[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