Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 24439

Formerly, the special unit for

absorbed dose was the rad 1 rad = .01

J/kg = .01 GyIonizing radiation.

Any type of radiation consisting of

charged particles or uncharged particles,

or both, that as a result of physical

interaction, creates ions by either

primary or secondary processes.

Charged particles could be positive or

negative electrons, protons, or other

heavy ions, and uncharged particles

could be X-rays, gamma rays, or

neutrons. (Note: positive electrons,

protons, heavy ions, or neutrons are not

approved for food irradiation.)

Irradiation

The purposeful application of

ionizing radiation (gamma rays, x-rays,

or electrons) to a product (device or

material) to achieve a desired benefit.

Gamma rays in commercial irradiation

come from radioactive cobalt-60 (60Co)

or cesium-137 (137Cs). X-rays

(technically referred to as

bremsstrahlung) are obtained using high

energy electrons from an electron

accelerator striking a target. Electrons

from an accelerator can also be used to

penetrate the product directly.

Kilogray (kGy)

Measure of absorbed dose. 1kGy =

1,000 Gy

Label Dosimeter

A device that can be affixed to an

article to be irradiated, and which

exhibits a quantifiable change in

property which can be related to

absorbed dose. This change in property

can be measured in situ. (Note: as of

1994, no such devices that have the

properties of a dosimeter are

commercially available for the levels

appropriate to quarantine treatments.)

Measurement Traceability

The ability to demonstrate and

document on a continuing basis that the

measurement results from a particular

measurement system are in agreement

with comparable measurement results

obtained with a national standard (or

some identifiable and accepted

standard) to a specified uncertainty.

Pest (Plant)

Any biotic agent capable of causing

damage to plants or plant products.

Phytosanitary Treatment

Subjecting or exposing a plant or

plant product to a process, action,

chemical or a physical influence proved

to have a measurable deleterious effect

on pest organisms.

Probit 9 (Mortality)

A statistical estimation of 99.99683

percent mortality in a population of live

organisms, corresponding to a survival

rate of 32 individuals per million.

Process Load

A volume of material with a specified

loading configuration irradiated as a

single entity.

Quarantine Security

A management decision concerning

the safety of a defined level of pest risk.

Additional mitigation is not required

when quarantine security is achieved.

Rad (rad or Radiation Absorbed Dose)

Special unit for absorbed dose that is

being superseded by the gray (Gy)

1 rad = 0.01 J/kg = 0.01 Gy

1 kilorad (krad) = 10 J/kg = 10 Gy

1 megarad (Mrad) = 1,000 J/kg = 1,000

Gy = 10 kGy

1Gy = 100 rads

1 kilogray = 100,000 rads

Radiation-Sensitive Indicators

Materials such as coated or

impregnated adhesive-backed

substrates, inks, or coatings that may be

affixed to, or printed on the irradiation

container and that undergo a visual

change when exposed to ionizing

radiation. These indicators, sometimes

referred to as go/no-go indicators, are

not dosimeters and are not a substitute

for proper dosimetry.

Systems Approach

A combination of multiple safeguards,

treatments or other mitigation measures.

At least two mitigation measures must

act independently to reduce risk.

Validation

Establishing documented evidence

that provides a high degree of assurance

that a specific process will consistently

produce a product (quarantine security)

meeting its predetermined

specifications and quality

characteristics.

Authority: 7 U.S.C. 150dd, 150ee, 150ff,

151–167, 450, 2803, and 2809; 21 U.S.C. 136

and 136a; 7 CFR 2.22, 2.80, 371.2(c).

Done in Washington, DC, this 8th day of

May 1996.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 96–12185 Filed 5–14–96; 8:45 am]

BILLING CODE 3410–34–P

FEDERAL RESERVE SYSTEM

12 CFR Part 211

[Regulation K; Docket No. R–0911]

International Banking Operations

AGENCY: Board of Governors of the

Federal Reserve System.

ACTION: Final rule.

SUMMARY: This final rule amends the

provisions of Regulation K regarding

interstate banking operations of foreign

banking organizations. The Riegle-Neal

Interstate Banking and Branching

Efficiency Act of 1994 (Interstate Act)

removed geographic restrictions on

interstate banking by foreign banks

effective September 29, 1995, and

requires certain foreign banks without

U.S. deposit-taking offices to select a

home state for the first time. The final

rule requires these foreign banks to

select a home state by June 30, 1996,

and removes outdated restrictions on

certain mergers by U.S. bank

subsidiaries of foreign banks outside the

home state of the foreign bank. Obsolete

and superseded provisions of

Regulation K concerning home state

selection also are deleted.

EFFECTIVE DATE: May 9, 1996.

FOR FURTHER INFORMATION CONTACT: Ann

E. Misback, Managing Senior Counsel

(202/452–3788), Douglas M. Ely, Senior

Attorney (202/452–5289), Andres L.

Navarrete, Attorney (202/452–2300),

Legal Division; Michael G. Martinson,

Assistant Director (202/452–3640),

Division of Banking Supervision and

Regulation, Board of Governors of the

Federal Reserve System. For users of

Telecommunication Device for the Deaf

[TDD] only, please contact Dorothea

Thompson (202/452–3544), Board of

Governors of the Federal Reserve

System, 20th and C Streets NW.,

Washington, D.C. 20551.

SUPPLEMENTARY INFORMATION:

The Interstate Act amended section 5

of the International Banking Act of 1978

(IBA), which governs interstate banking

and branching operations of foreign

banks. The Interstate Act also amended

the Bank Holding Company Act of 1956

(BHC Act), the Federal Deposit

Insurance Act and several other statutes

regarding interstate banking operations

of bank holding companies, national

banks and state banks. In order to

implement certain of these changes, the

final rule amends the provisions of

Regulation K regarding interstate

banking operations of foreign banking

organizations (12 CFR 211.22).

On December 26, 1995, the Board of

Governors of the Federal Reserve
24440 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

System (the Board) requested public

comment on a proposed rule (the

Proposed Rule) that would require

foreign banks with only agencies and

subsidiary commercial lending

companies in the United States to select

a home state, or have a home state

designated by the Board. 60 FR 67100.

The Proposed Rule also would remove

a restriction on the ability of foreign

banks to effect major bank mergers

through U.S. subsidiary banks located

outside the foreign banks’ home states,

and would delete certain outdated rules

governing home state selection.

The comment period ended on

February 5, 1996. The Board received a

single public comment on the Proposed

Rule from a trade association. The Board

has considered the comment and has

made changes to address it in the final

rule. Except as discussed below, the

Board’s final rule remains unchanged

from the Proposed Rule. In addition, the

Board requested and received comments

on other aspects of the Interstate Act as

it applies to foreign banks. The Board

will consider these comments in

connection with future review of the

provisions of Regulation K concerning

the interstate operation of foreign banks.

The commenter generally supported

the provisions of the Proposed Rule,

including its provisions requiring

certain foreign banks to select a home

state as contemplated by the Interstate

Act. The commenter suggested,

however, that the deadline for home

state selection by these banks be 60 days

from the publication of the final rule,

rather than March 31, 1996, as proposed

in the Proposed Rule. The commenter

requested this extension in order to give

these banks adequate time to assess the

consequences of their decision.

Although the Interstate Act removed

the geographic restrictions of the IBA on

the interstate acquisition of banks by

foreign banks, the home state of a

foreign bank continues to affect its

options for establishing additional

branches in the United States under the

IBA. In particular, the location of a

foreign bank’s home state is a factor

determining the ability of the foreign

bank to establish further interstate

branches pursuant to section 5 (a)(1)

and 5 (a)(2) of the IBA, as amended by

the Interstate Act. 12 U.S.C. § 3103

(a)(1), (a)(2).

Accordingly, the final rule allows

additional time for home state selection

by establishing June 30, 1996, as the

deadline for such selection. This

extension affords foreign banks affected

by the rule ample time in which to make

an informed home state selection.

The proposed rule provided that, in

the event a foreign bank required to

select a home state fails to do so, the

Board would exercise its authority to

determine a foreign bank’s home state.

In such cases, the Board generally will

designate as a foreign bank’s home state

the state in which the total assets of all

its offices, net of claims on affiliates or

other offices of the foreign bank, is the

largest, as reflected in the foreign bank’s

most recent report of condition, unless

other circumstances warrant designation

of a different home state.

Paperwork Reduction Act

In accordance with section 3506 of

the Paperwork Reduction Act of 1995

(44 U.S.C. Ch. 35; 5 CFR 1320 Appendix

A.1), the Board reviewed the rule under

the authority delegated to the Board by

the Office of Management and Budget.

No collections of information pursuant

to the Paperwork Reduction Act are

contained in the rule.

Regulatory Flexibility Act Analysis

Pursuant to section 605(b) of the

Regulatory Flexibility Act (Pub. L. 96–

354, 5 U.S.C. 601 et seq.), the Board

certifies that the final rule would not

have a significant economic impact on

a substantial number of small entities

that are subject to its regulation.

List of Subjects in 12 CFR Part 211

Exports, Federal Reserve System,

Foreign banking, Holding companies,

Investments, Reporting and

recordkeeping requirements.

For the reasons set out in the

preamble, the Board amends 12 CFR

Part 211 as set forth below:

PART 211—INTERNATIONAL

BANKING OPERATIONS

(REGULATION K)

1. The authority citation for Part 211

continues to read as follows:

Authority: 12 U.S.C. 221 et seq., 1818,

1841 et seq., 3101 et seq., 3901 et seq.

2. In § 211.22, paragraph (a) is revised;

paragraph (c) is removed; and paragraph

(d) is redesignated as paragraph (c) to

read as follows:

§ 211.22 Interstate banking operations of

foreign banking organizations.

(a) Determination of home state. (1) A

foreign bank (except a foreign bank to

which paragraph (a)(2) of this section

applies) that has any combination of

domestic agencies or subsidiary

commercial lending companies that

were established before September 29,

1994, in more than one state and have

been continuously operated shall select

its home state from those states in

which such offices or subsidiaries are

located. A foreign bank shall do so by

filing with the Board a declaration of

home state by June 30, 1996. In the

absence of such selection, the Board

shall designate the home state for such

foreign banks.

(2) A foreign bank that, as of

September 29, 1994, had declared a

home state or had a home state

determined pursuant to the law and

regulations in effect prior to that date

shall have that state as its home state.

(3) A foreign bank that has any

branches, agencies, subsidiary

commercial lending companies, or

subsidiary banks in one state, and has

no such offices or subsidiaries in any

other states, shall have as its home state

the state in which such offices or

subsidiaries are located.

* * * * *

By order of the Board of Governors of the

Federal Reserve System, May 9, 1996.

William W. Wiles,

Secretary of the Board.

[FR Doc. 96–12134 Filed 5–14–96; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 556

Animal Drugs, Feeds, and Related

Products; Gentamicin Injection

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

following actions on two new animal

drug applications (NADA’s) held by

Schering-Plough Animal Health: The

combination of two NADA’s into one

and the withdrawal of the other, the

codification of a supplemental NADA

approved by letter, the approval of a

supplemental NADA that provides for

the use of two higher product

concentrations at the same dosage and

for the same indications, and the

addition of a tolerance for residues of

gentamicin in chickens.

The approved, combined, and

supplemented NADA provides for use

of gentamicin sulfate injection for the

prevention of early mortality of day-old

chickens and 1- to 3-day-old turkeys

due to certain infections susceptible to

gentamicin.

EFFECTIVE DATE: May 15, 1996

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug