WORLD TRADE
ORGANIZATIONWT/DS245/R
15 July 2003
(03-3645)
Original: English
JAPAN – MEASURES AFFECTING THE IMPORTATION OF
APPLES
Report of the Panel
The report of the Panel on Japan – Measures Affecting the Importation of Apples is being circulated
to all Members, pursuant to the DSU.  The report is being circulated as an unrestricted document from15 July 2003 pursuant to the Procedures for the Circulation and Derestri ction of WTO Documents
(WT/L/452).  Members are reminded that in accordance with the DSU only parties to the dispute may
appeal a panel report.  An appeal shall be limited to issues of law covered in the Panel report and legal
interpretations developed by the Panel.  There shall be no ex parte  communications with the Panel or
Appellate Body concerning matters under consideration by the Panel or Appellate Body.
Note by the Secretariat:  This Panel Report shall be adopted by the Dispute Settlement Body (DSB) within 60 days after the date  of its
circulation unless a party to the dispute decides to appeal or the DSB decides by consensus not to adopt the report.  If the Pa nel Report is
appealed to the Appellate Body, it shall not be considered for adoption by the DSB until after the completion of the appeal.  I nformation on
the current status of the Panel Report is available from the WTO Secretariat.WT/DS245/R
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TABLE OF CONTENTS
Page
I. INTRO DUCTION ................................................................................................................. ...1
II. FACTUAL ASPECTS ............................................................................................................. .2
A. THE DISEASE AT ISSUE .................................................................................................................2
1. Fire blight ( Erwinia amylovora) ...............................................................................................2
2. Host plants.................................................................................................................. ...............3
3. Geographical distribution of fire blight..................................................................................3
4. Relevant technical and scientific terms...................................................................................3
B. JAPAN 'S FIRE BLIGHT MEASURES .................................................................................................4
C. INTERNATIONAL STANDARDS , GUIDELINES AND RECOMMENDATIONS ......................................6
1. The IPPC ..................................................................................................................... ..............6
2. International standards for phytosanitary measures (ISPMs) .............................................7
III. CLAIMS OF THE PARTIES ..................................................................................................9IV. ARGUMENTS OF THE PART IES ......................................................................................10
A.
THE SCOPE OF THE DISPUTE .......................................................................................................10
1. Relevant pr ovisions.......................................................................................................... .......10
2. Objection to submitted evidence............................................................................................11
B. THE MEASURE (OR MEASURES ) AT ISSUE ..................................................................................14
1. Fire blight status of Japan.................................................................................................. ....15
2. History of the dispute ....................................................................................................... ......15
C. APPLICATION OF THE SPS AGREEMENT .......................................................................................18
D. BURDEN OF PROOF .....................................................................................................................18
E. A RTICLE 2.2 ............................................................................................................................ ..21
1. General...................................................................................................................... ...............21
2. Nature of the scie ntific evidence ............................................................................................ 23
3. Transmission of the disease.................................................................................................. ..26
4. Pathway for transmission of the disease ...............................................................................31
5. Endophytic (internal) bacteria and mature apple fruit.......................................................336. Epiphytic bacteria and mature apple fruit...........................................................................37
7. Scientific evidence and the steps in Japan's systems approach ..........................................39
(i) Prohibition of imported apples from orchards in which any fire blight is detected ..............40
(ii) Prohibition of imported apples from any orchard should fire blight be detected
within a 500-meter buffer zone surrounding the orchard ......................................................41
(iii) Inspection of orchards three times yearly ...............................................................................42
(iv) Prohibition of imported apples unless treated with chlorine ..................................................44
(v) Prohibition of imported apples from US states other than Washington or Oregon ..............44WT/DS245/R
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(vi) Prohibition of imported apples unless other production, harvesting, and
importation requirements are met ...........................................................................................45
F. A RTICLE 5.1 ............................................................................................................................ ..46
1. General...................................................................................................................... ...............46
2. Evaluation of the likelihood of entry, establishmen t or spread ..........................................46
3. Evaluation of risk according to the measure which might be applied ...............................52
4. Measures based on an asse ssment of th e risks .....................................................................53
G. A RTICLE 5.2 ............................................................................................................................ ..55
H. A RTICLE 5.6 ............................................................................................................................ ..57
I. A RTICLE 5.7 ............................................................................................................................ ..62
J. A RTICLE 7 (ANNEX B ) ...............................................................................................................67
K. ARTICLE XI OF GATT ..................................................................................................................67
L. ARTICLE 4.2 OF THE AGREEMENT ON AGRICULTURE ................................................................68
V. SUMMARY OF THIRD P ARTY SUBMISSIONS..............................................................68
A. AUSTRALIA ............................................................................................................................... .68
1. Burden of proof.............................................................................................................. .........68
2. Standard for developing a prima facie presumption...........................................................69
3. Conflicting scientific evidence and opinion ..........................................................................69
4. The product at issue......................................................................................................... .......72
B. BRAZIL ............................................................................................................................... ........72
1. Issues in relation to the SPS Agreement ................................................................................72
2. Brazilian phytosanitary measures on US apples  .................................................................74
C. EUROPEAN COMMUNITIES .........................................................................................................75
1. Procedural issues............................................................................................................ .........75
2. Legal arguments on Articles 2.2, 5.1 and 5.7........................................................................76
D. NEW ZEALAND ...........................................................................................................................79
1. Scientific evidence rela ting to fire blight ..............................................................................80
2. Inconsistency of Japan's fire blight measures with the SPS Agreement ............................81
3. Chronology of bilateral discussion between New Zealand and Japan...............................82
4. Apple maturity and trade..................................................................................................... ..83
E. SEPARATE CUSTOMS TERRITORY OF TAIWAN , PENGHU , KINMEN AND MATSU .........................84
1. Chinese Taipei's measures on US apples ..............................................................................85
VI. PANEL'S CONSULTA TION WITH SCIENT IFIC EXPERTS ........................................86
A. PANEL 'S PROCEDURES ...............................................................................................................86
B. S UMMARY OF THE WRITTEN RESPONSES BY THE EXPERTS TO THE PANEL 'S QUESTIONS ..........87
VII. INTERIM  REVI EW............................................................................................................. 129
A. I NTRODUCTION ........................................................................................................................129WT/DS245/R
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B. C OMMENTS BY JAPAN .............................................................................................................130
1. Burden of proof.............................................................................................................. .......130
2. Article 2.2 of the SPS Agreement .........................................................................................131
3. Article 5.7 of the SPS Agreement .........................................................................................131
4. Article 5.1 of the SPS Agreement .........................................................................................132
5. Article 7 of the SPS Agreement ............................................................................................134
C. C OMMENTS BY THE UNITED STATES ......................................................................................134
1. Requests for additional findings..........................................................................................134
2. Comments on specific paragraphs of the Report...............................................................134
VIII. FINDINGS.................................................................................................................. ...........137
A. A PPROACH FOLLOWED BY THE PANEL ....................................................................................137
B. T HE MEASURE AT ISSUE AND THE PRODUCT SUBJECT TO THIS MEASURE ...............................140
1. The measure at issue......................................................................................................... ....140
(a) Summary of the argume nts of the parties ...............................................................................140
(b) Analysis of  the Panel ....................................................................................................... .......141
(i) One or more measures?....................................................................................................... ...142
(ii) Elements constituting the phyt osanitary measur e at issue......................................................144
2. The product subject to the phytosanitary measure at issue..............................................146
(a) Summary of the argume nts of the parties ...............................................................................146
(b) Analysis of  the Panel ....................................................................................................... .......146
C. P ROCEDURAL ISSUES ...............................................................................................................148
1. Introduction................................................................................................................. ..........148
2. Burden of proof.............................................................................................................. .......148
3. Japan's requests for preliminary rulings............................................................................151
(a) Intr oduction................................................................................................................ .............151
(b) Japan's request that we "remove" certain  pieces of evidence from the proceedings...............151
(c) Japan's request regarding some claims not developed by the United States in its first
submission ..................................................................................................................... .........152
(i) Summary of the argum ents of th e parties ...............................................................................152
(ii) Analysis of  the Panel...................................................................................................... .........152
- Request (a)................................................................................................................... .............. 153
- Request (b) ................................................................................................................... ............. 153
D. ARTICLE 2.2 OF THE SPS AGREEMENT .......................................................................................154
1. Summary of the argume nts of the parties ..........................................................................154
(a) United States............................................................................................................... ............154
(b) Japan ....................................................................................................................... ................155
2. Approach of the Panel with respect to the review of the phytosanitary measure
at issue under Article 2.2 of the SPS Agreement .................................................................155WT/DS245/R
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(a) Preliminary remarks: limitation of findings to whether the measure is maintained
"without sufficient scie ntific evidence" ..................................................................................155
(b) Determining whether the measure at issue is (or not) "maintained without sufficient
scientific eviden ce"........................................................................................................... ......156
(i) Introduction ................................................................................................................ ............156
(ii) What needs to be dem onstrated in substance?........................................................................157
(iii) How to demonstrate the existence or absen ce of sufficient scie ntific evidence? ....................158
- "Scientific  evidence" ......................................................................................................... ........ 158
- "Sufficient" scie ntific evidence .............................................................................................. ... 160
3. Preliminary question: the relevance and consequences of the notion of "mature,
symptomless" apple fruit in the assessment of the phytosanitary measure at issue
under Article 2.2 .............................................................................................................. .....163
(a) Summary of the argume nts of the parties ...............................................................................163
(b) Analysis of  the Panel ....................................................................................................... .......163
(i) Introduction ................................................................................................................ ............163
(ii) Mature, symptomless app les v. other apples ..........................................................................163
(iii) Relevance of addressing the risks related to both mature, symptomless apples and
other apples................................................................................................................... ..........165
4. Infestation and infection of ma ture, symptomless apple fruit ..........................................166
(a) Infes tation ................................................................................................................. ..............166
(i) Endophytic bacteria......................................................................................................... .......166
(ii) Epiphyti c bacte ria......................................................................................................... ..........167
(b) Infec tion................................................................................................................... ...............168
5. Risk of entry, establishment or spread of fire blight within Japan by imported
US apple fruit (apple fr uit as a pathway) ...........................................................................169
(a) Intr oduction................................................................................................................ .............169
(b) Mature, sympto mless appl e fruit............................................................................................. 169
(c) Apples other than "mature,  symptomless ap ple fruit" ............................................................171
(i) Capacity of infected apple fruit to serve as pathway..............................................................171
(ii) Error of handling and illegal action....................................................................................... 172
(d) Risk of completion of the pathway .........................................................................................17 4
6. Intermediate  conclu sion ...................................................................................................... .175
7. Conformity of the phytosanitary measure at issue with Article 2.2 of the SPS
Agreement ..............................................................................................................................1 76
(a) Absence of a "rational relationship" between the scientific evidence available and the
measure at  issue ............................................................................................................... .......176
(i) The prohibition of imported apples from any orchard (whether or not it is free of fire
blight) should fire blight be detected within a 500-meter buffer zone surrounding such
orchard........................................................................................................................ ............177WT/DS245/R
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(ii) The requirement that export orchards be inspected at least three times yearly (at
blossom, fruitlet, and harvest stages) for the presence of fire blight......................................179
(b) Conclu sion .................................................................................................................. ............180
8. Provisional conclusion on Article 2.2 of the SPS Agreement .............................................180
E. A RTICLE 5.7 OF THE SPS A GREEMENT ....................................................................................181
1. Summary of the argume nts of the parties ..........................................................................181
2. Analysis of the Panel........................................................................................................ .....182
3. Final conclusion on Article 2.2 of the SPS Agreement .......................................................184
F. ARTICLES 5.1 AND 5.2 OF THE SPS AGREEMENT .......................................................................185
1. Introduction................................................................................................................. ..........185
2. Japan's risk  assessment ...................................................................................................... ..186
(a) Requirements of a risk as sessment under Article 5.1 .............................................................186
(b) A risk assessment "as appropr iate to the ci rcumstances"........................................................186
(c) International risk assessment techniques developed by relevant international
organiza tions.................................................................................................................. .........187
(d) Japan's risk assessment in light of the requirements under Annex A, paragraph 4 of
the SPS Agreement ..................................................................................................................188
(i) Introduction ................................................................................................................ ............188
(ii) The disease at issue and the potential biological and economic consequences
associated with its entry, establishment or spread .................................................................189
(iii) The likelihood of entry, establishm ent or spread of the disease .............................................189
- Japan's 1999 PRA.............................................................................................................. ........ 191
- Assessment of Japan's risk assessment...................................................................................... 192
(iv) According to the SPS measur es which might be applied........................................................195
3. Is the measure "based on " a risk assessment?...................................................................197
4. Conclusion ................................................................................................................... ..........197
G. ARTICLE 5.6 OF THE SPS AGREEMENT .......................................................................................198
1. Summary of the argume nts of the parties ..........................................................................198
2. Analysis of the Panel........................................................................................................ .....199
H. ARTICLE 7 AND ANNEX B OF THE SPS AGREEMENT ..................................................................200
1. Summary of the argume nts of the parties ..........................................................................200
2. Assessment by the Panel...................................................................................................... .201
I. ARTICLE XI OF GATT 1994 .......................................................................................................204
J. OTHER CLAIMS INCLUDED IN THE REQUEST FOR ESTABLISHMENT OF THE PANEL ..................204
IX. CONCL USIONS ................................................................................................................. ..205
ANNEX 1 ........................................................................................................................ ....................207
ANNEX 2 ........................................................................................................................ ....................210
ANNEX 3 ........................................................................................................................ ....................212WT/DS245/R
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I. INTRODUCTION
1.1 In a communication dated 1 March 2002, the United States requested consultations with
Japan pursuant to Articles 1 and 4 of the Understanding on Rules and Procedures Governing the
Settlement of Disputes ("DSU"), Article XXIII of the General Agreement on Tariffs and Trade 1994
("GATT 1994"), Article 11 of the Agreement on the Application of Sanitary and Phytosanitary
Measures (" SPS Agreement ") and Article 19 of the Agreement on Agriculture, with respect to
restrictions imposed by Japan on imports of apples from the United States.1
1.2 The United States stated that since 1994, Japan had applied quarantine restrictions on US
apples imported into Japan to protect against the introduction of fire blight ( Erwinia amylovora ).
These restrictions included, inter alia , the prohibition of imported apples from orchards in which any
fire blight is detected, the requirement that export orchards be inspected three times yearly for the
presence of fire blight, the disqualification of any orchard from exporting to Japan should fire blight
be detected within a 500-metre buffer zone surrounding such orchard, and a post-harvest treatment ofexported apples with chlorine.  The United States alleged that Japan's measures were inconsistent with
Article XI of GATT 1994;  Articles 2.2, 2.3, 5.1, 5.2, 5.3, 5.6, 6.1, 6.2 and 7 and Annex B of the SPS
Agreement ;  and Article 14 of the Agreement on Agriculture.  Consultations were held on
18 April 2002, but failed to settle the dispute.
1.3 In a communication dated 7 May 2002, the United States requested the Dispute Settlement
Body ("DSB") to establish a panel pursuant to Articl e 6 of the DSU, with standard terms of reference
as set out in Article 7.1 of the DSU.
2  The US claims of inconsistency in their Request for the
Establishment of a Panel were identical to those set out in their request for consultations, except for
additional claims of inconsistency under Article 5.5 of the SPS Agreement  and Article 4.2 of the
Agreement on Agriculture, and omission of the pr evious claim under Article 14 of the Agreement on
Agriculture.
1.4 On 3 June 2002, the DSB established a panel in accordance with Article 6 of the DSU.3  In
accordance with Article 7.1 of the DSU, the terms of reference of the Panel were:
"To examine, in the light of the relevant provisions of the covered agreements cited
by the United States in document WT/DS 245/2, the matter referred to the DSB by the
United States in that document and to make such findings as will assist the DSB in
making the recommendations or in giving the rulings provided for in those
agreements."
1.5 On 16 July 2002, the Director-General determined the composition of the Panel as follows:
Chairman: Mr Michael Cartland
Panelists: Mr Christian Häberli
Ms Kathy-Ann Brown
1.6 Australia, Brazil, the European Communities, New Zealand and the Separate Customs
Territory of Taiwan, Penghu, Kinmen and Matsu rese rved their right to participate in the Panel
proceedings as third parties.
1.7 The Panel met with the parties on 21 and 22 October 2002.  It met with third parties on
22 October 2002.  The Panel consulted scientific and technical experts and met with them on 13 and
14 January 2003.  The Panel held a second meeting with the parties on 16 January 2003.
                                                     
1 WT/DS245/1.
2 WT/DS245/2.
3 WT/DS245/3.WT/DS245/R
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1.8 On 17 January 2003, the Chairman of the Panel informed the DSB that the Panel had not been
able to issue its report within six months.  The reasons for that delay were given in document
WT/DS245/4.
1.9 The Panel issued its interim report on 20 March 2003.  The Final Report was circulated to the
parties on 25 June 2003.  The report was circulated to Members in all three languages 15 July 2003.
II. FACTUAL ASPECTS
A. THE DISEASE AT ISSUE
1. Fire blight ( Erwinia amylovora)4
2.1 Erwinia amylovora  (E. amylovora ), the scientific name for the fire blight bacterium, was first
reported in the Hudson River Valley of New York State in the United States in 1793.  Symptoms of
infection of host plants with fire blight depend on the parts infected.  Infected flowers droop, wither,
and die, becoming dry and darkened in color.  Infected shoots and twigs wither, darken, and die; asshoots and twigs wither, they bend downwards resemb ling a shepherd’s crook.  Infected leaves take
on a curled, scorched appearance.
5  Infected fruit fail to develop fully, turning brown to black,
shrivelling, and becoming mummified, frequently remaining attached to the limb.  Limbs and trunks
of trees may also develop cankers, which, if disease development is severe, may result in plant death.
2.2 The most serious primary infection with fire blight is an over-wintering canker developed in
the previous season.  Fire blight bacteria overwint er exclusively in infected host plants.  In the
presence of warm, wet conditions in spring, the disease cycle commences when cankers on infected
hosts exude a bacterial-laden ooze or inoculum.  This inoculum is transmitted primarily through wind
and/or rain and by insects or birds to open flowers on the same or new host plants.  E. amylovora
bacteria multiply externally on the stigmas of these open flowers and enter the plant through stomata(openings through which the plant breathes), nectaries (plant glands that secrete nectar), or wounds.
The bacteria may spread within the host plant, causi ng disease in blossoms and fruiting spurs, twigs,
branches, or leaves.  New cankers (sunken areas surrounded by cracked bark) can be formed on
infected branches or twigs.  When bacteria form  a canker on the branches, this canker remains as an
over-wintering lesion until the next year.  Cankers generally cease ooze production during the hotsummer months and remain inactive until the following spring when they may reactivate and begin
the disease cycle anew.
2.3 Secondary infection can occur during the growing season.  The source of the secondary
inoculum is bacterial ooze exuding from lesions on shoots, leaves, fruits or branches and which is
carried by wind and/or rain, insects or birds.
2.4 Immature apples can be infected with E. amylovora  through natural openings in the skin (i.e.
lenticels) or by diseased branches.  The infection of fruit commonly occurs after hail storms in thesummer months.  Infected fruit exude bacterial ooze, become dry, mummify and remain on the
branches.
                                                     
4 Description compiled from "Report on Pest Risk Analysis concerning Fire Blight Pathogen ( Erwinia
amylovora ):  Fresh apples produced in the United States of America", Ministry of Agriculture, Forestry and
Fisheries, Japan, August 1999 (the "1999 PRA") (Exhibit USA-3 and Exhibit JPN-34) and US First Submission.
5 The name "fire blight" was apparently coined in 1817 to describe the sudden browning of leaves
associated with E. amylovora  "as if they had passed through a hot flame and causing a morbid matter to exude
from the pores of the bark", Coxe. W. A View of the Cultivation of Fr uit Trees, and the Management of
Orchards and Cider, Pears , M. Carey and Son, Philadelphia, 1817.WT/DS245/R
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2. Host plants
2.5 The fire blight disease affects numerous host plants of the Rosaceae family, including both
cultivated and native wild plants.  Fruit tree hosts include apples (genus Malus ), pears (genus Pyrus ),
quince (genus Cydonia ), and loquats (genus Eriobotrya ).  Important host plants used in hedges and
gardens include genera Cotoneaster , Crataegus  (hawthorn), Pyracantha  (firethorn), and Sorbus
(mountain ash), although individual species may not serve as hosts.6
3. Geographical distribution of fire blight
2.6 It is believed that the fire blight bacterium ( E. amylovora ) is native to North America.  By the
early 1900s, fire blight had been reported in Canada from Ontario to British Columbia, in northern
Mexico, and in the United States from the East Coast to California and the Pacific Northwest.  Fire
blight was reported in New Zealand in 1919, Great Britain in 1957, and Egypt in 1964.  The disease
has spread across northern and western Europe, alt hough Portugal and Finland remain fire blight-free,
and it remains localized in France and Switzerland and restricted to certain spots in Spain, Italy, andAustria.  Norway has reported eradication of the disease.
7  Fire blight has spread across the
Mediterranean region, including Greece, Turkey, Israel, Lebanon, Iran, and several Central European
countries.8  Latin America and substantial parts of Africa and Asia apparently remain fire blight-free.
In 1997, Australia reported the presence of fire blight in the Adelaide and Melbourne Botanical
Gardens, but eradication efforts were successful and no further outbreaks have been reported.
4. Relevant technical and scientific terms
Buffer zone
2.7 An area in which a specific pest does not occur or occurs at a low level and is officially
controlled, that either encloses or is adjacent to an infested area, an infested place of production, apest free area, a pest free place of production or a pest free production site, and in which phytosanitary
measures are taken to prevent spread of the pest .
Canker
2.8 A lesion on the bark of a tree or shrub caused by infection.  Fire blight cankers on limbs,
stem, and trunks appear as sunken, discoloured areas that often exhibit deep cracks in the bark at the
margins of the canker.  A hold-over canker is one in which the pathogen may survive the winter and,
if survival occurs, from which the inoculum for primary infections the following spring originate.
Disease (of plant)
2.9 A disorder of structure or function in a plant of such a degree as to produce or threaten to
produce detectable illness or disorder; a definable variety of such a disorder, usually with specificsigns or symptoms.
Endophytic and epiphytic
2.10 With respect to E. amylovora , the term endophytic is used when the bacterium occurs inside
a plant or apple fruit in a non-pathogenic relationship.  With respect to E. amylovora , the term
                                                     
6 European and Mediterranean Plant Protection Orga nization (EPPO), "Data Sheet on Quarantine Pests:
Erwinia amylovora", Quarantine for Europe, 1997, p. 1-2 (Exhibit USA-5).
7 At the Panel meeting with the experts on 14 January 2003, Dr Geider noted that there had been a
recent report of an outbreak of fire blight in Norway.
8 Commonwealth Agriculture Bureau International (CABI), Crop Protection Compendium: Data Sheet
on Erwinia amylovora (2002) "Notes on Distribution" (Exhibit USA-6).WT/DS245/R
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epiphytic  is used when the bacterium occurs on the outer surface of a plant or fruit in a non-
pathogenic relationship.
Entry, establishment and spread (of a pest)
2.11 Entry refers to the movement of a pest into an area where it is not yet present , or present but
not widely distributed and being officially controlled.  Establishment means the perpetuation, for the
foreseeable future, of a pest within an area after entry.  Spread refers to the expansion of the
geographical distribution of a pest within an area.
Infection
2.12 When an organism (e.g., E. amylovora ) has entered into a host plant (or fruit) establishing a
permanent or temporary pathogenic relationship with the host.
Infestation
2.13 Refers to the presence of the bacteria on the surface of a plant without any implication that
infection has occurred.9
Inoculum
2.14 Material consisting of or containing  bacteria to be introduced into or transferred to a host or
medium.  Inoculation is the introduction of inoculum  into a host or into a culture medium.  Inoculum
can also refer to potentially infective material available in soil, air or water and which by chance
results in the natural inoculation of a host.
Pathogen
2.15 Micro-organism causing disease.
Vector
2.16 An organism able to transport and transmit a pathogen.
B. JAPAN 'S FIRE BLIGHT MEASURES
2.17 The legislation of Japan relevant to this dispute is:
• Plant Protection Law No. 151 enacted on 4 May 1950 (and specifically Article 7
thereof);
• Plant Protection Law Enforcement Regulations enacted on 30 June 1950 (and
specifically Article 9 and Annexed table 2 thereof);
• Ministry of Agriculture, Forestry and Fisheries (MAFF) Notification No. 354 dated
10 March 1997; and
                                                     
9 The Panel has followed the scientific definition of bacterial infestation offered by the experts
consulted by the Panel.  See Anne 3, para. 67.  A general definition of infestation is to be found in International
Standards for Phytosanitary Measures No.5:  Glossary of Phytosanitary Terms , FAO, Rome 2002.  "Presence in
a commodity of a living pest of the plant or plant pr oduct concerned.  Infestation included infection."WT/DS245/R
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• MAFF "Detailed Rules for Plant Quarantine Enforcement Regulation Concerning
Fresh Fruit of Apple Produced in the United States of America " dated 1 April 1997.
2.18 Under the Plant Protection Law and the Enforcement Regulations, importation of host plants
of 15 quarantine pests, including fire blight bacteria and pests of rice plant not found in Japan, is
prohibited.10  The legislation, however, permits Japan to decide, on a case-by-case basis, to lift the
import prohibition with respect to plants and products according to certain criteria that have been
established by past practice.  These criteria are:
• Lifting is subject to a proposal of an alternative measure by a foreign government;
• the level of protection required of the proposed measure is that equivalent to import
prohibition; and
• the exporting government bears the burden of proving that the proposed measure
achieves the required level of protection.
2.19 Paragraph 25 of the Annexed List to Table 2 of the Plant Protection Law Enforcement
Regulations sets out conditions under which US apples may be imported into Japan: "Fresh fruit of
apple which are shipped from the United States of America directly to Japan without calling at anyport and which conform to the standards established by the Ministry of Agriculture, Forestry and
Fisheries".
11  The relevant standards are currently set by MAFF Notification No. 35412 and the related
Detailed Rules.13  These are:
(i) Fruit must be produced in designated fire blight-free orchards.  Designation of a fire
blight-free area as an export orchard is made by the United States Department of
Agriculture (USDA) upon application by the orchard owner. Any detection of a
blighted tree in this area by inspection will disqualify the orchard. Currently, thedesignation is made for orchards in  the States of Washington and Oregon;
14
(ii) the export orchard must be free of plants infected with fire blight and free of host
plants of fire blight (other than apples), whether or not infected;
                                                     
10 Article 7, paragraph 1, item 1 of the Law (Exhibits JPN-20 and USA-8) and Article 9, item 1 and
Annexed Table 2 of the Enforcement Regulation (Exhibits JPN-21 and USA-9).
11 Ministerial Ordinance No. 73: Plant Protection Law Enforcement Regulations, Annexed List, para.
25 (Exhibit JPN-21 and Exhibit USA-9). The United States contends that paragraph 25 of the Annexed List to
Table 2 of the Plant Protection Law Enforcement Regulations limits the importation of fresh fruit of apple fromthe United States to Golden Delicious and Red Delicious a pple varieties.  The Panel, however, notes that there is
disagreement between the parties as to the English translation of the aforementioned paragraph 25.  The Englishtranslation of paragraph 25 provided by Japan makes no mention of the Golden Delicious and Red Deliciousvariety requirement.
12 MAFF Notification No. 354, 10 March 1997, (Exhibit USA-10 and Exhibit JPN-22).  Notification
No. 354 replaced an earlier Notification No. 1184, which first put into place the Japanese fire blight restrictions.
See MAFF Notification No. 1184, 22 August 1994, (Exhibit USA-11).
13 MAFF Detailed Rules for US Apples, 1 April 1997, (US translation, Exhibit USA-12 and Exhibit
JPN-23).  The 1997 Detailed Rules amended but did not replace in full the 22 August 1994 Detailed Rules,which implemented MAFF Notification No. 1184.  It is therefore necessary to read the 1994 Detailed Rules in
conjunction with the 1997 Detailed Rules in order to understand the full scope of the Japanese fire blight
measures.  See MAFF Detailed Rules for US Apples, 22 August 1994, (US translation, Exhibit USA-13).
14 Japan argues that the current phytosanitary requirements against fire blight can be applicable to apple
fruit produced in other states, but that United States has not submitted documentation on the status of otherquarantine pests for states other than Washington and Oregon.  As such, Japan argues that this is a procedural
matter.   Japan, Response to Questions from the Panel, 13 November, 2002, Question 47
.WT/DS245/R
Page 6
(iii) the fire blight-free orchard must be surrounded by a 500-meter buffer zone.  Detection
of a blighted tree or plant in this zone will disqualify the export orchard;
(iv) the fire blight-free orchard and surrounding buffer zone must be inspected at least
three times annually.  US officials will visually inspect twice, at the blossom and the
fruitlet stages, the export area and the buffer zone for any symptom of fire blight.Japanese and US officials will jointly conduct visual inspection of these sites at
harvest time. Additional inspections are requ ired following any strong storm (such as
a hail storm);
(v) harvested apples must be treated with surface disinfection by soaking in sodium
hypochlorite solution (100 ppm or more effective chlorine concentration) for one
minute or longer;
(vi) containers for harvesting must be disinfected by a chlorine treatment;
(vii) the interior of the packing facility must be disinfected by a chlorine treatment;
(viii) fruit destined for Japan must be kept separated post-harvest from other fruit;
(ix) US plant protection officials must certify or declare that fruit are free of quarantine
pests, "are not infested/infected with . . . fire blight",  and were treated with chlorine;
and
(x) Japanese officials must confirm that the US official has made the necessary
certification and that the chlorine treatment and orchard designations were properly
made.  Japanese officials must also inspect both the disinfestation and packing
facilities.
C. 
INTERNATIONAL STANDARDS , GUIDELINES AND RECOMMENDATIONS
2.20 In their submissions, the parties considered certain international standards developed by the
Interim Commission on Phytosanitary Measures of the International Plant Protection Convention
("IPPC") as relevant to the dispute.  The SPS Agreement  makes reference, in a number of provisions,
to "relevant international standards, guidelin es and recommendations".  Annex A:3(c) of the SPS
Agreement  states that the international standards, guidelines and recommendations relevant for plant
health are those developed under the auspices of the IPPC in cooperation with regional organizations
operating within the fr amework of the IPPC.
1. The IPPC
2.21 The IPPC is an international treaty deposited and administered by the Food and Agriculture
Organization of the United Nations (FAO) but implemented through the cooperation of member
governments and regional plant protection organizations. The IPPC currently has 120 contracting
parties.
2.22 The first text of the IPPC was drafted in 1929 and came into force in 1952, adopted by the
FAO Conference one year prior to that.  Amendments were adopted by the FAO in 1979 and the
revised text came into force in 1991.  In response to the role of the IPPC in the context of the Uruguay
Round and the negotiation of the SPS Agreement , the FAO established a Secretariat for the IPPC in
1992, followed by the formation of the Committee of Experts on Phytosanitary Measures (CEPM) in1993.  Negotiations for amendments to the IPPC, in order to reflect contemporary changes,
particularly in light of the SPS Agreement , started in 1995 and were finalized in 1997 when the FAO
Conference adopted the New Revised Text of the IPPC.  The New Revised Text makes provision forWT/DS245/R
Page 7
the formation of a Commission on Phytosanitary Measures.  The amended IPPC will come into force
upon ratification by two thirds of its contracting parties.
2.23 The purpose of the IPPC is to secure common and effective action to prevent the spread and
introduction of pests of plants and plant products, and to promote appropriate measures for their
control.  An important role of the IPPC is that of  developing International Standards for Phytosanitary
Measures (ISPM).  National plant protection organiza tions or regional plant protection organizations
may submit draft standards to the Secretariat of the IPPC.  These drafts are reviewed, edited, and
referred by the Secretariat to the CEPM.  Alternatively, the IPPC Secretariat may form an
international working group or enlist experts to help draft a standard.  The CEPM considers the
proposals and recommends action.  ISPMs are adopted by the Interim Commission on Phytosantiary
Measures following a procedure that includes country consultation.
2. International standards for phytosanitary measures (ISPMs)
2.24 Two ISPMs that have been referred to in this dispute are ISPM 2 on Guidelines for Pest Risk
Analysis, adopted in 1996, and ISPM 11 on Pest Risk Analysis for Quarantine Pests, adopted in
2001.15
2.25 ISPM 2 provides general guidelines for pest risk analysis (PRA) whereas ISPM 11 establishes
guidelines for conducting a risk analysis for quarantine  pests.16  The former does not replace the
latter, therefore they have been designated by the IPPC as different  international standards.  However,
the two standards are related and present the same general framework for conducting a pest risk
assessment, although ISPM 11 outlines the analytical items in greater detail than ISPM 2.
2.26 Both ISPM 2 and ISPM 11 describe the PRA process as consisting of three stages.  Stage one
involves (a) the identification of a pathway, usually an imported product, that may allow the
introduction and/or spread of quarantine pests, and (b) the identification of a pest that may qualify as aquarantine pest.  Stage two considers the identified pests individually and examines, for each one,
whether the criteria for quarantine pest status are satisfied, that is, that the pest is of "potential
economic importance to the area endangered thereby and not yet present there, or present but not
widely distributed and being officially controlled".  Based on the information gathered under stages
one and two, stage three determines the appropriate phytosanitary measure(s) to be adopted.  Thethree stages are summarized in both PRA Guidelin es as:  "initiating the process for analysing risk",
"assessing pest risk" and "managing pest risk", respectively.
2.27 In ISPM 2, the process for pest risk assessment is broadly divided into five interrelated steps:
consideration of geographical and regulatory criteria;  economic importance criteria;  spread potential
after establishment;  potential economic importance;  and introduction potential.  The 1996 guidelines
provide a partial checklist of factors that might affect entry and establishment of a pest.
2.28 In ISPM 11, the process for pest risk assessment is set out in more detail.  The PRA process
can be broadly divided into three interrelated steps:  pest categorization,  assessment of the probability
of introduction and spread, and an assessment of potential economic consequences (including
environmental impacts).  Pest introduction is comprised of both entry and establishment.  Assessing
the probability of introduction requires an analysis of each of the pathways with which a pest may be
associated from its origin to its establishment in  the PRA area.  The 2001 guidelines identify the
                                                     
15 International Standard for Phytosanitary Measures  No.2:  Guidelines for Pest Risk Analysis , FAO,
Rome 1996 (Exhibit JPN-30), and International Standard for Phytosanitary Measures  No.11:  Pest Risk
Analysis for Quarantine Pests , FAO, Rome 2001 (Exhibit USA-15).
16 The IPPC defines a quarantine pest as:  a pest of potential economic importance to the area
endangered thereby and not yet present there, or present but not widely distributed and being officiallycontrolled.  International Standards for Phytosanitary Measures No.5:  Glossary of Phytosanitary Terms , p.14,
FAO, Rome 2002.WT/DS245/R
Page 8
following broad issues which should be considered and provides detailed guidance under each
heading:
(a) Probability of the pest being associated with the pathway at origin;
(b) probability of survival during transport or storage;
(c) probability of pest surviving existing pest management procedures;
(d) probability of transfer to a suitable host;
(e) probability of establishment;
(f) availability of suitable hosts, alternate hosts and vectors in the PRA area;
(g) suitability of environment;
(h) cultural practices and control measures;
(i) other characteristics of the pest affecting the probability of establishment;  and
(j) probability of spread after establishment.
2.29 ISPM 2 states that pest risk management should be proportional to the risk identified in the
assessment of risk.  Pest risk management options identified in the 1996 guidelines are:
(a) Inclusion in list of prohibited pests;
(b) phytosanitary inspection and certification prior to export;
(c) definition of requirements to be satisfied before export (e.g. treatment, origin from
pest-free area, growing season inspection, certification scheme);
(d) inspection at entry;
(e) treatment at point of entry, inspection station or, if appropriate, at place of
destination;
(f) detention in post-entry quarantine;
(g) post-entry measures (restrictions on use of product, control measures);  and
(h) prohibition of entry of specific products from specific origins.
2.30 Pest risk management options may also concer n ways of reducing risk of damage.  ISPM 2
states that the efficacy and impact of the various options in reducing risk to an acceptable level should
be evaluated in terms of the following factors:
(a) Biological effectiveness;
(b) cost/benefit of implementation;
(c) impact on existing regulations;
(d) commercial impact;WT/DS245/R
Page 9
(e) social impact;
(f) phytosanitary policy considerations;
(g) time to implement a new regulation;
(h) efficacy of option against other quarantine pests;  and
(i) environmental impact.
2.31 ISPM 11 identifies risk management options in more detail.  The 2001 guidelines specifically
state that zero-risk is not a reasonable option, and that the guiding principle for risk management
should be to manage risk to achieve the required degree of safety that can be justified and is feasible
within the limits of available options and resources.  As such, pest risk management (in the analytical
sense) is the process of identifying ways to react to a perceived risk, evaluating the efficacy of these
actions, and identifying the most appropriate options.  The uncertainties noted in the assessments of
economic consequences and probability of introduction should also be considered and included in the
selection of a pest management option.17  The ISPM lists examples of measures classified into broad
categories that relate to the pest status of the pathway in the country of origin. These include
measures:
(a) Applied to the consignment;
(b) applied to prevent or reduce original infestation in the crop;
(c) to ensure the area or place or site of production or crop is free from the pest;
(d) for other types of pathways (such as to curb natural spread);
(e) within the importing country;
(f) concerning the prohibition of commodities;  and
(g) phytosanitary certificates and other compliance measures.
2.32 Another ISPM referred to by Japan in this dispute was ISPM 10 on Requirements for the
Establishment of Pest Free Places of Production and Pest Free Production Sites.18
III. CLAIMS OF THE PARTIES
3.1 The United States  claimed that Japan prohibited the importation of apple fruit unless such
apples were produced, treated, and imported in accordance with Japan’s highly-restrictive fire blight
measures.  The United States did not question that fire blight was a plant disease of serious biologicaland economic consequences nor Japan’s right to enact measures to protect against the risks arising
from transmission of fire blight disease within its territory.  However, the United States claimed that
Japan’s measures on the importation of apple fruit were not consistent with Japan’s obligations under
the SPS Agreement  in that:
• Japan had failed to ensure that its fire  blight measures were not maintained
without sufficient scientific evidence and these measures were therefore
inconsistent with Article 2.2 of the SPS Agreement;
                                                     
17 Op. cit., ISPM 11, para 3.
18 International Standard for Phytosanitary Measures  No.10 : Requirements for the Establishment of
Pest Free Places of Production and Pest Free Production Sites , FAO, Rome 1999 (Exhibit JPN-24).WT/DS245/R
Page 10
• Japan had failed to ensure that its fi re blight measures were based on an
assessment of the risks to plant life or health and therefore these measures wereinconsistent with Article 5.1 of the SPS Agreement;
• In its assessment of risks, Japan had failed to take into account available scientific
evidence, relevant ecological and envi ronmental conditions, and quarantine or
other treatment and therefore had acted inco nsistently with Article 5.2 of the SPS
Agreement;
• Japan had failed to ensure that its fire  blight measures were not more trade-
restrictive than required to achieve its appropriate level of phytosanitary protection,taking into account technical and economic feasibility, and these measures were
therefore inconsistent with Article 5.6 of the SPS Agreement;
• Japan had failed to notify changes in and information on its fire blight measures
and therefore had acted inconsistently with Article 7 and Annex B of the SPS
Agreement.
The United States further claimed that Japan had acted inconsistently with its obligations under
Article XI of GATT 1994 and under Article 4.2 of the Agreement on Agriculture.   
3.2 Japan  argued that the United States had not established a prima facie case in respect of the
claims it had made.  Japan  claimed its measure was fully consistent with Articles 2.2, 5.1, 5.2, 5.6, 7,
and Annex B of the SPS Agreement , Article XI of GATT of 1994, and Article 4.2 of the Agreement
on Agriculture.  Alternatively, Japan claimed that the measure was a provisional measure in
conformity with Article 5.7 of the SPS Agreement  and was otherwise consistent with Articles 5.1, 5.2,
5.6, 7, and Annex B of the SPS Agreement , Article XI of GATT of 1994, and Article 4.2 of the
Agreement on Agriculture.
IV. ARGUMENTS OF THE PARTIES
A. 
THE SCOPE OF THE DISPUTE
1. Relevant provisions
4.1 Japan  observed that in the request for the establishment of a panel, the United States made
claims additional to those that it had set out in the request for consultations on Japan's measures on the
importation of apples.19  The additional claims of inconsistency concerned Article 5.5 of the SPS
Agreement  and Article 4.2 of the Agreement on Agriculture.  Japan noted that no bilateral
consultation had taken place in respect of Article 4.2 of the Agreement on Agriculture or Article 5.5of the SPS Agreement .  Article 4.5 of the DSU expressly provides that Members should attempt to
obtain satisfactory adjustment before resorting to further action.  Since the United States had made no
attempt to discuss these two provisions with Japan, and further, the United States had not made any
claim under these provisions in its written submi ssions, Japan asked that these provisions not be
included in the terms of reference for the Panel and that they be removed from the scope of theproceedings of the Panel.
20
4.2 The United States  argued that there was no requirement in the DSU to consult on a particular
claim in order to include that claim in a Panel request and to have such a claim form part of the
Panel’s terms of reference.  The purpose of consultations was to provide a better understanding of the
facts and circumstances of a dispute;  logically, then, a party might identify new claims in the course
                                                     
19 WT/DS245/2 and WT/DS245/1, respectively.
20 Letter to the Panel from Japan, 6 June 2002.WT/DS245/R
Page 11
of consultations.21  The United States further noted that the Panel had been established by the DSB
with standard terms of reference pursuant to DSU Article 7.1.  Both Article 4.2 of the Agreement on
Agriculture and Article 5.5 of the SPS Agreement  were named in the US panel request and both were
within the Panel’s terms of reference.  As the Panel was not able to alter its terms of reference, there
was no basis for Japan’s request to "remove" them from the scope of the proceedings.
4.3 In its first submission, Japan  argued that the United States had failed to substantiate its
claims under Article XI of GATT 1994, Article 4.2 of the Agreement on Agriculture and Articles 2.3,
5.3, 5.5, 6.1 or 6.2 of the SPS Agreement .  It requested, therefore, that the Panel remove these
provisions from the scope of the proceedings.  In its second submission, Japan  noted that the United
States had raised Article XI of GATT 1994 and Ar ticle 4.2 of the Agreement on Agriculture during
the course of the first substantive meeting of the Panel, but had still failed to make a specific case on
the basis of other provisions.  As such, Japan requested that the Panel should not consider the merit of
any of the provisions that the United States had not addressed, namely, Articles 2.3, 5.3, 5.5, 6.1 or6.2 of the SPS Agreement .
4.4 The United States  recalled that the Appellate Body had stated that: "[t]here is no requirement
in the DSU or in GATT practice for arguments on all claims relating to the matter referred to the DSB
to be set out in a complaining party’s first written submission to the panel".
22  Furthermore, in Chile –
Price Band System , the Appellate Body had reaffirmed that the question of whether or not a
complaining party has articulated a claim under a provision within the panel’s terms of reference
cannot be determined from the first written submission alone, but had to be examined on the basis of
the complaining party’s answers to panel questions and its rebuttal submission.23
4.5 The United States further noted that the European Communities had raised concerns whether
or not the United States had presented a prima facie case that Japan had violated certain provisions notcovered in the US first written submission, and that by that not stating all its claims in a first written
submission the United States could prevent the respondent from using all stages of the panel
proceeding to defend itself.
24  As the European Communities acknowledged, there is no requirement
in the DSU that a complaining party set out its arguments on all of its claims in its first written
submission.  Hence the United States argued that the Panel should defer its examination of whetherarguments had been made and whether these arguments were sufficient to satisfy a prima facie case
until the conclusion of all submissions.  Furthermore, there would be no prejudice to a respondent's
rights of defence so long as the complainant's arguments were made clear in the course of the
proceedings and the responding party was given sufficient opportunity to respond.  The United States
recalled that it had advanced argumentation in its oral statement to the Panel on Article 4.2 of the
Agreement on Agriculture and Article XI of GATT 1994, and Japan had had ample opportunity to
respond to those arguments.
25
2. Objection to submitted evidence
4.6 Japan  noted that in its first written submission, the United States included as exhibits
communications from Dr Tom van der Zwet, formerly  of the Appalachian Fruit Research Station in
West Virginia, and a letter by Professor Sherman Thomson of Utah State University.26  T h e
declaration by Dr van der Zwet and the letter of Professor Thomson contained clarifications as to ascientific paper they had jointly published in 1990 entitled "Population of Erwinia amylovora  on
                                                     
21 Reply of the United States to the Request by Japan for Preliminary Rulings, 16 October 2002.
22 Appellate Body Report in EC – Bananas III , para. 145;  also Appellate Body Report in Chile – Price
Band System,  para. 158.
23 Appellate Body Report in  Chile – Price Band System , paras. 154-57, 159-62.
24 Oral Statement of the European Communities in the Panel meeting with third parties, paras. 3-6.
25 Letter from the United States to the Panel on Arguments raised by Australia and the European
Communities, 1 November 2002.
26 Exhibits USA-18 and USA-19, respectively.WT/DS245/R
Page 12
External and Internal Apple Fruit Tissues".27  Japan stated that it had seen these pieces of evidence for
the first time in the US first submission.  Efforts to collect new scientific evidence should, first and
foremost, be made for the purpose of resolution of the matter through good faith consultations, if
necessary, under GATT Articles XXI I and XXIII, and Article 4 of the DSU.  Japan maintained that
the United States should have, and could have, made efforts to obtain and share these pieces ofevidence prior to the bilateral consultations, rather th an seeking to clarify the scientific evidence after
completion of the bilateral consultations.  In its view, the United States should have shared this
information, at the latest, during the Article 4 DSU consultations held on 18 April 2002.  In light of
these serious procedural and substantive flaws, Japan requested the Panel to remove the two
communications from the proceedings.
4.7 The United States  noted that the 60-day consultation period ended on 30 April 2002 and that
it had requested the establishment of a panel on 7 May 2002, whereas the declaration of Dr van derZwet was dated 16 July 2002, and the letter of Professor Thomson was dated 23 August 2002. Japan
had been made aware of the content of these communications as of the US first submission.  Japan's
contention that it would be denied an opportunity to settle the matter in good faith through bilateral
consultations should the Panel utilize these communications in its findings was erroneous. The dispute
settlement procedures envisioned the development of mutually satisfactory solutions at any stageduring a dispute;  that opportunity remained open to Japan, should it choose to pursue it.
28
4.8 The United States further argued that Australia’s suggestion that the defending party had to be
allowed the opportunity to reassess risk if the complaining party learnt of new scientific evidence
would upset the balance of rights and obligations  of WTO Members under the covered agreements.29
Nothing in the SPS Agreement  required that the United States, which had unsuccessfully pursued
cooperate efforts to obtain a relaxation of Japan’s fire blight measures, had to forego dispute
settlement when Japan was not in compliance with its WTO obligations.  Furthermore, nothing
prevented Japan from reassessing the risk pursuant to Article 5 of the SPS Agreement  in light of the
scientific evidence provided by Drs van der Zwet and Thomson.  Japan was familiar with the 1990
paper by van der Zwet et al., and aware of its ambiguities and inconsistencies.  Nonetheless, Japan
had not sought to clarify issues with the authors in the 12 years since the paper had been published.  It
was Japan that "should have, and could have, obtained" clarification of the 1990 paper long before
because of Japan’s obligation under Article 2.2 of the SPS Agreement  to ensure that its measure was
not maintained without sufficient scientific evidence, but Japan appeared to have been relying on an
inaccurate reading of the 1990 paper as a basis for its fire blight measures.
4.9 In Japan's  view, due process required that an expert’s opinion be subjected to cross-
examination;  this was of paramount importance when  the opinion related to the central issue of the
dispute.  Since the WTO dispute settlement proced ure was not designed to hear witnesses, however,
the parties and the Panel relied on documentary eviden ce.  In order to ensure objectivity, an implicit
assumption of the dispute resolution process was that parties should not introduce evidence in an
unfair manner. Moreover, while the United States insisted that Japan should have inquired with the
authors of van der Zwet et al. (1990) for clarification, Japan was not in a position to do so because the
conclusion of the article clearly indicated potential E. amylovora inside mature, symptomless apple
fruit.
4.10 The United States  recalled that the Panel’s working procedures required the parties to
"submit all factual evidence to the Panel no later than during the first substantive meeting, except with
respect to evidence necessary for purposes of rebuttals or answers to questions".30  The United States
                                                     
27 T. van der Zwet et al.  (1990) "Population of Erwinia amylovora  on External and Internal Apple Fruit
Tissues", Plant Disease 74, pp. 711-16 (Exhibit JPN-7, Exhibit USA-17).
28  DSU, Article 3.7.
29 Oral statement of Australia in the Panel meeting with third parties, para. 10.
30 Panel Working Procedures, para. 11, 5 August 2002, Annex 1.WT/DS245/R
Page 13
had complied with these procedures.  The working procedures and the DSU also provided Japan with
ample opportunity to comment on these two communi cations contained in the US first submission.
Furthermore, the United States argued that the Panel itself  was charged under Article 11 of the DSU
with making an "objective assessment of the matter".  Thus, the Panel could weigh the evidentiary
value of these communications in light of the original 1990 paper, comments by Japan, and the expert
advice provided by the scientific experts consulted by the Panel.
4.11 Japan  contended that fairness in this case required that the findings of an already published
paper should be revised or qualified only by another published paper.  Furthermore, the United States
had admitted in the first substantive meeting of the Panel that the US Government had drafted the
communications first.  As such, the letters focused only on what the United States wanted the authors
to state and there was no assurance of the objectivity of these unpublished, private  communications.
These documents only indicated to what extent the authors were prepared to support the US
Government and scientific objectivity could never be achieved by reading these documents.
4.12 The United States  explained that it had contacted Dr van der Zwet and posed specific
questions to him by telephone and e-mail communications.  His oral answers had been recorded in
writing, and returned to Dr van der Zwet, asking for his review.  Dr van der Zwet had made changes
to further clarify his answers, and had agreed that his answers could be made public.  The United
States had submitted specific questions to Professor Thomson by e-mail.  Dr Thomson had agreed thathis answers could be made public.  The resp ective author had signed each document.
4.13 The United States noted, furthermore, that Japan itself did not practice the purported
evidentiary rule mandated by "due process" and "fairness".  Japan had also presented unpublished
evidence, which had not been subjected to any cross-examination."
31  The United States did not object
to Japan’s introduction of previously unpublished evidence in its first written submission, and wasexamining this evidence.
4.14 Japan  was concerned by the US rejection of the notion of procedural fairness and objectivity
in the dispute settlement process.  Procedural fairness had paramount importance in any dispute and
genuine concerns had been expressed in this case, as demonstrated by the third party submission of
the European Communities.  In this context, Japa n stated that it was prepared to withdraw the
unpublished evidence that it had cited in its first submission
.  Japan emphasized that scientific
information which had not been available or accessible to Japan could not be taken into consideration
for determining whether or not the scientific evidence underlying its measure was sufficient under
Article 2.2, as the European Communities and Australia pointed out in their oral statements at the
third party meeting.
4.15 In a letter to the parties on 15 January 2003, the Panel  referred to Japan's request for a
preliminary ruling concerning the admissibility of  the declaration from Dr van der Zwet (USA-18)
and the letter from Professor Thomson (USA-19) submitted by the United States with its first written
submission.32  The Panel noted that, as a matter of principle, the parties were entitled to submit
evidence in support of their arguments.  Having considered the arguments of the parties, the Panel
was not convinced that, in this particular instance, it should exclude the aforementioned exhibits from
the proceedings  a priori .  This decision was without prejudice to the weight, if any, that the Panel
might ultimately ascribe to these documents, including in light of Japan's comments.
                                                     
31 "Communication" of Dr J.P. Paulin to Biosecurity Australia as reported in Australia’s "Draft Import
Risk Analysis on the Importation of Apples ( Malus x domestica  Borkh) from New Zealand"; (First Written
Submission of Japan, para. 124); reference for economic losses from fire blight outbreak in Melbourne,Australia, based on unpublished, anonymous "personal communication" (Exhibit JPN-10, para. 25);
unpublished, anonymous paper entitled "Verification of Roberts et al.  (1998) for pr obability of introduction and
establishment of Erwinia amylovora" (Exhibit JPN-16);  and unpublished, anonymous document entitled
"Occurrence Level of Fire Blight in 2000 When the Japan-U.S. Joint Experiment was Carried Out" (ExhibitJPN-33).
32 Panel letter to the Parties, 15 January 2003.WT/DS245/R
Page 14
4.16 Subsequent to the Panel’s ruling, Japan  requested that the Panel take fully into consideration
its position on this matter, and the question of how these exhibits had been obtained, when
determining what weight, if any, should be given to them.  Japan contended that the weight given to
these exhibits should be, at best, "negligible".
B. THE MEASURE (OR MEASURES ) AT ISSUE
4.17 The United States  observed that Japan prohibited the importation of US apples unless they
were produced, harvested and imported according to Japan's fire blight restrictions.  Japan currently
imposed nine requirements (related to fire blight) that had to be satisfied in order to import US
apples.33  All nine of these requirements had to be met before imports were permitted.  The United
States contended that Japan's prohibition on imports of US apples unless all of these requirements had
been met was inconsistent with Japan's obligations.  Moreover, each of the requirements could be
considered a separate phytosanitary measure within the meaning of the SPS Agreement .  As defined in
Annex A (and as relevant to this dispute), an SPS measure was "[a]ny measure applied ... to protect ...
plant life or health from risks arising from the entry, establishment or spread of pests, diseases, ... or
disease-causing organisms" and such "measures include all relevant laws, decrees, regulations,
requirements and procedures including, inter alia , end product criteria; processes and production
methods; testing, inspection, certification and approval procedures; [and] quarantine requirements".34
Thus, each of the nine requirements and procedures necessary for importation of US apples was a
phytosanitary measure, and each requirement was inconsistent with Japan’s obligations under
Article 2.2 of the SPS Agreement .
4.18 The United States indicated that it did not contest that fire blight was a plant disease of
serious biological and economic consequences, and it recognized Japan’s right to enact measures toprotect against the risks arising from transmission of fire blight disease within its territory.  However,
the United States argued that Japan could not restrict the importation of apples without scientific
evidence that exported apples could transmit the disease.
4.19 Japan  described its requirements on US apples as a "systemic approach"
35 comprised of
measures at various stages which extended from blossom to shipment.  The "systemic approach" as awhole was the minimum necessary set of requirements to achieve Japan's appropriate level of
protection.  Although the requirements were technically independent, they were inseparable and
integral parts of a single "measure".  Some of the components were interrelated.  For example, the
inspection and buffer zone requirements were necessary to ensure that the requirement of a disease-
free orchard was met.  The certification and confirmation requirements were logical procedural steps
to ensure that the other requirements had been met.  For these reasons, Japan argued that its
requirements should be considered as one measure, necessary to protect Japan from fire blight.
4.20 Japan argued that since the degree of prevalence of the disease at production sites, the States
of Washington and Oregon, varied from year to year, preventive measures should be such that would
provide security even during severe outbreaks, in order to effectively prevent the introduction of fire
blight into Japan.
4.21 The United States  claimed that each of Japan's fire blight restrictions (or requirements) could
be considered to be maintained without sufficient scientific evidence because there was no scientific
evidence that harvested, mature US apples, the exported commodity, could serve as a pathway for
introduction of fire blight to Japan.  Where there was not scientific evidence that each and every step
in any hypothetical pathway would be completed, there was no scientific evidence that the pathway
would be completed and that exported apple fruit could serve to introduce the disease to Japan.  The
                                                     
33Answers of the United States to Additional Questions from the Panel, 28 January 2003, para. 1.
34 SPS Agreement , Annex A, para. 1.
35 More usually referred to as a "systems approach".WT/DS245/R
Page 15
imposition of any of the Japanese fire blight restrictions (or requirements) on such apple fruit was
therefore inconsistent with Japan's obligations under Article 2.2 because there was not "sufficient
scientific evidence" to support any measure other than restricting importation to the exported
commodity.
4.22 Japan  countered that Article 2.2 of the SPS Agreement  provided "Members shall ensure that
any … phytosanitary measure … is not maintained without sufficient scientific evidence …"Therefore, it was the measure, not each step of the pathway, that had to be supported by scientific
evidence.  Japan nevertheless recalled that it had submitted relevant scientific evidence included in
scientific literature, international standards and SPS measures of other Members, for each component
of the measure in question.
4.23 The United States  responded that it did not agree that the legal requirement of "sufficient
scientific evidence" under Article 2.2 related to "each step of the pathway" identified by Japan rather
than to Japan’s fire blight measures.  However, for Japan to maintain any fire blight measure onimported US apple fruit consistent with Article 2.2, and for Japan to base any fire blight measures on
imported US apple fruit on an assessment of risks within the meaning of Article 5.1 and Annex A, the
imported commodity had to pose a risk to plant life or health within Japan; there had to be a
probability or likelihood of introduction of fire blight via that imported commodity.
4.24 The United States contended that the scientific experts had confirmed that there was no
scientific evidence that trade in apple fruit had ever spread fire blight.  The experts also confirmed,
through their answers to specific questions on the content of the scientific evidence, that there was no
scientific evidence that any hypothetical pathway via the imported commodity would be completed
because there was no evidence that at least one step in each such hypothetical pathway would be
completed.  Thus, there was no probability or likelihood of introduction of fire blight via imported USapple fruit, and such fruit did not pose a risk to plant life or health within Japan.
1. Fire blight status of Japan
4.25 The United States  noted that Japan claimed to be free of fire blight, despite scientific reports
in the Japanese literature that documented the occurrence and identification of the pathogen in Japan.
Despite substantial evidence to the contrary, for the purposes of this dispute the United States was
prepared to assume that Japan was, as it claimed, free of fire blight and fire blight bacteria.
4.26 Japan  did not dispute that reports of fire blight disease in Japan had been made periodically
since the start of the twentieth century.  However, these reports were considered unreliable by later
studies, and the prevailing academic view did not support the conclusions of these earlier studies.
36
Japan further maintained that had the earlier discoveries been of fire blight, the disease – given itsknown propagation ability - would by now have spread  throughout Japan.  Japan also indicated that a
plant pathogenic bacterium closely related to E. amylovora was reported in the 1990s to cause a fire
blight-like disease of pear on Hokkaido.  The disease, bacterial shoot blight of pear, had been
eradicated from Hokkaido after a five-year programme in the early 1990s.
2. History of the dispute
4.27 The United States  indicated that it had first requested market access for apples in
November 1982.  It had provided Japan with scientific evidence that fire blight was not transmitted onapple fruit as early as 1983.
37
                                                     
36 A. Mizuno et al. (2002, original in Japanese), "Examination of Alleged Occurrence of Fire Blight in
Japan", Research Bulletin of the Plant Protection Service Japan 39, (Exhibit JPN-13).
37 Chronology of US Efforts to Resolve the Dispute Bilaterally (Exhibit USA-1).WT/DS245/R
Page 16
4.28 Japan  noted that its Plant Protection Law of May 1950 and its Enforcement Regulation of
June 1950 prohibited the import of host plants of 15 quarantine pests, including fire blight bacteria
and pests of rice plant not found in Japan.  Japan could decide, on a case-by-case basis, to lift the
import prohibition with respect to plants and products on the basis of an alternative measure proposed
by the government of a supplying country, if the level of protection provided by the alternativemeasure was equivalent to the import prohibition.  The exporting government bore the burden of
proving that the proposed measure achieved the required level of protection.  The current
phytosanitary requirements were one such "alternative measure" proposed by the United States.  In
April 1991, the United States first proposed a set of phytosanitary measures for consideration by
Japan, and submitted a subsequent proposal in March 1994.  On the basis of these proposals, and
through subsequent bilateral discussions between the phytosanitary authorities, on 22 August 1994
Japan adopted the present phytosanitary requirements for fire blight required for importation of applesfrom the United States.  These requirements constituted the measure in dispute.
4.29 The United States  noted that New Zealand had also sought the lifting of Japan's prohibition
on the importation of apples linked to fire blight.  New Zealand’s efforts had resulted in a bilateral
agreement which predated that of the United States with Japan, and which contained the present
restrictions.  The United States had acquiesced to the fire blight measures imposed by Japan in 1994as an alternative to an outright ban on imported apple fruit.  However, the United States maintained
that it had accepted these measures reluctantly, recognizing that the scientific evidence did not support
the restrictions.   The United States argued that it had subsequently undertaken an active, prolonged,
good-faith effort to work with Japan to resolve the dispute on a technical level.  This included
presenting and explaining at numerous bilateral meetings the scientific evidence that mature applefruit were not a pathway for fire blight to Japan and proposing alternative measures for Japan’s
consideration.  The United States had even conducted joint research with Japan in 2000, even though
it was aware that this research duplicated numerous previous scientific studies that had evaluated the
incidence of endophytic and epiphytic bacteria on, or in, mature apple fruit.
4.30 Japan  argued that the United States had created confusion by submitting inconsistent
proposals, and had not presented convincing new evidence sufficient to justify any relaxation in
Japan's phytosanitary measure.
4.31 Japan indicated that the table below chronicled the bilateral contacts and proposals made by
both parties in relation to Japan's phytosanitary measure.WT/DS245/R
Page 17
Table - Bilateral Contacts and Proposals between the United States and Japan
regarding Fire Blight-Related Restrictions on Apple Fruit, 1995-2002
Date Proposal
February 1995 US proposal to narrow the width of the buffer zone from 500 meters
to 400 meters.
November 1996 US proposal (1) to narrow the width of the buffer zone to 10 meters,
(2) to reduce the number of site inspection routines from three to oneonly at the harvest time, and (3) continued chlorine treatment.  Japan
rejected the US proposal in December 1996.
September 1998 US proposal to (1) abolish the buffer zone requirement and (2) relax
site inspection routines from three times to one harvest inspection,
and (3) presentation of new evidence by Roberts et al . (1998).38
Japan did not accept the methods and results of the Roberts study, nor
the US proposal.
August 1999 US proposal (1) a 10-meter wide buffer zone, (2) inspection once at
harvest time, and (3) exportation only from orchards where the rate of
fire blight occurrence was not over 1%, except for apples from
infected trees and the 10-meter area surrounding them.
October 1999 Japan proposed a joint study with the US of two experiments, one on
the width of the buffer zone and the other on the number of
inspections.
April to December2000Joint US-Japanese experiments in Washington State during the 2000
growing season.
February 2001 US communicated to Japan the results of the joint experiments.
Japan stated that, inter alia , the experiment on the width of the buffer
zone was insufficient because it had failed to generate scientific
evidence indicating the level of risk during seasons of severe fire
blight outbreaks.  The inspection routines experiment had not beenperformed as per Japan’s proposal, as the United States was unable to
find suitable orchards for the experiment.  The United States had
instead designed and performed an experiment using artificially
inoculated apple twigs.
October 2001 Bilateral meeting, but no agreem ent as to how to evaluate the results
of the 2000 experiment.  Japan requested the United States to provide
additional information on five supplementary issues.
March 2002 US request for consultations under the DSU with respect to Japan's
apple import restrictions.
                                                     
38 R.G. Roberts et al.  (1998), "The potential for spread of Erwinia amylovora and fire blight via
commercial apple fruit; a critical review and risk assessment", Crop Protection 17,  pp. 19-28  (Exhibit
JPN-5, Exhibit USA-4).WT/DS245/R
Page 18
C. APPLICATION OF THE SPS AGREEMENT
4.32 The United States  argued that Japan’s measures were phytosanitary measures as defined
by the SPS Agreement  in Annex A.
4.33 Japan  did not dispute that the measure at issue was covered by the SPS Agreement .
D. BURDEN OF PROOF
4.34 The United States  recognized that in this dispute it bore the burden of proof of
establishing that Japan's fire blight measures were:  (i) maintained without sufficient scientific
evidence;  (ii) were not based on a risk assessment appropriate to the circumstances;  (iii) were
not the least trade restrictive necessary to achieve Japan's appropriate level of protection;  and (iv)
had not been notified in accordance with Article 7 and Annex B of the SPS Agreement .  As the
scientific evidence submitted by the United States demonstrated that mature, symptomless apples
had not disseminated fire blight and did not serve as a vector for the introduction of the disease,the lack of any justification for Japan's measure was evident.  The United States believed that it
had met its burden of proof under the SPS Agreement .
4.35 Japan  considered the issue of the burden of proof - who bore it and how - was central to
determine whether or not the scientific evidence underlying Japan’s measure was "sufficient"
under Article 2.2.  In its first submission, the United States had attempted to demonstrate"insufficiency" with information contradicting Japan’s scientific evidence.  The submission of
contradictory information did not by itself demonstrate that Japan’s scientific evidence was
insufficient. It only implied that there were various conditions that affected the presence or
absence of the bacteria in the fruit, and that the risk of dissemination might not manifest itself
under certain conditions. Unless those conditions were clearly established, Japan could not knowwhen mature, symptomless apples were safe.  The studies the United States cited merely
demonstrated that risks might not be present in certain, limited circumstances, not that the risk
may never be present or that risk management was unnecessary.
4.36 Japan  argued that the proof required of a complaining party was that the defendant’s
scientific evidence for the perception, identification and evaluation of the risk was conclusivelyrefuted, or the evidence was irrelevant to the introduction or maintenance of the risk management
measure in question.  In order for an exporting country to establish a prima facie case under
Article 2.2, it had to positively prove "insufficiency" of scientific evidence in this sense.  Japan
contended that this interpretation was consistent with the notion of judicial equity, which
emphasized the burden of proof of the United States as the party that naturally
39 possessed a large
amount of evidence on the bacteria ( E. amylovora ).  Furthermore, the objective of Japan’s
measure was to manage the risk according to its appropriate level of protection.  In order tocontrol that risk and to enable importation, Japan had to rely on the exporting country’s proposals
and cooperation, as they possessed the information required to evaluate the risk.
4.37 The United States recalled that Japan had an obligation under Article 2.2 not to maintain
a measure without sufficient scientific evidence.  The assignment of the burden of proof in
dispute settlement could not alter this obligation.  In Japan –Agricultural Products II , the United
States had argued that it would be impossible to prove that no scientific evidence supporting a
measure existed because it was impossible to prove a negative.  The Appellate Body had noted
                                                     
39 By virtue of the presence of E. amylovora  on the territory of the United States.WT/DS245/R
Page 19
that, in the context of an argument that there was no scientific evidence supporting a measure
under Article 2.2:
"[It is] sufficient . . . to raise a presumption that there are no relevant studies or
reports.  Raising [such] a presumption . . . is not an impossible burden.  The
United States could have requested Japan, pursuant to Article 5.8 of the SPS
Agreement , to provide 'an explanation of the reasons' for its varietal testing
requirement, in particular, as it applies to [several products].   Japan would, in
that case, be obliged to provide such an explanation.  The failure of Japan to
bring forward scientific studies or reports in support of its [measure] would have
been a strong indication that there are no such studies or reports.  The United
States could also have asked the Panel’s experts specific questions as to the
existence of relevant scientific studies or reports or it could have submitted to the
Panel the opinion of experts consulted by it on this issue."40
4.38 From this it was clear that while the burden of presenting facts and arguments
establishing a presumption of an absence of evidence lay with the United States, this burden was
not, in light of the nature of the obligation, a high one.  The United States had not simply brought
forward evidence that contradicted the evidence that Japan cited (although the evidence, properlyread, did significantly contradict Japan ’s reading of it).  Rather, it had brought forward scientific
evidence that:  (1) there was no scientific evidence that mature apple fruit had ever transmitted
E. amylovora  and introduced the disease;  (2) there was no scientific evidence that mature apple
fruit harvested from an orchard might be infected with E. amylovora ;  (3) there was no scientific
evidence that mature apple fruit harvested from an orchard might be endophytically contaminatedwith E. amylovora ;  and (4) there was no scientific evidence that a vector existed to transfer any
hypothetically surviving E. amylovora  on a discarded mature apple fruit within Japan to a
susceptible plant host.
4.39 The United States further observed that Japan had the same access to the scientific
evidence as any other WTO Member.  Further, Japan could not credibly fault the US creation of,and provision of, relevant scientific evidence over the course of the past 15 years.  Over that time,
the United States had conducted a comprehensive review of the fire blight literature and four
experiments, including even the repetition of a study documenting the absence of endophytic
bacteria in mature fruit, simply to obtain the evidence in the presence of Japanese scientists.  That
Japan continued to deny the affirmative scientific evidence of a lack of risk from mature apple
fruit supported a conclusion not that Japan lacked the ability to obtain evidence, but that it did not
wish to obtain it.
4.40 Japan  argued that the US arguments reflected its risk-taking approach.  The United
States had nothing to lose if fire blight were disseminated into Japan or any other country.  As
such, the US approach was not objective.  The United States would immediately recognize the
risk posed by apple fruit if it was required to guarantee that the apples would not disseminate the
disease.  Japan noted that Dr Paulin, in commenting on Australia’s draft risk assessment for fireblight, had clearly stated that the risk is "different from zero".
41  As such, one could not deny that
the risk was genuine.  Risk-taking could not be confused with objectivity.  For countries with fire
blight, the available evidence might imply too small a risk to worry about.  But for countries free
of the disease, the same evidence and the same risk could be significant.  Therefore even if some
                                                     
40 Appellate Body Report in Japan – Agricultural Products II, para. 137.
41 J.P. Paulin, Communication, Biosecurity Australia, Draft Import Risk Analysis on the
Importation of Apples ( Malus x domestica Borkh) from New Zealand (2000), (Exhibit NZL-4).WT/DS245/R
Page 20
evidence did not appear to be "sufficient" according to the "mainstream opinion", it had to be
evaluated in light of Member's right to act in a discretionary manner and to ensure its level of
protection.
4.41 Japan maintained that it’s interpretation was consistent with the Appellate Body’s ruling
in EC – Hormones on Article 5.1.  The Appellate Body had stated:
"[E]qually responsible and representative governments may act in good faith on
the basis of what, at a given time, may be a divergent opinion coming from
qualified and respected sources. By itself, this does not necessarily signal the
absence of a reasonable relationship between the SPS measure and the risk
assessment, especially where the risk involv ed is life-threatening in character and
is perceived to constitute a clear and imminent threat to public health and safety.
Determination of the presence or absence of that relationship can only be done ona case-by-case basis, after account is taken of all considerations rationally
bearing upon the issue of potential adverse health effects.
42 "
This ruling clarified that refutation by a mainstream opinion might not be enough to establish a
prima facie case under Article 5.1, which could be considered substantiation of Article 2.2.
4.42 Furthermore, Japan considered that an Arti cle 2.2 case inevitably raised issues relating to
the appropriate level of protection of the importing Member, which was also addressed in
Article 4 on equivalence.  In order to understand the SPS Agreement  in a coherent manner,
Article 2.2 had thus to be interpreted in light of Article 4.  An importing Member applied a
measure  designed to achieve its appropriate level of protection;  when an exporting Memberquestioned the sufficiency of the scientific evidence relating to this measure, the exporting
Member had to objectively demonstrate that the appropriate level of protection of the importing
Member would be achieved by an alternative SPS measure.  Otherwise, the importing Member
would be compelled to abolish the measure without any assurance of achieving its appropriate
level of protection.  As a result, the appropriate level of protection of the importing Memberwould be undermined and the object and purpose of the SPS measure to protect human, animal or
plant life or health, while promoting international trade, would not be achieved.  Therefore, Japan
argued, it could not be concluded that an exporting Member had established a prima facie case of
inconsistency with Article 2.2 when it had only shown that the risk might not exist under certain
limited circumstances.
4.43 The United States  argued that Japan had mischaracterized the relationship between
Article 2.2 and Article 4.  Article 4, which required a Member to accept a measure as equivalentto its own measure if the exporting Member objectively demonstrated that the measure achieved
the importing Member’s appropriate level of protection, presupposed that the measure imposed
by the importing Member was maintained with sufficient scientific evidence.  Article 4 could not
be read in such a way that an importing Member could escape this basic obligation under
Article 2.2.  Thus, while Article 4 could provide a particular avenue for the United States to seekrecognition of its measure as equivalent to a Japanese measure complying with Article 2.2, Japan
had to have sufficient scientific evidence to maintain its measure under Article 2.2 in the first
instance.  Japan's appropriate level of protection had no part to play in this analysis.
                                                     
42 Appellate Body Report in EC - Hormones , para. 194.WT/DS245/R
Page 21
4.44 Japan  observed that under Article 4, it would be obligated to accept apples on the basis
of the "mature, symptomless" criteria if, and only if, the United States objectively demonstrated
that Japan’s current phytosanitary requirements and the "mature, symptomless" criteria were
equivalent. If the only proof required of the Unit ed States under Article 2.2 was evidence that the
risk may not exist under certain, limited circumstances, it would be clearly inconsistent with
Article 4.  The exporting country would not have to provide evidence of equivalence, but wouldbe able to prevail by merely contradicting the importing country’s evidence.  Japan argued that
should this approach be allowed, the exporting country would always be able to amend or abolish
the SPS measure of the importing country, by supplying such non-conclusive evidence.  Such
proof evidently did not objectively demonstrate that the "mature, symptomless" criteria were the
equivalent of Japan's appropriate level of protection, which it described as equivalent to an import
prohibition.  The consequences for the importing country could be disastrous; as Japan would be
forced to accept a level of protection provided by a measure that had not been objectivelydemonstrated to be equivalent to that of its current measure and would be thus subject to a higher
level of risk.
4.45 In this connection, Japan requested the Panel to consider carefully whether the "mature,
symptomless" criteria would objectively achieve Japan’s level of protection.  This was the only
assurance of protection from fire blight that the United States argued was necessary.  If the Panelwas not convinced by the assurance of this criteria, Japan argued that the case under Article 2.2
had to be dismissed, because the burden of proof lay with the United States.
4.46 The United States  claimed that Japan was attempting to import into the analysis of the
US claim under Article 2.2, the concept of the appropriate level of protection from Article 5.6.  A
Member's appropriate level of protection formed an integral part of its commitments underArticle 5.6 to ensure that any phytosanitary measure was no more trade-restrictive than required,
taking into account technical and economic feasibility, to achieve its appropriate level of
protection.  As a result, in dispute settlement cases, a complaining Member could make a prima
facie case by showing, inter alia , that an alternative measure achieved the importing Member's
appropriate level of protection.  In this case, there was no basis for importing this concept into theUS claim under Article 2.2 that Japan's fire blight measures were maintained without sufficient
scientific evidence.
4.47 The United States argued that, to make its prima facie showing, it may demonstrate that
there was no "rational or objective relationship" between the SPS measure imposed on the
exported commodity and the scientific evidence of a risk to plant life or health within Japan posed
by such commodity.  The United States had satisfied its burden by demonstrating (as confirmed
by the scientific experts) that there was no scientific evidence that the exported commodity(harvested, mature apple fruit) posed a risk to plant life or health within Japan.  Japan’s
appropriate level of protection played no part in this analysis.
E. A
RTICLE 2.2
1. General
4.48 The United States  argued that the Japanese fire blight measures were inconsistent with
Article 2.2 of the SPS Agreement  because they were maintained without sufficient scientific
evidence. The obligation not to maintain an SPS measure "without sufficient scientific evidence"
had been at the centre of the Japan – Agricultural Products II  dispute.43  Both the Panel and
                                                     
43 Panel report and Appellate Body Report in Japan – Agricultural Products II.WT/DS245/R
Page 22
Appellate Body had read this phrase in light of the ordinary meaning of the word "sufficient" ("of
a quantity, extent, or scope adequate to a certain purpose or object"), and in the context of
Article 5.1 (there must be a rational relationship between a risk assessment and an SPS measure),
Article 3.3 (a scientific justification for an SPS measure exists if there is a rational relationship
between the SPS measure and available scientific evidence), and Article 5.7 (providing aqualified exemption from Article 2.2 for provisional SPS measures where "relevant" scientific
evidence is insufficient).
44   The Appellate Body had affirmed the conclusion of the Panel that the
obligation in Article 2.2 not to maintain an SPS measure "without sufficient scientific evidence"
required that "there be a rational or objective relationship between the SPS measure and the
scientific evidence".  Furthermore, "[w]hether there is a rational relationship between an SPS
measure and the scientific evidence is to be determined on a case-by-case basis and will depend
upon the particular circumstances of the case, including the characteristics of the measure at issueand the quality and quantity of the scientific evidence."
45
4.49 The United States maintained that there was no scientific evidence of any quality that the
imported commodity - mature apple fruit - had ever transmitted the disease or was a pathway for
introduction of fire blight.46  Thus, the first and most fundamental characteristic of the fire blight
measures, their application to mature apple fruit, was not supported by any scientific evidence.To the contrary, all of the scientific evidence showed that mature, symptomless apple fruit had
never transmitted and were not a pathway for the disease.  There could be no rational or objective
relationship between the Japanese fire blight measures and the scientific evidence because the
measures were directed at a commodity for which there was no evidence of risk to plant life or
health within Japan.  Thus, there was no evidence, let alone sufficient evidence, for Japan tomaintain its fire blight measures, and Japan was acting inconsistently with Article 2.2 of the SPS
Agreement .
4.50 Japan  argued that a variety of published literature on the ecology, properties and
survivability of E. amylovora  established that the bacteria were evidently capable of long-term
survival inside, or on the surface, of what the Un ited States termed "mature, symptomless" apple
fruit. The fact that bacteria could exist and survive inside mature, symptomless apple fruit meant
that the fruit could cause fire blight symptoms later on.  For Japan, the implication was profound:
apple fruit could be contaminated and yet be found fit for exportation.  Once introduced into
Japan, fire blight would have ample potential for growth and infection and lead to major negative,
irreversible consequences.
                                                     
44 Ibid., paras. 73-80.
45 Ibid., para. 84.
46 Under US law, exported apple fruit must be of a Federal or State grade that meets a minimum
quality established by regulation.  US Export Apple Act , 7 U.S.C. §  581.  Exported US apples must
currently satisfy at least the requirements for the "U.S. No. 1" grade, 7 C.F.R. §  33.10 (minimumrequirements for export apples), pursuant to which apples must be:
"[M]ature but not overripe, carefully hand-picked, clean, fairly well-formed; free from decay,
internal browning, internal breakdown, bitter pit, Jonathan spot, scald, freezing injury . . . and broken skin
or bruises except those which are incident to proper handling and packing.  The apples are also free from
damage caused by . . . sunburn or sprayburn, limb rubs, hail, drought spots, scars, stem or calyx cracks,disease, insects, [or] damage by other means . . .  "
United States Standards for Grades of Apples , 7 C.F.R. §  51.302 (requirements for US No. 1
same as for "U.S. Fancy", except for  "color, russeting,  and invisible water core").  Individual states may
have standards that exceed the federal standards for grades.  See, e.g., Washington Administrative Code
16-403-140 ("Washington State standard apple grades for extra fancy or fancy shall be equivalent to or
better than the U.S. standards for grades of apples ....").WT/DS245/R
Page 23
4.51 Furthermore, Japan contended that the US argument raised the two questions of:  (i) the
ambiguity/subjectivity of the criteria:  and (ii) the practicality of maintaining the appropriate
quality, the very two issues crystallized through the Panel process.  When asked under which
definition of "maturity" they believed that mature apple fruit would not disseminate the disease,
Japan was of the view that the experts had not been able to respond clearly.  Moreover, Dr Geider
and Dr Smith in particular, had expressly admitted that "immature" and "mature" were not twoclearly separate phenomena and that maturation was a "continuous process".  Indeed, van der
Zwet's et al . (1990) description of apple fruit as "mature" and the later disavowal of the
description by Dr van der Zwet and Professor Thomson were clear scientific evidence that
even experienced researchers might err.  In this connection, Japan emphasized that neither
Dr van der Zwet’s declaration nor Professor Thomson’s letter clearly explained that the tested
apples had been physiologically immature.  The 1990 study thus indicated that apple fruit at
physiological maturity might still be subject to bacterial infestation/infection.  There was alsowhat Japan believed to be agreement among the experts that the "symptoms" (which must be
recognized by the human eye) would be the key indicator of the risk, and that the symptoms
might not be always detected.
4.52 In Japan’s view, each of the current requirements, such as the designation of a fire blight-
free area, the necessity and width of a buffer zone, the frequency and timing of field inspectionsand surface disinfection, were reasonably supported by scientific evidence contained in relevant
literature, similar measures taken by other countries and international standards, and there was a
"rational or objective relationship" between the measure and the evidence.
2. Nature of the scientific evidence
4.53 The United States  argued that what at times might appear to be a highly technical
dispute in fact revolved around a simple biological reality:  mature apple fruit were not part of the
disease cycle for fire blight bacteria.  As a result, there was no scientific evidence that mature
apple fruit had ever transmitted or could serve as a pathway for the fire blight disease.  As
imports of mature apple fruit did not pose a risk to plant life or health within Japan, restricting
importation of apples to mature fruit (the exported commodity) was a measure that wasreasonably available and that achieved Japan’s appropriate level of protection.
4.54 Japan  maintained that a risk generally meant a negative, stochastic event, the likelihood
of which had to be assessed on the basis of previous observations.  The United States erred
because it limited the scope of "observations" too narrowly, only to "direct" evidence establishing
a pathway.  There was nothing in the SPS Agreement  which limited the kind of evidence under
Article 2.2 only to "direct" evidence;  the Article only referred to "scientific evidence".
Moreover, in phytosanitary protection, there might not be any such "direct" evidence. Risk still
existed even though there was no "direct" evidence for any pathway and, in order to assess the
risk, the scope of investigation had to be expanded to include various "indirect" observations.
Coupled with inherent difficulties in identify ing a definite cause of the spread, it was very
unlikely that anyone would be able to uncover a piece of direct  evidence.  The risk of a pathway
needed to be assessed on the basis of indirect observations.  Discarding these pieces of indirectevidence was not scientific.
4.55 The United States  claimed that Japan had not been able to identify any scientific
evidence that imports of apple fruit posed a risk of introduction of fire blight to Japan.  Scientific
evidence that apple fruit posed a risk of introduction of fire blight to Japan could have consisted
of:  (1) evidence that fruit had, in fact, introduced the disease to other areas and;  (2) evidence that
fruit were a pathway for introduction.  On the first point, Japan had failed to identify evidenceWT/DS245/R
Page 24
that imports of apple fruit had ever transmitted E. amylovora  to a new area.  On the second point,
Japan had neither identified each step necessary for imported apple fruit to serve as a hypothetical
pathway (for example, the five steps identified by the International Plant Protection Convention)47
nor cited the scientific evidence on which it relied to establish that each step of the hypotheticalpathway would be completed.  Japan had not identified evidence establishing a likelihood thatapple fruit could introduce fire blight to Japan because there was no such evidence.  The United
States believed that the scientific experts had unanimously stated that there was no scientific
evidence that trade in apple fruit had ever been the means of introducing fire blight into a new
area.  The experts had also unanimously confirmed that there was no scientific evidence that any
hypothetical pathway would be completed.
4.56 Japan  argued that a distinction had to be made between "direct" and "indirect" scientific
evidence.  "Direct" evidence was a conclusive scientific discovery, for example that E. amylovora
and fire blight, had been transmitted via apple fruit.  "Indirect" evidence showed the ability of
contaminated apple fruit to go through each of the steps necessary for it to eventually cause fire
blight in the importing country.  If the US interpretation were correct, importing Members would
be allowed to protect only against the known, established dissemination pathways, and no other
measure could be taken.  Following this line of argumentation, Japan believed that it would bestripped of any phytosanitary protection against the disease, because the exact pathway of trans-
oceanic dissemination of the disease had not been fully established.  For example, there was no
direct  evidence establishing a pathway through "immature, symptomful" apple fruit.  It was,
however, unreasonable that Japan would be forced to accept shipments of blighted apples under
the SPS Agreement  simply because there was no "direct" evidence establishing a pathway.
4.57 The United States  claimed that the Panel should look not at whether evidence was direct
or indirect but whether it was scientific.
48  Article 2.2 of the SPS Agreement  stated that a Member
shall ensure that an SPS measure is not maintained "without sufficient scientific evidence".  The
term "scientific evidence" was not defined in the SPS Agreement  but could be interpreted
according to the ordinary meaning of the words in th eir context, in light of the object and purpose
of the Agreement.  "Evidence" was defined as "something serving as a proof".49  "Scientific" was
defined as "[o]f, pertaining to, or of the nature of science; based on, regulated by, or engaged in
the application of science . . . ; valid according to the objective principles of the scientific
method".50  The "scientific method" was defined as "a method of procedure that has characterized
natural science since the 17th Century, consisting in systematic observation, testing, and
modification of hypotheses".51  Thus, "scientific evidence" should be understood as something
serving as proof that was valid according to the objective principles of the scientific method,understood as systematic observation, testing, and modification of hypotheses.  The United States
did not assert that evidence sufficient for Japan to maintain its fire blight measures had to be
                                                     
47 Op. cit., ISPM 11, paras. 2.2.1.1-2.2.1.5.
48 The United States noted that in its First Submission it had stated: "The evidence Japan cites is
circumstantial, not direct or scientific eviden ce, and Japan makes no assessment of the relative
effectiveness of this measure on reducing the likelihood of entry or overall disease risk" when discussingthe evidence that Japan cited to support its requirement that containers for harvesting be treated withchlorine.  The United States clarified that if use of the word "direct" in this passage had led to the repeatedinvocation of "indirect" and "direct", by Japan, it regretted the imposition on the Panel’s time and would becontent to argue simply that "circumstan tial" evidence was not "scientific" evidence.
49 The New Shorter Oxford English Dictionary , vol. 1, p. 867, Oxford University Press, 1993.
50 Ibid ., p. 2717.
51 Ibid. , p. 2717.WT/DS245/R
Page 25
direct or that it may not be indirect, but under Article 2.2 such evidence had to be scientific, i.e.,
valid according to the objective principles of the scientific method.
4.58 Japan  recalled that the United States claimed that Japan’s current phytosanitary
requirements had been without sufficient scientific evidence from as early as 1994, and that Japan
had been in violation of the SPS Agreement  when the instrument entered into force in 1995.
However, the current measure had been introduced on the basis of agreement between the twogovernments, in order to allow importation of American apples, while preventing introduction of
E. amylovora with the security equivalent of import prohibition.  It was unreasonable for the
United States to now claim that the evidence was insufficient from the beginning.
4.59 The United States  observed that it had acquiesced to the fire blight measures imposed by
Japan in 1994 as preferable to an outright ban on imported apple fruit, although it had recognized
that the scientific evidence did not support the restrictions imposed by Japan.  It had never
accepted the consistency of these measures with Japan’s WTO obligations.
4.60 Japan  stated that it was only in the course of the proceeding that it had access to new
information which might warrant a new risk assessment in light of the potential insufficiency of
the previous evidence.  Sufficiency of the evidence was without question until, at the earliest, the
date of the first US submission.
4.61 The United States  noted that Australia had also argued that a complaining party may not
"claim inconsistency [with Article 2.2] on the basis that the measure is not based on sufficient
scientific evidence, if the claims relating to the sufficiency  of evidence include evidence that was
not available to the respondent party at the time of the initiation of the WTO complaint".
52
Australia had further argued that "a WTO member apprised of new scientific evidence must beallowed the opportunity to reassess the risk in terms of the relevance of the evidence to the factorsenumerated in Article 5.2 of the SPS Agreement ".  However, the United States argued that a rule
that factual evidence not available at the initiation of the dispute settlement proceeding could not
be considered by a panel would bar evidence that could be relevant to the Panel’s factual
determinations.  Australia appeared to argue that a claim that scientific evidence was insufficient
could not rest on scientific evidence produced after the claim was made.  However, the situationAustralia posited did not arise in this dispute.  The US claim that the Japanese fire blight
measures were maintained without sufficient scientific evidence did not rest or even rely on
Dr van der Zwet's declaration or Professor Thomson's letter.  Rather, Japan’s fire blight measures
were inconsistent with Article 2.2 because there had never been any scientific evidence that
mature apple fruit transmitted the fire blight disease.
4.62 Japan  claimed that of the new information the United States had sought to introduce in
this proceeding, it did not consider the document s signed by Dr van der Zwet or by Professor
Thomson to offer any serious scientific information or new evidence which would warrant a new
risk assessment.  Nor would the sufficiency of the evidence be challenged by these documents.
Japan considered that the only new pieces of evidence were Roberts (2002) and Taylor et al .
(2002).
53  In its analysis, these pieces of evidence were not yet sufficient to warrant revision of
                                                     
52 Australian Statement at the third party session with the Panel, 22 October 2002, para. 10.
53 R.G. Roberts (2002), "Evaluation of Buffer Zone Size on the Incidence of Erwinia Amylovora
in Mature Apple Fruit and Associated Phytosanitary Risk", Acta Horticulture  590: 47-53 (Exhibit USA–
16);  and R.K. Taylor et al.  (2002), "The Viability and Persistence of Erwinia amylovora  in Apples
Discarded in an Orchard Environment", 590: 153-55.  Paper at 9th International Workshop on Fire Blight,
Napier New Zealand, 8-12 October 2001 (Exhibit USA–20).WT/DS245/R
Page 26
the current phytosanitary requirements.  However, Japan invited the United States to supplement
Roberts (2002) with answers to five additional questions.  Together, they could then be
considered in a formal, new pest risk analysis to judge whether the current phytosanitary
requirements needed to be revised.
3. Transmission of the disease
4.63 The United States underlined that the scientific literature revealed no evidence that
mature, symptomless apple fruit had ever transmitted fire blight disease.  The scientific evidence
established that such fruit had never transmitted and did not play a role in the transmission of fire
blight.  According to the United States, the scie ntific experts had unanimously stated that there
was no scientific evidence that trade in apple fruit had ever been the means of introducing fire
blight into a new area.  The United States quoted a number of studies in support of this
conclusion including:
Thomson (2000): "[I]t has never been demonstrated that mature fruit are involved in
dissemination of Erwinia amylovora  and serve as a source of new infections in orchards.
It would be extremely unlikely that contaminated fruit could be responsible for
establishing new outbreaks of fire blight."54
Roberts et al.  (1998): "Using published data on the incidence of E. amylovora  on mature,
symptomless apple fruit and several conservative assumptions, we have estimated the risk
of establishing new outbreaks of fire blight in previously blight-free areas, and found this
risk to be extremely low.  We have found no evidence in the scientific literature that
apple fruit in commercial shipments, whether contaminated with E. amylovora or not,
have provided inoculum for an outbreak of fire blight."55
European and Mediterranean Plant Protection Organization (1997):  "[T]he risk of [fire
blight] transmission on fruit is considered insignificant in current trade practice."56
Thomson (1992): "The presence of E. amylovora  on or in healthy fruit has not been
shown to be a source of inoculum in fruit orchards. ... It seems very remote that
contaminated fruit could be responsible for establishing new outbreaks."57
Roberts et al.  (1989): "[H]ealthy, mature apple fruit, even when harvested from blighted
trees, are unlikely to harbour E. amylovora  populations and therefore are unlikely to pose
a phytosanitary risk to areas free from fire blight."58
                                                     
54 S.V. Thomson, Epidemiology of Fire Blight, in Fire Blight: The Disease and Its Causative
Agent, Erwinia Amylovora , at 17 (J.L. Vanneste, ed.) (2000)  (citing additional sources concluding that
fruit do not transmit the disease) (Exhibit USA- 2).
55 Op. cit., Roberts, et. al. (1998), pp. 19-28.
56 EPPO, "Data Sheet on Quarantine Pests:  Erwinia amylovora", Quarantine for Europe , at 5:
Means of Movement and Dispersal (Exhibit USA-5).  The EPPO goes on to "recommend[] countries at
high risk  to prohibit importation of host plants for planting " but does not recommend any restrictions on
importation of fruit.  (emphasis added).
57 S.V. Thomson (1992), "Fire blight of apple and pear", Plant Diseases of International
Importance , vol. 3: Diseases of Fruit Crops 32-65 (J. Kumar et al., eds.).
58 R.G. Roberts et al.  (1989)  "Evaluation of Mature Apple Fruit from Washington State for the
Presence of Erwinia amylovora", Plant Disease 73: 917-21, at 920 (Exhibit USA–28).WT/DS245/R
Page 27
Dueck (1974): "[T]he risk of disseminating fire blight bacteria on symptomless mature
apples is considered negligible."59
4.64 In the absence of any affirmative evidence, the scientific literature described the risk of
transmitting fire blight disease through mature, symptomless apple fruit as "negligible",
"unlikely", "very remote", "insignificant", "extremely low", or "extremely unlikely".  The UnitedStates noted that in describing the risk of transmission as "negligible" rather than "zero", the
scientific reports merely reflected "the uncertainty that theoretically always remains [that an event
may occur] since science can never provide absolu te certainty" that an event may never occur.
60
4.65 Japan  questioned the conclusions of the United States, stating that there was no
ecological study that was available on the possible dissemination of fire blight via apple fruit.  As
a matter of common sense, it could be easily envisaged that E. amylovora, surviving either inside
or outside apple fruit, could be transmitted to nearby host plants, either by way of rain, wind,insects, etc.  Once such fruit was introduced into Japan, the bacteria would be exposed to its
environment at all stages of distribution, storage, consumption and disposal of the fruit, causing a
real risk of dissemination.
61
4.66 Japan further argued that the scientific evidence did not document  any cause of trans-
oceanic dissemination.  The absence of evidence attributing the cause to fruit did not demonstratethat the bacteria could have been transmitted only via budwood or nursery stock.  Furthermore,
the previous experiences of long-distance, trans-oceanic dissemination showed that E. amylovora
was capable of propagating into a new environment outside of its favoured host of budwood and
nursery stock.  Put in the context of van der Zwet et al,  (1990) and Goodman (1954)
62, which
found endophytic E. amylovora in apple fruit, these two pieces of evidence reinforced each other
and suggested a risk that endophytic E. amylovora in fruit could survive trans-oceanic shipment
and later cause fire blight in foreign destinations.
4.67 With respect to the latter point, the United States  explained that the van der Zwet et al.
(1990) paper had not isolated endophytic (internal) E. amylovora  from any harvested mature
apple fruit, the exported commodity.  In fact, according to the United States, the scientific expertshad unanimously stated that there was no scientific evidence that harvested mature apple fruit
would harbour internal populations of fire blight bacteria.  The United States also argued that
Japan had ignored the subsequent conclusions of the authors of the 1990 paper to the contrary -
conclusions based not on speculation, but on reviews of the scientific literature.  Professor
Thomson had written in 1992 that:  "The presence of E. amylovora on or in healthy fruit has not
been shown to be a source of inoculum in fruit orchards.  . . . It seems very remote that
contaminated fruit could be responsible for establishing new outbreaks."  Dr van der Zwet co-authored the Roberts et al.  (1998) paper cited in paragraph 4.63 above that concluded:  "We have
                                                     
59 J. Dueck (1974), "Survival of Erwinia amylovora in association with mature apple fruit",
Canadian Journal of Plant Science 54:  pp. 349-51, at 351 (Exhibit USA–42).
60 Appellate Body Report in EC – Hormones , para. 186, Panel Report, EC – Hormones ,
paras. 8.152-8.153.  As both the Panel and the Appellate Body concluded in EC –  Hormones , theoretical
uncertainty is not the kind of risk which a risk assessment and, therefore, an SPS measure, is to address.Thus for the United States, the scientific conclusion that mature, symptomless apple fruit posed a"negligible" or "insignificant" risk of transmitting the disease reflected the scientific evidence that exportedapples had never  transmitted fire blight and were not a pathway for the disease.
61 Probability of fire blight dissemination via mature, apparently healthy apple fruit (Exhibit JPN-
14).
62 R.N. Goodman (1954), Apple fruit a source of overwintering fireblight inoculum, Plant Disease
Reporter.  38: 414.WT/DS245/R
Page 28
found no evidence in the scientific literature that apple fruit in commercial shipments, whether
contaminated with E. amylovora or not, have provided inoculum for an outbreak of fire blight."
And Professor Thomson in 2000 wrote again: "[I]t has never been demonstrated that mature fruit
are involved in dissemination of E. amylovora  and serve as a source of new infection in
orchards."63  Japan apparently rested much of its case on a conjectural statement by two authors,
both of whom had published subsequent work explicitly drawing the opposite conclusion.
4.68 Japan  recalled its contention that the United States apparently believed that any
"scientific" evidence must be "direct" evidence.  If an event occurred infrequently and was
difficult to simulate, a scientific analysis would depend on indirect or circumstantial evidence.
Trans-oceanic dissemination of fire blight was one of these infrequent phenomena.  However,
such transmission had occurred four times during the 200-year history of fire blight:  (i) from the
United States to New Zealand in 1919;  (ii) from the United States to the United Kingdom in1957;  (iii) from the United States to Egypt in 1962;  and (iv) from the mainland United States to
Hawaii in 1965.  In these cases, transmission pathways had been variously discussed, but not
definitely identified.  The observation of only four cases could not establish that the likelihood of
dissemination through apple fruit was scientifically "negligible".  The likelihood of such
dissemination had to be inferred from available, often indirect, evidence such as the knownproperties of E. amylovora and apple fruit, as well as past studies and real experiences.
4.69 The United States  countered that none of these alleged instances of dissemination
involved apple fruit.  According to the United States, the experts had unanimously stated that
there was no scientific evidence that trade in apple fruit had ever been the means of introducing
fire blight into a new area.  The experts had also agreed that the scientific evidence indicated thatthe long-range means of transmission of fire blight was through movement of infected plants.  In
the scientific literature, the introduction of fire blight to New Zealand and Egypt had been linked
to movement of infected propagative material (nursery stock) and not to trade in apple fruit.
4.70 Japan  noted that there were two incidents of trans-oceanic dissemination that did not
involve budwood or nursery stock.  The dissemination of fire blight to the United Kingdom in1957 was attributed by some literature to contamination of cargo crates by the bacteria.  The
transmission  of fire blight to Hawaii in 1965 had been attributed by one report to blighted pear
fruit.  This implied that human acts of transporting fruit over an ocean could cause dispersion of
fire blight to a distant location.  This was the exact dissemination route - albeit through different
fruit - that Japan was concerned about.  Drs van der Zwet and Thomson had clearly perceived the
risk of long-distance dissemination via fruit from these two pieces of evidence:
"[t]he positive discovery of endophytic E. amylovora from 14 apples of two
cultivars in Utah requires caution and may partially explain the observations of
fruit blight symptoms on pear shipments to Hawaii and England."
64
4.71 The United States  observed that although Japan conceded that the dissemination of fire
blight to Great Britain did not appear to be associated with apple fruit, nonetheless, Japan
believed it " impl[ies]  that human acts of transporting fruit over an ocean can cause dispersion of
fire blight to a distant location".  Japan apparently believed that the introduction had been
demonstrated to be linked to contaminated pear fruit boxes from the United States.  Taken at face
                                                     
63 S.V. Thomson (2000), "Epidemiology of Fire Blight" , in Fire Blight: The Disease and Its
Causative Agent, Erwinia amylovora , at 17  (J.L. Vanneste, ed.), (Exhibit USA-2).
64 Op. cit., van der Zwet et al.  (1990).WT/DS245/R
Page 29
value, Japan was suggesting an implication from  evidence that, Japan itself admitted, did not
relate to apple fruit.  Whether or not an implica tion could rise to the level of scientific evidence,
the implication was robbed of foundation when one examined the literature related to the spread
of fire blight to Great Britain.  The literature made clear that contamination of bins was only one
theory on the source of inoculum;  equally probable was that the disease was introduced on
infected nursery stock (Great Britain Ministry of  Agriculture, Fisheries and Food (1969), Lelliot
(1959)).  Both of these primary accounts on the introduction of fire blight to Great Britain
explicitly rejected that dissemination could be linked to fruit.  The US also argued that the experts
had noted that the suggestion in the literature that contaminated fruit crates may have been
responsible for spread of fire blight to the United Kingdom seemed to be based entirely on
circumstantial evidence.  Dr Hayward had commented that "Overall there is little evidence to
support the [Japanese] statement that the pest has a remarkable degree of survival ability outside
the favourable host of the wood".65
4.72 Furthermore, the US review of the research literature confirmed that E. amylovora  was
not, in fact, found in Hawaii.  The only reference given for Japan's assertion that fire blight was
disseminated to Hawaii was a University of California newsletter that anecdotally related an
incidence of infected Californian pear fruit arriving in Hawaii.  Despite this anecdotal report, and
in spite of the movement of other fruit to Hawaii over decades, fire blight had never beenrecorded as occurring and was not known to occur in Hawaii.  Indeed, the United States claimed
that Hawaii was an excellent example of how unrestricted trade in mature, symptomless apple
fruit did not spread fire blight.  Although a number of fire blight host plants were found in Hawaii
(as well as the bird that Japan claimed might hypothetically vector epiphytic bacteria from a
discarded fruit to a susceptible plant host), Hawaii imported about 20 million apples annuallyfrom the US mainland without any restrictions due to fire blight and there had been no
introduction of fire blight to Hawaii.
4.73 Japan  maintained that the significance of the history was unmistakable:  the bacteria had
the ability to spread not only through the fa voured, insulated medium of budwood and nursery
stock, but through other, possibly less favorable media ( inter alia , cargo crates and fruits) as well.
Japan also noted what it termed overall confirmation by the experts of the presence of a real
"risk" (which included completion of the pathway) of dissemination of the disease from apple
fruit.
4.74 The United States  argued that the scientific evidence was further borne out by real world
experience.  Although fire blight was geographically dispersed in the United States, the United
States had exported 10,505,500 metric tons of apple fruit over the last 35 years (assuming 88
apples per 42 lb. box, approximately 48.5 billion ap ples) without a single instance of fire blight
being spread through exports of US apple fruit in that time.  Indeed, billions of fruit had been
shipped world-wide without a single documented instance of fire blight transmission via exported
apple fruit.
4.75 The United States underlined that only a tiny portion of these exports were made under
conditions as stringent as those set by Japan.
66  In fact, of 66 fire blight-free countries, 58
imposed no fire blight-related restrictions on imported fruit.  Over the past 35 years, the United
States had exported 4,794,495 metric tons of ap ple fruit, or approximately 22.1 billion apples, to
ten fire blight-free markets (Chinese Taipei, Hong Kong, Indonesia, Saudi Arabia, Thailand, the
                                                     
65 Para. 6.36.
66 The United States included a Table Detailing Fire  Blight Measures on Imported Apples in Fire
Blight-Free Areas (Exhibit USA-14).WT/DS245/R
Page 30
United Arab Emirates, Malaysia, Venezuela, the Philippines, and Colombia).  None of these
markets imposed measures similar to the Japanese requirements, and none of these areas had
reported transmission of fire blight through imports of US apple fruit.  Thus, although nearly all
trade in apple fruit occurred without any restrictions for fire blight, there was no evidence that fire
blight had ever spread through exported apples.
4.76 Japan  remarked that eight of the markets identified by the United States were in tropical
regions while the other two countries (Saudi Arabia and the United Arab Emirates) were in a
desert region.  None had the temperate climate of Japan.  Moreover, with the exception of
Chinese Taipei, none of the others had any signif icant apple production.  Clearly, none had the
favourable conditions for the introduction and establishment of E. amylovora .  Furthermore,
Hawaii's climate was not as favourable to fire blight as that of Japan.  Since these US figure on
apple exports were in the order of billions, any incremental risk caused by one additional applemight be very low.  However, what was in dispute was a phytosanitary mechanism that would
possibly affect the phytosanitary quality of all of these billions of apples for years to come.  So
however minute the risk might be for one additional  apple, the risk posed by billions  of apples
would be significantly higher.
4.77 The United States  argued that Japan had provided no citation nor any explanation for its
assertion that only countries with temperate climates were at risk for introduction of fire blight.  It
appeared that several countries without temperate climates nonetheless had fire blight, including
Cyprus, Iran, Israel, Jordan, Lebanon, Egypt, Bermuda, Guatemala, and Mexico. Japan had also
not explained why only apple producti on should be relevant as to whether or not fire blight might
be introduced into an area as there were numerous other host plants for fire blight.
4.78 Japan  contended that the alleged absence of measures similar to those of Japan merely
reflected the level of protection of these markets against the risk of fire blight.  Compared to
Japan, these countries and territories had hostile environments for the propagation of fire blight,
and they could afford to have a policy more tolerant of the risk.
4.79 The United States  argued that Japan had simply assumed  that the application of different
measures reflected a lower level of protection in these countries, rather than a recognition by
these countries that their equally stringent level of protection could be met through minimal or no
SPS measures.  This assumption by Japan was not supported by citation to any correspondence,
documents, or public statements by these countries explaining their appropriate level of
protection. Furthermore, Japan had failed to address the larger point that many more billions of
apple fruit had been traded between other countries, with and without fire blight, than reflected in
US export statistics.  Nonetheless, as the United States believed the experts had unanimouslyconfirmed, there was no evidence from anywhere in the world that fire blight had been introduced
or spread through trade in apple fruit.
4.80 Japan  stated that it had ideal climatic and geographic conditions for wide-scale spread
and occurrence of fire blight.  It was rich in susceptible hosts of E. amylovora  - with commercial
production of apples and pears valued at over 100 billion yen (more than US$800 million)annually and significant populations of horticultural hosts such as hawthorn, firethorn and
mountain ash in both urban and rural areas.  Japa n's temperate warm and humid climate would be
hospitable for the bacteria and Japan believed that the consequences of fire blight entry would be
recurrent and irreversible.  It would be virtually impossible to eradicate the disease once it was
hosted in Japan’s hospitable environment.  The economic damage reported from fire blightoutbreaks in other parts of the world would be more severe in Japan because of its hostWT/DS245/R
Page 31
populations and temperate climate.67 Indeed, out of a very limited number of fire blight-free
countries in the temperate region, two of them (Australia and the Republic of Korea) prohibited
the importation of apple fruit from fire blight-occurring countries entirely.
4.81 The United States  noted that Japan had apparently dismissed the possibility that the
disease could be eradicated before spread, despite evidence to the contrary from Australia and
Norway.  Japan also did not evaluate whether the disease, once established, could be preventedfrom spreading – even though Japan admitted the existence of evidence that Europe has
successfully done so.
4. Pathway for transmission of the disease
4.82 The United States  argued that not only was there no evidence that mature, symptomless
fruit had ever spread fire blight, but there was also no evidence that mature fruit could be a
pathway for the spread of the bacteria.  The scientific evidence indicated that:
(a) Fire blight bacteria were not  associated internally with the exported commodity
(mature, symptomless apple fruit);
(b) fire blight bacteria were rarely associated externally with the exported
commodity, even when harvested from blighted trees and orchards;
(c) even if a mature, symptomless apple had been externally contaminated with
bacteria, such bacteria were unlikely to survive normal commercial handling,storage, and transport of fruit;  and
(d) even if the imported commodity had been externally contaminated with bacteria,
there was no dispersal mechanism or vector to allow movement of such bacteria
from the fruit to a suitable host.
68
4.83 Because the chain of transmission – from association of bacteria with fruit, to bacterial
survival of handling, storage, and transport, to vectoring of bacteria to a suitable host - was never
completed, imports of apple fruit were not a means of, and could not result in, transmission of fire
blight bacteria to Japan.  Thus, as mature, symptomless apple fruit were not a pathway for the fire
blight disease, there was no scientific basis to restrict imports of such fruit.
4.84 Japan contended that a pathway to apple trees from infected apple fruit might or might
not be direct.  One could easily envisage complex, intertwined potential pathways from imported
fruit to an orchard, or to other host plants for fire blight bacteria.  Japan recalled that some authors
believed the transmission of the disease to the United Kingdom was due to contaminated cargo
crates destined to fruit orchards.  Japan failed to understand how dissemination from cargo crates
to orchards would be any more likely than dissemination from fruit to suburban host plants.  It
was scientifically sound to envisage, consider and evaluate a variety of potential routes of
propagation from fruit to other host plants in the environment.  Japan noted what it termed the
                                                     
67 Damages on apples in Michigan in 1991 were estimated to be US $3.8 million;  during the
1982-84 outbreak in Egypt, 95% of the Le Conte variety of pear was lost;  damages on pear in California in1976 were estimated to be US$4.7 million (Exhibit JPN-10 gives further examples of economic losses fromfire blight outbreaks).
68 The United States also noted that there are additional conditions, such as discard near a fire
blight host that is in a state receptiv e to infection, that also must be satisfied in order for exported fruit to
transmit the disease to an importing country.  See Roberts, et al.  (1998), pp. 19-28, at 24.WT/DS245/R
Page 32
overall confirmation by the experts of the presence of a real "risk" (which included completion of
the pathway) of the dissemination of the disease from apple fruit.  When asked if the bacteria
inside an infected apple fruit, inadvertently or erroneously found fit for export, would survive the
storage and other handling process, Japan believed the experts had unanimously acknowledged
that there was a real risk of dissemination.  In particular, Japan was of the view that Dr Smith hadclearly stated that the risk had to be managed.  In Japan's view, the experts could not have been
referring to mere theoretical uncertainty, because such a risk could not be "managed".  According
to Japan, since the experts had acknowledged that there was a real risk of dissemination, they had
admitted that the pathway would be complete.  Although the experts had recognized that the risk
arising from "mature, symptomless" apple fruit would be negligible, that risk would be negligible
only, as Japan believed that Dr Smith had stated, when phytosanitary requirements are met.
4.85 The United States  argued that Japan had presented at least three different hypothetical
pathways in the course of the proceeding.  These shifting arguments made the Panel’s analytical
task slightly more complex, but not more difficult as none of these hypothetical pathways was
supported by scientific evidence that established that the exported commodity presented a
probability or likelihood of introduction of fire blight to Japan.  The first hypothetical pathway
was identified in Japan’s first written submission: in this two-step pathway, (1) mature apple fruitwere either infected or endophytically contaminat ed and (2) such fruit then somehow transmitted
E. amylovora  and fire blight.  According to the United States, it had demonstrated, and the
experts had confirmed, that the first step in this pathway was not supported by any scientific
evidence and that none of the alleged four instances of trans-oceanic dissemination of fire blight
cited by Japan as "indirect" evidence provided any scientific evidence to establish a probability orlikelihood that imported mature apple fruit (as opposed to imported fire blight host plants) could
introduce fire blight to Japan.
4.86 The second hypothetical pathway that Japan identified was the importation of "mature,
apparently healthy, but infected" apple fruit.  According to the United States, it had demonstrated,
and the scientific experts had confirmed, that there was no scientific evidence that harvestedmature apple fruit would be infected with fire blight, no scientific evidence that mature apple fruit
would harbour endophytic (internal) populations of bacteria, and no scientific evidence that a
harvested fruit with epiphytic bacteria in the calyx would become infected.  Thus, there was no
scientific evidence to support the third step in Japan's hypothetical pathway, that imported apple
fruit would result in the presence of a "mature, apparently healthy but infected fruit" within
Japan.  Japan's hypothetical pathway was severed at this point, establishing that there was no
scientific evidence that the pathway would be completed.  Thus, there was no probability orlikelihood of introduction of fire blight to Japan via imported US apples.
4.87 Japan had presented a third hypothetical pathway when it had asked the scientific experts
to assume that an infected fruit would be imported.  However, as the United States believed the
experts had confirmed, the scientific evidence established that harvested fruit were horticulturally
mature and such fruit were not infected; thus, an infected fruit arriving in Japan would have to beimmature and would not pass through normal commercial processes of picking, sorting, storage,
inspection, and export.  (Indeed, Japan had conceded that exported US apples are mature and
apparently healthy.)  As a result, the United States was of the opinion that Japan's discussion with
the experts had not demonstrated any risk posed by the exported commodity (harvested mature
apple fruit) but rather had been based solely on the risk posed by something other than thatcommodity (infected, immature apple fruit).  Under the SPS Agreement , a phytosanitary measure
imposed on an exported commodity had to be based on a risk to plant life or health within Japan
posed by that exported commodity.  Because the scientific evidence established that a harvestedWT/DS245/R
Page 33
fruit would be horticulturally mature, and therefore not infected, exported US apples did not pose
a risk of introducing fire blight to Japan, even according to this alternative hypothetical pathway
that Japan had presented to the experts.
4.88 Thus, the United States contended that there was no scientific evidence that any of the
hypothetical pathways identified by Japan would be completed and that fire blight could be
introduced into Japan via imported US apple fruit.   Under Article 2.2, for there to be "sufficient
scientific evidence" to maintain a fire blight measure on imported apple fruit, there had to be a
"rational or objective relationship" between the scientific evidence of a risk to plant life or health
within Japan posed by imported apple fruit and that fire blight measure.  Where there was no
scientific evidence that mature apple fruit had ever transmitted fire blight and where there was no
scientific evidence that any hypothetical pathway involving mature apple fruit would be
completed, the exported commodity posed no risk to plant life or health within Japan.  As a result,
no measure could be imposed on imported apple fruit consistent with the SPS Agreement  to
protect against introduction of fire blight, except restricting importation to the exported
commodity: mature (and therefore symptomless) apple fruit.
4.89 Japan  countered that ISPM 2 on Guidelines for Pest Risk Analysis (the 1996 Guidelines)
did not require each step of a pathway to be supported by scientific evidence.  On the contrary,
the Guidelines stated that "[p]otential pathways which may not currently exist should be assessedif known.".
5. Endophytic (internal) bacteria and mature apple fruit
4.90 The United States  claimed that numerous studies had indicated that mature, symptomless
apple fruit did not harbour endophytic populations of the bacteria.
69  In particular:
Roberts (2002):  "This report on the joint Japanese-US research was the largest
investigation to date of whether mature, symptomless apple fruit harboured the bacterium
internally.  30,900 fruit from two sites in Wash ington State, USA, had been harvested at
0, 10, 25, 50, 100, or 300 meters from a source of fire blight inoculum.  Nine hundred
fruit had been analyzed at harvest for internal populations, and no bacteria had been
detected, even from trees with or directly adjacent to fire blight.  Thirty thousand fruithad been placed in commercial cold storage for 2-3 months (depending on date of
harvest).  None of these 30,000 fruit had developed external disease symptoms.  Of the
30,000 fruit, 1,500 had been sliced open, and no internal disease symptoms were present.
Of the 1,500 sliced fruit, the internal surfaces of 500 had been streaked and plated onto
selective media, and no fire blight bacteria had been isolated from any fruit ."
70
Van der Zwet et al.  (1990):  "One relevant experiment  had harvested immature, mature,
and some possibly mature fruit from four different geographic locations, and no internal
bacteria had been detected from any of the mature fruit (80 fruit from West Virginia,
                                                     
69 The United States noted that in most studies that tested mature, symptomless fruit for internal
and/or external bacterial populations, the experimental  designs were purposely biased in favor of positive
detection because fruit were not randomly selected but were frequently harvested from blighted trees andorchards, and often were harvested directly from blight ed spurs or shoots.  Nonetheless, these studies had
not detected internal populations of bacteria in mature, symptomless apple fruit and had very rarely
detected external populations of bacteria on such fruit.
70 Op. cit., Roberts (2002).WT/DS245/R
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USA) or possibly mature fruit (40 fruit fr om Washington, USA, 40 fruit from Utah, USA,
and 80 fruit from Ontario, Canada), even when harvested from blighted trees."71
Roberts et al.  (1989):  "No internal fire blight bacteria had been detected in 1,555 mature,
symptomless apple fruit harvested over two years from blighted (in some cases, severelyblighted) trees of seven apple cultivars grown at five locations in Washington, USA."
72
Dueck (1974):  "No internal bacteria had been isolated from any of 60 mature,
symptomless apple fruit harvested in Ontario, Canada, from severely infected trees.  The
report concluded: " Mature apples are highly resistant to infection.  Only when forcibly
introduced into the cortex were fruit infected. . . . [U]nder orchard conditions apples,
particularly from resistant cultivars, are not infected."73
The United States believed that the scientific experts had unanimously confirmed that there wasno scientific evidence that harvested mature apple fruit would harbour populations of fire blight
bacteria.
4.91 The United States observed that these results were not surprising as they reflected the
biology of the disease.  Blossoms that became in fected tended to abort their fruit and any fruit
that become infected (either through movement of the bacteria through internal tissues from a
canker to the fruit or through external wounding of the fruit) did not develop normally.  Instead,
they turned brown to black, shrivelled and, like the blossoms, remained attached to the spur,taking on a mummified appearance.  Thus, while immature apple fruit might contain detectable
levels of internal fire blight bacteria without yet having developed disease symptoms by the time
of harvest, mature, symptomless apple fruit would not harbour internal populations of fire blight
bacteria.
4.92 Japan  argued that a variety of published literature on the ecology, properties and
survivability of E. amylovora  established that:  (1) the bacteria were able to grow at a temperature
of 3-5 degrees to 37 degrees Celsius;  (2) the bacteria were facultative anaerobae;  and (3) they
had the ability to utilize as carbon sources glucose, fructose, or L-arabinose.  The bacteria were
evidently capable of survival inside or on the surface of apple fruit.  In addition, van der Zwet et
al. (1990) reported that:
(a) Mature Rome Beauty apples of West Virginia had developed internal fruit blight
symptoms after 37 to 121 days in cold storage, "presumably from endophyticbacteria";  and
(b) up to 21% of symptomless  Red Rome fruit harvested in July and August in the State
of West Virginia had endophytic bacteria;  and
(c) in a geographic survey, E. amylovora had been detected from the inside of 14
symptomless apple fruit sampled in July, August and September in the State of
Utah.
                                                     
71 Op. cit., van der Zwet et al.  (1990).
72 Op. cit., Roberts et al.  (1989).
73 Op. cit., Dueck (1974).WT/DS245/R
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4.93 Japan claimed that the United States had attempted to discount all of these findings.
First, the United States dismissed (b) and (c) above, as studies on "immature fruit".  For this
purpose, the United States had sought clarificat ion from Dr van der Zwet and Professor Thomson
if these were made on mature fruit.  However, Professor Thomson had observed in Thomson
(2000) that, "[v]an der Zwet et al.  (1990) recovered E. amylovora from inside mature apple
fruit".74  Moreover, in an earlier report of the same geographical survey, the authors had
summarized the characteristics of the tested apples as "[m]ature, apparently healthy" apples.
Furthermore, Roberts et al. (1998), co-authored by Dr van der Zwet, stated clearly that apple fruit
harvested in Utah, West Virginia, Washington and Ontario in table 4 of van der Zwet et al. (1990)
were mature and symptomless.
4.94 The United States recognized that van der Zwet (1990) had been the source of some
confusion as it reported on numerous different experiments conducted in different locations
without distinguishing between immature and mature fruit.  However, the "Geographic Survey"experimental data, especially as later clarified by two lead authors of the paper, supported the
position that mature, symptomless apples did not harbour internal populations of the bacterium.
75
The United States argued that the Roberts et al.  (1998) and Thomson (2000) papers were review
papers and therefore were intended to survey the literature.  Inaccurate reports on the findings in
van der Zwet et al.  (1990) could not be used to establish a fact not supported by that paper,
especially when efforts had been made to correct the errors of interpretation that had arisen from
this work.  Thomson (2000) had written:  "Van der Zwet et al.  (1990) recovered E. amylovora
from inside mature apple fruit only when it was grown within 60 cm of visible fire blight
infections."  These results, however, were presented in table 3 in van der Zwet et al.  (1990),
which had clearly indicated that the fruit in question were harvested in July and August 1986 andwere therefore immature apple fruit.  Thus, Thomson (2000) did not provide support for Japan’s
assertion that van der Zwet et al. (1990) recovered endophytic E. amylovora  from inside mature
apple fruit.  Dr van der Zwet himself had confirmed the immature status of these fruit in his
declaration.
76
4.95 Japan  also stated that the United States had discounted the internal fruit blight symptoms
which mature Rome Beauty apples had developed in cold storage, presumably from endophytic
bacteria, by citing the article’s observation that "[i]nternal fruit blight symptoms were difficult to
distinguish from other fruit rots".  However, the article continued:  "[r]andom sampling from the
surface of blighted fruit in storage resulted in recovery of E. amylovora ".  The article concluded:
"[a] few uninoculated fruit of Rome Beauty stored at 1 C developed fire blight.  Thus,
asymptomatic fruit of a susceptible cultivar, harvested from blighted trees, may develop fire
blight during commercial storage."77  The authors explicitly stated that the developed symptoms
were "fire blight".
4.96 The United States  replied that in the 1990 paper, Dr van der Zwet had clearly stated that
he could not reliably differentiate the internal decay symptoms present in the fruit as being fire
blight or fungal decay.  Therefore, his diagnosis of fire blight in stored fruit - in his words,
"presumably" caused by endophytic bacteria – would have been validated only if:  (1) the fruit
had been assayed for the presence of endophytic bacteria before storage and such bacteria had
been recovered;  and (2) the internal rots had been assayed microbiologically and E. amylovora
                                                     
74 Op. cit., Thompson (2000).
75 Van der Zwet Declaration, 16 July 2002 (Exhibit USA-18) and letter from S.V. Thomson, Utah
State University, to R.G. Roberts, US Department of Agriculture, 23 August 2002 (Exhibit USA-19).
76 Op. cit. (Exhibit USA-18).
77 Op. cit., van der Zwet et al.  (1990).WT/DS245/R
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had been isolated.  Neither condition had been satisfied according to the methods and
experimental results described in the paper.
4.97 Japan  claimed that despite attempts to revise van der Zwet et al . (1990), the United
States had failed to deny:  (1) the expression of fire blight in "mature, symptomless" apple fruit,
presumably from endophytic bacteria;  (2) recovery of the bacteria from core sections of applesharvested in July and August, some of which were mature;  and (3) recovery of the bacteria from
inside mature, apparently healthy apples harvested in July, August or September.  Van der Zwet
et al. (1990) had shown that mature apple fruit harboured the risk of endophytic E. amylovora .
While disagreeing with this objective evaluation of the evidence, the United States admitted that
the bacteria might exist inside close-to-mature apple fruit.  The only way that the US claim could
be compatible with the observed occurrence inside close-to-mature apple fruit would be if the
bacteria disappeared during the critical few days or weeks before maturation.  However, theUnited States had not provided a theory, much less evidence, to explain the implied
disappearance of the bacteria.
4.98 The United States  argued that in clarifying that no endophytic bacteria had been
recovered from any mature fruit in any of the experiments reported in the van der Zwet et al.
(1990) paper, the authors had merely confirmed what a careful reading of the 1990 papersuggested.  The only fruit expressly described in the 1990 paper as "mature" had been those in the
storage experiment reported in table 2; as the scientific experts had noted, endophytic bacteria
had not been recovered from these "mature" fruit (the fruit were not even tested for internal
bacteria) and thus the suspected symptoms were not confirmed as fire blight.  None of the fruit
involved in the geographic experiment reported in table 4 were described as "mature" in the 1990paper, and the authors had confirmed that no endophytic bacteria had been recovered from any
mature or possibly mature fruit in that experiment.  Thus, the 1990 paper itself did not claim that
internal bacteria had been isolated from any "mature" fruit; the authors’ recent statements merely
confirmed that fact.
4.99 Furthermore, Japan  argued that there was ambiguity in the concept of "maturity".
"Maturity" and "immaturity " were part of a continuum.  As such, maturity was inherently a
subjective concept and could allow a variety of interpretations.  Professor Thomson had
determined "maturity" in terms of "commercial" ma turity, or harvest dates.  By doing so, in his
letter of "clarification" the author pushed back the "maturity" dates so that the Utah apples tested
positive in the survey would became "immature".  All of those apple fruit could well have been
mature under the "physiological" maturity criteria, because physiological maturity supposedly
preceded commercial maturity.  Furthermore,  Japan strongly suspected that the authors of vander Zwet et al . (1990) might have considered that the apple fruit tested in the study were
"physiologically mature" on the basis of the colour, firmness of the tissue, and other features they
witnessed.  Otherwise, it was inconceivable that the authors continued repeatedly in later
publications to characterize the apples as being "mature".
78  Japan maintained that there was no
evidence to show that "physiologically mature" apple fruit would further undergo a decisiveprocess in which all endophytic bacteria would be eliminated by the time of the harvest.  Any
endophytic bacteria which had been found inside "physiologically" mature apple fruit were
therefore likely to survive until "commercial" ma turity in light of the ecology and other known
properties of the bacteria and apple fruit.  The "symptomless" criterion was even more difficult to
manage, because there would be no objective yardstick.  Japan noted that in Roberts et al. (1989),
a study that failed to recover the fire blight bacteria from inside mature, symptomless apples,
                                                     
78 Op. cit., Thomson (2000) and Roberts et al.  (1998).WT/DS245/R
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sampling was not randomized.  Japan further noted that there was what it believed was agreement
among the experts that the "symptom" (which must be recognized by the human eye) would be
the key indicator of the risk, and that it might not be always detected.  Indeed, the
ambiguity/subjectivity, confirmed by the experts, was further compounded by the less-than-
satisfactory practices surrounding the export of American apples.  Although the United States
alleged that "any infected, immature fruit would not pass through normal harvesting, sorting, andstorage procedures developed and applied by growers, distributors, and exporters, and … any
infected, immature fruit would not pass through grading and inspection procedures by Federal-
State inspectors, including application of the standards of the U.S. Apple Export Act", there was
clear evidence to the contrary showing that the none of the safeguards (including inspection by
Federal-State inspectors) worked.
 79
4.100  The United States  contended that E. amylovora  did not exist in mature fruit because
immature fruit that became infected with fire blight would not develop to maturity, as previouslydescribed.  Furthermore, there was a long-established scientific, commercial and horticultural
basis for the use of the concepts of physiological and commercial maturity.
80  The United States
believed the scientific experts had confirmed both of these points.
4.101  Japan  recalled that no study had ever been conducted concerning (latent) infection of
E. amylovora  through the pedicel of apple fruit.  Starting in 2002, therefore, Tsukamoto et al.  had
conducted experiments to clarify the ability of E. amylovora  to invade and multiply through the
pedicel.81  The study provided preliminary evidence that E. amylovora  could move and multiply
in the system of the pedicel in apple fruit.  Japan was of the view that the cause of the internal
browning of apple fruit in this experiment was worthy of further investigation.
4.102  The United States  commented that Japan's unsuccessful attempt to recover endophytic
bacteria from apple fruit by cutting open the pedicels and inoculating them with high numbers of
bacteria could not be considered an effort to ob tain additional necessary information to justify its
fire blight restrictions.  The preliminary results reported that E. amylovora  had not been found,
and the browning of the fruit could have many causes.  The study did not provide additional
information with respect to steps in Japan's hypothetical pathway – which the experts hadconcluded would not be completed.
6. Epiphytic bacteria and mature apple fruit
4.103  The United States  claimed that a review of the scientific literature suggested that the
epiphytic presence of fire blight bacteria on mature, symptomless apple fruit at harvest was
extremely rare.  In those few instances when external bacteria had been detected, the fruit had
been harvested from or within 10 meters of an infected tree in severely infected orchards.  Thus,
in most cases, mature, symptomless apples, even when harvested from infected trees or orchards,would not be externally contaminated with fire  blight bacteria.  The following authors had
provided relevant evidence:
                                                     
79 Comments of Japan on the US answers to additional questions from the Panel,
31 January 2003, para. 7.
80 See, e.g. , A.E. Watada et al. (1984), Terminology for the Description of Developmental Stages
of Horticultural Crops, Hort Science  19: 20-21 (Exhibit USA-41).
81 T. Tsukamoto et al.  (2003), "Invasion, Multiplication and Movement of Erwinia Amylovora  in
pedicel tissues of apple fruit", unpublished (Exhibits JPN-39 and JPN-42).WT/DS245/R
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Thomson (2000):  "Populations of E. amylovora  are rare on mature fruit and when
present are probably due to deposition from a nearby source of active inoculum.  In every
case where E. amylovora  has been detected on fruit, it has been from orchards with high
levels of fire blight infection."82
Hale and Taylor (1999):  "No epiphytic fire blight bacteria were isolated from calyxes(the opposite end of the fruit from the stem) of 150 mature fruit harvested from an
infected orchard."
83
Hale et al.  (1996):  "No epiphytic fire blight bacteria were found on the calyxes and
surfaces of 173 mature, symptomless apple fruit harvested from infected trees in New
Zealand."84
Clark et al.  (1993):  "No epiphytic fire blight bacteria were detected on calyxes of 750
mature, symptomless apple fruit even from within 20 cm of inoculated blight sources
(flowers) showing disease symptoms."85
van der Zwet et al. (1991):  "No epiphytic fire blight bacteria were detected on surfaces
or calyxes of apple fruit from six susceptible cultivars from blighted orchards in West
Virginia, USA."86
van der Zwet et al.  (1990):  "No epiphytic bacteria were recovered from 80 mature,
symptomless apple fruit from West Virginia, USA, 40 possibly mature fruit from
Washington, USA, and 80 possibly mature fruit from Ontario, Canada; of 40 possibly
mature fruit from Utah, USA, harvested in a severely blighted orchard, only 1 contained
epiphytic bacteria in the calyx.  No epiphytic bacteria were detected after storage on any
of 160 mature, symptomless fruit from Washington State, USA.  Epiphytic bacteria wererecovered after storage from 5 of 175 mature, presumably symptomless fruit harvested
within 10 meters of infection in severely blighted orchards in West Virginia, USA."
87
Roberts et al.  (1989):  "No epiphytic fire blight bacteria were detected on the surfaces of
1,555 mature, symptomless apple fruit harvested from blighted (in some cases, severely
blighted) trees of seven apple cultivars grown at five locations in Washington, USA."88
Sholberg (1988):  "Epiphytic bacteria were detected on approximately 18-54 (the actualnumber was not given) of 54 mature, presumably symptomless apples harvested from a
severely blighted orchard (including severely infected pear trees)."
89
                                                     
82 Op. cit., Thomson (2000).
83 C.N. Hale and R.K. Taylor (1999), "Effect of Cold Storage on Survival of Erwinia amylovora in
Apple Calyxes", Acta Horticulturae 489, pp. 139-43  (infected orchard had less than five strikes per tree).
84 C.N. Hale et al.  (1996), "Ecology and epidemiology of fire blight in New Zealand", Acta
Horticulturae 411, pp. 79-85.
85 R.G. Clark et al.  (1993), "A DNA Approach to Erwinia amylovora Detection in Large Scale
Apple Testing and in Epidemiological Studies", Acta Horticulturae 338, pp. 59-66 (Exhibit JPN-25).
86 van der Zwet et al.  (1991), "Evaluation of calyx tissues of several apple cultivars for the
presence of Erwinia amylovora", Phytopathology 81, p. 1194 (no indication of numbers of fruit tested).
87 Op. cit., van der Zwet et al.  (1990).
88 Op. cit., Roberts et al.  (1989).
89 P.L. Sholberg et al.  (1988), "Occurrence of Erwinia amylovora of pome fruit in British
Columbia in 1985 and its elimination from the apple surface", Canadian Journal of Plant Pathology  10:WT/DS245/R
Page 39
Hale et al.  (1987):  "Epiphytic bacteria were detected in the calyxes of 3 out of 2,100
mature, symptomless fruit harvested in New Zealand, and only from severely infected
trees in a severely blighted orchard; no isolations were made from fruit harvested from
moderately blighted orchards."90
Dueck (1974):  "No external bacteria were isolated from any of 60 mature, symptomlessapple fruit harvested in Ontario, Canada, from severely infected trees.  The report
concluded: "Furthermore, apples from severely infected trees of a susceptible cultivar,
having been exposed to high levels of inoculum during the growing season, were free of
the bacterium at harvest time".
91
The United States believed that the scientific experts had unanimously agreed that epiphytic calyxpopulations on mature apple fruit would only rarely occur when fruit were harvested from
orchards with severe fire blight and with nearby active sources of inoculum.
4.104  Japan  agreed that epiphytic bacteria sometimes existed on the surface including the
calyx – a part that was difficult to disinfect – of "mature, symptomless" apple fruit.  However,Japan did not agree with the conclusion that the external presence of the bacteria was extremely
rare.  Sholberg et al. (1988), for example, clearly stated that " E. amylovora may be present on
symptomless fruit at harvest under certain conditions".
92
4.105  The United States  argued that the rarity of external contamination of mature,
symptomless apple fruit was a logical consequence of the biology of the fire blight bacteria andthe disease cycle.  Bacteria were most prevalent in infected hosts during the spring, when
blossoms were present.  The bacterial inoculum that exuded in warm, wet conditions from
infected shoots, cankers, infected fruit and blossoms might infect new hosts via blossoms as well
as other natural plant openings.  However, as conditions in the orchard became less hospitable
(hotter and drier) and the opportunities for new infections (and, hence, the bacterium’sreproductive chances through blossoms and other openings) diminished during the apple fruit
growing season, the bacteria showed a marked d ecline in population counts, becoming extremely
rare on fruit by the time of harvest.  The scientific evidence indicated that bacteria on the surface
of fruit died within a short time.  Thus, on those rare instances in which external populations had
been detected, this was probably due to deposition from a nearby source of active fire blight.
7. Scientific evidence and the st eps in Japan's systems approach
4.106  The United States  argued that the Japanese prohibition on the importation of US apples
unless all nine fire blight requirements or restrictions were met was not supported by scientific
evidence.  In addition, as mature, symptomless apple fruit were not a pathway for the disease,
imported US apple fruit did not pose a phytosanitary risk to plant life or health within Japan, and
each of the specific restrictions imposed by the Japanese measures had no basis in science.
                                                                                                                                                             
178-82, 180 tbl. 2 (Exhibit JPN-37).  Epiphytic bacteria detected from fruit harvested from "severely
damaged" orchard in which "[a]lmost every . . . apple tree was infected" after August hail storm).Although the precise number of positive fruit was not given, the United States had calculated (based on theexperimental methods used) that 18-54 fruit could have been positive.
90 C.N. Hale et al.  (1987), "Occurrence of Erwinia amylovora on apple fruit in New Zealand",
Acta Horticulturae  217, pp. 33- 40, at 37  (fruit harvested from severely blighted, lightly infected, and fire
blight-free orchards) (Exhibit JPN-8).
91 Op. cit., Dueck (1974).
92 Op. cit., Sholberg et al. (1988).WT/DS245/R
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4.107  Japan  countered that its plant quarantine measure against fire blight was a "systemic
approach", which ensured conditions that would not allow the presence of fire blight bacteria
either outside or inside of apple fruit shipped to Japan.  This approach was consistent with the
relevant international standards of the IPPC and each component of the systems approach was
supported by scientific evidence.
(i) Prohibition of imported apples from orchards in which any fire blight is
detected
4.108  The United States noted that Japan prohibited any fruit from a "designated" export
orchard in which fire blight had been detected.  Japan deemed any occurrence of fire blight, no
matter how severe or light,  in an orchard to pose an unacceptable risk  of transmitting fire blight
on any fruit from that orchard.  Depending on the size of the orchard, Japan’s orchard freedom
requirement could prohibit fruit from being exported that was harvested tens, hundreds, orthousands of meters away from a single, lightly infected fire blight host (for example, an apple
tree with a single, inactive canker) that might have exhibited symptoms many months before
harvest (for example, one blighted blossom or shoot).  Such an indeterminate restriction bore no
rational or objective relationship to the scientific evidence.
4.109  Japan  argued that designation of a fire blight-free area was an essential element of its
"systemic approach".  Japan's requirement was in line with the Requirements for the
Establishment of Pest Free Places of Production and Pest Free Production Sites of the IPPC
(ISPM 10).  This standard defined a "pest free place of production" as:
"[A] place of production in which a specific pest does not occur as demonstrated
by scientific evidence and in which, where appropriate, this condition is beingofficially maintained for a defined period."
93
The IPPC requirements further provided that:
"[The pest free place of production] provides a means for an exporting country, if
so required by an importing country, to ensure that consignments of plants, plant
products or other regulated articles produced on, and/or moved from, the place ofproduction are free from the pest concerned."
 94
4.110  Japan observed that the efficacy of the fire blight-free area was demonstrated by a variety
of scientific studies that reported the relative absence of endophytic and epiphytic bacteria in
symptomless apples that were harvested from blight-free orchards.95  This was particularly the
case in Europe, where many countries favoured a fire blight-free area and a number of countries
required the growing of host plants in fire blight-free areas.96  The distance between a harvested
apple and an infected fire blight host depended on the scale of the orchard; variation in thisdistance would occur whenever a pest free area was designated.
                                                     
93 International Standard for Phytosanitary Measures No.10:   Requirements for the Establishment
of Pest Free Places of Production and Pest Free Production Sites , FAO, Rome 1999 (Exhibit JPN-24).
94 Ibid.
95 See, e.g.,  Hale et al. (1987), van der Zwet et al. (1990), Clark , et al.  (1993).
96 EPPO Standards; Phytosanitary Procedures, Erwinia amylovora,  Sampling and Test Methods
(1992) (Exhibit JPN-26).WT/DS245/R
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4.111  The United States  contended that the use of pest-free places of production or pest-free
production sites might be appropriately used to manage the risk identified with a particular
pathway. However, the scientific evidence demonstrated that mature apple fruit did not serve as a
pathway for the introduction of fire blight.  Thus, the conditions for establishing pest free places
of production or production sites were not relevant to ensuring that imported fruit were disease-
free and did not transmit fire blight.  The United States also noted that under US law andregulations, exported apple fruit must be disease-free (symptomless).
97  Thus, even if fire blight
disease was present in a production site or area, exported mature apple fruit did not facilitate the
introduction of E. amylovora  to new areas.
4.112  Japan  noted that the experts advising the Panel had all agreed that it would be reasonable
to require that imported apples come from a fire blight-free orchard.
4.113  The United States  observed that certain experts had expressed views on what restrictions
might be "reasonable" within the context of attempting to forge a "compromise" between theparties' views, to provide "transition time" for Japan to phase-in relaxed measures, to avoid
"squeez[ing] Japan" into eliminating its fire blight measures, and to propose measures that Japan
might adopt until Japan had "confidence" to liberalize further.  These comments were made in the
context of Japan's follow-up questions at the experts' session, which were phrased in terms of
what would be "reasonable" and not in terms of "what is the content of the scientific evidence".Thus, Japan had invited the experts to comment on matters beyond their expertise and mandate –
that was, to provide scientific and technical advice on the scientific evidence relating to fire blight
and exported apple fruit.
(ii) Prohibition of imported apples from any orchard should fire blight be detected
within a 500-meter buffer zone surrounding the orchard
4.114  The United States  recalled that the Japanese fire blight measures established that a
"designated" export orchard had to be surrounded by a 500-meter buffer zone.  If any fire blight
was detected in the 500-meter buffer zone, no fruit from the designated export orchard could be
exported to Japan.  Given that there was no scientific evidence that mature, symptomless apple
fruit were a pathway for the introduction of fire blight, even if the fruit were picked from highlyinfected trees, there was obviously no evidence to support a requirement for such a buffer zone.
According to the Unites States, the scientific experts had confirmed that buffer zones surrounding
orchards, which might be appropriate in fire blight-eradication efforts and in measures to ensure
fire blight-freedom for nurseries of fire blight host plants, were not relevant with respect to
contamination of mature apple fruit.
4.115  Japan  stated that the necessity of establishing a buffer zone was recognized by
ISPM 10.
98   If a blighted tree were found in the buffer zone, the designation as a pest-free place
of production would be cancelled.  Following th e IPPC recommendations, Japan considered that
the width of the buffer zone had to be determined on the basis of the distance over which the pest
was likely to spread naturally during the course of the growing season.  The requirement of a 500-
meter buffer zone was supported by the scientific evidence, inter alia :  (1) E. amylovora had been
isolated in a monitoring survey in Belgium at a point 250 meters away from the inoculum sourcein wet weather, and was detected 1 kilometer away by the indirect immunofluorescence method;
                                                     
97 See footnote 46.
98 "Where the biology of the pest is such that it is likely to enter the place of production or
production site from adjacent areas, it is necessary to  define a buffer zone around the place of production or
production site within which appropriate phytosanitary measures are applied."  Op. cit., ISPM 10, para. 1.1.WT/DS245/R
Page 42
and (2) a large-scale experiment over five seasons in New Zealand had not detected the bacteria
at the calyx end of 60,000 apples when the orchards were surrounded by a 500-meter buffer
zone.99
4.116  Japan further observed that international practice since the 1970s also supported the
introduction of a buffer zone of this size.  For example, EPPO's quarantine requirements forE. amylovora  provided that "countries which consider themselves to be at high risk can specify
that the [pest-free seedling] field, as well as the surrounding zone of radius of at least 250 meters,
must be inspected at least once in July/August and once in September/October and that spot
checks should be carried out in the surrounding zone of radius of at least 1 kilometer in places
where host plants are grown, at least once in July/October".
100  Germany required that if an
infection of fire blight was found, "diseased plant material and plants surrounding these places are
destroyed immediately over a radius of 500 meters".101  In the Netherlands, host plants of
E. amylovora  within 500 meters around the nuclear stock plots and the multiplication fields of
source-material were removed.102  These practices reflected recognition of a risk of spread of the
disease within the range of several hundred meters.
4.117  The United States  argued that none of the examples cited by Japan was pertinent.
Obviously, a report of 250 -meter dispersal did not support a 500-meter buffer requirement.  More
importantly, the report referenced by Japan contained serious flaws and was of limited (if any)
relevance to bacterial presence in, or on, mature, symptomless apple fruit.  In particular, the study
by J. van Vaerenbergh et al.  (1987), was based on a test that detected dead as well as live bacteria
and had failed to confirm that the "dispersed" bacteria were of the same strain as the bacteria
found on the source (and therefore not from some other  fire blight host in the area).  Furthermore,
the EPPO requirements were part of a fire blight eradication programme, not a programme to
address any risk of fire blight transmission on imported fruit.   The risk of transmission of fire
blight was known to be much greater for plants than for mature, symptomless fruit, and trade in
plants required significantly different measures than trade in fruit.103 
4.118  Japan  maintained that dead cells were unlikely to stay responsive to test techniques for a
long period of time, and no such other sources had been identified in the survey; therefore it was
reasonable to assume that live bacteria from the source were detected in the survey.  Japan also
argued that the buffer zone requirement of EPPO was for the purpose of ensuring that host plants
were grown in a disease-free environment – which was exactly the purpose of its "systemic
approach".
(iii) Inspection of orchards three times yearly
4.119  The United States  recalled that along with the requirements that an orchard and a 500-
meter buffer zone surrounding such orchard be free of fire blight, Japan required that the orchard
and buffer zone be inspected at least three times yearly, at the blossom, fruitlet (small fruit), and
                                                     
99 J. van Vaerenbergh et al. (1987), "Monitoring fireblight for official phytosanitary legislation in
Belgium", EPPO Bulletin  17, pp. 195-203, at 198 and Clark et al. (1993), p. 62.
100 EPPO, supra  n. 85.
101 W. Zeller (1987), Present Status of Fireblight in the Federal Republic of Germany, EPPO
Bulletin 17, pp. 223-224 (Exhibit JPN-27).
102 C.A.R. Meijneke (1979), "Prevention and Control of Fireblight", EPPO Bulletin  9(1), pp. 53-
62 (Exhibit JPN-19).
103 EPPO recommends "countries at high risk to prohibit importation of host plants for planting"
but does not recommend restrictions on importation of fruit, supra  n. 5.WT/DS245/R
Page 43
harvest seasons.  Further inspections could be required following strong storms, such as
hailstorms.  However, the scientific evidence indicated that fire blight bacteria had only rarely
been detected on the outside of mature, symptomless apple fruit harvested from, or within
10 meters of, severely infected trees in severely blighted orchards.  Only a harvest season
inspection that detected severely blighted orchards might be relevant to the likelihood that there
could be fire blight bacteria on the surface of mature, symptomless apple fruit.  However, eventhat inspection was unnecessary because there was no scientific evidence that mature,
symptomless apple fruit transmitted the bacteria.
4.120  Japan  claimed that field inspections were necessary to ensure the efficacy of the
"systemic approach".  The IPPC requirements provided:
"The verification of pest free status is done by [national plant protection
authorities] personnel … who undertake specific surveys to assess the pest free
status of the place of production … (and the buffer zone, if required). These mostoften take the form of field inspections … Pest free status may be verified by a
stated number or frequency of inspections or tests (e.g., three inspections at
monthly intervals) … Monitoring surveys should be conducted at adequate
frequency over one or more growing seasons [in the buffer zone]."
104
It was not feasible to confirm the absence of fire blight symptoms in each tree in an orchard, and
there was always a risk that detection errors might occur.  Inspection at blossom stage was
appropriate because this was when trees were most susceptible to fire blight infection, whereas it
was at fruitlet stage that the symptoms were most readily detectable.  According to the relevant
literature:  (1) the flower had the highest susceptibility to fire blight;  (2) the shoots and leaves
were actively growing at the fruitlet stage and the symptoms of fire blight were easily observed;and (3) the activity of E. amylovora  was high during these two stages.  Moreover, the typical
symptom of fire blight (exudation of bacterial ooze) appeared during these seasons.
4.121  The United States  observed that the blossom and fruitlet surveys would not reveal some
instances of harvest season fire blight because fire blight bacteria might infect new hosts after thesmall fruit season or the disease might express itself in an already infected host.
4.122  Japan  considered that a third inspection at the harvest stage was required exactly because
infection could still occur after the fruitlet stage, as the mechanism of invasion of E. amylovora
inside apple fruit was not known, and bacteria survived inside the fruit or at the calyx end.
4.123  The United States  argued that detecting all instances of fire blight in an orchard was
irrelevant to the question of whether bacteria would be present on mature, symptomless apple
fruit.  There was no scientific evidence that the presence of fire blight at the blossom or fruitletstages affected the likelihood that fire blight bacteria would be found on mature, symptomless
apple fruit.  Thus, the three inspections requirement bore no rational or objective relation to the
scientific evidence.
4.124  Japan maintained that  three inspections were the minimum requirement in order to
confirm that fire blight had not occurred in export orchards throughout the season, and the timingof these inspections was set at the three stages most suitable for detection of symptoms.  The US
argument erred in its refusal to acknowledge detection errors.  In addition, it was probable for the
                                                     
104Op. cit., ISPM 10, para. 2.2.3.WT/DS245/R
Page 44
symptoms at early stages to be pruned out, so only one inspection at harvest stage could never
ensure the fire blight-free status of the orchard.
(iv) Prohibition of imported apples unless treated with chlorine
4.125  The United States  recalled that Japan prohibited the importation of any apple fruit that
had not been treated by immersing the fruit for one minute in a tank containing 100 parts permillion free chlorine.  While there was scientific evidence relating to the effect of chlorine on
populations of fire blight bacteria, there was not a rational or objective relationship between
Japan’s chlorine treatment requirement and the scientific evidence that mature, symptomless
apple fruit were not a pathway for the fire blight disease.
4.126  Japan  argued that the surface of harvested apple fruit could be infected by E. amylovora ,
after harvest during the transportation, washing, selection and other steps.  As previously noted,
numerous studies had detected the bacteria on the surface of apples.
105  Therefore, the surface of
harvested apple fruit needed to be sterilized.
4.127  The United States did not contend that there was not scientific evidence of the efficacy
of a chlorine treatment in reducing external bacterial populations.  This evidence, however, did
not support any measures on harvested mature, symptomless apple fruit since there was no
evidence that mature, symptomless apple fruit transmitted the fire blight disease.
4.128  Japan  observed that the United States accepted the efficacy of the chlorine treatment and
the existence of scientific reports that detected epiphytic bacteria.  Nevertheless, the United States
rejected disinfection because apples had not be en shown (presumably by direct or documented
evidence) to be a pathway.  In Japan's view, this conclusion was the outcome of an erroneous
interpretation of the burden of proof.
(v) Prohibition of imported apples from US states other than Washington or
Oregon
4.129  The United States  recalled that Japan prohibited the importation of US fruit other than
fruit produced in designated export orchards within the States of Washington or Oregon.  The US
requests that Japan expand the list of states eligible to export apple fruit had been to no avail. TheUnited States argued that Japan had presented no evidence to support its limitation of imported
US apples to Washington or Oregon fruit.
4.130  Japan  contended that there was nothing arbitrary about permitting only the orchards in
the States of Washington and Oregon to export apples to Japan.  The reasons were that (1) the US
initial request was only for these states, and (2) the United States had submitted a proposal of
phytosanitary measures that would prevent the introduction of E. amylovora  into Japan only for
apple fruit produced in Washington and Oregon.
4.131  The United States  claimed that the scientific evidence established that mature,
symptomless apple fruit - regardless of origin - were not a pathway for the disease.  As there was
no scientific evidence that mature, symptomless apple fruit transmitted the disease, the
prohibition of US apples from states other than Washington or Oregon was not rationally or
objectively related to the scientific evidence.
                                                     
105 Op. cit., van der Zwet et al. (1990);  Sholberg et al. (1988).WT/DS245/R
Page 45
4.132  Japan  noted that the current phytosanitary requirements regarding fire blight were
applicable to apple fruit produced in other states, and it was possible to import those apple fruit
under the same conditions.  However, the United States had not submitted documentation that
described the status of other quarantine pests in states other than Washington and Oregon.
Consequently, the existence of other quarantine pests in other states was not known.  If the United
States could certify the absence of other pests, or if it proposed a measure that was suitable forpreventing the introduction of these pests, Japan would accept shipments of apples from other
states under the same conditions as for Washington and Oregon.
(vi) Prohibition of imported apples unless other production, harvesting, and
importation requirements are met
4.133  The United States  recalled that Japan prohibited the importation of US apples unless
other harvesting, production, and importation requirements were also met.  These included the
chlorine treatment of containers for harvesting, chlorine treatment of the packing site, and post-harvest separation of apples for export to Japan from apples for other destinations.  None of these
requirements bore a rational or objective relation to the scientific evidence.  According to the
United States, the scientific experts had not identified any scientific evidence that contamination
of mature apple fruit after harvest would occur th rough harvesting, packing storage, or transport.
4.134  Japan  claimed that the chlorine treatment of containers was necessary to avoid
contamination of fruit by contaminated harvest containers.  As fruit containers (cargo crates) were
suspected to be the cause of introduction of fire blight into the United Kingdom, the sterilization
of containers for harvest was necessary to prevent introduction of E. amylovora .  Chlorine
treatment of the packing site was a safety measure to prevent contamination of fruit by packing
line equipment.
4.135  The United States  noted that the chlorine treatment of containers for harvesting was
apparently based on a scientific study that presented circumstantial, not scientific, evidence that
contaminated fruit boxes could have been a source of inoculum.
106  This same study also stated
that the likelihood that fire blight was transmitted via infected fruit "is very slight and can
probably be ignored".107  According to the United States, the experts had agreed that there was no
scientific evidence that fruit cargo crates might spread fire blight.  The United States was of the
view that Dr Smith had remarked that even the idea that E. amylovora  could survive on crates as
ooze for any significant time is quite conjectural (let alone be transmitted from them).
4.136  The United States argued that Japan simply had not presented any supporting evidence of
contamination in the packing facility.108  The same was true with respect to Japan’s requirement
that apples destined for Japan be kept separated from fruit for other destinations.  The United
States was not aware of any evidence that supported these measures, hence there could be norational relationship between these requirements and evidence which did not exist.
4.137  Japan  contended that separation of fresh apple fruit for Japan from other fruit was
necessary to prevent the former from being contaminated by E. amylovora  after harvest.  Japan
argued that the US counter-argument rested solely on its rejection of any evidence other than
"direct" evidence, a position for that there was no textual support in the SPS Agreement .  
                                                     
106 R. A. Lelliot (1959), "Fire Blight of Pears in England", Agriculture  65, pp. 564-568.
107 Ibid.
108 US first submission, para. 62.WT/DS245/R
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F. ARTICLE 5.1
1. General
4.138  The United States  claimed that Japan’s fire blight measures were not "based on" a risk
assessment within the meaning of Article 5.1 and Annex A and therefore were inconsistent with
Article 5.1 of the SPS Agreement .  As the Appellate Body had noted in Australia - Salmon , to be
consistent with Article 5.1 a risk assessment had to:  "(1) identify the diseases whose entry,
establishment or spread a Member wants to prevent within its territory, as well as the potential
biological and economic consequences associated with the entry, establishment or spread of these
diseases;  (2) evaluate the likelihood of entry, establishment or spread of these diseases, as well as
the associated potential biological and economic consequences;  and (3) evaluate the likelihood of
entry, establishment or spread of these diseases according to the SPS measures which might be
applied."109
4.139  Japan  maintained that in line with its obligations under this provision, it had performed
two full pest risk analyses:  the first in 1996 and a second in 1999.110  The 1999 PRA in particular
had been performed specifically on US apples and was fully consistent with the International
Standards for Phytosanitary Measures No. 2: Guidelines for Pest Risk Analysis (hereinafter
"ISPM 2" or the "1996 Guidelines").111
2. Evaluation of the likelihood of entry, establishment or spread
4.140  The United States  did not contend that Japan’s 1999 PRA had not fulfilled the first
requirement under Article 5.1 - it had identified fire blight as the disease whose entry,
establishment or spread Japan wanted to prevent within its territory as well as potential associated
biological and economic consequences.  However,  the 1999 PRA had not fulfilled either of the
two remaining requirements. Japan had failed to fo cus on the scientific evidence relating to the
importation of apple fruit, making only general statements of possibility rather than an assessment
of the likelihood, or probability, of entry, establishment or spread.  The Appellate Body in
Australia – Salmon  had stated that "for a risk assessment to fall within the meaning of Article 5.1
and the first definition in paragraph 4 of Annex A, it was not sufficient that [it] conclude thatthere is a possibility of entry, establishment, or spread of diseases".  Further, the Appellate Body
in Australia – Salmon  had concluded that the second requirement for a risk assessment under
Article 5.1 would not be met when the assessment made "general and vague statements of mere
possibility of adverse effects occurring; statements which constitute neither a quantitative nor a
qualitative assessment of probability."
112
4.141  Japan  considered that the 1999 PRA was based on plain, undisputable logic.  No one
could challenge the likelihood of dissemination of the disease once it was introduced into thecountry.  The 1999 PRA had addressed not a theoretical possibility but the likelihood of the
introduction and spread of fire blight through apple fruit. The Appellate Body had clearly
established that risk assessments did not have to take the form of a quantitative analysis.
                                                     
109 Appellate Body Report in Australia – Salmon , para. 121.
110 "Pest Risk Analysis concerning Fire Blight Pathogen ( Erwinia amylovora ), Ministry of
Agriculture, Forestry and Fisheries, Japan, 1996 (the "1996 PRA") (Exhibit JPN-31);  and the 1999 PRA,
op. cit.
111 Op. cit., ISPM 2.
112 Appellate Body Report in  Australia  - Salmon,  paras. 123 and 129.WT/DS245/R
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Furthermore, it appeared to Japan that the United States was faulting the 1999 PRA because the
analysis had not reached the conclusion the United States desired to see – that "mature,
symptomless" apples did not disseminate the disease.  No case could, however, be established
against a risk assessment on such a basis.
4.142  The United States  contended that the fact that the Japanese Pest Risk Analysis had not
evaluated the likelihood or probability of entry was evident from its fundamental failure toidentify and discuss those scientific studies that were relevant to the apples to be imported.  A
proper focus on studies relevant to mature, symptomless fruit would have allowed Japan to begin
to assess the probability of imported US apples being infected or infested with fire blight bacteria.
Instead, Japan presented the results of studies on, inter alia , immature fruit, visibly infected or
damaged fruit, artificially wounded and inoculated fr uit in storage, visibly infected fruit left on
trees, apple leaves, and pear fruit.  Indeed, the 1999 PRA had explicitly dismissed certain
evidence on the basis that it related "only" to "symptomless" or "healthy looking" fruit that is"mature."
113  However, this was the very fruit that the United States sought to export to Japan and
for which Japan had to assess risk.
4.143  Japan  observed that the 1999 PRA had taken into account all available evidence that
related not only to apple trees but mature and immature, visibly blighted and symptomless apple
fruit - including van der Zwet et al. (1990).114
4.144  The United States  also argued that Japan’s 1999 PRA had not evaluated the likelihood of
entry because it failed to describe fully the st eps that had to be completed for entry of the
bacteria.  The International Standards for Phytosanitary Measures No. 11:  Pest Risk Analysis for
Quarantine Pests (hereinafter "ISPM 11" or the "2001 Guidelines") laid out the steps that
comprised an evaluation of the probability of entry:  (1) identification of relevant pathways;  (2)the probability of the pest being associated with the pathway at origin;  (3) the probability of
survival of the pest during transport or storage;  (4) the probability of the pest surviving existing
pest management procedures;  and (5) the probability of transfer of the pest to a suitable host.
115
4.145  Japan  observed that its 1999 PRA had been undertaken before the adoption of ISPM 11,
and could therefore be based only on the 1996 Guidelines.  However, the 2001 Guidelines weredeveloped from the 1996 Guidelines, and both had substantially the same framework.  For this
reason, Japan had not considered it necessary to review the 1999 PRA after the adoption of the
2001 Guidelines. Moreover, Article 5.1 provided "Members shall ensure that their …
phytosanitary measures are based on an assessment…of the risks to …plant life or health, taking
into account risk assessment techniques developed by the relevant international organizations."
Therefore, the obligation of an importing Member was to "take into account", not to "strictly
follow", such risk assessment techniques.
4.146  The United States  argued that since there was no scientific evidence that apple fruit had
ever introduced or spread fire blight, apple fruit might then only pose a risk of introduction of fire
blight to Japan if there was scientific evidence that fruit were a pathway for introduction.  Japan
had not identified each step necessary for imported apple fruit to serve as a hypothetical pathway.
Neither had Japan cited scientific evidence to establish that each step of the hypothetical pathwaywould be completed – understandably, since there was not scientific evidence to support each
step.
                                                     
113 Op. cit., the 1999 PRA, para. 1-1, p. 6.
114 Op. cit.
115 Op. cit., ISPM 11.WT/DS245/R
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4.147  The United States claimed that identification of each step necessary for imported apple
fruit to serve as a hypothetical pathway was not difficult using the five steps identified in
ISPM 11, above.  Applying these evaluative steps to the case of E. amylovora  and apple fruit, it
was possible to identify the actual steps that had to be completed for imported apple fruit to serve
as a pathway for the disease.  These steps were:  (1) apple fruit had to be externally or internallycontaminated with fire blight bacteria;  (2) the bacteria had to survive harvest, commercial
handling, and storage conditions;  (3) the bacteria had to survive transport (including cool
storage), handling, and discard conditions (including consumption);  (4) the apple fruit had to be
discarded near a host plant;  (5) the host had to be at a receptive stage (i.e., able to be infected);
(6) the bacteria had to be transferred from the discarded, contaminated fruit to a susceptible host;
and (7) suitable conditions had to exist for infection to occur and fire blight to develop.
116
4.148  Japan  contended that the 1999 PRA had identified the steps in the pathway necessary for
fire blight to be disseminated via mature, apparently healthy apple fruit imported from the United
States.  The steps in the pathway of dissemination by bacterial ooze, and the relevant scientific
evidence relating to these steps were:
(i) Mature, apparently healthy apple fruit that had E. amylovora  inside or in the
calyx were harvested in the United States (van der Zwet et al. 1990, Hale et al.
1987).
(ii) E. amylovora  inside or in the calyx of mature, apparently healthy apple fruit
survived through cold storage and transport (van der Zwet et al. 1990).
(iii) Mature, apparently healthy apple fruit were imported and sold in retail shops in
Japan.
(iv) Either internal fruit blight was discovered in households etc., and infected apple
fruit were discarded as garbage, and were transported by large birds (crows, etc.)
from garbage dumps to hedges, roadside trees such as hawthorn, cotoneaster, etc.
or to orchards near cities (often garbage dumps were located near hedges or
roadside trees in many cases);  OR
(v) People went to the suburbs for leisure bringing apple fruit, and apple fruit with
blighted cores were discarded after eating.
(vi) Under the warm and humid weather conditions of Japan, bacterial ooze exuded
from discarded apple fruit in the fields (Thomson 1992, Smith et al. 1986).
(vii) Bacterial ooze adhered to the beaks or legs of small birds (Schroth et al. 1974,
Seidal et al. 1994);  AND/OR bacterial ooze adhered to the mouths and legs of
insects (flies, ants, etc.). (Thomson et al . 1992, van der Zwet and Keil 1979);
AND/OR wind and rain dispersed aerosol that contained bacterial ooze (van der
Zwet. 1994).
(viii) Fire blight bacteria, which existed in bacterial ooze adhering to small birds or
insects, or in aerosol, invaded into susceptible organs (flowers etc.) or scars of
                                                     
116These steps are closely related to the linear model presented in Roberts et al.  (1998), but break
out two of the nodes in that model into sub-parts.  See Roberts et al. (1998), pp. 19-28, at 24-25.WT/DS245/R
Page 49
pear or apple trees in commercial orchards, and the pear or apple trees became a
primary inoculum source;  AND/OR the fire blight bacteria invaded into
susceptible organs (flowers etc.) or scars of susceptible host plants (hedges, road
trees, etc.), and the plants became primary inoculum sources (Thomson 1992, van
der Zwet 1994, Schroth et al. 1974).
4.149  Japan also maintained that the 1996 Guidelines did not require each step of a pathway to
be supported by scientific evidence.  On the contrary, the Guidelines stated that "[p]otential
pathways which may not currently exist should be assessed if known".
4.150  The United States  argued that it had reviewed Japan's 1999 PRA and had not been able
to find a description of any hypothetical pathway that identified the various steps that would need
to be completed in order for imported apple fruit to serve as a pathway.  The United States
maintained that, in fact, the scientific eviden ce demonstrated that steps in this hypothetical
pathway would not be completed.  For example, the United States believed that the scientificexperts had confirmed that there was no scientific evidence that endophytic (internal) fire blight
bacteria had been recovered from mature apple fruit harvested from an orchard.  Nor, as the
United States believed the scientific experts had unanimously confirmed, was there any scientific
evidence that "mature, apparently healthy but infected fruit" (steps (iv), (v) and (vi) existed;
rather, this appeared to be a conjectural creation by Japan.  The citation to van der Zwet et al.
(1990) did not provide "[e]vidence of E. amylovora  infection with apple fruit" (or, more
precisely, with "mature" apple fruit, the hypothetical pathway) because there was no experiment
reported in that paper establishing that E. amylovora  was the cause of fire blight infection in any
mature, harvested fruit.  While Hale et al.  (1987) recovered epiphytic bacteria from the calyxes of
a small number of fruit harvested from a severely blighted orchard (but recovered no bacteriafrom any fruit harvested from moderately blighted orchards), the paper provided no evidence that
epiphytic bacteria could infect a harvested, mature fruit or that there could exist any "mature,
apparently healthy, but infected fruit".  Moreov er, the United States believed that the scientific
experts had unanimously stated that there was no scientific evidence that any epiphytic calyx
populations can infect a mature apple fruit.  Finally, the cited studies by Thomson (1992) andSmith et al.  (1986) related to cankers and to infected, immature fruit and thus did not provide any
evidence that a harvested mature fruit might be infected or that "mature, apparently healthy but
infected" fruit existed.
4.151  Japan  contested the US conclusion that the external presence of the bacteria was
"extremely rare".  Sholberg et al.  (1988), for example, clearly stated that " E. amylovora  might be
present on symptomless fruit at harvest under certain conditions" and van der Zwet et al. (1990)
had shown that mature apple fruit harbor risk of endophytic E. amylovora .  Japan noted that the
United States admitted that the bacteria might exist inside close-to-mature apple fruit. The only
way that the US claim could be compatible with the observed occurrence inside close-to-mature
apple fruit was if the bacteria would disappear in  the critical few days or weeks of maturing.
However, the United States did not even provide a theory, not to mention evidence, to explain the
disappearance.
4.152  The United States  indicated that even in the rare instance in which mature, symptomless
fruit might be externally contaminated, such external populations of fire blight would die off
rapidly because the bacteria were vulnerable to environmental conditions and not suited to
external survival (other than on stigmas of developing flowers).  The 1999 PRA did not present
any evidence relating to the probability of survival of fire blight bacteria during commercialhandling, storage, and transport (steps 2, 3, and 4 of the 2001 Guidelines for evaluating the
probability of entry).  Rather, the scientific evidence established that any surviving epiphyticWT/DS245/R
Page 50
bacteria were extremely unlikely to survive harvest, commercial handling, storage, transport,
retail distribution, consumption and discard.  In fact , the effect of cool storage alone (for example,
through the 55-day mandatory cold treatment Japan required on US apples for codling moth)
made probability of survival of any epiphytic bacteria very unlikely.117  Furthermore, as the
United States believed the scientific experts had unanimously confirmed, there was simply noscientific evidence of the existence of a vector or the probability of the transfer of any
hypothetically surviving bacteria from a discarded fruit to a susceptible host (step 5 of the 2001
Guidelines).  Thus, the scientific evidence established that apple fruit did not serve as a pathway
because the necessary steps would not be completed.
4.153  Japan  countered that the storage experiment of van der Zwet et al. (1990) had shown that
mature Rome Beauty apples of West Virginia had developed internal fruit blight symptoms after
37 to 121 days in cold storage, "presumably from endophytic bacteria".  The study concluded "Afew uninoculated fruit of Rome Beauty stored at 1° C developed fire blight.  Thus, asymptomatic
fruit of a susceptible cultivar, harvested from blighted trees, may develop fire blight during
commercial storage."  While the 1999 PRA had not e xplicitly referred to this article, the analysis
did take it into account in examining the section entitled "probability of introduction into Japan
by normal transport method".  Furthermore, the 1999 PRA considered that latent E. amylovora
inside apparently healthy apple fruit could not be discovered by visual inspection.  Neither could
E. amylovora  inside apple fruit be disinfected by the surface chlorine treatment nor be eliminated
by "normal commercial fruit handling (such as removal of trash, sorting, rinsing, grading, and
packing)".
4.154  In addition, Japan indicated that the 1999 PRA had discussed the issue of transfer to a
suitable host and concluded that "In the course of the distribution, processing and consumption,
some [fresh fruit] can be released to the natural environment as leftovers, waste or useless
materials".
118  As a matter of common sense, it could easily be envisaged that surviving
E. amylovora , either inside or outside apple fruit, could be transmitted to nearby host plants,
either by way of rain, wind, insects, etc. Once such fruit were introduced into Japan, bacteriawould be exposed to the environment at all stages of distribution, storage, consumption and
disposal of the fruit, causing a real risk of dissemination.  Japan considered that one should
envisage complex, intertwined potential pathways from imported fruit to an orchard, as suggested
by the 2001 Guidelines.  Japan noted that the 2001 Guidelines stated that "[p]otential pathways,
which may not currently exist, should be assessed", and that "[e]stimation of the probability of
introduction of a pest … involves many uncertainties … this estimation is an extrapolation from
the situation where the pest occurs to the hypothetical situation."
4.155  The United States  noted that there was no scientific evidence of any vector to transfer
any hypothetically surviving bacteria from a discarded fruit to a susceptible host.
119  Japan’s
                                                     
117 In its first submission, the United States made reference to a large-scale study (Hale and Taylor
(1999) that had examined the survival of fire blight bacteria on fruit subject to normal commercial cooling
and storing by surface-inoculating fruit with varying numbers of bacteria and measuring surviving bacteria
after storage.  Under both "commercial conditions" and "laboratory conditions", the study had found that,of 570 inoculated fruit, bacteria had been eliminated on all but two fruit after storage for 25 days at cooltemperatures and 14 days at room temperature.  Bacteria were only isolated from some of the fruit that hadbeen inoculated with extremely large numbers of bacteria - levels far higher than those that have beenfound on harvested mature, symptomless fruit.
118 Op. cit., the 1999 PRA.
119 The US review of the scientific literature had revealed no report of a vector or mechanism by
which any fire blight bacteria on or in apple fruit had been transmitted to a susceptible host.  According toWT/DS245/R
Page 51
citation to van der Zwet & Keil (1979) was inapt as the "[e]vidence of Erwinia amylovora
dissemination by insects, birds, wind, and rain" referred to dissemination of bacteria from
diseased host plants.  There was no evidence that "insects, birds, wind and rain" would transfer
bacteria from epiphytically contaminated and discarded fruit;  in fact, the scientific evidence
confirmed that there was no vectoring of epiphytic bacteria from contaminated, discarded fruit.
Thus, the last step in Japan’s hypothetical pathway was also not supported by any scientificevidence.
4.156  Japan  argued that bacterial ooze could adhere to birds feeding on apple fruit discarded
by Japanese people in urban and rural areas, or to insects, or in aerosol and invade the susceptible
organs (flowers, etc) or scars of pear or apple trees in commercial orchards or other host plants.
In this context, Japan recalled the statement of Dr  Geider at the expert meeting that there was no
minimum number of bacteria necessary for multiplication.
4.157  The United States made clear that  it was not disputing the existence of vectors for
bacterial ooze within Japan, but as the scientific experts had confirmed, that there was no
scientific evidence that imported apple fruit would be blighted and produce bacterial ooze.
Therefore, Japan’s hypothetical pathway would not be completed.
4.158  Furthermore, the United States argued that Japan had presented no evaluation of the
likelihood or probability of establishment and spread of fire blight.  ISPM 11 laid out factors toconsider in evaluating the probabilities of both establishment and spread.  As regards the
probability of establishment, factors included the availability, quantity, and distribution of hosts
in the pest risk analysis area, the environmental suitability of the pest risk analysis area, the
reproductive strategy of the pest, its potential for adaptation, the method of pest survival, and
cultural practices and control measures in the pest risk analysis area.
120  As regards the probability
of spread, factors included the suitability of the natural environment for natural spread of the pest,
the presence of natural barriers, the potential for movement with commodities or conveyances,
the intended use of the commodity, potential vectors of the pest in the pest risk analysis area, and
potential natural enemies of the pest in the pest risk analysis area.121
4.159  The United States noted that Japan had presented evidence relating to some of these
factors, but its conclusions on possibilities again fell short of an evaluation of probabilities,
particularly as Japan had not considered important contrary evidence.  Japan had not identified
the probable means by which the fire blight bacteria would enter and therefore the likely place of
establishment (that is, the city, country, growing regions, or elsewhere).  Japan had also
apparently dismissed the possibility that the disease could be eradicated before spread, despite
contrary evidence from Australia and Norway.  Japan also had not evaluated whether the disease,
once established, could be prevented from spreadin g, despite admitting the existence of evidence
that Europe had successfully done so.  The failure to evaluate this evidence was all the more
striking given that EPPO recommended that Euro pean nations at high risk of fire blight
introduction restrict the importation of host plants for planting but not the importation of fruit of
fire blight hosts.
                                                                                                                                                             
the Roberts et al.  (1998) review study "There are no specific pathways recorded that document movement
of E. amylovora   from fruit, either imported or domestic in origin, to susceptible host tissues in an orchard
or nursery".
120 Op. cit., ISPM 11, para. 2.2.2.
121 Op. cit., ISPM 11, para. 2.2.3.WT/DS245/R
Page 52
4.160  Japan  countered that although the United States pointed out the desirability of further
evidence, it had failed to demonstrate how the perceived need could constitute a case of
inconsistency with the text of Article 5.1.  According to the overly strict US interpretation of
Article 5.1, many pest risk analyses implemented by other countries, including the United States,
could be inconsistent with this Article.  Such a situation, however, had not been foreseen by theSPS Agreement .
4.161  Japan considered that the pathway with "mature, apparently healthy but infected fruit"
and/or "bacterial ooze" was the most probable one, but did not preclude other possibilities,
including a pathway which began with a small colony of the bacteria in apple fruit.  As Japan
believed that Dr Geider had noted, that there was no definite minimum number of bacteria that
would be necessary to multiply and disseminate the disease.  The United States did not
understand the fact that the 1999 PRA could take into account only 1996 Guidelines.  Japan alsoconsidered that the suggested possibility of eradication of fire blight was merely illusory.
Introduction of the disease into Australia had been a very limited incident with only three trees
infected.  Moreover the fact that fire blight had been found not in orchards but at botanical
gardens in an urban area contributed to its successful eradication.  Japan was not aware of the
details of the eradication in Norway, but its cooler climatic conditions could have been the maincause of successful eradication.  With respect to the situation in Europe, Japan was of the view
that Europe was suffering from an expansion of the disease on a massive scale, due to its failure
to take appropriate measures.  In France, for example, the "protected zone" (or the fire blight-free
area) had diminished in size from the eastern half of the country in 1997 to only the island of
Corsica today.  
3. Evaluation of risk according to the measure which might be applied
4.162  The United States  recalled that with respect to the third requirement of a risk assessment
within the meaning of Article 5.1 and Annex A, Japan had to evaluate the likelihood of entry,
establishment or spread of fire blight disease according to the SPS measures which might be
applied.
122  As the Appellate Body had noted in Australia – Salmon , a risk assessment that
"identifies such measures but does not, in any substantial way, evaluate or assess their relative
effectiveness in reducing the overall disease risk" did not "fulfil the third requirement" for a risk
assessment, "i.e., it does not contain the required evaluation of the likelihood of entry,
establishment, or spread of the diseases of concern according to the SPS measures which might
be applied".123  The Japanese analysis of certain SPS measures which might be applied had not
met this requirement.  Japan had identified some SPS measures which might be applied to US
apples in that it had named those measures it already applied.  However, the 1999 PRA had notevaluated the "relative" effectiveness of any  of these measures in reducing the overall disease
risk.
4.163  The United States claimed that the 1999 PRA had also failed to consider the SPS
measures "which might be applied", rather than those measures which it had already applied.  The
United States had informed Japan that measures on mature, symptomless apples were notnecessary because these fruit did not serve as a pathway for the disease;  the United States had
even proposed compromise alternative measures to Japan.  Japan, however, had failed to consider
these alternative measures, although no other fire blight-free countries imposed the same fire
blight measures as Japan - indeed, the vast majority imposed no fire blight measures on imported
                                                     
122 Appellate Body Report in Australia–Salmon , para. 121.
123 Ibid., paras. 133-34.WT/DS245/R
Page 53
fruit at all.  Thus, Japan’s assessment of risk did not meet the third requirement of a risk
assessment within the meaning of Article 5.1 and Annex A of the SPS Agreement .
4.164  Japan  stressed that its phytosanitary requirements were based on the proposals of the
exporting government.  Indeed, Japan had considered a variety of US proposed "compromises"
during bilateral and technical meetings, and had proposed in 1999 to perform a joint study to
generate data supporting modification of the measure.  Unfortunately, the 2000 study had notbeen implemented the way Japan had hoped and had not generated data that would have
warranted modification of the conclusion of the 1999 PRA.  The United States had officially
proposed the "mature, symptomless" criteria for the first time only at the bilateral consultations in
April 2002.  Until then, the United States had only proposed to narrow the width of the buffer
zone and to reduce the number of field inspections. Japan also considered that when a country
planned to introduce a new measure, the efficacy and impact of more options should be taken into
account. However, when a measure was already in effect, the analysis and evaluation wouldinevitably focus on the current measure.
4.165  The United States  noted Japan’s suggestion that it could not have considered the
"mature, symptomless" criteria in its risk assessment because these were not officially proposed
until the 2002 WTO consultations.  However, Japan had been well aware of these criteria, which
first appeared in the fire blight literature in 1924 and which had been repeated often in theliterature through the last three decades.  Japan had expressly refused to consider scientific
evidence stating that "there are some reports that the possibility of fire blight transmission by
fresh apple fruit can be denied or neglected[,] [h]owever, in these reports, they only stated that
'symptomless, mature fruit' (McLarty 1922, Dueck  1974), 'healthy looking mature fruit' (Roberts
et al.  1989), ‘fruit harvested from symptomless orchards with[out] fire blight' (van der Zwet et al.
1990) are safe".  This rendered Japan's evaluation of the likelihood of entry inadequate and its
assessment of the risks of entry, establishment or spread of fire blight inconsistent with
Article 5.1.
4. Measures based on an assessment of the risks
4.166  The United States  further considered that Japan’s requirements on US apples were
inconsistent with Article 5.1 because the 1999 PRA results did not "sufficiently warrant" - i.e
reasonably support - the SPS measure.
124  As indicated by ISPM 11, the probability of entry of a
pest was linked to the probability of the pest being associated with the pathway at origin,
considering, for example, the prevalence of the pest in the source area, the occurrence of the pest
in a life-stage that would be associated with commodities,  seasonal timing, and commercial
procedures applied at the place of origin, such as handling, culling, roguing, and grading.  Thus,
to support measures on the importation of apples, Japan’s PRA had to have examined whether theexported commodity (mature, symptomless apple fruit) might serve as a pathway for the disease.
Japan had merely presented a list of scientific studies on the presence of fire blight bacteria on
apples without any evaluation of the relevance of the studies for the apples to be imported.   Such
an unreasoned recitation of evidence could not "reasonably support" the SPS measures Japan had
imposed.  Thus, the resulting analysis of the risk posed by imported apples did not "sufficientlywarrant" or "reasonably support" the Japanese fire blight measures.
4.167  Japan  stated that fire blight was often prevalent in the States of Washington and Oregon,
and the 1999 PRA noted that van der Zwet et al. (1990) had detected E. amylovora  inside mature,
                                                     
124 Appellate Body Report in EC – Hormones , para. 193.WT/DS245/R
Page 54
symptomless apples.  While it did not estimate numerical probabilities of contamination by the
bacteria, the PRA qualitatively evaluated the probability.   
4.168  Japan maintained that the 1999 PRA covered the path of analysis required by the 1996
and 2001 Guidelines.  The only issue which remained was how "new evidence" would impact on
the consistency of the 1999 PRA with Article 5.1.  Japan believed that conformity of a riskassessment under Article 5.1 should be assessed in light of information available at the time of
conducting the risk assessment.  Once a risk assessment was fully completed consistent with the
SPS Agreement , the party concerned had fulfilled its obligation, and it should not be held in
violation of the Agreement retroactively  because of the subsequent discovery of new evidence.
Article 5.1 should not be interpreted to require a full, formal risk assessment immediately each
time a new piece of evidence became available.  The importing Member should be given an
opportunity to consider whether or not the new information would warrant a new risk assessment.In this context, Japan had taken into account new data submitted by the United States and by New
Zealand during the proceedings, and concluded that they were not yet sufficient to warrant a
modification of the current phytosanitary requirements.
4.169  The United States  considered that, in general, the consistency of a measure with a
Member’s WTO obligations should be judged as of the time of establishment of the disputesettlement panel (assuming that the same measure was the subject of consultations).  It disagreed
with Australia’s argument that a Member that learnt of new scientific evidence must be allowed
the opportunity to reassess risk in accordance with the factors in Article 5.2 of the SPS
Agreement .
125  This would imply that an exporting Member could not pursue dispute settlement
until the importing Member had been given an opportunity to reassess risk.  Such a rule wouldupset the balance of rights and obligations of WTO Members.  Nothing in the SPS Agreement
required the United States, which had unsuccessfully attempted to work with Japan to relax its
current fire blight measures for nearly eight years, to forego dispute settlement when Japan was
not in compliance with its WTO obligations.  However, nothing prevented Japan from reassessing
risk pursuant to Article 5 of the SPS Agreement  in light of the scientific evidence while dispute
settlement proceedings were ongoing.
4.170  Furthermore, the United States stressed that the timing of availability of any scientific
evidence presented in this dispute should not alter the outcome of the Panel’s analysis of any
legal claim.  As the experts had confirmed, there had never been any scientific evidence that
mature apple fruit (the exported commodity) had ever transmitted fire blight or could serve as a
pathway for introduction of fire blight to Japan.  All of the most recent scientific evidence merely
served to confirm further this point.  Japan’s measure was based on nothing more than theoreticaluncertainties, such as, what if an infected, imma ture fruit were somehow imported along with the
exported commodity – even though the experts had stated such fruit would not be harvested
because they were immature and had symptoms of fire blight.  According to the Appellate Body
in EC – Hormones , such theoretical uncertainties were not the type of risk which a risk
assessment, and therefore any Japanese fire blight measure, were to address.
126
4.171  The United States recalled that in Australia – Salmon , the Appellate Body had confirmed
the relationship between Articles 5.1 and 2.2, stating that by maintaining an SPS measure "in
violation of Article 5.1, Australia had, by implication, also acted inconsistently with Article 2.2 of
                                                     
125 Australian Statement at the Third Party Session with the Panel, 22 October 2002, para. 10.
126 Appellate Body Report in  EC – Hormones , para. 186.WT/DS245/R
Page 55
the SPS Agreement ".127  Thus, to the extent that the Panel found that Japan had maintained the fire
blight measures without basing them on a risk assessment under Article 5.1, the Panel should also
conclude that Japan had acted inconsistently with Article 2.2.  Nevertheless, the United States
requested that the Panel find that Japan had breached Article 2.2 independently of its breach of
Article 5.1. An independent finding under Article 2.2 would assist the parties in achieving a
satisfactory settlement, and avoid the potential for further litigation, by making clear that Japan’sbreach could not be cured through mere redrafting of an analysis not based on scientific evidence.
G. A
RTICLE 5.2
4.172  The United States  claimed that Japan's 1999 PRA was flawed because it did not "take
into account" certain information identified in Article 5.2 of the SPS Agreement .  Article 5.2 sets
out certain information that must be taken into account when conducting a risk assessment,
including "available scientific evidence; . . . relevant ecological and environmental conditions;
and quarantine or other treatment".  Although the 1999 PRA presented some information relatingto fire blight, it had failed to take into account certain key pieces of information.  First, Japan had
failed to take into account available scientific evidence that mature, symptomless apple fruit did
not serve to transmit the fire blight disease.  As previously noted, in its 1999 PRA Japan had
identified, but expressly disregarded, literature that concluded that "mature, symptomless" fruit
did not transmit fire blight on the grounds that such reports referred only to "mature,
symptomless" fruit.
4.173  Japan  contended that it had taken into consideration the scientific evidence then
available in both its 1996 and 1999 PRAs.  Japan considered that the US complaint was about the
conclusion the analysis had drawn, rather than Japan’s failure to evaluate the evidence.  Japan had
fully reviewed the evidence about E.amylovora in mature, symptomless apple fruit.
4.174  The United States  further argued that Japan had failed to take into account relevant
ecological and environmental conditions in the States of Washington and Oregon.  Japan
expressly limited the importation of US apples to fruit harvested from orchards in Washington
and Oregon, but failed to consider the available scientific evidence relating to mature,
symptomless apples harvested from Washington.  Not a single mature, symptomless Washingtonapple fruit had ever tested positive for internal or external fire blight bacteria, even when
harvested from infected trees.
4.175  Japan  observed that both Washington and Oregon suffered from significant fire blight
outbreaks in 1985, 1988, 1993, 1994, 1997 and 1998, and the incidence of the disease in these
states was not generally low.
128.  Japan recalled that two joint US-Japan experiments had been
planned for 2000, one on the width of the buffer zone and another on the number of field
inspections.  Japan considered the buffer zone width experiment to be a joint experiment, andaccepted the results of the experiment as data for a non-severe fire blight year in the State of
Washington.  However, Japan did not consider that the ecology of fire blight (in this case, the
scattering distance of the bacteria) had been wholly revealed by the result.  Japan considered that
the US design of the second experiment on field inspections was illogical and it could not accept
the results.  At a technical meeting held in October 2001, Japan had invited the United States toprovide additional information on five items:
                                                     
127 Appellate Body Report in Australia – Salmon , para. 138.
128 Occurrence Level of Fire Blight in 2000 when the Japan-US Joint Experiment was Carried Out
(Exhibit JPN-33).WT/DS245/R
Page 56
(i) The situations of occurrence of fire blight in the States of Washington and
Oregon;
(ii) the difference between the two states and other states in terms of the occurrence
of fire blight;
(iii) the forecasting systems of fire blight in the States of Washington and Oregon;
(iv) the mechanism by which E. amylovora  invaded inside apple fruit;  and
(v) the spreading mechanism of fire blight in the State of Washington, especially the
scattering distance of E. amylovora .
4.176  On fire blight outbreaks since 1985, the United States  argued that the data Japan had
presented were not actual data on fire blight incidence but were merely the predicted fire blight
incidences calculated by an often inaccurate computer forecasting model (CougarBlight).  In
response to items (i) and (ii), the United States replied that the occurrence of fire blight inOregon, Washington, and the rest of the United Stat es were not systematically recorded because
the disease was endemic and not under official control.  Therefore, this data was unavailable.  For
item (iii), there were no official, mandated forecasting systems for fire blight outbreak.
CougarBlight and MaryBlight were two computer-forecasting programmes that were commonly
used, and Japan was well aware of them.  For item (iv), the United States had not provided dataon a mechanism by which E. amylovora  could "invade inside apple fruit" because it did not
invade inside mature apple fruit harvested from orchards, as amply demonstrated by the scientific
evidence.  Thus, Japan was requesting the United States to provide hypothetical data on a non-
existent phenomenon.  For item (v), the United States was unaware of any means of spreading
fire blight inside Washington State that had not been documented elsewhere for other areas:wind-driven rain, some insects, infected nursery stock, and contaminated pruning tools.  The
United States further noted that the request for this extra data had come two years after Japan
proposed the joint experiments and approximately ten months after the results of these same
experiments became available.  The request also was made despite the ample scientific evidence
that mature apple fruit do not transmit fire blight.  Finally, the United States noted that therequested data was for two years when the environmental conditions were conducive to fire blight
development and severe blight occurred in th e growing areas in central Washington (Roberts et
al. (1989)).  Nonetheless, no fire blight bacteria were detected inside mature fruit and no fire
blight disease developed in any fruit during the period of cold storage.
4.177  Japan  indicated that it was not satisfied with the US replies.  It had requested the
information in items (i) and (ii) because if the situations of occurrence of fire blight in
Washington and Oregon were substantially different from those of other states and the level ofoccurrence in 2000 was about average in the Pacific Northwest, these data would be helpful to
evaluate the results of the 2000 experiment.  Japan considered that it was negligent on the part of
an exporting country, such as the United States, not to have data on the occurrence situation of a
pest of serious concern to the importing country, Japan.  The intent behind item (iii) was to
ascertain if fire blight was adequately forecasted in Washington and Oregon, so that theinspections could be reduced during a low fire blight year.  However the reply of the United
States showed that fire blight in Washington and Oregon was not monitored at all.  Item (iv) was
also important as knowledge about how E. amylovora  invaded into fruit (only via infected
pollens, or through pedicel from infected branches, etc.) affected the timing of the orchard
inspections.  Finally, data on the spreading mechanism of fire blight in Washington and OregonWT/DS245/R
Page 57
States and especially the scattering distance of E. amylovora  (item (v)) had a bearing on the width
of the buffer zone.  The reply of the United States confirmed that the findings of J. Van
Vaerenbergh et al.  (1987) were relevant to both states.129
4.178  Japan further stated that obviously its access to information on the relevant ecological
and environmental conditions in the States of Washington and Oregon was limited.  In light of
judicial equity, the exporting Member should positively demonstrate such information that wassolely or generally available in that exporting Member.  This understanding of the SPS Agreement
was consistent with Article 6.3, which put the burden of proof on an exporting Member to
provide objective demonstration of any pest- or di sease-free areas or areas of low pest or disease
prevalence.
4.179  The United States  claimed that Japan had also failed to take into account quarantine or
other treatments.  While Japan had recognized in the 1999 PRA that the chlorine treatment it
currently required was adequate "to sterilize fire blight bacteria that may have attached to the
surface of fresh apple fruits", Japan had not considered the scientific evidence that chlorine
treatment by itself mitigated any possibility that bacteria could be found externally on mature,
symptomless apple fruit.  Thus, by failing to ta ke into account available scientific evidence,
relevant ecological and environmental conditions, and quarantine or other treatments, the United
States maintained that Japan had acted inconsistently with Article 5.2.
4.180  Japan  argued that studies showed that E. amylovora existed both inside and outside
mature apple fruit and it was evident that the bacteria inside apple fruit could not be eliminated by
the chlorine treatment.
H. A
RTICLE 5.6
4.181  The United States  claimed that Japan had acted inconsistently with Article 5.6 of the
SPS Agreement  because Japan's fire blight measures were more trade-restrictive than required to
achieve Japan’s appropriate level of phytosanitary protection.  The Panel and Appellate Body had
found in Australia – Salmon  that there were three elements necessary "to establish a violation of
Article 5.6".  First, there had to be another measure that "is reasonably available taking into
account technical and economic feasibility".  Second, the measure had to achieve "the Member’sappropriate level of sanitary or phytosanitary protection".  Third, the measure had to be
"significantly less restrictive to trade than the SPS measure contested".  If any one of the three
elements was not met, "the measure in dispute would be consistent with Article 5.6".
130  T h e
United States contended that restricting importation to mature, symptomless apple fruit was an
alternative measure that was reasonably available, achieved Japan’s appropriate level of
protection (ALOP), and was significantly less restrictive to trade than Japan's fire blight
measures.
4.182  Japan  argued that the United States had not established that exportation of "mature,
symptomless" apple fruit to Japan would achieve Japan’s appropriate level of protection, which
was to prevent introduction of E. amylovora  with the security equivalent of import prohibition.
The alternative proposed by the United States was:  (1) not based on scientific evidence;  (2) not
supported by real life experience;  (3) not practical to implement;  and (4) not scientifically
                                                     
129 "In or shortly after periods of rain, the pathogen could be isolated at a maximum distance of
250m from the hawthorn hedge and detected by up to 1km.", Vaerenbergh, et al.  (1987), op. cit.
130 Appellate Body Report in Australia – Salmon , para. 194; see also Panel Report in Australia –
Salmon , para. 8.167.WT/DS245/R
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sound.  As the measure proposed by the United States did not meet Japan's ALOP, Japan was
acting consistently with Article 5.6.
4.183  The United States  claimed that restricting the importation of apples to mature,
symptomless apple fruit was a reasonably available measure that was already in use.  US law and
regulations currently imposed the requirement that exported apples be mature and be free fromdecay, broken skin or bruises, or damage caused by disease or any other means.
131  In addition,
almost all (60 of 66) fire blight-free areas in  the world allowed US apples meeting US export
standards to be imported without any production restrictions or post-harvest treatments.  These
regions were, effectively, imposing only a mature, symptomless fruit measure on imported US
apples.
4.184  The United States  noted that compliance with the US Export Apple Act did not require
inspection of apple orchards, and there was no state regulation or requirement that requiredorchard inspections.  As the scientific evidence demonstrated that harvested fruit would be mature
and symptomless, regardless of whether they were harvested from orchards with fire blight or
without, orchard inspections for fire blight were neither necessary nor relevant to ensure that
exported apple fruit would be mature and symptomless.
4.185  Japan  noted that the experts appointed by the Panel had unanimously acknowledged that
it would be reasonable to establish a fire blight-free orchard, to implement field inspection(s) and
to require certification that the apple fruit were indeed produced in a fire blight-free area, in order
to achieve Japan’s appropriate level of protection.
4.186 The United States  stated that it was not arguing that compliance with the US Export
Apple Act as such would constitute the alternative measure that was reasonably available,although compliance with US law did achieve Japan’s appropriate level of protection.  Rather,
consistent with Article 2.2, Japan could require that imported apple fruit be restricted to mature
apple fruit.  Such a measure was reasonably available, achieved Japan’s appropriate level of
protection, and was significantly less restrictive to trade than Japan’s current fire blight measures.
The United States also commented that Japan's assertion that the experts had agreed that a fireblight-free orchard would be reasonable, misrepresented both the context and the content of the
experts' answers at the expert session.  In discussing certain measures as candidates for a
"compromise", the experts were no longer commenting on matters within their expertise or
mandate to provide scientific and technical advice on the scientific evidence relating to fire blight
and exported apple fruit.
                                                     
131 Under the US Export Apple Act, exported apple fruit had to be of a Federal or State grade that
met a minimum quality established by regulation.  Those regulations (7 C.F.R. § 33.10) currently requiredexported US apples to satisfy at least the requirements  for the "U.S. No. 1" grade, pursuant to which apples
had to be: mature but not overripe, carefully hand-picked, clean, fairly well-formed; free from decay,internal browning, internal breakdown, bitter pit, Jonathan spot, scald, freezing injury and broken skin or
bruises except those which were incident to proper handling and packing.  The apples were also free from
damage caused by sunburn or sprayburn, limb rubs, hail, drought spots, scars, stem or calyx cracks, disease,insects, [or] damage by other means".  Thus, US law and regulations required that exported fruit be mature(and also free from any disease symptoms). Apple fruit for export were inspected by Federal-Stateinspectors for compliance with the requirements of the US Export Apple Act, the applicable grade standard,
and any additional phytosanitary requirements of the export market.  Upon completion of the inspection,
including sampling of the shipment and visual inspectio n for pests and/or disease, an export certificate was
issued as to the quality/condition of the apples and a separate phytosanitary certificate was issued as tofreedom of quarantine pests/disease and a statement as to the required treatment.WT/DS245/R
Page 59
4.187  Japan  stated that the United States had not defined exactly what "mature, symptomless"
fruit would mean.  Nor had the United States defined specific means to produce, select and export
only such apple fruit.  In Japan – Agricultural Products II , the Appellate Body had held that,
under the prima facie rule, a measure should be argued and proven by the complaining party, and
the Panel was not allowed to compare the existing measure with another hypothetical  measure
that the complaining party did not  prove to be equally effective.  In this case, there was no
evidence provided by the United States that there was indeed an alternative "measure" which
would ensure that apple fruit shipped to Japan were of adequate quality.  Consequently, Japan
requested the Panel to consider not the hypothetical or ideal "mature, symptomless" criteria,
which the United States did not prove actually existed, but the ambiguous nature of the "mature,
symptomless" criteria as presented in this proceeding.  Japan maintained that the United States
had not met its burden of proof that such apples would indeed meet Japan’s level of protection.
4.188  The United States  described the normal procedures for apples destined to  markets other
than Japan.   Apples were harvested when the growers and consultants had determined that the
variety within the local growing location had reached optimum level of maturity for the various
marketing seasons; i.e., early, mid-season, and late season.132  Apples were harvested into bulk
bins and typically were delivered to cold storage facilities the same day as harvested, or the
following day (after overnight cooling in the orch ard).  Upon delivery to the cold storage/packing
facility, the field-run apples were placed in either regular cold storage rooms or in controlled
atmosphere ("CA") rooms.  Temperatures were maintained at, or near, 32 degrees F.  In CA
rooms, the oxygen was also maintained between 1% and 5%.  Due to the ability to preserve fruit
condition for 12 months or more under CA conditions, the duration of storage was determined by
the marketing plan of the growers and packing facilities and varied from several days to severalmonths.  As the fruit was needed for the market, it was removed from storage, separated from
leaves and other debris, and washed, sized, sorted, and graded by packing facility personnel.
133
Following grading the fruit was placed in the packages or containers that were used for shipmentand the shipping cartons were properly labeled as to variety, grade, size, responsibility, origin,
etc.
4.189  Prior to export, the apples were inspected by the Federal-State inspectors (eg.,
Washington State Department of Agriculture inspectors working under cooperative agreements
with US Department of Agriculture, Agricultural Marketing Service ("USDA-AMS") and Animal
Plant Health Inspection Service ("USDA-APHIS")) .  The apples were inspected for compliance
with the applicable grade standard, the require ments of the US Export Apple Act, and the
phytosanitary requirements of the receiving foreign country.  The phytosanitary inspection
included sampling of the shipment, visual inspection for pests and/or disease, and whenapplicable, certification of treatment.  Upon co mpletion of the inspection, an export certificate
was issued as to the quality and condition of the apples.  A separate phytosanitary certificate was
issued as to freedom of quarantine pests or disease and a statement as to the required treatment.
4.190  The United States explained that given the multiple human and machine-based
examinations that each fruit was subjected to, a nd the strict grade requirements that categorically
                                                     
132 For example, according to the Washington St ate Apple Commission, in mid-August, apple
growers started testing the maturity of their apples to  accurately predict when to harvest their crop to put in
controlled atmosphere rooms so the apples are mature, but not too ripe.  Firmness, skin color, seed color,
sugar level and flesh chlorophyll were tested.
133 Sometimes apples were pre-sorted and pre-sized, but not packaged, and returned to cold storage
in field bins.  When needed to fill an order for market, the particular variety, grade, and size of apples was
taken from cold storage, given a final washing, so rting/grading, and was then placed in the shipping
container and labelled.WT/DS245/R
Page 60
excluded immature fruit, it was extremely unlikel y that an immature fruit would be included in a
carton of mature, export-quality apple fruit.  The harvest process involved careful and repeated
assessment of the maturity of apple fruit utilizing numerous objective criteria.  Any very small
apples (those most likely to be immature) were eliminated from fresh market packs for
commercial reasons; i.e., they were not saleable.  Apples were held in cold storage for a period of
several days to several months (the vast majority being held for months), during which time the
apples continued to ripen, although at a greatly reduced rate.  Any immature fruit that had
inadvertently been harvested would likely show sh rivelling and might also show signs of chilling
injury (depending upon storage temperature), making such a fruit more easily detectable during
the subsequent sorting and grading operations.  According to the United States, the scientific
experts had confirmed that harvested fruit were mature and therefore not infected; any immature,
infected fruit would not be exported.
4.191  Japan  noted that a risk  of accidental contamination or erroneous grading was very real,
as had been recognized by the experts appointed by the Panel, given the obvious possibility of
human errors. While the degree of the risk was open to discussions, the experts had
acknowledged that a phytosanitary measure should be in place to manage that risk.  In this
context,  Japan indicated that in November 2002, Chinese Taipei had discovered codling mothlarva in apple fruit shipped from the State of Washington.  Apparently, the commercial screening
had not been rigorous enough to detect the codling moth larvae holes.  This was exactly one of
the risks which Japan's measures were necessary to protect against.  In other words, the United
States was proposing to replace the current phyto sanitary requirements with something (i) the
efficacy of which had been demonstrated to be questionable and was not known and (ii) thequality of which the United States did not guarantee.  It would be a grave mistake to assume the
proposal would achieve Japan's appropriate level of protection or would provide security at a
level comparable to that of the current requirements.
4.192  The United States  noted that Japan evidently relied  on the export of mature,
symptomless fruit.  Japan had stated that "[t]hese pieces of evidence demonstrate that aphytosanitary measure is needed to counter the risk of dissemination arising from the ambiguity
of the mature, symptomless criteria and that the accidental or intentional failure on the part of
American growers/shippers to ship apple fruit of  the adequate quality".  However, Japan’s fire
blight measures did not counter the unestablished and hypothetical risk of accidental or
intentional shipment of immature, infected fruit.  Even under the measures Japan had had in place
for the past eight years, a US grower or shipper complying with all of  the Japanese fire blight
measures hypothetically might still accidentally, or intentionally, include an immature, infectedfruit in a bin containing fruit intended for export to Japan – or in a container with any other
product being exported to Japan.  Japan’s fire blight measures would not protect against the risk
of that occurring.  However, as Japan had im plicitly acknowledged by implementing the current
measures, Japan was protected against hypothetical risks such as these precisely because the
exported commodity was the exported commodity.
4.193  The United States claimed that the scientific evidence established that a harvested fruit
would be horticulturally mature, and that the experts had confirmed that mature apples were not
infected.  (Despite Japan's insistence over the subjectivity of the "mature, symptomless" criteria,
Japan had not provided any scientific evidence that the terms "mature" and "symptomless" were
not objective concepts.)  Horticultural maturity was measured according to objective criteria, andgrowers, distributors, and exporters applied such criteria to ensure product that was commercially
saleable and of high quality.  US grading standards and law, enforced by Federal-State inspectors,
required exported apples to be mature and symptomless. Therefore, the scientific evidenceWT/DS245/R
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indicated that exported US apples were not infected and did not pose a risk of introducing fire
blight to Japan.
4.194  Japan  contended that when the experts had stated that there was no scientific evidence of
"mature, harvested" apple fruit disseminating fire blight disease, they had made clear that
"mature, symptomless", "mature" or "mature, harvested" apple fruit were concepts open to a
variety of interpretations.  Similarly, they acknowledged that "symptoms" might not be detectablein diverse circumstances.  In sum, what the experts had confirmed was that an ideal  mature,
symptomless apple fruit would bear only a very low degree of risk.  In real life, however, there
were a host of possibilities between immature, blighted apple fruit and ideally  mature,
symptomless apple fruit, and the experts acknowledged that maturation was a continuous process.
Moreover, according to Japan, the experts had unanimously acknowledged that there was a real
risk of dissemination from the bacteria inside an infected apple fruit, inadvertently or erroneously
found fit for export. In particular, Japan believed that Dr Smith had clearly stated that the risk hadto be "managed".
4.195  Japan further argued that the concept of "maturity" was easily manipulated.  Referring to
the declaration of Dr van der Zwet and the letter from Professor Thomson, Japan observed that it
had taken two separate negotiations with these authors for them to claim that what they had
previously written was not true.  Nevertheless, the experts were not certain under which concept,physiological or commercial maturity, the tested apples had been "immature".  Consequently, the
"mature, symptomless" criteria were based on subjective, relative concepts that did not provide
sufficient certainty to serve as the basis for phytosanitary measures.  The Organization of
Economic Co-operation and Development (OECD) Guidelines provided "objective tests for
determining ripeness of fruit", but for the purpose of standardizing marketing practices, forconsumer convenience.  These Guidelines were not based on bacteriological principles and did
not take into account phytosanitary concerns.
134  Moreover, it would be extremely difficult to
enforce the OECD Guidelines on every apple fruit shipped to Japan so as to ensure that security
was maintained.
4.196  Japan argued that the "mature, apparently healthy" apple fruit criteria could offer
security only when the mechanism by which the bacteria did not exist in such fruit was
identified.  An appropriate test method of determining ripeness of apple fruit could then be
developed taking into account the mechanism.
4.197  The United States  explained that the OECD guidelines specified several methods and
instruments that could be used for the determinat ion of horticultural (or commercial) maturity of
apple fruit.  Of the four methods given in the OECD guidelines, three were routinely used by
growers, fieldmen, and packinghouse personnel in the United States to determine correct harvestmaturity:  firmness, soluble solids, and starch.
135
4.198  According to the United States, the fact that Japan’s fire blight measures were more
trade-restrictive than necessary was also evident from the range of other possible measures that
were less trade-restrictive and that would more than achieve Japan’s appropriate level of                                                     
134 OECD Scheme for the Application of International Standards for Fruit and Vegetables  (1998)
Guidance on Objective Tests for Determining the Ripeness of Fruit.
135 As reflected in the OECD guidelines, fruit samples were evaluated sequentially during the pre-
harvest and harvest period to determine the point at which the fruit exhibited a combination of firmness,
soluble solids, and starch index values that were optimum for the proposed use of the fruit, which could
include immediate sale on the fresh market, regular atmosphere cold storage, or short- to long-termcontrolled atmosphere storage.WT/DS245/R
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protection.  Japan could, for example, require a phytosanitary certificate of fire blight freedom for
the exported commodity (mature apple fruit).  Other examples of such alternatives included:  (1)
requiring that imported mature, symptomless fruit be harvested in Washington or Oregon;  (2)
requiring that imported mature, symptomless fruit be harvested at least 10 meters from a source
of inoculum;  or (3) requiring that mature, symptomless fruit be treated with chlorine.  As thescientific evidence established that billions of exported apple fruit had never transmitted fire
blight and mature, symptomless fruit were not a pathway for the disease, any of these less trade-
restrictive measures would more than achieve Japan’s appropriate level of protection - although,
for the same reason, they also would be more trade-restrictive than necessary.  Only a
requirement that exported US apples be mature and symptomless could be considered as
necessary given the scientific evidence.
4.199  Restricting importation of US apples to mature, symptomless fruit would also be
significantly less restrictive to trade than the current Japanese fire blight measures.  The United
States recalled that one comprehensive scientific study had estimated that only 1% of US apples
were harvested from orchards that satisfied all of Japan's fire blight measures.  Under the US
proposed alternative measure, by definition, all US exports would qualify for export to Japan.
136
4.200  Japan  emphasized that the burden to prove that the real risk arising from the ambiguity
of the "mature, symptomless" criteria was negligib le lay with the United States.  In this respect,
the United States’ only evidence was the statistics of successful shipments with Saudi Arabia, the
United Arab Emirates and six other countries.  This evidence had been fully refuted by Japan.
None of these countries of the desert or tropical regions had a climate comparable to that of
Japan.  To the contrary, Japan had submitted direct evidence of failure in ensuring adequatequality of apples by Washington apple growers and shippers.  Consequently, the United States
had not met its burden of proof that such apples would indeed meet Japan’s level of protection.
I. A
RTICLE 5.7
4.201  The United States  noted that Japan had invoked Article 5.7 as an alternative defence, but
it did not believe that Japan had met the necessary requirements under that provision.  As notedby the Panel and Appellate Body in Japan - Agricultural Products II , Article 5.7 set out four
requirements that had to be met in order to adopt a provisional SPS measure exempt from
Article 2.2.  Pursuant to the first sentence of Article 5.7, the provisionally adopted measure could
be imposed only "[i]n cases where relevant scientific evidence is insufficient" and had to be
adopted "on the basis of available pertinent information".  Pursuant to the second sentence of
Article 5.7, the provisional measure could not be maintained unless the adopting Member
"seek[s] to obtain the additional information nece ssary for a more objective assessment of risk"
and "review[s] the . . . measure within a reasonable period of time".  The four requirements "are
clearly cumulative in nature" and "[w]henever one of these four requirements is not met, the
measure at issue is inconsistent with Article 5.7".
137
4.202  Japan  stated that, should the Panel find that Japan's measure was maintained "without
sufficient scientific evidence" in the sense of Article 2.2, it argued in the alternative that itsmeasure was a provisional measure consistent with Article 5.7.  Japan maintained that this
alternative argument was necessary only in the event that the Panel should:  (1) reject Japan's
interpretation of the burden of proof;  (2) accept the interpretation but find satisfactory the
                                                     
136 Op. cit., Roberts et al.  (1998).
137 Appellate Body Report in Japan – Agricultural Products II , para. 89.WT/DS245/R
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"mature, symptomless" criteria;  or (3) otherwise find that the scientific evidence had become
insufficient.
4.203  Japan understood the initial US claim to be that there was, allegedly,  no longer  sufficient
scientific evidence for Japan’s phytosanitary requirements in light of information which had
become available some time after 1994.  However, the United States had failed to identify
specifically when they believed the scientific evidence underlying Japan’s measure becameinsufficient.
4.204  The United States  argued that it was not claiming that the scientific evidence suddenly
became insufficient to support Japan’s fire blight measures at some point after 1994.  There had
never been scientific evidence that mature apple fruit transmitted the disease.  This evidence
predated the entry into force of Japan's fire blight measures in 1994 and continued to be the same.
Thus, Japan had been acting inconsistently with its commitment under Article 2.2 not to maintain
its fire blight measures without sufficient scient ific evidence since the entry into force of the SPS
Agreement  in 1995.
4.205  Japan  recalled that its current phytosanitary requirements were introduced on the basis of
an agreement between the two governments, in order to allow importation of US apple fruit while
preserving Japan’s appropriate level of protection.  The measures had been developed on the
basis of proposals from the United States, hence it was unreasonable for the United States to nowclaim that the evidence had been insufficient from the beginning.  Nonetheless, Japan clarified
that, should the Panel find the scientific evidence insufficient to support Japan's measure under
Article 2.2, the measure could be considered to be a provisional measure in the context of
Article 5.7 since the date of entry into force of the SPS Agreement .
4.206  The United States  reiterated that it had acquiesced to the fire blight measures in 1994 as
preferable to an outright ban on imported apple fruit, although it had recognized that the scientific
evidence did not support the restrictions imposed by Japan.  It had never accepted the consistency
of these measures with Japan’s WTO obligations.
4.207  The United States argued that the Panel’s analysis of Japan's alternative defence could
begin and end with the first requirement that the provisional measure be imposed only "[i]n caseswhere relevant scientific evidence is insufficient".  This required that, at the time the provisional
measure was adopted, the information necessary for an objective assessment of risk was lacking.
If there had been sufficient information to conduct a risk assessment and that information
supported a measure, there would be no need to adopt a measure "provisionally", since it could be
adopted "based on" the risk assessment pursuant to Article 5.1.  Likewise, if there were sufficient
information to conduct a risk assessment and that assessment indicated that a measure was not
justified, a Member which would not be able to adopt a measure under Article 5.1 should not then
be free to adopt a measure "provisionally" under Article 5.7.  Otherwise, the obligation in
Article 5.1 would become meaningless.
4.208  The United States contended that "sufficiency" in the first sentence of Article 5.7 should
be understood to relate to the information available for a risk assessment.  This was also
supported by the language of the second clause of that sentence.  "In cases where relevantscientific evidence is insufficient", provisional measures could be adopted "on the basis of
available pertinent information including that from the relevant international organizations as
well as from ... phytosanitary measures applied by other Members".  It would not be necessary to
adopt a measure "on the basis of" such "available pertinent information" if the measure could be
"based on" a risk assessment (which presupposed that there was sufficient scientific informationWT/DS245/R
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to conduct the risk assessment).   Thus, the phrase "[i]n cases where relevant scientific evidence
is insufficient" indicated that a provisional measure could be taken only where some piece of
scientific evidence bearing on or pertinent to a more objective assessment of risk was unavailable.
Japan had not demonstrated that the relevant scientific evidence was insufficient.
4.209  Japan  recalled that Article 5.7 did not define what a "provisional measure" was, but
conferred on an importing Member a right to "provisionally" adopt an SPS measure, subject to
the conditions therein.  The text of the Article suggested that a "provisional" measure was one
that would meet the two requirements in the first sentence of the Article, namely:  (i) the measure
was imposed in respect of a situation where "relev ant scientific information is insufficient";  and
(ii) the measure was adopted "on the basis of available pertinent information".  Indeed, the
Appellate Body in Japan – Agricultural Products II  appeared to concur with this interpretation
when it stated, "even if the varietal testing requirement were considered to be a provisionalmeasure adopted in accordance with the first sentence of Article 5.7 …".
138  Nonetheless, even if
the Panel were to conclude that "provisionality" related to the length of time, Japan’s measure
was "provisional" because only eight years had passed since the introduction of the current SPS
measure.
4.210  The United States  contended that the scientific evidence in this case was more than
sufficient to establish that imported mature apple fruit did not pose a risk to plant life or health
within Japan.  The scientific evidence established that exported fruit had not resulted in
introduction of fire blight to new areas, despite billions of fruit traded.  Major reviews of the
scientific evidence related to the epidemiology of the disease had either not considered it
necessary to describe the insignificant risk posed by trade in fruit or had explicitly concluded thatfruit were not implicated in spread of the diseas e.  The scientific evidence also established that
mature apple fruit were not a pathway for the diseas e.  According to the United States, the experts
had confirmed that any hypothetical pathway would not be completed because for every such
pathway there was at least one step for which there was no scientific evidence in support.  This
was not a case where the relevant scientific evidence was insufficient;  the evidence was morethan sufficient to establish that imported apple fruit had never transmitted and were not a means
of introduction of fire blight to Japan.  As a result, the first requirement under Article 5.7 was not
satisfied, and Japan could not adopt provisional measures pursuant to that provision.
4.211  Japan  believed that considerable scientific evidence existed to support its measure to
control the risk of fire blight in US apples.  If the Panel were to find that this evidence was not
sufficient under Article 2.2, it was nonetheless "available pertinent information" in the context of
Article 5.7.  These pieces of evidence demonstrated that a phytosanitary measure was needed tocounter the risk of dissemination of fire blight via imported US apples.
4.212  The United States claimed that Japan had not identified specific "available pertinent
information", but instead made vague references to "foreign SPS measures and a range of
literature".  Even if one were to consider the information that Japan had put forward with respect
to Article 2.2 as "available pertinent information", this would not support the measure.  None ofthis information even suggested that mature appl e fruit could serve as a pathway for fire blight.
Furthermore, foreign fire blight measures in the vast majority of cases either supported the
opposite conclusion (they were non-existent or minimal and had nevertheless not resulted in fire
blight transmission) or related to the prevention of fire blight spread on host plants (rather than on
                                                     
138 Appellate Body Report in Japan – Agricultural Products II, para. 94.WT/DS245/R
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fruit), such as the buffer zone measures.139  Speculation was not enough to justify application of a
"provisional" measure under Article 5.7.  If speculation were sufficient, Members would not need
to conduct risk assessments, nor would they need to maintain measures with sufficient scientific
evidence;  Article 5.7 would simply swallow the rest of the SPS Agreement .
4.213  Japan  argued that it was evident that its measure was based on available information,
including the SPS measures of other Members and a range of literature.  Evidence whichsupported its position included:
(i) Recovery of the bacteria in van der Zwet et al. (1990) and Hale et al. (1987)
from apparently healthy apple fruit at the very late stage of development
("mature/immature");
(ii) ambiguity of "maturity" as confirmed by the experts;
(iii) critical importance of the "symptomless" status as confirmed by the experts;
(iv) failure in the export practice of Washington apple growers/shippers as
demonstrated by the codling moth incident;
(v) overall confirmation by the experts of the presence of a real "risk" (which
included completion of the pathway) of dissemination of the disease from apple
fruit;
(vi) unknown fate of the bacteria inside the apple fruit;
(vii) relevant scientific evidence for each component of the measure in question,
included in scientific literature, international standards and SPS measures of
other Members;  and
(viii) several scientific articles supporting each step of the pathway.
4.214  In reply, the United States  claimed that even a cursory review of Japan's evidence
revealed that it did not relate to the steps in Japan's hypothetical pathway.  Likewise, the
"evidence" did not constitute "pertinent available information" within the meaning of the first
sentence of Article 5.7 because it was, in certain instances, nothing more than speculative (items
(i) to (vi)) and, in others, not "pertinent" to the exported commodity (items (vii) and (viii)).
4.215  The United States contended that Japan had also failed to meet the requirements of the
second sentence of Article 5.7, to "seek to obtain the additional information necessary for a more
objective assessment of risk".
4.216  Japan  recalled that the Appellate Body in Japan – Agricultural Products II , had stated
that "Article 5.7 does not specify what actual re sults must be achieved; the obligation is to 'seek
to obtain' additional information".
140  Japan had proposed, and implemented part of, a joint study
by experts of both countries in 2000 for the purpose of verifying if the current measure could be
replaced with another measure maintaining the same level of protection.  Japan was also seeking
                                                     
139 Exhibit USA-14 details fire blight measures imposed on imported apples in fire blight-free
areas.
140 Appellate Body Report in Japan – Agricultural Products II , para. 92.WT/DS245/R
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additional information on five items from the United States for the purpose of a "more objective
assessment of the risk", as had been noted in paragraph 4.175, above.
4.217  The United States  argued that Japan’s actions in connection with the joint study actually
confirmed that it had not been seeking such additional information.  Notwithstanding the clear
confirmation through this study of results which had been presented to Japan over the previoustwelve years, Japan had waited eight months after the results became known to inform the United
States of the alleged flaws in a study it had proposed and previously agreed to, and asked five
questions to which it knew the answers.  Ja pan had waited until the 2001 harvest season was
under way to comment, at which point it was too late to change its measure to allow shipment of
that crop, ensuring at least another year without significant US apple imports.  This, the United
States maintained, was evidence that Japan had affirmatively avoided relevant additional
information.  Furthermore, the United States claimed that even if Japan’s participation in the jointstudy could be considered an effort to obtain additional information with respect to the presence
of E. amylovora  in mature apple fruit, it provided no information with respect to other elements
of the pathway.  Here as well, Japan’s refusal to acknowledge information submitted to it over the
previous 12 years supported the conclusion that it was not seeking this information, but avoiding
it.
4.218  The United States claimed that Japan had also failed to meet the requirement of the final
element of Article 5.7, that it "review ... the ... measure within a reasonable period of time".  In
Japan – Agricultural Products II , the Panel had correctly concluded that Japan could not meet
this requirement if it was not even seeking the relevant information.
141  Japan in its 1996 and
1999 pest risk assessments had never examined, let alone sought, information and evidence oncritical elements of the pathway for transmission of fire blight, nor had Japan done so since.
Under these circumstances, it was clear that Japan had not reviewed the measure in the nearly
eight years since 1995, notwithstanding the periodic restatements (in response to US prodding) of
its speculation that mature apple fruit posed a risk of transmitting fire blight.
4.219 Japan  stated that the Appellate Body had held  that "[i]n our view, what constitutes a
'reasonable period of time' has to be established on a case-by-case basis and depends on the
specific circumstances of each case, including the difficulty of obtaining the additional
information necessary for the review and the characteristics of the provisional SPS measure".
142
The current SPS measure had first been introduced in August 1994, and only eight years had
passed since then.  A full review had been made of the measure at the time of the 1996 PRA, and
again in 1999, satisfying the requirement of a review in the second sentence.  Japan further noted
that new information for a further review would not be forthcoming unless the United Statescooperated, and the process of generating information naturally took time, as was evident from
the history of the two experiments conducted in 2000.  Japan also noted that it faced difficulties in
obtaining additional information through ecological studies.  Japan was unable to perform such
studies independently as it did not have native fire blight bacteria.  As such, cooperation from the
United States was essential.
4.220 The United States  did not believe that a provisional measure needed to be so identified at
the time it was adopted, as Article 5.7 did not provide for such a requirement.  However,
subsequent actions by the Member adopting the measure could demonstrate that a provisionally
                                                     
141 Panel Report in Japan – Agricultural Products II , para. 8.58.
142 Appellate Body Report in Japan – Agricultural Products II , para. 93.WT/DS245/R
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adopted measure that satisfied the requirements of the first sentence might not continue to benefit
from the qualified exemption under Article 5.7.
4.221 Japan  agreed that there was no requirement under Article 5.7 for a Member to label its
measure as "provisional".  The Article allowed the Member to adopt the measure "provisionally"
until such time when a more objective risk assessment was performed and a new measure was
introduced within a reasonable period of time, if necessary, as a result of the risk assessment.While Japan’s phytosanitary requirements were not formally labelled as a "provisional
regulation", the regulations establishing these requirements were in the form of a Ministerial
Ordinance or other less authoritative documents, which could easily be amended.
J. A
RTICLE 7 (ANNEX B )
4.222  The United States  claimed that despite years of bilateral discussions with Japan on its
fire blight measures, Japan had not complied with its basic notification obligations under
Article 7 and Annex B of the SPS Agreement .  Japan had substantively changed its fire blight
measures since the entry into force of the SPS Agreement  in 1995, but it had failed to notify these
changes. This made it significantly more difficult for WTO Members to understand exactly what
measures Japan had imposed to address fire blight.  Specifically, Japan appeared to have amended
or introduced MAFF Notification No. 354 on 10 March 1997, which set the requirements for
imports of US apples, and MAFF "Detailed Rules for U.S. Apples" on 1 April 1997, whichimplemented Notification No. 354, without notifying WTO Members.  By failing to notify the
changes made to its fire blight measures through these two instruments, Japan had acted
inconsistently with Article 7 and Annex B, paragraphs 5 and 7, of the SPS Agreement .
4.223  Japan  countered that it had not substantively changed its fire blight measures since the
entry into force of the SPS Agreement  in 1995.  Japan had notified that it would designate
E. amylovora  as one of the diseases that triggered import prohibition as from 1 April 1997, in
accordance with the provisions of Article 7 and Annex B.
143  This change of the regulatory status
of E. amylovora  did not affect in any way the measure at issue, which had already been in place.
The bacterium had already been placed in a high-risk category at the time of the introduction of
the phytosanitary measure.  No Member made any comments regarding the designation by thedeadline set out in the notification of 17 February 1997.  The amendments to the Notification and
the Detailed Rules in 1997 were technical re-phrasing of the regulations reflecting the designation
of the bacterium, and did not modify, in any way, the phytosanitary requirements against fire
blight.  The obligation of a Member under Article 7 of the SPS Agreement  was to notify
"changes" in its phytosanitary "measures".  Japan argued that it was thus fully compliant with the
provisions of Article 7 and Annex B.
K. 
ARTICLE XI OF GATT
4.224  The United States  claimed that Japan had acted inconsistently with its obligations under
Article XI of GATT 1994.  GATT Article XI pr ohibited Members from using prohibitions or
restrictions on imports other than duties, taxes, or charges.  The Japanese fire blight measures
prohibited the importation of apples from the United States unless produced, harvested, and
imported according to Japan’s fire blight restrictions.  Thus, Japan had acted inconsistently withGATT Article XI.
                                                     
143 G/SPS/N/JPN/19, 17 December 1996.WT/DS245/R
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4.225  In respect of Article XI of GATT 1994, Japan  countered that it had established that its
measure was consistent with the SPS Agreement , and invoked Article 2.4 of the SPS
Agreement .144
L. ARTICLE 4.2 OF THE AGREEMENT ON AGRICULTURE
4.226  The United States  claimed that Japan had also acted inconsistently with its obligations
under Article 4.2 of the Agreement on Agriculture.  Article 4.2 of the Agreement on Agriculture
prohibited Members from maintaining, resorting to, or reverting to any prohibited measures, such
as quantitative import restrictions, that impeded market access.  The Japanese fire blight measures
prohibited the importation of apples from the United States unless produced, harvested, and
imported according to Japan’s fire blight restrictions.  Thus, Japan had acted inconsistently with
Article 4.2 of the Agreement on Agriculture.
4.227  In respect of Article 4.2 of the Agreement on Agriculture, Japan  argued that the measure
in question was not a measure which had been "required to be converted into ordinary customs
duties", and therefore was not prohibited under that article.145
V. SUMMARY OF THIRD PARTY SUBMISSIONS
A. AUSTRALIA
5.1 Australia noted that fire blight was a serious disease of apples and pears, in terms of the
potential biological and economic consequences.  Australia and Japan were among the very few
fire blight disease-free countries where it was possible to grow apples and pears on a
commercially significant basis.  In accordance with the SPS Agreement , WTO Members were
entitled to take measures that might be necessar y to prevent the entry, establishment or spread of
exotic disease or pests.  Those rights did not require positive proof that the disease or pest inquestion would be introduced through an importe d product.  Rather, a WTO Member maintained
the right to take measures to guard against the likelihood of disease or pest transmission through
an imported product.
1. Burden of proof
5.2 In Australia's opinion, the adopted reports of several relevant WTO disputes had clarified
that the burden of proof rested on the complainant party and that assertions, in the case of the SPS
Agreement , had to be supported by relevant and reliable scientific evidence.  The Appellate Body
in EC –  Hormones  had acknowledged the importance of correctly allocating the burden of proof
in SPS disputes, which raised "multiple and complex issues of fact".
146  The Appellate Body had
stated that the complaining party bore the initial burden of proof to establish a prima facie case of
inconsistency with an identified provision of the SPS Agreement .  The Appellate Body had
reiterated that:
                                                     
144 See also Japan's procedural argument, paragraphs 4.1-4.3.
145 Ibid.
146 Appellate Body Report in EC - Hormones , para. 97.WT/DS245/R
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"a prima facie case is one which, in the absence of effective refutation by the
defending party, requires a panel, as a matter of law, to rule in favour of the
complaining party presenting the prima facie case".147
2. Standard for developing a prima facie presumption
5.3 Australia considered that when developing a prima facie case, all assertions must be
documented and relate to relevant legal tests including the likelihood  of entry, establishment or
spread.  Scientific evidence to support a prima facie  presumption should be valid scientific
evidence, based on scientific principles, including scientific studies.  In Australia's view, it was
insufficient to assert that there was no evidence of entry, establishment or spread of the disease in
question associated with the import of the product at issue, or according to a measure which
might be applied.
5.4 In the case before the Panel, it was Australia's assertion that the United States bore the
burden of establishing a prima facie case that there was not a rational or objective relationshipbetween Japan’s measures and the scientific evidence.  In doing so, it was Australia’s contention
that the United States could not rest its case on assertions about the quality and quantity of
scientific evidence relied upon by Japan.  The arguments of the United States had to be supported
by scientific evidence.
3. Conflicting scientific evidence and opinion
5.5 According to Australia, scientific evidence need not be monolithic in character and that
conflicting scientific evidence was not unusual;  in fact, it was rare for scientific opinion to be
unanimous.  As such, minority scientific opinion, based on valid scientific data, could not be
discounted as evidence.  The Appellate Body in EC – Hormone s, recognizing the realities of
conflicting scientific evidence , had considered that a risk assessment need not come to a
"monolithic conclusion" that coincided with the scientific conclusion or view implicit in the SPS
measure.
148  Nor had a risk assessment to embody only the majority scientific view.  Further, the
Appellate Body had emphasized the need for a practical or "real world" approach to risk.  A risk
assessment was not confined to an examination of only those factors susceptible to quantitative
analysis by empirical or experimental laboratory methods.149
5.6 In the case before the Panel, Australia argued that even when limited to mature and
symptomless apples, the available science showed there was no monolithic opinion on the risk of
transmission of fire blight through fruit.  In reply to a question from the Panel, Australia provided
its understanding of the conflicting views regarding the presence or absence of infestation and of
infection of fruit with fire blight.  Australia identified the following studies as supporting a view
of  infestation  (surface colonization) of fruit with E. amylovora:
                                                     
147 Ibid.,  para. 104.
148 Ibid. , para. 194.
149 Ibid., para. 187.WT/DS245/R
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Hale et al.  (1987) Isolated viable E. amylovora  from 3% of harvested mature apples from
a severely infected orchard (natural infection).
Sholberg et al.  (1988) Isolated viable E. amylovora  from 100% of fruit harvested in
September (coinciding with commercial harvest) from symptomless
apple trees grown adjacent to blighted pear trees.
Isolated an average of 103.3 colony-forming units (cfu) per ml of viable
E. amylovora  at harvest, from naturally contaminated, blemish free and
apparently healthy fruit from an orchard severely damaged by fire
blight after a hail storm.
van der Zwet et al.  (1990) Isolated viable E. amylovora  from the calyx, stem-end and surface of
apples, some harvested in September, from naturally infected orchards
in West Virginia and Utah.
In West Virginia, 5% (2/40) of healthy Delicious variety fruit
harvested 30 km away from infected orchards (see Methods section -Geographic survey) had calyx infestation. The population of
E. amylovora exceeded 1000 cfu per fruit.
Mature, symptomless, non-disinfested fruit (4%) developed blight
symptoms following injury (fruit injury experiment).
Australia understood that the maturity of the fruit used in the
experiments was either:  (i) "mature" (harvest date inferred as mid-
October);  (ii) "collected at harvest" (i.e. September – the use of the
word "harvest" supported an assumption of maturity);  (iii) "developing
fruit" (use of the word "developing" supported the assumption that the
fruit was not mature;  (iv) "harvested in August and September" (use ofthe word "harvested" supported an assumption of maturity); and (v)
"sampled in late July, August and September" (the apparent avoidance
of the terms "harvest" and "developing" supported the assumption
these fruit were of mixed maturity).
On the other hand, Australia understood the following studies to support a conclusion of non-
infestation of mature apple fruit:
Dueck (1974) Did not isolate E. amylovora  from external tissues of 60 mature apples
harvested from severely infected trees (natural infection).
Hale et al.  (1987) Did not isolate E. amylovora  from 1300 mature apples harvested from
two lightly (naturally) infected and three symptomless orchards.
Clark et al.  (1993) A DNA hybridization method did not detect E. amylovora  in calyxes
of either immature or mature apples harvested from within 20 cm ofthe inoculum source, in a season not conducive for spread of fire
blight.
Hale et al.  (1996) E. amylovora  was not detected either in the calyxes or on the surfaces
of  mature 173 fruit harvested (even) within 5 cm of inoculum sites,
approximately 4 months after artificial inoculation.WT/DS245/R
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With respect to the infection  (internal colonization) of mature fruit with E. amylovora, Australia
noted that the following studies supported a positive finding:
Goodman (1954) Recovered viable E. amylovora  from the tissues "directly beneath the
skin" of several apples that were retained on trees until February.These trees had been severely affected during the previous growing
season.  The report stated that the fruit had moist flesh, indicating that
they were not mummified and therefore supporting the conclusion that
they had developed normally.
van der Zwet et al.  (1990) One per cent mature (harvested in October) surface sterilized fruit from
a disease free tree developed blight in storage. Australia noted that the
results of this experiment were confirmed by diagnostic testsconducted on a random sample of blighted fruit.
Recovered viable E. amylovora  from the internal tissue of mature
Rome Beauty and Delicious variety apples, grown in blighted orchards
in Utah. According to the Methods section Delicious fruit (for the
"blighted category") were collected from healthy trees located 1-2 mfrom severely blighted Jonathan trees.
Anderson (1952) Isolated viable E. amylovora  from mature pears that had been
artificially inoculated and held in cold storage for several months.  This
demonstrated that E. amylovora  could survive in mature pear fruit.
McLarty (1924), (1925)
and (1926)Isolated viable E. amylovora  from apples that had been artificially
inoculated on the tree when they were immature, allowed to mature
and then held in storage for several months. This demonstrated thatE. amylovora  could withstand the physiological changes in fruit as it
matured.
5.7 In contrast, Australia indicated that the following studies supported a negative finding of
internal E. amylovora  in mature apple fruit.
Dueck (1974) Did not isolate viable E. amylovora  from internal tissues of 60 mature
apples harvested from severely infected trees (natural infection).
Roberts et al.  (1989) E. amylovora  was not recovered from core tissues of 1,555
symptomless fruit harvested from blighted trees and cold stored. The
authors clearly indicated that the fruit they had used in theirexperiments were  mature. The harvest dates ranged from late August
through to late September. Washington is at a higher latitude and
therefore fruit grown in West Virginia or Utah was expected to mature
earlier or at a similar time, subject to varietal differences.
Roberts (2002) E. amylovora  symptoms were not observed on core tissues of 1,500
symptomless fruit harvested from blighted trees (exposed to natural
and artificial inoculum).  Diagnostic tests on 500 of these fruit alsoproved negative. Australia noted that environmental conditions during
the experiment s reported in this work were apparently not conducive
for the disease.  Roberts et al (1989) in the discussion section noted the
implications of humid weather in Washington for the recovery ofWT/DS245/R
Page 72
E. amylovora  from fruit.
van der Zwet et al.  (1990) E. amylovora  was not recovered from the internal tissue of mature
apples grown in Washington, West Virginia and Ontario.
5.8 In accordance with these results, it was Australi a's view that the Panel should reaffirm the
principle that where there was conflicting science, governments could, in good faith, rely on
science that provided the appropriate level of protection the importing Member deemed
necessary.
4. The product at issue
5.9 Australia deemed it necessary to clearly identify the product at issue and to ensure that
claims, counterclaims, arguments and evidence related to the identical product.  In this context,
Australia recalled that in Australia – Salmon , the Appellate Body had found that the SPS measure
at issue in the dispute could only be the measure that was actually applied to the product at
issue.150 (emphasis added)  The United States in its request for a panel had identified the product
at issue as "apples".  As such, evidence submitted only in relation to mature, symptomless apples
would not be applicable to the first two tests of  Article 5.1 in establishing whether Japan’s risk
assessment met the criteria for a proper risk assessment.151  Because the United States had not
limited the product coverage of its complaint to mature, symptomless apples, it was Australia's
contention that a risk assessment would need to include an identification of the disease in applesof US origin, as well as the likelihood of entry, establishment or spread from all apples of US
origin, not just mature, symptomless apples.
B. 
BRAZIL
5.10 As a country with fire blight-free status that permitted the importation of US apples,
under the conditions set out below, Brazil had a special interest in this dispute.  As one of theworld's major exporters of agricultural products, Brazil was also interested in ensuring that the
SPS Agreement  was interpreted and implemented correctly.
1. Issues in relation to the SPS Agreement
5.11 Brazil noted that the United States claimed that Japan had acted inconsistently with
Article 2.2 of the SPS Agreement  because its measures were "maintained without sufficient
scientific evidence".  Article 2.2 of the SPS Agreement  states the general obligation of providing
sufficient scientific justification to underpin measures implemented by a Member.  It also statesthat sanitary and phytosanitary measures should be "based on scientific principles" and be
"applied to the extent necessary to protect human, animal or plant life or health".  In Brazil's
view, these three obligations should be taken into account together when determining whether or
not a country was acting in consistency with Article 2.2.
5.12 The intent of the SPS Agreement  was to protect human, animal, and plant health and life
from risks arising from trade in agricultural products while avoiding unnecessary restrictions to
                                                     
150 Ibid., para 103.
151 The first two tests to which Australia referred were the first two of three tests established in
paragraph 121 of the Appellate Body report in Australia - Salmon: identification of the disease and an
evaluation of the likelihood of entry, establishment or spread, as well as the associated consequences.WT/DS245/R
Page 73
trade.  For that reason, a sanitary measure should not only be based on scientific criteria but also
be applied only to the "extent necessary to protect human, animal or plant life or health.  In other
words, the measure should be the least restric tive to trade as possible.  This obligation was
reiterated in Article 5.6.
5.13 The best way for a country to comply with this requirement was to base its SPS
measures, to the extent possible, on international standards, guidelines, and recommendations.This was the desirable scenario for Brazil.  When countries based their measures on
internationally agreed standards, guidelines, and recommendations, they minimized potential
conflicts and reduced negative impacts to trade.
5.14 However, Brazil realized that countries faced situations where they had to adopt
measures that diverted from the international standard, guideline, or recommendation.  Where
specific circumstances related to the product and the pest required a different measure, countries
should base their measure on an appropriate risk assessment, that took into account "riskassessment techniques developed by the relevant international organizations", such as the IPPC.
The IPCC had developed objective criteria for pest risk assessments which, in Brazil's view,
helped countries to comply with their obligations under Articles 2.2, 5.1, 5.2 and 5.6 of the SPS
Agreement .
5.15 In this connection, Brazil recalled the findings of the Appellate Body in Australia -
Salmon  that a risk assessment within the meaning of Article 5.1 had to:
(i) Identify the diseases whose entry, establishment or spread a Member wants to
prevent within its territory, as well as the potential biological and economic
consequences associated with the entry, establishment or spread of these
diseases;
(ii) evaluate the likelihood of entry, establishment or spread of these diseases, as well
as the associated potential biological and economic consequences; and
(iii) evaluate the likelihood of entry, establishment or spread of these diseases
according to the SPS measures which might be applied.
5.16 Although the United States had not raised the question of equivalence of sanitary and
phytosanitary measures, for Brazil there seemed to be a close link between the US claims and theimplementation of Article 4 of the SPS Agreement .  Article 4 stated that "Members shall accept
the sanitary or phytosanitary measures of other Members as equivalent even if this measure
differs from their own or from those used by other Members trading in the same product".
Article 4 also indicated that in order for SPS measures to be considered equivalent, the exporting
country had to objectively demonstrate that the alternative measure achieved the appropriate levelof protection (ALOP) of the importing country, that  is, that its measure produced the same effect
in terms of achieving the ALOP of the importing country.  In this case, even if the Japanese
measures related to the import of US apples were consistent with the requirements of Article 2.2,
Japan should have given full consideration to the question of equivalence of the US sanitary
measures.  Brazil attached great importance to the implementation of Article 4 , which was a
useful tool for countries, especially developing country Members, to implement their obligations
under the SPS Agreement .WT/DS245/R
Page 74
5.17 Japan had submitted, as an alternative defence, that its measures were justifiable under
Article 5.7 of the SPS Agreement .  Brazil advocated a strict interpretation of Article 5.7 to prevent
its use as a disguised barrier to trade.  For a measure to be considered consistent with Article 5.7,
four requirements must be met fully and concurrently:
(a) "Relevant scientific information is insufficient";
(b) the measure is adopted "on the basis of available pertinent information, including
that from the relevant international organizations as well as from sanitary and
phytosanitary measures applied by other Members", (which meant that all
information relevant to the case should be taken into account);
(c) the country that applies the measure should seek to obtain "additional
information necessary for a more objective assessment of risk";  and
(d) the country that applies the measure should also seek to review the measure
accordingly within a reasonable period of time.
2. Brazilian phytosanitary measures on US apples  152
5.18 Although Brazil was fire blight-free, Brazilian legislation required only that the US
phytosanitary authorities certify that apples exported to Brazil be produced in fire blight-free
areas or receive post-harvest treatment.  Brazil stated that its sanitary measure was based on theavailable scientific information and was applied only to the extent necessary to protect its
territory from the entry and dissemination of the fire blight pest.
5.19 In specific terms, Instrução Normativa (Instruction Norm) No. 4/2001 of
11 January 2001, established specific sanitary requirements for some pests, including
E. amylovora  affecting apples produced in the United States.  This regulation covered two
situations where US apples could be exported to Brazil:
(a) Apples coming from non fire blight-free areas had to receive a post harvest
treatment before being exported.  US phytosanitary authorities had to certify that:
"The shipment was treated with TCM nº 14 to eliminate fire blight, under official
supervision attesting the treatment's efficacy for the pest".  TCM no. 14 requiredthat apples were submitted to an immersion bath with a chlorine solution at the
concentration of 100 ppm for 1 minute, with a view to eliminate fire blight.
(b) US phytosanitary authorities must certify that:  "The product was cultivated in an
area recognized by the phytosanitary authorities of the importing country as free
of fire blight, according with COSA VE Standard 3.2 - Requirements for
establishing pest free areas".
5.20 The Brazilian phytosanitary authorities had engaged in bilateral negotiations with their
US counterparts with a view to determining the area s considered free of fire blight.  After those
areas had been established, the only measure affecting the importation of US apples from pest-
free areas was a phytosanitary certificate attesting that the product came from one of the free
                                                     
152 Reply from Brazil to a question from the Panel, 13 November 2002.WT/DS245/R
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areas.  Apples were not required to undergo any further treatment or quarantine procedure.  Brazil
considered its measures on US apples to be in conformity with Article 6 of the SPS Agreement .
5.21 Brazilian requirements for the importation of apples from fire blight-free countries were
essentially the same.  The phytosanitary authorities of the exporting country had to certify that the
pest was not present in the country.
C. EUROPEAN COMMUNITIES
5.22 The European Communities stated that it was intervening as a third party because of
systemic interests related to the interpretation and application of the SPS Agreement .
1. Procedural issues
5.23 Japan, as the respondent party, had raised issues of general procedural interest for the
European Communities, especially in the context of relying on available scientific evidence to
support protection measures.
5.24 The European Communities noted that the United States had failed to state its claims with
regard to a number of articles that it had mentioned in the request for the establishment of the
Panel. The European Communities was of the view that the comprehensive identification of all
the claims at the earliest possible point in the procedure was of great importance for the correct
development of dispute settlement.153  The Appellate Body had made it clear on several occasions
that a Panel could not rule in favour of a complaining party "which has not established a primafacie case of inconsistency based on specific legal claims asserted by it".
154.   A panel could not
make a case for the complainant.  The issue of whether the United States had failed to
appropriately state all of its claims raised the further concern of whether the United States had
been able to submit a prima facie  case that Japan had violated certain provisions.
5.25 The European Communities was of the view that the practice of not stating all claims in
the first written submission prevented the respondent from using all the various stages of the
Panel procedure to properly defend itself.  This practice also prevented third parties from being
aware of the substance of certain claims at issue and making any pertinent contribution.
Furthermore the fact that the United States had deliberately chosen not to advance arguments on
all claims in this case, and then to defend itself against Japan's request to strike out certain claimsby defining this request as "premature", showed a clear disrespect for the rights of the respondent
                                                     
153 The European Communities recalled that in Chile – Price Band  System  dispute, the Appellate
Body made reference to its earlier case law that "there is no requirement in the DSU or in GATT practicefor arguments on all claims relating to the matter referred to the DSB to be set out in a complaining party'sfirst written submission to the panel."  However, the Appellate Body had further specified that: "Therequirements of due process and orderly procedure dict ate that claims must be made explicitly in WTO
dispute settlement.  Only in this way will the panel, other parties, and third parties understand that a
specific claim has been made, be aware of its dimensions, and have an adequate opportunity to address and
respond to it.  WTO Members must not be left to wonder what specific claims have been made againstthem in dispute settlement.  As we said in India – Patents :  'All parties engaged in dispute settlement under
the DSU must be fully forthcoming from the very beginning both as to the claims involved in a dispute and
as to the facts relating to those claims.  Claims must be stated clearly' (Appellate Body Report in India -
Patents , para. 94). (emphasis added), Appellate Body Report in Chile – Price Band System , paras. 158 and
164.
154 Appellate Body Report in Japan – Agricultural Products II,  para. 129.  See also Appellate
Body Report in Brazil – Aircraft , para. 194.WT/DS245/R
Page 76
and for the interests of third parties.  The Eu ropean Communities considered this attitude to be
contrary to Article 10 of the DSU.
5.26 The European Communities took note of Japan's argument that the United States had not
properly identified its claim because it had not indicated from which point in time the measures
applied by Japan should be considered as incompatible with the obligations under the SPS
Agreement .155   Japan further argued that unless the relevant point in time was identified, the
possibility opened by Article 5.7 could not be properly used, as it would be impossible for Japan
to determine the "reasonable period of time".
5.27 The European Communities considered that to be in line with the obligations under
Article 2.2 of the SPS Agreement,  "sufficient scientific evidence" had to support any sanitary or
phytosanitary measure at any point in time.  This meant that in cases where scientific evidence
available at the time of the introduction of the measure had been sufficient to justify the measurebut had later been overturned by new scientific evidence, the measure could no longer be
maintained.  However, in order to establish a prima facie case of violation of Article 2.2 and to
allow the correspondent to construct a defence, the European Communities was of the view that
the United States should have specified the point in time at which it considered that the Japanese
measures at issue had become "maintained without sufficient scientific evidence".  This wasparticularly true because the United States was not contesting the very adoption of the measures
under Article 2.2 but only their maintenance.
5.28 The European Communities noted Japan’s objection to the use, by the complainant, of
evidence, which had not been published, and which had been submitted to the respondent for the
first time with the complainant’s submission.  The European Communities viewed the issueraised by Japan as more than merely procedural.  The nature of the evidence to be considered
"sufficient" under Article 2.2 of the SPS Agreement  required that this be "public" and certainly
"scientific", i.e. reached through verified expert knowledge.  The European Communities argued
that the United States could not use arguments related to the submission of evidence to shift the
burden of proof under Article 2.2 of the SPS Agreement .
2. Legal arguments on Articles 2.2, 5.1 and 5.7
5.29 Article 2.2 of the SPS Agreement  creates an obligation for the Member to ensure that
sanitary or phytosanitary measures are "not maintained without sufficient scientific evidence",
apart from cases of application of Article 5.7 of the Agreement.  In this context, the European
Communities recalled that obviously it was possible that there could be different scientific
opinions about the need to protect plant life.  Certain scientific studies could conclude that there
were risks of spreading a plant disease while other studies could come to the opposite conclusion.As such, "scientific evidence" was the total of the available evidence.
156
5.30 The European Communities argued that th e crucial notion in that context was
"sufficient". The Appellate Body had found that there had to be a "sufficient or adequate
relationship between two elements, in casu , between the SPS measure and the scientific
                                                     
155 Japan first submission, paras. 18-28.
156 In Japan – Agricultural Products II , the Appellate Body referred to its report in EC - Hormones
with regard to the existence of "mainstream" scientific opinion" and "divergent opinion coming from
qualified and respected sources".  For the European Communities, both were "scientific evidence" in thesense of Article 2.2 of the SPS Agreement .WT/DS245/R
Page 77
evidence".  This relationship was also qualified as "rational or objective" and had to be
determined in each individual case according to its particular circumstances, including the
characteristics of the measure and the quality and quantity of scientific evidence.157
5.31 In this context, the distribution of the burden of proof was important.  In order to
establish an inconsistency of Japan’s measures with the obligations of Article 2.2, it was for the
United States to show in the first place, that these measures were not supported by sufficient
scientific evidence.  To do so, the United States might use any evidence available, including new
scientific evidence, which was available at the time when the measures were initially introduced.
However, the notion of evidence in Article 2.2 could not be understood to include scientific
information that was not available or accessible to the party imposing the SPS measures.
Therefore private or unpublished scientific evidence, of which the party had no knowledge, could
not be taken into account when establishing whether the scientific evidence on which the SPS
measure was based was (still) sufficient.  The European Communities argued that thisinterpretation of the notion of "evidence" as meaning " available  evidence" was in line with the
provisions on risk assessment as Article 5.2 that obliged Members to take into account " available
scientific evidence".
5.32 The European Communities recalled that Article 5.1 of the SPS Agreement  obliged
Members to ensure that their SPS measures were based on an assessment of the risks.  There wereat least three conditions for a risk assessment to be in line with Article 5.1.  The risk assessment
had to "identify" the diseases that the Member wanted to prevent and had to identify their
biological and economic consequences.  The risk assessment had also to evaluate the likelihood
of the entry, establishment or spread of the disease in the territory of the Member and the
potential biological and economic consequences.  Finally, the same likelihood and consequenceshad to be evaluated according to the SPS measures which may be applied.
158  
5.33 In the present case, Japan had clearly identified the disease.  With regard to the likelihood
of entry, establishment or spread of the disease within Japan it was established jurisprudence that
the risk assessment must not only establish a possibility but the "likelihood, i.e. probability" of
such entry, establishment or spread .159  Such risk assessment must refer to the likely
consequences of the imports to which SPS measures might be applied.  In the present case,
therefore, the risk assessment carried out by Japan must concern apples as imported from the
United States.  Finally, the risk assessment carried out by Japan must have evaluated the
likelihood of entry, establishment or spread of the disease through the importation of US apples in
the hypothesis of the SPS measures being applied.  In this regard, it was to be noted that a
reasonable relationship between the risk assessment and the SPS measure must exist.  However,
that did not mean that the risk assessment had to come to a monolithic conclusion that coincidedwith the scientific conclusion or view implicit in the SPS measure.  It might well be that in a
given case there were divergent views of qualified scientists about a particular issue, indicating a
state of scientific uncertainty.  It was also possible for Members to act in good faith on the basis
of what, at a given time, might be a divergent opinion coming from qualified and respected
sources.
160
                                                     
157 Appellate Body Report in Japan – Agricultural Products II , para.73 and para.84.
158 Appellate Body Report in Australia - Salmon , para.121; Appellate Body Report, Japan –
Agricultural Products II , para. 112.
159 Appellate Body Report in Australia - Salmon , para. 123.
160 Appellate Body Report in EC – Hormones , para. 194.WT/DS245/R
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5.34 The European Communities noted that Japan had submitted that if the Panel were to find
that the evidence it had relied on was insufficient, thus causing a violation of Article 2.2, Japan's
measures would still be justified under Article 5.7 of the SPS Agreement  and could be maintained
provisionally.  In light of this alternative defence under Article 5.7, the European Communities
restated its view that the precautionary principle had become a full-fledged and general principleof international law.
161  In addition, according to the Appellate Body, Article 5.7, together with
other provisions of the SPS Agreement , reflected the precautionary principle.162
5.35 In EC – Hormones , the Appellate Body had usefully clarified some of the aspects related
to the interpretation and application of the precautionary principle under the SPS Agreement .  In
particular, the Appellate Body had concurred with the European Communities that Article 5.7 did
not exhaust the relevance of the principle.  Thus, when reflected in the sixth paragraph of the
preamble and in Article 3.3 of the Agreement, it granted Members the right to establish their ownchosen level of protection.  With regard to the specifics of Article 5.7, it was clear to the
European Communities that a precautionary SPS measure had still to be based on an assessment
of the available pertinent information with regard to the risks posed by substances, diseases or
organisms present in a given good.
  There was no requirement to conduct a quantitative analysis
or to embody the view of the majority of the scientific community (assuming that there was someavailable scientific evidence to take into account).  A Member might well act in good faith on the
basis of non-quantifiable data of a factual or qualitative nature, as well as of a divergent opinion
coming from qualified and respected sources, or any new pertinent information that might
become available.
163
5.36 In Japan – Agricultural Products II , the Appellate Body had further clarified four
cumulative conditions for the application of Article 5.7.  The measure had to be:  (1) imposed in
respect of a situation where relevant scientific information was insufficient;  and (2) adopted on
the basis of available pertinent information.  Such a provisional measure might not be maintained
unless the Member which had adopted the measure;  (3) sought to obtain the additional
information necessary for a more objective assessment;  and (4) reviewed the measureaccordingly within a reasonable period of time.  These four requirements were cumulative and
equally important for the purpose of determining compliance with the provisions of Article 5.7.
Whenever one of these four requirements was not met, according to the ruling of the Appellate
Body, the measure was inconsistent with Article 5.7.
164   It was furthermore the view of the
                                                     
161 According to the European Communities, at in ternational level, the precautionary principle had
first been recognized in the World Charter for Nature, adopted by the UN General Assembly in 1982 and
had subsequently been incorporated into various international conventions on the protection of theenvironment.  At the beginning of nineties, the Rio Declaration that concluded the 1992 Rio Conference onthe Environment and Development, codified an application of this principle in its Principle 15, which statedthat:  "in order to protect the environment, the precautionary approach shall be widely applied by Statesaccording to their capability.  Where there are threats of serious or irreversible damage, lack of full
scientific certainty shall not be used as a reason  for postponing cost-effective measures to prevent
environmental degradation."  Since then, the United Nations Framework Convention on Climate Changeand the Convention of Biological Diversity had both referred to the Precautionary Principle .  On 28 January
2000, at the Conference of the Parties to the Convention on Biological Diversity, the Protocol on Biosafetyconcerning the safe transfer, handling and use of living modified organisms resulting from modernbiotechnology confirmed the key function of the precautionary principle.
162 Appellate Body Report in EC – Hormones , para. 124.
163 Appellate Body Report in EC – Hormones , paras. 172, 124, 187 and 194.
164 Appellate Body Report in Japan – Agricultural Products II , para. 89.WT/DS245/R
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European Communities that the "provisional" nature of the measures adopted on the basis of
Article 5.7 did not refer to a time limit but to the development of scientific knowledge.165
5.37 The European Communities further submitted that the application of the precautionary
principle under Article 5.7 of the SPS Agreement  should also take into account the following
criteria which it believed to be fully consistent with the Article 5.7 as interpreted by the Appellate
Body.166
5.38 Firstly, the SPS measures envisaged should be proportionate and no more trade restrictive
than was required to achieve the level of protection deemed to be appropriate by the Member that
applied them.  Precautionary measures should not, however, be assessed only against reduction of
immediate risks.  It was, in fact, in situations in which the adverse effects did not emerge until
long after exposure that the cause-effect relationships were more difficult to prove scientifically
and that – for this reason – the precautionary principle often had to be invoked.   In this case, the
potential long-term effects had to be taken into account in evaluating the proportionality of themeasures.
5.39 Secondly, the measures should not be discriminatory in their application.  Measures taken
under the precautionary principle should be designed to achieve an equivalent level of protection
without arbitrarily invoking the geographical origin or the nature of the production process to
apply different treatments in an arbitrary manner.   This was in line with the general obligation
expressed in Article 2.3 of the SPS Agreement.
5.40 The goal should be to achieve consistency between measures adopted in similar
circumstances or using similar approaches.  Of course, the comparability between two different
situations should be assessed on the basis of the available pertinent information in each case.
5.41 The measures adopted presupposed examination of the benefits and costs, economic and
non-economic, as appropriate, of action and lack of action.  This examination must consider
whether, on the basis of the available pertinent information, another measure was reasonably
available that achieved the appropriate level of protection and was significantly less restrictive on
trade.
5.42 The measures, although provisional, might be maintained as long as a more complete risk
assessment could not be conducted because the scientific data remained incomplete, imprecise or
inconclusive and as long as the risk was consider ed to be too high relative to the chosen level of
protection.  However, maintenance of the measures should depend on the development of
scientific knowledge.  Therefore, the regulatory  authorities should re-evaluate the data and the
measure once new scientific information was obtained.
D. 
NEW ZEALAND
5.43 New Zealand's participation as a third party reflected its "substantial interest" in the
issues of principle arising from Japan's fire blight measures that restrict the import of apples.  As
a nation whose economy relies heavily on agricultural exports, the proper implementation of the
SPS Agreement  was of fundamental importance to New Zealand.  New Zealand considered that
                                                     
165 See Communication of the European Commission on the Precautionary Principle ,
WT/CTE/W/147, G/TBT/W/137, of 27 June 2000.
166 These criteria have also be described in greater details in the Communication of the European
Commission on the Precautionary Principle , cited above, heading 6.3.WT/DS245/R
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the fire blight measures imposed by Japan were inconsistent with Japan's obligations under the
SPS Agreement .  Japan's measures also had significant practical consequences for New Zealand,
since they made exports of New Zealand apples to Japan uneconomic.
1. Scientific evidence relating to fire blight
5.44 Scientific evidence plays a fundamental role in the framework established by the SPS
Agreement .  The SPS Agreement  underlined the importance of sanitary or phytosanitary measures
being objectively justifiable, and emphasised the need to apply scientific principles and scientific
evidence in the development of measures.  Japan's fire blight measures on fresh apple imports
were not supported by scientific evidence and were inconsistent with the requirements of the SPS
Agreement .
5.45 Japan had explained that it was seeking to protect itself against the introduction of fire
blight via apple fruit imports.  Available scientific evidence had demonstrated, however, thatmature apple fruit had never been shown to cause the introduction of fire blight and that mature
apple fruit were not a pathway for fire blight .
5.46 The absence of a pathway via mature apple fruit was shown in the first instance by the
complete lack of evidence that fire blight had ev er been introduced into an area by mature apple
fruit from anywhere in the world, taking into account both incidents of trans-oceanic andcontinental dissemination of fire blight.
5.47 In the case of New  Zealand, the method of introduction (entry and establishment) of
E. amylovora  into New Zealand was not known, although one group of scientists believed that
fire blight was imported into New Zealand on nursery stock.
167  The method of introduction of
E. amylovora  into the United Kingdom was also not known.  It might have been introduced on
infected plant material or on contaminated fruit crates, but this had never been proved.168  In the
case of Hawaii, E.  amylovora  had been isolated in Hawaii in 1965 from rotten pears imported
from the United States.  Although the bacteria entered Hawaii at that time, it was not associated
with apple fruit, and it did not establish on host plants in Hawaii.  In the absence of establishment,
it could not be claimed that fire blight had been introduced to Hawaii.  Finally, in the case ofEgypt, fire blight had been reported to occur in Egypt in 1964.
169  While El-Helaly et al.  had not
directly addressed the question of the source of  introduction of the disease, however, they did
suggest that it was most likely to have been introduced on imported nursery stock from European
countries where the disease had long been established.
                                                     
167 New Zealand referred to publications by A.H. Cockayne (1920), "Fire Blight:  A Serious
Disease of Fruit Trees", New Zealand Journal of Agriculture  No. 20, pp. 156-157; J.A. Campbell (1920),
"The Orchard:  The Outbreak of Fire Blight", New Zealand Journal of Agriculture  No. 20, pp. 181-182;
J.D. Atkinson (1971), "Diseases of Tree Fruits", New Zealand Department of Scientific And Industrial
Research Information Series  81;  and W.G Bonn and T. van der Zwet (2000), "Distribution and Economic
Importance", in Fire Blight;  The Disease and its Causative Agent – Erwinia amylovora , Ed. J.L. Vanneste,
CAB International.
168 R.A. Lelliott (1959), Fire Blight of Pears in England, Agriculture  65 pp. 564-568;  T. van der
Zwet, and H.L. Keil (1979), "Fire Blight – A Bacterial Disease of Rosaceous Plants", US Department ofAgriculture Handbook No. 510, p. 12;  and Bonn & van der Zwet (2000) Fire Blight: the Disease and its
Causative Agent , Erwinia amylovora , at. 37-53 (J. L. Vanneste ed.).
169 El-Helaly, A.F., Abo-El-Daheb, M.K., El-Goorani, M.A. (1964), "The Occurrence of Fire
Blight Disease of Pear in Egypt", Phytopathologia Mediterranea  No.3, pp. 156-163.WT/DS245/R
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5.48 New Zealand stressed that scientific research using molecular techniques into the spread
of fire blight disease in Europe had concluded that despite the uncontrolled trade in apple fruit
into and within the European Union, introduction of fire blight had been via sequential spread or
the importation of infected planting material - but not by apple fruit.170  In this regard New
Zealand also noted that a paper published by Jock et al.  (2002) had demonstrated that, despite
barely controlled trade in fire blight host plants and plant products, the spread of fire blightaround Europe was normally sequential by vectors such as insects, birds and wind.
171
5.49 New Zealand stated that scientific experts who had studied the likelihood that fire blight
would be introduced via the importation of mature apple fruit had concluded that the risk that
such an event would occur was so low as to be neg ligible.  Scientific research into four key steps
of the chain of events making up the disease pathway justified this conclusion of negligible risk:
(i) Fire blight bacteria did not occur internally in mature apples.
(ii) The incidence of bacteria on the surface, including in the calyx, of mature
apples was very rare.
(iii) Normal post-harvest handling practices for apples exported to Japan (including
cold storage) had been shown to further reduce the likelihood of fire blight
bacteria being present on mature apples imports, which had already been shown
to be extremely unlikely.
(iv) Scientific evidence also supported the view that there was no vector to transfer
bacteria from a mature apple to a receptive host plant.  This, therefore, indicated
that there was a complete break in the transmission pathway at this point.
5.50 Mature apples were the only type of apples exported.  Immature fruit were not harvested
or exported, as fruit harvested when immature would not ripen and would be unmarketable.  Inaddition, mature apples were, by their nature, symptomless since infected blossom clusters or
fruitlets developed abnormally, and aborted or shrivelled on the branch.
2. Inconsistency of Japan's fire blight measures with the SPS Agreement
5.51 New Zealand considered that Japan's fire blig ht measures were inconsistent with Japan's
obligations under Articles 2.2, 5.1, 5.2 and 5.6 of the SPS Agreement .  In accordance with the
normal rules on burden of proof that were confirmed in the SPS context by the Appellate Body in
EC - Hormones , the United States was required to establish a prima facie case that Japan's
measure was inconsistent with the SPS Agreement .  It was then for Japan to present scientific
evidence satisfactory to rebut the presumption established by the United States.
5.52 According to  Article 2.2 of the SPS Agreement , Japan shall not maintain SPS measures
without sufficient scientific evidence.  In Japan – Agricultural Products II , the Appellate Body
stated that this meant there had to be a rational relationship between the scientific evidence and
                                                     
170 López, M.M., Gorris, M.T., Llop, P., Cambra, M., Borruel, M., Plaza, B.;  Roselló, M., García,
P, Palomo, J.L., and Berra, D. (1999).   Fire blight in Spain: situation and monitoring .  Acta Horticulturae
489, 187-191 ; Zhang,  Y., and Geider, K. (1997).   Differentiation of Erwinia amylovora strains by pulsed-
field gel electrophoresis .  Applied and Environmental Microbiology  63(11) 4421-4426.
171 Jock, S., Donat, V. Lopez, M.M., Bazzi, C., an d Geider, K. (2002), "Following spread of fire
blight in Western, Central and Southern Europe by molecular differentiation of Erwinia amylovora  strains
with PFGE analysis", Environmental Micobiology  4(2), pp. 106-114.WT/DS245/R
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the SPS measures being maintained.  In the view of New Zealand, the points made by Japan fell
well short of objective, scientific support for the application of fire blight measures to mature
apple fruit.  Japan's fire blight measures bore no rational relationship to the scientific evidence
since they regulated the importation of a commodity that the scientific evidence had shown was
not a pathway for the introduction of fire blight - the disease Japan aimed to protect itself against.
5.53 This case was also not one where Japan could rely on  Article 5.7 of the SPS Agreement  to
justify the imposition of its fire blight restrictions as provisional measures.  Scientific evidence
about the introduction of fire blight caused by imports of mature apples was  not insufficient.  In
fact, a significant quantity of scientific research had been conducted to investigate the sources of
introduction of fire blight to new areas, and to assess the nsk that mature apple imports would
result in introduction of fire blight.  None of this research had demonstrated a link between
mature apples and introduction of fire blight.
5.54 Under  Article 5.1 of the Agreement, Japan had to base its fire blight measures on a nsk
assessment.  Neither Japan's 1996 nor its 1999 Pest Risk Analyses (PRAs) on fire blight
constituted a "risk assessment" as required by Article 5 1 in the opinion of New Zealand.
Although Japan had fulfilled the first requirement of  a risk assessment in that it has identified fire
blight as the disease it wanted to prevent within its territory, Japan had neither evaluated thelikelihood of entry, establishment or spread of the disease nor had it evaluated those matters
according to the SPS measures which might be applied.  Japan's attempts at risk assessment were
not characterised by a systematic scientific approach.  Japan had not considered many of the
elements critical to a proper risk assessment of the introduction and spread of fire blight.  Much
of Japan's analysis related solely to the possibility  of fire blight bacteria arriving in the country,
rather than to the probability  of entry, establishment and spread of the disease.  Furthermore
Japan had not evaluated the relative effectiveness of each of its SPS measures in reducing the
overall risk purportedly presented by mature apples.  Japan had also not considered any
alternative measures other than those that it already imposed on the importation of apple fruit.
5.55 Article 5.2 required certain matters to be taken into account in the assessment of risk.  In
New Zealand's view, Japan had acted inconsistently with Article 5 2 by not taking into account all
available scientific evidence.
5.56 Finally, contrary to Japan's obligations under  Article 5.6 , Japan's fire blight measures
were patently more trade-restrictive than required.  The only measure required to achieve the
level of protection desired by Japan - that was, the prevention of any cases of entry and
establishment of fire blight bacteria or disease - was to restrict imports of apples to mature apple
fruit.
3. Chronology of bilateral discussion between New Zealand and Japan
5.57 In reply to a question from the Panel, New Zealand prepared a chronology and
description of bilateral discussions leading to Japan’s granting access to New Zealand apples with
restrictive conditions in May 1993.
172  The chronology charted communications between the
Ministry of Agriculture, Fisheries and Food of Japan (MAFF) and New Zealand as going back to
October 1983.  According to the chronology, New Zealand first made a proposal to Japan's
MAFF on fire blight in August 1987.  Bilateral discussions between New Zealand and Japan over
technical quarantine issues related to fire blight continued until May 1993, when apples from
                                                     
172 Exhibit NZL-12.WT/DS245/R
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New Zealand were granted access in accordance with certain restrictive conditions, similar to
those imposed on US apples.
4. Apple maturity and trade
5.58 Responding to a question from the Panel on apple maturity and export, New Zealand
noted that its pipfruit industry was primarily an export industry.  New Zealand exporters had
found it essential to develop comprehensive, ob jective maturity parameters for determining
optimum harvest timing in order to ensure that fruit had sufficient storage potential to withstand
many weeks of storage, shipping and distribution to offshore markets.  Fruit that was harvested in
an immature state would develop storage disorders (e.g. bitter pit, superficial scald) and had a
high tendency to shrivel.  More importantly, they would not develop the organoleptic
characteristics required in the market.
5.59 Many years of research and refinement by the pipfruit industry had resulted in the
development of objective maturity management specifications for each variety of apple.  Thesespecifications were based on a range of parameters including starch levels, fruit firmness,
percentage of soluble solids, titratable acid, background and foreground colour and length of
harvest period.  The specifications that defined when harvest should commence and when it
should finish were specific to each variety and would combine a range of parameters from the list
above.  In addition, the specifications were developed specifically for New Zealand conditions, inorder to ensure objectivity in the maturity asse ssment process.  The maturity parameters taken
into account by the New Zealand pipfruit industry were set out in Enzafruit’s 2002 Best Practice
Guidelines – Harvest Management.
173  The Best Practice Guidelines included protocols for the
measurement of each parameter.  The maturity management specifications and parameters
currently applied by New Zealand growers and exporters had been developed over the course ofat least two decades specifically for New Zealand conditions.  For example, starch pattern indices
charts set out specific North Island and South Island optimum starch content parameters for each
variety of apple to be exported.  Development of New Zealand-specific specifications had been
particularly valuable to ensure objectivity  in the maturity assessment process.  The Best Practice
Guidelines  were consistent with the overall framework, and used the same testing technologies,
as set out in the OECD Guidelines.
174
5.60 Until 2000, all apples exported from New Zealand were required to comply with the
maturity management specifications contained in the Best Practice Guidelines  in order to obtain
phytosanitary certification for export from the NZ Ministry of Agriculture and Forestry.  In 2000,
New Zealand’s pipfruit industry was deregulated, allowing additional exporters to enter the
market.  Since then, the Best Practice Guidelines  continued to be applied by New Zealand
growers as a matter of practice.  New Zealand exporters, including Enzafruit, conducted randomtesting of consignments to ensure that the apples sold to them by New Zealand growers and
supply centres (eg. pack houses and cool stores) met the optimum maturity management
specifications set out in the Best Practice Guidelines .
                                                     
173 Exhibit NZL-13.
174 New Zealand had also been actively involved in the OECD Scheme for the Application of
International Standards for Fruit and Vegetables – including in the development of the Guidance on
Objective Tests for Determining Ripeness of Fruit.  New Zealand’s experience in developing its own
maturity management specifications for exports of New Zealand pipfruit was of considerable value in theprocess of developing generic OECD Guidelines on maturity and ripeness.WT/DS245/R
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E. SEPARATE CUSTOMS TERRITORY OF TAIWAN , PENGHU , KINMEN AND MATSU
5.61 As a WTO Member free of fire blight and as a significant importer of US apples, the
Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu (Chinese Taipei) had a
substantial trade interest in the dispute before the Panel.  For Chinese Taipei, the key issue in this
dispute was the pathway of the fire blight bacterium and the proper risk assessment to beperformed in relation to it.  The SPS Agreement  provided an outline of procedures to be followed
by Members undertaking risk assessments.  These procedures had been explained and elaborated
in dispute-settlement decisions.  According to the Appellate Body in Australia – Salmon ,
Members adopting a specific SPS measure had to evaluate the likelihood of entry, establishment
or spread of the disease in question on all kinds of alternative measures.  In this context, it
appeared to Chinese Taipei that Japan should have performed a risk assessment on all kinds ofpossible measures, which might include those proposed by the United States.
5.62 Chinese Taipei noted that Article 4 of the SPS Agreement  had been invoked in this
dispute. Article 4, embodied the so-called "equivalence principle", which mandated that when
Members applied different SPS measures that achieved the same level of protection, these
measures should be regarded as equivalent.
5.63 With respect to the burden of proof in this case, Chinese Taipei noted that the initial
burden of proof lay with the complaining party, which had to establish a prima facie case of a
violation.  The United States had to meet its burden of proof by establishing a prima facie case of
a violation and, if it did so, then Japan should come forward with sufficient facts and arguments
so as to rebut the prima facie  case made by the United States.  In particular, Japan had to
demonstrate that its measures were :
(a) Applied only to the extent necessary to protect human, animal or plant life or
health;
(b) based on scientific principles and not maintained without sufficient scientific
evidence;
(c) based on an assessment, as appropriate to the circumstances, of the risks to
human, animal or plant life or health;  and
(d) based on risk assessment techniques developed by the relevant international
organization.
5.64 Chinese Taipei recalled that the United States had compiled a large amount of scientific
information to demonstrate that "mature, symp tomless apples rarely become the pathway for
transmitting fire blight bacteria" and that "restricting the importation of apples to mature,
symptomless apples was a reasonably available measure which would achieve Japan’sappropriate level of protection".  The United States further demonstrated that its laws and
regulations already imposed a requirement that exported apples be mature and be free from
decay, broken skin or bruises, or damage caused by disease or other problems.  In the view of
Chinese Taipei, the United States had met its obligation in providing scientific evidences to
establish a prima facie case.  It was thus incumbent upon Japan to demonstrate that it had takenthe US measure into consideration and, if it rejected the US position, to provide a scientifically
sound basis for doing so.WT/DS245/R
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5.65 According to Article 5.7 of the SPS Agreement , Members may provisionally adopt
sanitary and phytosanitary measures where relevant scientific evidence is insufficient.  In this
way, the "precautionary principle" had been embodied in the Agreement, at least in a limited way.
However, Chinese Taipei noted that any sanitary and phytosanitary measures instituted pursuant
to Article 5.7 must be temporary in nature, and that these measures should be reviewed within a
reasonable period of time while the Member imposing them sought to obtain the additionalinformation necessary for a proper risk assessment.  As each sanitary and phytosanitary measure
was employed to address a different need under different circumstances, and relevant scientific
evidence differed greatly, Chinese Taipei suggested that the best course was to adopt a case-by-
case approach in order to determine the appropriate length of the reasonable period of time
pursuant to Article 5.7 and the sufficiency of the development of scientific information.
5.66 According to the results obtained from the joint Japan-US experiments on fire blight in
2000, no fire blight bacteria had been detected on the surface of mature, symptomless apples.The experiment had been conducted in the US State of Washington for one year.  Chinese Taipei
affirmed and supported this scientific research undertaken jointly by Japan and the United States
and encouraged the parties to the dispute to perform further scientific research in order to resolve
their differences outstanding.  The United States could repeat the experiments it had performed in
other apple production areas where the climate and fire blight severity were different fromWashington State, and they could do so for more than one year.  Chinese Taipei argued that this
action would provide more representative results and clarify the misgivings of Japan on the
aforementioned joint scientific experiment.  They were further of the view that it might be
premature to rule that Japan had exhausted its recourse to Article 5.7.
1. Chinese Taipei's measures on US apples
5.67 In its first written submission, the United States had indicated that Chinese Taipei was its
leading export market for apples, with no reported transmission of fire blight despite the lack of
measures barring or impeding imports to guard against fire blight.  According to Chinese Taipei's
quarantine regulations, the importation of host plants or plant parts (excluding seeds) had to be
accompanied by a phytosanitary certificate issued by the plant quarantine authority of theexporting country, stating that the plants or plant parts had been thoroughly inspected and found
free from fire blight bacteria.  Otherwise, the plan ts or plant parts would be destroyed or returned.
Moreover, apples could be imported into Taiwan only after plant quarantine officers had
inspected them upon arrival.
5.68 In conclusion, Chinese Taipei considered that Japan was obliged to perform a risk
assessment on all possible kinds of alternative measures.  However, it was incumbent on the
exporting Member to demonstrate sufficient science-based and technical information supportingproposed alternative measures or criticism of proposed measures.  Finally, as the "precautionary
principle" was embodied in Article 5.7 of the SPS Agreement , and the relevant scientific evidence
differed greatly under different circumstances, Chinese Taipei suggested that the Panel adopt a
case-by-case approach to determining the length of the reasonable period of time pursuant to
Article 5.7 and the sufficiency of the development of scientific information.WT/DS245/R
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VI. PANEL'S CONSULTATION WITH SCIENTIFIC EXPERTS
A. PANEL 'S PROCEDURES
6.1 The Panel recalled that paragraph 2 of Article 11 of the SPS Agreement  provided that:
"In a dispute under this Agreement involving scientific or technical issues, a
panel should seek advice from experts chosen by the panel in consultation withthe parties to the dispute.  To this end, the panel may, when it deems it
appropriate, establish an advisory technical experts group, or consult the relevant
international organizations, at the request of either party to the dispute or on its
own initiative."
6.2 Noting that this Panel involved scientific or technical issues, the Panel consulted with
parties regarding the need for expert advice.  Ne ither party objected to the Panel's intention to
seek expert advice.  On 10 September 2002, the Panel wrote to the International Plant ProtectionConvention and to the parties to request the names of suitably qualified scientific experts.  After
consultation with the parties, the Panel communicated the following working procedures for
consultations with scientific and technical experts on 18 October 2002:
Nature of advice
1. On the basis of the first submissions from both parties, the Panel will
determine the areas in which it intends to seek expert advice.
Selection of experts and questions to experts
2. The Panel will seek expert advice from individual experts.
3. The Panel will solicit suggestions of possible experts from the Secretariat
of the International Plant Protection Convention (IPPC), and, subsequently, fromthe parties.  The parties are asked not to engage in direct contact with the
individuals suggested.
4. The Secretariat will seek a brief curriculum vitae from each individual
suggested.  These curricula vitae will be provided to the parties.  Parties will have
the opportunity to comment on and to make known any compelling objections toany particular expert under consideration.
5. The number of experts the Panel selects will be determined in light of the
number and types of issues on which advice will be sought, as well as by the
different areas on which each expert can provide expertise.
6.Experts will be appointed on the basis of their qualifications and the need for
specialized scientific expertise.
7. The Panel will inform the parties of the experts it has selected.WT/DS245/R
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8. The Panel will prepare specific questions for the experts.  Parties will have
the opportunity to comment on the proposed questions, or suggest additional
ones, before the questions are sent to the experts.
9. The experts will be provided with all relevant parts of the parties'
submissions on a confidential basis.
10. The experts will be requested to provide responses in writing.  Copies of
these written responses will be provided to the parties.  The parties will have the
opportunity to comment in writing on the responses from the experts.
Meeting with experts
11. The Panel intends to schedule a meeting with experts prior to the second
substantive meeting.  A date for the meeting will be agreed in consultation with
parties.  Prior to said meeting, the Panel would ensure that:  (i) the parties'
comments on the experts' responses would be provided to the experts;  (ii) theexperts would individually be provided with their colleagues' (the other experts)
responses to the Panel's questions.
12. Parties are free to include scientific experts in their delegations and may, of
course, submit scientific evidence.
6.3 The experts were invited to meet with the Pa nel and the parties to discuss their written
responses to the questions and to provide further information on 13 and 14 January 2003.  A
summary of the information provided by the expert s in writing is presented below.  A transcript
of the meeting with the experts is included in Annex 3.
6.4 The experts advising the Panel were:
Dr Klaus Geider , Professor of Molecular Genetics and Phytopathology, Max-Planck-
Institut für Zellbiologie, University of Heidelberg, Ladenburg, Germany;
Dr Chris Hale , Science Capability Leader, Insect Group (Plant Health and Fire Blight)
HortResearch, Auckland, New Zealand;
Dr Chris Hayward , Consultant on Bacterial Plant Diseases, Indooroopilly, Queensland,
Australia;  and,
Dr Ian Smith , Director-General, European and Mediterranean Plant Protection
Organization, Paris, France.
B. S
UMMARY OF THE WRITTEN RESPONSES BY THE EXPERTS TO THE PANEL 'S QUESTIONS
Maturation of fruit
Question 1:  Is there a commonly accepted definition or criterion (biological, physiological,
commercial, etc.) for determining if an apple fruit is mature?
If yes, is this definition accepted by farmers, packers, traders, inspection agents and
consumers in determining apple maturity?WT/DS245/R
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If no, is maturity an inherently subjective concept, decided by local farmers? Is there a
distinction between physiological and commercial maturity?  Please explain.
6.5 Dr Hale  replied that there were accepted definitions for determining if an apple fruit was
mature.  He defined physiological and commercial maturity as:
• Physiological maturity - point at which picked apples will ripen. If this point has
not been reached at harvest then fruit will not ripen and product will shrivel and
be unacceptable.
• Commercial maturity - start of the ripening process. The ripening process will
then continue and provide a product that is consumer-acceptable.
• Commercial maturity was usually determined by exporting companies.  However,
the definition of commercial maturity had to be accepted by other participants in
the apple industry, i.e. growers, packers, traders, inspection agents, and finally
consumers, or else the product would be unsaleable. Maturity assessments
included colour, starch index, soluble solids content, flesh firmness, acidity, and
ethylene production rate.
6.6 Dr Hayward stated that there were objective methods for the determination of the
maturity of apple fruit that formed the basis of the Organization of Economic Cooperation and
Development's (OECD) international standards.  Immature fruit will not ripen when picked and
would be unmarketable.  He  classified fruit as physiologically mature when they were at the stage
of development where, if they are detached, they continue to develop and ripen.  Commercialmaturity followed physiological maturity, and commercial mature fruit have the attributes
favoured by customers.
Question 2:  With respect to the maturation of apple fruit:
(a) If an apple fruit is naturally (rather than experimentally) infected with fire
blight, can it develop into a healthy-looking mature fruit?
6.7 Dr Geider  replied that dormant persistence of E. amylovora  in fruits was not documented
and was difficult to demonstrate.  When natural infections occurred at an advanced growth stage
in apples, the apples began to rot and ooze (exudate ) appeared.  An infected apple growing into a
healthy-looking fruit while colonized by E. amylovora  had never been described in the scientific
research literature.
6.8 Dr Hale  stated that it was important to make a distinction between infected and infested
fruit.  Infected fruit were diseased wherea s infested fruit were contaminated with E. amylovora
but not diseased .   Naturally infected fruit would be smal l, shrivelled, might show some lesions,
and would not mature.  Consequently, they were highly unlikely to develop into "healthy-looking
fruit".
6.9 Dr Hayward replied that  natural infection of an apple fruit would be the result of
infection of flowers through natural openings including stigmas and anthers, stomata on the
styles, fruit surfaces and sepals, hydathodes and the specialised stomata termed nectarthodes
located in the hypanthium (floral cup) (Thomson, 2000).  Disease progression depended onWT/DS245/R
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several factors such as rainfall (affecting the mobility of the inoculum) and the size of the
inoculum dose.  If the level of inoculum were high and the conditions conducive the flower
would wither and die.  If the level of the inoculum were lower it would usually decline and not
create infections (Thomson, 2000).  If the inoculum was at an intermediate level the fruitlet
would either abort or develop into an infected fr uit.  If the infection remained confined to the
calyx (the dried-up flower part), a healthy-looking mature fruit would develop.
6.10 Dr Smith  defined "infection" as meaning not just the presence of bacteria, but an active
process of pathogenesis.  On the basis of this definition, a diseased fruit could not develop into a
healthy-looking mature fruit.  E. amylovora  was not reported to cause latent infections of fruits.
Fruits were susceptible when they were young and ceased to be so as they matured.  Nor was
E. amylovora  reported naturally to cause storage rot of fruits.  A fruit naturally carrying bacteria
can develop into a healthy-looking mature fruit if these bacteria do not infect the fruit; in fact,
failing to infect, the bacteria would probably die long before the fruit matures.
(b) How long does it take for an infected apple fruit to develop visible symptoms of
fire blight?
6.11 Dr Geider  stated that immature apples were rarely used for experiments relating to fire
blight because they often did not show clear fire blight symptoms after inoculation.
6.12 Dr Hale  stated that if natural infection took place at the flowering stage, fruit were
unlikely to develop but instead to shrivel and blacken.  For immature fruit, visible signs would
depend on the severity of natural infection at flowering, weather conditions, and injury, e.g. from
hailstorms.  Artificially inoculated immature fruit took 3-4 days to show symptoms.  Mature fruit
were difficult to infect and were unlikely to develop symptoms unless inoculated with high
concentrations of E. amylovora  and kept in conditions highly conducive to multiplication of the
bacteria.
6.13 Dr Hayward replied that  the length of time it took for an infected apple fruit to develop
symptoms would depend on many factors:  the resistance of the host; the conduciveness of the
environment (especially temperature, rainfall and humidity), the route of inoculation and the
inoculum dosage.  He was unable to find any data about natural infections of apples throughwounds and the length of time it might take for symptoms to develop.
6.14 Dr Smith  stated that young fruits rapidly became infected after inoculum reached their
surface, especially if they were wounded, and the infection proceeded through the tissues of the
fruit within days.  The fruits were shrivelled and destroyed within very few weeks.
(c) Can healthy-looking apple fruit carry fire blight bacteria (either internally or
externally)?  Is there any relevant evidence in this respect regarding fruit
harvested from an orchard, as opposed to experimentally inoculated applefruit?
6.15 Dr Geider  replied that the persistence of E. amylovora  within healthy fruits had not been
documented.  Surface contamination could not be excluded and might be caused naturally by
insects (Hildebrand et al. , 2000) or by handling during or post harvest.
6.16 Dr Hale  noted that healthy-looking apple fruit from heavily infected orchards had been
shown to carry E. amylovora  infestations on the calyx tissues (Hale et al. ,1987).  Calyx
infestation was likely to be due to low level infestation at flowering which did not result inWT/DS245/R
Page 90
infection.  Bacteria might then survive, presumably at low levels, on the calyx.  Other reports of
E. amylovora  associated with the surface of mature fruit (Dueck 1974; Dueck & Morand 1975;
Sholberg et al.  1988; Roberts et al.  1989) were likely to be as a result of deposition of
E. amylovora  from nearby sources of inoculum.  Fruit from an orchard in which flowers were
artificially inoculated with E. amylovora  were shown by Hale et al.  (1996) to be free of calyx
infestation at harvest.
6.17 Dr Hayward  stated that healthy-looking apple fruit from naturally infected trees did not
contain detectable populations of E. amylovora  in the calyx, stem, peel or cortex (Dueck, 1974).
Roberts et al.  (1989) did not find E. amylovora  in core tissues or aqueous sonicates from 1,555
mature, symptomless fruit harvested from blighted trees of seven apple cultivars grown at five
locations in Washington State.  Roberts (in press, 2002) found no internal populations of
E. amylovora  in any of 900 fruit analyzed directly after harvest, even when harvested from trees
with or directly adjacent to fire blight.  E. amylovora  was not detected in washings from fruit
from orchards with 1-2 infections per tree, and was found on less than 1% of fruit from an
orchard severely affected by the disease (Hale et al. , 1987).  Clark et al.  (1993) did not detect
E. amylovora  in calyxes of either immature or mature apple fruit, even from within 20 cm of
inoculated blight sources (flowers), in a season not conducive to the spread of the disease duringflowering.  Dr Hayward stated that although the evidence was not monolithic, the conclusion he
drew from several independent studies was that E. amylovora  did not occur as an endophyte in
healthy-looking mature fruit and the presence of E. amylovora  as an epiphyte on fruit surfaces
was a rare event.
6.18 Dr Smith  answered that any surface in an infested orchard could carry fire blight bacteria
which were splashed onto it by rain.  There was disagreement about how long such populations
might survive under various conditions, and whether they could be considered as real "epiphytic
populations" (implying that they persist and even reproduce at a low level over quite long periods
of weeks or months) or merely transient contaminants (disappearing within days).  On fruits, the
critical question was not whethe r, but how long, such bacteria could be carried externally.
6.19 Dr Smith noted that, in theory, mature fruits could carry bacteria but this was unlikely
because contaminant inoculum was not normally available at the time when the fruits were
mature and because superficial populations mostly did not persist.  There was evidence that
bacteria persisted longer in the calyx (a relatively protected site different from the surface but not
strictly internal to the fruit) than on the surface.  Bacteria carried "internally" could in theory be
"endophytic", persisting inside the tissues of the fruit and reproducing at a low level without
infecting the fruit.  However, Dr Smith knew of no evidence that demonstrated that E. amylovora
could survive endophytically in apple fruit in this  way.  Internal bacteria could also in theory
cause a limited rot in the core of the apple, not externally visible. Although there were scattered
suggestions in the literature that this could very  occasionally occur, given the level of detail at
which the observations were described, it was not certain that these symptoms really concerned
fire blight, whether these observations concerned apple (as opposed to pear) fruit, or mature fruit.In any case, such observations were rare and of marginal significance, had not been
systematically studied, and were not taken into practical account in fire blight epidemiology.
(d) Is there any evidence or probability that  mature apple fruit have ever been the
means of introduction of fire blight in an area previously free of the disease?
6.20 Dr Geider  stressed that the establishment of fire blight in orchards not adjacent to plants
with fire blight was a rare event.  There was no evidence that trade in fruit had caused theWT/DS245/R
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establishment of the disease in any area.  In Europe, the fire blight outbreaks in Northern Italy
and Central Spain could be attributed to trade in plants from tree nurseries.  The spread of the
disease to all other European countries most likely occurred by sequential spread.
6.21 Dr Hale  stated that there was no evidence to suggest that mature apple fruit have ever
been the means of introduction (entry, establishment and spread) of fire blight into an area free of
the disease.
6.22 Dr Hayward  could find no evidence that mature apple fruit had ever been the means of
introduction of fire blight to an area previously free of the disease.
6.23 Dr Smith  replied that there was no evidence that mature apple fruit have ever been the
means of introduction of fire blight in an area previously free of the disease. Fire blight has been
introduced into many countries, and areas within countries, and there was no case in which it was
probable that mature apple fruit were the pathway.
Geographic spread of fire blight
Question 3:  Based on the scientific evidence available today, can you advise the Panel of the
means by which fire blight is transmitted?  Has there been a clarification of the science over
the years regarding the transmission of fire blight?  Please address the following specific
questions:
6.24 Dr Hale  stated that populations of E. amylovora  could multiply to high numbers in an
epiphytic  phase on some floral parts (Johnson & Stockwell 1998).  Endophytic populations of
E. amylovora  had been found in healthy buds.  However, there had been no success in
reactivating these bacteria to cause disease.  Infection events originating from endophytic bacteriamay be infrequent and were not responsible for major epidemics of fire blight.  It was often
difficult or impossible to determine the origin of inoculum in fire blight outbreaks.  Bees were a
major factor involved in the secondary local spread of fire blight from inoculum sources during
pollination.
6.25 Dr Hale further stated that long-term survival of E. amylovora  in the soil was unlikely.  It
was also unlikely that E. amylovora  in soil would be splashed on to flowers and shoot tips
(Thomson, 2000).  Fruit tended to decompose rapidly on the soil surface and those remaining
fruit hanging in trees usually did not show oozing or release of bacteria in the spring (Thomson,
2000).  E. amylovora  was rarely found on mature fruit and was then probably due to deposition
from nearby active sources of inoculum (Thomson, 2000).  In every instance where E. amylovora
had been detected on fruit, it had been on fruit from orchards with high levels of fire blight
infection or located near to severely infected orchards.  It had never been demonstrated thatmature fruit were involved in the dissemination of E. amylovora  and served as a source of new
infections.  Consequently it was considered to be  extremely unlikely that contaminated fruit could
be responsible for establishing new outbreaks of fire blight.
6.26 Dr Hayward replied that wind-driven rain and pollinating insects were the most
important vectors in transmission to flowers.  Tran smission over long distances, e.g. by migrating
birds such as starlings, on contaminated fruit boxes, on fruit, or in the form of fire blight strands
perhaps capable of long range aerial dispersal, were not amenable to experimental study and the
evidence, if there was any, was circumstantial.  The application of DNA-based methods to
distribution of strains of E. amylovora  (PFGE pattern analysis) had been a notable recentWT/DS245/R
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advance.  This was a powerful tool regarded by many as the gold standard for epidemiological
studies and enabled common sources of infection to be determined in disease outbreaks.
(a) Please comment on the scientific literature on how fire blight has spread so
fast globally. Is there scientific evidence to believe that this spread may be
related to the movement of mature apple fruit?
6.27 Dr Geider  noted that the disease remained confined to North America until the
beginning of the last century.  In the early 20th century, fire blight was first reported to have
occurred in Japan (see questions 35 and 36).  In 1919 fire blight was reported in New Zealand.
Fire blight in Europe was first detected in Engl and (1956), then in Egypt (1962) and from these
two countries presumably spread to Central and Western Europe and to Eastern Europe,
respectively.  In Australia, E. amylovora  was identified in 1997 as affecting a few plants in the
Melbourne Botanic Gardens.  After eradication of all fire blight host plants in the gardens andneighbouring areas, the pathogen was eradicated.  Disease symptoms resembling fire blight have
also been reported from Korea.
6.28 Dr Hale  stated that fire blight had taken 220 years to spread from New York State, USA
in 1780, to its latest geographic locations (Bonn & van der Zwet, 2000).  There was no scientific
evidence to suggest that the spread might be rela ted to the movement of mature apple fruit.  On
the contrary, most of the available evidence suggested that the major spread had been through the
movement of planting material.  New high yielding cultivars tended to be very susceptible and
high intensity plantings of these new cultivars had exacerbated the more rapid spread of fire
blight over the last 30 years. Spread of the disease to Europe and the Eastern Mediterranean was
thought to have been due to its introduction into the United Kingdom and Egypt, followed byincremental short-distance spread due to birds, wind-driven rain, aerosols, and the importation of
infected budwood or trees.
6.29 Dr Hayward  answered that the global spread of fire blight, particularly since the late
1950s through to the 1990s in Europe and the Mediterranean, seemed most likely to be
attributable to a combination of sequential spread and the importation of contaminated plants bynurseries.  Dr Hayward could find no evidence that this spread might be related to the movement
of mature apple fruit.
6.30 Dr Smith  observed that it had been a long time before fire blight first spread outside
North America, and it had been ten years before fire blight had moved outside the first country of
infection in Europe.  Even 20 years after its first appearance in the UK, fire blight was still
limited to areas along the North Sea and the Baltic.  In fact, fire blight had progressed southwards
rather slowly.  The later focus of fire blight in the eastern Mediterranean had spread more rapidly.By comparison, citrus leaf miner ( Phyllocnistis citrella ) had spread to the whole Mediterranean
basin within two years and glasshouse pests like Frankliniella occidentalis  and Liriomyza spp.
had spread around the world in 20 years.  Because fire blight did not spread very fast compared
with many other plant diseases, it had been possible to contain it.
6.31 Dr Smith further stated that fire blight spread very effectively over short distances, but
that it did not spread readily over long distances.  Though it was only conjecture that fire blight
had initially been spread in Europe by migrating birds, this explanation was at least consistent
with the geographical spread.  The geographical pattern was in no way consistent with spread on
fruits, and this pathway was inherently much less probable.  The new appearance of fire blight at
long distances from existing outbreaks could readily be attributed to the illegal import of infectedWT/DS245/R
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planting material.  Not only was there no evidence that fruits had ever introduced fire blight to an
area, but there was also no necessity to invoke such an improbable pathway since there were
much more probable alternatives.
(b) Several sources report that it was suspected that plant materials or fruit bins
contaminated with fire blight bacteria were responsible for the introduction of
the disease into the United Kingdom.  Please comment on the extent to whichthis hypothesis has been confirmed or e xperimentally tested in the UK case and
any of the other cases of trans-oceanic dissemination of fire blight.
6.32 Dr Geider answered that the precise source for distribution of fire blight into a "primary"
fire blight region such as New Zealand, England or Egypt could not be traced back.  His studies
of PFGE pattern in Europe and the Mediterranean region indicated a sequential spread from
England and Egypt into neighbouring countries.  However, the subsequent introduction of fire
blight into Northern Italy and Central Spain through human activities was an exception that couldbe traced back to trade in nursery plants.
6.33 Dr Hale  was not aware of any conclusive evidence regarding the method of introduction
of fire blight into the United Kingdom.  Suggestions that the disease might have been introduced
on infected plant material or on contaminated fruit crates had never been proved.  Lelliott (1959)
stated that it is not known how fire blight ente red the United Kingdom, but he also noted that "the
chance that it was introduced with infected fruit is very slight and can probably be ignored".  It
was possible that bacteria could have survived on contaminated fruit crates, but this was probably
unlikely as there was no scientific proof that the crates were contaminated or that contaminated
crates could represent a source of infection.
6.34 Dr Hayward stated that apparently there had been no tests of the hypotheses that fruit
bins or plant materials were the source of the first fire blight outbreak in the United Kingdom in
1957. Experiments (Keck et al.  1996) showing survival of E. amylovora on pieces of wood and
plastic in petri dishes do not relate to conditions under which fruit crates are stored and
transported.  Dried bacterial ooze on crate surfaces would be subject to the effects of desiccation,
diurnal temperature variation when not kept in cold storage, and probably to the deleteriouseffects of exposure to UV radiation.
6.35 Dr Smith replied that  planting material was the one commodity for which there was
almost direct evidence of a human-mediated international pathway.  In Europe, infected plants
were known to have been moved in trade, though not directly in relation to an outbreak.  Also,
several localized outbreaks (e.g. in Poland, in Romania) could be related to known imported
planting material, although it could not be proved that any particular imported plant was the
culprit. Thus, it was perfectly plausible that the original outbreak in the United Kingdom wasconnected with the illegal import of planting material.  The explanation involving fruit crates
seemed to be based entirely on circumstantial evidence and did not appear inherently very
probable.  Ooze on imported fruit crates would not come from fruits since the only fruits which
could release ooze would be immature (not harvested) ones.  It would have to come from shoot
cankers.  Although this idea had been presented in the literature because of an old Britishsuggestion on the subject, no European country had judged it necessary to establish phytosanitary
measures for crates (such as the Japanese requirement of chlorine treatment of containers for
harvesting).WT/DS245/R
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(c) Please comment on Japan's conclusion s in its first submission, paragraph 73,
that "… these incidents suggest a remarkable degree of (1) the survival ability
of the bacteria outside the favorable host of the wood …".
6.36 Dr Hayward stated that there was little evidence to support this statement.  E. amylovora
was a poor survivor in non-sterile soil – perhaps a reflection of its inability to compete with soilmicroflora.  E. amylovora  does not produce desiccation-resistant and UV-resistant cells.  It was
more likely to be able to survive when present as aggregates embedded in a polysaccharide
matrix of either bacterial or plant origin, as in bacterial ooze or fire blight strands, but there had
been a lack of investigation.
(d) Would you characterize the likelihood of dissemination through trade in apple
fruit as negligible based on historic and scientific evidence?  Please comment
in particular on any evidence of tran smission of the disease in the past.
6.37 Dr Geider  stated that the dissemination of fi re blight with apples could not be
scientifically totally excluded, but it appeared extremely unlikely either that it had occurred or
could occur.  In his research work, he had discovered an ordered occurrence of PFGE pattern
types in Europe and the Mediterranean region without there being any observed mixing of pattern
types - despite the essentially uncontrolled trade of fruits and plants in most European countries.If fruit trade had distributed the disease frequently, the East European pattern type Pt2 would also
be found in Central and Western Europe.
6.38 Dr Hale  considered the likelihood of dissemination through trade in apple fruit to be
highly unlikely based on the lack of historic and scientific evidence.  Historically, large volumes
of apple fruit had been traded world-wide from countries with fire blight and there was noscientific evidence that apple fruit had been the means by which fire blight had been introduced
into countries without the disease.
6.39 Dr Hayward  argued that the historic and scientific evidence suggested that the likelihood
of fruit being a pathway for introduction of fire blight was negligible.  Compelling evidence of
nursery stock as a pathway came from observations from Spain and Egypt.
6.40 Dr Smith  replied that there was a very small probability that healthy mature fruit could
still externally carry living bacteria after shipping.  There was then a very much smaller
probability that these bacteria could be transmitted to and infect host plants. In combination, the
likelihood was negligible.
Question 4:  Please confirm whether or not EPPO recommends countries at high risk to
prohibit importation of host plants for planting, with an exception to be made for importation
during the winter months (Exhibit USA-5).  EPPO does not recommend that importation offruits be prohibited, and states "it is widely accepted that fruits present an insignificant risk in
practice".  Please comment on this statement.
(a) Are the specific quarantine requirem ents recommended by EPPO (Japan’s
first submission, paragraph 162), applicable to seedlings, nursery stock orapple orchards?  Are they significant wi th respect to import requirements on
mature apples?WT/DS245/R
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6.41 Dr Geider opined that while there was evidence that a primary source of long distance
distribution could be the importation of latently infected host plants, fire blight had not often been
distributed that way.  However, based on research work in Northern Italy and Central Spain, he
was of the view that the most likely method of introduction of fire blight had been plant
importation, as the pattern type from those regions (Pt3) had not been found in countries adjacent
to the affected regions.  There was also a possibility that pattern Pt2 in Southern Italy could havebeen introduced with plants, since insects would not easily have been able to cover the maritime
distance from Egypt or Greece to Italy.  Birds could also be associated with the distribution of
these E. amylovora  strains and such remote places as the Greek islands or oases in Israel could
have received fire blight this way.
6.42 Dr Geider further was of the view that inspection of imported plants was the most
effective way to prevent new outbreaks of fire blight.  He did not think that buffer zone
regulations were necessary for the importation of mature apples, since these fruits had anextremely low risk of fire blight distribution.  However, he cautioned that apples should not be
exported if they were picked from a fire-blighted orchard so as to avoid the probably very low
risk of accidental contamination.
6.43 Dr Hale  considered the EPPO recommendations to have been specifically designed for
planting material - considered to be the major source of the disease and a major factor in thespread of the disease.  Fruit were considered by EPPO to be insignificant in the transmission of
fire blight and consequently the quarantine requirements for planting material were not relevant
in the context of fruit import/exports.
6.44 Dr Hayward noted that the specific quarantine requirements recommended by EPPO
applied to seedling and nursery stock rather than to apple orchards.  As such, these quarantinerequirements were eradication measures to be adopted when a pest incursion had occurred.
6.45 Dr Smith stated that the EPPO requirements covered plants for planting; fruit orchards
were not considered relevant since no plants for planting were moved from them, and no
requirements were recommended for fruits.  Since the EPPO requirements were considered
adequate for "plants for planting" from a nursery, which presented a much higher risk than fruits,it followed that they could be considered much more than sufficient for the lesser risk presented
by fruits.
(b) Please comment on Japan's statement (paragraph 97, Japan's first submission)
that "as a result" of the decision by EPPO "not to control shipments of fruit,
fire blight disease is rapidly expanding inside Europe".
6.46 Dr Geider  reasoned that on the basis of the ordered PFGE pattern type in Europe, it was
"pure speculation" to connect uncontrolled fruit shipments with disease expansion.  There was noindication that the disease moved with trade in apples.
6.47 Dr Hale  stated that there was no evidence that EPPO’s decision not to control shipments
of fruit was the cause of fire blight's spread inside Europe, and the shrinking of the protected
zone, particularly in France.  Evidence suggested that the disease was mainly transmitted over
long distances by the movement of latently infected planting material or planting material withundetected cankers.  Aerosols might also have played an important role in the rapid long distance
spread in Europe.  There was no evidence that the movement of fruit throughout Europe had
played a role in spread of the disease.WT/DS245/R
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6.48 Dr Hayward  noted that the EPPO decision not to control shipments of fruit was based on
their judgement that fruit were not a pathway for the introduction of fire blight. The evidence
suggested that expansion of the distribution of fire blight in Europe was most likely a function of
sequential transmission combined with distribution of latently infected nursery stock.
6.49 Dr Smith  stated that apple fruit were traded freely between, and within, European
countries and especially within the European Union - despite the very great interest of certain
countries in protecting themselves from the introduction of fire blight. The 1971 EPPO meeting
considering recommendations on regulations to address the risk of fire blight spread had
concluded "that because the risk involved in the importation of fruits is negligible, they would not
need to be subjected to special requirements".  EPPO recommendations were not mandatory.
Each country decided what measures it would apply (jointly in the case of the European Union).
A survey of the present regulations of EPPO member countries showed that no member country
maintained restrictions on apple fruit with respect to fire blight.  Dr Smith considered that Japan's
suggestion did not reflect the truth of the matter. The European countries then and now take
science-based and well considered decisions on pest risk management, and that it was absurd to
suggest that the national plant protection organizations of all these countries had been so
negligent as to not take account of a pathway if it might really allow the "rapid expansion" of fireblight.  Dr Smith added that apple and pear fruits had never been subject to phytosanitary
restrictions within Europe, and that in more recent times the EU had established its Single
Market.  It would not have been an easy matter in practice to prohibit, use phytosanitary
certificates for, or treat or inspect fruits, on a European scale and such considerations must also
have applied.
Question 5:  Please comment on any evid ence available regarding the distribution of
E. amylovora strains and the conclusions which may be drawn as to the pathway for the spread
of infection.
6.50 Dr Geider  replied that his research work on PFGE pattern types gave some information
regarding the spread of fire blight in the last century.  The only PFGE pattern type found in New
Zealand (Pt1), was also present in some strains from North America, England, Central Europe
and transiently from Australia.  This meant that the source of fire blight in New Zealand could not
be traced back with the current data.  It was likely that pattern type Pt1 in Central Europe was
introduced from England.  Pt1 in Australia could not be connected to a definable event, but given
the large numbers of tourists (1.5 million people per year) visiting the Melbourne Botanical
Gardens, it could have been a human source.  Taking into account the strict Australian quarantinemeasures at airports, dissemination by fruit was very unlikely.  One hypothesis was that
somebody had used a contaminated knife to take plant samples in the Melbourne Botanical
Gardens.
6.51 Dr Geider noted that the PFGE pattern types in Europe were well ordered.  It could be
assumed that the disease had been established before 1956 in England through the introduction ofinfected plants.  The repeated speculation about the introduction of fire blight in England (no fire
blight in Scotland) by contaminated wood such as crates from New Zealand could not be ruled
out, but the existence of the two major pattern types Pt1 and Pt4 pointed to at least two
introductions of fire blight.  Dr Geider had identified the two pattern types as those of strains
typically found in Canada.  As such, contaminated plants from Canada (or adjacent US regionswith fire blight) were one likely source.   Contaminated plant material from New Zealand had also
been suggested as another potential source of the infection and this hypothesis was supported by
molecular analysis that the PFGE pattern type  Pt1, exclusively found in New Zealand, wasWT/DS245/R
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recovered in many but not all English E. amylovora  strains.  A second introduction of fire blight
to England could have occurred with strains of another pattern type such as Pt4.175
6.52 The pattern type Pt2 from Egypt had only been found once in a strain claimed to be
isolated in California (Zhang and Geider, 1997) .  A connection could not be recovered, but its
origin in North America could be assumed.   Pattern type Pt2 from Egypt could easily be
distinguished from the other European patterns and had spread sequentially to neighbouringcountries including Northeast Turkey, Iran, Greece and the Balkans.  It had now reached
Hungary, and was close to the area with Pt1 in Austria.  The sequential spread could be explained
by carriage of the pathogen by bees and other blossom-visiting insects.  Any contribution of fruits
to the further spread of the disease was unlikely.  The E. amylovora  pattern types in North
America were diverse (typical given the long pe rsistence of the disease in the continent) and
contained the pattern types Pt1, Pt2 and Pt4 that had been found in Europe.
6.53 The pattern type Pt3 from Northern Italy and Central Spain could be associated with plant
imports from Belgium with the same pattern type.  There were some exceptions from the main
pattern types such as Pt5 (found in Bulgaria and Israel) or Pt6 in the area of Ravenna/Italy.  Other
variations of E. amylovora  were occasionally detected and showed a low level of spontaneous
changes in the bacterial genome.  No efforts had been made to follow further spread of peculiar
pattern types.
6.54 Dr Geider noted that it was puzzling why the Southern hemisphere was still free of fire
blight, although plant and fruit imports were not controlled stringently in Chile, Brazil, Argentine
or South Africa.  In contrast, Egypt, with a re latively hot climate unsuitable for good growth and
survival of E. amylovora , had become infected - most probably by contaminated plants.  There
was a low to moderate risk of fire blight distribution from trade in living host plants;  however,there was little risk associated with other plant materials.
6.55 Dr Hale  recalled that Jock et al.  (2002) had presented evidence for the distribution of
E. amylovora  strains in Europe and concluded that despite barely-controlled trade in fire blight
host plants and associated products (fruit), the patterns of distribution of strains indicated
sequential spread from areas with fire blight into previously fire blight-free areas.  There was noevidence that implicated fruit as a means of transmission of fire blight through Europe.
6.56 Dr Hayward  noted that both Jock et al.  (2002) and also Zhang and Geider (1997) had
examined the genetic diversity of strains of fire blight from all countries including the United
States - universally accepted as the centre of origin of fire blight disease on apples and pears.
Some North American strains were highly divergent in pattern from any of those occurring
elsewhere;  patterns of other American strains resembled those from strains in other parts of the
world.  Patterns Pt1 and Pt4 were found in strains from England, perhaps suggesting multipleintroductions;  Pt1 was also found in central Europe and eastern France.  Strains from Egypt,
Greece and Turkey had the same pattern (Pt2).  E. amylovora  showed greatest genetic diversity at
its centre of origin (USA).  Jock et al.  (2002) concluded that the appearance of Pt3 in northern
Italy and central Spain could be explained by the importation of contaminated plants by nurseries.
                                                     
175 A divergence of pattern types could be another explanation for different pattern types found in
England.WT/DS245/R
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Question 6:  Can the source of a fire blight infection be identified (eg, by DNA or other test)?
If, for example, an outbreak were to occur in  a country following importation of apple fruit
from all sources, could the source of the contaminated fruit be traced back?
6.57 Dr Geider noted that using PFGE analysis, it was possible to establish a general
relationship between E. amylovora  strains.  For example, diseased young apple trees in Southern
Germany, imported from northern Italy, displayed the typical Central European pattern type Pt1
from the surrounding area in Germany rather that the pattern type Pt3 found in Italy (Jock et al. ,
2002).  In other cases, such as the recent appearance of fire blight in central Spain, the infection
could be traced back to plant imports from Belgium.  The establishment of fire blight with Pt3 in
northern Italy could be explained by a similar in cident, although not proved due to the lack of
documentation on trade in plants in Italy.  Researchers were still working on more precise tools todescribe individual strains from fire blight areas.
6.58 Dr Hale answered that there was no evidence of apple fruit being the source of an
outbreak of fire blight.  It might be possible to determine the source of E. amylovora  strains
involved in future outbreaks of the disease if a detailed molecular analysis was carried out on a
large number of strains from sources world-wide (similar to that of Jock et al. , 2002), using
agreed technologies, and if the current pattern of distribution of the E. amylovora  strains could be
categorically stated.  At present, it was only possible to assign major pattern types to particular
areas/regions/countries.  However, Zhang & Geider (1997) had reported that there were peculiar
properties of individual strains that could be useful in tracing epidemic outbreaks.
6.59 Dr Hayward stated that  the PFGE typing procedure could enable determination of
common sources in particular outbreaks (such as the situation in northern Spain (Lopez et al. ,
1999) and probably also in Egypt).
6.60 Dr Smith stated that  the source of a fire blight infection could not be identified  with
certainty, though DNA and other tests might give strong indications.  E. amylovora  had been
categorized into strongly differentiated strains in only a few cases.  Most isolates were not sodistinctly identifiable, though conclusions could be drawn from comparisons based on many
isolates.
Potential pathways for fire blight transmission
Transmission of fire blight via apple fruit
Question 7:  Please comment on Japan's statement (paragraph 70, Japanese first submission)
that "No ecological study is available on possible  dissemination of fire blight via apple fruit".
6.61 Dr Geider  replied that the statement was  unrealistic.  There were generally accepted
methods of fire blight dissemination.  Long distance spread was mostly caused via latently
infected fire blight host plants in commercial  trade.  The most common method of short distance
spread was caused by blossom-visiting bees and similar insects.  Contaminated tools could
distribute the disease in an orchard through pruning activities.  "Strands" formed from ooze on
branches could be distributed by wind to other trees, even over intermediate distances.  In
addition, animals, especially birds, which had been contaminated with ooze from fire-blighted
plants might also occasionally be responsible for intermediate distance spread.  Sequential fireblight distribution was dominant as the pattern of fire blight infection.  New establishment of theWT/DS245/R
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disease by other than sequential distribution was so rare that it was not possible to conduct
ecological studies.
6.62 Dr Hale observed that  Taylor et al.  (2003) had studied apple fruit infested with a marked
strain of E. amylovora  discarded in an orchard at flowerin g with conditions conducive to fire
blight infection.  Their results had shown that ho st plants did not become infected and that no
E. amylovora  could be detected on either leaves or flowers when tested by PCR.  Hale et al.
(1996) had presented results from studies on the ecology of the possible dissemination of
E. amylovora  via apple fruit that had been infested (calyx) or contaminated (surface) and placed
adjacent to flowers in apple trees.  There had been no movement of E. amylovora  from the
inoculum source to blossoms and no symptoms had developed in the trees during the season.  No
E. amylovora  had been detected in calyxes or on surfaces of either immature or mature fruit even
from within 5 cm of the inoculum source.  However, there was no information available on the
use of naturally infested or naturally contaminated fruit for such experiments.
6.63 Dr Hayward noted the definition of ecology as "the study of relationships of organisms
or groups of organisms to their environments, both animate and inanimate" (Thain and Hickman,
1994).  Much of the research on fire blight had clearly been concerned with the relationship of the
pest ( E. amylovora ) to its hosts and their interaction wi th the environment.  With regard to
possible transmission of fire blight on fruit, much work had been concerned with survival of thepest on the epidermis or the calyx of fruit (e.g., Hale et al. , 1987; Hale et al. , 2001; Hale et al. ,
2002; Roberts 2002).  Some of these recent studies had used genetically marked (antibiotic
resistant) strains of the pest.
6.64 Dr Smith replied that  movement of E. amylovora  on apple fruit did not constitute a
significant element in the ecology of the pathogen.  Management of the disease in apple orchardsdid not have to take any account of the possibility that new infections arose from bacteria
persisting on harvested fruits, or even dropped or discarded fruits.  To that extent, no one had
thought it worthwhile to undertake such research.  Experiments could be devised in which
artificially inoculated fruits were placed in the vicinity of healthy trees, under various conditions.
However, significant and reproducible transmission could probably only be achieved by bringingthe fruits into an absurdly close vicinity to the susceptible tissues.  If individual cases of
transmission were obtained under more realistic conditions, it would be impossible to exclude
other means of transmission as the cause.  Dr Smith stated that it was very hard to do research on
very rare events and quoted the paper of Taylor et al.  (Exhibit USA-20) as a recent example of
such a study.
Question 8:  Please comment on any scientific studies which seek to quantify the risk or
probability of fire blight transmission at any step along potential pathways?
6.65 Dr Hale  replied that Roberts et al.  (1998), using published data from many different
sources on the incidence of E. amylovora  on mature, symptomless apple fruit, had sought to
estimate the risk of new outbreaks in fire blight-free areas.  In this work, estimates of probability
had been used at various steps, i.e. probability of calyx infestation in mature, symptomless fruit;probability of surface contamination of mature, symptomless fruit; probability of survival of
E. amylovora  on fruit through cool storage and shipping; probability of survival of E. amylovora
on fruit through discard; probability of fruit discarded when hosts are receptive and conditions
conducive for fire blight development; and probability of transfer of E. amylovora  from discarded
fruit to receptive hosts.  However, although there was some qualitative and quantitativeecological information on each of these steps (Hale et al. , 1996; Hale & Taylor, 1999; Taylor etWT/DS245/R
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al., 2002, 2003), the authors had not quantified the risk or probability of transmission of
E. amylovora  at any of these steps in the potential pathway.
6.66 Dr Hayward  noted that Roberts et al.  (1998) and Yamamura et al.  (2001) had relied on
the same published data but used a different approach to quantify the risk or probability of fire
blight transmission along potential pathways.  Roberts et al.  (1998) had used a simple linear
model to estimate the risk of a pest being introduced and established via commercial shipments of
mature apple fruit.  The probability of introduction had been estimated using three different levels
of phytosanitary stringency prior to export.  The authors had claimed that their assumptions were
conservative.  The study by Yamamura et al . (2001) was different in several respects.  In
particular, three assumptions had been made:
(a) That a beta distribution approximately described the proportion of infected fruits
in the production area of a given consignment;
(b) that every consignment contained fruits that were drawn at random from the
infinite population of the production area;  and
(c) each infected fruit caused infection of fire blight in the importing country by an
independent constant probability.
Dr Hayward stated that he was not in a position to judge whether these were valid assumptions –
such a judgement required the opinion of a statistician.  The author of the first study had revised
his estimates taking into account new published information, and also the requirement in the
Japanese protocol for a post-harvest chlorine treatment. (Roberts, 2002).  According to the author,
"These new estimates strongly reinforce the conclusion drawn in the original 1998 PRA that
international trade of commercial, export quality apple fruit poses a negligible risk of introducingfire blight to importing countries".
6.67 Dr Smith stated that in general it was desirable to try to quantify the probability of
movement along a pathway by estimating the probabilities of individual components and
calculating their overall product, which could be expressed for example as "once in so manythousand years".  This was preferable to the use of imprecise expressions such as "very probable",
"fairly probable", "extremely improbable".  Howe ver, it was commonly the case that some steps
on the pathway were subject to greater uncertainty than others.  The result was that the improved
precision arising from careful and realistic estimates for some steps was cancelled by the massive
uncertainty of others.
Question 9:  In the light of the IPPC Guidelines for Pest Ri sk Analysis of 1995 (Exhibit JPN-
30) and the IPPC Pest Risk Assessment standar d of 2001 (Exhibit USA-15), please describe the
sequence of events that would be necessary for E. amylovora on mature apple fruit imported
into Japan to be a pathway for the introduction of fire blight?  Are you aware of any evidence
that this pathway has ever been completed, either experimentally or in natural situations?
6.68 Dr Geider stated that the only way to spread fire blight with an apple was through
accidental heavy surface contamination (by hand, when harvested from a fire-blighted tree).  The
apple then had to be touched by a consumer or vi sited by an insect, who had to then immediately
have contact with leaves, or for more impact, with the blossoms of a fire blight host plant which
might then develop symptoms.  Dr Geider noted that even in his laboratory inoculations, byWT/DS245/R
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cutting leaf tips with scissors and inserting bacteria into the wound, not all apple seedlings
developed fire blight.
6.69 Dr Hale  described the sequence of events necessary for E. amylovora  on mature apple
fruit imported into Japan to be a pathway for the introduction of fire blight (i.e. entry,
establishment and spread) as follows:
(a) E. amylovora  had to be associated with mature, symptomless fruit, i.e. calyx
infestation or surface contamination;
(b) E. amylovora  had to survive storage and transport;
(c) E. amylovora  had to be transferred to a suitable host, which in turn was
dependent on the availability of suitable hosts, discard of fruit in the vicinity of
host plants, and the presence of a vector for transfer to the host;  and
(d) the establishment of E. amylovora  on a suitable host, which would be dependent
on the numbers of bacteria required for infection, and be related to environmentalconditions and the receptiveness of the host.
Dr Hale was not aware of any evidence to suggest that this pathway had ever been completed
either experimentally or in natural situations.  In fact, the evidence (Hale et al. , 1996; Hale &
Taylor, 1999; Taylor et al. , 2002, 2003) suggested that this pathway had not been completed
because:
(e) E. amylovora  was not associated with mature, symptomless fruit from orchards
without fire blight;
(f) E. amylovora  might be associated with mature, symptomless fruit from orchards
severely infected with fire blight, but E. amylovora  populations infesting fruit
calyxes tended to decline in cool storage (Hale & Taylor, 1999);  and
(g) E. amylovora  was not transferred from calyx-infested or surface-contaminated
fruit to suitable hosts in conditions conducive to spread of fire blight even when
fruit were placed adjacent to flowers and growing shoots (Hale et al. , 1996;
Taylor et al. , 2003).
6.70 Dr Hayward stated that for  mature apple fruit exported to Japan to be a pathway for the
introduction of fire blight the following conditions would have to apply:
(a) The pest was either in or on the calyx of mature apparently healthy fruit;
(b) the pest survived cold storage and transport;
(c) fruit were either dumped prior to retail or discarded by a consumer;
(d) infected apple fruit were placed in fields;  and
(e) birds, insects, or wind and rain disseminated bacterial ooze from the discarded
fruit to pears, apples or ornamental hosts in hedgerows.WT/DS245/R
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Dr Hayward was not aware that this pathway had ever been completed, either experimentally or
in natural situations.
6.71 Dr Smith  answered that the fruits should first be contaminated by E. amylovora .  This
had been experimentally shown to be possible, though at low levels, in orchards with a high levelof available inoculum.  Such contamination was most likely to be superficial or in the calyx.  The
bacteria had then to persist as a significant and viable population, first while the fruit was on the
tree, then at picking and during storage, and finally during shipping.  Some proportion of a lot of
contaminated fruits had then to be discarded, as waste from consumption, or as unsold fruits.  The
waste fruit material would in a few days, or at most weeks, decompose by the action of other
micro-organisms and E. amylovora  would not be expected to survive this process in competition.
So the next step had to intervene in the short time while some viable E. amylovora  remained.
Rainsplash would be the simplest mechanis m for transmission, but it seemed exceedingly
unlikely that fruit waste would be deposited in a suitable location.  Otherwise, it had to be
supposed that insects, or birds, could feed on the discarded fruit waste and then fly to apple trees.
It remained necessary to determine what insects would behave in this way.  Birds were
conjectured to have carried E. amylovora  on their feet from infected branches to infect new
shoots;  however it was less clear whether they might, by feeding on waste fruit, introduce
inoculum into a tree.  Finally, susceptible tissue had to be available at the time when the fruit
waste was discarded (this would most often not be the case, but long storage or inter-hemisphere
trade could make it possible).  A conceivable short-cut might occur if fruits became internally
infected and these fruits were not detected.  If this ever happened (which was debatable), thenthere was a stronger possibility that viable bacteria remained in the fruits during storage and
shipping.  Thereafter, the pathways joined.  If  such externally invisible internal infection
occurred, the phenomenon was certainly extremely rare, and this had also to be taken into account
in evaluating the probability of this pathway.  The only element of this pathway that appeared to
be confirmed experimentally was the initial superficial contamination of fruits by bacteria.  Theinformation on internal infection of fruits was based on very rare casual observations, and the
phenomenon had never, to his knowledge, been reproduced experimentally.
Question 10:  Are you aware of any studies whic h report the detection of endophytic bacteria in
mature, symptomless apple fruit?  Please describe your understanding of the state of
knowledge in this regard.
6.72 Dr Geider stated that it  was difficult to envisage naturally occurring endophytic bacteria
within an apple.
6.73 Dr Hale  replied that bacteria which multiply in internal tissues without causing disease
are normally considered to be endophytic (Thomson, 2000).  Van der Zwet et al.  (1990) had
recovered E. amylovora  from inside mature apple fruit only when it was grown within 60 cm of
visible fire blight infections.  It had never been demonstrated that mature, symptomless fruit wereinvolved in dissemination of endophytic E. amylovora  and served as a source of new infections in
orchards (Thomson, 2000).  It would be extremely unlikely that endophytically contaminated fruit
could be responsible for establishing new outbreaks of fire blight (Roberts et al. , 1989; van der
Zwet et al. , 1990;  Thomson, 1992 b;  Hale et al. , 1996).
6.74 Dr Hayward knew of no studies which reported the detection of endophytic bacteria in
mature, symptomless apple fruit – assuming that in the study of van der Zwet et al.  (1990)
positive samples came from immature fruit.  If the pest occurred as an endophyte in mature fruit it
would enter through the flower.  The presence of endophytic bacteria could be sought either inWT/DS245/R
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core samples from surface sterilized fruit (Roberts, 2002) or in the calyx (Hale et al. , 1987).  The
latter authors had not found the pest on the epidermis of commercially packed apple fruit and
only found it in low numbers from less than 1% of the calyx ends of fruit from an orchard
severely affected by the disease.  Roberts (2002) had not detected the pest in 900 fruit after
harvest, and of 30,000 fruit stored in cold storage for three months none developed fire blight.
6.75 Dr Smith replied that he  knew of no convincing evidence of endophytic bacteria in
symptomless apple fruit.  Van der Zwet et al.  (1990) had referred to endophytic infection but this
paper was not convincing in several respects.
Question 11:  Regarding bacteria in and/or on mature apple fruit, please explain how the
studies by van der Zwet & Beer, (1992, 1995, 1999) , Hale (1987) and van der Zwet et al. (1990)
differed, and the implications of their results.  Have the results of these studies been confirmed
by other experiments or studies?
6.76 Dr Geider  stated much data from experiments were open to personal interpretation and
judgement.  Evidence of colony hybridization was circumstantial and often flawed because of a
population of Pantoea agglomerans  (Erwinia herbicola ).  Some of the papers about E. amylovora
in apples gave a general report without documenting any detailed laboratory data.  It was unusual
for the authors to publish contradictory papers or statements, and it might be advisable to reassayfruits from various sources including fire blighted orchards
..
6.77 Dr Hale  noted that van der Zwet & Beer (1992, 1995, 1999) discussed the infection of
immature fruit through lenticels, wounds or infected spurs.  Immature fruit infection was most
common following hailstorms.  Infected apples nearing maturity turned brown, shrivelled, and
appeared mummified as they remained attached to the spur.  Infected fruit would not be harvested
as they would never become mature, symptomless fruit.  In Hale et al.  (1987), E. amylovora  had
not been detected in washings from mature fruit from orchards in which no fire blight symptoms
had been seen nor from fruit from orchards with low levels of infection (1-2 infections/tree).
E. amylovora  had been isolated from a small number (<1%) of fruit from a severely infected
orchard (75 infections/tree).  For both fully matu re and packed fruit, i.e. mature, symptomless
fruit, E. amylovora  had only been detected in the calyx and not on the fruit surface.  This
suggested that E. amylovora  could survive in the dried remnants  of flowers infested at flowering
time.  Hale et al.  (1987) had concluded from these results that apple fruit harvested from orchards
with no fire blight symptoms during the growing season were unlikely to constitute a means of
disseminating the disease.  Van der Zwet et al.  (1990) had not detected E. amylovora  on or in
fruit from two orchards without fire blight.  Endophytic populations had been recovered from
apples located within 30cm of blighted shoots but not from 60-200cm away.  E. amylovora  had
not been detected in core tissues of fruit from apparently healthy trees grown in four regions of
North America.  The authors had c oncluded that the dissemination of E. amylovora  to areas or
countries without fire blight was extremely unlikely when mature, symptomless, undamaged fruit
were harvested from apparently healthy trees in orchards free of fire blight.
6.78 Dr Hale also stated that van der Zwet et al.  (1990) had reported that disease developed
among surface-disinfested fruit after cold storage.  However, internal fruit blight symptoms had
been difficult to distinguish from those of other fruit rots.  E. amylovora  had been detected from
the surfaces of blighted fruit in storage, mainly  from fruit collected at or directly below blighted
shoots.  The authors stated that after one month of cold storage some of the disinfested fruit had
been blighted presumably from endophytic bacteria.  However, van der Zwet (Exhibit USA-18)had suggested that it was equally probable that damage to fruit at the time of disinfestation might
have allowed surface bacteria to enter fruit tissues.  A low incidence of blight had also beenWT/DS245/R
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observed among stored fruit harvested from  apparently healthy trees within 10m of fire blight
infected trees, van der Zwet (Exhibit USA-18).  E. amylovora  had been recovered from extremely
small numbers of asymptomatic fruit harvested from orchards with fire blight symptoms -
suggesting that small populations of bacteria might remain on the old flower parts in the calyx.
That E. amylovora  had not been recovered from mature fruit from resistant cultivars in West
Virginia or from Washington State fruit was indicative that mature fruit from symptomless trees
were unlikely to be infested with the bacterium.
6.79 Dr Hale noted that all the reports concluded, overall, that mature, symptomless apple fruit
harvested from orchards without fire blight symptoms did not harbour E. amylovora .  He noted
that it had now been confirmed that, on the occasions when E. amylovora  was associated with
fruit from symptomless trees, the trees were only 10m from severe blight sources.
6.80 Dr Hayward  noted that Hale et al.  (1987) did not use destructive sampling to obtain core
samples but relied on surface washing of shoots, flowers and fruits.  A later study (Roberts, 2002)
had confirmed that E. amylovora  did not occur as an endophyte in mature, healthy fruit.
6.81 Dr Smith answered that the three publications of van der Zwet & Beer were successive
versions of a practical guide to integrated disease management for fire blight, and not strictly
speaking "studies".  They clearly described "fruit blight", using phrases like "immature fruit maybecome infected", "infected apple and pear fruits turn brown and black, respectively, shrivel, and
appear mummified as they remain attached to the spur".  The inoculum for these infections had to
come initially from the fruit surface, and infected through wounds (hailstorms were cited as a
predisposing factor).  The description in these three publications was appropriate in the context of
practical fire blight management.  Fire blight wa s not important on harvested or stored fruits, and
these cases were therefore not referred to at all.
6.82 Dr Smith noted that  Hale et al.  (1987) had been concerned as to whether E. amylovora
could be detected on the surface of fruits or in the calyx.  They showed that the bacterium could
be detected, but that this depended on the level of inoculum in the orchard (the more inoculum,
the more likely was detection) and on the time of testing (more likely on immature than onmature fruit), and on the part of the fruit (contamination persisted longer in the calyx than on the
surface of the fruit).  This paper had presented coherent results, and was one of the few
demonstrations that E. amylovora  could in fact be recovered, at low levels, from mature fruits in
orchards, or from the calyx (only) of fully mature packed fruits.
6.83 Dr Smith described the paper of van der Zwet el al.  (1990) as concerned with whether
E. amylovora  could be recovered from outside or inside apple fruit when harvested from the
immediate proximity of blighted shoots and then stored, or when artificially inoculated andstored.  It was noteworthy because it was the only published paper that recorded the isolation of
E. amylovora  from core sections  of fruits – although it was not clear if these were symptomless
fruit, and their maturity was not specified.  However, the paper of van der Zwet el al.  (1990) had
presented a number of anomalous features.  In relation particularly to the experiment reported in
Table 2, the fruits which had been disinfested showed much more "disease" than those which hadnot.  This was a very strange result, which the authors failed to comment on or explain.  Twenty
fruits had been sampled (but it was not clear if they had been destroyed) each month, and it was
not clear what fruits remained and what the percentages of disease incidence referred to.WT/DS245/R
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Curiously, disease incidence seemed to decline in storage.  There was in fact no confirmation that
the disease symptoms were due to E. amylovora.176
6.84 Dr Smith observed that the experiments reported in the paper of van der Zwet et al.
(1990) were performed by different scientists at four widely separated locations in several
different years.  Such a situation was perfectly normal and acceptable, but it did engender
potential difficulties in interpreting results when there were contradictions and anomalies, such asin this case.  Overall, the study reported in the paper failed to convince. Experiments were said to
have been performed and procedures followed, but no results were reported.  He wondered
whether the research programme had not gone according to plan, and suggested that it might have
been better to repeat some of the experiments or design better ones before publishing certain
results.
Question 12:  Please comment on the informat ion provided in Exhibits USA-18 and USA-19 in
the light of  other available scientific eviden ce regarding epiphytic and endophytic bacteria on
or in mature, symptomless apple fruit.  In your view, is the value of the scientific information
provided in these exhibits affected by the fact that they were not published in a scientific
journal?
6.85 Dr Geider  stated that the scientific papers referred to seemed to be a collection (even at
the time of publication) of old data enriched with more recent observations.  The identification
methods were mainly classical and could have been undertaken by visual inspections of fruits for
rot - rots which could have been caused by micro-organisms other than E. amylovora .  The "Plant
Disease" paper gave the impression that the fire blight pathogen was found in late season.  Young
apples could possibly become infected through adverse weather conditions even late in growthand might thus carry the pathogen for some time.   However, Dr Geider did not think that they
would develop into mature fruits which could be  sold at market as the pathogen could not be
carried from an infected flower to the late stage of a matured apple.  Nevertheless, the letters of
Drs van der Zwet and Thomson weakened the conclusions of their 1990 paper.  Dr Geider also
stated his view that scientific arguments without new data were not so significant in their contentas to justify another publication.
6.86 Dr Hale  stated that the declaration from Dr van der Zwet (Exhibit USA-18) clearly
explained the situation relating to epiphytic and endophytic bacteria on or in mature, symptomless
fruit discussed in van der Zwet et al.  (1990):
(i) In most cases the fruit had definitely been immature.
(ii) The sources of fruit in the West Virginia experiments had either been from
blighted orchards or control orchards within 10m of blighted trees.
(iii) Only epiphytic bacteria had been isolated from immature fruit from West
Virginia orchards.  E. amylovora  had not been isolated from internal tissues.
                                                     
176 A plating procedure for washings from fruit was said to have been performed on sampled fruits
but no results were presented.  Concerning the results reported in Table 3, data for three years (1984, 1985,
1986) were confounded.  It was not clear how the bacteria were extracted (both core segments and wash
water were mentioned in Materials and Methods, but the latter case was not mentioned in Table 3).Controls were referred to in 1986, but seem to have been used for the experiments in all three years.WT/DS245/R
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(iv) In Utah, E. amylovora  had been recovered both on and in fruit from blighted
orchards.
(v) No E. amylovora  had been recovered either on or in fruit from Washington or
Ontario.
(vi) Epiphytic E. amylovora  had been isolated from the calyx of an immature apple
from a symptomless tree from within 10m of severely blighted trees.
(vii) In stored, mature fruit collected from various distances from blight sources,
internal symptoms had been difficult to distinguish from those of other rots.  The
blight referred to in disinfested fruit might have been due to endophytic
E. amylovora,  but might equally have been due to epiphytic E. amylovora
entering wounds after handling during the surface disinfestation process.
Professor Thomson’s letter (Exhibit USA-19) stated  that most fruit had been immature, and that
only Delicious fruit harvested on 29 September could have been near maturity.  Professor
Thomson had also clarified that all positive E. amylovora  detections had been either in or on
immature fruit with a single exception.  In this one case, epiphytic bacteria had been detected in
the calyx of an apple from a blighted tree in a severely blighted orchard.
6.87 Dr Hale indicated that the information presented in Exhibits USA-18 and USA-19
clarified a number of discussion points presented in van der Zwet et al.  (1990), and was
consistent with results obtained by other research workers (Hale et al. , 1996).  Although the
information provided in these exhibits was not published in a scientific journal, in his view the
exhibits were particularly valuable as they clarified a number of important points.
6.88 Dr Hayward stated that  Dueck (1974), Hale et al.  (1987) and Roberts (2002) had shown
that E. amylovora  did not occur on the epidermis of mature fruit or as an endophyte.  The first
author had not detected E. amylovora  on the surface of symptomless fruit of naturally infected
trees and had concluded that mature fruit presented a negligible risk for the dissemination of fire
blight bacteria. Sholberg et al.  (1988) had sampled fruit from apple trees inter-planted with
Bartlett pear (highly susceptible to fire blight) and found that all apple fruit and leaves were
contaminated with E. amylovora  at harvest.  Dr Hayward noted that papers published in scientific
journals were usually subjected to peer review by two referees and the editor.  Papers from a
research institute would commonly be required to undergo in-house review before submission -
this was also commonly the case with papers submitted by University staff.  As such, documents
that had not undergone any review process carried lesser weight.
6.89 Dr Smith felt it was  essential, in discussing van der Zwet et al.  (1990), to be clear
whether the fruits were mature or immature.  This was perhaps not a critical point at the time the
research had been carried out.  Dr Smith could not see any way to resolve this question other than
asking the authors, and their replies were more valuable than if they had been in a general
discussion on the subject published in a journal because they addressed specific questions.WT/DS245/R
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Question 13:  With regard to the citation of th e conclusions by Sholberg et al. (1988), can you
comment on the "certain conditions" in which E. amylovora may be present on symptomless
fruit at harvest?  How likely are these conditions to be found in apple fruit exported from the
states of Washington and Oregon?
6.90 Dr Geider  stated that contamination with E. amylovora  could occur at several stages of
fruit development.  It was very difficult to judge when, where and why contamination occurred
and what would be the next stages of pathogen development, although maturation into a fruit for
the market seemed unlikely.
6.91 Dr Hale  noted that Sholberg et al.  (1988) had isolated E. amylovora  from apple and pear
leaves at harvest and extrapolated that these "results show that E. amylovora  may be present on
symptomless fruit at harvest under certain conditions".  In this study, apple leaves and fruit had
been sampled and bulked together for each group of trees;  the apple trees were adjacent to fireblighted pear trees and the year of the study had been an extraordinary year for early fire blight.
The naturally contaminated fruit used for the surface disinfestation trials had come from an
orchard severely damaged by fire blight after a hail storm, resulting in blighted shoots and small
fruit exuding bacteria.  The "certain conditions" appeared to refer to fruit being sampled from
trees adjacent to fire blighted pears in a year particularly conducive to the disease, and naturallycontaminated "apparently healthy" fruit from an orchard severely damaged by fire blight.
Dr Hale's understanding was that these conditions would be unlikely to occur for apple fruit
exported from the States of Washington or Oregon.
6.92 Dr Hayward  considered the "certain conditions" to which Sholberg et al. (1988) referred
as the proximity of the apples to a gross infection source (Bartlett pear) during "an extraordinaryyear for early fire blight development in British Columbia" when the experiment was conducted.
Transmission of E. amylovora  from pear to apple would have been primarily through wind-driven
rain.  High humidity would have been required for colonization of leaves and fruit.  Dr Hayward
thought it highly improbable that any grower in Washington or Oregon would grow apples near
to a gross infection source such as Bartlett pear.  If the climatic conditions were drier and lesshumid, then secondary transmission would occur less often.
6.93 Dr Smith  noted that Sholberg et al.  (1998) had stated that these certain conditions
(proximity of blighted pear trees, extraordinar y year for early fire blight) were for British
Columbia.  While he was not competent to comment in detail on the similarity of conditions in
Washington or Oregon, at an elementary level he supposed the likelihood to be similar .
Question 14:  Please comment on the statistical methods and values assigned by Roberts, et al.
(1998) and by Yamamura, et al. (Exhibit JPN-15)  Please comment on the significance of the
different conclusions reached in these studies.
6.94 Dr Geider  noted that in most experiments one dealt with standard deviations.  In this
case, sampling studies had been applied.  Sampling studies could be used to claim validation of
an extensive survey, but they did not help in the case of accidental contamination.  He disagreedwith the characterization of extremely high risks for fire blight dissemination.  There were
numerous examples which demonstrated that localized foci of infection did not expand, such as
the recent infection in an orchard of the Biological Research Institute (BBA, Heidelberg-
Dossenheim), where apple seedlings had been imported from Belgium.  One seedling had
developed fire blight (pattern type Pt1), but the others had not, nor had any of the other trees inthe orchard.  The transient fire blight event in Australia in 1997 was another example.WT/DS245/R
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Discarded fruit
Question 15:  Japan's 1999 Pest Risk Analysis at  Section 2-2-4-3 considers, inter alia, the case
of un-marketed fresh fruits, and indicates that "if they are released as juice, leftovers, waste,
useless materials in the fields surrounding ranches or in a natural environment, they can bethe source of the disease".  What is your view about the likelihood of this pathway, specifically,
the likelihood that bacteria surviving on imported apple fruit would survive release as juice,
leftovers, waste, or useless materials and serve as a means of transmission of fire blight?  Is
there any information about the volumes of import ed fresh fruit that might be thrown away?
6.95 Dr Geider  stated that the detection of a pathogen in plant material was difficult at low
levels.  It could be shown that pollen collected by bees in the neighbourhood of a fire blightedorchard contained E. amylovora  (Bereswill et al. , 1994).  In this and the other cases, claims about
the amount, the rate of decay and persistence of E. amylovora  at a low level should be known.  It
could happen that an apple with E. amylovora  might release the bacteria into fruit juice.
However, commercial apple juice had to be sterilized immediately after pressing.  His own data
clearly indicated that E. amylovora  survival in soil-like environments rapidly diminished within
days (Hildebrand et al. , 2001).  Farm material could be contaminated with E. amylovor a and there
might also be some risk with nursery stocks of living fire blight host plants.
6.96 Dr Geider noted that retail stores might dispose of large amounts of fruits, such as apples
and pears, if they did not meet their quality standards.  However, the scenario of insects visiting
rotting fruit in a waste bin or in a garbage dump and carrying away E. amylovora  cells which
would eventually contaminate the nearby flowers of host plants was not realistic.  The pathogen
would most likely decay immediately in this en vironment and other bacteria would take over.
6.97 Dr Hale replied that there was a hypothetical risk that leftovers or waste material could
possibly carry E. amylovora  and provide a source of inoculum.  However, any contaminating
bacteria would then require dissemination to susceptible hosts at a receptive stage under climaticconditions conducive to infection.  Hale et al.  (1996) and Taylor et al.  (2002, 2003) had been
unsuccessful in attempts to transmit E. amylovora  from contaminated, discarded apples to
susceptible hosts, e.g. apples and cotoneasters at flowering (most susceptible stage).  Discarded
fruit had been visited and eaten by birds but had not resulted in transmission of E. amylovora  to
host plants;  ants, bees, flies, moths and spiders had not been contaminated and had not
transmitted E. amylovora  to susceptible host plants;  rainwater had not been contaminated, and
splash had not transmitted E. amylovora  from infested fruit to flowers or leaves.  Dr Hale also
stated that if E. amylovora  did survive on imported apple fruit then it was likely to be affected by
the processing into juice, which might include heat treatment.
6.98 Dr Hayward  had no information about the volumes of imported fresh fruit that might be
dumped.  He thought it highly unlikely that the E. amylovora  would survive in juice, leftovers or
other waste because these materials were high in fermentable sugar content.  The saprophyticrelatives of E. amylovora  (i.e., other members of the Enterobacteriaceae) were profusely
distributed in the environment and fermented a wide range of sugars, lowering the pH to a level
inimical to other bacteria.  Lactic acid bacteria and acetic acid bacteria would also be involved.
Many of the saprophytes would have a more rapid growth rate than E. amylovora .  In compost
there would be other interactions including the antibiotic effects of actinomycetes and fungi.WT/DS245/R
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6.99 Dr Smith replied that any bacteria which might be present in imported apple fruit would
not survive release as juice, leftovers etc.  They would very rapidly die out in competition with
other micro-organisms.  Their best chance of short-term survival would be for the fruits to be
simply discarded, without any processing.  Longer term survival would, according to available
information, be favoured by desiccation, but this applied mainly to dried bacterial ooze.  Imported
fruits would not carry ooze, and there was no obvious way in which fresh fruits carrying lowpopulations of bacteria could dry out while allowing these bacteria to survive.
Question 16:  Is there any evidence available regarding the spread of fire blight infection from
discarded, contaminated apple fruit, including in  orchards at the most vulnerable phase of the
growing cycle?  Please comment on the relevanc e of the study presented as Exhibit USA-20 to
Japan’s concern about risk from discarded apple fruit.
6.100  Dr Geider stated that there was no evidence that fire blight spread from discarded fruit.
Since the likelihood was very low, it would be impossible to trace back a fire blight outbreak to
that source.
6.101  Dr Hale  stated that evidence on these questions had been presented as Exhibit USA-20
and in Taylor et al.  2003.  Spread of E. amylovora  from inoculated (calyx-infested) apples to
susceptible hosts had not been detected over 2 seasons by either culture or PCR tests onrainwater, apple flowers or leaves, nor had it been associated with insects and spiders.  The
climatic conditions over the sampling period had been conducive to fire blight infection with
several moderate and high risk infection events occurring in each season.  The results
demonstrated that E. amylovora  present in contaminated apple calyxes was not transferred to
susceptible hosts that had been in a receptive stage at flowering.  Therefore, should E. amylovora
exist on exported commercial apple fruit, there was no evidence to suggest that these bacteria
would provide inoculum for new fire blight infections.  Consequently, there was a discontinuity
in the pathway for dissemination of E. amylovora  from an infected fruit to a susceptible host as
there was no demonstrated spread of the fire blight bacterium from the discarded fruit.
6.102  Dr Hayward  was not aware of any evidence regarding the spread of fire blight infection
from discarded contaminated apple fruit, including in  orchards at the most vulnerable phase of the
growth cycle. Taylor et al.  (2002, in press) had artificially inoculated apples at the calyx end of
the fruit with a genetically marked strain of E. amylovora.  The infested apples had been hung in
apple orchards at blossom time over a 20-day period.  Numbers of bacteria had declined 10,000-
fold during the time span of the experiment.  The genetically marked strain had never been
detected on apple flowers or leaves, in rainwater or in trapped insects.  The results suggested that
E. amylovora  was not spread from calyx-infested apples to susceptible hosts.
177
6.103  Dr Smith replied that Exhibit USA-20 confirmed the general understanding of fire blight
epidemiology, that fallen fruits did not provide a pathway of transmission for new infection.  It
was useful and relevant that this had been directly demonstrated.  Such a study could not prove
that such transmission never occured, but, unless reproducible results were obtained, such a study
could not prove that transmission would occur, either.
                                                     
177 Dr Hayward noted that an argument against the validity of these results was that the marked
strain might in some way be made less competitive as a result of the genetic modification (selection inculture of a mutant resistant to both rifampicin and nalidixic acid).WT/DS245/R
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Question 17:  In the risk assessment included as Exhibit USA-4, Parameter p(4) is the
probability that a fair to good host is at a receptive stage if fire blight contaminated fruit were
to be discarded near a host.  The author indicates that "We are considering the only receptive
stage for the plant as the flowering stage".   Please comment on this assumption.
6.104  Dr Geider considered the statement as  hardly correct since there was very low risk,
provided there was a contaminated apple, that insects would carry bacteria such as E. amylovora
to neighbouring plants (see Hildebrand et al. , 2000).  The flowering stage was the dominant stage
at which infection of a plant took place;  injuries, succulent shoots and stomata of leaves were
possible but much less common pathways for disease entry.
6.105  Dr Hale  noted that the authors considered flowering to be the only receptive stage for the
purpose of the model because the flowering stage was when the plant was at its most receptive.This was the stage when insects would be most likely to visit discarded fruit and then move to
open flowers and stigmas, where the bacteria could multiply (Thomson 2000).  The flowering
stage was the only stage when injury to tissues was not required in order to result in infection
with E. amylovora.  The infection of leaves and immature fruits, as a result of insects, wind or
rain, required damage to the plant surface e.g. hail damage or piercing insects (which were not thetypes of insects likely to visit decaying fruit).
6.106  Dr Hayward  stated that the published evidence indicated that the flowering stage was
the only receptive stage for transmission to occur through insects or wind-driven rain.  If birds
such as starlings were involved in long range transmission, as had been proposed, some other
route may have been involved but there was no data on this.
6.107  Dr Smith  stated that fire blight could also enter through wounds, but this was only
significant in situations where wounds were especially and unusually frequent (e.g. during
pruning, after a storm). These special situations did not invalidate the author's view on the "only
receptive stage", since woundings were relatively rare and random.
Question 18:  The above exhibit also includes a statement that "… survival in soil is not
considered epidemiologically significant".  Does this mean that waste is not considered to pose
a phytosanitary risk?
6.108  Dr Geider responded that E. amylovora  would decay rapidly in soil (Hildebrand et al. ,
2001), so there was no risk of dissemination of fire blight from the soil.  However, discarded
apples might not always be immediately covered with soil and could be accessible for insects.
Nevertheless, there remained the question of whether or not E. amylovora  was associated with the
discarded fruits and how long it would persist.
6.109  Dr Hale  replied that it was possible that decaying apples (waste) could release bacterial
cells into the soil, which might then be a reservoir for spread.  However, several researchers had
considered soil to be of little epidemiological significance (Thomson 2000).  Hildebrand et al.
(2001) had shown that populations of E. amylovora  declined rapidly in soil, presumably due to
predation by degrading micro-organisms.  Consequently, they considered that, although soil and
waste associated with soil could not totally be overlooked as a source of inoculum, it was unlikely
that E. amylovora  would be transmitted from soil via rain splash or by insect vectors to
susceptible flowers or shoot tips.WT/DS245/R
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6.110  Dr Hayward stated that it was very unlikely that apple waste was epidemiologically
significant  because E. amylovora  was a poor competitor in soil (Hildebrand et al. , 2001).
Bacterial pathogens of plant foliage were in general poor survivors as free cells in soil.  However
they often had a significant capacity for survival in seed or when they were embedded in the
vascular tissue of their host plants and buried in soil.  E. amylovora  had never been found in seed
of apple (van der Zwet 1990) or any other plant.  There was no evidence that the fire blightpathogen survived in soil in any "protected site " such as seed or vascular tissue.  Apple waste
composted or otherwise disposed of into the environment would decompose very quickly and
would not be a phytosanitary risk.
6.111  Dr Smith noted that great numbers of E. amylovora  must be washed onto and into the
soil every time it rained in an infected orchard.  They presumably died out in contact with soil
microflora.  Fruit wastes probably offered a better environment than soil, but they constituted a
very short-lived environment.
Contamination of apple fruit in the orchard
Question 19:  Please describe the current st ate of knowledge regarding the contamination
(internal or external) of mature apple fruit in the orchard.  In this context, please specifically
address the following:
(a) Please comment on the contribution of the study provided as Exhibit JPN-8 to
knowledge regarding epiphytic contamination of apple fruit.
(b) Please comment on the conclusions of Th omson (2000) in this respect.  Are
you aware of any other studies which may be relevant regarding contamination(internal or external) of mature apple fruit in the orchard?
6.112  Dr Geider  responded that his research work had shown that E. amylovora  could be
detected on insects caught in a fire-blighted orchard (Hildebrand et al. , 2000), so it was possible
that apples from a "severely blighted" orchard could become surface contaminated.  Also ooze
droplets and "strands" could contribute to this contamination.  He concluded that it was notadvisable for phytosanitary reasons to export apples picked in orchards with severe fire blight,
although apples might be harmless for disease distribution.
6.113  Dr Hale  noted that E. amylovora  had been isolated from calyxes but not from the
surfaces of mature apples from a severely infected orchard (75 infections/tree).  The calyx
infestation was likely to be as a result of infestation at flowering in the severely infected orchard.
E. amylovora  was not isolated from either calyxes or the surfaces of mature apples from three
lightly infected orchards (1-2 infections/tree) or  from six orchards with no fire blight symptoms.
As a result he concluded that fruit from orchards without symptoms was unlikely to constitute a
means of disseminating fire blight (Hale et al. , 1987).
6.114  Dr Hale agreed with the conclusions of Thomson (2000) that contamination of mature
fruit was rare and only occurred when there were active sources of fire blight either in the orchard
or close by.  Wherever E. amylovora  had been detected on mature fruit it had been associated
with fruit from orchards with high levels of fire blight infection.  Thomson’s conclusions
appeared logical, i.e. it was unlikely that contaminated fruit could be responsible for establishing
new outbreaks of fire blight.  Also, it had never been demonstrated that mature fruit were
involved in the dissemination of E. amylovora  and served as sources of new infections inWT/DS245/R
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orchards.  Dr Hale was not aware of any studies on contamination of mature fruit in orchards
other than those reviewed by Thomson (2000).
6.115  Dr Hayward  indicated that the evidence showed that E. amylovora  was rarely found on
the epidermis of apple fruit except under the "certain conditions" of Sholberg et al.  (1988) where
there had been a gross source of infection in close proximity and the climatic conditions hadfavoured secondary transmission.  Hale et al.  (1987) showed that there was no survival on the
epidermis but some in the calyx when the orchard was severely affected by fire blight.  Roberts
(2002) provided the most recent evidence that E. amylovora  did not exist in core samples of
mature, symptomless apple fruit.  Thomson (2000) had assessed the capacity of E. amylovora  as
an epiphyte and concluded that it was not a very successful epiphyte and that populations
declined within a few hours or days.  The exception was that the pistil surface was a favoured site
for epiphytic growth, yet according to Thomson "These colonised flowers do not appear anydifferent from  normal flowers and usually develop into healthy fruit" (Thomson, 1986).
Dr Hayward knew of no work which disputed Thomson's assessment.
6.116  Dr Smith  stated that the article of Hale et al.  (1987) confirmed the basic point that fire
blight bacteria could be isolated from fruit surf aces and calyces, mainly of immature fruit, but in
rare cases also of mature fruit, especially if the orchard was heavily infected.  The conclusions ofThomson (2000) seemed well-reasoned, considered endophytism at length, and did not refer to
the possibility that it might concern fruits (except to quote the results of van der Zwet et al. ,
1990).
Question 20 :  Please comment on the availability of testing techniques to identify the presence
of very low populations of E. amylovora on or in apple tissue.  Is there a minimum or thresholdlevel for the number of bacteria necessary for an outbreak of fire blight?
6.117  Dr Geider  noted that PCR analysis could detect about 100 bacteria in an assay.  The
absolute number depended on the efficiency of extraction, enrichment and contamination by plant
material interfering with PCR.  This amount and possibly less could also be applied to slices of
immature pears in order to obtain reproducible symptoms.  The ecology in nature was certainly
different, because in the common spread of fire  blight many flowers would be visited by many
insects, which might release only a few bacteria and some of them would eventually cause the
disease.
1.118  Dr Hale  noted that molecular techniques utilising PCR for the detection of  E. amylovora
had been developed (Bereswill et al. , 1992, 1995; McManus & Jones 1995; Maes et al. , 1996).
178
There were some quantitative data that suggested that E. amylovora  had to colonize the flower
and rapidly multiply on stigmas to reach populations ≥ 106 colony forming units at an early stage
in flower development (before 4-5 days after bud burst) in order to initiate infection (Thomson
2000; R.K. Taylor unpublished results). The population increase was likely to be dependent on
temperature and relative humidity, i.e. conditions must be conducive to the initiation of the
infection process.  Once pollination and subsequent fertilisation had taken place there were majorchanges in stigma receptivity and inhibitory compounds produced on the stigma which might
                                                     
178 Taylor et al. (2001) had provided an altern ative approach to the development of specific
primers for E. amylovora  and the application of PCR in the detection of E. amylovora  in plant material.
Using this method less than 10 colony forming units of E. amylovora were detected in apple tissue samples.
However, most PCR techniques detected both living and dead E. amylovora cells and consequently some
caution was required in interpreting the results, as dead E. amylovora  cells do not pose a phytosanitary risk.WT/DS245/R
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prevent colonization and infection as the flower aged.  Hale et al.  (1996) also suggested that
populations of E. amylovora  > 105 were necessary to cause flower infection and subsequent
symptoms in apple and cotoneaster.
6.119  Dr Hayward  stated that there was a consensus that the best method to detect low
numbers of a bacterium in a particular substrate such as soil or plant  material was to combine
culture with the polymerase chain reaction (a procedure known as BIO-PCR in which the lowpopulation was amplified in a selective liquid medium to numbers detectable using PCR).  He had
no information on a minimum or threshold level for the number of bacteria necessary for an
outbreak of fire blight.
Question 21:  What evidence is available rega rding the survival of E. amylovora in or on
mature apple fruit?  Is there any evidence that such internal or external bacteria can be the
source of outbreaks of infection?  Is there an y evidence relating specifically to mature apple
fruit harvested from an orchard rather than to experimentally inoculated apple fruit?
6.120  Dr Geider  noted that survival studies were rare in fire blight research as they were
tedious to do, dependent on many storage conditions of the bacteria associated with or without
plant material and because of the huge differences of recovery.  Apples were rarely used for
experimental inoculations because of difficulties in obtaining symptoms.
6.121  Dr Hale  indicated that E. amylovora  was not detected on the surface of fruit harvested
from either heavily or lightly naturally-infected orchards but that E. amylovora  did survive in
calyxes of a few fruit from severely infected orchards (Hale et al. , 1987; Hale & Taylor 1999).
However, E. amylovora  was not detected in these naturally-infested calyxes of mature fruit after a
period of cool storage.  Hale et al.  (1996) reported survival of E. amylovora  in apple calyxes after
experimental infestation and Taylor et al.  (2003) showed that small populations persisted in
artificially-infested calyxes of mature fruit after discard of these fruit in an orchard.  E. amylovora
did not appear to survive well on fruit as surface contaminants were likely to be adversely
affected by ultraviolet radiation.  There was no evidence that either internal or external
E. amylovora  associated with mature apple fruit were sources of outbreaks of fire blight in the
field.  However, internal E. amylovora  could possibly cause infection of immature fruit e.g.
infection at flowering might cause symptoms on immature fruit.
6.122  Dr Hayward stated that  E. amylovora  did not survive on the apple epidermis but had
limited capacity to survive in the calyx (Hale et al. , 1987; Hale et al. , 1999; Taylor et al. , 2002).
Cool storage reduced survival in the calyx (Hale et al. , 1999).  Roberts (2002) and Dueck (1974)
had shown that E. amylovora  did not occur as an endophyte in mature, symptomless fruit.  Dr
Hayward could find no evidence that epiphytic or endophytic populations on/in apple fruit couldbe the source of outbreaks of infection.  In the work of Roberts (2002), Dueck (1974), and Hale et
al. (1987), apple fruit were harvested from orchards;  in the later work of Hale and Taylor a
genetically marked strain of E. amylovora  had been used.
6.123  Dr Smith  referred to Sholberg et al.  (1988) who had conducted experiments with
artificially infected and naturally infected fruits.  Artificially infected fruits stored at 2-4°Cshowed about a ten-fold decrease in recovery per two months of cold store.  Natural inoculum did
not survive 5 months, but no detailed time course study had been done.  In general, at ambient
temperatures, E. amylovora  was only supposed to survive on plant surfaces for a few days.  Since
it was not at all clear that E. amylovora  ever normally existed within mature apple fruit, the
possibilities for studying survival under these conditions were limited.  Artificial contamination
could hardly be used because of the assumptions that would have to be made on where and howWT/DS245/R
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the bacteria were introduced.  Studies on naturally occurring bacteria in mature fruit would
require that a reliable source of such fruits could be found.  Dr Smith noted that the issue of
whether E. amylovora  on or in mature fruits can be a source of outbreaks had already been
extensively considered in replies to other questions.
Question 22:  Section 2-2-4-2 of the 1999 PRA on "Difficulty in detection by import
inspection" indicates that "E. amylovora has an  extremely high growth potential.  Even a
small amount of bacteria bursts into growth  under certain conditions."  Is propagation
capacity dependent on the host of the bacteria?  Does this apply specifically to mature apple
fruit?
6.124  Dr Geider  opined that fortunately for apple and pear production, the "growth potential"
of E. amylovora  in mature fruits was low to moderate.  Fire blight outbreaks required the
presence of fire blight in an area and favourable weather conditions.  The occasional fast spread
in orchards was unrelated to the rare establishment of fire blight in a region without the disease.
Nearly all dissemination of fire blight had been shown to be sequential: convincingly seen in the
spread from Egypt to Israel, Turkey, the Balkans to Hungary with the same pattern type Pt2 (Jock
et al. , 2002).  How fire blight got to New Zealand, to Egypt or to England was unknown.
Distribution to Northern Italy and Central Spain could be associated with plant imports, but not
with contaminated fruits.
6.125  Dr Hale stated that  the propagation capacity of E. amylovora  was dependent on the host
susceptibility and the environmental conditions encountered.  The most susceptible host plant
parts were flowers, young shoots, and immature fruit.  Pears were more susceptible than applesand immature pear fruit were preferred for diagnosis of fire blight because of their susceptibility
and rapid symptom development in pathogenicity tests.  There was no evidence to suggest that
E. amylovora  would "burst into growth" either in or on mature apple fruit under any conditions.
Experience showed that it was difficult to infect mature apples.
6.126  Dr Hayward stated that  the growth rate of E. amylovora  varied depending on the
environment, whether in artificial medium or in the tissue of a host plant.  Temperature, nutrient
availability and water activity were among the most important factors, and host plants differed in
susceptibility.  The propagation capacity (generation time) depended on the resistance or
susceptibility of the host, and this applied to apple fruit or any other plant part.  The most rapid
growth rate would only be attainable in artificial medium where all environmental parameters
were optimal for growth.  In the natural environment the bacteria would rarely have an
"extremely high growth potential."
6.127  Dr Smith stated that most bacteria had an extremely high growth potential and small
amounts of them would burst into growth under ce rtain conditions, so this statement was in no
way remarkable.  The fact that different hosts were more or less susceptible to fire blight might be
related to how fast bacteria multiply on that host.  There was no indication, to Dr Smith's
knowledge, that E. amylovora  multiplied at all on the surface or in the calyx of mature fruits.WT/DS245/R
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Orchard inspections
Question 23 :  With regard to the timing of inspections to determine whether an orchard is fire
blight-free, what is the relevance of the fact that the flower has the highest susceptibility of
infection?  If it is at the fruitlet stage when symptoms of fire blight are most easily observed,
why is inspection at an earlier stage relevant?  At a later stage?  Are you aware of any studies
where infection not detected at the fruitlet stage was detected at harvest? Is there any scientific
evidence that early season infections cannot be confirmed as fire blight during a harvest
season inspection?
6.128  Dr Geider  considered that flowers were the most common entry point for fire blight.
However, necrosis could be misleading since other bacteria such as Pseudomonads could cause
similar symptoms (without affecting other parts of the tree).  Even frost damage could result innecrosis.  Typical fire blight symptoms such as necrosis and ooze could be best seen on young
fruits. Nevertheless, unpredictable events such as hail storms could cause rapid dissemination at
all times of the "green season".  In his view, th e "best" inspection time would be after flowering
in June.  There was almost no chance of detecting fire blight if there were no visible symptoms of
the disease, however, inspections could never prove the absence of fire blight, they could onlyidentify fire blight when it was at an advanced stage.  When necrotic branches were pruned (a
common practice), there might not be any sign of fire blight at harvest.
6.129  Dr Hale  indicated that flowers had the greatest susceptibility and usually showed
dramatic symptoms, i.e. browning or blackening of  flowers.  Symptoms at this stage provided an
early warning of fire blight problems in an orchard.  Most severely infected flowers dropped fromthe tree.  Some flowers which had been lightly infected might continue to develop into fruitlets
after pollination.  If the infection continued to develop then the fruitlets ceased development,
became brown/black, shrivelled, and finally aborted.  However, in some instances the fruitlets
might remain attached throughout the growing season.  Immature fruit might also become
infected from shoot tip infection, particularly after hail storms.  Infection and symptomexpression in the orchard at flowering alerted gr owers to the fact that some flowers might be
infested (rather than infected) and that E. amylovora  might persist in the dried-up flower parts
(the calyx) of the developing fruit.  Inspection during the flowering to fruitlet development period
was likely to provide similar results.  Inspection at a later stage, at harvest, would provide a final
check on the fire blight status of the orchard.
6.130  Dr Hale further stated that there were no reports of infestation of fruit detected at harvest
that were not detected at the immature fruitlet stage.  Hale et al.  (1987) and Hale & Taylor (1999)
had found calyx infestation with E. amylovora  at harvest, but fire blight symptoms had been very
severe in the orchards during the season.  Hale & Clark (1990) had detected E. amylovora  from
symptomless immature fruit from two orchards with no detectable blossom symptoms.  However,
subsequent inspection had found fire blight in alternative hosts in the orchard.  There was no
evidence to suggest that early season infections causing fire blight symptoms in trees could not beconfirmed at harvest, unless infections had been pruned out.  Symptoms at harvest suggested that
infection had taken place earlier in the season.  In fact, Roberts (2002) had shown that fire blight
infections on trees at harvest (infections had been left on trees throughout the growing season)
could be confirmed as fire blight by isolation and PCR.  Thus a single preharvest inspection
should address Japan’s concern that any fire blight symptoms occurring in an orchard at any timeduring the season could be confirmed as being caused by E. amylovora.
6.131  Dr Hayward  replied that although the flower had the highest susceptibility to infection
there might be no evidence on inspection.  Thomson (1986) had shown that natural populations ofWT/DS245/R
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E. amylovora  occurred almost exclusively on pistils with populations often reaching one to 10
million colony forming units per healthy flower.  "These colonised flowers do not appear any
different from normal flowers and usually develop in to healthy fruit."  Inspection at the flowering
stage would not help in detection of this type of infection; complementary cultural studies would
be required.  It was at the fruitlet stage when symptoms were the most easily observed andinspection at an earlier stage seemed unnecessary.  He was not aware of any studies where
infection had not been detected at the fruitlet stage, but then detected at harvest.  Neither was he
aware of any scientific evidence that early season infections could not be confirmed as fire blight
during a harvest season inspection.
6.132  Dr Smith stated that while he was not really competent to answer the question, he
believed that in Europe the recommended inspection times were once in July/August and once
during September/October.
Buffer zones
Question 24:  What evidence is available regard ing the need for, or effectiveness of, buffer
zones around orchards with regard to fire blight contamination of mature apple fruit harvested
from the orchard? Does this differ from measures that would be appropriate with regard to afire blight eradication programme?
6.133  Dr Geider was of the view that  buffer zones to protect mature apples from fire blight was
not a reasonable measure, except when used to reduce the risk of late introduction of fire blight.
However, even then, almost mature apples might not be affected by the disease.
6.134  Dr Hale  stated that Japan based its requirement for buffer zones on:  (i) the 500-metre
eradication countermeasures against E. amylovora  in Europe (Meijneke 1979; Zeller, 1987);  (ii)
the 400-metre zone against citrus canker in Japan required by USA for Unshu oranges; and (iii)
the fact that van Vaerenbergh and Crepel (1987) showed dispersion of E. amylovora for 250
metres in humid weather.
6.135  However, measures for an eradication programme were not necessarily the same as those
required for a programme designed to reduce the risk of fire blight transmission on imported,
mature, symptomless apple fruit.  Clark et al.  (1993) had reported that since the introduction of
buffer zones, E. amylovora  had not been detected in calyxes of some 60,000 immature fruit tested
from inspected orchards.  However, most recently Roberts (2002) had shown conclusively that no
buffer zone of any size was justified by the existing scientific data, as fruit harvested from
blighted trees or adjacent to blighted trees had not harboured E. amylovora .  In this study 30,900
mature, symptomless fruit had been harvested zero to 300 metres from fire blight inoculum
sources.  None of the fruit which were subsequently cool-stored had developed fire blight
symptoms and none of the sliced fruit had yielded E. amylovora  - even when harvested from trees
directly adjacent to fire blight sources.
6.136  Dr Hayward stated that according to ISPM No.5 (1999) "Glossary of Phytosanitary
Terms" a buffer zone was:  "An area in which a specified pest does not occur or occurs at a low
level and is officially controlled, that either encloses or is adjacent to an infested area, an infested
place of production, a pest free area, a pest free place of production or a pest free production site,
and in which phytosanitary measures are taken to prevent spread of the pest".  The literature (e.g.
Zeller, 1987; Meijneke, 1979) confirmed that the 500-metre buffer zone was a recommendationfor eradication of fire blight, rather than requirement around a production site.  Roberts (2002, inWT/DS245/R
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press) had obtained results which indicated that a buffer zone of any size provided no
phytosanitary security.
6.137  Dr Smith stated that in  Europe buffer zones were important around nurseries, but the
issue did not arise for orchards.  In practice,  NPPOs found it most practical to eliminate
susceptible hosts in these buffer zones.  In other words, they inspected for the presence of hosts
(which was easier than inspecting or testing hosts for infection).  Published results on superficialcontamination of apple fruit by E. amylovora  strongly suggested that the dispersal involved was
only over very short distances;  it was very unlikely that bacteria carried from a tree in a
surrounding zone would make any significant or detectable contribution to surface populations on
fruits.  Fire blight eradication programmes were trying to prevent infection of shoots (mainly via
flowers) which remained in place slowly allowi ng bacterial development over months or even
years, until active cankers finally released inoculum for further spread.  Thus, a buffer zone
protected the official fire blight-free status of a place.
Question 25:  Does the size of a buffer zone for another disease of fruit, eg citrus canker, have
any scientific relevance with regard to the size of a buffer zone which might be appropriate to
ensure the fire blight –free status of an apple orchard?  Please explain.
6.138  Dr Geider  considered that a reasonable size for a buffer zone for fire blight protection
was the distance of bee flight.  Some biologists assumed that bees could cover up to 1 km from a
bee hive.
6.139  Dr Hale  noted that Stall (1988) had suggested that citrus canker could potentially be
transmitted on citrus fruit, as mature fruit did show symptoms, but there was no authenticated
record of this transmission taking place.  However, the epidemiology of fire blight was differentfrom that of many bacterial diseases, e.g. citrus canker, as there was no evidence of E. amylovora
being associated with lesions on mature fruit.  E. amylovora  might be found in infested calyxes,
but this was only in fruit from severely infected orchards (Hale et al. , 1987).  Dispersal of fire
blight and citrus canker had some similarities in that they could both be dispersed over short
distances by wind and rain, and over long distan ces by propagating material.  However, citrus
canker, unlike fire blight, was not dispersed by bees, but could be dispersed in infected cull fruit
and processed pulp.  Consequently, although fire blight and citrus canker were both bacterial
diseases their epidemiologies differed in the important factor that mature citrus fruit could show
symptoms of canker and could potentially transmit the disease whereas mature apples harvested
from orchards without fire blight symptoms did not harbour E. amylovora  and had never been
implicated in the spread of the disease.
6.140  Dr Hayward  stated that fire blight and citrus canker were both bacterial diseases
affecting the foliage and fruit  of their host plants.  Like most bacterial diseases affecting foliage
and fruit they shared a propensity towards secondary dispersal of inoculum by wind driven rain.
Otherwise there were many differences in epidem iology of the two diseases (Goto, 1992);  and it
was these differences that were important in determining the size of a buffer zone.  The zone size
recommended for citrus canker had no relevance to fire blight.  Insect transmission was a majorfactor for fire blight but not in citrus canker.  The range and diversity of other plants susceptible
to fire blight was great, including common hedg erow plants like hawthorn and ornamental shrubs
(e.g, Cotoneaster and Pyracantha) whereas the host range of citrus canker was much more
limited.
6.141  Dr Smith stated that the size of a buffer zone for another fruit disease, eg citrus canker
did not necessarily have any scientific relevance with regard to the size of a buffer zone whichWT/DS245/R
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might be appropriate to ensure the fire blight-free status of an apple orchard as it depended on the
biology of each disease.  Citrus canker, for example, was a disease in which the pathogen infected
shoots and leaves, and also caused limited cankers on the fruits, from which the bacterium could
continue to spread by rain splash from fruit to fruit.  Insects were not especially associated with
spread, and there was no especially receptive stage.  All these factors had to be taken into accountin deciding on the size of a buffer zone, and a really intimate knowledge of the disease was
needed.
Post-harvest treatment of apple fruit
Question 26:  Is there evidence available regarding the contamination of mature apple fruit by
harvest labour or other means in an orchard wh ere a source of  contamination exists?  Please
comment on the likelihood of contamination by:
(a) normal harvesting practices;
(b) pruning operations and contamination of agricultural machines/equipment;
(c) packing facilities with/without commingling fruit from different orchards;
(d) storage and/or overseas transport.
6.142  Dr Geider stated that since ooze formation was very low at the harvest time for apples,
there was little chance of fruit contamination with E. amylovora , even when there were some
undetected fire blight foci in an orchard.  The circumstances listed could contribute to a low
increase of hidden fruit contamination if fire blight still resided in a tree.  However, there wasalmost no risk of dissemination of the disease with fruit.
6.143  Dr Hale  stated that surface contamination of fruit due to pickers moving from tree to tree
could be possible in a severely infected orchard.  However, fruit for export was highly unlikely to
be harvested from heavily infected orchards (pre-harvest inspection would condemn the orchard).
Survival of E. amylovora  on the surface of mature fruit as contaminants was not likely even in
heavily infected orchards (Hale et al. , 1987).
6.144  He further noted that pruning operations were not carried out when fruit were mature and
consequently contamination was unlikely.  It was possible that agricultural equipment used in
severely infected orchards could become contaminated.  However, equipment was unlikely to be
moved from severely infected orchards to symptomless orchards under common hygiene
practices.
6.145  Dr Hale  indicated that there was no evidence to suggest that the contamination of fruit
was likely due to packing facilities.  Fruit from orchards with no symptoms of fire blight at
harvest were unlikely to be contaminated with E. amylovora.  It was also unlikely that fruit, even
from severely infected orchards, would be surface contaminated (Hale et al. , 1987) and
consequently contamination due to commingling of fruit from different orchards was not likely to
be an issue.
6.146  Dr Hale  observed that there was no evidence to suggest that there was any likelihood of
contamination during post-harvest storage or overseas transport of mature apple fruit.  In fact,
Hale & Taylor (1999) found that post-harvest cold storage reduced populations of E. amylovora
in both naturally and artificially-infested calyxes of mature apple fruit.  This suggested thatWT/DS245/R
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bacterial survival was likely to be adversely affected during normal cool storage and transport
conditions, thus reducing the likelihood of any pos sibility of contamination.  Normal commercial
practice was likely to clearly mark fruit boxes for different destinations and consequently
contamination with fruit for other destinations was also unlikely.
6.147  Dr Hayward  noted his lack of familiarity with normal harvesting practices, pruning
operations, etc., but stated that in his search of the fire blight literature he had not found anyevidence regarding the contamination of mature apple fruit by harvest labour or other means in an
orchard where a source of contamination existed.
6.148  Dr Smith replied that any possible level of contamination of mature fruits arising from
any of these points would not be of an order of magnitude that would make any significant
difference to the ultimate possibility of survival on the fruits and transmission to a susceptible
host.
Question 27 :  If fruit were disinfected prior to packing, in your view would this be sufficient to
remove the risk of spread of fire blight from packing facilities?  What would be the effect on
this risk if the fruit came from orchards free of fire blight;  those with low levels of infection?
6.149  Dr Geider replied that  fruit disinfection was mainly an act of good will.  Given the
general low risk of distributing fire blight with fruit, disinfection did not make sense as it couldlower fruit quality and might even create chlorinated compounds unhealthy for the consumer.
6.150  Dr Hale  considered that a chlorine wash prior to packing would remove any possible
surface contamination of fruit with E. amylovora.  It might also remove E. amylovora  from the
exposed parts of the calyx (see Exhibit USA-22).  However, it would not remove E. amylovora
located on the unexposed parts of the calyx-end of fruit from severely infected orchards.Evidence suggested that mature, symptomless fruit harvested from orchards with either no fire
blight symptoms or only low levels of infection would not harbour E. amylovora  either on the
surface or in the calyx (Hale et al. , 1987). Consequently, in the unlikely event of surface
contamination from the packing facility, disinf ection (disinfestation) prior to packing would
remove any hypothetical risk of spread from the facility.
6.151  Dr Hayward noted that questions 27-29 referred to disinfection of a fruit prior to
packing; purists  might argue that one should refer to disinfestation rather than disinfection in this
context.  For inanimate surfaces the term disinfection was correctly applied.  There was
substantial literature on the efficacy of post-harvest treatment of fruit and vegetables.  There were
risks; any treatment involving immersion in an aqueous medium could serve to mobilise or leach
inoculum from within protected sites such as stomates, lenticels, etc.  The result was that the
previously clean majority might be contaminated by the diseased minority.  There was also thegreater risk of injury to the fruit during post-harvest treatment handling and these injuries allowed
entry by many pests.  A post-harvest treatment of apple fruit prior to packing might be sufficient
to remove the risk of spread of fire blight from packing facilities but whether it was necessary
required careful judgement.  Apple fruit injured at the time of inoculation with E. amylovora  were
more likely to develop fire blight than those injured before or after inoculation (van der Zwet et
al., 1990).  If apples were harvested from a dis ease-free orchard a post-harvest treatment should
be avoided, unless required for other reasons.  If there was a low level of infection treatment
might be necessary.
6.152  Dr Smith stated that the risk of cross contamination between fruit batches was not
significant.  What was most important was clearl y to maintain the identity and integrity of theWT/DS245/R
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batches, and thus to ensure that fruit from a significantly infected orchard were not mistakenly
certified as coming from a fire blight-free orchard.
Question  28:  Can you confirm that the calyx of an apple is more difficult to disinfect than
other surfaces of the fruit?  Can you comment  on the efficacy of chlorine wash (or other
disinfection processes) on epiphytic bacteria which may exist in the calyx of the apple?  Pleasecomment on the relevant evidence available in this regard.
6.153  Dr Geider replied that  the calyx was difficult to access with disinfectants.  The surface of
apples could be quite water repellent and therefore less suitable.  The efficacy of apple treatment
depended on the structure of the apple surface, which could also affect accidental contamination
with E. amylovora .
6.154  Dr Hale  noted that calyx disinfestation (i.e. specifically in the calyx rather than on
 the
calyx) rather than disinfection was what was under  consideration.  The calyx of mature fruit was,
in his experience, very difficult to disinfest of E. amylovora .  However, viable populations of
E. amylovora  had been reduced in artificially-infested calyxes using periods of cold storage (Hale
& Taylor 1999).  External fruit surfaces could be easily disinfested of E. amylovora  using sodium
hypochlorite or benzalkonium chloride (Janis ciewicz & van der Zwet 1988; Roberts & Reymond
1989).179
6.155  Dr Hayward  noted that there was some evidence that the calyx of fruit was a protected
site for the survival of E. amylovora , which proliferated as an epiphyte on the stigmatic surfaces
(Thomson,1986) and the remnants of these surfaces were enclosed by the calyx.  Taylor et al.
(2002) had looked at the survival of E. amylovora  in discarded fruit and found that low levels of
E. amylovora  persisted after an initial sharp decline.   They commented that the persistence of
small populations might be because Braeburn apples had a closed calyx which might provide
some protection for E. amylovora  from adverse environmental conditions and that the calyx
region of the apple mainly consisted of dead plan t tissue  providing little or no nutrient for the
growth and survival of E. amylovora .  Hale and Clark (1990) had used a DNA probe to detect low
numbers of E. amylovora  in calyxes.  For both fully mature and packed fruit the pest had been
detected in washings only from the calyx end and not from the fruit epidermis - again suggesting
that the pathogen was more likely to survive in association with the dried remnants of the flower
parts (Hale et al. , 1987).  Sholberg et al.  (1988) had compared organic acid treatments (acetic,
propionic, etc.) and found they were equally effective.  Acetic acid treatment did not cause
phytotoxicity.  These organic acids were possibly more penetrative than chlorine and might
disinfest the calyx more readily.  The results of these authors showed that 1M acetic acid was aneffective surface sterilant.  Chlorine at 100 micrograms per ml (100 ppm) was not effective  "...
probably because the bacteria at the calyx end of the apple are protected from the action by
chlorine by the sepals" (Sholberg et al.  (1988)).
6.156  Dr Smith stated that while he was  not really competent to answer the question, it seemed
plausible that a water-based disinfectant would penetrate less well to all parts of the calyx cavity.
                                                     
179 Quoting his own unpublished results, Dr Hale stated that a chlorine (100 ppm) wash had not
satisfactorily disinfested E. amylovora  from the unexposed parts of the calyx of fruit artificially infested by
injecting suspensions of E. amylovora  directly into the calyx.  However, in the work reported in Exhibit
USA-22, the calyxes had been infested by placing drops of E. amylovora  suspension on the calyx-end of
the fruit and consequently the bacteria were more acces sible to the disinfestation treatment as they were on
the exposed parts of the calyx.WT/DS245/R
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Question 29:  Roberts, et al. (1998) contains  a reference to van der Zwet, et al. (1990),
regarding the testing of refrigerated, stored fruit.  The statement is made that a greater
proportion of "surface-sterilized fruit" developed visible fire blight symptoms than "non-
surface sterilized" fruit.  What kind of treatment was used for surface sterilization?  How does
this compare with the chlorine wash required by Japan?  What is the significance of finding
more fire blight on sterilized fruit than non-sterilized?
6.157  Dr Geider  stated that his experience was with surface sterilization of pears used for fire
blight experiments.  In the laboratory, this procedure was done to avoid fast fungal growth.
However, surface sterilized fruits often developed rot symptoms, and the surface sterilization of
pears had been discontinued.  It was possible that the removal of the epiphytic micro-organisms
opened the fruits to the entry of other micro-organisms.  In addition, sterilization might change
the surface structure of fruits, which could facilitate access by pathogens.  However, the meaningof the phrase "fire blight on surface-sterilized fruits" was unclear and how symptoms were
connected with fire blight.
6.158  Dr Hale  recalled that van der Zwet et al.  (1990) had surface-sterilized fruit by immersing
fruit for three minutes in 0.65% NaOCl and rinsing 3 times in distilled water.  The chlorine wash
requested by Japan was for fruit to be immersed for 1 min in NaOCl solution containing 100 ppmavailable chlorine.  Internal blight symptoms were difficult to distinguish from those of other fruit
rots.  Although van der Zwet et al.  (1990) had speculated that infection was from endophytic
E. amylovora , the fruit had not been tested to confirm the presence of endophytic bacteria.
Dr Hale considered that it was equally probable that the disinfestation process may have resulted
in infection of fruit by epiphytic (surface) bacteria.  The handling and disinfestation of the fruitcould have resulted in injuries that allowed surface bacteria to infect the fruit.
6.159  Dr Hayward suggested it was useful to compare the details of the disinfection process
used by Sholberg et al.  (1988) with that of van der Zwet et al.  (1990).  To ensure that Red
Delicious apples had been effectively surface-sterilized for experimental purposes, Sholberg et al.
(1988) used 400 micrograms per ml available chlorine prepared from commercial bleach (5.25%NaOCL) for 2 minutes, whereas the latter authors had treated their apple fruit with 0.65% sodium
hypochlorite for 3 minutes followed by three rinses in distilled water (one assumes sterile water
but this was not stated).  Considerably more disease had developed among the surface-disinfested
Rome Beauty fruit than among the non-disinfested ones.  It seems likely that these results were
due to the slow leaching of the pest from its protected site within the calyx, and possibly also to
injury during handling of the fruit, and the dispersal of the inoculum from some of the fruit to all
of the fruit.  The Japanese protocol proposed immersion in a sodium hypochlorite solution(chlorine level more than 100 ppm) for longer than one minute.  However, Sholberg et al.  (1988)
had found 100 ppm chlorine to be inadequate for surface sterilisation.
6.160  Dr Smith  referenced his reply to Question 11 and observed that the result of this study
was strange and unless it was confirmed by further work, this result should not be considered as a
convincing basis for any phytosanitary measure.
Question 30:  What is the likelihood of bacteria on apple fruit surviving normal commercial,
shipping and export procedures?  Does this likel ihood change if cool storage conditions are not
maintained?
6.161  Dr Geider  replied that in a dry environment, E. amylovora  would survive more
efficiently on apple surfaces.  Cool storage could increase survival, whereas moisture and other
micro-organisms would add to the decay of the pathogen (Hildebrand et al. , 2001).WT/DS245/R
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6.162  Dr Hale  noted that Hale & Taylor (1999) had shown that cool storage of mature apple
fruit reduced the survival of E. amylovora  in calyxes of artificially infested fruit.  Incubation of
fruit at 20oC for 14 days after cool storage (to simulate possible retail conditions after export) had
not resulted in an increase in the detectable levels of E. amylovora  in the calyxes.  In fact, there
had been a further reduction and E. amylovora  had only survived when calyxes were infested
with large numbers of bacteria, i.e. >105 colony forming units.  The number of calyx-infested
fruit from a severely infected orchard had been reduced from 2% at harvest to 0% after cool
storage.  After a further 14 days incubation at 20oC there had still been no detectable
E. amylovora  in the calyxes.  Consequently, there appeared to be no evidence for any likely
change in survival of E. amylovora if cool store conditions were not maintained.
6.163  Dr Hayward  considered there to be a low likelihood of bacteria on apple fruit surviving
normal commercial shipping and export procedures.  Sholberg et al.  (1988) had shown that cold
storage alone reduced the number of surface-borne E. amylovora  on artificially inoculated Red
Delicious apples and that it had reduced the number of bacteria on naturally contaminated
Newtown apples to levels below detection after storage at 2 C for 5 months.  Hale and Taylor
(1999) had shown that cool storage of mature, export quality apples in either the laboratory at 0 C
+/- 0.5 C or a commercial pack house (2 C +/- 0.5 C) for a period of 25 days had reduced thesurvival of E. amylovora  in calyxes of both inoculated and naturally infested fruit, and concluded
that cool-stored, mature, export quality fruit were unlikely to be a vector of the fire blight
bacterium.  Further, Roberts (2002, in press) had found that none of 30,000 fruit in cold storage
for 3 months developed fire blight.
6.164  Dr Hayward further stated that the minimum growth temperature for  E. amylovora  was
3-5 C.  If apples were stored at an ambient temperature permitting optimal growth (e.g., 18-28 C)
then any E. amylovora  present would presumably be able to proliferate but there was no data to
compare with Figure 1 in Sholberg et al.  (1988) which clearly showed a decline in survival to
extinction after six months storage at 2-4 C.  Dr Hayward noted that this likelihood would
increase at higher ambient  temperatures.
6.165  Dr Smith  noted that superficial bacteria (at least artificially applied) could apparently
survive months in cold store, while such populations were said by many authors to die out within
days on plant surfaces at ambient temperatures.
Question 31:  Is there any evidence regarding the ability of fruit cargo crates to spread fire
blight?  Is there any evidence that this could be a potential source of contamination if the fruit
came from orchards free of fire blight or from orchards with low levels of infection?
6.166  Dr Geider replied that there was no evidence that fruit cargo crates distributed fire
blight.  Fruit from orchards with low disease levels were not at all a risk for dissemination.
6.167  Dr Hale  stated that it had been suggested by Lelliott (1959) that fire blight might have
been introduced into the United Kingdom on contaminated fruit crates and that subsequent spread
in the United Kingdom might have been due to the use of recycled contaminated crates fromthose orchards where the initial fire blight symptoms had been observed.  However, this had
never been proved (Bonn & van der Zwet 2000).  Keck (1996) had reported that under laboratory
conditions E. amylovora  could survive for several months on wood of non-host plants or on
plastic (materials which might be used in cargo crates).  However, there had been no further
investigations to determine if contaminated crates could really represent a source of inoculum forthe spread of fire blight.  There was no evidence that cargo crates could be a potential source ofWT/DS245/R
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contamination if mature fruit came from orchards free of fire blight or from orchards with low
levels of infection.
6.168  Dr Hayward indicated that he  had found  no evidence regarding the ability of fruit cargo
crates to spread fire blight and in his opinion the likelihood was negligible.  In the example of the
UK outbreak (1957) the other possibility of introduction was on propagating material.  One of the
two E. amylovora strains found in the United Kingdom (Pt1) was present in New Zealand and in
parts of central Europe (Jock et al. , 2002).  There had never been insistence on the crate theory in
the United Kingdom (Lelliott, 1959).  Furthermore, as fire blight had spread through Europe and
the Mediterranean in the past four decades several examples had emerged of its introduction on
propagating material, but none of introduction on crates.
6.169  Dr Smith responded that there was no direct evidence of the spread of fire blight by fruit
cargo crates.  The idea that E. amylovora  could survive on crates as ooze for any significant time
was quite conjectural, and it was even less likely that it could be transmitted from them.  Thistheory had persisted in the literature because of opinions expressed by the very first British
scientists dealing with the first fire blight outbr eak in Europe, but he was not aware of any further
research on the issue.  The many European experts on fire blight attached no practical importance
to this idea.
Question 32:  Are there reasonably available me thods to inspect imports of mature apple fruit
for fire blight contamination?  Would routine inspection of shipments at import be feasible to
detect the presence of internal or external  fi re blight bacteria in or on apple fruit imports?
6.170  Dr Geide r answered that routine inspection of apples after harvest for fire blight
symptoms was not reasonable.  It was possible to take samples and to try to detect E. amylovora ,
but even if a few bacteria were unexpectedly detected this would not cause the establishment of
fire blight at the place of consumption for the reasons already given.
6.171  Dr Hale  stated that there were no recognized methods for inspection (e.g. visual) of
imports of mature apple fruit for contamination with E. amylovora .  It might well be possible to
develop technologies for sampling and PCR-based detection – although the time necessary toprocess samples might make them unworkable.  Consequently routine inspection of shipments at
import to detect the presence of E. amylovora  in or on apple fruit would be difficult.
6.172  Dr Hayward noted that there were no inspection methods which would routinely detect
fire blight on mature, symptomless fruit at the point of entry.  Tests to examine the calyx end of
fruit for low numbers of E. amylovora  would require a dedicated laboratory.
6.173  Dr Smith  indicated that the levels of contamination concerned were too low for there to
be a reasonably available method to inspect imports of mature apple fruit for fire blightcontamination.  Such inspection would necessitate impossibly large samples.
Question 33:  How does Japan's 1999 PRA compare with the IPPC Guidelines for Pest Risk
Analysis of 1995 (Exhibit JPN-30) and the IPPC Pest Risk Assessment standard of 2001
(Exhibit USA-15)?
6.174  Dr Ge ider stated that it was not possible to prove the total absence of a pathogen in plant
material.  Nonetheless, it was not reasonable to assume that bacteria on a fruit's surface could
establish fire blight.  He indicated that both PRAs tried to define risk of pest, the Japanese PRA
with more concern than the US PRA.  He questioned whether a general PRA was appropriate forWT/DS245/R
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fire blight, since too many assumptions were open for describing the problems with that disease.
Most risk assessment assays could not consider all the steps and random events in fruit harvest,
processing, trade and consumption.  Remote risk s could be estimated by considering historical
events in disease distribution, pattern analysis of strains and through consideration of the absence
of fire blight in the countries of the Southern hemisphere except New Zealand.
6.175  Dr Geider was of the opinion that  a decision to remove most restrictions on importation
of apples from fire blight countries should take into consideration that Japanese apple production
is highly sophisticated based on a demand for high quality apples, and the import of low quality
apples into Japan at cheap prices could undermine that country's disease controls, regardless of
the low risk of disseminating fire blight with apples.  As such, he personally favoured the
importation of apples from inspected US-orchards, without pre-treatment of the fruits.  While
chlorine treatment would certainly decrease epiphytic bacterial populations, chlorinated by-products could be unfavourable to human health and such treatment was not justified to protect
Japan from fire blight.
6.176  Dr Hale  noted that Japan’s PRA was in three parts:  (1) Fire Blight – details of the
disease and cause;  (2) Pest Risk Analysis concerning E. amylovor a;  and (3) Pest Risk Analysis
for quarantine measures on E. amylovora  for US fresh apple fruit.  The PRA followed, to a
certain extent, the 1996 IPPC Guidelines for Pest Risk Analysis.  However, it did not address the
commodity that was under dispute, i.e. mature, symptomless apple fruit, nor did it address a
number of the issues that were required to be addressed according to the IPPC Pest Risk
Assessment Standard of 2001.
6.177  Dr Hale stated that it appeared that Japan had prejudged the outcome of its risk
assessment in that it had stated that phytosanitary measures were required based on the
possibility, rather than the probability, of introduction of fire blight.  It therefore did not fulfil the
second requirement of a risk assessment (IPPC Pest  Risk Assessment Standard of 2001) as it did
not evaluate the likelihood (probability) of entry, establishment and spread through the
importation of mature, symptomless apples .  The PRA should also focus on mature, symptomless
apples, and not on all other types of fruits (immature), leaves, pears etc., as this was the product
that the United States wished to export.  In his opinion, the following key steps had been
overlooked for the probability of entry:
(i) identification of the relevant pathways;
(ii) probability of fire blight being associated with the pathway of origin;
(iii) probability of survival during transport and storage;
(iv) probability of fire blight surviving existing pest management procedures; and
(v) probability of transfer of fire blight to suitable hosts.
Japan had not provided an evaluation of the likelihood that the steps necessary for entry of fire
blight bacteria would be completed.  Their analysis of establishment and spread was similarly not
an evaluation as the likelihood of entry, establishment and spread needed to be evaluated
according to the measures that might be applied.  Some measures to reduce risk had beenidentified but not evaluated.
6.178  Dr Hale further observed that available scientific evidence that mature, symptomless
apples do not transmit fire blight had not been taken into account.  Thomson (2000) had statedWT/DS245/R
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that it has never been demonstrated that mature  apple fruit were involved in dissemination of
E. amylovora  or served as a source of new fire blight infections in orchards.  It was also
considered extremely unlikely that contaminated fruit could be responsible for establishing new
outbreaks of fire blight.
6.179  According to  Dr Hayward, Japan's 1999 PRA was of necessity based on the 1996 IPCC
Guidelines for Pest Risk Analysis.  There were substantial differences between these guidelinesand the later version (IPCC Pest Risk Assessment Standard of 2001).  Notably, stage 2: Pest Risk
Assessment was almost entirely different in the two documents.  The first version had seven sub-
headings in Stage 2, the later document 36.  Pest risk analysis had evolved with experience of its
application in the years between the first and second guidelines and it had been found necessary
to break down the elements of the process into th eir component parts.  The first eight sections in
the later document were concerned with "Pest Categorization" (absent from the 1996 Guidelines,
and also absent from the 1999 PRA from Japan).  There then followed probabilistic assessmentsof the entry of the pest; identification of pathways by which this might occur; probability of the
pest being associated with the pathway at origin; probability of survival during transport or
storage; probability of pest survival during pest management procedures; probability of transfer to
a suitable host; probability of establishment; probability of spread after establishment.  Such a
stepwise analysis would ideally be based on quantitative data but in the absence of data therecould be semi-quantitative or qualitative assessments.  Probabilities for each component could be
given a rating of "very low", "high" or "moderate", etc.  Estimates for the probability of
importation and the partial properties of distribution, establishment and spread could be combined
using a simulation-based approach to give an overall  estimate of the unrestricted annual risk
associated with a particular pest.  The importing country then had to decide whether theunrestricted risk was above or below the appropriate level of protection for that particular pest.
The Japanese PRA of 1999 contained much of the information which would be required for a
PRA in terms of the 2001 Guidelines, but the stepwise probabilistic assessments were lacking.
6.180  Dr Smith considered that the Japanese PRA satisfactorily addressed most of the
necessary aspects, notably the identity, probability of establishment, potential loss etc.  However,
nobody contested that E. amylovora  presented a real risk for Japan, and that it could be carried in
international trade.  According to the 1996 IPPC  standard (section 3), "a list of options for
reducing risks to an acceptable level should be assembled", "the efficacy and impact of the
various options in reducing risk to an acceptable level should be evaluated", "the positive and
negative aspects of the options should be specified", "countries should take particular note of the
Minimal Impact Principle".  The Japanese PRA did not consider the measures as "options".  It
was principally concerned to show that each of the measures already in place was effective insome respect, and concluded that all should therefore be applied.  The question of whether any
single measure, or a combination of fewer measures, could reduce the risk to an acceptable level
was not addressed.  Comparisons were made with measures used in other parts of the world, but
only to verify their effectiveness, not to establish their appropriateness for one particular pathway
(imported fruits).  Some of the measures referred to were in fact used for the risk management ofother commodities, such as nursery material.  The Japanese approach did not seem to allow for
the possibility of adjusting measures for differ ent commodities presenting different risks.  The
IPPC 2001 standard (section 3.4) stated that  "the measures should be as precise as possible as to
consignment type (hosts, parts of plants) and origin so as not to act as barriers to trade by limiting
the import of products where this is not justified". It envisaged single measures in the firstinstance, since it then continued "Combinations of two or more measures may be needed …".
The Japanese PRA had not clearly explained why all the measures it applied were needed.WT/DS245/R
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6.181  Dr Smith further noted that Japan referred to the "systemic approach" (more usually,
"Systems Approach"), which was now covered by  IPPC standard ISPM No.14.  Since a Systems
Approach was by its nature a combination of measures (or options, in the language of the PRA
standards), it should not be regarded as a single measure or option.  A Systems Approach might
be unnecessarily restrictive by comparison with its component measures and so not respect theminimum impact principle.
Question 34:  Stage 3 of the IPPC Guidelines for Pest Risk Analysis of 1995 (Exhibit JPN-30)
deals with risk management options.  The first step outlined at section 3.1 of the Guidelines is
the assembly of a list of options for reducing risks to an acceptable level.  The second step
outlined at section 3.2 of the Guidelines is to  evaluate the efficacy and impact of the various
options in reducing risk to an acceptable level. In your view, does the Japanese Pest Risk
Analysis of 1999 list options for reducing risks ?  Furthermore, does the Japanese Pest RiskAnalysis evaluate the efficacy and impact of vari ous options in reducing risk to an acceptable
level?
6.182  Dr Geider observed that section 3.1 sounded legally reasonable, but wondered whether
or not the listed options had been verified.  For fire blight, phytosanitary inspection of appleorchards could be a compromise between parties with restrictive and liberal fruit import regimes.
Post-harvest inspection was not useful to detect fire blight symptoms.  Prohibition of entry from a
specific origin could be applied only to areas without fire blight inspections.  It could be assumed
that liberalized access for apple imports to Japan would attract also other fire blight countries,
where inspections might be needed for some time.  Of course, there was also some concern aboutthe method and impact of inspections.  For example, did a necrotic branch of an apple tree mean
fire blight?  If confirmed, should this tree enda nger the harvest of a whole orchard with hundreds
or thousands of trees?  Also inspection by specialists might not detect low levels of fire blight,
and the disease could appear afterwards or increase later in the season.  The principle of measures
resulting in minimum impediments to trade could lead to a reasonable compromise betweenopposing opinions about severe restrictions or unregulated apple importations.
6.183  Dr Hale  stated that in Japan's 1999 PRA the following risk management options had
been considered:  (1)  designated areas - fire blight-free sites and buffer zones;  (2)  preventative
measures for post-harvest contamination;  and (3)  labelling after disinfection and inspection.
However, in Japan's 1999 PRA the following risk management options had not been not
considered:
• treatment at point of entry, inspection station, place of destination;
• detention in post-entry quarantine (may not be feasible for perishable
commodities, although apple fruit could be stored);
• post-entry measures (restrictions on use of commodity);
• prohibition of entry of specific commodities from specific origins.
Many of the options for reducing risk to an acceptable level were embedded in Japan's 1999 PRA,
but did not appear to have been effectively addressed.  Japan had identified some measures buthad not provided an evaluation of the efficacy and impact of the options in reducing risk to an
acceptable level in terms of the factors listed in the 1996 IPPC Guidelines for Pest Risk Analysis.
Information on some of the factors affecting various risk management options could be found in
the PRA but the efficacy and impact of the options (rather than of the disease itself) had not been
evaluated.  Japan had ranked the efficacy of import inspections very highly but this was theWT/DS245/R
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option that would be most difficult to achieve without the development of rapid molecular
E. amylovora  detection systems for checking samples of imported fruit.
6.184  Dr Hayward noted that a section of Japan's 1999 PRA was devoted to "Pest risk
management for E. amylovora ".  This section highlighted the difficulty of detecting the pest and
its potential for rapid growth from a low population level.  It was designated as a pathogensubject to import prohibition.  In the next part of the PRA, Chapter 3, pages 18-22, some of the
risk management options considered necessary, su ch as designation of pest free production areas,
the need for a buffer zone, the need for post-harvest  chlorine treatment of fruit, and the need for
adequate labelling were included.  However Japa n's PRA did not include an adequate evaluation
of the efficacy and impact of the various options in reducing risk to an acceptable level as
specified in the IPPC Guidelines of 2001.
6.185  Dr Smith replied by referencing his answer to Question 33.
Japan’s disease-free status
Question 35: Please comment on the divergence in  opinions regarding the occurrence of fire
blight in Japan, including Mizuno, et al (2002).
6.186  Dr Geider noted that the paper of Mizuno et al.  (2002) had reviewed possible fire blight
events in Japan.  In a recent paper for the Proceedings of the International Symposium in Asian
Pears 2001 (Geider et al. , 2002), Dr Geider had discussed the possibility that the report from
1903 could have really been based on fire blight events.  It was the published opinion of his
laboratory that a pear disease in Japan (not officially admitted) was not fire blight (Beer et al. ,
1996), but related to Asian pear blight from Korea (Kim et al. , 2001a).  The pathogen of 1903
could well have been fire blight, because the pathogen was reported to have been isolated from
apple, which was barely susceptible to Asian pear blight (Rhim et al. , 1999; Kim et al. , 2001b).
Mizuno et al.  had discussed several options for the causative agent of the disease in 1903.  There
were always difficulties with Gram-staining in laboratories and this was the main reason whyE. amylovora  was taxonomically incorrectly called Bacillus amylovorus  for a long time.
According to Dr Geider, it was not a valid argument to say that positive Gram-stains around 1900
in Japan subsequently ruled out the presence of E. amylovora . However, he noted that an answer
to this question did not provide information about fire blight in Japan at the present time.  The
recently considered pear disease was not identical with fire blight and other reports about
additional bacterial pathogens such as E. amylovora  were not known for Japan.
6.187  For Dr Hale, the evidence suggested that Bacterial Shoot Blight of Pear (BSBP) was
very similar to fire blight but could be di stinguished in physiological, biochemical and
pathogenicity characteristics.  Molecular techniques could be used to differentiate between
isolates and eventually the taxonomic position of the Japanese isolates in relation to
E. amylovora  would be determined.  The early reports on whether or not the disease was caused
by E. amylovora  or various fungi could not be verified and so should not be considered in this
dispute.
6.188  Dr Hayward noted that  Mizuno (2002) had concluded that the disease reported to be fire
blight of apple in Japan was apple canker caused by Valsa ceratosperma  and that the alleged fire
blight of pear was either a twig blight caused by Diaporthe sp. or bacterial shoot blight of pear.
In the past 15 years, the taxonomy of bacteria had become increasingly reliant on the use ofDNA-based methods.  There was evidence that the bacterium that caused shoot blight of pear in
Hokkaido, Japan, was distinct taxonomically from E. amylovora , the cause of fire blight of appleWT/DS245/R
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and pear and Rubus sp. in North America and elsewhere.  They may all have shared a common
ancestor, and it would be interest ing to know the sequence of evolutionary events given that fire
blight was first recognized over 200 years ago in the United States, whereas the other two
pathogens apparently originated in Korea and Japan.
6.189  Dr Smith  noted that it was commonplace to find that a pest had been recorded in a
country in the relatively early days of plant pathology and had not been later confirmed.
Scientific knowledge advanced, diagnostic techniques improved and the observations of earlier
scientists proved to be simply mistaken.  In addition, it was quite common for there to be early
records which seemed to be convincing, followed by a long period when the pest in question was
not reported again.  It was then inferred that it had disappeared.  So the early records of fire blight
in Japan could simply be disregarded with respect to any understanding of the present situation.
The problem with the agent of "bacterial shoot blight of pear" was that it did appear,bacteriologically, to have been E. amylovora  - maybe a distinct strain or pathovar with a different
host range and a different aggressiveness, but sti ll the same species.  Th is raised interesting
questions of where it had originated and if there were other distinctive E. amylovora  strains
elsewhere in the world.  But the disease no longer  occurred, and the pathogen could no longer be
found.  Furthermore, the presence of E. amylovora  in Japan would not as such invalidate
measures that Japan might take with respect to imports from other countries, provided that it was
"not widely distributed" (bacterial shoot blight was only found in Hokkaido) and equivalent
official control was applied within Japan (principle of non-discrimination).
Question 36: How do the findings regarding di sease symptoms observed in apple shoots in
the United States (at low percentage when they were injected with high-concentration bacterial
suspensions) compare with the findings of fire blight in mature apples (eg, when inoculated
with high concentrations of E. amylovora) as reported in various experiments and studies?
6.190  Dr Geider stated that  plant inoculation could (and often did) result in no appearance of
fire blight symptoms.  Statistically, the pathogen did not always multiply at the inoculation sites.This could depend on the experimental conditions, on the strains applied, and on the apple variety
or shape of the plant used.  Young shoots often reacted to bacterial injections at an intermediate to
high level. Bacteria in mature apple could certainly survive for a certain time in a moist and
sterile environment.
6.191  Dr Hale  noted that Beer et al.  (1996) had produced a low percentage of infection (typical
symptoms of fire blight) in apple shoots inoculat ed with high concentrations of BSBP bacteria.
However, the evidence suggested that the Japanese isolates were much less virulent on applesthan on pears in Japan, and consequently should be designated as pathogenic variants of
E. amylovora.   There were other known pathogenic variants of E. amylovora , isolated from Rubus
species, that did not cause disease symptoms on apples and pears.  Based on greenhouse studies,
the strains of E. amylovora  from Hokkaido exhibited a range of host specificity towards apple
cultivars not previously recognised.  In addition, their microbiological and molecular biologicalcharacteristics were distinct.
6.192  Dr Hale further stated that there were some reports (Anderson 1952; Dueck 1974;
Nachtigall et al. , 1985) that apples had developed blight symptoms in storage.  However, in all of
these cases the fruit were wounded and high inoculum levels (c10
9 cfu/ml) had been injected into
the apple cortex.  These conditions did not reflect the conditions likely to be encounterednaturally or the levels at which E. amylovora  would be likely to be associated with mature,
symptomless apple fruit.  Van der Zwet et al.  (1990) had reported that fruit collected from fire-WT/DS245/R
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blight free orchards developed internal blight symptoms in storage.  However, they had also noted
that symptoms were difficult to distinguish from those of other rots and they did not isolate
E. amylovora  from the blight-like symptoms to confirm the causal agent.  Van der Zwet (Exhibit
USA-18) also stated that heavily infected trees were nearby those from which the fruit were
harvested.  Roberts (2002) had repeated the storage trials in commercial cold storage using
mature, symptomless fruit from orchards containing sources of fire blight inoculum.  None of thefruit had developed either internal or external disease symptoms in storage and E. amylovora  had
not been isolated from any of the fruit sampled.
6.193  Dr Hayward observed that  Beer et al.  (1996) had reproduced "typical symptoms of fire
blight in response to inoculation with the Hokkaidian strains" in shoots of European and Asian
pear plants.  Four of the 220 vigorously grow ing apple shoots inoculated with the Hokkaidian
strains had developed typical symptoms of fire blight, when inoculated at high concentration
(billion  cfu per ml).  There were examples in the literature of phytobacteriology of misleading
results being obtained in pathogenicity tests when very high concentrations of inoculum were
used to inoculate non-host plants. The best known phenomenon was the hypersensitive response
elicited by pathogenic bacteria in non-host plants.  In his opinion, there might be similar doubts
about experiments where fire blight had been pr oduced in apples when inoculated with a massive
concentration of inoculum.
6.194  Dr Smith did not express an opinion but noted that it depended on  the type of
inoculation.  He further noted that all sorts of strange results could be obtained by artificially
inoculating plants with high concentrations of pathogens – which was one of the reasons why the
demonstration of Koch's postulates could be so difficult.
VII. INTERIM REVIEW
A. I
NTRODUCTION
7.1 The Panel issued the draft descriptive sections of its report (factual and arguments) to the
parties on 6 February 2003, in accordance with Article 15.1 of the DSU.  Both parties offered
written comments on the draft descriptive sections on 24 February 2003.  The Panel noted all
these comments and amended the draft descriptive part where appropriate.  The Panel issued itsinterim report to the parties on 20 March 2003, in accordance with Article 15.2 of the DSU.  In
communications dated 3 April 2003, both Japan and the United States requested that the Panel
review precise aspects of the interim report.  Neither of the parties requested an interim review
meeting.  On 11 April 2003, Japan and the United States provided written comments on each
other's comments on the interim report, as permitted by the Panel's working procedures.  The
Panel carefully reviewed the arguments made.  They are discussed in this section and, to the
extent necessary, are reflected in the findings section below, in accordance with Article 15.3 ofthe DSU.
180
                                                     
180 Section VII of this Report entitled "Interim Review" therefore forms part of the findings of the
final panel report, in accordance with Article 15.3 of the DSU.WT/DS245/R
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B. COMMENTS BY JAPAN181
1. Burden of proof
7.2 Japan's first comment relates to our statement in paragraph 8.44 according to which:
"We do not see the greater expertise of the exporting country as a factor which
should automatically justify a different allocation of the burden of proof."
7.3 Japan requests that we review that conclusion because of the difficulties it faces in
conducting field experiments on its territory and because of the problems occurring when
cooperation from exporting country governments is required.  We have explained, in
paragraphs 8.45-8.46 below, why we believe that such an argument is not compelling under the
circumstances of this case.  We would like to add that the United States is not the only country
where fire blight is present and where scientific experiments could be performed.
7.4 Japan's argument would imply in practice either that a more demanding standard of proof
to establish a prima facie case be imposed on the United States, or that Japan either be granted a
different standard of proof when rebutting the US arguments or be relieved of rebutting the US
claim.  Neither of these suggestions is supported  by the approach on burden of proof defined by
the Appellate Body in EC – Hormones  and recalled in paragraph 8.42 below.  Moreover, nowhere
does the SPS Agreement  provide for a specific standard of proof in relation to dispute settlement.
7.5 We also consider that our statement in paragraph 8.44 does not imply that an exporting
country will be "allowed to prevail by merely contradicting the evidence the importing country
has".182  We applied the principle of allocation of burden of proof as identified by the Appellate
Body in United States - Shirts and Blouses  and recalled, as mentioned in paragraph 8.42 below, in
the context of the SPS Agreement  in the Appellate Body Report on EC – Hormones.   T h e
requirement that the complainant make a prima faci e case is the same in a dispute relating to the
SPS Agreement  as under any other WTO agreement. In EC - Hormones , the Appellate Body
described the establishment of a prima facie case as follows:
"In accordance with our ruling in  United States – Wool Shirts and Blouses183, the
Panel should have begun the analysis of each legal provision by examiningwhether the United States and Canada had presented evidence and legal
arguments sufficient to demonstrate that the EC measures were inconsistent with
the obligations assumed by the European Communities under each Article of the
SPS Agreement  addressed by the Panel, i.e., Articles 3.1, 3.3, 5.1 and 5.5.  Only
after such a prima facie determination had been made by the Panel may the onus
be shifted to the European Communities to bring forward evidence and
arguments to disprove the complaining party's claim."
184
                                                     
181 This section is divided according to the sections of the findings on which comments have been
made.
182 Japan's comments, 3 April 2003, para. 3.
183Adopted 23 May 1997, WT/DS33/AB/R, pp. 14-16.
184 (original footnote) Our finding that the Panel erred in allocating the burden of proof generally to the Member
imposing the measure, however, does not deal with the quite separate issue of whether the United States and Canada
actually made a prima facie case of violation of each of the following Articles of the SPS Agreement:   3.1, 3.3, 5.1 and 5.5.
See in this respect, footnote 180 of this Report.WT/DS245/R
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This is exactly what we requested from the parties in this case.
2. Article 2.2 of the SPS Agreement
7.6 Japan requests us to review our assessment of the 1990 article of van der Zwet et al.  in
paragraphs 8.127-8.128 below.  We did not find Japan’s arguments in support of its request
sufficiently convincing.  In particular, Japan’s allegation that Professor van der Zwet admitted inRoberts et al.  (1998) that the tested apple fruit in van der Zwet et al. (1990) were mature and
symptomless is not supported by the information contained in that very article.  On the basis of
the nature of the information reported in the articles, the experts' views and the comments of
Professor van der Zwet himself in his stat ement of 16 July 2002, Exhibit USA-18, we see no
reason to change our assessment of van der Zwet et al.  (1990) and of Roberts et al.  (1998).
7.7 In response to comments from both parties, we revised our findings in section D.
3. Article 5.7 of the SPS Agreement
7.8 In its comments of 3 April 2003, Japan contests our reasoning under Article 5.7 of the
SPS Agreement .  Japan first claims that it should be possible to invoke Article 5.7, for example, in
situations where the process of scientific discovery is at work and thus available scientific
evidence is not conclusive, even though the quantity of the evidence is more than little.
7.9 We have no reason of principle to reject the hypothesis suggested by Japan, although we
note that the process of scientific discovery is by its nature an ongoing process.  It is possible that,
in a given situation, a lot of scientific research may have been carried out on a particular issue
without yielding sufficiently "relevant" – within the meaning of Article 5.7 - or reliable evidence.
In such a case, however, there is little or no reliable evidence on the subject matter at issue.  This
is not the case here.  There is a great deal of "relevant" scientific material available.  What Japanaddresses in its comment on paragraph 8.219 is, in fact, a question of weighing the evidence
before the Panel.  We have carefully reviewed the material submitted in this case and found that
the present situation was one where a lot of "relevant scientific evidence" had already been
accumulated.  Our assessment was not simply quantitative; it was also qualitative, as
demonstrated by the position we have taken on van der Zwet et al.  (1990) on the basis, inter alia ,
of the opinion of the experts consulted by the Panel.
185
7.10 Japan also argues that we should not include, in our assessment under Article 5.7,
scientific evidence which has become available after the date of entry into force of the SPS
Agreement  in 1995.  We do not see in the text of Article 5.7, or of Article 2.2 for that matter, any
reason to limit our assessment of the "relevant scientific evidence" to evidence available before
1995.  On the contrary, since Article 5.7 provides for an exception to Article 2.2, and an
assessment of the compatibility of a measure with Article 2.2 is made at the time the matter isreviewed by the Panel, there is no justification for assessing any alleged provisional measure at a
different date.  If we were to agree with Japan, a measure could be indefinitely maintained on a
provisional basis under Article 5.7, and the requirement that Members seek to obtain the
additional information for a more objective assessment of risks and review the phytosanitary
measure accordingly within a reasonable period of time would become ineffective.  Such aselective interpretation of Article 5.7 is not acceptable.
                                                     
185 See para. 8.127, below.WT/DS245/R
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4. Article 5.1 of the SPS Agreement
7.11 Japan argues that, contrary to what is mentioned in paragraph 8.247 below, the
conformity of a PRA under Article 5.1 should be asse ssed in light of information available at the
time when the PRA was conducted, and no later evidence should be considered.
7.12 We corrected paragraph  8.247 as far as the representation of Japan's arguments is
concerned.  However, we do not agree with Japan' s position that no information subsequent to the
completion of a PRA should be taken into consideration by a Panel, particularly if, as in the
present case, that PRA is already almost four years old at the time it is reviewed.  Some
assessment of the subsequent evolution of the scientific evidence is not only acceptable, it is also
necessary, if only to monitor the development of any new evidence which might require a
revision of the risk assessment.  One must not lose sight of the purpose of a risk assessment,
which is to serve as a basis for regulatory actions.  If the scientific evidence evolves, this may bean indication that the risk assessment should be reviewed or a new assessment undertaken.  It
would be also legally inconsistent to require, on the one hand, that phytosanitary measures not be
maintained without sufficient scientific evidence pursuant to Article 2.2
186 while, on the other
hand, accepting that risk assessments not be renewed in the face of new scientific evidence.187
Even though new evidence may not always justify a new risk assessment, it would be contrary to
the purpose of risk assessments under the SPS Agreement  to follow the approach advocated by
Japan.
7.13 In relation to our findings on Article 5.1, Japan further argues that the Panel was wrong in
stating in paragraph 8.271 that "the 1999 PRA is not sufficiently specific to the matter at issue
[apple fruit] to constitute a proper risk assessment under Article 5.1 of the SPS Agreement ".
According to Japan, the 1996 and 2001 IPPC Guide lines admit the initiation of a PRA by the
identification of a pest, as well as the identification of a pathway.  These Guidelines do not limit
the scope of the PRA to a particular host of bacteria, but rather allow for assessing a variety of
hosts.
7.14 We agree with Japan that the 1996 and 2001 IPPC Guidelines for PRAs do not limit
consideration to just one particular host of a kind of bacteria.  However, they do require that the
risk relating to the particular commodity to be imported be evaluated.  In its 1999 PRA, Japan
evaluated the risks associated with all possible hosts taken together, not sufficiently considering
the risks specifically associated with the commodity  at issue:  US apple fruit exported to Japan.
We therefore see no reason to change our findings in this respect.
7.15 Moreover, Japan contests our finding in paragraph 8.280 that "Japan's PRA does not
evaluate the likelihood of entry or spread of fire blight through the importation of apple fruits"because Japan's 1999 PRA does not suggest any precise evaluation of the degree of potentiality or
probability for the occurrence of the event and fails to provide more than an indication of a
potential for entry or spread, or does not assess the probability of such events occurring.  Japan
argues that, even though the 1999 PRA's use of the terms "suggest" or "can" to describe
                                                     
186 We note in this respect that "in connection with Article 2.2,  Japan believes that the provision
requires a measure to be based on sufficient scientific evidence available at the time of the finding of thePanel." (Japan's reply to question 4 of the Additional Questions from the Panel, 28 January 2003).
187 We note in this respect that the Appellate Body in EC – Hormones , recalled that "Article 2.2
and 5.1 should constantly be read together.  Article 2.2 informs Article 5.1: the elements that define thebasic obligation set out in Article 2.2 impart meaning to Article 5.1." (Appellate Body Report, para. 180)WT/DS245/R
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probability might have been misleading, Japan stated in its first written submission to the Panel
that the 1999 PRA addressed not a theoretical possibility but the likelihood of the introduction
and spread of fire blight through apple fruit.
7.16 We consider that the fact that Japan further elaborated before the Panel on the meaning of
the terms it used in its 1999 PRA cannot correct the fact that the 1999 PRA itself did not use the
terms used by Japan before the Panel and actually did not sufficiently evaluate the likelihood ofentry, establishment or spread of fire blight, as well as the associated potential biological and
economic consequences, within the meaning of Article 5.1 and Annex A, paragraph 4 of the SPS
Agreement .  It is not merely the use of some terms that is at issue here, it is the whole approach
followed by Japan in undertaking the 1999 PRA.  We recall that, in Australia – Salmon , the
Appellate Body insisted that a conclusion of mere possibility of entry, establishment or spread of
a disease was not sufficient to meet the requirements of Article 5.1
188, just as some  evaluation of
the likelihood of entry, establishment or spread was not sufficient either.189  Likewise, the
Appellate Body recalled that the existence of unknown or uncertain elements did not justify a
departure from the requirements of, inter alia , Article 5.1.190 In the light of the relatively strict
standard applied by the Appellate Body in Australia – Salmon , we see no reason to reconsider our
findings.
7.17 Japan further contests our reasoning and conclusions in paragraph 8.285 below.  Japan
claims that in 1999, it considered the US proposa l to narrow the width of the buffer zone and to
reduce the number of field inspection routines.  However, such consideration is not apparent in
the 1999 PRA.
7.18 In essence, Japan considers that, once a measure is in place, the analysis and evaluation
will inevitably focus on the existing measure, in the absence of alternative proposals.  Japanseems to suggest that it was up to the United States to bring to the attention of Japan the existence
of alternative measures or options.  We cannot agree with either of these points.  Regarding the
first one, there is no technical reason why, once a measure is in place, it would not be possible to
consider alternatives.  Japan argues as much, by stating that the analysis "will inevitably focus"
on the existing measure.  Yet, information on alternative options does not become less availablebecause one measure has been put in place by a Member.  Likewise, nothing in the text of
Article 5.1 and Annex A, paragraph 4, suggests that alternative options have to be proposed by
the exporting Member.  On the contrary, given the importance of the PRA to support the
imposition of a measure, it is in the interest of the importing Member to consider alternatives on
its own initiative.
7.19 We do not consider either that a requirement to consider alternative options would create
a situation where a Member could not be confident, at any time, of the consistency of its PRAswith Article 5.1 of the SPS Agreement .  First, this requirement does not result from the reasoning
of the Panel, but from the terms of Article 5.1 and Annex A, paragraph 4 of the SPS Agreement ,
which refer to "the SPS measures which might be applied", thus making it clear that a Member
has an obligation to consider other measures than those it actually applies.  Whether such a
requirement could actually create a problem of legal certainty for a Member performing riskassessments is not an issue before us.  Indeed, since Japan did not appear to have considered
measures other than those it applies
191, it clearly did not meet its obligation and it is not necessary
                                                     
188 Appellate Body Report, para. 123.
189 Ibid, para. 124.
190 Appellate Body Report, paras. 129-130.
191 See para. 8.285, below.WT/DS245/R
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to determine how far it should have gone in identifying "SPS measures that might be applied" to
comply with Article 5.1 and Annex A, paragraph 4 of the SPS Agreement .
5. Article 7 of the SPS Agreement
7.20 Finally, we took note of the factual information provided by Japan regarding Article 7
and Annex B to the SPS Agreement , as well as the additional comments of the United States.  As
a result we revised our findings on this claim.
C. COMMENTS BY THE UNITED STATES192
1. Requests for additional findings
7.21 The United States requests the Panel to make a number of additional findings, most of
which are essentially factual.  As a general remark, we believe that panels are bound by their
terms of reference, but they need only make the findings which they deem necessary for the
resolution of the case.  As a result, while we agr eed with some of the US requests, we did not find
it necessary to make all the additional findings that the United States requested in its
comments.193  We do not, for example, consider it necessary to make a finding that the United
States has raised a presumption that there is no scientific evidence that mature apples have ever
been the means of introduction of fire blight into a previously fire blight-free area, and Japan has
failed to rebut that presumption.  While we have some reliable indication that this statement bythe United States might well be correct, we see no need to make a specific finding on this
question.  Rather, we will use the information av ailable in support of our finding as to whether
apples exported from the United States into Japan could serve as a pathway for the entry,
establishment or spread of fire blight within Japan.
2. Comments on specific paragraphs of the Report
7.22 The United States also made a number of specific comments on paragraphs of the
findings.  In this respect, we clarified or corrected, as necessary a number of paragraphs.  This
was the case with paragraph 2.1.  Regarding paragraph 2.22, we have recognized the definition
contained in International Standards for Phytosanitary Measures No.5:  Glossary of
Phytosanitary Terms , FAO, Rome 2002.  However, we have clarified that, for the purposes of this
case, we have relied on an alternative definiti on given during the Panel meeting with the experts
which differentiates between infection and infestation.
194
7.23 The first specific comments of the United States on the findings relate to our
identification of the elements composing the phytosanitary measure at issue (paragraphs  8.22 to
8.25).  We originally were of the view that the two elements which the United States wants us to
include in the measure195 were not worth considering in an assessment of the measure as a whole ,
since their economic impact was very limited and these types of measures are commonly used by
                                                     
192 This section is divided according to the sections of the findings on which comments have been
made.
193 In addition to the discussion in this paragraph, see para. 7.25 below.
194 Annex 3, para. 67.
195 The two elements are:  (1) the certification by US plant protection officials that fruits are free
of fire blight and have been treated post harvest with chlorine;  and (2) the confirmation by Japanese
officials of the US officials' certification and inspectio n by Japanese officials of disinfection and packaging
facilities.WT/DS245/R
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Members.  However, we agree with the United States that, even though they are part of a broader
measure, they are phytosanitary measures within the meaning of Annex A, paragraph 1 of the
SPS Agreement .  Since they also were identified by the United States in its request for
establishment of a panel, they ought to be listed among the elements composing the phytosanitary
measure at issue.  We accordingly modified paragraphs 8.24 and 8.25.
7.24 The United States makes a second comment in relation to paragraph 8.25 and requests
that we make a finding that the prohibition of imports of US apples from states other than
Washington or Oregon is not rationally related to any scientific evidence of a risk of introduction
of fire blight via imported apples.  The United States argues that the failure of the United States to
provide documentation relating to other quarantine pests cannot justify the maintenance of a fire
blight restriction limiting importation from the states of Oregon and Washington exclusively.
7.25 We understand the position of Japan to be that what prevents the importation of apples
from states other than Oregon and Washington is not their fire blight status, but the status of otherquarantine pests.  Japan argues that if proper documentation were submitted by the United States
with respect to those other pests, shipments of apples from states other than Oregon and
Washington could be exported to Japan under the same conditions which apply to apples from
Oregon and Washington.
196  We agree that failure to provide documentation on other quarantine
pests than fire blight cannot justify the imposition of restrictions based on fire blight, but if aproduct cannot be exported for other phytosanitary reasons, the fact that it could be free of fire
blight will not make it exportable.  The United States did not demonstrate that Japan was
imposing measures relating to fire blight in rela tion to other quarantine pests.  We therefore see
no reason to make the ruling requested by the United States.
7.26 We also clarified paragraphs 8.84 and 8.88 to reflect what the United States had to
demonstrate under Article 2.2 of the SPS Agreement  in this particular case.  Paragraph 8.90 was
also modified to reflect more accurately the position of the United States.  However, we did not
find it necessary to modify paragraph 8.106 on burd en of proof.  Likewise, we find it relevant to
state in paragraph 8.212, that Japan, as the party invoking Article 5.7 of the SPS Agreement , bears
the burden to make a prima facie case.  The fact that the issue of burden of proof was notaddressed by the parties or that Japan clearly did not meet the four cumulative requirements in
order for the measure at issue to qualify for the exemption under Article 5.7 does not relieve the
Panel from applying the standards recalled by the Appellate Body in United States – Wool Shirts
and Blouses .  Each party has to prove its allegations.  This principle applies whether the provision
invoked is or is not an exception.  In this case, Japan invoked Article 5.7;  it had the burden to
establish its claim prima facie and failed to do so.
7.27 We also did not find it appropriate to amend the last sentence of paragraph 8.196.  Indeed
we consider that the two propositions of this sentence are logically connected.  If surface
E. amylovora  is found rarely on apples coming from severely infected orchards, the risk of entry,
establishment or spread of fire blight within Japan through apples coming from severely blighted
orchards can only be very low (assuming, as we did, that endophytic bacteria would not be found
in mature, symtomless apples).
7.28 The United States also claims that, even though its request for establishment of a panel
referred to "US apples" in general, it advanced  arguments only relating to mature, symptomless
apples.  The United States considers as a result that we need not address the issue of other apple
                                                     
196 See para. 4.132, above.WT/DS245/R
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fruit with respect to which the United States presented no evidence.  The United States requests
that we remove our finding in paragraph 8.161.
7.29 As mentioned in paragraph 8.33, we consider that the US claims are based on two
assumptions:  (a) that mature, symptomless apples are not a pathway for fire blight;  and (b)
shipments from the United States to Japan only contain mature, symptomless apples.  Theseassumptions were largely confirmed in our findings.
7.30 This said, the position defended by the United States in its request for review seems in
this respect to be contradictory.  On the one hand, it claims that requiring the importation of
mature, symptomless apples should be sufficient to meet the level of protection sought by Japan
in light of the established risk, thus assuming that only mature, symptomless apples will ever be
exported.  On the other hand, it claims that it did not address the issue relating to non mature or
damaged apples.  In our opinion, these issues are two sides of the same coin, and the UnitedStates actually had to address the issue of control to support the assumption that it exports only
mature, symptomless apples.
197  Indeed, the United States provided considerable information
regarding its control procedures.198  As a result, we do not believe that we go beyond our terms of
reference by considering the risk that apple fruit other than mature, symptomless apples could be
exported to Japan.
7.31 Moreover, even if we were to agree with the United States that the matter before us is
limited to mature, symptomless apples, we do believe that we are entitled to address Japan's
position that a risk of entry, establishment or spread could result from a malfunction in the sorting
of apples or of an illegal action in the country of exportation.  We cannot agree that we should
concentrate our findings exclusively on that very product simply because the United Statesapparently limits its claims, arguments and evidence to it.  The purpose of phytosanitary measures
is to prevent the introduction of diseases into the territory of the Member imposing them.  As
recalled by the Appellate Body in Australia – Salmon  with respect to Article 5.6 of the SPS
Agreement ,
"The determination of the appropriate level of protection, a notion defined in
paragraph 5 of Annex A, as 'the level of protection deemed appropriate by the
Member establishing a sanitary … measure', is a prerogative  of the Member
concerned and not of the panel or of the Appellate Body."
199
7.32 If we were to restrict our findings to "mature, symptomless apples", we would disregard
the position of Japan that the protection to be achieved by the measure should be equivalent to
that of an import prohibition.  It seems to us legitimate to consider all the aspects referred to by
Japan in relation to the importation of apples from the United States.  This issue is addressed inour discussion of Article 2.2, paragraphs 8.119-8.122.
7.33 We agree with the United States that our remarks regarding developmental or technical
circumstances prevailing in the importing Member in paragraph 8.239
200 were more an obiter
                                                     
197 See, e.g., paras. 4.188-4.190.
198 See, eg., paras. 4.182, 4.187-4.189, and the footnotes relating to these paragraphs.
199 Appellate Body Report on Australia – Salmon , para. 199.
200 This paragraph and the following paragraph previously read:
"It might be observed, in this context, that the requirement that the risk
assessment be 'appropriate to the circum stances' has been considered to leave
some flexibility for an assessment of risk 'on a case by case basis, in terms ofWT/DS245/R
Page 137
dictum  than a consideration necessary for the resolution of this case.  In paragraphs 8.45 and 8.46
we already considered that Japan was not put at a disadvantage in terms of submission of
evidence by the fact that its territory was free from fire blight.  We therefore adjusted
paragraphs 8.239-8.240.
7.34 We also clarified the US position as presented in paragraphs 8.265 and 8.284, even
though it seemed quite obvious from the context that the statements concerned originated inJapan's 1999 PRA.
7.35 Finally, we clarified the arguments of the United States in paragraph 8.295.
VIII.   FINDINGS
A. A
PPROACH FOLLOWED BY THE PANEL
8.1 The United States raises the following claims:
(a) Japan's measures on US apples are inconsistent with Article 2.2 of the SPS
Agreement  because they are "maintained without sufficient scientific evidence";
(b) Japan's measures on US apples are inconsistent with Article 5.1 of the SPS
Agreement  because they are not based on a risk assessment;
(c) by failing to take into account certain information in its assessment of risks,
Japan has acted inconsistently with Article 5.2 of the SPS Agreement ;
(d) Japan's measures are inconsistent with Article 5.6 of the SPS Agreement  because
they are more trade-restrictive than required to achieve Japan's appropriate level
of protection;
(e) Japan has failed to notify changes to its fire blight measures and to provide
information as required by Article 7 and Annex B of the SPS Agreement ;
(f) in addition, the United States developed, at the first and second substantive
meetings with the Panel, two of the claims against Japan that it had listed in its
request for establishment of a panel but not developed in its first written
                                                                                                                                                             
product, origin and destination, in particular country-specific destinations'.  The
Panel is of the view that 'appropriate to the circumstances' might also be withregard to the developmental or technical circumstances prevailing in theimporting Member.  For example, what might be expected in terms of a riskassessment put forward by a developing country with limited plant protectionservices and trained professional staff may not be 'appropriate' with respect to an
importing country with sophisticated plant protection services and highly trained
professional staff.  Furthermore, the access the importing country has to relevantdata and scientific information might be relevant in consideration of whether arisk assessment is 'appropriate to the circumstances'.
'In this dispute, the Panel notes that both parties are developed
countries with highly sophisticated plant protection services and skilled
professional staff.  Furthermore, the Panel has already found no evidence that
Japan did not have ready access to the relevant scientific evidence necessary toconduct an appropriate risk assessment."WT/DS245/R
Page 138
submission: the violation of Article XI of GATT 1994 and of Article 4.2 of the
Agreement on Agriculture.
8.2 Japan makes the following main arguments in response:
(a) Japan requests that the claims contained in the request for establishment of a
panel but not raised in consultations and/or not developed in the first writtensubmission of the United States be "rem oved" from the proceedings of the Panel;
(b) Japan's measure is not "maintained without sufficient scientific evidence" and is
consistent with Article 2.2 of the SPS Agreement .  Alternatively, Japan's measure
is justifiable as a provisional phytosanitary measure under Article 5.7 of the SPS
Agreement ;
(c) Japan has conducted a risk assessment ("Pest Risk Analysis" – "PRA") compliant
with Article 5.1 of the SPS Agreement ;
(d) Japan's PRA is consistent with the requirements of Article 5.2;
(e) Japan's measure is consistent with Article 5.6 of the SPS Agreement ;
(f) Japan acted in compliance with Article 7 and Annex B of the SPS Agreement
regarding transparency.
8.3 Having regard to the arguments of the parties, we will first define what we consider to be
the phytosanitary measure at issue and the product subject to this measure.  We will then address
the procedural issues raised by the parties, in particular the treatment of the burden of proof and
the preliminary rulings requested by Japan.
8.4 Thereafter, giving due consideration to the order in which the parties have argued the
case and consistent with the opinions of the Appellate Body in EC – Hormones  and in Australia –
Salmon
201, we will address the issues before us in the following order:
(a) We will first address the application of Article 2.2 of the SPS Agreement  to the
phytosanitary measure at issue.  However, we note that Japan presented an
alternative defence under Article 5.7 of the SPS Agreement , in the event that the
United States should successfully establish violation of Article 2.2.  We recallthat, in Japan – Agricultural Products II , the panel faced a comparable situation
where Japan had presented a defence under both Article 2.2 and Article 5.7.  In
                                                     
201 Appellate Body Report in EC – Hormones , para. 250, where the Appellate Body expressed its
surprise at the fact that the panel began its analysis of the whole case with Articles 3 and 5, and not by
focussing on Article 2 that is captioned "Basic Rights and Obligations", an approach that, to the Appellate
Body, appeared "logically attractive".
In Australia – Salmon  case, at para. 138 of its report, the Appellate Body considered that:
"by maintaining an import prohibition on fresh, chilled or frozen ocean-caught Pacific salmon, in violation of Article 5.1, Australia has, byimplication, also acted inconsistently with Article 2.2 of the SPS
Agreement ."
However, we do not read this finding as implying that we should  address the US claim of violation
of Article 5.1 before its claims on Article 2.2.WT/DS245/R
Page 139
that case, the panel refrained from making a final finding of violation of
Article 2.2 until it had reached a conclusion on the application of Article 5.7.  It
recalled that Article 2.2 of the SPS Agreement  provides that Members shall
ensure that any phytosanitary measure "is not maintained without sufficient
scientific evidence, except as provided for in paragraph 7 of Article 5 " and
concluded that it had to examine whether the measure at issue was a measuremeeting the requirements in Article 5.7.  If the measure at issue met these
requirements, it would not find a violation of Article 2.2.
202  We believe it
appropriate to follow, in this case too, the approach of the panel in Japan –
Agricultural Products II .  There is only one situation where it may not be
necessary to address Article 5.7.  This is if we find that the measure or measures
as a whole is/are "not maintained without sufficient scientific evidence" within
the meaning of Article 2.2.  If we were to find, however, that part or all of themeasure or measures at issue is/are maintained without sufficient scientific
evidence, we would suspend our final conclusion on the consistency of the
measure(s) at issue with that provision until we have completed our examination
under Article 5.7 of the SPS Agreement .
(b) In that context, our analysis of the conformity of part or all of the phytosanitary
measure(s) at issue with Article 5.7 will immediately follow our analysis of the
US claim under Article 2.2.
(c) At that juncture, should we find the measure or measures at issue to be
inconsistent with both Article 2.2 and Article 5.7, we could legitimately abstain
from making any findings on the other claims  of the United States.  However, we
are of the view that findings regarding, more particularly, the claims raised with
respect to Japan's obligations in terms of risk assessment may assist the Dispute
Settlement Body (DSB) in making su fficiently precise recommendations and
rulings so as to allow for prompt compliance, in order to ensure effective
resolution of the dispute.
203  This is why we will also address the claims relating
to those obligations, beginning with Article 5.1 (risk assessment).
(d) We will then continue our assessment of the matter with the examination of the
claims regarding Article 7 and Annex B to the SPS Agreement.   For reasons
explained in Section G below, we will not review the US claims under
Article 5.6.
(e) Finally, for the reasons explained in Sections I and J, we do not intend to make
findings with respect to the US claims on Articles XI of the GATT 1994,Article 4.2 of the Agreement on Agriculture and the other claims not developed
by the United States in its submissions before the Panel.
                                                     
202 Japan – Agricultural Products II , para. 8.41, emphasis in the original.
203 See Appellate Body Report in Australia – Salmon , para. 223.WT/DS245/R
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B. THE MEASURE AT ISSUE AND THE PRODUCT SUBJECT TO THIS MEASURE
1. The measure at issue
(a) Summary of the arguments of the parties204
8.5 According to the United States, Japan maintains measures restricting the importation of
US apples in connection with fire blight or the fire blight disease-causing organism,Erwinia amylovora (hereafter E. amylovora) .  The United States has identified nine specific
prohibitions or requirements imposed by Japan:
205
(a) The prohibition of imported apples from US states other than apples produced in
designated areas in the states of Oregon or Washington206;
(b) the prohibition of imported apples from orchards in which any fire blight is
detected on plants or in which host plants of fire blight (other than apple trees)
are found, whether or not infected;
(c) the prohibition of imported apples from any orchard (whether or not it is free of
fire blight) should fire blight be detected within a 500-meter buffer zone
surrounding such orchard;
(d) the requirement that export orchards be inspected three times yearly (at blossom,
fruitlet, and harvest stages) for the presence of fire blight for purposes ofapplying the above-mentioned prohibitions;
(e) a post-harvest surface treatment of apples for export with chlorine;
(f) production requirements, such as chlorine treatment of containers for harvesting
and chlorine treatment of the packing facility;
(g) post-harvest separation of apples for export to Japan from fruits destined to other
markets;
(h) certification by US plant protection officials that fruits are free of fire blight and
have been treated post harvest with chlorine; and
(i) confirmation by Japanese officials of the US officials' certification and inspection
by Japanese officials of disinfection and packaging facilities.
                                                     
204 A detailed account of Japan's measures and of the arguments of the parties can be found in
paras. 2.17-2.19, and paras. 4.17-4.33, respectively.
205 US Request for Establishment of a Panel, WT/DS245/2; US First Submission, para. 19; US
Answers to Additional Questions from the Panel, 28 January 2003, para. 2.
206 The United States contends that paragraph 25 of the Annexed List to Table 2 of the Plant
Protection Law Enforcement Regulations limits the importation of fresh fruit of apple from the UnitedStates to Golden Delicious and Red Delicious apple va rieties.  The Panel, however, notes that there is
disagreement between the parties as to the English translation of the aforementioned paragraph 25.  The
English translation of paragraph 25 provided by Japan makes no mention of the Golden Delicious and Red
Delicious variety requirement.  Ministerial Ordinance No. 73: Plant Protection Law EnforcementRegulations, Annexed List, para. 25 (Exhibit JPN-21 and Exhibit USA-9).WT/DS245/R
Page 141
8.6 Japan does not dispute the description of the requirements at issue made by the United
States.  Japan recalls, however, that points (h) and (i) above are not included in its description of
its fire blight requirements since "certification or declaration by officials of the exporting
country" and "confirmation by Japanese officials" are mere procedural steps to ensure compliance
with the substantive requirements and are common for all phytosanitary measures.  On the other
hand, Japan describes the disinfection of the harvest containers and the disinfection of thepacking facilities (item(f)) as two separate elements of its requirements.
8.7 The United States considers that the means through which Japan maintains these
restrictions and requirements consist of:  (i) the Plant Protection Law (Law No. 151; enacted
4 May 1950), as amended;  (ii) the Plant Protection Regulations (Ministry of Agriculture,
Forestry, and Fisheries Ordinance No. 73, enacted 30 June 1950), as amended;  (iii) Ministry of
Agriculture, Forestry and Fisheries Notification No. 354 (dated 10 March 1997);  and (iv) related
detailed rules and regulations, including Ministry of Agriculture, Forestry, and FisheriesCircular 8103.
8.8 The United States argues that Japan prohibits the importation of apples from the United
States unless all of the requirements referred to above are satisfied.  While this cumulative
requirement is, in its view, contrary to the SPS Agreement , the United States also contends that
each of the nine specific requirements listed above could be considered as a separatephytosanitary measure and that each of them is inconsistent with Japan's obligations under
Article 2.2 of the SPS Agreement  because they are maintained without sufficient scientific
evidence.
8.9 Japan does not dispute that the measure is covered by the SPS Agreement .  However,
Japan argues that its requirements constitute a "systemic approach".
207  The systems approach
consists of approving only those apples produced in environmental conditions that will not allow
the presence of fire blight bacteria, both outside and inside of apple fruit, at various stages from
blossom to growth, harvest and shipment.  Japan therefore disputes the allegation of the United
States that each aspect of the measure could be addressed in isolation.  Even though each
requirement is technically independent, some of the components are interrelated.  As a whole they
are, in Japan's view, cumulative, inseparable and integral parts of a single measure.208
(b) Analysis of the Panel
8.10 Before going any further, we need first to clarify the relevance, in our assessment, of
treating the Japanese requirements and restrictions at issue as one single measure or as a
combination of several individual measures.  As stated by the Appellate Body in Australia –
Salmon209, our findings must assist the DSB in making sufficiently precise recommendations and
rulings so as to allow for prompt compliance, in order to ensure effective resolution of the
dispute.  In that context, given the number of requirements identified by the United States, it may
be relevant to address each of them as a separate "measure".  However, we note that Japan
insisted on the fact that those requirements are part of one single systems approach.  Furthermore,
                                                     
207 Hereafter "systems approach".  ("The integration of different pest risk management measures,
at least two of which act independently, and which cumulatively achieve the appropriate level ofphytosanitary protection".  International Standard for Phytosanitary Measures  No.5:  Glossary of
Phytosanitary Terms  , FAO, Rome, 2002).
208 Japan, Response to Additional Questions from the Panel, 28 January 2003, Question 1.
209 Appellate Body Report, para. 223.WT/DS245/R
Page 142
some of the requirements are clearly interrelated .  For example, the requirement of a buffer zone
is directly related to the requirement that the export orchard be disease-free.
(i) One or more measures?
8.11 We recall that the concept of "measure" is not defined in the DSU, even though the term
"measures at issue" is found in Article 6.2 regarding the establishment of a panel.  The use of theterm "measures at issue" in plural suggests that a matter brought before the DSB may refer to
several "measures".  This said, Article 19.1 refers to "a measure" that is found to be inconsistent.
The definition of the concept is the result of the practice of panels and the Appellate Body under
the GATT and the WTO.  "Measure", for the purpose of dispute resolution under GATT and the
WTO, has generally been understood to refer to an action in which there was "sufficient
government involvement".
210
8.12 We note that Annex A, paragraph 1, of the SPS Agreement  provides a definition of
"phytosanitary measure".  In Australia – Salmon , the Appellate Body, by referring to the "sanitary
measure at issue in this dispute", seems to have implied that a "measure" in a phytosanitary case
should be defined with reference to the definition of "phytosanitary measure" in the SPS
Agreement .211
8.13 Paragraph 1 of Annex A of the SPS Agreement  defines as a phytosanitary measure "all
measures applied to protect animal or plant life or health within the territory of the Member from
risks arising from the entry, establishment or spread of pests, diseases, disease-carrying
organisms or disease-causing organisms".  However, this definition provides little direct guidance
in determining whether we should treat the several requirements identified by the United States
together as one measure or separately as individual measures.
8.14 We recall, however, that panels and the Appellate Body have in the past considered as
one single "measure" legal requirements comprised of several obligations, some simply
prohibiting importation, some allowing importation under certain conditions.  In Australia –
Salmon , the Appellate Body considered that the measure at issue was a text called QP86A, as
confirmed by an Australian decision of 1996.  As mentioned by the Appellate Body, QP86A"impose[d] an import prohibition, [but also] delegate[d] authority to the Director of Quarantine to
allow imports that have been subject to such treatment as is likely, in his opinion, to prevent the
introduction of any disease".
212 The Appellate Body nonetheless described the measure as a
whole as an "import prohibition".213
                                                     
210 Panel Report in Japan - Film , paras. 10.55-10.56, referring to GATT panel reports Japan –
Semiconductors , para. 102 and EC – Restrictions on Imports of Dessert Apples  (Complaint by Chile),
para.126.
211 We also note that in Japan – Agricultural products II , the Appellate Body characterised varietal
testing as a regulation, within the meaning of paragraph 1 of Annex B, implicitly identifying it as a
"measure" under paragraph 1 of Annex A.
212 Appellate Body Report in Australia -Salmon , para. 98.
213 The Appellate Body rejected the description of the measure by the panel as two sides of the
same coin because part of the measure (the heat treatment requirement) did not actually apply to fresh
salmon (see paras. 103-104).  On the treatment of a legislation with several requirements as one measure,
see also Appellate Body Report in EC – Asbestos , para. 64 :
"In our view, the proper legal character of the measure at issue cannot be determinedunless the measure is examined as a whole.  Article 1 of the Decree contains broad,WT/DS245/R
Page 143
8.15  We note that in this instance, on the one hand, the United States does not suggest that it
would be inappropriate for us to treat the nine "requirements" it identified as one single measure.
Indeed, it considers that none of those requirements is justified, as long as the exported product is
mature, symptomless apples.  On the other hand, Japan objects to our reviewing each of these
requirements separately, as it considers them to be the necessary elements of a systems approach.
8.16 We further note that these requirements cumulatively constitute the measures actually
applied  by Japan to the importation of US apple fruit to protect itself against the entry,
establishment or spread of fire blight within its territory.  As noted above, they are interrelated,
and it is this entire set of requirements that must be met in order for US apples to be exported to
Japan.  We recall in this respect the Appellate Body's statement, in Australia – Salmon , that "the
SPS measure at issue can only be the measure which is actually  applied to the product at issue".214
8.17 In the light of the above, we consider that there is no legal, logical or factual obstacle to
treating the requirements identified by the United States as one single phytosanitary measurewithin the meaning of the SPS Agreement .  There are, on the contrary, good reasons to do so, in
particular the fact that both parties themselves have argued the case as an "all or nothing"
exercise.  We note in this regard that the United States did not argue that part or all of the
requirements it identified were not "necessary" within the meaning of Article 2.2 of the SPS
Agreement .  Rather, the United States argues that there was not sufficient scientific evidence to
support any of those requirements.  Treating the requirements at issue as one measure is,
therefore, appropriate, especially in the context of Article 2.2 of the SPS Agreement , provided that
we determine that the measure as a whole is – or is not – compatible with the SPS Agreement .
8.18 However, we do not exclude that, as we carry out our analysis, especially under
Article 2.2 of the SPS Agreement , we may be apprised of scientific evidence to support certain
aspects of the measure and not others.  In this regard, the Panel is guided by the opinions of the
experts which it appointed to serve as scientific and technical advisers.
215  While this may, in
                                                                                                                                                             
general prohibitions on asbestos and products containing asbestos.  However, the scope
and generality of those prohibitions can only be understood in light of the exceptions to it
which, albeit for a limited period,  permit , inter alia ,  the use of certain products
containing asbestos and, principally, products containing chrysotile asbestos fibres.  Themeasure is, therefore,  not  a  total  prohibition on asbestos fibres, because it also includes
provisions that  permit ,  for a limited duration, the use of asbestos in certain situations.
Thus, to characterize the measure simply as a general prohibition, and to examine it assuch, overlooks the complexities of the measure, which include both prohibitive and
permissive elements.  In addition, we observe that the exceptions in the measure would
have no autonomous legal significance in the absence of the prohibitions.  We, therefore,conclude that the measure at issue is to be examined as an integrated whole, taking intoaccount, as appropriate, the prohibitive and the permissive elements that are part of it."
214 Appellate Body Report in Australia - Salmon , para. 103 (emphasis in the original).
215 Noting that this Panel involved scientific or technical issues, and noting that both parties
acknowledged that the Panel may need to consult with scientific and technical experts, we decided,
pursuant to Article 13.1 of the DSU and Article 11.2 of the SPS Agreement , to select and appoint specialists
in the field of plant pathology and pathogenic bact eria.  The procedure followed for the selection and
consultation of the experts is described in paras. 6.1- 6.4 above.  The experts appointed by the Panel were:
Dr Klaus Geider, Professor of Molecular Genetics and Phytopathology, Max-Planck-Institut fürZellbiologie, University of Heidelberg, Ladenburg, Germany;  Dr Chris Hale, Science Capability Leader,
Insect Group (Plant Health and Fire Blight) HortRe search, Auckland, New Zealand;  Dr Chris Hayward,
Consultant on Bacterial Plant Diseases, Indooroopilly, Queensland, Australia;  and Dr Ian Smith, Director-General, European Plant Protection Organization, Paris,  France.  Consistent with the principles recalled byWT/DS245/R
Page 144
principle, justify specific findings on those aspects of the measure, we recall that neither the
United States nor Japan have taken the view that the phytosanitary measure at issue could be
partly justified under the SPS Agreement .  The United States' position is that none of the aspects
of the measure is justified with respect to the importation of mature, symptomless apple fruit.
Japan argues, on the contrary, that each of the components of the measure is inseparably part of asystems approach.
8.19 We may of course conclude that one aspect of a measure is illegal and not others, even
when the complainant argues that the measure as a whole is illegal.  Indeed, since the SPS
Agreement  establishes different rights and obligations, it may be also appropriate, depending on
the provision at issue, to consider the specific requirements individually.  However, to assume
such a subdivision would disregard the way in which those requirements are presented by the
parties and applied, i.e., as one single measure.
8.20 For these reasons, we find that we should consider together the requirements
identified by the United States as the phyto sanitary measure at issue in this dispute.
(ii) Elements constituting the phytosanitary measure at issue
8.21 We note that the parties disagree as to the actual number of requirements imposed by
Japan with respect to the importation of US apples.  We recall that the United States listed ninerequirements and that although Japan lists the requirements differently, Japan does not dispute the
description made by the United States, except with regard to two items.
8.22 Concerning the first one (certification by US plant protection officials that fruits are free
of fire blight and have been treated post harvest with chlorine), we agree with Japan that it is
essentially a procedural requirement and that phytosanitary certificates are common practice ininternational trade.  Indeed, we note that the re levant international standards setting body in this
respect, the Interim Commission on Phytosanitary Measures, has adopted standards for such
certificates.
216  Furthermore, we note that the US Apple Export Act provides for the issuance of
phytosanitary certificates for apples exported from the United States that are of a certain grade
and quality.  In this respect, our opinion is without prejudice as to what exactly should becertified.
8.23 Regarding the second item (i.e., the confirmation by Japanese officials of the US
officials' certification and inspection by Japanese officials of disinfection and packaging
facilities), it appears that they do not entail significant additional obligations for the United States
compared with the other requirements identified.
8.24 However, we note that both requirements fall within the definition of phytosanitary
measures contained in Annex A, paragraph 1, of the SPS Agreement , which includes "inspection,
certification and approval procedures".  We also note that the definition in Annex A, paragraph 1,
does not consider the trade effect of a given measure as a factor to determine whether such a
measure is or is not a phytosanitary measure.  While such requirements are common practices
and, on their own, may not have justified the initiation of this case by the United States, we note
                                                                                                                                                             
the Appellate Body regarding burden of proof, the opinions of the experts were used by the Panel to assess
the factual allegations raised by the parties in support of their claims.
216 Op. cit., ISPM 12.WT/DS245/R
Page 145
that they are part of the measure as a whole and that, in combination with other elements of that
measure, they may contribute to the restrictive effect of the measure at issue.
8.25 For these reasons, we conclude that th e measure at issue is composed of the
following elements:
(a) Fruit must be produced in designated fire blight-free orchards.  Designation
of a fire blight-free area as an export orchard is made by the United StatesDepartment of Agriculture (USDA) upon application by the orchard owner.
Any detection of a blighted tree in this area by inspection will disqualify the
orchard.  For the time being, the designation is accepted only for orchards in
the states of Washington and Oregon
217;
(b) the export orchard must be free of plants  infected with fire blight and free of
host plants of fire blight (other than apples), whether or not infected;
(c) the fire blight-free orchard must be surrounded by a 500-meter buffer zone.
Detection of a blighted tree or plant in this zone will disqualify the export
orchard;
(d) the fire blight-free orchard and surrounding buffer zone must be inspected
at least three times annually.  US officials will visually inspect twice, at the
blossom and the fruitlet stages, the export area and the buffer zone for anysymptom of fire blight.  Japanese and US officials will jointly conduct visual
inspection of these sites at harvest time.  Additional inspections are required
following any strong storm (such as a hail storm);
(e) harvested apples must be treated with surface disinfection by soaking in
sodium hypochlorite solution;
(f) containers for harvesting  must be disinfected by a chlorine treatment;
(g) the interior of the packing facility  must be disinfected by a chlorine
treatment;
(h) fruit destined for Japan must be kept separated post-harvest from other
fruit;
(i) US plant protection officials must certify that fruits are free from fire blight
and have been treated post harvest with chlorine;  and
                                                     
217 Japan argues that the current phytosanitary requirements against fire blight can be applicable to
apple fruit produced in other States, but that the United States has not submitted documentation on the
status of other quarantine pests for states other than Washington and Oregon.  As such, Japan argues that
this is a procedural matter.   (Japan, Response to Questions from the Panel, 13 November 2002,
Question 47)  The United States argues that Japan prohibits the importation of US fruit other than fruitproduced in designated export orchards within either of the two states of Washington or Oregon.  TheUnited States has in the past requested that Japan expand the list of states eligible to export apple fruit toJapan, to no avail.  While there is scientific evidence th at fire blight bacteria are not associated internally or
externally with mature, symptomless apple fruit from the state of Washington, there is not a rational or
objective relationship between the scientific evidence and Japan's prohibition of apples other than thoseharvested in the states of Washington or Oregon (US First Submission, para. 58).WT/DS245/R
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(j) Japanese officials must confirm the US officials’ certification and Japanese
officials must inspect packaging facilities.
2. The product subject to the phytosanitary measure at issue
(a) Summary of the arguments of the parties218
8.26 The United States argues that the commodity subject to the measure at issue is the
product it allegedly exports, i.e., "mature, symptomless apples".  Japan contests the notions of
"mature" and "symptomless" as subjective.  The United States replies that these notions are
scientifically supported.
(b) Analysis of the Panel
8.27 On the basis of the information before us, we understand that Japan's concern is that fire
blight could be introduced into its territory through apples imported from the United States and
their containers (e.g., crates).
8.28 Japan argues that:
(a) fire blight bacteria are capable of long-term survival inside or on the surface of
"mature, symptomless" apples, such that the apple fruit could develop fire blight
symptoms  sometime after their selection and packing for export.  Hence, apple
fruit could be contaminated and yet be found fit for exportation.  Once introducedinto Japan, fire blight would have ample potential for growth and infection with
major negative, irreversible consequences
219; and that
(b) there is a very real risk of accidental contamination or erroneous grading, which
could lead to the introduction of infected or infested apples in a shipment of
otherwise mature, symptomless apple fruit bound for Japan, or to thecontamination of crates.
220
Hence, in the absence of an appropriate quarantine inspection method or internal appledisinfection treatment technique, Japan considers that a systems approach is the only viable
alternative (short of import prohibition) to ensure that there is no presence of fire blight bacteria
either inside or outside of apple fruit shipped to Japan.
221
8.29 We recall the argument of the United States that it exports only mature, symptomless
apples, which it claims have been proven not to be a pathway for fire blight (i.e., they are not
capable of transmitting fire blight to other hosts).  We understand the US position to be that, in
that context, none of the requirements contained in the measure at issue is compatible with the
SPS Agreement .
                                                     
218 For a more detailed account of the arguments of the parties see, inter alia , paras. 4.51, 4.63-
4.64 and 4.99.
219 Para. 4.50.
220 Para. 4.190.
221 Paras. 4.19-4.20.WT/DS245/R
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8.30 In light of the claims and arguments of the parties, we consider it essential to identify
precisely the "product" subject to the measure at issue.222  Indeed, if we consider that "product" to
be limited to "mature, symptomless apple fruit", as claimed by the United States, many aspects of
the measure at issue might, ipso facto , lose their raison d'être and may become incompatible with
the SPS Agreement .  This could be the case for most of the requirements, which under the
measure currently applied by Japan, take place before harvesting.  If, on the contrary, weconclude that the product at issue is "any apple to be shipped to Japan from the United States",
then we actually need to address the justifica tion of the requirements imposed by Japan as a
whole.
8.31 We note that some requirements may appear to relate to the apples that cannot  be
exported (prohibitions), whereas some others apply only to those that can be exported.  If we
follow the US definition of the product at i ssue, we run the risk of reviewing only the
requirements applying to mature, symptomless apples, which would be illogical.
8.32 We also note that the request for establishment of a panel submitted by the United States
only refers to "US apples", which is less specific than "mature, symptomless apples".
223 The
request for establishment of a panel is the document that defines our mandate.  It is not
exclusively a limitation to our jurisdiction, it defines it positively too. The fact that the United
States intended to address "only" mature, symptomless apples in its submission does not affectour mandate.
224  We also recall the arguments of the parties and the experts regarding the notion
of "mature" and "symptomless" apple fruit, and the fact that the susceptibility of apples to
infestation or infection by E. amylovora  is related to the maturity of apples.  In this respect, the
experts were able to provide definitions of, and to distinguish between, "physiological" and
"commercial" maturity.  Furthermore, the experts confirmed that there were widely used andaccepted objective methods for determining the maturity of apples.
225
8.33 Without prejudice to our discussion of the merits of this case, we feel bound at this early
stage of our reasoning not to prejudge our conclusions by unduly restricting the scope of our
findings to mature, symptomless apple fruit.  Indeed, we believe that the US claim that the
product at issue is "mature, symptomless apples" is based essentially on two assumptions: (a)mature, symptomless apple fruit are not a pathway for fire blight and (b) shipments from the
United States to Japan only contain mature, symptomless apples.  In our opinion, these
assumptions can only be verified through a review of the merits of the case, in particular the
central question of whether, and under which conditions, apples may or may not act as a pathway
for fire blight.
8.34 We therefore conclude that we should consid er the measure at issue as applicable to
apple fruit produced in the United States for exportation to Japan.
                                                     
222 We note in this respect that an approach aiming at identifying precisely the product subject to
the measure was confirmed by the Appellate Body in Australia – Salmon , paras. 94-95.
223 See WT/DS245/2: "Japan currently maintains measures restricting the importation of US apples
in connection with fire blight or the fire blight disease-causing organism, Erwinia amylovora"  (underlining
added).
224 We note in this respect that Japan claims that it was made aware of the concept of "mature,
symptomless apples" during the consultations.  This sugg ests that, by the time the United States requested
the establishment of this Panel, it could have referred specifically to "mature, symptomless apples".
225 Dr Hale, para. 6.5.WT/DS245/R
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C. PROCEDURAL ISSUES
1. Introduction
8.35 In its first submission, Japan requested the Panel to address three "procedural issues".226
8.36 Japan requested that we exercise our authority under paragraph 9 of our Working
Procedures227 to seek clarification from the United States of the time as of which it considers that
the Japanese measure at issue was no longer supported by sufficient scientific evidence.  The
United States subsequently stated in reply to a qu estion from the Panel that it considered that the
measure had never been compatible with the SPS Agreement .228  As a result, we find that it is no
longer necessary to address this request by Japan.
8.37 Japan also requested in its first written submission that we "remove", in accordance with
paragraph 10 of our Working Procedures, two documents submitted by the United States as
evidence in its first submission.
8.38 Moreover, Japan requested that, in accordance with paragraph 10 of our Working
Procedures, we "remove" from the "scope of our proceedings" all the provisions that the United
States did not address in its first submission.
8.39 In addition, while it seems undisputed by the parties that the United States bears the
burden of presenting a prima facie case for each of its claims, Japan has, on several occasions229,
raised questions relating in particular to the administration of evidence, including the accessibility
of the information, the fact that scientific evidence should not be limited to "direct evidence" and
the standard of proof to be applied by the Panel.  Since these questions are primarily of a
procedural nature, we consider it appropriate to address them at this stage.
8.40 As a result, in this section we will:
(a) Under a heading regarding burden of proof, recall the general obligations of the
parties in terms of burden of proof, including with respect to the question of the
general access of Japan to scientific information;
(b) Under a heading relating to Japan’s requests made under paragraph 10 of our
Working Procedures, recall our decision regarding the treatment of the twocommunications the admissibility of which is contested by Japan and address
Japan’s request on the scope of our mandate in relation to the US claims not
developed in the first submission of the United States.
2. Burden of proof
8.41 At the outset, we find it important to clarify that, as recalled by the Appellate Body in
EC – Hormones , there is not any necessary connection between "the undertaking of Members to
                                                     
226 Japan first submission, paras. 17-34.
227 The Working Procedures for the Panel are reproduced in Annex 1 and the Working Procedures
for the consultation of experts are contained in para. 6.2 of the Report..
228 US Response to Questions from the Panel, 13 November 2002, para.87.
229 Japan first submission, paras. 17-34, 47-50, 129-141, Japan Second Submission, paras. 1, 38-
47.WT/DS245/R
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ensure, for example, that SPS measures are 'applied only to the extent necessary to protect
human, animal or plant life or health …' and the allocation of burden of proof in a dispute
settlement proceeding.  Article 5.8 of the SPS Agreement  does not purport to address burden of
proof problems; it does not deal with a dispute settlement situation".230  A distinction must
therefore be made between the obligations of Members in adopting and maintaining the measures
concerned and the separate issue of burden of proof in dispute proceedings.
8.42 As  a result, we shall apply the principles of allocation of the burden of proof as identified
by the Appellate Body in EC – Hormones :
"The initial burden lies on the complaining party, which must establish a prima
facie case of inconsistency with a particular provision of the SPS Agreement  on
the part of the defending party, or more precisely, of its SPS measure or measures
complained about.  When that prima facie case is made, the burden of proof
moves to the defending party, which must in turn counter or refute the claimedinconsistency."
231
8.43 We nonetheless note that Japan raised some specific questions regarding the burden of
proof in general and the nature of admissible evidence.
8.44 Japan argues that the United States, as the exporting country affected by the disease,
would "naturally" have more information on the E. amylovora  bacteria.  We do not see the greater
expertise of the exporting country as a factor that should automatically justify a different
allocation of the burden of proof or the imposition of a heavier burden of proof on one party.
8.45 We do not disagree that specific pieces of scientific evidence may be more readily
available in some countries than others, and in the case of a disease-free country, that evidence
relating to the spread of that disease may naturally be less extensively developed within thatterritory than in a country with direct exposure to the disease.  However, this should not mean
that a Member should be exempted from an obligation to provide evidence of its allegations
simply because its territory is free from a particular disease, or that a heavier burden of proof
should be imposed ipso facto  on a Member simply because its territory is not disease-free.
Indeed, a number of developing countries affected by a pest or disease may not have theresources to gather information on that pest and may need to rely on information gathered in other
countries.
8.46 We note, moreover, that Japan could have s ought to perform or commission research on
E. amylovora  in third countries.  Japan has in the past undertaken studies in relation to fire blight-
like diseases of pears, and in 2002 regarding fire blight in apples.  Furthermore, Japan proposed
and engaged in joint field experiments with th e United States regarding fire blight in US
apples.
232
8.47 In addition, Japan has been arguing that evidence should be limited to public information.
In the case of scientific evidence, it should have been peer reviewed by other scientists.  We note
that virtually all of the evidence presented in this case, with the exception of the most recent
                                                     
230 Appellate Body Report in EC – Hormones , para. 102.
231 Appellate Body Report in EC – Hormones , para. 98.  See also the Panel Report in Australia –
Salmon - Article 21.5  (Canada) , para. 7.37 and the Panel Report in Japan – Agricultural Products II , para.
8.13.
232 See discussion in paras. 4.174-4.178.WT/DS245/R
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research undertaken by both countries233 and the clarifications sought by the United States234, is
publicly available.
8.48 As a result, we do not consider that Japan should be exempted from its obligation to
sufficiently support its allegations or that a heavier burden of proof should be imposed on the
United States for the reasons alleged by Japan above.  In drawing this conclusion, however, webear in mind the duty of all parties in a dispute to cooperate in the proceedings, including, as
necessary, in the gathering of information rele vant to the Panel's assessment of the matter.
8.49 A related question is whether the Panel should consider evidence that became available
only after the establishment of the Panel.  Our approach in this respect should be pragmatic.
Besides the situation contemplated in paragraph 11 of our Working Procedures, we decided not to
reject evidence submitted by a party on which the other party had had an opportunity to comment,
whether it took advantage of such an opportunity or not.  This is without prejudice to theadmissibility of such evidence on other grounds or the weight that we might eventually give to
such evidence.
8.50 However, our discussion above does not dispose of the question of the actual standard or
level of proof that must be satisfied for each claim to succeed.  As recalled by the Appellate Body
in US – Wool Shirts and Blouses:
"In the context of the GATT 1994 and the WTO Agreement , precisely how much
and precisely what kind of evidence will be required to establish [a prima facie
case] will necessarily vary from measure to measure, provision to provision, and
case to case."
235
8.51 We are therefore of the view that this aspect will be more appropriately addressed in the
sections regarding each claim.236
                                                     
233 Exhibits JPN-33, JPN-39, JPN-42, USA-32 to USA-39.
234 Exhibits USA-18 and USA-19.
235 Appellate Body Report in US – Wool Shirts and Blouses , p. 335.
236 This is without prejudice to the standard of review for fact-finding to be applied in this case.
As recalled by the Appellate Body in EC – Hormones :
"The standard of review appropriately applicable in proceedings underthe SPS Agreement , of course, must reflect the balance established in
that Agreement between the jurisdictional competences conceded by
the Members to the WTO and the jurisdictional competences retainedby the Members for themselves.  To adopt a standard of review notclearly rooted in the text of the SPS Agreement  itself, may well amount
to changing that finely draw balance;  and neither a panel nor theAppellate Body is authorized to do that.
… In our view, Article 11 of the DSU bears directly on this matter and,
in effect, articulates with great succinctness but with sufficient claritythe appropriate standard of review for panels in respect of both theascertainment of facts and the legal characterization of such facts underthe relevant agreements.So far as fact-finding by panels is concerned, their activities are always
constrained by the mandate of Article 11 of the DSU:  the applicable
standard is neither de novo  review as such, nor 'total deference', but
rather the 'objective assessment of the facts'.  Many panels have in theWT/DS245/R
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3. Japan's requests for preliminary rulings
(a) Introduction
8.52 As mentioned above, Japan requested that we issue a preliminary ruling on two issues, in
accordance with paragraph 10 of our Working Procedures.  First, Japan requested that we
"remove" two documents submitted by the United States as evidence237 essentially:
(a) because these documents were submitted in such a way that Japan was prevented
from discussing them during consultations, with the consequence that it was
denied an opportunity to settle the matter in good faith through bilateral
consultations;  and
(b) because the probative value of those communications is questionable, given the
conditions in which they were obtained.238
Indeed, Japan contends that the declarations at issue were pre-worded by the United States to suitits position.
239
8.53 Second, Japan requests that we "remove" from the "scope of our proceedings" all the
provisions that the United States did not address in its first submission.
8.54 At our request, the United States submitted written comments before our first substantive
meeting.240  The issues were further addressed by the parties at our first meeting and subsequently
by Japan in its second written submission and during our second substantive meeting with the
parties.
(b) Japan's request that we "remove" certain pieces of evidence from the proceedings
8.55 With regard to Japan's first request, in a letter dated 15 January 2003, we informed the
parties of the following:
"The Panel refers to Japan's request for a preliminary ruling concerning the
admissibility of two exhibits submitted by the United States with its first written
submission, namely the declaration from T. van der Zwet (USA – 18) and the
letter from S. V. Thomson (USA – 19).
The Panel notes that, as a matter of principle, the parties are entitled to submit
evidence in support of their arguments.  Having considered the arguments of the
                                                                                                                                                             
past refused to undertake de novo  review, wisely, since under current
practice and systems, they are in any case poorly suited to engage insuch a review.  On the other hand, 'total deference to the findings of the
national authorities', it has been well said, 'could not ensure an
'objective assessment' as foreseen by Article 11 of the DSU'"(paras. 115-117).
237 These documents are (a) a declaration by Dr Tom van der Zwet (Exhibit USA-18) and a letter
by Professor Sherman Thomson (Exhibit USA-19).
238 A detailed account of the arguments of the parties can be found in paras. 4.6-4.16.
239 Comments of Japan on Experts' Responses, 23 December 2002,  paras. 13 and 17.
240 Reply of the United States to the Request by Japan for Preliminary Rulings, 16 October 2002.
See paras. 4.7, 4.8, 4.10, 4.12, 4.13.WT/DS245/R
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parties, the Panel is not convinced that, in this particular instance, it should
exclude the aforementioned exhibits from the proceedings  a priori .  This decision
is without prejudice to the weight, if any, that the Panel may ultimately ascribe to
these documents, including in light of Japan's comments.
Japan may, if it deems necessary, make further representations or ask additional
questions regarding the contents of these documents in the course of the second
substantive meeting."
8.56 We confirm our decision not to reject the two pieces of evidence submitted by the United
States as Exhibits USA-18 and USA-19.  We are of the view that our obligation, pursuant to
Article 11 of the DSU, to make an objective assessment of the matter before us, including an
objective assessment of the facts of the case, imposes on us an obligation not to exclude a priori
any evidence submitted in due time by any party.  However, the fact that we accepted theevidence at issue as a matter of principle is, as stated in the letter above, without prejudice to the
weight that we will ultimately give to these exhibits in our discussion of the substance of this
case.  We also note that, consistent with the practice of panels, we provided Japan with the
opportunity to comment on the substance of these documents.
(c) Japan's request regarding some claims not developed by the United States in its first
submission
(i) Summary of the arguments of the parties
241
8.57 Japan requests that we "remove" from the scope of our proceedings a number of claims
contained in the request of the United States for the establishment of the Panel.  With respect to
Article 4.2 of the Agreement on Agriculture and Article 5.5 of the SPS Agreement,  Japan argues
that no bilateral consultations were held.  Regarding Article XI GATT 1994, Article 4.2 of the
Agreement on Agriculture and Articles 2.3, 5.3, 5.5, 6.1 and 6.2 of the SPS Agreement , Japan
argues that the United States should not be entitled to develop those claims during these
proceedings since it did not address them in its first submission.
8.58 The United States argues that there is no basis for the Panel to remove claims that are
within the Panel’s terms of reference as established by the DSB.  There is, in its view, no
obligation under the DSU to consult on a particular claim in order to include that claim in the
Panel’s terms of reference.  The purpose of consultations is to provide a better understanding of
the facts and circumstances of a dispute.  Logically, then, a party may identify new claims in the
course of consultations and include them in the request for establishment of a panel.
(ii) Analysis of the Panel
8.59 We understand that Japan wants us to declare that the claims at issue are either not
properly before the Panel or should otherwise not be addressed by the Panel.  In other words,
Japan wants us to interpret our terms of reference, as defined by Article 7 of the DSU and the US
request for establishment of a panel.  Japan’s request seems to be based on two reasons:
(a) Some of those claims (those regarding Article 4.2 of the Agreement on
Agriculture and Article 5.5 of the SPS Agreement ) were not found in the initial
                                                     
241 A detailed account of the arguments of the parties can be found in paras. 4.1-4.5 of this Report.WT/DS245/R
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request for consultations contained in document WT/DS245/1 (hereafter
"Request (a)");  and
(b) Some of those claims (those regarding Article XI GATT 1994, Article 4.2 of the
Agreement on Agriculture and Articles 2.3, 5.3, 5.5, 6.1 and 6.2 of the SPS
Agreement ) were not developed in the US first written submission (hereafter
"Request (b)").
- Request (a)
8.60 Concerning the claims referred to under (a) above, we first recall that, even though the
United States included Article 5.5 in its request for establishment of a panel, it did not submit any
argument or evidence in support of that claim.  As a result, it is not necessary for the Panel to
issue any ruling on the admissibility of a claim that was not addressed by the complaining party.
8.61 Regarding the claim of the United States under Article 4.2 of the Agreement on
Agriculture, we consider that, in the light of our findings on the merits of this case242, it is not
necessary to decide on the admissibility of that claim.
8.62 For these reasons, we refrain from making any finding on Japan's request that those
claims be "removed" from these proceedings by the Panel because they were not found in the
initial request for consultations.
- Request (b)
8.63 As regards the claims referred to under (b) above, we first note that we are bound by our
terms of reference.243  We also note that the Appellate Body in EC – Bananas  stated that:
"There is no requirement in the DSU or in GATT practice for arguments on all
claims relating to the matter referred to the DSB to be set out in a complaining
party’s first submission to the panel.  It is the panel’s terms of reference,governed by Article 7 of the DSU, which set out the claims of the complaining
parties relating to the matter referred to the DSB."
244
8.64 Therefore, it is well established that a complainant is not prevented, as a matter of
principle, from developing in its second submis sion arguments relating to a claim that is within
the terms of reference of the panel, even if it did not do so in its first written submission.
8.65 In the present case, the United States made arguments in relation to its claims under
Article XI GATT 1994 and Article 4.2 of the Ag reement on Agriculture only during our two
substantive hearings with the parties.  Such a tactic may seem questionable since nothing
prevented the United States from presenting arguments on these claims in its first submission, and
such an approach may significantly limit the possibility for the defending party to argue in
response, depending on the circumstances of the case, or at least could unduly delay the
proceedings.
                                                     
242 See para. 8.336 below.  See also paras. 8.63-8.66.
243 Appellate Body Report in India – Patents (US) , paras. 92-93.
244 Appellate Body Report in EC – Bananas , para. 145.  This position has been reaffirmed recently
in the Report of the Appellate Body in EC – Sardines , para. 280 and in the Report of the Appellate Body in
Chile – Price Band System , para. 158.WT/DS245/R
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8.66  Taking into account the established practice on issues such as this, and having given due
consideration to Japan's request, we decided that the most appropriate way to deal with this issue
was to give Japan sufficient opportunity to reply.  We declined to rule on this issue at the first
substantive meeting and made the following stat ement at our second meeting with the parties:
"Referring to the letter we sent yesterday [reproduced in paragraph 8.55 above],
we addressed only one of the issues on which a preliminary ruling had been
sought by Japan.  We did not address the other point as we intend to address that
in the findings.  Since one party referred to this other issue this morning, the
Panel notes that it is still open to the parties to make further comment on it at this
meeting or within the deadlines for comment on matters arising from this
meeting by close of business Tuesday 28 January"245.
The US claims under Article XI GATT 1994 and Article 4.2 of the Agreement on Agriculture are
discussed in Sections I and J below.
D. ARTICLE 2.2 OF THE SPS AGREEMENT
1. Summary of the arguments of the parties246
(a) United States
8.67 The United States argues that Japan's fire blight measure is inconsistent with Article 2.2
of the SPS Agreement  because it is maintained without sufficient scientific evidence, contrary to
the last requirement of that Article.
8.68 The United States argues that in Japan – Agricultural Products II , the Appellate Body
interpreted the relevant part of Article 2.2 in light of the ordinary meaning of the word"sufficient" ("of a quantity, extent, or scope adequate to a certain purpose or object") and in the
context of Articles 5.1, 3.3 and 5.7.  The Appellate Body affirmed the conclusion of the panel that
the obligation in Article 2.2 not to maintain an SPS measure "without sufficient scientific
evidence" requires that "there be a rational or objective relationship between the SPS measure and
the scientific evidence" which is to be determined on a case-by-case basis and will depend on theparticular circumstances of the case, "including the characteristics of the measure at issue and the
quality and quantity of the scientific evidence".
247
8.69 The United States argues that there is no evidence that the apple fruit sought to be
exported from the United States, i.e. mature, symptomless apples, have ever transmitted and or
would transmit fire blight disease to Japan.248  All of the scientific evidence shows that mature,
symptomless apples are not a pathway for the disease.
8.70 The United States adds that scientific evidence is borne out by real world experience.
Over the past 35 years, there has not been a single reported instance of fire blight spread through
                                                     
245 Statement by the Chairman of the Panel, Mr Michael Cartland, at the Panel meeting with the
parties on 16 January 2003.
246 A detailed account of the arguments of the parties can be found in paras. 4.48-4.137 of this
Report.
247 US first submission, para. 22.
248 US first submission, para. 23-24.WT/DS245/R
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export of US apples.  Thus, there is no rational or objective relationship between the scientific
evidence and the Japanese fire blight measures.
8.71 The United States further argues that mature, symptomless apples do not serve as a
"pathway" for fire blight disease.  The Inte rnational Plant Protection Convention defines a
pathway as "[a]ny means that allows the entry, establishment or spread of a pest".  Phytosanitary
measures under the SPS Agreement  must, by their nature, address a risk that arises due to an
identifiable pathway.
(b) Japan
8.72 Japan  argues that each of the current requirements on the importation of US apples to
prevent the entry of fire blight is reasonably supported by scientific evidence, similar measures
taken by other countries and international standards.  As such, Japan contends that there is a
"rational or objective relationship" between the measure and the evidence.
8.73 Japan argues that a variety of published literature on the ecology, properties and
survivability of E. amylovora  establish that the bacteria is evidently capable of long-term survival
inside or on the surface of what the United States termed "mature, symptomless" apple fruit.  The
fact that bacteria could exist and survive inside  mature, symptomless apple fruit means that the
fruit could cause fire blight symptoms later on.  As such, apple fruit could be contaminated and
yet be found fit for exportation.  Once introduced into Japan, fire blight would have amplepotential for growth and infection and lead to major negative, irreversible consequences.
Previous instances of trans-oceanic dissemination of fire blight showed the survivability of
bacterium and no ecological study had pin-pointed the exact pathway for transmission of the
diseases in those cases.  As such, apple fruit could not be ruled out as a vector for the
transmission of fire blight.
8.74 Japan also contends that the United States places too much weight on "direct evidence" in
assessing the risk of introducing fire blight with apple fruit.  If one considers also the "indirect"
scientific evidence, then Japan argues that there is evidence that contaminated apple fruit can go
through each of the steps necessary for it to eventually cause fire blight in the importing country.
8.75 Japan further argues that the US criteria of mature, symptomless apple fruit is ambiguous.
"Immature" and "mature" apples are not two cl early separate phenomena.  Japan contends that
maturation is a "continuous process".  Such an ambiguous concept is therefore, in the view of
Japan, unworkable.
8.76 Apple export data supplied by the United States are misleading, according to Japan.
Japan notes that the top ten markets for US apples have very different climatic conditions from
Japan (eight being found in the tropical region and the other two in desert climes).  As such, none
has favourable conditions for the establishment of fire blight, unlike Japan.
2. Approach of the Panel with respect to the review of the phytosanitary measure at
issue under Article 2.2 of the SPS Agreement
(a) Preliminary remarks: limitation of findings to whether the measure is maintained
"without sufficient scientific evidence"
8.77 Having reviewed the arguments of the parties, we note that the US claim regarding the
violation by Japan of Article 2.2 of the SPS Agreement  is limited to the allegation that theWT/DS245/R
Page 156
measure at issue is maintained "without sufficient scientific evidence".  We are therefore not
requested to identify a violation, or the absence thereof, of any other requirement of Article 2.2 of
the SPS Agreement , such as whether the phytosanitary measure is based on scientific principles,
even though these other requirements may be useful in understanding the extent of Japan's
obligations under that Article.  This said, it is essential to recall, as a first step of our analysis,what the parties must demonstrate in relation to this very specific aspect of Article 2.2.
8.78 In this respect, we should also be careful not to confuse the requirement that a measure is
not maintained without sufficient scientific evidence with the requirement of Article 5.6 of the
SPS Agreement  that the measure is "not more trade-restrictive than required to achieve [Japan's]
appropriate level of … phytosanitary protection".  In other words, while we might find that some
specific requirements of the measure at issue are not supported by sufficient scientific evidence,
our findings should be limited to Article 2.2.
(b) Determining whether the measure at issue is (or not) "maintained without sufficient
scientific evidence"
(i) Introduction
8.79 The relevant part of Article 2.2 of the SPS Agreement  reads as follows:
"Members shall ensure that any sanitary or phytosanitary measure … is not
maintained without sufficient scientific evidence, except as provided for in
paragraph 7 of Article 5."
8.80 First, we recall that, as mentioned above, Japan has argued that the measure would still be
justified under Article 5.7 of the SPS Agreement , even if it were found to be maintained without
sufficient scientific evidence.  We have already discussed the interrelation between Article 2.2and Article 5.7 in the section regarding our general approach to this case.  The arguments of
Japan regarding Article 5.7 will be addressed imme diately after this section.  At this stage, we
will address the claim made by the United States specifically under Article 2.2 of the SPS
Agreement , i.e., that Japan maintains the measure at issue without sufficient scientific evidence,
and Japan's arguments relating specifically to that provision.
8.81 Second, it is clear that we must determine in general whether the phytosanitary measure
at issue is maintained without sufficient scientific evidence.  However, before we can address the
evidence submitted by each party, it is necessary to identify what , in substance, needs to be
demonstrated.
8.82 Third, we will need to determine how parties can demonstrate their respective views.  We
note that the parties have extensively discussed the question of the evidence that may be
submitted in these proceedings.  In this respect, we note that the term "sufficient scientificevidence" contains a number of elements that need to be taken into consideration:
(a) First, the very notion of "scientific evidence" seems to exclude elements of
information that cannot be considered as "evidence".  The same notion also
seems to exclude any evidence that is not "scientific".
(b) Second, the term "sufficient" seems to address not only the quantity and quality
of the evidence as such, but also the "causal link" between the phytosanitaryWT/DS245/R
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measure at issue and the scientific evidence establishing a phytosanitary risk and
justifying the measure.
8.83 We will therefore need to address the question of (a) the nature of the evidence that may
be accepted and (b) the quality of the evidence to be accepted.
(ii) What needs to be demonstrated in substance?
8.84 We note that the approach followed by the United States in order to demonstrate that the
phytosanitary measure at issue is maintained without sufficient scientific evidence consists, in
substance, of trying to establish that there is no evidence that "mature, symptomless apples" have
introduced or could serve as a pathway for the entry, establishment or spread of  fire blight by
alleging that:
(a) There is no evidence that mature, symptomless apple fruit can be infected by
E. amylovora;
(b) there is no scientific evidence that mature, symptomless apples can be
endophytically249 infested by the bacteria;
(c) scientific evidence shows that presence of epiphytic250 bacteria is rare and limited
to apples harvested on or very close to blighted trees;  and
(d) there is no evidence that apples, even on those rare occasions that epiphytic
bacteria is present, can act as a pathway for the dissemination of fire blight.Indeed, such bacteria are unlikely to survive normal commercial handling,
storage and transport of fruit.  In addition, even if the infested apple is placed
near a suitable host that is receptive to an infection, there is no dispersal
mechanism or vector to allow movement of such bacteria from the fruit to that
host.
8.85 Japan, on the contrary, argues that:
(a) Fire blight can be harboured in or on mature, symptomless apple fruit;
(b) apple fruit is a possible pathway for the transmission of the disease;
(c) trans-oceanic dissemination of the disease has previously occurred;  and
(d) it must also protect itself against failures in the control systems of exporting
countries which could lead to the introduction of contaminated apples.
In the absence of any reliable quarantine inspection methods to detect fire blight in or on mature,
symptomless apples, Japan views a systems approach as necessary.
8.86 A first issue to consider is, therefore, whether there is sufficient scientific evidence,
within the meaning of Article 2.2 of the SPS Agreement , to support the view that "mature,
symptomless apple fruit" can harbour the bacteria causing fire blight.  If the United States were to
                                                     
249 See definition of endophytic and epiphytic, para. 2.10.
250 Idem .WT/DS245/R
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demonstrate that this is not the case, most of the restrictions imposed by Japan would not be
justified.
8.87 However, even if it were the case that mature, symptomless apples cannot be infected and
do not harbour endophytic or epiphytic populations of bacteria susceptible of transmitting fire
blight to a host plant in Japan, this may not exclude the possibility that fire blight-free applesbecome contaminated after they are harvested, nor does it exclude a risk of failure in the control
procedures which normally lead to the exportation of only "mature, symptomless apples".  This
consideration implies that we have previously established that apples other than "mature,
symptomless apples" could pose a higher risk and, thus, that we do not limit our analysis to
mature, symptomless apple fruit.
8.88 Conversely, even if the United States were to fail to demonstrate that there is not
sufficient evidence supporting the view that  mature, symptomless apples have introduced
fireblight or could serve as a pathway for the entry, establishment or spread of fire blight, this
would not, ipso facto , imply that the Japanese measure as a whole  is maintained with sufficient
scientific evidence.  We recall that this measure is composed of a number of elements all of
which Japan presents as indispensable in the framework of a systems approach.  If we were to
find that some of these elements are redundant, i.e., that their imposition in the context of thephytosanitary measure at issue is not justified as such in response to a scientifically established
risk, or that other elements of the measure already serve the same purpose, we may find that these
elements are maintained without sufficient scientific evidence.  Under such circumstances, the
measure as a whole, at least to the extent it includes those "redundant" requirements, would be
deemed to be imposed without sufficient scientific evidence.
8.89 In order to address this question, we will assess the following five elements:
(a) As a preliminary matter, whether the notion of mature, symptomless apple fruit is
scientifically supported and whether it is appropriate to restrict our examination
of the measure at issue to its application to mature, symptomless apples;
(b) whether mature apple fruit can be infected;
(c) whether endophytic bacteria may be found in mature apple fruit;
(d) whether mature apple fruit may harbour epiphytic bacteria;
(e) whether infested or infected apple fruit harbouring endophytic or epiphytic
bacteria can complete the fire blight transmission pathway, i.e. whether the
bacteria can survive commercial handling, storage and transportation and
whether, once it has entered Japan, it can transmit the bacteria to host plants at a
receptive stage (apple as a pathway).
(iii) How to demonstrate the existence or absence of sufficient scientific evidence?
- "Scientific evidence"
8.90 We note that previous cases have essentially dealt with the question of sufficient
scientific evidence.  In this case, however, both parties have addressed the question of the nature
of the evidence that should be considered.  The United States argues that evidence underWT/DS245/R
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Article 2.2 must be scientific, i.e. valid according to the objective principles of the scientific
method.  Circumstantial evidence should, in its view, be rejected.  Japan argues that the US
approach to "evidence", limited to "direct" evidence, is inappropriate.  In Japan's view, "indirect"
evidence should also be taken into account.  Japan defines "direct" evidence as "conclusive
scientific discovery", whereas "indirect" evidence would be, for instance, evidence that would
show the ability of contaminated apple fruit to go through each step of the pathway that couldeventually cause fire blight in the importing country.
8.91 Starting with the notion of "scientific" evidence, we do not see the positions of the United
States and Japan as fundamentally incompatible.  It seems to us that Japan refers to scientific
evidence when it points to both "direct" and "indirect" evidence.  The only difference between
"direct" and "indirect" evidence if we follow Japan' s view is, in a sense, the degree of relationship
of the evidence with the facts that Japan wishes to  demonstrate with this evidence.  In any event,
indirect evidence may be scientific, even if it does not directly prove the facts.
8.92 We consider that, in accordance with the general principles of interpretation of public
international law, we must give full meaning to the term "scientific" and conclude that, in the
context of Article 2.2, the evidence to be considered should be evidence gathered through
scientific methods, excluding by the same token information not acquired through a scientific
method.  We further note that scientific evidence may include evidence that a particular risk mayoccur (e.g., the entry, establishment or spread of the bacteria that causes fire blight disease) as
well as evidence that a particular requirement may reduce or eliminate that risk (e.g., the
effectiveness of chlorine treatm ent in eliminating the bacteria).
8.93 Likewise, the use of the term "evidence" must also be given full significance.
Negotiators could have used the term "information", as in Article 5.7, if they considered that anymaterial could be used.  By using the term "scientific evidence", Article 2.2 excludes in essence
not only insufficiently substantiated information, but also such things as a non-demonstrated
hypothesis.
8.94 We note that the parties and the experts have discussed the notion of "circumstantial
evidence".  In this respect, we recall the view  expressed by Dr Smith regarding the relevance of
"circumstantial evidence" as far as the study of fire blight is concerned:
"… fire blight is a well studied disease, much observed and so that there is a very
large body of direct evidence concerning fire blight.  The existence of this body
of direct evidence gives one a perspective in evaluating indirect evidence and in
judging and insofar as you cannot necessarily draw a sharp dividing line in
deciding whether circumstantial evidence is useful in trying to decide whether
what is the risk of a certain scenario.  In plant health it is important to keep one'sfeet on the ground, to consider the direct evidence first and to evaluate
conjectural scenarios rather carefully in relation to what is really known about,
for example, fire blight.  We live in a world now in which various risks have
been recently identified - risks of the entry of alien species from other continents,
risks of the movement of living modified organisms - where there is little directevidence and most of the evidence that has to be used is of a circumstantial kind.
Where there is no direct evidence, it is not possible to use it as a kind of
counterweight in one's judgements.  But in plant health there is direct evidence.WT/DS245/R
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A lot of work has been done and it does assist one in making judgements in
relation to evidence which is less certain."251
8.95 We find that this statement supports, in this particular case, an approach that favours
relying on scientifically produced evidence rather than on purely circumstantial evidence.  At the
very least, Dr Smith's statement suggests that, in the case of fire blight, any circumstantialevidence should be considered in the light of the substantial body of scientific evidence already
available.
8.96 We do not believe that our approach is overly restrictive or that it could lead to the sort of
scenario suggested by Japan, where a Member could only protect itself against known, well
established dissemination pathways.
8.97 First, our approach is consistent with the structure of the SPS Agreement , which allows a
Member to invoke Article 5.7 when it does not yet have "sufficient scientific evidence", and inthose circumstances to rely on "available pertinent information".  We recall in this respect that the
Appellate Body stated that:
"Article 5.7 operates as a qualified  exemption from the obligation under 2.2 not
to maintain SPS measures without sufficient scientific evidence.  An overly
broad and flexible interpretation of that obligation would render Article 5.7meaningless."
252
8.98 Second, requiring "scientific evidence" does not limit the field of scientific evidence
available to Members to support their measures.  "Direct" or "indirect" evidence may be equally
considered.  The only difference is not one of scientific quality, but one of probative value within
the legal meaning of the term, since it is obvious that evidence which does not directly prove afact might not have as much weight as evidence directly proving it, if it is available.
8.99 On the basis of the above, we conclude that:
(a) We will consider all relevant evidence that can be considered "scientific",
and do not exclude a priori  that "indirect" evidence may be pertinent to our
assessment, provided that it is scientific in nature;
(b) This is without prejudice to the probativ e value to be ascribed to each piece
of evidence in the course of our assessment.
- "Sufficient" scientific evidence
8.100  The requirement that a measure not be maintained without sufficient scientific evidence
has been addressed by panels and by the Appellate Body in other cases.  Therefore, we find it
appropriate to consider from the outset the conclusions they reached to the extent that they have
already clarified the meaning of the terms in which we are interested.  Indeed, reports adopted bythe DSB have discussed the meaning of those provisions in accordance with the general
principles of international law regarding the interpretation of treaties – as set out in Articles 31 to
                                                     
251 Transcript from Panel meeting with experts of 13 January (afternoon) and 14 January
(morning) 2003 (hereafter Annex 3), para. 338.
252 Appellate Body Report in Japan – Agricultural Products II , para. 80 (emphasis in the original).WT/DS245/R
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33 of the Vienna Convention on the Law of Trea ties – pursuant to Article 3.2 of the DSU.
Therefore, we see no reason to perform the same analysis again if it is not necessary.  We further
interpret the provisions of Article 2.2 of the SPS Agreement  only to the extent that their meaning
has not been fully clarified in previous adopted reports, as was the case for the terms "scientific
evidence".
8.101  We first note that the meaning of the term "sufficient" in the expression "sufficient
scientific evidence" has been addressed by the Appellate Body in Japan – Agricultural
Products II  as follows:
"The ordinary meaning of 'sufficient' is 'of a quantity, extent, or scope adequate
to a certain purpose or object'.  From th is, we conclude that 'sufficiency' is a
relational concept.  'Sufficiency' requires the existence of a sufficient or adequate
relationship between two elements, in casu , between the SPS measure and the
scientific evidence."
…
"The context of the word 'sufficient' or, more generally, the phrase ‘maintained
without sufficient scientific evidence in Article 2.2, includes Article 5.1, as well
as Articles 3.3 and 5.7 of the SPS Agreement."
8.102  When addressing the meaning of the term "sufficient", we thus enter the realm of the
relationship between the phytosanitary measure at issue and the "scientific evidence" relating to
the risk that the phytosanitary measure is supposed to address.  An adequate relationship  is thus
required between the restriction on imports of apples applied by Japan and the relevant scientific
evidence.  Such an adequate relationship would not be satisfied in a situation where only patent
insufficiency  would be considered as not "sufficient".253
8.103  It should be recalled that the adequate relationship between the SPS measure and the
scientific evidence requires "a rational or objective relationship".  As recalled by the Appellate
Body,
"Whether there is a rational relationship between an SPS measure and the
scientific evidence is to be determined on a case-by-case basis and will dependupon the particular circumstances of the case, including the characteristics of the
measure at issue and the quality and quantity of the scientific evidence."
254
8.104  From the above, it appears that the term "sufficient" is clearly to be considered in relation
to the phytosanitary measure itself.  This said, we should not leave aside the fact that scientific
evidence relates to a risk and is supposed to confirm the existence of a given risk.  In the present
case, the United States denies that mature, symp tomless apple fruit carry the risk of transmitting
fire blight.  The United States also argues that there would be possibilities to successfullyeradicate fire blight, as suggested by the experience of Norway and Australia, if it were
introduced by accident into Japan.  Japan disputes this contention and identifies a series of risks
that are ignored by the United States: contamination of mature, symptomless apples;
contamination of crates; inclusion by mistake of a contaminated apple in an otherwise healthy
                                                     
253 Appellate Body Report in Japan – Agricultural Products II , para. 82.
254 Appellate Body Report in Japan – Agricultural Products II , para. 84.WT/DS245/R
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consignment bound for Japan, transfer of bacteria by birds or insects and, ultimately, the risk of
introduction of fire blight on a territory which is, for the moment, free from it.
8.105  However, neither party denies the ecological and economic impact that the introduction
of fire blight could have in Japan.  Under those circumstances, we should, when determining the
weight of the evidence before us, "bear in mind that responsible, representative governmentscommonly act from a perspective of prudence and precaution when risks of irreversible …
damages … are concerned".
255
8.106  Japan argues that, in order for the United States to establish a prima facie case under
Article 2.2, it has to positively prove the "insufficiency" of scientific evidence.  The United States
claims that there is simply no scientific evidence supporting the measure at issue.  Under these
circumstances, and in application of the reasoning of the Appellate Body in Japan – Agricultural
Products II , we consider that the United States should raise a presumption that there are no
relevant  scientific studies or reports in order to demonstrate that the measure at issue is not
supported by sufficient scientific evidence.256  If Japan submits elements to rebut that
presumption, we would have to weigh the evidence before us.
8.107  Japan also argues that we should take into account the requirements of Article 4 of the
SPS Agreement  when considering whether the measure at issue is supported by sufficient
scientific evidence.  We agree that other provisions of the SPS Agreement  are part of the context
of Article 2.2, as recalled by the Appellate Body in Japan – Agricultural Products II .257
However, Article 4 deals with the specific question of the recognition of equivalence of measures.
Unlike Articles 3.3, 5.1 and 5.7, the purpose of Article 4 is clearly different from that of
Article 2.2.  We also note that the United States did not raise any claim under Article 4 and thatthis Article is not a defence against violations of other provisions of the SPS Agreement .  As a
result, we see no reason to consider Japan's arguments regarding Article 4 in our assessment of
Article 2.2, other than to the extent that Article 4 might form part of the relevant context in the
interpretation of Article 2.2.
8.108  On the basis of the above, we conclude that:
(a) The United States should raise a presumption that there are no relevant
scientific studies or reports supporting the measure at issue in order to
demonstrate that the measure at issue is not supported by sufficient
scientific evidence.  If Japan submits elements to rebut that presumption, we
would have to weigh the evidence before us.
(b) There is no reason to consider Japan’s arguments regarding Article 4 in our
assessment of Article 2.2, other than to the extent that Article 4 might formpart of the relevant context in the interpretation of Article 2.2.
                                                     
255 Appellate Body Report in EC – Hormones , para. 124.
256 Appellate Body Report in Japan – Agricultural Products II , para. 137.
257 Appellate Body Report in Japan – Agricultural Products II , para. 74.WT/DS245/R
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3. Preliminary question: the relevance and consequences of the notion of "mature,
symptomless" apple fruit in the assessment of the phytosanitary measure at issue
under Article 2.2
(a) Summary of the arguments of the parties258
8.109  The United States argues that the product it exports to Japan is "mature, symptomless
apple fruit".  It adds that there is a long established scientific, commercial and horticultural basisfor the use of the concepts of physiological and commercial maturity.  In the US view, this
distinction is relevant because mature fruit, unlike immature fruit, is not susceptible to
contamination by E. amylovora  and cannot host or develop fire blight.
8.110  Japan challenges the concepts of "mature" and "symptomless" apples.  Japan argues that
the concept of maturity is inherently subjective and that there is an ambiguity in using it, since
"physiological maturity" and "commercial maturity" should be distinguished.  Japan considers
that maturity is a continuing process.  Japan is of the view that endophytic bacteria found inphysiologically immature apples are likely
259 to survive until "commercial maturity" in light of
the ecology and other known properties of the bacteria.  Japan adds that close-to-mature apples
have been found to harbour E. amylovora  and even display signs of serious infection, such as
bacterial ooze.  Japan also claims that the United States has not submitted any scientific
explanation for the fact that the bacteria E. amylovora  can be found in close-to-mature apples, but
allegedly not in mature apples.
(b) Analysis of the Panel
(i) Introduction
8.111  When discussing the product at issue in this case in paragraphs 8.26-8.34 above, we
considered that we could not prejudge our conclusions by unduly restricting, from the outset, thescope of our findings to mature, symptomless apple fruit.  In the context of Article 2.2 we
consider that the discussion of the parties raises two main issues: one is the relevance of the
concept of "mature, symptomless" apple in terms of risk of fire blight transmission; the second is
the risk related to apples other than mature, symptomless apples, such as immature or damaged
apples.
8.112  If we find that there is pertinence in differentiating "mature, symptomless" apples from
other apples (e.g. immature or damaged apples), we will proceed with a specific analysis of the
risks attached to each category.
(ii) Mature, symptomless apples v. other apples
8.113   We note that the experts commented, at our request, on the concept of maturity and
whether a naturally infected apple could develop into a healthy looking fruit.
260  Regarding the
concept of maturity, Dr Hale confirmed that there were accepted definitions for determining if anapple fruit is physiologically and commercially mature.  An apple will be deemed to be
physiologically mature when it reaches the point at which, if picked, it will ripen.  If an apple is
                                                     
258 A detailed account of the arguments of the parties can be found in paras. 4.90-4.102 and 4.192-
4.198 of this Report.
259 Japan second submission, 13 November 2003, para. 27.
260 Paras. 6.5-6.10.WT/DS245/R
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not mature at the time it is harvested, then it will not ripen.  It will shrivel and be unacceptable.261
Maturity assessment includes colour, starch index, soluble solid content, flesh firmness, acidity,
and ethylene production rate.  Dr Hayward stated that there were objective methods for the
determination of the maturity of apples which formed the basis of the OECD international
guidelines.262  For Dr Hayward, as for Dr Hale, an apple fruit was physiologically mature when it
was at the stage of development where, even when detached, it continued to develop and ripen.263
Having regard to the evidence submitted by the parties and the opinions of the experts consultedby the Panel, we consider that the concept of maturity is relatively well defined as the moment
when the apple fruit is at a stage where it will ripen even if detached from the tree.  We conclude
from this that it is scientifically possible to differentiate between mature and immature apples.
8.114  However, the experts noted that maturation was a continuous process.
264 We understand
from the opinions of the experts that they considered  this issue to be relevant with regard to the
susceptibility  of the apple to fire blight.  Dr Smith agreed with Dr Geider that whatever made an
immature apple permissive to the introduction of the bacteria did not necessarily have much to do
with what later made it physiologically mature or commercially mature.265  According to these
experts, it is clear that very young apples are susceptible to E. amylovora,  but that by the time
they have reached commercial maturity, they are no longer susceptible.  At some point inbetween immaturity and commercial maturity, they lose that susceptibility.
266
8.115  As a result, we consider that the differentiation between mature and immature apples is
relevant in terms of the risk of contamination of the fruit.
8.116  We also note that the experts  stated that fruits infected at fruitlet level would not develop
into healthy looking fruit.267  Dr Geider considered that a dormant persistence of E. amylovora  in
fruit was not documented and was difficult to demonstrate.268  Naturally infected fruits would be
small, shrivelled, might show some lesions, and would not mature.  Consequently, they were
highly unlikely to develop into healthy-looking  fruit.269  In addition, when natural infections
occur at an advanced growth stage in apples, e.g. as a result of hailstorms, the apples begin to rot
and ooze (exudate).270
8.117  The experts did indicate that if the bacteria remained confined to the outside of the fruit,
including in the calyx at the blossom end, a healthy looking fruit could develop.  However, none
of the experts reported knowing of any scientific studies where the bacteria on the surface of the
fruit or harboured in the calyx had ever infected the inside of the apple. Likewise, attempts to
develop infection by cutting the pedicel of the apple and placing a large quantity of E. amylovora
on the cut pedicel failed to convincingly demonstrate infection of the inside of the apple.271
                                                     
261 Para. 6.5.
262 Para. 6.6.
263 Ibid.
264 Annex 3, Dr Hale, para. 91.
265 Annex 3, Dr Geider, Dr Hale, Dr Smith, paras. 89, 91, 95.
266 Annex 3, Dr Smith, para. 95.
267 For the purpose of this case, the terms "symptomless" and "health-looking" will be used
indifferently.
268 Para. 6.7.
269 See also, Dr Hale, para. 6.8.
270 Dr Geider, para. 6.7.
271 Annex 3, Drs Geider, Hale, Hayward, Smith, paras. 178, 180, 181, 182.WT/DS245/R
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8.118  As a result, we consider that the concept of "symptomless" is also scientifically pertinent.
Indeed, insofar as dormant persistence of E. amylovora  has not been documented, any infection is
very likely to be visibly identifiable.
(iii) Relevance of addressing the risks related to both mature, symptomless apples and other
apples
8.119  The above discussion tends to suggest not only that mature, symptomless apples may
present a low risk of acting as an effective pathway, but also that apples other than mature,
symptomless apples may carry a higher risk in terms of contamination.  We recall that Annex A,
paragraph 1 of the SPS Agreement  defines as a phytosanitary measure "any measure applied to
protect plant life or health within the territory of a Member from risks arising from the entry,
establishment or spread of pests, diseases, disease-carrying organisms or disease-causing
organisms."  This definition does not limit the scope of application of phytosanitary measures to
the product that the exporting country claims to export.  In order to be effective, a phytosanitarymeasure should cover all forms of a product that may actually be imported.
8.120  We recall in this respect that in EC – Hormones , the Appellate Body considered it
legitimate for the European Communities to consider not only the scientific risks  arising from the
ingestion by human beings of residues of hormones in meat, but also the closely related risks
arising from the failure to observe the requirements of good veterinary practice in theadministration of hormones for growth promo tion purposes, in combination with multiple
problems relating to the detection and control of such failure.
272  We recognize that the Appellate
Body expressed this view in the context of a risk assessment under Article 5.1 and 5.2.  However,
we first note the central role of Article 5.1 in the SPS Agreement.273  Second, the following
statement of the Appellate Body is, in our view, indicative of a general application of thisprinciple under the SPS Agreement :
"We consider that the object and purpose of the SPS Agreement  justify the
examination and evaluation of all such risks for human health, whatever their
precise and immediate origin may be."
274
8.121  Under those circumstances, it seems to us legitimate to consider all the aspects referred to
by Japan in relation to the importation of apples from the United States, including
                                                     
272 Appellate Body Report in EC – Hormones , para. 205.
273 See Appellate Body Report in EC – Hormones  para. 180, where the Appellate Body mentioned
that:
"180. At the outset, two preliminary considerations need to be brought out.  The first is that the
Panel considered that Article 5.1 may be viewed as a specific application of the basic obligations
contained in Article 2.2 of the SPS Agreement160, which reads as follows:
Members shall ensure that any sanitary or phytosanitary measure is applied only to the
extent necessary to protect human, animal or plant life or health, is based on scientific
principles and is not maintained without sufficient scientific evidence , except as provided
for in paragraph 7 of Article 5.  (underlining added)
We agree with this general consideration and would also stress that Articles 2.2 and 5.1 should
constantly be read together.  Article 2.2 informs Article 5.1:  the elements that define the basic
obligation set out in Article 2.2 impart meaning to Article 5.1."
274 Appellate Body Report in EC – Hormones , para. 206.WT/DS245/R
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human/technical errors in the sorting of apples or illegal actions which would lead to the
importation of infested/infected apples.275
8.122  On the basis of the above, we conclude that  it is not only useful, but also relevant to
differentiate, in our assessment of the evidence regarding transmission of the disease,
between the risks related to physiologically mature and apparently healthy apple fruit onthe one hand, and the risks related to other apples (immature, mature but damaged) on the
other hand, even if the latter may only ac cidentally enter the territory of Japan.
4. Infestation and infection
276 of mature, symptomless apple fruit
(a) Infestation
(i) Endophytic bacteria
8.123  According to the United States, numerous studies indicate that mature, symptomless
apple fruit do not harbour endophytic populations of the bacteria, even when harvested fromblighted apple trees.  These results reflect the biol ogy of the disease.  Apples infected with the
bacteria do not mature.  Immature apples may contain detectable levels of endophytic fire blight,
but mature, symptomless apples would not harbour internal populations of bacteria.  Van der
Zwet et al.  (1990), on which Japan relies, did not distinguish between immature and mature
fruits.  The United States further argues that the attempt to recover endophytic bacteria byTsukamoto et al.  (2003) was not successful.
277  The preliminary results showed that E. amylovora
had not been found.  The study did not provide additional information with respect to steps in
Japan's hypothetical pathway, which experts have concluded could not be completed.
8.124  Japan argues that the United States only demonstrated that risk may not be present in
certain, limited circumstances.  The bacteria is capable of surviving in varying conditions.  Inaddition, Japan, relying on van der Zwet et al.  (1990), argues that endophytic E. amylovora  had
been found in mature apple fruit.  Such findings were confirmed by Roberts et al.  (1998).  Japan
argues that the United States has not explained how endophytic E. amylovora  could be found in
close-to-mature apples and disappear in the few days or weeks before maturation.  Japan also
recalls that Tsukamoto et al.  (2003) have conducted experiments to clarify the ability of
E. amylovora  to invade and multiply through the pedicel (stem).
278
                                                     
275 However, since the importation of immature, infected apples may only occur as a result of a
handling error or an illegal action, we address the question of the contamination only in relation to thecompletion of the pathway.
276 In para. 6.8 above, Dr Hale stated that it was important to make a distinction between infected
and infested fruit.  Infected fruit were diseased  whereas infested fruit were contaminated with E. amylovora
but not diseased. See also Dr Smith, para. 6.10, who defined infection as meaning not just the presence of
bacteria, but an active process of pathogenesis.  Dr Hayward, Annex 3, para. 67: "if I can quote definitionsgiven in a guide to the terms in use in plant pathology:  'Infection is the entry of an organism or virus into ahost, the plant, and the establishment of a permanent or temporary parasitic relationship'. Whereasinfestation means, or to infest:  'To overrun the surface of a plant.  When used in reference to micro-organisms or virus particles on plant surfaces, there is  no implication that infection has occurred."  As
indicated in para. 2.15, the Panel will use the definition used by the experts.
277 Exhibits JPN-39 and JPN-42.
278 Ibid.WT/DS245/R
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8.125  We note that the views of the experts on this question is that there is no evidence that
mature apple fruit will harbour endophytic bacteria.279  Dr Smith added that a few papers
described endophytic bacteria, but the experts consulted by the Panel were not convinced by
those descriptions.280
8.126  The experts consulted by the Panel also stated that E. amylovora did not occur as an
endophyte in healthy-looking mature fruit.281
8.127  Based on the scientific evidence available to us in these proceedings, we note that the
observation of the existence of endophytic populations in mature apple fruit is based essentially
on one single study whose findings in this respect are not clear and are disputed:  van der Zwet et
al. (1990).282  That study, although it recorded the isolation of E. amylovora  from harvested fruit,
did not specify the degree of maturity of the fruit or whether it was symptomless or not.283  The
study also appeared to report in a single paper different series of experiments in different
locations and conditions, and not to contain a sufficiently precise description of the conditions ofthe experiment to allow for a precise conclusion to be drawn from them.
284  This in itself made its
conclusions relatively confused, difficult to interpret or even unconvincing, as was suggested by
the experts consulted by the Panel.285  Furthermore, clarifications sought by the United States
from the main authors of this study cast further doubt on conclusions that  E. amylovora was
found inside commercially mature fruit.286  The Roberts et al. (1998) study cited by Japan simply
reports on the findings in van der Zwet et al.  (1990) and does not report on any new evidence in
this regard.  The fact that van der Zwet collaborated in Roberts et al. (1998) does not, in our view,
affect the conclusion drawn from the experts' vi ews and the author's comments of 16 July 2002.
8.128  We therefore conclude, on the basis of the information made available to the Panel,
that there is not sufficient scientific evidence to conclude that mature, symptomless appleswould harbour endophytic populations of bacteria.
(ii) Epiphytic bacteria
8.129  The United States claims that a review of the scientific literature suggests that the
presence of epiphytic bacteria on mature, symptomless fruits at harvest is extremely rare.  In
those few instances where external bacteria had been detected, the fruit had been harvested fromor within 10 meters of an infected tree in severely infected orchards.  The United States concludes
that in most cases, mature, symptomless apples, even when harvested from infected trees or
orchards, would not be externally contaminated with fire blight bacteria.
8.130  The United States also argues that the biology of the fire blight bacteria and the disease
cycle is such that the bacteria shows a decline in population counts as the season advances and
                                                     
279 Annex 3, paras. 28, 29, 54, 57, 59, 63, 75, 76,  80, 82, 83, 360-363.  See also paras. 6.72-6.75.
280 Annex 3, para. 363.
281 Paras. 6.15-6.19 and  6.72-6.75; Annex 3, paras. 59, 76 and 82.
282 Paras. 6.72-6.75.
283 Annex 3, Dr Smith, para. 53.
284 Dr Smith and Dr Geider, Annex 3, paras.54, 56, 57.
285 Dr Hale and Dr Smith, paras. 6.77-6.79, 6.81-6.84, 6.86-6.87 and 6.89, respectively.
286 We note that while these declarations confirm ou r conclusion that the results of this study are
unclear, our conclusions in this respect are not dependent on them.WT/DS245/R
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the conditions turn less hospitable, becoming extremely rare on fruits at the time of harvest.  The
scientific evidence indicates that bacteria on the surface of fruits die within a short time.287
8.131  Japan does not agree with the conclusion that the external presence of the bacteria is
extremely rare.  Japan refers to Sholberg et al.  (1988) to claim that E. amylovora  may be present
on symptomless fruit at harvest under certain conditions.
8.132  In this regard, we note Dr Hayward's remark that Sholberg's study showed susceptibility
only when apple trees were inter-planted with heavily infected pear trees288 and that the very
different management practices pertaining to apple and pear fruit apparently preclude
interplanting of the two crops.289
8.133  The United States argued that mature apples will rarely harbour epiphytic bacteria, even
when harvested in heavily blighted orchards.
8.134  We recall that the experts did not exclude that bacteria could be found on the surface of
apples in heavily infected orchards.290  They also observed that epiphytic bacteria could result
when early infection of blossoms did not lead to the development of fire blight and some of the
bacteria remained confined in the calyx.  Some of the experts questioned whether these surface or
calyx populations could be considered as real epiphytic populations capable of transmitting fire
blight.  Indeed, "epiphytic" implied that the bacteria could persist and even reproduce at lowlevels over a period of weeks or months, which did not seem to be the case with surface
E. amylovora .
291
8.135  We note in this regard that the experts concurred in considering that even apples
harvested very close to sources of inoculum did not harbour large populations of epiphytic
bacteria.292
8.136  We therefore conclude, on the basis of the information made available to the Panel,
that there is not sufficient scientific evidence to conclude that mature, symptomless apples
are likely to harbour epiphytic populations of bacteria capable of transmitting
E. amylovora .
(b) Infection
8.137  Japan argues that there could exist mature, apparently healthy, but infected fruits.  The
United States claims that scientific evidence shows that mature apples cannot be infected.
8.138  We note that the information before the Panel tend to demonstrate that it is unlikely that a
mature apple will be infected.  If an immature apple is infected, it will not develop into a mature,
healthy-looking fruit.  If it does, then it is likely that the bacteria will not have developed.293  The
                                                     
287 Dr Hayward, para. 6.36, Dr Hale, para. 6.121,  Dr Hayward, para. 6.122, Dr Smith, para. 6.123.
288 Annex 3, Dr Hayward, para. 205.
289 US answers to Additional Questions from the Panel, 28 January 2003, para.44.
290 Dr Hale, paras. 6.24-6.25 and 6.113-6.114
291 Dr Smith, paras 6.18-6.19.
292 Para. 6.17; Annex 3, paras. 364-367;  see also paras. 223-236.
293 Dr Smith, paras. 6.10 and 6.19.WT/DS245/R
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experts consulted by the Panel have also agreed that there was no scientific evidence that a
mature harvested apple fruit will be subsequently infected.294
8.139  We therefore conclude, on the basis of the information made available to the Panel,
that mature apples are unlikely to be infected  by fire blight if they do not show any
symptoms.
5. Risk of entry, establishment or spread of fire blight within Japan by imported US
apple fruit (apple fruit as a pathway)
(a) Introduction
8.140  The United States argues that not only is there no evidence that mature, symptomless
apples have ever spread fire blight, but there is  also no evidence that mature fruit could be a
pathway for the spread of the bacteria.  The evidence concerning infestation and infection of
mature apples does not support Japan's proposed pa thways.  Japan contends that pathways may or
may not be direct;  contaminated cargo crates were a possibility, as was propagation from fruit toother plants in the environment.
8.141  The parties and experts have primarily discussed the risk of transmission by mature
apples, because this is the commodity normally exported and on which scientific experiments
have been performed.  However, for the reasons mentioned above, we also find it necessary to
assess the risk of transmission through apples other than mature, symptomless apples:  essentiallyimmature, infected or infested apples.
8.142  Since we have reached the conclusion that infection of mature apples has not been
established, that populations of endophytic bacteria have not been found in mature apples and that
ephithytic bacteria populations are very rare, we need to address at this stage only the two last
steps of the pathway for fire blight transmission:  (a) the survival of the bacteria throughcommercial handling, storage and transportation;  and (b) the existence of a vector permitting the
contamination of a host plant in Japan by the imported apple.
8.143  We are mindful of the indirect pathways suggested by Japan.  However, with the
exception of the contamination by blighted apples of crates subsequently re-used in Japan, we
consider that they are all dependent on the existence of a vector allowing the contamination of ahost plant by an imported apple once in Japan.  With respect to indirect contamination by infested
or infected cargo crates, we consider that the evidence before us does not support the opinion that
they could operate as a vector of transmission.  On the contrary, the evidence shows that E.
amylovora  is not likely to survive on crates. 
295
(b) Mature, symptomless apple fruit
8.144  The United States argues that the scientific literature reveals that there is no evidence that
mature, symptomless apple fruit ever transmitted fire blight disease, i.e. provided  inoculum foran outbreak of fire blight.
296  The risk is, according to the aut hors, "negligible", "unlikely", "very
remote", "insignificant", "extremely low" or "ext remely unlikely".  The United States considers
that by describing the risk of transmission as "negligible" rather than "zero", the scientific reports
                                                     
294 Annex 3, paras. 355, 356, 357, 358.
295 Paras. 6.26, 6.32-6.35, 6.166-6. 169, Annex 3, Dr Smith, para. 241.
296 Exhibits USA-4; USA-5; USA-28; USA-42.WT/DS245/R
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merely reflected "the uncertainty that theoretic ally always remains [that an event may occur]
since science can never provide absolute certainty" that an event may never occur.297  Both the
panel and the Appellate Body in EC – Hormones  concluded that theoretical uncertainty is not the
kind of risk which a risk assessment and, therefore, an SPS measure, is to address.298
8.145  The United States argues that it is not established that the four instances identified of
trans-oceanic dissemination of fire blight were attributable to apple fruit.299  Indeed, in relation to
one of these, it disputes that it even constitutes a case of trans-oceanic dissemination.
8.146  Japan argues that there is no ecological study available on the possible dissemination of
fire blight via apple fruit.  Japan argues that, as a matter of common sense, it could be envisaged
that E. amylovora  could be transmitted to nearby host plants, either by way of rain, wind, insects,
etc.  Once such fruit was introduced into Japan, the bacteria would be exposed to its environment
at all the stages of distribution, storage, consumption and disposal of the fruit, causing a real riskof dissemination.
300  Japan adds that there is no scientific evidence documenting trans-oceanic
dissemination.  The absence of evidence attributing the cause to apple fruit does not demonstrate
that the bacteria was transmitted only via budwood or nursery stock.  This indirect or
circumstantial evidence, together with van der Zwet et al.  (1990), suggests a risk that endophytic
E. amylovora  in fruit could survive trans-oceanic shipment and later cause fire blight in foreign
destinations.
8.147  In light of the elements before us in these proceedings, we conclude that there is scientific
evidence suggesting that epiphytic bacteria could be found on mature, symptomless apples.
However, the number of apples contaminated with epiphytic bacteria in severely blighted
orchards has been found to represent a very small percentage301 and it is not clear whether this
form of bacteria could actually transmit the disease to a host, in other words, whether the
successive steps of the pathway could be completed.302  In fact, Dr Hale and others reported that
large-scale experiments to cause infection via surface and calyx-infested fruits had all been
unsuccessful.303 We note in this respect that in its risk assessment under Article 5.1, Japan itself
failed to clearly identify transmission pathways for apples.304
8.148   Japan also insists on the resilience of the bacteria and its capacity for rapid reproduction.
However, the experts consulted by the Panel have expressed doubt on this matter and contested
the notion that the bacteria is actually that resistant.305  E. amylovora  does not seem to be capable
of surviving the competition with other bacteria  involved in the apple decomposition process.306
                                                     
297 The United States refers to the Appellate Body Report in EC – Hormones (United States),
para. 186.
298 Appellate Body Report in EC - Hormones (United States),  para. 186; Panel Report  in EC -
Hormones , paras. 8.152-8.153.
299 Paras. 4.68-4.72.
300 Exhibit JPN-14.
301 Annex 3, Dr Hale, para. 202.
302 Paras. 6.69-6.71.
303 Annex 3, Dr Hale, para. 238;  paras. 364-381;  see also para. 6.101, Exhibits JPN-8 and JPN-
29.
304 See section F.2 below.
305 Paras. 6.36, 6.108-6.111, 6.124-6.127.
306 Paras. 6.71, 6.109-6.111.WT/DS245/R
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8.149  Drs Geider, Hale, Hayward and Smith categorically stated that there was no evidence to
suggest that mature apple fruit had ever been the means of introduction (entry, establishment and
spread) of fire blight into an area free of the disease.307  The experts further agreed that the
historic and scientific evidence suggested that the likelihood of fruit being a pathway for
introduction of fire blight was negligible.308  Dr Hayward indicated that the standard scientific
definition of "negligible" was a likelihood of between zero and one in one million.309  I n  D r
Smith's view, "not only was there no evidence that fruits had ever introduced fire blight to an
area, but there was also no necessity to invoke such an improbable pathway since there were
much more probable alternatives".310  Dr Geider explained "new establishment of the disease by
other than sequential distribution was so rare that it was not possible to conduct ecological
studies".311
8.150  We also note the comment of Dr Geider that in his view, the highest risk of fire blight
contamination is from travellers to Japan bringing in contaminated plants or fruits which are notlikely to be detected by phytosanitary controls.
312
8.151  We note, however, that Dr Geider has expressed the view that apples should not be
exported if they were picked from a fire blighted orchard, so as to avoid the probably very low
risk of accidental contamination.313 He added that it was not advisable for phytosanitary reasons
to export apples picked in orchards with severe fire blight, although such apples might beharmless as regards disease distribution.
314
8.152  We also note that many factors can interfere in the transmission process described by
Japan, and we are mindful that, as recalled by the experts, it may be very difficult to
experimentally replicate all possible pathways and combinations of circumstances and thus
exclude categorically all possibilities of transmission.
8.153  We conclude from these elements that the scientific evidence presented to the Panel
show that, with respect to mature, symptomless apple fruits, the risk that the transmission
pathway be completed is "negligible".  Nevertheless, the experts consulted by the Panel,
while firmly considering that transmission by mature apple fruit is unlikely, suggested, inter
alia, that apples from severely blighted orchards (the only documented situation of
relatively heavy infestation of mature apples) not be exported.
(c) Apples other than "mature, symptomless apple fruit"
(i) Capacity of infected apple fruit to serve as pathway
8.154  We have already concluded above that the risk that mature, symptomless apple fruit be a
vector for the entry, establishment or spread of fire blight within Japan is negligible, even if
infested with epiphytic E. amylovora .  We understand Japan’s argumentation to imply that an
infected apple could serve as a vector for the entry, establishment or spread of fire blight within
                                                     
307 Paras. 6.20-6.23.
308 Paras. 6.37-6.40, also Annex 3, paras. 382-385.
309 Annex 3, para. 332.
310 Para. 6.31.  The most probable route identified by the experts was the entry of  infected
planting materials.
311 Para. 6.61.
312 Annex 3, paras. 263, 398 and 431.
313 Para. 6.42.
314 Para. .6.112.WT/DS245/R
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Japan.  We note that the United States did not claim that infected apples would not act as a
pathway.  As we have mentioned above, the US position in this case is that it exports only
mature, symptomless apple fruit to Japan.  Even though the United States did not submit evidence
regarding transmission of fire blight through immature apple fruit, it argues that the pathway is
unlikely to be completed.  Having regard to the arguments of the parties, it is necessary todetermine, even before we proceed to address the possibility of an error or illegal action, whether
there is a more than theoretical possibility that  infected apple fruit could be a vector for the
introduction of fire blight into Japan.
8.155  According to the experts, the primary conditi on for transmission of fire blight is heavy
contamination, either on the surface
315, or internally, in order for the bacteria to survive through
all the various steps in a sufficiently large number to be capable of later contaminating a host
plant or fruit.  However, this does not mean that large numbers of bacteria are necessary tocontaminate a host plant.
316
8.156  The information before the Panel relates esse ntially to mature apples.  Immature apples
are hardly ever used in scientific experiments.  We have noted that most of the obstacles to the
survival of the bacteria and, later, the contamination of a host plant referred to by the experts
relate to the progressive disappearance of bacteria capable of reproducing and contaminating ahost plant (lengthy storage in cold but humid conditions
317, handling, limited capacity of
E. amylovora  to compete in a hostile bacterial envi ronment, such as in decaying fruit or
unsterilized soil).  We recall, however, the prudence expressed by the experts regarding the
exportation of apples harvested in blighted orchards.  Under these circumstances, if survival of
epiphytic bacteria on mature apples throughout their commercial handling, transportation andstorage cannot be totally excluded, a fortiori , survival in an infected,  immature apple of most
probably much larger quantities of bacteria is possible too.  We note in this respect the comment
of Dr Smith that "a conceivable short-cut [to contamination through epiphytic populations
harboured by mature, symptomless apples] might o ccur if fruits became internally infected and
these fruits were not detected.  If this ever happened (which is debatable), then there was astronger possibility that viable bacteria remained in the fruit during storage and shipping".
8.157  We therefore conclude that infected apples are capable of harbouring populations of
bacteria which could survive through the various stages of commercial handling, storage
and transportation.
(ii) Error of handling and illegal action
8.158  Japan further argues that the risk of accidental contamination or erroneous grading is very
real, and cites as an example the recent report of codling moth being found in a shipment of USapples to Chinese Taipei.
318
8.159  The United States argues that fruit for export are subject to multiple human and machine-
based examinations, which along with the strict grading requirements it applies, make it
extremely unlikely that immature fruit would be exported.  Furthermore, the United States
                                                     
315 Dr Geider, para. 6.68, Dr Hale, para. 6.69, Dr Smith, para. 6.71.
316 Dr Geider, Annex 3, para. 235.
317 Annex 3, paras. 208-216.
318 Para. 4.191.WT/DS245/R
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contends that Japan's current measures do not counter the "unestablished and hypothetical" risk of
accidental or intentional shipment of immature, infected fruit.319
8.160  We recall that the Appellate Body in EC – Hormones  deemed consideration of the risk of
error of handling or of illegal action legitimate in the SPS context. 320  We note that in this case
too, the experts have admitted the possibility of an error of handling.  The Panel recalls the
comments by Dr Smith that:
"… people often suppose that inspection is  efficient, 100 per cent efficient even,
at a given moment.  Sometimes, in special cases, it is.  There are some pests
which you can be certain to find when you examine an infested item, but this is
exceptional.  In plant quarantine, in general terms, whether you are inspecting
trees in an orchard or fruits in a crate or plants being shipped you cannot be 100
per cent certain by inspection that the unit you are inspecting is healthy.  So you
automatically in the system have a certain tolerance and run a certain risk ofsome infected plants.  The only way you can improve your chances is to look at
more plants so basically you have to select a sampling system which gives you a
certain level of security.  This is what is inherent in the idea of managed risk
which I mentioned earlier yesterday.  Managed risk implies that whatever you do,
there is a small risk of missing what you are looking for.  You recognize thatwhat you are doing is not 100 per cent efficient but you have to do a trade-off
between practicality and cost on the one hand and the risk which you are running
on the other."
321
Furthermore, Dr Smith stated that:
" … there will be a certain small risk that, if such infected fruit were present, they
will not be detected but will in some way pass through the system."322
Moreover, Dr Geider considered that surface contamination could not be excluded and might becaused naturally by insects but also by handling during or post harvest.
323  On the other hand, the
Panel recalled the view of Dr Geider that the highest risk of fire blight contamination was fromtravellers to Japan bringing in contaminated plants or fruits.
324
8.161  We therefore conclude that errors of handlin g or illegal actions are risks that may
be, in principle, legitimately considered by Japan.   These risks have been acknowledged by
the experts, even though they consider  them to be "small" or "debatable".325
8.162  We now need to determine whether one or more infested or infected apple fruit entering
Japanese territory could actually transmit fire blig ht to a host plant, i.e. complete the pathway.
                                                     
319 Paras. 4.188-4.190, 4.192-4.193.
320 Appellate Body Report in EC – Hormones , para. 205.
321 Annex 3, para. 303.
322 Annex 3, para. 266.  See also para. 327.
323 Para. 6.15.
324 Annex 3, paras. 263, 398 and 431.
325 Annex 3, Dr Smith, para. 266;  and para. 6.71.WT/DS245/R
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(d) Risk of completion of the pathway
8.163  It is our understanding that epiphytic bacteria could apparently survive commercial
handling, storage and transport in the calyx, but their number would be reduced by commercial
storage that combines cool temperatures and high humidity to avoid dessication.326  In some
circumstances, bacteria will apparently no longer be discernible.327  According to Dr Smith, there
is a stronger possibility that viable bacteria remained in the fruit during storage or shipping if the
fruit was internally infected.328  Survival of an epiphytic population of E. amylovora  seems to
depend also on the quantity of bacteria in the calyx.  The chance of retrieving bacteria after
commercial storage depends on the quantity that existed originally.  The experts mentioned in this
respect that experiments use artificial inoculation of large quantities of bacteria.329
8.164  This seems to imply that the likelihood that a naturally infested apple will contain a
population capable of transmitting fire blight when it reaches Japan is apparently limited, eventhough survival is not excluded.
330 The risk seems to be more important in the case of infected
apples.
8.165  The second point to address is the existence of a vector to transmit the bacteria to a host
plant.  The parties have addressed the situation where the fruit would be released as juice or
discarded.  They have also addressed contamination though rain splashes, insects or birds.
8.166  We note that experiments trying to reproduce the conditions applicable to discarded
apples have not led to any visible contamination,331 even when ooze was reported to exist.  The
experts themselves listed a number of cumulative conditions for a successful completion of the
pathway.332  While the experts agreed that short distance contamination was possible through rain
splash or bees, this essentially related to contamination at the flowering stage, not tocontamination from apple fruit.  Contamination by birds was not established.
333  In light of these
conditions, the experts considered the completion of the pathway to be unlikely.
8.167  We note in this respect that Japan did not submit sufficient scientific evidence in support
of its allegation that the last step of the pathway had been completed or was likely to be
completed.  The evidence submitted by Japan was essentially circumstantial or deemedunconvincing by the experts.
8.168  We therefore conclude, on the basis of the evidence submitted to the Panel, that it
has not been established with sufficient scientific  evidence that the last stage of the pathway
(i.e. the transmission of fire blight to a host plant) would likely be completed.
                                                     
326 Annex 3, paras. 208-216.  Diminution in the number of bacteria is less in cold but dry
conditions.
327 Annex 3, Drs Hale, Hayward, Annex 3, paras. 209, 212.
328 Para. 6.71.
329 Annex 3, Drs Hale, Geider, Annex 3, paras. 211, 215.
330 Annex 3, Dr Hale, para. 211.
331 Dr Hale, para. 6.69.
332 Dr Hayward, para. 6.70, Dr Smith, para. 6.71.
333 Annex 3, Dr Smith, para. 241 and Dr Geider, para. 263.WT/DS245/R
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6. Intermediate conclusion
8.169  On the basis of the above, we note, in light of the elements placed before us by the
parties, as well as in light of the comments of the experts appointed by the Panel, that the
scientific evidence suggests a negligible risk of possible transmission of fire blight through apple
fruit.
8.170  In making our assessment, we consider that the quality and quantity of scientific evidence
at issue is relevant.  We note in this respect that, although we did not exclude the relevance
a priori  of indirect evidence, there appears to be, in this instance, a significant amount of direct
evidence, including through extensive trade in ap ples to blight free areas, suggesting that such
contamination is unlikely.  By contrast, scientif ic evidence, direct or indirect, to suggest the
possibility of contamination in the various scenarios envisaged above is significantly more
limited.  The elements submitted by Japan are in fact largely hypothetical or circumstantial.334
8.171  In particular, the following points can be highlighted:
(a) If infection or infestation of immature apple fruit is not contested, infection of
mature, symptomless apples has not been established;
(b) the possible presence of endophytic bacteria in mature, symptomless apples is not
generally established;
(c) the presence of epiphytic bacteria in mature, symptomless apples is considered to
be extremely rare;
(d) assuming that either of the situations of infection or infestation listed above
would arise, the entry, establishment or spread of the disease as a result of the
presence of these bacteria in or on apple fruit would require the completion of an
additional sequence of events which is deemed unlikely, and which has not evenbeen experimentally established to date.
8.172  We further recall the opinion of the experts that due to the development of new scientific
research tools, in particular DNA-based methods, they were more confident than ever before that
there was only a negligible chance of fire blight being transmitted through apple fruit.
335
8.173  Nonetheless, we note that even if the scientific evidence before us demonstrates that
apple fruit is highly unlikely to be a pathway for the entry, establishment and spread of fire blight
within Japan, it does suggest that some slight risk of contamination cannot be totally excluded.
The experts all categorized this risk as "negligible".336  Dr Smith observed that "from a scientific
position, the logical conclusion of saying that there is an absolutely negligible risk of movement
of fire blight with fruits is in fact a completely unrestricted trade".337  However, none of the
experts were comfortable with the notion of eliminating "in one step" all phytosanitary controls,
taking into account Japan’s island environment and climate.338
                                                     
334 Exhibit JPN-40.
335 Annex 3, para.342;  Dr Smith, para. 343.
336 Annex 3, paras. 382-386.
337 Annex 3, para. 419.
338 Annex 3, paras. 386, 389, 409, 411, 413, 414, 419, 423, 424, 426 and 429.WT/DS245/R
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8.174  Furthermore, we note that Japan is concerned as well with the risk that something other
than mature, symptomless apples may actually be imported.  The latter risk would seem to arise
primarily as a result of human or technical error, or illegal actions.  Responding to a question
from Japan regarding "uncontrollable risks based on real world experience" such as the finding of
codling moth in US apples exported to Ch inese Taipei, Dr Smith replied "… when the
phytosanitary system is changed it should be changed under circumstances that retain some
degree of control on what is happening and not in a single step that removes control
altogether".339
8.175  We do not agree with the United States that the scientific prudence displayed by the
experts should be completely assimilated to a "theoretical risk" within the meaning given to that
terms by the Appellate Body in EC – Hormones .  On the other hand, we can only note that Japan
did not submit "sufficient scientific evidence" in support of its allegation that the pathway couldbe completed.
8.176  On the basis of the information made availa ble to the Panel, we conclude that there
is not sufficient scientific evidence that apple fruit are likely to serve as a pathway for the
entry, establishment or spread of fire blight within Japan.
7. Conformity of the phytosanitary measure at issue with Article 2.2 of the SPS
Agreement
(a) Absence of a "rational relationship" between the scientific evidence available and the
measure at issue
8.177  We recall that the claim of the United States under Article 2.2 is that the phytosanitary
measure at issue is maintained "without sufficient scientific evidence" We also recall that theUnited States argues that none of the requirements  contained in the measure has a basis in
science.
8.178  We recall the position of Japan that each individual requirement contained in the
phytosanitary measure at issue is essential to prevent the risks of entry, establishment or spread of
fire blight within Japan and that all these requirements are applied cumulatively, and not
alternatively, by Japan to apple fruit imported from the United States.
8.179  In paragraph 8.20 above, we concluded that we should consider the requirements
identified by the United States together as the phytosanitary measure at issue in this dispute.  Our
finding of whether the phytosanitary measure at issue is not maintained without sufficient
scientific evidence pursuant to Article 2.2 should, consequently, relate to the measure as a whole,
not to individual requirements thereof, even though, as acknowledged by the Panel, each of these
elements may be considered to individually constitute a phytosanitary measure within themeaning of paragraph 1 of Annex A to the SPS Agreement .
8.180  As mentioned in paragraphs 8.101-8.103, above, a rational or objective relationship  is
required between the phytosanitary measure at issue applied by Japan and the relevant scientific
evidence. Such a rational or objective relationship is to be determined on a case-by-case basis and
depends on the particular circumstances of the case, including the characteristics of the measure
                                                     
339 Annex 3, para. 423.WT/DS245/R
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at issue and the quality and quantity of the scientific evidence.340  We understand this requirement
to mean that a measure as a whole should be considered to be maintained "without sufficient
scientific evidence" if one or more of its elements are not justified by the relevant scientific
evidence addressing the risk at issue.
8.181  In paragraph 8.176 above, we concluded, on the basis of the elements before us, that
there was not sufficient scientific evidence  to support the view that apples are likely to serve as a
pathway for the entry, establishment or spread of  fire blight within Japan.  Given the negligible
risk identified on the basis of the scientific evid ence and the nature of the elements composing the
phytosanitary measure at issue, the measure on the face of it is disproportionate to that risk.
8.182  More particularly, having regard to the arguments of the parties and the opinions of the
experts, we have found that the following requirements are instances of elements of the measure
at issue which are most obviously "maintained without sufficient scientific evidence", either as
such or when applied in cumulation with others, taking into consideration the risks to beaddressed:
(a) The prohibition of imported apples from any orchard (whether or not it is free of
fire blight) should fire blight be detected within a 500-meter buffer zone
surrounding such orchard;  and
(b) the requirement that export orchards be inspected at least three times yearly (at
blossom, fruitlet, and harvest stages) for the presence of fire blight for purposes
of applying the above-mentioned prohibitions.
341
(i) The prohibition of imported apples from any orchard (whether or not it is free of fire
blight) should fire blight be detected within a 500-meter buffer zone surrounding such
orchard
8.183  The United States argues that since mature, symptomless apples are not a pathway for the
introduction of fire blight, even if picked from a highly infected tree, buffer zones are not
relevant.  According to the United States, the EPPO requirements on which Japan relies to justify
the obligation to set up a 500-meter buffer zone around orchards are part of an eradication
programme, not a protection against transmission through imported fruits.
8.184  Japan argues that the practice of buffer zones is recognized by the IPPC Requirements for
the Establishment of Pest-Free Places of Production and Pest Free Production Sites.342  The 500-
metre buffer zone is supported by scientific evidence that E. amylovora  could be found at some
distance from points of inoculum.343  Furthermore, buffer zones are necessary to ensure that host
plants are grown in a disease-free environment.  Japan submitted a number of elements justifying
in its view a 500-meter buffer zone.344
8.185  We have found above that there is not sufficient scientific evidence supporting the view
that infested or infected apples are likely to serve as a pathway for the entry, establishment or
spread of fire blight within Japan.  However, even if this were not the case, we are of the opinion
                                                     
340 Appellate Body Report in Japan – Agricultural Products II , para. 84.
341 Para. 8.25.
342 International Standard for Phytosanitary Measures  No.10 : Requirements for the Establishment
of Pest Free Places of Production and Pest Free Production Sites , FAO, Rome 1999 (Exhibit JPN-24).
343 Exhibit JPN-25; JPN-26; JPN-27; JPN-19.
344 Japan First Submission, paras. 158-165.WT/DS245/R
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that the prohibition of imported apples from any orchard (whether or not it is free of fire blight)
should fire blight be detected within a 500-meter buffer zone surrounding such orchard is not
supported by sufficient scientific evidence.
8.186  We note that the agreed purpose of a buffer zone is to avoid the contamination of a fire
blight-free orchard by bacteria carried from outside by creating a zone that will be difficult for thebacteria to cross, e.g. by removing any potential host plants from the buffer zone.
345
8.187  We recall that the experts have noted the relevance of a buffer zone for disease
eradication purposes.346  However, measures for an eradication programme are not necessarily the
same as those required to reduce the risk of fire blight transmission through imported, mature,
symptomless apple fruit.  In that context, we cannot assume, as Japan does, that the suggestion
made in the studies of Meijneke (1979)347 and Zeller (1987)348 for a 500-meter eradication
countermeasure  in Europe is necessarily relevant for justifying a buffer zone to ensure that apple
fruit is free of bacteria.  Even if one were to rely, as proposed by Japan, on van Vaerenbergh et al.
(1987),349 which showed dispersion of E. amylovora  for 250 meters in humid weather, and on the
measures required by the United States against citrus canker for Unshu oranges (400-meter buffer
zone), a 500-meter buffer zone for apples is still not scientifically supported.350
8.188  We also note that the experts have stated that buffer zones are useful to protect nursery
stocks over several years.  Dr Smith noted that buffer zones are more suitable for nurseries where
one is looking at a situation where the nursery should be free and remain free over a period of
years, since fire blight can develop rather slowly on planting material.351  At the same time,
infected nursery stocks are known to be the most common pathway for the introduction of fire
blight into regions not adjacent to infected areas.352
8.189  However, the experts expressed doubts as to the usefulness of a buffer-zone to protect an
orchard from fire blight.  Dr Hale recalled that Roberts (2002)353 had shown conclusively that no
buffer zone of any size was justified by the existing scientific data, as fruit harvested from
blighted trees or adjacent to blighted trees had not harboured E. amylovora .354  D r  S m i t h
considered that, as far as fire blight is concerned:
                                                     
345 Annex 3, Dr Geider, para. 319.  Dr Hayward quoted ISPM 5 (1999) Glossary of Phytosanitary
terms,  according to which a buffer zone was "An area in  which a specified pest does not occur or occurs at
a low level and is officially controlled, that either en closes or is adjacent to … a pest free area, a pest free
place of production or a pest free production site, and in which phytosanitary measures are taken to prevent
spread of the pest."
346 Annex 3, paras. 314, 319 and 320.
347 Exhibit JPN-19.
348 Exhibit JPN-27.
349 See para. 4.115.
350 Dr Hale, Dr Hayward and Dr Smith concur in their assessment that the epidemiology of fire
blight was different from that of many bacterial di seases such as citrus canker (Dr Hale, para. 6.139, Dr
Hayward, para. 6.140, Dr Smith, para. 6.141).  The experts also considered that the zone size recommendedfor citrus canker had no relevance for fire blight (Dr Hayward, para. 6.140; Dr Smith, para. 6.141).
351 Annex 3, para. 320, see also para. 6.137.
352 Paras. 6.28, 6.29, 6.31, 6.32, 6.41, 6.47.
353 Exhibit USA-16.
354 Dr Hale, paras. 6.134-6.135;  Dr Hayward also refers to Roberts (2002, in press) which has
obtained results that have indicated that a buffer zo ne of any size provides no phytosanitary security
(Annex 3, para. 315).WT/DS245/R
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"the possibility that fire blight should enter an orchard during a given growing
season from outside the orchard from a canker infection in which the bacteria
multiplies and from that multiplication infects fruit is almost impossible.  We
already query the possibility that fruits can be significantly infected within the
orchard so the fruits are very unlikely to be directly infected by inoculum coming
from a joining orchard and if the inoculum comes into the orchard what it firsthas to do is establish itself, establish the disease in the orchard and from that the
disease has to spread to the fruit and in the most favourable circumstances this
could not happen until the following growing season.  So for that reason I doubt
whether a buffer zone is really necessary in the case of fire blight."
355
8.190  Both the United States and the experts consulted by the Panel also referred to studies
examining 30,900 mature, symptomless fruits harvested between 0 and 300 meters from fire
blight inoculum sources which found that none of the fruits that were subsequently cool-storedhad developed fire blight symptoms and none of the sliced fruit had yielded E. amylovora,  even
when harvested from trees directly adjacent to fire blight sources.
356
8.191  We therefore conclude that, on the basis of the evidence before us, the requirement
by Japan of a 500-meter buffer zone, to prevent contamination of US apple fruit with fire
blight, does not bear a rational relation ship to the scientific evidence available.
8.192  Even if a buffer zone were sufficiently justified scientifically to avoid the contamination
of apple fruit, we also recall that it is applied cumulatively with other measures which are
intended to ensure that the apple fruit is free of fire blight when exported, such as the surface
treatment requirement or orchard inspections.  In that context, the requirement of a buffer zone
would be redundant.
(ii) The requirement that export orchards be inspected at least three times yearly (at
blossom, fruitlet, and harvest stages) for the presence of fire blight
8.193  The United States recalls that Japan requires that the orchards and buffer zones be
inspected at least three times yearly, at the blossom, fruitlet and harvest seasons.  The United
States also notes that additional inspections are required following any strong storm (such as ahail storm).  The United States argues that only a harvest season inspection that detected severely
blighted orchards might be relevant for assessing the likelihood that there could be fire blight
bacteria on the surface of mature, symptomless apples.  However, the United States contends that
even that inspection is unnecessary because there is no scientific evidence that mature,
symptomless apple fruit can act as a pathway for the entry, establishment or spread of fire blight
within Japan.
8.194  Japan argues that field inspections are necessary to ensure the efficacy of the systems
approach.  Inspection at the blossom stage was necessary because this was when the trees were
most susceptible to infection.  However, infection by E. amylovora was most visible at the fruitlet
stage.  A third inspection at the harvest stage was necessary because infection could occur after
the fruitlet stage and the mechanism of invasion of E. amylovora inside apples was not known.
8.195  We have found above that there is not sufficient scientific evidence supporting the view
that infested or infected apples are likely to serve as a pathway for the entry, establishment or
                                                     
355 Annex 3, para. 314, see also Dr Geider, para. 319.
356 Paras. 6.134-6.136.WT/DS245/R
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spread of fire blight within Japan.  However, even if this were not the case, we are of the opinion
that the requirement that export orchards be inspected at least three times yearly (at blossom,
fruitlet, and harvest stages) for the presence of fire blight is not supported by sufficient scientific
evidence.
8.196  Whilst the experts considered that inspection was necessary for identification of the
disease-free status of an orchard, all of them said that three inspections were more than what was
necessary to detect whether there was significant fire blight infection.357  Even with uninspected
orchards the experts thought the risk to Japan of the entry, establishment or spread  of fire blight
was very low as surface E. amylovora  was found only rarely on apples even from severely
infected orchards.358
8.197  We therefore conclude that the requirement by Japan that US export orchards be
inspected at least three times yearly (at blossom, fruitlet, and harvest stages) for thepresence of fire blight does not bear a ration al relationship to the scientific evidence
available.
(b) Conclusion
8.198  For the reasons mentioned above, we conclude that the phytosanitary measure at
issue is clearly disproportionate to the risk id entified on the basis of the scientific evidence
available.  In particular, some of the requireme nts applied by Japan as integral parts of the
measure at issue are, either individually or when applied cumulatively with the other
requirements of that measure, not supported by sufficient scientific evidence within the
meaning of Article 2.2 of the SPS Agreement .
8. Provisional conclusion on Article 2.2 of the SPS Agreement
8.199  On the basis of the above, we conclude th at the phytosanitary measure at issue is, as
a whole, maintained "without sufficient scientific evidence" within the meaning of
Article 2.2 of the SPS Agreement .
8.200  We note that Article 2.2 of the SPS Agreement  provides that "Members shall ensure that
any … phytosanitary measure … is not maintained without sufficient scientific evidence, except
as provided for in paragraph 7 of Article 5 ".  We recall that the panel in Japan – Agricultural
Products II , having found that the phytosanitary at issue violated Article 2.2 but noting that the
defendant was also invoking Article 5.7, concluded that it had to examine next whether that
measure met the requirements in Article 5.7.  The panel concluded that if the phytosanitary
measure at issue met these requirements, it could not find that it violates Article 2.2.
359
8.201  We agree with this approach and refrain from making final findings with respect to the
consistency of the measure at issue with Article 2.2 until we have completed our analysis underArticle 5.7.
                                                     
357 Annex 3, paras. 268, 273-283, 303.
358 Dr Hayward, para. 6.74;  Dr Hale, paras. 6.25, 6.113, 6.139, 6.145, 6.150;  see also Annex 3,
Dr Smith, para. 310.
359 Panel Report in Japan – Agricultural Products II , para. 8.48.WT/DS245/R
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8.202  We therefore proceed with our analysis of the applicability of Article 5.7 of the SPS
Agreement  to the phytosanitary measure at issue.
E. ARTICLE 5.7 OF THE SPS A GREEMENT
1. Summary of the arguments of the parties360
8.203  Japan argues that should the Panel find the scientific evidence insufficient to support
Japan's measure under Article 2.2, the measure could be considered to be a provisional measurein the context of Article 5.7 since the date of entry into force of the SPS Agreement.
8.204  The United States argues that the Panel’s analysis of Japan's alternative defence under
Article 5.7 can begin and end with the first requirement of that Article that the provisional
measure be imposed only "[i]n cases where relevant scientific evidence is insufficient".  The
United States contends that Japan had not demonstrated that the relevant scientific evidence was
insufficient.  Indeed, the United States argues that there has never been scientific evidence that
mature apple fruit transmitted the disease.
8.205  The United States contends that the scientific evidence predated the entry into force of
Japan's fire blight measures in 1994 and continued to be the same thereafter.  Thus, Japan has
been acting inconsistently with  its commitment under Article 2.2 not to maintain its fire blight
measures without sufficient scientific evidence since the entry into force of the SPS Agreement  in
1995.
8.206  Japan recalls that its current phytosanitary requirements were introduced on the basis of
an agreement between the Governments of Japan and the United States, in order to allow
importation of US apple fruit while preserving Japan’s appropriate level of protection.  The
measures were developed on the basis of proposa ls from the United States.  As such, Japan
contends that it is unreasonable for the United States to now claim that the evidence had beeninsufficient from the beginning.
8.207  The United States argues that it acquiesced to the fire blight measures which Japan
introduced in 1994 as preferable to an outright ban on imported apple fruit, although it had
recognized that the scientific evidence did not support the restrictions imposed by Japan.  The
United States contends that it never accepted the consistency of these measures with Japan’sWTO obligations.
8.208  Japan believes that considerable scientific evidence exists to support its measure to
control the risk of fire blight in US apples.  And, if the Panel were to find that this evidence was
not sufficient under Article 2.2, it is nonetheless "available pertinent information" in the context
of Article 5.7.  Together, these pieces of evidence demonstrate that a phytosanitary measure is
needed to counter the risk of dissemination of fire blight via imported US apples.
                                                     
360 A detailed account of the arguments of the parties can be found in paras. 4.201-4.221 of this
Report.WT/DS245/R
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2. Analysis of the Panel
8.209  Article 5.7 reads as follows:
"In cases where relevant scientific evidence is insufficient, a Member may
provisionally adopt sanitary or phytosanitary measures on the basis of available
pertinent information, including that from  the relevant international organizations
as well as from sanitary or phytosanitary measures applied by other Members.  In
such circumstances, Members shall seek to obtain the additional information
necessary for a more objective assessment of risk and review the sanitary or
phytosanitary measures accordingly within a reasonable period of time."
8.210  We understand Japan to be claiming that the phytosanitary measure at issue is justified
under Article 5.7 "in the alternative", should the Panel find that the measure is maintained
without sufficient scientific evidence within the meaning of Article 2.2.  We first note that
arguing in the alternative is a well-established judicial practice and arguing a point in the
alternative of another point often implies that there may be some contradictions between the two
lines of argumentation if they were presented concurrently.
8.211  In this instance, we have determined above that Japan's measure is maintained without
sufficient scientific evidence within the meaning of Article 2.2, which is the circumstance inwhich Japan invokes Article 5.7 in the alternative and claims that this provisional measure has
been in place since the date of entry into force of the SPS Agreement  in 1995.
8.212  We will therefore now consider whether the measure at issue can be justified as a
provisional measure within the meaning of Article 5.7 of the SPS Agreement .  Before doing so,
however, we find it relevant to recall that the burden is on Japan, as the party invoking Article 5.7to make a prima facie case in support of its position.
8.213  We recall that the Appellate Body in Japan – Agricultural Products II  noted that
Article 5.7 sets out four requirements which have to be met in order for a measure to be justified
as a provisional measure.  These requirements, cumulative in nature, are the following:
(i) The measure is imposed in respect of a situation where "relevant scientific
evidence is insufficient";
(ii) the measure is adopted on the basis of "available pertinent information".
Pursuant to the second sentence of Article 5.7, such a provisional measure may not be maintained
unless the Member which adopted the measure:
(iii) "seek[s] to obtain the additional info rmation necessary for a more objective
assessment of risk; and
(iv) "review[s] the … measure accordingly within a reasonable period of time."
The Appellate Body added that "whenever one of these four requirements is not met, the measure
at issue is inconsistent with Article 5.7".
361
                                                     
361 Appellate Body Report in Japan – Agricultural Products II , para. 89 (emphasis in the original).WT/DS245/R
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8.214  We note that we may begin our examination with either the requirements of the first
sentence or of the second sentence of Article 5.7.362  However, in the light of the arguments of the
parties, we proceed to consider the first requirement under Article 5.7, first sentence, i.e. that the
measure is imposed in respect of a situation where "relevant scientific evidence is insufficient".
8.215  We first note that the existence of a situation where "relevant scientific evidence is
insufficient" cannot be merely presumed on the basis of the fact that the measure at issue has been
found to be maintained "without sufficient scientific evidence" pursuant to Article 2.2.  The fact
that a particular measure, in this instance the set of requirements applied by Japan to the
importation of US apple fruit, is found to be maintained without sufficient scientific evidence
may not necessarily dispose of the separate question, under Article 5.7, of whether the situation is
one where "relevant scientific evidence" is insufficient.
8.216  We recall from our discussion regarding Article 2.2 that the "situation" addressed by the
measure at issue in this case is not one where the measure is imposed in respect of a situation
where "relevant scientific evidence is insufficient", but where, on the contrary, a wealth of
information is available.  It should be noted first that Article 5.7 refers to "relevant scientific
evidence" which implies that the body of material that might be considered includes not only
evidence supporting Japan's position, but also evidence supporting other views.  In the course ofour analysis under Article 2.2 we have come across an important amount of relevant evidence,
including scientific studies and reports on the risk of transmission of fire blight through apples.
This information was submitted not only by the parties but also by the experts consulted by the
Panel.  The fact that this information may not all support Japan’s opinion is in our view not
pertinent in the context of this first requirement of Article 5.7.  It is indisputable that a large
amount of relevant scientific evidence is available.
 363
8.217  We note that Japan argues that, on certain aspects of the dissemination of the bacteria, the
evidence is not sufficient.  Japan argues, for instance, that there is limited evidence on what
happens to  E. amylovora  inside immature apples that would ensure it was not found in mature
apples.  Likewise, Japan argues that not enoug h studies have been performed on the potential
completion of contamination pathways.
8.218  We recall that the requirement concerning scient ific evidence relates to the insufficiency
of relevant scientific evidence regarding what the Appellate Body in Japan – Agricultural
Products II  describes as a "situation"364 and Article 5.7 even more generally as a "case".  From
the use of these terms, we conclude that the te rm "insufficient relevant scientific evidence" is
                                                     
362 In Japan – Agricultural Products II , the Appellate Body confirmed that the panel could begin
its analysis with any one of the four requirements mentioned above.  It concluded that:
"…the Panel did not err in its application of Article 5.7 by firstexamining whether the varietal testing requirement meets therequirements of the second sentence of Article 5.7.  Having established
that the requirements of the second sentence of Article 5.7 are not met,
there was no need for the panel to examine the requirements of the firstsentence." (Appellate Body Report in Japan – Agricultural Products II ,
para. 91).
363 See, for example, Annex 3, Dr Smith, para. 338:
"Well, I would certainly support Geider in his view that fire blight is a well studied disease
[Annex 3, para. 336], much observed and so that there is a very large body of direct evidence concerning
fire blight."
364 Appellate Body Report in Japan – Agricultural Products II , para. 89.WT/DS245/R
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meant to refer to evidence in general  on the phytosanitary question at issue, in this instance the
risk of transmission of fire blight through apple fruit.
8.219  The current "situation", where scientific studies as well as practical experience have
accumulated for the past 200 years, is clearly not the type of situation Article 5.7 was intended to
address.  Article 5.7 was obviously designed to be invoked in situations where little, or no,reliable evidence was available on the subject matter at issue.  With regard to fire blight, not only
a large quantity but a high quality of scientific evidence has been produced over the years that
describes the risk of transmission of fire blight through apple fruit as negligible.
365  Moreover,
this is evidence in which the experts have expressed strong and increasing confidence.  We
therefore are of the view that the first condition of the first sentence of Article 5.7 is not met.
8.220  Even if we were to accept Japan's arguments that "relevant scientific evidence" in
Article 5.7 may refer to a specific aspect of a phytosanitary problem, we recall that the expertshave indicated that even on the specific scientific questions raised by Japan, there is a large
volume of relevant scientific evidence.  This is the case regarding the absence of endophytic
bacteria in mature apple fruit
366 and the risk of transmission of fire blight by apple fruit.367  As
mentioned above, the fact that it does not support Japan's views is of no relevance.  Article 5.7
does not refer to evidence supporting the views of the Member wishing to impose SPS measures.
8.221  For these reasons we conclude that the present "situation" is one where there is sufficient
relevant scientific evidence available, and that the first condition for invoking Article 5.7 is
consequently not met.
8.222  We therefore find that, since the first require ment of the first sentence of Article 5.7
is not met, and since the requirements of Article 5.7 are cumulative, Japan has failed toestablish that the phytosanitary measure at issue is a provisional measure justified under
Article 5.7 of the SPS Agreement .
3. Final conclusion on Article 2.2 of the SPS Agreement
8.223  In paragraph 8.199 above, we provisionally concluded that the phytosanitary measure at
issue is maintained without sufficient scientific evidence, within the meaning of Article 2.2.  Wehave found in the preceding section that the phytosanitary measure at issue was not a provisional
measure maintained in accordance with the requirements of Article 5.7.
8.224  Consequently, we conclude that the United States has made a prima facie case that,
by maintaining the measure at issue "without sufficient scientific evidence", Japan has
violated its obligations under Article 2.2 of the SPS Agreement .  Japan has failed to rebut
that presumption.
8.225  We note in this respect that our conclusion is based on the evidence submitted by the
parties and the opinions of the experts consulted by the Panel.  This conclusion relates to the
application of the measure at issue  as a whole.   This conclusion does not imply that no SPS
measure would be compatible with Article 2.2, nor does it prejudge the question whether certain
                                                     
365 Annex 3, Dr Hale and Dr Smith, paras. 342 and 343.
366Annex 3:  Dr Geider, paras. 63, 115, 355, 360;  Dr Hale, paras. 356, 361;  Dr Hayward,
paras. 357, 362;  Dr Smith, paras. 358, 363.  See also paras. 6.7-6.10, 6.15-6.19.
367 Paras. 6.20-6.25 and 6.37-6.40.WT/DS245/R
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elements of the measure at issue could, individually or in combination with others, be compatible
with Article 2.2.
8.226  Indeed, we recall that the experts considered, inter alia , that it would be appropriate not
to export apples from (severely) blighted orchards368 and that they would not be comfortable with
a complete and immediate removal of the phytosanitary measures imposed by Japan, given the
phytosanitary situation of that Member.369
8.227  For the reasons mentioned in paragraph 8.4(c) above, we now proceed with an
examination of the US claims regarding Japan's risk analysis.
F. ARTICLES 5.1 AND 5.2 OF THE SPS AGREEMENT
1. Introduction
8.228  The United States submits that the measure at issue is inconsistent with Articles 5.1 and
5.2 of the SPS Agreement , in that it is not based on a risk assessment, as required under these
provisions.
8.229  The relevant paragraphs of Article 5 read as follows:
"1. Members shall ensure that their sanitary or phytosanitary measures are
based on an assessment, as appropriate to the circumstances, of the risks to
human, animal or plant life or health, taking into account risk assessment
techniques developed by the relevant international organizations.
2. In the assessment of risks, Members shall take into account available
scientific evidence; relevant processes and production methods; relevant
inspection, sampling and testing methods; prevalence of specific diseases or
pests; existence of pest- or disease-free areas; relevant ecological and
environmental conditions; and quarantine and other treatment."
8.230  These provisions directly inform each other, in that paragraph 2 sheds light on the
elements that are of relevance in the assessment of risks foreseen in paragraph 1.  In addition, the
notion of risk assessment is defined in Annex A of the SPS Agreement .  The relevant part of
paragraph 4 of Annex A reads as follows:
"4. Risk assessment  – The evaluation of the likelihood of entry,
establishment or spread of a pest or disease within the territory of an importing
Member according to the sanitary or phytosanitary measures which might be
applied, and of the associated potential biological and economic consequences;
..."
8.231  We also recall the Appellate Body's observation that Article 2.2 informs Article 5.1 and
that they should "constantly be read together".370  We will therefore examine the US claims under
Article 5 paragraphs 1 and 2 in light of each other, bearing in mind also, to the extent relevant,our analysis under Article 2.2 above.
                                                     
368 Annex 3:  Dr Smith, paras 266, 411 and 429;  Dr Hale, paras. 269, 410 and 414;  Dr Geider,
paras. 409 and 413.
369 Annex 3:  Dr Geider, paras. 409 and 424;  Dr Hale, para. 410;  Dr Smith, para. 419.
370 Appellate Body Report in EC – Hormones , para. 180.WT/DS245/R
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8.232  We will first turn to Article 5.1, which contains the general requirement for Members to
base their measures on a risk assessment.  However, because Article 5.2 imparts meaning to the
general obligation contained in paragraph 1 to base measures on an "assessment … of risks",  we
may also consider elements contained in Article 5.2 in the course of our analysis under
Article 5.1.
8.233  As has been noted by previous panels, the general obligation reflected in Article 5.1
contains two elements:
(a) an assessment of risks;  and
(b) that Members ensure that their SPS measures are based on  such an assessment.
8.234  These two elements will be considered in turn.
2. Japan's risk assessment
(a) Requirements of a risk assessment under Article 5.1
8.235  As noted above, Article 5.1 requires an assessment "as appropriate to the circumstances,
of the risks to human, animal or plant life or health, taking into account risk assessment
techniques developed by the relevant international organizations".  In this instance, the measure at
issue is a phytosanitary measure.
8.236  Accordingly, taking into account the relevant definition of a risk assessment in Annex A
paragraph 4,  the risk assessment in relation to the measure at issue involves an evaluation of:
(a) "the likelihood of entry, establishment or spread of a pest or disease within the
territory of an importing Member according to the sanitary or phytosanitary
measures which might be applied, and of the associated potential biological and
economic consequences" (Annex A paragraph 4);
(b) whether this risk assessment is "as appropriate to the circumstances";
(c) whether the risk assessment takes "into account risk assessment techniques
developed by the relevant international organizations".
8.237  The last two factors, in our view, pervade the entire assessment of the risk, as defined in
Annex A, paragraph 4.  Their consideration is therefore generally relevant to our assessment ofthe risk assessment itself as a whole, and we will consider them first.
(b) A risk assessment "as appropriate to the circumstances"
8.238  As noted above, the measure at issue is a phytosanitary measure, where the risks are with
regard to plant life and health.  Neither party contends that there is any risk to human or animal
health from fire blight disease, nor risk of "other damage to the territory" of Japan.  An
appropriate risk assessment must therefore focus on the risks related to plant life and health.
8.239  It might be observed, in this context, that the requirement that the risk assessment be
"appropriate to the circumstances" has been considered to leave some flexibility for anWT/DS245/R
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assessment of risk "on a case by case basis, in terms of product, origin and destination, in
particular country-specific situations".371
8.240  A relevant circumstance in this case is, in our view, the fact that Japan is considered to be
fire blight-free, as well as its specific climatic conditions, which make it a potentially favourable
environment for the spread of fire blight, should the disease enter the country.372
(c) International risk assessment techniques developed by relevant international
organizations.
8.241  We recall that Article 5.1 requires the "risk assessment techniques developed by the
relevant international organizations" to be "taken into account".  We note first that this expression
does not impose that a risk assessment under Article 5.1 be "based on" or "in conformity with"
such risk assessment techniques.  This suggests that such techniques should be considered
relevant, but that a failure to respect each and every aspect of them would not necessarily,  per se ,
signal that the risk assessment on which the measure is based is not in conformity with therequirements of Article 5.1.  Nonetheless, reference to these risk assessment techniques can
provide very useful guidance as to whether the risk assessment at issue constitutes a proper risk
assessment within the meaning of Article 5.1.  In particular, it can shed useful light, in this
dispute, on the US argument that Japan has failed to evaluate the likelihood of entry because it
failed to consider all the steps in the pathway that would lead to apple fruit being a vector for theentry and transmission of the disease.
8.242  In this instance, it is not disputed that the relevant international organization is the
IPPC.
373  However, the parties have referred to two separate instruments.  The United States has
referred to the most recent International Standard for Phytosanitary Measures (ISPM) developed
by the IPPC for Quarantine Pests, namely ISPM 11 on Pest Risk Analysis for Quarantine Pests,adopted in 2001.  Japan, on the other hand, has noted that the relevant standard at the time of
conduct of its own pest risk analysis was ISPM 2 on Guidelines for Pest Risk Analysis.  Both of
these instruments are described in more detail in section II. C. 2 above.
374
8.243  With regard to the question of whether ISPM 2 or ISPM 11 should be taken into account
in this case, we note that both instruments descri be pest risk analysis as involving three stages:
(1) the identification of a pathway that may allo w the introduction and/or spread of a quarantine
pest, and the identification of that pest;  (2) an examination of the specific pest in light of the
criteria for quarantine pest status;  and, finally, (3) the determination of the appropriate
phytosanitary measure.  Compared to the previous guidelines, ISPM 11 sets out in more detail
(and in a manner more closely resembling the definition of a risk assessment under the SPS
Agreement ), the specific steps involved in a PRA which include an assessment of the probability
of introduction and spread.  The assessment of the probability of introduction itself is indicated asrequiring an analysis of each of the pathways for entry with which a pest might be associated.
375
8.244  Although the 2001 ISPM provides a greater degree of detail to guide the conduct of a
specific PRA, both parties agree that both build on the same framework, and that the detailed
                                                     
371 Report of the Panel in Australia- Salmon , para. 8.71.
372 We note in this respect that these factors relate to some of the factors required to be taken into
account under Article 5.2 of the SPS Agreement , which refers inter alia  to "prevalence of specific diseases
or pests; existence of pest- or disease-free areas;  relevant ecological and environmental conditions".
373 See para. 2.20.
374 Paras. 2.24 ff.
375 Ibid.WT/DS245/R
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differences between them are not significant to this dispute, although for opposite reasons.  In
Japan's view, the Japanese PRA took into account the 1996 guidelines and did not need any
review as a result of the 2001 instrument.  In  the US view,  Japan's PRA does not meet the
standard of either of the two instruments.   We shall therefore not seek to analyse a priori  the
details of the differences between the two guidelines, but rather focus on the key issue of whetherJapan's PRA sufficiently identifies and assesses, as suggested under both instruments, the
possible pathways for the introduction and spread of fire blight through apple fruit and the
likelihood/probability for their being realized.
(d) Japan's risk assessment in light of the requirements under Annex A, paragraph 4 of the
SPS Agreement
(i) Introduction
8.245  As noted by the panel in Australia – Salmon  and endorsed by the Appellate Body, an
evaluation of the "likelihood of entry, establishment or spread of a pest or disease within the
territory of an importing Member according to the sanitary or phytosanitary measures which
might be applied, and of the associated potential biological and economic consequence"
encompasses two distinct elements, which together constitute the relevant risk assessment in
relation to phytosanitary measures:  (1) an evaluation of the likelihood of entry, establishment orspread of a pest or disease within the territory  of an importing Member according to the sanitary
or phytosanitary measures which might be applied;  and (2) an evaluation of the "potential
biological and economic consequences associated with such entry or spread".
376
8.246  These elements will be considered in turn.  First, however, we should determine the
factual elements on which our assessment of Japan's risk assessment should be based.  In thisrespect, we note that Japan has conducted two risk assessments of relevance to the entry and
spread of fire blight:  one in 1996, concerning various pests, including fire blight, and another in
1999 concerning specifically fire blight on apples imported from the United States (hereafter the
"1999 PRA").
8.247  We note that the parties agree that the 1999 PRA is the main relevant document.
Contrary to the United States, however, Japan does not agree that conformity with Article 5.1 can
be also assessed in light of subsequent information.  We also recall that a Member is not required
to perform its own risk assessment under Article 5.1, but to base its measure on a risk assessment
appropriate to the circumstances.
8.248  In this instance, Japan has conducted its own risk assessments, and the parties have
particularly focused on Japan's most recent and most specific PRA, conducted in 1999.  We will
thus consider principally the 1999 PRA as the relevant risk assessment in this case, but we do notexclude that other elements, including subsequent information, could also be of relevance.
8.249  Having determined that these are the relevant elements to consider, we now turn to an
examination of the various elements of Japan's risk assessment in order to assess whether the
United States has made a prima facie case that Japan's measure is not based on a risk assessment
within the meaning of Article 5.1.
                                                     
376 Panel Report in Australia – Salmon , para 8.72, and Appellate Body Report in Australia –
Salmon,  para 120.WT/DS245/R
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8.250  The Appellate Body has clarified that, on the basis of the definition of a risk assessment
contained in Annex A, paragraph 4, first sentence (which is the relevant one in this instance):
 "a risk assessment within the meaning of Article 5.1 must:
 (1) identify  the diseases whose entry, establishment or spread a
Member wants to prevent within its territory, as well as the
potential biological and economic consequences associated withthe entry, establishment or spread of these diseases;
 (2) evaluate the likelihood  of entry, establishment or spread of these
diseases, as well as the associated potential biological and
economic consequences;  and
 (3) evaluate the likelihood of entry, establishment or spread of these
diseases according to the SPS measures which might be
applied ."377
8.251  These will be considered in turn.
(ii) The disease at issue and the potential biological and economic consequences associated
with its entry, establishment or spread
8.252  The United States does not dispute, in this instance, that Japan's risk assessment fulfils
the first of the three conditions listed in paragraph 8.250, in that it has "identified fire blight as thedisease whose entry, establishment, or spread Japan wants to prevent within its territory as well as
potential associated biological and economic consequences".
378
8.253  However, the United States considers that Japan has failed to meet the other requirements
of a risk assessment under Article 5.1, namely  the evaluation of the likelihood of entry,
establishment or spread of that disease (item (iii) below); according to the SPS measures whichmight be applied (item (iv) below).
(iii) The likelihood of entry, establishment or spread of the disease
8.254  The United States argues that Japan has failed to evaluate the likelihood of entry ,
establishment or spread of fire blight within Japan, in particular because it has, in its view,
"fail[ed] to focus on scientific evidence relating to the importation of apples, making only generalstatements of possibility rather than an assessment of probability of entry, establishment or
spread".
379  The United States recalls in particular the Appellate Body's observation that "it is not
sufficient that a risk assessment conclude that there is a possibility of entry, establishment or
spread of diseases and associated biological and economic consequences" … it "must evaluate the
'likelihood', i.e., the 'probability' of entry, establishment or spread …".380
                                                     
377 Appellate Body Report in Australia – Salmon , para. 121.  In Japan – Agricultural Products II ,
the Appellate Body endorsed the aforesaid three-pronged test.  See para. 112. This test was also used by thePanel in Australia – Salmon (Article 21.5 – Canada) , para. 7.41.
378 US first submission, para. 66.
379 US first submission, para. 69.
380 Appellate Body Report in Australia – Salmon , para. 123.WT/DS245/R
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8.255  Japan responds that the US arguments are groundless, and that Japan's risk assessment
"reflects available evidence and reasonably supports its current phytosanitary requirements".381
Japan considers that the 1999 PRA had addressed not a theoretical possibility but the likelihoodof the introduction and spread of fire blight through apple fruit.
8.256  We understand the United States to argue both that the risk assessment at issue lacks the
required "specificity" in relation to the product at issue/the source of the risk, i.e. the importation
of apples, and also that the assessment performed does not sufficiently evaluate the likelihood  of
entry, establishment or spread, as required under Article 5.1.
8.257  With regard to the specificity required of a risk assessment under Article 5.1, we note
first that it has been clarified on previous occasions that the risk assessment must be specific to
the disease at issue, and, where several diseases are at issue, specific to each disease.
382  In this
instance, the United States does not challenge the specificity of the risk assessment in relation tothe disease at issue, but rather in relation to the product whose importation would lead to the
introduction of the disease at issue:  the United States thus argues that no evidence is presented as
to the probability of entry, establishment or spread of the bacteria through apple fruit
383, and, in
particular, the relevant paragraph entitled "Probability of Transmission via fresh apples", does not
"distinguish between evidence relevant to the exported commodity from other evidence".384 More
generally, the United States notes that a proper risk analysis should have focused on the
probability of US apples being infested or infect ed with fire blight, rather than focusing on
damaged fruit, immature fruit, apple leaves, etc.385
8.258  Japan notes in response that the risk analysis "obviously took into account all available
scientific evidence that relates not only to appl e trees but mature and immature, visibly blighted
and symptomless apple fruit as well – including van der Zwet et al.  (1990)".386
8.259  With regard to the assessment of the "likelihood" of the entry, establishment or spread of
the disease, the United States argues that there is no evidence of spread from apples in the past,
and no evidence that the hypothetical pathway of spread through mature apples could be
completed.  The United States also argues that Japan's PRA ignores key steps in the assessment,and in this respect also has failed to evaluate the likelihood of entry, establishment and spread of
the disease.
8.260  Japan contends that the 1999 PRA identified the steps in the pathway necessary for fire
blight to be disseminated via mature, apparently healthy apple fruit imported from the United
States.
387  Japan notes that the very objective of the assessment in the 1999 PRA was to assess US
apple fruit as a potential pathway.  Furthermore, while the 1999 PRA did not estimate numerical
probabilities of contamination by the bacteria, the PRA had qualitatively evaluated theprobability.
388
                                                     
381 Japan first submission, para. 211.
382 Panel report in Australia – Salmon , para. 8.74.
383 US first submission para. 73.
384 Ibid., para 74.
385 US first submission, para. 75.
386 Japan first submission, para, 203.
387 Japan first submission, paras. 202-211.
388 Japan second submission, paras. 58-67.WT/DS245/R
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8.261  We will first examine the relevant parts of Japan's 1999 PRA before assessing it in light
of the parties' arguments.
- Japan's 1999 PRA
8.262  Examining Japan's 1999 PRA, we first note that it refers in its subtitle to "Fresh apples
produced in the United States of America".  We note that the structure of this document is to
focus first on a description of the disease, followed by a general pest risk analysis forE. amylovora, before addressing quarantine measures for "US fresh apple fruit", and finally
including a chapter on "Pest risk analysis for quarantine measures on E. amylovora  for US fresh
apple fruit".  The initial chapter describing fire blight contains a section entitled "Probability of
transmission via fresh apples".  In this section, reference is made to the possibility for immature
fruit to be infected through natural openings in the skin, lenticels or diseased branches.  Reference
is also made to a number of studies describing the isolation of E amylovora  from apple fruit
("mature fruits harvested in severely infected orchards" (Hale et al.  1997), "fresh apple fruit" (van
der Zwet et al.  1990) or "young apples") as well as reports describing the survival of
E. amylovora  on fresh mature apple fruit (McLarty, 1922).
389
8.263  The general PRA contained in Chapter 2 begins with an analysis of the susceptibility of
Japan to fire blight, were it to be introduced into the country (i.e. the presence of host plants,
favourable climatic conditions, and an estimation of the probability for expansion) and on thepotential impact, should this expansion occur (Section 2-2-3).  A subsequent section focuses on
the "Introduction potential" (Section 2-2-4).  In the first part of that section, "the parts of plants
which can be infected with E. amylovora , namely, fresh plants (including fresh fruit, flowers …)"
are identified as some of those that can introduce E. amylovora  into Japan.
390  In this section, it
thus appears that fresh fruit is considered to be a "host plant", alongside cut flowers or nurserystock.  Within the same section, under the heading "Main uses of plants after importation" the
different types of "plants" are referred to.  With regard to fruit, it is noted that :
"fresh fruit are used for raw food or processing and supplied through markets ….
However, not all of them are distributed or consumed completely by such usages.
In the course of the distribution, processing and consumption, some can bereleased to the natural environment as leftovers, waste or useless materials.
In this way, if imported stocks and pollen are contaminated with E. amylovora ,
they become the direct cause for the occu rrence of fire blight because they are
directly brought into agricultural production area.  When contaminated cut
flowers and fresh fruit are released as juice, leftovers, waste, useless materials in
the fields surrounding ranches or in a natural environment, they can be the source
of the disease."
391
8.264  The conclusions reached in light of the general PRA for E. amylovora , were that
imported host plants should not be infected with E. amylovora  and that "to avoid the introduction
of E. amylovora , it must be designated as pathogen subject to importation prohibition …".392
                                                     
389 Exhibit JPN-32, para 1-1, page 5.
390 Ibid, para. 2-2-4-1.
391 Ibid, para. 2-2-4-3.
392 Ibid, para. 2-3-2.WT/DS245/R
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8.265  The following and final chapter of the 1999 PRA is devoted to a "Pest risk analysis for
quarantine measures on E. amylovora  for US fresh apple fruit".  The introduction to this section
indicates that Japan needs "to review whether or not 'plant quarantine measures against
E. amylovora  concerning US fresh apple fruit', which have been taken by Japan based on the
proposal by the US government since 1994393, are adequate as an alternative to lift the import
prohibition measures against E. amylovora"394  A section is then devoted to each of the measures
in place, which concludes that they provide a level of protection equivalent to the import ban.
- Assessment of Japan's risk assessment
Specificity of the PRA8.266  We first turn to the US argument that the 1999 PRA fails to focus specifically on the
product at issue, namely fresh apple fruit.
8.267  We first note in this respect that it has been recognized, in prior cases, that a risk
assessment conducted under Article 5.1 of the SPS Agreement  should be sufficiently specific to
the risk at issue.  In particular, we recall the findings of the panel in EC - Hormones , as upheld by
the Appellate Body, that studies relating to the carcinogenicity of certain hormones in general,
without an evaluation of the specific potential for carcinogenic effects arising from the presence
of hormones in food or meat products, were insufficient to support the measure at issue.
8.268  In this instance, the United States notes that Japan's PRA refers to a number of possible
hosts of fire blight (such as cut flowers, shoots, plants), rather than focusing on apples.  We first
note in this respect that Japan's PRA, which in part describes in general terms the risk of entry,
establishment or spread of the disease through various possible hosts, including but not
exclusively apple fruit, often either addresses these other hosts or includes the consideration ofapple fruit within a broader category, as one of the possible "plant hosts", without specifically
distinguishing it from other potential sources of infection, for the purposes of evaluating the
general likelihood of entry, establishment and spread of the disease.  Japan states that while the
objective of the 1999 PRA was to assess US fruit, all potential pathways were considered.
8.269  While we do not exclude that a consideration of other possible hosts of the disease may
be relevant in a risk assessment directed at the evaluation of the likelihood of entry, establishment
and spread through apple fruit, it could be expected that the possible relevance of these other
hosts/factors to contamination through apple fruit would be explained, and that conclusions
relating to the likelihood of entry, establishment or spread specifically through apple fruit would
be clearly identified, since the announced objective of the assessment is precisely to evaluate the
risk in relation to that particular product.
8.270  In this respect, we note in particular that Chapter 2 of the 1999 PRA, which contains the
general pest risk analysis concerning E. amylovora , includes very general conclusions that
"E. amylovora  is risk Grade A (extremely high)".  This conclusion, however, is based on an
overall assessment of possible modes of contam ination, where apple fruit is only one of the
possible hosts/vectors considered.  As cited above, only one paragraph in that chapter specifically
                                                     
393 The United States, however, argues that it accepted the fire blight measures imposed by Japan
only reluctantly, recognizing that the scientific evidence did not support the restrictions.  See para. 4.29
above.
394 Exhibit JPN-32, para. 3-1.WT/DS245/R
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addresses fresh fruit, simply noting that not all fruit are distributed or consumed totally and "in
the course of distribution, processing and consumption, some can be released to the natural
environment as leftovers, waste or useless materials".395  Thus, although the risk assessment is
intended to be conducted, as indicated by its very  title, in relation to the importation of US fresh
apple fruit, the main portion of the PRA is conducted on the basis of a general assessment of
possibilities of introduction of fire blight into Japan, through a variety of hosts, including - but notexclusively - apple fruit.
8.271  There is no clear indication in the document as how the other possible vectors might be of
relevance to an assessment of the likelihood of entry, establishment or spread through apple fruit
specifically.  Indeed, the conclusion of the PRA does not purport to relate exclusively to the
introduction of the disease through apple fruit, but rather more generally, apparently, through any
susceptible host/vector.  The scientific evidence submitted by both parties leaves no doubt that
the risk of introduction and spread of the disease varies considerably according to the host plant,with nursery stock and budding material identified as known sources for the spread of fire blight
in some cases.  We therefore conclude that, in this respect, the 1999 PRA is not sufficiently
specific to the matter at issue to constitute a proper risk assessment under Article 5.1 of the
SPS Agreement .
Evaluation of likelihood (possibilities vs. probabilities)8.272  Turning now to the actual evaluation of "likelihood" of entry, or spread of fire blight
through the importation of apple fruit, as reflected in the 1999 PRA, we recall the US argument
that Japan's risk assessment falls short of the requirements of Article 5.1 in that it identifies mere
"possibilities" rather than "probabilities" of entry, establishment or spread, as required under
Article 5.1.
8.273  We recall in this respect that Annex A, paragraph 4, requires a risk assessment, with
respect to phytosanitary measures, to contain an evaluation of the "likelihood" of entry,
establishment or spread of the disease.  As has been clarified by the Appellate Body, this
evaluation of likelihood involves more than a mere identification of "possibilities".  It requires an
assessment of probability  of entry, and, in the words of the Appellate Body, "probability implies
a higher degree or a "threshold of potentiality or possibility".
396  It is also understood, however,
that such probability need not be expressed in quantitative terms, but may be expressed in
qualitative terms.
8.274  Japan has used in the context of its PRA, a general "scale" of grades in order to rank the
risks at issue, ranging from A (extremely high) to D (extremely low).  In this instance, the general
PRA on E. amylovora leads, as already mentioned, to an overall ranking for the "total assessment
of E. amylovora " of a "Grade A (extremely high)" risk.  However, as noted above, that conclusion
does not appear to specifically evaluate the likelihood of entry, establishment or spread through
apple fruit, which is at issue here.  In those parts of the PRA that do relate directly to the
probability of entry specifically through apple fruit, the report does not suggest any precise
evaluation of the "degree of potentiality" or probability for the occurrence of the event.  Thus, in
a section entitled "Probability of transmission via fresh apples", it is noted that "immature applescan be infected ..." (emphasis added), and that a number of studies report the presence of
E. amylovora  in association with apple fruit.  In conclusion, it is noted that:
                                                     
395 Ibid, para 2-2-4-3.
396 Appellate Body Report in EC – Hormones , para 184.WT/DS245/R
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"Those reports, therefore, suggest the probability  of transmission via fresh apple
fruit.  Although several reports have described that the possibility  of transmission
of E. amylovora by fresh apple fruit can be denied or ignored, these reports have
only mentioned that 'symptomless mature fruit' (McLarty 1922, Dueck 1974)
'apparently healthy mature fruit' (Roberts et al. 1989), and 'the fruit harvested in
fire blight symptomless orchards' (van der Zwet et al.  1990) are safe."397
(emphasis added)
8.275  Although the term "probability" is used here to describe the conclusion to be drawn from
the cited studies398, it does not seem to reflect any particular assessment of the degree of
likelihood of the event.  Indeed, the reference to "probability" is even made in a somewhat
hypothetical mode (probability is "suggested").  Similarly, the following paragraph appears to
confirm that the cited studies lead to the identification of a possibility of apple fruit acting as apossible pathway for the entry of fire blight, but it does not indicate any quantitative or qualitative
assessment of the probability of this occurring:
"As mentioned above, the mature apple fruit harvested in fire blight occurring
orchards can carry E. amylovora  and, in addition, the mature fruit not carrying
E. amylovora can be contaminated by harvesting operation, etc., in the orchard
where there are sources.  In particular, when scarred fruit is infected with
E. amylovora  and becomes rotten, it can be considered to exude bacterial ooze.
Such fruit can be the source of transmission after being imported."399 (emphasis
added)
8.276  These terms clearly point to the identification of a possibility of entry, establishment and
spread, but do not, in our view, amount to an ev aluation of the likelihood of entry within the
meaning of Article 5.1 of the SPS Agreement , in that they do not assess the probability of such
entry beyond the identification of the potential for entry, establishment or spread.  In particular,
they do not address the likelihood of an apple becoming contaminated by the harvesting
operation, nor the likelihood that a damaged fruit will be included in the export shipment, nor thelikelihood that such a fruit, were it to be shipped, would become rotten.
8.277  Another section of Japan's PRA purports to consider the probability of introduction
through "normal transport method".  Fruit is mentioned as one of the potential sources of entry
along with other "host plants" through "normal transport method", so that if the importation of
these plants is not prohibited, "it can easily increase the probability of introduction of
E. amylovora  into Japan together with host plants".
400  Finally, the PRA identifies the possibility
for fruit to be disposed of, or discarded in, possible host areas and concludes that it thus "can" bethe source of contamination after importation.  These elements, which are dispersed throughout
the PRA along with consideration of other possible vectors for the entry, establishment or spread
of fire blight within Japan, provide some evaluation of various possible steps for the entry,
establishment and spread of fire blight though the importation of apple fruit.
                                                     
397 Exhibit JPN-32, para. 1-1, p.7.
398 Note this is translated from the Japanese language.  The text used here is the version provided
by Japan.
399 Exhibit JPN-32, para 1-1.
400 Section 2-2-4-1 of the 1999 PRA.WT/DS245/R
Page 195
8.278  However, these appear to be intertwined with other possible vectors, which have
otherwise been identified much more clearly as potential sources of contamination (such as
nursery stock or plants), and it is difficult to discern, from the structure and contents of the PRA,
an effort to evaluate specifically the likelihood of entry, establishment or spread from the
importation of apple fruit.  Furthermore, to the extent that it might be considered to identify the
potential for each of the relevant steps to be comp leted, the PRA fails, as noted above, to provide
more than an indication of a potential for entry, establishment or spread, and does not assess the
probability for such events to occur, as required under Article 5.1.
8.279  We further recall the inadequacies in the 1999 PRA identified by Dr Hale and Dr Smith.
According to Dr Hale, the following key steps had been overlooked for the probability of entry:
• identification of the relevant pathways;
• probability of fire blight being associated with the pathway of origin;
• probability of survival during transport and storage;
• probability of fire blight surviving existing pest management procedures; and
• probability of transfer of fire blight to suitable host.401
8.280  In light of the above, we conclude that Japan's PRA does not evaluate the likelihood
of entry, establishment or spread of fire blight through the importation of apple fruit, as
foreseen in Article 5.1 and Annex A, paragraph 4, of the SPS Agreement .
(iv) According to the SPS measures which might be applied
8.281  As noted above, Article 5.1 and Annex A, paragraph 4 of the SPS Agreement  require
measures to be based on an assessment of risks "according to the SPS measure which might be
applied".  In this instance, the United States contends that Japan's risk assessment does notcomply with this condition because, although it clearly identifies some SPS measures that might
apply to US apples, it does not "in any substantial way, evaluate their relative effectiveness in
reducing the overall disease risk" as required under Article 5.1.
402  The United States also notes
that Japan failed to consider any alternative measures to those that it was already applying, and in
particular did not consider some alternative measures proposed by the United States in 1997.
8.282  Japan notes that the current measures (in particular the limitation of imports of apples
from the states of Oregon and Washington) were established on the basis of a proposal by the
United States itself.  It also notes that the "mature, symptomless" criteria now mentioned by the
United States was not proposed at any stage prior to the consultations held in April 2002.
8.283  With regard to the requirement that the evaluation be conducted "according to the
sanitary or phytosanitary measures which might be applied", we note that this expression refers to
the measures which might  be applied, not merely to the measures which are being  applied.  This
suggests to us that it cannot be assumed that it would be sufficient, under this provision, to simply
consider the particular measures that are already in place, to the exclusion of other possible
alternatives.
8.284  In this instance, it is apparent from the introductory paragraph of the last chapter of
Japan's PRA that it has aimed specifically to assess "whether or not 'plant quarantine measures
                                                     
401 Dr Hale, para. 6.177.  See also Dr Smith, para. 6.181-6.181.
402 US first submission para 83, citing Appellate Body Report in Australia – Salmon , para. 133.WT/DS245/R
Page 196
against E.  amylovora  concerning US fresh apple fruit', which have been taken by Japan based on
the proposal by the US government since 1994, are adequate".403
8.285  We note, in this respect, that Japan does not appear to have considered any alternative
measures other than these existing measures.  We recall that the requirement that the risk
assessment be "appropriate to the circumstances" , has been considered to leave some flexibility
for an assessment of risk, "on a case to case basis, in terms of product, origin and destination, in
particular country specific situations".404  Arguably, in this instance, part of the circumstances of
this particular risk assessment was the fact that the overall Japanese scheme involves an a priori
prohibition of imports of host plants of fire blight and that this risk assessment was being
conducted specifically to verify the viability of a specific set of measures, in order to lift the ban
in circumstances suggested and identified by the exporting country itself.  The terms of this
provision, which refers generally to the measures which "might be applied", suggest to us,however, that consideration should be given not just to those specific measures which are
currently in application, but at least to a potential range of relevant measures.  Japan has not, in
this instance, attempted to identify any other ri sk-mitigating measures than those actually applied
as a result of its discussions with the United States.  In this respect, Japan has not, in our view,
properly evaluated the likelihood of entry "according to the SPS measures that might be applied".
8.286  With regard to the actual evaluation performed by Japan in relation to those measures
which it has identified, we recall the Appellate Body's observation in the Australia – Salmon  case
that "some" evaluation of the likelihood of entry [according to the SPS measures which might be
applied] is not enough.
405  We also note that in reaching its conclusion that the Australian risk
assessment did not, in that case, meet the third requirement for risk assessments of this type (i.e.an evaluation according to the SPS measures that might be applied ), the Appellate Body
highlighted the following observations of the pane l with regard to the quarantine policy options
considered to reduce the total risk associated with the disease of concern:
"the … Report does not substantively evaluate the relative risks associated with
these different options.  Even though the definition of risk assessment requires an"evaluation … according to the sanitary … measures which might be applied",
the … Report identifies such measures but does not, in any substantial way,
evaluate or assess their relative effectiveness in reducing the overall disease
risk."
406
8.287  In this instance, each of the measures applied is considered and described in turn in
Japan's 1999 PRA, and a brief conclusion is drawn in respect of each of them.  While this
analysis might be considered to provide "some" evaluation of the risk of entry, establishment orspread and its mitigation through the relevant measure, it seems to suffer from flaws in part
linked to the insufficiency of the evaluation of the likelihood itself, and provides only a cursory
assessment of some of the proposed measures.  The evaluation "according to the measure which
might be applied" is considerably less substantial in terms of consideration of the relevant
scientific evidence than that found to be insufficient in the Australia – Salmon  case.
                                                     
403 1999 PRA, Section 3-1. The United States, however, argues that it accepted the fire blight
measures imposed by Japan only reluctantly, recognizing that the scientific evidence did not support therestrictions.  See para. 4.29 above.
404 Report of the Panel in Australia – Salmon , para 8.71.
405 Appellate Body Report in Australia – Salmon , para. 134.
406 Ibid, para. 133, citing from panel report para 8.90.WT/DS245/R
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8.288  We also note that a general conclusion is drawn that "so long as [the group of measures
under consideration] are adequately obeyed, there is no possibility that fresh apples exported to
Japan would be infected with or contaminated by E. amylovora  through any of cultivation,
harvest, selection of fruit, packing or transportation, and E. amylovora  could never, of course, be
introduced via those fruit".407  However, no attempt is made to assess the "relative effectiveness"
of the various individual requirements applied, and the assessment appears to be based on theassumption from the outset that all these measures would apply cumulatively.  In our view,
however, an assessment "according to the SPS measur es that might be applied" suggests that it
would not be sufficient, where a number of distinct measures are considered, to simply draw a
general conclusion on their overall combined efficiency, without any analysis of their relative
effectiveness and whether and why all of them in combination are required in order to reduce or
eliminate the possibility of entry, establishment or spread of the disease.
8.289  We further recall the opinions of Dr Hale and Dr Smith that the 1999 PRA "appeared to
prejudge the outcome of its risk assessment"
408 and that "it was principally concerned to show
that each of the measures already in place was effective in some respect, and concluded that all
should therefore be applied".409  Dr Smith in particular noted that "the question of whether any
single measure or combination of fewer measures, could reduce the risk to an acceptable level
was not addressed".410  He further concluded that: "the Japanese PRA had not clearly explained
why all the measures it applied were needed".411
8.290  In light of the above, we find that Japan's 1999 PRA concerning fire blight in
relation to fresh apples produced in the United  States does not meet the requirements of a
risk assessment within the meaning of Article 5.1, as defined in Annex A, paragraph 4, of
the SPS Agreement .
3. Is the measure "based on" a risk assessment?
8.291  In light of our finding above that Japan's PRA does not amount to a risk assessment
within the meaning of Article 5.1, we must al so, as a consequence, conclude that Japan's
measures are not "based on" a risk assessment .  We therefore do not examine this issue
further.
4. Conclusion
8.292  In conclusion, we find that the United States has made a prima facie case that Japan
has violated Article 5.1 of the SPS Agreement, which Japan has not rebutted.  In light of this
finding, we do not find it necessary to cons ider whether the measure at issue is also in
violation of Article 5.2 of the Agreement, which identifies further specific factors that
Members are required to take into a ccount in their assessment of risks.
                                                     
407 1999 PRA, section 3-2-3.
408 Dr Hale, para. 6.177.
409 Dr Smith, para. 6.180.
410 Ibid.
411 Ibid.WT/DS245/R
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G. ARTICLE 5.6 OF THE SPS AGREEMENT
1. Summary of the arguments of the parties412
8.293  The United States claims that Japan has acted inconsistently with Article 5.6 of the SPS
Agreement  because Japan's fire blight measures are more trade-restrictive than required to
achieve Japan’s appropriate level of phytosanitary protection.  The United States contends thatrestricting importation to mature, symptomless apple fruit is an alternative measure that is
reasonably available, achieves Japan’s appropriate level of protection (ALOP), and is
significantly less restrictive to trade than Japan's fire blight measures.
8.294  The United States contends that the fact that Japan’s fire blight measures are more trade-
restrictive than necessary is also evident from the range of other possible measures that could be
envisaged that are less trade-restrictive and that would more than achieve Japan’s appropriate
level of protection.  The United States identified four possible measures:
(a) Japan could require a phytosanitary certificate that the exported commodity
(mature apple fruit) is free from fire blight;
(b) Japan could require that imported mature, symptomless fruits be harvested in the
states of Washington or Oregon;
(c) Japan could require that imported mature, symptomless fruits be harvested
 at
least 10 meters from a source of inoculum;
(d) Japan could require that imported mature, symptomless fruits be treated with
chlorine.
8.295  The United States adds that as the scientific evidence established that apple fruit had
never transmitted fire blight and that mature, symptomless fruit are not a pathway for the disease,any of these less trade-restrictive measures would more than achieve Japan’s appropriate level of
protection.  However, for the same reason, the United States argues that, with the exception of the
alternative measure in 8.294(a) above, they would also be more trade-restrictive than necessary.
Hence, the United States believes that a requirement that exported US apples be mature and
symptomless, including through the submission of a phytosanitary certificate, would constitute
the only requirement that could be considered as necessary given the scientific evidence.
8.296  The United States argues that its grading standards and law, enforced by federal and/or
state inspectors, require exported apples to be mature and symptomless.  Apples exported from
the United States are inspected for compliance and each fruit passes multiple human and
machine-based examinations which categorically exclude immature fruit.
8.297  Japan argues that the exportation of "mature, symptomless" apple fruit to Japan would
not achieve Japan’s appropriate level of protection.  The alternative proposed by the United Statesis (1) not based on scientific evidence, (2) not supported by real life experience, (3) not practical
to implement, and (4) not scientifically sound.  Japan claims that the United States has not
defined exactly what "mature, symptomless" fruit would mean.  Nor has the United States defined
                                                     
412 A detailed account of the arguments of the parties can be found in paras. 4.181-4.200 of this
Report.WT/DS245/R
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specific means to produce, select and export only such apple fruit.  Consequently, Japan requests
the Panel to consider the "mature, symptomless" criteria as ambiguous and easily manipulated.
Japan argues that the "mature, apparently healthy" apple fruit criteria could offer security only
when the mechanism by which the bacteria did not exist in such fruit was identified.
8.298  Japan believes that the risk  of accidental contamination or erroneous grading is very real.
As such, the United States is proposing to replace Japan's current phytosanitary requirements withsomething:  (1) the efficacy of which is questionable;  and (2) the quality of which the United
States does not guarantee.  On this basis, Japan argues that it would be a grave mistake to assume
the US proposal would achieve Japan's appropriate level of protection or would provide security
at a level comparable to that of the current requirements.
2. Analysis of the Panel
8.299  We have already found above that the phytosanitary measure at issue (i.e. Japan's
measure as a whole), breaches Articles 2.2, 5.7 and 5.1 of the SPS Agreement .  We note that, as
stated by the Appellate Body in Australia – Salmon ,
"a panel has to address those claims on which a finding is necessary in order to
enable the DSB to make sufficiently precise recommendations and rulings so as
to allow for prompt compliance by a Member with those recommendations and
rulings 'in order to ensure effective resolution of disputes to the benefit of allMembers'."
413
8.300  Therefore, we find it relevant to consider the merits of making a finding in relation to
Article 5.6 of the SPS Agreement .  As recalled by the Appellate Body in United States – Wool
Shirts and Blouses , "a panel need only address those claims which must be  addressed in order to
resolve the matter at issue".414  Therefore, we must determine whether this additional finding
would be necessary for the formulation of sufficiently precise recommendations and rulings so as
to allow for prompt compliance by Japan.
8.301  We note that Article 5.6 of the SPS Agreement  provides as follows:
"Without prejudice to paragraph 2 of Article 3, when establishing or maintaining
sanitary or phytosanitary measures to achieve the appropriate level of sanitary orphytosanitary protection, Members shall ensure that such measures are not more
trade-restrictive than required to achieve their appropriate level of sanitary or
phytosanitary protection, taking into account technical and economic
feasibility."[footnote 3]
Footnote 3 to Article 5.6 of the SPS Agreement  reads as follows:
"For purposes of paragraph 6 of Article 5, a measure is not more trade restrictive
than required unless there is another measure, reasonably available taking intoaccount technical and economic feasibility, that achieves the appropriate level of
sanitary or phytosanitary protection and is significantly less restrictive to trade."
                                                     
413 Appellate Body Report in Australia – Salmon , para. 223, quoting Article 21.1 of the DSU.
414 Appellate Body Report in United States – Wool Shirts and Blouses , p. 340.WT/DS245/R
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8.302  We recall that what we are reviewing in this case – including with respect to the US
claim under Article 5.6 - is the phytosanitary measure at issue  as a whole , not certain elements of
it.  In particular, we are not expected to reach a conclusion as to whether some elements of that
measure would individually meet the requirements of Article 5.6.  Likewise, we are not mandated
to find whether some alternative measure would be compatible with the SPS Agreement  while
meeting Japan's phytosanitary objectives.415
8.303  We have already found that the phytosanitary measure at issue is maintained without
sufficient scientific evidence, in contravention of Article 2.2.  In other words, this measure cannot
be maintained as such by Japan.  A finding under Article 5.6 would not add anything in terms of
legal implications.416  In particular, it would not automatically mean that any alternative measure
that could be identified would be the only acceptable alternative to Japan's phytosanitary measure
in terms of the requirements of Article 5.6.  Such a finding would simply establish that Japan'sphytosanitary measure as a whole  is more trade-restrictive than required to achieve Japan's
appropriate level of phytosanitary protection.  In a context where it has already been established
that the phytosanitary measure at issue cannot be maintained, another finding to the same effect
that the measure cannot be maintained would be of no practical advantage and thus would be of
no assistance to the DSB.
8.304  We therefore decide to exercise judicial economy with regard to the US claim under
Article 5.6 and refrain from making any finding.
H. 
ARTICLE 7 AND ANNEX B OF THE SPS AGREEMENT
1. Summary of the arguments of the parties417
8.305  The United States claims that Japan has acted in violation of Article 7 and Annex B,
paragraphs 5 and 7 of the SPS Agreement , in that it has not notified changes introduced to its fire
blight measures since the entry into force of the SPS Agreement  in 1995.  More specifically, the
United States considers that Japan should have notified to WTO Members the changes effected
through Japan's MAFF Notification No. 354, dated 10 March 1997, because it changes Japan's
fire blight restrictions and imposes a regulation not based on international standards.
8.306  The United States notes that Japan has substantively changed its fire blight measures
since 1995, and has failed to notify these changes.  The United States points to four distinct
measures by which Japan imposes its requirements regarding fire blight measures: the Plant
Protection Law No. 151, Article 7;  the Plant Protection Law Enforcement Regulations, Article 9
and Annexed Table 2;  the MAFF Notification No. 354;  and the MAFF Detailed Rules for US
Apples.  The United States argues that the latter two of these measures "appear to have been
amended or introduced since 1995 without being notified to WTO Members".418
8.307  Japan considers that, contrary to the US assertions, it did not substantively change its fire
blight measures since the entry into force of the SPS Agreement  in 1995.  It further notes that it
                                                     
415 See para. 8.225.
416 We recall in this respect that our recommendations are limited, pursuant to Article 19.1 of the
DSU, to recommend that the Member concerned bring its measure into conformity with the SPS
Agreement .
417 A detailed account of the arguments of the parties can be found in paras. 4.222-4.223 of this
Report.
418 US first submission, para. 114.WT/DS245/R
Page 201
had notified that it would designate E. amylovora  as one of the diseases that trigger import
prohibition as of 1 April 1997, in accordance with the requirements of Article 7 and Annex B.419
In Japan's view, the amendments to the notification and the Detailed Rules in 1997 were technicalrephrasing of the regulations reflecting the designation of the bacterium, which did not modify in
any way the phytosanitary requirements against fire blight.
8.308  In response, the United States observes that this notification "provided notice that Japan's
Plant Protection Law Enforcement Regulations would be amended to designate E. amylovora  as a
pest subject to import prohibition"
420, but that in its view, a notification of changes to the Plant
Protection Act could not be considered as a notification of changes to other fire blight measures.
2. Assessment by the Panel
8.309  Article 7 of the SPS Agreement  provides as follows:
"Members shall notify changes in their sanitary or phytosanitary measures and
shall provide information on their sanitary or phytosanitary measures inaccordance with the provisions of Annex B."
8.310  Annex B to the SPS Agreement  contains a number of provisions relating to transparency
of SPS measures, including notifications.  More specifically, paragraph 5 of Annex B foresees the
notification of SPS regulations if a number of conditions are cumulatively met, i.e.:
(a) where a relevant international standard does not exist or the content of the
proposed measure is not substantially the same as the content of an international
standard, guideline or recommendation, and
(b) if the regulation may have a significant effect on trade of other Members.
Paragraph 7 of Annex B, which the United States also argues has been violated by Japan,
provides that notifications shall be in French, Spanish or English.  The Committee on SPSMeasures has adopted recommended guidelines with regard to paragraphs 5 and 6 of Annex B.
421
8.311  We understand the US claim in respect of Article 7 and Annex B to be limited to two
measures only:  MAFF Notification No. 354 of March 1997 and the Detailed Rules for US
Apples of April 1997, replacing prior similar instru ments.  In the US view, the notification made
by Japan in respect of its Plant Protection Law Enforcement Regulation does not "cover" these
separate instruments.  Japan, for its part, has indicated in response to a question from the Panel
that this notification has no relationship or relevance to the measures at issue, because the change
in the regulatory status of E.  amylovora (i.e. its designation as one of the pests that automatically
triggers importation prohibition of host plants) did not in any way affect the measure at issue,
which was  already in place.
8.312  Both parties thus seem to agree that although Japan made, in 1997, a notification through
which it identified fire blight as a pest triggering import prohibition under the Plant Protection
Act, this notification is not directly relevant to the measures whose notification is a issue here, i.e.
MAFF Notification No. 354 and the 1997 Detailed Ru les for US Apples.  The question before us
                                                     
419 Notification contained in G/SPS/N/JPN/19.
420 US answers to additional questions from the Panel, 28 January 2003, para. 42.
421 G/SPS/7/Rev.2, April 2002, and earlier recommendations.WT/DS245/R
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is therefore whether these two instruments, which are subsequent to the entry into force of the
SPS Agreement , should have been notified under Article 7 and Annex B.
8.313  It is not disputed that the present situation is one where "an international standard,
guideline or recommendation does not exist [regarding E. amylovora ] or the content of a
proposed sanitary or phytosanitary regulation is not substantially the same as the content of aninternational standard, guideline or recommendation".  Therefore, we must  determine whether
the changes identified above constitute changes which are required to be notified under Article 7
because, inter alia , they "may have a significant effect on trade of other Members" in the context
of the chapeau to Paragraph 5 of Annex B.
8.314  We consider that the most important factor in this regard is whether the change affects
the conditions of market access for the product concerned, that is, would the exported product
(apple fruit from the United States in this case) st ill be permitted to enter Japan if they complied
with the prescription contained in the previous regulations.
422  If this is not the case, then we must
consider whether the change could be considered to potentially have a significant  effect on trade
of other Members.  In this regard, it would be relevant to consider whether the change has
resulted in any increase in production, packaging and sales costs, such as more onerous treatment
requirements or more time-consuming administrative formalities.
8.315  We note that the United States essentially states that Japan "substantially changed its fire
blight measures since the entry into force of the SPS Agreement ".  The United States adds that
Japan appeared to have amended or introduced MAFF Notification No. 354 on 10 March 1997,
which set the requirements for imports of US apples into Japan, and MAFF "Detailed Rules for
US Apples" on 1 April 1997, which implemented Notification No. 354.  However, the UnitedStates did not specify in what respect Japan had "substantially changed" its fire blight measures.
On the other hand, Japan does not admit that it changed its phytosanitary measures for fire blight
since 1994.
8.316  We recall that, in EC – Hormones , the Appellate Body noted that
"… Panels are inhibited from addressing legal claims falling outside their terms
of reference. However, nothing in the DSU limits the faculty of a panel freely to
use arguments submitted by any of the parties – or to develop its own legal
reasoning – to support its own findings and conclusions on the matter under its
consideration."
8.317  However, the Appellate Body clarified in Korea – Dairy  that "[B]oth 'claims' and
'arguments' are distinct from the 'evidence' which the complainant or respondent presents to
support its assertions of facts and arguments".
423  We note in this regard that the party making an
allegation must provide sufficient evidence in support of this allegation, and that a panel should
not entertain a claim for which a prima facie case has not been made.424  In the present case, the
United States has effectively argued that Japan had substantially changed its fire blight measures
since the entry into force of the SPS Agreement.  However, the United States limited its
                                                     
422 This approach is in line with the discussion of  the concept of "significant effect on trade of
other Members" in the notification procedures adopted and revised by the SPS Committee G/SPS/7/Rev.2,
para. 7).
423 Appellate Body in Korea – Dairy , para. 139.
424 Appellate Body Report in Japan – Agricultural Products II , para.126.WT/DS245/R
Page 203
argumentation to mention that new regulations had been implemented and to attach translations
of the regulations to its first written submission.  It did not specify in what respect these new
regulations departed from the previous ones.
8.318  Indeed, either the United States knows in which respect the 1997 texts differ from the
ones they replace – in which case it could and should have mentioned it in its submissions - or it
does not, in which case it cannot be deemed to have established a prima facie case.  In eithersituation, for the Panel to examine the regulations at issue to identify differences would be
equivalent to "making a case" for the United States, something we are not allowed to do.  For
these reasons we conclude that the United States did not establish a prima facie case in relation to
the violation of Article 7 and Annex B of the SPS Agreement .
8.319  Even if we were to address that claim, we do not consider that a violation of Article 7 and
Annex B has been established. Article 7 of the SPS Agreement  requires Members to notify
"changes" in their SPS measures.
425  We note that the MAFF Notification No. 354, dated 10
March 1997, replaced MAFF notification No. 1184, of 22 August 1994.426  Similarly, the
Detailed Rules for US Apples, dated 1 April 1997, replaced the MAFF Detailed Rules for US
Apples of 22 August 1994.427  We note that both of the preceding instruments predated the entry
into force of the SPS Agreement .  We should therefore consider whether the new instruments
adopted in 1997 (subsequent to the entry into force of the Agreement) introduced changes inJapan's SPS measures such that they should have been notified to WTO Members under Article 7
of the SPS Agreement .
8.320  In comparing the MAFF Notification of 1997 with that of 1994, it seems that they both
overall follow a very similar structure and contents.  Nonetheless, it can be noted that:  (1) in the
definition of the plants and areas, the 1994 Notification requires that the designation of the area ofproduction as "under intensive pests and diseases control", whereas the 1997 Notification refers
to areas "where intensive control for coddling moth is conducted and also where the US plant
protection authority inspect at proper times" (para. 1);  (2) the phytosanitary certificate required
under the 1994 Notification refers to codling moth only, whereas the 1997 certificate refers both
to codling moth and fire blight;  and (3) a requirement for the fruit surface to be sterilized wasadded in the 1997 Notification, compared with the 1994 Notification.
8.321  We recall that the MAFF Notification of 1997 has included a requirement for the fruit
surface to be sterilized which did not appear in the 1994 MAFF Notification as such.  Yet, this
requirement was already applicable to apples exported from the United States pursuant to another
legal instruments:  the 1994 MAFF "Detailed Rules for US Apples", at paragraph 6(2).
8.322  We note that a phytosanitary certificate which included only the information required
according to the 1994 MAFF Notification would presumably no longer be acceptable since it didnot contain the specific information regarding also fire blight required according to the 1997
notification.  We note however, on the basis of information submitted by Japan at the interim
review stage, that the additional requirements re sulting from the 1997 Notification are limited and
unlikely to "have a significant effect on trade" in apples from the United States.
                                                     
425 In this respect, we do not believe that changes of legal instruments require, in all instances,
notification.
426 Exhibit US-11.
427 Exhibit US-12.WT/DS245/R
Page 204
8.323  Finally, we note the differences in the definitions of plants and areas in the 1994 and the
1997 Notifications.  Since measures were already applied in relation to fire blight before 1997,
we do not consider that the change in definitions that we identified would be such as to "have
significant effect on trade" in apples from the United States.
8.324  We conclude, therefore, that the MAFF Notification of 1997 may reflect a change in a
phytosanitary measure whose content is "not substantially the same as the content of an
international standard".  However, we do not consider that those changes "may have a significant
effect on trade of other Members" and that Japan was required to notify them in accordance with
Article 7 and Annex B of the SPS Agreement .
8.325  As for the MAFF Detailed Rules for US apples, the 1994 rules already refer to designated
areas as areas "with no infection and non-export area or buffer zone in accordance with the
following conditions for fire blight" and defines buffer zones and disease-free status for theseareas.  These appear to be unchanged in the 1997 Detailed Rules.  The 1994 Detailed Rules
already clearly contain detailed requirements specifically concerning fire blight, and some of
these are adjusted in the 1997 Detailed Rules, although it is difficult to judge how substantial
such changes actually are.
8.326  We note that most of the changes in the MAFF Detailed Rules for US Apples do not
appear to have resulted in any further change which might have affected the access of US apples
to Japan.  However, when considering the Detailed Rules that have been translated into English
from the Japanese language it is difficult to de termine whether a change is strictly editorial or
whether a more substantial change has been introduced.  We are therefore unable to reach any
conclusion as to whether Japan was required to notify the changes in the MAFF Detailed Rulesfor US Apples introduced in 1997.
8.327  For these reasons, we find that the United States failed to make a prima facie case in
relation to the violation of Article 7 and Annex B of the SPS Agreement .
I. 
ARTICLE XI OF GATT 1994
8.328  We have found above that the phytosanitary measure at issue violates Articles 2.2, 5.7
and 5.1 of the SPS Agreement.  Under those circumstances, we find it appropriate to exercise
judicial economy as previous panels did in similar situations in relation to alleged violations of
provisions of GATT 1994.428
8.329  Since we have found that the phytosanitary measure at issue is inconsistent with the
requirements of the SPS Agreement , we see no need to further examine whether this
measure is also inconsistent with Article XI of GATT 1994.
J. OTHER CLAIMS INCLUDED IN THE REQUEST FOR ESTABLISHMENT OF THE PANEL
8.330  We recall that the United States' request for establishment of a panel contains, in addition
to the claims already addressed above, the following claims:
                                                     
428 Panel Report in EC – Hormones (Canada) , para. 8.275; Panel Report in Australia – Salmon ,
para. 8.185.WT/DS245/R
Page 205
"These measures appear to be inconsistent with the commitments and obligations
of Japan under … Article 4.2 of the Agreement on Agriculture , and Articles … ,
2.3, … , … , 5.3, 5.5, … , 6.1, 6.2 … of the Agreement on the Application of
Sanitary and Phytosanitary Measures  (SPS Agreement ).  Japan's measures also
appear to nullify or impair the benefits accruing to the United States directly or
indirectly under the cited agreements." 429
8.331  Out of these claims, only one – the violation of Article 4.2 of the Agreement on
Agriculture -  was briefly addressed by the United States in its oral submissions before the Panel.
8.332  As mentioned above430, we are mindful that our findings must assist the DSB in making
sufficiently precise recommendations and rulings so as to allow for prompt compliance, in order
to ensure effective resolution of the dispute.  Since we have found that the phytosanitary measure
at issue is inconsistent with several provisions of the SPS Agreement , we see no particular reason
to address the claim of the United States regarding Article 4.2.
8.333  Therefore, we exercise judicial economy and refrain from making any findings with
regard to Article 4.2 of the Agreement on Agriculture.
8.334  Regarding the other provisions referred to in the US request for establishment of a panel,
namely Articles 2.3, 5.3, 5.5, 6.1 and 6.2 of the SPS Agreement , we recall that they were not
addressed by the United States in any of its submissions.  While they could be considered to bewithin our terms of reference, we note that, in order for us to make a finding on these claim, the
United States should have made a prima facie case for each of them.  The United States did not
make such a prima facie case for each of these claims.
8.335  Under these circumstances, we refrain from making any finding regarding the
consistency of the phytosanitary measure at issue with Articles 2.3, 5.3, 5.5, 6.1 and 6.2 ofthe SPS Agreement .
8.336  Finally, since we found a violation of the SPS Agreement , we see no need to
determine whether Japan's measures also nullifi es or impairs the benefits accruing to the
United States directly or indirectly under the cited agreements in the absence of violation.
IX. CONCLUSIONS
9.1 In light of the findings above, we reach the following conclusions:
(a) Japan, by maintaining the phytosani tary measure at issue, violated
Article 2.2 of the SPS Agreement  not to maintain phytosanitary measures
"without sufficient scientific evidence, except as provided for in paragraph 7
of Article 5";
(b) the phytosanitary measure at issue does not comply with the requirement
under Article 5.7 of the SPS Agreement  that relevant scientific evidence be
insufficient in order to justify the application of the phytosanitary measure
at issue as a provisionally adopted measure;  and
                                                     
429 WT/DS245/2 (emphasis in the original).
430 See, e.g., para. 8.4, referring to the Appellate Body Report in Australia - Salmon , para. 223.WT/DS245/R
Page 206
(c) the phytosanitary measure at issue is not based on a risk assessment within
the meaning of Article 5.1 of the SPS Agreement .
9.2 Article 3.8 of the DSU provides that "[i]n cases where there is an infringement of the
obligations assumed under a covered agreement [including the SPS Agreement ], the action is
considered prima facie to constitute a case of  nullification or impairment".  We note that Japanfailed to rebut this presumption.  We conclude that, to the extent Japan has acted inconsistently
with the SPS Agreement , it has nullified or impaired the benefits accruing to the United States
under the SPS Agreement .
9.3 We recommend that the Dispute Settlement Body request Japan to bring the
phytosanitary measure in dispute into conformity with its obligations under the SPS Agreement.WT/DS245/R
Page 207
ANNEX 1
JAPAN – MEASURES AFFECTING THE IMPORTATION OF APPLES (DS245)
Working Procedures for the Panel
1. In its proceedings the Panel shall follow the relevant provisions of the Dispute Settlement
Understanding (DSU).  In addition, the following working procedures shall apply.
2. The panel shall meet in closed session.  The parties to the dispute, and interested third
parties, shall be present at the meetings only when invited by the Panel to appear before it.
3. The deliberations of the Panel and the documents submitted to it shall be kept confidential.
Nothing in the DSU shall preclude a party to a dispute from disclosing statements of its own
positions to the public.  Members shall treat as confidential information submitted by another
Member to the Panel which that Member has designated as confidential.  Where a party to a
dispute submits a confidential version of its written submissions to the Panel, it shall also, uponrequest of a Member, provide a non-confidential summary of the information contained in its
submissions that could be disclosed to the public.
4. Before the first substantive meeting of the Panel with the parties, the parties to the dispute
shall transmit to the Panel written submissions in which they present the facts of the case and theirarguments.  Third parties may transmit to the Panel written submissions after the first written
submissions of the parties have been submitted.
5. At its first substantive meeting with the parties, the Panel shall ask the United States to
present its case.  Subsequently, and still at the same meeting, Japan will be asked to present itspoint of view.  Third parties will be asked to pres ent their views thereafter at the separate session of
the same meeting set aside for that purpose.  The parties will then be allowed an opportunity for
final statements, with the United States presenting its statement first.
6. All third parties which have notified their inte rest in the dispute to the Dispute Settlement
Body shall be invited in writing to present thei r views during a session of the first substantive
meeting of the Panel set aside for that purpose.  All such third parties may be present during the
entirety of this session.
7. Formal rebuttals shall be made at a second substantive meeting of the Panel. Japan shall
have the right to take the floor first, to be foll owed by the United States.  The parties shall submit,
prior to that meeting, written rebuttals to the Panel.
8. Within seven days following the submission or presentation concerned, each of the parties
and third parties shall provide the Panel with an executive summary of the claims and arguments
contained in their written submissions and oral presentations.  The executive summaries will be
used only for the purpose of assisting the Panel in drafting a concise arguments section of the Panelreport to the Members.  They shall not in any way serve as a substitute for the submissions of the
parties in the Panel’s examination of the case.  The executive summaries of the written submissions
to be provided by each party should not exceed 10 pages in length each and the executive
summaries of the oral presentations should not exceed 5 pages in length each.  The summary to be
provided by each third party shall summarize their written submission and oral presentation, andshould not exceed 5 pages in length.WT/DS245/R
Page 208
9. The Panel may at any time put questions to the parties and to the third parties and ask them
for explanations either in the course of a meeting or in writing.  Answers to questions shall be
submitted in writing by the date(s) specified by the Panel.  Answers to questions after the first
meeting shall be submitted in writing at the same time as the written rebuttals, unless the Panelspecifies a different deadline.
10. A party shall submit any request for a preliminary ruling not later than its first submission
to the Panel.  If the complaining party request s such a ruling, the respondent shall submit its
response to the request in its first submission.  If the respondent requests such a  ruling, the
complaining party shall submit its response to the request prior to the first substantive meeting of
the Panel, at a time to be determined by the Panel in light of the request.  Exceptions to thisprocedure will be granted upon a showing of good cause.
11. Parties shall submit all factual evidence to the Panel no later than during the first
substantive meeting, except with respect to evidence necessary for purposes of rebuttals or answers
to questions.  Exceptions to this procedure will be granted upon a showing of good cause.  In suchcases, the other party shall be accorded a period of time for comment, as appropriate.
12. The parties to the dispute have the right to determine the composition of their own
delegations. The parties shall have the responsibility for all members of their delegations and shall
ensure that all members of the delegation act in accordance with the rules of the DSU and theWorking Procedures of this Panel, particularly in regard to confidentiality of the proceedings.
13. The parties to the dispute and any third party invited to present its views shall make
available to the Panel and the other party or parties a written version of their oral statements,
preferably at the end of the meeting, and in any event not later than the day following the meeting.
Parties and third parties are encouraged to provide the Panel and other participants in the meeting
with a provisional written version of their oral statements at the time the oral statement is
presented.
14. In the interest of full transparency, the presentations, rebuttals and statements shall be
made in the presence of the parties.  Moreover, each party's written submissions, including
responses to questions put by the Panel, shall be made available to the other party.
15. To facilitate the maintenance of the record of the dispute, and to maximize the clarity of
submissions, in particular the references to exhibits submitted by parties, parties shall sequentially
number their exhibits throughout the course of the dispute.  For example, exhibits submitted by the
United States could be numbered USA-1, USA-2, etc.  If the last exhibit in connection with thefirst submission was numbered USA-5, the first exhibit of the next submission thus would be
numbered USA-6.
16. Following issuance of the interim report, the parties shall have two weeks to submit written
requests to review precise aspects of the interim report and to request a further meeting with thePanel.  The right to request such a meeting must be  exercised no later than at that time.  Following
receipt of any written requests for review, if no further meeting with the Panel is requested, the
parties shall have the opportunity, within a time-period specified by the Panel, to submit written
comments on the other party's written requests for review.  Such comments shall be strictly limited
to responding to the other party's written request for review.WT/DS245/R
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17. The following procedures regarding service of documents shall apply:
(a) Each party shall serve its submissions directly on the other party.  Each party shall,
in addition, serve its first written submission on third parties.  Each third party
shall serve its submissions on the parties and other third parties.  Parties and third
parties shall confirm, at the time a submission is provided to the Panel, that copieshave been served as required.
(b) The parties and the third parties should provide their written submissions to the
Dispute Settlement Registrar by 5:30 p.m. on the deadlines established by the
Panel. The parties and the third parties shall provide the Panel with 10 paper
copies of their written submissions.  All these copies must be filed with the
Dispute Settlement Registrar, Mr Ferdinand Ferranco (Office 3154).
(c) At the time they provide paper copies of their submissions, the parties and third
parties shall also provide the Panel with an electronic copy of the submissions on a
diskette or as an e-mail attachment, if possible in a format compatible with the
Secretariat's software (e-mail to the Dispute Settlement Registrar at
Dsregistry@wto.org, with a copy to the Secretary of the Panel, Mr Michael
Roberts at michael.roberts@wto.org, Ms. Gretchen Stanton atgretchen.stanton@wto.org, Ms. Kerry Allbeury at kerry.allbeury@wto.org and Mr
Yves Renouf at yves.renouf@wto.org )
(d) Parties and third parties shall provide the Panel with written copies of their oral
submissions no later than the day following the date of the presentation.  Written
replies to questions shall be submitted by a date to be decided by the Panel.WT/DS245/R
Page 210
ANNEX 2
ABBREVIATIONS USED FOR DISPUTE SETTLEMENT CASES
REFERRED TO IN THE REPORT
SHORT TITLE FULL TITLE
Australia – Salmon Panel Report, Australia – Measures Affecting Importation of Salmon ,
WT/DS18/R and Corr.1, adopted 6 November 1998, as modified by the AppellateBody Report, DSR 1998:VIII, 3407.
Australia – Salmon Appellate Body Report, Australia – Measures Affecting Importation of Salmon ,
WT/DS18/AB/R, adopted 6 November 1998, DSR 1998:VIII, 3327.
Australia – Salmon(Article 21.5 – Canada)Panel Report, Australia – Measures Affecting Importation of Salmon – Recourse
to Article 21.5 of the DSU by Canada , WT/DS18/RW, adopted 20 March 2000,
DSR 2000:IV, 2035
Brazil – Aircraft Appellate Body Report, Brazil – Export Financing Programme for Aircraft ,
WT/DS46/AB/R, adopted 20 August 1999, DSR 1999:III, 1161.
Chile – Price Band System Panel Report, Chile – Price Band System and Safeguard Measures Relating to
Certain Agricultural Products , WT/DS207/R, 3 May 2002, adopted
23 October 2002, as modified by the Appellate Body Report, WT/DS207AB/R.
Chile – Price Band System Appellate Body Report, Chile – Price Band System and Safeguard Measures
Relating to Certain Agricultural Products , WT/DS207/AB/R, adopted
23 October 2002.
EC – Asbestos Appellate Body Report, European Communities – Measures Affecting Asbestos
and Asbestos-Containing Products , WT/DS135/AB/R, adopted 5 April 2001.
EC – Bananas III Appellate Body Report, European Communities – Regime for the Importation,
Sale and Distribution of Bananas , WT/DS27/AB/R, adopted 25 September 1997,
DSR 1997:II, 591.
EC – Hormones (Canada) Panel Report, EC Measures Concerning Meat and Meat Products (Hormones) –
Complaint by Canada , WT/DS48/R/CAN, adopted 13 February 1998, as
modified by the Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R,
DSR 1998:II, 235.
EC – Hormones (US) Panel Report, EC Measures Concerning Meat and Meat Products (Hormones) –
Complaint by the United States , WT/DS26/R/USA, adopted 13 February 1998, as
modified by the Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R,
DSR 1998:III, 699.
EEC – Dessert Apples Panel Report, European Economic Community  – Restrictions on Imports of
Dessert Apples  – Complaint by Chile  ("EEC – Dessert Apples ), adopted
12 July 1983, BISD 30S/129.
EC – Sardines Appellate Body Report, European Communities – Trade Description of Sardines ,
WT/DS231/AB/R, adopted 2002.
India – Patents (EC) Panel Report, India – Patent Protection for Pharmaceutical and Agricultural
Chemical Products – Complaint by the European Communities , WT/DS79/R,
adopted 22 September 1998, DSR 1998:VI, 2661.
India – Patents (US) Panel Report, India – Patent Protection for Pharmaceutical and Agricultural
Chemical Products , WT/DS50/R, adopted 16 January 1998, as modified by the
Appellate Body Report, WT/DS50/AB/R, DSR 1998:I, 41.WT/DS245/R
Page 211
SHORT TITLE FULL TITLE
Japan – Agricultural
Products IIPanel Report, Japan – Measures Affecting Agricultural Products , WT/DS76/R,
adopted 19 March 1999, as modified by the Appellate Body Report,
WT/DS76/AB/R, DSR 1999:I, 315.
Japan – Film Panel Report, Japan – Measures Affecting Consumer Photographic Film and
Paper , WT/DS44/R, adopted 22 April 1998, DSR 1998:IV, 1179.
Japan – Semi-Conductors Panel Report, Japan – Trade in Semi-Conductors  ("Japan – Semi-Conductors "),
adopted 4 May 1988, BISD 35S/116.
Korea - Dairy Panel Report, Korea – Definitive Safeguard Measure on Imports of Certain Dairy
Products  ("Korea – Dairy" ), WT/DS98/R and Corr.1, adopted 12 January 2000,
as modified by the Appellate Body Report, WT/DS98/AB/R/, DSR 2000:I, 49
US – Wool Shirts and
BlousesAppellate Body Report, United States – Measure Affecting Imports of Woven
Wool Shirts and Blouses from India , WT/DS33/AB/R and Corr.1, adopted
23 May 1997, DSR 1997:I, 323.WT/DS245/R
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ANNEX 3
TRANSCRIPT FROM PANEL MEETING WITH EXPERTS
OF 13 JANUARY (AFTERNOON) AND 14 JANUARY (MORNING) 2003
MONDAY, 13 JANUARY
Chairman
1. Good afternoon.  I would like to welcome the parties and our four experts to this meeting of the
Panel on Japan – Measures Affecting the Importation of Apples.  First of all I would like to say a word
about interpretation and microphones.  The Panel has acceded to the Japanese delegation's request forthem to provide continuous and consecutive modes of translation between Japanese and English.  The
English channel, for the benefit of the experts, is channel 1.  May I request Japan to confirm that all
necessary arrangements are in place?  Thank you.  Partly because of the interpretation and because the
proceedings are recorded, and the tapes form part of the record of this Panel, I would request everyone
taking the floor to make use of the microphone, to switch the microphone on when they begin to speakand off when they are finished.  Let me now go to in troductions.  I would like to begin by introducing the
members of this panel.  On my right is Dr. Kathy-Ann Brown of the Mission of St. Lucia;  and on my left,
Mr. Christian Häeberli of the Swiss Federal Office of Agriculture;  and myself, Michael Cartland, from
Hong Kong, and I am Chairman of the Panel.
2. Assisting the Panel in its work are the Panel Secretary, Mr. Michael Roberts, aided by
Mrs. Gretchen Stanton from the Agriculture and Commodities Division, and the Legal Adviser,Ms. Kerry Allbeury, supported by Mr. Yves Renouf, who will be joining us later, from the Legal Affairs
Division.
3. I would like to identify and introduce the four ex perts.  We have first Dr. Klaus Geider, Professor
of Molecular Genetics and Phytopathology from the Max-Planck Institute for Cell Biology at theUniversity of Heidlelberg in Germany.  Secondly, we have Dr. Chris Hale, a Science Capability Leader,
Insect Group, Plant Health and Fire blight, Hort Re search, Auckland, New Zealand.  Third we have Dr.
Chris Hayward, Consultant on Bacterial Plant Diseases, Indooroopilly, Queensland, Australia.  I hope I
got the name of the place correct.  Dr. Ian Smith, finally, is Director-General of the European and
Mediterranean Plant Protection Organization, in Paris.
4. Perhaps for the benefit of the experts, I could also invite the heads of delegations to introduce
themselves and the other members of their rather large delegations.  If your delegation has not already
done so, it would be appreciated if you could submit a list of your delegation's members to the Panel
Secretary.  I will begin with the United States please.
United States
5. Thank you Mr. Chairman, on behalf of the United States.  My name is Juan Millán.  I am an
Assistant General Counsel with the office of the US Trade Representative in Washington D.C.  The
gentleman to my right, my peripatetic colleague is Stephen Kho from the US Mission here in Geneva, and
I will ask the remainder of the members of my delegation to please introduce themselves seeing as we are
quite strung out along the length of this room.WT/DS245/R
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My name is Dr. Rodney Roberts, I am a plant pat hologist with the Agricultural Research Service
in Wenatchee, Washington.
Alan Green, Assistant Deputy Administra tor, Plant Protection and Quarantine.
Mike Guidicipietro, Trade Specialist on Phytosanitary Issues, USDA, APHIS.
Dr. Kenneth Vick, US Department of Agriculture, Washington, D.C.
Paul McGowan, Trade Director for Asia, Plant Protection and Quarantine.Garrett Weiner, Legal Intern, at the US Mission to the WTO.Lynn Alfalla, with USDA, APHIS.  I am Director for Asia Trade Policy.
Anne Dawson, I'm the Japan Desk Officer for the Foreign Agricultural Service, USDA.
Gregg Young.  I am with the US Mission here – Agriculture.
Chairman
6. Thank you very much.  Perhaps I could now invite the delegation of Japan to perform the same
function.
Japan
7. Thank you, Mr. Chairman and members of the Panel.  My name is Masatoshi Sakano.  I am
Deputy Director-General of Agricu ltural Production Bureau, Ministry of Agriculture, Forestry and
Fisheries of Japan.  Now I will let each of the Japanese delegation introduce themselves.
My name is Noboru Saito, Director, Plant Protection Division, Ministry of Agriculture, Forestry
and Fisheries.
Masaru Kitamura, Legal Adviser, Ministry of Agriculture, Forestry and Fisheries.
My name is Masao Goto, Plant Bacteriologist and Professor Emeritus of Shizuoka University.Akira Sugiyama, Director of WT O Dispute Settlement Division, Ministry of Foreign Affairs.
Yayoi Matsuda, Dispute Settlement Officer here in the Mission in Geneva.
My name is Hiromichi Matsushima, Agriculture Counsellor, Japanese Mission, here.
My name is Katsuhiro Saka, Agriculture Attaché, Japanese Mission in Geneva.
My name is Junichi Taniuchi, Deputy Director, Plant Protection Division, Agricultural
Production Bureau, Ministry of Agriculture, Forestry and Fisheries.
My name is Hiroyuki Yamaguchi.  I am from Plant Protection Division, Ministry of Agriculture.
My name is Akifumi Mizuno, Ministry of Agriculture in Tokyo.
My name is Kenji Shinoda, Official and Attorney, International Agreements Division, Treaty
Bureau, Ministry of Foreign Affairs.
My name is Akira Uchida from the WTO Dispute Settlement Division, Ministry of Foreign
Affairs.
My name is Ryosuke Hirooka, Internationa l Affairs Bureau in Agriculture Ministry.
Aya Iino, covering dispute settlement issues in Japanese Mission here.WT/DS245/R
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Chairman
8. Thank you very much.  Turning now to the establishment of the Panel and Terms of Reference, as
a preliminary matter I should recall that at its meeting on 3 June 2002, the Dispute Settlement Bodydecided in accordance with Article VI of the Disp ute Settlement Understanding, to establish a panel
pursuant to a request by the United States.  I further recall that the Panel held a first substantive meeting
with the parties on 21 October 2002.  Both the panel an d the parties recognized the need for the panel to
consult with experts possessing specialized scientific expertise on the issues arising in the dispute.  In
conjunction with the parties, the panel agreed on working procedures for its consultations with scientificand technical experts.  These working procedures were communicated to the parties on 18 October 2002.
After consultation with the International Plant Protection Convention and having received the views of
the parties, the panel appointed Drs. Geider, Hale, Hayward and Smith to serve as scientific experts in this
dispute.  In accordance with the working procedur es and after comment by the parties, the panel
communicated questions to the experts.  The experts were requested to reply by 12 December 2002, andthese replies were communicated to the parties.  Comments received from the parties on the experts'
replies were circulated to the experts.  I hope that reflects everyone's understanding of what has actually
happened so far.
9. Conduct of the meeting.  The purpose of today's meeting is for the experts to meet the panel and
the parties, and to discuss their written responses to the questions and to provide further information.
Today's meeting will proceed as follows:  Firstly I should like to request the experts to make introductory
or general remarks and then I will open the floor to the parties.  We hope that after the parties have
completed their questions, we will be able to take a short break of fifteen minutes or so, after which the
panel will ask certain questions to the experts.  I should say at this stage that we do envisage the need to
reflect on the outcome of today's session, and we would appreciate the opportunity to come back for a
further session with the experts tomorrow.  I think that if we could convene in this room at 11 o'clock forthat purpose tomorrow that would be a convenient arrangement.
10. The experts are welcome in their introductory remarks to address any point where they believe
further clarification is needed, particularly in the light of the parties' comments to any of the expert
responses to the panel's written questions.  Finally, at the end of our session tomorrow, I shall of courseallow the experts time to make any closing remarks th at they should wish.  I would like to recall that the
meetings of the panels in the WTO are tape recorded.  I have mentioned this already at the beginning.
The only point is to remember to use your microphones.  I would also further remind the parties and I
would wish to draw the attention of the experts to the fact that the proceedings of this panel are
confidential, as provided for in Article XVIII of the DSU.  Unless there are any comments or questions atthis stage, we can now proceed.  Japan.
Japan
11. Thank you Mr. Chairman.  I am sorry to pose questions first before we go into the substance but
we would appreciate it very much if you would clar ify a bit further how exactly the floor will be open to
the parties.  Is it going to be alternate one question by one question or substance by substance?  These
kinds of matters need to be clarified.  Thank you.
Chairman
12. I have proposed to give the floor to each delegation in turn to ask all the questions that they wish
to ask, and then I will give the floor to the other delegation to ask all the questions that they wish to ask,so in fact we will take it one delegation at a time.  [Discussion within the Panel and with the Secretariat.]WT/DS245/R
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13. I am inclined to start with the United States, asking  them to present an issue, or a series of issues.
If Japan has questions on the same subjects, then we will stay on those subjects until we have exhausted
them, and then Japan can ask a question on another subject.  Are the parties content to do that, on an
alternating basis?
United States
14. Subject-matter by subject-matter would seem to us to make more sense than a strict alternating
question by question.  However, we would also be open to asking all of our questions in sequence, so I'll
give you another 15 seconds to decide.
Chairman
15. No, no, I think we have decided.  I think we have spent long enough on that.
Japan
16. We are in your capable hands, Mr. Chairman, of course, but your suggestion of subject by subject
seems to make more sense to us.  Thank you.
Chairman
17. Thank you.  I suggest we hear from the experts in alphabetical order, starting with Dr. Geider, for
the introductory comments.  I think I have already observed that the panel does not envisage that we are
going to finish this afternoon.  The process today is for the introductory comments and for the questionsfrom the parties to the experts, and after a break the Panel will put some questions.  That said, I think I
will now invite the experts to take the floor with their opening remarks, and perhaps I can begin with Dr.
Geider.  Dr. Geider, thank you, you have the floor.
Dr. Geider
18. Thank you, Mr. Chairman.  Of course it is difficult for a scientist to take this issue in parts, but
one hopes that there could be a final solution.  When we talk about fire blight we have to distinguish two
situations.  One is short-distance distribution which is mainly thought to occur with insects, especiallywith bees visiting flowers, with wind and with bird s.  I think here we should not discuss much about
short-distance distribution, unless fire blight is established from a long-distance distribution, which is
very rare.  We think that the trade of imported latently infected host plants are mainly the cause of fire
blight establishment in remote areas.  And when we come to some sort of message we can contribute in
this case, we have carefully, as far as we could, investigated the spread of fire blight in Europe and theMediterranean region.  What we can say is that fire blight occurred at certain points which were the
source of the disease and then it spread sequentially.  I think that this sequential spread was noted by the
US delegation and it was also noted in one of the reports of New Zealand.  So that means fire blight
occurred in England and it occurred in Egypt and th en no novel occurrence was visible until recently in
central Spain and northern Italy, and I think in these two cases we could certainly assume that fire blightwas established by import of plants from nurseries.  And we know by the patterns we use to dissect the
strains that these nurseries were probably located far from northern Italy and far from Spain, probably
from Belgium.  And these are exceptions, but in all other cases fire blight spreads from the source in
England and the source in Egypt to other countries.  Of course we cannot go back to the original situation.
What happened that fire blight came to England a nd what happened that fire blight came to Egypt?
Actually, in the recent issue of the International Workshop on Fire blight which was held in New Zealand,
Eve Billing made some speculations about the origin  of fire blight in England, and it is somehow of
course getting a little bit into the argumentation of the Japanese delegation, that fire blight might haveWT/DS245/R
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occurred by import of contaminated pears and that the pears leaked out and wood caskets were
contaminated and afterwards they were used in farms for collecting apples.
19. The other point is does fire blight stick to mature apples and what are the data and what are the
reasons?  Of course I think when fire blight, which means E. amylovora , is getting to the apples, it could
happen that the pathogen will stick there for quite a bit of time.  We have actually done a few experiments
in that direction, but I have noticed that the Japanese scientists in Yokohama have done similar things in
that they have inoculated apples and found that the pathogen can stick with these apples for quite a bit of
time, that means for weeks and maybe even for a couple of months.
20. In our hands we did not really see a systemic spread of fire blight or E. amylovora  in the apple.  It
was located in the inoculation sites and the symptoms which appeared were very minor.  There was alittle bit of browning and maybe a little of fungus growth but not a systemic spread on the whole apple.
Therefore we think that when an apple is getting somehow contaminated accidentally in the harvest it can
carry the disease further on, but I think it is not really a source of the disease because we have no
examples that any apple that was spreading fire blight in Europe or in countries we have notice on.
21. What I proposed in my comments on the questions of the panel were a couple of measurements
that can be used in order to control the contamination and persistence of E. amylovora  on apples, and the
delegations might consider if those experiments are meaningful and they might be done in one or the
other lab and we are also open to help on this occasion.  Because in a few of my comments my colleagues
were somehow accused of doing things not extensively and not too carefully, it is of course the sort ofscience in which it is very difficult to get to a judgement and things can happen or they cannot happen the
next time and therefore it is a very difficult decision what is really getting on an apple which is infected or
inoculated with fire blight.
22. At the end I want to make a few comments about fi re blight in Germany.  The fire blight started
in the north and it was slowly carried on to the s outh and now it is heavily in the south and almost
disappeared in the north.  The old question if fire blight was in Japan or has been in Japan or is still in
Japan is a little bit difficult to answer because there are not really widespread observations about the
disease and there are not too many samples which were taken.  Also I cannot really judge how the
scientists in Japan deal with possible necrotic diseases on apples and pears.  Of course when Tom van der
Zwet is stating in the first chapter of the fire blight book that Japan has had fire blight since 1903, I would
somehow object this notation although I feel that fire blight in 1903 might have occurred but itdisappeared.  I think what we have in Japan as an Asian fire blight is probably something else, and we
have accumulated a lot of data and published them in a couple of journals and the last one came out this
month, that the disease which exists in Japan is probably different from fire blight.  So I think fire blight,
in my opinion, disappeared when it was in Japan in 1903.  So that is what I want to comment.
Chairman
23. Thank you very much Dr. Geider.  Can I just clarify that when you use the word "we" that you
are referring to your team at the Max-Planck Institute?
Dr. Geider
24. Yes, right.WT/DS245/R
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Chairman
25. Let me now invite in alphabetical order, Dr. Chris Hale, to take the floor for introductory
remarks.
Dr. Hale
26. Thank you Mr. Chairman.  I would like to preface my remarks by just giving you some idea of
my area of expertise.  I am a plant pathologist by training and in particular have worked on bacterial
diseases of plants and the epidemiology of these bact erial diseases.  I have been involved in science
management for a period of about twenty years in the area of plant protection and during this time I have
managed a number of programmes on the ecology of E. amylovora  and on the epidemiology of fire blight.
27. I would like to thank the panel for the opportunity to provide responses to a number of questions.
My responses were in the form of opinions in most  cases, rather than direct answers, as the panel
specifically requested, in most cases, opinions.  The expert advisers were expected to provide these
opinions and I realize that the parties will also have opinions and that these may differ.  There are a
number of points arising from the comments on the expert advisers' responses to the panel's questions,
which will no doubt be addressed at various stages during the meeting.  For example, fruit maturity,endophytic bacteria, export practices, possible pathways for introduction of fire blight, orchard
inspections and buffer zones.  I am not a plant physiologist and consequently cannot provide detailed
information on fruit maturity and marketing and my responses in this area are consequently limited.
However, in the area of maturity of fruit, comprehensive objective maturity parameters were discussed
within the New Zealand answer to question 2 from the panel, and these have been certainly adopted bythe industry in New Zealand.  I am under the impression that similar systems apply also to the United
States.  The details of the various practices are given in the New Zealand response to questions, which
was New Zealand Exhibit No.13.
28. On endophytic bacteria, my group has found no evidence of multiplication of bacteria within
fruit, and there doesn't seem to be any evidence of mature symptomless fruit disseminating endophytic
E. amylovora .  Of course we have this question about endophytic bacteria.  In the work that we have done
over many years, we certainly can find bacteria on tissue in the calyx of the fruit, but there does not seem
to be any evidence of multiplication and I don't consider this to be convincing evidence of endophytic
bacteria.
29. In the work of Tom van der Zwet, I really feel that, having read that paper, it fails to convince me
that E. amylovora  is in fact endophytic.  Just to move on, to a continuation of that part of the work, I was
quite surprised to find in the comments of Japan on the expert responses, that the letters or the declaration
by Dr. van der Zwet and the letter by Professor Thom son were supposedly pre-worded letters.  This was
completely new knowledge as far as I was concerned, and I think this goes for the rest of the experts as
well.
30. As far as export practices are concerned, the comments by Japan relating to codling moth  larvae
in the US apples exported to Chinese Taipei are also  new to the procedure. I don't think the situation was
brought up in the second written submission of Ja pan, dated 13 November, and I presume this was
because the information was not generally available at that time.
31. On the pathway of possible introduction of fire blight into countries where the disease has not
been recorded, a lot of the work that we have done recently has been experimental research on discarded
fruit and it is very difficult to do this work unless artificial contamination of fruit is used.  In fact, in our
work we have used heavily infested fruit, and large numbers of them, and placed them in orchards.  If youare trying to use naturally infested or naturally contaminated fruit, it is very difficult because you cannotWT/DS245/R
Page 218
actually detect whether there are any bacteria present until the fruit have been destructively sampled.
There is also, in our view, no evidence that survival in artificially infested fruit is any different from that
in naturally infested fruit in the environment.
32. And then on to the effect of discard of blighted cores.  In my opinion there appears to be very
little evidence of any core infection of mature, symptomless fruit.  In the area of orchard inspections, I
agree that orchard inspection and fire blight-free orchards are important.  However, I realize that there is a
divergence of opinion on timing of inspections.  On the area of buffer zones, in New Zealand buffer zones
were put in place as a requirement for apple exports to Japan at the request of Japan Ministry of
Agriculture, Fisheries and Forestry.  It is very difficult to inspect such large buffer areas in New Zealand
due to the relatively small size of orchards and the frequent difficulty in traversing adjacent mountains
and rivers.  I think that leads on to the work by Roberts which was reported in 2002, where infected pearswere kept in orchards to continuously provide a source of inoculum and there seems to be no evidence
that buffer zones provided any additional phytosanitary security.  Mr. Chairman those are some of the
remarks that I wanted to make at this early stage.
Chairman
33. Thank you very much, Dr. Hale.  Perhaps I could now invite Dr. Hayward for any introductory
remarks.
Dr. Hayward
34. Thank you, Mr. Chairman.  For the past 40 years my principal research interest has been in the
plant pathogenic bacteria and the diseases they cause.  As the first bacteriologist to be appointed to what
was then the Commonwealth Mycological Institute at Kew in January 1959, I was charged with the
isolation and identification of bacteria from a great variety of moribund plant material.  My background is
in microbiology and plant pathology.  In my last year at Kew, which was 1964, the warm and wet springprovided conditions ideal for epidemic fire blight in the south west London suburbs extending from Kew
(including the Royal Botanic Gardens) through Richm ond and on to Hampton Court Gardens.  Fire blight
was widely manifest in home gardens and roads, along roadsides on cotoneaster, pyracantha, Sorbus
species and many other ornamental members of the Rosaceae.  I moved to Australia in 1965.  Fire blight
does not occur in Australia and there were no further opportunities to witness the effects of the disease
except on visits to the United States and British Colombia.  Since 1965 I've worked on phenotypic
diversity and more recently genetic diversity and phylogeny, using DNA based methods, in bacterialpathogens of importance in the tropics and sub-tropics, particularly Ralstonia solanacearum  the cause of
wilts in many economically important crop plants.  I now work as a consultant on bacterial plant diseases.
35. Almost two years ago, I was asked by the Depart ment of Agriculture, Fisheries and Forestry,
Australia, to provide technical advice to the risk an alysis panel considering the application made by the
Government of the Philippines to export fresh green bananas to Australia.  One of the diseases of concern
is a bacterial disease known as Moko caused by Ralstonia solanacearum .  I've looked in detail at the
likelihood of the entry and establishment and spread of Moko disease as well as the associated potential
biological and economic consequences.  There are some similarities and several major differences
between green bananas as a possible pathway for entry of Moko disease and the matter of mature applesand fire blight.  Now to the matter we're dealing with here.
36. Since preparing responses to questions 1 to 36 posed by the Panel, I've obtained copies of all the
documents not available to me at the end of November last year.  Most importantly, I have the paper by
Mizuno et al . (2002) published in the journal of General Plant Pathology, Japan, which relates toWT/DS245/R
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question 35.  I can add comments now, but I think probably it would be better later when I expect this
question will be considered.  Thank you.
Chairman
37. Thank you, Dr. Hayward.  I would now like to invite Dr. Smith to make his introductory remarks.
Dr. Smith
38. Thank you Mr. Chairman.  Working as I do for an international organization, the European and
Mediterranean Plant Protection Organization, I have a responsibility to advise member governments of
our organization on the measures which they may take in relation to quarantine pests, and in particular to
advise them on how to conduct pest risk analysis, which is an internationally agreed procedure for
deciding which pests require measures and for justifying those measures.  And it is in this area, pest riskanalysis, that I would like to make a few comments.
39. First of all, the question has been raised concerning the proof of a scientific phenomenon.  It has
been said several times in the documents that it is impossible to prove that a rare event can never happen
and this is clearly accepted.  But I would like to add that it is also very difficult to prove that a rare eventis happening, because it is rare.  If scientists have to design experiments to observe such events and be
satisfied that they are really occurring in the way th at they predict, those experiments have to be very
strictly controlled indeed to make sure that the very occasional events that they observe really confirm the
hypothesis, or that they might not be due to some other cause (experimental error, interaction with some
other factor or whatever).  So, from my point of view , it is very difficult to set out to conduct scientific
research on unlikely rare events and it is by no means certain that some questions can ever be
satisfactorily settled.
40. Coming now to the process of pest risk analysis, there are international guidelines for this, two
international standards under the International Plant Protection Convention.  At the moment, we could saythat the second one, which is International Standard No. 11, is the one which is in force and is the most
recent and the most important.  Throughout this document, it is stressed that pest risk analysis is first of
all concerned with data obtained from areas where pests occur.  Basically, observations are made on how
pests behave where they occur, and then inferences are made about how they might behave in another
place.
41. The text of these standards has been structured in this way precisely to discourage wilder flights
of conjecture about events which might occur and to try to keep the scientific arguments firmly on the
ground.  In this particular case, we are talking about a pathway which is the import of apple fruit.  And, in
the international standards, it is advised that in a pest risk analysis, the analyst should allow for known
pathways and should also consider other possible pathways.  One of the reasons for investigating other
pathways is that their role in carrying pests from one country to another may in fact be quite differentfrom what was initially supposed.  Therefore the analyst should examine all possible pathways to make
sure the pest is not entering easily by some other path which is different from the one which is mainly
under consideration.  In the present case we have the opposite situation, however.  The pathway which is
of main interest is one which is considered by most people to be an unlikely one, and one which has not
been found in practice to occur in reality.  It still needs to be evaluated, but its evaluation could lead tovarious conclusions.  It could lead to the conclusion that this pathway is real and that it should be taken
into account in taking phytosanitary measures.  But it could also lead to the conclusion that this possible
pathway is of no importance in practical terms, that there are no practical measures to be taken and so this
pathway can be ignored.  So when the PRA standard says that known pathways should be considered and
also possible pathways should be considered, it does not mean to say that measures have to be taken forall pathways.  It means that each has to be evaluated for its importance and, in relation to its importance,WT/DS245/R
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strict measures may be appropriate or mild measures may be appropriate or no measures may be
appropriate.  That is the purpose of the analysis.
42. Now, finally, I would like to refer again to the st andard on pest risk analysis which mentions a
principle called the Principle of Managed Risk.  I think this principle has not particularly been invoked inthe documents which have been presented so far.  It is one of the principles appearing in International
Standards on Phytosanitary Measures No. 1.  This prin ciple says "because some risk of introduction of a
quarantine pest always exists, countries shall agree to a policy of risk management when formulating
phytosanitary measures".  In the text of Standard No. 11 it is also written "since zero risk is not a
reasonable option, the guiding principle for risk management should be to manage risk to achieve the
required degree of safety that can be justified and is feasible within the limits of available options and
resources".  I think it is important to bear in mind that pest risk management, according to internationalstandards, should take into account this Principle of Managed Risk.  Not only the Principle of Minimal
Impact which has already been mentioned, but also the Principle of Managed Risk.  And on the basis of
this principle it should be possible to manage risks which are open to some uncertainty.  Part of the
problem in the case we are considering is that there is uncertainty about the possible importance of apples
as a pathway.  Pest risk management still has to try to find the most appropriate way to manage that riskdespite the uncertainty.  This is a kind of uncertainty management, we might say.  So I do underline that
the text of these international standards have foreseen many such situations and that it may be useful to
quote them in further consideration of the problem which we face at the moment.  Thank you, Mr.
Chairman.
Chairman
43. Dr. Smith, thank you very much.  I'd now like to open up the meeting by inviting the parties to
pose questions to the experts.  As I said earlier, I propose that the parties be given the opportunity to posetheir questions taking issues in alternate order and starting with the applicant, the United States.  United
States, you have the floor for the first issue.
United States
44. Thank you, Mr. Chairman.  Before I start with the first topic it occurred to me that it might be
useful for my delegation to confer briefly in light of what the experts have said, to consider the questions
that we had prepared and whether or not we might adjust or even not ask certain of the questions.  It
might be more efficient to the proceedings.  Could we take a short break of no more than five minutes?
Chairman agrees.
Chairman
45. Let's resume and let me thank the US delegation for keeping to the five minutes, and invite them
to continue with questions on their first issue.
United States
46. Thank you, Mr. Chairman.  I thought you were going to charge me for taking six minutes so I
appreciate the comment.  Let me start by briefly th anking the experts for the evident care with which they
have prepared answers to the Panel's questions and, in particular, for their citations to the scientific
evidence which certainly made it easier for me and the United States, and I believe probably the Panel as
well, to understand and evaluate those answers.  The Panel suggested that we take this session as anopportunity to dialogue with the experts, so I will try not to repeat comments of the United States that weWT/DS245/R
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previously submitted on the experts' answers or some of the major points on which we found the experts
to be in agreement, some of the major points in this dispute.
47. Instead, and it may be a little chopped up because of the format of this session, what I would like
to do is to turn to particular steps in the hypothe tical pathway that's been proposed for transmission or
introduction of fire blight via imported apple fruit and ask some questions for clarification of the scientificevidence or lack thereof.  So, the first subject matt er of my questions relates to endophytic presence in
mature apple fruit.
48. In response to question 11 from the Panel, Dr. Smith noted that van der Zwet et al.  (1990) is, and
I'll quote from your answer Dr. Smith, "the only published paper to my knowledge which records
isolation of E. amylovora  from core sections of fruits".  And the paper itself, in combination with Dr. van
der Zwet's declaration, tells us that this isol ation was only from devel oping or immature fruit.
49. If I may pause here briefly.  Dr. Hale, you men tioned the description of this declaration as pre-
worded.  In submissions to the Panel we have made clear the process by which this declaration was
developed.  Japan has chosen to characterize that declar ation as pre-worded.  In fact, as we have described
the process, questions were posed to Dr. van der Zwet and Professor Thomson.  They provided answersand those answers were reduced to writing and then sent to the two gentlemen who reviewed the answers,
which were their own oral answers, and made changes.  We then asked whether we would be able to use
these documents, make them public and use them in this procedure, and they both agreed, and having
made changes to their answers they then signed these documents and permitted the United States to
submit them as exhibits.  So I'm not certain how the characterization of pre-worded can really be made,but that's the situation for your information.
50. To return to my question, as I said, the paper in  combination with this declaration tells us that
these isolations from core sections of fruit was only from developing or immature fruit.  Dr. Smith, I'd
like to ask you whether, after reading the other experts' answers as well as the Parties' comments on thoseanswers, this is still your view of the experiments reported in van der Zwet et al.  (1990).
Dr. Smith
51. Mr. Chairman, I had originally understood that the experts would answer in order, but I take it
that you wish me to reply directly to this point.
Chairman
52. This point has been specifically directed to you so perhaps on this occasion and on all occasions
where it's specifically directed the expert to whom it's directed can reply first, and then we'll revert to the
alphabetical order for the others to address the same question.
Dr. Smith
53. In this article, Mr. Chairman, in several instances E. amylovora  has been re-isolated from the core
sections of fruits under conditions which should make sure, in principle, that there is not a contamination
from the surface of the fruit or from some other part of th e fruit.  What is not made clear in the paper is,
first of all, whether the presence of those bacteria is associated with any symptoms or not.  My inference
is that there are no symptoms.  I think that if there had been symptoms they would have been described.
That would seem to imply that the fruits are not in fact diseased and that small numbers of bacteria have
somehow entered the fruit and have remained there.  And in the paper itself, the maturity of the fruit
concerned was not specified, but then the later declarations make it clear that the fruits concerned were
not mature.  For me, the most significant point about these observations is that the fruits are not diseased,WT/DS245/R
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so we are talking about very low levels of contamination by bacteria.  Bacteria have been re-isolated from
the fruits but that does not mean to say that there are large populations of bacteria there.  Are they more or
less important than bacteria which you can re-isolate from the surface of the fruit?  It is not really possible
to tell.  If those bacteria had been causing symptoms, if it could be shown that they were damaging the
fruits and multiplying in large numbers inside the fruits themselves, the risk could be much greater, butthis is not recorded in the paper.
54. I have said that these are the only results to my knowledge where has been recorded from core
sections of fruits but also that other published papers refer to such internal infections only casually.  There
are other remarks in other papers about bacteria being recorded from the insides of fruits, but I think that
this van der Zwet paper is the only one which tried to investigate the phenomenon generally.  My main
emphasis is that the data as presented does not show more than a low level of contamination in thosecases and correspondingly a low risk.  In general, I have made it clear in my reply that I feel that the
results of van der Zwet et al. (1990) are confused, that the materials and methods of that paper describe
various procedures which they said they would follow but for which no results are subsequently reported,
and one is left with a feeling of dissatisfaction that the experiments were set up with a certain purpose and
yet the experiments were not completed and for one reason or another the results are not presented.  Thisis really the basis for my feeling that this research did not go exactly according to plan and when research
does not go to plan it is sometimes better not to publish it.  If you do publish it maybe you should
continue the research and do better experiments in order to obtain clearer conclusions on issues which are
certainly important.
Chairman
55. Thank you, Dr. Smith.  Can I ask Dr. Geider if you wish to say anything in response to this
question?
Dr. Geider
56. Nothing at all.  I agree with Dr. Smith that this paper was probably written as a collection of data
without getting a good feeling that everything which was claimed in that paper was scientifically verified.
I think the main problem in science is that methods of course change, and at the end you're not sure if the
old papers still have the same impact as papers with new methods.  In this case I think there is too much
emphasis put on the question if this paper is really a message.  I would say it's a possibility that these
things could have happened and it might not exactly be what is claimed in the paper.
57. We, that means my lab, are quite cautious about endophytic bacteria because you really have to
show that they are endophytic and this is not so easy to  do.  I think these bacteria have to be labelled and
not just plated.   There is something and this is probably fire blight, although in this case, you have to
carefully examine individual colonies to find out if this is fire blight or something else.  In the older days,in 1990 and the paper is going back into the 1980s, the methods were not so advanced and, therefore, it
could really have happened that it was put up by contamination and other things.  And we have to look to
the authors who are Tom Van der Zwet and Sherman Thomson and Gordon Bonn, all three of them are
advanced scientists.  I personally don't think that they have done the experiments themselves, so they trust
other people and I don't know with three different comp licated labs if everything that was published was
really exactly what was extracted here by the Panel.  For those reasons I would agree to be very cautious
to use that paper as the document that E. amylovora can be endophytic.
Chairman
58. Thank you, Dr. Geider.  Dr. Hale, on this subject?WT/DS245/R
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Dr. Hale
59. I'd like to reiterate what Dr. Geider has said.  I feel very much the same.  Certainly, in my
laboratory we have looked at core tissue and we have found no E. amylovora  in core tissue, apart from in
the calyx end of a core taken through an apple from an orchard with a high level of fire blight in the trees.
One of the points that Dr. van der Zwet admitted in his declaration is that the fruit, in fact, was taken
from, or fairly close to, areas in the orchard where there were fire blight-affected trees.  It is quite
possible, from work that we have done as well, that the calyx, in fact is infested, not infected but infested,
and very low numbers of E. amylovora are present.  Also when the core tissue was being taken right the
way through the fruit, the calyx end tissue is the area where most of the bacteria are likely to be found.
Again, from reading the paper, I'm not totally conv inced that this is showing us that there were
endophytic bacteria in the fruit.
Chairman
60. Thank you very much.  Dr. Hayward?
Dr. Hayward
61. Thank you Mr. Chairman.  I didn't have the courage to respond to this question in my document,
in my responses last November.  However, having h eard Dr. Smith and having read what he's written, I
think I support that quite strongly.  He says that "it may be noted that the experiments reported in the
paper were performed by different scientists at four widely separate locations in several years".  I think
that gives us some hint as to the problems that may have occurred.  And later he says "It is my conclusion
that overall the study reported in this paper fails to convince.  Experiments are said to be performed and
procedures followed and no results are reported".  I think I support this. Thank you.
Chairman
62. Thank you very much.  I think I would like at this stage to interject a question from the Panel to
get clarification about some of the terms that have been used.  So, the question is this:  Would it be right
to conclude that if an apple fruit is infected with E. amylovora , this means it has fire blight disease?  If an
apple is infested with E. amylovora , this means that E. amylovora bacteria is present but the fruit is NOT
diseased?  If the fruit is infested, the bacteria may be present either inside the tissues of the fruit,
endophytic contamination, or on the surface of the fruit, epiphytic contamination?  Would those be
correct understandings?  Perhaps I can do it in the alphabetical order, Dr. Geider?
Dr. Geider
63. I think, in general, the scientific claim of end ophytic bacteria is still not very well established.
Many of my colleagues have had similar intentions to show that the bacteria is inside of plant tissue but
very few have really shown that they're inside.  I think it's scientifically, or via lab work, very difficult todissect what is infected.  And of course when there are symptoms, you may say the symptoms are coming
from the pathogen or they may be coming from something else and we all have to deal with bacteria,
viruses and of course with fungi.  The question is "Is not everything you see really is a disease?"  When
you say infested, it could be on the surface, it could be somewhere but to my knowledge, nobody has ever
really shown that bacteria, especially E. amylovora  inside and is in the tissue.  And for those reasons I
think we are getting a little bit into a very sophisticated argumentation – what is there?  And it doesn't
answer the question "Does that spread fire blight?"  I think that in the end it doesn't really matter to go
into scientific details here, what is symbiotic and endo -symbiotic or what is outside.  I think it's finally:
“Is it spreading fire blight?”  And I would say ther e is no evidence that endo-symbiotic bacteria, likeWT/DS245/R
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E. amylovora , can really be found and that they can be connected to spread of fire blight.  I’m maybe not
answering your question completely;  perhaps somebody else can pick it up again.  Thank you.
Chairman
64. We come to Dr. Hale now and perhaps he could address the question because I think it was from
him that I heard the terms "infected" and "infested".
Dr. Hale
65. Yes, again I really have very little more to say than Dr. Geider has said.  My feeling has always
been that if we have an infection, we have a fruit which is infected, then it is diseased in some way.
Whereas, if we have an infested fruit, it is contaminated and may be carrying low levels of bacteria butthe fruit or plant part is not actually diseased.  So, I think, infested is really more a contamination rather
than a disease-causing part of the overall strategy of the bacterium.  I have no more to say than that.
Chairman
66. Thank you very much.  Dr. Hayward?
Dr. Hayward
67. Mr. Chairman, if I can quote definitions given in a guide to the terms in use in plant pathology:
"Infection is the entry of an organism or virus into a host, the plant, and the establishment of a permanent
or temporary parasitic relationship".  Whereas infestation means, or to infest:  "To overrun the surface of
a plant.  When used in reference to micro-organisms or virus particles on plant surfaces, there is no
implication that infection has occurred."
Chairman
68. Thank you.  Do you have anything to add, Dr. Smith?
Dr. Smith
69. I would just add a word about epiphytic and endophytic.  I think it is generally understood that an
infesting or contaminating population on the surface of a plant is epiphytic, if in some sense it persists.
This implies that it is alive, that it is multiplying, that it has some existence in time, whereas infestation or
contamination could actually be temporary.  And, in the same way, I would say that an endophytic
population in a plant is present somehow within the plan t, between the cells or in spaces that exist inside
the plant.  If it is endophytic this implies that it is  surviving, persisting and perhaps even multiplying.
Otherwise, it is again simply a contaminant and may die out after a certain time.  But these are difficult
questions to investigate, to know exactly how a popula tion of bacteria behaves inside a plant tissue.  If
you observe that it remains at the same level over a period of time, are the same cells staying alive for a
very long time or are they turning over slowly?  This is the kind of question that is very difficult toanswer.  But certainly both epiphytic and endophy tic imply survival whereas contamination does not
necessarily imply survival.  A contaminant population may die out rather quickly.
Chairman
70. Thank you very much.  I was interrupting the United States' questions on that first issue.  Do you
wish to continue with that?  Japan, you have a reaction on this point?WT/DS245/R
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Japan
71. Certainly we can respond but ...
Chairman
72. Sorry, I understood you'd asked for the floor, but if this is not the case ... Sorry, yes.  This is still
continuing on the first issue I presume.
United States
73. Sorry, Mr. Chairman, I'd lost my place briefly.  I was actually going to ask the other experts to
address the question that I'd placed to Dr. Smith.  I really only have at this time one more question in this
subject area of endophytic presence and maybe I'll start with Dr. Hayward.  I believe in your written
response to Question 2, you had said that the evidence on presence of E. amylovora  as an endophyte in
apple fruit is not monolithic and then later in your  answer to Question 10 you said that, assuming the
positive fruit in van der Zwet et al. (1990) to be immature, "I know of no studies that report the detection
of endophytic bacteria in mature symptomless fruit".  And so I wanted to ask you first, and then the other
experts as well, whether there is any scientific evidence that endophytic E. amylovora  has been isolated
from mature apple fruit.
Dr. Hayward
74. Mr. Chairman, I didn't use the word monolithic in the answer to Question 2 – it was somewhere
else, but that's not really important.  I stand by what I wrote then.  I don't have any evidence.  Sorry, what
was the question which you posed?  Relating to my response to Question 10 or Question 11?
United States
75. I believe it was in your answer to Question 10 that you wrote "I know of no studies that report the
detection of endophytic bacteria in mature symptomless fruit" assuming that the results from van der
Zwet were wrong.
Dr. Hayward
76. Yes, well I don't have any other evidence.
Chairman
77. I assume that doesn't call for any response from the other experts?
United States
78. Can we assume then that the experts agree with that statement?
Chairman
79. I thought we were simply confirming the wording th at had been put into the experts' answers.  Do
the others have anything to say?  Dr. Geider.
Dr. Geider
80. Just to repeat my statements.  I think here in the audience it is very easy to talk about endophytic
bacteria but in scientific terms it's very difficult.  I spent quite some time in cooperation with some lab in
Aberdeen, Scotland and they were claiming that you can see endophytic bacteria, but we were not sure atthe end there what we really saw.  It was not really connected to the presence of E. amylovora  in fruit, butWT/DS245/R
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at least it was in the special forms of the bacteria in plant tissue.  Finally, we could not make a final
decision what endophytic is and for those reasons I think we are getting beyond science here.  We just
feel that there must be something inside an apple and it will get out and then we have the disease, but I
don't think that is the case here.  I think this is artifi cial and it's not what can be really followed in the lab.
Chairman
81. Thank you.  Dr. Hale?
Dr. Hale
82. Certainly based on the experience that we've had working with bacteria associated with fruit, I
agree entirely with what Dr. Hayward said.  I have no evidence whatsoever from any work that we'vedone, whether it be reported or published or not, or whether it's just laboratory work, that we could say
there were any endophytic bacteria in mature, symptomless apple fruit.
Chairman
83. Dr. Smith?  Nothing to add?  Thank you.  Are we finished on that topic?
United States
84. Yes, we have.  Thank you.
Chairman
85. Thank you very much.  Now, I would like to invite the delegation of Japan to present its first
issue and questions on it.  It's also open to you on the issue we've just heard.  Thank you.
Japan
86. Thank you, Mr. Chairman.  We also very much appreciate the efforts the experts expended in
preparing the written responses, and I understand it must have taken you a great deal of time to analyze
our discussions as well as the written responses to the answers to the questions by the experts.
87. I may sound a little bit less professional on the questions of plant pathology, but let me start my
question in this way.  It seems to me that there have been a number of definitions on maturity.  In thisproceeding, we heard there's a concept by the name of physiological maturity, there is another concept of
commercial maturity and also the third concept of horticultural maturity, or maybe picking dates or
harvest dates proposed by the United States.  Let me start with a very general question, a very amateurish
question first.  Is maturity or immaturity, or ma ture apples and immature apples, do these two things
reflect a dichotomy or are they in some stage of a continuum?  Is this, so to speak, the transition from
immaturity to maturity a continuous pr ocess, something which is in continuum?
Chairman
88. It's a reference to the first question from the Panel and the question was whether the process is a
continuum, whether it is continuous.
Dr. Geider
89. I'm certainly not the best person to ask anyhow because we are not really working with apples in
all stages of development.  I think in terms of fire blight, it might be a question of how permissive anapple is in which stage  to distribute or at least to accept the bacteria and to multiply them.  I think this isWT/DS245/R
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a matter of maturity but it can also be a matter of the cultivar and other circumstances.  For those reasons,
I think to answer that question completely will not be too helpful in order to say something about the
presence and multiplication of E. amylovora .  That is my opinion, but I'm not really the person who can
define maturity of an apple.
Chairman
90. Thank you.  Dr. Hale?
Dr. Hale
91. I think we all have problems defining the real maturity of an apple.  As far as I'm concerned, I go
by the response from New Zealand as to what a mature apple is, as really it relates more or less to whether
the apple is at a stage where it is in fact going to ripen.  The physiological maturity is a stage where oncethe apple is picked it will, in fact, carry on to ripen.  Commercial maturity really is at the next stage, if
you like, with continuation of that physiological ma turity to a stage where the fruit is going to be
acceptable in the marketplace.  So, I guess, if you want to look at it like that, it is a continuum.  But, as
Dr. Geider has mentioned, whether or not the stage, whether it's physiologically mature or commercially
or horticulturally mature, has any bearing on the ability of bacteria associated with that fruit to causedisease is a question which is very difficult to answ er.  And probably it may not be of any use for us to
answer that one as far as the disease is concerned, and whether it's going to be transmitted.
Chairman
92. Thank you very much.  Dr. Hayward?
Dr. Hayward
93. Mr. Chairman, I have nothing to add to that.
Chairman
94. Thank you.  Dr. Smith?
Dr. Smith
95. Mr. Chairman, I think I would agree with Dr. Geider that whatever it is that makes an immature
apple susceptible to fire blight has not necessarily much to do with what later makes it physiologicallymature or commercially mature.  I think these just repr esent points in time in the development of an apple.
It is clear that very young apples are susceptible.  It would seem that by the time apples have reached the
time when they are commercially mature they are no longer susceptible and that at some point in between,
they lose that susceptibility.  But I would hesita te to say exactly when or exactly why they do so.
Chairman
96. Thank you.  Have you any further questions on that?
Japan
97. Yes, I have quite a few sets of questions.  I think we were talking about the beginning of the
pathway.  I think we finally understand from the answers that it is a very continuous process of maturing
of the apple and at an earlier stage, apples are very susceptible and that that susceptibility will decrease as
time goes on.  So what ever does the United States mean by the term "maturity"?  I recall that Dr. Smith
observed that "apples tested by van der Zwet et al. (1990) were not mature". I think all the other expertsWT/DS245/R
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agreed with his description of the study.  May I ask each one of the experts under which definition do you
believe the apples of the van der Zwet et al.  (1990) were not mature?
Chairman
98. Under which definition do you believe the apples of the van der Zwet et al.  (1990) were not
mature?
Dr. Geider
99. I feel rather like a prophet to look back and to k now what they considered to be mature.  I think it
was probably done by eye.  There were some sort of opinion on that and that ok, this looks immature and
this is mature.  But I have to tell you that scientis ts of course want to pick up something peculiar and
probably they said: oh, we found something that is an apple which looks mature and therefore we have
now shown fire blight can exist in mature apples.  I think this is a tendency we are all forced actually by
publishing papers to find something new and unexpected and this might be the final solution of that
paper, as I say, exaggerated a little bit, and saying: oh, we saw symptoms on apples which are mature -
and another thing is that of course where there are problems with apples, they have a tendency to ripenearlier.  They get into a mature stage just because th ey are struggling with something inside, so this could
be another point, but it is all sort of guesses and I have no idea to say backwards why they said it was a
mature apple.
Dr. Hale
100. I can only go along what Dr. van der Zwet and Professor Thomson have said on this particular
issue.  I don't think that it is really a major point as to  whether they were mature or not.  I think that to try
to go back and re-analyse work which was done in 1990, using some of the techniques that were availableat that time, is perhaps not the way to go and I would be much happier if we had data from work which
had been done more recently, using the techniques which are now available, as Dr. Geider suggested very
early on. I think that my own feeling is that we ar e attaching probably far too much importance to this
particular paper.
Dr. Hayward
101. Again, I would refer to the declarations by Dr. van der Zwet and Professor Thomson.  To answer
the question from Japan directly, the fruit taken in July and August must have been by definition,immature.  So I think the answer lies in the declaration by those two authorities and in their paper.  The
fruit came at a time of the season when they could not have been other than immature.
Dr. Smith
102. I would support the position of Dr. Hayward.
Chairman
103. Thank you very much.  Anything further on this topic?  [Pause]  Well, to an issue which is related
to the same topic, otherwise we will go on to the next issue from the US.
Japan
104. Thank you.  Let me start.  When I first read about this continuation between immature apple and
mature apple, my first impression was that when you are talking about the immature apples, you are
talking about fruitlets or very small ones.  But as the process goes on I believe if it is really a continuousWT/DS245/R
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process, something very near to maturity, or maybe even physiologically mature apples, could be indeed
not just infested body but also infected.  We have searched various websites and we found a picture of
apples which show symptoms only a few weeks before the harvest stage.  Has this been distributed?
Chairman
105. I only have the black and white version.
Japan
106. Exhibit JPN-41.  This is a picture we saw, we found on the website of the Michigan State
University, which is captioned that the fruit was infected only a few weeks before harvest.  So whatever it
is, it must be very close to whatever maturity it is, or even maybe physiologically mature.  And it seems
to me that these two fairly large apples show serious symptoms.
Chairman
107. Is the question clear?
Japan
108. No, it is not a question.
Chairman
109. I think we should stick to questions.  We seem to be on much the same issue that the US was on
at the beginning.  I thought we had agreed that we would alternate the issues.  Do you want to start an
issue which is different, because we still seem to be mining the same topic; have we finished with that
topic now and can we go on to another one?
Dr. Geider
110. Just to make a comment on that apple, or apples.  I think I did not have to look at the internet.  I
actually presented not a Korean brown apple but a brow n apple in my report; I think that those things can
really happen that apples get sorts of fire blight and they get ooze when fire blight is striking a tree.  But
on the other hand, there are several questions coming up and one is of course, that I have to admit that
even in my apples I presented in my report, we have never shown that the ooze which is coming out was
caused by E. amylovora .  It could have been something else.  This picture was taken in 1988, in the fire
blight outbreak in July in the Heidelberg area of Germany and of course it was quite obvious that this all
and the same as here looks like what we would expect from fire blight and I have no personal reason to
disprove that assumption.  On the other hand the question is this apple really mature?  To me it is looking
quite green and for those reasons it could be immature.  I don't know, they don't even say the variety or
what they used, it could be Granny Smith, or what, anyhow, I think it's you see the difficulty.  They makethe statement a few weeks before harvest and they sa y it's mature but I doubt that.  I think it is still an
apple in a developmental state where it is getting mature and I would not really agree on that and the same
thing of course is the problem is that what is coming out here is it really ooze from E. amylovora or is it
some sort of soft rot mixed with something else?  I can't say.
Dr. Hale
111. Just to follow up on that one, I consider many of the apples which are also in this cluster are fairly
green, and I would say that they are immature.  If those fruit had been infected at some stage, then thatmight, in fact, bring on the maturity and cause reddening as if the fruit is starting to mature.  Again we
have no proof that what is exuding from those apples is E. amylovora .WT/DS245/R
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Dr. Hayward
112. I don't have anything to add to that, Mr. Chairman.
Dr. Smith
113. Well, Mr. Chairman, these are certainly not symptomless apples!
Japan
114. My question wasn't really meant to ask you whether these are mature.  Matter of fact it seems to
me immature, but my question was this is very large, and they are at this stage it still get infected by
something.  It seems to me it’s a fire blight bacteria .  So, generally speaking even at this stage, can these
apples be infected?  We are not talking about only very young fruits but fairly close to maturity applescan be infected.  Am I correct to say that, or do the experts agree?
Dr. Geider
115. Actually when I commented to the first question or the first part of the Panel's question, I said that
apple is not very susceptible and actually we are not using it all in the lab to look to screen strains of
E. amylovora , or mutants or whatever we do.  I think apple is not so susceptible that it is a lab tool.  It is
something which you can notice in nature and I don't know what other labs, we cannot ask Dr. Hayward,
but Dr. Hale is using apples in the lab.  So I think the experience in the lab about apple as a tool to lookfor fire blight is very limited and for those reasons I cannot answer the question is an apple in this stage is
susceptible to show fire blight symptoms.
Dr. Hale
116. Mr. Chairman, I really can't add too much more to that.  I think that we again find it very difficult
and I mentioned this in my response, to infect a pples as they become mature, but I agree with the
comment that Dr. Smith made, this is not a symptomless fruit, and in most of the comments I made I am
talking about mature, symptomless apple fruit from orchards which are not showing fire blight symptoms.My feelings in looking at that picture is that the orchard must have had fairly high levels of fire blight in
it.
Dr. Hayward
117. Mr. Chairman, this illustration refers to the fire blight epidemic in South West Michigan.  We are
told nothing about it.  There must have been some severe meteorological disturbance I should think,
perhaps severe hail damage.  Indeed, the illustration you provide Dr. Geider, in your, I think 'After Hail
Damage'.  Well, we know nothing about the history of this particular crop.  There must presumably havebeen some severe damage.  That is all I'm going to say about that.
Chairman
118. Since you have brought that up, perhaps I could go back to Dr. Geider because in the answer to
Question 12 from the Panel, you made reference to van der Zwet's successor at the US Department of
Agriculture, in Kearneysville as having informed colleagues about late growth stage infection of apples
with fire blight after a hail storm.  I wonder if y ou could expand on the source of this information and its
relevance to the claim that mature apples are symptomless?WT/DS245/R
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Dr. Geider
119. Ok, what happened was actually that there was a severe hail-storm and Dr. Norelli informed a
couple of colleagues that they are facing fire blight problem.  I don't know if somebody else here in the
audience was informed.  It was actually there were many pictures taken with hail and impressive glassdamage of greenhouses and very little bit of fire blight.  Of course you can expect that.  When hail is
coming into an orchard there is damage, fire blight may occur two weeks or later and for those reasons I
think this was not too impressive for an outbreak of fire blight.  The only message which is coming out is
that a hail storm can really cause outbreaks which are unpredictable.  I think is spring when there are
flowers and when there are insects visiting flowers, so th e distribution of fire blight is quite clear, but later
on when there is a hail storm those things can happen and its really not in our hands what will be coming
up with fire blight or if there is nothing coming up and for those reasons I think we should be always
aware that late events which could even occur just before harvest could affect all the fire blight in
orchards.
Chairman
120. To go back to Dr. Smith, please take the floor on that.
Dr. Smith
121. I think Mr. Chairman, that one of the important points is that when fire blight bacteria multiply
and infect apple fruit they cause symptoms, and you can see they are there, you can see that something is
happening.  Under the normal situation in which fruit is being inspected and certified for movement, such
fruit would not be accepted..  There may be certain extreme situations (orchards with a very high level of
fire blight or extreme weather situations) in which fruit which is not very small and very immature but
rather older, may become infected.  But then you see something like this and I think this is why the
insistence is that what is really safe is mature symptomless fruit.  Fruits like these, whether they aremature or not, clearly present a danger, but they should not be traded.
Japan
122. Thank you.  So since Dr. Hayward raised the question of damage, external damage which may be
a conduit to the bacteria inside the fruit and as we read the experts' opinions we understand that there are
possibly two possible ways of bacteria reaching the apple fruit.  One is contamination of the stigma
during the flower stage and the possible external damage.  We wondered whether those two are the only
possible roads of infestation and we did a little bit of experiments very recently which has been providedand distributed to you as Exhibit No.39 and 42.
Chairman
123. Have these been made available to the experts and to the other parties?
Japan
124. Yes.  There are some pictures here in colour!
United States
125. May I ask a quick question Mr. Chairman?  I notice that Japan's questions started with definitions
of maturity.  Now we are moving on to different ways in which fruit may become infected.  I am happy to
let Japan ask another question, although I have lost track  in my notes whether this is four or five.  And
can I just confirm  that we will have the opportunity to pose a question of our own at some point?  Thank
you.WT/DS245/R
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Chairman
126. Absolutely yes.  I think we want to try to break  the continuum at some stage otherwise we won't
be able to alternate the issues.
Japan
127. Well, in fact, the next set of questions will complete the cycle.
Chairman
128. Ok
Japan
129. Thank you and so we wonder whether there will be any possible other roads of infestation or
entry of bacteria inside apple fruits and we found, so we did a little bit of research projects and the results
already are out, and I wish to introduce Professor Goto to explain the results and purpose and somediscussions of the study, if I may.
Chairman
130. So your question is what's the experts' reaction to these?….
Japan
131. Yes, yes ….
Professor Goto (Japan)
132. Thank you Mr. Chairman, members of the Panel and all of the experts.  I read carefully all the
literature cited in the documents of both parties to th is dispute as an adviser of the Japanese delegation to
this meeting.  As a result I noticed a question which was not satisfactorily explained in the literature.  The
question is on the infection and all infestation of apple fruit via pedicel or stem.  Most attention of the past
studies was focused exclusively on calyx, fruit surface and fruit itself and the infection and/or infestation
of apple fruit via pedicel or stem was rarely discussed.  Perhaps the only exception was the data listed in
Table 4 of van der Zwet et al. 1990.
133. Therefore I requested the scientists of Yokohama Plant Protection Station of Japan to conduct
preliminary experiments on the infection, multiplication and movement of E. amylovora  in pedicel of
mature apple fruits.  The experiment was conducted through to evaluate the ability of E. amylovora  to
invade fruit pedicel, to multiply in this tissue and to further to move inside of apple fruit.  The materials
and the method are explained in the paper distributed to you submitted as Exhibits JPN-39 and JPN-42.
The results were that E. amylovora  clearly showed rapid ingress into the pedicel and active multiplication
there.  Moreover, it was suggested that the bacteria further moved into fruit within several days because
E. amylovora  was detected in the vascular tissue.  These pictures show that if an apple tree has an internal
E. amylovora  population, the fruit are continuously exposed to introduction of the bacteria through
pedicel, regardless of the maturing stage of fruit, until they are harvested. Although further investigation
is necessary, the route of the introduction of E. amylovora  into apple fruit may not be limited to stigmas
of flowers in early season and accidental injuries of fruit surfaces thereafter.  I cannot fail to emphasize
that the results of this experiment are clearly consistent with some of the experimental results of van der
Zwet et al. (1990), especially in the pathological survey that detection of E. amylovora  in upper core wasWT/DS245/R
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clearly correlated with that in stem with regards to  Rome Beauty apples harvested from blighted Utah
orchard.
134. Also, the results of the storage experiment can be explained by the same discovery, namely it is
considered that E. amylovora  remaining in pedicel or upper core later caused the fruit blight inside of
apple fruit during the cold storage.  Unfortunately E. amylovora  couldn't be detected inside of apple fruit
in the first experiment.  However, the bubble formation on top of the apple fruit suggests that
physiological activity of fruit was depressed by invasion of E. amylovora  and that caused induction and
the propagation of anaerobic bacteria.  This phenomenon occurred because the apple fruit were harvested
in Japan which had rich micro-flora and the high humidity and different results will be obtained in the
United States with a relatively poor micro-flora.
135. To sum up, these results of these very recent experiments indicate that the available information
on the fruit infection is far from enough to draw any decisive conclusion, in spite of enormous number of
articles on fire blight in the long history of research.  Thank you.
Chairman
136. Can I clarify what the question is therefore, for the experts?
Japan
137. Yes, Do you have any comments?
Dr. Geider
138. I agree with Dr. Goto that this type of experime nt has not been routinely performed in labs and
therefore it is somehow novel or maybe a parallel appr oach of old data of Tom van der Zwet.  Of course
what I would expect is when you cut the pedicel and you put E. amylovora . solution on top it will be
sucked in and it will somehow be in the apple after some time and afterwards of course you can ask forsymptoms.  I think I would agree with the first part that E. amylovora  is in and the bacteria which are
presented here in the sort of MS medium look like E. amylovora  and therefore things are ok and there is
not doubt on that but I have to say that the pedicel tissue is of course something different from the apple
although it belongs usually to the apple.  Yes I think we all eat apples which are not harvested without
pedicels so this could some sort of attraction for fire  blight which is in the stem which is getting to this
part of the apple and it will stick there.  The other part which are the figures 6 and 7 look a little bit
unusual to me, a thing is foaming at the left side is fr om my opinion not typical for fire blight at all.  I
think it could be some other micro organism and you sa y you find these apples rich in micro-flora it might
be something else but I have never seen E. amylovora  foaming on a plant surface like that although I can
be wrong by doing not the same experiment.
139. The next pictures which are of brown apples look to me quite rotten and of course I have to
believe you that this is fire blight and we see those symptoms coming up from E. amylovora .  If you don't
mind we can repeat that experiment at home with labelled E. amylovora  and find out if everything which
is seen here is really E. amylovora  or something else and for those reasons I think we should keep this as
an interesting experiment in the lab but a little bit caut ious in interpretation if this clearly shows that apple
can be infected just from fire blight coming from the stem section through the pedicel into the apple.  Iwould be a little bit cautious in saying that.
Dr. Hale
140. Yes, I would like to just follow that up because I th ink that Dr. Geider is quite right.  If you cut
the surface and you put a pure suspension of E. amylovora  on that cut surface then it is likely to be suckedWT/DS245/R
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into that vascular system.  It may well be because of this sudden impact of large amounts of E. amylovora
in that area that there is some tissue breakdown an d what is happening then is that the anaerobic or
fermentative bacteria are breaking down carbohydrates  around that area at the top, or breaking down the
plant tissue, releasing carbohydrates which may, in fact, enhance the growth of E. amylovora  at that stage.
But I think it really is quite an artificial situation to cut the surface like that and then just let the bacteria
get sucked in.
Dr. Hayward
141. Mr. Chairman, I agree with what both the previous  speakers have said, but I would like to refer to
the last paragraph in the discussion to this paper, which seems to me to make an assumption which is not
warranted.  The paragraph begins:  "We consider that this phenomenon, (and the authors are referring to
the figure 6, left) we consider the gas formation due to possibly anaerobic bacteria, possibly other
Enterobacteriaceae .  We consider that this phenomenon might develop because these apples wereharvested in Japan, which has complicated and rich micro-flora under high temperature and humidity and
different results will be obtained from apples harvested in the United States which has rather micro-flora."
I can't see that that is a scientific statement.  We don't have the experience the experiments haven't been
done in the United States.  The comparable experiments have not been done.  How can it be said that the
micro-flora is poor in one part of the world as co mpared with another, without having I don't understand
that statement.  Thank you.
Dr. Smith
142. I think Mr. Chairman, that experiments done under artificial conditions of this kind can give one
some insights into what might happen, but the first point in my mind, is what is supposed to happen in
nature?  Apples in fact are mainly attached to the trees by their pedicels.  They are not cut and so the
question is, supposing that there were a canker on the branch, can the bacterium spread through the
pedicel into the fruit under those conditions?  And such an experiment would also have to be done to seewhether the results obtained in the laboratory have any relation to a natural situation.  In the comments
that I made earlier, I said that all kinds of strange results can be obtained by artificially inoculating plants
with high concentrations of pathogen.  Such experiments can guide you as to what might happen, but they
do not really provide conclusive evidence of what is happening on an apple tree.
Chairman
143. Thank you very much.  Are we now at the point where we can go onto another issue, or are we
still on .. You have another question relating to the same topic?  So you have a question back to theexperts on what they have just said?  Please go ahead.
Professor Goto (Japan)
144. Dr. Smith, I would like to ask a question about y our comment. I think that every expert would
agree to the fact that there is latent infection with E. amylovora  on branch in nature.  Also, various studies
have reported the existence of very small cankers on branch in nature. Then, do you think that  E.
amylovora can move from a canker on branch into fruit through xylem?
Dr. Geider
145. Ok, I probably got at least the end of the question.
Chairman:
146. Would you like to have it repeated?WT/DS245/R
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Dr. Geider
147. No, no it is ok.  It is always a question how does E. amylovora  move in plants and we did quite a
bit of work showing that the bacteria are moving towards the root system and it is unexpected but it is inagreement with data which were before obtained by  Bob Goodman in Missouri.  So I think the question
that it's moving from a canker in the stem up and gett ing into branches and finally into fruits is very
unlikely.  I think all our data are objective against this assumption, I think the only thing which could be
assumed is that a tip of a shoot is getting newly infect ed with fire blight and the bacteria are moving down
and they are hitting apples and then they get this way into the pedicel and finally into the fruit.  But ingeneral, shoots are not this much any more in the late part of the season, that means in August, September
shoots are mature and they do not sprout any more and for those reasons I think fire blight is restricted to
older parts of the plant and this movement can do at least to the data we have in the lab cannot occur.
Dr. Hale
148. I have nothing to add to that.
Dr. Hayward
149. I have nothing to add to that.
Chairman
150. Any more questions from Japan?
Professor Goto (Japan)
151. I would like to ask a question about Dr. Haywar d’s comment. As I mentioned at the beginning,
this experiment is a preliminary one. In the last paragraph of the paper on the preliminary experiment, we
stated that Clostridium  sp. could be involved in the bubble formation. We have considered that if the
infection occurs like this and a lot of ethylene would come out, anaerobic condition could be produced.
Then, Clostridium  sp. could multiply under anaerobic condition. Of course, Enterobacteriaceae could
multiply and form the bubble. I think that both can occu r. Dr. Hayward, do you think that neither situation
can occur under this condition?
Dr. Hayward
152. Thank you Mr. Chairman.  I don't have any quarrel with the statement made by Professor Goto.  I
merely drew attention to the last paragraph in relation to the comment made about the micro-flora in the
United States.  That is why I raised the matter.  I think the interesting phenomenon is its clearly a gassy
response implying fermentation of soluble sugars, maybe polysaccharides from the fruit by bacteria which
could be, as suggested I think, facultative anaerobes or even possibly anaerobic bacteria, and thecomparison was made in the last paragraph with the known Clostridium sp. response on potato.  So I have
no disagreement I think either possibility that Professor Goto has raised is likely.  But that is not really
why I raised the matter.
Dr. Geider
153. A short question about this browning.  To me it looks that there is some sort of saprophyte
coming up and its just colonised the tissue and I would say this could be explanation that this sort of foam
is coming out.  Would you agree on that?WT/DS245/R
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Dr. Hayward
154. Yes.
Chairman
155. You are talking about these pictures here?  Yes.  Thank you.  Japan, any more? This is the last
one?
Japan
156. Let's forget the mature, immature distinction of continuum or continuous process for a while.
Nonetheless in some of the experiments bacteria were  isolated inside the apple.  I wonder what would
happen to maybe a small population of bacteria in th e following few weeks.  Would they die or would
they somehow multiply and how quickly they will complete whatever process?
Dr. Geider
157. Just to repeat the question – how were the bacteria introduced into the fruit just by damaging the
fruit outside or by the pedicels?  Is that it?
Japan
158. I am sorry, I am referring to van der Zwet et al. (1990).  In van der Zwet et al. (1990) some very
small population of bacteria were recovered from fruits and the question is what the fate of those bacteria
would have been?  Would they have died, or would they have survived and multiplied in whatever it is
and how long would it have taken for the bacteria to perform that process?
Dr. Geider
159. I think it is getting back to the old problem with that paper.  In 1990 of course they did probably
some plating assays there to find out that there is E. amylovora .  Really I am unable to comment how this
bacteria behaved before – were they in the fruit, were they epiphytic or were they just a contamination by
hands getting to the fruit?  I think we really dwell now on a paper a little bit difficult in terms of how it
was created and how all the data were interpreted.  Usually to our opinion and I agree on that with many
of my colleagues, including Jean-Pierre Paulin, saying that persistence of fire blight in plant tissue is a
very difficult issue, you cannot really judge here what is going on there.  Is the population staying?  Is itgoing up or down?  And actually we discussed that  issue when there was transient occurrence of fire
blight in the Botanic Garden of Melbourne if plants which were imported and put into the garden could
have carried fire blight for decades, maybe thirty years or so, and finally we gave up.  I think there is no
real research on the point about persistence of this pathogen, specifically E. amylovora , in plant tissue.
The only point is that there is something in the population increases and you get symptoms and you seethe symptoms and you say that’s fire blight.
Chairman
160. Thank you.  Dr. Hale, in asking you to address this question, can I add a related question from the
Panel?  In your reply to Question 10 from us, with reference to Thomson (2000), you stated that
endophytic bacteria can "multiply in internal tissues without causing disease".  So the question is, can
these bacteria nonetheless spread the disease to other hosts?WT/DS245/R
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Dr Hale
161. Right.  I'm not necessarily talking about fire blight in this situation.  This is a situation of
endophytic bacteria in plant tissue generally and not necessarily fire blight.
Chairman
162. Do you have anything else you wish to say on the question as originally formulated?
Dr. Hale
163. Can you just go back to that question again?  The original question? I don't really have any
information on that other than to corroborate what Dr. Geider has said.
Chairman
164. Dr. Hayward?
Dr. Hayward
165. Mr. Chairman, I have nothing to add to what Dr. Geider said.
Chairman
166. Dr. Smith?
Dr. Smith
167. I think that, in van der Zwet et al.  (1990), as far as we can infer, the fruits were symptomless.  Of
course it's impossible to say with any certainty what eventually might have happened to those fruits.  But,
because, in general, internal infections with fire blight are not found in mature fruits, we would suppose
that nothing would have happened to those bacteria;  they would simply have stayed there at the same
level or perhaps declined.  But I am really making a conjecture there because I do not think that this is asituation which has been investigated.  But I would s uppose that the population could not increase, so that
the situation of those bacteria as a phytosanitary risk  would not be very different from those that might be
in the calyx or which might be on the outside.
Chairman
168. Thank you very much.  Can we now bring that particular discussion to a close and revert to the
United States to the questions on their next issue.
United States
169. Thank you Mr. Chairman.  We do wish to move matters along.  It did seem to us there were a
couple of issues raised by the Japanese questions and the experts' responses that could bear some
clarification.  In particular, while I'm sorry that the Japanese scientists had to spend the holiday seasonconducting new research, I'm doubly sorry that the experts have not had much time to review these
exhibits that were only presented on Friday and th is morning.  And I thought that I may have heard
perhaps a slight mis-statement from one or more of the experts with regards to the result of this
experiment.  In particular I'm looking at the one fr om Friday.  I thought that someone had mentioned that
while this really does look like fruit rot, how can you know that this is fire blight or why do you reportthis as fire blight and I'm looking at the discussion of this first experiment (this is Exhibit JPN-39) and
actually if you refer to the colour exhibits with the plates that were passed out, you go down to number 6,
you can see scoops in the cortex of the fruit.  If you then read the discussion it says the discs of mesocarpsWT/DS245/R
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were gouged out at the same intervals using a sterilised cork borer.  Detection of E. amylovora  from these
discs was carried out as described above and no E. amylovora  was detected in any disc .  The cause of
browning has not been clarified yet.  I read this report to be that in fact they're not recording this as fire
blight infection caused by E. amylovora  because they didn't detect any E. amylovora  within the cortex of
the fruit from these discs that you can see in the colour plates that have been gouged out.  But as I'm not ascientist and Dr. Roberts has not had time to properly train me on what to say, I thought that it might be
expedient for me to turn to Dr. Roberts and perhaps he could give some reactions to this paper and then
we could ask the Panel's experts for their reactions to that reading.
Chairman
170. As long as this is framed in the form of a fixed question to the experts.
United States
171. Just as Japan has phrased its questions.  Thank you.
Dr. Roberts
172. I've only had a brief time to read this paper as well but I have a couple of comments that I think
bear consideration and perhaps comment by the Panel in light of their statements previously.  First I
would like to reiterate what Mr. Millán has indicated and that is that contrary to the claim, the fruit
mesocarp was not infected by fire blight and I think perhaps the experts were under the impression that
this was a fire blight infection when in fact it was not.  Additionally I do not feel that infection of the
pedicel occurred either.  There was no ooze present.  We see a little discoloration of the tissue but pedicelbrowning was reported primarily at the point at which the pedicel was cut for the inoculum and this is
likely due to oxidated browning.  Many times you cu t plant tissue it turns brown, due to the production of
polyphenols and so it's not at all clear or confirmed that this fruit became infected with fire blight at all.
As the experts have commented, removing the abscission layer before placing the inoculum onto the
pedicel removes a major barrier to infestation and invasion by many micro-organisms.  That this is atotally artificial construct is reflected in the fact th at stems have never been shown to harbour an internal
bacteria, internal populations of the E. amylovora , in studies of fruit exposed to naturally-occurring
inoculum, referring to Sholberg et al.  (1988) and my own work in 1989 which, by the way, both of these
studies did evaluate the presence of E. amylovora  in stems of fruit that were harvested from trees that had
fire blight, and none was found.  Of course we didn't cut the ends of the stems off and put the bacterium
on there, we just looked at what happens in nature.  Now, the abscission layer serves as a barrier to entry
of micro-organisms and also restricts the loss of water from the fruit.  Removing this abscission layerallowed, apparently in this experiment, the transp iring apple to draw in the aqueous suspension of E.
amylovora .  Even so, neither infection nor infestation of the fruit cortex occurred even after 10 days of
incubation under the artificial method of inoculation and incubation under near ideal conditions
apparently.  So I would be interested in the Panel's further reflection of the significance of this work in
light of this additional, perhaps clarifying information.
Chairman
173. Thank you.   Before I ask the experts to respond to that perhaps I should first of all say that we
had envisaged in fact that we would probably have come to an end of this afternoon's session by now, but
we haven't done so and it is a useful process we would like to continue with but unfortunately one of ournumber Mr. Häberli has to leave us and he will be back tomorrow but we propose to continue with just
the other two panellists.  I hope that's acceptable to the parties.  Dr. Geider, perhaps I could ask you to
respond to the US.WT/DS245/R
Page 239
Dr. Geider
174. Just maybe repeating in different statements what I said before – the browning of the fruit is
caused by something else and of course I didn't have the time too much to read all the statements and
there was no E. amylovora  involved anyhow,  I think this is a clear point.  The other point is about this
figure 7 – the left apple here which shows some sort of browning from inside, I would assume that this is
very similar, that there is some sort of rotting bact erium or something else but of course you have to take
samples out and the question is: was that done?  An apple which has this browning and was assayed for
fire blight or for E. amylovora  or was that just kept as it is?  The question is to the Japanese party.
Chairman
175. Does Japan wish to respond to that at this time?  Are you able to respond to it?
Professor Goto (Japan)
176. We just started this experiment last December, so we have had only one month since then. In
addition, apple fruit season has already passed. Therefore, we will study this topic intensively from
autumn this year, and further examine how the browning of the fruit was caused, whether or not E.
amylovora  can be isolated by other isolation methods from the rotten part of the apple fruit and from the
base of pedicel where the bubble was formed, how the bacteria can move inside of apple fruit after
invasion through pedicel, etc. On the last point, Crosse et al. (1972) already reported that the bacteria
could move quickly both upwards and downwards through main vein from the inoculated point.
Dr. Roberts has pointed out that the infection of the pedicel did not occur in this experiment. We would
agree with him if “infection” were defined as “oozing”. We would like to emphasize, however, that
pedicel could play an important role for multiplication and movement of the bacteria. Therefore, we
would like to examine these issues from completely  different viewpoint and wish to demonstrate what
kind of role the pedicel infection with E. amylovora  could play in infection and fruit blight inside of apple
fruit.
Chairman
177. Thank you.  Dr. Geider, you asked that question.
Dr. Geider
178. I have an agreement and a disagreement.  I think what, I have followed the work of Goodman and
personal discussions with him.  E. amylovora  is moving mainly downward, it's moving a little bit upwards
but mainly downwards as a plant so I think that this is also in agreement with our results we published a
couple of years ago.  With ooze formation and the pedicel, I'm of course not so convinced that must
happen all the time because ooze formation requires a special environment which is not always realisedespecially in plant tissue they can just get necrotic and showing no ooze.  Ooze needs humidity and
certain conditions, so I think ooze formation might not be applicable for all plant tissue tested.
Chairman
179. Dr. Hale?  Anything on what has just transpired?
Dr. Hale
180. Yes, just looking at the pictures.  I just feel ag ain that we haven't really got any proof that the
symptoms are caused by fire blight.  Okay, admittedly E. amylovora  placed on the pedicel, the cut
pedicel, is probably being sucked into the vascular system and consequently it may multiply a little there,
particularly as the fruit is breaking down.  So, one would expect to find E. amylovora  there. However, justWT/DS245/R
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looking at the rot-type symptoms now, the fact that nothing has entered the mesocarp, and also that
picture No. 7 certainly, to me, looks far more like a fruit rotting than it does to symptoms caused by fire
blight.
Dr. Hayward
181. I don't really have anything to add.  I think it was useful for Dr. Roberts to point it out that those
cork borer extracts, none of that resulted in isolation of E. amylovora .  And looking at the paper I see that
the results are actually in the fourth paragraph of the discussion.
Dr. Smith
182. One interesting thing about what's done here is that these symptoms do result from inoculation of
the pedicels with E. amylovora .  I assume that in the control apples nothing happened.  So this is evidence
of some kind that if you introduce E. amylovora  into an apple in various ways you can actually trigger
infection of the apple by saprophytic bacteria which are not E. amylovora  and various strange phenomena
can be obtained. I recall van der Zwet et al.  (1990) who found that, when they surface-sterilized apples
and put them into store, those which had been exposed to E. amylovora  beforehand rotted much more
than those that had not and yet the surface sterilization is supposed to destroy the bacteria.  So, there is nodoubt that strange things can be done and the interactions between E. amylovora  and other bacteria may
cause strange effects.  But whether these correspond to anything in nature, I am inclined to doubt.
United States
183. At this time our preference would actually be to whether we could stop proceedings for today and
begin tomorrow only because we have additional questions along this subject-matter but we just feel it
would probably be more appropriate and given procedural ly useful since this is an oral discussion and
discourse here for all 3 panellists to be present, so if that is alright with you and with Japan, that is our
preference.
Chairman
184. The problem is that time will be limited tomorrow and it's not tonight, so if we give up this time
now we may come to the end of the available time without having asked all the questions and having
given everybody the opportunity …
United States
185. We understand that but again, just looking at our questions and maybe I don't know how many
questions – this is why we're raising this now, to see wh at other, what the Panel's view is and what Japan's
view is but, I mean, we feel that tomorrow would be  sufficient time to cover, at least our questions and
then some, but I don't know, maybe both either the Panel or Japan may have just an overwhelming
amount of questions – I just think in this situation it is useful to have all 3 Panellists present when there's
nothing on record here.
Chairman
186. The time-limit again for Mr. Häberli tomorrow is 2 p.m. so after 2 p.m. he will not be available so
we would then have to, if we are going to start at  11, we would really only have a couple of hours.  I
would ask you to take that into consideration.WT/DS245/R
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187. We are prepared to make a proposal that would hopefully address the concerns.  We suggest that
we resume with all 3 Panel members at 9 a.m. tomorrow morning and hopefully aim to complete the
process by the end of the morning and we wo uld adjourn now.  Any problems with that?
United States
188. Mr. Chairman, just to confirm then that we would be able to have an opportunity to go through
the procedure as you laid it out in the beginning, I mean through that time-period.  For example, should
there be a problem and we are not able to get through closing statements by the experts, will we still make
time for that as well?  Because after what you've said we consider that we were not aware that we only
had limited time tomorrow as well.
Chairman
189. Well the situation is that we are still in the questions from parties to experts and we are going to
follow the procedure as laid out, so the next stage after that will be, once the parties' questions are all
exhausted, will be a brief suspension while the Panel reflects for 15 minutes or so and then we will come
back with our questions.  Just on that, it would be  helpful to know whether there are still a lot more
questions to come from the Parties or whether we've made good progress, or whether we've only just
begun.
United States
190. Depending on how you define questions, we have 3 questions only to ask.  This might be 3
subject matters but I don't think these questions will take very long.  It's more multiple questions, because
as drafted we might pose a question to an individual expert and then ask the other experts to comment aswell, so we would only have 3 questions for you, for the experts.
Japan
191. Well if we try to reduce specific questions, we have quite a few more questions, however I'd say
several questions.
Chairman
192. How many is several?  Less than ten?  Less than five?
Japan
193. It's a continuum!
Chairman
194. I think that the best we can say is that we ca n try to advance the process, hoping that we can
finish between 9 and 2.  Of course it's still open to  go on with the other 2 Panellists.  We have no control
over our colleague's commitments but I don't think we can offer more than that really.  We're quite
prepared to go on tonight but if you would prefer to  start in the morning then I think that proposal we
made would maximise the available time.  So we wi ll adjourn now and resume at 9 tomorrow morning
unless there's any….WT/DS245/R
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United States
195. Your proposal's fine with us.
Chairman
196. So we'll adjourn now and resume in this room at 9 tomorrow morning.  Thank you very much.WT/DS245/R
Page 243
TUESDAY, 14 JANUARY
United States
197. Yesterday we started to follow the hypothetical pathway for fire blight and we asked whether
there was any scientific evidence of endophytic populations of bacteria in harvested mature fruit.  The
experts replied there was none.  Today’s questions will address epiphytic populations of bacteria alongeach step of the hypothetical pathway – that is, mature, harvested fruit.  With reference to panel question
19, I want to focus on what evidence there is of the hypothetical risk of epiphytic E. amylovora  on apple
fruit.  A question to Dr. Hale with regard to Thomson (2000):  In your answer you stated that you agreed
with Thomson’s conclusions that "contamination of mature fruit is rare and only occurs when there are
active sources of fire blight either in the orchard or close by.  Wherever E amylovora  has been detected on
mature fruit it has been associated with fruit from orchards with high levels of fire blight infection".  Dr.
Hale, based on our reading of Thomson (2000), we assume that the literature you were considering inmaking this statement was Hale et al.  (1987), Sholberg et al.  (1988), and van der Zwet et al.  (1990)
because these three active sources of fire blight and severely blighted orchards?
Dr. Hale
198. Yes.
United States
199. And "rare" because most of the literature which attempted to isolate or recover live E. amylovora
from mature fruit harvested from blighted trees and orchards did not isolate E. amylovora ?
Dr. Hale
200. In subsequent observations, we have only found epiphytic E. amylovora  in calyxes when
harvested from New Zealand orch ards with high populations of E. amylovora and severe fire blight
symptoms .
United States
201. With reference to the studies of Thomson (2000), Hale et al (1987) and Sholberg et al.  (1988),
there were different levels of infection in the orchards.  In your 1987 study Dr. Hale, your results were
from a highly infected orchards and E. amylovora was only found in the calyxes of less than 1 per cent of
apples. In Hale and Taylor's 1999 study of a severely infected orchard, 2 per cent of fruit had
E. amylovora isolated from them using two different techniques .  These confirm that any findings of
E. amylovora are rare?
Dr. Hale
202. The results of the 1987 paper were from a heavily infected orchard with 75 strikes per tree and we
found E. amylovora in the calyxes of less than 1 per cent of fruit from blighted trees.  For fruit from a
highly infected orchard harvested in 1999, less than 2 per cent of fruit had epiphytic E. amylovora in the
calyx.  PCR (Polymerase Chain Reaction) had been used  to positively identify the bacteria, but PCR will
give positive results even if the bacteria are dead. A further enrichment technique was also used for
detection.WT/DS245/R
Page 244
United States
203. Thank you.  I would like to ask the other e xperts whether they would agree with these
conclusions of Thomson (2000) and Dr. Hale.  Dr. Smith, you wrote that "The conclusions of Thomson
(2000) seem well reasoned".  Could you confirm that you were considering these conclusions?
Dr. Smith
204. I support my written answer.  Thomson (2000) seems well-reasoned.
Dr. Hayward
205. Nothing to add to my written reply.  Thomson found that the pistil surface was the most
susceptible for E. amylovora.  I am not aware of any work which disputes Thomson's study.  Sholberg's
study showed susceptibility only when apple trees were inter-planted with heavily infected pear trees.
Dr. Geider
206. Many smear effects if the orchard is heavily blighted.  Bees and insects can carry bacteria and
leave bacteria sitting on apples.  Rain also.  So heavily blighted orchards should not be used for export of
apples.  I agree with Thomson's conclusions.
United States
207. My understanding from your responses is that epiphytic bacterial populations may rarely be
recovered from calyxes of mature fruit harvested from severely infected orchards with nearby sources of
active inoculum.  The next step in the hypothetical pathway would be that this epiphytically contaminatedfruit is cleaned, sorted, sized and graded, etc. and put into cold storage.  In fact, to be exported to Japan,
US apples are required to undergo cold storage at less than 2.2° C for 55 days before shipping.  On the
effect of cool storage, I’d like to clarify whethe r there may be some divergence of opinion among the
experts re the effect of cold storage.  In Dr Geider's reply to Question 30, he commented that "cool
storage will increase survival, whereas moisture and other microorganisms will add to the decay of thepathogen".  In considering Dr. Geider’s response, and contrary to our previous comment on this answer,
it’s come to our attention that, in fact, commercial co ld storage of apples is at relatively high relative
humidity levels: 85-95 per cent.  For example the "Operations Guide for Export Apples" for Fresh New
Zealand states that commercial cold stores in New Zealand use 90 per cent relative humidity plus or
minus 5 per cent.  Information from the University of Maine show 90-95 per cent humidity used.  The
reason being that apple fruit stored at low temp erature and low humidity would shrivel and shrink,
reducing fruit quality.  Are any of the experts familia r with relative humidity in commercial cold storage?
Dr. Geider
208. Not doing survival studies on apples but other surfaces – plastics, agar etc- in a defined
environment can show that E. amylovora survives at low humidity and in a sterile environment.  General
rule, cold and sterile better for survival than moist and the presence of other micro-organisms.
Dr. Hale
209. In Hale & Taylor (1999) apples were studied in commercial storage conditions to look at survival
in the calyx end associated with dried up flowers.  Fruit from a naturally infected orchard included about
2 per cent with E. amylovora on  calyx before storage.  Cold storage at 2°C for 25 days is the requirement
for codling moth disinfestations of apples required by Japan.  After cold storage, we found no evidence of
fire blight bacteria in the calyx.  We postulated that phenolic compounds from the re-hydrated dried-upWT/DS245/R
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flower remnants may affect the survival of the bacteria.  I know that apples are stored at relatively high
humidity to avoid desiccation.
United States
210. Given cool storage conditions of 55 days for codling moth in the US case what is the likelihood
of E. amylovora surviving in calyxes?
Dr. Hale
211. The likelihood of survival is reduced but we can't, as scientists, say there is no risk.  You certainly
reduce the number of bacteria surviving.  When apples were artificially inoculated before cold storage at
the highest dose of 10 (to the power of 7) and then left in retail conditions for a further 14 days we found
a further drop off in numbers of bacteria surviving.
Dr. Hayward
212. Sholberg et al. (1988) found that cool storage reduced E. amylovora on Newtown apples  to below
detection levels.  I'm not sure if it was under commercial storage conditions though…..
Dr. Smith
213. Concerning the effects of cold storage reducing E. amylovora, I think we need to know the initial
levels we are starting from.  Normally, E. amylovora levels would drop even under regular conditions
over time.  If it is cold and dry, numbers would drop less quickly; if there is high humidity, levels would
drop more.
Dr. Hayward
214. I can't find the reference for Sholberg et al.  (1988).  I don't recall any reference to the relative
humidity in the study as being controlled.
Dr. Geider
215. Reducing levels depends on where we start from .  If you start with high doses of inoculum, for
example 10 (to the power 8), you will find something .  Is low number of bacteria meaningful to spread
disease?  The answer is no.  If you inoculate at high levels you will find something at the end.
Dr. Smith
216. All experiments done on fruit use high inoculum leve ls before passing the fruit directly into cold
storage.  Under real conditions fruit would be handled  and then put into cold storage.  This would be at
ambient temperatures.  So the levels of E. amylovora on the fruit would already be falling by the time the
apples reached cold storage.
United States
217. I'd like to turn now to the step in the hypothetical  pathway relating to the fruit once it has arrived
in Japan.  Again, my understanding from your previous responses is:  There is no scientific evidence of
endophytic E. amylovora  bacteria and only rarely is epiphytic bacteria found in calyxes.  Epiphytic
bacteria is reduced by handling and storage.  What happens when it arrives?  The experts were unanimous
in that there was no risk of transfer from discarded fruit to an orchard.   Looking at Japan's description of
potential pathways in Exhibit JPN-14, Japan indicates that imported fruit with endophytic or epiphyticbacteria result in infected fruit that produce ooze.  Is there any scientific evidence of ooze from apples
with E. amylovora  in the calyx ?WT/DS245/R
Page 246
Dr. Geider
218. No.  To get ooze from mature apples has not been described.  Unrealistic even if artificially
inoculated with high number.  I was never able to get infection and have never seen ooze.
Dr. Hayward
219. I agree.  It is highly unlikely that you could get ooze from residual populations in the calyx.
Dr. Smith
220. I would agree.
Chairman
221. On this question on the presence of E. amylovora  and ooze, the Panel would be most grateful if
you would assist us in our understanding of the terms bacteria, ooze and inoculum in relation to the
transmission of fire blight?  In particular, is the simple presence of bacteria on an apple sufficient to
constitute a risk of transmission by any vector ?  Or  must the bacteria be in the form of ooze to be
infectious to a host plant?
Dr. Hayward
222. Ooze consists of large populations of bacteria and exopolysaccharide.  Ooze is the outcome of a
severe infection on a susceptible host.
Dr. Hale
223. Bacteria associated with ooze are in a very active stage of multiplication.  This is not the case
with the bacteria found in the calyx of the apple.
Dr. Geider
224. Ooze is beneficial for E. amylovora  bacteria to stop them from drying out.  Polysaccharides in the
ooze provide nutrients and help protect against the plant's natural defence mechanisms. However even
naked bacteria not covered by ooze can multiply and infect if they find a suitable environment – but
E. amylovora  suffer without ooze protection.
Dr. Smith
225. No-one has observed the production of ooze from the calyx of an  apple.  The bacteria would
have to multiply massively, and they could do this on ly if they infected the apple leading to visible
symptoms.  In the calyx you have perhaps tens or hundreds of bacteria surviving, whereas in a little ooze
you have got thousands of  millions of bacteria.  The quantities are of a completely different order of
magnitude.  The bacteria have multiplied intensively; they are there in enormous numbers and the reason
why ooze is much more infective is primarily because of these enormous numbers.
Dr. Hayward
226. Mr. Chairman can I add to that.  I agree with that entirely.  I was a little bit cautious about
attempting to put numbers in ooze from say a pear or an apple or indeed a fire blight strand, but in the
context of the kind of diseases I work with we talk about bacterial ooze from infected potatoes withWT/DS245/R
Page 247
brown rot and you are talking about of the order of 1010 per millilitre.  Does anybody have a figure for
ooze?
Dr. Geider
227. We are getting a little bit diverse in this respect and of course when you see something like ooze
it is a mass of bacteria, of polysaccharides and of water so this is what you can see by eye when you lookwith a microscope you can see a little bit more when they are very small droplets but when you use a
higher solution even with a microscope you can stain capsules and you still see that there is something
around bacteria which is finally visible as ooze on a branch or whatever where the infection occurs.  So I
think ooze in one sense is a visible accumulation of many bacteria in this complex mixture but it can be
turned down to a single cell which is covered over with a capsule which is composed of
exopolysaccharides which is finally the form which is the ooze which we see.  So I think these are all
stages.  One is the macroscopic status, the other one is the microscopic stage but in both cases we haveexopolysaccharides and without those exopolysaccharides the bacteria are a little bit helpless and they
suffer from their environment.
Chairman
228. So does the ooze or perhaps the polysaccharides in the ooze attract other vectors such as birds,
insects or bees?
Dr. Geider
229. The answer is no in this sense because it does not contain sugars which are attractive.  I have
never tasted it but people think what attracts insects is the moisture.  There is something which is humidand they go to that and then they get contaminated  but I think by itself the exopolysaccharides are too
large to be sensed as something useful for insects.
Dr. Hayward
230. Can I just add a little bit. It is a water-loving substratum.  It's hydrophilic isn't it.  Recalling van
der Zwet (1972) where they describe the appearance or enhancement of fire blight strand formation which
is allied ooze.  Fire blight strand formation by application of an oil spray and these strands were coming
out from length cells and stigma and other natural openings.  Now I think in that paper there is quite
precise data about the amount of plant polysaccharide, the numbers of bacteria.  Strand is a manifestation
of ooze is it not?  So there should be data somewhere.
Dr. Smith
231. I would like to add some more remarks concerning the production of ooze from the bacteria in the
calyx.  Now first of all nobody has observed it but we can still argue about what would be happening if it
were possible.  You start with, as I said, some hundred s of bacteria that you can recover from a calyx and
if ooze is to form those bacteria have got to multiply themselves from a few hundreds to hundreds of
millions and how can they do that?  They can only do it by infecting the apple because bacteria can onlygrow if they are actively using a substrate and the only substrate available to them in an apple fruit is the
apple tissue.  So that is only possible if they infect and in fact if the apple is diseased.  So between the
bacteria in the calyx and the production of ooze there must be a phase of infection which would be visible
also as a blighting of the fruit which then finally lead s to the formation of ooze or bacterial strands.  So it
is not conceivable that ooze could be formed without some other symptoms that could be detected.WT/DS245/R
Page 248
Chairman
232. Moving on from that, you've talked about the high concentrations of bacteria in ooze.  Are you
aware of any studies on the concentrations of bacteria needed to infect the host plant whether or not it's in
use.  In fact how likely is it that fire blight bact eria would be found at such concentrations if they are
definable on mature epiphytically infested apples.
Dr. Smith
233. The question of the inoculum needed to infect is a very technical one and I defer to my colleagues
to reply to you on that one.
Dr. Hayward
234. I don't have data relating to apples but Crosse and Goodman (1972) described an experiment
where they took young apple leaves and cut them at the apex just at the apex and cut the apex of the leaf
off and sprayed inoculum at different concentrations and they found a minimal dosage of 38 cells.  I think
that is correct.
Dr. Geider
235. Of course I think this is an endless question in phytopathology.  How many pathogens do you
need to cause a disease?  I still think when the environment and everything is appropriate and ideal for
multiplication you can go down to very low numbers and we have published data with slices from
immature, freshly harvested pears and you can easily go down to about 50 bacteria in order to produce
symptoms which means they will multiply and they will produce ooze and you can see that after a coupleof days.  So I think a low number of bacteria is still capable to produce symptoms in the environment
which is suitable.  In natural environments many bacteria have to visit flowers or leaves and damage them
this is less known.  I think the experience is the more bacteria you use the more often you get symptoms
when you cut down the number you will have to work hard to see anything because the bacteria will
disappear and nothing will happen so I think the experience is not to go to very low numbers otherwiseyou can work forever without seeing anything, but still back to the question is it possible to cause
symptoms with very few bacteria I think in certai n environments like immature pear slices it is.
Dr. Hale
236. I agree entirely with what Dr. Geider has said and it really depends a lot on the environment as to
whether or not you are going to get infection.
United States
237. I think it was Dr. Geider and it was sort of suggested by Dr. Hale, you talk about different
environments under ideal conditions or a cell applied directly to certain flower parts and I am wondering
about suitable environments.  In the hypothetical pathway we were talking about epiphytic populations in
the calyx and Dr. Smith has said, how is it even c onceivable that you would have epiphytic populations
multiplying in a calyx that would result in fruit infect ion?.  There must be something sort of intervening
so I guess the question is how suitable is the calyx for bacterial multiplication such that you might get
numbers sufficient that it would conceivable that it would transferred and this really goes to the work that
you did Dr. Hale where you tried to find movement of bacterial populations in a calyx to a susceptible
host.WT/DS245/R
Page 249
Dr. Hale
238. From the work that we have done we have never found any multiplication of bacteria in the calyx
of fruit.  Even when we have put high levels of bacteria in the calyx we have not found multiplication and
the numbers usually decrease.  They don't increase.  Then of course somehow the bacteria have to get out
of the calyx end of the fruit and on to a susceptible part of a plant under conducive conditions for
infection.  As Dr. Geider pointed out it could be very low numbers that are required to get there, but thenumber of steps which are required suggests to me that the chances are very slim and the work that we
have done and the discard paper show that we have not been able to find a means of getting from
reasonably high numbers of bacteria in a calyx end of a fruit through to infecting a flower or any shoot
tissue or even getting onto the surfaces of plant tissue.
United States
239. And your point about the high bacterial numbers is  to distinguish it from what you would expect
to find in the calyx of an apple that has been imported and gone through all of the steps we discussed?
Dr. Hale
240. Exactly, yes.  I consider the numbers would be very low and, as Dr. Smith has pointed out earlier,
we are not talking about large numbers of bacteria associated with the calyx end of a fruit even if it hascome from an orchard which is heavily infected with fire blight.
Dr. Smith
241. I would like to illustrate the way that this has been thought about in the past.  Two of the
pathways that have been invoked for the introduction of fire blight into new areas are firstly being carriedby birds and secondly contaminated fruit crates.  Now both of these have been suggested without any firm
proof but they have been suggested by plant bacteriologists as plausible pathways and in both cases the
supposition has been quite clearly that it must have been ooze which was involved.  The only way in
which you could imagine that bacteria could survive on a crate is if they were contaminated with ooze.  In
other words sufficiently large numbers of bacteria protected by the ooze could perhaps survive.  Similarlythe idea that birds might have carried fire blight between different European countries is based on the idea
that in perching on infected trees their feet were contaminated by ooze and it was this ooze which was
carried from one country to another and the bacteria survived because they were protected in the ooze.
Neither of these pathways invoke the idea that small numbers of bacteria could have been carried by
either of these pathways.  The only way to make these pathways plausible is to invoke the idea of ooze -
in other words very large numbers of bacteria.
Dr. Hayward
242. The only thing I would like to add is that the calyx is dead tissue is it not?  And it is dry tissue and
it at best is only a possible protected site for survival, not for proliferation as you have pointed out.
Chairman
243. So by that you mean that it is protected from other things like rain or access by insects or birds.
Dr. Hale
244. And also protected from UV light which is UV radiation which is quite important as far as
bacterial survival is concerned and even on the surface of the fruit as well.WT/DS245/R
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Chairman
245. This explains why you see the calyx as the most highly infectious part.
Dr. Hale
246. No, the part which may be infested.
Dr. Hayward
247. Could I add to that the matter of protection is a matter of access.  When the question of
sterilization of apples with chlorine and other compounds was considered several people raised,
Dr. Smith, Dr. Hale, Dr. Geider,  that in fact there isn't a ready access of the surface sterilizing substance
fluid because of air bubbles and so on in the calyx - is that correct?
Dr. Hale
248. Certainly there is no access to those parts of the calyx tissue which are not exposed to the surface.
The calyx of an apple fruit - if you look at an apple fruit - the parts of the calyx are on the outside of the
fruit and parts of the calyx are within the cavity at the calyx end of the fruit.  If there are bacteria on the
calyx which are on the exposed part then I think ther e was a paper in the US which shows sterilization
treatment such as chlorine will, in fact, remove those bacteria.  However, we have found that the bacteria
inside the calyx or on the calyx tissue is unexposed to the outside of the fruit, are those parts which are
difficult to get at with the surface sterilant.
Chairman
249. So that does not count as epiphytic if it is on the inside part of the fruit?
Dr. Hale
250. No, because the calyx is essentially not part of the internal tissue of the fruit.
Chairman
251. Still epiphytic?
Dr. Hale
252. Yes.
Dr. Smith
253. To clarify that you can imagine the remains of the ca lyx as a little pocket folded into the fruit.  Its
surface is continuous with the outside but it nevertheless is protected because air or liquid can only enter
this little cavity through the terminal opening.  I must say that my written remarks about bubbles or the
rough surface of the calyx are just common sense.  They are not based on any investigation as to what
happens when liquid is placed on apples.  I do not know of any study as to how well a surface sterilantpenetrates into the calyx.  But one can see that the surface may repel water to a certain extent, and for one
reason or another the surface sterilant may not penetrate fully into the calyx.
Chairman
254. Have we completed the questions?WT/DS245/R
Page 251
United States
255. That completes our questions and I want to thank the experts for helping me walk through some
of that scientific evidence and we look forward to an  opportunity to pose follow-up questions later in this
session. Thank you.
Chairman
256. Thank you very much. Can I now turn to the Japanese delegation and invite Japan to put whatever
remaining questions they have to the experts.  You have the floor.
Japan
257. Thank you.  So it doesn't have to be epiphytic bacteria.  Thank you.
258. It seems to me just listening to the discussions that there may be some divergence of opinions
about the number of bacteria required to cause new infections somewhere else.  Some experts believe that
ooze is essential whereas Dr. Geider seems to believe that that question depends on the variety of factors
inherent in the environment.  Let me take one step backwards and revisit the discussions we had
yesterday.  I recall there was a consistency amongst th e experts that the concept of maturity is something
of a continuous process.  Apples start maturing and then later on ripen and perhaps as I recall it was Dr.
Smith who pointed out that the issue will be whether there will be any symptoms.  Probably if symptoms
are there that should be detectable and it will never be exported into Japan.  Having said that let me start
with the question of survivability of the bacteria.  Y ou might recall you saw this picture of fairly heavy
infection of young maturing apple fruits and it seems to me some of the fruits are exuding ooze here.Suppose that this apple was mistakenly harvested and put into commercial storage for 55 days at a high
level of humidity at 2°C and after completing all the commercial processing just assume that this apple
was mistakenly put into commercial storage.  Can bacteria on these apple fruits survive?
Dr. Geider
259. I am afraid I have to repeat from yesterday.  We have to assume that all the symptoms we see on
this apple are coming up from fire blight and nothing else which is open to discussion.  Usually, you don't
get this extensive rot because E. amylovora  is not a soft rot but what we call a dry rot or necrotic-type so
all the soft E. amylovora can produce those symptoms.  But anyhow let's assume that most of the bacteria
or the ooze is composed of E. amylovora  the question is do they contribute to spread of fire blight when
packed into a harvest which is exported.  I would say when those heavily infected fruits are exported there
is of course a chance that things will survive and get into another country and I think otherwise thedisease would never get distributed and I refer to Eve Billing's article about fire blight in England where
she was saying that this most probably caused by oozing pears which were brought from the US into
England and they leaked out into the caskets and finally these were used in farms for apple production.
So I think when you have those circumstantial events it cannot be excluded that something must happen.
On the other hand of course, and that is my intention in my comments, we have to cautious to avoid thosethings.  To avoid heavily blighted orchards and to avoid suspicious fruits and what I understand from
harvesting that all the fruits are inspected as they are visibly OK and I agree with Dr. Smith that fruits
which are without any symptoms are probably not heavily infected with fire blight.  I think this would be
a very artificial assumption which has never been realized and I think that will never probably happen that
the food which is looking completely healthy is heavily infected.  I think this is out of scientific scope andtherefore we can say this apple which is on the internet is probably a danger, but it would not be exported.WT/DS245/R
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Dr. Hale
260. I agree entirely.  I think that it is unlikely that  those fruits would pass through picking, packing,
harvesting process and so on and the inspection processes which go on before the fruit become ready to
ship.  Those fruit would not, in fact, be likely to be shipped or exported.
Dr. Hayward
261. I agree entirely with what the two previous speakers have said and I have nothing to add.
Japan
262. So my next question was how likely it is that shippers will be able to successfully detect
symptoms.  I am sure symptoms - will they be large or  small and lighter?  Dr. Smith said in the context of
discussions on epiphytic bacteria that if there are going to be any ooze there could be symptoms thatcould be detected.  How certain is it that farmers or shippers will assure or ensure that apples with
symptoms will never be exported into Japan, or for the next 25 years?
Dr. Geider
263. Of course you can make the worst scenario and what will happen when somebody overlooks
something and these things can occur but many thin gs can occur.  My feeling is the highest danger
coming from fire blight is from tourists.  They ta ke something which is contaminated and they bring it
into the country and touch other things and then the disease might get infested in a way which we cannot
overlook.  I think with all these things an apple wh ich is somehow contaminated or infected with fire
blight, going through all the controls and finally ending up in a market is thinkable, but all the experiencewe have, and I pointed out in my introduction that even in Europe with all these fruits activities back and
forth, we cannot see that in any country fire blight was reintroduced by looking at the pattern which is
coming up in European countries that they are all well organized and no mixing, so that means fire blight
is certainly distributed widely with all sorts of activities and in Europe we can include also activities with
whole plants so I think fire blight is really something which is ordered and rarely distributed outsideorchards by insects or birds and wind.
Dr. Hale
264. I think another aspect of this is probably something that Dr. Geider pointed out earlier on.  In
order to have fruit showing symptoms it is more than likely that the orchard had relatively heavy
symptoms during the year.  Inspection processes hopefully would eliminate the export of fruit from
heavily infected orchards.
Dr. Hayward
265. Nothing to add on this point.
Dr. Smith
266. I think that the process in which fruit is harvested, sorted and selected for export is a process
which can be audited and indeed is.  So that a certain degree of quality can be guaranteed.  Nevertheless
there will be a certain small risk that, if such infected fruit were present, they will not be detected but will
in some way pass through the system.  That is the reason why those who regulate in relation to fire blight
are also interested in the general condition of the orchards in which the fruits are taken.  We have heardthat the conditions of heavily infested orchards are almost necessary for you to get this kind of symptom
on fruits.  The requirement is often made that fruit should come from orchards which are fire blight free.WT/DS245/R
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Now from my point of view what is necessary is to ensure that the orchard is free from fire blight.  It is
only heavily infested orchards where you have such risks.  There is no doubt that to avoid this chance of a
mistake in the sorting process you take one step up the line and inspect the orchard as well and make sure
no active fire blight is in the orchard.  How severely you apply this and what extent, how many
inspections, how many years you maintain those inspections, whether you have a buffer zone or other
questions can be argued over.  In relation to fruits I would say that such an inspection regime of theorchard can be fairly light.  It can be much lighter than the regime that would be used for inspecting
nurseries where you are looking for the possibility of infected plants as oppose to infected fruits.  This is a
different issue and as a point of principle your best protection against the mistakes in the sorting process
is to work with fruits from clean orchards in the first place.
Chairman
267. Can I just take you on a little bit further from there.  You've talked about precautionary measures
and said it is arguable how necessary they are but there must be a relationship between those and the
degree of risk involved.  Could you comment for example on the question of designated areas being
inspected - orchards being inspected say three times yearly - is that a sufficient requirement for the
circumstances or is it more than necessary for the sort of risk that you have in mind and is there any other
scientific evidence that would relate to the degree of such controls that are necessary in relation to therisk?
Dr. Smith
268. There are many options that can be taken in applying such precautionary measures.  The first is
the number of inspections, of which the minimum would be one, but according to circumstances suchinspections sometime apply up to three in a season and sometimes they go back to the preceding season.  I
am not talking about fire blight but the most general case.  In extreme cases the requirement is sometimes
made that the disease in question has never been seen on the land concerned.  There is also a geographical
criterion.  It may be sufficient to inspect only the trees which have been harvested which would be a
minimum requirement or you could make the requirement for the whole field which is concerned but isnot always the case that fruit from a single field goes to the same destination - it may be divided later and
go to different places with different requirements.  The requirement may be made not only for the field, it
may be made for the whole place of production so that although other parts of the place of production
may not be exporting apples you could ask that all of the place of production was inspected the
appropriate number of times.  A further step is to ask for immediate vicinity freedom which implies that
there is a buffer zone of a certain size around the place of production which must also be free from
disease and you could take it even further and ask for radius freedom which means over quite aconsiderable defined distance the disease should not be found.  So there are many variables that you can
play with in deciding on the level of intensity of your inspection.  This is a case-by-case question and the
authorities have to work out in each individual case what they think is necessary.  It is finally a matter of
judgement by comparison with equivalent cases that have been used in the past and I think it difficult on a
purely scientific basis to be able to declare that for the certain disease there are good scientific reasons forinsisting on three inspections when two or one would be sufficient.  It comes finally to a question of
expert judgement and experience.  If I take the example of nurseries under European conditions,
requirements of this kind are made for propagating material which is exported from nurseries.  The
European regime for this material is a severe one - it concerns the whole place of production and a zone
around it.  There is one inspection regime for the place of production, with two inspections in the growingseason, and a different regime for the surrounding zone.  That I would call a fairly heavy regime, which is
appropriate for plants intended to be planted because if they have fire blight, it is very likely the disease
will express itself where they are used.  If it were a question of applying such requirements for orchards, I
would say fairly categorically that the regime which is appropriate for nursery plants is more severe than
is needed for orchards.  That is for the simple reason th at the intended use of the fruits is to be consumed,WT/DS245/R
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processed or destroyed - not to survive, and so manifestly it is not necessary to apply measures of such
stringency in the case of fruits.  But I would hesita te to advise exactly what should be the inspection
regime for an orchard.  Turning it round, I would sa y that a single inspection of the orchard in the
growing season, without the buffer zone would give you a good guarantee that the orchard was not
heavily infested by fire blight and we have been hearing that infection of mature fruits only happens inorchards that are heavily infected.  So from those conclusions an expert might reasonably decide that to
avoid the possibility that there would be heavily infected fruit coming out of an orchard it is enough to
make sure that the orchard itself is not heavily infected by a single season growing inspection.
Dr. Hale
269. No I don't really have anything to add - I think Dr. Smith has summed that up very, very well -
very clearly and I think that that is exactly the way I would feel about things as well.
Dr. Geider
270. I think it's of course a matter of trust and harvest efforts with fire blight outbreaks in the orchards
it would be really a pity when they are doing that so I hope that there are some standards and of course to
keep the standards some inspections might be useful and beneficial. To my experience, just to find fireblight in the area is often not so easy.  I asked colleagues in Eastern Canada to show me fire blight
orchards and we had to drive hundreds of kilometres to find the next orchard which was really in a bad
shape where fire blight persisted but in all other orchards around there was no fire blight at all and I think
all inspections would have been good and without any concern so I think it is a little bit a matter of
personal feeling and balance and finally of course we have to trust farmers that they are not doingcompletely wrong and I don't know this impact is really  applicable in trade or is it that farmers try to sell
everything - that is sometimes the feeling that people develop on the market here.
Dr. Hale
271. Just following up on what Dr. Geider said and wi th my own experience as far as New Zealand is
concerned.  We  do not try to sell everything - it would be a ridiculous situation for us to sell everything.
We only sell the highest possible quality to the markets which pay the highest prices.  So, as far as New
Zealand is concerned, that is what happens and I would assume that the United States has a similar
situation.
Dr. Smith
272. An orchard or any other plot of land should be inspected.  This has the administrative
consequence that the Plant Protection Authorities in the exporting country must know that that producer
intends to export to a given destination because they have to be warned in advance of the need to inspect.
Otherwise they will not carry out the inspection and they will not be able to certify.  This system has to be
controlled and in such a system farmers have no freedom of action in this respect.  If they have not been
inspected and the certificate is not delivered, then they cannot export.  The authorities need at the
beginning of each growing season to determine which farmers are intending to export to which
destinations in order to be able to put in place the necessary inspection regime.  So I do not think there
should be any serious concern in this case.  The administrative aspects of the system normally function
very well.WT/DS245/R
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Dr. Hayward
273. We are considering question 23, aren't we on the orchard inspections? And Dr. Smith said earlier
that one inspection should be sufficient, but my question would be what is the optimum time for making
that inspection at flowering, at a later stage - can I ask that?
Chairman
274. Yes!
Dr. Smith
275. Well Mr. Chairman I didn't know that this was a session where the experts ask each other
questions! I must say that I am an expert on phytosanitary regulations, but not an expert on fire blight and
so I cannot answer that question.  But perhaps my coll eagues here who have looked at a lot of fire blight
in orchards are in a better place to be able to confirm my suggestion that you should be able by a singleinspection to tell whether an orchard is heavily infest ed with fire blight and what would be the best time.
Dr. Hale
276. If it was going to be one inspection I would say that inspection should be done at harvest time
because if it is a heavily infected orchard there is no way that the grower can have pruned out allinfections within that orchard.  I think my answer or iginally to the question was that I have always felt
that an early season inspection, whether it be at flowering or at the fruitlet stage, is quite important for
two reasons: one it alerts the grower or the exporter to the fact that the orchard is not going to be suitable
and consequently the grower is not going to export to a specific market;  and secondly, because of the
information, the grower or exporter can then divert th at fruit to markets where there is no problem as far
as fire blight is concerned.  It is very important when dealing with large quantities of fruit for logistical
purposes to be able to make those decisions relatively early in the season and it is certainly the case that
we in New Zealand were looking at.  However, I realize that the costs and so on of more than one
inspection are high and consequently if we were going to go to a single inspection I would say that the
pre-harvest inspection would be adequate.
Chairman
277. So other inspections at blossom time and harvest time would be overkill perhaps?
Dr. Hale
278. I think the minimum would be the pre-harvest a nd the maximum requirement would be an earlier
season inspection as well.
Chairman
279. So that is two?
Dr. Hale
280. Yes, that would be a maximum of two, but I think , from experience, that the pre-harvest
inspection would be adequate.  An earlier season inspection from a commercial point of view, would be
useful because, as I mentioned, the fruit from those orchards would not be harvested and sent to a country
which had specific regulations as far as fire blight is concerned.  There are very few of those in the world.WT/DS245/R
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Dr. Geider
281. In my statement I favoured the time after flowering for the scientific reasons.  One is when you
do inspection during flowering you can be misled by other symptoms - there are other necrotic bacteria
which can cause blackening of flowers and therefore this can be misleading what you see.  At harvest
time it is a very important time because this is telling about the quality of the apples for against fire blightbut I feel it is not an easy to see.  I think no farmer would leave all necrotic branches until harvest - he has
to do something - prune them or otherwise it would be  endangering his whole orchard so I don't know Dr.
Hale means - if they are pruned branches would that be an indication that there was fire blight so
therefore the orchard is suspicious or is it just that you expect that at the harvest there would still
symptoms available which can be seen by inspectors .  For those reasons, I think after flowering maybe
three, four, five, six weeks would be a good time because then it is clear when there are necrotic
symptoms coming up and there is even ooze connected with these symptoms it is a good time for fireblight and this is clear - all other stages are difficult and for those reasons I personally favour this period.
Dr. Hale
282. Yes, I agree with Dr. Geider.  I think that if there is going to be a single inspection, then perhaps
the earlier one would be more useful and cover both fire blight and logistics.
Dr. Smith
283. Well, Dr. Hale has put his finger on another aspect of such an inspection regime which is that it
has to be organized in the exporting country.  The fact of doing it at all is the main constraint because it
requires that orchards should be individually identifi ed, that they should be registered, that the authority
has to keep a register of them, has to have a whole system for following what is going on and to put such
a thing in place where otherwise it would not exist is a heavy task.  On the other hand I rather have the
impression that, whether you are in New Zealand or th e United States, if you are exporting apples those
orchards are in any case bound to be under surveillance.  So that, for the authorities of the exporting
country, once the orchards are part of the system, whether they inspect early or late, once or twice, doesnot make such a very great difference to the task they have to undertake.  They may choose to do it as Dr.
Hale suggests in a way which is most convenient for the growers by doing it early.  All sorts of other
considerations come into play in deciding how to organize the inspection of an orchard or nursery in the
most efficient way possible.
Chairman
284. There was mention made of pruning of infected branches that were discovered in these
inspections.  Could you tell us what is the effect on the possible level of infection of fire blight in apples
from pruning such branches?
Dr. Smith
285. Well, I have to refer to my colleagues who know the question directly.  All I can say is that the
basic purpose of pruning away infected branches is to reduce the risk of fire blight.  The question is:  does
it do it primarily in the current season or does it carry over to the next season?  I would have thought that
the main purpose was for future seasons because by the time you have pruned them away they may
already have caused whatever undesirable effects you might expect in the current season.
Dr. Geider
286. Of course I think this is a delicate question in practical approaches.  That depends how the
growers do that.  Do they sterilize their scissors and whatever they use carefully and otherwise they mightWT/DS245/R
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carry the disease onto other trees and in other parts of the tree.  This is not so easily done because you are
somehow climbing a tree and you prune something and then you have to disinfect your scissors and how
do you do that? You use alcohol or chlorine solutions and so this is already a difficult point.  The next
point which was pointed out by Bob Goodman is that of course pruned branches have a tendency to shoot
again and therefore open for secondary infections though it is a little bit a balance what is the best way to
do.  I cannot give recommendations and think there must  be experience which is coming up by growers -
how they see the development of fire blight in orchards and I don't know if…
Dr. Hale
287. What Dr. Geider says is correct.  Unless you are going to prune out properly and sterilize between
cuts then, of course, the disease may manifest itself even more obviously within the orchard.
Chairman
288. I will now hand the floor back to Japan.  Thank you.
Japan
289. The concepts of heavy infection on orchards may raise some questions.  It is arguable to what sort
of percentage infection would be heavy or substantial and there ought to be some fairly artificial limits ofhow many percentages or in our case our preference is  zero - no tolerance.  I wonder, this question is
certainly based on science, but may also apply to the level of protection which Japan wants.  That is my
impression.  Is that the kind of statement that experts would agree: that the level of protection should be
something which definitely needs to be considered in determining the level of infection from zero to
something ?
Dr. Smith
290. Well, naturally the criterion used in practice is whether any infection is found.  An inspector
follows a procedure and if he finds any infection the orchard is disqualified.  What determines the level of
tolerance is the intensity of the inspection.  So a protocol has to be set out which lays out how an orchardis inspected and how many trees are examined, in what way, what samples are taken.  Such protocols
exist for fire blight.  You can devise a light protoc ol or a heavy protocol.  A light protocol would only
detect a heavy infection, while a heavy protocol woul d detect a light infection.  However, I do not mean
to imply that there is a qualitative difference between the heavily infected and lightly infected orchards .
There is not.  In the end, the only discriminating factor you can use is the intensity of your inspection.
Dr. Geider
291. I somehow agree on that.  I wonder about no tolera nce.  It is very difficult to judge from a
necrotic branch is that is fire blight.  You have to  be very careful of excluding other possibilities which
means the inspection has to be followed by some sort of reliable assays and even these assays must be a
little bit higher level otherwise people can easily cl aim that they have seen something so therefore this
orchard is disqualified.  I think just to get the whol e process in a meaningful way - it is still complicated
and I don't know how the inspection should occur.  If  the Japanese people will come to the United States
and then I see something and they will take samples and they will give it to a lab in the States or they
bring it back to Japan - probably not do that - so the question is a little bit difficult and therefore would
still agree in this respect that the symptoms must be a little bit more than once or twice there must be
really a good indication that this is fire blight and can be identified and controlled pretty much after theinspection.WT/DS245/R
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Dr. Hale
292. To reiterate what Dr. Geider has said - I agree with  the notion there.  It has got to be not only the
inspection but certainly a follow-up on identification of what is causing possible symptoms.  As  Dr.
Geider pointed out there are a number of organisms which can cause symptoms similar to fire blight and
if you look at question number 35 where some of the ea rly reports of fire blight in Japan have since been
attributed to fungal diseases.  Thank you.
Dr. Hayward
293. I think the question from Japan was really asking how do we define the intensity of infection so
isn't this defined in terms of the number of strikes per tree?  How do you define the level of intensity of
infection - people like plant breeders must be able to define the level of resistance in a new cultivar.  How
do you it?  When you say you have a heavily infested orchard what do you mean by that?
Dr. Hale
294. In  the work we have done we have talked about a heavily infected orchard in which we have said
there are 75 to 100 strikes per tree.  So this is a heavily infected orchard.  If we only find the odd strike in
the orchard, that is a lightly infected orchard, and if we find nothing we are assuming that it is, in fact, anorchard free of symptoms of fire blight.
Dr. Smith
295. I stress that, in practice, all the inspection protocols used for phytosanitary purposes of this kind
are effectively working with zero tolerance.  That is to say that when you follow the protocol, if you find
a single strike, the orchard is considered to be infected.  In view of Dr. Hale's description of a heavily
infected orchard, you hardly need an inspection protocol at all.  So, quite a light inspection procedure
would be enough to ensure that you were dealing with orchards that are not heavily infected.
Japan
296. I would like to invite Professor Goto to discuss.
Professor Goto (Japan)
297. I would like to thank the experts for your broad debate.  I really appreciate that as an academic in
phytopathology.  I would just like to confirm the consensus reached by the experts that for the fruit
exporting country the important point is that the orchard is blight free.  Is that true?  Is that the consensus
reached by the experts?  Another question that I have to the experts.  For any bacterial disease or anydisease for plants from the beginning of occurrence up to harvest of that plant the situation of the disease
would fluctuate continuously depending on what envir onment they are exposed to during that period.  So
sometimes the disease would inadvertently increase in occurrence and at other stages that might decline.
Is that also the agreement by the experts?
Dr. Geider
298. In this case, the answer is yes because what we discussed about the fire blight in orchards there
can be a period where fire blight is heavy - you can of course try to get rid of the symptoms by pruning
for instance and finally it might be very low or not visible any more.  So this, with all diseases, is always
a problem - when is the peak and that is the best time to detect it and we all know from medicine here thateven doctors have the same problem.  The disease cannot be picked up and they are not in the right level
so this is the same for plant disease.  For those reasons, there is no proof to say there is no fire blight in anWT/DS245/R
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orchard.  That means you have to inspect everything in terms of analysis, in very broad scale and you
might be lucky to find something which is fire blight, confirm that, and say I did all my best and I found
fire blight symptoms and could confirm it so I think to prove the absence of a disease is almost
impossible.  The only thing you can say is I see something and they are symptoms so this could be disease
and then I identify it to be what I expect.
Professor Goto (Japan)
299. Thank you.  Well if that is the case - just one-time inspection at the time of harvest is something
that I would like to raise the question to the experts because some of the experts might say that one time
at the harvest would be the follow-up of all the previous stages before harvest but that has been discussed
before for a grower.  If he or she sees an occurrence of a disease then of course a grower's natural desire
would be to control that so that there would be pruni ng of that branch.  Therefore, a one-time inspection
would not be able to really check the occurrence of the disease from the budding to the harvesting stage
of that plant because that means there will be some kind of a latent infection or small lesion remaining on
the field from the start of the early stage of this plant to the actual harvest because if the grower proves at
the beginning stage when he or she sees the disease then there might be some of that latent infection or
the small lesions are remaining in the field.  So fr om the importing country's standpoint the more times,
the more frequent the inspection the better.  That is  the view of the importing country, but what do the
experts say on this point?
Dr. Geider
300. I think in theory I agree, but for practical reason s we disagree.  I think it is almost impossible to
follow the development of a disease in orchards fr om blooming to harvest.  That means the inspector
would have to live on the farm and he has to be very clever to find out and quickly drive to get to a point
where fire blight might occur.  Practically that is impossible. So I think we have to compromise in some
way otherwise you have to say it is impossible to export any apples because there is always a low risk that
something might have happened in the orchard so the whole thing is fictitious.
Dr. Hale
301. One of the reasons I have always been a proponent of a reasonably early season inspection is that
what we are really worried about - or could be worried about - is calyx infestation.  With infection of fruit
during the season - those fruits are unlikely to be harvested in any case.  An early season inspection would
pick up any likelihood of calyxes actually carrying ba cteria and I think that any other fruit during the
season becomes infected it is not going to be harvested.  So, that is one of the reasons I have always been
a proponent of an earlier inspection.  I still think a pre-harvest one is a final check on the status of thatorchard.
Chairman
302. But you put the limit at two?  Thank you.  Now Dr. Smith.
Dr. Smith
303. In discussing these questions, Mr Chairman, people often suppose that inspection is  efficient,
100 per cent efficient even, at a given moment.  Sometimes, in special cases, it is.  There are some pests
which  you can be certain to find when you examine an infested item, but this is exceptional. In plant
quarantine, in general terms, whether you are inspecting trees in an orchard or fruits in a crate or plantsbeing shipped you cannot be 100 per cent certain by inspection that the unit you are inspecting is healthy.
So you automatically in the system have a certain tolerance and run a certain risk of some infected plants.
The only way you can improve your chances is to look at more plants so basically you have to select aWT/DS245/R
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sampling system which gives you a certain level of security. This is what is inherent in the idea of
managed risk which I mentioned earlier yesterday.  Managed risk implies that whatever you do, there is a
small risk of missing what you are looking for.  You recognize that what you are doing is not 100 per cent
efficient but you have to do a trade-off between practicality and cost on the one hand and the risk which
you are running on the other.
Dr. Hayward
304. The thing I would add is that Professor Goto in his question referred to latent infections which
were not recognized and these latent infections were present at the time of harvest - I would doubt very
much whether they have any relevance at all to the health of the fruit.
Professor Goto (Japan)
305. Thank you very much for those comments of all the experts and what I meant in my previous
questions is not exactly what Dr. Geider said in his comments.  In other words, I do not mean that the
inspectors should live in the orchards throughout the growing season up to the actual harvest time.  That
would be in a quite extreme case.  I am not meaning that.  What I mean, in effect, is that compared to a
single inspection - either it is at the beginning of the season or towards the late stage near about to harvesttime - compared to that single inspection, three times inspections certainly seem to be better.  As Dr.
Smith said, if three times inspections are conducted during the season that can quite certainly and
effectively reduce the risk of remaining infection of the disease that is from the importing country's
viewpoint.  I would like to know if it is al so the opinion of these four experts?  Is it?
Dr. Smith
306. I think we have been over this ground.
Dr. Geider
307. We have been over this ground.  I don't really know what else I should say.  I think three
inspections are more effective than one inspection.  I personally would say it is much more effort without
much more value.  This is my opinion.
Dr. Smith
308. I have nothing to add to this.
Professor Goto (Japan)
309. Thank you very much.  I would just like to go back to Dr. Hale's comments regarding the cost of
those inspections.   Obviously if the exporting countries of the fruit conduct three times inspection the
cost would increase compared to just one single inspection.  However, for the importing countries of these
fruits if the inspection time is just kept to once and consequently, if the diseased fruit imported into
importing countries and if consequently the disease in question makes an occurrence in that case the costfor the importing countries would increase exponentia lly and it is almost impossible to compare to the
cost of let us say three times inspection.  I would like to know what the four experts think of this
particular case.
Dr. Smith
310. Well, I am not sure I will answer that question directly, but rather by trying to say that in some
way you have to match the intensity and costs of measures to the risks.  I mentioned already that theWT/DS245/R
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inspection regime with which I am familiar is the one which is used in Europe for nursery plants. In the
case of a nursery the European Union recommends two inspections.  I point out again that if a plant in a
nursery is infected and exported, planted and used, if that plant carries fire blight then it will nearly
certainly introduce fire blight into the country to which it is exported.  So the risk from such plants is very
high indeed;  whereas if a single infection of a tree in an orchard is accidentally missed then the
probability that the fruits from that tree will be infected and will after transport, storage and use willtransmit fire blight is many thousands, even millions times lower than the risk from that nursery plant
which is being exported.  So if two are enough in the EU for nursery plants, it seems to me three are too
many for fruit.
Dr. Geider
311. Something about the nursery plants even in this case fire blight might not always spread out of
one plant.  We have such examples, in my report, that a plant which is imported from Belgium got fireblight and we noticed that and identified the disease unambiguously and there was no occurrence in the
environment.  There were many orchards of BBA nearby which is dealing with insect diseases and we
still couldn't see anything in the other plant.  So the ri sk even in an infected plant to distribute fire blight
is not 100 per cent.  It is something between 0.1 and something higher.
Dr. Smith
312. Yes, I accept that.  I have overstated my point.
Japan
313. Two more questions.  One is about the buffer zone or how effective a buffer zone could possibly
be.  Hearing all the discussions I think the issue is how effective an inspection can be and what level of
protection these inspections will provide.  Isn't a buffer zone a mechanism to ensure the high quality of
inspections inside an orchard?  Would the experts agree with that description? If there is a buffer zone
surrounding an orchard and there is an orchard which we want to be fire blight free wouldn't a buffer zone
ensure the quality of inspections to be done inside the orchard?  Would the experts agree with thatdescription?
Dr. Smith
314. It is clear that if a buffer zone is put in place around the place of production this increases the
security to a certain degree.  But creating such a buffer zone and administering it and inspecting it is in
itself a costly procedure and therefore one must be certain that it is necessary to do this and that the added
value of a buffer zone is justified.  Now if you think about the scientific justification of a buffer zone, itlies in the possibility that the pest concerned could rather easily move into the field or orchard concerned
from outside.  Between the time at which the last inspection was carried out and the time at which fruits
were exported, there would be a significant possibility that the pest would enter.  For some insects that is
a real possibility.  They can indeed fly in and multiply rapidly so that in those extreme cases there are
good reasons for buffer zones.  I would say in the case of fire blight the possibility that fire blight shouldenter an orchard during a given growing season fro m outside the orchard, form a canker infection in
which the bacteria multiply and, from that multiplication, infect fruit is almost impossible. We already
query the possibility that fruits can be significantly infected within the orchard so the fruits are very
unlikely to be directly infected by inoculum coming from an adjoining orchard.  If the inoculum comes
into the orchard, what it first has to do is establish the disease in the orchard and from that the disease hasto spread to the fruit and in the most favourable circumstances this could not happen until the following
growing season.  So for that reason I doubt whether a buffer zone is really necessary in the case of fire
blight.WT/DS245/R
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Dr. Hayward
315. Chairman, we do have evidence that Roberts (2002) in press has obtained results that have
indicated that a buffer zone of any size provides no phytosanitary security.
Chairman
316. Does the panel have a copy of that?  We do.  There was one other document you cited yesterday
that I am not sure the Panel has got.  It was a directory of phytosanitary terms.
Dr. Hayward
317. Yes, the British Society of Plant Pathology 1973 publication.  I can provide that.  And Mr.
Chairman there were also one or two other papers that were not presented by any of the parties.  For
example, Crosse and Goodman (1972) which I think might have been …
Chairman
318. If you could let the Panel secretary have thos e. Any other comments from the experts on those
questions.
Dr. Geider
319. Of course I agree with Dr. Smith that a buffer zone increases security and it's a little bit difficult
to follow that up too.  On the other hand of course the definition of buffer zone is also very difficult.  We
have many measurements and the terms are very strict in laws and quarantine so they tried to avoid fire
blight by removing all sorts of host plants and potential hosts of fire blight, but it did not really help.  So Ithink for those reasons buffer zones have to be really strictly defined and all host plants which could be
eventually harbouring have to be removed and finally I think it would be a very big effort to realize that.
Dr. Smith
320. That is true, but I do stress also the buffer zones that Dr. Geider is referring to have the purpose of
protecting nurseries, not orchards.  Even their original purpose was to attempt to eradicate fire blight
altogether.  For example in Switzerland measures of this kind were used 10 or 15 years ago when fire
blight first appeared.  Even in the case of the same disease, the value of a buffer zone depends on the
product you are talking about - whether about fruits or plants for planting.  It is much more important in
the case of propagating material that the nursery should be free and remain free over a period of years.
But, as fire blight can develop rather slowly on planting material and your security depends not only on
the state of the nursery in the given season but also in the past, you are looking at a situation in which anursery remains free from fire blight for a long period to give you the level of security that you need.
Japan
321. The final question has to do with post harvest treatment by chlorine.  Is there any reason that any
of the experts is opposed to post harvest treatment for phytosanitary purposes?
Dr. Geider
322. Actually in my report I had one reason which was a little bit a personal one saying that chlorine
treatment is not good for health.  This is a personal point, not so important.  The other point is that this
treatment will also change the micro-flora, epiphytic on the apples and our experience is this is usuallynot very beneficial for the firmness and the durability of the apples.  They just get easier exposed to softWT/DS245/R
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rots and all sorts of things and for those reasons I would not really favour this treatment just to be sure
that fire blight has been removed if present.
Dr. Smith
323. I think, in terms of efficacy, then there is eviden ce that these treatments will destroy fire blight
bacteria on the surface of fruits.  The question is how should such measures be used.  I believe that somecountries which import apple fruits require treatment as the only measure they apply.  Indeed it could be
argued that such a disinfection treatment is quite ad equate to remove the phytosanitary risk by itself.
Conversely, if the system is already in place that ensures that the fruits are taken from a fire blight free
orchard, treatment of the fruit with a disinfectant is superfluous.  I think in many circumstances one
would look on these as alternatives rather than as complementary to each other.  Putting both measures
into place is asking for a very high level of phytosanitary security.  One can argue whether it is necessary
to combine measures in this way or whether a single method would be sufficient in the circumstances offruits.
Dr. Hale
324. I agree with what Dr. Smith has said.  We have evidence that the surface of the fruit can be
disinfested by a chlorine treatment but as Dr. Smith says, if we take fruit from an orchard which has beeninspected and is not showing any symptoms of the disease then the probability of any of those fruits either
being contaminated on the surface or in the calyx is extremely low and the use of a further treatment is, in
my opinion, unnecessary and from Dr. Geider's point of view environmentally and health wise it is not a
good thing at all.
Dr. Hayward
325. The only thing I would add is that if cold storage for 55 days at 2°C is as effective as it seems to
be in reducing any residual population, that woul d be far preferable to any chemical treatment.
Chairman
326. Just arising from one of your earlier questions th ere is one follow-up point I would like to bring
up with Dr. Smith.  This actually comes from your answer to question No. 27 in which you stated that
what is important is clearly to maintain the identity and integrity of batches and thus to ensure that fruits
from a significantly infected orchard are not mistakenly certified as coming from a fire blight free
orchard.  I think this was touched on in the discussion about infected fruit being accidentally included and
I think it was probably a reference to the same thing,  but how feasible is it to ensure this identity
preservation?  Is it common practice to ensure it or what is the incidence of mistakes?
Dr. Smith
327. The authority which is responsible for phytosanitary certification has an obligation to maintain
the identity and integrity of batches.  The whole system of phytosanitary certification depends on this.
Under the International Plant Protection Convention, countries are required to have in place systemswhich enable them to do this effectively, by  employment of qualified staff and so on.  This is set out in
some detail in international standards.  Having said that, of course, one cannot totally exclude the
possibility that these systems sometimes go wrong.  There is a small risk that batches of lots of fruits or
materials could be confused.  For this reason, both the national authorities and sometimes the authorities
of the importing countries like to put in place occasional audits to make sure that everything isfunctioning correctly.  This aspect of phytosanitary security is vital.  One absolutely depends upon it and
it has to function correctly in relation to any material which is certified.WT/DS245/R
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Chairman
328. So would you characterize the risk which you have mentioned as being remote unlikely to occur
in practice or how would you characterize it?
Dr. Smith
329. I would characterize it as remote, because in the present case we are dealing with a high profile
commodity exported from the US to Japan, where the authorities of both countries are very much
concerned that everything should proceed safely.
Dr. Geider
330. Just to add something.  Even with the leftover  of a very remote occurrence that something is
going wrong the question is does that affect the distribution of the disease and I still would say that thereis a sort of feeling which was expressed here yesterda y that this chance is also extremely low so I think
altogether it is not an essential question that we have to rely on.
Dr. Hale
331. Yes, I would agree with the two previous speakers.  I think the chances are remote.  That's all I
can say really.
Dr. Hayward
332. Maybe we should use the term negligible.  That is the standard term of a likelihood of between
zero and one in a million.
Chairman
333. Now we have reached the point where we have actually completed the questions from the parties
to the experts.  As it happens we have also exhausted most of the questions that the panel had.  We
actually asked most of our questions in writing ahead of the session and we have had very goodcomprehensive written answers from the experts for which we are very grateful.  We had a number of
points for clarification but most of those have now gone.  I think we have just two remaining and I think
if we put those orally now we can dispense with having a 15-minute break.  These are questions to all the
experts and the first one is: as you are no doubt aware of reading of the arguments of the parties a
distinction in the notion of scientific evidence between direct and indirect scientific evidence has been
made.  Without commenting on any legal issues which may be associated with this distinction could you
please elaborate on what type of information you believe to constitute scientific evidence whether thisdirect/indirect distinction has any significance and if so what in scientific terms?  Can we get the precise
reference to where that distinction was made? OK.  Thank you.  Can we go on?  Dr. Geider just to clarify
this.  This distinction between direct and indirect scientific evidence was made in several places, but this
is paragraph 18 of the Executive Summary of the statement of Japan at the first substantive meeting in
October and they are quoting the US or at least referring to the US in saying the United States apparentlybelieves that any scientific evidence must be direct evidence without such evidence the US argues that
Japan must immediately abolish its phytosanitary meas ures.  And this is from US answers to questions
from the Panel and it's at a footnote 67 to paragraph 89 which is replying to question 38.  The evidence
Japan cites is circumstantial not direct or scientific evidence and Japan makes no assessment of the
relative effectiveness of this measure on reducing the likelihood of entry or overall disease risk.  Wouldthe US want to say something about this before we…WT/DS245/R
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United States
334. Yes, in fact if you would like to read the full footnote that would be fine, but I have the first
submission in front of me and will give you the sentence the proceeds the sentence that you started:  This
is in the first written submission of the US, paragraph 85, subparagraph numbered 6 where we are listing
the various restrictions that Japan applies and we say here with respect to chlorine treatment of containers
for harvesting Japan claims that the requirement is necessary to avoid contamination of fruit bycontaminated harvest containers.  The evidence Japan cites is circumstantial not direct or scientific
evidence and Japan makes no assessment of the relative effectiveness of this measure on reducing the
likelihood of entry or overall disease risk.  I will read the footnote references if you like or …
Chairman
335. I hope that that has said enough to clarify the question.
Dr. Geider
336. Things would be so easy that we not be here!  Maybe I can cite one of my colleagues, Eve
Billing, who is one of the experts of fire blight and she was citing the philosopher Feyneman.  The value
of science and the same scientific knowledge is a body of statements of varying degrees of certainty some
most unsure, some nearly sure, none absolutely certai n.  So this is the right answer on the problem.  I
would say with fire blight we are in a difficult situation because long-distance transmission rarely
happened and for those reasons we do not have scientific data and we cannot of course do experiments on
that issue.  I think no country in the world would be willing to allow this experiment without having a
very good reason - maybe some island in Japan or somewhere else is suited to doing this experiment to
import apples, discard them and find out if something will happen to the trees.  So I think we are really ina very difficult situation on a scientific terms what is direct and indirect evidence and both parties are
somehow right but I have the feeling the Japanese party is a little bit squeezing things in a way that all
thinkable events can happen and this can be realistic and for my feeling is this is a little bit too much.  All
the experience we have accumulated to 200 years about fire blight is that the risk of spread is not so
extreme, it is not an Ebola virus - even with Ebola virus it is ending suddenly in an environment so for
those reasons we feel that the Japanese argumentation is a little bit too far going for scientific evidence
and the American one is maybe somehow reasonable saying there is no proof but I have to say there can
be no final proof that these things which is proposed by the Japanese delegation can never happen and I
think we somehow agree on that in the discussions too.
Chairman
337. Any other comments on that?  Dr. Smith?
Dr. Smith
338. Well, I would certainly support Geider in his view th at fire blight is a well studied disease, much
observed and so that there is a very large body of direct evidence concerning fire blight.  The existence of
this body of direct evidence gives one a perspective in evaluating indirect evidence and, insofar as youcannot necessarily draw a sharp dividing line, in deciding whether circumstantial evidence is useful and in
trying to decide what is the risk of a certain scenario.  In plant health, it is important to keep one's feet on
the ground, to consider the direct evidence first and to evaluate conjectural scenarios rather carefully in
relation to what is really known about, for example, fire blight.  We live in a world now in which various
risks have been recently identified - risks of the entry of alien species from other continents, risks of themovement of living modified organisms - where there is little direct evidence and most of the evidence
that has to be used is of a circumstantial kind.  Where there is no direct evidence, it is not possible to use
it as a kind of counterweight in one's judgements.  But in plant health there is direct evidence.  A lot ofWT/DS245/R
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work has been done and it does assist one in making judgements in relation to evidence which is less
certain.
Chairman
339. Thank you.  I think that is leading into or even addressing my final question which is: has there
been any significant change in the relative scientif ic evidence regarding apple fruit as a pathway for the
transmission of fire blight since the ince ption of the Phytosanitary Agreement in 1995?
Dr. Geider
340. I think the tools to identify bacteria have probably got improved there are more ways of course
PCR was published in 1992 but maybe not so widely used in 1995 or did not get it into this contribution
at that time so I think there are more tools about existence of the pathogen in this case E. amylovora  in
fruits and in other environments.  Maybe the idea if this is really saying something about distribution of
fire blight I think it might not really have changed in that time.
Dr. Hayward
341. I would just like to add to that that I think that th e field of investigation that Dr. Geider refers to,
the sensitivity and specificity of the methods used which are DNA based have improved dramatically and
one can anticipate that they have already shown a potential to be automated for processing of plant
material.  This will advance.  It's a little bit like your new computer; it's out of date as soon as you have
bought it and I think the field of molecular identification or DNA based identification has advanced
dramatically in the last five years in particular and we can anticipate that it will advance greatly in the
next five years.
Dr. Hale
342. As a practitioner in the work on ecology and epidemiology of the organism and the disease the
modern detection techniques have revolutionized what we can actually find out.  Certainly in the area oflooking at parts of the potential pathway for transmit ting the disease, I think we have shown in a number
of the exhibits that have been put forward that we have advanced since 1995 and, in fact we are much
more confident now than perhaps we would have been seven years ago in the fact that there is a negligible
chance of the disease being transmitted in fruit.
Dr. Smith
343. I would certainly agree with Dr. Hale that if the same discussion had taken place ten years ago,
the information then available would probably have led to a disagreement along rather similar lines.  The
information that has been published since then establishes as a result of scientific experimentation how
bacteria in fact behave on fruits, how they surv ive, whether there can be epiphytic infection, what
happens to bacteria in calyx and so on.  Although maybe scientists ten years might have asserted fairly
categorically that they did not think that these things would happen, since 1995 or the early 90s papershave been published which confirm that they do not.  So scientists would be satisfied now that their
conclusion that fire blight is very unlikely to be carried by fruits in international trade was supported by
scientific results whereas ten years ago it was supported more by their own convictions of what was likely
or unlikely.
Chairman
344. Now in the time that you have been dealing w ith these questions, actually the Panel has thought
of one more question not necessarily related to the one we have just been dealing with but will put thisWT/DS245/R
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quickly to you and ask for your patience in addressi ng it.  How do the experts view the IPPC standards
1995 and 2001 for risk assessment techniques in practical terms?  Do you have experience or information
on cases at hand?  Are such risk assessments common practice today or is the Australian risk assessment
of New Zealand apples rather an exception?
Dr. Hayward
345. Although procedures used in Australia are highly confidential, like they are here, they adopt the
same rigour of pest risk analysis to mangos, pineapples, fresh green bananas as they do to apples from
New Zealand so I think Australia is a strong player in this field.  They have used ISPM 11 of 2001 and I
think that is a very considerable advance on the firs t document of 1995.  I think the reason is that there
has been experience gained by various countries and to me there is no comparison between the two
documents.  The later document of 2001 I have used myself and has been modified and fine tuned by
various people but it is a useable document and extremely helpful in my experience.
Dr. Hale
346. This is nothing to do with any argument between Australia and New Zealand.  The pest risk
assessment methods that have been put in place are adopted by New Zealand for a number of diseases and
with just as much rigour as the Australians as well.   Yes, I think that the changes that have come about
between 1995 and 2001 as far as assessments are concerned are is an important advance.
Dr. Smith
347. In the framework of the phytosanitary regulations of the EU such pest risk analysis methods are
now regularly used in relation to the development of any new measure.  It has taken a few years for this tocome into operation, but as things are now, any new measure which is proposed (and even an emergency
measure or provisional measure) is subject to a form of pest risk analysis.  A question arises concerning
measures which have been in place for many years, before the modern techniques of pest risk analysis
were available.  They were put in place by  the use of a scientific judgement which was in many respects
equivalent to pest risk analysis.  In any cases where there is some doubt about measures which are inplace at the moment, the scientific experts in the EU would call on PRA Standard No. 11 as their
reference point for deciding on the validity of their measures.
Chairman
348. Thank you very much.  There are no other comments on that.  I would like to thank you for your
patience and the specific way you have addressed the panel's questions.  Before I proceed any further I
would like to know whether either of the parties wish to put any further additional questions to the
experts?  The US?
United States
349. May I just clarify with you what the procedure would be for the remainder of this session?
Chairman
350. I believe that the next stage would be to invite the experts to make final comments and if they
wish to do so and then propose to close the meeting.
United States
351. If this would be our only opportunity to ask fo llow-up questions as yesterday could I request we
have a short recess so that I can gather with my delegation?WT/DS245/R
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Chairman
352. I suggest we take 10 minutes if you can keep to that for your purpose.  Ten minutes and then after
that any final questions to the parties.
Chairman
353. Thank you.  Can we now resume at the point where we were inviting the parties to put any final
questions they might have to the experts.  The US?
United States
354. Thank you Mr. Chairman and thanks for your indulge nce of our break period.  This may feel a bit
repetitive to the experts but hopefully it is something that we could do fairly quickly because I expect youwill have yes or no answers.  I am not threatening you just trying to lay out the parameters of my
questions.  The first is and is to all of the experts so if you each could respond that would be appreciated.
The first relates to the fruit itself and it is:  is there any scientific evidence that a mature harvested fruit
will be infected?
Dr. Geider
355. I would say no, but I pointed out apples are any how difficult to do … and get symptoms so I
think at this stage apples that are immature are not very open like pears are so I think the evidence to my
experience, I can say no.
Dr. Hale
356. If we are talking about a mature fruit that is harvested?  Then my answer is no.
Dr. Hayward
357. No such evidence.
Dr. Smith
358. And nor have I.
United States
359. I thank the experts very much.  The second question is:  is there any scientific evidence that
mature fruit harvested from an orchard will harbour internal populations of fire blight bacteria - these arethe endophytic populations we were discussing earlier.
Dr. Geider
360. I think even in this case we discussed in a little more detail and the answer was as far as I got the
point was no.
Dr. Hale
361. I agree with that.WT/DS245/R
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Dr. Hayward
362. No such evidence.
Dr. Smith
363. To be more precise, papers describing such evidence have been considered but we are not
convinced by this evidence.
United States
364. The third question is we discussed earlier that there was some scientific evidence that from
severely infected orchards with active sources of inoculum that rarely epiphytic populations could be
isolated from the calyx of such fruit. My question is:  is there any scientific evidence that epiphytic calyx
populations can infect a mature harvested apple fruit?
Dr. Geider
365. I would say no.  Of course I think the point is that the same fruit that the calyx is infested and the
fruit is sent out and I think that has not been reported and nobody has seen that and therefore I would say
no here.
Dr. Hale
366. I have no evidence of this and I have extensively used experimentation which has put … in the
calyx end fruit and have never found any infection.
Dr. Hayward
367. I also think it's highly unlikely that you could get transition from the calyx.  It is a small
population in a dead substratum and is not an active population.
United States
368. So you say highly unlikely and so is there any scientific evidence?
Dr. Hale
369. I have nothing that would support such an idea.  No.
Dr. Smith
370. I know of no evidence.
United States
371. The next question:  is there any scientific evidence that any epiphytic calyx populations in a
harvested mature apple fruit that hypothetically would survive through importation into an importing
country can be vectored through from a discarded apple fruit to a susceptible host?
Dr. Geider
372. I think this is also very remote.  It is close to zero but of course in theory it cannot be excluded by
all means, but I still would say it's almost zero.WT/DS245/R
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United States
373. So when you say it's almost zero is that there is no scientific evidence that this vectoring has …
Dr. Geider
374. No, this is actually a very difficult experiment to do here.  I think to look for apples which are
infested in the calyx and get them to a garbage depos it and find out if there is carrying the disease I think
this is a scientifically impossible experiment so we have to be honest in saying we don't see that there is a
good chance but it is close to zero but not zero.
United States
375. Perhaps we could turn to Dr. Hale to describe such a difficult experiment.
Dr. Hale
376. We have done difficult experiments like that and we have reported them.  We have no scientific
evidence from the work that we have done that there is any transmission, but as Dr. Geider has pointed
out, as scientists, it is very difficult to say that it is totally impossible.
United States
377. No, I appreciate that and in fact would not expect a scientist to ever say that something can be
totally excluded.
Dr. Hayward
378. I think the likelihood is negligible as we defined previously between zero and one in a million.
United States
379. OK and could you answer the question of whether there is any scientific evidence of vectoring?
Dr. Hayward
380. I have no evidence of that at all, no.
Dr. Smith
381. Equally, I think there is no evidence of this and in any case it appears exceedingly unlikely.
United States
382. I thank the experts and Dr. Hayward actually you kind of predicted what my final question would
be in your answer to this last question.  Given the foregoing answers to my questions I was wondering
whether the experts could please tell us what is th e risk of introducing fire blight that is entry
establishment or spread of E. amylovora  to an importing country via imported harvested mature apple
fruit? What is the risk of introducing fire blight?  Any imported mature apple fruit?
Dr. Geider
383. I think it is referring to your last question then.  Still it is very low yes or negligible.WT/DS245/R
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Dr. Hale
384. Yes, I would say negligible too.
Dr. Hayward
385. I would say negligible.
Dr. Smith
386. I would also say negligible, but would add provided that the systems were in place in the
exporting country to ensure that what is exported does exactly correspond to what is specified.
United States
387. Just a clarification there.  You are saying that in fact mature fruit is a mature fruit that is it is not
infected.
Dr. Smith
388. Well no I think I am saying a bit more.  Certainly that  it is mature fruit, but also that [pause].  Mr.
Chairman this puts me in a slightly difficult position.  The implication behind this question is that,
provided one knew that the fruits were mature, they could be exported without any phytosanitarymeasure.  Now I don't believe that fruits should be exported without any phytosanitary measure in these
circumstances.  At the very least one would suppose that they were accompanied by a phytosanitary
certificate.  The phytosanitary certificate attests first of all that the fruits are free from quarantine pests
including fire blight and it attests also that any requirements that are made are satisfied.  I would not make
an absolute statement that no requirements are needed for mature apples.  I believe there are certainrequirements to be made by the exporting country to certify the export of mature apples according to the
standard procedures used under the International Pl ant Protection Convention and if those certification
procedures are followed then yes the risk is negligible.
Chairman
389. Can I just clarify that the other three experts were also speaking in subject of the same
qualification.  Yes.
United States
390. I want to thank the experts very much and Dr. Sm ith for that clarification which I think was very
helpful to us and this concludes our follow-up questions.  Thank you Mr. Chairman.
Chairman
391. Can I now invite the Japanese delegation to put any final questions they may have to the experts.
Japan
392. Thank you Mr. Chairman and thank you for your patience.  The first question: would the infested
apple fruits bear the risk of disseminating the disease into the importing country?
Dr. Geider
393. In fact that means there are symptoms too?  I think when it really happens that an apple which
shows fire blight symptoms which are advanced is important - it is a risk, but I think this is coming backto the old question.  Is this a normal event or a negligible event and I think we all agreed to some pointWT/DS245/R
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this should not occur but as outlined with millions of efforts there might be something which can come up
in this way so it cannot be completely excluded.  On the other hand, even in this case, I am not convinced
that this automatically implies that fire blight will come up in that country where the apples are finally on
the market so I think even that risk of heavily infect ed apples it must be a lot of additional circumstances
that fire blight get established in the environment of th is apple so I would say it is still negligible that this
event can occur.
Dr. Hale
394. I think that what Dr. Geider has said is absolutely correct and the situation is that we are pretty
well convinced that a mature apple fruit which is of export quality and likely to be exported would not, in
fact, be carrying the disease and cause an outbreak in another country.
Dr. Hayward
395. I think the question refers directly to Exhibit JPN-14.  As I understand it with ISPM 11 you could
do a probabilistic assessment of each step in the pathway assuming that pathway can be completed and
that is extremely uncertain.  I think if you did that - I can't really anticipate that - but based on the
evidence we have I would agree that the possibility is negligible.
Dr. Smith
396. I would support the other statements Mr. Chairman.
Japan
397. Is there any serious possibility or risk that apples with symptoms may go undetected through
export procedures for the next 25 years?
Dr. Geider
398. You are asking us a little bit too much in the future.  Of course I am always wondering when I
read the paper of Tom van der Zwet and others.  R odney Roberts already made the statement that the
likelihood is 35,000 years and a little bit more and that is a precise answer to an event.  Of course
mathematically I think it is probably correct to do this  judgement.  On the other hand of course fire blight
is not really predictable and just to get something wh ich I have in my summary towards the end.  It is of
course a big question - what will happen when apples trade between the US and Japan is liberalized
completely and fire blight will be in Japan afterwards.  Can somebody say this was due to the import of
apples or was it another event which finally came up to introduce fire blight and I would still say the otherevent is much more likely but both events will come together and you have apple imports and you have
fire blight.  This is a very difficult situation which cannot be foreseen and it cannot be really answered
right now, but I still think that both events can happen that apples will be in Japan, but fire blight is
coming by other means to the country and I cannot really say what we should do afterwards.  Would you
blame us that we were not strict enough to seize that situation and this is the situation which cannot beforeseen?
Dr. Hale
399. I would just like to concur with Dr. Geider because I think it is a very difficult question for us to
answer and I don't think we are really in a position to do so.WT/DS245/R
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Dr. Hayward
400. Since zero tolerance is not an option we are talking about something a little bit above that.
Dr. Smith
401. Apples and pears have been traded as fruits between many countries in the world for the last 50 to
100 years, sometimes with strict requirements and so metimes with no requirements, and it was our initial
view as experts that in no case have fruits been known to introduce fire blight.  However, international
trade is intensifying.  It is difficult for us, as phytosanitary experts, to calculate in terms of volume of
trade and intensity of measures how we can compare the past period with the one that's coming.
Nevertheless I think the past period does reassure us to a certain extent that fruits have not carried fire
blight, and lead us to suppose that by maintaining measures it should be possible to continue to protect
countries which do not have fire blight provided that they are in an isolated situation.  Fire blight has
spread in Europe because the countries are contiguous and no human activity could stop it because it wasbeing spread by wind, rain and birds.  But Japan is an island, Australia is an island.  It is a perfectly
reasonable endeavour to suppose that it is possible by phytosanitary measures to continue to exclude fire
blight from them.
Dr. Geider
402. An additional remark to that is that of course it  is remarkable that most countries in the southern
hemisphere are without fire blight except New Zeal and.  I am asking the question, I would assume that
the import restrictions for fruits and plants in South America are not very high so Chile has a lot of apples
which actually we get into Germany and Argentina and Brazil there is also some growth of apples which
might not be as big as the other two countries.  The question still is they didn't get fire blight.  Is thatbecause they are not carefully enough if they have some or is it for sure that even with strict detection
methods there is no fire blight in South America.
Dr. Hayward
403. New Zealand has had fire blight since 1919.  Now the Australian quarantine and inspection
service attempts to prevent movement of fresh fruit and vegetables from any external source but I think
their estimates are that they only intercept perhaps 10 per cent of all vegetable material.  I don't have an
exact figure but it is obvious it should be self-evident that no quarantine, no inspection service at port of
entry, airports, docks, etc. could possibly given human nature intercept all introductions of fresh fruit and
vegetables.  There must during that 80 years have been at least some fresh fruit brought in from New
Zealand.  We cannot quantify this can we?  It is all very theoretical.  Anyway we can say that fire blight
from whatever source has never got into Australia by that means through port of entry whereas citruscanker for example been found on plants in the Northern Australia on at least five or six occasions and
has been eradicated.  It has not been brought in - it has been detected on fruit at port of entry - citrus
canker on citrus fruits but the only incursions were in Northern Australia resulting in eradication of those
plants.
Dr. Hale
404. Just as a follow-up we have had exactly the same situation in New Zealand where citrus canker
did appear and has been eradicated but that was on plants and not fruit.
Dr. Smith
405. I think the comment from Japan was posing the question whether you can rely on the correct
implementation of phytosanitary measures in long term.  Is there an adequate guarantee that systems will
continue to function?  Obviously one cannot say this categorically.  But past experience does show that byWT/DS245/R
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the use of phytosanitary measures, countries have excluded fire blight.  They have excluded it for the last
50 to 100 years.  I who work in plant quarantine specifically believe that it is a worthwhile activity and it
can be conducted successfully.  The measures which exporting and importing countries take can be
successfully used in the long term.
Dr. Geider
406. Just to ask the US delegation what are the restrictions or regulations between the US and South
America?  Is there free export of apples and pears or are they many regulations or no?
Chairman
407. Sorry, but this is a discussion which started with the Japanese question perhaps we can just keep
it in that direction.  Let us come to that later.
Japan
408. I am confused.  A couple of hours ago you were discussing and you said you were in agreement
that fire blight free orchards will be effective and will be important to protect against the risk of spread of
the disease.  Are you still in that position or are you now suggesting that we should abolish that?
Dr. Geider
409. I think it is probably you feel that sort of compromise.  We are saying even with uninspected
orchards the chance to transmit fire blight to Japan is very low.  On the other hand we do not feel that we
could squeeze Japan into that situation and saying we are now helpless to all apple imports from othercountries.  I don't know, maybe in five or ten years these restrictions can be abolished and no
measurements are necessary and for those reasons for a transition time it would be a good decision to
keep into that measurement and do inspections to make sure that you have done something and I think we
all agree that you cannot do everything and this is just  what is the most reasonable approach at the present
time.
Dr. Hale
410. I am sure Dr. Smith is going to want to talk about what I was going to mention and that is the fact
that export phytosanitary regulations will prevail in any case and I just feel like Dr. Geider that we
probably do need some phytosanitary regulation in place.
Dr. Smith
411. Well it has to be said that apple fruits in Europe are traded completely freely between different
European countries.  There is no inspection of orchards, no registration of orchards, no phytosanitary
certificate, no interference of plant health authorities in any way at all in the trade in apples.  Apples in
theory in Europe could be taken from a heavily infected fire blight orchard and traded.  Perhaps that has
happened (though ordinary commercial quality standards for fruits should reduce the risk).  Despite this,nobody can cite an instance when fruits have transmitted fire blight.  So certainly the European position is
that you do not need measures for fruits in trade.  However, it is accepted that different countries have an
appropriate level of protection which they decide for themselves.  We can reasonably expect that Japan
would in fact have a higher level of protection for this disease than the European countries.  If a measure
is needed, the requirement that the fruits should come from an orchard free from fire blight appears frommy point of view the most effective single measure that could be put in place.WT/DS245/R
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Japan
412. Thank you for the clarification.  So having heard what you have told us this morning my final
impression is that Japan is entitled to have a different level of protection and in order to achieve that level
of protection the requirement of shipments from a fire  blight free orchard with inspections is a reasonable
one to achieve the level of protection and that it is something experts would recommend.
Dr. Geider
413. Of course I think it is reasonable when you feel Japan is threatened by fruits imports that you
have to be careful to prevent any risk which is not zero so I think really you should do this measurements
for at least some time and get more acquainted.  I th ink the problem is, and the same for Australia, the
people are not acquainted with fire blight and don't know enough of what are the symptoms, how do I see
and detect a level which is fast and efficient so there are a couple of problems and would still say to be
safe some sort of measurements are reasonable at this time.
Dr. Hale
414. My only qualification would be not inspections but inspection.
Dr. Hayward
415. I wish we could play back the answer that Dr. Smith gave just a minute or two ago.  On the basis
of what you said and the experience of European trade in apples it might be unreasonable to expect any
special treatment.  Am I putting words into your mouth?  Didn't you just say that in spite of massive
unregulated, uninspected, untreated trade in apples  there has been no introduction of fire blight.
Dr. Smith
416. Well, the declaration that no case has been known in which fruits have carried the disease is a
negative statement based on the fact that, where the disease has been introduced from one country to
another, we can find other explanations.  The overall pattern of spread does not appear, in the way that it
manifests itself geographically, related to the fruit trade.  However, in a continent where there is a lot offire blight, it is impossible to say that it has never happened, or that an infected fruit was never carried in
trade and in some way or another infected an orchard.  The general background is one where you would
not see this event.  All we can say is as far as we know that in new areas in which fire blight did not
previously occur, when it was introduced it does not seem to have been by this pathway, but we have not
done a systematic study to say were apples traded between those particular countries at the time.  If it was
important for us in Europe to answer this question, we would have to analyse it further.  In my written
replies, I used the wording "appropriate level of protection" because the Members of the WTO have thepossibility of deciding on different measures on the basis of the same scientific evidence if they choose to
do so.  Although from a scientific point of view it might appear to us as experts that there was
inconsistency in the approaches of the authorities in different countries, countries have the sovereign right
to decide that they will take more stringent measures in the face of the same risk.
Chairman
417. … Subject to the provisions of the SPS Agreement.
Japan
418. So in essence you feel Dr. Smith, there is some risk which may have to be accidental
contamination in infected fruits carried over or in some cases where farmers, shippers and growers cheat
and that would be accidentally included in shipments and brought onto Japanese soil.  It is unquantifiable,WT/DS245/R
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but I believe it is a risk because I might remind you that Taiwan recently discovered codling moth for the
first time in the past 25 years.  It was supposedly those apples were codling moth-free but it happened.  I
would imagine it was an accident, but it indicates or shows some evidence that whatever procedure,
export guarantees or inspections may never be an adequately established level of safety.  Is it to counter
that risk that you feel a fire blight free orchard would be an appropriate response to that?
Dr. Smith
419. I think that a country which opens a new trade which did not previously exist, subject to certain
phytosanitary requirements, can reasonably wish to monitor the operation of what goes on during the
course of such trade for a certain time to be satisfied that all the components of their phytosanitary
protection is working correctly.  Whether it is safe to import mature apples depends on a satisfactory
phytosanitary system in the exporting country which can provide guarantees.  So it maybe, as Dr. Geiderhas suggested, that in 10 or 20 years time the Japanese phytosanitary authorities might come to the
conclusion that they are perfectly happy with the movement of apples from the United States if
experience shows them that in actual fact there ar e never any incidents and nothing is found.  Then they
may then ultimately change their regime.  There are now quite heavy and multiple requirements in place.
If there were to be a substantial lightening of those requirements, the country concerned would wish tomaintain some protection initially.  From a scientific position, the logical conclusion of saying that there
is an absolutely negligible risk of movement of fire blight with fruits is in fact a completely unrestricted
trade.  Now, even as a scientist looking at this, I find it hard to see that one would make this change in one
step!  There should be phytosanitary control, i.e. at least phytosanitary certification of  fruits.  To remove
measures altogether takes away any control, and leaves everything to the discretion of growers andtraders.  It is difficult for experts to make judgements on what should be the phytosanitary policies of
countries.  These policies are conditioned by concerns which go beyond those which we have been
discussing and the SPS Agreement must take into account the necessity for such policies.  I think it is not
for us as scientific experts to try to make judgements on what governments should or should not do in
those cases.
Chairman
420. Thank you very much.
Japan
421. Perhaps you can tell me why you feel that some measure will be necessary?  Is it because there
ought to be some compromise?  Or is it because ther e is some need for a compromise or because there is
some uncontrollable risk, nevertheless, based on the real world experience, such as finding codling moth
apple?
Chairman
422. Do you feel you have answered this question already or is it
Dr. Smith
423. Well Mr. Chairman I think I have answered this question.  Until a particular system applied to
phytosanitary security is put into place one is only trying to forecast how it operates.  For that reason,
when the phytosanitary system is changed it should be changed under circumstances that retain somedegree of control on what is happening and not in a single step that removes control altogether.  This is
not a precautionary principle but just ordinary prudence.  I am not sure that this is something that has to
be argued on scientific terms.  It is a matter of public policy.WT/DS245/R
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Dr. Geider
424. I think I made remarks on that too and it legally asks the Americans about South America.  I think
we still can learn of course from other habits and grades of apples if the risk is really so high and it is a
little pity that nobody from South America is here that the Panel can ask these people what is your  policy
on American apple imports so I still would say in the case of Japan if you really feel that there is a riskand the other is saying the risk is very low that you are entitled to impose regulations in some way but I
still, for my personal feeling, these regulations should be not so high that they are very difficult and costly
to perform and that will finally end up in a barrier of trade and I think we discussed that a couple of times
and Dr. Hale pointed out three inspections are a lot and finally it is getting into impossible measurements
and would really abolish trade of apples from the US to Japan and I understand that the reason we are
here is that restrictions right now are so high in th e level that Americans feel that this should be changed
in some way.
Chairman
425. Thank you.  The reference to South America - I believe the point is covered in a reply to the
Panel's question to Brazil, third party question.  There was only one question put by the Panel to Brazil
and the answer you will find addresses the point you are referring to you.  Are there any other comments
on the Japanese question?  Dr. Smith.
Dr. Smith
426. I would like to say that the IPPC provides for phy tosanitary certificate.  It does not  regard them
as a special phytosanitary measure or requirement but as being a normal and regular way of ensuring thatplants and plant products can be traded safely. It makes sure that the exporting country does identify
consignments and inspect them, and verify their state before they are exported.  I think the greatest risk
that might arise for apples that were exported to Japan would be that they would be taken from infected
orchards. In an unregulated trade of apples you w ould not know where the apples were coming from.
Phytosanitary certificates partly give you a phytosanitary guarantee and partly a guarantee of identity andintegrity.  Any importing country can reasonably require this identity guarantee which it is a very minimal
level of security and perfectly justifiable in this case.
Japan
427. Perhaps I was misunderstanding you.  So export certificates certainly ensures that all the
requirements are met and what I am interested in is what sort of requirements would be, should be, and
based on the discussion I am hearing, the suggestion is that some sort of fire blight free orchard withinspection or inspections - once again I am repeating my other question but am I right to understand the
response that way?
Chairman
428. If this is a repeat of the question you might consider whether you need to offer any further answer
to what you have already said.
Dr. Smith
429. That's right.  I think that if a system of phytosa nitary certification is in place then the requirement
that the fruit should come from a healthy orchard is a reasonable requirement.  That is partly because thesimple inspection of the fruit may not be an adequate measure for you to determine if they were mixed or
contaminated by fruit from infected orchards.WT/DS245/R
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Chairman
430. This now brings us to the final stage of the meeting.  Before closing the meeting I would like to
offer the experts an opportunity to make any final co mments that they wish to make and let me clarify
first of all that the Secretary of the Panel will prepare a summary of your written responses and a record
of today's meeting and each of you will be asked to review this summary to confirm that it is correct andcorrectly reflects what you have said both in the written and the oral answers that you have given.  So
perhaps with that said I could proceed to invite Dr. Geider first if there are any final comments you wish
to make.
Dr. Geider
431. Of course I think it is difficult now to say someth ing new.  So I think we all agreed that in the
novel introduction of fire blight in countries are very rare and the reasons for introductions can be guessedand we somehow agreed it was probably mainly or only due to trade of plants which were latently or even
obviously infected by the disease and although the disease is somehow bound for a while to the species
where it first appears and it's obvious in Italy it is sticking to pears, in other countries it is sticking to
apples and I am a little bit wondering that the Japanese delegation did not pick up that there is a
substantive growth of Nashi pears in the country which are obviously although hosts for the disease andsince there are no pathovars of E. amylovora  all the host plants can be affected and of course we should
not only talk about apples and pears, it could be also a target for the disease and therefore the Japanese
should of course also look that there is some sort of remote danger for the pear production of this fire
blight.  OK, so this is one point and of course the other point is appearance and disappearance of fire
blight and there is this one example of Australia.  The other point is about Japan 1903 and I think we donot have to discuss that further on except that it was fire blight or something else - obviously whatever it
was this disappeared and to my opinion, but I am not certainly entitled to make a comment on pear
disease in Japan, there could be something else and I don't know if this is endangering other pear
productions in the world or not?  OK, so this one point.  Another point is disappearance of fire blight in
Norway, but I have learnt from my colleagues in these days that fire blight reappeared in Norway so it isunpredictable in many instances and what could happen in New Zealand is that fire blight is not obvious
for a couple of seasons and then will reappear so it's a disease which is really unpredictable and of course
there are many events that some sorts of strains which are located in areas like we found in Northern Italy
that disappeared and others took over, and Al Jones, w ho is another fire blight expert in America, told me
that certain strains will move very slowly to other parts where they originated so it is back and forth with
many events which are considering fire blight.  At the end I would really summarize it once more that
import of fruits cannot be blamed, at least to our best knowledge we expressed in these days, for newoutbreaks of fire blight in a country.  A very final point I wanted to make is, since we are talking about, is
big risks of fire blight in some countries.  We should be a little bit cautious in a way.  In modern times we
are all publicly exposed and we all know about these big discussions about terrorism in the world and I
think even Japan is not free - not in political terms,  that people try to do something bad for a country.
When we really expose the fire blight to be a big thr eat of half of the world I think that would also be not
very wise.  Fire blight is not I think to be or not to be.  It can be managed in many ways and I think it
would be really a bad thing when we give other people the impression that fire blight is something so
special that they get attracted to do hostile actions in a country and I think this is certainly not a point here
in this Panel to come to a statement, but it should be somewhere considered in the background that this is
also of course a way to deal with fire blight and it would be a pity when those things would occur, incountries which do not have fire blight, in the future.
Chairman
432. Thank you Dr. Geider.  Now Dr. Hale.WT/DS245/R
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Dr. Hale
433. Thank you.  I haven't a huge amount to say, but just to pick up on what Dr. Geider was saying.
We have about 220 years of history of fire blight and we have no evidence of transmission with fruit and
as Dr. Smith pointed out there are many effective ways in moving fire blight around and fruit is not one of
them.  I was interested in the comment which was brought up about direct evidence.  It is interesting tonote that there is a huge amount of research which has gone on with this particular disease and it is
important, I think, to note that the detection techniques which we have developed over the last few years
are providing far more confidence than we previously  had in ecological and epidemiological studies.  I
think that we now are able to almost categorically say that there will be no movement of fire blight
through fruit which is taken from healthy orchards.  There are risk management systems and pest risk
analysis and we have been through those in a fair amount of detail so good mechanisms are available and
these are universally agreed now through the International Plant Protection Convention and I think this isimportant that these are in place.  I think that it is very important also that the work that was carried out
in the United States, which showed that buffer zones do not provide any real phytosanitary security, is
taken into account and it is interesting that this has not been a topic which has been discussed in great
detail at this meeting.  As Dr. Smith pointed out, in Europe there appear to be no need for measures to be
put in place for fire blight and the possible transmission as far as fruit is concerned.  I agree with whatmost other people have said about the level of protection which is sought by various countries and
through their sovereign rights they have this available to them.  I realize that Japan is certainly not used to
being able to cope with fire blight and consequently seeks high levels of protection rather than
unrestricted trade in fruit until Japan has confidence in  the fact that healthy fruit will not be transmitting
the disease.  That's really all I have to say.  I woul d just like to thank the Panel for the questions that they
have put and also for the discussions that we have had with the US and Japan over the last two days.
Thank you.
Chairman
434. Thank you very much Dr. Hale.
Dr. Hayward
435. I have listened very carefully over the last two days to the comments that everybody has made on
all sides and the first point I would like to make is I see no reason to modify what I have put in my
responses to questions 1-36.  The second point is that we didn't cover all the questions and there is no
problem in that - obviously the discussion was going to focus on the central issues concerning trade in
apples and the risks and consequences.  I was particularly interested in questions 35 and 36 andDr. Geider mentioned that there was a record in 1903 which might have been the fire blight in Japan.
Having read the review by Mizuno et al.  (2002) on the status of fire blight and the status of that record I
accept their suggestion that there was a misidentification or confusion with a fungal canker.  Also in
relation to this I read the United States responses to the Panel's 36 questions and in relation to question 35
I think the United States suggested that it was a cont roversial matter - I am referring to bacterial shoot
blight of pear in Hokkaido and the status of the berry  strains in the United States.  I think we need to
rethink the relationship of all these organisms in the light of modern evidence on genetic relationships.
Modern taxonomy of bacteria is polyphasic ideally - polyphasic meaning that it is a combination of
phenotypic - looking at the all the external properties of an organism - its phenotype and then looking at
its basic genetic constitution and so that is the genotype and all this information is integrated together.Now speaking as a microbiologist when I look at all th is evidence it is not controversial at all.  When I
look at the paper by Mizuno et al.  (2002) in the journal of General Plant Pathology - to me it is not
controversial at all.  The evidence is solid and very sound, but the problem is we don't have a
nomenclature which copes with the differences - these are quite different agents and the nomenclatureWT/DS245/R
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doesn't cope with it.  I think it might foreshadow  a system where you have not perhaps pathovars or
biovars but sub-species being covered by the code of the nomenclature and subspecies would sit better in
phytosanitary regulations.  I mean you would have say a subspecies amylovora for the apple and pear
strains from North America you would have a subspecies rubi for the raspberry strains and then you'd
have a subspecies pyri perhaps but I think I shouldn't say, but question 35 wasn't covered.  To me it is notcontroversial.  The status of these different organisms as described in various publications recently is to
me quite clear as a microbiologist.  These are different agents that the nomenclature we have for these
different agents isn't adequate at this stage, in my opinion.
Chairman
436. Thank you very much Dr. Hayward.  Last, but not least, Dr. Smith.
Dr. Smith
437. Well I have been associated with the development of the International Standards of Phytosanitary
Measures which have been put in place by FAO at the direct instigation of the World Trade Organization
and so I would like to underline that there are several such standards which are very relevant to this case.
These include Standard No. 1 (principles of plant quarantine in relation to international trade) and alsoStandards 2 and 11, but I think mainly 11, which is the standard for pest risk analysis.  Now until the
present time I have not heard of any formalized disp ute in relation to measures where these standards
were applied.  It is important, I think, now that these standards have been accepted internationally, that
they should indeed be respected.  One purpose of drawing up these standards was to create conditions in
which disagreements could be settled .  So if I am allowed to urge the Panel to do anything in particular, Iwould urge them to take good account of these international standards in their decision because we in the
phytosanitary sector depend on their application in future and it is very important to us that they should be
well interpreted and well implemented.
Chairman
438. Dr. Smith thank you very much.  After this meeting the Panel will of course want to reflect very
carefully on everything that has transpired here yesterday and today as well as on all the written material
which has preceded the meeting.  This is obviously not something we can do immediately but as a result
of this I cannot rule out the possibility that we might want to revert to the experts with additional
questions if that review seems to warrant it.  If we do so we will try to do so as soon as possible and we
would hope that the written replies would also be ava ilable as soon as they can be produced and we would
see that they were copied to the parties with an opportunity to comment on the replies and the questions.So we are reserving the right to possibly revert back to you.  That said, I would like on behalf of the Panel
to thank our four distinguished experts very sincerely for your enormous effort so far.  We found the very
thorough exhaustive written replies you have given extremely helpful and as far as we were concerned
they enabled us to reduce our own questions to a mi nimum in this Panel meeting.  So thank you very
much and before I close the meeting I would just like to remind the parties that we will be meeting withthem again on Thursday in this same room - starting  at 11am and not 10am as originally communicated to
you.  If there are no other matters with my thanks again to the experts.  Thank you all of you for your
cooperation today.  This meeting of the Panel is now closed.
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