[Federal Register Volume 60, Number 146 (Monday, July 31, 1995)]
[Rules and Regulations]
[Pages 38956-38957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18688]
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DEPARTMENT OF COMMERCE
Bureau of Export Administration
15 CFR Parts 778 and 799
[Docket No. 950720186-5186-01]
RIN 0694-AA69
Revisions to the Export Administration Regulations: Exports of
Vaccines
AGENCY: Bureau of Export Administration, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Export Administration maintains the Commerce
Control List (CCL), which appears in the Export Administration
Regulations (EAR). This rule revises the scope of controls applicable
to vaccines that contain Australia Group (AG) controlled microorganisms
or toxins that are currently classified under 1C61B. This rule amends
the CCL by creating a new Export Control Classification Number (ECCN)
1C91F to authorize the export of vaccines that contain AG-controlled
microorganisms or toxins under the provisions of General License G-DEST
to eligible destinations (i.e. all destinations except Country Groups S
and Z, and Iran).
This rule will reduce the licensing and paperwork burden on U.S.
exporters of vaccines without jeopardizing U.S. policy objectives in
stemming the proliferation of biological weapons.
EFFECTIVE DATE: This rule is effective July 26, 1995.
FOR FURTHER INFORMATION CONTACT: For questions on vaccines, call James
Seevaratnam, Bureau of Export Administration, telephone: (202) 482-
3343; or Patricia Sefcik, telephone: (202) 482-0707.
SUPPLEMENTARY INFORMATION:
Background
ECCN 1C61B contains a list of microorganisms and toxins that
require a validated license to all destinations except Canada. The list
of controlled organisms corresponds to the list of controlled items
agreed to by the Australia Group, a multilateral group dedicated to
preventing the proliferation of chemical and biological weapons. This
rule removes validated export licensing requirements on vaccines that
contain microorganisms or toxins controlled under ECCN 1C61B because
there is no consensus for multilateral controls under the Australia
Group and because the United States Government agrees that it is highly
unlikely that vaccines, whether live, attenuated or dead, can directly
aid in the development, production and weaponization of biological
weapons agents.
Specifically, this rule amends the CCL by creating a new Export
Control Classification Number (ECCN) 1C91F to authorize the export of
vaccines that contain AG-controlled microorganisms or toxins under the
provisions of General License G-DEST to eligible destinations (i.e. all
destinations except Country Groups S and Z, and Iran). Extra caution
should be exercised when making any large shipment (i.e. 5,000 doses or
more), or when making any shipment to destinations, projects, or
facilities of proliferation concern that are identified in Supplement
No. 5 to Part 778 of the EAR. Also note that pursuant to the Iraqi
Sanctions Regulations (31 CFR 575.205 of January 18, 1991), no goods,
technology (including technical data or other information), or services
may be exported from the United States, or if subject to U.S.
jurisdiction, exported or reexported from a third county to Iraq, to
any entity owned or controlled by the Government of Iraq, except as
authorized by the Department of Treasury's Office of Foreign Assets
Control.
This export licensing liberalization has no effect on the
regulatory requirements of any other agency or department, e.g., Food
and Drug Administration, U.S. Department of Agriculture.
[[Page 38957]]
Although the Export Administration Act (EAA) expired on August 20,
1994, the President invoked the International Emergency Economic Powers
Act and continued in effect, to the extent permitted by law, the
provisions of the EAA and the EAR in Executive Order 12924 of August
19, 1994.
Rulemaking Requirements
1. This final rule has been determined to be not significant for
purposes of Executive Order 12866.
2. This rule involves collections of information subject to the
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These
collections have been approved by the Office of Management and Budget
under control numbers 0694-0005, 0694-0010 and 0694-0067.
3. This rule does not contain policies with Federalism implications
sufficient to warrant preparation of a Federalism assessment under
Executive Order 12612.
4. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by section
553 of the Administrative Procedure Act (5 U.S.C. 553) or by any other
law, under section 3(a) of the Regulatory Flexibility Act (5 U.S.C.
603(a) and 604(a)) no initial or final Regulatory Flexibility Analysis
has to be or will be prepared.
5. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a foreign and military affairs
function of the United States. No other law requires that a notice of
proposed rulemaking and an opportunity for public comment be given for
this rule.
Therefore, this regulation is issued in final form. Although there
is no formal comment period, public comments on this regulation are
welcome on a continuing basis. Comments should be submitted to Sharron
Cook, Regulatory Policy Division, Bureau of Export Administration,
Department of Commerce, P.O. Box 273, Washington, DC 20044.
List of Subjects
15 CFR Part 778
Exports, Nuclear energy, Reporting and recordkeeping requirements.
15 CFR Part 799
Exports, Reporting and recordkeeping requirements.
Accordingly, Parts 778 and 799 of the Export Administration
Regulations (15 CFR Parts 730-799) are amended as follows:
1. The authority citations for 15 CFR Part 778 continues to read as
follows:
Authority: Pub. L. 90-351, 82 Stat. 197 (18 U.S.C. 2510 et
seq.), as amended; Pub. L. 95-223, 91 Stat. 1626 (50 U.S.C. 1701 et
seq.); Pub. L. 95-242, 92 Stat. 120 (22 U.S.C. 3201 et seq. and 42
U.S.C. 2139a); Pub. L. 96-72, 93 Stat. 503 (50 U.S.C. App. 2401 et
seq.), as amended [(extended by Pub. L. 103-10, 107 Stat. 40 and by
Pub. L. 103-277, 108 Stat. 1407)]; Pub. L. 102-484, 106 Stat. 2575
(22 U.S.C. 6004); E.O. 12002 of July 7, 1977 (42 FR 35623, July 7,
1977), as amended; E.O. 12058 of May 11, 1978 (43 FR 20947, May 16,
1978); E.O. 12214 of May 2, 1980 (45 FR 29783, May 6, 1980); E.O.
12851 of June 11, 1993 (58 FR 33181, June 15, 1993); E.O. 12867 of
September 30, 1993 (58 FR 51747, October 4, 1993); E.O. 12924 of
August 19, 1994 (59 FR 43437 of August 23, 1994); and E.O. 12938 of
November 14, 1994 (59 FR 59099 of November 16, 1994).
2. The authority citation for 15 CFR Part 799 continues to read as
follows:
Authority: 50 U.S.C. App. 5, as amended; Pub. L. 264, 59 Stat.
619 (22 U.S.C. 287c), as amended; Pub. L. 90-351, 82 Stat. 197 (18
U.S.C. 2510 et seq.), as amended; sec. 101, Pub. L. 93-153, 87 Stat.
576 (30 U.S.C. 185), as amended; sec. 103, Pub. L. 94-163, 89 Stat.
877 (42 U.S.C. 6212), as amended; secs. 201 and 201(11)(e), Pub. L.
94-258, 90 Stat. 309 (10 U.S.C. 7420 and 7430(e)), as amended; Pub.
L. 95-223, 91 Stat. 1626 (50 U.S.C. 1701 et seq.); Pub. L. 95-242,
92 Stat. 120 (22 U.S.C. 3201 et seq. and 42 U.S.C. 2139a); sec. 208,
Pub. L. 95-372, 92 Stat. 668 (43 U.S.C. 1354); Pub. L. 96-72, 93
Stat. 503 (50 U.S.C. App. 2401 et seq.), as amended; sec. 125, Pub.
L. 99-64, 99 Stat. 156 (46 U.S.C. 466c); Pub. L. 102-484, 106 Stat.
2575 (22 U.S.C. 6004); E.O. 11912 of April 13, 1976 (41 FR 15825,
April 15, 1976); E.O. 12002 of July 7, 1977 (42 FR 35623, July 7,
1977), as amended; E.O. 12058 of May 11, 1978 (43 FR 20947, May 16,
1978); E.O. 12214 of May 2, 1980 (45 FR 29783, May 6, 1980); E.O.
12851 of June 11, 1993 (58 FR 33181, June 15, 1993); E.O. 12867 of
September 30, 1993 (58 FR 51747, October 4, 1993); E.O 12918 of May
26, 1994 (59 FR 28205, May 31, 1994); E.O. 12924 of August 19, 1994
(59 FR 43437 of August 23, 1994); and E.O. 12938 of November 14,
1994 (59 FR 59099 of November 16, 1994).
PART 778--[AMENDED]
3. Section 778.8(a)(3) is revised to read as follows:
Sec. 778.8 Chemical precursors and biological agents, and associated
equipment, software, and technology.
(a) * * *
(3) Viruses, viroids, bacteria, fungi, and protozoa controlled by
ECCN 1C61B require a validated license to all destinations except
Canada. Vaccines that contain items controlled under ECCN 1C61B are
controlled by ECCN 1C91F, and are eligible for General License G-DEST
to all destinations except Country Groups S and Z, and Iran.
* * * * *
PART 799--[AMENDED]
Supplement No. 1 to Sec. 799.1 [Amended]
4. In Category 1 (Materials), ECCN 1C61B is amended by revising the
heading and the Requirements Section, and a new ECCN 1C91F is added
immediately following ECCN 1C88D, to read as follows:
1C61B Microorganisms and toxins.
Requirements
Validated License Required: QSTVWYZ
Unit: $ Value
Reason for Control: CB
GLV: $0
GCT: No
GFW: No
Note: Notwithstanding the provisions of this entry, all vaccines
are excluded from the scope of this entry. See ECCN 1C91F.
* * * * *
1C91F Vaccines containing microorganisms and/or toxins controlled by
ECCN 1C61B.
Requirements
Validated License Required: SZ, Iran
Unit: $ Value
Reason for Control: FP
GLV: No
GCT: No
GFW: No
Note: Vaccines that do not contain items controlled by ECCN
1C61B are controlled by ECCN 1C96G.
Dated: July 26, 1995.
Iain S. Baird,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 95-18688 Filed 7-28-95; 8:45 am]
BILLING CODE 3510-DT-P