nkl sp implementation guide 0912 us - croplife.org...2010, of the nagoya – kuala lumpur...

CropLife International/Global Industry Coalition

Implementation Guide

to the

NAGOYA – KUALA LUMPURSUPPLEMENTARY PROTOCOLON LIABILITY AND REDRESS TO THECARTAGENA PROTOCOL ON BIOSAFETY

April 2013

Table of Contents

Foreword .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Introduction.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

General Considerations .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Explanation of the Guide Format and Notations .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Implementation Guide .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Annex I: Determination of Damage (with alternative texts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Annex II: Response Measures (with alternative texts) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Compiled Example Text with Selected Alternatives.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

CropLife International/Global Industry Coalition SP Implementation Guide September 2012

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CropLife International is the global federation representing the research-based plant science industry that develops, manufacturesand sells products and services designed to improve the global production of food, feed, fibre and fuel in a sustainable way.As a global network, CropLife International acts as an ambassador for the plant science industry, encouraging understanding anddialogue whilst promoting sound science and agricultural technology in the context of sustainable agriculture and development.CropLife International represents a network of regional and national associations in 91 countries and is led by the major R&D-driven plant science companies such as BASF, Bayer CropScience, Dow AgroSciences, DuPont Pioneer, FMC, Monsanto,Sumitomo Chemical and Syngenta.

The Global Industry Coalition (GIC) for the Cartagena Protocol on Biosafety receives input and direction from trade associationsrepresenting thousands of companies from all over the world. Participants include associations representing and companiesengaged in a variety of industrial sectors such as plant science, seeds, agricultural biotechnology, food production, animalagriculture, human and animal health care, and the environment.

In our capacity as Co-chairs of the international negotiating process that culminated with the adoption on October 15th,2010, of the Nagoya – Kuala Lumpur Supplementary Protocol, it is a pleasure to acknowledge by means of the presentforeword the contribution made by CropLife International and the Global industry Coalition to the discussions and to thefinal outcome.

For more than eight years a working group comprised of Government representatives, members of the academic sector,industry representatives and Non-Governmental Organisations engaged together in a long dialogue in the context of theCartagena Protocol on Biosafety. As a result, rules and procedures in the field of liability and redress relating to livingmodified organisms were developed.

However, international negotiating processes often imply that the texts that finally achieve the consensus of all participantsare not as clearly drafted and as straightforward as one would wish. These instruments define terms in a way thatsometimes differ from their common use, they often include expressions that seem redundant or even contradictory to alayman, and they incorporate provisions that, without a clear understanding of the travaux préparatoires, would be verydifficult to read.

It is for that reason that we welcome the publication of this Guide which, in our view, constitutes a valuable tool forGovernments to better understand and consequently better apply at the domestic level the provisions of the SupplementaryProtocol. The authors have done an excellent job in making accessible to a broader public, in an orderly and friendlymanner, the provisions of the Supplementary Protocol and therefore promoting and facilitating the understanding of theTreaty for the benefit of the conservation and sustainable use of biological diversity around the world.

René Lefeber Jimena Nieto Co-chair Co-chair

Foreword

1 For more information on The Compact, see www.biodiversitycompact.org. 3


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The primary purpose of this Implementation Guide is to assist countries that do not have existing mechanisms toaddress damage to the conservation and sustainable use of biodiversity to develop a system for identifying responsibleoperators and requiring response measures in conformity with the Nagoya-Kuala Lumpur Supplementary Protocol(Supplementary Protocol) to the Cartagena Protocol on Biosafety (Protocol) under the Convention on BiologicalDiversity (Convention).

Every attempt has been made to retain as much as possible the exact language of the Supplementary Protocol.Changes have been made only where necessary to convert text for use as a domestic regulation. The SupplementaryProtocol itself, however, heavily relies on domestic law to fill in important definitions and provisions. Where domesticlaw in a country does not exist on the various points identified in the Supplementary Protocol or is inconsistent withthe Supplementary Protocol, this Guide provides examples of text that could be considered by the government inamending or creating domestic law. The sources of most of the content, which are specified in the explanations, are:(a) the European Union’s Directive 2004/35 of the European Parliament and of the Council on environmental liabilitywith regard to the prevention and remedying of environmental damage (ELD); or (b) The Compact: A ContractualMechanism for Response in the Event of Damage to Biological Diversity Caused by the Release of a Living ModifiedOrganism (Compact)1.

Introduction

1 For more information on The Compact, see www.biodiversitycompact.org.

Redress for damage to biodiversity:The Supplementary Protocol provides a framework,including key definitions, to be used by countries to put inplace systems at the national level to ensure that persons(operators) responsible for damage (an adverse effect on theconservation and sustainable use of biodiversity as definedin Supplementary Protocol, Art. 2, hereafter “damage”)caused by living modified organisms (LMOs) undertake orpay for response measures to address that damage.

The scope of the Supplementary Protocol is limited todamage caused by LMOs that find their origin in atransboundary movement. However, the same system can(and should, for reasons of implementing the “polluterpays” principle and to also ensure compliance with WTOobligations) also apply to damage caused by domesticactivities with LMOs.

To avoid a situation of non-compliance, a country thatbecomes Party to the Supplementary Protocol should havethe necessary legal measures and administrative systems inplace upon entry into force of the Supplementary Protocolfor that country.

The starting point for any country to implement theSupplementary Protocol is a detailed analysis of existingdomestic law. The following step-wise approach issuggested:

Countries should first examine their domestic laws todetermine whether sufficient domestic rules and proceduresalready exist to address potential damage to theenvironment or to biological diversity. If applicable rulesexist, they should be carefully analysed for compliance andconsistency with all aspects of the Supplementary Protocol.

• Does national legislation already provide for liability andresponse in the case of any damage to the environmentor biodiversity? A general instrument applying to damageto the environment or biodiversity (from any cause), andwhich provides for notification, assessment of damageand identification of those responsible for it, as well asgovernmental authority to order operators that causedamage to undertake appropriate response measures,would likely comply with the Supplementary Protocol.In addition, such an instrument has the added advantageof ensuring that those responsible for any damage to theenvironment or biodiversity must redress it, not only inthe case of biotechnology. This is more consistent withthe Convention and provides better protection for theenvironment.

• Where rules providing for redress for damage to theenvironment or biodiversity do not exist, are insufficient,or are contrary to the requirements of the SupplementaryProtocol, a comprehensive plan for amendment or

General Considerations

2 See Prof. Lucas Bergkamp, Liability and Redress: Existing Legal Solutions for Traditional Damage (January 2004).http://www.ecoconsult.ch/uploads/1144-CropLife_Handbook.pdf

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creation of new legal instruments should be developed.This includes review and consideration of numerousspecific areas left by the Supplementary Protocol todomestic law. A country’s ratification plan thereforeshould include systematic consideration of allreferences in the Supplementary Protocol to domesticlaw.

General Principles:In considering the relationship of the SupplementaryProtocol with domestic law and the applicability ofdomestic laws in implementing the SupplementaryProtocol, countries should apply general principles forprotecting the environment and biodiversity and establisha system for the fair, efficient and predictable resolutionof claims of damage. Considerations include:

• Protection of biodiversity as a “public good” by thestate.

• Science-based evidence and decisions.• Responsibility channeled to the “operator” who caused

the damage (the “polluter” pays).• Legal due process. • Independent unbiased decision-makers.• Recognition of existing jurisprudence or legislation:

Where there is developed jurisprudence and law, thereis no reason to change basic approaches to liabilityand redress in relation to a new, but thoroughlyassessed and regulated technology.

• Practical and fair application.• Social responsibility: Balance risks and benefits by

adequately protecting biodiversity while appropriatelyenabling the use of technology that contributes to foodand agricultural security.

Civil Liability:The Supplementary Protocol requires that its Partiesprovide in their domestic law for civil liability for materialor personal damage (also known as “traditional damages”)related to damage as defined in the SupplementaryProtocol. Since virtually every country in the world alreadyhas civil law covering traditional damages2, they cansimply apply existing law to meet this obligation asforeseen in Article 12.2(a).

Caveats:Transposing international frameworks into national law isa complex process. In the case of the SupplementaryProtocol, the process may appear even more complexbecause the Supplementary Protocol framework defers todomestic law in 18 instances. On the other hand, themany references to domestic law may be seen asfacilitating ratification and implementation because theyprovide flexibility for countries with different legalsystems.


63 See UNEP/CBD/BS/COP-MOP/1/15, Annex III (p. 73).

Compliance with the Cartagena Protocol onBiosafety:The Supplementary Protocol obviously builds on theProtocol and national biosafety legislation put in place toimplement the Protocol. Thus, compliance with theSupplementary Protocol follows and flows fromcompliance with the Protocol. This situation gives rise toa number of fundamental points that should be well-considered and addressed:

• If legally binding domestic biosafety legislation exists,it should be evaluated to determine the extent to whichit is consistent with the Protocol. For example,definitions in domestic legislation should be the sameas those found in the Protocol (the SupplementaryProtocol incorporates by reference all Protocoldefinitions). If definitions in domestic law differ fromthe Protocol or the Convention, inconsistencies,misunderstandings and misinterpretation will likelyresult.

• Other aspects of Protocol compliance should also beconsidered. For example, timeframes for proceduresshould be within stated Protocol limits; provisionsconsistent with the Protocol on the treatment ofconfidentiality should be incorporated; and informationrequirements and risk assessment should be consistentwith the Protocol requirements and annexes.

• The Implementation Toolkit developed as part ofcapacity building work under the Protocol provides auseful checklist to assess compliance with Protocolobligations3. Deficiencies or inconsistencies in nationalbiosafety legislation can be identified using thisToolkit. Any deviations should be addressed prior to oras part of the plan to implement and comply with theSupplementary Protocol.

• Once Protocol-compliant national biosafety legislationis in place, it should be placed on the BiosafetyClearing House along with a declaration pursuant toProtocol Article 14.4 that the domestic regulationapplies.

Relationship between Protocol andSupplementary Protocol Implementation:• If a law is already in place that is compliant with the

Protocol, it may be possible to implement theSupplementary Protocol through a separate regulation,order or decree pursuant to that law. If the biosafetylaw is not Protocol compliant, one may considermerging the two processes and addressing bothProtocol and Supplementary Protocol obligations andcompliance in a single instrument.

• This Guide provides explanations and example texts toimplement the Supplementary Protocol in a new stand-alone legal instrument. With slight modifications, thetexts also could be incorporated into existing biosafetylaw.

• Regardless of the approach that is chosen, it isimperative that all the related legal instruments areconsistent with the Protocol, the SupplementaryProtocol and each other, and that they do not redefineterms or overlap. The relationship between a new legalinstrument and those already in existence should beclear in the text and any provisions in previouslyexisting legislation that are being replaced should beexplicitly revoked.

Supplementary Protocol Text:The text of the Supplementary Protocol is set out in blue print and placed in text boxes in the Guide for ease of reference.Underlining has been added to highlight references to domestic law.

Example Text:• An example of possible text to implement the provisions of the Supplementary Protocol is provided. • For a limited number of provisions, two alternative examples are provided for countries to consider. Example Text is

presented in two colours. Blue print indicates that the text can be found in the Supplementary Protocol. • Any deletions or insertions suggested to implement the Supplementary Protocol at the national level are clearly marked

in red. • Throughout the Guide, capital letters have been used for defined terms (e.g., Living Modified Organism). These edits

are not marked as changes in the Example Text. • Curly brackets { } are used where information specific to a country needs to be inserted, i.e., the name of the country

or a reference to an existing domestic law. • Square brackets [ ] mark text that may be deleted depending on the existence of relevant domestic law.• The term “regulation” is used in these Guidelines but should be replaced by the relevant national term (e.g., law,

decree, order or other legal measure).

Explanation:Commentary and guidance concerning possible text to implement each relevant provision of the Supplementary Protocolare provided in italicised text following the Example Text.

Explanation of the Guide Format and Notations

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Reaffirming the precautionary approach contained inPrinciple 15 of the Rio Declaration on Environment andDevelopment,

Recognising the need to provide for appropriate responsemeasures where there is damage or sufficient likelihoodof damage, consistent with the Protocol,

Recalling Article 27 of the Protocol,

Have agreed as follows:

Hereby adopts the following:

Explanation: The Supplementary Protocol languageshould be replaced with preambular clauses appropriatefor this type of national legislation. Reference should bemade to the country’s status as a Party to the Protocoland Party to the Supplementary Protocol, taking dueregard for ensuring that legal measures andadministrative systems are in place prior to depositing aninstrument of ratification/accession. See IntroductoryNote for further explanation of the relationship betweenthe Protocol, the Supplementary Protocol and existingdomestic legislation.

Reference also should be made to existing nationalbiosafety laws, regulations, etc.

Example text:

Article 1 Objective

The objective of this Supplementary Protocol Regulationis to contribute to the conservation and sustainable useof Biological Diversity, taking also into account risks tohuman health, by providing international rules andprocedures in the field of liability and redress relating toLiving Modified Organisms in accordance with theSupplementary Protocol.

Explanation: It is necessary to convert theSupplementary Protocol language for domestic law tostate the objective of the Regulation.

Example text:

Regulation No. ___ (Liability and Redress relating toLiving Modified Organisms) 2012

Explanation: The title of the Regulation should appearwith relevant citations, numbering, date, etc.

Example text:

Whereas

The Parties to this Supplementary Protocol,

Being Parties to the Cartagena Protocol on Biosafety tothe Convention on Biological Diversity, hereinafterreferred to as “the Protocol”,

{name of country} is Party to the Cartagena Protocol onBiosafety to the Convention on Biological Diversityhereinafter referred to as the “Protocol” pursuant to {citenational legal measure related to ratification oraccession} and has ratified/acceded to the Nagoya-KualaLumpur Supplementary Protocol on Liability and Redressto the Cartagena Protocol on Biosafety, hereinafterreferred to as the “Supplementary Protocol” pursuant to{cite national legal measure related to ratification oraccession},

Recalling {e.g., Biosafety Law No. __ of 20__ andRegulation No. __ of 20__},

Taking into account Principle 13 of the Rio Declarationon Environment and Development,

Implementation Guide

NAGOYA – KUALA LUMPUR SUPPLEMENTARYPROTOCOL ON LIABILITY AND REDRESS TO THECARTAGENA PROTOCOL ON BIOSAFETY

The Parties to this Supplementary Protocol,

Being Parties to the Cartagena Protocol on Biosafetyto the Convention on Biological Diversity, hereinafterreferred to as “the Protocol”,

Taking into account Principle 13 of the RioDeclaration on Environment and Development,

Reaffirming the precautionary approach contained inPrinciple 15 of the Rio Declaration on Environmentand Development,

Recognising the need to provide for appropriateresponse measures where there is damage orsufficient likelihood of damage, consistent with theProtocol,

Recalling Article 27 of the Protocol,

Have agreed as follows:

Article 1 Objective

The objective of this Supplementary Protocol is tocontribute to the conservation and sustainable use ofbiological diversity, taking also into account risks tohuman health, by providing international rules andprocedures in the field of liability and redressrelating to living modified organisms.

Article 2 Use of terms

1. The terms used in Article 2 of the Convention onBiological Diversity, hereinafter referred to as “theConvention”, and Article 3 of the Protocol shallapply to this Supplementary Protocol.

(Article 2 Use of terms continued….)

Example text:

2. In addition, for the purposes of this SupplementaryProtocol:

a. “Conference of the Parties serving as the meetingof the Parties to the Protocol” means theConference of the Parties to the Convention servingas the meeting of the Parties to the Protocol;

k. “Damage” means an adverse effect on theconservation and sustainable use of BiologicalDiversity, taking also into account risks to humanhealth, that:

i. Is measurable or otherwise observable takinginto account, wherever available,scientifically-established Baselines recognisedor established by a Competent Authority underthis Regulation that takes into account anyother human induced variation and naturalvariation; and

ii. Is significant as set out in paragraph 23below;

Explanation: Supplementary Protocol Article 2.a. is notrelevant to domestic regulations so has not beenincluded in the Regulation.

To ensure consistency with the Supplementary Protocol,the definition of Damage is incorporated into theRegulation. Paragraph b.i. refers to Baselines“recognised” by the Competent Authority. In cases wherea Baseline already exists, it may be recognised. Wherethat is not yet the case, the Competent Authority mayestablish a Baseline as part of its work to identifyDamage, etc. Accordingly, the words “or established”have been added to the Supplementary Protocoldefinition.

Example text:


1. The following terms used in Article 2 of theConvention on Biological Diversity, hereinafter referred toas “the Convention”, and Article 3 of the Protocol shallapply to this Regulation and its annexes: SupplementaryProtocol.

a. “Convention” means the Convention on BiologicalDiversity;

b. “Protocol” means the Cartagena Protocol onBiosafety to the Convention on Biological Diversity;

c. “Supplementary Protocol” means the Nagoya-KualaLumpur Supplementary Protocol on Liability andRedress to the Cartagena Protocol on Biosafety;

d. "Biological Diversity" means the variability amongliving organisms from all sources including, interalia, terrestrial, marine and other aquaticecosystems and the ecological complexes of whichthey are part; this includes diversity within species,between species and of ecosystems;

e. "Habitat" means the place or type of site where anorganism or population naturally occurs;

f. "Ecosystem" means a dynamic complex of plant,animal and micro-organism communities and theirnon-living environment interacting as a functionalunit;

g. "Contained use" means any operation, undertakenwithin a facility, installation or other physicalstructure, which involves living modified organismsthat are controlled by specific measures thateffectively limit their contact with, and their impacton, the external environment;

h. "Living Modified Organism" means any livingorganism that possesses a novel combination ofgenetic material obtained through the use ofmodern biotechnology;

i. "Living Organism" means any biological entitycapable of transferring or replicating geneticmaterial, including sterile organisms, viruses andviroids;

j. "Modern Biotechnology" means the application of: i. In vitro nucleic acid techniques, including

recombinant deoxyribonucleic acid (DNA) anddirect injection of nucleic acid into cells ororganelles, or

ii. Fusion of cells beyond the taxonomic family,that overcome natural physiological reproductive orrecombination barriers and that are not techniquesused in traditional breeding and selection.

Explanation: For ease of reference and to assureconsistency, the key terms from the Convention andProtocol are incorporated into this text. Alternatively,reference could be made to domestic law if all therelevant Convention and Protocol terms are found thereinwithout change. It would be helpful to reorder the termsalphabetically in actual legislation.

2. In addition, for the purposes of thisSupplementary Protocol:a. “Conference of the Parties serving as the

meeting of the Parties to the Protocol” meansthe Conference of the Parties to the Conventionserving as the meeting of the Parties to theProtocol;

b. “Damage” means an adverse effect on theconservation and sustainable use of biologicaldiversity, taking also into account risks tohuman health, that:i. Is measurable or otherwise observable

taking into account, wherever available,scientifically-established baselinesrecognised by a competent authority thattakes into account any other humaninduced variation and natural variation;and


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Example text:

l) “Operator” means any person in direct or indirectcontrol of the Living Modified Organism [inaccordance with which could, as {citation toappropriate and as determined by domestic law}]. ,include, inter alia, the permit holder, person whoplaced the living modified organism on the market,developer, producer, notifier, exporter, importer,carrier or supplier;

Explanation: Article 2.2.c of the Supplementary Protocoldefers to domestic law and provides a non-exhaustive listof examples of persons who could be held responsible asthe “Operator”. If the term “operator” already is defined ina relevant existing national law, the text in square bracketsshould be retained and completed with a reference to thelaw. In cases where appropriate domestic law does notexist, the text in square brackets should be deleted.

In countries where the term is not defined or thedefinition is not appropriate for this context, “Operator”needs to be explicitly defined in the Regulation. Tooperationalize the “polluter pays principle,” the term“Operator” should focus on the person in direct orindirect control of the product or the activity that causedthe Damage (i.e., the person who in fact and legallycaused or should have prevented the Damage). Examplesof who might be an operator (i.e., the developer whocreated the LMO, the grower who planted it in aproscribed area, etc.) are not necessary or appropriate inthe regulation, as the “control” test will establish theidentity of the Operator.

d. “Response measures” means reasonable actions to:i. Prevent, minimise, contain, mitigate, or

otherwise avoid damage, as appropriate;ii. Restore biological diversity through actions to

be undertaken in the following order ofpreference:a. Restoration of biological diversity to the

condition that existed before the damageoccurred, or its nearest equivalent; andwhere the competent authority determinesthis is not possible;

b. Restoration by, inter alia, replacing theloss of biological diversity with othercomponents of biological diversity for thesame, or for another type of use either atthe same or, as appropriate, at analternative location.

c. “Operator” means any person in direct or indirectcontrol of the living modified organism whichcould, as appropriate and as determined bydomestic law, include, inter alia, the permitholder, person who placed the living modifiedorganism on the market, developer, producer,notifier, exporter, importer, carrier or supplier;


Example text (part i):

m. “Response Measures” means reasonable actions to:i. Prevent, minimise, contain, mitigate, or

otherwise avoid Damage, as appropriate;ii. Restore Biological Diversity through actions to

be undertaken in the following order ofpreference:a) Restoration of Biological Diversity to the

Baseline Ccondition that existed beforethe damage occurred, or its nearestequivalent; and where the CompetentAuthority determines this is not possible;

b) Restoration by, inter alia, replacing theloss of Biological Diversity with othercomponents of Biological Diversity for thesame, or for another type of use either atthe same or, as appropriate, at analternative location;

Explanation: The Supplementary Protocol definition of“Response Measures” is incorporated. Reference also ismade to the “Baseline Condition”, which has also beenincluded as a new defined term. The Baseline Conditionis an essential concept in the application of ResponseMeasures since the state of Biological Diversity to beachieved with the application of the Response Measureswill be determined by the specific circumstances of theDamage and the resulting effects on the viability andsustainability of the affected species and ecosystem, andthe Baseline is no longer the relevant end point in thatdetermination.

Example text (part ii):

n. “Competent Authority” for purposes of thisRegulation means {name of minister, agency oroffice};

Explanation: It is necessary to specify the office oragency that will make determinations and carry out theobligations of the Regulation for the government (e.g.,Ministry of Agriculture; National Agriculture Institute,etc.). Additional details about the Competent Authoritymay be placed in Article 15 below.

Example Text (part iii):

o. “Baseline” means the condition at the time of theDamage of the natural resources and services thatwould have existed had the Damage not occurred,estimated on the basis of the Best InformationAvailable;

p. “Baseline Condition” means the state of BiologicalDiversity that is the goal of the restoration plan forthe species or Ecosystem alleged to be Damagedand that represents the condition that existedbefore Damage occurred to that species orEcosystem, which is satisfied when:


Example text:

23. Damage is established only in the case of asignificant adverse effect:

a. A “significant” adverse effect is to be determined onthe basis of factors, such as:An effect is adverse if itis a qualitative or quantitative changes that:b. The extent of the adversely Negatively affects the

components of Biological Diversity; c. The reduction of Reduces the ability of

components of Biological Diversity to providegoods and services; or

d. The extent of any adverse Negatively affects onhuman health in the context of the Protocol.

b. An adverse effect is significant based upon theextent of the adverse effects in 2.a., above, and if itresults inThe long-term or permanent change, to beunderstood as change that will not be redressedthrough natural recovery within a reasonable periodof time.

Explanation: The Supplementary Protocol provides variousfactors that may be considered by Parties to determinewhen a change is both adverse and qualifies as“significant”. The text is revised to provide greater clarityabout these two distinct elements.

Example text:

Article 3 Scope1. This Regulation Supplementary Protocol applies toDamage resulting from authorised import or use of LivingModified Organisms intended for which find their origin ina transboundary movement. The living modified organismsreferred to are those:

a. Intended for dDirect use as food or feed, or forprocessing;

b. Destined for cContained use; andc. Intended for iIntentional introduction into the

environment.

2. With respect to intentional transboundary movements,this Supplementary Protocol applies to damage resulting

i. population dynamics data for the species allegedto be Damaged demonstrate that the species canmaintain itself on a long-term basis as a viablecomponent of the Ecosystem;

ii. the natural range of the species has beenincreased to a sustainable level;

iii. a sufficient Habitat exists to maintain thespecies on a long-term basis; or

iv. one or more other species in the affectedEcosystem related to or dependent upon thespecies alleged to be Damaged can maintainitself on a long-term basis as a viable componentof the Ecosystem;

Explanation: The term “Baseline” has been addedbecause it is essential to the assessment of potentialDamage. The Example Text is adapted from Article 2(14)of the ELD. The term “Baseline Condition” has beenadded because it is important in the determination ofappropriate and sufficient Response Measures. Theseterms, which are not defined in the SupplementaryProtocol, help clarify the determination and application ofResponse Measures.

Example text (part iv):

q. “Best Available Information” means the peer-reviewedor peer-reviewable information obtained through thegenerally accepted scientific methodology used in therelevant scientific community of endeavour (such asgenetics, ecology, microbiology, species populationdynamics, and social sciences), including suchinformation found on the Biosafety Clearing House ofthe Protocol. This methodology must consist of atestable hypothesis, existence and maintenance ofstandards controlling the technique’s operation, andan acceptable known or potential rate of error, andthe results must be repeatable. Best AvailableInformation must be used in the determination ofeach element of a claim for Response Measures.

Explanation: “Best Available Information” is a term usedin the ELD, however, it is not defined in that instrument.To increase clarity and predictability, in the Example Text,the ELD terminology is used and is defined based onlanguage from the Compact. Also incorporated in thisdefinition is the reference to the Biosafety Clearing Housefound in Article 5.3 of the Supplementary Protocol.

3. A “significant” adverse effect is to be determinedon the basis of factors, such as:a. The long-term or permanent change, to be

understood as change that will not beredressed through natural recovery within areasonable period of time;

b. The extent of the qualitative or quantitativechanges that adversely affect the componentsof biological diversity;

c. The reduction of the ability of components ofbiological diversity to provide goods andservices;

d. The extent of any adverse effects on humanhealth in the context of the Protocol.

Article 3 Scope

1. This Supplementary Protocol applies to damageresulting from living modified organisms whichfind their origin in a transboundary movement.The living modified organisms referred to arethose:a. Intended for direct use as food or feed, or for

processing;b. Destined for contained use;c. Intended for intentional introduction into the

environment.2. With respect to intentional transboundary

movements, this Supplementary Protocol appliesto damage resulting from any authorised use ofthe living modified organisms referred to inparagraph 1 above.

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(Article 3 Scope continued…)

Example text:

5. 4. This Regulation Supplementary Protocol applies toDamage that occursed in areas within the limits of thenational jurisdiction of {name of country}Parties.

Explanation: Domestic regulations may only apply toDamage that occurs within national jurisdiction.

Explanation: The example texts provided in this Guideensure that liability and redress provisions apply equallyto Damage caused by domestic activities and foreignactivities, thus avoiding any WTO implications orviolations. No further text is required in relation toSupplementary Protocol paragraphs 6-7.

Example text:

Article 4 Causation

1. A causal link shall be established by the CompetentAuthority between the Damage and the Living ModifiedOrganism in question.

Alternative A, where causation is established bydomestic law:

[2. Causation shall be established in accordance with{citation to appropriate domestic law}].

Alternative B, where domestic law does not provide clearguidance on causation:

[2. The Competent Authority shall determine that:a. General causation exists, i.e. the change can

generally be caused by the Living ModifiedOrganism in question;

b. Specific causation exists, i.e. the Damage would nothave occurred but for the release of the LivingModified Organism in question, and results directlyfrom the phenotypic or genotypic modification of

from any authorised use of the living modified organismsreferred to in paragraph 1 above.

Explanation: When Damage occurs, it is irrelevantwhether it was caused by domestic or foreign operators.Accordingly, the liability and redress provisions of theRegulation should apply equally to Damage caused bydomestic activities and foreign activities, thus avoidingany WTO implications or violations. The proposed textcovers all approved activities, whether domestic orinvolving a transboundary movement.


Example text:

3. 2. This Regulation Supplementary Protocol alsoapplies to Damage resulting from:

a. Uunintentional transboundary movements asreferred to in Article 17 of the Protocol;as well asdamage resulting from

b. Iillegal transboundary movements as referred to inArticle 25 of the Protocol; and

c. Unintentional or illegal introduction of LivingModified Organisms into the environment undernational law.

Explanation: This text follows the SupplementaryProtocol text but, in addition, clarifies in paragraph thatthe Regulation also applies to Damage resulting fromunapproved activities and activities that are illegal undernational law.


Example text:

4. 3. This Regulation Supplementary Protocol applies toDamage resulting from the release of a transboundarymovement of a Living Modified Organism as specified inparagraphs 1 or 2 that occurred startedafter the entryinto force of this Regulation.Supplementary Protocol forthe Party into whose jurisdiction the transboundarymovement was made

Explanation: New rules can only be applied on aprospective basis.

4. This Supplementary Protocol applies to damageresulting from a transboundary movement of livingmodified organisms that started after the entryinto force of this Supplementary Protocol for theParty into whose jurisdiction the transboundarymovement was made.

6. Parties may use criteria set out in their domesticlaw to address damage that occurs within thelimits of their national jurisdiction.

7. Domestic law implementing this SupplementaryProtocol shall also apply to damage resulting fromtransboundary movements of living modifiedorganisms from non-Parties.

5. This Supplementary Protocol applies to damagethat occurred in areas within the limits of thenational jurisdiction of Parties.

3. This Supplementary Protocol also applies todamage resulting from unintentionaltransboundary movements as referred to in Article17 of the Protocol as well as damage resultingfrom illegal transboundary movements as referredto in Article 25 of the Protocol.

Article 4 Causation

A causal link shall be established between thedamage and the living modified organism in questionin accordance with domestic law.

the Living Modified Organism in question; andc. No superseding event alters the chain of events that

otherwise might have connected the release of theLiving Modified Organism in question to theDamage.]

Explanation: The prevention and remedying of Damageshould be implemented through the application of the“polluter pays” principle. The fundamental principleshould therefore be that an Operator whose activity hascaused the Damage is held responsible. Various“causation” tests ensure that this is the case.

Nearly every country’s civil laws will provide guidance onestablishing causation. In this case, Alternative A can beused with a citation to the relevant law.

In cases where appropriate domestic law does not exist,the second alternative provides and explains the keycomponents of causation. At a minimum, an Operatorshould be held responsible only when the three distinctelements of causation are proven: (a) general causation,(b) specific causation, and (c) the lack of anysuperseding event.

Example text:

Article 5 Response Measures

1. Parties shall require t In the event of Damage, tTheappropriate Operator or operators, in the event ofdamage, subject to any requirements of the competentauthority, shall to:

a. Immediately inform the Competent Authority;b. Evaluate the Damage; andc. Take appropriate Response Measures.

Explanation: In defining the appropriate ResponseMeasures, countries first need to assess whetherResponse Measures complying with the principles as setout in the Supplementary Protocol already exist. If thatis not the case or only partly the case, countries shouldinclude detailed provisions on how Response Measures,in the form of restoration or compensation, will beidentified.

In paragraph 1), the plural term “Operators” is notnecessary (and does not appear elsewhere in theSupplementary Protocol) and therefore has beenremoved to avoid interpretation problems elsewhere.Under the Supplementary Protocol and this Regulation,one or more than one Operator can be held responsiblewhile using only the singular term. In addition, the text

2. The competent authority shall:a. Identify the operator which has caused the

damage;b. Evaluate the damage; andc. Determine which response measures should be

taken by the operator.

Article 5 Response measures

1. Parties shall require the appropriate operatoror operators, in the event of damage, subjectto any requirements of the competentauthority, to:a. Immediately inform the competent authority;b. Evaluate the damage; andc. Take appropriate response measures.

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is streamlined for domestic use but maintains theobligation on the Operator to notify the CompetentAuthority and take action as appropriate.

(Article 5 Response Measures continued…)

Example Text:

2. The Ccompetent Aauthority shall:a. Identify the Operator which has caused the Damage

in accordance with Article 4 and Article 6 of theRegulation;

b. Evaluate the Damage in accordance with Annex I;and

c. Determine which Response Measures should betaken by the Operator in accordance with Annex II.

Explanation: The Supplementary Protocol text has beenused for paragraph 2 but references to relevant provisionsin the Regulation are added for clarity. In addition, it maybe necessary to create Standard Operating Procedures toguide the Competent Authority in making determinationsand implementing them. This can be done bygovernmental decree or order following the creation ofthe Regulation. See also Article 15.

Reference is also made in this provision to the twoannexes that have been added to provide detailedprovisions on determining Damage (Annex I) and onidentifying the appropriate Response Measures (Annex II).


Example Text:

3. Where relevant Best Available Information, includingavailable scientific information or information available inthe Biosafety Clearing-House, indicates that there is asufficient likelihood that Damage will result if timelyResponse Measures are not taken, the Operator shall berequired to take appropriate Response Measures so as toavoid such Damage.

3. Where relevant information, including availablescientific information or information available inthe Biosafety Clearing-House, indicates thatthere is a sufficient likelihood that damage willresult if timely response measures are not taken,the operator shall be required to take appropriateresponse measures so as to avoid such damage.

4. The competent authority may implementappropriate response measures, including,in particular, when the operator has failed todo so.


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Example Text:

6. Decisions of the Competent Authority requiring theOperator to take Response Measures must should bereasoned. Such decisions shall should be notified inwriting to the Operator. Domestic law shall provide forremedies, including the opportunity for administrative orjudicial review of such decisions. The CompetentAuthority shall, in accordance with domestic law, alsoinform the Operator of the available remedies, includingadministrative and judicial review.

Explanation: The permissive language of theSupplementary Protocol (“should”) has been changed tomandates (“shall”) since only this formulation ispossible in domestic legislation. Article 5, paragraph 6of the Supplementary Protocol requires Parties to informOperators of available remedies. These should includeboth administrative review (review of a decision by theCompetent Authority on request by the Operator) andjudicial review (provision for an Operator to access acourt of law to review the results of an administrativereview). Reference may be made to domestic law.

Explanation: No provisions are necessary in domesticregulations.

Example text:

Article 6 Exemptions

Alternative A

1. Parties may provide, in their domestic law, for thefollowing exemptions:An Operator shall not be held liable upon proof that theDamage was caused by:

a. An Act of God or force majeure; orb. An act of war or civil unrest.

Explanation: The primary defenses found in most liabilitysystems are included in the Example Text as permittedunder Article 6.1 of the Supplementary Protocol. Theword “or” between paragraphs (a) and (b) is necessary toensure that both standard defenses are available.

4. The Competent Authority may implement appropriateResponse Measures, including, in particular, when theOperator has failed to do so.

Explanation: Paragraph 3 uses the term “Best AvailableInformation” found in the ELD and, as noted previously,has been defined to include scientific information onthe Biosafety Clearing House.


Example Text:

5. The Competent Authority has the right to recover fromthe Operator the costs and expenses of, and incidentalto, the evaluation of the Damage and theimplementation of any such appropriate ResponseMeasures. Parties may provide, in their domestic law, forother situations in which the operator may not berequired to bear the costs and expenses. The CompetentAuthority shall not recover costs or expenses ofResponse Measures in situations where the Damage inquestion is the result of an event defined as anexemption in Article 6 of the Regulation or asuperseding event as defined in Article 4 of theRegulation.

Explanation: The first sentence of paragraph 5 of theSupplementary Protocol has been included in theExample Text without change. The second sentence ofparagraph 5 permits Parties to include additionalsituations in which an Operator may not be required tobear costs. Nothing has been added. Instead, theExample Text simply refers to Articles 4 and 6 of theRegulation which identify cases in which an Operator isnot held responsible.


6. Decisions of the competent authority requiring theoperator to take response measures should bereasoned. Such decisions should be notified tothe operator. Domestic law shall provide forremedies, including the opportunity foradministrative or judicial review of such decisions.The competent authority shall, in accordance withdomestic law, also inform the operator of theavailable remedies. Recourse to such remediesshall not impede the competent authority fromtaking response measures in appropriatecircumstances, unless otherwise provided bydomestic law.

7. In implementing this Article and with a view todefining the specific response measures to berequired or taken by the competent authority,Parties may, as appropriate, assess whetherresponse measures are already addressed by theirdomestic law on civil liability.

8. Response measures shall be implemented inaccordance with domestic law.

5. The competent authority has the right to recoverfrom the operator the costs and expenses of, andincidental to, the evaluation of the damage andthe implementation of any such appropriateresponse measures. Parties may provide, in theirdomestic law, for other situations in which theoperator may not be required to bear the costsand expenses.


1. Parties may provide, in their domestic law, for thefollowing exemptions:a. Act of God or force majeure; andb. Act of war or civil unrest.

Example text:

Article 7 Time Limitations

Parties may provide, in their domestic law, for:a. Relative and/or absolute time limits including for

actions related to response measures; and

The commencement of the period to which a time limitapplies.

The Competent Authority shall notify the Operator of adecision in relation to Response Measures no later thanthe earliest date of:

a. Three (3) years from the date on which theCompetent Authority knew or should have known ofthe Damage; or

b. Twenty (20) years after the first authorisation orrelease in the environment (whichever is earliest)of the Living Modified Organism in questionalleged to have caused the Damage; provided, thatthis twenty year time limitation shall be tolled(suspended) if the Living Modified Organism inquestion has caused Damage for which ResponseMeasures have been ordered.

Explanation: Time limitations are central to alladministrative and civil justice systems; they requiretimely action by those with rights or obligations andprovide finality for all concerned. The three year relativetime limit provides a Competent Authority withsufficient time to make the necessary determinationswhen Damage is discovered or alleged. The absolutetime limit of twenty years to notify an Operator of afinding of responsibility runs from the first release ofthe Living Modified Organism anywhere in the world.This provides sufficient time for any Damage tomaterialise and the Competent Authority to act. Boththe relative and absolute time limits suggested in theExample Text are standard in existing administrative andcivil liability systems.

Example text:

Example text:


Alternative B

Parties may provide, in their domestic law, for any otherexemptions or mitigations as they may deem fit.

1. An Operator shall not be held liable upon proof thatthe Damage was caused by:


2. In addition, an Operator shall not be held liableupon proof that the Damage was caused by:

a. An act or omission that was the subject of acompulsory order by the government;

b. Realisation of a risk:i Specifically assessed in compliance with Annex

III of the Protocol (including those risks forwhich management measures were proposed inthe risk assessment), where:

a) the risk assessment was accepted by thegovernmental authority responsible forthe proposed activity with the LivingModified Organism; and

b) an authorisation for the Living ModifiedOrganism in question was granted; and

ii The Damage is consistent with the type,magnitude and probability of harm presented inthe risk assessment; or

c. Realisation of a risk posed by an activityspecifically authorised or specifically permitted byapplicable law or regulations.

Explanation: The Supplementary Protocol gives widediscretion to Parties to include additional defenses.The first defense arises when Damage occurs becauseof compulsory compliance by an Operator with agovernmental order or mandate.

The three additional defenses included in the ExampleText Alternative B relate to risk or conduct specificallyapproved by the government (these are taken from theCompact). Each of these defences is grounded in fulland complete compliance by the Operator with therequirements imposed by the Competent Authority,whether through compulsory order, under to therequirements for risk assessment pursuant to theProtocol and national law, or by law or regulation.Fairness dictates that the Operator be exonerated fromresponsibility given proof of full compliance with allrequirements imposed by the Competent Authority.

Article 7 Time limits

Parties may provide, in their domestic law, for:a. Relative and/or absolute time limits including

for actions related to response measures; andb. The commencement of the period to which a

time limit applies.

Article 8 Financial limits

Parties may provide, in their domestic law, forfinancial limits for the recovery of costs andexpenses related to response measures.

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2. Parties may provide, in their domestic law, forany other exemptions or mitigations as they maydeem fit.


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Explanation: The Supplementary Protocol does notmandate Parties to impose financial securityrequirements. If a Party were to elect to do so, however,any such requirements imposed exclusively onbiotechnology would need to be supported by ajustification that can withstand WTO scrutiny. In fact,most countries already have in place legal requirementsfor doing business. These requirements automaticallyapply to any business activity that takes place in thecountry and also can be relied on in the context ofimplementing the Supplementary Protocol. Hence, inmost cases, there is no need for any additional, specificrequirements related to the release of an LMO. Wheregeneral corporate or business law establishing therequired capitalisation, assets, insurance or otherfinancial security to conduct the particular businessactivity is lacking, it should be developed and equitablyapplied to all enterprises.



Parties may provide, in their domestic law, for financiallimits for the recovery of costs and expenses related toresponse measures.

In the event that an Operator is ordered to provideResponse Measures, the following financial limits willapply for Incidents of Damage:

a. For a single of incident of Damage caused by anLMO, a maximum sum of [enter amount]; and

b. For all incidents of Damage caused by that LMO,a maximum sum of [enter the amount].

Explanation: Financial limits create a balance between therisk of any potential Damage and the benefits offered byLMOs, such as enhanced production of food, feed, fiberand fuel.

Financial limits should take into account:

1) potential costs of Response Measures (which wouldcurrently be purely speculative and cannot be estimatedbecause there are no incidents of Damage by an LMOand no experience on which to base an actuarialcalculation); and

2) the ability of all potential Operators to pay or to obtaininsurance or provide some other form of financialsecurity as provided by applicable corporate andbusiness law (applied without discrimination todomestic and foreign enterprise); and

3) how insurability of potential liability under this law,decree or regulation may be best facilitated.

Example text:

Article 9 Right of recourse

This Regulation Supplementary Protocol shall not limit orrestrict any right of recourse or indemnity that an Operatormay have against any other person.

Explanation: This provision preserves existing rights undercorporate or civil law.


This Supplementary Protocol shall not limit orrestrict any right of recourse or indemnity that anoperator may have against any other person.

Article 11 Responsibility of States for internationallywrongful acts

This Supplementary Protocol shall not affect therights and obligations of States under the rulesof general international law with respect to theresponsibility of States for internationallywrongful acts.

Article 10 Financial security

1. Parties retain the right to provide, in theirdomestic law, for financial security.

2. Parties shall exercise the right referred to inparagraph 1 above in a manner consistent withtheir rights and obligations under internationallaw, taking into account the final threepreambular paragraphs of the Protocol.

3. The first meeting of the Conference of the Partiesserving as the meeting of the Parties to theProtocol after the entry into force of theSupplementary Protocol shall request theSecretariat to undertake a comprehensive studywhich shall address, inter alia:a. The modalities of financial security

mechanisms;b. An assessment of the environmental, economic

and social impacts of such mechanisms, inparticular on developing countries; and

c. An identification of the appropriate entities toprovide financial security.

Article 12 Implementation and relation to civilliability

1. Parties shall provide, in their domestic law, forrules and procedures that address damage. Toimplement this obligation, Parties shall provide forresponse measures in accordance with thisSupplementary Protocol and may, as appropriate:a. Apply their existing domestic law, including,

where applicable, general rules and procedureson civil liability;

b. Apply or develop civil liability rules andprocedures specifically for this purpose; or

c. Apply or develop a combination of both.

Explanation: As noted previously, where existing lawalready addresses an issue to which the SupplementaryProtocol defers to domestic law, that law should bereferenced or incorporated. This Regulation proposesprovisions for domestic regulation where current law issilent on the relevant points.

Since nearly every country already has a systemproviding for civil liability and redress, countries shouldidentify their own systems and can chose to simplyapply them to establish liability and provide for redressin the case of traditional damage. Please seeIntroductory Note.


Article 15 Secretariat

The Secretariat established by Article 24 of theConvention shall serve as the secretariat to thisSupplementary Protocol.

Article 13 Assessment and review

The Conference of the Parties serving as the meetingof the Parties to the Protocol shall undertake areview of the effectiveness of this SupplementaryProtocol five years after its entry into force and everyfive years thereafter, provided information requiringsuch a review has been made available by Parties.The review shall be undertaken in the context of theassessment and review of the Protocol as specified inArticle 35 of the Protocol, unless otherwise decidedby the Parties to this Supplementary Protocol. Thefirst review shall include a review of the effectivenessof Articles 10 and 12.

Article 14 Conference of the Parties serving as themeeting of the Parties to the Protocol

1. Subject to paragraph 2 of Article 32 of theConvention, the Conference of the Parties servingas the meeting of the Parties to the Protocol shallserve as the meeting of the Parties to thisSupplementary Protocol.

2. The Conference of the Parties serving as themeeting of the Parties to the Protocol shall keepunder regular review the implementation of thisSupplementary Protocol and shall make, within itsmandate, the decisions necessary to promote itseffective implementation. It shall perform thefunctions assigned to it by this SupplementaryProtocol and,mutatis mutandis, the functionsassigned to it by paragraphs 4 (a) and (f) ofArticle 29 of the Protocol.

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Article 17 Signature

This Supplementary Protocol shall be open forsignature by Parties to the Protocol at the UnitedNations Headquarters in New York from 7 March2011 to 6 March 2012.

Article 16 Relationship with the Convention and theProtocol

1. This Supplementary Protocol shall supplement theProtocol and shall neither modify nor amend theProtocol.

2. This Supplementary Protocol shall not affect therights and obligations of the Parties to thisSupplementary Protocol under the Convention andthe Protocol.

3. Except as otherwise provided in thisSupplementary Protocol, the provisions of theConvention and the Protocol shall apply, mutatismutandis, to this Supplementary Protocol.

4. Without prejudice to paragraph 3 above, thisSupplementary Protocol shall not affect the rightsand obligations of a Party under international law.

2. Parties shall, with the aim of providing adequaterules and procedures in their domestic law on civilliability for material or personal damageassociated with the damage as defined in Article2, paragraph 2 (b):a. Continue to apply their existing general law on

civil liability;b. Develop and apply or continue to apply civil

liability law specifically for that purpose; orc. Develop and apply or continue to apply a

combination of both.3. When developing civil liability law as referred to in

subparagraphs (b) or (c) of paragraphs 1 or 2above, Parties shall, as appropriate, address, interalia, the following elements:a. Damage;b. Standard of liability including strict or fault-

based liability;c. Channelling of liability, where appropriate;d. Right to bring claims.


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Example text:

Article 10 Entry into Force

1.This Regulation shall enter into force on the __ dayfollowing its publication.

2.{Articles x – y of Biosafety Law N. __} concerningliability and redress shall be revoked upon entry intoforce of this Regulation.

Explanation: A provision providing for the entry into forceof the Regulation needs to be included. If existingbiosafety law or regulation addresses liability relating toLiving Modified Organisms, those provisions should beexplicitly revoked upon entry into force of thisRegulation.

Article 19 Reservations

No reservations may be made to this SupplementaryProtocol.

Article 20 Withdrawal

1. At any time after two years from the date onwhich this Supplementary Protocol has enteredinto force for a Party, that Party may withdrawfrom this Supplementary Protocol by givingwritten notification to the Depositary.

2. Any such withdrawal shall take place upon expiryof one year after the date of its receipt by theDepositary, or on such later date as may bespecified in the notification of the withdrawal.

3. Any Party which withdraws from the Protocol inaccordance with Article 39 of the Protocol shallbe considered as also having withdrawn from thisSupplementary Protocol.


Example text:

Adopted ….

Explanation: Any formalities for the adoption of theRegulation in accordance with domestic law can beinserted.

Article 18 Entry into force

1. This Supplementary Protocol shall enter into forceon the ninetieth day after the date of deposit ofthe fortieth instrument of ratification, acceptance,approval or accession by States or regionaleconomic integration organisations that areParties to the Protocol.

2. This Supplementary Protocol shall enter into forcefor a State or regional economic integrationorganisation that ratifies, accepts or approves itor accedes thereto after the deposit of the fortiethinstrument as referred to in paragraph 1 above,on the ninetieth day after the date on which thatState or regional economic integrationorganisation deposits its instrument of ratification,acceptance, approval, or accession, or on the dateon which the Protocol enters into force for thatState or regional economic integrationorganisation, whichever shall be the later.

3. For the purposes of paragraphs 1 and 2 above,any instrument deposited by a regional economicintegration organisation shall not be counted asadditional to those deposited by member States ofsuch organisation.

Article 21 Authentic texts

The original of this Supplementary Protocol, of whichthe Arabic, Chinese, English, French, Russian andSpanish texts are equally authentic, shall bedeposited with the Secretary-General of the UnitedNations.

IN WITNESS WHEREOF the undersigned, being dulyauthorised to that effect, have signed thisSupplementary Protocol.

DONE at Nagoya on this fifteenth day of October twothousand and ten.

Explanation: These provisions help to guide the processof determining the Damage for which an Operator maybe held liable.

Two alternatives are provided for this Annex. AlternativeA is based on ELD language and Alternative B is basedon Compact language. Changes to the original ELD textare marked in red. Citations in the original text to EUlaw have been omitted.

Example text:

Annex I: Determination of Damage

[Alternative A (taken from the ELD, Annex I):

1) Damage is determined by comparing the nature andquantum of change in the species or Ecosystem fromthe Baseline. To determine if there is a measurablechange in Biological Diversity, the Baseline mustfirst be established. Then the conditions alleged torepresent change or Damage must be compared tothat Baseline to verify that there has been ameasurable change from the Baseline. If measurablechange has occurred, it must then be determinedwhether the measurable change is significant andadverse.

2) The significance of any Damage that has adverseeffects on reaching or maintaining the favourableconservation status of Habitats or species has to beassessed by reference to the conservation status atthe time of Damage, the services provided and theircapacity for natural regeneration.

3) The Competent Authority shall base its determinationof the Baseline and the comparison of the Baselineto the conditions alleged to represent Damage onBest Available Information, including an assessmentof inter alia the following:

a) the number of species, their density or the areacovered,

b) the role of the particular species or of thedamaged area in relation to the species or theHabitat conservations, the rarity of the speciesor Habitat (assessed at local; regional and higherlevel including Community level);

c) the species capacity for propagation (accordingto the dynamics specific to that species or tothat population), its viability or the Habitat’scapacity for natural regeneration (according tothe dynamics specific to its characteristicspecies or to their populations);

d) the species’ or Habitat’s capacity, after Damagehas occurred, to recover within a short time,without any intervention other than increased

Annex I: Determination of Damage

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protection measures, to a condition which leads,solely by virtue of the dynamics of the speciesor the Habitat, to a condition deemed equivalentor superior to the Baseline Condition.

4) The following are examples of changes to a speciesthat are not significant and adverse changes per se:

a) Negative variations that are smaller than naturalfluctuations regarded as normal for the speciesor Habitat in question;

b) Negative variations due to natural causes orresulting from intervention relating to the normalmanagement of sites, as defined in Habitatrecords or target documents or as carried onpreviously by owners or Operators;

c) Damage to species or Habitats for which it isestablished that they will recover, within a shorttime and without intervention, either to theBaseline Condition or to a condition whichleads, solely by virtue of the dynamics of thespecies or Habitat, to a condition deemedequivalent or superior to the BaselineCondition.]

[Alternative B (paragraphs 2), 3), 4) and thesubparagraphs of 5) taken from the Compact)

1) Damage is determined by comparing the nature andquantum of change in the species or Ecosystemfrom the Baseline. To determine if there is ameasurable change in Biological Diversity, theBaseline must first be established. Then theconditions alleged to represent change or Damagemust be compared to that Baseline to verify thatthere has been a measurable change from theBaseline. If measurable change has occurred, itmust then be determined whether the measurablechange is significant and adverse.

2) The Competent Authority shall base itsdetermination of the Baseline and the comparison ofthe Baseline to the conditions alleged to representDamage on Best Available Information, taking intoaccount inter alia the following:

(a) the nature and characteristics of the species;(b) the functionality or natural resource service

provided by the species;(c) any other human induced variation; and(d) any other natural variation, including

a. the natural range/distribution of speciesand the naturally occurring fluctuation innumbers and distribution of the speciesover time;


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b. the interaction of the species within theEcosystem and the species’ capacity fornatural regeneration;

c. the species’ capacity for propagation;d. the species’ capacity for recovery within a

reasonable period of time under naturalrestorative forces.

3) A measurable change is a significant and adversechange only when, as a result of that change:

(a) population dynamics data for the species allegedto be Damaged demonstrate that the speciescannot maintain itself on a long-term basis or areliable component of its natural Habitat;

(b) the natural range of the species has beenreduced to an unsustainable level;

(c) a sufficient Habitat no longer exists to maintainthe species on a long-term basis; or

(d) one or more other species in the affectedEcosystem related to or dependent upon thespecies alleged to be Damaged cannot maintainitself on a long-term basis as a viable componentof the Ecosystem.

4) In assessing whether there has been significant andadverse change, the Competent Authority shall takeinto consideration the life histories of the species, ona qualitative and quantitative basis, which maydemonstrate naturally occurring changes over time(increases and decreases) in population census,geographical distribution, gene frequency, and otherbiological parameters. Such naturally occurringchanges in these or other parameters are notsignificant and adverse change per se, as they may benecessary for the adaptation of the species or thenatural evolution of the Ecosystem. Also, suchchanges may be a factor in the determination ofwhether significant and adverse change has occurredbut are not sufficient in and of themselves toestablish such significant and adverse change.]

5) The following are examples of changes to a speciesthat are not significant and adverse changes per se:

(a) a change in Biological Diversity which is withinthe historical or expected range of fluctuationsregarded as “normal” for the species;

(b) a change in Biological Diversity due to naturalcauses or resulting from intervention relating tothe normal management of the Ecosystem;

(c) a change in Biological Diversity for which it isdetermined that any resulting reduction innumbers or distribution of species will bereversed or will recover due to natural restorativeforces to the Baseline Condition or to a condition

which leads, solely by virtue of the dynamics ofthe species or its Ecosystem, to a condition atleast equivalent to the Baseline Condition;

(d) a change in Biological Diversity which isconsistent with the risk assessment, and resultsfrom the intended use, of the Living ModifiedOrganism in question authorised (e.g. thereduction or loss of the target pest species);

(e) a change in the genetic content of a species thatdoes not significantly impact its functionality,interactions within its Ecosystem or itsconservation status;

(f) the mere presence of the Living ModifiedOrganism in question or unique genetic elementsfrom the Living Modified Organism in question inthe species or within the Ecosystem; or

(g) a change in Biological Diversity resulting fromactions, activities or events which would haveoccurred even if the Living Modified Organism inquestion’s unmodified counterpart was used (e.g.the conventional crop of the same species as theLiving Modified Organism in question).]

Annex II: Response Measures

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Explanation: This annex provides a detailed overview ofthe elements to be taken into consideration in selectingResponse Measures for the restoration plan and forcompensation if restoration is not possible.

Two alternatives are provided for this Annex. AlternativeA is based on ELD language and Alternative B is basedon Compact language. Changes to the original ELD textare marked in red. Citations in the original text to EUlaw have been omitted.

Example text:

Annex II: Response Measures

[Alternative A, (adapted from the ELD)

This Annex sets out a common framework to be followedin order to choose the most appropriate measures toensure the remedying restoration of environmentalDamage.

1) Remediation Restoration of Damage to water orprotected species or natural Habitats Remedying ofenvironmentalDamage, in relation to water orprotected species or natural Habitats, is achievedthrough the restoration of the environment to itsBaseline Condition by way of primary, complementaryand compensatory remediation restoration, where:

(a) ‘Primary' remediation restoration is any remedialresponse measure which returns the damagednatural resources and/or impaired services to, ortowards, Baseline Condition;

(b) ‘Complementary' remediation restoration is anyremedial Response Measure taken in relation tonatural resources and/or services to compensatefor the fact that primary remediation restorationdoes not result in fully restoring the damagednatural resources and/or services;

(c) ‘Compensatory' remediation restoration is anyaction taken to compensate for interim losses ofnatural resources and/or services that occur fromthe date of Damage occurring until primaryremediation restoration has achieved its fulleffect;

(d) ‘Interim Losses' means losses which result fromthe fact that the damaged natural resourcesand/or services are not able to perform theirecological functions or provide services to othernatural resources or to the public until theprimary or complementary measures have takeneffect. It does not consist of financialcompensation to members of the public.

Where primary remediation restoration does not result inthe restoration of the environment to its BaselineCondition, then complementary remediation restorationwill be undertaken. In addition, compensatory

remediation restoration will be undertaken tocompensate for the Interim Losses.Remedying Restoration of environmentalDamage, interms of Damage to water or protected species or naturalHabitats, also implies that any significant risk of humanhealth being adversely affected be removed.

1.1. Remediation Restoration objectivesPurpose of primary remediation restoration1.1.1. The purpose of primary remediation restoration isto restore the damaged natural resources and/or servicesto, or towards, Baseline Condition.

Purpose of complementary remediation restoration1.1.2. Where the damaged natural resources and/orservices do not return to their Baseline Condition, thencomplementary remediation restoration will beundertaken. The purpose of complementary remediationrestoration is to provide a similar level of naturalresources and/or services, including, as appropriate, atan alternative site, as would have been provided if thedamaged site had been returned to its BaselineCondition. Where possible and appropriate thealternative site should be geographically linked to thedamaged site, taking into account the interests of theaffected population.

Purpose of compensatory remediation restoration1.1.3. Compensatory remediation restoration shall beundertaken to compensate for the Interim Loss of naturalresources and services pending recovery. Thiscompensation consists of additional improvements toprotected natural Habitats and species or water at eitherthe damaged site or at an alternative site. It does notconsist of financial compensation to members of thepublic.

1.2. Identification of remedial Restoration ResponseMeasuresIdentification of primary remedial Response Measures1.2.1. Options comprised of actions to directly restorethe natural resources and services towards BaselineCondition on an accelerated time frame, or throughnatural recovery, shall be considered.

Identification of complementary and compensatoryremedial Response Measures1.2.2. When determining the scale of complementaryand compensatory remedial Response Measures, the useof resource-to-resource or service-to-service equivalenceapproaches shall be considered first. Under theseapproaches, actions that provide natural resources and/orservices of the same type, quality and quantity as thosedamaged shall be considered first. Where this is notpossible, then alternative natural resources and/orservices shall be provided. For example, a reduction inquality could be offset by an increase in the quantity ofremedial Response Measures.


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1.2.3. If it is not possible to use the first choiceresource-to-resource or service-to-service equivalenceapproaches, then alternative valuation techniques shallbe used. The Competent Authority may prescribe themethod, for example monetary valuation, to determinethe extent of the necessary complementary andcompensatory remedial Response Measures. If valuationof the lost resources and/or services is practicable, butvaluation of the replacement natural resources and/orservices cannot be performed within a reasonable time-frame or at a reasonable cost, then the CompetentAuthority may choose remedial Response Measureswhose cost is equivalent to the estimated monetary valueof the lost natural resources and/or services.

The complementary and compensatory remedialResponse Measures should be so designed that theyprovide for additional natural resources and/or services toreflect time preferences and the time profile of theremedial Response Measures. For example, the longerthe period of time before the Baseline Condition isreached, the greater the amount of compensatoryremedial Response Measures that will be undertaken(other things being equal).

1.3. Choice of the remedial options Response Measures1.3.1. The reasonable remedial options ResponseMeasures should be evaluated, using best availabletechnologies, based on the following criteria:— The effect of each option on public health and safety,— The cost of implementing the option,— The likelihood of success of each option,— The extent to which each option will prevent futureDamage, and avoid collateral damage as a result ofimplementing the option,— The extent to which each option benefits to eachcomponent of the natural resource and/or service,—The extent to which each option takes account ofrelevant social, economic and cultural concerns andother relevant factors specific to the locality,— The length of time it will take for the restoration ofthe Damage to be effective,— The extent to which each option achieves therestoration of site of the environmentalDamage,— The geographical linkage to the damaged site.

When evaluating the different identified remedial optionsResponse Measures, primary remedial ResponseMeasures that do not fully restore the damaged water orprotected species or natural Habitat to the BaselineCondition or that restore it more slowly can be chosen.This decision can be taken only if the natural resourcesand/or services foregone at the primary site as a result ofthe decision are compensated for by increasingcomplementary or compensatory actions to provide asimilar level of natural resources and/or services as wereforegone. This will be the case, for example, when theequivalent natural resources and/or services could beprovided elsewhere at a lower cost. These additionalremedial Response Measures shall be determined in

accordance with the rules set out in section 1.2.2.

1.3.3. Notwithstanding the rules set out in section1.3.2. and in accordance with Article 7(3), theCompetent Authority is entitled to decide that no furtherResponse Measures should be taken if:

(a) the remedial Response Measures already takensecure that there is no longer any significant riskof adversely affecting human health, water orprotected species and natural Habitats, and

(b) the cost of the Response Measures that should betaken to reach Baseline Condition or similar levelwould be disproportionate to the environmentalbenefits to be obtained.

2. Remediation Restoration of land DamageThe necessary Response Measures shall be taken toensure, as a minimum, that the relevant contaminantsare removed, controlled, contained or diminished so thatthe contaminated land, taking account of its current useor approved future use at the time of the Damage, nolonger poses any significant risk of adversely affectinghuman health. The presence of such risks shall beassessed through risk-assessment procedures taking intoaccount the characteristic and function of the soil, thetype and concentration of the harmful substances,preparations, organisms or micro-organisms, their riskand the possibility of their dispersion. Use shall beascertained on the basis of the land use regulations, orother relevant regulations, in force, if any, when theDamage occurred.

If the use of the land is changed, all necessary ResponseMeasures shall be taken to prevent any adverse effectson human health.

If land use regulations, or other relevant regulations, arelacking, the nature of the relevant area where theDamage occurred, taking into account its expecteddevelopment, shall determine the use of the specificarea.

A natural recovery option, that is to say an option inwhich no direct human intervention in the recoveryprocess would be taken, shall be considered.]

[Alternative B (adapted from the Compact)

1) Restoration is the preferred form of response. TheCompetent Authority shall propose a restoration planand the Operator may offer an alternative restorationplan. Absent agreement on the restoration planbetween the Operator and the Competent Authority,the restoration plan will be determined by theCompetent Authority in accordance with the following:(a) The restoration plan shall be designed to achieve

the Baseline Condition and be based on BestAvailable Information. The restoration plan shallnot exceed that which is necessary to achieve the

4 The Secretariat of the Convention on Biological Diversity has published a manuscript entitled, An Exploration of Tools andMethodologies For Valuation of Biodiversity and Biodiversity Resources and Functions,” as Convention Technical Series No. 28,containing case studies of the application of valuation methodologies described in the manuscript and which may be applicable in theAssessment and Arbitration Process if consistent with the terms and conditions of the Compact.

Baseline Condition.(b) The restoration plan shall take into account the

characteristics of the Ecosystem in which Damageis alleged to have occurred, such as whether it is(i) a protected area, (ii) a centre of origin, or (iii) adeveloped, industrialised or degraded Ecosystem.

(c) The restoration plan shall take into accountnegative impacts, if any, on public health or on anEcosystem proven to have been caused by theDamage.

(d) The determination based on Best AvailableInformation of the scope, methods and processesof a restoration plan may consider as appropriatethe precautionary approach as it is described inPrinciple 15 of the Rio Declaration. For therestoration plan to include a different scope,method or process for a related or dependentspecies (Ecosystem approach) than the scope,method or process for the Damaged species, theCompetent Authority must demonstrate throughBest Available Information that impacts to relatedor dependent species require such a differentscope, method or process.

(e) The restoration plan shall take into accountbenefits from the release of the Living ModifiedOrganism in question.

(f) Where the Competent Authority determines thatrestoration of the biological diversity to theBaseline Condition of the Damaged species orEcosystem is not possible, the CompetentAuthority shall articulate the reasons for thedetermination. If the Competent Authority and theOperator agree, the restoration plan may insteadprovide for restoration by replacing the loss ofbiological diversity with other components ofbiological diversity for the same, or for anothertype of use either at the same, or as appropriate,at an alternative location;

(g) The restoration plan shall include detailed costs ofimplementing the restoration plan;

(h) The restoration plan shall incorporate amechanism for the Competent Authority toaddress any future requests for amendments tothe restoration plan that are agreed to by theOperator and the Competent Authority or are thesubject of contention between the Operator andthe Competent Authority.

2) Compensation is only available when:(a) restoration is not possible;(b) it is not technically or financially feasible to

achieve the Baseline Condition; or(c) the cost of implementing the restoration plan

exceeds the economic value of the Damage.

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3) Where the Competent Authority seeks compensation,the amount of compensation shall be determinedthrough a valuation method4 based on objectiveprocesses and objective criteria. The valuation:(a) shall be supported by evidence based upon the

Best Available Information;(b) shall take into account an assessment of the loss

of functionality, value, use or natural resourceservices from the species resulting directly fromand attributable only to the change from theBaseline and any projected future loss offunction, value, use and natural resourceservices; the effect of such loss on establisheddomestic customs and the characteristics of theecosystem where Damage has occurred, such aswhether it is (i) a protected area, (ii) a centre oforigin, or (iii) a developed, industrialised ordegraded Ecosystem;

(c) shall take into account negative impacts, if any,on public health or on an Ecosystem proven tohave been caused by the Damage;

(d) shall take into account benefits from release ofthe Living Modified Organism in question;

(e) shall take into account the cost of restoration;and

4) The Competent Authority shall take into account: (a) all benefits resulting from the release of the

Living Modified Organism, including any increasein the function, value, or natural resourceservices of or to the species, any other species orthe Ecosystem compared to any loss of function,value, or natural resource service of the Damagedspecies;

(b) the natural restorative processes of the species orEcosystem would reverse any such loss; and

(c) whether restoration would eliminate orsubstantially reduce the benefits from the releaseof the Living Modified Organism.

5) Any restoration plan shall be tailored to preserve thebenefits from the Release of the LMO. Where anyDamage is determined by a Competent Authority to besufficiently reversible or repairable to a BaselineCondition by natural restorative processes within areasonable time, there shall be no obligation by theOperator for restoration. If Response Measures cannotbe so tailored, the Competent Authority shalldetermine Response Measures ex aequo et bono,including appropriate restoration, a combination ofrestoration and compensation, compensation insteadof restoration or no compensation or restoration.]


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Regulation No. ___ (Liability and Redress relating toLiving Modified Organisms) 2012

Whereas

{name of country} is Party to the Cartagena Protocol onBiosafety to the Convention on Biological Diversityhereinafter referred to as the “Protocol” pursuant to {citenational legal measure related to ratification oraccession} and has ratified/acceded to the Nagoya-KualaLumpur Supplementary Protocol on Liability and Redressto the Cartagena Protocol on Biosafety, hereinafterreferred to as the “Supplementary Protocol” pursuant to{cite national legal measure related to ratification oraccession},

Recalling {e.g., Biosafety Law No. __ of 20__ andRegulation No. __ of 20__},

Taking into account Principle 13 of the Rio Declarationon Environment and Development,

Reaffirming the precautionary approach contained inPrinciple 15 of the Rio Declaration on Environment andDevelopment,

Recognising the need to provide for appropriate responsemeasures where there is damage or sufficient likelihoodof damage, consistent with the Protocol,

Hereby adopts the following:

Article 1 Objective

The objective of this Regulation is to contribute to theconservation and sustainable use of Biological Diversity,taking also into account risks to human health, byproviding rules and procedures in the field of liabilityand redress relating to Living Modified Organisms inaccordance with the Supplementary Protocol.


1. The following terms shall apply to this Regulationand its annexes:

a. “Convention” means the Convention on BiologicalDiversity;

b. “Protocol” means the Cartagena Protocol onBiosafety to the Convention on BiologicalDiversity;

c. “Supplementary Protocol” means the Nagoya-Kuala Lumpur Supplementary Protocol onLiability and Redress to the Cartagena Protocolon Biosafety;

d. “Biological Diversity” means the variability amongliving organisms from all sources including, inter

alia, terrestrial, marine and other aquaticecosystems and the ecological complexes ofwhich they are part; this includes diversity withinspecies, between species and of ecosystems;

e. “Habitat” means the place or type of site wherean organism or population naturally occurs;

f. “Ecosystem” means a dynamic complex of plant,animal and micro-organism communities andtheir non-living environment interacting as afunctional unit;

g. ”Contained use” means any operation,undertaken within a facility, installation or otherphysical structure, which involves living modifiedorganisms that are controlled by specificmeasures that effectively limit their contact with,and their impact on, the external environment;

h. “Living Modified Organism” means any livingorganism that possesses a novel combination ofgenetic material obtained through the use ofmodern biotechnology;

i. “Living Organism” means any biological entitycapable of transferring or replicating geneticmaterial, including sterile organisms, viruses andviroids;

j. “Modern Biotechnology” means the applicationof:

i. In vitro nucleic acid techniques, includingrecombinant deoxyribonucleic acid (DNA)and direct injection of nucleic acid intocells or organelles, or

that overcome natural physiological reproductiveor recombination barriers and that are nottechniques used in traditional breeding andselection.

k. “Damage” means an adverse effect on theconservation and sustainable use of BiologicalDiversity, taking also into account risks to humanhealth, that:

i. Is measurable or otherwise observabletaking into account, wherever available,scientifically-established Baselinesrecognised or established by a CompetentAuthority under this Regulation that takesinto account any other human inducedvariation and natural variation; and


l. “Operator” means any person in direct or indirectcontrol of the Living Modified Organism [inaccordance with {citation to appropriate domesticlaw}];

m.“Response Measures” means reasonable actionsto:

i. Prevent, minimise, contain, mitigate, orotherwise avoid Damage, as appropriate;

ii. Restore Biological Diversity throughactions to be undertaken in the following

Compiled Example Text with Selected Alternatives

ii. Fusion of cells beyond the taxonomic family,

order of preference:a) Restoration of Biological Diversity

to the Baseline Condition or itsnearest equivalent; and where theCompetent Authority determinesthis is not possible;

b) Restoration by, inter alia, replacingthe loss of Biological Diversity withother components of BiologicalDiversity for the same, or foranother type of use either at thesame or, as appropriate, at analternative location;

n. “Competent Authority” for purposes of thisRegulation means {name of minister, agency oroffice};

o. “Baseline” means the condition at the time ofthe Damage of the natural resources and servicesthat would have existed had the Damage notoccurred, estimated on the basis of the BestInformation Available;

p. “Baseline Condition” means the state ofBiological Diversity that is the goal of therestoration plan for the species or Ecosystemalleged to be Damaged and that represents thecondition that existed before Damage occurred tothat species or Ecosystem, which is satisfiedwhen:

i. population dynamics data for the speciesalleged to be Damaged demonstrate thatthe species can maintain itself on a long-term basis as a viable component of theEcosystem;

ii. the natural range of the species has beenincreased to a sustainable level;

iii. a sufficient Habitat exists to maintain thespecies on a long-term basis; or

iv. one or more other species in the affectedEcosystem related to or dependent uponthe species alleged to be Damaged canmaintain itself on a long-term basis as aviable component of the Ecosystem;

q. “Best Available Information” means the peer-reviewed or peer-reviewable information obtainedthrough the generally accepted scientificmethodology used in the relevant scientificcommunity of endeavour (such as genetics,ecology, microbiology, species populationdynamics, and social sciences), including suchinformation found on the Biosafety ClearingHouse of the Protocol. This methodology mustconsist of a testable hypothesis, existence andmaintenance of standards controlling thetechnique’s operation, and an acceptable knownor potential rate of error, and the results must berepeatable. Best Available Information must beused in the determination of each element of aclaim for Response Measures.

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2. Damage is established only in the case of asignificant adverse effect:

a. An effect is adverse if it is a qualitative orquantitative change that:

i. Negatively affects the components ofBiological Diversity;

ii. Reduces the ability of components ofBiological Diversity to provide goods andservices; or

iii.Negatively Affects human health in thecontext of the Protocol.

b. An adverse effect is significant based upon theextent of the adverse effect in 2.a above and if itresults in long-term or permanent change, to beunderstood as change that will not be redressedthrough natural recovery within a reasonableperiod of time.

Article 3 Scope

1. This Regulation applies to Damage resulting fromauthorised import or use of Living ModifiedOrganisms intended for:

a. Direct use as food or feed, or for processing;b. Contained use; andc. Intentional introduction into the environment.

2. This Regulation also applies to Damage resultingfrom:

a. Unintentional transboundary movements asreferred to in Article 17 of the Protocol;

b. Illegal transboundary movements as referred to inArticle 25 of the Protocol; and

c. Unintentional or illegal introduction of LivingModified Organisms into the environment undernational law.

3. This Regulation applies to Damage resulting from therelease of a Living Modified Organism as specified inparagraphs 1 or 2 that occurred after the entry into forceof this Regulation.

4. This Regulation applies to Damage that occurs inareas within the limits of the national jurisdiction of{name of country}.

Article 4 Causation (Alternative B)

1. A causal link shall be established by the CompetentAuthority between the Damage and the LivingModified Organism in question.

2. The Competent Authority shall determine that:


26

a. General causation exists, i.e. the change cangenerally be caused by the Living ModifiedOrganism in question;

b. Specific causation exists, i.e. the Damage wouldnot have occurred but for the release of the LivingModified Organism in question, and resultsdirectly from the phenotypic or genotypicmodification of the Living Modified Organism inquestion; and

c. No superseding event alters the chain of eventsthat otherwise might have connected the release ofthe Living Modified Organism in question to theDamage.

Article 5 Response Measures

1. In the event of Damage, the appropriate Operatorshall:

a. Immediately inform the Competent Authority;b. Evaluate the Damage; andc. Take appropriate Response Measures.

2. The Competent Authority shall:

a. Identify the Operator which has caused theDamage in accordance with Article 4 and Article 6of the Regulation;

b. Evaluate the Damage in accordance with Annex I;and

c. Determine which Response Measures should betaken by the Operator in accordance with Annex II.

3. Where relevant Best Available Information indicatesthat there is a sufficient likelihood that Damage willresult if timely Response Measures are not taken, theOperator shall be required to take appropriateResponse Measures so as to avoid such Damage.

4. The Competent Authority may implement appropriateResponse Measures, including, in particular, whenthe Operator has failed to do so.

5. The Competent Authority has the right to recoverfrom the Operator the costs and expenses of, andincidental to, the evaluation of the Damage and theimplementation of any such appropriate ResponseMeasures. The Competent Authority shall not recovercosts or expenses of Response Measures in situationswhere the Damage in question is the result of anevent defined as an exemption in Article 6 of theRegulation or a superseding event as defined inArticle 4 of the Regulation.

6. Decisions of the Competent Authority requiring theOperator to take Response Measures must bereasoned. Such decisions shall be notified in writingto the Operator. The Competent Authority shall informthe Operator of the available remedies, includingadministrative and judicial review.

Article 6 Exemptions (Alternative B)

1. An Operator shall not be held liable upon proofthat the Damage was caused by:


2. In addition, an Operator shall not be held liableupon proof that the Damage was caused by:

a. An act or omission that was the subject of acompulsory order by the government;

b. Realisation of a risk:i. Specifically assessed in compliance with

Annex III of the Protocol (including thoserisks for which management measureswere proposed in the risk assessment),where:

a) the risk assessment was acceptedby the governmental authorityresponsible for the proposedactivity with the Living ModifiedOrganism; and

b) an authorisation for the LivingModified Organism in questionwas granted; and

ii. The Damage is consistent with the type,magnitude and probability of harmpresented in the risk assessment; or

c. Realisation of a risk posed by an activityspecifically authorised or specifically permittedby applicable law or regulations.

Article 7 Time Limitations

The Competent Authority shall notify the Operator of adecision in relation to Response Measures no later thanthe earliest date of:

a. Three (3) years from the date on which theCompetent Authority knew or should have knownof the Damage; or

b. Twenty (20) years after the first authorisation orrelease in the environment (whichever isearliest) of the Living Modified Organism inquestion alleged to have caused the Damage;provided, that this twenty year time limitationshall be tolled (suspended) if the LivingModified Organism in question has causedDamage for which Response Measures havebeen ordered.


In the event that an Operator is ordered to provideResponse Measures, the following financial limits willapply for Incidents of Damage:

a. For a single of incident of Damage caused by anLMO, a maximum sum of [enter amount]; and

b. For all incidents of Damage caused by that LMO,a maximum sum of [enter amount].


This Regulation shall not limit or restrict any right ofrecourse or indemnity that an Operator may have againstany other person.

Article 10 Financial Security

1. This Regulation shall enter into force on the __ dayfollowing its publication.

2. {Articles x – y of Biosafety Law N. __} concerningliability and redress shall be revoked upon entry intoforce of this Regulation.

Adopted ….{any necessary formalities}

Annex I: Determination of Damage(to be completed based on choice of alternatives)

Annex II: Response Measures(to be completed based on choice of alternatives)

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Date of publication: April 2013

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