NATIONAL STANDARDS FOR PHYTO SANITARY MEASURES  
 
 
 
 
NSPM : 11 
 
 
 
 
Pest risk analysis for quarantine pests including analysis of ecological  
risk and living modified organisms  
2013  
 
 
 
 
 
(This standard is approved by (the NPPO and) the Quarantine Committee of  Nepal, chaired by the 
secretary of the Ministry of Agriculture Development on 1st December 2013 and, is submitted by National 
Plant Quarantine Program to the National Notification Authority to be notified to the WTO member states)  
 1 
 Table of Contents  
1. Introduction  ................................ ................................ ................................ ................................ ................  1 
1.1 Scope  ................................ ................................ ................................ ................................ ...................  1 
1.2 References  ................................ ................................ ................................ ................................ ..........  1 
1.3 Definitions  ................................ ................................ ................................ ................................ ............  1 
1.4 Outline of requirements  ................................ ................................ ................................ .....................  2 
2. Background  ................................ ................................ ................................ ................................ ................  2 
3. Requirements  ................................ ................................ ................................ ................................ ............  4 
4.  Three stages PRA for quarantine pests:  ................................ ................................ ..............................  4 
4.1 Initiation  ................................ ................................ ................................ ................................ ................  4 
4.2 Risk assessment  ................................ ................................ ................................ ................................ . 4 
4.3 Risk management: ................................ ................................ ................................ ..............................  4 
PRA Stage -I ................................ ................................ ................................ ................................ ..................  4 
4.1.1 Initiation Stage  ................................ ................................ ................................ .............................  4 
Conclusion of Stage -1................................ ................................ ................................ ................................ .. 7 
Stage II  ................................ ................................ ................................ ................................ ..............................  7 
4.2 Pest Risk Assessment  ................................ ................................ ................................ .......................  7 
4.2.1 Pest categorization  ................................ ................................ ................................ ......................  7 
Identity of the Pest  ................................ ................................ ................................ ................................ .. 8 
Presence or absence of the Pest in PRA area  ................................ ................................ ..........................  8 
Regulatory status  ................................ ................................ ................................ ................................ ..... 8 
Potential for establishment and spread in PRA area  ................................ ................................ ...............  9 
Potential for economic consequences in PRA area  ................................ ................................ .................  9 
4.2.2 Conclusion of pest cat egorization  ................................ ................................ .............................  9 
4.2.3 Assessment of the probability of introduction and spread  ................................ ....................  9 
4.2.4 Probability of entry of a pest  ................................ ................................ ................................ .... 10 
4.2.3 Probability of establishment  ................................ ................................ ................................ ..... 12 
4.2.4 Probability of spread after establishment  ................................ ................................ ..............  13 
4.2.4 Conclusion on the probability of introduction and spread  ................................ ...................  14 
4.2.5 Conclusion regarding endangered areas  ................................ ................................ ..............  15 
4.2.6 Assessment of potential economic consequences  ................................ ..............................  15 2 
 4.2.7 Analysis of economic consequences  ................................ ................................ .....................  16 
4.2.8 Analytical techniques  ................................ ................................ ................................ ................  17 
4.2.9 Conclusion of the assessment of economic consequences  ................................ ...............  17 
4.2.10 Economic consequences at endangered area  ................................ ................................ ... 17 
4. 2.11 Degree of uncertainty  ................................ ................................ ................................ ............  17 
4.2.12 Conclusion of pest risk assessment  ................................ ................................ .....................  17 
Stage III  ................................ ................................ ................................ ................................ .........................  18 
4.3 Pest Risk Management  ................................ ................................ ................................ ....................  18 
4.3.1 Level of risk  ................................ ................................ ................................ ................................  18 
4.3.2 Monitoring and review of phytosanitary measures  ................................ ...............................  23 
5. Documentation of Pest Risk Analysis  ................................ ................................ ................................ .. 23 
Annex - 1: Comments on the s cope of the IPPC:  ................................ ................................ ...................  24 
Annex -2: Determining potential for a living modified organism to be a pest  ................................ ...... 26 
Annex -2.1: Information requi red on LMO include  ................................ ................................ .................  28 
Annex -3: Pest Risk Analyses of Carnation and Gerbera   (an example of PRA done in Nepal;  for 
reference only ). ................................ ................................ ................................ ................................ ............  29 
 
Table 4: Global disease, Nepal list, Potential quarantine pest (PQP) of carnation  ..........................  31 
 
 1 
  1. Introduction   
1.1 Scope  
This Standard on Pest risk analysis (PRA) is developed as a guidan ce document for assessing 
the economic risks from potential quarantine pest including the risk from living modified 
organisms to plants and plant products . Subsequently, it directs to evaluate the risk management 
measures, identifying a justifiable and pra ctical  option  to achieve the required degree of safety in 
plants and plant products. PRA is needed in designing appropriate level of pest risk management 
approach  in the country.  The PRA methodology adopted is also applicable to carry out PRA for 
the fore st plants, wild flora, including the analysis of risks to the environment and biological 
diversity  (see Annex 1) . NSPM preparation based on guidelines and recommendations developed 
within the framework of the IPPC. This standard also adopted the principles , recommendations 
and format of ISPM to achieve international harmonization of phytosanitary measures with the 
aim to facilitate trade.  
1.2 References  
CBD 1992  Convention on Biological Diversity  Montreal, CBD     
IPPC  1997  International Plant Protection Con vention Rome, IPPC, FAO.   
ISPM 2 1995  Guidelines for pest risk analysis  Rome, IPPC, FAO  [Published  1996] 
[Revised ; now ISPM 2: 2007]  
ISPM 4  1995  Requirements for the establishment of pest free areas  Rome, IPPC, FAO  
[Published  1996]  
ISPM 5 Glossary of ph ytosanitary terms, Rome, IPPC, FAO  
ISPM 8 1998 Determination  of pest status in an area Ro me, IPPC, FAO   
WTO 1994 Agreement on the Application of Sanitary and Phytosanitary Measures 
Geneva, World  Trade Organization  
ISPM 11 2004 Pest  risk analysis for quara ntine pests including analysis of environmental 
risks and living modified organisms . 
 NPQP 2006 : Generic Pest Risk Analysis of Citrus, Hariharhar B hawan Pulchwoke  
1.3 Definitions   
The definitions of phytosanitary terms used  in the text are from Glossary of  Phytosanitory 
terms (ISPM 5) unless specified below with *marks  
Endangered Area:    An area where ecological factors favor the establishment of a pest 
whose presence in the area will result in economically important loss  2 
 * Local environmental condition :   the agro ecological situation of the area in relation to 
which a PRA is conducted  
Entry:   Movement of a pest into an area where it is not yet present or present but no 
widely distributed and being officially controlled  
Establishment:  The perpetuation, for t he foreseeable future, of a pest within an area 
after entry.  
*Introduction : Entry of a pest resulting in its establishment.  
 Entry potential Area :   Probability of entry  :  An officially defined country, part of a 
country or all or parts of several count ries [FAO, 1990;revised FAO, 1995; CEPM, 1999; 
based on the World Trade Organization Agreement on the Application of Sanitary and 
Phytosanitary Measures]  
* NSPM:  National Standard for Phytosanitary Measure   developed to suit the local 
condition to safegua rd the plant life and health.   
NPPO:  Official service established by a government to discharge the functions specified 
by the IPPC [FAO, 1990; formerly Plant Protection Organization (National)]  
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]  
 1.4 Outline of requirements  
This National standard for Phytosanitary Measures ( NSPM ) on PRA  is, to identify pests 
and/ pathways of quarantine value and analyze the  potential  risk, in specified  endangered  
areas and identify where possible the risk management options  for plants and plant 
product s based  on the  assessment  of  the potential phytosanitary risk to cult ivated and 
wild plant and plant /s products from LMOS with genetic modification (gene, new gene 
sequence that regulates other genes or gene product and results in new trait and 
characteristic) and to identify ris k mitigation measures.  The PRA follows a process defined 
by the three stages as given below ;  
 
 
 
 
 
(Fig -1): Three stages Of PRA  
2. Background  
The Plant Protection Act, (PPA) 2007,  supports to facilitate  the agro-forest trade by appropriate 
phytosanitary application & reduce the risks arising from the entry, establishm ent or spread of Risk 
management  Initiation 
stage  
 Risk 
assessment 
stage  3 
 exotic pests. As per the prerogative of the PPA, PRA is essential to decide as to whether a 
particular commodity could be permitted entry or not in the country depending on t he risks 
involved in its introduction.  It is to be noted that Standards in themselves are not regulatory 
instruments, but come into force once the countries establish requirements within their national 
legislation.    
 
National Plant Protection Organizatio n (NPPO) is designated official contact point to maintain 
Coordination among the different  relevant institutions , to carry  out s urveillance of standing crops, 
forest plants and plant products in storage & in transit for pest attack,  & infestation  managemen t 
and issuance of Phytosanitary Certification for exporting plants & plant products . It is also 
responsible for developing , and enforce ment of relevant Phytosanitary  measures. However, 
depending upon the intensity  of economic damage from the pest , a bilate ral negotiation between 
the National Plant Protection Organizations (NPPOs) of the importing and exporting countries can 
be arranged and as per the need the PRA should be initiated. While defining phytosanitary  
management options it is necessary to take no te of the principle of equivalence . Some of the 
globally agreed phytosanitary  management options such as cold disinfestations treatments, 
chemical disinfestations treatments, irradiation, Pest free area, systems approaches, or 
combinations of the above can  be considered where feasible  without detailed management option 
analysis. NSPM , should take into account the risks /benefits that are likely to accrue from pest 
and introduct ion of the planting material. In view of the wide climatic range and agro ecologi cal 
variation and likely presence of many different pests, having different geographic distributions and 
host ranges, importing countries may require  information on PRA on specific pests  and by  
commodity and NPPO Nepal should be well prepared on this line .  
 
In addition to the above, initiation of Pest risk analysis should also consider factors, such as 
availability of trained personnel, efficacious detection techniques , capacity  and skill of the 
inspectors,  treatments at the point of entry quarantine, kn owledge about the life cycle of the pest, 
existence of races and strains, world distribution, modes of transmission, factors favoring 
establishment and spread of pests/ availability of safeguards, and adequacy of the survey and 
surveillance program in gene ral in local condition  ( see Annex  3 for ref. only) . 4 
  3. Requirements   
Information gathering is an essential element of all stages of PRA .  All contracting party 
shall have official contact point in particular to cooperate to the extent practicable and 
provide technical and biologica l information necessary for PRA  (IPPC Art  VIII1c).  
4.  Three stages PRA for quarantine pests:  
4.1 Initiation : This step involves mainly analysis work supporting pests and pathways 
identification in relation to the risk analysi s in identified area /s including  LMOs having 
characteristics to cause potential risk to plants and plant products  (See Annex 2) .  
 
4.2 Risk assessment : After identification of the pest and pathways, the second steps is 
to verify whether the pest under evaluation  falls under the category of quarantine 
importance or not. It is an important step in PRA as it evaluates the probability of pest 
entry, its establishment, and spread, causing potential economic and environmental 
damage. It is essential to analyze th ese factors critically for PRA in identified area.  
 
4.3 Risk management:  This steps supports to identify and evaluate the management 
options to reduce the ec onomic or environmental damage. While analyzing the 
management options  it should be based, on the f indings from step 2 and select  the options  
considering the efficacy, feasibility, impact and its applicability in local situation  based on 
technical justification . 
 
 If need occurs, LMOs should be   assessed   following all the three steps for phytosanitar y 
risk analysis in plants and plants material used as agricultural crops, food and fe ed, 
ornamental plants or agro –forests  products .  Similarly, biological control agents modified to 
improve their performance and pests modified to alter their pathogenic ch aracteristic and 
genetically modified organisms used as bio fertilizer should also be assessed for risk in 
plants and plants health in similar manner. If bio agents or organism with potential threat to 
human and animal health is found the n the NPPO  should notify the relevant authorities . 
 PRA Stage -I 
4.1.1 Initiation Stage  
Usually the PRA process is initiated when:  5 
  The  pathway with potential pest hazard  risk is identified  
 The pest  requiring phytosanitary measures is identified   
 When there is revision of  Phytosanitary related policies from government or its  
signatory body  
 When a contracting party desires  information on particular pests or pathways or 
phytosanitary measures  
In case of LMOs when the  NPPO feels that there is risk for plants for use in agricultural 
crops, for  food, feed, ornamental plants, or managed forest,  or used  as bio control agents, 
modified to improve the performance, and pest modified  to alter the their pathogenic 
characters then it should apply the PRA principle as in non LMOs and initiate the PRA .   
 4.1.1. 2 The pathway with potential pest hazard risk is identified:  
PRA should be carried out if the following condition occurs:  
 International trade initiated in a commodity not previously imported into the country 
(a plant or plant  product, including genetically altered plants) or a commodity from a 
new area or new country of origin.  
 New plant species are imported for scientific research purposes  
 New pathway other than commodity import is identified such as natural spread, 
packing m aterial, mail, garbage, passenger baggage, etc.  
 A list of pests likely to be associated with the pathway (e.g. carried by the 
commodity). It is preferable to prioritize the listing, based on expert judgment on 
pest distribution and types of pests and then decide if further PRA process is 
required or not.  
4.1.1.3 PRA initiated by the identification of a pest  
 Identify the pests their present mode of distribution and association with host plants, 
commodities and if the followings situation occurs then PRA may  be required : 
 an emergency arises after  an outbreak of a new pest within identified  PRA area  
 an emergency arises on interception of a new pest on an imported commodity  
 a new pest risk is identified by scientific research  
 a pest is introduced into an area  
 a pest is reported to be more damaging in an area other than in its area of origin  
 a request is made to import an organism  
 an organism is identified as a vector for other pests  6 
  an organism is genetically altered in a way which clearly identifies its poten tial as a 
plant pest  
4.1.1. 4 PRA initiated by the review or revision of a policy  
A new or revised PRA should be developed when the following situation occurs:  
 a national decision is taken to review phytosanitary regulations, requirements or 
operations  
 a proposal made by another country or by an international organization (RPPO, 
FAO) is reviewed  
 a new treatment or loss of a treatment system, a new process, or new information 
impacts on an earlier decision  
4.1.1. 5 Identification of PRA area  
 Primarily, the PR A area should be defined as precisely as possible  based on the scientific 
Information  essential  to justify the PRA . The relevant information supporting   identification 
of the area should be gathered in depth and the based on the findings of the analysis t he 
area should be identified. Information on PRA should be collected from the official contact 
point of the concern contracting parties . 
 Information  
Information to identify  the PRA area,  include, Pests and  their identification , present 
distribution status , associated  host plants, alternate host, and other commodities . For 
environmental risks, the variety of sources of information will generally be wider than 
traditionally used by NPPOs. Broader inputs may be required including impact 
assessments. For LMOs,  information required for a risk analysis may be included, however 
as mentioned earlier the matter should be discussed at NPPO meeting and take necessary 
action as per the decision    
4.1.1.6 Previous PRA  
If previously  done PRA exists , its status should be  checked from present perspective as 
circumstances  and information may have changed. The possibility of using a PRA from a 
similar pathway or pest, that may partly or entirely replace the  need for a new PRA, should 
also be investigated. A wider discussion among the PRA specialist and NPPO body should 
be held and decision should be taken regarding  whether pathways, pests or policies have 
already been subjected to the PRA process, either nationally or internationally be adopted 
or not .  7 
  Conclusion  of Stage  -1  
 At the end of this step, analyzed information on t he pests , pathways of concern required 
for PRA area should be gathered and based on the analysis result decision for next step 
should be taken . For LMOs at the end of Stage 1 NPPO may decide whether t he LMO  
connected organism is  a potential pest and needs to be assessed further in Stage 2 or if it 
is not a potential pest then it needs no further analysis.  
 
Stage II  
 4.2 Pest  Risk Assessment  
PRA should be judged against the principles of necessity, mini mal impact, transparency, 
equivalence, risk analysis, managed risk and non -discrimination as set out in ISPM No. 1 : 
Principles of plant quarantine as related to international trade (FAO, 1995) . The process 
for pest risk assessment is broadly  divided into t hree steps and in most cases these steps 
will be applied in following sequences.  
 4.2.1  Pest  categorization  
 Primarily t his process is to identify whether the pest concern meets the criteria to be a 
quarantine pest or not and based on this decision PRA is  made.  The categorization is 
done considering the following points:  
 Assessment  of the probability of introduction and spread  and economic impact from it .   
 Assessment of potential economic consequences (including environmental/social  
impacts)  for LMOs PRA , it is assumed that the LMO once it is assessed as a potential 
quarantine pest due to new or altered characteristics or properties resulting from the 
genetic modification the Pest Risk Assessment should be carried out on a case -by-
case basis.  
 Identify pe st/s requiring the PRA and discard the others associated with the pathways. 
After completing this process if the pest/s is found to be of a quarantine value then 
further action for risk assessment should be continued.  
 It must be noted that, the evaluation  of a pathway associated with a commodity, a 
number of individual PRAs may be necessary for the various pests potentially 
associated with the pathway.  8 
 4.2.1.1 Elements of categorization  
The following elements should be considered  while categorization  of a quarantine pest  is 
done:  
 Identity of the pest  
 Presence or absence in the PRA area  
 Regulatory status  
 Potential for establishment and spread in PRA area  
 Potential for economic consequences (including environmental consequences) in 
the PRA area  
Identity of t he Pest :  
The identity of the pest should be clearly defined to ensure that the assessment is being 
performed on a distinct organism, and that biological information used in the assessment is 
relevant to the organism in question and is internationally reco gnized. If this is not possible 
because the causal agent of particular symptoms has not yet been fully identified, then 
technical support from the international taxonomic organization should be sought.  
The taxonomic unit for the pest is generally at specie s level. The use of a higher or lower 
taxonomic level should be supported by scientific rationale . In the case of levels below the 
species, this should include evidence demonstrating that factors such as differences in 
virulence, host range or vector relat ionships that are significant enough to affect 
phytosanitary status.  
In cases where a vector is involved, the vector may also be considered a pest to the extent 
that it is associated with the causal organism and is required for transmission of the pest.  
In the case of LMOs, information regarding characteristics of the recipient or parent 
organism, the donor organism, the genetic construct the gene or transgenic vector and the 
nature of the genetic modification  needs to be looked at. 
 
Presence or absence of  the Pest in PRA area  
The pest should be absent from all or a defined part of the PRA area. Same principle 
applies in case of LMO of phytosanitary concern.  
 
Regulatory status  
If the pest is present but not widely distributed in the PRA area, it should be un der official 
control or expected to be under official contr ol in the near future.  (Refer ISPM No. 5 
Glossary of phytosanitary terms, Supplement No. 1 on official control, in particular Section 9 
 5.7. In the case of LMOs, official control should relate to the  phytosanitary measures 
applied because of the pest nature of the LMO ) 
 
Potential for establishment and spread in PRA area  
Empirical Evidence should be available to support the conclusion that the pest could 
become established or spread in the PRA area. Th e PRA area should have 
ecological/climatic conditions including those in protected conditions suitable for the 
establishment and spread of the pest and where relevant, host species (or near relatives) ; 
alternate hosts and vectors should be present in the P RA area.  
For LMOs :( Refer  Annex -3) 
Potential for economic consequences in PRA area  
Assessment should be done in such a way that it clearly indicates that the pest is likely to 
have an unacceptable economic impact (including environmental impact) in the P RA area. 
(Refer Glossary of phytosanitary terms, Supplement No. 2: Guidelines on the 
understanding of potential economic importance and related terms .) 
4.2.2 Conclusion of pest categorization  
 After analyzing the information on above criteria and if  observ ed that the pest has the 
potential to be a quarantine pest, the PRA process should continue. If a pest does not fulfill 
all of the criteria for a quarantine pest, the PRA process for that pest may be stopped.  If 
sufficient information is not available and  uncertainties’ continues then PRA should be 
continued.  
4.2.3 Assessment  of the probability of introduction and spread  
Pest introduction means both entry and establishment. Assessing the probability of 
introduction is an important step  in PRA and require s an analysis of each of the pathways 
from its origin to its new PRA area  and its establishment. In a PRA initiated by a specific 
pathway (usually an imported commodity), the probability of pest entry is evaluated for the 
pathway in question. The probabili ties for pest entry with other pathways need to be 
investigated correspondingly.  
 
For risk analyses that have been initiated for a specific pest, with no particular commodity 
or pathway under consideration, the potential of all probable pathways should be  
considered. The assessment of probability of spread is based primarily on biological 
considerations similar to those for entry and establishment.  10 
 With respect to a plant being assessed as a pest, a place where the plant can grow in the 
PRA area  need to be  assed. In the case of plants to be imported, the concepts of entry, 
establishment and spread have to be considered differently. Plants for planting that are 
imported will enter and then be maintained in an intended habitat, probably in substantial 
numbers  and for an indeterminate period. The risk arises because of the probability that 
the plant may spread from the intended habitat to unintended habitats within the PRA area, 
and then establish in that habitat. The risk arises because of the probability that  the plant 
may escape or be diverted from the intended use to an unintended habitat and establish 
there.  
Assessing the probability of introduction of an LMO requires an analysis of both intentional 
and unintentional pathways of introduction, and intended use.  
4.2.4 Probability  of entry of a pest  
The probability of entry of a pest depends on the pathways from the exporting country to 
the destination, and the frequency and quantity of pests associated with them. The higher 
the number of pathways, the great er the probability of the pest entering the PRA area is 
more. Documented pathways for the pest to enter new areas should be noted. Potential 
pathways, which may not currently exist, should be assessed. Pest interception data may 
provide evidence of the abi lity of a pest to be associated with a pathway and to survive in 
transport or storage. In the case of plants to be imported, the plants will enter and an 
assessment of probability of entry will not be required.  
  4.2.4.1  Identification of pathways for a P RA initiated by a pest  
All relevant pathways should be assessed. They can be identified principally in relation to 
the geographical distribution and host range of the pest. Consignments of plants and plant 
products moving in international trade are the pr incipal pathways of concern. Existing 
patterns of such trade will, to a substantial extent, determine which pathways are relevant. 
Other pathways such as other types of commodities, packing materials, persons, baggage, 
mail, conveyances and the exchange of  scientific material should be considered where 
appropriate. Entry by natural means should also be assessed, as natural spread is likely to 
reduce the effectiveness of phytosanitary measures.  For LMOs, all relevant pathways of 
introduction should be consi dered (intentional and unintentional  
4.2.4.2 Probability  of pest being associated with pathway at origin  
The probability of the pest being associated, spatially or temporally, with the pathway at 
origin should be estimated. Factors to consider are : 11 
  Preval ence of the pest in the source area  
 Occurrence of the pest in a life stage that would be associated with commodities, 
containers, or conveyances  
 Volume and frequency of movement along the pathway  
 Pest management, cultural and commercial procedures appli ed at the place of 
origin (application of plant protection products, handling, culling, roguing, grading).  
4.2.4.3 Probability of survival during transport or storage  
Factors to consider are : 
 Conditions of transport and duration of the life cycle of the pe st in relation to time in 
transport and storage  
 Vulnerability of the life stages during transport or storage  
 Prevalence of pest likely to be associated with a consignment  
 Commercial procedures (e.g. refrigeration) applied to consignments in the country 
of origin,  
4.2.4.4 Probability  of pest surviving existing pest management procedures  
Existing pest management procedures including phytosanitary procedures applied to 
consignments against other pests from origin to end use should be evaluated for 
effectiv eness against the pest in question. The probability that the pest will go undetected 
during inspection or survive other existing phytosanitary procedures should be estimated.  
4.2.4.5  Probability of transfer to a suitable host  
Factors to be considered ar e: 
 dispersal mechanisms, including vectors to allow movement from the pathway to a 
suitable host  
 whether the imported commodity is to be sent to a few or many destination points 
in the PRA area  
 proximity of entry, transit and destination points to suitab le hosts  
 time of year at which import takes place  
 intended use of the commodity (e.g. for planting, processing and consumption) 
risks from by -products and waste  
It is to be remember ed that there is a much higher probability of introduction (e.g. planting ) 
than others (e.g. processing). The probability associated with any growth, processing, or 
disposal of the commodity in the vicinity of suitable hosts should also be considered.  12 
  For LMOs, the probability of gene flow and gene transfer should be consider ed, when 
there is characteristic of phytosanitary concern that may be transferred  
 4.2.3 Probability of establishment  
 This is one of the important steps in PRA. Thus reliable biological information (life cycle, 
host range, epidemiology, survival etc.) sh ould be obtained from the areas where the pest 
currently occurs. The situation in the PRA area can then be compared with that in the 
areas where it currently occurs (taking account also of protec ted environments such as 
glass -or greenhouses) and expert jud gment used to assess the probability of 
establishment comparable  pests need to  be looked at .  
Factors to consider are : 
 Environmental suitability and availability, quantity and distribution of hosts in the 
PRA   
 Potential for adaptation of the pest  
 Reprodu ctive strategy of the pest  
 Method of pest survival  
 Cultural practices and control measures  
In considering probability of establishment, it should be noted that a transient pest (see 
ISPM 8: 1998) may not be able to establish in the PRA area (e.g. because  of unsuitable 
climatic conditions) but could still have unacceptable economic consequences (see IPPC 
Article VII.3). In the case of plants to be imported, the assessment of the probability of 
establishment concerns the unintended habitats. For LMOs, the s urvival capacity without 
human intervention should also be considered : 
 Availability of suitable hosts, alternate hosts and vectors in the PRA area  
 Hosts and alternate hosts availability and wide distribution, within geographic 
proximity to allow the pest t o complete its life cycle,   
 Whether a vector, if needed for dispersal of the pest, is already present in the PRA 
area or likely to be introduced  
 Whether another vector species occurs  
4.2.3 .1 Assess suitability of environment  
 All a biotic  factors affects  the biological activities of the pests, hosts and vectors. So these these 
factors should be critically analyzed.   13 
  Suitability of climate, soil, pest and host competition for the development of the pest, its 
host its vector, and their ability to survive p eriods of climatic stress and complete life 
cycles,  
 Whether the interaction between these organisms in the area of origin is maintained in the 
PRA area  is to the benefit or detriment of the pest  
 The probability of establishment in a protected environmen t, (e.g. in glasshouses,) should 
also be considered.  Where applicable climatic modeling systems may be used to 
compare climatic data on the known distribution of a pest with that in the PRA area.  
 Cultural practices and control measures  
 Practices employe d during the cultivation/production of the host crops  in the origin  should 
be compared with such practices in the PRA area.  It may influence its ability to establish.  
 The availability (or lack) of suitable methods for eradication should also be considere d 
where applicable . 
 
For LMOs, it may also be appropriate to consider specific cultural, control or management 
practices.  
 
Pest management programs  or natural enemies  present already  in the PRA area which 
reduce the probability of establishment may be con sidered. Pests for which control is not 
feasible should be considered to present a greater risk than those for which treatment is 
easily accomplished.  
4.2.3.2 Other  characteristics of the pest affecting the probability of establishment  
 Reproductive strat egy of the pests and method of pest survival  Characteristics, 
which enable the pest to reproduce effectively in the new environment, such as  
parthenogenesis/self crossing, duration of the  life cycle, number of generations per 
year, resting stage etc., sho uld be identified and analyze .  
 Genetic adaptability : Whether the species is polymorphic and the degree to which 
the pest has demonstrated the ability to adapt to conditions like those in the PRA 
area should be considered : 
4.2.4 Probability  of spread after  establishment  
 A pest with a high potential for spread may also have a high potential for 
establishment, and possibilities for its successful containment and/or eradication 
are more limited.  14 
  To estimate the   probability of spread of the pest, reliable bi ological information should be 
obtained from areas where the pest currently occurs. The situation in the PRA area can 
then be carefully compared with that in the areas where the pest currently occurs and 
expert judgment used to assess the probability of sp read.  
 Factors to consider are:  
 suitability of the natural and/or managed environment for natural spread of the pest  
 presence of natural barriers  
 the potential for movement with commodities or conveyances  
 intended use of the commodity  
 potential vector s of the pest in the PRA area  
 Potential  natural enemies of the pest in the PRA area.  
 In the case of plants to be imported, the assessment of spread concerns , spread 
from the intended habitat or the intended use to an unintended habitat, where the 
pest ma y establish. Further spread may then occur to other unintended habitats. 
The information on probability of spread is used to estimate how rapidly a pest’s 
potential economic importance may be expressed within the PRA area. This also 
has significance if the  pest is liable to enter and establish in an area of low potential 
economic importance and then spread to an area of high potential economic 
importance. In addition it may be important in the risk management stage when 
considering the feasibility of contai nment or eradication of an introduced pest.  
Certain pests may not cause injurious effects on plants immediately after they establish, 
and in particular may only spread after a certain time. In assessing the probability of 
spread , this should be considered , based on evidence of such behavior .  
4.2.4 Conclusion  on the probability of introduction and spread  
The overall probability of introduction should be expressed in terms of: 
 suitability of the area,  
 its environmental conditions   
 Existing  phytosanitary m easures.  
Inferences should be based on appropriate quantitative or qualitative data, along with the 
methods used for analysis. The probability of introduction may be expressed as a 
comparison with that obtained from PRAs on other pests.  15 
 4.2.5 Conclusion r egarding endangered areas  
The part of the PRA area where ecological factors favors the establishment of the pest 
should be identified in order to define the endangered area. This may be the whole of the 
PRA area or a part of the area . 
4.2.6 Assessment  of potential economic consequences  
Wherever appropriate, quantitative data that will provide monetary values should be 
obtained  to assess the effects of the pest Risk.  Qualitative data may also be used.  
Involvement of an Agriculture economist for loss assess ment is required.  However, i n 
many instances, detailed analysis of the estimated economic consequences is not 
necessary if there is sufficient evidence or it is widely agreed that the introduction of a pest 
will have unacceptable economic consequences (in cluding environmental consequences). 
In such cases, risk assessment will primarily focus on the probability of introduction and 
spread. It will, however, be necessary to examine economic factors in greater detail when 
the level of economic consequences is in question, or when the level of economic 
consequences is needed to evaluate the strength of measures used for risk management 
or in assessing the cost -benefit of exclusion or control . 
4.2.6.1 Pest  effects   
In order to estimate the potential economic impo rtance of the pest, information should be 
obtained from areas where the pest occurs naturally or has been introduced  lately . This 
information should be compared with the situation in the PRA area. Case histories 
concerning comparable pests can be considere d.  
The basic method for estimating the potential economic importance of pests includes : 
 Pests affecting uncultivated/unmanaged plants weeds and/or invasive plants and 
pests affecting plants through effects on other organisms.  
 Plants to be imported for pl anting, the long -term consequences for the intended 
habitat may be included in the assessment. Planting may affect further use or have 
a harmful effect on the intended habitat.  
 Environmental effects and consequences considered  should result from effects o n 
plants. Such effects, however, on plants may be less significant than the effects 
and/or consequences on other organisms or systems. For example, a minor weed 
may be significantly allergic for humans or minor plant pathos gen may produce 
toxins that seri ously affect livestock . 
 16 
 Direct  pest effects  
For identification and characterization of the direct effects the followings  points should  be 
considered : 
 Known or potential host plants (in the field, under protected cultivation, or in the wild)  
 Types, amount  and frequency of damage  
 Crop losses, in yield and quality  
 Biotic factors (e.g. adaptability and virulence of the pest) affecting damage and losses  
 A biotic factors (e.g. climate) affecting damage and losses  
 Rate of spread and rate of reproduction  
 Control measures (including existing measures), their efficacy and cost and effect on 
existing production practices  
 
Indirect  pest effects  
 Effects on domestic markets, including in particular effects on export market access  
 Changes to producer costs or input  demands, including control costs  
 Environmental and other undesired effects of control measures  
 capacity to act as a vector for other pests  
 Social  and other effects (e.g. tourism).  
 Effects on human and animal health (e.g. toxicity allergen icity, water tables, 
tourism , recreational uses, animal grazing, hunting ) 
4.2.7 Analysis of economic consequences  
In practice, economic consequences should be expressed with time, and may concern one 
year, several years or an indeterminate period. The total economic co nsequences over 
more than one year can be expressed as net present value of annual economic 
consequences, and an appropriate discount rate selected to calculate net present value. 
Appropriate analysis may be used to estimate potential economic consequences  over the 
period of time when a pest is spreading in the PRA area. In addition, many of the factors or 
effects considered above could be expected to change over time, with the consequent 
effects of potential economic consequences. In such instances, e xpert  judgment and 
estimations will be required.  
4.2.7.1 Analysis of commercial consequences  
As determined above, most of the direct effects of a pest and some of the indirect effects 
will be of a commercial nature, or have consequences for an identified mark et. These 17 
 effects, which may be positive  or negative, should be identified and quantified.  Especially 
the consideration of the following  may be  useful.   
 Effect of pest -induced changes to producer profits that result from changes in 
production costs,  yiel ds or prices  
 Effect of pest -induced changes in quantities demanded or prices paid for 
commodities. This could include quality changes in products and/or Quarantine -
related trade restrictions resulting from a pest introduction  
4.2.8 Analytical  techniques  
There are analytical techniques which can be used in consultation with experts in 
economics to make a more detailed analysis of the potential economic effects of a 
quarantine pest. These should incorporate all of the effects that have been identified. 
Econ omic impact is described in ISPM 5 Supplement 2 (Guidelines on the understanding 
of potential economic importance and related terms including reference to environmental 
considerations  and also refer ISPM 11 and NSPM on PRA ) 
4.2.9 Conclusion of the assessm ent of economic consequences  
Wherever appropriate, the output of the assessment of economic consequences described 
in this step should be in terms of a monetary value.  However depending upon the 
availability of the information the economic consequences c an also be expressed 
qualitatively or using quantitative measures without monetary terms.  
4.2.10 Economic consequences at endangered area  
The part or whole of the PRA area where presence of quarantine pest will cause economic 
loss should be identified pro perly.  
4. 2.11 Degree of uncertainty  
 Mainly , because of unavailability of required science based information the estimation of 
the economic los ses and its consequences  may sometime need to be extrapolated using 
expert judgments , thus area of uncertainty  and   degree of uncertainties need to be 
carefully transparently documented. These estimates, with associated uncertainties, are 
utilized in the pest risk management stage of the PRA  
4.2.12 Conclusion of p est risk assessment    
After carrying out all above  steps of pest Risk assessment  based on the findings all  or 
some  of the categorized pests may be considered for pest risk management. A 
quantitative or qualitative estimate of the probability of introduction of a pest or pests, and 18 
 a corresponding quantita tive or qualitative estimate of economic consequences should be 
documented .  
 
Stage III 
4.3 Pest  Risk Management  
The conclusions from pest risk assessment should be used  to decide whether risk 
management is required or not.  The guiding principle for risk  management should be to 
manage risk to achieve the required degree of safety that can be justified and is feasible 
within the limits of available options and resources for the purpose.  The estimates, with 
associated uncertainties, should be utilized while  taking the decision for assessing the  
suitable pest risk management options.  
4.3.1 Level  of risk  
The principle of “managed risk” (ISPM 1:1993 , Principles  of plant quarantine as related to  
International  trade) states that: “Because some risk of introduc tion of a quarantine pest 
always exists, countries shall agree to a policy of risk management when formulating 
phytosanitary measures.” In implementing this principle, NPPO  should  discuss and   
decide what level of risk is acceptable in the context of a gricultural trade facilitation.  
Technical  information required to make decisions in the pest risk management process will 
be based on the information collected during the preceding stages of PRA  especially on 
reasons  for initiating the process of estimation o f the probability of introduction to the PRA 
area and evaluation of potential economic consequences.  
4.3.1 .2 Acceptability  of risk  
Overall risk is determined by the examination of the outputs of the assessments of the 
probability of introduction and the e conomic impact. If the risk is found to be unacceptable, 
then the firs t step in risk management is identifying  possible phytosanitary measures that  
will reduce the risk to,  or below an  acceptable level. Measures are not justified if the risk is 
already acc eptable or must be accepted because it is not manageable (as may be the 
case with natural spread).  
4.3.1.3 Identification  and selection of appropriate risk management options  
Appropriate measures should be chosen based on their effectiveness in reducing t he 
probability of introduction of the pest. The choice should be based on phytosanitary  
principles of ISPM 1:1993:  19 
  Phytosanitary measures shown to be cost -effective and feasible.   
The benefit from the use of phytosanitary measures is that the pest will n ot be introduced 
and there will not be any potential economic consequences. The cost -benefit analysis for 
each of the minimum measures found to provide acceptable security may be estimated. 
Those measures with an acceptable benefit -to-cost ratio should be considered the 
Principle  of “minimal impact”. Measures should not be more trade restrictive than 
necessary. Measures should be applied to the minimum area necessary for the effective 
protection of the endangered area.  
 Reasses sment of previous requirements  
No additional measures should be imposed if existing measures are effect ive based on the 
Principle of “equivalence”.   If different phytosanitary measures with the same effect are 
identified, they should be accepted as alternatives.   If the pest under con sideration is 
established in the PRA area but of limited distribution and under official control, the 
phytosanitary measures in relation to import should not be more stringent than those 
applied within the PRA area. Likewise, phytosanitary measures should not discriminate 
between exporting countries of the same phytosanitary status . 
 Principle of non -discrimination  and the concept of official control also apply to pests 
affecting uncultivated/unmanaged plants weeds and/or invasive plants and pests 
affecting plants through effects on other organisms . 
If any of these become established in the PRA area and if official control is applied, then 
phytosanitary measures at import should not be more stringent than the official control 
measures.  
The major risk of intro duction of plant pests is with imported consignments of plants and 
plant products, but (especially for a PRA performed on a particular pest) it is necessary to 
consider the risk of introduction with other types of pathways (e.g. packing materials, 
conveyan ces, travellers and their luggage , and the natural spread of a pest).  
The measures listed below are examples of those that are most commonly applied to 
traded commodities . (e.g .)  
Measures:  
 applied to the consignment  
 applied to prevent or reduce origin al infestation in the crop  
 to ensure the area or place of production is free from the pest  
 concerning the prohibition of commodities  20 
 4.3.1.4 Options  for consignments  
Measures may include any combinations of the following : 
 inspection or testing for freedo m from a pest or to a specified pest tolerance ,  
sample size  should be adequate to give an acceptable probability of detecting the 
pest  
 prohibition of parts of the host a pre -entry or post -entry quarantine system  
 This system should be considered to be  the most intensive form of inspection or 
testing where suitable facilities and resources are available, and may be the only 
option for certain pests not detectable on entry specified treatment of the consignment 
such treatments are applied post -harvest an d could include chemical, thermal, 
irradiation or other physical methods restrictions  on end use, distribution and periods of 
entry of the commodity.  
 Measures may also be applied to restrict the import of consignments of pest  
For LMOs, as for other organi sms, information may have to be obtained  concerning the 
risk management  measures applied to the LMO in the country of export .These should be 
assessed  to determine if they are appropriate for the conditions in the PRA area and, if 
appropriate, the intended  use should be transparent.  
 For LMOs, measures may also include procedures for the provision of information on the 
phytosanitary  integrity of consignments (e.g. tracing systems, documentation systems, and 
identity preservation  systems).  
4.3.1 .5 Options preventing or reducing infestation in the crop  
Measure  may include:  
 treatment of the crop, field, or place of production  . 
 growing plants under specially protected conditions (glasshouse, isolation)  
 harvesting of plants at a certain age or a specified ti me of year  
 Production  in a certification scheme. An officially monitore d plant production 
scheme usually involves a number of carefully controlled generations, beginning 
with nuclear stock plants of high  health status. It may be specified that the plants 
be derived from plants within a limited number of generations . 
Measures may be applied to reduce the probability that LMOs (or genetic material from 
LMOs) that pose  a phytosanitary risk could be in other crops. These include  management 
systems  
 (e.g. buffe r zones,)   
 Management  of genetic characteristic and host preference.    21 
  control of reproductive ability (e.g. male sterility)  
 control of alternative hosts  
4.3.1.6 Options  ensuring that the area, place or site of production or crop is free from  pest . 
Measu res include  
 Pest Free area development and maintenance   
 pest-free production site  
 inspection of crop to confirm pest freedom  
4.3.1.7 Options for other types of pathways  
For many types of pathways, the measures considered above for plants and plant produc ts 
to detect the pest  in the consignment or to prevent infestation of the consignment  may also 
be used. For certain types of pathways, the following factors should be considered : 
 Natural spread of a pest includes movement of the pest by flight, wind disper sal, 
transport by vectors  such as insects or birds and natural migration. If the pest is 
entering the PRA area by  natural spread, or is likely to enter in the immediate future, 
phytosanitary measures may have  little effect.  
 
4.3.1.8 Control measures appli ed in the area of origin could be considered.  
 Containment  or eradication, supported by suppression and surveillance, in the PRA 
area after entry  of the pest could be considered.  
 Measures for human travellers and their baggage could include targeted inspe ctions, 
publicity and  fines or incentives. In a few cases, treatments may be possible.  
 Contaminated machinery or modes of transport (ships, trains, planes, road transport) 
could be subjected to cleaning or disinfestations  
 Options within the importing coun try  
Certain measures applied within the importing country may also be useful for 
consideration. For plants to be imported, where there is a high level of uncertainty 
regarding pest risk, it may be  decided not to take phytosanitary measures at import, but  
only to apply surveillance or other procedures after entry (e.g. by or under the supervision 
of the NPPO).  
 The potential for risk from LMO pests depends in part on the intended use. As for other 
organisms,  22 
  For LMOs, as with other pests, options within t he country also include the use of 
emergency measures  related to phytosanitary risks. Any emergency measures should 
be consistent with Article VII.6 of the  IPPC .  
 
If no satisfactory measure to reduce risk to an acceptable level can be found, the final 
option may be to prohibit importation  of the relevant commodities. This should be viewed 
as a measure of last resort and should be considered in light of the anticipated efficacy, 
especially in instances where the incentives for illegal import may be signifi cant.  
 
4.3.1 .9  Phytosanitary  certificates and other compliance measures  
Risk management includes the consideration of appropriate compliance procedures. The 
most important of these is export certification. The issuance of phytosanitary certificates 
provides official assurance that a consignment is “considered to be free from the 
quarantine pests specified by the importing contracting party and to conform to the current 
phytosanitary requirements of the importing contracting party.” It thus confirms that the 
specified risk management options have been followed. An additional declaration may be 
required to indicate that a particular measure has been carried out. Other compliance 
measures may be used subject to bilateral or multilateral agreemen t 
 Information  on phytosanitary certificates regarding LMOs (as with any other 
regulated articles) should only be related to phytosanitary measures ( See annex 3)  
4.3.1.10  Conclusion  of pest risk management  
The result of the pest risk management procedure will be either  that no measures are 
identified which are considered appropriate or the selection of one or more management 
options that have been found to lower the risk associated with the pest(s) to an acceptable 
level. These management options form the basis of phyto sanitary regulations or 
requirements.  
 
These management options form the basis of phytosanitary regulations or requirements.  It 
is to be remembered that t he application and maintenance of such regulations is subject to 
certain obligations in the case of c ontracting parties to the IPPC.  
 
 Phytosanitary measures taken in relation to environmental hazards should, as 
appropriate, be notified to relevant competent authorities responsible for national 
biodiversity policie s, strategies and action  plans .  23 
 4.3.2 Monitoring  and review of phytosanitary measures  
The information supporting the pest risk analysis should be periodically reviewed to ensure 
that any new information that becomes available does not invalidate the decision taken  on 
risk management.  
5. Docu mentation of Pest Risk Analysis   
The whole process from initiation to pest risk management should be sufficiently documented 
so that when a review or a dispute arises, the sources of information and rational used in 
reaching the management decision can be clearly demonstrated : 
 purpose for the PRA  
 pest, pest list, pathways, PRA area, endangered area  
 sources of information  
 categorized pest list  
 conclusions of risk assessment probability  
 consequences  
 risk management  
 options identified  
 options selected  
 
 
 24 
 Annex - 1: Comments on the scope of the IPPC : 
 
 a) On environmental  risks  
The full range of pests covered by the IPPC extends beyond pests directly affecting cultivated plants. The 
coverage of the IPPC definition of plant pests includes weeds and other species that have indirect effects  
on plants, and the Convention applies to the protection of wild flora. The scope of the IPPC also  extends to 
organisms which are pests because they are:  Directly  affect uncultivated/unmanaged plants  
Introduction of these pests may have few commercial consequences, and therefore they have been  less 
likely  to be evaluated, regulated and/or placed under official control. An example of this type of pest can 
be peach Aphid.  
In addition to pests that directly affect host plants,  there are those, like most weeds/invasive plants , which  
affect plants primarily by other processes such as competition.  
b) Pest  risk analysis for living modified organisms  
Phytosanitary risks that may be associated with a living modified organism are wit hin the scope of the 
International  Plant Protection Convention and should be considered using pest risk analysis to make 
decisions  regarding pest risk management.  The analysis of LMOs includes consideration of the following.   
Some LMOs may present a phyt osanitary risk and therefore warrant a PRA LMOs . However other will not 
present a phytosanitary risks beyond those posed by related non -LMOs and  therefore will not warrant a 
complete PRA. For examp le, modifications to change the physiological characteristi cs of a plant (e.g. 
ripening time, storage life) may not present any phytosanitary  risk. The pest risk that may be posed by an 
LMO is dependent on a combination of factors, including the characteristics of the donor and recipient 
organisms, the genetic alt eration , and the specific new trait or traits. Therefore, part of the 
supplementary text (see Annex 2) provides  guidance on how to determine if an LMO is a potential pest.  
PRA may constitute only a portion of the overall risk analysis for import and relea se of a LMO.  
 Some cases may  occur  requir ing  the assessment of risks to human or animal health, or to the 
environment , beyond that covered by the IPPC. This standard on ly relates to the assessment a 
management of phytosanitary risks. As with other organ isms or pathways assessed by an NPPO, LMOs 
may present other risks not falling within the scope of the IPPC. When an NPPO discovers  potential for 
risks that are not of phytosanitary concern it may be appropriate to notify  the relevant authorities.  
Phytosa nitary risks from LMOs may result from certain traits introduced into the organism, such  as those 
that increase the potential for establishment and spread, or from inserted gene  sequences that do not 
alter the pest characteristics of the organism but that  might act  independently of the organism or have 
unintended consequences. In cases of phytosanitary risks related to gene flow, the LMO is acting more as 25 
 a potential vector  or pathway for introduction of a genetic construct of phytosanitary concern rather  than 
as a pest in and of itself. Therefore, the term “pest” should be unde rstood to include the potential of an 
LMO to act as a vector or pathway for introduction of a gene presenting a potential phytosanitary risk. The 
risk analysis procedures of the IPP C are generally concerned with phenotypic characteristics  rather than 
genotypic characteristics. However, genotypic characteristics may need to be considered when assessing 
the phytosanitary risks of LMOs.  Potential phytosanitary risks that may be associa ted with LMOs could 
also be associated with non -LMOs. It may be useful to consider risks associated with LMOs in the context 
of risks posed by the non -modified recipient or parental organisms, or similar organisms, in the PRA  26 
 Annex -2: Determining potentia l for a living modified organism to be a pest  
 
This annex is relevant for living modified organisms only where there is potential for 
phytosanitary risks from the LMO associated with some characteristic or property related 
to the genetic modification. Oth er phytosanitary risks associated with the organism  should 
be assessed under other appropriate NSPMs / ISPM . The information requirements in 
determining th e potential for an LMO to be a pest  is same as mentioned in stage 2 of PRA. 
Potential  phytosanitary r isks for LMOs may include:  
 Changes in adaptive characteristics which may increase the potential for 
introduction or spread, for  example alterations  tolerance to adverse environmental 
conditions (e.g. drought, freezing, salinity)  
 reproductive biology  
 dispersal ability of pests  
 growth rate or vigour  
 host range  
 pest resistance  
 pesticide (including herbicide) resistance or tolerance  
 Adverse effects of gene flow or gene transfer including, for exampletransfer of 
pesticide or pest resistance genes to comp atible species  
 the potential to overcome existing reproductive and recombination barriers resulting 
in pest  risks  
 potential for hybridization with existing organisms or pathogens to result in  
pathogenicity or   increased pathogenicity.  
 
Adverse effect s on non -target organisms including , for example:  biological control 
agent or organism otherwise claimed  to be beneficial effects on other organisms, such as 
biological control agents, beneficial organisms, or soil fauna and micro  flora, nitrogen -fixing 
bacteria, that result in a phytosanitary impact (indirect effects) capacity to vector other 
pests negative direct or indirect effects of plant -produced pesticides on non -target 
organisms  beneficial to plants.  Genotypic and phenotypic instability including, f or example, 
reversi on of an organism intended as bio control agent to a virulent form.  
  
 27 
 Other injurious effects , e.g. 
Phytosanitary risks presented by new traits in organisms that do not normally pose 
phytosanitary risk  novel or enhanced capacity for v irus recombination, trans -encapsulation  
and synergy events related to the presence of virus sequences phytosanitary risks 
resulting from nucleic acid sequences (markers, promoters, terminators etc.) present in the 
insert.  
 
The potential phytosanitary risk s identified above can also be ass ociated with non -LMOs. 
The risk analysis procedures of the IPPC are generally concerned with phenoty pic 
characteristics rather than genotypic characteristics. However, genotypic characteristics  
may need to be considered wh en assessing the phytosanitary risks of LMOs. If there is no 
indication that new traits resulting from genetic modifications have phytosanitary risks, the 
LMO may require no further consideration.   It may be useful to consider potential risks in 
the conte xt of risks posed by the non -modified recipients or parental organisms, or similar 
organisms, in the PRA area.  
 
In cases of phytosanitary risks related to gene flow, the LMO is acting more as a potential 
vector or pathway  for introduction of a genetic con struct of phytosanitary conce rn rather 
than as a pest in and of itself. Therefore, the term “pest” should be understood to include 
the potential of an LMO to act as a vector  or pathway for introduction of a gene presenting 
a potential phytosanitary risk.  
 
Factors that may result in the need to subject a :  
LMO to Stage 2 of the PRA includ e: 
 of knowledge about a particular modification event  
 the credibility of information if it is an unfamiliar modification event  
 insufficient data on the behavior  of the LM O in environments similar to the PRA 
area  
 field experience, research trials or laboratory data  indicating that the LMO may 
pose  
 phytosanitary risks (see subsections a. to e. above)  where the  LMO expresses 
characteristics that  indicating the risk to pla nt and plant products  28 
  LMO being a pest where there are PRAs for similar organisms (including LMOs) or 
risk analyses carried out for other purposes that indicate a pest potential 
experience in other countries.  
 Factors that may lead to the conclusion that an  LMO is not a potential pest and/or 
requires no further  
 Consideration  to be done include  where the genetic modification in similar or 
related organisms has previously been assessed by the  NPPO (or other 
recognized experts or agencies) as having no phytosa nitary risk where  the LMO is 
to be confined in a reliable containment system and not be released evidence  from 
research trials that the LMO is unlikely to be a pest under the use proposed 
experience  in other countries.  
 
Annex -2.1: Information required on LMO  include  
Name, identity and taxonomic status of the LMO (including any relevant identifying codes) 
and the risk management measures applied to the LMO in the country of export  taxonomi c 
status, common name, point o collection or acquisition, and charact eristics of the donor 
organism  description of the nucleic acid or the modification introduced (including genetic 
construct) and the resulting genotypic and phenotypic characteristics of the LMO  details of 
the transformation process  appropriate detection an d identification methods and their 
specificity, sensitivity and reliability  intended use including intended containment . 
 
Quantity or volume of the LMO to be imported  (Information regarding pest status is an 
obligation under the IPPC (Article VIII.1c) faci litated by official contact points (Article 
VIII.2). A country may have obligations to provide information about LMOs under other 
international agreements such as the Cartagena Protocol on Biosafety to the Convention 
on Biological Diversity (2000; Cartagen a Protocol). The Cartagena Protocol has a Bio  
safety Clearing -house that may contain relevant information. Information on LMOs is 
sometimes commercially sensitive and applicable obligations with regard to release and 
handling of information should be obser ved. 
 29 
 Annex -3: Pest Risk Analyses of Carnation and Gerbera   (an example of PRA  
done in Nep al; for reference only ). 
 
The process of evaluating biological or other scientific and economic evidence to 
determine whether a pest should be regulated and the stren gth of any phytosanitary 
measures to be taken against it. This system aims to provide a framework in which the 
risks associated with the importation of plant commodities and the introduction of pests 
into new areas can be identified and assessed. It does n ot generate conclusions, but 
presents scientific information to aid the selection of appropriate measures for reducing 
risk and facilitating the movement of plants and plant products.  
This process is known as  pest risk analysis (PRA )   
 
PRA comprises three  stages:  
 
Stage 1. Initiation   
           - identifying the reason for the PRA and the pests of concern to the PRA area;  
 
Stage 2. Risk assessment  
- determining the likelihood of entry, establishment, spread and economic damage 
of an individual pest in ord er to determine whether it meets the criteria of a 
regulated pest;  
 
Stage 3. Risk management  
           - selecting the appropriate management options to reduce the risks identified in 
Stage 2.  
 
Users should be familiar with the International Standards for  Phytosanitary Measures 
(ISPMs)  published by the Food and Agriculture Organization of the United Nations (FAO)  
Phytosanitary regulation  
Official rule to prevent the introduction and or spread of the quarantine pest or to limit the 
economic impact limited n on quarantine pest, including establishment of the procedure 
for phytosanitary certification.  
The main purpose of PRA for the potential quarantine pest (PQP) is to check the 
introduction of such pest which might cause devastating effect to the crops if ent ered and 
hence to avoid the inevitable damage due to the consequence of the plant diseases or 
pest damages.  
In order to remain competitive in the international trade and commerce a comprehensive 
disease data base and PRA needs to be developed and brought out on priority especially 
for the banana export and import. Carnation and gerbera are an important cut flower 
which has great commercial and aesthetic value for export and import and would be 30 
 integral part of agro -economy. In this respect plant quarantine  has given terms of 
reference to perform Pest Risk Analysis (PRA) of Carnation and gerbera.  
 As per the TOR following work has been performed:  
 Carnation and Gerbera   Pest list have been prepared using the provided 
template:  
 A extensive review was done to c ollect pertinent data with consultation of major 
plant protection journals, proceedings, annual reports, pamphlets, booklets, 
CD-ROMs’ (Crop Protection Compendium, CPC 2007) etc from different 
National and private organizations of this country.  
 Prepared gl obal pest list (fungi, bacteria, virus, phytoplasma) known to occur 
on Carnation and Gerbera  using the pest data sheet format.  
 Crop Protection Compendium (CPC 2007) was used for Nepal pest list and 
global pest list preparation.  
 Prepared a national quaranti ne and regulated non -quarantine pest  (bacteria, 
fungi, virus,  phytoplasma) list for Carnation and Gerbera    
 Prepared global list of pest (bacteria, fungi, virus,viroid, phytoplasma) known to 
occur on Carnation and Gerbera   using pest data sheet format in formation using 
CABI, CD -ROM.  
 Pest Risk Analysis (PRA) on Carnation and Gerbera   have been completed 
using CABI, CD -ROM  
 Suggestions of preparing framework for annexes to be proposed plant 
quarantine regulation  
 Provided reports of Carnation and Gerbera   pest list and PRA to assist in 
compilation of reports  
Carnation  
Forty -eight pathogens (pests) have been recorded as a global pest of Carnation round 
the world wherever it has been grown. Out of 48 pathogens (pest), fungi were recorded 
thirty - seven,   bacteri a 4 and viruses were seven.  
There are eight pathogens (pest) recorded from Nepal (CPC 2007). Seven fungal 
diseases have been recorded from Nepal  (Table 1).  There was only one bacterium 
pathogen has been recorded from National reports, Proceedings and Annua l Reports. 
There are no viral diseases recorded in Nepal.  Hence, presently, a ll together eight 
diseases are reported in carnation in Nepal.  
 A list of 40 potential quarantine pest (PQP)/pathogens were identified for pest risk analysis 
(PRA) which has been  shown in (Table 1). This list is derived after subtracting the pests 
reported in Carnation  Nepal list + reported in CPC (2007) + reported in literatures for Nepal 
(hosts other than carnation from the global carnation  pests found in CPC (2007).There were 
30 fungi, three bacteria and seven viruses  identified for PRA.   31 
 Forty pathogen/pest list of was prepared according to its gravity of likelihood to entry, 
spread, risk assessment and risk management with additional declaration. The detail 
concerned columns  could be seen in Sheet 1 -48 and table 1, 2& 3  
Pest Risk Analysis of the potential quarantine pests of Carnation  indicated the following 
four diseases being quarantine pests in circumstances carnation material needs to import 
from other parts of the world to Nepal. Besides these, 12 pathogens (pest) required 
additional declaration and 8 (pest) pathogens does not requires additional declaration to 
import carnation in Nepal while sixteen pathogens have no detail information (Table 
2&3).There are 19 quarantine  pest (pathogens ) have been identified for Nepal and need 
additional declaration on import. Table 3  
A summary list of Global disease, Nepal list, Potential quarantine pest (PQP) of carnation 
has been presented in Table 4.  
Table 4: Global disease, Nepal l ist, Potential quarantine pest (PQP) of carnation  
Pest type  Global pest  Nepal list  Potential Quarantine Pest 
(PQP)  
Fungi  37 7 30 
Bacterium  4 1 3 
Viruses  7 - 7 
Total  48 8 40 
 
 
Gerbera  
Pest risk analysis (PRA) provide a framework in which the risks ass ociated with the 
importation of plant commodities and the introduction of pests into new areas can be 
identified and assessed. It does not generate conclusions, but presents scientific 
information to aid the selection of appropriate measures for reducing r isk and facilitating 
the movement of plants and plant products.  
The disease causing pest of gerbera is found to be 14 globally worldwide as global pest 
(pathogens) and six of them are reported in Nepal and eight pest (pathogens)  are 
considered as potenti al quarantine pest (PQP) for Nepal. Out of 14 global pest of gerbera 
12 were fungi, one bacteria and one virus observed globally in the world. Similarly in 
Nepal list 5 fungi and one virus was recorded while six fungi and one bacterium pest was 32 
 recorded as  potential quarantine pest (pathogen) for Nepal. There are two quarantine 
pest (pathogens) identified in case of gerbera.  
Conclusion  
Forty -eight pest (pathogens) pathogens have been recorded from different parts of world 
globally. Among them 37 were funga l, 7 viral , and 4 were bacterial pathogens. However, 
only 8 pathogens are found in Nepal responsible for carnation diseases and the rest 40 
were considered as potential quarantine pest for Nepal. PRA has been carried out for 
Potential Quarantine Pest.  
Similarly in case of Gerbera there are 14 global pest (pathogens) reported worldwide. Six 
of them are reported in Nepal and eight pests  (pathogens) are considered as potential 
quarantine pest (PQP) for Nepal.  
Adopting similar methodology PRA for Citrus, Lenti l and pest data base for some other 
commodities were prepared