39162 Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Rules and Regulations 

availability of this material at the FAA, call 

(816) 329–4148. 

(4) You may also review copies of the 

service information that is incorporated by 

reference at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at an NARA facility, call 202–741– 

6030, or go to http://www.archives.gov/ 

federal_register/code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Kansas City, Missouri, on June 

21, 2012. 

James E. Jackson, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–15752 Filed 6–29–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 774 

[Docket No. 120112039–2176–03] 

RIN 0694–AF45 

Implementation of the Understandings 

Reached at the 2011 Australia Group 

(AG) Plenary Meeting and Other AGRelated Clarifications to the EAR 

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 2011 

plenary meeting of the Australia Group 

(AG). This rule amends the Commerce 

Control List (CCL) entry in the EAR that 

controls human and zoonotic pathogens 

and ‘‘toxins’’ and the entry that controls 

genetic elements and genetically 

modified organisms to reflect changes to 

the AG ‘‘List of Biological Agents for 

Export Control’’ that were made based 

on the understandings adopted at the 

June 2011 AG plenary meeting. In 

addition, this rule amends the CCL 

entries in the EAR that control chemical 

manufacturing facilities and equipment, 

and equipment capable of use in 

handling biological materials to reflect 

the June 2011 AG plenary changes to the 

‘‘Control List of Dual-Use Chemical 

Manufacturing Facilities and Equipment 

and Related Technology and Software’’ 

and the ‘‘Control List of Dual-Use 

Biological Equipment and Related 

Technology and Software,’’ respectively. 

DATES: This rule is effective July 2, 

2012. 

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 June 2011 plenary meeting of the 

Australia Group (AG). 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. 

The June 2011 AG plenary meeting 

adopted understandings that affected 

the AG ‘‘List of Biological Agents for 

Export Control,’’ the AG ‘‘Control List of 

Dual-Use Chemical Manufacturing 

Facilities and Equipment and Related 

Technology and Software’’ and the AG 

‘‘Control List of Dual-Use Biological 

Equipment and Related Technology and 

Software.’’ 

This rule amends Export Control 

Classification Numbers (ECCNs) 1C351 

and 1C353 to reflect the AG changes to 

the ‘‘List of Biological Agents for Export 

Control.’’ Specifically, ECCN 1C351 

(Human and zoonotic pathogens and 

‘‘toxins’’) is amended by removing and 

reserving paragraph .b (Rickettsiae), 

since these organisms are more 

appropriately identified as bacteria. 

Coxiella burnetii and Rickettsia 

prowasecki (a.k.a. Rickettsia 

prowazekii), which were previously 

controlled under ECCN 1C351.b.2 and 

.b.3, respectively, are now controlled as 

bacteria under ECCN 1C351.c.10 and 

.c.13, respectively. Bartonella Quintana 

(Rochalimea Quintana, Rickettsia 

Quintana) and Rickettsia rickettsii, 

which were previously controlled under 

ECCN 1C351.b.1 and .b.4, respectively, 

are removed from ECCN 1C351, since 

they are no longer included on the AG 

‘‘List of Biological Agents.’’ 

ECCN 1C353 (Genetic elements and 

genetically modified organisms) is 

amended by revising Technical Note 1 

and adding a new Technical Note 4 to 

clarify that this ECCN controls certain 

de novo chemically synthesized genetic 

material and artificially-produced 

organisms. Specifically, Technical Note 

1 to ECCN 1C353 is revised to indicate 

that ‘‘genetic elements’’ also include 

chromosomes, genomes, plasmids, 

transposons, and vectors that have been 

‘‘chemically synthesized in whole or in 

part.’’ New Technical Note 4 to ECCN 

1C353 indicates that ‘‘genetically 

modified organisms’’ include 

‘‘organisms in which the genetic 

material (nucleic acid sequences) has 

been altered in a way that does not 

occur naturally by mating and/or 

natural recombination, and 

encompasses those produced artificially 

in whole or in part.’’ 

This rule also amends ECCN 2B350 

(Chemical manufacturing facilities and 

equipment) by adding a new Technical 

Note 3, at the end of the entry, to clarify 

that materials used for gaskets, packing, 

seals, screws or washers, or other 

materials performing a sealing function, 

do not determine the control status of 

the items listed in ECCN 2B350, 

provided that such components are 

designed to be interchangeable. 

In addition, this rule amends ECCN 

2B352 (Equipment capable of use in 

handling biological materials) by 

revising the introductory text of 

paragraph .d.1 to remove the phrase 

‘‘without propagation of aerosols.’’ 

Participating countries at the 2011 AG 

plenary agreed that this phrase was 

redundant, as it applied to cross 

(tangential) flow filtration equipment 

capable of separation of pathogenic 

microorganisms, viruses, toxins or cell 

cultures. 

Finally, this rule amends ECCNs 

2B350 and 2B352 to clarify certain 

control parameters for pumps (i.e., 

multiple-seal and seal-less pumps and 

vacuum pumps) and steam sterilizable 

freeze-drying (lyophilization) 

equipment, respectively. Specifically, 

ECCN 2B350.i is amended by adding 

two parenthetical phrases in the 

introductory text to specify the 

maximum flow-rate of such pumps in 

liters of water per hour, as follows: 

‘‘multiple-seal and seal-less pumps with 

manufacturer’s specified maximum 

flow-rate greater than 0.6 m3/hour (600 

liters/hour), or vacuum pumps with 

manufacturer’s specified maximum 

flow-rate greater than 5 m3/hour (5,000 

liters/hour).’’ ECCN 2B352.e is amended 


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Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Rules and Regulations 39163 

by adding two parenthetical phrases 

that specify the condenser capacity of 

such equipment in liters of water per 24 

hours, as follows: ‘‘10 kgs of ice or 

greater in 24 hours (10 liters of water or 

greater in 24 hours), but less than 1,000 

kgs of ice in 24 hours (less than 1,000 

liters of water in 24 hours).’’ These 

changes are being made by BIS in order 

to indicate these AG control parameters 

in units of measure that are more 

commonly used in the United States. 

None of the changes made by this rule 

increase the scope of the controls in 

ECCNs 1C351, 1C353, 2B350 and 2B352. 

Except for the removal of Bartonella 

Quintana and Rickettsia rickettsii from 

ECCN 1C351, the items that are 

controlled under these ECCNs remain 

the same. 

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 extended by the 

Notice of August 12, 2011, 76 FR 50661 

(August 16, 2011), 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 2011 AG plenary meeting 

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 in 15 CFR Part 774 

Exports, Foreign trade, Reporting and 

recordkeeping requirements. 

Accordingly, part 774 of the Export 

Administration Regulations (15 CFR 

parts 730–774) is amended as follows: 

PART 774—[AMENDED] 

■ 1. 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 12, 2011, 76 

FR 50661 (August 16, 2011). 

■ 2. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 1, 

ECCN 1C351 is amended under the 

‘‘Items’’ paragraph in the List of Items 

Controlled section by removing and 

reserving paragraph b. and by revising 

paragraph c. to read as follows: 

Supplement No. 1 to Part 774—The 

Commerce Control List 

* * * * * 

1C351 Human and zoonotic pathogens 

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

Controlled). 

* * * * * 

List of Items Controlled 

* * * * * 

Items: 

* * * * * 

b. [Reserved] 

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. Chlamydophila psittaci (formerly 

known as Chlamydia psittaci); 

c.8. Clostridium botulinum; 

c.9. Clostridium perfringens, epsilon toxin 

producing types; 

c.10. Coxiella burnetii; 

c.11. Enterohaemorrhagic Escherichia coli, 

serotype O157 and other verotoxin producing 

serotypes; 

c.12. Francisella tularensis; 

c.13. Rickettsia prowasecki (a.k.a. 

Rickettsia prowazekii); 

c.14. Salmonella typhi; 

c.15. Shigella dysenteriae; 

c.16. Vibrio cholerae; or 

c.17. Yersinia pestis. 

* * * * * 

■ 3. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 1, 


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39164 Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Rules and Regulations 

ECCN 1C353 is amended under the 

‘‘Items’’ paragraph in the List of Items 

Controlled section by revising Technical 

Note 1 and by adding a new Technical 

Note 4 in numerical order, to read as 

follows: 

1C353 Genetic elements and genetically 

modified organisms, as follows (see List of 

Items Controlled). 

* * * * * 

List of Items Controlled 

* * * * * 

Items: 

* * * * * 

Technical Notes: 1. ‘‘Genetic elements’’ 

include, inter alia, chromosomes, genomes, 

plasmids, transposons, and vectors, whether 

genetically modified or unmodified, or 

chemically synthesized in whole or in part. 

* * * * * 

4. ‘‘Genetically modified organisms’’ 

include organisms in which the genetic 

material (nucleic acid sequences) has been 

altered in a way that does not occur naturally 

by mating and/or natural recombination, and 

encompasses those produced artificially in 

whole or in part. 

■ 4. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 2, 

ECCN 2B350 is amended under the 

‘‘Items’’ paragraph in the List of Items 

Controlled section by revising the 

introductory text of paragraph i. and by 

adding a new ‘‘Technical Note 3,’’ in 

numerical order, 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 

* * * * * 

Items: 

* * * * * 

i. Multiple-seal and seal-less pumps with 

manufacturer’s specified maximum flow-rate 

greater than 0.6 m3/hour (600 liters/hour), or 

vacuum pumps with manufacturer’s 

specified maximum flow-rate greater than 5 

m3/hour (5,000 liters/hour) (under standard 

temperature (273 K (0 °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 following 

materials: 

* * * * * 

Technical Note 3: The materials used for 

gaskets, packing, seals, screws or washers, or 

other materials performing a sealing function, 

do not determine the control status of the 

items in this ECCN, provided that such 

components are designed to be 

interchangeable. 

■ 5. In Supplement No. 1 to Part 774 

(the Commerce Control List), Category 2, 

ECCN 2B352 is amended under the 

‘‘Items’’ paragraph in the List of Items 

Controlled section by revising the 

introductory text of paragraph d.1 and 

by revising paragraph e to read as 

follows: 

2B352 Equipment capable of use in 

handling biological materials, as follows (see 

List of Items Controlled). 

* * * * * 

List of Items Controlled 

* * * * * 

Items: 

* * * * * 

d. * * * 

d.1. Cross (tangential) flow filtration 

equipment capable of separation of 

pathogenic microorganisms, viruses, toxins 

or cell cultures having all of the following 

characteristics: 

* * * * * 

e. Steam sterilizable freeze-drying 

(lyophilization) equipment with a condenser 

capacity of 10 kgs of ice or greater in 24 

hours (10 liters of water or greater in 24 

hours), but less than 1,000 kgs of ice in 24 

hours (less than 1,000 liters of water in 24 

hours). 

* * * * * 

Dated: June 22, 2012. 

Kevin J. Wolf 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2012–16001 Filed 6–29–12; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 147 

[Docket No. USCG–2011–1143] 

RIN 1625–AA00 

Safety Zone; KULLUK, Outer 

Continental Shelf Mobile Offshore 

Drilling Unit (MODU), Beaufort Sea, AK 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a 500-meter safety zone in 

the navigable waters, from the surface to 

seabed, around the MODU KULLUK 

while anchored or deploying and 

recovering moorings on location in 

order to drill exploratory wells at 

various prospects located in the 

Beaufort Sea Outer Continental Shelf, 

Alaska, on or about July 1, 2012, 

through November 30, 2012. See TABLE 

1. The purpose of the temporary safety 

zone is to protect the MODU from 

surface and subsurface vessels that are 

operating outside the normal shipping 

channels and fairways. Placing a safety 

zone around the MODU will 

significantly reduce the threat of 

allisions that could result in oil spills, 

and releases of natural gas, and thereby 

protect the safety of life, property, and 

the environment. Lawful 

demonstrations may be conducted 

outside of the safety zone. 

DATES: The temporary safety zone 

becomes effective on July 1, 2012, and 

terminates on December 1, 2012, unless 

sooner terminated by the Commander, 

Seventeenth Coast Guard District. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2011–1143 and are 

available online by going to http:// 

www.regulations.gov, inserting USCG– 

2011–1143 in the ‘‘Keyword’’ box, and 

then clicking ‘‘Search.’’ This material is 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LT Jason Smilie, Seventeenth 

Coast Guard District (dpi); telephone 

907–463–2809, 

Jason.A.Smilie@uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On February 23, 2012, the Coast 

Guard published a notice of proposed 

rulemaking (NPRM) entitled ‘‘Safety 

Zone; KULLUK, Outer Continental Shelf 

Mobile Offshore Drilling Unit (MODU), 

Beaufort Sea, Alaska’’ in the Federal 

Register (77 FR 10711). The NPRM 

included a 30-day comment period. We 

received 2 (two) submissions with 

comments on the proposed rule. No 

public meeting was requested, and none 

was held. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. The Coast Guard finds that 

good cause exists for making this rule 

effective less than 30 days after 

publication because to do otherwise 

would be contrary to the public interest 

since immediate action is required to 

protect mariners, vessels, and the 


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