Revisions to the Export Administration Regulations: Exports of Vaccines

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]

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