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