Document ID: BIS-2022-0023-0007
Agency: bis
Document Type: Proposed Rule
Title: Section 1758 Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides
Posted Date: 2023-04-20T04:00Z

[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Proposed Rules]
[Pages 24341-24346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08269]

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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 88 , No. 76 / Thursday, April 20, 2023 / 
Proposed Rules  

[[Page 24341]]

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 230412-0100]
RIN 0694-AI84

Section 1758 Technology Export Controls on Instruments for the 
Automated Chemical Synthesis of Peptides

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

ACTION: Proposed rule.

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SUMMARY: The Bureau of Industry and Security (BIS), maintains controls 
on the export, reexport and transfer (in-country) of dual-use items and 
less sensitive military items pursuant to the Export Administration 
Regulations (EAR). Certain instruments for the automated synthesis of 
peptides (automated peptide synthesizers) have been identified by BIS 
as a Section 1758 emerging and foundational technology. In this rule, 
BIS proposes controls for these automated peptide synthesizers. BIS is 
seeking public comments on the proposed controls, detailed below.

DATES: Comments must be received by BIS no later than May 22, 2023.

ADDRESSES: You may submit comments, identified by regulations.gov 
docket number BIS-2022-0023 or by RIN 0694-AI84, through any of the 
following:
     Federal eRulemaking Portal: https://www.regulations.gov. 
You can find this advance notice of proposed rulemaking by searching 
for its regulations.gov docket number, which is BIS-2022-0023.
     Email: [email protected]. Include RIN 0694-AI84 
in the subject line of the message.
    All filers using the portal or email should include the name of the 
person or entity submitting the comments in the name of their file(s), 
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 to be made publicly 
available.
    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 or rebuttal 
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 https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions on automated peptide 
synthesizers, 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 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: 

Background

Identification of Section 1758 Technologies

    As part of the National Defense Authorization Act (NDAA) for Fiscal 
Year 2019 (Pub. L. 115-232), the United States Congress enacted the 
Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852). Section 
1758 of ECRA authorizes BIS to establish appropriate controls on the 
export, reexport or transfer (in-country) of emerging and foundational 
technologies essential to the national security of the United States. 
ECRA does not differentiate between the terms ``emerging technology'' 
and ``foundational technology,'' nor does it provide specific 
definitions or other guidance for these terms. Given this, and to 
ensure greater efficiency in implementing controls for such items, BIS 
has chosen to characterize such technologies as ``Section 1758 
technologies'', rather than characterizing a specific technology as 
either ``emerging'' or ``foundational.''
    As described in section 1758(a)(2)(B) of ECRA, the identification 
of Section 1758 technologies takes into account: (i) the development of 
these 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.
    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. In so doing, the Secretary must 
consider the potential end-uses and end-users of Section 1758 
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. Also, section 1758(a)(2)(C) of ECRA requires the interagency 
process for identifying Section 1758 technologies to include a notice 
and comment period.

November 19, 2018 Advance Notice of Proposed Rulemaking

    On November 19, 2018, BIS published an advance notice of proposed 
rulemaking (ANPRM), ``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 
technology categories concerning which BIS sought public comment to 
determine whether there are specific emerging technologies that are 
essential

[[Page 24342]]

to U.S. national security and for which effective controls can be 
implemented.

September 13, 2022 Advance Notice of Proposed Rulemaking on Instruments 
for the Automated Chemical Synthesis of Peptides

    On September 13, 2022, BIS published an ANPRM, ``Request for 
Comments Concerning the Imposition of Section 1758 Technology Export 
Controls on Instruments for the Automated Chemical Synthesis of 
Peptides'' (87 FR 55930) (September 13 ANPRM).
    As described in the September 13 ANPRM, peptides and polypeptides 
are polymeric chains of amino acids, linked together by peptide bonds. 
Proteins are three-dimensional (3D) macromolecules composed of one or 
more folded large chains of polypeptides. Proteins must fold into the 
correct 3D shape to be functionally active.
    The first peptide bond was synthesized over 100 years ago; however, 
in the last few decades advances in chemical synthesis methods have 
established automated peptide synthesis as a common laboratory 
technique.\1\ Long-established synthesis methods using 
fluorenylmethyloxycarbonyl (Fmoc) chemistry can reliably and routinely 
produce high quality polypeptides around 50 amino acids in length.\2\
---------------------------------------------------------------------------

    \1\ R.B. Merrifield, Solid Phase Peptide Synthesis. I. The 
Synthesis of a Tetrapeptide, 85 J. of the Am. Chem. Soc'y 2149, 
2149-54 (1963).
    \2\ Da'san M. M. Jaradat, Thirteen decades of peptide synthesis: 
key developments in solid phase peptide synthesis and amide bond 
formation utilized in peptide ligation, 50 Amino Acids 39, 39-68 
(2018); Sameer S. Kulkarni et al., Rapid and efficient protein 
synthesis through expansion of the native chemical ligation concept, 
2 Nature Reviews 1, 1-17 (2018).
---------------------------------------------------------------------------

    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.\3\ Most protein toxins on the Commerce Control 
List (CCL), which 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.
---------------------------------------------------------------------------

    \3\ Kulkarni, supra note 2, at 1-17.
---------------------------------------------------------------------------

    BIS received five comments in response to the publication of its 
September 13 ANPRM. The substance of the comments, together with BIS's 
responses, are detailed below.
    Comment 1: One commenter stated that synthesis of toxins using 
automated peptide synthesis is not viable, with the minor exception of 
conotoxins. The commenter also stated that synthesis of the alpha-
conotoxins would not be possible at quantities necessary to cause a 
significant environmental or terroristic threat.
    BIS Response 1: BIS concurs that automated peptide synthesizers are 
currently limited to the production of shorter peptide toxins, 
including CCL controlled conotoxins. However, BIS believes that the 
current instrumentation can produce enough peptide toxin to cause 
mortality and morbidity within a given population.
    Comment 2: One commenter stated that controlled toxins can be 
produced manually, and that automation simply speeds up this process. 
Another commenter stated that export controls for the reagents and 
consumables could potentially control access to peptide synthesis. 
However, they further stated that major manufacturers of these items 
are located outside of the United States.
    BIS Response 2: BIS appreciates the comments about availability of 
reagents and consumables for both automated and manual production of 
peptides. BIS will continue to investigate potential export controls on 
the consumables for peptide synthesis.
    Comment 3: One commenter stated that new technological developments 
for peptide synthesizers aid in making many different types of peptides 
faster, more efficiently, and at lower cost. They further state that 
this is primarily useful for research for screening many different 
peptides for drug candidates.
    BIS Response 3: BIS concurs with the usefulness of multiplexed 
automated peptide synthesizers for potential therapeutic development. 
However, BIS notes that these features can also be useful for other, 
more dangerous purposes, such as in a weapons program.
    Comment 4: A common comment was that BIS should not unilaterally 
control these technologies. A common thread was that these controls 
could have a dramatic impact on the leadership of U.S. technology in 
the field as customers would obtain the technology from Europe where it 
is unrestricted. One commenter noted that the U.S. Government should 
allow free use by academia to benefit overall development of 
biomolecular research.
    BIS Response 4: BIS will work with its international partners to 
provide multilateral controls for these technologies. However, BIS can 
take unilateral action regarding these technologies going forward, as 
necessary. BIS welcomes additional input on control of these 
technologies, as indicated and facilitated by this rule's proposed 
regulatory text.
    Comment 5: One commenter noted that at this time, the majority of 
large-scale production of peptides occurs manually.
    BIS Response 5: While this may be true, and worth looking at for 
further possible regulatory response, BIS is not inclined to halt the 
proposal of regulatory text for automated peptide synthesizers. 
However, BIS notes that this and other related information is relevant 
to fully understanding the automated peptide synthesizer market and 
appreciates the information.

Proposed Regulatory Changes

    With this rule, BIS proposes changes to ECCN 2B352. The proposed 
text will create a new item paragraph .k, which will contain three 
subparagraphs .k.1, .k.2, and .k.3. Item paragraph .k will control 
peptide synthesizers that are: partly or entirely automated (.k.1), 
capable of generating continuous peptide sequences greater than 75 
amino acids (.k.2), and capable of producing 100 mg of peptide at 75% 
or greater purity in a single run (.k.3). Items controls under item 
paragraph .k would retain reasons for control that apply to the entire 
ECCN, which are proliferation of chemical and biological weapons (CB) 
column 2 and anti-terrorism (AT) column 1.

Request for Comments

    Consistent with section 1758 of ECRA, BIS welcomes comments on the 
following proposed control text for automated peptide synthesizers.

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S. 
McCain National Defense Authorization Act for 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 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, distribute impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting

[[Page 24343]]

flexibility. This proposed rule has been determined to be significant 
under Executive Order 12866.
    2. Notwithstanding any other provision of law, no person may be 
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 a 
collection currently approved by OMB under control number 0694-0088, 
Simplified Network Application Processing System. This collection 
includes, among other things, license applications, and carries a 
burden estimate of 29.4 minutes for a manual or electronic submission 
for a total burden estimate of 31,919 hours. BIS does not expect the 
burden hours associated with this collection to change. BIS estimates 
an increase by about 40 new licenses for these items each year, within 
the bounds of existing estimates. 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 proposed rule does not contain policies with federalism 
implications as that term is defined under 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. However, 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 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 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, five of which were specific to this technology. 
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 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.
    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).

[[Page 24344]]

    Based on the analysis provided above, the amendments proposed in 
this rule would 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 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 2B352, 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 peptide synthesizers 
controlled under ECCN 2B352 that would have captured a greater number 
of such items. 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 these technologies. BIS has determined that proposing 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 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 
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 proposed in this 
rule).
    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, items proposed for control 
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 proposed controls.

Conclusion

    BIS has identified the items 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.

List of Subjects in 15 CFR Part 774

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 774 of the Export Administration Regulations (15 
CFR parts 730-774) is proposed to be amended as follows:

PART 774--THE COMMERCE CONTROL LIST

0
1. 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--[Amended]

0
2. Category 2 is amended by revising ECCN 2B352 to read as follows:

Category 2--Materials Processing

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

* * * * *
2B352 Equipment capable of use in handling biological materials, as 
follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

[[Page 24345]]

 
                                              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:
    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 the continuous separation 
of pathogenic microorganisms, without the propagation of aerosols, 
and having all of the following characteristics:
    c.1. One or more sealing joints within the steam containment 
area;
    c.2. A flow rate greater than 100 liters per hour;
    c.3. ``Parts'' or ``components'' of polished stainless steel or 
titanium; and
    c.4. Capable of in-situ steam sterilization in a closed state.

    Technical Note to 2B352.c:
    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;

[[Page 24346]]

    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:
    k.1. Partly or entirely automated;
    k.2. Capable of generating continuous peptide sequences greater 
than 75 amino acids; and
    k.3. Capable of producing 100 mg of peptide at 75% or greater 
purity in a single run.
* * * * *

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2023-08269 Filed 4-19-23; 8:45 am]
BILLING CODE 3510-33-P