This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

24433

Vol. 61, No. 95

Wednesday, May 15, 1996

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

7 CFR Part 319

[Docket No. 95–088–1]

The Application of Irradiation to

Phytosanitary Problems

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice of policy.

SUMMARY: This document sets forth a

policy statement that shares positions

and policies of the Animal and Plant

Health Inspection Service (APHIS)

concerning the use of irradiation as a

treatment for plant pests of quarantine

significance.

In preparing this document, we have

reviewed and evaluated pertinent and

contemporary information concerning

irradiation as a phytosanitary treatment

or potential treatment. We have

examined this information against the

background of regulatory and

operational parameters associated with

APHIS, Plant Protection and

Quarantine’s (PPQ’s) mission and

authority. The objective of this effort has

been to generate a reference document

that describes policies, procedures, and

regulations specifically related to

irradiation as a phytosanitary treatment.

This document is designed for review

and comment.

ADDRESSES: There are several ways to

comment on this document. Because we

hope to develop a dialogue among

persons interested in contributing to the

improvement of these policies, the

preferred method of commenting is to

subscribe to an e-mail mailing list we

are establishing for the discussion of the

policy issues. After you subscribe, on an

ongoing basis you will receive e-mail

copies of all comments submitted to the

mailing list. Those wishing to subscribe

to this service should send an e-mail

message to

‘‘majordomo@info.aphis.usda.gov’’—

without the quotation marks—and leave

the subject area empty. In the body of

the message, type ‘‘subscribe irrad’’—

again without the quotes—and then

send the message.

You can also subscribe to this mailing

list or file individual e-mail comments

using a form contained in a World Wide

Web site devoted to this document. The

site also contains downloadable copies

of this document and may also have

additional background documents on

irradiation, and links to other sites

concerning radiation and the irradiation

of products. The address (URL) of the

World Wide Web site is:

www.aphis.usda.gov/ppd/irrad.

You may also submit comments by

postal mail. To do so, please send an

original and three copies of your

comments to Docket No. 95–088–1,

Regulatory Analysis and Development,

PPD, APHIS, Suite 3C03, 4700 River

Road Unit 118, Riverdale, MD 20737–

1238. Please state that your comments

refer to Docket No. 95–046–1. Postal and

e-mail comments received may be

inspected at USDA, room 1141, South

Building, 14th Street and Independence

Avenue SW., Washington, DC, between

8 a.m. and 4:30 p.m., Monday through

Friday, except holidays. Persons

wishing to inspect comments are

requested to call ahead on (202) 690–

2817 to facilitate entry into the

comment reading room.

FOR FURTHER INFORMATION CONTACT: Mr.

Robert Griffin, Senior Plant Pathologist,

USDA, APHIS, PPD, 4700 River Road

Unit 117, Riverdale, MD 20737–1228;

(301) 734–3576; e-mail

rgriffin@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Development of Policy Statement

The first draft of these positions and

policies was introduced in October 1994

during the annual meeting of the North

American Plant Protection Organization

(NAPPO). Subsequent review has

included NAPPO participants and a

broadening circle of individual experts,

organizations, and agencies interested

in, involved in, or impacted by

irradiation as a phytosanitary treatment.

Numerous modifications have been

made as additional information has

been collected and reviewed. This

document is not final or authoritative,

and does not establish any agency

requirements. Any requirements

concerning irradiation that APHIS

develops will be promulgated through

rulemaking published in the Federal

Register.

Since 1989, the only formally adopted

regulatory policy for irradiation as a

phytosanitary treatment in the United

States has been based on Title 7 of the

Code of Federal Regulations (7 CFR

318.13–4f, ‘‘Administrative instructions

for approving an irradiation treatment as

a condition for certification of papayas

for movement from Hawaii’’). This

authorization is specific for a

commodity, place of origin, and

program, but is designed for a complex

of fruit flies rather than a single pest.

While routine commercial shipments

were never realized under this

regulation due to the lack of a treatment

facility in Hawaii, the authorization has

proven useful from the standpoint of

beginning to establish policies for

irradiation as a phytosanitary treatment

in the United States.

Six years later, PPQ remains

dedicated to using the most up-to-date,

appropriate and least intrusive

technology to provide quarantine

security, and the need for alternative

treatments and pest mitigation systems

is greater than ever. Global trade

pressures and the possible loss of

methyl bromide as a fumigant for

regulatory pest treatments make it

imperative that practical treatment

options be explored.

At the same time, irradiation

treatment has matured significantly.

Technological advances, greater

experience, and an increasingly larger

body of research indicate that

irradiation has important potential as a

treatment for quarantine pest problems.

It is in this light that PPQ now seeks

to expand the regulatory framework

addressing irradiation treatment and

develop comprehensive policy

statements that will facilitate the

development and formalization of new

treatments for phytosanitary

applications. This policy statement

provides a sketch from which final

policies can be codified after broad

review and input.

Position Summary

The regulations at 7 CFR 318.13–4f

provide administrative instructions for

an irradiation treatment as a condition

for the certification of fresh papayas
24434 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

moving to the mainland States from

Hawaii. These were the first regulations

authorizing the use of irradiation as a

quarantine treatment, and the

regulations set a number of policy

precedents. The regulations included

the following five basic principles or

policies for irradiation:

1. Requirement that irradiation

facilities meet certain APHIS standards;

2. Monitoring based on inspection of

treatment records and unannounced

visits;

3. Policy that the Department is not

responsible for damage resulting from

intolerance to the prescribed dose;

4. Reliance on the authority and

regulations of the United States Nuclear

Regulatory Commission to ensure U.S.

facilities are constructed and operated

in a safe manner; and

5. Reliance on the authority and

regulations of the United States Food

and Drug Administration (FDA) to

ensure irradiated foods are wholesome

for human consumption.

The precedents described above

remain valid to the extent that the same

would apply to any new regulations

developed by PPQ for the authorization

of other treatments. However, additional

clarity and completeness are necessary

to address the range of commodity, pest,

treatment, and operational issues

potentially involved with the approval

of irradiation treatments for

phytosanitary problems. In addition,

new information needs to be considered

in adjusting existing policies, and

program designs must be adapted to

address the unique situations created by

authorizing treatments conducted

outside the United States. Therefore, in

addition to the five policy precedents

established by the existing regulations,

APHIS has identified 28 additional

policies, for a total of 33 policies

relevant to irradiation.

The following are summary

statements of the 28 additional policies

and positions:

6. PPQ does not endorse the position

that irradiation treatment should be the

only replacement for methyl bromide.

PPQ believes that there is adequate

scientific evidence to show that

irradiation provides an alternative

treatment to be explored and developed,

and PPQ recognizes that irradiation has

potentially broad applications in the

treatment of quarantine plant pests.

7. The highest priority for treatment

approval is generally given to treatments

deemed by PPQ to have the greatest

potential immediate need, use, and

benefit.

8. Treatment schedules approved by

PPQ must have been demonstrated

experimentally to achieve the level of

efficacy required for a defined level of

quarantine security.

9. To the extent possible, PPQ will

ensure consistent requirements for both

import and export authorizations, and

align domestic requirements with

foreign requirements as fairly as

possible.

10. Specific authorizations for the use

of irradiation as a phytosanitary

treatment will initially be provided by

PPQ on a case by case basis following

a pest risk analysis, the evaluation of

efficacy data, and the approval of

operational protocols.

11. Irradiation may be used as a single

treatment achieving quarantine security,

or as part of a multiple treatment, or as

a component in a pest mitigation system

(systems approach).

12. Measures aimed at reducing pest

presence prior to treatment are

encouraged but will not be required for

treatments achieving quarantine

security. However, a very low initial

infestation rate is important for

enhancing the acceptance and use of

irradiation as a treatment and for

alleviating regulatory concerns arising

from the detection of living pests in the

irradiated product.

13. In those instances where pest

organisms survive treatment, it is

essential for quarantine purposes that

the organism is unable to reproduce,

and it is desirable for the organism to be

unable to emerge from the commodity

unless it can be easily distinguished

from a non-irradiated pest of the same

species.

14. Live stages of pest organisms, or

their signs or symptoms, found in a

commodity following a PPQ prescribed

and approved irradiation treatment will

be presumed by PPQ to have been

effectively treated unless evidence

exists to indicate that the integrity of the

treatment was inadequate. PPQ may

perform or require laboratory or other

analyses on surviving pest organisms, or

employ any available technology to

verify efficacy. Authorizations may be

suspended or modified and the

requirements for system integrity may

be adjusted based upon the results of

such studies.

15. Ionizing energy (radiation) may be

provided by radionuclides (gamma rays

from cobalt-60 or cesium-137), electrons

generated from machine sources, or by

x-rays. PPQ is not concerned with

specifically describing the requirements

for equipment except to the extent that

equipment used for plant quarantine

treatments is capable of irradiating

commodities to the specifications

required for approved treatments.

16. Irradiation treatment must be

carried out to ensure that the minimum

absorbed dose (Dmin) required to assure

quarantine security is fully attained

throughout the commodity. The

schedule process for Dmin must account

for uncertainty associated with the

dosimetry system employed.

17. Definition of the lower dose limit

is essential to the approval of irradiation

treatments for quarantine purposes.

Definition of the upper dose limit is not

critical to determining quarantine

security, but is important from a quality

standpoint and to identify potential

problems with the FDA limit for the

maximum dose for food (currently 1

kilogray - see 21 CFR 179.26). PPQ will

not be concerned with defining the

upper dose limit except to the extent

that it is necessary to determine the

feasibility of a particular treatment.

18. Treatments must be proven with

adequate dosimetry in accordance with

relevant internationally accepted

standards, such as those published by

the American Society for Testing and

Materials (ASTM) or similar

organizations. The dosimetry systems

must be completely described,

including records related to identifying

specific suppliers, batches, processing

dates, locations, and procedures as well

as the means of calibration (reference

dosimetry) used.

19. PPQ will confer with the

Agricultural Research Service (ARS),

United States Department of Agriculture

(USDA) concerning the adequacy of

treatment data, research protocols, and

treatment design. ARS will identify or

concur with the minimum dose for

efficacy at the level defined by PPQ as

providing quarantine security for a pest

or complex of pests. Other experts may

also be asked to provide input.

20. Dosages may be generic relative to

a pest group or to a commodity.

21. PPQ may prescribe treatments

with doses higher than what is

indicated as effective by available data.

This will be done to expedite the

incorporation of new treatments while

providing a measure of safety when PPQ

and ARS judge the data to be

inconclusive to the extent necessary for

approving a less rigorous treatment. All

treatments will be subject to amendment

as new information is evaluated. PPQ

expects that modifications to an existing

treatment will be more easily and

quickly accomplished than approval of

a new treatment.

22. An irradiation program protocol,

describing the details of a program

surrounding a specific commodity

treatment and facility processes (import

or export, domestic or foreign), will be

developed prior to the approval of a

new facility or a new commodity for an

existing facility.
Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 24435

1Note: Packaging materials may require FDA

approval.

2The FDA establishes the maximum absorbed

ionizing radiation dose for food (currently

established at 1 kilogray for the disinfestation of

food for arthropods—21 CFR 179.26). Irradiation

treatments designed for the treatment of other than

arthropods in food must receive FDA approval as

well.

23. Treatment facilities must be

licensed by relevant national

authorities. When not conflicting with

national authority, compliance with the

criteria of the International Inventory of

Authorized Food Irradiation Facilities,

established by the International

Consultative Group on Food Irradiation

(ICGFI), is also recommended for

facilities treating food items.

24. Treatment facilities will be subject

to the prior approval of PPQ and will be

subject to periodic unannounced

monitoring. Recertification by PPQ will

be done on an annual basis or following

repairs, modifications, or adjustments in

equipment affecting the delivery of

treatments. Source replenishment (in

the case of radionuclide facilities) will

require additional dose mapping.

25. Dose mapping of the product in

every geometric packing configuration,

arrangement, and product density that

will be used during routine treatments

will be required prior to PPQ approval

of a facility. Dose mapping must be

performed in accordance with relevant

internationally accepted standards such

as those published by ASTM or similar

organizations.

26. The irradiation treatment can be

applied as an integral part of packing

operations, or it may be done at a

central location such as the port of

embarkation after packing or packaging.

Treatment may also be performed at the

port of arrival or a designated location

in the destination country when

safeguards are deemed by PPQ to be

adequate and operationally feasible.

27. The irradiation treatment may be

applied to bulk or continuous

unpackaged commodities, or the

commodities may be packaged at the

time of treatment. If unpackaged or

exposed in packaging,1 commodities

will require safeguarding immediately

following treatment to ensure that they

do not become reinfested or

contaminated after treatment.

28. Treated and untreated

commodities must be adequately

segregated and handled under

conditions that will safeguard against

cross-infestation or mistaken identity.

Appropriate procedures specific to each

facility and commodity treatment

program must be approved by PPQ in

advance.

29. Direct PPQ supervision of

treatment programs may not be

necessary for programs deemed by PPQ

to provide adequate system integrity.

Minimum criteria include PPQ approval

of the treatment facility, National Plant

Protection Organization (NPPO)

certification of treatments, and PPQ

approval of a program protocol for

system integrity. PPQ will directly and

routinely verify the adequacy of

treatment facilities. PPQ presence may

also be necessary for the monitoring of

related program activities and system

integrity.

30. Requirements for program

protocols and system integrity will be

harmonized with FDA, the USDA Food

Safety Inspection Service (FSIS), and

other regulatory authorities to the extent

possible.

31. Phytosanitary certificates issued

in accordance with the International

Plant Protection Convention (IPPC) may

be used as official documentation

verifying the successful completion of a

treatment. Certificates must specifically

identify the treated lot and record the

prescribed minimum dose and the

verified minimum dose. The maximum

dose may also be required in order to

comply with FDA requirements for

some commodities.

32. PPQ is committed to harmonizing

with other U.S. agencies, States, foreign

counterparts, and regulatory bodies

involved with the development,

approval, and application of irradiation

treatments for phytosanitary problems.

PPQ will make every attempt to avoid

overlap, conflict, and ambiguity

associated with the relationship of PPQ

regulations to those of other authorities.

33. PPQ is committed to increasing its

own depth of understanding concerning

irradiation as a treatment for

phytosanitary problems and expanding

its expertise for the approval of

treatments and the certification of

facilities.

Research Protocols

General PPQ Requirements for the

Acceptance of Irradiation as a

Quarantine Treatment

Irradiation as a single treatment, part

of a multiple treatment, or combined

with other pest mitigation measures as

a component of a systems approach,

must have a scientifically demonstrated

level of efficacy. The research necessary

to demonstrate efficacy for PPQ begins

with laboratory scale tests designed to

provide results that can be analyzed

statistically to hypothesize the

parameters necessary to attain a defined

level of quarantine security.

Unlike most other PPQ treatment

approvals, irradiation treatments may

not always require a second level of

confirmatory testing to demonstrate that

the treatment is efficacious under the

conditions associated with the

commercial treatment of the

commodity. However, the equipment,

processes, and dosimetry for any

specific treatment facility must be

approved and monitored by PPQ to

ensure that commercial treatments

comply with the parameters for

approved treatments.

Judging the feasibility of treatments

for commercial applications is outside

the scope of PPQ’s authority and

responsibility. Likewise, concerns

related to phytotoxicity and issues of

quality are not the responsibility of

PPQ. Therefore, primary responsibility

falls upon the research and commercial

sectors to ensure that treatments

demonstrated to be efficacious against

pests of quarantine concern are also

practical for commercial use.

The efficacy of the treatment as

demonstrated against naked pests in

vitro is the primary criterion for

approval in most cases,2 but concurrent

phytotoxicity studies are important and

appropriate in order to determine the

commercial feasibility of proposed

treatments even though data of this

nature will not normally be required by

PPQ to demonstrate efficacy.

General Research Protocol

If Unknown, Determine the Pest or Pests

That Are of Quarantine Significance

and Would be Expected to be Found on

or Within the Commodity at the Time of

Export

Submit this information to PPQ for

concurrence. PPQ will assess the risks

associated with any quarantine

significant pest or pests. Irradiation may

serve as the means of mitigating the

risks identified in the risk analysis

process.

Determine the Most Tolerant Life-stage

of the Pest(s) of Concern That Would be

Encountered at the Time of Treatment

If not documented in the literature,

this must be determined through

research. Research to determine the

most tolerant life-stage may be done

with naked organisms outside the

commodity. Submit this information to

PPQ for concurrence.

Determine the Minimum Absorbed

Dosage (Dmin) and the Type of

Radiation Required to Maintain

Quarantine Security

Experimental design must utilize

sampling methods and sample sizes

appropriate for statistical tests to be

used. In some instances, efficacy may be
24436 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

3Quarantine security may be defined in terms of

mortality or in terms of other criteria that would

ensure that survivors are not able to reproduce and

are not confused with untreated pests encountered

inside and outside the commodity. In the case of

fruit flies, PPQ has established the criterion as ‘‘the

non-emergence of adults,’’ referring to interruption

of the developmental sequence leading to an adult

that can emerge from the commodity.

4Note: In general, sterility is more acceptable for

organisms that remain in (or on) the host.

Demonstrating the efficacy of treating organisms for

sterility may be difficult to accomplish without full

information on the factors favoring successful

reproduction.

inferred from the literature for related

species and commodities when

complete laboratory investigations are

not possible.3 The means of calibration

(reference dosimetry) must be described

in detail and should be developed in

accordance with relevant accepted

standards, such as those published by

ASTM or similar organizations. Submit

the proposed experimental design to

PPQ for concurrence.

Confirm That the Proposed Irradiation

Dosage Will Provide Quarantine

Security by Testing Large Numbers of

Organisms

Submit the proposed experimental

design to PPQ for concurrence. Analyze

data statistically.

Analyze data statistically

Submit the proposed statistical

methodology to PPQ for concurrence.

Describe Specific Conditions Necessary

for Commercial Application of the

Proposed Treatment Methodology.

Specify Maximum and Minimum

Absorbed Dose

Submit proposed treatment regime

and conditions necessary for

commercial-scale treatment to PPQ for

review. This does not mean that

commercial-scale testing is necessary,

only that the conditions for commercialscale treatments be described to PPQ

prior to building a facility or configuring

existing facilities for quarantine

treatments. This provides PPQ the

opportunity to address components of

design, monitoring, safeguarding, and

commodity handling that will be

essential for the ultimate approval of a

specific facility.

Specific Research Protocol: Quarantine

Significant Fruit Flies

Quarantine security for a single

treatment protocol will be defined as the

prevention of adult emergence at the

99.9968 percent level with 95 percent

confidence as demonstrated by a valid

statistical method.

Specific Research Protocol: Quarantine

Significant External Feeders,

Hitchhikers, and Surface Contaminants

Quarantine security for a single

treatment protocol will be defined as

achieving 99.9968 percent sterility or

mortality at the 95 percent confidence

level, depending on the pest. Large scale

or commercial confirmatory testing may

be waived if satisfactory evidence can

be presented showing that conditions in

small scale testing are representative of

commercial practices.

Specific Research Protocol: Quarantine

Significant Systemic Organisms

Quarantine security for a single

treatment protocol will be defined as

achieving 99.9968 percent sterility or

mortality 4 at the 95 percent confidence

level, depending on the pest. Efficacy

must be demonstrated with lab scale

testing of organisms in host material.

System Integrity (Quality Assurance/

Quality Control)

Post-treatment safeguard methods are

critical for irradiation treatments, as

they are for many other commodity

treatments, because the pest may

continue to live and develop following

treatment. As a result, confidence in the

adequacy of irradiation treatment rests

with the assurance that the treatment:

(a) Is efficacious against the pest

under specific conditions, and

(b) Has been properly conducted and

the commodity safeguarded.

To ensure condition (a) is met, strict

research protocols and dosimetry

requirements prevent lack of efficacy

that would lead to treatment failure.

Condition (b) is assured by well

designed and closely monitored systems

for treatment delivery and safeguards

that assure system integrity.

This section addresses the policies

being considered by PPQ for ensuring

system integrity in the application of

irradiation to phytosanitary problems.

The focus of these policies is the

achievement of quarantine security.

Product quality is a commercial

responsibility that must also be

considered.

A. Pretreatment Conditions

Packers and treatment facility

operators must keep complete records

concerning sources (growers) supplying

commodities for treatment. These

records must be available for PPQ

review in the event a trace-back is

necessary. Trace-back capability is

important when pests other than the

target pests have been detected.

Untreated commodities and other

agricultural products must be stored

separately from treated commodities

and appropriately marked. A fail-safe

means of moving the commodity from

receiving areas to treatment areas in a

timely fashion and without mistaken

identity or risk of cross-contamination is

essential.

Packaging prior to irradiation is

desirable to prevent reinfestation if

irradiation is done at the export source,

and to prevent the accidental escape of

target pests at the destination if the

treatment is applied at the destination.

B. Treatment Conditions

An accurate measure of absorbed dose

is critical to determining and

monitoring adequacy. The required

number and frequency of these

measurements will be prescribed by

PPQ based on the specific equipment,

processes, configurations, and

commodities.

Approved, standardized dosimetry

must demonstrate that the absorbed

dose range, including areas of the

minimum and maximum dose is well

mapped, controlled, and recorded for

specific pests, commodities, and

equipment.

Dosimetry must consider variations

due to density and composition of the

material treated, variations in shape and

size, variations in orientation of the

product, stacking, volume, and

packaging.

Absorbed dose must be measured

using calibrated dosimeters approved in

advance by PPQ. Dosimeters must be

calibrated to a recognized national or

international standard.

The number of dosimeters used shall

be in accordance with relevant

internationally accepted standards, such

as those published by ASTM.

Complete dosimetry records must be

kept by the treatment facility for at least

1 year after treatment. These records

must be available to PPQ for review at

any time.

Facilities and control procedures

must have approval and licensing in

conformance with local, national, and,

where applicable, international

regulatory bodies having authority over

the particular situation or location. For

non-U.S. locations, PPQ must judge

these to be adequate and equivalent to

U.S. standards.

Facilities must be certified by PPQ for

use initially and at least annually. An

increase or decrease in radioisotope or

major modification to equipment that

impacts the delivered dose must be

reviewed by PPQ prior to recertification.

Approval will be based on a common

set of criteria plus those specific to the

site and commodity programs.

Significant variance in dose delivery

(based on PPQ monitoring of dosimetry
Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 24437

records) may provide the basis for

requiring recertification.

Products not treated according to

required schedules must be removed

and discarded or otherwise eliminated

from shipments for export. Retreatment

is not allowed unless it can be

demonstrated that there is a high degree

of confidence that retreatment will not

result in misidentification or crosscontamination, or conflict with other

restrictions.

C. Post-treatment Conditions

Treated commodities must be

protected from reinfestation by pestproof packaging or other safeguards if

treated outside the U.S.

Packages must be marked and labeled

with treatment lot numbers and other

identifying features allowing the

identification of treatment lots and

trace-back (packing and treatment

facility identification and locations,

dates of packing and treatment).

D. Documentation and Monitoring

A phytosanitary certificate will be

accepted as certification of treatment.

Minimum information to provide

includes identification of the shipment

by treatment lot and certification of the

target minimum dose and the verified

minimum absorbed dose.

The treatment operator must have

reliable and probative evidence of

correct treatment for each lot certified.

Regulatory Framework

Existing Regulations

Few PPQ treatments are specifically

described within the Code of Federal

Regulations (CFR). Most approved

treatments are included in the PPQ

Treatment Manual, which is

incorporated into the CFR by reference.

An irradiation treatment for papayas

from Hawaii is the only irradiation

treatment currently approved by PPQ.

This authorization is specific for a

commodity, origin, and program but is

designed for a complex of fruit flies

rather than a single pest. The

authorization has proven useful from

the standpoint of beginning to establish

policies for irradiation as a

phytosanitary treatment in the United

States.

Proposed Processes and Structure for

New Regulations

The degree of sophisticated work and

testing needed to develop and prove an

irradiation treatment program make it

essential that the criteria for approval be

clearly understood in advance. A

specific and comprehensive statement

of policies combined with a pre-defined

strategy for regulatory incorporation are

essential to ensuring that the

development and implementation of

new treatments is not unduly stifled by

regulatory requirements nor too liberal

as to allow failures.

PPQ assumes that many additional

requests for treatment approvals will be

specific for pest-commodity-origin

combinations and will include unique

provisions for particular program

parameters. Single pest treatments as

well as broader targets, such as entire

groups of pests, are likely to be

explored. A number of individual

authorizations corresponding to items

within regulated commodity groups

(such as fruits and vegetables or logs

and lumber) will be necessary. There is

also the potential for broad spectrum

uses resulting in authorizations that

cross the lines of existing regulated

commodity groups. There is a need to

provide general statements of policy and

background requirements that pertain to

all irradiation treatments. Any

requirements concerning irradiation that

APHIS develops will be promulgated

through rulemaking published in the

Federal Register.

The following is offered as a

regulatory framework and policy

communication strategy for irradiation

treatment:

• Use draft position documents to

solicit input in the development of

policies and the collection of pertinent

information.

• Use Federal Register publication

and other methods to widely circulate

policy statements.

• Use notice and comment

rulemaking to propose and ultimately

codify new treatments approved by

PPQ.

• Commodity specific treatments may

be incorporated through additions to the

regulations specific to the commodity

group (i.e., fruits and vegetables).

• Treatments with broader

applications (either crossing the lines of

regulated groups, or having broad

spectrum pest effectiveness) may be

incorporated into the CFR without being

associated with an existing regulated

group.

Needs and Unresolved Issues

There is a need to develop standards

for conducting and reporting the

findings of irradiation efficacy research

for quarantine decision making,

including:

—Confirmatory testing requirements

with sufficient numbers to

demonstrate quarantine security

—Standardized dosimetry and details

concerning the methods used

—Information concerning the condition

or viability of test organisms and

survivors

—Information concerning the condition

of the commodity before and after

treatment

—Appropriate number of replications

—Appropriate methods of statistical

analysis

—Criteria for combining data for

different organisms or species

—Criteria for the substitution of

organisms

There is a need for additional research

on product tolerance, in order to:

—Establish tolerance ranges for more

commodities

—Characterize treatment variables that

affect phytotoxicity

There is a need for additional research

on the efficacy of irradiation for other

pests and diseases, including:

—Data supporting generic doses for

commodity and pest groups

—Treatments for other arthropods,

diseases, nematodes, noxious weeds

—Coordination with other quarantine

and food safety concerns, i.e., animal

products

Research is needed to develop

methods to verify the adequacy of

treatments, particularly a means for

verifying that a live pest that has

survived treatment has been adequately

irradiated. This also requires

development of dosimeters appropriate

to the relatively low levels of irradiation

used for quarantine treatments.

Research is needed to determine the

conditions under which in vitro efficacy

data can be considered acceptable in

lieu of in vivo or in situ data.

There is a need to increase the

number of facilities available for

treatment research.

A coordinated system is needed for

storing and accessing data associated

with irradiation treatments for

quarantine purposes.

There is a need for integration and

coordination with food safety and other

authorities involved in regulatory

aspects of applying irradiation to

agricultural commodities.

There is a need to identify critical

control points for purposes of avoiding

hazards (process failures) associated

with treatment.

There is a need to determine the load

required to have statistically meaningful

results.

Finally, there is a need to develop

estimates of the influence of climate or

other environmental effects on the pest’s

susceptibility to irradiation treatment.
24438 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

Current Initiatives

1. Generic Doses for Fruit Flies

An exhaustive review of the scientific

literature concerning the efficacy of

irradiation treatments for fruit flies in

fresh fruits and vegetables has been

conducted by ARS with the goal of

determining whether generic dosages

could be recommended. An evaluation

of the results by ARS and PPQ provided

the basis for the commodity-generic

dosages listed below.

Tephritid species Common name

Min. absorbed dose

(Gy)

Bactrocera dorsalis5 ......................................................................................................... Oriental fruit fly ......................................... 250

Ceratitis capitata ............................................................................................................... Mediterranean fruit fly ............................... 225

Bactrocera cucurbitae ....................................................................................................... Melon fly ................................................... 210

Anastrepha suspensa ....................................................................................................... Caribbean fruit fly ..................................... 150

Anastrepha ludens ............................................................................................................ Mexican fruit fly ........................................ 150

Anastrepha obliqua ........................................................................................................... West Indian fruit fly ................................... 150

Anastrepha serpentina ..................................................................................................... Sapote fruit fly .......................................... 150

Bactrocera tryoni .............................................................................................................. Queensland fruit fly .................................. 150

Bactrocera jarvisi .............................................................................................................. (No common name) .................................. 150

5 Unless noted as Bactrocera dorsalis complex, B. dorsalis refers specifically to the species as described by R.A.I. Drew and D.L. Hancock

(1994) ‘‘The Bactrocera dorsalis complex of fruit flies (Diptera: Tephritidae: Dacinae) in Asia.’’ Bulletin of Entomological Research: Supplemental

Series Number 2 in Supplement 2. CAB International, pp 68.

These dosages are generic in the sense

that the prescribed dose is deemed

appropriate regardless of the

commodity. In cases where more than

one of the listed species is of concern,

the prescribed dose would be the dose

for the most tolerant species. All doses

are subject to adjustment based on the

scientific evidence supporting a

different dose.

2. Modification of 7 CFR 318.13–4f

(Papaya From Hawaii)

The regulations at 7 CFR 318.13–4f

have not been used for routine

commercial shipments due to the lack of

a treatment facility in Hawaii. Recently

however, PPQ has been approached

concerning the potential for modifying

the existing regulations to allow for

shipping to northern areas of the

mainland U.S. for treatment, and to

include tropical fruits such as lychee,

rambutan, carambola, and cherimoya

under a modification of the existing

authorization for papaya.

Pest risk analyses have been done or

are underway to determine if quarantine

significant pests other than fruit flies are

associated with other tropical fruits of

interest. At the same time, PPQ has

authorized a few experimental

shipments from Hawaii to Chicago for

treatment at the dose prescribed in the

existing regulations.

Test shipments were authorized

under strict safeguards and supervision.

Each shipment was designed to provide

PPQ with information and experience

required to determine whether suitable

program protocols could be developed

and what conditions would be most

appropriate. The results may provide

sufficient basis for proposing

modifications to the existing regulation.

3. Universal Treatment for Logs, Lumber

and Unmanufactured Wood Products

Interest is high in exploring the

potential to use irradiation as a means

to address phytosanitary problems in

raw wood products. Logs from Russia

are the primary commercial focus at this

time.

Russian researchers have conducted

research and provided data in support

of adopting a generic dose for treating

raw logs. PPQ has formed a science

panel consisting of scientists from

APHIS, ARS, and the Forest Service to

establish a research protocol, review

data, and oversee the research effort

toward a generic dose providing probit

9 mortality for all organisms of concern

in logs from Russia. If approved, the

treatment will be included among the

universal treatment options in 7 CFR

319.40.

Definitions

Absorbed Dose

Quantity of radiation energy imparted

per unit of mass of a specified material

(D=de/dm). The mathematical

relationship is the quotient of de by dm,

where de is the mean energy imparted

by ionizing radiation to matter of mass

dm. The unit of absorbed dose is the

gray (Gy) where 1 gray is equivalent to

the absorption of 1 joule per kilogram

(=100 rad).

Absorbed-Dose Mapping

Measurement of the absorbed-dose

distribution within a process load

through the use of dosimeters placed at

specified locations.

Absorbed-Dose Rate

The absorbed dose in a material per

incremental time interval, ie. the

quotient of dD by dt (D=dD/dt). The unit

for absorbed-dose rate is gray per second

(Gy/s)

Dmax

The maximum absorbed dose within

the process load.

Dmin

The minimum absorbed dose within

the process load.

Dose Uniformity Ratio

Ratio of the maximum to the

minimum absorbed dose within the

process load. The concept is also

referred to as the max/min dose ratio.

U=Dmax/Dmin

Dosimeter

A device that, when irradiated,

exhibits a quantifiable change in some

property of the device which can be

related to absorbed dose in a given

material using appropriate analytical

instrumentation and techniques.

Dosimetry System

A system used for determining

absorbed dose, consisting of dosimeters,

measurement instruments and their

associated reference standards, and

procedures for the system’s use.

Efficacy (Treatment)

Capability of a treatment to produce a

defined, measurable, and reproducible

effect on pests.

Fruit Flies

Quarantine significant species of

Tephritidae.

Gray (Gy)

Unit of absorbed dose where 1 Gy is

equivalent to the absorption of 1 joule

per kilogram.

1 Gy = 1 J/kg
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