Implementation of the Understandings Reached at the 2012 Australia Group (AG) Plenary Meeting and the 2012 AG Intersessional Decisions; Changes to Select Agent Controls
Federal Register, Volume 78 Issue 108 (Wednesday, June 5, 2013)
Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)
Rules and Regulations
Pages 33692-33698
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-13270
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 742, and 774
Docket No. 120806310-2310-01
RIN 0694-AF76
Implementation of the Understandings Reached at the 2012 Australia Group (AG) Plenary Meeting and the 2012 AG Intersessional Decisions; Changes to Select Agent Controls
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to implement the understandings reached at the June 2012 plenary meeting of the Australia Group (AG) and the 2012 AG intersessional decisions. Specifically, this rule amends the Commerce Control List (CCL) entry in the EAR that controls human and zoonotic pathogens and ``toxins'' to reflect changes to the AG ``List of Biological Agents for Export Control'' that were made based on the understandings adopted at the June 2012 AG plenary meeting. These changes included the addition of three pathogens and clarifications to two other items. This rule also amends the CCL entry in the EAR that controls plant pathogens to reflect: The 2012 AG Plenary agreement to add five pathogens to the AG ``List of Plant Pathogens for Export Control;'' and the AG intersessional clarifications to six pathogens identified on this AG list. In addition, the CCL entry in the EAR that controls equipment capable of handling biological materials is amended to reflect the 2012 AG intersessional decision to add certain spray-drying equipment to the AG ``Control List of Dual-Use Biological Equipment and Related Technology and Software.'' This rule also removes the CCL entry that controls select agents not identified on any of the AG common controls lists, but identified on the CCL because they are (or were, until recently) subject to controls maintained by the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, on their possession, use, and transfer within the United States. Rather than continuing to control these select agents in a separate CCL entry, this rule adds those select agents that remain subject to the CDC/APHIS controls (as well as a recent addition to the list of select agents) to the AG-related CCL entries that control human and zoonotic pathogens and ``toxins'' and plant pathogens, respectively.
DATES: This rule is effective June 5, 2013.
ADDRESSES: Send comments regarding this collection of information, including suggestions for reducing the burden, to Jasmeet Seehra, Office of Management and Budget (OMB), by email to Jasmeet_K._Seehra@omb.eop.gov, or by fax to (202) 395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, 14th Street & Pennsylvania Avenue NW., Room 2705, Washington, DC 20230.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical and Biological Controls Division, Office of Nonproliferation and Treaty Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343.
SUPPLEMENTARY INFORMATION:
Background
The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) to implement the understandings reached at the Australia Group (AG) plenary meeting held in Paris, France, on June 12-15, 2012. This rule also implements the recommendations presented at the AG intersessional implementation meeting held in Ottawa, Canada, on February 14-16, 2012, and adopted pursuant to the AG silent approval procedure, which closed on March 23, 2012. The AG is a multilateral forum consisting of 40 participating countries that maintain 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.
June 2012 AG Plenary Changes
The June 2012 AG plenary meeting adopted understandings that affected the AG ``List of Biological Agents for Export Control'' and the AG ``List of Plant Pathogens for Export Control.''
This rule amends Export Control Classification Number (ECCN) 1C351 to reflect the AG plenary changes to the ``List of Biological Agents for Export Control.'' Specifically, ECCN 1C351 (Human and zoonotic pathogens and ``toxins'') is amended by adding botulinum neurotoxin producing strains of the following bacteria to 1C351.c: Clostridium argentinense (formerly known as Clostridium botulinum Type G); Clostridium baratii; and Clostridium butyricum. ECCN 1C351.c is partially renumbered to control these bacteria under 1C351.c.8., .c.9, and .c.11, respectively, while the bacteria previously controlled under these subparagraphs (Clostridium botulinum; Clostridium perfringens, epsilon toxin producing types; and Coxiella burnetii) are now controlled under 1C351.c.10, .c.12. and .c.13, respectively. In addition, bacteria previously controlled under 1C351.c.12 through .c.17 are now controlled under 1C351.c.14 through
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.c.16 (Francisella tularensis; Rickettsia prowazekii; and Salmonella typhi) and 1C351.c.18 through .c 20 (Shigella dysenteriae; Vibrio cholerae; and Yersinia pestis). Also note, with respect to ECCN 1C351.c.15 as amended by this rule, that the listing for the bacterium ``Rickettsia prowasecki (a.k.a. Rickettsia prowazekii)'' is amended to read ``Rickettsia prowazekii,'' consistent with the listing of this bacterium in the AG ``List of Biological Agents for Export Control'' and the commonly accepted spelling of this bacterium within the scientific community.
This rule also amends ECCN 1C351.c to clarify that the controls on ``Escherichia coli and other verotoxin producing serotypes'' apply to ``Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups.'' These bacteria are now controlled under 1C351.c.17. Prior to the publication of this rule and the partial renumbering of 1C351.c, these bacteria were controlled under 1C351.c.11. In addition, this rule amends 1C351.d.14 to clarify that the controls on ``Staphylococcus aureus toxins'' apply to ``Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F).''
This rule amends ECCN 1C354 (Plant pathogens) to reflect the AG plenary changes to the ``List of Plant Pathogens for Export Control.'' Specifically, ECCN 1C354 is amended by adding the following five fungi to 1C354.b: Peronosclerospora philippinensis (Peronosclerospora sacchari); Sclerophthora rayssiae var. zeae; Synchytrium endobioticum; Tilletia indica; and Thecaphora solani. These fungi are controlled under 1C354.b.7 through .b.11, respectively.
2012 AG Intersessional Changes
This rule also implements the recommendations presented at the AG intersessional implementation meeting held in February 2012 and adopted pursuant to the AG silent approval procedure. These recommendations included changes to the AG ``List of Plant Pathogens for Export Control'' and the AG ``Control List of Dual-Use Biological Equipment and Related Technology and Software.'' This rule amends ECCN 1C354 (Plant pathogens) to reflect the AG intersessional changes to the ``List of Plant Pathogens for Export Control.'' Specifically, ECCN 1C354.a (Bacteria) is amended to clarify that the controls for ``Xanthomonas campestris pv. citri'' in 1C354.a.2 apply to ``Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas campestris pv. citri)'' and that the controls for ``Ralstonia solanacearum'' in 1C354.a.5 apply to ``Ralstonia solanacearum, race 3, biovar 2.'' This rule also amends ECCN 1C354.b (Fungi) to reorder the wording of the controls for ``Colletotrichum coffeanum var. virulans (Colletotrichum kahawae)'' in 1C354.b.1 to read ``Colletotrichum kahawae (Colletotrichum coffeanum var. virulans).'' In addition, this rule amends the controls for ``Puccinia graminis'' in 1C354.b.4 to clarify that they apply to ``Puccinnia graminis ssp. graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis syn. Puccinia graminis f. sp. tritici)'' and the controls for ``Magnaporthe grisea'' in 1C354.b.6 to clarify that they apply to ``Magnaporthe oryzae (Pyricularia oryzae).'' Furthermore, this rule amends 1C354.c to clarify the controls for ``Potato Andean latent tymovirus'' in 1C354.c.1 to read ``Andean potato latent virus (Potato Andean latent tymovirus).''
In addition, this rule amends ECCN 2B352 (Equipment capable of use in handling biological materials) to reflect the AG intersessional changes to the ``Control List of Dual-Use Biological Equipment and Related Technology and Software.'' Specifically, this rule adds controls for certain spray-drying equipment under 2B352.f. Those items that were controlled under 2B352.f through .h, prior to the publication of this rule, are now controlled under 2B352.g through .i, respectively. ECCN 2B352.f, as revised by this rule, now controls spray-drying equipment capable of drying toxins or pathogenic microorganisms and having all of the following characteristics: (1) A water evaporation capacity of >= 0.4 kg/h and 2 for this ECCN), but not identified on the Australia Group (AG) ``List of Biological Agents for Export Control,'' as follows:
b.1. Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments;
b.2. SARS-associated coronavirus (SARS-CoV); or
b.3. Tick-borne encephalitis virus (Siberian subtype, formerly West Siberian virus--see 1C351.a.35 for Far Eastern subtype).
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Bacteria identified on the Australia Group (AG) ``List of Biological Agents for Export Control,'' 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. Chlamydophila psittaci (formerly known as Chlamydia psittaci);
c.8. Clostriduim argentinense (formerly known as Clostridium botulinum Type G), botulinum neurotoxin producing strains;
c.9. Clostridium baratii, botulinum neurotoxin producing strains;
c.10. Clostridium botulinum;
c.11. Clostridium butyricum, botulinum neurotoxin producing strains;
c.12. Clostridium perfringens, epsilon toxin producing types;
c.13. Coxiella burnetii;
c.14. Francisella tularensis;
c.15. Rickettsia prowazekii;
c.16. Salmonella typhi;
c.17. Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups;
Note: Shiga toxin producing Escherichia coli (STEC) is also known as enterohaemorrhagic E. coli (EHEC) or verocytotoxin producing E. coli (VTEC).
c.18. Shigella dysenteriae;
c.19. Vibrio cholerae; or
c.20. Yersinia pestis.
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``Toxins'' identified on the Australia Group (AG) ``List of Biological Agents for Export Control,'' as follows, and ``subunits'' thereof:
* * * * *
d.14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known as Staphylococcus enterotoxin F);
* * * * *
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1-- Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C352 is amended by revising the ``License Requirement Note'' under the License Requirements section and by
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revising the ``Related Controls'' paragraph under the List of Items Controlled section to read as follows:
1C352 Animal pathogens, as follows (see List of Items Controlled).
License Requirements
* * * * *
License Requirements Notes:
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All vaccines are excluded from the scope of this ECCN. See ECCN 1C991 for vaccines.
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Unless specified elsewhere in this ECCN 1C352 (e.g., in License Requirement Note 1), this ECCN controls all biological agents, regardless of quantity or attenuation, that are identified in the List of Items Controlled for this ECCN, including small quantities or attenuated strains of select biological agents that are excluded from the lists of select biological agents or ``toxins'' by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, or the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, in accordance with their regulations in 9 CFR part 121 and 42 CFR part 73, respectively.
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: (1) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, maintain controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN (for APHIS, see 7 CFR 331.3(b), 9 CFR 121.3(b), and 9 CFR 121.4(b); for CDC, see 42 CFR 73.3(b) and 42 CFR 73.4(b)). (2) See 22 CFR part 121, Category XIV(b), for modified biological agents and biologically derived substances that are subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls.
Related Definitions: * * *
Items:
* * * * *
0
-
In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1-- Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C353 is amended, under the License Requirements section, by revising the ``License Requirements Note'' and, under the List of Items Controlled section, by revising the ``Related Controls'' paragraph, by revising paragraphs a.1. and b.1. in the ``Items'' paragraph, and by revising Technical Note 3, to read as follows:
1C353 Genetic elements and genetically modified organisms, as follows (see List of Items Controlled).
License Requirements
* * * * *
License Requirements Notes:
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Vaccines that contain genetic elements or genetically modified organisms identified in this ECCN are controlled by ECCN 1C991.
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Unless specified elsewhere in this ECCN 1C353 (e.g., in License Requirement Note 1), this ECCN controls genetic elements or genetically modified organisms for all biological agents and ``toxins,'' regardless of quantity or attenuation, that are identified in the List of Items Controlled for this ECCN, including genetic elements or genetically modified organisms for attenuated strains of select biological agents or ``toxins'' that are excluded from the lists of select biological agents or ``toxins'' by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, or the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, in accordance with the APHIS regulations in 7 CFR part 331 and 9 CFR part 121 and the CDC regulations in 42 CFR part 73.
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: (1) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, and the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, maintain controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN, including (but not limited to) certain genetic elements, recombinant nucleic acids, and recombinant organisms associated with the agents or toxins in ECCN 1C351, 1C352, or 1C354 (for APHIS, see 7 CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42 CFR 73.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified biological agents and biologically derived substances that are subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls.
Related Definition: * * *
Items:
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* * *
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. * * *
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* * *
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. * * *
Technical Notes:
* * * * *
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``Nucleic acid sequences associated with the pathogenicity of any of the microorganisms controlled by 1C351.a to .c, 1C352, or 1C354'' means any sequence specific to the relevant controlled microorganism that:
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In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
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Is known to enhance the ability of a microorganism controlled by 1C351.a to .c, 1C352, or 1C354, or any other organism into which it may be inserted or otherwise integrated, to cause serious harm to human, animal or plant health.
* * * * *
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C354 is amended by revising the ``License Requirements Note'' under the License Requirements section and by revising the ``Related Controls'' paragraph and the ``Items'' paragraph under the List of Items Controlled section to read as follows:
1C354 Plant pathogens, as follows (see List of Items Controlled).
License Requirements
* * * * *
License Requirements Notes:
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All vaccines are excluded from the scope of this ECCN. See ECCN 1C991 for vaccines.
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Unless specified elsewhere in this ECCN 1C354 (e.g., in License Requirement Note 1), this ECCN controls all biological agents, regardless of quantity or attenuation, that are identified in the List of Items Controlled for this ECCN, including small quantities or attenuated strains of select biological agents that are excluded from the list of PPQ select agents and ``toxins'' by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, in accordance with their regulations in 7 CFR part 331.
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: (1) The Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, maintains controls on the possession, use, and transfer within the United States of certain items controlled by this ECCN (see 7 CFR 331.3(c), 9 CFR 121.3(c), and 9 CFR 121.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified biological agents and biologically derived substances that are subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls.
Related Definition: * * *
Items:
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Bacteria, as follows:
a.1. Xanthomonas albilineans;
a.2. Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas campestris pv. citri);
a.3. Xanthomonas oryzae this species of proteobacteria is identified on the APHIS ``select agents'' list (see Related Controls paragraph for this ECCN), but only the pathovar Xanthomonas oryzae pv. oryzae (syn. Pseudomonas campestris pv. oryzae) is identified on the Australia Group (AG) ``List of Plant Pathogens for Export Control'';
a.4. Clavibacter michiganensis subspecies sepedonicus (syn. Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum);
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a.5. Ralstonia solanacearum, race 3, biovar 2;
a.6. Raythayibactor toxicus this bacterium is identified on the APHIS ``select agents'' list (see the Related Controls paragraph for this ECCN), but is not identified on the Australia Group (AG) ``List of Plant Pathogens for Export Control''.
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Fungi, as follows:
b.1. Colletotrichum kahawae (Colletotrichum coffeanum var. virulans);
b.2. Cochliobolus miyabeanus (Helminthosporium oryzae);
b.3. Microcyclus ulei (syn. Dothidella ulei);
b.4. Puccinnia graminis ssp. graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii (Puccinia graminis syn. Puccinia graminis f. sp. tritici);
b.5. Puccinia striiformis (syn. Puccinia glumarum);
b.6. Magnaporthe oryzae (Pyricularia oryzae);
b.7. Peronosclerospora philippinensis (Peronosclerospora sacchari);
b.8. Sclerophthora rayssiae var. zeae;
b.9. Synchytrium endobioticum;
b.10. Tilletia indica;
b.11. Thecaphora solani;
b.12. Phoma glycinicola (formerly Pyrenochaeta glycines) this fungus is identified on the APHIS ``select agents'' list (see the Related Controls paragraph for this ECCN), but is not identified on the Australia Group (AG) ``List of Plant Pathogens for Export Control''.
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Viruses, as follows:
c.1. Andean potato latent virus (Potato Andean latent tymovirus);
c.2. Potato spindle tuber viroid.
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C360 is removed.
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1C991 is amended under the List of Items Controlled section by revising the fourth sentence in the ``Related Definitions'' paragraph and by revising paragraph a. in the ``Items'' paragraph 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: * * *
Related Controls: * * *
Related Definitions: * * * Biological toxins in any other configuration, including bulk shipments, or for any other end-uses are controlled by ECCN 1C351. * * *
Items:
-
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Vaccines against items controlled by ECCN 1C351, 1C352, 1C353 or 1C354.
* * * * *
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1E001 is amended by revising the ECCN heading and by revising the ``Control(s)'' language for ``Country Chart--CB Column 1'' in the License Requirements section to read as follows:
1E001 ``Technology'' according to the General Technology Note for the ``Development'' or ``Production'' of items controlled by 1A001.b, 1A001.c, 1A002, 1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008, 1A101, 1B (except 1B999), or 1C (except 1C355, 1C980 to 1C984, 1C988, 1C990, 1C991, 1C995 to 1C999).
License Requirements
Reason for Control: NS, MT, NP, CB, RS, AT
Control(s) Country chart
* * * * *
CB applies to ``technology'' for items CB Column 1.
controlled by 1C351, 1C352, 1C353, or
1C354.
* * * * *
License Requirements Note: * * *
* * * * *
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 1--Special Materials and Related Equipment, Chemicals, ``Microorganisms'' and ``Toxins,'' ECCN 1E351 is amended by revising the ECCN heading and by revising the ``Control(s)'' language for ``Country Chart--CB Column 1'' in the License Requirements section to read as follows:
1E351 ``Technology'' according to the ``General Technology Note'' for the disposal of chemicals or microbiological materials controlled by 1C350, 1C351, 1C352, 1C353, or 1C354.
License Requirements
Reason for Control: CB, AT
Control(s) Country chart
CB applies to ``technology'' for the CB Column 1.
disposal of items controlled by 1C351,
1C352, 1C353, or 1C354.
* * * * *
* * * * *
0
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In Supplement No. 1 to Part 774 (the Commerce Control List), Category 2--Materials Processing, ECCN 2B352 is amended under the ``Items'' paragraph in the List of Items Controlled section by redesignating paragraphs f. through h. as paragraphs g. through i., respectively, and adding a new paragraph f. 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: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
* * * * *
-
-
Spray-drying equipment capable of drying toxins or pathogenic microorganisms having all of the flowing characteristics:
f.1. A water evaporation capacity of >= 0.4 kg/h and
