[Federal Register Volume 68, Number 111 (Tuesday, June 10, 2003)]
[Rules and Regulations]
[Pages 34526-34533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14602]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 742, 745, and 774

[Docket No. 030523133-3133-01]
RIN 0694-AC70


Implementation of the Understandings Reached at the June 2002 
Australia Group (AG) Plenary Meeting and the AG Intersessional Decision 
on Cross Flow Filtration Equipment--Chemical and Biological Weapons 
Controls in the Export Administration Regulations

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Bureau of Industry and Security (BIS) is publishing this 
final rule to describe the understandings reached at the June 2002 
plenary meeting of the Australia Group (AG) and to amend the Export 
Administration Regulations (EAR), as needed, to implement these AG 
understandings. This final rule amends the licensing policy provisions 
in the EAR that apply to exports and reexports of items on the AG 
control list by clarifying several factors that are among those used to 
evaluate license applications for these AG-listed items and by 
identifying additional factors not previously listed in the EAR. In 
addition, this rule clarifies the circumstances under which BIS would 
deny license applications to export or reexport these AG-listed items. 
All of these changes are intended to ensure that the EAR provisions 
that apply to AG-listed items are consistent with the ``Guidelines for 
Transfers of Sensitive Chemical or Biological Items,'' which were 
adopted at the June 2002 AG plenary meeting.
    This rule also implements understandings reached at the June 2002 
plenary meeting concerning AG controls on fermenters and toxins. The 
control threshold for AG-listed fermenters described on the Commerce 
Control List (CCL) is lowered from a capacity of 100 liters or greater 
to a capacity of 20 liters or greater. In addition, this rule adds 
eight new toxins to the list of AG-listed human and zoonotic pathogens 
and toxins described on the CCL.
    In addition to the AG plenary meeting changes described above, this 
rule implements an AG intersessional decision concerning cross 
(tangential) flow filtration equipment.
    The rule makes corrections in four CCL entries that contain AG-
listed items. One entry, containing AG-listed genetic elements and 
genetically modified organisms, is amended to correct errors in the use 
of the terms ``organism'' and ``microorganism.'' Another entry, 
containing AG-listed chemical manufacturing facilities and equipment, 
is amended to clarify the scope of that entry's controls on certain 
valves containing nickel and nickel alloys and on agitators for use in 
reaction vessels or reactors. Two other CCL entries are amended to 
clarify the license requirements that apply to technology for the 
``development'' or ``production'' of AG-listed valves containing nickel 
and nickel alloys. In addition, the rule amends the AG-based licensing 
provisions in the EAR to identify certain CCL entries that were 
inadvertently omitted when BIS amended these provisions on previous 
occasions.
    Finally, this rule updates the list of countries that are currently 
States Parties to the Chemical Weapons Convention (CWC) by adding six 
countries that recently became States Parties: Andorra, Guatemala, 
Palau, Saint Vincent and the Grenadines, Samoa, and Thailand.

DATES: This rule is effective June 10, 2003.

ADDRESSES: Written comments should be sent to Willard Fisher, 
Regulatory Policy Division, Office of Exporter Services, Bureau of 
Industry and Security, Room 2705, 14th Street and Pennsylvania Avenue, 
NW., Washington, DC 20230.

FOR FURTHER INFORMATION CONTACT: Douglas Brown, Office of Chemical and 
Biological Controls and Treaty Compliance, Bureau of Industry and 
Security, Telephone: (202) 482-7900.

SUPPLEMENTARY INFORMATION:

Background

A. Revisions to the EAR Based on the June 2002 Plenary Meeting of the 
Australia Group

    The Bureau of Industry and Security (BIS) is amending the Export 
Administration Regulations (EAR) to implement understandings reached at 
the annual plenary meeting of the Australia Group (AG) that was held in 
Paris on June 3-6, 2002. The Australia Group is a multilateral forum, 
consisting of 33 participating countries, that maintains export 
controls on a list of chemicals, biological agents, and related 
equipment and technology that could be used in a chemical or biological 
weapons program. The AG periodically reviews items on its control list 
to enhance the effectiveness of participating governments' national 
controls and to achieve greater harmonization among these controls.
    This rule implements two understandings reached at the June 2002 
plenary meeting concerning AG controls on fermenters and toxins. The 
control threshold for AG-listed fermenters, described in ECCN 2B352.b 
on the Commerce Control List (CCL), is lowered from a capacity (i.e., 
volume) of 100 liters or greater to a capacity of 20 liters or greater. 
In addition, this rule adds the following eight toxins to the list of 
AG-listed toxins described in ECCN 1C351.d on the CCL: (1) abrin, (2) 
cholera toxin, (3) diacetoxyscirpenol toxin, (4) T-2 toxin, (5) HT-2 
toxin, (6) modeccin toxin, (7) volkensin toxin, and (8) viscum album 
lectin 1 (viscumin). These AG-listed toxins, along with all other items 
controlled by ECCN 1C351, require a license for export or reexport to 
all destinations, worldwide.
    This rule makes conforming changes to the List of Items Controlled 
in ECCN 1C991 by revising ECCN 1C991.d to include medical products 
containing any of the eight toxins that were added to ECCN 1C351.d by 
this rule. In addition, this rule revises the Related Definitions 
paragraph in the List of Items Controlled by ECCN 1C991 by adding the 
AG definition of ``vaccine,'' which was adopted at the June 2002 AG 
plenary meeting. For the purpose of ECCN 1C991, ``vaccine'' is defined 
as a medicinal (or veterinary) product in a pharmaceutical formulation, 
approved by the U.S. Food and Drug Administration or the U.S. 
Department of Agriculture to be marketed as a medical (or veterinary) 
product or for use in clinical trials, that is intended to stimulate a 
protective immunological response in humans or animals in order to 
prevent disease in those to whom or to which it is administered. ECCN 
1C991.a is revised to conform with the AG definition of ``vaccine'' by 
clarifying the control language to indicate that 1C991.a controls 
vaccines against items controlled by ECCN 1C351, 1C352, 1C353, or 
1C354.
    This final rule also amends the EAR to ensure that the licensing 
policy provisions in the EAR that apply to AG-listed items are 
consistent with the ``Guidelines for Transfers of Sensitive Chemical or 
Biological Items,'' which were adopted by the AG at the June 2002 
plenary meeting. Specifically, this rule amends section 742.2(b)(2) of 
the EAR by clarifying several factors that are among those used to 
evaluate license applications to export or reexport these AG-listed 
items and by identifying

[[Page 34527]]

additional factors not previously listed in the EAR. The additional 
licensing factors that are now identified in the EAR include: (1) The 
reliability of the parties to the transaction (including previous 
licensing history, information on any clandestine or illegal 
procurement activities, and the end-user's ability to securely handle 
and store the items to be exported); (2) relevant information about 
proliferation and terrorism activities (including those involving any 
parties to the transaction); (3) the risk of diversion of the items; 
and (4) the applicability of other multilateral export control or 
nonproliferation agreements (e.g., the Chemical Weapons Convention and 
the Biological and Toxin Weapons Convention) to the transaction.
    In addition, this rule clarifies the circumstances under which BIS 
would deny license applications to export or reexport AG-listed 
chemical and biological items. Specifically, this rule amends section 
742.2(b)(1) of the EAR to show that where an export is intended to be 
used in a chemical weapons or biological weapons program, or for 
chemical or biological weapons terrorism purposes, it is deemed to make 
a material contribution to the design, development production, 
stockpiling, or use of chemical or biological weapons. Note that 
certain AG-listed chemicals also are controlled for Chemical Weapons 
Convention (CW) reasons and, therefore, are subject to the licensing 
requirements and policies described in section 742.18 of the EAR, as 
well as those in section 742.2 of the EAR.

B. Additional Understandings Reached at the June 2002 Plenary Meeting 
of the Australia Group That Conform With Existing Provisions in the EAR

    Certain understandings reached at the June 2002 plenary meeting of 
the Australia Group (AG) do not require any regulatory action by the 
BIS, because they are adequately addressed by existing provisions in 
the EAR. These understandings are important because they represent a 
significant step by AG participating countries to further harmonize 
controls on AG-listed items and related technology.
    Participating countries in the AG reached an understanding, at the 
June 2002 plenary meeting, to control transfers of technology for the 
``development'' or ``production'' of AG-listed dual-use biological 
equipment. Since this technology currently is controlled by the EAR 
under ECCNs 2E001 and 2E002, this rule makes no changes in existing EAR 
controls on such technology.
    The AG participating countries also agreed, for the first time, to 
establish AG controls on the intangible transfer of information and 
knowledge that could be used for chemical or biological weapons 
purposes. The transfer of such information and knowledge currently is 
defined in the EAR as ``technical assistance,'' which may take such 
forms as instruction, skills, training, working knowledge, and 
consulting services and may involve the transfer of ``technical data'' 
(``technical assistance'' is described in the note that follows the 
definition of ``technology'' in section 772.1 of the EAR). Since the 
EAR currently define ``technology'' (e.g., technology for AG-listed 
items) to include ``technical data'' or ``technical assistance,'' this 
rule makes no changes in existing EAR controls that apply to the 
provision of ``technical assistance.''
    Finally, the AG participating countries agreed to expand the 
license requirement for exports of AG-listed biological agents to apply 
to all destinations, with an exception for intra-European Union (EU) 
trade. In accordance with section 742.2(a)(1) of the EAR, these AG-
listed biological agents currently are controlled under ECCNs 1C351, 
1C352, 1C353, and 1C354 on the CCL and require a license, for CB 
(chemical/biological) reasons, to all of the destinations indicated 
under CB Column 1 in the Commerce Country Chart (Supplement No. 1 to 
part 738 of the EAR), i.e., all destinations, worldwide. Since the EAR 
currently have a worldwide licensing requirement for these biological 
agents, this rule makes no changes in the existing EAR licensing 
provisions for these agents. In addition, please note that the EAR 
continue to require a license for reexports of U.S.-origin AG-listed 
biological agents to all destinations, including reexports among EU 
member countries.

C. Revisions to the EAR Based on an Intersessional Decision by the 
Australia Group

    BIS is amending the EAR to implement an intersessional decision by 
the AG that was made prior to the June 2002 plenary meeting. 
Specifically, this rule revises AG controls on cross (tangential) flow 
filtration equipment by amending ECCN 2B352.d to lower the control 
threshold for such equipment from a total filtration area equal to or 
greater than 5 square meters (5 m2) to a total filtration 
area equal to or greater than 1 square meter (1 m2). In 
addition, this rule revises 2B352.d to indicate that the ECCN controls 
not only cross (tangential) flow filtration equipment capable of in-
situ sterilization, but also such equipment capable of being 
disinfected in-situ. A technical note is added to 2B352.d to define the 
terms ``sterilized'' and ``disinfected'' and to demonstrate how the 
processes of ``disinfection'' and ``sterilization'' are distinct from 
the process of ``sanitization.'' This rule also adds a nota bene (i.e., 
N.B.) to 2B352.d that excludes reverse osmosis equipment, as specified 
by the manufacturer, from control under this ECCN.
    In addition, this rule amends 2B352.d to control cross (tangential) 
flow filtration components that: (1) have a filtration area equal to or 
greater than 0.2 square meters (0.2 m2) for each component 
and (2) are designed for use with the cross (tangential) flow 
filtration equipment described in 2B352.d.

D. Corrections to ECCN 1C353 (Genetic Elements and Genetically Modified 
Organisms) and ECCN 2B350 (Chemical Manufacturing Facilities and 
Equipment).

    This rule amends the heading and the List of Items Controlled in 
ECCN 1C353 to correct errors in the use of the terms ``organism'' and 
``microorganism.'' The revisions to this ECCN that were made in a final 
rule published by BIS on May 31, 2002 (67 FR 37977) incorrectly used 
the term ``organisms'' in 1C353.a.1 and .b.1 when referring to 
``microorganisms'' controlled by 1C351.a. to .c. In addition, that rule 
did not revise the heading of the ECCN to include the term genetically 
modified ``organisms.'' This rule corrects these errors.
    In addition, this rule amends the heading in ECCN 2B350 to indicate 
that this entry does not control valves described in ECCN 2A292. BIS 
published a rule, on August 29, 2002 (67 FR 55594), that revised the 
heading of ECCN 2B350 to exclude valves controlled by ECCN 2A226; 
however, an exclusion for valves controlled by ECCN 2A292 was 
unintentionally omitted. This rule corrects that omission. Valves 
controlled by ECCN 2A226 or ECCN 2A292, which also meet or exceed the 
technical parameters described in ECCN 2B350.g, continue to be subject 
to CB controls (as well as NP and AT controls) even though they are not 
controlled under ECCN 2B350.
    This rule also amends the List of Items Controlled in ECCN 2B350 to 
clarify that 2B350.b controls only those agitators that are for use in 
reaction vessels or reactors described in 2B350.a.

E. Corrections to Sec.  742.2 (Proliferation of Chemical and Biological 
Weapons) and ECCNs 2E001 and 2E002

    This rule revises Sec.  742.2(a)(3) of the EAR, which identifies 
ECCNs

[[Page 34528]]

containing items that require a license to Country Group D:3 
destinations for CB reasons, to include a reference to medical products 
controlled by ECCN 1C991.d. A reference to these medical products was 
inadvertently omitted in previous rulemakings. ECCN 1C991.d controls 
medical products containing biological toxins controlled by ECCN 
1C351.d.2 through .d.19, except biological toxins controlled for CW 
reasons under 1C351.d.5 or .d.6.
    This rule also revises Sec.  742.2(a)(3) of the EAR and ECCNs 2E001 
and 2E002 to clarify the control status of technology for valves 
described in ECCN 2A226 or 2A292 that also possess the characteristics 
of valves described in ECCN 2B350.g. The control status of the valves, 
themselves, was first clarified in a final rule published by BIS on 
August 29, 2002 (67 FR 55594) and is further clarified in this rule 
(see the changes to the heading of ECCN 2B350, as described in part D, 
Background, in the SUPPLEMENTARY INFORMATION section of this rule). 
First, this rule revises Sec.  742.2(a)(3) to clarify that 
``development'' and ``production'' technology for valves controlled by 
ECCN 2A226 or 2A292 for CB reasons (i.e., valves in 2A226 or 2A292 that 
also possess the characteristics of valves described in ECCN 2B350.g) 
is controlled under ECCNs 2E001 (``development'' technology) and 2E002 
(``production'' technology) and requires a license to Country Group D:3 
destinations for CB reasons--note that this technology also requires a 
license to certain destinations for NP and AT reasons. Second, this 
rule revises Sec.  742.2(a)(3) to indicate that ``use'' technology for 
valves controlled by ECCN 2A226 or 2A292 for CB reasons is controlled 
under ECCNs 2E201 and 2E290, respectively, and requires a license to 
Country Group D:3 destinations for CB reasons--note that this 
technology also requires a license to certain destinations for NP and 
AT reasons. Third, this rule revises the License Requirements sections 
of ECCNs 2E001 and 2E002 on the CCL to indicate that CB controls apply 
to technology in these ECCNs for the ``development'' or ``production,'' 
respectively, of valves controlled for CB reasons under ECCN 2A226 or 
2A292.

F. Clarifications to ECCNs 1C351 and 1C991

    This rule revises the heading of ECCN 1C351 to clarify that this 
entry controls certain zoonotic pathogens and toxins that are the 
causative organisms for a number of zoonoses (i.e., diseases of animals 
that may be transmitted to humans under natural conditions). In 
addition, this rule revises ECCN 1C991.d to clarify that it does not 
control medical products containing botulinum toxins described in ECCN 
1C351.d.1. Medical products containing 1C351.d.1 toxins are controlled 
by 1C991.c for anti-terrorism (AT) reasons only, while the medical 
products in 1C991.d are controlled for both CB and AT reasons.

G. Changes to the EAR Based on the Addition of New States Parties to 
the Chemical Weapons Convention (CWC)

    This rule revises Supplement No. 2 to part 745 of the EAR (titled 
``States Parties to the Convention on the Prohibition of the 
Development, Production, Stockpiling, and Use of Chemical Weapons and 
on Their Destruction'') by adding the names of six countries that have 
recently become States Parties to the CWC (i.e., Andorra, Guatemala, 
Palau, Saint Vincent and the Grenadines, Samoa, and Thailand).

Savings Clause

    Shipments of items removed from license exception eligibility or 
NLR authorization as a result of this regulatory action that were on 
dock for loading, on lighter, laden aboard an exporting carrier, or en 
route aboard a carrier to a port of export, on June 10, 2003, pursuant 
to actual orders for export to a foreign destination, may proceed to 
that destination under the previous license exception eligibility or 
NLR authorization provisions so long as they have been exported from 
the United States before July 10, 2003. Any such items not actually 
exported before midnight, on July 10, 2003, require a license in 
accordance with this regulation.

Rulemaking Requirements

    1. This rule has been determined to be not significant for purposes 
of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with, a collection of information subject to the 
requirements of the Paperwork Reduction Act, unless that collection of 
information displays a currently valid OMB Control Number. This rule 
contains collections of information subject to the requirements of 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 0694-0088 and 0694-0117.
    3. This rule does not contain policies with Federalism implications 
as that term is defined in Executive Order 13132.
    4. 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 military and foreign affairs 
function of the United States (Sec. 5 U.S.C. 553(a)(1)). Further, no 
other law requires that a notice of proposed rulemaking and an 
opportunity for public comment be given for this final rule. Because a 
notice of proposed rulemaking and an opportunity for public comment are 
not required to be given for this rule under 5 U.S.C. 553 or by any 
other law, the analytical requirements of the Regulatory Flexibility 
Act (5 U.S.C. 601 et seq.) are not applicable.
    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 Willard 
Fisher, Regulatory Policy Division, Bureau of Industry and Security, 
U.S. Department of Commerce, Room 2705, 14th Street and Pennsylvania 
Avenue, NW., Washington, DC 20230.

List of Subjects

15 CFR Part 742

    Exports, Foreign trade.

15 CFR Part 745

    Administrative practice and procedure, Chemicals, Exports, Foreign 
trade, Reporting and recordkeeping requirements.

15 CFR Part 774

    Exports, Foreign trade, Reporting and recordkeeping requirements.

0
Accordingly, parts 742, 745, and 774 of the Export Administration 
Regulations (15 CFR parts 730-799) are amended as follows:

PART 742--[AMENDED]

0
1. The authority citation for 15 CFR part 742 continues to read as 
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
18 U.S.C. 2510 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 
sec. 901-911, Pub. L. 106-387; sec. 221, Pub. L. 107-56; E.O. 12058, 
43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 
CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., 
p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; notice of November 9, 
2001, 66 FR 56965, 3 CFR, 2001 Comp., p. 917; notice of August 14, 
2002, 67 FR 53721, August 16, 2002.


[[Page 34529]]



0
2. Section 742.2 is amended by revising paragraphs (a)(3) and (b) to 
read as follows:


Sec.  742.2  Proliferation of chemical and biological weapons.

    (a) * * *
    (3) If CB Column 3 of the Country Chart (Supplement No. 1 to part 
738 of the EAR) is indicated in the appropriate ECCN, a license is 
required to Country Group D:3 (see Supplement No. 1 to part 740 of the 
EAR) for the following:
    (i) Equipment and materials identified in ECCN 2B350 or 2B351 on 
the CCL, and valves controlled by ECCN 2A226 or ECCN 2A292 having the 
characteristics of those described in 2B350.g, which can be used in the 
production of chemical weapons precursors or chemical warfare agents;
    (ii) Equipment and materials identified in ECCN 2B352, which can be 
used in the production of biological agents;
    (iii) Medical products identified in ECCN 1C991.d;
    (iv) Technology identified in ECCN 2E001, 2E002, or 2E301 for:
    (A) The development, production, or use of items controlled by ECCN 
2B350, 2B351, or 2B352; or
    (B) The development or production of valves controlled by ECCN 
2A226 or 2A292 having the characteristics of those described in ECCN 
2B350.g; and
    (v) Technology identified in ECCN 2E201 or 2E290 for the use of 
valves controlled by ECCN 2A226 or 2A292 having the characteristics of 
those described in 2B350.g.
* * * * *
    (b) Licensing policy. (1) License applications for the items 
described in paragraph (a) of this section will be considered on a 
case-by-case basis to determine whether the export or reexport would 
make a material contribution to the design, development, production, 
stockpiling or use of chemical of biological weapons. When an export or 
reexport is deemed to make such a material contribution, the license 
will be denied. When an export or reexport is intended to be used in a 
chemical weapons or biological weapons program, or for chemical or 
biological weapons terrorism purposes, it is deemed to make a material 
contribution. The factors listed in paragraph (b)(2) of this section 
are among those that will be considered to determine what action should 
be taken on license applications for these items.
    (2) The following factors are among those that will be considered 
to determine what action should be taken on license applications for 
the items described in paragraph (a) of this section:
    (i) The specific nature of the end-use, including the 
appropriateness of the stated end-use;
    (ii) The significance of the export and reexport in terms of its 
potential contribution to the design, development, production, 
stockpiling, or use of chemical or biological weapons;
    (iii) The nonproliferation credentials of the importing country, 
including the importing country's chemical and biological capabilities 
and objectives;
    (iv) The risk that the items will be diverted for use in a chemical 
weapons or biological weapons program, or for chemical weapons or 
biological weapons terrorism purposes;
    (v) The reliability of the parties to the transaction, including 
whether:
    (A) An export or reexport license application involving any such 
parties has previously been denied;
    (B) Any such parties have been engaged in clandestine or illegal 
procurement activities;
    (C) The end-user is capable of securely handling and storing the 
items to be exported or reexported;
    (vi) Relevant information about proliferation and terrorism 
activities, including activities involving the design, development, 
production, stockpiling, or use of chemical or biological weapons by 
any parties to the transaction;
    (vii) The types of assurances or guarantees against the design, 
development, production, stockpiling, or use of chemical or biological 
weapons that are given in a particular case, including any relevant 
assurances provided by the importing country or the end-user;
    (viii) The applicability of other multilateral export control or 
nonproliferation agreements (e.g., the Chemical Weapons Convention and 
the Biological and Toxin Weapons Convention) to the transaction; and
    (ix) The existence of a pre-existing contract.
    (3) BIS will review license applications in accordance with the 
licensing policy described in paragraph (b)(1) of this section for 
items not described in paragraph (a) of this section that:
    (i) Require a license for reasons other than short supply; and
    (ii) Could be destined for the design, development, production, 
stockpiling, or use of chemical or biological weapons, or for a 
facility engaged in such activities.
* * * * *

PART 745--[AMENDED]

0
4. The authority citation for 15 CFR part 745 continues to read as 
follows:

    Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 
CFR, 1994 Comp., p. 950; notice of November 9, 2000, 65 FR 68063, 3 
CFR, 2000 Comp., p. 408.


0
5. Supplement No. 2 to part 745 is amended by revising the undesignated 
center heading ``List of States Parties as of May 1, 2002'' to read 
``List of States Parties as of April 1, 2003'' and by adding, in 
alphabetical order, the countries ``Andorra'', ``Guatemala'', 
``Palau'', ``Saint Vincent and the Grenadines'', ``Samoa'' and 
``Thailand'.

PART 774--[AMENDED]

0
6. The authority citation for 15 CFR part 774 continues to read as 
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
10 U.S.C. 7420; 10 U.S.C. 7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C. 
287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 
185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. 
app. 466c; 50 U.S.C. app. 5; sec. 901-911, Pub. L. 106-387; sec. 
221, Pub. L. 107-56; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; notice of 
August 14, 2002, 67 FR 53721, August 16, 2002.


0
7. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN 
1C351 is amended by revising the heading of the ECCN and the List of 
Items Controlled to read as follows:

1C351 Human and zoonotic pathogens and ``toxins'', as follows (see List 
of Items Controlled).
* * * * *

List of Items Controlled

    Unit: Value.
    Related Controls: Certain forms of ricin and saxitoxin in 
1C351.d.5. and d.6 are CWC Schedule 1 chemicals (see Sec.  742.18 of 
the EAR). The U.S. Government must provide advance notification and 
annual reports to the OPCW of all exports of Schedule 1 chemicals. see 
Sec.  745.1 of the EAR for notification procedures. see 22 CFR part 
121, Category XIV and Sec.  121.7 for additional CWC Schedule 1 
chemicals controlled by the Department of State. All vaccines and 
``immunotoxins'' are excluded from the scope of this entry. Certain 
medical products and diagnostic and food testing kits that contain 
biological toxins controlled under paragraph (d) of this entry, with 
the exception of toxins controlled for CW reasons under d.5 and d.6, 
are excluded

[[Page 34530]]

from the scope of this entry. Vaccines, ``immunotoxins'', certain 
medical products, and diagnostic and food testing kits excluded from 
the scope of this entry are controlled under ECCN 1C991. For the 
purposes of this entry, only saxitoxin is controlled under paragraph 
d.6; other members of the paralytic shellfish poison family (e.g. 
neosaxitoxin) are classified as EAR99.
    Related Definitions: 1. For the purposes of this entry 
``immunotoxin'' is defined as an antibody-toxin conjugate intended to 
destroy specific target cells (e.g., tumor cells) that bear antigens 
homologous to the antibody. 2. For the purposes of this entry 
``subunit'' is defined as a portion of the ``toxin''.
    Items:
a. Viruses, as follows:
    a.1. Chikungunya virus;
    a.2. Congo-Crimean haemorrhagic fever virus;
    a.3. Dengue fever virus;
    a.4. Eastern equine encephalitis virus;
    a.5. Ebola virus;
    a.6. Hantaan virus;
    a.7. Japanese encephalitis virus;
    a.8. Junin virus;
    a.9. Lassa fever virus
    a.10. Lymphocytic choriomeningitis virus;
    a.11. Machupo virus;
    a.12. Marburg virus;
    a.13. Monkey pox virus;
    a.14. Rift Valley fever virus;
    a.15. Tick-borne encephalitis virus (Russian Spring-Summer 
encephalitis virus);
    a.16. Variola virus;
    a.17. Venezuelan equine encephalitis virus;
    a.18. Western equine encephalitis virus;
    a.19. White pox; or
    a.20. Yellow fever virus.
b. Rickettsiae, as follows:
    b.1. Bartonella quintana (Rochalimea quintana, Rickettsia 
quintana);
    b.2. Coxiella burnetii;
    b.3. Rickettsia prowasecki; or
    b.4. Rickettsia rickettsii.
c. Bacteria, as follows:
    c.1. Bacillus anthracis;
    c.2. Brucella abortus;
    c.3. Brucella melitensis;
    c.4. Brucella suis;
    c.5. Burkholderia mallei (Pseudomonas mallei);
    c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
    c.7. Chlamydia psittaci;
    c.8. Clostridium botulinum;
    c.9. Francisella tularensis;
    c.10. Salmonella typhi;
    c.11. Shigella dysenteriae;
    c.12. Vibrio cholerae; or
    c.13. Yersinia pestis.
d. ``Toxins'', as follows, and ``subunits'' thereof:
    d.1. Botulinum toxins;
    d.2. Clostridium perfringens toxins;
    d.3. Conotoxin;
    d.4. Microcystin (Cyanginosin);
    d.5. Ricin;
    d.6. Saxitoxin;
    d.7. Shiga toxin;
    d.8. Staphylococcus aureus toxins;
    d.9. Tetrodotoxin;
    d.10. Verotoxin;
    d.11. Aflatoxins;
    d.12. Abrin;
    d.13. Cholera toxin;
    d.14. Diacetoxyscirpenol toxin;
    d.15. T-2 toxin;
    d.16. HT-2 toxin;
    d.17. Modeccin toxin;
    d.18. Volkensin toxin; or
    d.19. Viscum Album Lectin 1 (Viscumin).
    8. In Supplement No. 1 to part 774 (the Commerce Control List), 
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN 
1C353 is amended by revising the ECCN heading and the List of Items 
Controlled to read as follows:

1C353 Genetic elements and genetically modified organisms, as follows 
(see List of Items Controlled).
* * * * *

List of Items Controlled

    Unit: $ value.
    Related Controls: Vaccines that contain genetic elements or 
genetically modified organisms identified in this entry are controlled 
by ECCN 1C991.
    Related Definitions: N/A.
    Items:

a. Genetic elements, as follows:
    a.1. Genetic elements that contain nucleic acid sequences 
associated with the pathogenicity of microorganisms controlled by 
1C351.a. to .c, 1C352, or 1C354;
    a.2. Genetic elements that contain nucleic acid sequences coding 
for any of the ``toxins'' controlled by 1C351.d or ``subunits of 
toxins'' thereof.

    Technical Note: Genetic elements include, inter alia, 
chromosomes, genomes, plasmids, transposons, and vectors, whether 
genetically modified or unmodified.

b. Genetically modified organisms, as follows:
    b.1. Genetically modified organisms that contain nucleic acid 
sequences associated with the pathogenicity of microorganisms 
controlled by 1C351.a. to .c, 1C352, or 1C354;
    b.2. Genetically modified organisms that contain nucleic acid 
sequences coding for any of the ``toxins'' controlled by 1C351.d or 
``subunits of toxins'' thereof.

0
9. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN 
1C991 is amended by revising the List of Items Controlled to read as 
follows:

1C991 Vaccines, immunotoxins, medical products, diagnostic and food 
testing kits, as follows (see List of Items Controlled).
* * * * *

List of Items Controlled

    Unit: $ value.
    Related Controls: Medical products containing ricin or saxitoxin, 
as follows, are controlled for CW reasons under ECCN 1C351:
    (1) Ricinus Communis AgglutininII (RCAII), 
also known as ricin D, or Ricinus Communis LectinIII 
(RCLIII);
    (2) Ricinus Communis LectinIV (RCLIV), also 
known as ricin E; or
    (3) Saxitoxin identified by C.A.S. 35523-89-8.
    Related Definitions: For the purpose of this entry, ``immunotoxin'' 
is defined as an antibody-toxin conjugate intended to destroy specific 
target cells (e.g., tumor cells) that bear antigens homologous to the 
antibody. For the purpose of this entry, ``medical products'' are: (1) 
pharmaceutical formulations designed for human administration in the 
treatment of medical conditions, (2) prepackaged for distribution as 
medical products, and (3) approved by the U.S. Food and Drug 
Administration to be marketed as medical products. For the purpose of 
this entry, ``diagnostic and food testing kits'' are specifically 
developed, packaged and marketed for diagnostic or public health 
purposes. Biological toxins in any other configuration, including bulk 
shipments, or for any other end-uses are controlled by ECCN 1C351. For 
the purpose of this entry, ``vaccine'' is defined as a medicinal (or 
veterinary) product in a pharmaceutical formulation, approved by the 
U.S. Food and Drug Administration or the U.S. Department of Agriculture 
to be marketed as a medical (or veterinary) product or for use in 
clinical trials, that is intended to stimulate a protective 
immunological response in humans or animals in order to prevent disease 
in those to whom or to which it is administered.
    Items:
    a. Vaccines against items controlled by ECCN 1C351, 1C352, 1C353, 
or 1C354;
    b. Immunotoxins containing items controlled by 1C351.d;
    c. Medical products containing botulinum toxins controlled by ECCN 
1C351.d.1;
    d. Medical products containing items controlled by ECCN 1C351.d, 
except

[[Page 34531]]

botulinum toxins controlled by ECCN 1C351.d.1 and items controlled for 
CW reasons under 1C351.d.5 or .d.6; and
    e. Diagnostic and food testing kits containing items controlled by 
ECCN 1C351.d, except items controlled for CW reasons under ECCN 
1C351.d.5 or .d.6.
    10. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2--Materials Processing, ECCN 2B350 is amended by revising the 
ECCN heading and the List of Items Controlled to read as follows:

2B350 Chemical manufacturing facilities and equipment, except valves 
controlled by 2A226 or 2A292, as follows (see List of Items 
Controlled).
* * * * *

List of Items Controlled

    Unit: Equipment in number.
    Related Controls: The controls in this entry do not apply to 
equipment that is: (a) Specially designed for use in civil applications 
(e.g., food processing, pulp and paper processing, or water 
purification); AND (b) inappropriate, by the nature of its design, for 
use in storing, processing, producing or conducting and controlling the 
flow of chemical weapons precursors controlled by 1C350.
    Related Definitions: For purposes of this entry the term ``chemical 
warfare agents'' are those agents subject to the export licensing 
authority of the U.S. Department of State, Office of Defense Trade 
Controls. (See 22 CFR part 121)
    Items:

a. Reaction vessels or reactors, with or without agitators, with total 
internal (geometric) volume greater than 0.1 m\3\ (100 liters) and less 
than 20 m\3\ (20,000 liters), where all surfaces that come in direct 
contact with the chemical(s) being processed or contained are made from 
any of the following materials:
    a.1. Alloys with more than 25% nickel and 20% chromium by weight;
    a.2. Fluoropolymers;
    a.3. Glass (including vitrified or enameled coating or glass 
lining);
    a.4. Nickel or alloys with more than 40% nickel by weight;
    a.5. Tantalum or tantalum alloys;
    a.6. Titanium or titanium alloys; or
    a.7. Zirconium or zirconium alloys.
b. Agitators for use in reaction vessels or reactors described in 
2B350.a, and impellers, blades or shafts designed for such agitators, 
where all surfaces that come in direct contact with the chemical(s) 
being processed or contained are made from any of the following 
materials:
    b.1. Alloys with more than 25% nickel and 20% chromium by weight;
    b.2. Fluoropolymers;
    b.3. Glass (including vitrified or enameled coatings or glass 
lining);
    b.4. Nickel or alloys with more than 40% nickel by weight;
    b.5. Tantalum or tantalum alloys;
    b.6. Titanium or titanium alloys; or
    b.7. Zirconium or zirconium alloys.
c. Storage tanks, containers or receivers with a total internal 
(geometric) volume greater than 0.1 m3 (100 liters) where all surfaces 
that come in direct contact with the chemical(s) being processed or 
contained are made from any of the following materials:
    c.1. Alloys with more than 25% nickel and 20% chromium by weight;
    c.2. Fluoropolymers;
    c.3. Glass (including vitrified or enameled coatings or glass 
lining);
    c.4. Nickel or alloys with more than 40% nickel by weight;
    c.5. Tantalum or tantalum alloys;
    c.6. Titanium or titanium alloys; or
    c.7. Zirconium or zirconium alloys.
d. Heat exchangers or condensers with a heat transfer surface area of 
less than 20 m\2\, but greater than 0.15 m\2\, and tubes, plates, coils 
or blocks (cores) designed for such heat exchangers or condensers, 
where all surfaces that come in direct contact with the chemical(s) 
being processed are made from any of the following materials:
    d.1. Alloys with more than 25% nickel and 20% chromium by weight;
    d.2. Fluoropolymers;
    d.3. Glass (including vitrified or enameled coatings or glass 
lining);
    d.4. Graphite or carbon-graphite;
    d.5. Nickel or alloys with more than 40% nickel by weight;
    d.6. Silicon carbide;
    d.7. Tantalum or tantalum alloys;
    d.8. Titanium or titanium alloys;
    d.9. Titanium carbide; or
    d.10. Zirconium or zirconium alloys.
e. Distillation or absorption columns of internal diameter greater than 
0.1 m, and liquid distributors, vapor distributors or liquid collectors 
designed for such distillation or absorption columns, where all 
surfaces that come in direct contact with the chemical(s) being 
processed are made from any of the following materials:
    e.1. Alloys with more than 25% nickel and 20% chromium by weight;
    e.2. Fluoropolymers;
    e.3. Glass (including vitrified or enameled coatings or glass 
lining);
    e.4. Graphite or carbon-graphite;
    e.5. Nickel or alloys with more than 40% nickel by weight;
    e.6. Tantalum or tantalum alloys;
    e.7. Titanium or titanium alloys; or
    e.8. Zirconium or zirconium alloys.
f. Remotely operated filling equipment in which all surfaces that come 
in direct contact with the chemical(s) being processed are made from 
any of the following materials:
    f.1. Alloys with more than 25% nickel and 20% chromium by weight; 
or
    f.2. Nickel or alloys with more than 40% nickel by weight.
g. Valves with nominal sizes greater than 1.0 cm (\3/8\ in.), and 
casings (valve bodies) or preformed casing liners designed for such 
valves, in which all surfaces that come in direct contact with the 
chemical(s) being processed or contained are made from any of the 
following materials:
    g.1. Nickel or alloys with more than 40% nickel by weight;
    g.2. Alloys with more than 25% nickel and 20% chromium by weight;
    g.3. Fluoropolymers;
    g.4. Glass or glass lined (including vitrified or enameled 
coatings);
    g.5. Tantalum or tantalum alloys;
    g.6. Titanium or titanium alloys; or
    g.7. Zirconium or zirconium alloys.
h. Multi-walled piping incorporating a leak detection port, in which 
all surfaces that come in direct contact with the chemical(s) being 
processed or contained are made from any of the following materials:
    h.1. Alloys with more than 25% nickel and 20% chromium by weight;
    h.2. Fluoropolymers;
    h.3. Glass (including vitrified or enameled coatings or glass 
lining);
    h.4. Graphite or carbon-graphite;
    h.5. Nickel or alloys with more than 40% nickel by weight;
    h.6. Tantalum or tantalum alloys;
    h.7. Titanium or titanium alloys; or
    h.8. Zirconium or zirconium alloys.
i. Multiple-seal, canned drive, magnetic drive, bellows or diaphragm 
pumps, with manufacturer's specified maximum flow-rate greater than 0.6 
m\3\/hour, or vacuum pumps with manufacturer's specified maximum flow-
rate greater than 5 m\3\/hour (under standard temperature (273 K 
(0[deg] C)) and pressure (101.3 kPa) conditions), and casings (pump 
bodies), preformed casing liners, impellers, rotors or jet pump nozzles 
designed for such pumps, in which all surfaces that come into direct 
contact with the chemical(s) being processed are made from any of the 
of the following materials:

[[Page 34532]]

    i.1. Alloys with more than 25% nickel and 20% chromium by weight;
    i.2. Ceramics;
    i.3. Ferrosilicon;
    i.4. Fluoropolymers;
    i.5. Glass (including vitrified or enameled coatings or glass 
lining);
    i.6. Graphite or carbon-graphite;
    i.7. Nickel or alloys with more than 40% nickel by weight;
    i.8. Tantalum or tantalum alloys;
    i.9. Titanium or titanium alloys, or
    i.10. Zirconium or zirconium alloys.
j. Incinerators designed to destroy chemical warfare agents, chemical 
weapons precursors controlled by 1C350, or chemical munitions having 
specially designed waste supply systems, special handling facilities 
and an average combustion chamber temperature greater than 1000[deg] C 
in which all surfaces in the waste supply system that come into direct 
contact with the waste products are made from or lined with any of the 
following materials:
    j.1. Alloys with more than 25% nickel and 20% chromium by weight;
    j.2. Ceramics; or
    j.3. Nickel or alloys with more than 40% nickel by weight.

    Technical Note: Carbon-graphite is a composition consisting 
primarily of graphite and amorphous carbon, in which the graphite is 
8 percent or more by weight of the composition.


0
11. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2--Materials Processing, ECCN 2B352 is amended by revising the 
List of Items Controlled to read as follows:

2B352 Equipment capable of use in handling biological materials, as 
follows (see List of Items Controlled).
* * * * *

List of Items Controlled

    Unit: Equipment in number
    Related Controls: N/A
    Related Definitions: For purposes of this entry, isolators include 
flexible isolators, dry boxes, anaerobic chambers and glove boxes.
    Items:
    a. Complete containment facilities at P3 or P4 containment level.

    Technical Note: P3 or P4 (BL3, BL4, L3, L4) containment levels 
are as specified in the WHO Laboratory Biosafety Manual (Geneva, 
1983).

    b. Fermenters capable of cultivation of pathogenic microorganisms, 
viruses, or for toxin production, without the propagation of aerosols, 
having a capacity equal to or greater than 20 liters.

    Technical Note: Fermenters include bioreactors, chemostats, and 
continuous-flow systems.

c. Centrifugal separators capable of the continuous separation of 
pathogenic microorganisms, without the propagation of aerosols, and 
having all of the following characteristics:
    c.1. One or more sealing joints within the steam containment area;
    c.2. A flow rate greater than 100 liters per hour;
    c.3. Components of polished stainless steel or titanium; and
    c.4. Capable of in-situ steam sterilization in a closed state.

    Technical Note: Centrifugal separators include decanters.

d. Cross (tangential) flow filtration equipment and accessories, as 
follows:
    d.1. Cross (tangential) flow filtration equipment capable of 
separation of pathogenic microorganisms, viruses, toxins or cell 
cultures, without the propagation of aerosols, having all of the 
following characteristics:
    d.1.a. A total filtration area equal to or greater than 1 square 
meter (1 m\2\); and
    d.1.b. Capable of being sterilized or disinfected in-situ.

    N.B.: 2B352.d.1 does not control reverse osmosis equipment, as 
specified by the manufacturer.

    d.2. Cross (tangential) flow filtration components (e.g., modules, 
elements, cassettes, cartridges, units or plates) with filtration area 
equal to or greater than 0.2 square meters (0.2 m\2\) for each 
component and designed for use in cross (tangential) flow filtration 
equipment controlled by 2B352.d.1.

    Technical Note: In this ECCN, ``sterilized'' denotes the 
elimination of all viable microbes from the equipment through the 
use of either physical (e.g., steam) or chemical agents. 
``Disinfected'' denotes the destruction of potential microbial 
infectivity in the equipment through the use of chemical agents with 
a germicidal effect. ``Disinfection'' and ``sterilization'' are 
distinct from ``sanitization'', the latter referring to cleaning 
procedures designed to lower the microbial content of equipment 
without necessarily achieving elimination of all microbial 
infectivity or viability.

e. Steam sterilizable freeze-drying equipment with a condenser capacity 
of 10 kgs of ice or greater in 24 hours, but less than 1,000 kgs of ice 
in 24 hours.
f. Protective and containment equipment, as follows:
    f.1. Protective full or half suits, or hoods dependant upon a 
tethered external air supply and operating under positive pressure;

    Technical Note: This entry does not control suits designed to be 
worn with self-contained breathing apparatus.

    f.2. Class III biological safety cabinets or isolators with similar 
performance standards, e.g., flexible isolators, dry boxes, anaerobic 
chambers, glove boxes or laminar flow hoods (closed with vertical 
flow).
g. Chambers designed for aerosol challenge testing with microorganisms, 
viruses, or toxins and having a capacity of 1 m\3\ or greater.

0
12. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2--Materials Processing, ECCN 2E001 is amended by revising the 
License Requirements section to read as follows:
2E001 ``Technology according to the General Technology Note for the 
``development'' of equipment or ``software'' controlled by 2A (except 
2A991, 2A993, or 2A994), 2B (except 2B991, 2B993, 2B996, 2B997 or 
2B998), or 2D (except 2D991, 2D992, or 2D994).

License Requirements

    Reason for Control: NS, MT, NP, CB, AT

------------------------------------------------------------------------
               Control(s)                         Country chart
------------------------------------------------------------------------
NS applies to ``technology'' for items   NS Column 1
 controlled by 2A001, 2B001 to 2B009,
 2D001 or 2D002.
MT applies to ``technology'' for items   MT Column 1
 controlled by 2B004, 2B009, 2B018,
 2B104, 2B105, 2B109, 2B116, 2B117,
 2D001 or 2D101 for MT reasons.
NP applies to ``technology'' for items   NP Column 1
 controlled by 2A225, 2A226, 2B001,
 2B004, 2B006, 2B007, 2B009, 2B104,
 2B109, 2B116, 2B201, 2B204, 2B206,
 2B207, 2B209, 2B225 to 2B232, 2D001,
 2D002, 2D101, 2D201 or 2D202 for NP
 reasons.
NP applies to ``technology'' for items   NP Column 2
 controlled by 2A290 to 2A293, 2B290,
 or 2D290 for NP reasons.
CB applies to ``technology'' for         CB Column 3
 equipment controlled by 2B350 to 2B352
 and for valves controlled by 2A226 or
 2A292 having the characteristics of
 those controlled by 2B350.g.

[[Page 34533]]

 
AT applies to entire entry.............  AT Column 1
------------------------------------------------------------------------


    License Requirement Notes: See Sec.  743.1 of the EAR for 
reporting requirements for exports under License Exceptions.

* * * * *

0
13. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2--Materials Processing, ECCN 2E002 is amended by revising the 
License Requirements section to read as follows:
2E002 ``Technology'' according to the General Technology Note for the 
``production'' of equipment controlled by 2A, (except 2A991, 2A993, or 
2A994) or 2B (except 2B991, 2B993, 2B996, 2B997, or 2B998).

License Requirements

    Reason for Control: NS, MT, NP, CB, AT

------------------------------------------------------------------------
               Control(s)                         Country chart
------------------------------------------------------------------------
NS applies to ``technology'' for         NS Column 1
 equipment controlled by 2A001, 2B001
 to 2B009.
MT applies to ``technology'' for         MT Column 1
 equipment controlled by 2B004, 2B009,
 2B018, 2B104, 2B105, 2B109, 2B116 or
 2B117 for MT reasons.
NP applies to ``technology'' for         NP Column 1
 equipment controlled by 2A225, 2A226,
 2B001, 2B004, 2B006, 2B007, 2B009,
 2B104, 2B109, 2B116, 2B201, 2B204,
 2B206, 2B207, 2B209, 2B225 to 2B232
 for NP reasons.
NP applies to ``technology'' for         NP Column 2
 equipment controlled by 2A290 to
 2A293, 2B290 for NP reasons.
CB applies to ``technology'' for         CB Column 3
 equipment controlled by 2B350 to 2B352
 and for valves controlled by 2A226 or
 2A292 having the characteristics of
 those controlled by 2B350.g.
AT applies to entire entry.............  AT Column 1
------------------------------------------------------------------------


    License Requirement Notes: See Sec.  743.1 of the EAR for 
reporting requirements for exports under License Exceptions.

* * * * *

    Dated: May 29, 2003.
James J. Jochum,
Assistant Secretary for Export Administration.
[FR Doc. 03-14602 Filed 6-9-03; 8:45 am]
BILLING CODE 3510-33-P