WORLD TRADE
ORGANIZATIONG/SPS/GEN/233
2 March 2001
(01-1036)
Committee on Sanitary and Phytosanitary Measures Original:  English
BIOSECURITY RISK ANALYSIS POLICY STATEMENT
Information Paper from New Zealand
Introduction1. The Biosecurity Authority of the New Zealand Ministry of Agriculture and Forestry (MAF
Biosecurity) has finalized a new policy statement on conducting and applying import risk analyses,
and for the information of Members is submitting it to the Committee in this document.
2. The Ministry of Agriculture and Forestry (MAF) is New Zealand’s leading biosecurity agency,
and is responsible for approximately 95 per cent of the government’s biosecurity activities.  This
policy statement relates to MAF Biosecurity’s responsibilities for establishing scientifically-sound
import health standards that specify the conditions to be met before goods that might pose a risk to
New Zealand’s biosecurity may be imported.  Such import health standards must be based on a risk
analysis.
3. The policy statement that follows was developed to enhance consistency within MAF Biosecurity
in risk analysis, and to ensure that MAF Biosecurity operates according to its legal obligations
(especially the Biosecurity Act 1993 and the WTO "Agreement on the Application of Sanitary and
Phytosanitary Measures" or SPS Agreement).  It aims to be a clear statement to stakeholders
(domestic and international) of how MAF Biosecurity conducts and applies import risk analysis.
4. The risk analysis policy statement was develope d by officials within MAF Biosecurity, and before
being finalized was subject to extensive consultation with other biosecurity agencies, interestedparties (stakeholder groups) and counterpart agencies in other countries.
BIOSECURITY AUTHORITY POLICY STATEMENT ON CONDUCTING IMPORT
RISK ANALYSES AND APPLYING THEM IN THE DEVELOPMENT
OF IMPORT HEALTH STANDARDS
I. PURPOSE AND SCOPE
1.1 Purpose
This policy statement sets out the principles to which the Biosecurity Authority (MAF
Biosecurity) will adhere when conducting risk analyses and applying them to effectively manage risks
associated with the importation of "risk goods".
This policy principally covers the science-based assessment of risks ("risk analysis") and the
development and issuing of import health standards under the Biosecurity Act 1993.G/SPS/GEN/233
Page 2
1.2 Background
One of MAF Biosecurity’s principal functions is protecting New Zealand’s biosecurity and
biodiversity by administering part III of the Biosecurity Act 1993, which deals with the "effective
management of risks associated with the importation of risk goods" (s 16).
"Risk goods" are defined in s 2 of the act as:
any organism, organic material, or other thing, or substance, that (by reason of its nature,
origin, or other relevant factors) it is reasonable to suspect constitutes, harbours, or
contains an organism that may:
(a) cause unwanted harm to natural and physical resources or human health in New
Zealand; or
(b) interfere with the diagnosis, management, or treatment, in New Zealand, of pests or
unwanted organisms.
1.3 Risk analysis
Risk analysis provides the best means of ensuring that chief technical officers (CTOs), or
those acting under their delegated authority, fulfil their legal obligations under section 22 of the
Biosecurity Act when developing import health standards.
Risk analysis is a management tool that incorpor ates scientific methods to enable regulators to
gather and assess information and data in a thorough, consistent, logical and transparent way.  It
ensures that:
• organisms that may cause unwanted harm are identified;
• the likelihood of these organisms being introduced into New Zealand and the nature
and possible effect on people, the environment and the economy is assessed;
• appropriate biosecurity measures to effectively manage the risks posed by these
organisms are developed,  and
• the results, conclusions and recommendations arising from the analysis are effectively
communicated amongst interested parties.
Risk analysis also allows regulators to make the best use of available resources.
MAF Biosecurity is committed to developing a high level of expertise in risk analysis, and
consistently using risk analysis in the development of import health standards.
1.4 MAF Biosecurity’s accountabilities
[This section will be completed when the memorandums of understanding with other departments
are finalised]
1.5 Related documents
MAF Biosecurity Authority will develop import health standards under the Biosecurity Act:
• taking into account the risk analysis techniques developed by the world organisation
for animal health or Office International des Epizooties (OIE), and those developedG/SPS/GEN/233
Page 3
under the auspices of the Interim Commission on Phytosanitary Measures (ICPM)
operating within the framework of the International Plant Protection Convention
(IPPC) (see Appendix A);
• in accordance with the Biosecurity Counc il policy statement on interdepartmental
consultation on risk analyses and import health standards under section 22 of the
Biosecurity Act 1993 (17 December 1998);
• in accordance with the MAF Biosecurity Authority policy statement on consultation
(29 February 2000);
• in accordance with the Protocol on harmonization of quarantine administrative
procedures  (1988) to the Australia New Zealand Closer Economic Relations Trade
Agreement.
Within MAF Biosecurity the Animal Biosecurity, Forest Biosecurity and Plants Biosecurity groups
will develop and document their procedures for conducting risk analyses in accordance with this
policy.
II. IMPORT RISK ANALYSIS
2.1 Use of risk analysis
All import health standards prepared by MAF Biosecurity under part III of the Biosecurity
Act will be based on a risk analysis, which may assess a commodity or a pest/pathway combination.
MAF Biosecurity may use the risk analyses of other parties, including other countries or
relevant international organisations.  However, before doing this MAF Biosecurity will carefully
evaluate the risk analysis and modify it, if necessary, for New Zealand circumstances.
2.2 Terminology used in risk analysis
MAF Biosecurity risk analyses will use relevant international terminology:  that of the OIE
when dealing with animal health or zoonoses1, and that of the IPPC when dealing with phytosanitary
matters.2  Each risk analysis will contain a glossary of the terms used which have a different meaning
in different risk analysis lexicons.
2.3 Key elements in risk analyses
Section 22(5) of the Biosecurity Act sets out the elements that must be considered when an
import health standard (IHS) is developed.  Because all MAF IHSs are to be based on a risk analysis,
the obligation to have regard to certain matters is set out here.  Under this policy statement, MAF risk
analysts must ensure these matters are properly considered when risks are assessed and any sanitary or
phytosanitary measures recommended.
                                                     
1 The Office International des Epizooties International animal health code, mammals, birds and bees
(2000) defines "Risk analysis" as "The process composed of hazard identification, risk assessment, risk
management and risk communication" (terms which are themselves defined).
2 The International Standard for Phytosanitary Measures number 5 ( Glossary of phytosanitary terms ,
1999) defines "Pest risk analysis" as "The process of evaluating biological or other scientific and economicevidence to determine whether a pest should be regulated and the strength of any phytosanitary measures to betaken against it".G/SPS/GEN/233
Page 4
Section 22(5) of the act states:
(5) When making a recommendation to the Director-General in accordance with
this section, the chief technical officer must have regard to the following
matters:
(a) The likelihood that goods of the kind or description to be specified in the
import health standard may bring organisms into New Zealand;
(b) The nature and possible effect on people, the New Zealand environment, and
the New Zealand economy of any organisms that goods of the kind or
description specified in the import health standard may bring into New
Zealand;
(c) New Zealand's international obligations;
(d) Such other matters as the chief technical officer considers relevant to the
purpose of this Part.
The SPS Agreement and related WTO jurisprudence also set out what is required in a risk
analysis.  A risk analysis will:
• identify the organisms whose entry, establishment or spread New Zealand wishes to
prevent;
• identify for those organisms the associated potential biological, economic and
environmental consequences of entry, establishment or spread;
• evaluate the likelihood of the entry, establishment and spread of those organisms, and
the associated potential biological, economic and environmental consequences3;
• evaluate how the sanitary or phytosanitary measures that might be applied would
affect the likelihood of the entry, establishment or spread of those organisms.4
The requirements of both the Biosecurity Act and the SPS Agreement are reflected in sections 2.4-2.8
of this policy statement.
2.4 How things are to be considered
The act requires a decision-maker to "have regard to" the matters listed in s 22(5).  This
means that they must take the criteria into account and consider them when making a decision.  It is
up to the decision-maker to decide how much weight to give each consideration, so long as the
ultimate decision is not unreasonable or irrational.
For instance, there is a procedural obligation in the Biosecurity Act to consider possible
effects on social, cultural and aesthetic conditions that affect or are affected by components of the
                                                     
3 It is not sufficient for a risk analysis to conclude that there is a "possibility" of entry, establishment or
spread of an organism (with associated potential cons equences); a valid risk analysis must evaluate the
likelihood (i.e. probability).  The evaluation of likelihood can be expressed either quantitatively or qualitatively,and the risk evaluated must be an ascertainable risk rather than a theoretical uncertainty.
4 To facilitate the possible development of import health standards, any sanitary or phytosanitary
measures recommended shall be justified in the risk analysis and not be more trade restrictive than required,taking into account technical and economic feasibility.G/SPS/GEN/233
Page 5
broad definition of "environment".  The act allows, but does not require, importation decisions to be
made on the basis of such considerations.
MAF risk analysts will document how the statutory criteria were taken into account for each
risk analysis.
2.5 Organisms and the likelihood of introduction
The analysis may be of the risks posed by an organism or a number of organisms associated
with the importation of risk goods.  All organisms that are being considered must be listed in the risk
analysis.
2.6 Effects on people, the economy and environment
Risk analysts must consider the potential effects on people, the economy or environment of
organisms that may be introduced as a consequence of importing risk goods.  The potential effects of
importing the risk goods themselves (such as economic effects on domestic producers) cannot beconsidered in a biosecurity risk analysis.
2.6.1 People
A risk analysis for a commodity that may harbour zoonotic organisms cannot be completed
until the risks associated with such organisms are addressed.  In such cases risk analysts will develop
and apply risk analyses in cooperation with other agencies, particularly the Ministry of Health.
2.6.2 Economy
Risk analysts must consider economic effects that could arise from the introduction,
establishment or spread of organisms, including:
• the potential damage in terms of loss of production or sales in the event of the entry,
establishment or spread of a pest or disease;  and
• the costs of control or eradication in New Zealand;
and should consider the relative cost-effectiveness of alternative approaches to limiting risks.
The economic analysis of possible effects on the New Zealand economy need extend only as
far as is necessary for the risk analyst to reasonably establish appropriate conditions for the
importation of risk goods.  It does not necessarily need to extend to a precise quantification of every
potential effect on the economy.  If similar risks have previously been assessed in a risk analysis or in
the development of an import health standard, such an analysis need be repeated only if newinformation has come to light or if relevant circumstances have changed.
2.6.3 Environment
Under the Biosecurity Act the New Zealand "environment" is defined as:
Environment includes:(a) ecosystems and their constituent parts, including people and their communities;
(b) all natural and physical resources;G/SPS/GEN/233
Page 6
(c) amenity values;  and
(d) the aesthetic, cultural, economic, and social conditions that affect or are affected by
any matter referred to in paragraphs (a) to (c) of this definition.
2.7 International obligations
In common with other jurisdictions, New Zealand is a party to a multitude of international
agreements.  As a party to a treaty, New Zealand is obliged to comply with the relevant treaty
provisions and, where necessary, give full effect to them in its domestic law.  Risk analysts should
have regard to these obligations when conducting a risk analysis and recommending sanitary or
phytosanitary measures.
International agreements of treaty status to which New Zealand is a party and which are
relevant to part III of the Biosecurity Act include:
• the General Agreement on Tariffs and Trade 1994;
• the Agreement on the Application of Sanitary and Phytosanitary Measures (1994);
• the Convention on Biological Diversity (1992);
• the Australia New Zealand Closer Economic Relations Trade Agreement (1983);
• the International Plant Protection Convention (1952).
There are other relevant international agreements to which New Zealand is a party, but which are not
of treaty status and thus do not create any legal obligations unless they are incorporated in other,treaty-status international instruments.  These include:
• The Rio Declaration on Environment and Development (1992).
2.8 Consideration of other matters
In recommending sanitary or phytosanitary measures, a risk analyst can also consider any
other matters that are relevant to the purpose of part III of the Biosecurity Act:  if they relate to the
"effective management of risks associated with the importation of risk goods" (s 16).
This could include the possible disease impacts or effects on the environment of the risk
goods themselves, if they were an organism (e.g. a pathogen imported for diagnostic work);  as these
cannot be considered under paragraphs (a) and (b) of s 22(5).
The nature and possible effect on the New Zealand environment of new organisms for which
approval to import for release is given under the Hazardous Substances and New Organisms Act 1996will not be considered by MAF.  That assessment is the responsibility of the Environmental Risk
Management Authority (ERMA New Zealand).
2.9 Dealing with uncertainty or lack of knowledge
Uncertainty results from both variation inherent in biological systems and from lack of
information.  MAF Biosecurity will incorporate a level of precaution in its import risk analyses to
account for uncertainty, for instance when making a professional judgement on whether available
information is sufficient, when making assumptions or selecting parameters for quantitative risk
analyses, and when recommending risk manageme nt decisions based on a risk analysis.  What
constitutes sufficient scientific evidence will need to be decided on a case-by-case basis depending on
the degree of uncertainty and the severity of potential harm.G/SPS/GEN/233
Page 7
Where biosecurity risk management measures are adopted in situations where there is not
sufficient scientific evidence necessary for a comprehensive analysis of risks, MAF Biosecurity
Authority will take appropriate steps to seek the additional information necessary for a more objective
assessment of risk and review the measure accordingly within a reasonable period of time.
2.10 Process for conducting risk analyses
When carrying out import risk analyses MAF Biosecurity will:
• invite the participation of other departments whose biosecurity responsibilities might
be affected, as outlined in the Biosecurity Council policy statement on
interdepartmental consultation on risk analyses and import health standards undersection 22 of the Biosecurity Act 1993.
• ensure risk analyses are reviewed within MAF, prior to being peer-reviewed by
appropriately-qualified experts outside MAF.  Peer reviewers will be given specific
terms of reference for their critique.  Each critique will be, in turn, reviewed and,
where appropriate, incorporated into the analysis.  If suggestions  arising from the
critique are not adopted the rationale for doing this must be documented.
• undertake consultation in accordance with the MAF Biosecurity Authority policy
statement on consultation .
• prepare an analysis of all submissions and make this available to all those who made
submissions.
• publish the subsequent decision of a chief technical officer to issue, or not issue as the
case may be, standard(s) based on the risk analysis.
2.11 Consultation
Consultation is an integral part of the risk management process.  MAF Biosecurity recognizes
that consultation is an iterative and collaborative pr ocess involving a two-way dialogue from the very
start of the risk management process.  Every reas onable opportunity will be extended to stakeholders
to involve them directly in the process through an appropriate forum or medium.
MAF Biosecurity undertakes to consider with an open mind all concerns raised and to provide
timely feedback.  To ensure that a meaningful dialogue is established all parties should acknowledge
that, while they have a right to propose an alternat ive view, they also have an obligation to provide
reasoned argument.
2.12 Work programmes
Each group in MAF Biosecurity carrying out risk  analyses will develop in advance an annual
work programme of risk analyses which will be discussed with consultation committees, andpublished.G/SPS/GEN/233
Page 8
III. CONSIDERATIONS WHEN DEVELOPING IMPORT HEALTH STANDARDS
UNDER S 22 OF THE BIOSECURITY ACT
3.1 Background
Under s 22 of the Biosecurity Act 1993, the Di rector-General of MAF may issue an import
health standard (IHS) specifying the requirements for the importation of risk goods.  This authority is
delegated to MAF Biosecurity Authority chief technical officers (CTOs).
Import health standards are issued following the recommendation of a CTO.  Within MAF the
authority to make such recommendations is delegated to those national managers and national
advisers within the Animal Biosecurity, Forest Biosecurity and Plants Biosecurity groups whose
duties include the development of IHSs.  (The Biosecurity Policy Coordination group maintainscurrent schedules of delegations.)
3.2 Standards to be based on a risk analysis
Under this policy the domestic and international legal obligations relating to developing an
IHS are set out in sections 2.4-2.8, as they must be considered by risk analysts.
The development of an IHS is a separate process from a risk analysis, but the sanitary or
phytosanitary measures applied in an IHS must be based on those recommended in a risk analysis
approved by the CTO.  "Based on" means that there must be a rational relationship between the riskanalysis and the IHS developed;  any IHS must  be reasonably supported by a risk analysis.
If there is a difference between the recommended measures in the risk analysis and those
finally adopted in an IHS, the reasons justifying the differences must be detailed in a bridging
document.  The person recommending that an IHS be issued under section 22(5) of the BiosecurityAct is responsible for checking that the IHS meets the obligations in that section of the act (as
discussed in sections 2.4-2.8 of this policy statement).
Provided the sanitary or phytosanitary measures contained in an IHS are based on a risk
analysis no further consultation is required before the IHS is issued.  (However, every government
department with biosecurity responsibilities must still be notified as required under section 22(8) of
the Biosecurity Act.)  If different measures are used then a round of stakeholder consultation must beundertaken followed by a review of submissions as set out in MAF Biosecurity’s consultation policy.G/SPS/GEN/233
Page 9
APPENDIX A:  RISK ANALYSIS TECHNIQUES DEVELOPED BY RELEVANT
INTERNATIONAL ORGANIZATIONS
Under the SPS Agreement, international standards, guidelines and recommendations
developed by "relevant international organisations" are defined in annex A, paragraph 3 as:
• "for animal health and zoonoses, the standards, guidelines and recommendations
developed under the auspices of the International Office of Epizootics;
• for plant health, the international standards, guidelines and recommendations
developed under the auspices of the Secretariat of the International Plant ProtectionConvention in cooperation with regional  organizations operating within the
framework of the International Plant Protection Convention."
The relevant guidelines for risk analysis are:
• contained in the current edition of the OIE International animal health code,
mammals, birds and bees .  In the ninth edition (2000), this is chapters 1.3.1 and 1.3.2;
pp 21-28.
• IPPC (1996) Guidelines for pest risk analysis .  International Standards for
Phytosanitary Measures; ISPM Publication No. 2.
__________