Introduction to Law International, UE, French Dispositions introduction to law... · Introduction to Law International, UE, French Dispositions ... ISPM No. 23 (2005) ... release

Introduction to LawInternational, UE, French Dispositions

Dominique COUTINOTEuropean Biological Control Laboratory

USDA – ARSMontferrier-sur-Lez

France, [email protected]

www.ars-ebcl.org

QUARANTINE CONTAINMENT – IMPORTS and EXPORTS

Dominique COUTINOT – March 21, 2011

Manager of quarantine activity, Airfreight Security,

Biological Control and Environment

Co-host of the Informal Group of Containment

Explorations in Europe, North Africa,

Cambodia, Croatia, Kazakhstan,

Republic of Georgia, Turkey

Contribution to the establishment of Biological Control Agents in the U.S.A.

USDA-ARSCampus de Baillarguet

Montferrier-sur-Lez (34)France

[email protected]

Dominique COUTINOT

• Hierarchy of the texts (Norms - standards)

• The French Constitution

• International law

• EU legislation

• French legislation

• French regulations

D. COUTINOT 2011. Introduction to Law – International, European Union, French Dispositions

I. Introduction to Law

An evoked text is presented according to:

- its hierarchical level, - its degree of importance, - its date of publication, - on the international, EU and national level.

- It is important to recall that the legal provisions apply to any person or morals, public or private.


I. Introduction to Law

International

provisions

UE provisions

Regulation

Directive

Advice

Decision

French

provisions Law

Decree

Ordinance

Circular

Codification

Constitution

Agreement - Convention - Treaty

International Standards

Regional Standards

©D. COUTINOT 2011. Introduction to Law – International, European Union, French Dispositions

I.1 HIERARCHY OF NORMS

October 4th, 1958

- located at the top of the hierarchy of the standards

- described the essential values of the country and basic rights recognized with the individuals and the groupings.

The Constitution organizes the relations between- executive power- legislative power - justice authority

it specifies the operation of these three entities.


I.2 The French Constitution

- the Constitution,

- the declaration of the human rights and the citizen of 1789,

- the preamble to the Constitution of 1946,

- the preamble to the Constitution of 1958,

- the organic law concerning with the adoption of the finance laws of the Constitution of 1958,

- the constitutional law relating to the charter of the environment of 2005,

Organic law : “text voted by the Parliament according to a particular procedure and having for object the organization of the public authorities and the application of the Constitution”


I.2 The Block of constitutionality

Can amongst other things emit decisions relating to control of constitutionality of the standards.

These decisions are essential:

- with the public authorities

- with all the administrative authorities and jurisdictional.


I.2 The Constitutional council

- Important - Very often incomplete- Suffer from slowness in its implementation

agreement - charter - convention - pact - protocol – treaty

In France any text of international significance must be:- adoptee - ratified- promulgated- published with the Journal Officiel de la République française


I.3 International Law

Convention

- when it qualifies bilateral agreements,

- get busy for technical matters,

in particular in consular, tax and customs right.

Agreement

In practice international: agreement - charter convention - pact -protocol - treaty, are employed in an indifferent way.

In international law - agreement gets along of any international engagement.

In practice constitutional French, it acts of an international engagement subjected to the approval of the government.

Consular right = commercial justice

Ratification - Accession - Acceptance - Approval


I.3 Convention

Regulation

• Adoptee by the Council of Ministers of the UE,

• Of general interest,

• Applicable directly in any Member State,

• Into force: the twentieth day after its publication with the J.O.C.E. (exceptcontrary provisions),

• Be integrated automatically into the internal legal order of the MemberStates,

• Under national legislative provisions without preliminary transcription.


I.4 EU Provisions

Decision

- Text of direct application,

- Constitutes an obligatory act,

- In all its elements for the recipients whom it designates:

Member States,

Private individuals,

Natural people or morals.


I.4 UE Provisions

Directive

- Addresses itself to the Member States recipients

- Dregs as for the result to reach within a time limit.

- The States keep the control of the form and the means necessary to achieve the goal laid down by the directive.

- Must be transcribed in the international law of each State throughlegislative measures or lawful.


I.4 EU provisions

Advice

- Do not involve legal obligation

- Formulated following an external initiative

Contains:

- a general appreciation of certain processes

- a contribution to the preparation of later legal documents.


I.4 EU provisions

Law

- Voted by the Parliament,

- Must be not opposite to the higher legal standards.

- After its coding: declines itself in the form of articles within the codes concerned (L & R)

Codes: Rural - Environment - Customs –Labor - Public health


I.5 French Law

Decree

- Executory decision often with general range determining the generalprinciples,

- Signed by the President of the Republic or the Prime Minister very oftencontresigned by the ministers in charge of the application,

- Must be in conformity with the legislation, opinion is taken near the Council of State.


I.5 French Law

Ordinance

(Ministerial order – decision – decree)

in application to the decree by:

- the Government,

- central services or outsides of the Ministries,

precises and clarifies the law.

It can be taken by the prefect, the mayor or the vice-chancellor.


I.5 French Law

Circular

- Very often ministerial

- Technical document

- Frame the operation of the legislative measures or lawful.


I.5 French Law

International provisions

EU provisions

French provisions

French regulations

Administrative

Agreements-Conventions-Protocoles

International standards

Regulations - Decisions-Directives-Advices

Laws - Codification

Codes : Rural-Environment

Customs - Labor

Decrees – Ordinances - Circulars

Circulars-Notes of information

Constitution


I.6 HIERARCHY OF NORMS

InternationalDispositions

UEDispositions

Regulation

Directive

Advice

Decision

FrenchLaw Law

Decree

Ordinance

Circular

Codification

Constitution

SPM Agreement

IPPC Convention

CBD Convention

CITES Convention

IIPC Standard NIMP 3 EPPO Standards PM6

OECD Advices


Nagoya Protocol ABS Regime

II. INTERNATIONAL

The agreement instituting the World Trade Organization

(WTO) outline agreement including a series of multilateral

agreements:

- General Agreement on Tariffs and Trade (GATT)

- the agreement on the technical obstacles with the trade (OTC)

- the agreement on sanitary and phytosanitary measures (SPM)

- the agreement on agriculture

- the agreement on the aspects of the intellectual property laws

which touch with trade (ADPIC).


II.1 Agreements of Marrakech 1994

The Agreement on the application of sanitary and phytosanitary measures

(SPM) of World Trade Organization (WTO - GATT 1994)

-Applies to sanitary and phytosanitary measures who directly can

or indirectly affect the international trade.

-It makes it possible to take sanitary and phytosanitary measures

necessary to the protection of health and the life of the people and

the animals or with the safeguarding of the plants, under

conditions.

- These measures can be taken only if they are founded on

scientific principles, they should not in no case to establish an

arbitrary or unjustified discrimination between the members.


II.1 The SPM Agreement

The object is the prevention of the dissemination and the

introduction of pest.

• Promotion and adoption of measures against pests

• Legislative measures, lawful and technical

• Official organization of the protection of the plants

• Concern the plants, crop products, stock rooms, packing,

containers, ground, objects and materials likely to carry or

disseminate harmful organisms.

• Parties can: “to prohibit or restrict the entry on their territory of

agents of biological control and other organisms of plant health

importance considered beneficial” (Art.VII.1.d.).

1951 – revised in 1997 – into force October 2, 2005


II.2 The IPPC Convention

any species,

strain or biotype of plant, animal

or pathogen agent

harmful for plants

or crop products.

Harmful Organism - Pest


II.2 IPPC

ISPM No. 1 (2006) Phytosanitary principles for the protection of plants and the application of phytosanitary measures in international trade

ISPM No. 2 (2007) Framework for pest risk analysis

ISPM No. 3 (2005) Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms

ISPM No. 4 (1995) Requirements for the establishment of pest free areas

ISPM No. 5 (2009) Glossary of phytosanitary terms

ISPM No. 6 (1997) Guidelines for surveillance

ISPM No. 7 (1997) Export certification system

ISPM No. 8 (1998) Determination of pest status in an area

ISPM No. 9 (1998) Guidelines for pest eradication programmes

ISPM No. 10 (1999) Requirements for the establishment of pest free places of production and pest free production sites

ISPM No. 11 (2004) Pest risk analysis for quarantine pests, including analysis of environmental risks and living modified organisms

ISPM No. 12 (2001) Guidelines for phytosanitary certificates

ISPM No. 13 (2001) Guidelines for the notification of non-compliance and emergency action

ISPM No. 14 (2002) The use of integrated measures in a systems approach for pest risk management

ISPM No. 15 (2009) Guidelines for regulating wood packaging material in international trade

ISPM No. 16 (2002) Regulated non-quarantine pests: concept and application

ISPM No. 17 (2002) Pest reporting

ISPM No. 18 (2003) Guidelines for the use of irradiation as a phytosanitary measure

ISPM No. 19 (2003) Guidelines on lists of regulated pests

ISPM No. 20 (2004) Guidelines for a phytosanitary import regulatory system

ISPM No. 21 (2004) Pest risk analysis for regulated non-quarantine pests

ISPM No. 22 (2005) Requirements for the establishment of areas of low pest prevalence

ISPM No. 23 (2005) Guidelines for inspection

ISPM No. 24 (2005) Guidelines for the determination and recognition of equivalence of phytosanitary measures

ISPM No. 25 (2006) Consignments in transit

ISPM No. 26 (2006) Establishment of pest free areas for fruit flies (Tephritidae)

ISPM No. 27 (2006) Diagnostic protocols for regulated pests

ISPM No. 28 (2009) Phytosanitary treatments for regulated pests

ISPM No. 29 (2007) Recognition of pest free areas and areas of low pest prevalence

ISPM No. 30 (2008) Establishment of areas of low pest prevalence for fruit flies (Tephritidae)

ISPM No. 31 (2008) Methodologies for sampling consignments

ISPM No. 32 (2009) Categorization of commodities according to their pest risk


II.2 INTERNATIONAL STANDARDS FOR

PHYTOSANITARY MEASURES (ISPMs)

ISPM No. 3 (2005) Guidelines for the export, shipment,

import and release of biological control agents and other

beneficial organisms

« ISPM 3.1996. ex. Code of conduct for the importation and the

release of exotic BCAs».

• Principle: A biological control agent can be

potentially harmful

• Risk management: Export, Forwarding, Importation

& release of BC agents

• Responsabilities: Contracting parties, NOPP

Importing & ExportingD. COUTINOT 2011. Introduction to Law – International, European Union, French Dispositions

II.2 The ISPM n°3

THE USE AND EXCHANGE OF BIOLOGICAL CONTROL AGENTS

FOR FOOD AND AGRICULTURE

BACKGROUND STUDY PAPER NO. 47. October, 2009

prepared at the request of the Secretariat of the Commission on Genetic

Resources for Food and Agriculture by the Global Commission on Biological

Control and Access and Benefit-Sharing of the International Organization for

Biological Control of Noxious Animals and Plants (IOBC), as a contribution to

the cross-sectoral theme,

Consideration of policies and arrangements for access and benefit-

sharing for genetic resources for food and agriculture, which the

Commission will consider at its Twelfth Regular Session.

Matthew J.W. Cock; Joop C van Lenteren; Jacques Brodeur; Barbara Barratt; Franz Bigler; Karel Bolckmans; Fernando L Cônsoli; Fabian Haas;

Peter G Mason; José R Parra. 2009. Do new Access and Benefit Sharing procedures under the Convention on Biological Diversity threaten the

future of Biological Control? Biocontrol


II.2 or II.3 Before the Nagoya Meeting

European and Mediterranean Plant Protection Organization

1951

50 MEMBERS

10 REGIONAL STANDARDS FOR PHYTOSANITARY MEASURES

• Evaluation biologique des produits phytosanitaires

• Bonne pratique phytosanitaire en agriculture et en

protection des plantes.

• System for risk evaluation

• Mesures phytosanitaires générales

• Mesures phytosanitaires par organisme nuisible

• Procédures phytosanitaires

• Production de végétaux sains destinés à la plantation

• Analyses du Risque Phytosanitaire (ARP)

• Safe use of Biological Control

• Protocoles de diagnostic pour les organismes réglementés

• Mesures phytosanitaires par marchandise

• Systèmes de lutte nationaux réglementaires


II.2 The EPPO Organization

http://www.eppo.org/index.htm

EPPO Standards on Safe use of Biological Control

PM 6/1(1) 1999. FIRST IMPORT OF EXOTIC BIOLOGICAL

CONTROL AGENTS FOR RESEARCH UNDER CONTAINED

CONDITIONS

Advices from the national authority: installations of containment and

procedures. General precautions: packing, people handling, health

risks animal and human and respect of conventions and regulations in

force.

PM 6/2(2) 2010. IMPORT AND RELEASE OF EXOTIC BIOLOGICAL

CONTROL AGENTS

File for releasing, evaluation of the risks, environmental impact,…

PM 6/3(2) 2002. List of biological control agents widely used in

the EPPO region

List of commercially biological control agents and list it BCA

introduced successfully into the OEPP area.


II.2 The EPPO Standards


II.2 The NEPPO a new organization

Signed in 1993, Rabat, MoroccoEffective: January 8, 2009

Organization:•President: Dr Mohamed ElHaj AlOOBA (Soudan)•Vice president: Dr Hassan Kacem Mohamed BEKHEIT (Egypt)•Executive Director: M Mekki CHOUIBANI (Morocco)•Executive Comitee: Algeria Jordan, Libya, Pakistan, Syria et Tunisia.

Near East Plant Protection Organization(NEPPO)

AlgeriaEgyptJordanLibyaMalte

MoroccoPakistanSoudan

SyriaTunisia

Avenue Hadj Ahmed Cherkaoui,Rabat, Agdal, Morocco

[email protected]


Guidance for Information Requirements for Regulation of Invertebrates as

Biological Control Agents (IBCAs), 2004.

INSECTS, ACARINA & NEMATODES

- NORMALLY MORE SPECIFIC THAN THE CHEMICALS

- LESS HIGH RISKS

- USE SUCCESSFULLY WITHOUT SIGNIFICANT DAMAGE

RECOMMENDATIONS FOR THE OECD COUNTRIES (33)

- CATCH IN CONSIDERATION OF THE RISKS

- LIST OF THE IBCA USE SUCCESSFULLY

- HARMONIZATION OF THE REQUIREMENTS TO RELEASE IT

- TO MAKE SURE OF THE EFFECTIVENESS OF BCA PRODUCTS


II.2 The OECD Guidance

Evaluation of Risks

• Identity and characterization

• Biology and ecology

• Geographical distribution

• Information relative with the

human health

• Evaluation of the risks for the

environment

• Evaluation of the effectiveness

• Quality control

• Benefit of the use

Information

before the introduction of a

biological control agent (OECD, 2004)

It is highly advised to contact the indicated national authority, in order to take

note of the national requirements relating to the development of the evaluation

dossier of the risks.

© A. Blanchet

COUTINOT, D. 2006. An evaluation of the risks before the introduction of biological control agent ? ».

AFPP - Avignon, October 11-12 2006. pp 343-350.

II.2 The OECD Guidance

Rio de Janeiro, 1992 1st article - Objectives

- conservation of biological diversity,

- the durable use of its elements

- a satisfactory access to the genetic resources,

- the division right and equitable of the advantages rising from the

exploitation of the genetic resources,

- a satisfactory access to the genetic resources

- suitable transfer of the relevant techniques, taking into account all

the rights on these resources and to the techniques,

- an adequate financing.D. COUTINOT 2011. Introduction to Law – International, European Union, French Dispositions

II.3 Convention on Biological Diversity

Although recognized by the CDB as management method biological

control against invading exotic plants is only object of rare

programs in the European Union:

-In England: biological control program against Fallopia

japonica (Japanese knotweed) by using an insect Spyllidae

Aphalara itadori

-In France: in the island “La Réunion”, it should be noted the

recent introduction of Cibdela janthina (Hymenoptera:

Tenthredidae) against Rubus alceifolius (Rosaceae).

T. Le Bourgeois © Cirad, 2008

Article 8h. Each party:

“Prevents from introducing, control or eradicates the exotic species

which threaten of the ecosystems, the habitats or the species”


II.3 CBD

The Nagoya Protocol on Access to Genetic Resources and

the Fair and Equitable Sharing of Benefits Arising from their

Utilization to the Convention on Biological Diversity was

adopted at the tenth Conference of the Parties on 29th

October 2010, in Nagoya, Japan.

The objective is the fair and equitable sharing of the benefits

arising from the utilization of genetic resources.

The Protocol is the instrument for the implementation of the

ABS provisions of the Convention.

Open to signature February 2, 2011 to February 1, 2012.

COUTINOT Dominique.ESA International Branch Meeting, Mini Symposium. San Diego, California. December 12, 2010

II.3 New Protocol to the Convention on

Biological Diversity

II.3 The Nagoya Protocol Annex I

MONETARY AND NON-MONETARY BENEFITS

1.Monetary benefits may include, but not be limited to:

(a)Access fees/fee per sample collected or otherwise acquired; (b)Up-front payments; (c)Milestone payments; (d)Payment of royalties;

(e)Licence fees in case of commercialization; (f)Special fees to be paid to trust funds supporting conservation and sustainable use of

biodiversity;

(g)Salaries and preferential terms where mutually agreed; (h)Research funding; (i)Joint ventures; (j)Joint ownership of relevant intellectual

property rights.

2.Non-monetary benefits may include, but not be limited to:

(a)Sharing of research and development results;

(b)Collaboration, cooperation and contribution in scientific research and development programmes, particularly biotechnological research

activities,

where possible in the Party providing genetic resources;

(c)Participation in product development;

(d)Collaboration, cooperation and contribution in education and training;

(e)Admittance to ex situ facilities of genetic resources and to databases;

(f)Transfer to the provider of the genetic resources of knowledge and technology under fair and most favourable terms, including on

concessional

And preferential terms where agreed, in particular, knowledge and technology

that make use of genetic resources, including biotechnology, or that are relevant to the conservation and sustainable utilization of biological

diversity;

(g)Strengthening capacities for technology transfer;

(h)Institutional capacity-building;

(i)Human and material resources to strengthen the capacities for the administration and enforcement of access regulations;

(j)Training related to genetic resources with the full participation of countries providing genetic resources, and where possible,

in such countries;

(k)Access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories

and taxonomic studies;

(l)Contributions to the local economy;

(m)Research directed towards priority needs, such as health and food security, taking into account domestic uses of genetic resources

in the Party providing genetic resources;

(n)Institutional and professional relationships that can arise from an access and benefit sharing agreement and subsequent collaborative

activities;

(o)Food and livelihood security benefits;

(p)Social recognition;

(q)Joint ownership of relevant intellectual property rights.

February 6, 2011 ... Algeria, Brazil, Colombia and Yemen has signed the Nagoya Protocol

- The international trade of the specimens of fauna and flora

regulates wild fauna and flora,

- Relates to export, the reforwarding and the importation of plants

and of live animals or died or their parts and products.

- On the basis of certificate and system of license which can be

delivered so certain conditions are met.

- Each party indicates a body of management, charged to issue

these licenses and certificates.

- The animal species and vegetable, subjected to regulation are

registered with the appendices of Convention.

Washington 3 mars 1973 – into force July 1st 1975.

Amended at Bonn, June 22, 1979


II.4 The CITES Convention

2.5 INTERNATIONAL CONVENTIONSConvention internationale pour la réglementation de la chasse à la baleine. Washington, 2 décembre 1946

Convention internationale pour la protection des végétaux. Rome, 1951

Convention internationale pour la conservation des thonidés de l’Atlantique. Rio de Janeiro, 14 mai 1960

Convention relative aux zones humides d’importance internationale, particulièrement comme habitat des oiseaux d’eaux.

Ramsar, 2 février 1971

Convention concernant la protection du patrimoine mondial culturel et naturel. Paris, 16 novembre 1972

Convention sur le commerce international des espèces de faune et de flore sauvages menacées d’extinction (CITES).

Washington, 3 mars 1973

Convention sur la pêche et la conservation pour les pêcheries et la conservation des ressources biologiques dans la mer Baltique

et les Belts. Gdansk, 13 septembre 1973

Convention sur la protection du milieu marin de la zone de la mer Baltique. Helsinki, 22 mars 1974

Convention pour la protection de la mer Méditerranée contre la pollution. Barcelone, 16 février 1976

Convention sur la conservation des espèces migratrices appartenant à la faune sauvage. Bonn, 23 juin 1979

Convention relative à la conservation de la vie sauvage et du milieu naturel de l’Europe. Berne, 19 septembre 1979

Convention sur la future coopération multilatérale dans la pêche de l’Atlantique du Nord-Est. Londres, 18 novembre 1980

Convention relative à la conservation du saumon dans l’Atlantique nord. Reykjavik, 2 mars 1982

Convention sur le droit de la mer. Montego Bay, 1982

Convention pour la protection de la couche d’ozone. Vienne, 22 mars 1985

Convention sur l’évaluation de l’impact sur l’environnement dans un contexte transfrontière. Espoo, 25 février 1991

Convention relative à la protection des Alpes. Salsbourg, 7 novembre 1991

Convention sur la protection et l’utilisation des cours d’eau transfrontières et des lacs internationaux. Helsinki, 17 mars 1992

Convention sur la protection de la mer noire contre la pollution. Bucarest, 21 avril 1992

Convention-cadre des Nations Unies sur les changements climatiques. New York, 9 mai 1992

Convention sur la diversité biologique (CDB). Rio de Janeiro, juin 1992

Convention pour la protection du milieu marin de l’Atlantique du Nord-Est (OSPR). Paris, 22 septembre 1992

Convention concernant la coopération pour la protection et l’utilisation durable du Danube. Sofia, 29 juin 1994

Convention sur l’accès à l’information, la participation du public au processus décisionnel et à l’accès à la justice

en matière d’environnement.

Aarhus, 25 juin 1998

Convention internationale relative à la protection du Rhin. 12 avril 1999, n’est pas en vigueur

Convention européenne du paysage. Florence, 20 octobre 2000

Traité international sur les ressources phytogénétiques pour l’alimentation et l’agriculture. Rome, 3 novembre 2001

BIOPROSPECTION FOR SCIENTIFIC PURPOSES

with the title of Plant Protection

and/or Biodiversity

PrinciplesSovereign rights of each Country

Right of Property

Concerns

Research Institutes,

Public and Private Laboratories or Companies, or Universities

Moral or IndividualCOUTINOT Dominique.ESA International Branch Meeting, Mini Symposium. San Diego, California. December 12, 2010

II. International Principles

International

Dispositions

UE

Legislation

French

Legislation Law

Decree

Ordinance

Circular

Codification

Constitution

Agreement – Convention

International standards Regional standards

Directive 2000/29/CE

Directive 91/414/CE


Phytopharmacological products

UE Prohibitions


III. EU DISPOSITIONS

Scientific Conditions

Regulation 1107/2009/CE - June 14, 2011

Directive 2000/29/CE (77/93/CEE codified) of the Council of May 8th, 2000.

Relate to the protection measures against the introduction into the

Community of harmful organisms to the plants or the crop products and

against their propagation inside the Community.

List of pests whose introduction and dissemination are prohibited:

Appendix I.

List of pests whose introduction and dissemination are prohibited

so present on certain plants or crop products: Appendix II.

List plants or crop products whose introduction is prohibited:

Appendix III.

Plants, crop products and other objects subjected to particular

requirements: Appendix IV.

List plants, crop products and other objects having to be subjected to a

plant health inspection on the place of production:

annexes V: part A for EC , annexes V: part B for third country

rectifiée par : (4) rectificatif publié au J.O.C.E. n° L 002 du 07.01.2003, p. 40.rectificatif publié au J.O.C.E. n° L 045 du 19.02.2003, p. 28. rectificatif publié au J.O.U.E. n° L 137 du

31.05.2005, p. 48. modifiée par : (1) directive 2001/33/CE du 8 mai 2001(2) directive 2002/28/CE du 19 mars 2002 (3) directive 2002/36/CE du 29 avril 2002 (5) directive 2002/89/CE du 28

novembre 2002 (6) directive 2003/22/CE du 24 mars 2003 (7) directive 2003/47/CE du 4 juin 2003 (8) directive 2003/116/CE du 4 décembre 2003 (9) directive 2004/31/CE du 17 mars 2004

(10) directive 2004/70/CE du 28 avril 2004 (11) directive 2004/102/CE du 5 octobre 2004 (12) directive 2005/15/CE du 28 février 2005 (13) directive 2005/16/CE du 2 mars 2005 (14) directive

2005/77/CE du 11 novembre 2005.

III.1 Directive 2000/29/CE

10. Conotrachelus nenuphar (Herbst)

10.1. Diabrotica barberi Smith et Lawrence

10.2. Diabrotica undecimpunctata howardi Barber ]

10.3. Diabrotica undecimpunctata undecimpunctata

Mannerheim

10.4. Diabrotica virgifera Le Conte

11. Heliothis zea (Boddie)

11.1. Hirschmanniella spp, à l'exception de Hirschmaniella

gracilis (de Man) Luc et Goodey

12. Liriomyza sativae Blanchard

13. Longidorus diadecturus Eveleigh et Allen

14. Monochamus spp. (non européen)

15. Myndus crudus Van Duzee

16. Nacobbus aberrans (Thorne) Thorne et Allen

« 16.1 Naupactus leucoloma Boheman » [modifié par (3)]

17. Premnotrypes spp. (non européen)

18. Pseudopithyophthorus minutissimus (Zimmermann)

19. Pseudopithyophthorus pruinosus (Eichhoff)

20. Scaphoideus luteolus (Van Duzee)

21. Spodoptera eridania (Cramer)

22. Spodoptera frugiperda (Smith)

23. Spodoptera litura (Fabricius)

24. Thrips palmi Karny

26. Xiphinema americanum Cobb sensu lato (populations

non européennes)

27. Xiphinema californicum Lamberti et Bleve-Zacheo

1. Acleris spp. (non européen)

2. Amauromyza maculosa (Malloch)

3. Anomala orientalis Waterhouse

4. Anoplophora chinensis (Thompson)

« 4.1Anoplophora glabripennis (Motschulsky) » [(3)]

5. Anoplophora malasiaca (Forster)

6. Arrhenodes minutus Drury »

7. Bemisia tabaci Genn. (populations non-européennes)

vecteur de virus tels que :

(a) Bean golden mosaic virus

(b) Cowpea mild mottle virus

(c) Lettuce infectious yellows virus

(d) Pepper mild tigré virus

(e) Squash leaf curl virus

(f) Euphorbia mosaic virus

(g) Florida tomato virus

8.Cicadellidae (non européens) connus en tant que vecteurs de

la maladie de Pierce (causée par Xylella

fastidiosa), tels que :

(a) Carneocephala fulgida Nottingham

(b) Draeculacephala minerva Ball

(c) Graphocephala atropunctata (Signoret)

9. Choristoneura spp. (non européen)

a) Insects, acarinae and nematodsAPPENDIX I Part A

III.1 Directive 2000/29/EC

(a) Anastrepha fraterculus (Wiedemann)

(b) Anastrepha ludens (Loew)

(c) Anastrepha obliqua Macquart

(d) Anastrepha suspensa (Loew)

(e) Dacus ciliatus Loew

(f) Bactrocera cucurbitae Coquillett

(g) Bactrocera dorsalis (Hendel)

(h) Bactrocera tryoni (Froggatt)

(i) Bactrocera tsuneonis (Miyake)

(j) Bactrocera zonata (Saunders)

(k) Epochra canadensis (Loew)

(l) Neoceratitis cyanescens (Bezzi)

(m) Ceratitis quinaria (Bezzi)

(n) Ceratitis rosa Karsch

(o) Rhacochlaena japonica Ito

(p) Rhagoletis cingulata (Loew)

(q) Rhagoletis completa Cresson

(r) Rhagoletis fausta (Östen-Sacken)

(s) Rhagoletis indifferens Curran

(t) Rhagoletis mendax Curran

(u) Rhagoletis pomonella Walsh

(v) Rhagoletis ribicola Doane

(w) Rhagoletis suavis (Loew)

APPENDIX I Part A

25. Tephritidae (non european ) as:


APPENDIX I Part A

b) Bacteria

1. Xylella fastidiosa (Well et Raju)

c) FUNGI

1. Ceratocystis fagacearum (Bretz) Hunt

2. Chrysomyxa arctostaphyli Dietel

3. Cronartium spp. (non européen)

4. Endocronartium spp. (non européen)

5. Guignardia laricina (Saw.) Yamamoto et Ito

6. Gymnosporangium spp. (non européen)

7. Inonotus weirii (Murrill) Kotlaba et Pouzar

8. Melampsora farlowii (Arthur) Davis

9. Monilinia fructicola (Winter) Honey

10. Mycosphaerella larici-leptolepis Ito et al.

11. Mycosphaerella populorum G.E. Thompson

12. Phoma andina Turkensteen

13. Phyllosticta solitaria Ell. et Ev.

14. Septoria lycopersici Speg. var. malagutii Ciccarone et Boerema

15. Thecaphora solani Barrus

15.1.Tilletia indica Mitra

16. Trechispora brinkmannii (Bresad.) Rogers


ANNEXE I Part A

d) Virus

1. Mycoplasme de la nécrose du phloème d'Ulmus

2. Virus et organismes analogues de la pomme de terre :

(a) Andean potato latent virus

(b) Andean potato mottle virus

(c) Arracacha virus B, oca strain

(d) Potato black ringspot virus

(e) Potato spindle tuber viroid

(f) Potato virus T

(g) Isolats non européens des virus A, M, S, V, X et Y,

ainsi que du « Potato leaf roll virus »

3. Tobacco ringspot virus

4. Tomato ringspot virus

5. Virus et organismes analogues de Cydonia Mill.,

Fragaria L., Malus Mill., Prunus L., Pyrus L.,

Ribes L., Rubus L. et Vitis L. tels que :

(a) Blueberry leaf mottle virus

(b) Cherry rasp leaf virus (américain)

(c) Peach mosaic virus (américain)

(d) Peach phony rickettsia

(e) Peach rosette mosaic virus

(f) Peach rosette mycoplasm

(g) Peach X-disease mycoplasm

(h) Peach yellows mycoplasm

(i) Plum line pattern virus (américain)

(j) Raspberry leaf curl virus (américain)

(k) Strawberry latent « C » virus

(l) Strawberry vein banding virus

(m) Strawberry witches broom mycoplasm

(mycoplasme des balais de sorcière du fraisier)

(n) Virus non européens de Cydonia Mill., Fragaria L.,

Malus Mill., Prunus L., Pyrus L., Ribes

L., Rubus L. et Vitis L.

6. Virus transmis par Bemisia tabaci Genn., tels que :

(a) Bean golden mosaic virus

(b) Cowpea mild mottle virus

(c) Lettuce infectious yellows virus

(d) Pepper mild tigré virus

(e) Squash leaf curl virus

(f) Euphorbia mosaic virus

(g) Florida tomato virus

e) PARASITIC PLANTS

1. Arceuthobium spp. (non européenne)

(Classa: Magnoliopsida Family : Santalaceae)


Conditions in which certain harmful organisms, and otherobjects enumerated with appendices I with V of the directive 2000/29/CE (77/93/CE) of the Council

can be introduced or circulate in the Community or certain protected areas of the Community for work at ends of test or scientific purposes or for work on the varietal selections.

• Work requiring the use of harmful organisms, of plants, crop products and other objects,

• Circulation and detention of the alive material

• Official letter of Authorization

• Approval of the activities



Directive 2008/61/CE (codification of the directive 95/44/CE)

concerning the marketing of the phytopharmacological

products.

APPENDIX I. active Substances whose incorporation is authorized in

the phytopharmacological products.

APPENDIX III. Conditions to fill to introduce the file of authorization.

PART B. Preparations of micro-organisms or virus.

APPENDIX VI. Uniform principles for the evaluation and the

authorization. Directive 2005/25/CE of the Council of March 14th,

2005 modifying Appendix VI with regard to the phytopharmacological

products containing of micro organisms.



Directive 91/414/CEE July 15th, 1991

concerning the marketing of the phytopharmacological products and

abrogation of the directives 79/117/CEE and 91/414/CEE the Council

For memory

Micro-organisms registered with appendix I of the directive 91/414/CE:

Ampelomyces quisqualis, Bacillus subtilis, Coniothyrium minitans,

Gliocladium catenulatum, Paecilomyces fumosoroseus, Pseudomonas

chlororaphis, Virus of the polyhédrose nuclear Spodoptera exigua;

Micro-organisms under examination for the inscription with appendix I:

Virus of the polyhédrose nuclear Helicoverpa armigera, Granulovirus

Adoxophyes orana, Virus of the polyhédrose nuclear Spodoptera

littoralis.


III.4 Regulation 1107/2009/EU

Regulation (EC) No 1107/2009 of the European Parliament and the Council

of October 21st, 2009

DIRECTIVE 2009/128/EC OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 21 October 2009 establishing a framework for Community

action to achieve the sustainable use of pesticides

Development and introduction of integrated pest management and of

alternative approaches or techniques in order to reduce dependency on the

use of pesticides.

Member States shall take all necessary measures to promote low pesticide-

input pest management, giving wherever possible priority to non-chemical

methods; shall establish or support the establishment of necessary conditions

for the implementation of integrated pest management. (article 14)

Trainings : notions on integrated pest management strategies and techniques,

integrated crop management strategies and techniques, organic farming

principles, biological pest control methods (Appendix I), Sustainable

biological, physical and other non-chemical methods must be preferred to

chemical methods if they provide satisfactory pest control. (Appendix III).

Une révolution philosophique phytosanitaire!

New text - EU

III.5 EU PHYTOSANITARY REVOLUTION

Article 23 - Transposition

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with

this Directive by 14 December 2011..

Regulation (EC) n°338/97 of the Council of December 9th, 1996

relating to the protection of the species of wild fauna and flora by

the control of their trade

Regulation (EC) n°318/2008 of the commission of March 31st,

2008 modifying payment (EC) n°338/97 council relating to the

protection of the species of fauna and flora savages by the control

of their trade.

Regulation (EC) N° 811/2008 of the Commission of August 13th,

2008 suspending the introduction into the Community ofspecimens of certain species of wild fauna and flora

Collect, detention, circulation, importations & exportations for scientific purposes


III.6 EU and CITES Convention

The ERBIC Project - 1998 à 2002 (EU)

« Evaluation of environmental risks of the introductions of Biological Control in Europe »

• Evaluation of the non-

intentional effects

• Selection of the non-target

species for the tests of

specificity

• Specificity of the BCA

• To measure and predict the

impacts of the BCA

• Risk crossing between species

• Evaluation of the potential

acclimatization of the BCA at

the time of releases

• Evaluation of the contaminants of the BCA

• Evaluation after release

• Molecular methods for the identification of the BCA the concept of Eco-region

• Statistical tools to evaluate the non-intentional effects Evaluation of the environmental risks: NZ

• Evaluation of the environmental risks: Methods Risks and Benefit

Bigler et al. (2006) Environmental Impact of Invertebrates for Biological Control of Arthropods.

III.7 The EU Project: ERBIC

Countries

with legislation

In preparation

No legislation

from BIGLER F., LOOMANS A. & VAN LENTEREN J. 2005.

2d International Symposium on Biological Control of Arthropods

THE REBECA PROJECT

« REGULATIONS OF THE BIOLOGICAL CONTROL AGENTS »

« Proposal for « UE directive » harmonization of UE regulations »

III.8 The EU Project: REBECA

FRENCH LEGISLATION

Laws

Rural code

Environment code Customs code Labor code

Decree 2006-910Decree 2003-768 Decree 2005-1783

May 24 2006, May 30 2006May 15, June 1998

Standards for agreement 2002

Ordinances

©

Standards for renewal 2004


IV. FRENCH LAW

International

provisions

UE provisions Regulation

Directive

Advice

Decision

Constitution

Agreement - Convention - Treaty

International Standards Regional Standards

Decree L258

Law 2010-788 July 12, 2010. Environnement

L258 Exotic macro-organisms and Biological Control

Approbation of the IPPC

Law n° 2005-153 of February 21st, 2005 authorizing the approval of

International convention for the protection of the plants (together an

appendix), such as it results from the amendments adopted in Rome by

the twenty-ninth session of the conference of the United Nations for the

food and agriculture

Decree n° 2005-1515 of the bearing December 1st, 2005 publication

international convention for the protection of the plants (together an

appendix), such as it results from the amendments adopted in Rome by

the 29th session of the conference United Nations for the food and agriculture on November 17th, 1997

D. COUTINOT 2011. Notions de Droit - Dispositions Internationales - Droit Communautaire - Droit Français

VI. FRENCH LAW

Customs CODE

Rural CODE

Article 38 violations with the regulation for the importation of prohibited good

Protection measures against pests - L251-4 and L251.6 Phytosanitary control of the plants - L251-12

Specific measures - L251-18

Penal provisions - L251-19 and L251-20

Article L251-4 is interdict to introduce, hold and transport harmfulorganisms, except authorized exceptions.

Deliver IV - Fauna and FloraTitle 1st: Protection of Fauna and the Flora

Chapter 1st: Safeguarding and monitoring of the biological diversity

Environment CODE


IV.1 FRENCH LEGISLATION

Environment CODE PRESERVATION OF BIOLOGICAL PATRIMONY

Art. L411-3

is prohibited the introduction into the natural environment, voluntary, by negligence or imprudence of any specimen of an animal specie or plant nonindigenous or indicated by the administrative authority.The introduction can be authorized by the administrative authority.

A decree from the Council of State specifies the conditions of this article

Loi n° 95-101 du 2 février 1995 visant à interdire l’introduction d’espèces exogènes (art. 56-VI)Loi nº 2005-157 du 23 février 2005 relative au développement des territoires ruraux (art. 128 II, art. 129 II)

Décret n°2007-15 du 4 janvier 2007 relatif aux espèces animales non domestiques ainsi qu’aux espèces végétales non cultivées et modifiant le code de l’environnementDécret n°2007-397 du 22 mars 2007 relatif à la partie réglementaire du code de l’environnement



Organization and with attributions of regionalmanagements of the food, agriculture and the forest

Biological monitoring of the territory and with themaintenance of the sanitary good state of theplants;

Controls relating to the marketing and the use ofthe plant health products, the fertilizing matters andthe supports of culture.

Animation of the preventive actions of the healthhazards and environmental related to the use ofthese products;

Diffusion of knowledge and information as regardsprotection of the plants.

DECREE n° 2008-1406

DECREE n° 2003-768 Lawful part of book II of the rural code Protection of the plants


VI.2 FRENCH REGULATIONS

DECREE n° 2005-1783

Provisions of adaptation to the Communitylegislation in the field of the sanitary control of the plants and modifying the rural code (lawful part)

The minister in charge for agriculture and the minister in charge for the customs fix by decree:

The list of the prohibited harmful organisms, list plants, crop products and other objectssubjected to control or prohibited and plant health requirements


VI.3 FRENCH REGULATIONS

Phytosanitary requirements of the plants, cropproducts and other Transcription objects of the directive 2000/29/CE

List prohibited harmful organisms

List plants, crop products and other objectssubjected to control or prohibited.

Conditions to fill for the introduction or circulation of certain harmful organisms, vegetable, crop products and other objectsfor scientific purposes.

Arrêté 10 juin 1998

Arrêté 24 mai 2006


VI. 4 FRENCH REGULATIONS

Decree of May 15th, 1998

drawing up the list of the agents entitled to proceed with the control of

work at ends of test for scientific purposes or for work on the varietalselections.

Decree of May 18th, 2009

fixing the list of the frontier stations of veterinary control and plant health

Appendix I. Frontier Stations

Appendix II. Official controls of the intended products to the animal feeds

coming from third country

Appendix III.Plant health controls of whole or part of the plants, the cropproducts and other objects


VI. 3 FRENCH REGULATIONS

Ministry for agriculture, Head office of the food. 2002

Certifications of the installations for the introduction or the circulation

of certain harmful organisms, vegetable, crop products and other

objects for work at ends of test or scientists purposes or for work on the

varietal selections concerned with the provisions of the directive 2000/29/CE modified”.

• Procedures relative at the request of approval of the installations.

• Requirements according to the levels of containment.

• Determination of the level of containment according to the regulatedmaterials: arthropods, bacteria, fungi, nematodes, virus.


VI.4 FRENCH ADMINISTRATIVE DISPOSALS

Procedure of renewal of approval within the framework of the directive 2008/61/CE

Memorandum DGAL/SDQPV/N2004-8111 April 13th, 2004

PRINCIPLES FOR THE RENEWAL OF THE AGREEMENT PLANT

QUARANTINE

Procedure based on the file examination of renewal in 4 parts:

1. Concise presentation of the laboratory and the evolution of its

installation since the delivery of approval

2. Quarantine activities during preceding approval

3. Protocol of use of quarantine: registers and procedures,

4. Actions of maintenance during preceding approval.


VI.5 FRENCH ADMINISTRATIVE DISPOSALS


The entry on the territory and the introduction into the

environment of a nonindigenous macro-organism useful for the

plants within the framework of the biological control should be

subjected with an prior approval.

• L-258 articles of the rural code.

• Decree of the ministry for agriculture and the ministry in charge of

the environment.

• Request will relate to the containment measures

• Preliminary risk analyzes in the event of releasing

• 2 years – 75 000€

JORF n°0160 of July 13th, 2010 page 12905

LAW n° 2010-788 of July 12th, 2010

National engagement for the environment

• Technical school of Containment• Montpellier, April 2010

• Presentation of the futur articles L258

• Decree Project• Introduction exotic macro organisms for scientific purposes

• Visit of the French expert X. Langlet DGAL, october 2010

• Talks with the scientific Community

• Parlementary Mission• Antoine Herth, French deputy (Bas-Rhin) and farmer , was nammed by

decree to be in charge of a 3 months mission on Biocontrol, and willintercede to the Ministry of Agriculture to value the potentiality in the scope of the French plan Ecophyto 2018.

L258 – Preparation of the Decree

• Autorization – without Risk Analysis

• Autorization dependent from containment measures

• Autorisation Request : contain? To who?

• Agreement to the title directive 2008/61/CE

• Without agreement?

• Type of containment? – Level (solid, liquid, air)

• Import BCA/hosts (regulated or not)

• Transfer of living material to an other research institute? –Scientific agreement

• Detention, circulation on French territory: – experimentationsin third countries (EU and others)

L258 - Questions

Demande d’entréesur le Territoire

Analyse du risque phytosanitaireet environnemental

Non systématique

Autorisation préalable

Subordonnée au respect de mesures de confinement

Arrêté conjoint MAAP / MEEDDM

b) Macro-organismesnon définis au préalable

a) Macro-organismesdéfinis au préalable

- Organismes / Hôtes réglementés- Organismes / Hôtes non réglementés- Types de confinement

NS1

NS2

NS3

Autres (adaptés)

- Subordonnée à description de la structure d’accueil- Subordonnée à description des travaux envisagés- Demande portant sur des antagonistes de ravageurs/plantes ciblés-Subordonnée à la transmission d’un rapport d’activité- identification organismes collectés-Précision des organismes faisant l’objet des travaux

- Subordonnée à description de la structure d’accueil-Identification des macro-organismes-Taxonomie (Ordre, Famille, Genre, espèce, descripteur)- Date de récolte- Lieu de récolte (localité, département/province, pays)- Nom(s) du (des) collecteur(s)- Structure/personne responsable de la collecte

Proposition de schémas fonctionnels concernant l’entrée sur le territoire de macro-organismes à des fins de travaux scientifiques

INTERNATIONALPROVISIONS

UE LEGISLATION

FRENCHLEGISLATION Law

Decree Ordinance Circular

Constitution


IPPC Convention

CBD Convention

CITES Convention

IIPC Standard ISPM 3 EPPO Standards PM6

OECD Advices


Directive 91/414/CE

UE CONDITIONS

Phytopharmacological products

UE PROHIBITIONS


Rural code Environment code Customs code Labor code

Agreements SPM

Nagoya Protocol ABS Regime

Regulation 1107/2009/CE Directive 2009/128/CE

L258 Exotic Macro-organisms BC

LEGAL PACKAGERelevant for Biological Control

Collections, Importations, Exportations, Use of BC Agents

Plant Protection – Agriculture – Biodiversity - Environment

Collection Permit

Export Permit

Letter of Authority Permit

or Declaration of Importation

Phytosanitary Certificate

CITES Declaration

Release Authorization

Release Permit

Veterinary Control 2011

Import of BC agents 2011 ?

EU Import Control System 2011

Country of Origin

Collections – Exportations

Importations in France (EU)

Releases by a 3d Country

European Biological Control

Laboratory

EBCL-USDA-ARS

Montpellier, France (EU)

French agreements

Under specific conditions

Quarantine Activity Certified

Quarantines: 170 m2

Importations

Insects - Plants

Known loader

Security program

Exportations

Living Beneficials

Import – Export

French customs

FEDEX

Country of Origin

U.S. Cooperators

U.S. Agriculture

Benefits sharing

Scientific Collaboration

Knowledge of Legislation

New Data

New Species

Reports

Scientific Papers

Reduction of Pests $

ABS Regime 2011 ?

Under International Conventions, Legislation and Regulations

in force in European Union, France and Country of Origin © Dominique COUTINOT

• International Adhesion of certain exporting countries and

respect of the above mentionned conventions.

• European Union Decisions must be taken more quickly at the

time of scientifically proven facts.

• France Decree from the Council of State specifying the

conditions for application of the articles L.258

Biological Control and Exotic macro-organisms

• UE/EEZ /EPPO Harmonization for the regulation of the

invertebrate BCA

• TEXTS Ignored, should be regularly carried to

knowledge.


CONCLUSIONS

• Trainings

• Conferences

• Publications

• Collaborations

• EBCL staff

• EBCL students

• EBCL visitors

• Research Institutes

• Privates companies

• Ministry of agriculture

• Informal group of containment


CONCLUSIONS

COUTINOT D. (in press). Prélèvement, Détention, Importation, Circulation, Exportation, et Lâchers

d’organismes vivants à des fins de recherche ou de contrôle biologique : aspects législatifs et

réglementaires. "Des Insectes et des Plantes". Editions Publibook collection "Biologie & Environnement".

COUTINOT D. 2010. Conservation and protection of the biodiversity: legislation and lawful aspects. P49. In

Biodiversity, Dossier Agropolis International, 84pp.

COUTINOT D. 2010. Dispositions Internationales et Régionales, Droit Communautaire relatifs à la Lutte

Biologique. Proceedings du Septième Congrès de l’Association Marocaine de Protection des Plantes, mai

2010, Rabat, Maroc, 501-508.

COUTINOT D. 2009. Les principaux textes législatifs et réglementaires relatifs aux micro-organismes. Pp. 103-

104 « La lutte biologique. Application aux arthropodes ravageurs et aux adventices », Collection

TECHNOSUP, Editions Ellipses.

COUTINOT D. 2006. Une évaluation des risques avant l’introduction d’organismes auxiliaires ?

Conférence AFPP « L'entretien des espaces verts, jardins, gazons, forêts, zones aquatiques

et autres zones non agricoles ». Avignon, 11-12 octobre 2006. pp. 343-350.

COUTINOT D. 2005. Dispositions Internationales, Droit Communautaire, Dispositions Législatives et

réglementaires françaises relatives à la Lutte Biologique. 5pp. 7ème Conférence Internationale sur les

Ravageurs en Agriculture, Montpellier, France. 26-27 octobre 2005.

COUTINOT D. 2003. www.ars-ebcl.org Dispositions Législatives et Réglementaires. Organismes nuisibles,

végétaux, produits végétaux et organismes génétiquement modifiés : quelles règles pour leur confinement,

leur circulation et leur détention ?

COUTINOT D., P. EHRET, G. THEISSEN. 2006. Importation d’organismes exotiques à des fins scientifiques.

Droit Communautaire & Dispositions Législatives et Réglementaires Françaises. Pp 98-104. In: Invasive

Plants in the Mediterranean Type Regions of the World. Meze (France), May 25-27, 2005. Proceedings

Sarah Brunel, Editor. Environmental Encounters Series, No.59. Council of Europe Publishing. 428pp.


PUBLICATIONS

http://www.ars-ebcl.org/







http://www.ars-ebcl.org/Download/French_Version.pdf








CIPV www.fao.org

CDB www.biodiv.org

CITES www.cites.org

OEPP www.eppo.org

Droit communautaire http://europa.eu.int

Droit français www.legifrance.gouv.fr

Veille Législative

Santé végétale UE & France http://www.agrilegis.fr

GalatéePro http://galateepro.agriculture.gouv.fr

sur abonnement : textes consolidés

Normes Agrilegis

Quelques sites

[email protected]

www.ars-ebcl.org

[email protected] www.ars-ebcl.org

QUARANTINE CONTAINMENT – IMPORTS and EXPORTS

Dominique COUTINOT – March 21, 2011

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