76842 Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 

Background 

The DOD contracts for passenger and 

air cargo movements from air carriers 

certificated by the FAA. The DOD is 

congressionally mandated to conduct 

capability evaluations of contracted 

carriers. These evaluations ensure each 

carrier is able to satisfy the unique 

requirements of military contracts and 

to adhere to the DOD Commercial Air 

Carrier Quality and Safety 

Requirements. These evaluations apply 

only to carriers under contract with the 

DOD or carriers wanting to enter into 

contracts with the DOD. 

DOD commercial air carrier evaluators 

require uninterrupted access to the 

flight deck to perform their reviews. For 

many years, DOD commercial air carrier 

evaluators relied on the FAA, the air 

carrier, and the pilot in command 

authorizing their access to conduct the 

air carrier evaluation mission. Language 

contained in 14 CFR parts 121 and 135 

did not include DOD commercial air 

carrier evaluators among those 

individuals authorized access to the 

flight deck. 

The absence of direct authority in the 

regulation listing and the lack of a wellknown DOD evaluator credential 

significantly hindered the 

congressionally mandated DOD air 

carrier evaluations. 

The amendments in the final rule 

make clear the authority of DOD 

commercial air carrier evaluators to 

conduct cockpit evaluations by 

including them in the regulation text. 

These changes, with the creation of the 

S&A Form 110B evaluator credential, 

have alleviated the problems DOD 

commercial air carrier evaluators have 

faced in the field. 

Discussion of Comments 

The FAA received comments from a 

private citizen and a commercial air 

carrier. The content of the two letters 

was identical. These comments are 

addressed below. 

The commenters stated that allowing 

cockpit access to the DOD evaluators 

was not ‘‘prudent or necessary’’ and the 

potential existed for DOD evaluators to 

abuse the process by wanting ‘‘free 

rides.’’

FAA response: The FAA does not 

agree with the commenters. The DOD is 

required by law to conduct carrier 

evaluations including cockpit 

observations. The DOD coordinates 

these observations in advance with the 

air carrier. Flight crews are made aware 

of the presence of the DOD evaluator 

before the flight. Surprise evaluations 

are not part of this program and DOD 

evaluators must show proper 

documentation, including their S&A 

Form 110B credential and military 

orders, to gain access to the aircraft. 

Additionally, these evaluations only 

occur on air carriers participating, or 

applying to participate, in the DOD 

program. The process currently in place 

safeguards the security of the aircraft 

and does not allow for ‘‘free ride’’ abuse 

by the evaluators. 

The FAA received comments 

regarding the possible falsification of 

the new credential being issued to DOD 

evaluators and the potential for 

increased costs to the air carrier by 

having to verify the evaluator’s 

documentation. 

FAA response: The FAA does not 

agree that the credential is easily 

falsified. The new credential issued to 

DOD air carrier evaluators has the same 

security features as the credentials 

carried by FAA inspectors and are 

difficult to falsify. In addition, DOD 

evaluators must present military orders 

with their S&A Form 110B credential. 

Verifying the credential and military 

order should not take any more time 

than in the past, and we expect the costs 

to be minimal. Again, these evaluations 

only occur on air carriers participating, 

or applying to participate, in the DOD 

program. 

Conclusion 

After consideration of the comments 

submitted in response to the final rule, 

the FAA has determined that no further 

rulemaking action is necessary. The 

final rule, ‘‘DOD Commercial Air Carrier 

Evaluators’’ remains in effect as 

adopted.

Issued in Washington, DC, on December 

15, 2004. 

Marion C. Blakey, 

Administrator.

[FR Doc. 04–27896 Filed 12–22–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF COMMERCE

Bureau of Industry and Security 

15 CFR Part 774 

[Docket No. 041123328–4328–01] 

RIN 0694–AD16 

Revision of Export Control 

Classification Number (ECCN) 2B351 

To Conform With the Australia Group 

(AG) ‘‘Control List of Dual-Use 

Chemical Manufacturing Facilities and 

Equipment and Related Technology’’

AGENCY: Bureau of Industry and 

Security, Commerce.

ACTION: Final rule.

SUMMARY: The Bureau of Industry and 

Security (BIS) is publishing this final 

rule to amend the Export 

Administration Regulations (EAR) by 

revising the Commerce Control List 

(CCL) entry that describes controls on 

certain toxic gas monitoring systems to 

conform with the Australia Group (AG) 

‘‘Control List of Dual-Use Chemical 

Manufacturing Facilities and Equipment 

and Related Technology.’’ Specifically, 

this final rule removes a technical note 

that contained an overly broad 

description of the types of toxic gas 

monitoring systems and detectors 

subject to chemical/biological (CB) 

controls under the EAR. The note 

covered a number of toxic gas 

monitoring systems and detectors not 

included on the AG control list. By 

removing the technical note, this final 

rule eliminates the CB license 

requirement for these toxic gas 

monitoring systems and detectors. Toxic 

gas monitoring systems and detectors 

that are included on the AG control list 

continue to require a license, for CB 

reasons, to certain destinations.

DATES: This rule is effective December 

23, 2004.

ADDRESSES: You may submit comments, 

identified by RIN 0694–AD16, by any of 

the following methods: 

• E-mail: wfisher@bis.doc.gov.

Include ‘‘RIN 0694–AD16’’ in the 

subject line of the message. 

• Fax: (202) 482–3355. Please alert 

the Regulatory Policy Division, by 

calling (202) 482–2440, if you are faxing 

comments. 

• Mail or Hand Delivery/Courier: 

Willard Fisher, U.S. Department of 

Commerce, Bureau of Industry and 

Security, Regulatory Policy Division, 

14th St. & Pennsylvania Avenue, NW., 

Room 2705, Washington, DC 20230, 

ATTN: RIN 0694–AD16.

FOR FURTHER INFORMATION CONTACT:

Mark Sagrans, Office of 

Nonproliferation and Treaty 

Compliance, Bureau of Industry and 

Security, Telephone: (202) 482–7900.

SUPPLEMENTARY INFORMATION: 

Background 

The Bureau of Industry and Security 

(BIS) is amending the Export 

Administration Regulations (EAR) by 

revising Export Control Classification 

Number (ECCN) 2B351 on the 

Commerce Control List (CCL) 

(Supplement No. 1 to Part 774 of the 

EAR) to conform with the Australia 

Group (AG) ‘‘Control List of Dual-Use 

Chemical Manufacturing Facilities and 

Equipment and Related Technology.’’

Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 76843

The AG is a multilateral forum, 

consisting of 38 participating countries, 

that maintains export controls on a list 

of chemicals, biological agents, and 

related equipment and technology that 

could be used in a chemical or 

biological weapons program. The AG 

periodically reviews items on its control 

list to enhance the effectiveness of 

participating governments’ national 

controls and to achieve greater 

harmonization among these controls. 

Specifically, this rule revises ECCN 

2B351 by removing the Technical Note 

at the end of the entry. BIS is removing 

this Technical Note because it is not 

included in the AG ‘‘Control List of 

Dual-Use Chemical Manufacturing 

Facilities and Equipment and Related 

Technology’’ and its inclusion in ECCN 

2B351 resulted in controls on certain 

toxic gas monitoring systems and 

devices not designed for the detection of 

chemical warfare agents or precursors. 

The wording of the Technical Note 

indicated that the toxic gas monitoring 

systems controlled under ECCN 2B351.a 

included systems (such as 

environmental air pollution detectors, 

anesthetic gas monitors for patients, and 

sulfur hexafluoride detectors) that have 

a detection capability for chemicals, 

which contain phosphorus, sulfur, 

fluorine or chlorine, but are not 

controlled under ECCN 1C350. 

As a result of the removal of the 

Technical Note by this final rule, ECCN 

2B351.a no longer controls toxic gas 

monitoring systems that have a 

detection capability for chemicals (other 

than chemical warfare agents), which 

contain phosphorus, sulfur, fluorine or 

chlorine, but are not controlled under 

ECCN 1C350. A license no longer is 

required, for chemical/biological (CB) 

reasons, to export or reexport such 

systems; however, such systems may 

require a license for reasons specified 

elsewhere in the EAR (e.g., the enduser/end-use restrictions described in 

Part 744 of the EAR or the restrictions 

described in Part 746 of the EAR that 

apply to embargoed countries). Systems 

designed for continuous operation that 

are capable of detecting chemical 

warfare agents or any of the chemicals 

controlled under ECCN 1C350 

(including those containing phosphorus, 

sulfur, fluorine or chlorine), at 

concentrations of less than 0.3 mg/m3, 

continue to be controlled under ECCN 

2B351.a and continue to require a 

license, for CB reasons, to destinations 

listed in Country Group D:3 (as 

specified in Supplement No. 1 to Part 

740 of the EAR). 

Although the Export Administration 

Act expired on August 20, 2001, 

Executive Order 13222 of August 17, 

2001 (3 CFR, 2001 Comp., p. 783 

(2002)), as extended by the Notice of 

August 6, 2004 (69 FR 48763, August 

10, 2004), continues the Regulations in 

effect under the International 

Emergency Economic Powers Act . 

Rulemaking Requirements 

1. This rule has been determined to be 

not significant for purposes of Executive 

Order 12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to, nor shall any person be 

subject to a penalty for failure to comply 

with, a collection of information subject 

to the requirements of the Paperwork 

Reduction Act 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 

David Rostker, Office of Management 

and Budget (OMB), by e-mail to 

David_Rostker@omb.eop.gov, or by fax 

to (202) 395–7285; and to the Regulatory 

Policy Division, Bureau of Industry and 

Security, Department of Commerce, P.O. 

Box 273, Washington, DC 20044.

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 (5 U.S.C. 553(a)(1)). Further, no 

other law requires that a notice of 

proposed rulemaking and an 

opportunity for public comment be 

given for this final rule. Because a 

notice of proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule under 

5 U.S.C. 553 or by any other law, the 

analytical requirements of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.) are not applicable. 

Therefore, this regulation is issued in 

final form. Although there is no formal 

comment period, public comments on 

this regulation are welcome on a 

continuing basis.

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 730–799) 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); 18 U.S.C. 2510 et seq.; 22 U.S.C. 

287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 

30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 

U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 

466c; 50 U.S.C. app. 5; Sec. 901–911, Pub. L. 

106–387; Sec. 221, Pub. L. 107–56; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 6, 2004, 68 

FR 47833 (August 10, 2004).

Supplement No. 1 to Part 774

[Amended]

■ 2. In Supplement No. 1 to Part 774 (the 

Commerce Control List), Category 2—

Materials Processing, ECCN 2B351 is 

revised to read as follows: 

2B351 Toxic gas monitoring systems 

that operate on-line and dedicated 

detectors therefor.

License Requirements 

Reason for Control: CB, AT.

Control(s) Country chart 

CB applies to entire entry ..... CB Column 3. 

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

License Exceptions 

LVS: N/A 

GBS: N/A 

CIV: N/A 

List of Items Controlled 

Unit: Equipment in number. 

Related Controls: See ECCNs 1A004 and 

1A995 for detection equipment that is not 

covered by this entry. 

Related Definitions: For the purposes of 

this entry, the term ‘‘continuous operation’’

describes the capability of the equipment to 

operate on line without human intervention. 

The intent of this entry is to control toxic gas 

monitoring systems capable of collection and 

detection of samples in environments such as 

chemical plants, rather than those used for 

batch-mode operation in laboratories. 

Items:

a. Designed for continuous operation and 

usable for the detection of chemical warfare 

agents or chemicals controlled by 1C350 at 

concentrations of less than 0.3 mg/m3; or 

b. Designed for the detection of 

cholinesterase-inhibiting activity.

76844 Federal Register / Vol. 69, No. 246 / Thursday, December 23, 2004 / Rules and Regulations 

Dated: December 16, 2004. 

Peter Lichtenbaum, 

Assistant Secretary for Export 

Administration.

[FR Doc. 04–28104 Filed 12–22–04; 8:45 am] 

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 179

[Docket No. 2003F–0088] 

Irradiation in the Production, 

Processing and Handling of Food

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

food additive regulations by establishing 

a new maximum permitted energy level 

of x rays for treating food of 7.5 million 

electron volts (MeV) provided that the x 

rays are generated from machine sources 

that use tantalum or gold as the target 

material, with no change in the 

maximum permitted dose levels or uses 

currently permitted by FDA’s food 

additive regulations. This action is in 

response to a petition filed by Ion Beam 

Applications.

DATES: This rule is effective December 

23, 2004. Submit written objections and 

request for a hearing by January 24, 

2005. See Section VII of this document 

for information on the filing of 

objections.

ADDRESSES: You may submit written 

objections and requests for a hearing, 

identified by Docket No. 2003F–0088, 

by any of the following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 2003F–0088 in the 

subject line of your e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

objections received will be posted 

without change to http://www.fda.gov/

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document.

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.fda.gov/ohrms/dockets/

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Celeste Johnston, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, 301–436–1282.

SUPPLEMENTARY INFORMATION:

I. Introduction 

In a notice published in the Federal 

Register of March 13, 2003 (68 FR 

12087), FDA announced that a food 

additive petition (FAP 3M4745) had 

been filed by Ion Beam Applications 

(IBA), 6000 Poplar Ave., suite 426, 

Memphis, TN. Since the publication of 

this notice, IBA has been sold to PPM 

Ventures, which subsequently changed 

its name to Sterigenics International, 

Inc., 2015 Spring Rd., suite 650, Oak 

Brook, IL 60523. As a result, the rights 

to FAP 3M4745 have been transferred 

from IBA to Sterigenics International, 

Inc. The petition proposed that the food 

additive regulations in § 179.26 Ionizing 

radiation for the treatment of food (21 

CFR 179.26) be amended by increasing 

the maximum permitted energy level of 

x rays for treating food to 7.5 MeV from 

the currently permitted maximum level 

of 5 MeV. Higher x ray energy will 

result in an increased concentration of 

x rays in the forward direction and 

increased penetration of these x rays in 

materials. This increased emission 

efficiency (i.e., concentration of x rays 

produced in the forward direction) will 

result in reduced treatment time for 

food, and therefore, higher production 

rates and lower treatment costs. The 

increased penetration of 7.5 MeV versus 

5 MeV x rays will allow for the 

irradiation of larger packages.

II. Evaluation of Safety

A source of radiation used to treat 

food meets the definition of a food 

additive under section 201(s) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 321(s)). Under 

section 409(c)(3)(A) of the act (21 U.S.C. 

348(c)(3)(A)), a food additive cannot be 

approved for a particular use unless a 

fair evaluation of the data available to 

FDA establishes that the additive is safe 

for that use. FDA’s food additive 

regulations in 21 CFR 170.3(i) define 

safe as ‘‘a reasonable certainty in the 

minds of competent scientists that the 

substance is not harmful under the 

intended conditions of use.’’

III. Evaluation of the Safety of the 

Petitioned Use of 7.5 MeV X Rays

A. Safety Concerns of Higher Energy X 

rays

The maximum energy limit of an xray machine is the maximum energy of 

the individual x-ray photons produced 

by that machine. When individual 

photons of x rays are absorbed by food, 

the absorbed energy causes atoms to be 

ionized until all the energy is converted 

into heat or chemical change. The 

amount of change in the food will 

depend on the total energy absorbed 

(i.e., dose). Because this petition seeks 

only to raise the maximum energy limit 

for x rays used for treating food, with no 

change in the maximum doses currently 

permitted by § 179.26, FDA concludes 

that the petition presents no new 

chemical issue, and that the only safety 

issue to be addressed is the potential for 

inducing radioactivity in the food.

Food, as well as other natural 

materials, displays low levels of 

naturally occurring radioactivity, such 

as that due to the presence of 

potassium-40 or carbon-14. To assess 

the safety of increasing the maximum 

energy of x rays to 7.5 MeV, the 

petitioner evaluated the potential for 7.5 

MeV x rays to induce additional 

radioactivity in food. X rays with 

energies above an atom’s threshold 

energy are capable of ejecting neutrons 

or protons from the nuclei of some 

atoms that have absorbed the x-ray 

energy. The threshold energy needed to 

cause the emission of a proton is higher 

than 7.5 MeV; therefore, the primary 

mechanism for inducing radioactivity in 

food by 7.5 MeV x rays will be from the 

loss of a neutron. This may in some 

cases result in the formation of 

radioactive nuclei. Radioactive nuclei 

are unstable and decay to a more stable 

form, spontaneously emitting particles 

and electromagnetic radiation in the 

form of gamma rays (i.e., high-energy 

photons). Often, this transition can 

occur very rapidly, such that an isotope 

produced in food from x rays will decay 

to a stable, nonradioactive state before 

leaving the irradiation facility. However, 

some radioactive isotopes could be 

sufficiently stable to be present in food