```
[Federal Register Volume 61, Number 95 (Wednesday, May 15, 1996)]
[Rules and Regulations]
[Pages 24433-24439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12185]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

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.

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

[[Page 24433]]

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.

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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 
``[email protected]''--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 [email protected].

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

[[Page 24434]]

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.

[[Page 24435]]

    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.
---------------------------------------------------------------------------

    \1\ Note: Packaging materials may require FDA approval.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ The 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.
---------------------------------------------------------------------------

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

[[Page 24436]]

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.
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    \3\ Quarantine 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.
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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 
commercial-scale 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.
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    \4\Note: 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.
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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

[[Page 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 cross-contamination, or conflict with other 
restrictions.

C. Post-treatment Conditions

    Treated commodities must be protected from reinfestation by pest-
proof 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.

[[Page 24438]]

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.

----------------------------------------------------------------------------------------------------------------
                                                                                                         Min.   
           Tephritid species                                    Common name                            absorbed 
                                                                                                      dose (Gy) 
----------------------------------------------------------------------------------------------------------------
Bactrocera dorsalis 5.................  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

[[Page 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
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