33692 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

interim staff guidance in the Federal 

Register (76 FR 1100) for public 

comment. Two comment letters were 

received and considered during the 

revision of the draft interim staff 

guidance. The guidance was also 

enhanced based on comments received 

on the proposed rule. 

The interim staff guidance document 

describes methods acceptable to the 

NRC staff for implementing the new 

requirements in the Distribution of 

Source Material Rule. The approaches 

and methods described in the document 

are provided for information only. 

Methods and solutions different from 

those described in the document are 

acceptable if they meet the revised 

requirements. The guidance is provided 

in the form of questions and answers on 

the primary provisions of the 

Distribution of Source Material Rule. 

Guidance consistent with the revised 10 

CFR part 40 will be incorporated into 

the next revision of relevant volumes of 

NUREG–1556, ‘‘Consolidated Guidance 

About Materials Licenses’’ (current 

ADAMS Accession Nos. ML022830847 

and ML003681951). 

Congressional Review Act 

This interim staff guidance is a rule as 

designated in the Congressional Review 

Act of 1996 (5 U.S.C. 801–808). 

However, the Office of Management and 

Budget has not found it to be a major 

rule as designated in the Congressional 

Review Act. 

Dated at Rockville, Maryland, this 30th day 

of May, 2013. 

For the Nuclear Regulatory Commission. 

Brian J. McDermott, 

Director, Division of Materials Safety and 

State Agreements, Office of Federal and State 

Materials and Environmental Management 

Programs. 

[FR Doc. 2013–13344 Filed 6–4–13; 8:45 am] 

BILLING CODE 7590–01–P 

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. 

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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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 33693 

.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 

≤ 400 kg/h; (2) the ability to generate a 

typical mean product particles size of 

≤ 10 micrometers with existing fittings 

or by minimal modification of the spraydryer with atomization nozzles enabling 

generation of the required particle size; 

and (3) capable of being sterilized or 

disinfected in situ. 

Select Agent Changes to the CCL 

This rule removes ECCN 1C360 

(Select agents). This ECCN controlled 

select agents not included on any of the 

AG common controls lists that were 

identified on the CCL because they are 

(or were, until recently) subject to 

controls maintained by 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, on their possession, use, and 

transfer within the United States. 

As a result of amendments by CDC to 

the list of ‘‘HHS select agents’’ in 42 

CFR 73.3 and the list of ‘‘Overlap select 

agents and toxins’’ in 42 CFR 73.4 and 

amendments by APHIS to the list of 

‘‘Plant Protection and Quarantine (PPQ) 

select agents and toxins’’ in 7 CFR 331.3 

and the list of ‘‘Veterinary Services (VS) 

select agents and toxins’’ in 9 CFR 

121.3, ten of the eighteen select agents 

that were listed in ECCN 1C360 are no 

longer included on the CDC/APHIS 

select agents lists. For this reason, as 

well as to assist exporters to more easily 

identify all of the select agents that are 

subject to the chemical/biological (CB) 

controls described in Section 742.2(a)(1) 

of the EAR (i.e., CB Column 1), BIS is 

removing ECCN 1C360 from the CCL 

and adding the select agents that were 

controlled by ECCN 1C360, and 

continue to be identified on the CDC/ 

APHIS lists, to the appropriate AGrelated ECCNs on the CCL (i.e., ECCNs 

1C351 and 1C354). Prior to the 

publication of this rule, the CDC/APHIS 

select agents listed in these ECCNs 

included only those select agents that 

were also identified on one of the AG 

common control lists. 

As a result of the changes described 

above, the following select agents that 

were controlled by ECCN 1C360 are no 

longer listed on the CCL: Central 

European tick-borne encephalitis 

viruses (i.e., Absettarov, Hanzalova, 

Hypr, and Kumlinge); Cercopithecine 

herpesvirus 1 (Herpes B virus); Flexal 

virus; Akabane virus; Bovine 

spongiform encephalopathy agent; 

Camel pox virus; Malignant catarrhal 

fever virus; Menangle virus; Erhlichia 

ruminantium (a.k.a. Cowdria 

ruminantium); and Xylella fastidiosa pv. 

citrus variegated chlorosis (CVC). 

Three select agents that were 

controlled under ECCN 1C360 and 

continue to be identified on the CDC/ 

APHIS select agents lists are now 

controlled on the CCL, as follows: 

Reconstructed replication competent 

forms of the 1918 pandemic influenza 

virus containing any portion of the 

coding regions of all eight gene 

segments (now controlled under ECCN 

1C351.b.1); Rathayibacter toxicus (now 

controlled under ECCN 1C354.a.6); and 

Phoma glycinicola, formerly 

Pyrenochaeta glycines (now controlled 

under ECCN 1C354.b.12). None of these 

select agents are identified on any of the 

AG common control lists; however, they 

continue to be subject to CB controls 

(for those destinations indicated under 

CB Column 1 on the Commerce Country 

Chart in Supplement No. 1 to part 738 

of the EAR), as well as anti-terrorism 


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33694 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

(AT) controls (for those destinations 

indicated under AT Column 1 on the 

Commerce Country Chart—Country 

Group E:1, in Supplement No. 1 to part 

740 of the EAR, lists those countries 

designated as ‘‘terrorist-supporting 

countries’’ for purposes of the AT 

controls in the EAR). 

In addition, three select agents that 

were controlled under ECCN 1C360, and 

continue to be identified on the APHIS 

select agents lists, have been added to 

the AG ‘‘List of Plant Pathogens for 

Export Control,’’ in accordance with the 

understandings reached at the 2012 AG 

Plenary (see the discussion of the 2012 

AG Plenary changes, above). These 

select agents are now controlled on the 

CCL as follows: Peronosclerospora 

philippinensis (Peronosclerospora 

sacchari) (now controlled under ECCN 

1C354.b.7); Sclerophthora rayssiae var. 

zeae (now controlled under ECCN 

1C354.b.8); and Synchytrium 

endobioticum (now controlled under 

ECCN 1C354.b.9). This rule also amends 

ECCN 1C354.a.3 to include the species 

of proteobacteria identified as 

Xanthomonas oryzae, which is 

identified on the APHIS list of PPQ 

select agents and toxins; however, only 

the pathovar Xanthomonas oryzae pv. 

oryzae (syn. Pseudomonas campestris 

pv. oryzae) is identified on the AG ‘‘List 

of Plant Pathogens for Export Control.’’ 

Like all other items controlled under 

ECCN 1C354, these select agents are 

subject to CB Column 1 controls, as well 

as AT Column 1 controls. 

Furthermore, this rule eliminates 

redundant controls on two bacteria of 

the Mycoplasma mycoides cluster: 

Mycoplasma capricolum subspecies 

capripneumoniae and Mycoplasma 

mycoides subspecies mycoides small 

colony. These bacteria were identified 

under ECCN 1C360.b.2 and ECCN 

1C352.b.1, prior to the publication of 

this rule, but are now controlled under 

ECCN 1C352.b.1, only. Both bacteria 

continue to be identified on the list of 

‘‘VS Select Agents and Toxins’’ 

maintained by APHIS, as well as the AG 

‘‘List of Plant Pathogens for Export 

Control.’’ Like all other items controlled 

under ECCN 1C352, these bacteria are 

subject to CB Column 1 controls, as well 

as AT Column 1 controls. 

This rule also amends ECCN 1C351 by 

adding SARS-associated coronavirus 

(SARS-CoV) under 1C351.b.2 and tickborne encephalitis virus (Siberian 

subtype) under 1C351.b.3. Both viruses 

were recently included in CDC’s list of 

‘‘HHS select agents and toxins,’’ but are 

not identified on any of the AG common 

control lists. However, like all other 

items controlled under ECCN 1C351, 

these viruses are subject to CB Column 

1 controls, as well as AT Column 1 

controls. Another tick-borne 

encephalitis virus (Far Eastern subtype, 

formerly known as Russian SpringSummer encephalitis virus) is 

controlled under ECCN 1C351.a.35 and 

is currently included in both CDC’s list 

of ‘‘HHS select agents and toxins’’ and 

the AG ‘‘List of Biological Agents for 

Export Control.’’ This rule amends 

ECCN 1C351.a.35 to reflect the current 

nomenclature (i.e., Far Eastern subtype) 

used by the International Committee on 

Taxonomy of Viruses. 

In addition to the select agents 

changes described above, this rule 

makes conforming changes to Sections 

740.20 and 742.2 of the EAR and to 

ECCNs 1C353, 1C991, 1E001 and 1E351 

to reflect the removal of ECCN 1C360 

from the CCL. Specifically, Section 

740.20(b)(2)(v) is amended by removing 

two references to ECCN 1C360 from the 

description of biological items that are 

not eligible for License Exception 

Strategic Trade Authorization (STA). 

The items that were controlled under 

ECCN 1C360 and that remain on the 

CCL are now controlled under ECCN 

1C351.a or .b, ECCN 1C352 or ECCN 

1C354, all of which are identified in 

paragraph (b)(2)(v). Section 

742.2(a)(1)(i) of the EAR is amended by 

removing the reference to ECCN 1C360 

from the description of the license 

requirements that apply to items 

controlled for CB reasons to destinations 

indicated under CB Column 1 on the 

Commerce Country Chart. ECCN 1C353 

is amended by removing references to 

ECCN 1C360 from the following: The 

Related Controls paragraph; paragraphs 

a.1. and b.1. in the Items paragraph 

under the List of Items Controlled; and 

Technical Note 3. ECCN 1C991 is 

amended by removing references to 

ECCN 1C360 from the fourth sentence of 

the Related Definitions paragraph and 

from paragraph a. in the Items 

paragraph under the List of Items 

Controlled. ECCN 1E001 is amended by 

removing the reference to ECCN 1C360 

from the control language for ‘‘Country 

Chart—CB Column 1’’ in the License 

Requirements section. ECCN 1E351 is 

amended by removing references to 

ECCN 1C360 from the ECCN heading 

and from the controls language for 

‘‘Country Chart—CB Column 1’’ in the 

License Requirements section. 

Finally, this rule amends ECCNs 

1C351, 1C352, 1C353, and 1C354 by 

revising the License Requirements 

Note(s) in the License Requirements 

section of each ECCN to add a note 

indicating that ECCNs 1C351, 1C352, 

1C353, and 1C354 control all biological 

agents or ‘‘toxins,’’ regardless of 

quantity or attenuation, that are 

identified in the List of Items Controlled 

for each ECCN (or, in the case of ECCN 

1C353, genetic elements or genetically 

modified organisms for such agents or 

‘‘toxins’’), including small quantities or 

attenuated strains of select biological 

agents or ‘‘toxins’’ that are excluded 

from the lists of select biological agents 

or ‘‘toxins’’ by APHIS or CDC, in 

accordance with the APHIS regulations 

in 7 CFR part 331 or 9 CFR part 121 or 

the CDC regulations in 42 CFR part 73. 

These changes do not affect the scope of 

ECCNs 1C351, 1C352, 1C353, and 1C354 

and conform with the controls described 

in the AG common control lists and in 

the AG ‘‘Guidelines for Transfers of 

Sensitive Chemical or Biological Items,’’ 

neither of which provide an exemption 

from control for attenuated strains of 

biological agents or toxins. In 

conjunction with these changes, this 

rule amends the Related Controls 

paragraph in each of these four ECCNs 

to add a sentence referencing 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. 

Effect of This Rule on the Scope of the 

CB Controls in the EAR 

The changes made by this rule only 

marginally affect the scope of the EAR 

controls on biological agents and toxins. 

With the removal of ECCN 1C360 from 

the CCL, ten select agents that were 

controlled under this ECCN prior to the 

publication of this rule are no longer 

identified on the CCL and are classified 

as EAR99, instead. All of these select 

agents were recently removed from the 

CDC/APHIS select agents lists. In 

addition, six other select agents that 

were controlled under ECCN 1C360 

have been moved to ECCN 1C351 or 

ECCN 1C354 and continue to require a 

license for CB reasons to destinations 

indicated under CB Column 1 on the 

Commerce Country Chart and for AT 

reasons to destinations indicated under 

AT Column 1—all of these select agents 

continue to be identified on the CDC/ 

APHIS select agents lists. Two 

additional select agents (Mycoplasma 

capricolum subspecies 

capripneumoniae and Mycoplasma 

mycoides subspecies mycoides small 

colony) also were controlled under 

ECCN 1C360 and continue to be 

identified on the CDC/APHIS select 

agents lists. As indicated above, this 

rule did not add these select agents to 

ECCN 1C352 because they were already 

described in ECCN 1C352.b.1 (i.e., the 

ECCN 1C360 controls on these select 

agents duplicated the controls in ECCN 


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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 33695 

1C352). This rule also adds two viruses 

that were recently included in CDC’s list 

of ‘‘HHS select agents and toxins’’ (i.e., 

SARS-associated coronavirus and tickborne encephalitis virus, Siberian 

subtype) to ECCN 1C351.b. 

Based on the understandings reached 

at the June 2012 AG Plenary meeting, 

this rule also adds three bacteria to 

ECCN 1C351 and two fungi to ECCN 

1C354, none of which were identified 

on the CCL prior to the publication of 

this rule. The AG Plenary also added 

three additional fungi to the ‘‘List of 

Plant Pathogens for Export Control,’’ but 

these fungi were already controlled 

under ECCN 1C360, based on their 

inclusion by APHIS on the list of PPQ 

select agents and toxins (7 CFR part 

331), and are now controlled under 

ECCN 1C354 (i.e., these fungi are among 

the six select agents that have been 

moved by this rule from ECCN 1C360 to 

ECCN 1C351 or ECCN 1C354, as 

indicated above). 

To summarize the biological agent 

and toxin changes described above, this 

rule removes ten CDC/APHIS select 

agents from the CCL, while adding three 

AG-listed bacteria and two fungi, as 

well as two viruses that were recently 

identified on CDC’s list of ‘‘HHS select 

agents and toxins.’’ These changes are 

not expected to significantly affect the 

scope of the EAR controls on biological 

agents and toxins, because BIS estimates 

that there will be no increase in the 

number of license applications for these 

items. 

Finally, this rule expands the scope of 

the EAR controls that apply to dual-use 

equipment capable of handling 

biological materials by amending ECCN 

2B352 to add certain spray-drying 

equipment. This change is not expected 

to significantly affect the scope of the 

EAR controls on such equipment, 

because BIS anticipates only a small 

increase in the number of license 

applications. 

Although the Export Administration 

Act expired on August 20, 2001, the 

President, through Executive Order 

13222 of August 17, 2001, 3 CFR, 2001 

Comp., p. 783 (2002), as amended by 

Executive Order 13637 of March 8, 

2013, 78 FR 16129 (March 13, 2013), 

and as extended by the Notice of August 

15, 2012, 77 FR 49699 (August 16, 

2012), has continued the EAR in effect 

under the International Emergency 

Economic Powers Act. 

Rulemaking Requirements 

1. Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been designated a ‘‘significant 

regulatory action’’ although not 

economically significant, under section 

3(f) of Executive Order 12866. 

Accordingly, the rule has been reviewed 

by the Office of Management and 

Budget. 

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 of 1995 (44 U.S.C. 3501 

et seq.) (PRA), unless that collection of 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This rule 

contains a collection of information 

subject to the requirements of the PRA. 

This collection has been approved by 

OMB under Control Number 0694–0088 

(Multi-Purpose Application), which 

carries a burden hour estimate of 58 

minutes to prepare and submit form 

BIS–748. Send comments regarding this 

burden estimate or any other aspect of 

this collection of information, including 

suggestions for reducing the burden, to 

Jasmeet Seehra, Office of Management 

and Budget (OMB), and to the 

Regulatory Policy Division, Bureau of 

Industry and Security, Department of 

Commerce, as indicated in the 

ADDRESSES section of this rule. 

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 (See 5 U.S.C. 553(a)(1)). 

Immediate implementation of these 

amendments is non-discretionary and 

fulfills the United States’ international 

obligation to the Australia Group (AG). 

The AG contributes to international 

security and regional stability through 

the harmonization of export controls 

and seeks to ensure that exports do not 

contribute to the development of 

chemical and biological weapons. The 

AG consists of 40 member countries that 

act on a consensus basis and the 

amendments set forth in this rule 

implement the understandings reached 

at the June 2012 AG plenary meeting, 

the 2012 AG intersessional changes, and 

other changes that are necessary to 

ensure consistency with the controls 

maintained by the AG. Since the United 

States is a significant exporter of the 

items in this rule, immediate 

implementation of this provision is 

necessary for the AG to achieve its 

purpose. Any delay in implementation 

will create a disruption in the 

movement of affected items globally 

because of disharmony between export 

control measures implemented by AG 

members, resulting in tension between 

member countries. Export controls work 

best when all countries implement the 

same export controls in a timely and 

coordinated manner. 

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 

the Administrative Procedure Act 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. 

List of Subjects 

15 CFR Part 740 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 774 

Exports, Reporting and recordkeeping 

requirements. 

For the reasons stated in the 

preamble, parts 740, 742, and 774 of the 

Export Administration Regulations (15 

CFR parts 730–774) are amended as 

follows: 

PART 740—[AMENDED] 

■ 1. The authority citation for 15 CFR 

Part 740 continues to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; 

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 15, 2012, 77 

FR 49699 (August 16, 2012). 

■ 2. Section 740.20 is amended by 

revising paragraph (b)(2)(v) to read as 

follows: 


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33696 Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations 

§ 740.20 License Exception Strategic 

Trade Authorization (STA). 

* * * * * 

(b) * * * 

(2) * * * 

(v) License Exception STA may not be 

used for any item controlled by ECCN 

1C351.a, .b, .c, d.11, .d.12 or .e, ECCNs 

1C352, 1C353, 1C354, 1E001 (i.e., for 

technology, as specified in ECCN 1E001, 

for items controlled by ECCN 1C351.a, 

.b, .c, .d.11, .d.12 or .e or ECCNs 1C352, 

1C353, or 1C354) or ECCN 1E351. 

* * * * * 

PART 742—[AMENDED] 

■ 3. 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.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; Sec 1503, Pub. L. 108–11, 117 

Stat. 559; 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; Presidential Determination 

2003–23 of May 7, 2003, 68 FR 26459, May 

16, 2003; Notice of August 15, 2012, 77 FR 

49699 (August 16, 2012); Notice of November 

9, 2011, 76 FR 70319 (November 10, 2011). 

§ 742.2 [Amended] 

■ 4. Section 742.2 is amended by 

removing the phrase ‘‘ECCNs 1C351, 

1C352, 1C353, 1C354, and 1C360’’ in 

paragraph (a)(1)(i) and adding in its 

place the phrase ‘‘ECCNs 1C351, 1C352, 

1C353, and 1C354’’. 

PART 774—[AMENDED] 

■ 5. 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); 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; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22 

U.S.C. 7201 et seq.; 22 U.S.C. 7210; 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 15, 2012, 77 

FR 49699 (August 16, 2012). 

Supplement No. 1 to Part 774— 

[Amended] 

■ 6. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 

1—Special Materials and Related 

Equipment, Chemicals, 

‘‘Microorganisms’’ and ‘‘Toxins,’’ ECCN 

1C351 is amended by adding a new 

Note 4 in the ‘‘License Requirements 

Notes’’ under the License Requirements 

section, by revising the ‘‘Related 

Controls’’ paragraph under the List of 

Items Controlled section, and, in the 

‘‘Items’’ paragraph under the List of 

Items Controlled section, by revising the 

heading of paragraph a., by revising 

paragraph a.35, by adding a new 

paragraph b., by revising paragraph c., 

by revising the heading of paragraph d., 

and by revising paragraph d.14 to read 

as follows: 

1C351 Human and zoonotic pathogens and 

‘‘toxins’’, as follows (see List of Items 

Controlled). 

License Requirements 

* * * * * 

License Requirement Notes: * * * 

4. Unless specified elsewhere in this ECCN 

1C351 (e.g., in License Requirement Notes 1– 

3), this ECCN controls all biological agents 

and ‘‘toxins,’’ 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 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 their regulations in 9 CFR 

part 121 and 42 CFR part 73, respectively. 

* * * * * 

List of Items Controlled 

Unit: * * * 

Related Controls: (1) Certain forms of ricin 

and saxitoxin in 1C351.d.11. and d.12 are 

CWC Schedule 1 chemicals (see § 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 § 745.1 of the 

EAR for notification procedures. See 22 

CFR part 121, Category XIV and § 121.7 for 

CWC Schedule 1 chemicals that are subject 

to the export licensing jurisdiction of the 

U.S. Department of State, Directorate of 

Defense Trade Controls. (2) 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)). (3) 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: 

a. Viruses identified on the Australia 

Group (AG) ‘‘List of Biological Agents for 

Export Control,’’ as follows: 

* * * * * 

a.35. Tick-borne encephalitis virus (Far 

Eastern subtype, formerly known as Russian 

Spring-Summer encephalitis virus—see 

1C351.b.3 for Siberian subtype); 

* * * * * 

b. Viruses identified on the APHIS/CDC 

‘‘select agents’’ lists (see Related Controls 

paragraph #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 (SARSCoV); or 

b.3. Tick-borne encephalitis virus (Siberian 

subtype, formerly West Siberian virus—see 

1C351.a.35 for Far Eastern subtype). 

c. 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. 

d. ‘‘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); 

* * * * * 

■ 7. 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: 

1. All vaccines are excluded from the scope 

of this ECCN. See ECCN 1C991 for vaccines. 

2. 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: 

* * * * * 

■ 8. 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: 

1. Vaccines that contain genetic elements 

or genetically modified organisms identified 

in this ECCN are controlled by ECCN 1C991. 

2. 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: 

a. * * * 

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. * * * 

b. * * * 

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: 

* * * * * 

3. ‘‘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: 

a. In itself or through its transcribed or 

translated products represents a significant 

hazard to human, animal or plant health; or 

b. 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. 

* * * * * 

■ 9. 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: 

1. All vaccines are excluded from the scope 

of this ECCN. See ECCN 1C991 for vaccines. 

2. 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: 

a. 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’’]. 

b. 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’’]. 

c. Viruses, as follows: 

c.1. Andean potato latent virus (Potato 

Andean latent tymovirus); 

c.2. Potato spindle tuber viroid. 

■ 10. 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. 

■ 11. 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: 

a. Vaccines against items controlled by 

ECCN 1C351, 1C352, 1C353 or 1C354. 

* * * * * 

■ 12. 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 controlled by 1C351, 

1C352, 1C353, or 1C354.

CB Column 

1. 

* * * * * 

License Requirements Note: * * * 

* * * * * 

■ 13. 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 disposal of items controlled by 1C351, 1C352, 

1C353, or 1C354.

CB Column 

1. 

* * * * * 

* * * * * 

■ 14. 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: 

* * * * * 

f. 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 ≤ 400 kg/h; 

f.2. The ability to generate a typical mean 

product particle size of ≤ 10 micrometers 

with existing fittings or by minimal 

modification of the spray-dryer with 

atomization nozzles enabling generation of 

the required particle size; and 

f.3. Capable of being sterilized or 

disinfected in situ. 

* * * * * 

Dated: May 29, 2013. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2013–13270 Filed 6–4–13; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

[Docket No. FDA–2013–N–0002] 

New Animal Drugs; Dexmedetomidine; 

Lasalocid; Melengestrol; Monensin; 

and Tylosin; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Correcting amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

document amending the animal drug 

regulations to reflect approval actions 

for new animal drug applications and 

abbreviated new animal drug 

applications during March 2013 that 

appeared in the Federal Register of 

April 30, 2013. FDA is correcting the 

approved strengths of dexmedetomidine 

hydrochloride injectable solution. This 

correction is being made to improve the 

accuracy of the animal drug regulations. 

DATES: This rule is effective June 5, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 


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