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