International plant protection convention
Manual on Equivalence between pest risk management measures
Draft version 17 August 2012
Send comments to M. Megan Quinlan, Research Fellow, Imperial College London[QMM1]
(please indicate if your comments are confidential or may be cited/shared)
IPPC Secretariat,
Food and Agriculture Organization of the United Nations,
VialedelleTerme di Caracalla,
Rome, 00153
Italy
This paper presents information on equivalence between pest risk management measures, as a component of the National Phytosanitary Capacity Building Strategy 2010 adopted by the Commission on Phytosanitary Measures of the International Plant Protection Convention. The work represented herein has been prepared and reviewed by contracting parties, regional plant protection organizations, donors, international organizations and phytosanitary experts from seven FAO regions. It is consistent with the agreed definition of National Phytosanitary Capacity and the CPM adopted strategy.[QMM2]
Table of Contents
Acronyms
Glossary of Terms
Executive Summary
I.Introduction and definition of equivalence
A.The importance of equivalence in the world trade
B.IPPC definition of equivalence
C.What equivalence does not mean
D.The drivers for seeking equivalence
II.Historic context for Equivalence (up through the SPS)
A.Agreement on alternative measures: commodity treatments and host status
B.System wide equivalence: recognition of inspection systems, export certification, etc.
C.European approach to requirements
D.The advent of SPS and relevant principles
III.Common practice in plant health
A.Case by case nature (end point rather than system equivalence)
B.Technical or operational agreements
C.Mutual recognition
D.Formal equivalence and notified agreements
E.ISPMs, regional agreements and other agreements that are equivalency agreements
IV.The ISPM on equivalence and other relevant ISPMs
A.Key principles
B.Attempts to define ALOP and efficacy
C.Other ISPMs including systems approach
D.ISPM 15–a global example of equivalence
E.The ISPM on equivalence
F.Remaining needs for clarification or support
V.Emerging issues and developments
A.Bilateral vs. regional or global negotiations
B.PRAs carried out for similar conditions or pests/pathway, rather than individually
C.(IPPC Technical Panels – if occurring there)
D.Increased quantification and modelling
VI.Conclusions and recommendations
Bibliography and other resources I am aware that a lot of these do not yet appear, and others already in are not yet listed
A.(Annex on its use in other fields [especially OIE and Codex], although distinct)
B.Text of most relevant agreements
Acronyms
ALOP / Appropriate level of protectionCPM
EFSA
FAO
ICPM
IPPC / International Plant Protection Convention
ISPM / International Standard for Phytosanitary Measures
NPPO / National Plant Protection Organisation
OIE / World Organisation for Animal Health
PHL
PRA / Pest Risk Analysis
RPPO
SPS / Sanitary and Phytosanitary measures
WTO / World Trade Organisation
Executive Summary
- Introduction and definition of equivalence
- The importance of equivalence in the world trade
There is wide agreement that trade poses thepotential threat of moving plant pests (including diseases) into new areas, or of increasing populations of pests already present but which have significant economic consequences, for example when infesting planting material. History has shown that, despite the challenges to a small population of pests establishing in a new location, this threat does become a reality. The impact on crop production, native flora and biodiversity, and those economically dependent on plants can be very high. This is why agreement has been reached amongst most countries of the world to collaborate in preventing the spread of such pests, especially across national borders.
Plant pests* may be introduced not only through agricultural trade, but also through non-agricultural trade if carrying susceptible materials (e.g. dunnage*, handicrafts, household effects, etc) or simply “hitch hiking” pests (e.g. on military equipment, used cars and other goods, etc), through postal deliveries or the travelling public, or by natural means (e.g. wind and weather events, the pest’s own mobility, etc). Agricultural trade is the primary pathway* for introduction* of most exotic pests, however, so that regulating trade has a significant impact on the risk from pests not yet established in any particular area.
A competing objective globally is the demand for goods to flow among countries with less restriction from tariffs on imports or subsidies on exports. This demand has been demonstrated through decades of negotiation under the process of the General Agreement for Tariffs and Trade (GATT) and the current membership to the World Trade Organisation (WTO). The pursuit of “free trade” recognised that non-tariff restrictions could be valid but should be justified, or countries would simply impose non-tariff barriers to replace the tariff barriers of the past. From the beginning, however, GATT noted the need for trade restrictions aimed at protecting human, animal and plant health. These restrictions are based on the estimated risk associated with specific trade.
In the international movement of agricultural trade, there are alternative ways to achieve a level of risk accepted by a national governmental authority – the National Plant Protection Organisation (NPPO) (WTO SPS, 2000).
“Equivalence” is an important principle underlying both free trade and national sovereignty in protection of domestic plant resources. While countries retain the sovereign right to protect domestic plant resources under the International Plant Protection Convention (IPPC), which is the intergovernmental treaty on plant health, which is deposited with the Food and Agriculture Organization (FAO) of the United Nations, there are many options for reducing the phytosanitary risk posed by trade. If risk can be managed, the objective of protection of resources can be met, at the same time there is facilitation of more open markets. In general terms, exporting countries can employ risk management measures which are alternative to those required by importing countries, as long as equivalency in the outcome can be demonstrated. Equivalence is one of the basic principles for plant health (IPPC, 2006 – ISPM 1).
Various NPPOs surveyed have indicated the potential benefits from equivalence agreements:
- Opening trade that would otherwise be prohibited
- Continuing trade with a Systems Approach when an individual measures is not/no longer achieving compliance [equivalence with the original target level of protection, perhaps, rather than with the outcome in reality]
- Continuing trade when the existing measure is no longer available or is considered objectionable for other reasons (impact to the environment, quality impact on product, etc)
- Introducing a Systems Approach that then allows flexibility (adjusting effectiveness by adding or removing measures, targeting non-compliance without stopping all trade, etc)
- A means to open discussion of technical justification of existing measures (without going to a formal dispute)
There is no attempt to calculate the volume or value of horticultural or other regulated agricultural trade currently occurring using pest risk management measures which are equivalent to previously applied, possibly more restrictive measures. The historic review in section II gives a sense of the widespread application of the general concept, however, prior even to international agreement and guidance. A discussion of drivers gives a sense of the growing importance equivalence will have for future trade.
- IPPC definition of equivalence
An early definition of equivalence was of measures that are “not identical but have the same effect” (FAO, 1995) indicating that the outcome or impact of the measures in terms of the pest risk would need to be the same, while the measures themselves differed. The use of the word “effect” was more appropriate for a commodity treatment than other forms of phytosanitary measures (e.g. surveillance, Pest Free Areas,certification, inspection, etc). The definition of equivalence was revised to address ambiguities and cover the range of situations.[QMM3](Although the ISPM 24 on equivalence was not yet updated at the time of this report.)
Over some years, the definition of “equivalence (of phytosanitary measures)” evolved to be [comments added]: “the situation where, for a specified pest risk [therefore limiting the pest species, area, possibly period of time, etc], different phytosanitary measures achieve a contracting party’s appropriate level of protection [this replaces the wording of “effect” to tie in more closely to the WTO SPS concept of meeting a country’s defined tolerance to risk] (FAO, 1995; revised CEPM, 1999; based on the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures; revised ISPM No. 24, 2005).
This current definition (Box 1) captures much of the history of development of the concept, as laid out in this report.
- What equivalence does not mean
There are cases in which a combination of measures or a new measure or technology has allowed movement of plant products when previously there was a prohibition of trade. Clearly, the alternative phytosanitary measure(s) cannot meet the same effect as prohibition, which would essentially be zero risk. This is a key reason for considering an importing NPPO’s ALOP rather than a set effect, as was suggested in the original definition.
There are many examples where trade was – and still is – initiated using a combination or duplicative measures beyond the ALOP. This is done when the exporters chose to meet the unreasonable demands simply because the market access is worth it. This is not in the spirit of the IPPC or the SPS Agreement, but is also not breaking any rules if all parties agree. When measures are redundant and no justification is provided (e.g. due to some lack of confidence on a particular component of the pest risk), this is a political or economic decision not complying with the principle of proportionality to the risk. Trying to match this level is not truly a case of equivalence.
The requirement for similar end-point pest mortality levels came about in early cases of commodity treatments developed for replacement of ethylene dibromide (EDB), methyl bromide (MB) or other broad spectrum fumigants. This led to wide use of probit-9 statistics as the basis for acceptance of new treatments. This criterion has been long and widely debated. It is possible for measures to achieve the importing NPPO’s ALOP without reaching an effect demonstrated to the level of probit-9, and therefore the equivalent measures would not actually have the same effect. If the ALOP can be met with alternative measures, the original statistical validation of a treatment is not relevant to the alternatives.
Another point of controversy over the years has been the presence of a live pest that is not viable or is sterile. If there is documentation or an operational agreement using a treatment known to have a sub-lethal target effect, many argue that the presence of this organism does not indicate non-compliance. This issue continues to be contentious in some trade situations. The more recent endorsement of ISPMs on irradiation as a treatment shows a deepening of understanding of the threat of introduction of a pest, versus simply entry at the point of entry to a country, without perhaps movement beyond that point. This issue does not fall under equivalence per se.[QMM4]
Equivalence also does not mean that all countries, shipping consignments* with the same pest risk, may be allowed to use the same alternative measures; at least not without additional safeguards. The ISPM no. 24 on equivalence (IPPC, 2005) clearly states that the capacity of the exporting country’s NPPO to apply the measure or measures may also be evaluated as an important component of the likelihood of meeting the importing NPPO’s ALOP.
- The drivers for seeking equivalence
The most commonly cited driver has been the loss of a chemical treatment such as a pesticide or postharvest fumigant, Methyl Bromide being an obvious example.The environmental impact of an existing option is also mentioned, even if the measure is still available.
Another driver noted has been continued non-compliance with existing measures due to some challenge in the application of those measures. Frequently, this has led to a Systems Approach,considered equivalent to the existing option, in order to maintain trade. A correlating driver is the issue of pesticide residues. Not surprisingly, if the number of detections of a pest in shipments rises, a common response to is apply more pesticides, sometimes beyond the recommended dosage. Detentions due to pesticide residues are not directly related to the IPPC, but may cause an export sector to ask the NPPO to look for better options in terms of pest risk management.
Sometimes the existing option has negative impacts on quality of the product. This frequently has been noted with MB fumigation. In this case, an equivalent alternative, often a Systems Approach, is sought for market reasons.
At times, constraints in resources are the driver. This may be due to funding, capacity and work load of the NPPO employees, infrastructure or to limited volume of particular trade, which cannot justify the existing option. If the existing option requires financing of importing NPPO inspection on site, for example at a treatment facility, this may lead to petition for alternatives that may be carried out in transit or upon arrival to the port of entry, so as to avoid that administrative cost. Even highly developed countries may not have the infrastructure in place for managing a new pest situation so that treatment in transit or upon arrival is a useful emergency measure, to be replaced over time with equivalent measures to be carried out in the country of export.
Political sensitivities were mentioned in the survey. A driver, which may have been even more common in the past is seeking equivalent measures when previously trade was prohibited. Various interviewees have commented that there are situations in which the existing measures are not justified, or there are new or additional requirements (i.e. due to the change in a pest status). These may be treated to some degree as equivalence negotiations, but in actual fact these are political negotiations.
Drivers for seeking Equivalence have been identified from various sources, including survey results and interviews. Similar drivers were identified in a study on the application of Systems Approach (Quinlan & Ikin, 2009). Examples of equivalence that are not Systems Approach are included below, however, as there is no requirement for combined measures to be used in negotiation of equivalence; it is simply a common scenario that more than one measure is needed to replace an existing option.
In general, the drivers for seeking Equivalence are on an upward trend. Most respondents to the survey expect more equivalence requests and negotiations in the future than in the past.
- Historic context for Equivalence (up through the SPS)
- Agreement on alternative measures: commodity treatments and host status
[historic examples]
- System wide equivalence: recognition of inspection systems, export certification, etc.
Generally in plant health, equivalence is agreed bilaterally for particular pest risk/commodity/source of trade, as discussed further in section IV. This is in contrast to the application of equivalence under the OIE and Codex Alimentarius for animal health and food safety, respectively.
Yet, one can observe informal processes in the past for entire systems, well before the ISPM 24 was written. These agreements were primarily ad hoc, based on years of experience with trade and the building of mutual trust. For this reason, there may not have been transparency in the criteria for the recognition. Furthermore, examples are not well documented, possibly because of the political ramifications of granting recognition to one exporting NPPO and not others.
In contrast to these examples, the evolution of the MERCOSUR mutual recognition has been a more deliberate and transparent process.
Some shared vision for pest risk and plant health has led to no less fundamental, even though much less comprehensive, agreements between Australia and New Zealand.
- European approach to requirements
Members of the European Union have followed a somewhat different path. The Treaty of the Functioning of the European Union (Title III. Agriculture and Fisheries, Article 43; see Consolidated Version of the Treaty on the Functioning of the European Union, 2008 O.J. C 115/47) is cited as the basis for the common plant health policy (XXX, 2010). The Plant Health Directive 77/93/EEC (1977) harmonised trade between Member States of the then European Community and began a common set of rules for trade with third parties (Baker & Pemberton, 1993). There were numerous exceptions, however, with many national regulations being more stringent than the regional approach. In 1993, with the Maastricht Treaty, the entire European Community emerged as a single market, essentially eliminating internal borders. The aim of protecting the entire territory against regulated pests required a common definition of harmful organisms against which import regulations would be imposed.
From the period of the creation of the European Common Market, the plant health legislation covering members of the European Union (and some non-members that have chosen to match that legislation) has offered alternative measures against the same pest risk.The principal legislation is the Plant Health Directive (2000/29/EC). Based on the technically justified and transparent pest list provided in this legislation, a country with the pest in question present is prohibited from trade of host material as a starting point. However, once the pest list is established, other options for risk management generally are offered. Pest free areas or pest free places of production are commonly offered as options to prohibition of trade from countries with the target pest already present. In some cases, additional options include commodity treatments.
The legislation was developed in the spirit of the WTO SPSwith an underlying objective to avoid prohibition of trade when possible. Some derogations, which are based on the principles of a Systems Approach, have been adopted to change requirements over time (e.g. Decisions 2003/63, 2002/887, 2002/499, 2005/51, 2004/4, 2003/249, 93/423). This occurs generally when pest detections have been unacceptably high, frequent or on going from particular sources but further demonstrates the commitment to avoiding prohibition (in the opinion of the author).