Japan - Measures Affecting Agricultural Products
Report of the Panel
(Continued)
B. Japan's Plant Protection Law and the Enforcement Regulation
1. General
- The legislation relevant to this dispute is contained in the
Japanese Plant Protection Law, enacted on 4 May 1950, as amended (the
"Plant Protection Law").
9
The applicable regulation is the Plant Protection Law Enforcement
Regulation (the "Enforcement Regulation"), enacted 30 June
1950, as amended. 10
- The stated objective of the Plant Protection Law is to ensure the
"stabilization and development of agricultural production by
inspecting export plants, imported plants and domestic plants, by
controlling injurious animals and plants, and by preventing the
outbreak or spreading thereof". 11
- The Plant Protection Law identifies as "quarantine pests"
those pests whose existence has not been confirmed in Japan, or those
which exist in part of the Japanese territory and are subject to
official control (Article 5.2 of the Plant Protection Law). Subsequent
to such identification, the Plant Protection Law establishes an
inspection mechanism for imported plants and plant products:
(a) all imported plants and plant products have to be accompanied
by a phytosanitary certificate, in principle, which states that the
plants and plant products are considered free from the quarantine
pests (Article 6, paragraph 1 of the Plant Protection Law);
(b) in certain cases, a growing-site inspection by the foreign
authorities is mandatory (Article 6, paragraph 2). This mechanism was
introduced by the 1996 amendment of the Plant Protection Law, and took
effect April 1998;
(c) upon entering the Japanese territory, plants and plant products
have to be inspected by plant quarantine officers at one of the 101
major ports (or airports) of entry designated by the Enforcement
Regulation (Article 6, paragraph 3; Article 8, paragraph 1); and,
(d) certain plants may be subjected to post-entry inspection at a
post-entry quarantine station for viruses and other pests which might
not be detected by the visual inspection at the ports of entry
(Article 8, paragraph 7).
- If a plant or a plant product fails to pass the above inspection, it
will either be destroyed or disinfected/disinfested under the Plant
Protection Law. In order to counter the risk of inadvertent
introduction of particularly harmful quarantine pests, the Plant
Protection Law delegates to the Ministry of Agriculture, Forestry and
Fisheries ("MAFF") the authority to prohibit importation of
certain host plants from countries or areas infested by the pests
(Article 7, paragraph 1, item 1). 12
This authority is exercised in the form of a list of prohibited
products, which is contained in a table annexed to the Enforcement
Regulation. 13 This
"Annexed Table" identifies the quarantine pest which
constitutes the cause of the import prohibition, the countries or
areas from which importation is prohibited, and the prohibited host
plants and their specific parts.
- In practice, the confirmation process for efficacy of disinfestation
treatment consists of two parts: the process applicable to the initial
lifting of the import prohibition and the test for the approval of
additional varieties. These are contained in two sets of guidelines
developed in 1987 and which have, to date, not been published �
although they are available to interested parties. 14
The contents of these are summarized below.
2. Initial lifting of prohibition
- The "Experimental Guideline for Lifting Import Ban -
Fumigation" ("Guidelines for initial lifting") outline
the procedure applicable to the initial lifting of the prohibition.
The procedure includes the following:
Basic Tests (small-scale dose-mortality tests) 15
(a) Determination of the most resistant stage of insects to
fumigation (a comparative test of susceptibility between development
stages) estimated through small-scale dose-mortality tests.
(b) Estimation of treatment schedule achieving 100 per cent
mortality.
Large-Scale Mortality Test
The efficacy of the chosen treatment is tested using 30,000 insects
at the most resistant stage on the variety (the representative variety).
Japan accepts the efficacy of the treatment if no insect survives, as an
approximation of probit 9.
On-site confirmatory test
The results of the test are further confirmed on site by Japanese
experts in the on-site test using 10,000 sample insects (on the
representative variety).
3. Lifting of prohibition for additional varieties
- The guidelines for the approval of additional varieties are set out
in "Experimental Guide for Cultivar Comparison Test on Insect
Mortality � Fumigation". These include:
Basic test (small-scale dose-mortality test)
As the most resistant development stage of the insect is identified
when (part of) the species is approved for the first time, this test
targets only the comparative efficacy between the approved varieties and
the newly proposed varieties. Response of insects in additional
varieties is tested for different levels of treatment (e.g., the amount
of fumigant, the length of cold treatment). The results are typically
analyzed by comparing LD50 by probit analysis. If the new
varieties are found to show equivalent or superior effectiveness
compared to approved varieties, no large-scale mortality test is
necessary. If the result is significantly less effective, however, a new
treatment standard has to be developed and tested by a large-scale
experiment.
On-site confirmatory test
This test is performed on one representative variety. Japanese
experts are sent to confirm the on-site test.
Table 1
Test Schedule for Initial and Additional Lifting
|
Tests
(purpose) |
|
|
Initial lifting of prohibition |
Lifting of prohibition for additional varieties |
|
Test insects |
Subject varieties |
|
|
Dose-response
(1) identification of the most resistant development stage of
the pest; and
(2) identification of the representative variety16 |
2,000 in total (200 per one dose bracket times five dose brackets
in two replicates) |
ALL |
YES (for (1) and (2)) |
YES (for (2)) |
Large-Scale
Confirmation of efficacy |
30,000 (10,000 each in three replicates) |
ONE |
YES |
NO* |
On-Site Confirmatory Final confirmation |
10,000 |
ONE |
YES |
YES |
* This assumes that the existing treatment would be found by
basic tests to be adequate for new varieties. If not, a new
treatment would have to be established and confirmed by large-scale
tests. |
C. Relevant International Standards, Guidelines and recommendations -
the IPPC
1. General
- The SPS Agreement makes reference, in a number of provisions, to the
"relevant international standards, guidelines 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
Secretariat of the International Plant Protection Convention
("IPPC" or "the Convention") in cooperation with
regional organizations operating within the framework of the IPPC.
- 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 106 contracting
parties.
- The purpose of the Convention 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 standard-setting.
- The first text of the international convention 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) in 1993. Negotiations for amendments to the
Convention, 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 for 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. Guidelines for Pest Risk Analysis
- Generally, IPPC standards have their origin in national or regional
initiatives, and/or are drafted by expert groups organized by the IPPC
Secretariat. The topics and priorities for draft standards are
determined by the Secretariat in consultation with Regional Plant
Protection Organizations and their members. IPPC standards fall within
two categories: reference standards and other standards.
- Among the IPPC's completed standards is the Guidelines for Pest Risk
Analysis ("PRA Guidelines"), adopted in 1995.
17
The IPPC describes the PRA Guidelines 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 a quarantine 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". Finally, based on the information gathered
under Stages one and two, Stage three determines the appropriate
phytosanitary measure(s) to be adopted. This pest risk management to
protect the endangered areas should be proportional to the risk
identified in the pest risk assessment. The three stages are summarized
in the PRA Guidelines as: "initiating the process for analysing
risk", "assessing pest risk" and "managing pest
risk", respectively.
- Pest risk management options include18:
- inclusion in list of prohibited pests;
- phytosanitary inspection and certification prior to export;
- definition of requirements to be satisfied before export (e.g.
treatment, origin from pest-free area, growing season inspection,
certification scheme);
- inspection at entry;
- treatment at point of entry, inspection station or, if
appropriate, at place of destination;
- detention in post-entry quarantine;
- post-entry measures (restrictions on use of product, control
measures); and,
- prohibition of entry of specific products from specific origins.
- Pest risk management options may also concern ways of reducing risk
of damage. The PRA Guidelines state that the efficacy and impact of
the various options in reducing risk to an acceptable level should be
evaluated in terms of the following factors19:
- biological effectiveness;
- cost/benefit of implementation;
- impact on existing regulations;
- commercial impact;
- social impact;
- phytosanitary policy considerations;
- time to implement a new regulation;
- efficacy of option against other quarantine pests; and,
- environmental impact.
- In sum, the PRA Guidelines define a procedure by which a pest risk
analysis should be performed, and lay down relevant factors which
should be taken into account by the authorities in the process.
III. Claims of the Parties
- The United States claimed that Japan's varietal testing
requirement as it applied to quarantine treatments for codling moth
was an unjustified barrier to trade and was inconsistent with the SPS
Agreement. As a result of Japan's measure, maintained ostensibly for
plant health ("phytosanitary") reasons, Japan effectively
blocked access to its market for US varieties that competed with a
number of Japanese produced varieties of the same product. The United
States claimed that Japan's varietal testing measure had failed each
of the following obligations under the SPS Agreement in that it:
- was maintained without sufficient scientific evidence (Article
2.2);
- was not based on scientific principles (Article 2.2);
- was not based on an assessment, as appropriate to the
circumstances, of the risks to human, animal or plant life or health
(Article 5.1);
- had not taken into account available scientific evidence; relevant
processes and production methods; relevant inspection, sampling and
testing methods; prevalence of specific pests; relevant ecological
and environmental conditions; and quarantine or other treatment
(Article 5.2);
- was more trade-restrictive than required to achieve the
appropriate level of sanitary or phytosanitary protection, taking
into account technical and economic feasibility (Article 5.6);
- was not transparent in that one Enquiry Point was not responsible
for the provision of answers to all reasonable questions from
interested Members regarding the measure and there was furthermore
no published source for the measure itself (Article 7); and,
- it was reliant upon control and inspection procedures, and applied
to a modified product (i.e. a different variety of a product), was
not limited in its information requirements to what was necessary
for appropriate control and inspection procedures, and was not
limited to what was necessary to determine whether adequate
confidence existed that the product still met the regulations
concerned (Article 8 and Annex C).
- In its request for consultations, the United States claimed that the
fact that Japan's varietal testing requirement was not a legitimate
phytosanitary measure meant that it was also inconsistent with Article
XI of GATT 1994 and Article 4 of the Agreement on Agriculture.
However, the United States did not pursue these claims in its
submissions or in its oral statements to the Panel, nor did it request
findings with respect to these claims.
- Japan claimed that its policy was fully consistent with the
relevant articles of the SPS Agreement, Article XI of GATT 1994 and
Article 4 of the Agreement on Agriculture. In particular, Japan
emphasized that the measure was entirely based on phytosanitary
considerations and that the suggestion by the United States to the
contrary was false.
To continue with Arguments of the Parties
9 Law No. 151 of 1950;
most recently amended in 1996. (Japan, Exhibit 6)
10 MAFF Ordinance No.73
of 1950. (Japan, Exhibit 7)
11 The Plant Protection
Law, Article 1.
12 In addition, the
Plant Protection Law prohibits the importation of quarantine pests, soil
or plants contaminated by soil and packages containing these articles
(Article 7, paragraph 1, items 2 to 4).
13 List of the Plants
Subject to Import Prohibition, Plant Protection Law Enforcement Regulation
Annexed Table 2. (Japan, Exhibit 8)
14 Contained in Japan,
Exhibit 10.
15 A glossary of
technical and scientific terms is contained in paragraphs 2.11 to 2.17.
16 See paragraph 2.23
(under Large-Scale Mortality Test).
17 International
Standards for Phytosanitary Measures, Guidelines for Pest Risk Analysis,
FAO Publication No.2. (US Exhibit 5)
18 PRA Guidelines, p.20.
19 PRA Guidelines, p.20.
|