Guidance on commodity risk assessment for the evaluation of high risk plants dossiers.

Article 42 of the European Regulation (EU) 2016/2031, on the protective measures against pests of plants, introduces the concept of 'high risk plants, plant products and other objects' that are identified on the basis of a preliminary assessment to be followed by a commodity risk assessment. Following a request of the European Commission, this Guidance was developed to establish the methodology to be followed when performing a commodity risk assessment for high risk commodities (high risk plants, plant products and other objects). The commodity risk assessment performed by EFSA will be based on the information provided by the National Plant Protection Organisations of non-EU countries requesting a lifting of import prohibition of a high risk commodity. Following international standards on pest risk analysis, this Guidance describes a two-step approach for the assessment of pest risk associated with a specified commodity. In the first step, pests, associated with the commodity, that require risk mitigation measures are identified. In the second step, the overall efficacy of proposed risk reduction options for each pest is evaluated. A conclusion on the pest-freedom status of the commodity is achieved. The method requires key uncertainties to be identified.

Introduction

Background as provided by the European Commission

The new Plant Health Regulation (EU) 2016/20311, on the protective measures against pests of plants, will be applying from December 2019. Provisions within the above Regulation are in place for the listing of ‘high risk plants, plant products and other objects’ (Article 42) on the basis of a preliminary assessment, and to be followed by a commodity risk assessment. A list of ‘high risk plants, plant products and other objects’ has been published (EU) 2018/20192. Scientific opinions are therefore needed to support the European Commission and the Member States in the work connected to Article 42 of Regulation (EU) 2016/2031, as stipulated in the terms of reference.

Terms of Reference as provided by the European Commission

In view of the above and in accordance with Article 29 of Regulation (EC) No. 178/20023, the Commission asks EFSA to provide scientific opinions in the field of plant health.

In particular, EFSA is expected to prepare and deliver risk assessments for commodities that shall be listed in the relevant Implementing Acts as “High risk plants, plant products and other objects”. Article 42, paragraphs 4 and 5, establishes that a risk assessment is needed as a follow‐up to evaluate whether the commodities will remain prohibited, removed from the list and additional measures will be applied or removed from the list without any additional measures. This task is expected to be on‐going, with a regular flow of dossiers being sent by the applicant required for the risk assessment.

Therefore, to facilitate the correct handling of the dossiers and the acquisition of the required data for the commodity risk assessment, a format for the submission of the required data for each dossier is needed.

Furthermore, a standard methodology for the performance of “commodity risk assessment” based on the work already done by Member States and other international organizations needs to be set.

Interpretation of the Terms of Reference

As a result of the classification of commodities as ‘high risk plants, plant products and other objects’, their import into the EU will be prohibited. Requests for lifting the import prohibition can be sent to the European Commission by the National Plant Protection Organisation of the country of origin4 (hereinafter referred in this Guidance as the applicant).

In January 2018, the European Commission requested EFSA to provide scientific assistance in standardising the information requirements for dossiers to support applicants (countries of origin) requests for lifting the import prohibition of high risk plants, plant products and other objects as specified in Regulation (EU) 2016/2031. In a Technical Report (EFSA, 2018), EFSA specified information and data required to perform a commodity risk assessment. In this document, guidance on a standard methodology for the performance of commodity risk assessment is given dealing with plant health,5 following the international standard for pest risk assessment (ISPM 11, FAO, 2013a). The objectives of the commodity risk assessment are to: (1) identify pests that may require risk mitigation measures;6 and (2) evaluate the overall efficacy of the measures currently applied.

Data and methodologies

The Panel performs its commodity risk assessment following the relevant guiding principles and steps presented in the EFSA guidance on quantitative pest risk assessment (EFSA PLH Panel, 2018), in the guidance on evaluation of the effectiveness of risk‐reducing options (EFSA PLH Panel, 2012) and in the International Standard for Phytosanitary Measures No 11 and No 21 (FAO, 2004, 2013a). It should be noted that the Panel's conclusions are formulated to respect its remit and particularly with regard to the principle of separation between risk assessment and risk management (EFSA founding regulation (EU) No. 178/2002).

The data and supporting information provided in the dossier submitted by the applicant form the basis of the commodity risk assessment. In evaluating the dossier provided, EFSA PLH Panel assumes that the applicant followed the instructions contained in the Technical Report (EFSA, 2018).

Guidance is provided on the methodology to be used in the commodity risk assessment and concerns the evaluation of commodity data, identification of pests potentially associated with the commodity and evaluation of the risk mitigation measures.

https://gd.eppo.int/

https://www.cabi.org/cpc/

http://www.theplantlist.org/

http://www.indexfungorum.org/

http://www.mycobank.org/

http://plpnemweb.ucdavis.edu/

https://fauna-eu.org/

https://nt.ars-grin.gov/

At several points in the risk assessment process, additional information may be required. Figure 1 gives an overview of the points in the assessment process when this may be the case. This could include requests for clarifications or additional documentation from the applicant.

Figure 1

Critical decision points that may affect the progress of the assessment

Evaluation of commodity data

The purpose of this section is to provide an unambiguous description of the commodity and its production and handling process.

The following questions need to be answered to determine whether an unambiguous description of the commodity has been provided, as indicated in Sections 3.1–3.6 of the Technical Report, hereafter referred as TR (EFSA, 2018):

Is the plant correctly identified as stated in Section 3.1 of the TR, according to a recognised authority (e.g. The Plant List – http://www.theplantlist.org)?

Is a description of plants for planting (according to Annex 1 of ISPM 36, FAO, 2016) and of the growing medium (according to ISPM 40, FAO, 2017a) provided according to Section 3.2 of the TR?

Is the type of certification of the plants for planting described according to Section 3.3 of the TR?

For fruit or vegetables, are the part/s of the plant, as well as the presentation (i.e. the presence of leaves, sepals, or fruit on the vine, etc.) appropriately described according to Section 3.4 of the TR?

For wood, is the type of wood described according to ISPM 39 (FAO, 2017b) (Section 3.5 of the TR)?

For other commodities, are they appropriately described according to Section 3.6 of the TR?

The following questions need to be answered to determine whether the processes and places of production of the commodity have been provided (Sections 3.7–3.13 of the TR):

Is the timing of agronomic practices/production processes and phenology of the crop described according to Section 3.7 of the TR?

Is the general sanitary status and phytosanitary management of the crop described according to Section 3.8 of the TR?

Is the intended use of the commodity described according to Section 3.9 of the TR?

Are the production‐areas clearly specified and described (including map/s) according to Sections 3.10 and 3.11 of the TR?

Is the climate classification for the production area provided according to Section 3.12 of the TR?

Are colour pictures and the descriptions informative and provided according to Section 3.13 of the TR?

Evaluation of the identification of pests potentially associated with the commodity in the country of origin

The purpose of this section is to identify and list the relevant pests associated with the commodity in the country of origin. Distinction is made between pests that are regulated in the EU (EU regulated) and those that are not regulated in the EU (non‐EU regulated). For the group of non‐EU regulated pests, a decision has to be made whether a pest categorisation is needed to confirm if the pest fulfils the criteria to be considered for Union quarantine pest status (see Figure 1). The end result is a list of pests for which risk mitigation measures may be required.

The following questions need to be answered to determine whether the two pest lists (Sections 4.1–4.4 of the TR) are complete and correctly classified and if the additional information on the selected relevant pests is provided (Sections 4.4 and Subsections 4.4.1–4.4.11 of the TR):

Is the list of all pests potentially associated with the plant species or genus of the commodity in the country of origin compiled according to Section 4.1 of the TR?

Are all the EU regulated pests included in Table D1, according to Section 4.2 of the TR?

For each pest species:

Is the most recent valid scientific name provided?

Is the pest status (presence or absence) provided according to ISPM 8 (FAO, 1998)?

If applicable, is sufficient evidence for the pest‐free areas status in the country of origin given according to ISPM 4 (FAO, 1995)?

Is the regulatory status (i.e. quarantine pests, regulated non‐quarantine pests, non‐regulated pest) in the country of origin provided?

Is the evidence given on the association of the pest with the commodity satisfactory?

Are all pests identified that may need risk mitigation measures?

Are all the non‐regulated pests in the EU included in Table D2, according to Section 4.3 of the TR?

For each pest species:

Is the most recent valid scientific name provided?

Is the pest status (presence or absence) in the EU provided and correctly classified?

If applicable, is sufficient evidence for the pest‐free area status in the country of origin given according to ISPM 4 (FAO, 1995)?

Is the regulatory status in the country of origin provided?

Is there sufficient evidence given on the association of the pest with the commodity?

Is there sufficient evidence of the impact of the pest?

Are all pests that may need risk mitigation measures identified?

In Table D3 of the TR, all pests, present in the applicant country, associated with the commodity and that may need risk mitigation measures or/and pose a potential risk for the EU are identified and summarised by the applicant.

For each of the identified relevant pests listed in Table D3 of the TR, check that the following information is provided (according to Section 4.4 of the TR):

Scientific name, synonyms and if applicable, common name(s) in English.

Taxonomic classification, including at least class, order, family, genus, species and information below species level if relevant (e.g. subspecies, pathovar, etc.).

Geographical distribution of the pest in the country: provide if applicable, pest distributions/pest‐free areas maps for each pest, considering a map as stated in Section 3.10. of the TR as a background layer.

Prevalence of the pest during the season (e.g. percentage of infested plants/fruit during the different phenological stages indicated in Section 3.7 of the TR).

Relevant biological characteristics (e.g. life cycle, association with the pathway, thermal requirements, environmental conditions for symptom/disease expression) of the pest.

Main hosts of the pest, including alternate hosts if relevant, vector(s) required.

In the case of arthropods and nematodes, for each stage (e.g. egg, larva/nymph, pupa, adult), indicate the part of the plant where it can be found, describe the type of damage. Provide information whether any latent phase or asymptomatic infestation/infection stages are known for the pest species. Indicate also if the pest can be a vector of any plant pathogen.

For fungi, bacteria, viruses, phytoplasmas, describe the symptom(s) in the commodity and the part of the plant where it can be found, describe the type of damage. Provide information whether any latent phase or asymptomatic infestation/infection stages is known for the pest species. Indicate also if the pest can be a vector of any plant pathogens.

In the case of any other living organism (e.g. parasitic plants, snails), describe their association with the commodity.

Indicate the impact caused by the pest in the country of origin.

If available provide any pest risk assessments or pest risk analysis already performed on the pest.

Additional information or evidence (optional).

Table 1

List of the EU regulated pests, present in the applicant country and known to be associated with the plant species or genus of the commodity

Pest species	Taxonomic information	Pest status in the country of origin	Pest‐free area(s) in the country of origin	Evidence and uncertainty on pest status and pest‐free area(s)	Regulatory status in the country of origin	Can the pest be associated with the commodity?	Evidence and uncertainty on association with the commodity	Pest for which risk mitigation measures may be required
			☐			☐		☐
			☐			☐		☐
			☐			☐		☐
			☐			☐		☐
			☐			☐		☐
			☐			☐		☐

Table 2

List of pests not regulated in the EU, present in the applicant country and known to be associated with the plant species or genus of the commodity

Pest species	Taxonomic information	Status in the EU (present/absent)	Pest‐ free area(s) in country of origin	Evidence and uncertainty on pest status and pest‐free area(s)	Regulatory status in applicant country	Can the pest be associated with the commodity?	Evidence and uncertainty on association with the commodity	Does the pest have impact in applicant country	Evidence and uncertainty on the level of impact	Pest of potential risk for EU
			☐			☐		☐		☐
			☐			☐		☐		☐
			☐			☐		☐		☐
			☐			☐		☐		☐
			☐			☐		☐		☐
			☐			☐		☐		☐
			☐			☐		☐		☐
			☐			☐		☐		☐

Description and assessment of the efficacy of risk mitigation measures

The purpose of this section is to evaluate if the risk mitigation measures described in the dossier are sufficient in order to achieve pest freedom of the consignment for each pest identified in Section 4 (Table 3) of this Guidance.

Table 3

Summary table of identified relevant pest species associated with the commodity and that may have a potential risk for the EU (selected from Tables 1 and 2)

Pest species associated with the commodity	Regulated pests in EU
	☐
	☐
	☐
	☐
	☐
	☐
	☐
	☐

The following questions need to be answered to evaluate the risk mitigation measures as indicated in Sections 5.1–5.5 of the TR:

Is the description of the risk mitigation measures of the commodity provided according to Section 5.1 and Appendix E of the TR?

Is the information on phytosanitary regulations and inspection systems relevant and complete for the crop of interest or associated regulated pests (Section 5.2 of the TR)?

Is the description of the surveillance and monitoring systems sufficiently detailed according to Section 5.3 of the TR?

Is the information on trade provided according to Section 5.4 of the TR?

Is the information on post‐harvest processes and transport provided according to Section 5.5 of the TR?

Uncertainty

Conclusions

Recommendations

As with all EFSA guidances, this Guidance should be regularly reviewed (EFSA Scientific Committee, 2015) to take into account the experiences of the Panel and the needs of those requesting and using the commodity risk assessments.

Glossary

A list of pests present in an area which may be associated with the specific commodity (FAO, 2018)

Control (of a pest) is defined in ISPM 5 (FAO 2018) as “Suppression, containment or eradication of a pest population” (FAO, 1995).

Control measures are measures that have a direct effect on pest abundance.

Supporting measures are organisational measures or procedures supporting the choice of appropriate RRO that do not directly affect pest abundance.

Any means that allows the entry or spread of a pest (FAO, 2018)

The process for determining whether a pest has or has not the characteristics of quarantine pest or those of a regulated non‐quarantine pest (FAO, 2018).

An area in which a specific pest is absent as demonstrated by scientific evidence and in which, where appropriate, this condition is being officially maintained.

Without pests (or specific pest) in numbers or quantities that can be detected by the application of phytosanitary procedures (ISPM 15 – FAO, 2013b).

Any legislation, regulation or official procedure having the purpose to prevent the introduction or spread of quarantine pests, or to limit the economic impact of regulated non‐quarantine pests (FAO, 2018)

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, 2018)

See definition of Risk Reduction Option

A measure acting on pest introduction and/or pest spread and/or the magnitude of the biological impact of the pest should the pest be present. A RRO may become a phytosanitary measure, action or procedure according to the decision of the risk manager. In this Guidance the term “Risk mitigation measure” is also used as synonym of Risk reduction option

Abbreviations

European and Mediterranean Plant Protection Organization

Food and Agriculture Organization

International Standard for Phytosanitary Measures

EFSA Panel on Plant Health

risk reduction option (synonym of Risk mitigation measure)

Standalone measure

Technical Report

This appendix lists all the potential pests that were excluded from the assessment (e.g. there is no evidence of impact).

Table 4

Example of a table that can be used to evaluate the efficacy of RROs for each pest/likelihood terms

Pest species	RRO1	RRO2	RRO3	RRO4	RRO5	RROn	Limiting factors	Pest‐freedom ratings
Pest 1	x	x	x					Likely
Pest 2			x	SA	x			Extremely likely
Pest n

Table 5

Likelihood classes and corresponding subjective probability ranges for the evaluation of probability to realise pest‐free consignments given the RROs acting on the pest under consideration

Probability term	Probability of one consignment being ‘pest free’	Explanation referring to consignments
Almost certain	99.95–100%	More than 9,995 of 10,000 consignments are on average pest free (Less than 5 of 10,000 are infested; on average at most one of every 2,000 consignments is infested)
Extremely likely	99.90–99.95%	Between 9,990 and 9,995 of 10,000 consignments are on average pest free (Between 5 and 10 of 10,000 are infested; on average at most one of every 1,000 consignments is infested).
Very likely	99.5–99.9%	Between 995 and 999 of 1,000 consignments are on average pest free (Between 1 and 5 of 1,000 are infested; on average at most one of every 200 consignments is infested)
Likely	99.0–99.5%	Between 990 and 995 of 1,000 consignments are on average pest free (Between 5 and 10 of 1,000 are infested; on average at most one of every 100 consignments is infested)
Moderate likely	95–99%	Between 95 and 99 of 100 consignments are on average pest free (Between 1 and 5 of 100 are infested; on average at most one of every 20 consignments is infested)
Unlikely	90–95%	Between 90 and 95 of 100 consignments are on average pest free (Between 5 and 10 of 100 are infested; on average at most one of every 10 consignments is infested)
Very unlikely	50–90%	Between 5 and 9 of 10 consignments are on average pest free (Between 1 and 5 of 10 are infested; on average at most one out of two consignments is infested)
Extremely unlikely	0–50%	Between 0 and 5 of 10 consignments are on average pest free (Between 5 and 10 of 10 are infested; on average at most every consignments is infested)

Table 6

Concluding table

Pest species	Likelihood of pest‐freedom	Justification	Key uncertainties
Pest 1			List key uncertainties that affect the final conclusion. If no key uncertainties, insert ‘none’
Pest 2
Pest n