[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Rules and Regulations]
[Pages 49531-49539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17505]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF STATE

22 CFR Part 121

[Public Notice: 9466]
RIN 1400-AD03


Amendment to the International Traffic in Arms Regulations: 
Revision of U.S. Munitions List Categories XIV and XVIII

AGENCY: Department of State.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: As part of the President's Export Control Reform effort, the 
Department of State amends the International Traffic in Arms 
Regulations (ITAR) to revise Categories XIV (toxicological agents, 
including chemical agents, biological agents, and associated equipment) 
and XVIII (directed energy weapons) of the U.S. Munitions List (USML) 
to describe more precisely the articles warranting control on the USML. 
The revisions contained in this rule are part of the Department of 
State's retrospective plan under E.O. 13563, completed on August 17, 
2011. The Department of State's full plan can be accessed at http://www.state.gov/documents/organization/181028.pdf.

DATES: This Final rule is effective on December 31, 2016.

FOR FURTHER INFORMATION CONTACT: Mr. C. Edward Peartree, Director, 
Office of Defense Trade Controls Policy, Department of State, telephone 
(202) 663-2792; email [email protected]. ATTN: ITAR 
Amendment--USML Categories XIV and XVIII.

SUPPLEMENTARY INFORMATION: The Directorate of Defense Trade Controls 
(DDTC), U.S. Department of State, administers the International Traffic 
in Arms Regulations (ITAR) (22 CFR parts 120-130). The items subject to 
the jurisdiction of the ITAR, i.e., ``defense articles,'' are 
identified on the ITAR's U.S. Munitions List (USML) (22 CFR 121.1). 
With few exceptions, items not subject to the export control 
jurisdiction of the ITAR are subject to the jurisdiction of the Export 
Administration Regulations (``EAR,'' 15 CFR parts 730-774, which 
includes the Commerce Control List (CCL) in Supplement No. 1 to Part 
774), administered by the Bureau of Industry and Security (BIS), U.S. 
Department of Commerce. Both the ITAR and the EAR impose license 
requirements on exports and reexports. Items not subject to the ITAR or 
to the exclusive licensing jurisdiction of any other set of regulations 
are subject to the EAR.
    All references to the USML in this rule are to the list of defense 
articles controlled for the purpose of export or temporary import 
pursuant to the ITAR, and not to the defense articles on the USML that 
are controlled by the Bureau of Alcohol, Tobacco, Firearms and 
Explosives (ATFE) for the purpose of permanent import under its 
regulations. See 27 CFR part 447. Pursuant to section 38(a)(1) of the 
Arms Export Control Act (AECA), all defense articles controlled for 
export or import are part of the USML under the AECA. The list of 
defense articles controlled by ATFE for the purpose of permanent import 
is the U.S. Munitions Import List (USMIL). The transfer of defense 
articles from the ITAR's USML to the EAR's CCL does not affect the list 
of defense articles controlled on the USMIL.

Revision of Category XIV

    This final rule revises USML Category XIV, covering toxicological 
agents, including chemical agents, biological agents, and associated 
equipment. The revisions are undertaken in order to more accurately 
describe the articles

[[Page 49532]]

within the subject categories, and to establish a ``bright line'' 
between the USML and the CCL for the control of these articles. The 
Department published a proposed rule for these revisions on June 17, 
2015 (80 FR 34572).
    This final rule adopts for those pathogens and toxins that meet 
specific capabilities listed in paragraph (b) the ``Tier 1'' pathogens 
and toxins established in the Department of Health and Human Services 
and the United States Department of Agriculture select agents and 
toxins regulations (42 CFR part 73 and 9 CFR part 121). The Tier 1 
pathogens and toxins that do not meet these capabilities remain 
controlled in Export Control Classification Number (ECCN) 1C351 on the 
CCL.
    Additionally, this rule, in concert with the analogous rule 
published by the Department of Commerce, moves riot control agents to 
the export jurisdiction of the Department of Commerce, as well as the 
articles covered previously in paragraphs (j), (k), and (l), which 
include test facilities, equipment for the destruction of chemical and 
biological agents, and tooling for production of articles in paragraph 
(f), respectively.
    Other changes include the addition of paragraph (a)(5) to control 
chemical warfare agents ``adapted for use in war'' and not elsewhere 
enumerated, as well as the removal of paragraphs (f)(3) and (f)(6) and 
movement to the CCL of equipment for the sample collection and 
decontamination or remediation of chemical agents and biological 
agents. Paragraph (f)(5) for collective protection was removed and 
partially combined in paragraph (f)(4) or the CCL. Paragraph (g) 
enumerates antibodies, recombinant protective antigens, 
polynucleotides, biopolymers, or biocatalysts exclusively funded by a 
Department of Defense contract for detection of the biological agents 
listed in paragraph (b)(1)(ii).
    The Department notes that the controls in paragraph (f)(2) that 
include the phrase ``developed under a Department of Defense contract 
or other funding authorization'' do not apply when the Department of 
Defense acts solely as a servicing agency for a contract on behalf of 
another agency of the U.S. government. Moreover, ``other funding 
authorization'' refers to other funding authorization from the 
Department of Defense.
    The Department notes that the controls in paragraphs (g)(1) and (h) 
that include the phrase ``exclusively funded by a Department of Defense 
contract'' do not apply when the Department of Defense acts solely as a 
servicing agency for a contract on behalf of another agency of the U.S. 
government, or, for example, in cases where the Department of Defense 
provides initial funding for the development of an item but another 
agency of the U.S. government provides funding to further develop or 
adapt the item.
    Paragraph (h) enumerates certain vaccines funded exclusively by the 
Department of Defense, as well as certain vaccines controlled in (h)(4) 
that are specially designed for the sole purpose of protecting against 
biological agents and biologically derived substances identified in 
(b). Thus, the scope of vaccines controlled in (h)(4) is circumscribed 
by the nature of funding and the satisfaction of the term ``specially 
designed'' as that term is defined in ITAR Sec.  120.41. In evaluating 
the scope of this control, please note that the Department offers a 
decision tool to aid exporters in determining whether a defense article 
meets the definition of ``specially designed.'' This tool is available 
at http://www.pmddtc.state.gov/licensing/dt_SpeciallyDesigned.htm.
    Paragraph (i) is updated to provide better clarity on the scope of 
the control by including examples of Department of Defense tools that 
are used to determine or estimate potential effects of chemical or 
biological weapons strikes and incidents in order to plan to mitigate 
their impacts.
    A new paragraph (x) has been added to USML Category XIV, allowing 
ITAR licensing on behalf of the Department of Commerce for commodities, 
software, and technology subject to the EAR, provided those 
commodities, software, and technology are to be used in or with defense 
articles controlled in USML Category XIV and are described in the 
purchase documentation submitted with the application. The intent of 
paragraph (x) is not to impose ITAR jurisdiction on commodities, 
software, and technology subject to EAR controls. Items described in 
paragraph (x) remain subject to the jurisdiction of the EAR. The 
Department added the paragraph as a regulatory reference point in 
response to industry requests to be able to use a Department of State 
license to export shipments that have a mix of ITAR controlled items 
and EAR controlled items for use in or with items described in that 
category.
    Finally, this rule establishes USML control in subparagraph (f)(2) 
of certain chemical or biological agent equipment only when it contains 
reagents, algorithms, coefficients, software, libraries, spectral 
databases, or alarm set point levels developed under a Department of 
Defense contract or other funding authorization.
    One commenter questioned whether the use of the words ``to 
include'' in proposed paragraph (a) was meant to indicate an all-
inclusive list or only examples of controlled agents. The Department 
has modified paragraph (a) to replace ``to include'' with the all-
inclusive ``as follows'' in light of this comment, and in order to 
align this language with the comparable language that appears in 
paragraph (b).
    A commenting party suggested that the removal of former 
subparagraph (n)(2) would inhibit university research with respect to 
agents controlled by paragraph (a). The Department disagreed with this 
comment because former subparagraph (n)(2) applied only to agents 
controlled in paragraph (b).
    Several commenters expressed confusion with respect to subparagraph 
(b)(1), arguing that, for example, the list in subparagraph (b)(1)(ii) 
was incomplete, or represented a migration to ITAR control of agents or 
research formerly subject to the EAR. The Department clarifies that all 
of the biological agents subject to control under revised paragraph (b) 
were also subject to ITAR control under former paragraph (b), which 
generally controlled those biological agents or biologically derived 
substances that were specifically developed, configured, adapted, or 
modified for the purpose of increasing their capability to produce 
casualties in humans or livestock, degrade equipment, or damage crops.
    By contrast, subparagraph (b)(1) of revised Category XIV controls 
only those agents that meet the criteria of both subparagraphs 
(b)(1)(i) and (b)(1)(ii). To be controlled, the agent must be one of 
the specific listed microorganisms or toxins, or their non-naturally 
occurring genetic elements, and it must have been modified in a manner 
that is known or reasonably expected to result in an increase of at 
least one of two specific criteria. Subparagraph (b)(2) controls only 
biological agents that meet the criteria of subparagraph (b)(2)(i) and 
do so in a manner that is known or reasonably expected to result in an 
increase of at least one of three specific criteria in (b)(2)(ii). 
Subparagraphs (b)(1) and (b)(2) represent a narrowing of the universe 
of agents subject to control under the paragraph (b), and a more 
specific means of control than the broad, generic language of former 
paragraph (b).
    One commenting party recommended an exclusion in paragraph (b) for 
research funded by the National Institutes of Health, the Centers for 
Disease Control and Prevention, or the U.S. Department of Agriculture. 
Given the refined and narrowed scope of

[[Page 49533]]

control in paragraph (b) as described above, which focuses on specific 
and weaponized biological agents, the Department disagreed with this 
suggestion because it is overly broad.
    Four commenting parties argued that regulation of biological agents 
in paragraph (b) is not necessary in the manner proposed because of the 
existence of the Federal Select Agent Program and the Dual Use Research 
of Concern policy. The Department disagreed with these comments because 
the referenced program and policy are not munitions export control 
regimes and do not share the national security and foreign policy 
objectives of the ITAR. As stated above, the articles described in 
revised paragraph (b) were subject to the ITAR under the previous 
Category XIV and do not include any biological agents that were not 
previously subject to the ITAR; as such, there is no expansion of 
control beyond what existed previously, and the relationship between 
these agents and the Federal Select Agent Program or Dual Use Research 
of Concern policy is unchanged.
    One commenting party observed that subparagraph (b)(1)(ii) of the 
proposed rule adopted the Tier 1 list of select agents meeting certain 
criteria, but did not incorporate the exclusions of the Federal Select 
Agent Program. Revised Category XIV is not intended to intersect with 
the Federal Select Agent Program. The ITAR and Federal Select Agent 
Program do not share identical objectives; accordingly, it would be 
inappropriate to provide common exclusions for largely unrelated 
regulatory concerns.
    Four commenters requested the reinstatement of former subparagraph 
(n)(2), which provided an exclusion for agents otherwise controlled in 
paragraph (b) that had been modified for civil applications. The 
Department disagreed with these comments because, as noted above, 
paragraph (b) has been reduced in scope significantly to control only 
weaponized strains of specified agents. By contrast, former paragraph 
(b) required the subparagraph (n)(2) exclusion because it was otherwise 
overly broad. Since the revised paragraph (b) does not capture 
modifications that would be undertaken for civil applications that do 
not merit control, the subparagraph (n)(2) exclusion is no longer 
appropriate.
    One commenting party stated that former paragraph (b) was in 
essence an empty box because the export licensing of biological agents 
as munitions would violate the Biological Weapons Convention (BWC). The 
Department disagreed with this comment because such treatment of 
biological agents does not violate the BWC when used in the development 
of countermeasures, which serve ``prophylactic'' or ``protective'' 
purposes explicitly permitted by the BWC. Moreover, prevention of the 
acquisition of weaponized biological agents for impermissible purposes, 
as is achieved through regulation of such agents under the ITAR, is 
consistent with the objectives of the BWC.
    A commenter expressed the view that based on proposed paragraph 
(b), an expression vector that produces Ebola virus envelope protein 
for use in pseudotyping minimal lentiviral vectors, even though 
harmless in itself, might be subject to ITAR control because the 
envelope is a pathogenicity factor to Ebola virus, even in the absence 
of Ebola virus. The Department disagrees with this comment because the 
described item would not be controlled by paragraph (b) unless it 
satisfied the criteria of subparagraph (b)(1)(i), particularly taken 
together with Note 2 to paragraph (b).
    One commenter suggested that the list of biological agents in 
paragraph (b)(1)(ii) fails to take into account the danger and exposure 
risk presented by each toxin. The Department notes, as stated above, 
that the list in subparagraph (b)(1)(ii) does not stand alone as a list 
of agents subject to control. To be subject to the ITAR, an agent 
listed in subparagraph (b)(1)(ii) must also meet the criteria of 
subparagraph (b)(1)(i).
    Four commenting parties indicated that the properties referenced in 
subparagraph (b)(1)(i) and (b)(2)(ii) are not properties for which 
researchers would typically test, and that the proposed language might 
result in mandatory testing for these properties to avoid inadvertent 
violations. The Department revised the language in these subparagraphs 
to limit the analysis of modifications to those that are known to or 
are reasonably expected to result in an increase in the subject 
properties.
    Two commenters suggested that the research subject to control in 
subparagraph (b)(1) should focus on the intent or purpose of the 
research. The Department disagreed with this comment in light of the 
revisions made to subparagraphs (b)(1)(i) and (b)(2)(ii) in response to 
public comments, and also in order to avoid the introduction of an 
intent or end use-based control, which has been a longstanding 
objective of the ECR initiative.
    Three commenting parties observed that the use of ``e.g.'' in 
subparagraph (b)(1)(i)(A) suggests that the parenthetical examples of 
persistence in a field environment is not complete. The Department 
changed ``e.g.'' to ``i.e.,'' and updated the parenthetical list 
accordingly.
    One commenter requested a definition of ``persistence in a field 
environment'' in subparagraph (b)(2)(i)(A) to avoid ambiguity. The 
Department refined the subparagraph to provide more comprehensive 
criteria.
    Three commenters noted that ECCN 1C352 has been combined with ECCN 
1C351, and that any references to the former should be deleted from 
Category XIV. The Department agrees with these comments.
    Two commenting parties submitted comments that suggested a 
misunderstanding that references in subparagraph (b)(2) to ECCNs 1C351, 
1C353, and 1C354 would move agents controlled under those ECCNs to the 
jurisdiction of the Department of State. No biological agents are moved 
from the CCL to the USML as a result of this rulemaking, nor was such 
movement suggested in the proposed rule. The ECCNs are referenced 
merely in order to better define the articles subject to control, to 
which the criteria of both subparagraphs (b)(2)(i) and (b)(2)(ii) must 
apply.
    Two commenting parties observed that the use of ``e.g.'' in 
subparagraph (b)(2)(ii)(A) suggests that the parenthetical examples of 
persistence in a field environment is not complete. The Department 
changed ``e.g.'' to ``i.e.,'' and updated the parenthetical list 
accordingly.
    Similarly, two commenting parties observed that the use of ``e.g.'' 
in subparagraph (b)(2)(ii)(B) indicates that the list of possible 
dispersal characteristics is not complete. In this case, the Department 
confirms that the parenthetical list is intended to be exemplary in 
nature.
    One commenter stated that Note 2 to paragraph (b)'s limitation to 
wild type agents is still unnecessarily restrictive with respect to the 
agents listed in subparagraph (b)(1)(ii). The Department disagreed with 
this comment because, as indicated previously, to be subject to the 
ITAR an agent listed in subparagraph (b)(2)(ii) must also meet the 
criteria of subparagraph (b)(2)(i).
    A commenter remarked that the controls described in the proposed 
rule would establish ITAR control over technical data and research and 
development activities related to, inter alia, biological agents 
described in paragraph (b). Bearing in mind the fact that all agents 
controlled under revised paragraph (b) were subject to control under 
former paragraph (b), the Department believes that control over

[[Page 49534]]

such information and activities is appropriate given the narrowed scope 
of revised paragraph (b) to specific weaponized biological agents.
    A commenting party identified typographical errors in subparagraphs 
(c)(4) and (c)(5). The Department made the appropriate corrections.
    Two commenters requested clarification regarding the phrase 
``Department of Defense contract or funding authorization,'' as it 
appears in subparagraphs (f)(1)(ii), (f)(2), and (f)(2)(ii). The 
Department clarifies that the quoted language captures a range of 
possible Department of Defense funding authorization mechanisms that 
extend beyond contracts, such as grants. While these subparagraphs do 
not require exclusive funding by the Department of Defense to cause the 
articles to become subject to ITAR control, and there is no de minimis 
funding level that triggers control, the use of ``specially designed'' 
in certain of these subparagraphs limits the scope of control, in 
addition to other specific criteria set forth in the subparagraphs.
    A commenting party questioned the intent and meaning of Note 3 to 
paragraph (f)(2). The Department deleted the note.
    Two commenting parties recommended a revision to subparagraph 
(f)(2)(i) to control only relevant equipment for chemical or biological 
agents specified in the Department of Defense contract or other funding 
authorization as intended for control under USML Category XIV, or to 
clarify the funding mechanism that specifies the chemical or biological 
agent and thus triggers the provision. The Department disagreed with 
the former comment because it would introduce a discretionary contract 
mechanism that could allow for the subjective application or removal of 
ITAR control, but modified the subparagraph to better define the scope 
of control. The modifications clarify the link between the funding 
mechanisms referenced in subparagraph (f)(2) and (f)(2)(ii).
    One commenting party recommended the movement to the EAR of all 
articles controlled in subparagraph (f)(4), or the removal of the 
Significant Military Equipment (SME) designation at a minimum. The 
Department disagreed with this comment because the commenter did not 
provide a sufficient rationale to compel removal from the USML or the 
SME designation for these articles.
    A comment recommended that subparagraph (f)(4)(iii) be revised to 
remove the trade name ASZM-TEDA and instead specify the parameters or 
criteria that merit control for activated carbon products. The 
Department revised the subparagraph to reference the specification that 
merits control.
    Two commenters observed that paragraph (f)(4)(iv) would not 
distinguish between military and non-military protective apparel, but 
would rely on a ``breakthrough test'' that could capture garments 
designed to National Fire Protection Association standards or designed 
to integrate with civil gas masks if they met breakthrough levels. The 
Department has refined subparagraph (f)(4)(iv) to the same paragraph to 
more precisely describe the articles that warrant control and 
incorporated the elements described in the prior Note into the control 
parameters.
    One commenting party recommended that Chemical Agent Resistant 
Coatings (CARC) be moved from subparagraph (f)(7) to the EAR. The 
Department updated the subparagraph to control the appropriate 
specification, but disagreed with the remainder of the comment in order 
to maintain ITAR control over coatings that have been qualified to 
military specifications.
    A commenter suggested the replacement of the word ``qualified'' in 
subparagraph (f)(7) with the phrase ``meet the requirements of.'' The 
Department disagreed with this comment because the phrasing used is 
intended to mean that the article has in fact been qualified by the 
Department of Defense to the relevant standard.
    One commenting party recommended the removal of the SME designation 
for subparagraph (f)(7). The Department disagreed with this comment 
because the commenter did not provide a sufficient rationale for 
removal of the designation.
    Three commenting parties suggested that subparagraph (g)(1) should 
control relevant articles based on parameters or criteria other than 
the funding source. The Department notes that subparagraph (g)(1) 
controls only those relevant articles that are exclusively funded by 
the Department of Defense, for detection of the biological agents 
listed in subparagraph (b)(1)(ii). The Department believes that this is 
an appropriately tailored subparagraph, particularly in light of the 
requirement that Department of Defense funding be exclusive.
    One commenter presented a similar comment with respect to the 
analogous exclusive funding provision in subparagraph (h). Again, the 
Department disagrees with this comment because the exclusive funding 
requirement narrows the range of controlled vaccines to an appropriate 
scope.
    A commenting party suggested that the use of specially designed in 
paragraph (h) undermines the notion of control due to funding source, 
as certain vaccines could be released through ITAR Sec.  120.41(b). The 
Department disagrees with this comment because it is not likely that 
ITAR Sec.  120.41(b) would allow for the release of vaccines that were 
exclusively funded by the Department of Defense to protect against 
biological agents controlled under paragraph (b).
    A commenter requested clarification as to whether subparagraph 
(h)(4) is subject to the requirement that the vaccine be funded 
exclusively by a Department of Defense contract or other funding 
authorization. Since this exclusive funding requirement appears in 
subparagraph (h), the Department confirms that this is the case.

Revision of Category XVIII

    This final rule revises USML Category XVIII, covering directed 
energy weapons. As with USML Category XIV, the revisions are undertaken 
in order to more accurately describe the articles within the subject 
categories, and to establish a ``bright line'' between the USML and the 
CCL for the control of these articles. This final rule revises 
paragraph (a) to control only those articles that, other than as a 
result of incidental, accidental, or collateral effect, achieve the 
effects described in the paragraph by way of non-acoustic techniques.
    The articles controlled previously in paragraphs (c) and (d) are 
moved to the export control jurisdiction of the Department of Commerce.
    The remaining paragraphs in this category underwent conforming 
changes to bring their structures into alignment with the analogous 
provisions found in other revised USML categories.
    A commenting party suggested that the reference in proposed 
paragraph (a) to the ``primary purpose'' of system or equipment at 
issue was unclear. The Department revised the paragraph to remove this 
language and clarify the intended scope of control.
    Two commenting parties recommended revisions to the structure of 
paragraph (a). The Department revised the paragraph text to enhance 
clarity and readability.
    A commenter noted that ``flash blindness,'' as used in proposed 
paragraph (a), has no commonly understood meaning. The Department 
revised the subject language to clarify the intended scope of control.

[[Page 49535]]

    One commenting party recommended the addition of a note to 
paragraph (a) to confirm that the paragraph does not control articles 
subject to control under subparagraphs XI(a)(4)(iii) or XII(b)(9). The 
Department disagrees with this comment because the USML Order of Review 
establishes that the paragraph that most specifically identifies a 
given article will control that article; accordingly, it is not 
necessary to add clarifying notes of this nature.
    A commenter observed that it was not clear what ``associated 
systems or equipment'' meant in proposed paragraph (e). The Department 
revised the paragraph to match the structure of analogous paragraphs 
found in other revised USML categories.
    A commenting party recommended a note to paragraph (e) that would 
indicate that components, parts, accessories, attachments and 
associated systems or equipment specially designed for articles 
controlled under paragraph XVIII(e) are subject to the EAR. Noting that 
no such note has been applied to the analogous paragraphs in other 
revised USML categories, the Department disagrees with this comment 
because the inclusion of ``specially designed'' in paragraph (e) 
provides the intended scope of control for the articles at issue.

Regulatory Findings

Administrative Procedure Act

    The Department of State is of the opinion that controlling the 
import and export of defense articles and services is a foreign affairs 
function of the United States Government and that rules implementing 
this function are exempt from sections 553 (Rulemaking) and 554 
(Adjudications) of the Administrative Procedure Act. Although the 
Department is of the opinion that this rule is exempt from the 
rulemaking provisions of the APA, the Department published this rule as 
a proposed rule (80 FR 34572) with a 60-day provision for public 
comment and without prejudice to its determination that controlling the 
import and export of defense services is a foreign affairs function.

Regulatory Flexibility Act

    Since the Department is of the opinion that this rule is exempt 
from the rulemaking provisions of 5 U.S.C. 553, it does not require 
analysis under the Regulatory Flexibility Act.

Unfunded Mandates Reform Act of 1995

    This amendment does not involve a mandate that will result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100 million or more in any year and it 
will not significantly or uniquely affect small governments. Therefore, 
no actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This amendment has been found not to be a major rule within the 
meaning of the Small Business Regulatory Enforcement Fairness Act of 
1996.

Executive Orders 12372 and 13132

    This amendment will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 13132, it is determined that this amendment does not have 
sufficient federalism implications to require consultations or warrant 
the preparation of a federalism summary impact statement. The 
regulations implementing Executive Order 12372 regarding 
intergovernmental consultation on Federal programs and activities do 
not apply to this amendment.

Executive Order 12866 and 13563

    Executive Orders 12866 and 13563 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, distributed impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has been designated a ``significant regulatory 
action,'' although not economically significant, under section 3(f) of 
Executive Order 12866. Accordingly, the rule has been reviewed by the 
Office of Management and Budget (OMB).

Executive Order 12988

    The Department of State has reviewed the amendment in light of 
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate 
ambiguity, minimize litigation, establish clear legal standards, and 
reduce burden.

Executive Order 13175

    The Department of State has determined that this rulemaking will 
not have tribal implications, will not impose substantial direct 
compliance costs on Indian tribal governments, and will not preempt 
tribal law. Accordingly, Executive Order 13175 does not apply to this 
rulemaking.

Paperwork Reduction Act

    Following is a listing of approved collections that will be 
affected by revision of the U.S. Munitions List (USML) and the Commerce 
Control List pursuant to the President's Export Control Reform (ECR) 
initiative. This rule continues the implementation of ECR. The list of 
collections pertains to revision of the USML in its entirety, not only 
to the categories published in this rule. The Department is not 
proposing or making changes to these collections in this rule. The 
information collections impacted by the ECR initiative are as follows:
    (1) Statement of Registration, DS-2032, OMB No. 1405-0002.
    (2) Application/License for Permanent Export of Unclassified 
Defense Articles and Related Unclassified Technical Data, DSP-5, OMB 
No. 1405-0003.
    (3) Application/License for Temporary Import of Unclassified 
Defense Articles, DSP-61, OMB No. 1405-0013.
    (4) Application/License for Temporary Export of Unclassified 
Defense Articles, DSP-73, OMB No. 1405-0023.
    (5) Application for Amendment to License for Export or Import of 
Classified or Unclassified Defense Articles and Related Technical Data, 
DSP-6, -62, -74, -119, OMB No. 1405-0092.
    (6) Request for Approval of Manufacturing License Agreements, 
Technical Assistance Agreements, and Other Agreements, DSP-5, OMB No. 
1405-0093.
    (7) Maintenance of Records by Registrants, OMB No. 1405-0111.

List of Subjects in 22 CFR Part 121

    Arms and munitions, Exports.

    Accordingly, for the reasons set forth above, title 22, chapter I, 
subchapter M, part 121 is amended as follows:

PART 121--THE UNITED STATES MUNITIONS LIST

0
1. The authority citation for part 121 continues to read as follows:

    Authority: Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 
U.S.C. 2752, 2778, 2797); 22 U.S.C. 2651a; Pub. L. 105-261, 112 
Stat. 1920; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.


[[Page 49536]]



0
2. Section 121.1 is amended by revising U.S. Munitions List Categories 
XIV and XVIII to read as follows:


Sec.  121.1  The United States Munitions List.

* * * * *

Category XIV--Toxicological Agents, Including Chemical Agents, 
Biological Agents, and Associated Equipment

    *(a) Chemical agents, as follows:
    (1) Nerve agents, as follows:
    (i) O-Alkyl (equal to or less than C10, including 
cycloalkyl) alkyl (Methyl, Ethyl, n-Propyl or Isopropyl) 
phosphonofluoridates, such as: Sarin (GB): O-Isopropyl 
methylphosphonofluoridate (CAS 107-44-8) (CWC Schedule 1A); and Soman 
(GD): O-Pinacolyl methylphosphonofluoridate (CAS 96-64-0) (CWC Schedule 
1A);
    (ii) O-Alkyl (equal to or less than C10, including 
cycloalkyl) N,N-dialkyl (Methyl, Ethyl, n-Propyl or Isopropyl) 
phosphoramidocyanidates, such as: Tabun (GA): O-Ethyl N, N-
dimethylphosphoramidocyanidate (CAS 77-81-6) (CWC Schedule 1A); or
    (iii) O-Alkyl (H or equal to or less than C10, including 
cycloalkyl) S-2-dialkyl (Methyl, Ethyl, n-Propyl or Isopropyl) 
aminoethyl alkyl (Methyl, Ethyl, n-Propyl or Isopropyl) 
phosphonothiolates and corresponding alkylated and protonated salts, 
such as VX: O-Ethyl S-2-diisopropylaminoethyl methyl phosphonothiolate 
(CAS 50782-69-9) (CWC Schedule 1A);
    (2) Amiton: O,O-Diethyl S-[2(diethylamino)ethyl] phosphorothiolate 
and corresponding alkylated or protonated salts (CAS 78-53-5) (CWC 
Schedule 2A);
    (3) Vesicant agents, as follows:
    (i) Sulfur mustards, such as: 2-Chloroethylchloromethylsulfide (CAS 
2625-76-5) (CWC Schedule 1A); Bis(2-chloroethyl)sulfide (HD) (CAS 505-
60-2) (CWC Schedule 1A); Bis(2-chloroethylthio)methane (CAS 63839-13-6) 
(CWC Schedule 1A); 1,2-bis (2-chloroethylthio)ethane (CAS 3563-36-8) 
(CWC Schedule 1A); 1,3-bis (2-chloroethylthio)-n-propane (CAS 63905-10-
2) (CWC Schedule 1A); 1,4-bis (2-chloroethylthio)-n-butane (CWC 
Schedule 1A); 1,5-bis (2-chloroethylthio)-n-pentane (CWC Schedule 1A); 
Bis (2-chloroethylthiomethyl)ether (CWC Schedule 1A); Bis (2-
chloroethylthioethyl)ether (CAS 63918-89-8) (CWC Schedule 1A);
    (ii) Lewisites, such as: 2-chlorovinyldichloroarsine (CAS 541-25-3) 
(CWC Schedule 1A); Tris (2-chlorovinyl) arsine (CAS 40334-70-1) (CWC 
Schedule 1A); Bis (2-chlorovinyl) chloroarsine (CAS 40334-69-8) (CWC 
Schedule 1A);
    (iii) Nitrogen mustards, or their protonated salts, as follows:
    (A) HN1: Bis (2-chloroethyl) ethylamine (CAS 538-07-8) (CWC 
Schedule 1A);
    (B) HN2: Bis (2-chloroethyl) methylamine (CAS 51-75-2) (CWC 
Schedule 1A);
    (C) HN3: Tris (2-chloroethyl) amine (CAS 555-77-1) (CWC Schedule 
1A); or
    (D) Other nitrogen mustards, or their salts, having a propyl, 
isopropyl, butyl, isobutyl, or tertiary butyl group on the bis(2-
chloroethyl) amine base;

    Note 1 to paragraph (a)(3)(iii): Pharmaceutical formulations 
containing nitrogen mustards or certain reference standards for 
these formulations are not considered to be chemical agents and are 
subject to the EAR when: (1) The pharmaceutical is in the form of a 
final medical product; or (2) the reference standard contains salts 
of HN2 [bis(2-chloroethyl) methylamine], the quantity to be shipped 
is 150 milligrams or less, and individual shipments do not exceed 
twelve per calendar year per end user.


    Note 2 to paragraph (a)(3)(iii): A ``final medical product,'' as 
used in this paragraph, is a pharmaceutical formulation that is (1) 
designed for testing and administration in the treatment of human 
medical conditions, (2) prepackaged for distribution as a clinical 
or medical product, and (3) approved for marketing by the Food and 
Drug Administration or has a valid investigational new drug 
application (IND) in effect, in accordance with 21 CFR part 312.

    (iv) Ethyldichloroarsine (ED) (CAS 598-14-1); or
    (v) Methyldichloroarsine (MD) (CAS 593-89-5);
    (4) Incapacitating agents, such as:
    (i) 3-Quinuclindinyl benzilate (BZ) (CAS 6581-06-2) (CWC Schedule 
2A);
    (ii) Diphenylchloroarsine (DA) (CAS 712-48-1); or
    (iii) Diphenylcyanoarsine (DC) (CAS 23525-22-6);
    (5) Chemical warfare agents not enumerated above adapted for use in 
war to produce casualties in humans or animals, degrade equipment, or 
damage crops or the environment. (See the CCL at ECCNs 1C350, 1C355, 
and 1C395 for control of certain chemicals not adapted for use in war.)

    Note to paragraph (a)(5): ``Adapted for use in war'' means any 
modification or selection (such as altering purity, shelf life, 
dissemination characteristics, or resistance to ultraviolet 
radiation) designed to increase the effectiveness in producing 
casualties in humans or animals, degrading equipment, or damaging 
crops or the environment.


    Note 1 to paragraph (a): Paragraph (a) of this category does not 
include the following: Cyanogen chloride, Hydrocyanic acid, 
Chlorine, Carbonyl chloride (Phosgene), Ethyl bromoacetate, Xylyl 
bromide, Benzyl bromide, Benzyl iodide, Chloro acetone, Chloropicrin 
(trichloronitromethane), Fluorine, and Liquid pepper.


    Note 2 to paragraph (a): Regarding U.S. obligations under the 
Chemical Weapons Convention (CWC), refer to Chemical Weapons 
Convention Regulations (CWCR) (15 CFR parts 710 through 721). As 
appropriate, the CWC schedule is provided to assist the exporter.

    *(b) Biological agents and biologically derived substances and 
genetic elements thereof as follows:
    (1) Genetically modified biological agents:
    (i) Having non-naturally occurring genetic modifications that are 
known to or are reasonably expected to result in an increase in any of 
the following:
    (A) Persistence in a field environment (i.e., resistance to oxygen, 
UV damage, temperature extremes, arid conditions, or decontamination 
processes); or
    (B) The ability to defeat or overcome standard detection methods, 
personnel protection, natural or acquired host immunity, host immune 
response, or response to standard medical countermeasures; and
    (ii) Being any micro-organisms/toxins or their non-naturally 
occurring genetic elements as listed below:
    (A) Bacillus anthracis;
    (B) Botulinum neurotoxin producing species of Clostridium;
    (C) Burkholderia mallei;
    (D) Burkholderia pseudomallei;
    (E) Ebola virus;
    (F) Foot-and-mouth disease virus;
    (G) Francisella tularensis;
    (H) Marburg virus;
    (I) Variola major virus (Smallpox virus);
    (J) Variola minor virus (Alastrim);
    (K) Yersinia pestis; or
    (L) Rinderpest virus.
    (2) Biological agent or biologically derived substances controlled 
in ECCNs 1C351, 1C353, or 1C354:
    (i) Physically modified, formulated, or produced as any of the 
following:
    (A) 1-10 micron particle size;
    (B) Particle-absorbed or combined with nano-particles;
    (C) Having coatings/surfactants, or
    (D) By microencapsulation; and
    (ii) Meeting the criteria of paragraph (b)(2)(i) of this category 
in a manner that is known to or is reasonably expected to result in an 
increase in any of the following:
    (A) Persistence in a field environment (i.e., resistant to oxygen, 
UV damage, temperature extremes, arid conditions, or decontamination 
processes);
    (B) Dispersal characteristics (e.g., reduced susceptibility to 
shear forces, optimized electrostatic charges); or

[[Page 49537]]

    (C) The ability to defeat or overcome: standard detection methods, 
personnel protection, natural or acquired host immunity, or response to 
standard medical countermeasures.

    Note 1 to paragraph (b): Non-naturally occurring means that the 
modification has not already been observed in nature, was not 
discovered from samples obtained from nature, and was developed with 
human intervention.


    Note 2 to paragraph (b): This paragraph does not control 
biological agents or biologically derived substances when these 
agents or substances have been demonstrated to be attenuated 
relative to natural pathogenic isolates and are incapable of causing 
disease or intoxication of ordinarily affected and relevant species 
(e.g., humans, livestock, crop plants) due to the attenuation of 
virulence or pathogenic factors. This paragraph also does not 
control genetic elements, nucleic acids, or nucleic acid sequences 
(whether recombinant or synthetic) that are unable to produce or 
direct the biosynthesis of infectious or functional forms of the 
biological agents or biologically derived substances that are 
capable of causing disease or intoxication of ordinarily affected 
and relevant species.


    Note 3 to paragraph (b): Biological agents or biologically 
derived substances that meet both paragraphs (b)(1) and (b)(2) of 
this category are controlled in paragraph (b)(1).

    *(c) Chemical agent binary precursors and key precursors, as 
follows:
    (1) Alkyl (Methyl, Ethyl, n-Propyl or Isopropyl) phosphonyl 
difluorides, such as: DF: Methyl Phosphonyldifluoride (CAS 676-99-3) 
(CWC Schedule 1B); Methylphosphinyldifluoride (CAS 753-59-3) (CWC 
Schedule 2B);
    (2) O-Alkyl (H or equal to or less than C10, including 
cycloalkyl) O-2-dialkyl (methyl, ethyl, n-Propyl or isopropyl) 
aminoethyl alkyl (methyl, ethyl, N-propyl or isopropyl) phosphonite and 
corresponding alkylated and protonated salts, such as QL: O-Ethyl-2-di-
isopropylaminoethyl methylphosphonite (CAS 57856-11-8) (CWC Schedule 
1B);
    (3) Chlorosarin: O-Isopropyl methylphosphonochloridate (CAS 1445-
76-7) (CWC Schedule 1B);
    (4) Chlorosoman: O-Pinacolyl methylphosphonochloridate (CAS 7040-
57-5) (CWC Schedule 1B); or
    (5) Methylphosphonyl dichloride (CAS 676-97-1) (CWC Schedule 2B); 
Methylphosphinyldichloride (CAS 676-83-5) (CWC Schedule 2B).
    (d) [Reserved]
    (e) Defoliants, as follows:
    (1) 2,4,5-trichlorophenoxyacetic acid (CAS 93-76-5) mixed with 2,4-
dichlorophenoxyacetic acid (CAS 94-75-7) (Agent Orange (CAS 39277-47-
9)); or
    (2) Butyl 2-chloro-4-fluorophenoxyacetate (LNF).
    *(f) Parts, components, accessories, attachments, associated 
equipment, materials, and systems, as follows:
    (1) Any equipment for the dissemination, dispersion, or testing of 
articles controlled in paragraphs (a), (b), (c), or (e) of this 
category, as follows:
    (i) Any equipment ``specially designed'' for the dissemination and 
dispersion of articles controlled in paragraphs (a), (b), (c), or (e) 
of this category; or
    (ii) Any equipment ``specially designed'' for testing the articles 
controlled in paragraphs (a), (b), (c), (e), or (f)(4) of this category 
and developed under a Department of Defense contract or other funding 
authorization.
    (2) Any equipment, containing reagents, algorithms, coefficients, 
software, libraries, spectral databases, or alarm set point levels 
developed under a Department of Defense contract or other funding 
authorization, for the detection, identification, warning, or 
monitoring of:
    (i) Articles controlled in paragraphs (a) or (b) of this category; 
or
    (ii) Chemical agents or biological agents specified in the 
Department of Defense contract or other funding authorization.

    Note 1 to paragraph (f)(2): This paragraph does not control 
articles that are (a) determined to be subject to the EAR via a 
commodity jurisdiction determination (see Sec.  120.4 of this 
subchapter), or (b) identified in the relevant Department of Defense 
contract or other funding authorization as being developed for both 
civil and military applications.


    Note 2 to paragraph (f)(2): Note 1 does not apply to defense 
articles enumerated on the USML.

    (3) [Reserved]
    (4) For individual protection or collective protection against the 
articles controlled in paragraphs (a) and (b) of this category, as 
follows:
    (i) M53 Chemical Biological Protective Mask or M50 Joint Service 
General Purpose Mask (JSGPM);
    (ii) Filter cartridges containing sorbents controlled in paragraph 
(f)(4)(iii) or (n) of this category;
    (iii) Carbon meeting MIL-DTL-32101 specifications (e.g., ASZM-TEDA 
carbon); or
    (iv) Ensembles, garments, suits, jackets, pants, boots, or socks 
for individual protection, and liners for collective protection that 
allow no more than 1% breakthrough of GD or no more than 2% 
breakthrough of any other chemical controlled in paragraph (a) of this 
category, when evaluated by executing the applicable standard method(s) 
of testing described in the current version of Test Operating Protocols 
(TOPs) 08-2-201 or 08-2-501 and using the defined Department of 
Defense-specific requirements;
    (5)-(6) [Reserved]
    (7) Chemical Agent Resistant Coatings that have been qualified to 
military specifications (MIL-PRF-32348, MIL-DTL-64159, MIL-C-46168, or 
MIL-DTL-53039); or
    (8) Any part, component, accessory, attachment, equipment, or 
system that:
    (i) Is classified;
    (ii) Is manufactured using classified production data; or
    (iii) Is being developed using classified information.

    Note to paragraph (f)(8): ``Classified'' means classified 
pursuant to Executive Order 13526, or predecessor order, and a 
security classification guide developed pursuant thereto or 
equivalent, or to the corresponding classification rules of another 
government.

    (g) Antibodies, recombinant protective antigens, polynucleotides, 
biopolymers, or biocatalysts (including their expression vectors, 
viruses, plasmids, or cultures of specific cells modified to produce 
them) as follows:
    (1) When exclusively funded by a Department of Defense contract for 
detection of the biological agents at paragraph (b)(1)(ii) of this 
category even if naturally occurring;
    (2) Joint Biological Agent Identification and Diagnostic System 
(JBAIDS) Freeze Dried reagents listed by JRPD-ASY-No and Description 
respectively as follows:
    (i) JRPD-ASY-0016 Q-Fever IVD Kit;
    (ii) JRPD-ASY-0100 Vaccinia (Orthopox);
    (iii) JRPD-ASY-0106 Brucella melitensis (Brucellosis);
    (iv) JRPD-ASY-0108 Rickettsia prowazekii (Rickettsia);
    (v) JRPD-ASY-0109 Burkholderia ssp. (Burkholderia);
    (vi) JRPD-ASY-0112 Eastern equine encephalitis (EEE);
    (vii) JRPD-ASY-0113 Western equine encephalitis (WEE);
    (viii) JRPD-ASY-0114 Venezuelan equine encephalitis (VEE);
    (ix) JRPD-ASY-0122 Coxiella burnetii (Coxiella);
    (x) JRPD-ASY-0136 Influenza A/H5 IVD Detection Kit;
    (xi) JRPD-ASY-0137 Influenza A/B IVD Detection Kit; or
    (xii) JRPD-ASY-0138 Influenza A Subtype IVD Detection Kit;
    (3) Critical Reagent Polymerase (CRP) Chain Reactions (PCR) assay 
kits with Catalog-ID and Catalog-ID Product respectively as follows:

[[Page 49538]]

    (i) PCR-BRU-1FB-B-K Brucella Target 1 FastBlock Master Mix 
Biotinylated;
    (ii) PCR-BRU-1FB-K Brucella Target 1 FastBlock Master Mix;
    (iii) PCR-BRU-1R-K Brucella Target 1 LightCycler/RAPID Master Mix;
    (iv) PCR-BURK-2FB-B-K Burkholderia Target 2 FastBlock Master Mix 
Biotinylated;
    (v) PCR-BURK-2FB-K Burkholderia Target 2 FastBlock Master Mix;
    (vi) PCR-BURK-2R-K Burkholderia Target 2 LightCycler/RAPID Master 
Mix;
    (vii) PCR-BURK-3FB-B-K Burkholderia Target 3 FastBlock Master Mix 
Biotinylated;
    (viii) PCR-BURK-3FB-K Burkholderia Target 3 FastBlock Master Mix;
    (ix) PCR-BURK-3R-K Burkholderia Target 3 LightCycler/RAPID Master 
Mix;
    (x) PCR-COX-1FB-B-K Coxiella burnetii Target 1 FastBlock Master Mix 
Biotinylated;
    (xi) PCR-COX-1R-K Coxiella burnetii Target 1 LightCycler/RAPID 
Master Mix;
    (xii) PCR-COX-2R-K Coxiella burnetii Target 2 LightCycler/RAPID 
Master Mix;
    (xiii) PCR-OP-1FB-B-K Orthopox Target 1 FastBlock Master Mix 
Biotinylated;
    (xiv) PCR-OP-1FB-K Orthopox Target 1 FastBlock Master Mix;
    (xv) PCR-OP-1R-K Orthopox Target 1 LightCycler/RAPID Master Mix;
    (xvi) PCR-OP-2FB-B-K Orthopox Target 2 FastBlock Master Mix 
Biotinylated;
    (xvii) PCR-OP-3R-K Orthopox Target 3 LightCycler/RAPID Master Mix;
    (xviii) PCR-RAZOR-BT-X PCR-RAZOR-BT-X RAZOR CRP BioThreat-X 
Screening Pouch;
    (xix) PCR-RIC-1FB-K Ricin Target 1 FastBlock Master Mix;
    (xx) PCR-RIC-1R-K Ricin Target 1 LightCycler/RAPID Master Mix;
    (xxi) PCR-RIC-2R-K Ricin Target 2 LightCycler/RAPID Master Mix; or
    (xxii) PCR-VEE-1R-K Venezuelan equine encephalitis Target 1 
LightCycler/RAPID Master Mix; or
    (4) Critical Reagent Program Antibodies with Catalog ID and Product 
respectively as follows:
    (i) AB-AG-RIC Aff. Goat anti-Ricin;
    (ii) AB-ALVG-MAB Anti-Alphavirus Generic Mab;
    (iii) AB-AR-SEB Aff. Rabbit anti-SEB;
    (iv) AB-BRU-M-MAB1 Anti-Brucella melitensis Mab 1;
    (v) AB-BRU-M-MAB2 Anti-Brucella melitensis Mab 2;
    (vi) AB-BRU-M-MAB3 Anti-Brucella melitensis Mab 3;
    (vii) AB-BRU-M-MAB4 Anti-Brucella melitensis Mab 4;
    (viii) AB-CHOL-0139-MAB Anti-V.cholerae 0139 Mab;
    (ix) AB-CHOL-01-MAB Anti-V. cholerae 01 Mab;
    (x) AB-COX-MAB Anti-Coxiella Mab;
    (xi) AB-EEE-MAB Anti-EEE Mab;
    (xii) AB-G-BRU-A Goat anti-Brucella abortus;
    (xiii) AB-G-BRU-M Goat anti-Brucella melitensis;
    (xiv) AB-G-BRU-S Goat anti-Brucella suis;
    (xv) AB-G-CHOL-01 Goat anti-V.cholerae 0:1;
    (xvi) AB-G-COL-139 Goat anti-V.cholerae 0:139;
    (xvii) AB-G-DENG Goat anti-Dengue;
    (xviii) AB-G-RIC Goat anti-Ricin;
    (xix) AB-G-SAL-T Goat anti-S. typhi;
    (xx) AB-G-SEA Goat anti-SEA;
    (xxi) AB-G-SEB Goat anti-SEB;
    (xxii) AB-G-SEC Goat anti-SEC;
    (xxiii) AB-G-SED Goat anti-SED;
    (xxiv) AB-G-SEE Goat anti-SEE;
    (xxv) AB-G-SHIG-D Goat anti-Shigella dysenteriae;
    (xxvi) AB-R-BA-PA Rabbit anti-Protective Antigen;
    (xxvii) AB-R-COX Rabbit anti-C. burnetii;
    (xxviii) AB-RIC-MAB1 Anti-Ricin Mab 1;
    (xxix) AB-RIC-MAB2 Anti-Ricin Mab 2;
    (xxx) AB-RIC-MAB3 Anti-Ricin Mab3;
    (xxxi) AB-R-SEB Rabbit anti-SEB;
    (xxxii) AB-R-VACC Rabbit anti-Vaccinia;
    (xxxiii) AB-SEB-MAB Anti-SEB Mab;
    (xxxiv) AB-SLT2-MAB Anti-Shigella-like t x2 Mab;
    (xxxv) AB-T2T-MAB1 Anti-T2 Mab 1;
    (xxxvi) AB-T2T-MAB2 Anti-T2 Toxin 2;
    (xxxvii) AB-VACC-MAB1 Anti-Vaccinia Mab 1;
    (xxxviii) AB-VACC-MAB2 Anti-Vaccinia Mab 2;
    (xxxix) AB-VACC-MAB3 Anti-Vaccinia Mab 3;
    (xl) AB-VACC-MAB4 Anti-Vaccinia Mab 4;
    (xli) AB-VACC-MAB5 Anti-Vaccinia Mab 5;
    (xlii) AB-VACC-MAB6 Anti-Vaccinia Mab 6;
    (xliii) AB-VEE-MAB1 Anti-VEE Mab 1;
    (xliv) AB-VEE-MAB2 Anti-VEE Mab 2;
    (xlv) AB-VEE-MAB3 Anti-VEE Mab 3;
    (xlvi) AB-VEE-MAB4 Anti-VEE Mab 4;
    (xlvii) AB-VEE-MAB5 Anti-VEE Mab 5;
    (xlviii) AB-VEE-MAB6 Anti-VEE Mab 6; or
    (xlix) AB-WEE-MAB Anti-WEE Complex Mab.
    (h) Vaccines exclusively funded by a Department of Defense 
contract, as follows:
    (1) Recombinant Botulinum Toxin A/B Vaccine;
    (2) Recombinant Plague Vaccine;
    (3) Trivalent Filovirus Vaccine; or
    (4) Vaccines specially designed for the sole purpose of protecting 
against biological agents and biologically derived substances 
identified in paragraph (b) of this category.

    Note to paragraph (h): See ECCN 1A607.k for military medical 
countermeasures such as autoinjectors, combopens, and creams.

    (i) Modeling or simulation tools, including software controlled in 
paragraph (m) of this category, for chemical or biological weapons 
design, development, or employment developed or produced under a 
Department of Defense contract or other funding authorization (e.g., 
the Department of Defense's HPAC, SCIPUFF, and the Joint Effects Model 
(JEM)).
    (j)-(l) [Reserved]
    (m) Technical data (as defined in Sec.  120.10 of this subchapter) 
and defense services (as defined in Sec.  120.9 of this subchapter) 
directly related to the defense articles enumerated in paragraphs (a) 
through (l) and (n) of this category. (See Sec.  125.4 of this 
subchapter for exemptions.)
    (n) Developmental countermeasures or sorbents funded by the 
Department of Defense via contract or other funding authorization;

    Note 1 to paragraph (n): This paragraph does not control 
countermeasures or sorbents that are (a) in production, (b) 
determined to be subject to the EAR via a commodity jurisdiction 
determination (see Sec.  120.4 of this subchapter), or (c) 
identified in the relevant Department of Defense contract or other 
funding authorization as being developed for both civil and military 
applications.


    Note 2 to paragraph (n): Note 1 does not apply to defense 
articles enumerated on the USML, whether in production or 
development.


    Note 3 to paragraph (n): This paragraph is applicable only to 
those contracts and funding authorizations that are dated July 28, 
2017, or later.

    (o)-(w) [Reserved]
    (x) Commodities, software, and technology subject to the EAR (see 
Sec.  120.42 of this subchapter) used in or with defense articles 
controlled in this category.

    Note to paragraph (x): Use of this paragraph is limited to 
license applications for defense articles controlled in this 
category where the purchase documentation includes

[[Page 49539]]

commodities, software, or technology subject to the EAR (see Sec.  
123.1(b) of this subchapter).

* * * * *

Category XVIII--Directed Energy Weapons

    * (a) Directed energy weapons as follows:
    (1) Systems or equipment that, other than as a result of 
incidental, accidental, or collateral effect:
    (i) Degrade, destroy or cause mission-abort of a target;
    (ii) Disturb, disable, or damage electronic circuitry, sensors or 
explosive devices remotely;
    (iii) Deny area access;
    (iv) Cause lethal effects; or
    (v) Cause ocular disruption or blindness; and
    (2) Use any non-acoustic technique such as lasers (including 
continuous wave or pulsed lasers), particle beams, particle 
accelerators that project a charged or neutral particle beam, high 
power radio-frequency (RF), or high pulsed power or high average power 
radio frequency beam transmitters.
    *(b) Systems or equipment specially designed to detect, identify, 
or provide defense against articles specified in paragraph (a) of this 
category.
    (c)-(d) [Reserved]
    (e) Components, parts, accessories, attachments, systems or 
associated equipment specially designed for any of the articles in 
paragraphs (a) or (b) of this category.
    (f) Developmental directed energy weapons funded by the Department 
of Defense via contract or other funding authorization, and specially 
designed parts and components therefor;

    Note 1 to paragraph (f): This paragraph does not control 
directed energy weapons (a) in production, (b) determined to be 
subject to the EAR via a commodity jurisdiction determination (see 
Sec.  120.4 of this subchapter), or (c) identified in the relevant 
Department of Defense contract or other funding authorization as 
being developed for both civil and military applications.


    Note 2 to paragraph (f): Note 1 does not apply to defense 
articles enumerated on the USML, whether in production or 
development.


    Note 3 to paragraph (f): This paragraph is applicable only to 
those contracts and funding authorizations that are dated July 28, 
2017, or later.

    (g) Technical data (see Sec.  120.10 of this subchapter) and 
defense services (as defined in Sec.  120.9 of this subchapter) 
directly related to the defense articles enumerated in paragraphs (a) 
through (e) of this category;
    (x) Commodities, software, and technology subject to the EAR (see 
Sec.  120.42 of this subchapter) used in or with defense articles 
controlled in this category.

    Note to paragraph (x): Use of this paragraph is limited to 
license applications for defense articles controlled in this 
category where the purchase documentation includes commodities, 
software, or technology subject to the EAR (see Sec.  123.1(b) of 
this subchapter).


 Rose E. Gottemoeller,
 Under Secretary, Arms Control and International Security, Department 
of State.
[FR Doc. 2016-17505 Filed 7-27-16; 8:45 am]
 BILLING CODE 4710-25-P