Codex Alimentarius
Commission and the
International Plant
Protection Convention
Relationship of CAC
and IPPC to the WTO
 Two of the “three sisters” named in the SPS
Agreement:
 Codex Alimentarius Commission = food safety
 International Plant Protection Convention = plant
health (phytosanitary)
 Responsible for “international standards,
guidelines, or recommendations (Art 3
Harmonization)
 “Members shall…”
Standards
 Codex Alimentarius (Codex)
 International Plant Protection
Convention (IPPC)
 North American Plant Protection
Organization (NAPPO)
 ASTM, ISO
Codex Alimentarius
Commission
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Standard setting since 1963
Intergovernmental body-165 members
Not an international treaty
Joint FAO/WHO Secretariat
Objectives:
 Protecting health of the consumer
 Ensuring fair practices in the food trade
Food Safety
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CONCEPT IS DIFFICULT TO ACCEPT
 IPFFI 1970- 1982
Karlsruhe, Germany
 International Agencies, National Governments
 Feeding studies, 10 kGy
 Research showed no indication of radiation-
induced carcinogens or other toxic substances
 FAO-IAEA-WHO meeting in 1982
Conclusions
Irradiation of any commodity
up to 10 kGy presented:
• No nutritional problems
• No toxicological hazard
• No microbiological problems
Codex Alimentarius
 Codex General Standard for Irradiated
Food (CAC/RS 106- 1979)
 Revised 1983
 Revised 2003
 Code of Practice for the Operation of
Irradiation Facilities
Codex General Standard
 First International Standard for irradiated
food
 Established requirements for the process
 The Code of Practice is considered an
“Advisory Text”
Codex General Standard
 General Requirements:
 Radiation Sources
 10kGy as the maximum overall average
absorbed dose,except when necessary to
achieve a legitimate technological purpose
 Facilities and control of the Process
(according code of practice)
 Re-irradiation allowed for products with low
moisture
Codex General Standard
for Irradiated Food
 Labeling for the purposes of shipping documents
 Labeling of pre-packaged foods requires labeling of
whole irradiated foods, of ingredients of foods, and
of single ingredient products that have been
prepared from irradiated raw ingredients
 Optional international symbol: RADURA
Code of Practice
 Refers to the operation of irradiation facilities
(60Co, 137Cs or X-rays and electrons)
 Control of the process: measuring the absorbed
radiation dose and monitoring the physical
parameters of the process
 Irradiation Facilities: parameters, dwell time (or
transport speed), bulk density of the material,
source-product, geometry
 Dosimetry
Limiting factors
 Petition needed for changes
 Codex limited to 10 kGy but may be
more if “necessary to achieve a
legitimate technological purpose”
(CodexStan 106-1983, Rev. 1-2003)
IPPC
 An international treaty since 1953; Revised in
1973 and 1997
 Has its own membership (170)
 Not limited to applications in trade
 Secretariat in FAO
 Harmonization role began with the
phytosanitary certificate
 Standard setting started in 1993
 Currently 29 ISPMs
IPPC Standards
 Reference, concept, or specific
 Usually adopted by consensus of
Commission on Phytosanitary
Measures (CPM); meets annually
 Currently no concept standard for
treatments
 ISPM No. 18 (irradiation) is the first
specific treatment standard
Treatment objectives
The phytosanitary objective is to achieve
the appropriate level of phytosanitary
protection.
The regulatory objective is to prevent the
introduction or spread of regulated pests.
The operational objective is to ensure that
measures (e.g., treatments) are feasible and
efficacious, and applied correctly
Effectiveness
 Often based on standards for other
phytosanitary treatments (e.g., fumigation)
 Probit 9 (99.9968% response, usually mortality)
 Disadvantages
• Normally an extremely high level of security
• Not always possible to work with the large number of
pests required for appropriate research
New Concept
Irradiation is a phytosanitary
treatment with different options for
a desired response:
• Inability of insects to emerge or to fly
• Sterility
• Inactivation
• Mortality
Situation #1
The pest is sedentary (attached to fruit), is
not expected to escape into the
environment after treatment, or is not
expected to be detected or trigger a
regulatory response.
Sterility is an acceptable response to
provide phytosanitary security while
minimizing treatment rigor and the
potential for phytotoxic effects.
Situation #2
Pest can escape the treated commodity, be
detected in the environment, be practically
indistinguishable from untreated pests,
and trigger a regulatory response.
The required response need not be
mortality, but must be more than sterility
to prevent adult emergence (e.g., fruit
flies).
Situation #3
Tubers/bulbs for consumption are
regulated as propagative material
because they can be a pathway for the
introduction of serious pests if
propagated.
The required response can be inactivation
to the level of sprout inhibition.
Summary
 Irradiation is different than other
treatments in many ways
 Various responses may be possible for
irradiation treatment
 Regulatory criteria play an important
role in deciding the most appropriate
response
Required Response
… a specified level of effect for a treatment
(ISPM # 18; Guidelines for the use of irradiation as a
phytosanitary measure; IPPC 2003)
 An effect (e.g., mortality)
 Specified level (e.g., probit 9)
ISPM No. 18
 Introduction:
 Scope, references, definitions and abbreviations
and outline of requirements
 Technical Requirements:
 Authority, treatment objective, treatment,
dosimetry, approval of facilities, system integrity,
documentation, inspection, research
 Two annexes and two appendices:
 Annexes: Specific approved treatments; checklist
for facility approval
 Appendices: Estimates of minimum absorbed dose
doses for selected pest groups, research protocol
Authority
The National Plant Protection Organization
(NPPO) is responsible for the evaluation,
adoption and use of irradiation as
phytosanitary measure
Objective
The objective is to prevent the introduction or
spread of regulated pests. This may be realized by
achieving certain responses from the treatment of
targeted pests.
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Mortality
Non emergence of adults
Sterility
Inactivation
Efficacy is defined by NPPO of the importing
country:
Efficacy concepts:
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Description of required response: e.g., sterility
Statistical level of response required, e.g., Probit 9
Treatment
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Source: 60 Co, 137 Cs, electron beam 10Mev, X-ray 5MeV;
Gy = unit for absorbed dose
Variables: Dose rate, treatment time, temp, humidity,
ventilation, modified atmosphere
Dmin: fully attained throughout the commodity
Required response: Mortality (rarely), live target pests may be
found after treatment
Application:
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as an integral part of packing operation
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to bulk unpackaged commodities
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at centralized locations such as the port of embarkation
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Annex 1 (lists the approved doses)
Dosimetry
 Ensures that the required Dmin for a
particular commodity was delivered to all
parts of the consignment
 Dosimetry systems should be calibrated
according to international/national standards
 Components:
 Dose mapping
 Routine dosimetry
Approval of facilities
Treatment facilities for phytosanitary
treatment must be approved by nuclear
regulatory authorities and the NPPO in the
country where the facility is located
Annex 2: Checklist for facility approval
premises, personnel, product handling,
irradiation, treatment, packaging and
labeling, documentation
System Integrity
The NPPO is responsible for ensuring system integrity
• Security at the treatment facility: Treated commodity
should be segregated, clearly identified. and handled and
safeguard against contamination
• Labeling: Packages should be labeled with treatment lot
numbers ,treatment facility, location, dates of packing and
treatment
• Verification: Processes should be verified through
monitoring and audits of facility treatments, free access to
documentation and records of the treatment facility.
Documentation
 Documentation of procedures: Consignment
handling procedures, configuration of the commodity
during treatment, critical process parameters and the
means for monitoring, dosimetry, labeling,
recordkeeping and documentation requirements
Facility records and traceability: Identification of
facility and responsible parties, identity of
commodities, treated, purpose of treatment, target
regulated pest(s), packer, grower and identification,
place of production, quantity in each lot, absorbed
doses (target and measured), and date of treatment
Inspection/Certification
 Export Inspection: documentation verification and
examination for non-target pests
 Phytosanitary certification: Validates the successful
completion of a treatment
 Import inspection: the detection of live stages of target
pests do not represent treatment failures
 Verification for treatment efficacy in export
and import: Include laboratory tests or analysis
 Administration and documentation: The NPPO
has the ability and resources to evaluate, monitor
and authorize irradiation for phytosanitary purposes
Research Protocol
Appendix 2 provides guidance on undertaking
research for the irradiation of regulated pests
Minimum absorbed doses
for pest groups
Pest Group
Dmin (Gy)
Pest Group Dmin (Gy)
Aphids and
whiteflies
(Homopetara)
50- 100
Thrips
150 -250
Seed weevils
70 -300
Bores
200 -350
Scarab beetles
50 -150
Spider mites
200 -350
Fruit flies
50 -250
Coleopetra
50 -400
Weevils
80 -165
Lepidoptera
100 -1000
Borers
100 -280
Nematodes
~ 4000
ISPM No. 18 Trivia
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1st specific standard for risk management
1st standard for a phytosanitary treatment
Only standard with annexes & appendices
Introduces concept of “required response”
Introduces concept of different endpoints
Introduces concept of system integrity
Completed jointly with IAEA
The future
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Specific treatments adopted by IPPC
Feasibility studies
Bilateral agreements
Expand tolerance research
Adjustments in regulatory frameworks
Increased consumer acceptance