Implementation of Certain Australia Group Decisions, 104408-104418 [2024-30425]

Agencies

• DEPARTMENT OF COMMERCE
• Bureau of Industry and Security

[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Rules and Regulations]
[Pages 104408-104418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30425]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 742 and 774

[Docket No. 241212-0324]
RIN 0694-AJ83


Implementation of Certain Australia Group Decisions

AGENCY: Bureau of Industry and Security, Department of Commerce.

ACTION: Final rule.

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SUMMARY: The Bureau of Industry and Security (BIS) is amending the 
Export Administration Regulations (EAR) to implement changes agreed to 
by Australia Group (AG) member countries at recent meetings. These 
include controlling: instruments for the automated chemical synthesis 
of peptides (automated peptide synthesizers), dipropylamine, and 
neosaxitoxin; and revising the controls for botulinum toxins, toxic gas 
monitors, and centrifugal separators. This rule also makes minor 
conforming changes for the new controls and revisions to existing 
controls.

DATES: This rule is effective December 23, 2024.

FOR FURTHER INFORMATION CONTACT: 
    For questions on pathogens and toxins discussed in this rule, 
contact Dr. Lauren Reynolds, Chemical and Biological Controls Division, 
Office of Nonproliferation and Foreign Policy Controls, Bureau of 
Industry and Security, Telephone: (202) 482-2794, Email: 
[email protected].
    For all other questions pertaining to this rule, contact Logan 
Norton, Regulatory Policy Division, Office of Exporter Services, Bureau 
of Industry and Security, U.S. Department of Commerce, (202) 482-1762, 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

The Australia Group

    BIS is amending the Export Administration Regulations (EAR) (15 CFR 
parts 730-774) to reflect the decisions made at the 2023 Intersessional 
Meeting in Rome, Italy, the 2023 Plenary Meeting in Paris, France, the 
2024 Intersessional Meeting in Berlin, Germany and the 2024 Plenary 
Meeting in Paris, France. The Australia Group (AG) is a multilateral 
forum consisting of 42 participating countries and the European Union. 
These participants 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.

Regulatory Changes

    As stated above, this rule implements changes agreed upon at the 
2023 and 2024 Intersessional and Plenary Meetings of the AG. The 
changes made at each meeting are described below in chronological 
order.

2023 Intersessional

    The AG meeting of the 2023 Intersessional determined that not all 
AG members assess gas detection systems with the same criteria. Prior 
to this rule, the control text only referred to the ability to detect 
chemical warfare agents or AG controlled precursors at a concentration 
of less than 0.3 mg/m\3\. This made it unclear if a gas detection 
system with a noise level near 0.3 mg/m\3\ was controlled, without 
taking into account the instrument detection limit. As a result, the AG 
agreed to a uniform way of applying the control language on toxic gas 
monitors and monitoring systems. To clarify the text, the AG agreed to 
the new term called `minimum detection limit' and a corresponding 
definition, both detailed below, to the control text.
    The AG agreed to two changes to ECCN 2B351. First, in item 
paragraph .a, ``at concentrations of less than'' is replaced with 
```minimum detection limit' of'', which is still followed by the 0.3 
mg/m\3\ concentration measurement. Second, it adds a technical note 
defining `minimum detection limit' as the lowest detectable 
concentration of the analyte required to produce a signal greater than 
three times the standard deviation of the toxic gas monitor's or 
monitoring system's signal when measuring a blank sample; 
alternatively, in the case of toxic gas monitors or monitoring systems 
having a deadband or programmed zero suppression, the `minimum 
detection limit' is the lowest detectable concentration required to 
produce a reading.

2023 Plenary

    In the 2023 Plenary Meeting, the AG reached consensus on three 
primary revisions, mostly impacting ECCNs 1C350.d and 1C351.d.
    ECCN 1C350.d had multiple changes. In February 2020 the AG added a 
number of precursors to the chemical weapons precursors control list. 
However, dipropylamine, which is also useful for the synthesis of the 
corresponding AG-controlled precursors, was not yet controlled. The AG 
determined that it was important to address this issue by controlling 
dipropylamine. Under ECCN 1C350, (C.A.S. #142-84-7) Dipropylamine was 
added as .d.11. The items that had been listed in item paragraphs .d.11 
through .d.49 remain, with their item paragraphs shifting up by a 
factor of one.
    Botulinum toxins can be neurotoxins or non-neurotoxins. Previously, 
the AG had not specifically stated if only botulinum neurotoxins should 
be captured by ECCN 1C351.d.3 or if all botulinum toxins are included. 
The AG agreed to update the language to ``botulinum neurotoxins'' 
noting the greater risk of their use in chemical and biological weapons 
activities relative to other botulinum toxins. Under ECCN 1C351, item 
paragraph .d.3 was revised to read as ``botulinum neurotoxins'' as 
opposed to previously reading ``botulinum toxins.'' Conforming

[[Page 104409]]

changes were made in ECCN 1C991.c.1, .c.2, .d.1, and .d.3.
    Neosaxitoxin is a potent neurotoxin causing similar symptoms to 
saxitoxin and gonyautoxins, both of which were controlled at the 2022 
Plenary Meeting, in humans and animals. The AG found that the high 
toxicity of neosaxitoxin has been demonstrated in scientific models, as 
well as its resistance to heat; these factors make this toxin a 
potential threat as it could be used as a biological weapon like 
saxitoxin. Therefore, the AG agreed to control neosaxitoxin under the 
``List of Human and Animal Pathogens and Toxins for Export Control.'' 
BIS details the toxins on this list under ECCN 1C351.d. To facilitate 
this addition, item paragraph .d.12 was redesignated to control 
neosaxitoxin (NEO), which shifted what had been in item paragraphs 
.d.12 through .d.21 up by a factor of one. Given this new control, 
license requirement note 2 to ECCN 1C351, which discussed neosaxitoxin, 
is removed, shifting notes 3 through 5 down by a factor of one. 
Additionally, multiple references to the item paragraphs for ricin and 
saxitoxin (now item paragraphs .d.15 and .d.16, respectively), had to 
be updated; these conforming changes occurred in: Sec.  742.2(a)(1)(i), 
(a)(2)(ii), and (a)(2)(vi)(B); Sec.  742.18(a)(1), (b)(1)(i), 
(b)(1)(ii), and (b)(1)(iii); ECCNs 1C351, 1C353, 1C991, 1E001, and 
1E351.

2024 Intersessional

    Prior to the publication of this rule, centrifugal separators were 
already controlled under ECCN 2B352.c. Since these controls were put 
into place, the technology and characteristics of newly available 
single-use centrifugal separators shows a potential for abuse 
comparable to that of the listed centrifugal separators. Single-use 
centrifugal separators are new to market and are increasingly used in 
the biopharmaceutical industry. Single-use centrifugal separators are 
mainly designed for the separation of protein expressing cell cultures. 
Available single-use centrifugal separators create new ways of 
processing cell culture-based fermentations with a yield of 98% or 
more. Most single-use centrifugal separators systems are flexible in 
usage and simple for scaling. Therefore, the AG felt it necessary to 
revise the control text for these items, accounting for single-use 
centrifugal separators.
    To best facilitate these revisions, structural changes were made to 
the existing ECCN 2B352.c. Prior to this rule, item paragraph .c 
comprised of c.1 through c.4, controlling multiple-use centrifugal 
separators. These parameters are now combined into a single .c.1, with 
new item paragraphs .c.1.a through .c; one parameter, what was .c.2 (a 
flow rate greater than 100 liters per hour), has been shifted up into 
the introductory text of .c, such that it applies to both single-use 
and multiple-use centrifugal separators. Now, item paragraph .c.2 will 
detail control text for single-use centrifugal separators, in which all 
components that come in direct contact with the substances being 
processed are disposable or single-use. As a conforming change, the 
technical note to item paragraph .c is revised to include single-use 
centrifugal separators.

2024 Plenary

    At the 2024 Plenary Meeting, the AG reached consensus on 
controlling instruments for automated peptide synthesizers. Recent 
advances in peptide synthesis technology and instrumentation have 
increased both the speed of peptide synthesis and the length of peptide 
products, including peptides and proteins greater than 100 amino acids 
in length.\1\ Most protein toxins that are controlled under ECCN 1C351 
are over 100 amino acids in length and have an average length of 300 
amino acids (with the notable exception of conotoxins, which range 
between 10-100 amino acids in length). Consequently, absent the 
imposition of additional controls on the export, reexport or transfer 
(in-country) of certain peptide synthesis technology and 
instrumentation (e.g., automated peptide synthesizers), there would be 
an increased risk that such technology and instrumentation could be 
used to produce controlled toxins for biological weapons purposes.
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    \1\ Sameer S. Kulkarni et al., Rapid and Efficient Protein 
Synthesis Through Expansion of the Native Chemical Ligation Concept, 
Nature Revs. Chemistry, Mar. 29, 2018, page 1.
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    Automated peptide synthesizers are controlled under new item 
paragraph .k in ECCN 2B352. Item paragraph .k, contains two 
subparagraphs, .k.1 and .k.2. Item paragraph .k controls peptide 
synthesizers that are both: partly or entirely automated (.k.1) and 
capable of generating peptides at a `system synthesis scale' of 1 mmol 
or greater (.k.2). Item paragraph .k includes a technical note, 
providing a definition of a `system synthesis scale' as follows: 
denotes the maximum amount of peptide (mmol) that can be produced by 
the instrument using the largest compatible reaction vessels (L). For 
multiple peptides produced in parallel, this is the sum of the largest 
compatible reaction vessels (L). The new controls also include a nota 
bene referring readers to ECCN 2B350 for other chemical reaction 
vessels or reactors.

RIN History

    On April 20, 2023, BIS published Section 1758 Technology Export 
Controls on Instruments for the Automated Chemical Synthesis of 
Peptides (88 FR 24341) (Peptide Synthesizers Proposed Rule), seeking 
comments on proposed additional controls of peptide synthesizers. That 
rule, published under RIN 0694-AI84, which is its U.S. Government 
regulatory identification number, proposed identifying automated 
peptide synthesizers as emerging and foundational technologies 
consistent with Section 1758 of the Export Control Reform Act of 2018 
(ECRA), 50 U.S.C. 4801-4852. Section 1758 provides that BIS identify 
emerging and foundational technologies that are essential to U.S. 
national security and are not critical technologies, as that term is 
defined in the Defense Production Act of 1950, as amended. This final 
rule finalizes those proposed changes; however, this rule includes 
additional changes outside of the scope of the Peptide Synthesizers 
Proposed Rule and includes items that are not Section 1758 
technologies. Those changes are consistent with the authorities 
described in Section 1753 of ECRA (50 U.S.C. 4812) to regulate the 
export, reexport, and transfer (in-country) of items subject to U.S. 
jurisdiction as well as the mandate to seek multilateral controls. 
Pursuant to Section 1762(a) of ECRA (50 U.S.C. 4821(a)), these changes 
can be imposed in a final rule without prior notice and comment. To 
avoid public confusion, BIS created a new RIN for this rule, RIN 0694-
AJ83, to encompass the finalized version of the proposed Section 1758 
technologies and the additional changes.

Public Comments in Response to Peptide Synthesizers Proposed Rule

    BIS published two actions, an Advanced Notice of Proposed 
Rulemaking (87 FR 55930 (Sept. 13, 2022)) and the Peptide Synthesizers 
Proposed Rule to better inform the AG process through public comments. 
BIS received five comments from the public on the 2022 advanced notice 
of proposed rulemaking, to which BIS responded in the Peptide 
Synthesizers Proposed Rule, but received no comments on the Peptide 
Synthesizers Proposed Rule itself.

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S. 
McCain National Defense Authorization Act for

[[Page 104410]]

Fiscal Year 2019, which included the Export Control Reform Act of 2018 
(ECRA), 50 U.S.C. 4801-4852. ECRA provides the legal basis for BIS's 
principal authorities and serves as the authority under which BIS 
issues this rule. In particular, and as noted elsewhere, Section 1753 
of ECRA (50 U.S.C. 4812) authorizes the regulation of exports, 
reexports, and transfers (in-country) of items subject to U.S. 
jurisdiction as well as the mandate to ``seek to secure the cooperation 
of other governments and multilateral organizations to impose control 
systems that are consistent, to the extent possible, with the controls 
imposed under'' the EAR. Further, ECRA notes that the ``national 
security and foreign policy of the United States require that the 
export, reexport, and in-country transfer of items . . . be controlled 
. . . [t]o carry out obligations and commitments under international 
agreements and arrangements, including multilateral export control 
regimes.'' 50 U.S.C. 4811(2)(E). Further, Section 1754(a)(1) through 
(16) of ECRA (50 U.S.C. 4813(a)(1) through (16)) authorizes, inter 
alia: (1) the establishment of a list of controlled items; (2) the 
prohibition of unauthorized exports, reexports, and transfers (in-
country); (3) the requirement of licenses or other authorizations for 
exports, reexports, and transfers (in-country) of controlled items; (4) 
the apprising of the public of changes in policy, regulations, and 
procedures; and (5) any other action necessary to carry out ECRA that 
is not otherwise prohibited by law. Pursuant to Section 1762(a) of ECRA 
(50 U.S.C. 4821(a)), these changes can be imposed in a final rule 
without prior notice and comment.

Rulemaking Requirements

    1. This rule has been determined to be a significant regulatory 
action for purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is 
required to respond to or 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 regulation involves 
collections previously approved by OMB under control number 0694-0088, 
Simplified Network Application Processing System, which includes, among 
other things, license applications and commodity classifications, and 
carries a burden estimate of 29.4 minutes for a manual or electronic 
submission for a total burden estimate of 35,739 hours. BIS estimates 
an increase of 40 new licenses each year, which would be an increase of 
25 burden hours. This minimal burden hour increase is within existing 
estimates for this collection. Additional information regarding these 
collections of information--including all background materials--can be 
found at https://www.reginfo.gov/public/do/PRAMain by using the search 
function to enter either the title of the collection or the OMB Control 
Number.
    3. This rule does not contain policies with federalism implications 
as that term is defined in Executive Order 13132.
    4. As stated in the preamble of this final rule, the amendments 
contained in this rule reflect decisions made by the AG. Therefore, 
pursuant to Section 1762 of 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. Because a notice of proposed 
rulemaking and an opportunity for public comment are not required to be 
given for this final rule by the APA or any other law, the analytical 
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), 
as amended by the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA) (5 U.S.C. 601 et seq.), are not applicable. However, 
specifically on the changes related to the Peptide Synthesizers 
Proposed Rule, the following applies: Consistent with the emerging and 
foundational technologies notice and comment requirements in Section 
1758(a)(2)(C) of ECRA (50 U.S.C. 4817(a)(2)(C)), BIS published Peptide 
Synthesizers Proposed Rule to provide the public with notice and the 
opportunity to comment on its proposal to amend ECCN 2B352 as detailed 
above, the synthesis and collection of which BIS had identified for 
evaluation according to the criteria in Section 1758 of ECRA pertaining 
to emerging and foundational technologies. No public comments were made 
on the proposed rule.
    Consistent with the Small Business Regulatory Enforcement Fairness 
Act of 1996 (SBREFA) (5 U.S.C. 601 et seq.), BIS has prepared the 
following final regulatory flexibility analysis (FRFA) of the impact 
that this final rule will have on small businesses. This only applies 
to the portions of the rule that finalize changes to Peptide 
Synthesizers Proposed Rule; the other changes in this rule are exempt 
under ECRA from this requirement.

Description of the Reasons Why Action Is Being Considered

    The policy reasons for issuing this final 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 Final Rule

    The objective of the Section 1758 portions of this final 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.
    Other than the discussions above about the regulatory history of 
these items, no other Federal rules duplicate, overlap, or conflict 
with this final rule.

Number and Description of Small Entities Regulated by the Final Action

    This final rule will apply to all persons engaged in the export, 
reexport or transfer (in-country) of the automated peptide synthesizers 
proposed for control under ECCN 2B352 and the related ``technology'' 
subject to the EAR. Presently, these instruments and related 
``technology'' are used in research and development activities in the 
biotechnology field (e.g., U.S. university, military and industrial 
laboratories). Therefore, BIS anticipates that the final controls will 
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 will 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. However, in the Peptide 
Synthesizers Proposed Rule, 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

[[Page 104411]]

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 
40 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 16 license applications per year 
from small businesses, or roughly 40% of the 40 estimated license 
applications.
    The amendments finalized in this rule also 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) per year. 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, this rule will not impose a 
significant economic impact on a substantial number of small 
businesses.

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

    The changes in this rule and the corresponding reporting, 
recordkeeping, and other compliance requirements are discussed in the 
background section of the preamble of this document and, consequently, 
are not repeated here. To the extent that compliance with the changes 
in this rule would impose a burden on persons, including small 
businesses, BIS believes the burden will be minimal.

Significant Alternatives and Underlying Analysis

    As noted above, BIS does not believe that this rule will have a 
significant economic impact on small businesses. Nevertheless, 
consistent with 5 U.S.C. 603(c), BIS considered significant 
alternatives as outlined in the Peptide Synthesizers Proposed Rule. 
However, those options 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 these 
technologies. BIS has determined that finalizing focused controls on 
the items detailed above 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 allowing 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 
equipment 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 finalized by 
this rule).
    This final rule does not contain an exemption for small businesses 
from this license requirement because BIS and its interagency partners 
had to assess whether these controls are essential to U.S. national 
security. Specifically, items controlled could be used for nefarious 
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 controls.

Conclusion

    The FRFA prepared by BIS requested comments on the analyses and 
conclusions contained therein, including the overall conclusion that 
the amendments in the Peptide Synthesizers Proposed Rule would not have 
a significant economic impact on a substantial number of small 
entities. BIS did not receive any comments in response to the analyses 
and conclusions contained in the IRFA for the Peptide Synthesizers 
Proposed Rule.

List of Subjects

15 CFR Part 742

    Exports and Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, parts 742, and 774 of the Export Administration 
Regulations (15 CFR parts 730-774) is amended as follows:

PART 742--CONTROL POLICY--CCL BASED CONTROLS

0
1. 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 1, 2023, 88 FR 75475 (November 3, 
2023).


0
2. Amend Sec.  742.2 by revising paragraphs (a)(1)(i), (a)(2)(ii), and 
(a)(2)(vi) to read as follows:


Sec.  742.2  Proliferation of chemical and biological weapons.

    (a) * * *
    (1) * * *
    (i) Toxins identified in ECCNs 1C351.d.15 and .16;
* * * * *
    (2) * * *
    (ii) Human pathogens, zoonoses, toxins, animal pathogens, 
genetically modified microorganisms and plant pathogens identified in 
ECCNs 1C351 (except .d.15 and .16), 1C353 (except genetic elements of 
toxins in ECCN 1C351.d.15 and .16), and 1C354; and
* * * * *

[[Page 104412]]

    (vi) Technology (ECCNs 1E001 and 1E351) for:
    (A) Production and/or disposal of chemical precursors described in 
ECCN 1C350; and
    (B) Production and/or disposal of microbiological commodities 
described in paragraph (a)(2)(ii) of this section (except toxins and 
genetic elements of those toxins in ECCN 1C351.d.15 and .16). * * *
* * * * *

0
3. Amend Sec.  742.18 by revising paragraphs (a)(1), (b)(1)(i) 
introductory text, (b)(1)(ii), and (b)(1)(iii) to read as follows:


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

* * * * *
    (a) License requirements--(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 Australia, Canada, 
and the United Kingdom. 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
4. 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.

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

0
5. Supplement no.1 to part 774 is revised as follows:
0
a. In Category 1 revise ECCNs 1C350, 1C351, 1C353, 1C991, 1E001, and 
1E351; and
0
b. Under Category 2 revise ECCNs 2B351 and 2B352.
    The revisions read as follows:

Category 1--Materials, Chemicals, Microorganisms and Toxins

C. ``MATERIALS''

* * * * *
1C350 Chemicals that may be used as precursors for toxic chemical 
agents (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 2.
 

    CW applies to 1C350.b and .c. The Commerce Country Chart is not 
designed to determine licensing requirements for items controlled 
for CW reasons. A license is required, for CW reasons, to export or 
reexport Schedule 2 chemicals and mixtures identified in 1C350.b to 
States not Party to the CWC (destinations not listed in Supplement 
No. 2 to part 745 of the EAR). A license is required, for CW 
reasons, to export Schedule 3 chemicals and mixtures identified in 
1C350.c to States not Party to the CWC, unless an End-Use 
Certificate issued by the government of the importing country has 
been obtained by the exporter prior to export. A license is 
required, for CW reasons, to reexport Schedule 3 chemicals and 
mixtures identified in 1C350.c from a State not Party to the CWC to 
any other State not Party to the CWC. (See Sec.  742.18 of the EAR 
for license requirements and policies for toxic and precursor 
chemicals controlled for CW reasons. See Sec.  745.2 of the EAR for 
End-Use Certificate requirements that apply to exports of Schedule 3 
chemicals to countries not listed in Supplement No. 2 to part 745 of 
the EAR.)
    AT applies to entire entry. The Commerce Country Chart is not 
designed to determine licensing requirements for items controlled 
for AT reasons in 1C350. A license is required, for AT reasons, to 
export or reexport items controlled by 1C350 to a country in Country 
Group E:1 of Supplement No. 1 to part 740 of the EAR. (See part 742 
of the EAR for additional information on the AT controls that apply 
to Iran, North Korea, and Syria. See part 746 of the EAR for 
additional information on sanctions that apply to Iran, North Korea, 
and Syria.)

License Requirement Notes

    1. SAMPLE SHIPMENTS: Subject to the following requirements and 
restrictions, a license is not required for sample shipments when 
the cumulative total of these shipments does not exceed a 55-gallon 
container or 200 kg of a single chemical to any one consignee during 
a calendar year. A consignee that receives a sample shipment under 
this exclusion may not resell, transfer, or reexport the sample 
shipment, but may use the sample shipment for any other legal 
purpose unrelated to chemical weapons.
    a. Chemicals Not Eligible
    A. [Reserved]
    B. CWC Schedule 2 chemicals (States not Party to the CWC). No 
CWC Schedule 2 chemical or mixture identified in 1C350.b is eligible 
for sample shipment to States not Party to the CWC (destinations not 
listed in Supplement No. 2 to part 745 of the EAR) without a 
license.
    b. Countries Not Eligible: Countries in Country Group E:1 of 
Supplement No. 1 to part 740 of the EAR are not eligible to receive 
sample shipments of any chemicals controlled by this ECCN without a 
license.
    c. Sample shipments that require an End-Use Certificate for CW 
reasons: No CWC Schedule 3 chemical or mixture identified in 1C350.c 
is eligible for sample shipment to States not Party to the CWC 
(destinations not listed in Supplement No. 2 to part 745 of the EAR) 
without a license, unless an End-Use Certificate issued by the 
government of the importing country is obtained by the exporter 
prior to export (see Sec.  745.2 of the EAR for End-Use Certificate 
requirements).
    d. Sample shipments that require a license for reasons set forth 
elsewhere in the EAR: Sample shipments, as described in this Note 1, 
may require a license for reasons set forth elsewhere in the EAR. 
See, in particular, the end-use/end-user restrictions in part 744 of 
the EAR, and the restrictions that apply to embargoed countries in 
part 746 of the EAR.
    e. Annual report requirement. The exporter is required to submit 
an annual written report for shipments of samples made under this 
Note 1. The report must be on company letterhead stationery (titled 
``Report of Sample Shipments of Chemical Precursors'' at the top of 
the first page) and identify the chemical(s), Chemical Abstract 
Service Registry (C.A.S.) number(s), quantity(ies), the ultimate 
consignee's name and address, and the date of export for all sample 
shipments that were made during the previous calendar year. The 
report must be submitted no later than February 28 of the year 
following the calendar year in which the sample shipments were made, 
to: U.S. Department of

[[Page 104413]]

Commerce, Bureau of Industry and Security, 14th Street and 
Pennsylvania Ave. NW, Room 2099B, Washington, DC 20230, Attn: 
``Report of Sample Shipments of Chemical Precursors.''
    2. MIXTURES:
    a. Mixtures that contain precursor chemicals identified in ECCN 
1C350, in concentrations that are below the levels indicated in 
1C350.b through .d, are controlled by ECCN 1C395 or 1C995 and are 
subject to the licensing requirements specified in those ECCNs.
    b. A license is not required under this ECCN for a mixture, when 
the controlled chemical in the mixture is a normal ingredient in 
consumer goods packaged for retail sale for personal use. Such 
consumer goods are designated EAR99. However, a license may be 
required for reasons set forth elsewhere in the EAR.
    Note to Mixtures: Calculation of concentrations of AG-controlled 
chemicals:
    a. Exclusion. No chemical may be added to the mixture (solution) 
for the sole purpose of circumventing the Export Administration 
Regulations;
    b. Percent Weight Calculation. When calculating the percentage, 
by weight, of ingredients in a chemical mixture, include all 
ingredients of the mixture, including those that act as solvents.
    3. COMPOUNDS. Compounds created with any chemicals identified in 
this ECCN 1C350 may be shipped NLR (No License Required), without 
obtaining an End-Use Certificate, unless those compounds are also 
identified in this entry or require a license for reasons set forth 
elsewhere in the EAR.
    4. TESTING KITS: Certain medical, analytical, diagnostic, and 
food testing kits containing small quantities of chemicals 
identified in this ECCN 1C350, are excluded from the scope of this 
ECCN and are controlled under ECCN 1C395 or 1C995. (Note that 
replacement reagents for such kits are controlled by this ECCN 1C350 
if the reagents contain one or more of the precursor chemicals 
identified in 1C350 in concentrations equal to or greater than the 
control levels for mixtures indicated in 1C350.)
    Technical Notes:
    1. For purposes of this entry, a ``mixture'' is defined as a 
solid, liquid or gaseous product made up of two or more ingredients 
that do not react together under normal storage conditions.
    2. The scope of this control applicable to Hydrogen Fluoride 
(see 1C350.d.14 in the List of Items Controlled) includes its 
liquid, gaseous, and aqueous phases, and hydrates.
    3. Precursor chemicals in ECCN 1C350 are listed by name, 
Chemical Abstract Service (CAS) number and CWC Schedule (where 
applicable). Precursor chemicals of the same structural formula 
(e.g., hydrates, isotopically-labeled forms or all possible 
stereoisomers) are controlled by ECCN 1C350, regardless of name or 
CAS number. CAS numbers are shown to assist in identifying whether a 
particular precursor chemical or mixture is controlled under ECCN 
1C350, irrespective of nomenclature. However, CAS numbers cannot be 
used as unique identifiers in all situations because some forms of 
the listed precursor chemical have different CAS numbers, and 
mixtures containing a precursor chemical listed in ECCN 1C350 may 
also have different CAS numbers.

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: See USML Category XIV for related chemical agent 
binary precursors and key precursors ``subject to the ITAR'' (see 22 
CFR parts 120 through 130).
Related Definitions: See Sec.  770.2(k) of the EAR for synonyms for 
the chemicals listed in this entry.
    Items:

    a. [Reserved]
    b. Australia Group-controlled precursor chemicals also 
identified as Schedule 2 chemicals under the CWC, as follows, and 
mixtures in which at least one of the following chemicals 
constitutes 30 percent or more of the weight of the mixture:
    b.1. (C.A.S. #7784-34-1) Arsenic trichloride;
    b.2. (C.A.S. #76-93-7) Benzilic acid;
    b.3. (C.A.S. #78-38-6) Diethyl ethylphosphonate;
    b.4. (C.A.S. #683-08-9) Diethyl methylphosphonate;
    b.5. (C.A.S. #15715-41-0) Diethyl methylphosphonite;
    b.6. (C.A.S. #2404-03-7) Diethyl-N,N-dimethylphosphoroamidate;
    b.7. (C.A.S. #41480-75-5) N,N-Diisopropylaminoethanethiol 
hydrochloride;
    b.8. (C.A.S. #5842-07-9) N,N-Diisopropyl-beta-aminoethane thiol;
    b.9. (C.A.S. #96-80-0) N,N-Diisopropyl-beta-aminoethanol;
    b.10. (C.A.S. #96-79-7), N,N-Diisopropyl-beta-aminoethyl 
chloride;
    b.11. (C.A.S. #4261-68-1) N,N-Diisopropyl-beta-aminoethyl 
chloride hydrochloride;
    b.12. (C.A.S. #6163-75-3) Dimethyl ethylphosphonate;
    b.13. (C.A.S. #756-79-6) Dimethyl methylphosphonate;
    b.14. (C.A.S. #677-43-0) N,N-dimethylamino-phosphoryl 
dichloride;
    b.15. (C.A.S. #1498-40-4) Ethyl phosphonous dichloride [Ethyl 
phosphinyl dichloride];
    b.16. (C.A.S. #430-78-4) Ethyl phosphonus difluoride [Ethyl 
phosphinyl difluoride];
    b.17. (C.A.S. #1066-50-8) Ethyl phosphonyl dichloride;
    b.18. (C.A.S. #993-13-5) Methylphosphonic acid;
    b.19. (C.A.S. #676-98-2) Methylphosphonothioic dichloride.
    b.20. (C.A.S. #464-07-3) Pinacolyl alcohol;
    b.21. (C.A.S. #1619-34-7) 3-Quinuclidinol;
    b.22. (C.A.S. #111-48-8) Thiodiglycol.
    c. Australia Group-controlled precursor chemicals also 
identified as Schedule 3 chemicals under the CWC, as follows, and 
mixtures in which at least one of the following chemicals 
constitutes 30 percent or more of the weight of the mixture:
    c.1. (C.A.S. #762-04-9) Diethyl phosphite;
    c.2. (C.A.S. #868-85-9) Dimethyl phosphite (dimethyl hydrogen 
phosphite);
    c.3. (C.A.S. #139-87-7) Ethyldiethanolamine;
    c.4. (C.A.S. #10025-87-3) Phosphorus oxychloride;
    c.5. (C.A.S. #10026-13-8) Phosphorus pentachloride;
    c.6. (C.A.S. #7719-12-2) Phosphorus trichloride;
    c.7. (C.A.S. #10545-99-0) Sulfur dichloride;
    c.8. (C.A.S. #10025-67-9) Sulfur monochloride;
    c.9. (C.A.S. #7719-09-7) Thionyl chloride;
    c.10. (C.A.S. #102-71-6) Triethanolamine;
    c.11. (C.A.S. #122-52-1) Triethyl phosphite;
    c.12. (C.A.S. #121-45-9) Trimethyl phosphite.
    d. Other Australia Group-controlled precursor chemicals not also 
identified as Schedule 1, 2, or 3 chemicals under the CWC, as 
follows, and mixtures in which at least one of the following 
chemicals constitutes 30 percent or more of the weight of the 
mixture:
    d.1. (C.A.S. #1341-49-7) Ammonium hydrogen fluoride;
    d.2. (C.A.S. #107-07-3) 2-Chloroethanol;
    d.3. (C.A.S. #109-89-7) Diethylamine;
    d.4. (C.A.S. #100-37-8) N,N-Diethylaminoethanol;
    d.5. (C.A.S. #589-57-1) Diethyl chlorophosphite;
    d.6. (C.A.S. #298-06-6) O,O-Diethyl phosphorodithioate;
    d.7. (C.A.S. #2465-65-8) O,O-Diethyl phosphorothioate;
    d.8. (C.A.S. #108-18-9) Di-isopropylamine;
    d.9. (C.A.S. #124-40-3) Dimethylamine;
    d.10. (C.A.S. #506-59-2) Dimethylamine hydrochloride;
    d.11. (C.A.S. #142-84-7) Dipropylamine
    d.12. (C.A.S. #762-77-6) Ethyl chlorofluorophosphate;
    d.13. (C.A.S. #1498-51-7) Ethyl dichlorophosphate;
    d.14. (C.A.S. #460-52-6) Ethyl difluorophosphate;
    d.15. (C.A.S. #7664-39-3) Hydrogen fluoride;
    d.16. (C.A.S. #3554-74-3) 3-Hydroxyl-1-methylpiperidine;
    d.17. (C.A.S. #76-89-1) Methyl benzilate;
    d.18. (C.A.S. #754-01-8) Methyl chlorofluorophosphate;
    d.19. (C.A.S. #677-24-7) Methyl dichlorophosphate;
    d.20. (C.A.S. #22382-13-4) Methyl difluorophosphate;
    d.21. (C.A.S. #14277-06-6) N,N Diethylacetamidine;
    d.22. (C.A.S. #53510-30-8) N,N-Diethylbutanamidine;
    d.23. (C.A.S. #90324-67-7) N,N-Diethylformamidine;
    d.24. (C.A.S. #1342789-47-2) N,N Diethylisobutanamidine;
    d.25. (C.A.S. #84764-73-8) N,N-Diethylpropanamidine;
    d.26. (C.A.S. #1315467-17-4) N,N-Diisopropylbutanamidine;
    d.27. (C.A.S. #857522-08-8) N,N-Diisopropylformamidine;
    d.28. (C.A.S. #2909-14-0) N,N-Dimethylacetamidine;

[[Page 104414]]

    d.29. (C.A.S. #1340437-35-5) N,N-Dimethylbutanamidine;
    d.30. (C.A.S. #44205-42-7) N,N-Dimethylformamidine;
    d.31. (C.A.S. #321881-25-8) N,N-Dimethylisobutanamidine;
    d.32. (C.A.S. #56776-14-8) N,N-Dimethylpropanamidine;
    d.33. (C.A.S. #1339586-99-0) N,N-Dipropylacetamidine;
    d.34. C.A.S. #1342422-35-8) N,N-Dipropylbutanamidine;
    d.35. (C.A.S. #48044-20-8) N,N-Dipropylformamidine;
    d.36. (C.A.S. #1342700-45-1) N,N-Dipropylisobutanamidine;
    d.37. (C.A.S. #1341496-89-6) N,N-Dipropylpropanamidine;
    d.38. (C.A.S. #1314-80-3) Phosphorus pentasulfide;
    d.39. (C.A.S. #75-97-8) Pinacolone;
    d.40. (C.A.S. #7789-29-9) Potassium bifluoride;
    d.41. (C.A.S. #151-50-8) Potassium cyanide;
    d.42. (C.A.S. #7789-23-3) Potassium fluoride;
    d.43. (C.A.S. #3731-38-2) 3-Quinuclidone;
    d.44. (C.A.S. #1333-83-1) Sodium bifluoride;
    d.45. (C.A.S. #143-33-9) Sodium cyanide;
    d.46. (C.A.S. #7681-49-4) Sodium fluoride;
    d.47. (C.A.S. #16893-85-9) Sodium hexafluorosilicate;
    d.48. (C.A.S. #1313-82-2) Sodium sulfide;
    d.49. (C.A.S. #637-39-8) Triethanolamine hydrochloride;
    d.50. (C.A.S. #116-17-6) Tri-isopropyl phosphite.

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 items controlled by           CB Column 1.
 1C351.d.15 and .16.
CB applies to entire entry................  CB Column 2.
 

    CW applies to 1C351.d.15 and .d.16 and a license is required for 
CW reasons for all destinations, including Australia, Canada, and 
the United Kingdom, 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.
                Control(s)                       No. 1  to part 738)
 
AT applies to entire entry................  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.
    2. 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.
    3. 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.
    4. 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

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 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 
USML Category XIV for modified biological agents and biologically 
derived substances that are ``subject to the ITAR'' (see 22 CFR 
parts 120 through 130).
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;

[[Page 104415]]

    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 neurotoxins;
    d.4. Brevetoxins;
    d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and 
iota toxins;
    d.6. Conotoxins;
    d.7. Diacetoxyscirpenol;
    d.8. Gonyautoxins;
    d.9. HT-2 toxin;
    d.10. Microcystins (Cyanginosins);
    d.11. Modeccin;
    d.12. Neosaxitoxin (NEO);
    d.13. Nodularins;
    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.
* * * * *
1C353 Genetic elements and genetically modified organisms, 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 genetic elements of items     CB Column 1.
 controlled by 1C351.d.15 and .16.
CB applies to entire entry................  CB Column 2.
AT applies to entire entry................  AT Column 1.
 

    License Requirements Notes:
    1. Vaccines that contain genetic elements or genetically 
modified organisms identified in this ECCN are controlled by ECCN 
1C991.
    2. Unless specified elsewhere in this ECCN 1C353 (e.g., in 
License Requirement Note 1), this ECCN controls genetic elements or 
genetically modified organisms for all biological agents and 
``toxins,'' regardless of quantity or attenuation, that are 
identified in the List of Items Controlled for this ECCN, including 
genetic elements or genetically modified organisms for 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, or the Centers for Disease Control and Prevention 
(CDC), U.S. Department of Health and Human Services, in accordance 
with the APHIS regulations in 7 CFR part 331 and 9 CFR part 121 and 
the CDC regulations in 42 CFR part 73.

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) 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, 
including (but not limited to) certain genetic elements, recombinant 
nucleic acids, and recombinant organisms associated with the agents 
or toxins in ECCN 1C351 or 1C354 (for APHIS, see 7 CFR 331.3(c), 9 
CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42 
CFR 73.4(c)). (2) See USML Category XIV for modified biological 
agents and biologically derived substances that are ``subject to the 
ITAR'' (see 22 CFR parts 120 through 130).
Related Definition: N/A
Items:

    a. Any genetically modified organism that contains, or any 
genetic element that codes for, any of the following:
    a.1. Any gene, genes, translated product or translated products 
specific to any virus controlled by 1C351.a or .b or 1C354.c;
    a.2. Any gene or genes specific to any bacterium controlled by 
1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.b, 
and which;
    a.2.a. In itself or through its transcribed or translated 
products represents a significant hazard to human, animal or plant 
health; or
    a.2.b. Could endow or enhance pathogenicity; or
    a.3. Any toxins, or their subunits, controlled by 1C351.d.
    b. [Reserved].
    Technical Notes:
    1. Genetically modified organisms include organisms in which the 
nucleic acid sequences have been created or altered by deliberate 
molecular manipulation.
    2. ``Genetic elements'' include, inter alia, chromosomes, 
genomes, plasmids, transposons, vectors, and inactivated organisms 
containing recoverable nucleic acid fragments, whether genetically 
modified or unmodified, or chemically synthesized in whole or in 
part. For the purposes of this

[[Page 104416]]

ECCN 1C353, nucleic acids from an inactivated organism, virus, or 
sample are considered to be `recoverable' if the inactivation and 
preparation of the material is intended or known to facilitate 
isolation, purification, amplification, detection, or identification 
of nucleic acids.
    3. This ECCN does not control nucleic acid sequences of shiga 
toxin producing Escherichia coli of serogroups O26, O45, O103, O104, 
O111, O121, O145, O157, and other shiga toxin producing serogroups, 
other than those genetic elements coding for shiga toxin, or for its 
subunits.
    4. `Endow or enhance pathogenicity' is defined as when the 
insertion or integration of the nucleic acid sequence or sequences 
is/are likely to enable or increase a recipient organism's ability 
to be used to deliberately cause disease or death. This might 
include alterations to, inter alia: virulence, transmissibility, 
stability, route of infection, host range, reproducibility, ability 
to evade or suppress host immunity, resistance to medical 
countermeasures, or detectability.
* * * * *
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 
neurotoxins controlled by ECCN 1C351.d.3, conotoxins controlled by 
ECCN 1C351.d.6, 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 neurotoxins 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 neurotoxins 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 
neurotoxins 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.15 or .d.16).
* * * * *

E. ``Technology''

1E001 ``Technology'' according to the General Technology Note for 
the ``development'' or ``production'' of items controlled by 1A002, 
1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008 1A101, 1A231, 1B (except 
1B608, 1B613 or 1B999), or 1C (except 1C355, 1C608, 1C980 to 1C984, 
1C988, 1C990, 1C991, 1C995 to 1C999).

License Requirements

Reason for Control: NS, MT, NP, CB, RS, AT

 
                                              Country chart  (see Supp.
                Control(s)                       No. 1  to part 738)
 
NS applies to ``technology'' for items      NS Column 1.
 controlled by 1A002, 1A003, 1A005,
 1A006.b, 1A007, 1B001 to 1B003, 1B018,
 1C001 to 1C011, or 1C018.
NS applies to ``technology'' for items      NS Column 2.
 controlled by 1A004.
MT applies to ``technology'' for items      MT Column 1.
 controlled by 1A101, 1B001, 1B101, 1B102,
 1B115 to 1B119, 1C001, 1C007, 1C011,
 1C101, 1C102, 1C107, 1C111, 1C116, 1C117,
 or 1C118 for MT reasons.
NP applies to ``technology'' for items      NP Column 1.
 controlled by 1A002, 1A007, 1A231, 1B001,
 1B101, 1B201, 1B225, 1B226, 1B228 to
 1B234, 1C002, 1C010, 1C111, 1C116, 1C202,
 1C210, 1C216, 1C225 to 1C237, or 1C239 to
 1C241 for NP reasons.
CB applies to ``technology'' for items      CB Column 1.
 controlled by 1C351.d.15 and .16 and the
 1C353 genetic elements of toxins in ECCN
 1C351.d.15 and .16.
CB applies to ``technology'' for items      CB Column 2.
 controlled by 1C351, 1C353, or 1C354; and
 CB applies to ``technology'' for
 materials controlled by 1C350 and for
 chemical detection systems and dedicated
 detectors therefor, in 1A004.c, that also
 have the technical characteristics
 described in 2B351.a.
RS applies to technology for equipment      RS Column 2.
 controlled in 1A004.d.
AT applies to entire entry................  AT Column 1.
 

Reporting Requirements

See Sec.  743.1 of the EAR for reporting requirements for exports 
under License Exceptions, and Validated End-User authorizations.

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

TSR: Yes, except for the following:
(1) Items controlled for MT reasons; or
(2) Exports and reexports to destinations outside of those countries 
listed in Country Group A:5 (See Supplement No. 1 to part

[[Page 104417]]

740 of the EAR) of ``technology'' for the ``development'' or 
production'' of the following:
(a) Items controlled by 1C001; or
(b) Items controlled by 1A002.a which are composite structures or 
laminates having an organic ``matrix'' and being made from materials 
listed under 1C010.c or 1C010.d.

Special Conditions for STA

STA: License Exception STA may not be used to ship or transmit 
``technology'' according to the General Technology Note for the 
``development'' or ``production'' of equipment and materials 
specified by ECCNs 1A002, 1C001, 1C007.c, 1C010.c or d or 1C012 to 
any of the destinations listed in Country Group A:6 (See Supplement 
No. 1 to part 740 of the EAR).

List of Items Controlled

Related Controls (1) Also see ECCNs 1E101, 1E201, and 1E202. (2) See 
ECCN 1E608 for ``technology'' for items classified under ECCN 1B608 
or 1C608 that, immediately prior to July 1, 2014, were classified 
under ECCN 1B018.a or 1C018.b through .m (note that ECCN 1E001 
controls ``development'' and ``production'' ``technology'' for 
chlorine trifluoride controlled by ECCN 1C111.a.3.f--see ECCN 1E101 
for controls on ``use'' ``technology'' for chlorine trifluoride). 
(3) See ECCN 1E002.g for control libraries (parametric technical 
databases) ``specially designed'' or modified to enable equipment to 
perform the functions of equipment controlled under ECCN 1A004.c 
(Nuclear, biological and chemical (NBC) detection systems) or ECCN 
1A004.d (Equipment for detecting or identifying explosives 
residues). (4) ``Technology'' for lithium isotope separation (see 
related ECCN 1B233) and ``technology'' for items described in ECCN 
1C012 are subject to the export licensing authority of the 
Department of Energy (see 10 CFR part 810). (5) ``Technology'' for 
items described in ECCN 1A102 is ``subject to the ITAR'' (see 22 CFR 
parts 120 through 130).
Related Definitions: N/A
Items:

    The list of items controlled is contained in the ECCN heading.
* * * * *
1E351 ``Technology'' according to the ``General Technology Note'' 
for the disposal of chemicals or microbiological materials 
controlled by 1C350, 1C351, 1C353, or 1C354.

License Requirements

Reason for Control: CB, AT

 
                                              Country chart  (see Supp.
                Control(s)                       No. 1  to part 738)
 
CB applies to ``technology'' for the        CB Column 1.
 disposal of items controlled by
 1C351.d.15 and .16 and the 1C353 genetic
 elements of toxins in ECCN 1C351.d.15 and
 .16.
CB applies to ``technology'' for the        CB Column 2.
 disposal of items controlled by 1C351,
 1C353, or 1C354; and CB applies to
 ``technology'' for the disposal of items
 controlled by 1C350.
AT applies to entire entry................  AT Column 1.
 

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

TSR: N/A

List of Items Controlled

Related Controls: N/A
Related Definitions: N/A
Items:

    The list of items controlled is contained in the ECCN heading.
* * * * *

Category 2--Materials Processing

B. ``Test'', ``Inspection'' and ``Production Equipment''

* * * * *
2B351 Toxic gas monitors and monitoring systems, and their dedicated 
detecting ``parts'' and ``components'' (i.e., detectors, sensor 
devices, and replaceable sensor cartridges), as follows, except 
those systems and detectors controlled by ECCN 1A004.c (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 entire entry................  CB Column 2.
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: See ECCN 2D351 for ``software'' for toxic gas 
monitors and monitoring systems, and their dedicated detecting 
``parts'' and ``components,'' controlled by this ECCN. Also see ECCN 
1A004, which controls chemical detection systems and ``specially 
designed'' ``parts'' and ``components'' therefor that are 
``specially designed'' or modified for detection or identification 
of chemical warfare agents, but not ``specially designed'' for 
military use, and ECCN 1A995, which controls certain detection 
equipment, ``parts'' and ``components'' not controlled by ECCN 1A004 
or by this ECCN.
Related Definitions: (1) For the purposes of this entry, the term 
``dedicated'' means committed entirely to a single purpose or 
device. (2) For the purposes of this entry, the term ``continuous 
operation'' describes the capability of the equipment to operate on 
line without human intervention. The intent of this entry is to 
control toxic gas monitors and monitoring systems capable of 
collection and detection of samples in environments such as chemical 
plants, rather than those used for batch-mode operation in 
laboratories.
Items:

    a. Designed for continuous operation and usable for the 
detection of chemical warfare agents or precursor chemicals 
controlled by 1C350 `minimum detection limit' of 0.3 mg/m\3\; or
    b. Designed for the detection of cholinesterase-inhibiting 
activity.
    Technical note: The `minimum detection limit` of toxic gas 
monitors or monitoring systems is the lowest detectable 
concentration of the analyte required to produce a signal greater 
than three times the standard deviation of the toxic gas monitor's 
or monitoring system's signal when measuring a blank sample.
    In the case of toxic gas monitors or monitoring systems having a 
deadband or programmed zero suppression, the `minimum detection 
limit' is the lowest detectable concentration required to produce a 
reading.

2B352 Equipment Capable of Use in Handling Biological Materials, 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 entire entry................  CB Column 2.
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: See ECCNs 1A004 and 1A995 for protective equipment 
that is not covered by this entry. Also see ECCN 9A120 for controls 
on certain ``UAV'' systems designed or modified to dispense an 
aerosol and capable of carrying elements of a payload in the form of 
a particulate or liquid, other than fuel ``parts'' or ``components'' 
of such vehicles, of a volume greater than 20 liters.
Related Definitions: (1) ``Lighter than air vehicles''--balloons and 
airships that rely on hot air or on lighter-than-air gases, such as 
helium or hydrogen, for their lift. (2) ``UAVs''--Unmanned Aerial 
Vehicles. (3) ``VMD''--Volume Median Diameter.
Items:

    a. Containment facilities and related equipment, as follows:
    a.1. Complete containment facilities at P3 or P4 containment 
level.
    Technical Note to 2B352.a.1: P3 or P4 (BL3, BL4, L3, L4) 
containment levels are as specified in the WHO Laboratory Biosafety 
Manual (3rd edition, Geneva, 2004).
    a.2. Equipment designed for fixed installation in containment 
facilities specified in paragraph a.1 of this ECCN, as follows:

[[Page 104418]]

    a.2.a. Double-door pass-through decontamination autoclaves;
    a.2.b. Breathing air suit decontamination showers;
    a.2.c. Mechanical-seal or inflatable-seal walkthrough doors.
    b. Fermenters and components as follows:
    b.1. Fermenters capable of cultivation of micro-organisms or of 
live cells for the production of viruses or toxins, without the 
propagation of aerosols, having a total internal volume of 20 liters 
or greater.
    b.2. Components designed for such fermenters, as follows:
    b.2.a. Cultivation chambers designed to be sterilized or 
disinfected in situ;
    b.2.b. Cultivation chamber holding devices; or
    b.2.c. Process control units capable of simultaneously 
monitoring and controlling two or more fermentation system 
parameters (e.g., temperature, pH, nutrients, agitation, dissolved 
oxygen, air flow, foam control).
    Technical Notes to 2B352.b:
    1. Fermenters include bioreactors (including single-use 
(disposable) bioreactors), chemostats and continuous-flow systems.
    2. Cultivation chamber holding devices controlled by 2B352.b.2.b 
include single-use cultivation chambers with rigid walls.
    c. Centrifugal separators capable of continuous separation, 
without the propagation of aerosols, having a flow rate greater than 
100 liters per hour, as follows:
    c.1. Centrifugal separators having all of the following 
characteristics:
    c.1.a. One or more sealing joints within the steam containment 
area;
    c.1.b. Components of polished stainless steel or titanium; and
    c.1.c. Capable of in-situ steam sterilization in a closed state.
    c.2. Single-use centrifugal separators, in which all components 
that come in direct contact with the substances being processed are 
disposable or single-use.
    Technical Note to 2B352.c: Centrifugal separators and single-use 
centrifugal separators include decanters.
    d. Cross (tangential) flow filtration equipment and 
``accessories'', as follows:
    d.1. Cross (tangential) flow filtration equipment capable of 
separation of microorganisms, viruses, toxins or cell cultures 
having all of the following characteristics:
    d.1.a. A total filtration area equal to or greater than 1 square 
meter (1 m\2\); and
    d.1.b. Having any of the following characteristics:
    d.1.b.1. Capable of being sterilized or disinfected in-situ; or
    d.1.b.2. Using disposable or single-use filtration ``parts'' or 
``components''.
    N.B.: 2B352.d.1 does not control reverse osmosis and 
hemodialysis equipment, as specified by the manufacturer.
    d.2. Cross (tangential) flow filtration ``parts'' or 
``components'' (e.g., modules, elements, cassettes, cartridges, 
units or plates) with filtration area equal to or greater than 0.2 
square meters (0.2 m\2\) for each ``part'' or ``component'' and 
designed for use in cross (tangential) flow filtration equipment 
controlled by 2B352.d.1.
    Technical Note: In this ECCN, ``sterilized'' denotes the 
elimination of all viable microbes from the equipment through the 
use of either physical (e.g., steam) or chemical agents. 
``Disinfected'' denotes a process to reduce the number of 
microorganisms, but not usually of bacterial spores, through the use 
of chemical agents, without necessarily killing or removing all 
organisms.
    e. Steam, gas or vapor sterilizable freeze-drying equipment with 
a condenser capacity of 10 kg of ice or greater in 24 hours (10 
liters of water or greater in 24 hours) and less than 1000 kg of ice 
in 24 hours (less than 1,000 liters of water in 24 hours).
    f. Spray-drying equipment capable of drying toxins or pathogenic 
microorganisms having all of the following characteristics:
    f.1. A water evaporation capacity of >=0.4 kg/h and <=400 kg/h;
    f.2. The ability to generate a typical mean product particle 
size of <=10 micrometers with existing fittings or by minimal 
modification of the spray-dryer with atomization nozzles enabling 
generation of the required particle size; and
    f.3. Capable of being sterilized or disinfected in situ.
    g. Protective and containment equipment, as follows:
    g.1. Protective full or half suits, or hoods dependent upon a 
tethered external air supply and operating under positive pressure.
    Technical Note to 2B352.g.1: 2B352.g.1 does not control suits 
designed to be worn with self-contained breathing apparatus.
    g.2. Biocontainment chambers, isolators, or biological safety 
cabinets having all of the following characteristics, for normal 
operation:
    g.2.a. Fully enclosed workspace where the operator is separated 
from the work by a physical barrier;
    g.2.b. Able to operate at negative pressure;
    g.2.c. Means to safely manipulate items in the workspace; and
    g.2.d. Supply and exhaust air to and from the workspace is high-
efficiency particulate air (HEPA) filtered.
    Note 1 to 2B352.g.2: 2B352.g.2 controls class III biosafety 
cabinets, as specified in the WHO Laboratory Biosafety Manual (3rd 
edition, Geneva, 2004) or constructed in accordance with national 
standards, regulations or guidance.
    Note 2 to 2B352.g.2: 2B352.g.2 controls any isolator having all 
of the characteristics described in 2B352.g.2.a through g.2.d, 
regardless of its intended use and its designation, except for 
medical isolators ``specially designed'' for barrier nursing or 
transportation of infected patients.
    h. Aerosol inhalation equipment designed for aerosol challenge 
testing with microorganisms, viruses or toxins, as follows:
    h.1. Whole-body exposure chambers having a capacity of 1 cubic 
meter or greater;
    h.2. Nose-only exposure apparatus utilizing directed aerosol 
flow and having a capacity for the exposure of 12 or more rodents, 
or two or more animals other than rodents, and closed animal 
restraint tubes designed for use with such apparatus.
    i. Spraying or fogging systems and ``parts'' and ``components'' 
therefor, as follows:
    i.1. Complete spraying or fogging systems, ``specially 
designed'' or modified for fitting to aircraft, ``lighter than air 
vehicles,'' or ``UAVs,'' capable of delivering, from a liquid 
suspension, an initial droplet ``VMD'' of less than 50 microns at a 
flow rate of greater than 2 liters per minute;
    i.2. Spray booms or arrays of aerosol generating units, 
``specially designed'' or modified for fitting to aircraft, 
``lighter than air vehicles,'' or ``UAVs,'' capable of delivering, 
from a liquid suspension, an initial droplet ``VMD'' of less than 50 
microns at a flow rate of greater than 2 liters per minute;
    i.3. Aerosol generating units ``specially designed'' for fitting 
to the systems as specified in paragraphs i.1 and i.2 of this ECCN.
    Technical Notes to 2B352.i:
    1. Aerosol generating units are devices ``specially designed'' 
or modified for fitting to aircraft and include nozzles, rotary drum 
atomizers and similar devices.
    2. This ECCN does not control spraying or fogging systems, 
``parts'' and ``components,'' as specified in 2B352.i, that are 
demonstrated not to be capable of delivering biological agents in 
the form of infectious aerosols.
    3. Droplet size for spray equipment or nozzles ``specially 
designed'' for use on aircraft or ``UAVs'' should be measured using 
either of the following methods (pending the adoption of 
internationally accepted standards):
    a. Doppler laser method,
    b. Forward laser diffraction method.
    j. Nucleic acid assemblers and synthesizers that are both:
    j.1 Partly or entirely automated; and
    j.2. Designed to generate continuous nucleic acids greater than 
1.5 kilobases in length with error rates less than 5% in a single 
run.
    k. Peptide synthesizers that are both:
    k.1 Partly or entirely automated; and
    k.2 Capable of generating peptides at a `system synthesis scale' 
of 1 mmol or greater.
    Technical Note to 2B352.k: `System synthesis scale' denotes the 
maximum amount of peptide (mmol) that can be produced by the 
instrument using the largest compatible reaction vessels (L). For 
multiple peptides produced in parallel, this is the sum of the 
largest compatible reaction vessels (L).
    N.B. to paragraph .k: See ECCN 2B350 for other chemical reaction 
vessels or reactors.
* * * * *

Matthew S. Borman,
Principal Deputy Assistant Secretary for Export Administration.
[FR Doc. 2024-30425 Filed 12-20-24; 8:45 am]
BILLING CODE 3510-33-P