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INTERNATIONAL PLANT PROTECTION CONVENTION

Manual on Equivalence between pest risk

management measuresDraft version 17 August 2012

Send comments to M. Megan Quinlan, Research Fellow, Imperial College Londonm.quinlan@imperial.ac.uk

(please indicate if your comments are confidential or may be cited/shared)

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.

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IPPC Secretariat,Food and Agriculture Organization of the United Nations,Viale delle Terme di Caracalla,Rome, 00153Italy

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Table of Contents

Acronyms 4

Glossary of Terms 5

Executive Summary 8

I. Introduction and definition of equivalence 9A. The importance of equivalence in the world trade 9

B. IPPC definition of equivalence 10

C. What equivalence does not mean 11

D. The drivers for seeking equivalence 12

II. Historic context for Equivalence (up through the SPS) 13A. Agreement on alternative measures: commodity treatments and host status 13

B. System wide equivalence: recognition of inspection systems, export certification, etc.14

C. European approach to requirements 14

D. The advent of SPS and relevant principles 15

III. Common practice in plant health 16A. Case by case nature (end point rather than system equivalence) 16

B. Technical or operational agreements 17

C. Mutual recognition 17

D. Formal equivalence and notified agreements 17

E. ISPMs, regional agreements and other agreements that are equivalency agreements 17

IV. The ISPM on equivalence and other relevant ISPMs 17

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A. Key principles 17

B. Attempts to define ALOP and efficacy 18

C. Other ISPMs including systems approach 19

D. ISPM 15–a global example of equivalence 19

E. The ISPM on equivalence 19

F. Remaining needs for clarification or support 19

V. Emerging issues and developments 21A. Bilateral vs. regional or global negotiations 21

B. PRAs carried out for similar conditions or pests/pathway, rather than individually 21

C. (IPPC Technical Panels – if occurring there) 21

D. Increased quantification and modelling 21

VI. Conclusions and recommendations 21Bibliography and other resources I am aware that a lot of these do not yet appear, and others already in are not yet listed 22

A. (Annex on its use in other fields [especially OIE and Codex], although distinct) 26

B. Text of most relevant agreements 26

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Acronyms

ALOP Appropriate level of protection

CPM

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

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Executive Summary

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I. Introduction and definition of equivalence

A. The importance of equivalence in the world trade

There is wide agreement that trade poses the potential 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).

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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.

B. 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. (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,

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BOX 1. [EQUIVALENCE OF PHYTOSANITARY MEASURES

the situation where, for a specified pest risk, different phytosanitary measures achieve a contracting party’s appropriate level of protection [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]. ]

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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.

C. 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.

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.

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D. 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.

II. Historic context for Equivalence (up through the SPS)

A. Agreement on alternative measures: commodity treatments and host status

[historic examples]

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B. 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.

C. 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.

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The legislation was developed in the spirit of the WTO SPS with 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).

So again, although not explicitly developed under Equivalence, these examples of single or combined measures listed in EU Directives for the same pest risk situation, must be considered “equivalent” in so far as they are accepted as alternatives for achieving the same ALOP, in as much as there is a single ALOP for the entire EU. (It is suggested that Annex 4 on emergency actions from its beginnings is based on the principle of equivalence (personal communication from survey respondent).)

As always, there appear to be exceptions. Within the EU, there is not a binding harmonised approach to diagnostics for plant health, for example. This and a number of other concerns lead to a recent evaluation of the Community’s Plant Health Regime (XXX, 2010). The European Commission is currently working to update Plant Health Legislation.

The final risk management decisions in the EU are taken by the Standing Committee on Plant Health, which is convened by DG SANCO in the European Commission (Council of Europe, 2009). Since the formation of the European Food Safety Authority (EFSA) (Regulation (EC) no. 178/2002) and the creation of the Panel on Plant Health (referred to as PLH Panel) of EFSA in 2006, matters of Equivalence have been referred to this body for technical review. This is because of the nature of EFSA as the primary source of scientific review and advice on risks, in this case risks posed by plant pests. Exporting country NPPOs wishing to propose alternative measures to those in the legislation, still present the request to DG SANCO, but it is assessed by the EFSA PLH Panel.

D. The advent of SPS and relevant principles

The advent of the SPS Agreement had significant influence on the evolution of the IPPC and its governance.

The 1951 version of the IPPC text has an objective to “secure common and effective action to prevent the spread and introduction of pests (including weeds) of plants (including wild flora) and plant products, and to promote appropriate measures for their control.” This original convention language did not cover harmonisation and equivalence (Van der Graaff, 1999).

Before the formation of a Secretariat for the IPPC (established in 1992 and operational in 1993), the Plant Production and Protection Division of FAO coordinated activities of the convention. Van der Graaff & Ikin (1993) describe how the parties in the GATT approached the FAO to seek stronger coordination of the objectives of the IPPC and to add specific, trade-related objectives which emerged from the GATT negotiations. The need for a stronger unified voice on plant health necessitated a stronger IPPC, rather than a fragmented response from the stronger Regional Plant Protection Organisations (RPPOs) of that period (Stanton, 1993).

The demand for “safe” free trade culminated in the World Trade Organisation’s (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (referred to as the SPS Agreement). However, the thrust of the agreement is to prevent the misuse of rights. It states that: “Members shall

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ensure that any sanitary or phytosanitary measure is applied only to the extent necessary” (Article 2, paragraph 2). From this period, prohibition of trade is employed – and indeed tolerated – much less than in the past, because of international commitment to free trade.

The concept of equivalence was made explicit in the WTO SPS Agreement (Article 4). This reference reminds us the fundamental objective of equivalence is to open and maintain trade that otherwise might be restricted by prohibition or lack of options for risk management. The right of countries to protect their own plant resources is acknowledged, but this is not the primary objective under the trade-oriented framework of this

reference.

At the time, Equivalence was considered an added support to countries that might not have the same technologies and infrastructure available for treating commodities, for example (Thiermann, 1999). The 1980s and early 1990s were indeed a period of rapid development of commodity treatments (Hallman & Quinlan, 1996); some of which were not readily available to developing countries.

In this way, the use of risk analysis was promulgated as a way to enhance transparency of national regulatory decisions, use of proportionality (“necessity”) in imposing measures and the scientific justification of any measures that would deviate from the existing and future ISPMs. Principles of non-discrimination and the formalised use of the term “equivalence” appear to arise during this period of transition to the 1997 version of the IPPC convention text.

The IPPC text included equivalence as a general principle of the convention (FAO, 1995). The membership body of the IPPC, the Commission on Phytosanitary Measures (CPM), eventually endorsed an International Standard on Phytosanitary Measures (ISPM) providing guidelines for the determination and recognition of equivalence of phytosanitary measures (IPPC, 2005) in 2005.

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Box 3. Article 4 of the SPS Agreement: Equivalence1. Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.

2. Members shall, upon request, enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures.

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III. Common practice in plant health

A. Case by case nature (end point rather than system equivalence)

Information regarding the application of equivalence and perspectives and experiences is collected from various sources. As noted, official notification of equivalence agreements has been virtually non-existent and thus does not provide data. Discussion of the concept at the SPS Committee has put a few perspectives in to the record. Comments from countries on the draft of ISPM 24, during country consultation, provide a useful view of concerns and understanding, even though much of these did not make the final edit.

A survey of NPPOs in 2011 and 2012 allowed for documentation of common practice. Although only a dozen countries responded, each of the FAO Regions (Africa, Near East, Europe, Asia, Pacific, Latin America and Caribbean, and North America) was represented by this response. The survey may not be representational in other ways (e.g. of the greatest volume of trade or of the range of experiences). Finally, individual interviews of government officials were conducted and are cited, where permitted.

B. Technical or operational agreements

C. Mutual recognition

The US equivalency agreement on irradiation is designed to ensure market access for irradiated products from the USA, if the US is opening its borders to irradiated products itself.

D. Formal equivalence and notified agreements

The SPS Committee has

[Still researching if there are any formal notifications in plant health!]

E. ISPMs, regional agreements and other agreements that are equivalency agreements

[Repetitious of the section III?]

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IV. The ISPM on equivalence and other

relevant ISPMs

A. Key principles

The probability that a pest will enter, establish in and possibly spread through an area where it is not yet present can be estimated based on, among other things, the biology of the pest of concern and the conditions of the importing country or region. The consequences of such an introduction vary according to the conditions of the importing country or region, including: presence of the host of the pest, economic or environmental importance of the host plants, availability of control measures or means to eradicate a new introduction, social impact of carrying out the control measures and so forth. The risk posed by an exotic pest associated with trade (whether actually present in the consignments or not) is the probability of an introduction times the consequences of it. Risk considers what might happen, probabilistically and in the future. This risk is estimated using a Pest Risk Assessment methodology described below; with the addition of possible risk reducing or pest risk management* measures, the Pest Risk Analysis (PRA)* is the foundation of decision making regarding trade between countries or regions.

Equivalence negotiations require agreement on the initial assessment of risk and conclusions regarding the need for pest risk management measures. The threshold level of accepted or tolerated risk must also be articulated sufficiently to allow consideration of pest risk management measures.

The impact of management measures on the pest risk relates to the efficacy of the measures, as well as to the level of the threat.

B. Attempts to define ALOP and efficacy

“Efficacy (treatment)” appears in the official IPPC glossary as “a defined, measureable and reproducible effect by a prescribed treatment [from ISPM no. 18, 2003]; the term “efficacy” is not defined for other types of phytosanitary measures at this time.

Expert working groups under the IPPC were convened for the development of an ISPM on efficacy. This process has been stalled, but the reports reveal the complexity of the issues, as discussed further in section III B.

Each country has the right to set the level of protection to be achieved, either due to low inherent risk or by using risk management measures against introduction of injurious pests that could cause economic or environmental impact, which are not already present. If this Appropriate Level of

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PHYTOSANITARY PRINCIPLES FOR THE PROTECTION OF PLANTS AND THE APPLICATION OF PHYTOSANITARY MEASURES IN INTERNATIONAL TRADE

(IPPC 2006 – ISPM 1)

1.10 Equivalence of phytosanitary measures

Importing contracting parties should recognize alternative phytosanitary measures proposed by exporting contracting parties as equivalent when those measures are demonstrated to achieve the appropriate level of protection determined by the importing contracting party.

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Protection (ALOP) cannot be reached through the addition of management measures, then the country can prohibit the trade.

The ALOP is a key component of the IPPC definition of equivalence, as noted in both ISPMs 1 and 24, but has not been well defined. There may be various ways to set the ALOP, varying from a defined economic threshold of potential impact to a more nebulous sense of matching the post-management measures risk level was has been accepted over years of trade historically. The underlying problem with this concept in plant health is that there is not an agreed, harmonised framework for comparing widely varying technical information on the range of phytosanitary measures in terms of impact (Bigsby, 2001, and others), so that even with historic precedence, it is not always clear what is the ALOP to be reached (or if it has been reached). At this stage, there is little documentation from national governments on how the NPPO decides that measures are “enough” to meet this ALOP. It is not realistic to expect this to be transparent in the immediate future, although the spirit of the IPPC would require more transparency.

In 2005, at the Interim Commission on Phytosanitary Measures (ICPM-7), the decision was taken to produce an ISPM or supplement to describe the use of the term appropriate level of protection (IPPC, 2005 – specification 36). A draft IPSM on ALOP was prepared and discussed by the IPPC Standards Committee. Eventually in the November 2008 meeting (IPPC, 2008) the decision was made to table the draft for the time being. The topic proved to be challenging and “it remained the remit of the SPS Committee to define ALOP”, as it arose as terminology from the SPS rather than the IPPC (IPPC, 2008). Despite this, the term appears in ISPMs.

(more details on the IPPC process, or just leave it as above – that it did not get agreed??)

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

Some of the issues requiring more clarification were identified by respondents to the global survey or individual interviews. These include:

generally more guidance on how to negotiate equivalence less complicated, time consuming and onerous methods for agreeing to equivalence (such as a

common framework for evaluation) increased capacity to carry out Systems Approach assistance with understanding the data required or how to determine efficacy more transparency in the review of information submitted guidance on how to remove measures when no longer justified (when less would meet the

ALOP)

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ways to avoid the long process of negotiation when, in the end, the industry will not comply or attempt to use the equivalent measures negotiated (i.e. how to make sure that the measures will be implemented before going through the negotiation)

improved coordination within countries, so that the NPPO has authority to complete equivalence negotiations and, once concluded, the inspectors, Customs etc are informed

how to proceed when equivalence negotiations are held back by what appear to be political and protectionist delays

the continued use of the IPPC to reach agreement on equivalent measures through ISPMs (e.g. the variety of approved treatments for ISPM 15 treatment of dunnage)

There was also comment on the failure of the Doha Round of GATT negotiations. There is some question as to whether there is any hope for multilateral solutions through WTO. While a valid observation, this concern is not explored in the current report.

From this and other sources, it appears that the main challenges for NPPOs seeking Equivalence agreements are:

The time and resources required to negotiate the equivalence The delays and lack of transparency in evaluation process of the market country’s NPPO Lack of a common framework for considering the impact or efficacy of measures, and thus

for comparing them The issue of capacity for application of measures – varying views of the need for assistance in

capacity or favoured treatment versus the need of an importing country to ensure the ALOP Overall capacity to carry out new measures, especially Systems Approach

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V. Emerging issues and developments

A. Bilateral vs. regional or global negotiations

A trend towards more requests for equivalent measures (whether called this or not) was observed by most parties. Certainly the pressure on the drivers for equivalence is rising.

While the opinion of best practice is overwhelmingly to negotiate bilaterally, there is a possible move towards more regional approaches and appreciation for the more specific technical ISPMs which take the burden off individual countries to negotiate.

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

EFSA (2012) has developed an approach to determination of equivalence

VI. Conclusions and recommendations

The concept of equivalence of pest risk management measures in plant health has a long history as a common sense approach to the requirement for alternative measures when the existing option(s) is not ideal. Earliest documented cases of the need for alternative measures includes lack of infrastructure, for example for commodity treatments, or conversely availability of infrastructure, e.g. through development assistance funding; market reasons, such as quality reduction from use of a treatment; increased understanding of host preferences, which allowed less severe measures for non-hosts or marginal hosts; the desire for recognition of a more holistic approach to management of pest populations, following on from IPM; and the use of areas with low prevalence of a pest population (prior to the ISPM on this topic). The concept of equivalent measures matured with the search for alternatives to end-point treatments alone, in particular post-harvest, broad spectrum fumigants such as EDB and MB. The development of Systems Approach (ISPM 14, 2002) also gave rise to requests for recognition of equivalence.

Historically, the majority of cases in which alternative measures have been accepted to replace existing practices were based on individual, ad hoc trade; this was generally for a particular commodity or commodity class (i.e. situations with a pathway or commodity based PRA). This recognition was negotiated bilaterally in most instances. An important exception is the European Union which provided alternative measures in the legislation, so that any of the listed management options would be accepted unless some indication of failure of the measures emerged.

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Examples of entire systems being recognised as equivalent are less common. Some of the earliest examples arose from the work load pressures related to high volume trade. In these historic cases, mutual trust had already developed before such steps were taken and the process of recognition was not transparent nor officially declared as equivalence.

The negotiation process for the SPS Agreement brought an enhanced focus on the IPPC, and its governing bodies, as the global voice of plant health. It also introduced precision to the concept of equivalence but focusing on the level of risk accepted by the importing country NPPO as the target for equivalent measures, rather than duplication of the effect of a measure.

The international plant health community, through the mechanisms of the IPPC, has debated key concepts relating to equivalence for more than a decade. This was advanced through the revision of ISPM 1 (2006; original document endorsed by the FAO Conference in 1993), which lays out the general principles underlying plant health, as well as operational principles. Attempts to codify understanding of the appropriate level of protection (ALOP) and efficacy of measures did not result in ISPMs, but contributed to discussions. Other key concepts, including on inspection (ISPM 23) sampling (ISPM 31), were clarified. The ISPM 24 on determination of equivalence was endorsed by the ICPM in 2005.

The period since the endorsement of IPSM 24 has seen a rise in the requests for recognition of equivalence, according to NPPOs surveyed. There is little anecdotal evidence, however, that this is due to the ISPM. Instead, drivers for seeking equivalence in recent years appear to be related to loss of pesticides; impact on market quality; and situations in which the existing measure(s) is not reaching compliance levels for some reason that can be addressed by switching approaches. Possibly increased confidence of lower resource exporting country NPPOs will also lead to the increase in equivalence proposals, supported by recent tools and capacity enhancing projects.

Another driver may be the more clear guidance on evaluation of treatments – with the ISPMs on treatments (28) and irradiation in particular (ISPM 18 and annexes 1-12 of ISPM 28) – has also contributed to the upward trend of requests for recognition of equivalence, although international equivalence agreements, such as the options encapsulated in ISPM 15 (2009) are available for all countries and do not require bilateral negotiation and recognition. Future ISPMs could introduce broader use of system wide equivalence agreements.

For the present, the use of equivalence in plant health remains overwhelmingly undocumented and proceeds in a common sense, but case by case, manner. Improvements in PRA methodologies and interest in quantifying the risk management measures could lead to significant changes in the use of this principle for plant health over the next decade.

Primary recommendations are:

To encourage more transparency through the notification and documentation of plant health equivalence agreements of all types;

To follow national and regional efforts in using tools and models to support transparent and consistent decision making;

To encourage discussions of emerging frameworks for consideration of equivalence per se;

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To consider development of an ISPM, supplement or other official guidance for estimating the efficacy of pest risk management measures and for the operational aspects of determination of equivalence;

To seek agreement and harmonisation on information required for consideration of equivalence, as well as the appropriate time period for such considerations;

To encourage further refinement of systems for determination of national appropriate level of protection thresholds.

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Bibliography and other resources I am aware that a lot of these do not yet appear, and

others already in are not yet listed

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Annex A. Glossary of Terms

MOVE TO BECOME ANNEX A? Not complete. I am considering that the first time each term is noted, to put * in the text, or to put the word as bold, to show that it is in the glossary. (It may be better to put this as an annex.)

appropriate level of protection

Appropriate level of sanitary or phytosanitary protection - The level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory. (Source: WTO SPS Agreement)

NOTE: Many Members otherwise refer to this concept as the "acceptable level of risk".

audit Periodic official review to verify that a treatment or Systems Approach is being carried out according to the information stated in the DSS. This review is based on the treatment audit trail.

audit trail The necessary and sufficient documentary evidence that a measure is being carried out in accordance with the information stated in the DSS.

control point A step in a system where specific procedures can be applied to achieve a defined effect and can be measured, monitored, controlled and corrected [ISPM No. 14, 2002]

efficacy (treatment)

A defined, measurable, and reproducible effect by a prescribed treatment [ISPM No. 18, 2003]

entry (of a pest) Movement of a pest into an area where it is not yet present, or present but not widely distributed and being officially controlled [FAO, 1995]

free from (of a consignment,

field or place of production)

Without pests (or a specific pest) in numbers or quantities that can be detected by the application of phytosanitary procedures [FAO, 1990; revised FAO, 1995; CEPM, 1999]

interception (of a pest)

The detection of a pest during inspection or testing of an imported consignment [FAO, 1990; revised CEPM, 1996]

monitoring of control point(s)

A planned sequence of observations or measurements {official or not} at predetermined Control Points (CPs) to determine whether the Systems Approach plan has been followed. Therefore each CP monitoring consists of the verifications of the measures relevant to that CP.

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pathway Any means that allows the entry or spread of a pest [FAO, 1990; revised FAO, 1995]

pest Any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products [FAO, 1990; revised FAO, 1995; IPPC, 1997]

Pest Free Area An area in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained [FAO, 1995]

pest free place of production

Place of production in which a specific pest does not occur as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained for a defined period [ISPM No. 10, 1999]

pest free production site

A defined portion of 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 being officially maintained for a defined period and that is managed as a separate unit in the same way as a pest free place of production [ISPM No. 10, 1999]

pest risk (for quarantine pests)

The probability of introduction and spread of a pest and the magnitude of the associated potential economic consequences (see Glossary Supplement No. 2) [ISPM No. 2, 2007]

pest risk (for regulated non-quarantine pests)

The probability that a pest in plants for planting affects the intended use of those plants with an economically unacceptable impact (see Glossary Supplement No. 2) [ISPM No. 2, 2007]

Pest Risk Analysis (PRA)

The process of evaluating biological or other scientific and economic evidence to determine whether an organism is a pest, whether it should be regulated, and the strength of any phytosanitary measures to be taken against it [FAO, 1995; revised IPPC, 1997; ISPM No. 2, 2007]

pest risk assessment (for quarantine pests)

Evaluation of the probability of the introduction and spread of a pest and the magnitude of the associated potential economic consequences (see Glossary Supplement No. 2) [FAO, 1995; revised ISPM No. 11, 2001; ISPM No. 2, 2007]

pest risk assessment (for regulated non-quarantine pests)

Evaluation of the probability that a pest in plants for planting affects the intended use of those plants with an economically unacceptable impact (see Glossary Supplement No. 2) [ICPM, 2005]

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pest risk management (for quarantine pests)

Evaluation and selection of options to reduce the risk of introduction and spread of a pest [FAO, 1995; revised ISPM No. 11, 2001]

pest risk management (for regulated non-quarantine pests)

Evaluation and selection of options to reduce the risk that a pest in plants for planting causes an economically unacceptable impact on the intended use of those plants (see Glossary Supplement No. 2) [I

pest status (in an area)

Presence or absence, at the present time, of a pest in an area, including where appropriate its distribution, as officially determined using expert judgement on the basis of current and historical pest records and other information [CEPM, 1997; revised ICPM, 1998]

place of production

Any premises or collection of fields operated as a single production or farming unit. This may include production sites which are separately managed for phytosanitary purposes [FAO, 1990; revised CEPM, 1999]

point of entry Airport, seaport or land border point officially designated for the importation of consignments, and/or entrance of passengers [FAO, 1995]

quarantine pest A pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled [FAO, 1990; revised FAO, 1995; IPPC 1997]

required response

A specified level of effect for a treatment [ISPM No. 18, 2003]

systems approach(es)

The integration of different risk management measures, at least two of which act independently, and which cumulatively achieve the appropriate level of protection against regulated pests [ISPM No. 14, 2002; revised ICPM, 2005]

treatment Official procedure for the killing, inactivation or removal of pests, or for rendering pests infertile or for devitalization [FAO, 1990, revised FAO, 1995; ISPM No. 15, 2002; ISPM No. 18, 2003; ICPM, 2005]

verification A procedure or measure to quantify the actual, or mathematically related proxy, effectiveness of a risk management measure. The purpose of verification is to assess how close the outcome is to the stated expected efficacy.

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A. Text of most relevant agreements

SPS agreement – relevant article Forms for notification of equivalence ISPM no. 24

Article 4: Equivalence1. Members shall accept the sanitary or phytosanitary measures of other Members as equivalent,even if these measures differ from their own or from those used by other Members trading in the sameproduct, if the exporting Member objectively demonstrates to the importing Member that its measuresachieve the importing Member's appropriate level of sanitary or phytosanitary protection. For thispurpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures.2. Members shall, upon request, enter into consultations with the aim of achieving bilateral andmultilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures.

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ANNEX E: NOTIFICATION OF RECOGNITION OF EQUIVALENCE

RECOMMENDED PROCEDURES FOR THE COMPLETION OF

THE NOTIFICATION FORMAT

In accordance with the Decision on Equivalence (G/SPS/19), a Member which has made a determination recognizing the equivalence of sanitary or phytosanitary measures of another Member or Members shall notify other Members through the Secretariat of the measure(s) recognized to be equivalent and of the products affected by this recognition.

For the purposes of this notification, equivalence is defined to be the state wherein sanitary or phytosanitary measures applied in an exporting Member, though different from the measures applied in an importing Member, achieve, as demonstrated by the exporting Member and recognized by the importing Member, the importing Member’s appropriate level of sanitary or phytosanitary protection.

A determination of the recognition of equivalence may be with respect to a specific measure or measures related to a certain product or categories of products, or on a systems-wide basis.

Notification should also be made of significant variations to existing equivalence arrangements, including their suspension or rescission.

Item Description Item Description

1. Member notifying Government, including the competent authorities of the European

Communities, which is making the notification.

2. Title of the text stating

determination of the

recognition of equivalence

Title of any formal or informal agreement, Memorandum of

Understanding or other document establishing the determination of recognition of equivalence.

3. Parties involved Name of the exporting Member or Members whose measure has been determined to be equivalent.

4. Date of entry into force of

the determination of the

recognition of equivalence

and any associated

procedures or regulations

Date from which procedures, regulations or other measures based on the determination of recognition of equivalence took effect.

5. Products covered (HS or

CCCN where applicable,

otherwise national tariff

heading)

Tariff item number(s) (normally HS, chapter or heading and number) as

contained in national schedules deposited with the WTO of the product(s) which are imported on the basis of the determination of the recognition of equivalence.

6. Brief description of the Clearly indicate the nature of the recognition of equivalence, including

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measure(s) recognized to

be equivalent

which measure(s) of the exporting Member have been determined to be equivalent and which elements of the importing Member's usual requirements are met by these equivalent measures.

7. Further information

available from:

The agency or authority from which an interested Member may request further information regarding the specific determination of equivalence being notified. If this is the National Enquiry Point, check the box provided. If available from another body, give its address, fax number and (if available) E-mail address. Provide the website address of the document, if available.

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WORLD TRADE G/SPS/N/EQV/#

ORGANIZATION Date of circulation

(00-0000)

_________________________________________________________________________________________________

Committee on Sanitary and Phytosanitary Measures Original:

NOTIFICATION OF DETERMINATION OF THE RECOGNITION OF EQUIVALENCE

OF SANITARY OR PHYTOSANITARY MEASURES

The following notification of determination of the recognition of equivalence has been received.

1. Member notifying:

2. Title of the text stating the determination of the recognition of equivalence:

3. Parties involved:

4. Date of entry into force of the determination of the recognition of equivalence andany associated procedures or regulations (dd/mm/yy):

5. Products covered (HS or CCCN where applicable, otherwise national tariffheading):

6. Description of measures recognized to be equivalent:

7. Further information available from:

[ ] National Enquiry Point [ ] Other (specify)

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