This Guidelines and Practices Manual is a useful reference instrument for the application of Saint Lucia’s Biosafety Act.

It is intended to assist persons who are subject to the Act.

This Manual supplies additional information on the Biosafety Act, supporting Regulations and clarifies the functions with respect to the administration of the Act.

The Manual presents guidelines and proposes best practices, not binding rules. Any scenarios or examples used are instructive only and should not be viewed as statements of the law. It should not be used as a replacement for legal advice. Please consult with legal counsel where there is doubt on the proper application of the Act.

For further information on this Guidelines and Practices Manual, please contact:

The Sustainable Development and Environment DivisionDepartment of Sustainable DevelopmentMinistry of Education, Innovation, Gender and Sustainable DevelopmentCaribbean CinemasChocSaint LuciaEmail: slubiosafety@govt.lcWebsite:lc.biosafetyclearinghouse.net Phone: 1(758)451 8746Fax: 1(758) 450 1904

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CONTENTS

1. INTRODUCTION...........................................................................................................................................5

1.1 PURPOSE OF THE MANUAL...................................................................................................................5

1.2 PURPOSES OF THE BIOSAFETY ACT................................................................................................6

1.3 INTRODUCTION TO BIOSAFETY ACT..............................................................................................7

1.3.1 PRINCIPLES UNDERLYING THE BIOSAFETY ACT......................................................................7

1.3.2 HOW THE ACT WORKS.............................................................................................................................8

1.4 TO WHAT AND TO WHOM DOES THE BIOSAFETY ACT APPLY?......................................9

1.4.1 TO WHAT GENETICALLY MODIFIED ORGANISM DOES THE BIOSAFETY ACT APPLY?..............................................................................................................................................................9

1.4.2 TO WHOM DOES THE BIOSAFETY ACT APPLY?......................................................................12

1.5 SCOPE OF THE BIOSAFETY ACT.......................................................................................................13

1.5.1 WHAT THE BIOSAFETY ACT DOES NOT APPLY TO...............................................................13

1.6 COVERAGE OF BIOSAFETY ACT IN LIGHT OF EXISTING ENACTMENTS....................14

2. ADMINISTRATION SYSTEM................................................................................................................15

2.1 OVERVIEW...................................................................................................................................................15

2.2 COMPOSITION, ROLES AND RESPONSIBILITIES OF EACH COMPONENT.................15

2.3 PROTECTION..............................................................................................................................................19

3. LICENSING PROCESS..............................................................................................................................20

3.1 OVERVIEW...................................................................................................................................................20

3.2 ACTIVITY TO BE LICENSED................................................................................................................20

3.3 APPLICATION FOR A LICENCE..........................................................................................................21

3.4 CONSIDERING AN APPLICATION.....................................................................................................22

3.4.1 RECEIPT OF APPLICATION ................................................................................................................22

3.5 DETERMINING AN APPLICATION...................................................................................................25

3.6 ISSUE OF LICENCE....................................................................................................................................26

3.7 REVIEW OF DECISION .........................................................................................................................26

3.8 APPEALS....................................................................................................................................................... 27

3.9 EXEMPTIONS..............................................................................................................................................27

3.10 PUBLICATION RELATING TO LICENSING PROCESS..............................................................28

3.11 REGISTER..................................................................................................................................................... 28

3.12 RESPONSIBILITIES OF LICENSEES..................................................................................................29

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3.7 ALLOCATION OF FEES...........................................................................................................................31

4 MONITORING, COMPLIANCE AND ENFORCEMENT...............................................................34

4.1 OVERVIEW...................................................................................................................................................34

4.2 MONITORING.............................................................................................................................................34

4.3 COMPLIANCE..............................................................................................................................................37

4.4 ENFORCEMENT.........................................................................................................................................39

4.5 PUBLICATION RELATING TO MONITORING, COMPLIANCE AND ENFORCEMENT …………………………………………………………………………………………………………………………. 42

4.6 REGISTER OF MONITORING, COMPLIANCE AND ENFORCEMENT ……………..........42

APPENDIX.................................................................................................................................................................................. 44

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1. INTRODUCTION

This introduction provides:

(a) the purpose of the Manual;

(b) the purposes of the Biosafety Act;

(c) a short summary of the Biosafety Act, including the principles essential to the legislation and how the Act works;

(d) to what and to whom the Biosafety Act applies; and

(e) distinguishing the coverage of the Biosafety Act from the coverage of other enactments.1.1 OSE OF THE MANUAL

1.1 PURPOSE OF THE MANUAL

The Biosafety Guidelines and Practices Manual is intended as a reference instrument to assist the Ministry responsible for biodiversity and biosafety matters and Competent National Authorities with applying and administering the Act.

The Manual is intended to explain the legislation and to offer guidance on approaches and procedures. The information contained in the Manual is not meant to present binding rules. Any examples used are for illustrative purposes only and should not be used as authority for any decisions made under the Act.

The sections of the Manual consider various sections of the Biosafety Act. The first section is an overall introduction to the Biosafety Act. At the back of many of the sections are “Key Points”. These pages include summaries of the important things to remember in the preceding section and, in some cases, decision flow charts or tables. They are meant to be used by readers as quick reminders or checklists about a particular topic but are not meant as a substitute for the more comprehensive section content or for referring to the Act and the Regulations.

The Act and Regulations can be found at: http//www.lc.biosafetyclearinghouse.net

Throughout the Manual there are references to “Minister” and “Unit”. These refer to the Minister responsible for biodiversity or biosafety matters, currently the Minister of Education, Innovation, Gender and Sustainable Development.

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Biosafety refers to the prevention of large-scale loss of biological integrity focusing on ecology and human health.

1.2 PURPOSES OF THE BIOSAFETY ACT

One of the purposes of the Biosafety Act is based on the meaning of biosafety.

Another purpose of the Biosafety Act is to implement the Cartagena Protocol on Biosafety and other international instruments. The Cartagena Protocol on Biosafety is an international agreement which covers the transboundary movement, transit, handling and use of living modified organisms that have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health (Article 4).

Transboundary Movement

Movement of genetically modified organisms from

From one country To another country

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1.3 INTRODUCTION TO BIOSAFETY ACT

The Biosafety Act contains measures which are wider than the Cartagena Protocol for regulation of genetically modified organisms including living modified organisms and implementation of the Cartagena Protocol on Biosafety.

1.3.1 PRINCIPLES UNDERLYING THE BIOSAFETY ACT

The Biosafety Act is based on the following principles:

Principle DescriptionPrecautionary Approach

Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of genetically modified organisms on the conservation and sustainable use of biological diversity, taking into account risks to human health, does not prevent taking a decision, as appropriate, in order to avoid or minimize such potential adverse effects.

Risk Assessment Identification of any potential adverse effects of genetically modified organisms on the conservation and sustainable use of biological diversity, taking into account risks to human and animal health

Advance informed agreement procedure

Notification, acknowledgment and decision-making processes under the Protocol form part of the advance informed procedure.

Public awareness and participation

The public to be consulted throughout the decision-making process and the results of decisions made available to the public

Confidential information

A person has the right to request that information identified as part of the procedure be treated as confidential and give justification for the request

Risk Management Establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments

Emergency measures Appropriate steps to be taken to notify potentially affected states and relevant international organizations

Handling, Transport, Packaging and Identification

Measures required for handling, packaging and transporting of genetically modified organisms under conditions of safety taking into account relevant international rules and standards

Requirements on identification require the setting out of information for documentation accompanying shipments of genetically modified organisms. An importer or exporter must ensure that an intentional transboundary movement is accompanied by documentation

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Principle Descriptionidentifying the genetically modified organism and providing contact details of persons responsible for such movement.

Illegal Transbounday Movements

Adoption of appropriate measures aimed at preventing and if appropriate penalizing movements carried out in contravention of such measures

Socio-Economic Considerations

Value of biological diversity to indigenous and local communities must be considered

Polluter pays Person responsible for paying for any damage caused by the genetically modified organism

Review of decision Any decision in relation to the genetically modified organism to be reviewable in certain circumstances

1.3.2 HOW THE ACT WORKS

The Act –

promotes coordination among relevant agencies responsible for plant, animal health, food safety and trade

designates the National Focal Point and Competent National Authorities for the purposes of the Cartagena Protocol on Biosafety

establishes an inter-departmental committee on biosafety establishes a strong and effective mechanism for risk emergency response system for

the environmental release, commercial production and transboundary movement of genetically modified organisms

promotes public participation in and public awareness of biosafety prohibits persons from carrying out activities involving genetically modified organisms

unless a licence is obtained in accordance with the Act establishes a scheme to assess risks to plant, animal and human health associated with

various activities involving genetically modified organisms establishes strong and effective remedies for contravention of the Act provides for reviews of decisions and investigation and resolution of complaints makes provision for monitoring and enforcement creates a centralized, publicly accessible database of all licensed genetically modified

organisms.

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1.4 TO WHAT AND TO WHOM DOES THE BIOSAFETY ACT APPLY?

The Biosafety Act applies to “genetically modified organisms” that are subject to a transboundary movement or movements within Saint Lucia, in transit in Saint Lucia, produced or used in Saint Lucia by any “person”.

1.4.1 TO WHAT GENETICALLY MODIFIED ORGANISM DOES THE BIOSAFETY ACT APPLY?

The Biosafety Act applies to a genetically modified organism

that has genetic material

that is modified by the activity of manipulating recombinant deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) molecules through the use of modern biotechnology;

is specified in the Act.

Genetic material

Genetic material refers to any type of plant, animal, microbial or other origin containing contain nucleic acids consisting of genetic information passed on from parent to offspring. A sequence of nucleic acids responsible for a particular trait is called a gene.

A gene is an example of a nucleic acid consisting of genetic information which controls specific traits, for example, eye colour, fur colour, height, size or other traits of an animal.

Therefore, genetic material covers nucleic acids of plant, animal, microbial or other origin which has genetic information and additionally any material of plant, animal, microbial or other origin, such as entire organisms or parts of organisms that have nucleic acids consisting of genetic information.

Modern biotechnology

for the purposes of the Act modern biotechnology refers to

the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid and direct injection of nucleic acid into cells or organelles; or

fusion of cells beyond the taxonomic family. (Section 2 of the Act)

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In vitro nucleic acid techniques and cell fusion are procedures that permit great evolutionary barriers to be crossed, and for genetic material to be shifted among organisms that have not been known to have genetic contact. Laboratory techniques are used now to directly insert genetic material from one organism into another. These techniques allow for rearrangements of genetic material into combinations that would not occur through recombination events during normal cell and organism reproduction.

As new techniques of changing the genetic information within organisms are evolving every day, the definition of “modern biotechnology” is worded so that new techniques are considered by stating that techniques include “in vitro nucleic acid techniques” and “fusion of cells.”

Living modified organism

Under the Act a living modified organism is a biological entity

capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;

possessed of a novel combination of genetic material; obtained through the use of biotechnology. (Section 2 of the Act)

Organisms specified in the Act

These organisms identified below are specified in the Act:

The Act applies to the following organisms from its commencement

Soyabeans Rice Maize/corn Corn Rose Papaya

Canola/Oilseed/ Carnations Sugar beets Phalaenopsis Tomato PotatoRapeseed sp. Moth orchid

Alfa Alfa Flax/Linseed Lentil Melon Squash Sunflower

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The Act applies to the following organisms from its commencement

Tobacco Wheat

Some organisms listed in the Act are not applicable until the Minister publishes an Order in the Gazette. These organism are:

GM sweetcorn in tins Oil from GM soy beans; margarine from GM soy bean oil; oil from GM rapeseed/canola; cornflakes from GM corn; starch from GM corn; products containing GM corn starch bread with GM soy protein or GM soy flour; glucose (dextrose), glucose syrup and other ingredients with GM corn starch peanut puff snacks tacos containing GM corn starch. Additives which are produced from GM plants:

o sugar from GM sugar beet;o lecithin from GM soy beans;o vitamin E (tocopherol) from GM soy beans; ando cellulose from GM cotton, used as thickening agents and binder

Micro-organisms:o wheat beer with GM yeast;o yeast extract from GM yeast;o Yeast Biomass - S. cerevisiaeo yoghurt with GM lactobacilli (lactic acid bacteria);o salami (raw sausages) with GM lactobacilli (lactic acid bacteria);o Bacterial Biomass - B. lactofermentum (additive in Animal feed)o blue cheese with GM moulds; ando Quorn (protein from protazoa) from GM fungi.

Pharmaceuticals

The Act applies to Pharmaceuticals made from genetically modified products for human use not covered

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by the World Health Organization’s Certification Scheme on Phamaceutical Products Moving in International Commerce

Pharmaceuticals used for animals.

1.4.2 TO WHOM DOES THE BIOSAFETY ACT APPLY?

The Act applies to the Crown and persons generally.

The Crown

The Crown refers to

the Ministers departments of the Government statutory corporations representing the Crown any officers or employees of the Crown or of any Ministers, departments, corporations

or authorities in the performance of his functions as such officers or employees.

Person

Person means an individual human being and includes a legal person, such as a company or any other institution that has a separate legal personality.

Examples

Farmers Supermarkets including Super J Supermarket, Glace Supermarket and Dilly’s Supermarket

Wholesalers, such as Peter & Co., W.B. Hutchinson and Renwick

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Laboratories General public

1.5 SCOPE OF THE BIOSAFETY ACT

1.5.1 WHAT THE BIOSAFETY ACT DOES NOT APPLY TO

The Act does not apply to organisms arising from techniques, such as

in vitro insemination; conjugation; transduction; or any other natural process.

Technique DescriptionIn vitro insemination Process used to make a new organism through

fertilization of an egg outside the body of the organism in a container, such as a plastic dish. Products of this type of insemination are not included in the scope of the Act as they have not undergone a manipulation of genetic material.

Conjugation The transfer of genetic material between cells by direct cell-to-cell contact or by a bridge-like connection between cells. It is equivalent to sexual reproduction or mating because it involves the exchange of genetic material. The genetic information is frequently beneficial to the recipient, for example an antibiotic but sometimes they are not beneficial and act as parasites. Like, in vitro insemination conjugation is not included as the parent genetic material is not altered from its original composition.

Transduction Process whereby without physical contact DNA is transferred from one bacterium to

another by a virus; or

foreign DNA is introduced into another cell by a viral vector.

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Technique Description

Other natural process A natural process is an existing method in or produced by nature rather than the intent of human beings.

1.6 COVERAGE OF BIOSAFETY ACT IN LIGHT OF EXISTING ENACTMENTS

The Biosafety Act will exist together with other enactments that are currently in effect in Saint Lucia that have an impact on genetically modified organisms. It adds to the legislative framework and is not meant to replace any present provisions in any other enactment. Box 1 in the Appendix identifies the areas concerning genetically modified organisms that are covered by other enactments.

KEY POINTSTO WHAT AND WHOM THE BIOSAFETY ACT APPLIES

Genetically modified organisms whose genetic material is modified by modern biotechnology including living modified organisms, pharmaceuticals and genetically modified organisms specified in Schedule 1 to the Act. Some of the genetically modified organisms specified in Schedule 1 will not be regulated until the Minister makes an order to give effect to that part of Schedule 1.

The Biosafety Act applies to all persons both human beings, companies, Departments of Government and Statutory Corporations involved with genetically modified organisms.

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2. ADMINISTRATION SYSTEM

2.1 OVERVIEW

This section covers the administrative structure presented in the Biosafety Act, namely –

the Minister; the Competent National Authority the National Focal Point the Biosafety Committee the Biosafety Scientific and Technical Advisory Sub-Committee the Biosafety Tribunal the Courts.

2.2 COMPOSITION, ROLES AND RESPONSIBILITIES OF EACH COMPONENT

The composition and roles and responsibilities of each component of the administration system is described in the box below.

Component Composition Roles and responsibilitiesThe Minister Person responsible for biodiversity

and biosafety mattersResponsible for the ActAmends Schedules to the ActMakes Regulations on the advice of the Biosafety Committee

Competent National Authority

Chief Veterinary Officer or Designated alternativePlant Protection and Plant Quarantine ServicesMinistry responsible for HealthMinistry responsible for CommercePesticides and Toxic Chemicals Control Board

Receives applications for licenses

Submit applications to the Sustainable Development and Environment Officer

Issue licenses

Maintain records of applications and licenses

Monitor and enforce the ActNational Focal Point

Sustainable Development and Environment Division, Department of Sustainable Development

As the national focal point, the this division has as part of its responsibilities to

Liaise with the Secretariat of the Protocol

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Component Composition Roles and responsibilities Receive, process and

respond to information from the Secretariat

Facilitate national, regional and international information sharing

Serve as the Secretariat of the Biosafety Committee

Keep biosafety website Provide information to the

Biosafety clearing house Create and keep register in

an electronic data storage and retrieval system

Sustainable Development and

Environment Officer

Secretary to the Biosafety Committee

Prepare reports on the Protocol

Liaises with established regional bodies with regard to regional harmonization within the context of regionalization and the Caribbean Community Single Market and Economy

Public Education Specialist Public awareness

Public notification- prepares a summary of the application and distributes it for public feedback

Information Technology Specialist Provide information to the biosafety website and biosafety clearing house

Inspectors Assigned as an inspector by a Competent National Authority under the laws stated in Box 2 in

Monitor and enforce the Act

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Component Composition Roles and responsibilitiesthe Appendix

Appointed to monitor or enforce any biosafety related law to monitor or enforce that legislation specified in the Box 2 in the Appendix

Biosafety Committee

One public officer from o Ministry responsible for

Agricultureo Ministry responsible for

Sustainable Development, Energy, Science and Technology;

o Attorney General’s Chambers;

o Ministry responsible for Health;

o the Ministry responsible for Pharmacies;

o the Ministry responsible for Environmental Health;

o the Ministry responsible for Commerce and Consumer affairs;

o the National Emergency Management Organization;

o the Department of Customs and Excise;

o Saint Lucia Solid Waste Management Authority

o At least four members representing various private sector interests and non-governmental organizations;

the Sustainable Development and Environment Officer who is ex-officio, Secretary to the Committee

Reviews and makes decisions on applications, notifications and petitions in consultation with the Sub-Committee in conformity with the requirements of the Act

Responds to complaints

Establishes administrative mechanisms to ensure the appropriate handling, dissemination and storage of documents and data in connection with the processing of applications and notifications and other matters covered under the Act

Promotes public awareness, education and participation concerning the activities regulated under the Act including through the publication of guidance and other materials that explain and elaborate on the risk assessment, risk management and authorization processes

Monitors development in the area of biotechnology and provide advice and recommendations to the Permanent Secretary and the Minister

Makes recommendations to the National Emergency Management Organization, on appropriate

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Component Composition Roles and responsibilities Co-opted persons

To be dissolved if a body is created for coordination of agricultural health and food safety and its duties exercised by that body

emergency measures in order to minimize any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health

Makes recommendations to the Pharmacy Council or the Bureau of Standards for labelling requirements for pharmaceuticals used for human and animal health

Consults with and obtain assistance from a Competent National Authority or any other Ministry or Department of Government in the areas identified in Box 3 in the Appendix

Biosafety Scientific and Technical Advisory Sub-Committee

Set up by the Minister on the recommendation of the Biosafety Committee

Consists of experts from the following fields

agronomy molecular biology toxicology human health environmental science socio-economic

development animal health experience in areas related

to the fields

Co-opted members including persons from regional or other countries, with expert knowledge or experience

Conduct risk assessments

Review risk assessment

Review and determine risk management and risk communication measures

Make recommendations on application, other appropriate scientifically sound conditions and risk management measures; and

Provide such other expert advice and assistance

Establish a sub-sub-committee drawn from governmental agencies or independent institutions

Regulate its own proceedings.

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Component Composition Roles and responsibilitiesBiosafety Tribunal Established under of the Act

consists of three or five members, appointed by the Chief Justice

headed by a Chairperson who is a legal practitioner of not less than five years standing

other members training or experience in one or more of the following or related areas

o agronomyo molecular biology

o toxicologyo human healtho environmental science

Hear and determine appeals made by persons

against any decision made by the Biosafety Committee under the Act including the exercise of enforcement powers under the Act; and

complaints

Co-opted persons Assist and advise the Tribunal

Recording Secretary appointed by the Chief Justice

No voting rights

Keep a written record of all proceedings of the Tribunal

The Courts Magistrate Issue warrantsImpose penalties

Judge Hear and determine further appeals

2.3 PROTECTION

An action cannot be made against the Biosafety Committee or any person acting under the Biosafety Act for anything done or omitted to be done in good faith and in the administration or discharge of any functions, duties or powers under the Act. An act or omission is performed in good faith if the person performing the act or omission does so with a sincere purpose without taking an unfair advantage over another person or to fulfill any promise to act or not to act.

KEY POINTSBIOSAFETY ADMINISTRATION SYSTEM

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MinisterResponsible for the Act

Competent National AuthorityReceives application for a licence and issues licence

Monitor and enforce the Act

Sustainable Development and Environment DivisionSecretariat

Biosafety CommitteeDecision Making

Biosafety Scientific and Technical Advisory Sub-CommitteeRisk Assessment

Biosafety TribunalHears and determines appeals and complaints

The CourtsIssue warrants

Impose punishmentHears and determines further appeals

3. LICENSING PROCESS

3.1 OVERVIEW

This section presents the licensing process for activities involving genetically modified organisms adopted in the Act.

A person cannot carry out any activities involving a genetically modified organism until the person is issued with a licence in that regard under the Act.

3.2 ACTIVITY TO BE LICENSED

The licenses and the activities for which they apply are identified below.

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CONTAINED USE LICENCEAny operation or activity, in which a genetically modified organism is produced, grown, stored, destroyed or used in some other way in a laboratory, installation or other physical structure in which stringent physical barriers are employed either alone or together with chemical or biological barriers, to limit contact between the genetically modified organism on the one hand and humans and the environment on the other hand

DIRECT USE AS FOOD, FEED OR PROCESSING LICENCEIncludes activities that result in genetically modified fruits or vegetables for human consumptiongenetically modified soya or corn intended for processing into edible oilsgenetically modified grain for feeding to animalsgenetically modified organisms used in industrial processing in the productionof plastics and oils

INTENTIONAL INTRODUCTION INTO THE ENVIRONMENT LICENCEDeliberate release of a genetically modified organism for which no specific containment measures are in place to limit their contact with and to provide a level consideration for safety for the general population and the environmentIncludesthe use of genetically modified organisms in field trialsthe growing of agricultural genetically modified organismsthe release of transgenic fishDoes not include a genetically modified organisms imported for direct use for food, feed or for processing

IMPORT LICENCETo bring into Saint Lucia a genetically modified organism

EXPORT LICENCETo take out of Saint Lucia a genetically modified organism

TRANSIT AND TRANSSHIPMENT LICENCETo pass through Saint LuciaTo transfer from one form of transport to another

3.3 APPLICATION FOR A LICENCE

All applications must be

addressed to the Secretary of the Biosafety Committee; submitted to the Competent National Authority in triplicate as follows:

Type of organism Competent National AuthorityAnimals Chief Veterinary Officer or his or

her designatePlants Plant Protection and Plant

Quarantine ServicesPharmaceuticals Ministry responsible for HealthImport or export Ministry responsible for CommercePesticide or toxic chemical Pesticides and Toxic Chemicals

Control Board

in the form set out as Form 1 in Schedule 1 to the Regulations; accompanied with the application fee as specified in Schedule 2 to the

Regulations.

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PUNISHMENT FOR MAKING AN APPLICATION FOR A LICENCE DELIBERATELY OR CARELESSLY USING FRAUD, DECEPTION, MISREPRESENTATION, MISLEADING OR INACCURATE INFORMATION

$10,000 Imprisonment for a term of 2 years Both $10,000 and imprisonment for 2 years

PUNISHMENT WHEN ACTIVITY NOT LICENSED

Fine of $10,000/imprisonment for 10 years/both Dispose by destruction in accordance with the Waste Management Act and to the satisfaction of the

Competent National Authority (at the expense of the person who does not have the licence) (not relevant to contained use licence)

Genetically modified organism subject to quarantine procedures under the Quarantine Act.

An application may be submitted through the slubiosafety@govt.lc, or by hard copy forms downloaded from the website at www.govt.lc or lc.biosafetyclearinghouse.net and mailed, faxed or emailed to the Competent National Authority.

If the activity is not within the control of the Competent National Authority, the Competent National Authority should contact the applicant to confirm that they have applied in the right Authority, and to redirect the applicant to the correct Competent National Authority, if necessary.

Confidential information

An applicant can identify information provided in an application which is to be treated as confidential and may have to justify claims of confidentiality if requested to do so.

Confidential information does not include The name and address of the applicantA general description of the genetically modified organismA summary of risk assessments performed on the genetically modified organismAny methods and plans for emergency response

An application may be withdrawn by an applicant at any time before the issue of a licence.

3.4 CONSIDERING AN APPLICATION

3.4.1 RECEIPT OF APPLICATION

On receipt of an application, the Competent National Authority will keep one copy of the application and submit 2 copies of the application to the Sustainable Development and Environment Officer responsible for biodiversity. In the case of an application that may multi-sectoral, the Competent National Authority will submit a copy of the application to the relevant Competent National Authority and the Sustainable Development Officer responsible for biodiversity.

If an application does not include all the prescribed information, the Sustainable Development and Environment Officer may treat the application as invalid. The Sustainable Development and Environment Officer should directly and as soon as possible contact the applicant to request missing information. If an application is multi-sectoral, the Sustainable Development and Environment Officer will submit the application to the relevant Competent National Authority.

Generally, the Sustainable Development and Environment Officer should not complete applications on behalf of applicants using information held on file as this information could be

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out dated. In addition, procedural fairness issues could arise if the Sustainable Development and Environment Officer takes information into account without the knowledge of the applicant.

To fulfill record keeping responsibilities, the Sustainable Development and Environment Division should retain records of incomplete applications. The Biosafety Act does not specify how much time applicants have to provide missing or extra information requested by the Sustainable Development and Environment Officer. The Sustainable Development and Environment Officer should set reasonable timeframes for applicants to supply this information taking into consideration:

• the amount and complexity of the information requested

• the applicant’s capacity to provide information in that timeframe, and

• whether a timeframe applies to when the applicant must submit the application.

If an applicant does not supply the information requested by the Sustainable Development and Environment Officer, a record of the incomplete application must be retained.

Once satisfied that the application is valid, the Sustainable Development and Environment Officer will keep one copy of the application and submit the other copy to the Biosafety Committee.

Timeframe for assessing an application

The timeframe for processing an application does not begin until an application is valid.

When calculating the timeframe, the day the application is received is included. “Day” means calendar day. However, if the last day of the timeframe falls on a non-business day, the next business day will be the last day.

Timeframe for assessing an applicationType of application TimeframeContained use licence The Act does not specify the time for

assessment of an application. This means it must be done as soon as possible.

Direct use as food, feed or processing licence The Act does not specify the time for assessment of an application. This means it must be done as soon as possible.

Intentional Introduction Into the environment licence

The Act does not specify the time for assessment of an application. This means it must be done as soon as possible.

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Import licence For first imports only advance informed agreement procedure must be followed and, if all information is submitted, a decision must be communicated within 270 days from receipt of application.

within 90 days of receipt of application, Sustainable Development and Environment Division is to acknowledge receipt of application in writing

within 10 days of receipt of the risk assessment report submitted by the Sub-Committee, the Committee will provide the risk assessment report to the applicant for comments

within 30 days of receipt of the risk assessment report, the applicant will submit comments, in writing, on the risk assessment to the Committee

where additional information is requested, final written decision to be provided within 60 days of receipt of additional information

Export licence The Act does not specify the time for assessment of an application. This means it must be done as soon as possible.

Transit and Transhipment licence The Act does not specify the time for assessment of an application. This means it must be done as soon as possible.

Following the Advance Informed Agreement procedure in the case of first imports, a failure by

the Sustainable Development and Environment Division to acknowledge receipt of an application does not imply its consent to an import for intentional introduction into the environment

the Biosafety Committee to communicate its decision within 270 days of the date of receipt of the application does not imply its consent to an import for intentional introduction into the environment and the applicant may be informed that the period specified in the Act is extended by a defined period of time.

When the Biosafety Committee receives an application, it may take any of the following actions:

Actions to be taken on receipt of application

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Type of application Actions

Application for contained use licence Request in writing that the applicant provide additional information including a risk assessmentCause the laboratory, installation or physical structure to be inspected and reported on by the Physical Planning and Development Division

Application for import licence for intentional introduction into the environment

Submit the application for the conduct of a risk assessment by the Biosafety Scientific and Technical Advisory Sub-Committee

Request additional information if required and inform the applicant of the procedure to be followed in taking further action on the application

Require that a Social Impact Assessment is carried out if the introduction of the genetically modified organism could significantly affect the social, ethical or religious values of Saint Lucia

All applications Acknowledge receipt in writing within 90 days

Accept claims to confidentiality and at all times preserve and aid in preserving confidentiality except if under legal obligation.

Refuse a claim to confidentiality, inform the applicant of its decision to disclose the information providing the applicant with the reasons for its decision and review any comments submitted by the applicant and notify the applicant before disclosing the confidential information

Communicate decision on application within 270 days

The matters to be considered by the Biosafety Committee when considering an application are specified below.

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Matters to be considered The information submitted in the applicationThe risk assessment reportWritten comments of the applicant in consultation with the Sub-CommitteeAny relevant comments submitted by the publicSocio-economic considerations on the basis of a Social Impact Assessment Best available scientific evidence or ecological principlesPrecautionary approach where little or no scientific evidence is available In the case of an application for a contained use licence, the report and any representation made concerning the laboratory, installation or other physical structure by the applicant

3.5 DETERMINING AN APPLICATION

Granting a licence

The Biosafety Committee may grant a licence or impose any condition it considers appropriate on granting a licence.

Refusal to grant

The Biosafety Committee may refuse to grant a licence.

Giving notice of the determination

In the case of an import licence, within 270 days of the date of receipt of an application, the Biosafety Committee will communicate, in writing, to the applicant and to the Public Education Specialist who will inform the Biosafety Clearing-House of the decision -

approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same genetically modified organism

prohibiting the import.

On the recommendation of the Biosafety Committee, the Competent National Authority must notify an applicant of the grant or refusal and give reasons in writing for the grant with conditions or refusal to grant a licence.

The Biosafety Committee will submit its recommendation to the Competent National Authority for the grant with or without conditions or refusal of a licence.

3.6 ISSUE OF LICENCE

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If granted, the Competent National Authority must issue the licensee a licence. A licence issued by the Competent National Authority must be in the forms specified in Forms 2-6 of the Schedule 1 to the Regulations and be issued on payment of the licence fee of $200 for a licence for contained use, direct use as food, feed or processing, intentional introduction into the environment and import and $100 for a licence for export and transit and transshipment as specified in Schedule 2 of the Regulations.

The Biosafety Act does not specify how much time the Competent National Authority has to issue the licence. This means it must be done as soon as possible after the recommendation to grant the licence is provided.

Duration and effect of licence

A licence issued under this Act is valid for the period specified in the licence. A licence issued pursuant to the Biosafety Act, unless the licence provides otherwise, authorizes only the licensee to engage in the activity identified in the licence in relation to the genetically modified organism identified in the licence.

3.7 REVIEW OF DECISION

The Biosafety Committee may, at any time, in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health, review and change a decision regarding the grant or refusal of a licence.

Where the Committee changes a decision, the Biosafety Committee will, within 30 days, inform any licensee of that decision setting out the reasons for its decision.

Any person may request the Committee to review a decision it has made in respect of a licence if that person considers that

a change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based; or

additional relevant scientific or technical information has become available.

When a request is made to the Committee, it will, within 90 days, respond in writing to the request setting out the reasons for its decision.

3.8 APPEALS

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A decision to refuse to grant a licence, to grant a licence subject to conditions, suspend or revoke a licence is a reviewable decision under the Biosafety Act.

An applicant or licensee can, within 30 days from receipt of notice of the decision, appeal in writing to the Tribunal, setting out the grounds on which the appeal is made.

Before determining an appeal referred to it under the Act, the Tribunal will give the applicant, licensee or Committee the opportunity of appearing before and being heard by it.

3.9 EXEMPTIONS

The Biosafety Committee may exempt any provision of the Biosafety Act in the instances stated below.

ExemptionsSufficient experience or information exists to conclude that a genetically modified organism does not pose a significant risk to the conservation and sustainable use of biological diversity taking into account risks to human healthAdequate measures are applied to ensure the safe intentional transboundary movement of living modified organismsIt is agreed by a meeting of the parties to the Cartagena Protocol on Biosafety that a genetically modified organism is not likely to have adverse effects on the conservation and sustainable use of biological diversity and human health. However, this may not always be the case as research continues.

When the Biosafety Committee determines that an exemption can be made, it will send its recommendations to the relevant Competent National Authority.

A person can also make a petition to the Biosafety Committee for an exemption from the requirements of the Act. The procedure for a petition for exemption is indicated in the diagram below.

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3.10 PUBLICATION RELATING TO LICENSING PROCESS

The Public Education Specialist must publish in the Gazette and at least two newspapers in general and at least weekly circulation, or in any other media in Saint Lucia a summary of an application, decision, cancellation or notice within the timeframes specified below.

Nature of publication TimeframeApplication for licence Within one week after review by Sustainable

Development and Environment OfficerDecision on application ImmediatelyPetition for exemption Within ten days of receiptDecision on petition for exemption ImmediatelyNotice of appeal On receipt Decision on appeal On the making of the decisionSuspension, revocation or change of decision Immediately

The person to whom any application, decision, cancellation or notice relates is responsible for paying the costs of the publication.

When the publication is made, members of the public can submit comments on an application, decision, cancellation or notice within 14 days of its publication. The comments will then be submitted by the Public Education Specialist to the Sustainable Development and Environment Officer to be considered by the Biosafety Committee when making a determination.

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3.11 REGISTER

The Sustainable Development and Environment Division must create and keep a register that contains the information set out below.

Information on the registerOn an application, information includingName and address of applicantDate of applicationGenetically modified organism in relation to which the application is being madeDate and effect of a decision on an applicationPetitions for exemptionDate and effect of decision on petition for exemptionAppeal and the decision on the appealSuspension, revocation or change of decision of a licence

The register can be kept in an electronic form and a person can obtain information in the register and take copies of the information on the payment of $1.00 per page.

3.12 RESPONSIBILITIES OF LICENSEES

The responsibilities of a licensee stated in the Biosafety Act are as follows:

Type of Licence Responsibility of LicenseeContained use licence Take safety precautions

Conduct good microbiological practice Keep records

Direct use as food, feed or processing licence

Labelling of all products above a limit of 0.9%

Indication in writing to operator receiving a product containing GMORetain information on GMO for a minimum of 5 years

Intentional Introduction Into the Environment licence

When making a genetically modified organism available to third parties whether in return for payment or free of charge (placing on the market)

must ensure that information is transmitted in writing to the recipient of the product that the product contains or consists of a genetically modified organism

for use only and directly as food or feed or for processing shall ensure that a declaration of use in the form set out as Form 8 in Schedule 1 to the Regulations and a list of the genetically modified organism that has been used to constitute the mixture is transmitted in writing to the recipient of the product

must have in place, for five years from each transaction,

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Type of Licence Responsibility of Licenseesystems and standardized procedures to allow the holding of information and the identification of the sender and recipient to whom the products have been made available

Import or export licence Ensure that documentation accompanying the genetically modified organism that is intended for import or export clearly identifies the genetically modified organism and specifies

a brief description of the organisms, including common and scientific name, relevant traits and genetic modification, including transgenic traits and characteristics such as events of transformation or, where available and applicable, a reference to a system of unique identification

any requirements for safe handling, storage, transport and use of the genetically modified organisms as provided under applicable existing international requirements, the Act or Regulations made under the Act, or under any agreement entered into by the importer and exporter

the contact point for further information the name and address of the importer and exporter a declaration specified as form 9 of Schedule 1 to the

Regulations that the movement is in conformity with the requirements of the Protocol.

Ensure that documentation accompanying a genetically modified organism that is intended for import for contained use is clearly identified as a genetically modified organism destined for contained use and specify

a brief description of the organisms, including common and scientific names;

the name, address and contact details of the consignee and importer or exporter

any requirements for safe handling, storage, transport and use of the genetically modified organism under applicable existing international instruments, this Act or Regulations made under the Act or under any agreements entered into by the importer and exporter;

where appropriate, further information should include the commercial names of the genetically modified organism, if available, new or modified traits and genetic modification, including transgenic traits and characteristics such as events of transformation, risk class, specification of use, any unique identification, where available, as a key to accessing information in the Biosafety Clearing House

a declaration in the form set out as Form 8 in Schedule 1 to the Regulations that the movement is in conformity with the requirements of the Protocol.

All licenses Give information when requested on any activity with a genetically

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Type of Licence Responsibility of Licenseemodified organism

Labelling and documents to accompany packaging when transported (See regulations 16,17 and 18 of the Biosafety Regulations)

Segregation and transport by road (See regulations 19 and 20 of the Biosafety Regulations)

Advise the Biosafety Committee of any significant new scientific information indicating that a genetically modified organism may

adversely affect the conservation and sustainable use of biological diversity, taking into account risks to human health

pose potential risks not previously known or considered the measures put in place to ensure the continued safe use of

the genetically modified organism.

3.7 ALLOCATION OF FEES

The fees collected under the Act must be paid into the National Conservation Fund.

Saint Lucia is one of the parties participating in the Caribbean Challenge Initiative and as such has committed to creating a National Conservation Fund. It is envisaged that the Caribbean Biodiversity Fund will disburse funds to the National Conservation Fund so that Saint Lucia will have sustainable sources of revenue for the conservation of biological resource and management of protected areas. Finance for biosafety related expenses including the operation of lab facilities and risk management will be taken from this Fund.

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KEY POINTSLICENSING PROCESS

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3 MONITORING, COMPLIANCE AND ENFORCEMENT

4.1 OVERVIEW

In this section of the manual monitoring, compliance and enforcement are highlighted. The Biosafety Act contains provisions on monitoring, compliance and enforcement.

4.2 MONITORING

Purpose

A monitoring activity assesses compliance with the Biosafety Act generally or with specific obligations. A Competent National Authority can then make informed decisions about any further regulatory actions that may be necessary. Monitoring can be directed at a licensee or activity. Competent National Authorities should use monitoring activities to influence compliance with the Biosafety Act. Information obtained through monitoring assists National Competent Authorities identify issues requiring a regulatory response and assess the effectiveness of previous regulatory interventions. Monitoring also provides a strong incentive for licensees to comply with their statutory obligations.

There are various forms of monitoring activities, set out in the table below.

Monitoring ActivitiesType Description BenefitsRisk assessment Assesses all risks posed by a

genetically modified organism.Must be carried out in accordance with Annex III of the Cartagena Protocol (See Box 4 in the Appendix) with the necessary modifications taking into account recognized risk assessment techniques.A risk assessment report giving the opinion, with justifications, on the grant or refusal of an application and an indication of any measures or actions that

An applicant will provide the - characteristics of the recipient,

parental organism and donor organisms;

characteristics of the genetically modified organism;

safety considerations for human and animal health;

environmental considerations; socio-economic considerations; risk management plan (See

regulation 21 of the Biosafety Regulations for requirements);

monitoring plan; control of release; waste treatment; emergency response plan; and

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Monitoring ActivitiesType Description Benefits

need to be taken to ensure the safe use of the genetically modified organism to be prepared.

other available scientific evidence;in order to identify and evaluate the possible adverse effects of a genetically modified organism on the conservation and sustainable use of biological diversity, taking into account risks to human health.

Costs of the risk assessment or review of risk assessment paid by the applicant.

Risk Management Ensures appropriate mechanisms, measures or strategies are in place to regulate, manage and control risks identified during the risk assessment process or under the ActImposes mechanisms, measures or strategies to the extent necessary to prevent adverse effects of a genetically modified organism on the conservation and sustainable use of biological diversity, taking into account risks to human health.

Order published in the Gazette declaring the area to be a genetically modified control area or a genetic resource centre.Prevention of any genetically modified organism which has an adverse effect on the conservation and sustainable use of biological diversity taking into account risks to human

Prevents the adverse effects of a genetically modified organism on the conservation and sustainable use of biological diversity, taking into account risks to human health.

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Monitoring ActivitiesType Description Benefits

health from entering the free zone.

Consultation with persons making notification of unintentional introduction into the environment

Person will provide notification of unintentional introduction into the environment with the following information

available relevant information on the estimated quantities and relevant characteristics or traits of the genetically modified organism;

information on the circumstances and estimated date of the introduction of the genetically modified organism;

any available information about the possible adverse effect on the conservation and sustainable use of biological diversity or risk to human health, as well as available information about possible risk management measures;

any other relevant information; and

a point of contact for further information.

Determines whether any action is necessary to minimize any adverse effect on the conservation and sustainable use of biological diversity taking into account risks to human health.Risk management measures will be imposed and the operator will have to take the necessary action and pay any costs associated with such action.

The following are notified of the unintentional introduction into the environment

affected or potentially affected countries or persons;

the Sustainable Development and Environment Division which will in turn notify the Biosafety Clearing-House established under the Protocol;

where appropriate, relevant international organizations; and

the National Emergency Management Organization.

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4.3 COMPLIANCE

The compliance measures available under the Biosafety Act are as set out below.

Compliance measuresType Description Form Effect PunishmentCancellation of application (section 41)

An application is cancelled if the applicant does not provide additional information as requested within 30 days of the information being requested.

None Applicant of the cancellation and return the cancelled application to the applicant

None

Conditions on licence

Requirement that the person holding the licence must comply

None Failure to comply with any condition is a contravention of the Act

Suspension or revocation of licence (See below)

Suspension or revocation of licence

Licence suspended or revoked if the licensee –

has been convicted of an offence under the Act or the Regulations made under the Act

fails to comply with the conditions imposed on the licence

in the opinion of the Committee, new information or a review of existing information about the genetically modified organism establishes risks to human or animal health, biological diversity or the environment, based on the precautionary approach.

Competent National Authority gives to the licensee notice in writing of the proposal and reasons for the proposal invites the licensee to show reasons in writing or otherwise why the Committee should not proceed as proposed within 21 days

Licensee given notice in writing of the revocation and information concerning the right of appeal under the Act

None Destruction of any growing organism and the sterilization of the soil in which they are being grown in accordance with any applicable law and on payment of compensation.

None

Cessation notice and imposition of additional risk management measures

Issued where there is an imminent danger posed to the conservation and sustainable use of biological diversity, taking into account risks to human health, on the basis of -

Form 12 of Schedule 1 to the Regulations

Causes the immediate cessation of any activity covered by a licence and

$50,000, imprisonment for a term not exceeding six years or to

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Compliance measuresType Description Form Effect Punishment(section 63) tests conducted and evaluated in

a manner consistent with accepted scientific procedures; or

other validated scientific evidence.

Obtain assistance from a police officer to ensure that the cessation notice is complied with.

for the immediate imposition of additional risk management measures with respect to such activity.

both fine and imprisonment

Notice to remedy contravention (section 64)

Issued where it appears that a person has failed, refused or neglected to comply with the requirements of the Act.

Form 13 in Schedule 1 to the Regulations

Specifies the remedy to be employed and the time in which the person must remedy the contravention

$2,000.

Entry and execution of remedial works (section 65)

Entry onto land and taking of steps to remedy contravention where the steps required to be taken under a notice to remedy contravention have not been taken within the period specified in the notice.

No form required

The person to whom the notice to remedy contravention relates is responsible for paying for the steps taken.

Pay a fine not exceeding $10,000 for obstruction or interference

Order for payment of compensation (section 66)

Issued where loss or damage is caused by the contravention of the Act.Damage refers to an adverse effect on the conservation and sustainable use of biologicial diversity, taking into account risks to human health, that –

is measurable or otherwise observable taking into account, wherever available, scientifically established baselines that takes into account any other human induced variation and natural variation; and

is significant on the basis of factors, such as –

o the long-term or permanent change, to be understood as change that will not be redressed through natural recovery within a reasonable period of time,

Form 14 in the Schedule 1 in the Regulations

The person to whom the order relates is responsible for paying for the loss or damage caused by contravention of the Act.

None

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Compliance measuresType Description Form Effect Punishment

o the extent of the qualitative or quantitative changes that adversely affect the components of biological diversity,

o the reduction of the ability of components of biological diversity to provide goods and services,

o the extent of any adverse effects on human health in the context of the Protocol.

Injunctive relief through the court system (section 67)

Institute a civil action for an injunction through the Attorney General’s Chambers

None Prevents any person from violating the provisions of the Act

Enforces any notice to remedy contravention or a cessation notice

None

4.4 ENFORCEMENT

Inspections

An inspector has power to enter premises if he has a reasonable suspects that there is an imminent danger posed to the conservation and sustainable use of biological diversity, taking into account risks to human health, or has to conduct an investigation into a complaint. (Section 57)

An inspector may enter the premises and do the things listed below.

Actions an inspector may takeInspect and gather informationBring any equipment or material required for exercising the power

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Actions an inspector may takeRequire that the premises be left undisturbed for the purpose of any test or inspection, records from the occupier of the premises or any person to help with the investigationTake samplesCopy or take an extract from a record at the premisesDo any other act or thing necessary or convenient to be done to carry out an inspection

In exercising these powers the inspector must

show proof of identity receive consent from the occupier of the premises when consent is not obtained the inspector has to obtain a warrant under section 58 of

the Biosafety Act not use force in executing the warrant unless he is accompanied by a police officer and

the use of force is specifically authorised in the warrant.

Any costs incurred by an inspector in exercising the powers under the Act must be paid by the person being inspected.

Offences relating to inspections

Assault or obstruction of an inspector

Pay not more than $5000/Imprisonment for not more than one year/both

Failure to give an inspector assistance or informationKnowingly giving false information to an inspectorGiving information that prevents the inspector from exercising his powersOffering inducement to prevent an inspector from exercising powers

Forfeiture

Forfeiture is provided as an option of enforcement under the Biosafety Act. The Two types of forfeiture are described below.

Forfeiture by consent Owner or person in lawful possession at the time of seizure of a genetically modified organism, product or thing willfully gives consent in writing to the forfeiture of the genetically modified organism, product or thing to the Crown.

Forfeiture by the Court Person found guilty by a court of committing an offence

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against the Act is ordered by the court to forfeit to the Crown anything produced to the court that relates to the commission of the offence.

Before making the order the court must give an owner or interested parties an opportunity of being heard to give reasons for not making the order.

The Competent National Authority on the advice of the Biosafety Committee will give the Court directions on the manner of sale or other disposal.

An application for the release of forfeited property may be made to the Competent National Authority by a person

other than the convicted person whose property has been forfeited to the Crown who has any right or claim or an interest in, or ownership of, any such property that is

recognized by fairness within twenty-eight days of the conviction that led to the forfeiture.

When considering an application for the release of forfeited property, the Competent National Authority should consider the matters listed below.

Considerations when deciding an application for the release of forfeited propertyRelationship between the person applying for release of the property and the person convicted of the offenceExtent to which the applicant was in a position to foresee that the property would be used in connection with the commission of an offence against the Act when it passed to the possession of the offender

After considering an application, the Competent National Authority, on the advice of the Committee, may order the release of the forfeited property on payment to the Crown of an amount the Competent National Authority thinks appropriate, being an amount that does not exceed the amount the property forfeited would, in the estimation of the Committee, be likely to realize if sold by public auction.

Offences

The violations for failing to adhere to the Act have been identified above. (See punishment in the sections on Categories of licences, Application for licence, Compliance and Inspection.)

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Complaints

4.5 PUBLICATION RELATING TO MONITORING, COMPLIANCE AND ENFORCEMENT

The Public Education Specialist has to publish in the Gazette and at least two newspapers in general and at least weekly circulation or in any other media in Saint Lucia a summary of any cessation notice, notice to remedy cause of contravention issued under the Biosafety Bill or complaint received.

4.6 REGISTER OF MONITORING, COMPLIANCE AND ENFORCEMENT

The register created and kept by the Sustainable Development and Environment Division should contain information on any cessation notice, notice to remedy cause of contravention or complaint.

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KEY POINTSMONITORING, COMPLIANCE AND ENFORCEMENT

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MONITORING

Risk AssessmentRisk ManagementConsultation with person making notification of intentional introduction into the environment

COMPLIANCE

Cancellation of applicationConditions on granted licenceSuspension or revocation of licenceCessation noticeNotice to remedy contraventionEntry and execution of remedial worksOrder for payment of compensationInjunctive relief

ENFORCEMENT

InspectionsForfeitureOffencesComplaints

APPENDIX

Box 1

Enactment/Draft Legislation CoverageAgricultural Small Tenancies Act, Cap. 5.03

Regulation of small agricultural tenancies.

Animals (Disease and Importation) Act, Cap. 7.17

Control of the importation of animals, birds, reptiles and insects and regulation of diseased animals.

Draft Food Safety Act Food safety.Fisheries Act, Cap. 7.15 Marine reserves and aquaculture.

Plant Protection Act, Cap. 7.12 Control of pests and diseases injurious to plants and the prevention of the introduction of exotic species.

Praedial Larceny Act, Cap. 3.05 Prevention of praedial larceny.Water and Sewerage Act, Cap. 9.03 Management of water resources.

External Trade Act, Cap. 13.11 Control the importation and exportation of goods.

Free Zone Act, Cap. 15.17 Establishment and operation of free zones.

Education Act, Cap. 18.01 Provision of a regulatory system for the delivery of educational services in Saint Lucia.

Customs (Control and Management) Act, Cap. 15.05

Regulation of goods entering and leaving a customs port, airport or area.

Special Development Areas Act, Cap. 15.29

Designation of certain areas as special development areas.

Public Health Act, Cap. 11.01 Promotion and preservation of the health of Saint Lucians.

Physical Planning and Development Act, Cap. 5.12

Provides for the use of land.

Shipping Act, Cap. 13.27 Regulation of packaging and handling of dangerous goods.

Cultural Development Foundation Act, Cap. 17.04

Regulation of the promotion, development and management of

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Enactment/Draft Legislation Coveragethe arts and culture.

Constituency Council Act, No. 1 of 2012

To establish Constituency Councils to assist with the management of resources to be used for the development of constituencies.

Disaster Management Act, No. 30 of 2006

Makes provision for the mitigation of, preparedness for, response to and recovery from emergencies and disasters.

Land Conservation and Improvement Act, Cap. 5.10*

Ensures proper conservation and improvement of land and water resources.

National Conservation Authority Act, Cap. 6.01

Controls, maintains or develops beaches and protected areas.

Pesticides and Toxic Chemical Control Act, Cap. 11.15

Regulation of pesticides and toxic chemicals.

Pharmacy Act, Cap. 11.21 Regulation of the supply of drugs and poisons.

Standards Act, Cap. 13.25 Makes provision for the preparation and promotion of standards in relation to goods, services, processes and practices.

Saint Lucia Air and Sea Ports Authority Act, Cap. 8.13

Makes provision for co-ordinated and integrated systems of airports, seaports and port services.

Saint Lucia National Trust Act, Cap. 6.02

Promotion and preservation for the benefit and enjoyment of Saint Lucia of submarine and subterranean areas of beauty of natural or historic interest and preservation of their natural aspect, features, animals and plant life.

Box 2

InspectorsCompetent National Authority Legislation

Animals (Disease and Importation) Act, Cap. 7.17,External Trade Act, Cap. 13.11, Pesticides and Toxic Chemicals

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Control Act, Cap. 11.15, Pharmacy Act, Cap. 11.21,Plant Protection Act, Cap. 7.12, Quarantine Act, Cap. 11.16 Veterinary Surgeons Act, Cap. 11.09.

Appointed to monitor and enforce biosafety related legislation

Agricultural Small Tenancies Act, Cap. 5.03;Cultural Development Foundation Act, Cap. 17.04;Customs (Control and Management) Act, Cap. 15.05;Disaster Management Act, No. 30 of 2006;Draft Food Safety Act;Education Act, Cap. 18.01;Fisheries Act, Cap. 7.15;Forest, Soil and Water Conservation Act, Cap. 7.09;Free Zone Act, Cap. 15.17;Land Conservation and Improvement Act, Cap. 5.10;National Conservation Authority Act, Cap. 6.01;Physical Planning and Development Act, Cap. 5.12;Praedial Larceny Act, Cap. 3.05;Public Health Act, Cap. 11.01;Saint Lucia Air and Sea Ports Authority Act, Cap. 8.13;Saint Lucia National Trust Act, Cap. 6.02;Shipping Act, Cap. 13.27;Special Development Areas Act, Cap. 15.29;Standards Act, Cap. 13.25;Water and Sewerage Act, Cap. 9.03.

Box 3

The areas for consultation and assistance are highlighted in the table below:

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Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

Ministry of Agriculture, Food Production, Fisheries and Rural DevelopmentMinister responsible for agriculture As a preventative

measure may declare specified measures for good husbandry.

Veterinary Authority (Competent National Authority)

Veterinary officers may give veterinary attention and animal husbandry advisory and supervisory services to Government Departments, institutions and livestock projects and such other services relating to animal health and animal husbandry.

Collect information.

Periodic reviews of the operations of license holders in the course of inspection duties.

Fisheries Aquaculture, fisheries research and marine reserves.

Plant Protection and Plant Quarantine Services (Competent National Authority)

Regulate the importation of plant material if it threatens agricultural resources of Saint Lucia.

Designated officers may stop, and without warrant search and examine a person, receptacle or carrier and seize, detain, treat, destroy or otherwise dispose of planting material.

Perform periodic reviews 49

Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

of the operations of license holders in the course of inspection duties.

Public education and awareness campaigns geared at informing farmers and other agricultural partners about modern biotechnology, the Act and how they can give feedback through the various outlets for public education and participation.

Pesticides and Toxic Chemicals Control Board (Competent National Authority)

Regulate the use of pesticides or toxic chemicals to ensure that they do not pose an undue threat of harm to human or animal health or safety. Pesticides originating from genetically modified organisms may be listed as prohibited or restricted for importation.

Ministry of Commerce, Business Development, Investment and Consumer Affairs

Commerce and Industry (Competent National Authority)

Regulate the importation or exportation of goods, such as frozen fish, meat and processed goods.

Consumer Affairs Recall of products and inform the Ministry responsible for health.

Free Zone Management Authority In considering an application, take into consideration whether the proposed business

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Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

enterprise will not have a deleterious effect on the environment having regard to any environmental impact assessment made for the purpose.

Saint Lucia Bureau of Standards Prepare and promote standards.

Develop standards for handling, production, import and labeling.

Establish Laboratory Accreditation Scheme for national laboratories

Inspectors to enforce periodic review of policy.

Ministry of Education, Human Resource Development and LabourMinistry of Education Prescribing the course

and curricula for students of the various divisions in teachers’ colleges.

Ministry of Finance and Economic AffairsCustoms and Excise Department Examine and take

account of goods imported or exported and search persons who are arriving in or leaving Saint Lucia.

Comptroller of Customs notifies plant quarantine of the arrival of planting material.

Customs officer detains goods and notifies relevant authority of arrival of relevant goods.

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Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

Minister responsible for finance Regulate activities in special development areas.

Ministry of Health, Wellness, Human Services and Gender RelationsEnvironmental Health Containment of

organisms considered harmful to health and the environment.

Safety of food produced in, imported into or exported from Saint Lucia to ensure safety and quality of food.

Chief Medical Officer As Quarantine Authority under the Quarantine Act can assist with emergency measures.

Pharmacy Council (Competent National Authority)

Impose standards and requirements for packaging, labeling, storage and dispensing of pharmaceuticals.

Ministry of Home Affairs and National SecurityRoyal Saint Lucia Police Force Enforce the Praedial

Larceny Act which prohibits the stealing of agricultural produce through crop production, animal husbandry, aquaculture, mariculture, horticulture or forestry for profit or subsistence.

Provide assistance for enforcement of the Biosafety Act.

Implement training programmes.

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Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

Ministry of Infrastructure, Port Services and TransportSaint Lucia Air and Sea Ports Authority Assists with enforcement

of the provisions of any law relating to quarantine.

Transport Regulate the packing and stowing of goods that may be dangerous and the precautions that should be taken in relation to such goods on ships.

Ministry of Legal AffairsCourts Impose penaltiesLegislative Drafting Unit Enact legislation and

amend legislationMinistry of Physical Development, Housing and Urban Renewal

Physical Planning and Development Division Allocate land for conservation and for use for agricultural, residential, industrial, commercial, touristic, institutional, recreational or other purposes specified in the plan.

Compile lists of places of natural beauty or natural interest, including submarine and subterranean areas, and their flora and fauna.

Where it is desirable to afford special protection to any area, the Minister may by Order published in the Gazette declare that area to be an environmental protection area.

Ministry of Sustainable Development, Energy, Science and Technology, Energy, Science and Technology

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Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

Forestry Department To declare any land other than Crown lands to be a protected forest for the preservation of health.

Land Conservation Board Advise on land use on matters concerning land conservation and improvement of land. Protection Order to restrict the cultivation of crops.

National Conservation Authority Preservation of flora and fauna from any negative effects of any activity.

Water Resource Management Serve a notice on occupiers of land where an act or omission of good agricultural practice is likely to cause pollution to water.

Saint Lucia National Trust Advise on preservation of submarine and subterranean areas of beauty of natural or historic interest from adverse effects of genetically modified organisms.

Solid Waste Management Authority Help in decision making regarding disposal.

Assist in inspection of sites after remediation efforts.

Ministry of Transformation, Local Government and Community EmpowermentConstituency Councils Make recommendations

to the Minister on programmes and projects which will benefit constituencies.

To build relevant

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Competent National Authority/Department/Statutory Body

Areas for Consultation/Assistance

databases with respect to the constituency in collaboration with other government departments.

Ministry of Tourism, Heritage and the Creative IndustriesCultural Development Foundation Undertake research into

various aspects of culture.

Office of the Prime MinisterNational Emergency Management Organisation

Risk management, risk assessment and risk communication involving genetically modified organisms.

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Box 4

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Annex IIIRISK ASSESSMENTObjective1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.Use of risk assessment2. Risk assessment is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms. General principles3. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations.4. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk.5. Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.6. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.Methodology7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances.8. To fulfil its objective, risk assessment entails, as appropriate, the following steps:(a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health;(b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism;(c) An evaluation of the consequences should these adverse effects be realized;(d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;(e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and(f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.Points to consider9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects:(a) Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, centres of origin and centres of genetic diversity, if known, and a description of the habitat where the organisms may persist or proliferate;(b) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organisms;(c) Vector. Characteristics of the vector, including its identity, if any, and its source or origin, and its host range;(d) Insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced;(e) Living modified organism. Identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms;(f) Detection and identification of the living modified organism. Suggested detection and identification methods and their specificity, sensitivity and reliability;(g) Information relating to the intended use. Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and(h) Receiving environment. Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity and centres of origin of the likely potential receiving environment.