of less than 1 minute per response;
     OMB Control Number 0607-0152 (Automated Export System 
(AES) Program)--this collection carries a burden hour estimate of 3 
minutes per electronic submission and contains the Electronic Export 
Information (EEI) filing requirements under the Automated Export System 
(AES).
    Although this proposed rule would make important changes to the EAR 
for items controlled for CB reasons, BIS believes that these increases 
would not greatly exceed existing estimates. BIS does believe the 
number of applications will increase by 15 because, although there are 
few (if any) commercial applications for these marine toxins, a small 
number of these toxins may be exported for use in research and

[[Page 31199]]

development activities. BIS requests comments concerning the 
anticipated increase in burden hours and costs as a result of the 
changes proposed by this rule. Comments on the methodology associated 
with calculating the cost or burden increases, or any other aspect of 
this collection, may be submitted via www.regulations.gov by searching 
for OMB Control Number 0694-0088.
    BIS expects the burden hours associated with OMB control numbers 
0694-0088 and 0694-0096 to increase by 7 hours and 39 minutes (i.e., 15 
applications x 30.6 minutes per response) for a total estimated cost 
increase of $230 (i.e., 7 hours and 39 minutes x $30 per hour). The $30 
per hour cost estimate for OMB control number 0694-0088 is consistent 
with the salary data for export compliance specialists currently 
available through glassdoor.com (glassdoor.com estimates that an export 
compliance specialist makes $55,280 annually, which computes to roughly 
$26.58 per hour). Note that any increase in the burden hours associated 
with OMB control number 0607-0152 would not necessarily be in direct 
correlation with any increase in the aforementioned OMB information 
collections, because there could be multiple shipments (and, hence, 
multiple EEI filings) associated with an individual export license.
    3. This proposed rule does not contain policies with federalism 
implications as that term is defined in Executive Order 13132.
    4. Pursuant to Section 1762 of the Export Control Reform Act of 
2018 (ECRA) (50 U.S.C. 4821), this action is exempt from the 
Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for 
notice of proposed rulemaking, opportunity for public participation and 
delay in effective date. Notwithstanding, BIS believes this proposed 
rule would benefit from public comment prior to issuance. Consistent 
with the Regulatory Flexibility Act, as amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et 
seq.), BIS has prepared the following initial regulatory flexibility 
analysis (IRFA) of the impact that this proposed rule, if adopted, 
would have on small businesses.

Description of the Reasons Why Action Is Being Considered

    The policy reasons for issuing this proposed rule are discussed in 
the background section of the preamble of this document and, 
consequently, are not repeated here.

Statement of the Objectives of, and Legal Basis for, the Proposed Rule; 
Identification of All Relevant Federal Rules Which May Duplicate, 
Overlap or Conflict With the Proposed Rule

    The objective of this proposed rule, and all other Section 1758 
technology proposed rules published by BIS, is to control emerging and 
foundational technologies identified by BIS and its interagency 
partners as being essential to U.S. national security. The legal basis 
for this proposed rule is as follows: 50 U.S.C. 4801-4852.
    No other Federal rules duplicate, overlap, or conflict with this 
proposed rule.

Number and Description of Small Entities Regulated by the Proposed 
Action

    This proposed rule would apply to all persons engaged in the 
export, reexport or transfer (in-country) of the marine toxins proposed 
for control under ECCN 1C351 and the related ``technology'' subject to 
the EAR. Presently, these toxins and related ``technology'' are used in 
research and development activities in the biotechnology field (e.g., 
U.S. university and military laboratories). Therefore, BIS anticipates 
that the proposed controls would result in `deemed' export license 
applications (for the release of ``technology'' to foreign nationals 
located within the United States) to allow access to this 
``technology'' by foreign students and faculty at U.S. universities, as 
well as by non-U.S. employees of U.S. biochemical firms. There would 
most likely also be `deemed' reexport license applications for the 
release of this ``technology'' to third-country foreign nationals 
located in foreign countries who are engaged in research and 
development activities involving this ``technology.''
    BIS does not collect or maintain the data necessary to determine 
how many of the affected persons are small entities as that term is 
used by the Small Business Administration. Prior to issuing this 
proposed rule, BIS received 36 comments on biotechnology in response to 
its November 19 ANPRM. None of these commenters specifically identified 
themselves as small businesses, although small businesses may have 
chosen to provide input through larger entities, such as trade 
associations.
    However, BIS was able to estimate the number of license 
applications that the agency anticipates receiving as a result of this 
proposed rule and is using that estimate as a means of assessing the 
impact on small businesses. Using the North American Industry 
Classification System Codes (NAICS) 541714 (Research and Technology in 
Biotechnology (except Nanobiotechnology)), BIS determined that the 
standard small business size in this industry is 1,000 employees. Using 
Table 1a of the Census Bureau's 2019 Exports by Company Type and 
Employment Size and extrapolating to 1,000 employees, BIS then 
estimated that approximately 40% of all identified companies that 
export in this industry are small businesses. BIS also estimates that 
it will receive 15 license applications per year for the items 
described in this proposed rule (see the PRA estimates described in 
Rulemaking Requirements #2, above). Based on that information, BIS 
estimates that the agency will receive approximately 6 license 
applications per year from small businesses, or roughly 40% of the 15 
estimated license applications.
    In addition, based on the burden estimate for OMB under control 
numbers 0694-0088 (Simplified Network Application Processing System) 
and 0694-0096 (Five Year Records Retention Period), BIS expects that 
the total burden hours for small businesses associated with these EAR-
related collections would increase only slightly, by just under 3 hours 
and 4 minutes (i.e., 6 applications x 30.6 minutes per response), for a 
total estimated cost increase of just under $92 (i.e., 3 hours and 4 
minutes x $30 per hour).
    The amendments proposed in this rule, if implemented, also would 
trigger a small information collection burden under the U.S. Census 
Bureau's Foreign Trade Regulations (FTR) (15 CFR part 30), which 
contain the Electronic Export Information (EEI) filing requirements 
under the Automated Export System (AES). This FTR-related information 
collection has been approved by OMB under control number 0607-0152 
(Automated Export System (AES) Program) and carries a burden hour 
estimate of 3 minutes per electronic submission. This collection, 
together with the aforementioned EAR-related information collections, 
would result in a total estimated cost increase to small businesses of 
just under $94 (i.e., 3 hours and 7 minutes x $30 per hour). Note that, 
for purposes of consistency, the $30 per hour cost estimate used for 
the EAR-related information collections described above is also applied 
to this FTR-related information collection (which also would involve 
work performed by export compliance specialists).
    Based on the analysis provided above, the amendments proposed in 
this rule would not impose a significant

[[Page 31200]]

economic impact on a substantial number of small businesses.

Description of the Projected Reporting, Recordkeeping, and Other 
Compliance Requirements of the Proposed Rule

    The changes proposed in this rule, if adopted, would mean that 
certain items currently eligible for export, reexport or transfer (in-
country) to most destinations under the No License Required (NLR) 
designation would require an EAR authorization (i.e., in accordance 
with the terms and conditions of an EAR license exception or a license 
issued by BIS). Adding these items to the CCL, to be controlled under 
ECCN 1C351, may also change the export clearance requirements under the 
FTR for certain exports of these items by triggering an EEI filing 
requirement in AES (note that the requirement generally does not apply 
to items below a certain value that are classified as EAR99, i.e., 
subject to the EAR, but not listed under an ECCN on the CCL).
    To the extent that compliance with the changes proposed in this 
rule would impose a burden on persons, including small businesses, BIS 
believes the burden would be minimal. The reclassification process 
would need to be done only once per license applicant for exports, 
reexports or transfers (in-country) of these emerging technology items 
and, consequently, would constitute a one-time burden for each 
applicant. Similarly, assessing the availability of license exceptions 
and/or applying for and using BIS licenses would impose some minimal 
burden on persons, including small businesses.
    However, it should be noted that these EAR requirements would 
likely have less impact than might otherwise be the case, because of 
the resources that BIS makes available to all exporters, including 
small businesses. Specifically, BIS's website has free on-line training 
explaining export basics, including instructions on how to register for 
and use BIS's online license application tool, and tips on how to 
complete a license application for chemical and biological items. BIS 
also provides free export counseling by telephone and email via both 
its Washington, DC and Western Regional offices. In addition, BIS 
accepts requests for commodity classifications and processes them 
without charge to assist those exporters who need assistance in 
classifying their items for the purpose of determining whether any CCL-
based license requirements would apply.

Significant Alternatives and Underlying Analysis

    As noted above, BIS does not believe that the amendments proposed 
in this rule, if published in a final rule, would have a significant 
economic impact on small businesses. Nevertheless, consistent with 5 
U.S.C. 603(c), BIS considered significant alternatives to these 
proposed amendments to assess whether the alternatives would: (1) 
Accomplish the stated objectives of this proposed rule (consistent with 
the emerging technology requirements in ECRA); and (2) minimize any 
significant economic impact of this proposed rule on small entities. 
BIS could have proposed a much broader control on marine toxins 
controlled under ECCN 1C351 that would have captured a greater number 
of such toxins. However, that option would have had a greater impact 
not only on small businesses, but also on research and development 
laboratories (both academic and corporate), which are involved in 
advancing biological technology. BIS has determined that proposing 
focused controls on those marine toxins capable of posing a greater 
risk to human/animal health and the environment (i.e., the four toxins 
proposed for control under ECCN 1C351 and corresponding ``development'' 
and production ``technology'' in ECCN 1E001) is the least disruptive 
alternative for implementing export controls in a manner consistent 
with controlling technology that has been determined, through the 
Section 1758 technology interagency process authorized under ECRA, to 
be essential to U.S. national security.
    BIS is not proposing different compliance or reporting requirements 
for small businesses. If a small business is subject to a compliance 
requirement for the export, reexport or transfer (in-country) of this 
``software'' and related ``technology,'' then it would submit a license 
application using the same process as any other company (i.e., 
electronically via SNAP-R). The license application process is free of 
charge to all entities, including small businesses. In addition, as 
noted above, the resources and other compliance tools made available by 
BIS typically serve to lessen the impact of any EAR license 
requirements on small businesses.
    Lastly, consistent with 5 U.S.C. 603(c), BIS assessed the use of 
performance standards rather than design standards and also considered 
whether an exemption for small businesses was practical under the 
circumstances (i.e., within the context of the changes proposed in this 
rule).
    BIS determined that the use of design standards was the most 
appropriate approach for regulating exports/reexports of these toxins. 
Although the marine toxins that warrant control under this proposed 
rule are naturally occurring, dual-use biological toxins, they can now 
be more easily isolated and purified due to novel synthesis methods and 
equipment. For this reason, the absence of export controls on such 
toxins could be exploited for biological weapons purposes. However, 
because these toxins and related ``technology'' are dual-use items, 
they also have legitimate commercial and scientific applications. 
Consequently, controlling these toxins and the related ``technology'' 
based on design standards is the most appropriate way to impose export 
controls in a manner that would enhance U.S. national security, but 
also consider the legitimate commercial and scientific applications for 
these toxins.
    This proposed rule does not contain an exemption for small 
businesses from this license requirement because BIS and its 
interagency partners are assessing whether these controls are essential 
to U.S. national security. Specifically, these toxins and related 
``technology'' could be used for biological weapons purposes and, as 
such, controlling these items on the CCL may be determined to be 
essential to U.S. national security pursuant to the interagency process 
for identifying emerging and foundational technologies that is 
described in Section 1758(a) of ECRA (50 U.S.C. 4817(a)). An exemption 
for small businesses would undermine the effectiveness of these 
proposed controls.

Conclusion

    BIS has identified the synthesis and collection of the marine 
toxins and the related ``technology'' addressed in this proposed rule 
as a technology suitable for evaluation under Section 1758 of ECRA that 
warrants public notice and comment. Consequently, consistent with the 
Regulatory Flexibility Act, BIS has prepared this IRFA addressing the 
impact that this proposed rule, if adopted, would have on small 
entities. BIS's assessment indicates that the amendments proposed in 
this rule would not have a significant economic impact on a substantial 
number of small entities.
    Please submit any comments concerning this IRFA in accordance with 
the instructions provided in the ADDRESSES section of this proposed 
rule.

[[Page 31201]]

List of Subjects

15 CFR Part 740

    Administrative practice and procedure, Exports, Reporting and 
recordkeeping requirements, Terrorism.

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements, Terrorism.

    For the reasons stated in the preamble, parts 740, 742 and 774 of 
the Export Administration Regulations (15 CFR parts 730-774) are 
proposed to be amended as follows:

PART 740--LICENSE EXCEPTIONS

0
1. The authority citation for part 740 continues to read as follows:

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR 
58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 
2001 Comp., p. 783.

0
2. Section 740.20 is amended by revising paragraph (b)(2)(v) and 
paragraph (b)(2)(vi) introductory text to read as follows:

Sec.  740.20   License Exception Strategic Trade Authorization (STA).

* * * * *
    (b) * * *
    (2) * * *
    (v) License Exception STA may not be used for any item controlled 
by ECCN 1C351.a, .b, .c, .d.15, .d.16 or .e, ECCNs 1C353, 1C354, 1E001 
(i.e., for technology, as specified in ECCN 1E001, for items controlled 
by ECCN 1C351.a, .b, .c, .d.15, .d.16 or .e or ECCNs 1C353 or 1C354) or 
ECCN 1E351.
    (vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.14 and 
1C351.d.17 through 1C351.d.22 are authorized under License Exception 
STA to destinations indicated in Country Group A:5 (See supplement no. 
1 to part 740), subject to the following limits. For purposes of this 
paragraph (b)(2)(vi), all such toxins that are sent from one exporter, 
reexporter or transferor to a single end-user, on the same day, 
constitute one shipment.
* * * * *

PART 742--CONTROL POLICY--CCL BASED CONTROLS

0
3. The authority citation for part 742 continues to read as follows:

    Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50 
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 
U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 
59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 
783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 
Comp., p. 320; Notice of November 10, 2021, 86 FR 62891 (November 
12, 2021).

0
4. Section 742.18 is amended by revising paragraph (a)(1), paragraph 
(b)(1)(i) introductory text, and paragraphs (b)(1)(ii) and (iii) to 
read as follows:

Sec.  742.18   Chemical Weapons Convention (CWC or Convention).

* * * * *
    (a) * * *
    (1) Schedule 1 chemicals and mixtures controlled under ECCN 1C351. 
A license is required for CW reasons to export or reexport Schedule 1 
chemicals controlled under ECCN 1C351.d.15 or .d.16 to all destinations 
including Canada. CW applies to 1C351.d.15 for ricin in the form of 
Ricinus Communis AgglutininII (RCAII), which is also known 
as ricin D or Ricinus Communis LectinIII (RCLIII), and 
Ricinus Communis LectinIV (RCLIV), which is also known as 
ricin E. CW applies to 1C351.d.16 for saxitoxin identified by C.A.S. 
#35523-89-8. (Note that the advance notification procedures and annual 
reporting requirements described in Sec.  745.1 of the EAR also apply 
to exports of Schedule 1 chemicals.)
* * * * *
    (b) * * *
    (1) * * *
    (i) Exports to States Parties to the CWC. Applications to export 
Schedule 1 Chemicals controlled under ECCN 1C351.d.15 or .d.16 to 
States Parties to the CWC (destinations listed in supplement no. 2 to 
part 745 of the EAR) generally will be denied, unless all of the 
following conditions are met:
* * * * *
    (ii) Exports to States not party to the CWC. Applications to export 
Schedule 1 chemicals controlled under ECCN 1C351.d.15 or .d.16 to 
States not Party to the CWC (destinations not listed in supplement no. 
2 to part 745 of the EAR) generally will be denied, consistent with 
U.S. obligations under the CWC to prohibit exports of these chemicals 
to States not Party to the CWC.
    (iii) Reexports. Applications to reexport Schedule 1 chemicals 
controlled under ECCN 1C351.d.15 or .d.16 generally will be denied to 
all destinations (including both States Parties to the CWC and States 
not Party to the CWC).
* * * * *

PART 774--THE COMMERCE CONTROL LIST

0
5. The authority citation for part 774 continues to read as follows:

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

0
6. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1, revise ECCNs 1C351 and 1C991 to read as follows:

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

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

    Reason for Control: CB, CW, AT

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

    CW applies to 1C351.d.15 and .d.16 and a license is required for 
CW reasons for all destinations, including Canada, as follows: CW 
applies to 1C351.d.15 for ricin in the form of (1) Ricinus communis 
AgglutininII (RCAII), also known as ricin D or Ricinus 
Communis LectinIII (RCLIII) and (2) Ricinus communis 
LectinIV (RCLIV), also known as ricin E. CW applies to 
1C351.d.16 for saxitoxin identified by C.A.S. #35523-89-8. See 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. No.
                Control(s)                         1 to part 738)
 
AT applies to entire entry................  AT Column 1.
 

    License Requirement Notes: 1. All vaccines and `immunotoxins' 
are excluded from the scope of this entry. Certain medical products 
and diagnostic and food testing kits that contain biological toxins 
controlled under 1C351.d, with the exception of toxins controlled 
for CW reasons under 1C351.d.15 or .d.16, are excluded from the 
scope of this entry. Vaccines, `immunotoxins,' certain medical 
products, and diagnostic and food testing kits excluded from the 
scope of this entry are controlled under ECCN 1C991.

[[Page 31202]]

    2. For the purposes of this entry, only saxitoxin is controlled 
under 1C351.d.16; other members of the paralytic shellfish poison 
family (e.g., neosaxitoxin) are designated EAR99.
    3. Clostridium perfringens strains, other than the epsilon 
toxin-producing strains of Clostridium perfringens described in 
1C351.c.12, are excluded from the scope of this entry, since they 
may be used as positive control cultures for food testing and 
quality control.
    4. Unless specified elsewhere in this ECCN 1C351 (e.g., in 
License Requirement Notes 1-3), this ECCN controls all biological 
agents and ``toxins,'' regardless of quantity or attenuation, that 
are identified in the List of Items Controlled for this ECCN, 
including small quantities or attenuated strains of select 
biological agents or ``toxins'' that are excluded from the lists of 
select biological agents or ``toxins'' by the Animal and Plant 
Health Inspection Service (APHIS), U.S. Department of Agriculture 
(USDA), or the Centers for Disease Control and Prevention (CDC), 
U.S. Department of Health and Human Services (HHS), in accordance 
with their regulations in 9 CFR part 121 and 42 CFR part 73, 
respectively.
    5. Biological agents and pathogens are controlled under this 
ECCN 1C351 when they are an isolated live culture of a pathogen 
agent, or a preparation of a toxin agent that has been isolated or 
extracted from any source or material, including living material 
that has been deliberately inoculated or contaminated with the 
agent. Isolated live cultures of a pathogen agent include live 
cultures in dormant form or in dried preparations, whether the agent 
is natural, enhanced or modified.

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

LVS: N/A
GBS: N/A

Special Conditions for STA

STA: (1) Paragraph (c)(1) of License Exception STA (Sec.  
740.20(c)(1)) may be used for items in 1C351.d.1 through 1C351.d.14 
and 1C351.d.17 through 1C351.d.22. See 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.

List of Items Controlled

Related Controls: (1) Certain forms of ricin and saxitoxin in 
1C351.d.15 and .d.16 are CWC Schedule 1 chemicals (see 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. Clostridium argentinense (formerly known as Clostridium 
botulinum Type G), botulinum neurotoxin producing strains;
    c.9. Clostridium baratii, botulinum neurotoxin producing 
strains;
    c.10. Clostridium botulinum;
    c.11. Clostridium butyricum, botulinum neurotoxin producing 
strains;

[[Page 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

 
                                              Country chart  (see Supp.
                Control(s)                       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