[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Proposed Rules]
[Pages 34572-34579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14472]


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DEPARTMENT OF STATE

22 CFR Part 121

RIN 1400-AD03
[Public Notice: 9166]


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

AGENCY: Department of State.

ACTION: Proposed rule.

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SUMMARY: As part of the President's Export Control Reform effort, the 
Department of State proposes to amend 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: The Department of State will accept comments on this proposed 
rule until August 17, 2015.

ADDRESSES: Interested parties may submit comments within 60 days of the 
date of publication by one of the following methods:
     Email: [email protected] with the subject line, 
``ITAR Amendment--Categories XIV and XVIII.''
     Internet: At www.regulations.gov, search for this proposed 
rule by using this rule's RIN (1400-AD03).
    Comments received after that date will be considered if feasible, 
but consideration cannot be assured. Those submitting comments should 
not include any personally identifying information they do not wish to 
be made public or information for which a claim of confidentiality is 
asserted because those comments and/or transmittal emails will be made 
available for public inspection and copying after the close of the 
comment period via the Directorate of Defense Trade Controls Web site 
at www.pmddtc.state.gov. Parties who wish to comment anonymously may do 
so by submitting their comments via www.regulations.gov, leaving the 
fields that would identify the commenter blank and including no 
identifying information in the comment itself. Comments submitted via 
www.regulations.gov are immediately available for public inspection.

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.

Revision of Category XIV

    This proposed rule revises USML Category XIV, covering 
toxicological agents, including chemical agents, biological agents, and 
associated equipment. The revisions are proposed in order to advance 
the national security objectives of greater interoperability with U.S. 
allies, enhancing the defense industrial base, and permitting the U.S. 
government to focus its resources on transactions of greater concern. 
Additionally, the revisions are intended to more accurately describe 
the articles within the subject categories, in order to establish a 
``bright line'' between the USML and the CCL for the control of these 
articles.
    This proposed rule implements changes consistent with the 
requirements of Executive Order 13546 on Optimizing the Security of 
Biological Select Agents and Toxins in the United States, which 
includes direction to address variations in, and limited coordination 
of, individual executive departments' and agencies' oversight that add 
to the cost and complexity of compliance. It also directs a risk-based 
tiering of the biological select agent list. As a result, the proposed 
control language in paragraph (b) adopts the ``Tier 1'' pathogens and 
toxins established in the Department of Health and Human Services and 
the United States Department of Agriculture select agent regulations 
(42 CFR part 73 and 9 CFR 121) for those pathogens and toxins that meet 
specific capabilities listed in paragraph (b). The Tier 1 pathogens and 
toxins that do not meet these capabilities remain controlled in Export 
Control Classification Number (ECCN) 1C351 or 1C352 on the CCL.
    Additionally, this rule, in concert with the analogous proposed 
rule published by the Department of

[[Page 34573]]

Commerce, proposes the movement of riot control agents to the export 
jurisdiction of the Department of Commerce, as well as the articles 
covered currently 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 (f)(4) or the CCL. Proposed 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.
    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.
    Proposed paragraph (h) enumerates certain vaccines funded 
exclusively by the Department of Defense, as well as certain vaccines 
controlled in (h)(2) 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)(2) is circumscribed by the nature of funding, the satisfaction of 
the term ``specially designed'' as that term is defined in ITAR Sec.  
120.41, and the limitations in (b) that control only those biological 
agents and biologically derived substances meeting specific criteria. 
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.
    Proposed revised 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.
    Finally, the rule proposes to only control on the USML chemical or 
biological agent detectors when they contain Department of Defense 
reagents, spectra, algorithms, databases, etc.

Revision of Category XVIII

    This proposed rule revises USML Category XVIII, covering directed 
energy weapons. As with USML Category XIV, the revisions are proposed 
in order to advance the national security objectives set forth above 
and to more accurately describe the articles within the subject 
categories, in order to establish a ``bright line'' between the USML 
and the CCL for the control of these articles. A change proposed in 
this rule would revise paragraph (a) to control only those items that 
satisfy the paragraph's definition of ``directed energy weapon,'' which 
focuses on the sole or primary purpose of the article in order to 
exclude those items that might achieve the same effect in an 
incidental, accidental, or collateral manner.
    The articles controlled currently in paragraphs (c) and (d) would 
move to the export control jurisdiction of the Department of Commerce.
    The remaining paragraphs in this category would undergo conforming 
changes to bring their structures into alignment with the analogous 
provisions found in other revised USML categories.

Request for Comments

    The proposed revisions to the USML will control items in normal 
commercial use and on the Wassenaar Arrangement's Dual Use List. The 
Department welcomes the assistance of users of the lists and requests 
input on the following:
    (1) A key goal of this rulemaking is to ensure the USML and the CCL 
together control all the items that meet Wassenaar Arrangement 
commitments embodied in Munitions List Categories 7 (WA-ML7) and 19 
(WA-ML19). The public is therefore asked to identify any potential lack 
of coverage brought about by the proposed rules for Categories XIV and 
XVIII contained in this proposed rule and the new Category 1 and 
Category 6 ECCNs published separately by the Department of Commerce 
when reviewed together.
    (2) Another key goal of this rulemaking is to identify items 
proposed for control on the USML or the CCL that are not controlled on 
the Wassenaar Arrangement's Munitions or Dual Use List. The public is 
therefore asked to identify any potential expansion of coverage brought 
about by the proposed rules for Categories XIV and XVIII contained in 
this proposed rule and the new Category 1 and Category 6 ECCNs 
published separately by the Department of Commerce when reviewed 
together.
    (3) A third key goal of this rulemaking is to establish a ``bright 
line'' between the USML and the CCL for the control of these materials. 
The public is asked to provide specific examples of toxicological 
agents, including chemical agents, biological agents, and associated 
equipment, as well as directed energy weapons, whose jurisdiction would 
be in doubt based on this revision. The public is also asked to comment 
on whether there is a sufficiently clear line drawn between the 
biological items proposed for control by USML Category XIV(b) and those 
proposed for control under the CCL.
    (4) Although the proposed revisions to the USML do not preclude the 
possibility that items in normal commercial use would or should be 
ITAR-controlled because, e.g., they provide the United States with a 
critical military or intelligence advantage, the U.S. government does 
not want to inadvertently control items on the ITAR that are in normal 
commercial use. Items that would be controlled on the USML in this 
proposed rule have been identified as possessing parameters or 
characteristics that provide a critical military or intelligence 
advantage. The public is thus asked to provide specific examples of 
items, or associated technical data, if any, that would be controlled 
in the revised USML Categories XIV or XVIII that are now in normal 
commercial use, or that are

[[Page 34574]]

commonly used or produced in civilian scientific laboratories. The 
examples should demonstrate actual commercial or civilian scientific 
use, not just potential or theoretical use, with supporting documents, 
as well as foreign availability of such items. Additionally, for any 
criteria the public believes control items in normal commercial or 
civilian scientific use, the public is asked to identify parameters or 
characteristics that cover items exclusively or primarily in military 
use. Finally, for any criteria the public believes control items in 
normal commercial use, the public is asked to identify the multilateral 
controls (such as the Wassenaar Arrangement's Dual Use List), if any, 
for such items, and the consequences of such items being controlled on 
the USML.
    (5) The public is asked to provide comment on the proposed 
definition of ``non-naturally occurring'' in Note 2 to Category XIV(b), 
if the proposed definition does not appear to be comprehensive. The 
public is also asked to comment on ``non-naturally occurring'' in the 
context of genetic modification and consider whether the definition is 
sufficient to distinguish military or intelligence purposes from 
commercial or civilian purposes.
    (6) The public is asked to provide specific examples of reagents 
that may be inadvertently controlled by Category XIV(b), XIV(f), 
XIV(g), or XIV(m), that are commonly used for scientific research and 
development, or medical countermeasures that may similarly be 
inadvertently controlled and the dissemination of which would be in the 
interest of public health or medical preparedness.
    (7) The public is asked to specifically evaluate and comment on the 
decision process outlined in the proposed rule that would be used to 
determine whether vaccines that are intended to be developed and used 
to protect public and veterinary health against any event resulting 
from exposure to naturally occurring or non-naturally occurring 
pathogens or toxins is sufficiently clear to allow research and 
commercial entities to determine whether a vaccine would 
unintentionally be captured under this rule. Please provide specific 
examples that demonstrate how the proposed rule would prevent or hinder 
the ability to develop or utilize vaccines for public health or 
veterinary benefit under this proposed language and decision process.
    (8) In the interest of ensuring the security of and control over 
certain types of chemical and biological detection equipment, Category 
XIV(f)(2) could incidentally impose ITAR controls on certain civilian 
and public health equipment containing the items listed in paragraph 
(f)(2). Accordingly, as proposed, paragraph (f)(2) may control 
detection equipment that may not warrant ITAR control, but contains 
items that are fully or partially Defense-funded. The Department 
requests comment from the public, including specific examples of 
equipment that the public believes may be unintentionally controlled by 
this text by virtue of Defense funding.
    In addition, the Department acknowledges that some members of the 
public may not be able comment meaningfully on this matter because they 
lack full awareness of items that have previously been fully or 
partially developed under Defense funding. To the extent that 
commenters require specific additional information about the scope of 
Defense funding in certain contexts, the Department requests that 
commenters identify any relevant gaps in knowledge.

Regulatory Analysis and Notices

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 is publishing this 
rule 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. As noted above, and also 
without prejudice to the Department position that this rulemaking is 
not subject to the APA, the Department previously published a related 
Advance Notice of Proposed Rulemaking (RIN 1400-AC78) on December 10, 
2010 (75 FR 76935), and accepted comments for 60 days.

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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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.

[[Page 34575]]

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 and the description of the manner in which they will be 
affected pertains to revision of the USML in its entirety, not only to 
the categories published in this rule. In accordance with the Paperwork 
Reduction Act, the Department of State will request comment on these 
collections from all interested persons. In particular, the Department 
will seek comment on changes to licensing burden based on 
implementation of regulatory changes pursuant to ECR, and on projected 
changes based on continued implementation of regulatory changes 
pursuant to ECR. The affected information collections are as follows:
    (1) Statement of Registration, DS-2032, OMB No. 1405-0002. The 
Department estimates that between 3,000 and 5,000 of currently-
registered persons will not need to maintain registration following 
full revision of the USML. This would result in a burden reduction of 
between 6,000 and 10,000 hours annually, based on a revised time burden 
of two hours to complete a Statement of Registration.
    (2) Application/License for Permanent Export of Unclassified 
Defense Articles and Related Unclassified Technical Data, DSP-5, OMB 
No. 1405-0003. The Department estimates that there will be 35,000 fewer 
DSP-5 submissions annually following full revision of the USML. This 
would result in a burden reduction of 35,000 hours annually.
    (3) Application/License for Temporary Import of Unclassified 
Defense Articles, DSP-61, OMB No. 1405-0013. The Department estimates 
that there will be 200 fewer DSP-61 submissions annually following full 
revision of the USML. This would result in a burden reduction of 100 
hours annually.
    (4) Application/License for Temporary Export of Unclassified 
Defense Articles, DSP-73, OMB No. 1405-0023. The Department estimates 
that there will be 800 fewer DSP-73 submissions annually following full 
revision of the USML. This would result in a burden reduction of 800 
hours annually.
    (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. The Department estimates that 
there will be 2,000 fewer amendment submissions annually following full 
revision of the USML. This would result in a burden reduction of 1,000 
hours annually.
    (6) Request for Approval of Manufacturing License Agreements, 
Technical Assistance Agreements, and Other Agreements, DSP-5, OMB No. 
1405-0093. The Department estimates that there will be 1,000 fewer 
agreement submissions annually following full revision of the USML. 
This would result in a burden reduction of 2,000 hours annually.
    (7) Maintenance of Records by Registrants, OMB No. 1405-0111. The 
requirement to actively maintain records pursuant to provisions of the 
International Traffic in Arms Regulations (ITAR) will decline 
commensurate with the drop in the number of persons who will be 
required to register with the Department pursuant to the ITAR. As 
stated above, the Department estimates that up to 5,000 of the 
currently-registered persons will not need to maintain registration 
following full revision of the USML. This would result in a burden 
reduction of 100,000 hours annually. However, the ITAR does provide for 
the maintenance of records for a period of five years. Therefore, 
persons newly relieved of the requirement to register with the 
Department may still be required to maintain records.

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 proposed to be 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.

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, to include:
    (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:

[[Page 34576]]

    (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 by the Food and Drug 
Administration to be marketed as a clinical or medical product or 
for use as an ``Investigational New Drug'' (IND) (see 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 722). 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 which 
result in an increase in any of the following:
    (A) Persistence in a field environment (e.g., resistance to oxygen, 
UV damage, temperature extremes, or arid conditions); 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, 1C352, 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 results in an increase in any of the following:
    (A) Persistence in a field environment (e.g., resistant to oxygen, 
UV damage, temperature extremes, or arid conditions);
    (B) Dispersal characteristics (e.g., reduce the susceptibility to 
shear forces, optimize electrostatic charges); or
    (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-Pinakolyl methylphosphonochloridate (CAS 7040-
57-5) (CWC Schedule 1B); or
    (5) Methlyphosphonyl 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) Equipment or items, as follows:

[[Page 34577]]

    (1) Any equipment for the dissemination, dispersion, or testing of 
items controlled in paragraphs (a), (b), (c), or (e) of this category, 
as follows:
    (i) Any equipment ``specially designed'' for the dissemination and 
dispersion of items controlled in paragraphs (a), (b), (c), or (e) of 
this category; or
    (ii) Any equipment ``specially designed'' for testing the items 
controlled in paragraphs (a), (b), (c), (e), or (f)(4) of this category 
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) Items controlled in paragraphs (a) or (b) of this category; or
    (ii) Chemical or biological agents specified by a Department of 
Defense contract or other funding authorization.

    Note 1 to paragraph (f)(2): This paragraph does not control 
items 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.


    Note 3 to paragraph (f)(2): This paragraph is applicable only to 
those contracts and funding authorizations that are dated [DATE ONE 
YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE], or later.

    (3) [Reserved]
    (4) For individual protection or collective protection against the 
items 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) of this category;
    (iii) 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% of HD;

    Note to paragraph (f)(4)(iv): Evaluation is made by applying 10 
mg of GD or HD to a 1-inch swatch. Ambient air is directed through 
the swatch for 24 hours and sampled/tested from the opposite side of 
the swatch using a gas chromatograph with flame photometric detector 
(FPD) or pulsed FPD (PFPD) and using sorption/desorption tools to 
increase sensitivity.

    (5) [Reserved]
    (6) [Reserved]
    (7) Chemical Agent Resistant Coatings that have been qualified to 
military specifications (MIL-DTL-64159, MIL-C-46168, or MIL-C-53039); 
or
    (8) Any equipment, material, tooling, hardware or test equipment 
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:
    (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;

[[Page 34578]]

    (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 [DATE ONE 
YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE], 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 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 (DEW): systems or equipment that, as 
their sole or primary purpose (i.e., not as a result of incidental, 
accidental or collateral effect), degrade, destroy or cause mission-
abort of a target; disturb, disable, or damage electronic circuitry, 
sensors or explosive devices remotely; deny area access; cause lethal 
effects; or cause permanent or flash blindness using 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, and associated 
systems or equipment specially designed for any of the articles in 
paragraphs (a) and (b) of this category.
    (f) Developmental directed energy weapons funded by the Department 
of Defense via contract or other funding authorization;

    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 [DATE ONE 
YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE], or later.

    (g) 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 (e) of this category;
    (h)-(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

[[Page 34579]]

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).


    Dated: June 3, 2015.
 Rose E. Gottemoeller,
 Under Secretary, Arms Control and International Security, Department 
of State.
[FR Doc. 2015-14472 Filed 6-16-15; 8:45 am]
 BILLING CODE 4710-25-P