Quiero saber acerca de...

jbell on DSKJLSW7X2PROD with RULES

Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations 1C354, but that act against agents or other disease causing organisms that are not identified in any of these ECCNs.
This uncertainty caused some concern among manufacturers and exporters about the correct classification and licensing policies for such vaccines.
The clarifications in this rule to the scope of the vaccine controls in ECCN
1C991.a are also in response to recent scientific and medical developments.
For example, viruses controlled under ECCN 1C351 e.g., vesicular stomatitis virus, yellow fever virus, and Newcastle disease virus are being modified to express surface proteins of other target organisms or cells for stimulating immune response to the surface protein, thus acting as vaccines against those targets. These medical products can be designed for the following purposes: 1
Vaccination against agents controlled by ECCN 1C351 e.g., Ebolavirus or Chikungunya virus; 2 to protect against uncontrolled agents; or 3 as oncolytic medical products for treating specific cancers oncolytic virotherapy is an emerging treatment that uses replication competent viruses to destroy cancers.
This final rule addresses industrys concerns and the recent scientific and medical developments described above by revising ECCN 1C991.a to read as follows: Vaccines containing, or designed for use against, items controlled by ECCN 1C351, 1C353 or 1C354. As a result of this change, ECCN 1C991.a now clearly indicates that it controls all vaccines that contain items controlled by ECCN
1C351, 1C353 or 1C354, as well as those vaccines that are designed for use against these items.
This rule also amends ECCN 1C991 by expanding the scope of medical products controlled under this ECCN, consistent with the release i.e., exclusion note for such products in the List of Human and Animal Pathogens and Toxins for Export Control, to include medical products containing genetically modified organisms or genetic elements controlled under ECCN
1C353.a.3. In addition, the control text for medical products in ECCN 1C991 is renumbered by listing medical products that are subject to chemical/biological CB controls, as well as anti-terrorism AT controls, under ECCN 1C991.c and listing medical products that are subject only to AT controls, under ECCN
1C991.d. Prior to the effective date of this final rule, the former were listed under ECCN 1C991.d, while the latter were listed under ECCN 1C991.c. This change is intended to emphasize the more stringent controls that apply to the medical products now described in
VerDate Sep<11>2014

16:55 Jan 06, 2021

Jkt 253001

ECCN 1C991.c i.e., CB controls, in addition to AT controls and to clearly indicate that the CB controls that apply to most of the medical products controlled under this ECCN do not apply to the medical products now controlled under ECCN 1C991.d, which are subject only to AT controls the controls that apply to items in ECCN
1C991 are described in more detail, below. A conforming amendment is made to 742.2a3 of the EAR to reflect this change in paragraph sequencing.
This rule also makes a technical correction to the definition of medical products in the Related Definitions paragraph under the List of Items Controlled for ECCN 1C991 by adding the parenthetical phrase or veterinary to the criterion describing pharmaceutical formulations. The criterion, as corrected, reads as follows:
1 pharmaceutical formulations designed for testing and human or veterinary administration in the treatment of medical conditions. In addition, the definition of immunotoxins in the Related Definitions paragraph of ECCN 1C351
and ECCN 1C991 is clarified to read as follows: immunotoxins are monoclonal antibodies linked to a toxin with the intention of destroying a specific target cell while leaving adjacent cells intact.
This rule also adds a Technical Note at the beginning of the Items paragraph in the List of Items Controlled under ECCN 1C991 to clarify that, for purposes of the controls described in this ECCN, toxins means those toxins, or their subunits, controlled under ECCN 1C351.d.
Note that all items controlled by ECCN 1C991, including the vaccines described in ECCN 1C991.a, require a license for AT reasons to the destinations indicated under AT
Column 1 on the Commerce Country Chart in Supplement No. 1 to part 738
of the EAR also see the AT license requirements described in part 742 of the EAR that apply to Iran, North Korea, Sudan and Syria. In addition, the medical products now controlled by ECCN 1C991.c as renumbered by this rule require a license for CB reasons, as well as AT reasons, to the destinations indicated under CB Column 3 and AT
Column 1, respectively, on the Commerce Country Chart. A license also is required to certain destinations in accordance with the embargoes and other special controls described in part 746 of the EAR.
Anticipated Impact of This Final Rule Prior to the publication of this final rule, paragraph a of ECCN 1C991

PO 00000

Frm 00013

Fmt 4700

Sfmt 4700

945

included only those vaccines designed to protect against biological agents controlled under ECCN 1C351, 1C353 or 1C354 on the CCL. For example, the vaccine for protection against Ebola was previously and continues to be classified for control under ECCN
1C991, because Ebola, itself, is a controlled biological agent. The Ebola vaccine also contains genetic elements for recombinant vesicular stomatitis virus VSV, a controlled virus, and a common vector for vaccine development.
However, ECCN 1C991 did not previously include vaccines containing controlled biological agents that were not also designed to protect against a controlled agent. Other VSV-based vaccines against EAR99 agents i.e., agents not controlled on the CCL, such as SARS-CoV2, were controlled to all destinations under ECCN 1C353, because they did not act against a controlled agent as previously required by the ECCN 1C991 vaccine control text.
This rule amends the vaccine controls in paragraph a of ECCN 1C991 to more accurately reflect the scope of the AG
release note for vaccines, which exempts vaccines from control under the AG List of Human and Animal Pathogens and Toxins. Specifically, the AG release note exempts from control all vaccines containing one or more of the biological agents identified on this AG common control list.
Although certain COVID vaccines are not affected by this rule, the development of an unknown number of other vaccines, COVID and otherwise, is expected to be greatly facilitated as a result of these amendments to the vaccine controls in ECCN 1C991.
Effective with the publication of this rule, COVID vaccines containing genetic elements of items controlled by ECCN
1C353 such as VSV are now controlled under ECCN 1C991, instead of ECCN
1C353. Consequently, instead of requiring a license for export or reexport to all destinations, a license is required only to a much more limited number of destinations i.e., countries of concern for anti-terrorism AT reasons.
A specific example of the impact of this rule is a VSVSARS-CoV2 vaccine, which is a vesicular stomatitis virus modified by adding the gene for the coronavirus spike protein. Because this vaccine acts against SARS-CoV2, which is not controlled under ECCN
1C351, it was not classified as an ECCN
1C991 vaccine, prior to the publication of this rule. Instead, it was controlled under ECCN 1C353, in spite of having received FDA approval and being packaged for patient use, because it contains genetic elements from VSV a
E:FRFM07JAR1.SGM

07JAR1