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

It is intended to assist personswho are subject to the Act.

This Manual suppliesadditionalinformationon the Biosafety Act,supportingRegulations andclarifies the functions with respect to the administration of the Act.

The Manual presents guidelines and proposes best practices, not binding rules. Any scenariosor 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 isdoubt on the proper application of the Act.

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

The Sustainable Development and Environment Division

Department of Sustainable Development

Ministry of Education, Innovation, Gender and Sustainable Development

Caribbean Cinemas

Choc

Saint Lucia

Email:

Website:lc.biosafetyclearinghouse.net

Phone: 1(758)451 8746

Fax: 1(758) 450 1904

Contents

1.INTRODUCTION

1.1PURPOSE OF THE MANUAL

1.2PURPOSES OF THE BIOSAFETY ACT

1.3INTRODUCTION TO BIOSAFETY ACT

1.3.1PRINCIPLES UNDERLYING THE BIOSAFETY ACT

1.3.2HOW THE ACT WORKS

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

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

1.4.2TO WHOM DOES THE BIOSAFETY ACT APPLY?

1.5SCOPE OF THE BIOSAFETY ACT

1.5.1WHAT THE BIOSAFETY ACT DOES NOT APPLY TO

1.6COVERAGE OF BIOSAFETY ACT IN LIGHT OF EXISTING ENACTMENTS

2.ADMINISTRATION SYSTEM

2.1OVERVIEW

2.2COMPOSITION, ROLES AND RESPONSIBILITIES OF EACH COMPONENT

2.3PROTECTION

3.LICENSING PROCESS

3.1OVERVIEW

3.2ACTIVITY TO BE LICENSED

3.3APPLICATION FOR A LICENCE

3.4CONSIDERING AN APPLICATION

3.4.1RECEIPT OF APPLICATION

3.5DETERMINING AN APPLICATION

3.6ISSUE OF LICENCE

3.7REVIEW OF DECISION

3.8APPEALS

3.9EXEMPTIONS

3.10PUBLICATION RELATING TO LICENSING PROCESS

3.11REGISTER

3.12RESPONSIBILITIES OF LICENSEES

3.7ALLOCATION OF FEES

4MONITORING, COMPLIANCE AND ENFORCEMENT

4.1OVERVIEW

4.2MONITORING

4.3COMPLIANCE

4.4ENFORCEMENT

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

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

APPENDIX

1.Introduction

Thisintroduction provides:

(a)the purpose of the Manual;

(b)the purposes of the BiosafetyAct;

(c)a shortsummary of the BiosafetyAct, including the principles essentialto thelegislation and how the Act works;

(d)to what and to whom the BiosafetyActapplies; and

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

1.1Purpose 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 Authoritieswith 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//

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.

1.2PURPOSES OF THE BIOSAFETY ACT

One of the purposes of the Biosafety Actis 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

1.3INTRODUCTION 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.

1.3.1PRINCIPLES UNDERLYING THE BIOSAFETY Act

The Biosafety Act is based on the following principles:

Principle / Description
Precautionary 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 identifying 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

1.3.2HOW 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 licensedgenetically modified organisms.

1.4TO 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”.

1.4.1TO 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;
  • isspecified in the Act.

Genetic material

Genetic materialrefers 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 thathave nucleic acids consisting of genetic information.

Modern biotechnology

for the purposes of the Act modern biotechnologyrefers 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)

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 everyday, 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 organismis 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 Potato
Rapeseed sp. Moth orchid

Alfa Alfa Flax/Linseed Lentil Melon Squash Sunflower

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:
  • sugar from GM sugar beet;
  • lecithin from GM soy beans;
  • vitamin E (tocopherol) from GM soy beans; and
  • cellulose from GM cotton, used as thickening agents and binder
  • Micro-organisms:
  • wheat beer with GM yeast;
  • yeast extract from GM yeast;
  • Yeast Biomass - S. cerevisiae
  • yoghurt with GM lactobacilli (lactic acid bacteria);
  • salami (raw sausages) with GM lactobacilli (lactic acid bacteria);
  • Bacterial Biomass - B. lactofermentum (additive in Animal feed)
  • blue cheese with GM moulds; and
  • Quorn (protein from protazoa) from GM fungi.

Pharmaceuticals
The Act applies to
  • Pharmaceuticals made from genetically modified products for human use not covered by the World Health Organization’s Certification Scheme on Phamaceutical Products Moving in International Commerce
  • Pharmaceuticals used for animals.

1.4.2TO 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

Laboratories /
General public

1.5SCOPE OF THE BIOSAFETY Act

1.5.1WHAT 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 / Description
In 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.

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

1.6coverage of biosafety Act in light of existing enactments

The Biosafety Act willexist 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 1in the Appendixidentifies the areas concerning genetically modified organisms that are covered by other enactments.

KEY POINTS
TO 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.

2.ADMINISTRATIon system

2.1OVERVIEW

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.

2.2composition,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 responsibilities
The Minister / Person responsible for biodiversity and biosafety matters / Responsible for the Act
Amends Schedules to the Act
Makes Regulations on the advice of the Biosafety Committee
Competent National Authority / Chief Veterinary Officer or Designated alternative
Plant Protection and Plant Quarantine Services
Ministry responsible for Health
Ministry responsible for Commerce
Pesticides 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 Act
National 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
  • 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 the Appendix
Appointed to monitor or enforce any biosafety related law to monitor or enforce that legislation specified in the Box 2 in the Appendix / Monitor and enforce the Act
Biosafety Committee /
  • One public officer from
  • Ministry responsible for Agriculture
  • Ministry responsible for Sustainable Development, Energy, Science and Technology;
  • Attorney General’s Chambers;
  • Ministry responsible for Health;
  • the Ministry responsible for Pharmacies;
  • the Ministry responsible for EnvironmentalHealth;
  • the Ministry responsible for Commerce and Consumer affairs;
  • the National Emergency Management Organization;
  • the Department of Customs and Excise;
  • Saint Lucia Solid Waste Management Authority
  • 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
  • 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 / 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 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 recommendationson 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 itsown proceedings.
Biosafety 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
  • agronomy
  • molecular biology
  • toxicology
  • human health
  • 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 warrants
Impose penalties
Judge / Hear and determine further appeals

2.3Protection

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.