Source: https://www.federalregister.gov/documents/2016/07/28/2016-17505/amendment-to-the-international-traffic-in-arms-regulations-revision-of-us-munitions-list-categories
Timestamp: 2018-08-21 18:40:13
Document Index: 651372745

Matched Legal Cases: ['art 73', 'art 121', '§\u2009120', '§\u2009120', '§\u2009120', 'art 312', 'arts 710', '§\u2009120', '§\u2009120', '§\u2009120', '§\u2009125', '§\u2009123', '§\u2009120', '§\u2009120']

A Rule by the State Department on 07/28/2016
49531-49539 (9 pages)
https://www.federalregister.gov/d/2016-17505 https://www.federalregister.gov/d/2016-17505
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.
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 Start Printed Page 49532within 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.
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.
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 § 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.
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).
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 Start Printed Page 49533control 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.
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.
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.
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.
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 Start Printed Page 49534such information and activities is appropriate given the narrowed scope of revised paragraph (b) to specific weaponized biological agents.
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.
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.
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.
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 § 120.41(b). The Department disagrees with this comment because it is not likely that ITAR § 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).
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.
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.
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.Start Printed Page 49535
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.
End Authority Start Printed Page 49536 Start Amendment Part
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.
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.
“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.
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) Dispersal characteristics (e.g., reduced susceptibility to shear forces, optimized electrostatic charges); orStart Printed Page 49537
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.
(4) Chlorosoman: O-Pinacolyl methylphosphonochloridate (CAS 7040-57-5) (CWC Schedule 1B); or
(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
(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.
This paragraph does not control articles that are (a) determined to be subject to the EAR via a commodity jurisdiction determination (see § 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.
(3) Critical Reagent Polymerase (CRP) Chain Reactions (PCR) assay kits with Catalog-ID and Catalog-ID Product respectively as follows:Start Printed Page 49538
(1) Recombinant Botulinum ToxinA/B Vaccine;
(m) Technical data (as defined in § 120.10 of this subchapter) and defense services (as defined in § 120.9 of this subchapter) directly related to the defense articles enumerated in paragraphs (a) through (l) and (n) of this category. (See § 125.4 of this subchapter for exemptions.)
This paragraph is applicable only to those contracts and funding authorizations that are dated July 28, 2017, or later.
Use of this paragraph is limited to license applications for defense articles controlled in this category where the purchase documentation includes Start Printed Page 49539commodities, software, or technology subject to the EAR (see § 123.1(b) of this subchapter).
* (a) Directed energy weapons as follows:
(g) Technical data (see § 120.10 of this subchapter) and defense services (as defined in § 120.9 of this subchapter) directly related to the defense articles enumerated in paragraphs (a) through (e) of this category;
[FR Doc. 2016-17505 Filed 7-27-16; 8:45 am]