The Scottish Government

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ANNEX

Proposals in respect of The Seed (Registration, Licensing and Enforcement) ( Scotland) Regulations 2006

This consultation document indicates the principal issues arising from the proposal to make the Seed (Registration, Licensing and Enforcement) (Scotland) Regulations 2006.

1. Impact of European Council Directive 2004/117

1.1 Background

Council Directive 2004/117/ EC formalises the scheme for an experiment which permits licensed personnel to carry out official seed sampling and official seed testing functions, under official supervision.

EC Seeds Marketing Directives require official certification of seed of the main commercial crop species before marketing, to ensure that seed sold to farmers and growers meets specified standards. The Directives are implemented in Scotland by regulations concerned with different species groups ( e.g. cereals) and by regulations controlling the registration of seed companies and licensing of seed trade personnel to undertake crop inspection, seed sampling and seed testing under official supervision.

1.2 Summary of Changes

Directive 2004/117/ EC)

a) It incorporates the provisions of the temporary experiment permitting seed to be sampled and tested by licensed personnel (Commission Decision 98/320/ EC) into the Cereals, Fodder Plant, and Oil and Fibre Plant Seed Directives on a permanent basis.

b) The level of official checks required on crops inspected, seed sampled and seed tested by licensed personnel are set at a minimum of 5% across the board.

c) It requires all member States to accept requests for certification of "not finally certified" seed of agricultural species harvested in an equivalent third country, provided the seed is of a generation eligible for import as "not finally certified" and the seed satisfies directive seed conditions. Previously, only the Member State where the preceding generation was certified or produced was actually obliged to certify the seed.

d) The definition of equivalence of seed harvested in a third country is amended to allow the Council of Ministers to extend equivalence to all seed generations. This amendment does not apply to vegetable seed produced in third countries for which there are no Community equivalence arrangements in place.

The provisions of the temporary experiment permitting seed to be sampled and tested by licensed personnel ((a) above) were incorporated into the 2005 Cereals, Fodder Plant, and 2004 Oil and Fibre Plant Seed Regulations, therefore no substantive changes are required to implement (a), although changes are required to cross reference to Community legislation.

The regulations do not require change to implement (b) - (d) above.

The level of checks on licensed personnel ((b) above) are left to the discretion of the Member State and these are set administratively, however we propose to include the minimum level as prescribed by the Commission.

General Licence No. 2005/2 already provides for final certification of "not finally certified" seed imported from equivalent third countries, in all circumstances where this is permitted by the Directives ((c) above).

2. Registration of Seed Merchants, Seed Processors or Seed Packers

2.1 Seed Merchants, Seed Processors or Seed Packers

We have made provisions in the regulations for matters relating to Seed Merchants, Seed Processors or Seed Packers. These are:-

a) The premises that are available to the applicant.

b) The machinery, equipment and facilities that are available to the applicant.

c) The personnel and services that are available to the applicant.

d) Where the applicant is a body corporate or a partnership, the individual who is the responsible person within the organisation.

e) Where the activities carried out by the applicant include the preparation of seed mixtures intended for use as fodder plants, the person who has direct responsibility for the mixing operations.

f) Whether the procedures employed by the applicant in carrying out mixing operations in relation to seed mixtures intended for use as fodder plants are sufficient to ensure that mixed or blended seed lots are as uniform, and show as little evidence of heterogeneity, as is practicable.

2.2 The Responsible Person

A body corporate or partnership applying for or holding a registration the person will require to designate a person as the "Responsible Person" who will be the point of contact within that organisation for all communications relating to compliance with seeds regulations. The registered person ( e.g. the company) will retain ultimate responsibility for compliance with seeds regulations.

2.3 Records of Mixtures

It is will be a condition of licence that requirement by the "Registered Person" a record of seed mixtures intended for use as fodder plants be kept. Details of these requirements will be provided in a guidance booklet to be issued in due course.

2.4 Statutory Conditions

We are now introducing statutory conditions that may be imposed on a registered person. Some of these are subject to time limits and are as follows-

a) In the case of a body corporate or a partnership, to notify the Scottish Ministers within 21 days of any change of the body corporate or partnership's name or the address of its registered or principal office or any premises being used by it for the purpose of carrying on the business of seed merchant, seed packer or seed processor.

b) In the case of a registered person other than a body corporate or a partnership, to notify the Scottish Ministers within 21 days of any change of name or address of that person or of premises being used by that person for the purpose of the carrying on the business of seed merchant, seed packer or seed processor.

c) In the case of a body corporate or a partnership, to notify the Scottish Ministers within 21 days of any change regarding the responsible person.

d) In the case of the preparation of seed mixtures intended for use as fodder plants, to notify the Scottish Ministers within 21 days of any change regarding the person with direct responsibility for the mixing operation.

e) To keep such records as the Scottish Ministers may require of transactions in seeds and of the treatment, testing and other operations undertaken by the registered person or on that person's behalf in relation to any seeds or their disposal including records relating to-

(i) seed crops;

(ii) the date on which official labels are used (by reference to the unique label number) and the seed lots for which they are used;

(iii) in the case of seed intended for marketing, the number and weight of seed lots processed and the date on which they are processed together with species, category and level;

2.5 Revocation of Registration

The grounds of revocation are expanded. Scottish Ministers may revoke a registration if the registered person has failed to comply with a condition of registration or has been found guilty of committing an offence under section 16(7) of the Plant Varieties and Seeds Act 1964.

2.6 Public Register

It is the Department's intention to resume publishing the Public Register of Seed Merchants, Seed Processors and Seed Packers. The information contained in the register will be as follows-

a) Name

b) Business address

c) The name of the responsible person and their contact telephone number will also appear in the register.

For those working from home, this address will only appear if the person states that they wish their home address to be published in the public register. However, we do require an address for the Register and if you do not want your home address to appear, then we are content to publish another address, (e.g. PO Box Number) where correspondence can be sent.

Optional information appearing in the public register will include -

d) You will be given the option whether or not E-mail addresses, telephone and fax numbers, will also appear in the Register.

We intend to publish this information. It will also be available on the Scottish Executive website.

2.7 Variation of Registration

The applicant may apply to Scottish Ministers for a variation of the registration. E.g. If a registered Seed Merchant wants to include seed processing, they would apply to the Scottish Minister asking them to vary their licence.

3. Licensed Crop Inspectors & Seed Samplers

3.1 Crop Inspectors -Functions

The new regulations now put on a statutory footing a number of functions undertaken by the crop inspectors. These are currently included in the licence issued to crop inspectors-

a) To inspect crops in accordance with instructions issued from time to time by or on behalf of the Scottish Ministers for the purposes of the Seed Marketing Regulations to determine whether the crops meet the relevant standards prescribed in the Seed Marketing Regulations including-

(i) confirmation of the identity of the variety insofar as possible;

(ii) the detection and recording of any species impurities or varietal impurities;

(iii) the checking of compliance with isolation requirements; and

(iv) the assessment of the general condition of the crop including-

(v) whether the crop is in a suitable condition for inspection;

(vi) any pesticide spray damage that may have been caused to the crop; and

(vii) the existence of weeds and diseases.

b) to issue a field inspection report following the inspection of a seed crop in accordance with the Seed Marketing Regulations.

3.2 Crop Inspectors - Conditions

It is our intention to provide for a minimum number of crop inspections to be carried out annually, which will be taken into consideration for assessing the continued competence of a licensed crop inspector.

3.3 Seed Samplers

The new regulations will include the option to vary the functions of samplers who prepare mixtures and to accommodate those samplers who only re-package, re-label, and re-seal.

3.4 Seed Samplers - Conditions

There is now a requirement that a licensed seed sampler can carry out functions for another business only with the agreement of the employer and the Scottish Ministers. We propose that this will be part of the conditions of a seed sampler's licence.

3.5 Statement of Commitment

For Licensed Crop Inspectors and Seed Samplers, there is now a statutory requirement for a "statement of commitment" to carry out the functions specified in the licence in accordance with instructions issued by the Scottish Ministers. This is effectively no change as this statement has traditionally appeared in the licence.

3.6 Variation of Licence

For Licensed Crop Inspectors and Seed Samplers there is now a new provision which allows them to apply to the Scottish Ministers for a variation of the functions or conditions in their licence.

3.7 Revocation and Suspension of Licences

An updated procedure for deciding whether to revoke or suspend licences is to be introduced.

a) The possibility of revocation of a licence is to be retained. In addition, suspension of licences will be retained for licensed seed testing stations and introduced for crop inspectors and seed samplers. A licence may be suspended for any period up to its unexpired duration and shall cease to have effect during the period of suspension.

b) We are introducing new procedures for the immediate suspension of a licence where the Scottish Ministers are of the opinion that a crop inspector or seed sampler may have acted in a manner which has caused or is likely to cause prejudice to the proper operation of the seed certification system. Suspension with immediate effect has always been possible, but it is proposed that it should only take place on these specific grounds and be subject to procedures which guarantee the licence holder early consideration of the full circumstances whilst protecting the certification system from immediate prejudice.

c) As well as possible revocation for breach of conditions, there is now a provision which allows the licence to be revoked for failure to carry out functions.

3.8 Termination of a Licence

There is now a provision for the licence holder to apply to the Scottish Ministers to terminate their licence.

3.9 Public Register

It is the Department's intention to publish a register of all Licensed Crop Inspectors & Seed Samplers. The information contained in the register will be as follows-

a) Name

b) Business address

c) The name of the responsible person and their contact telephone number will also appear in the register.

For those working from home, this address will only appear if the person states that they wish their home address to be published in the public register. However, we do require an address for the Register and if you do not want your home address to appear, then we are content to publish another address, (eg. PO.Box) where correspondence can be sent.

Optional information appearing in the public register will include -

d) You will be given the option whether or not E-mail addresses, telephone and fax numbers, will also appear in the Register.

We intend to publish this information. It will also be available on the Scottish Executive website.

4. Licensed Seed Testing Stations (LSTS)

4.1 Licences

A LSTS belonging to a registered person will only be permitted carry out statutory testing on seed lots produced by or on behalf of that person unless otherwise agreed between the registered person, the applicant for certification and the Scottish Ministers.

4.2 Person in Charge

As with regist ered persons, there will be a statutory requirement for the applicant for a LSTS licence to nominate a Person in Charge and to provide the name and address of the Person in Charge on the licence application. The Person in Charge will be the designated point of contact for communication regarding compliance with seeds regulations. The Person in Charge will have no specific statutory duties but may have duties arising from conditions attached to any licence issued. Where a registered person owns the LSTS, the Person in Charge or the responsible person for the registered business may be the same person or alternatively different persons may hold each respective position.

4.3 Analyst in Charge

The Analyst in Charge of a LSTS shall-

a) have direct responsibility for the technical operations of the licensed seed testing station;

b) exercise supervision of the work of all seed analysts assisting in statutory seed testing carried out at the LSTS; and

c) be in effective control of all statutory seed testing carried out at the LSTS and have direct responsibility for the issuing of results of statutory seed tests.

These will be statutory duties and failure to carry them out may lead to suspension of revocation of the LSTS licence.

4.4 Knowledge and Qualifications

The matters to be taken into account by the Scottish Ministers for personnel working in a LSTS in connection with the application for a licence shall be-

a) qualifications attained in seed testing and laboratory management of the Analyst in Charge; and

b) qualifications attained in seed testing of any seed analysts.

4.5 Notification of Change

The licence holder shall be obliged to notify any change regarding the person appointed to act as the Analyst in Charge of the LSTS or regarding the Responsible Person to the Scottish Ministers within 21 days.

4.6 Reserve Portions

There will be a statutory requirement for a reserve portion to be retained for every sample of seed submitted for certification. These reserve portions shall be delivered to an authorised officer on request.

4.7 Variation of Licence

The licence holder may apply to Scottish Ministers for a variation of licence. E.g.-

a) to authorise statutory seed testing on another species of seed in addition to, or instead of, the species specified in the licence; or

b) in respect of the functions specified in, or the conditions attached to, the licence.

4.8 Suspension and Revocation of Licence

The new regulations provide for certain matters to be taken into consideration in connection with suspension or revocation of a LSTS licence-

The Scottish Ministers will have the option to suspend or revoke a LSTS licence if it appears to them that-

a) there has been a breach of the conditions of the licence;

b) a person acting as an Analyst in Charge of the licensed seed testing station-

(i) is no longer competent to act as such;

(ii) has failed to comply with the duties; or

(iii) is otherwise unfit to perform the duties of Analyst in Charge;

c) there is no longer a person acting as Analyst in Charge of the LSTS; or

d) a seed analyst carrying out statutory seed testing at the LSTS is no longer competent to do so.

e) the numbers of qualified and unqualified persons employed at the LSTS shall be maintained at a level deemed by the Scottish Ministers to be satisfactory in the light of the work to be undertaken and the performance of the LSTS in seed testing and management. The LSTS shall carry out any adjustment of the numbers of persons employed in it, or the maximum numbers of tests (statutory and non-statutory) to be undertaken as may be considered necessary by the Scottish Ministers.

f) the qualified staff employed at the LSTS shall attend such training and refresher courses, and participate in such comparative testing exercises, as the Scottish Ministers may consider necessary.

Suspension of a licence with immediate effect will be on the same basis as that described in respect of licensed crop inspectors and licensed seed samplers.

A licence may be suspended for any period up to its unexpired duration and shall cease to have effect during the period of suspension.

4.9 Breach of Conditions LSTS Licence Conditions as a Criminal Offence.

Regulation 9(3) of the Seeds (Registration, Licensing and Enforcement) Regulations 1985 made breach of a LSTS licence an offence. It is proposed that the provision will not be re-enacted, leaving suspension and revocation of a LSTS licence as the ultimate sanction for breach of licence conditions.

4.10 Public Register

It is the Department's intention to publish a register of LSTS. The information contained in the register will be as follows-

a) Name

b) Business address

c) The names of the Responsible Person and Analyst in Charge and their contact telephone number will also appear in the register.

You will be given the option to also supply - E-mail addresses, telephone and fax numbers, which will also appear in the Register.

We intend to publish this information. It will also be available on the Scottish Executive website.

5. Representations

5.1 Representations Process

Following immediate suspension of the various licences and registrations, we intend to make provision for a speedier process for final determination of the question of suspension. These provisions are-

a) as soon as reasonably practicable and not later than 7 days after making the decision to give the person concerned notice of the decision and the reasons for it;

b) inform the person concerned of the right to make representations to them and the manner in which and the time (being not less than 7 days) within which such representations may be made;

c) decide within 21 days of the date of the decision whether the suspension is to remain in force or be withdrawn; and

give the person concerned notice of their decision, together with the reasons for it and, where appropriate, notice of the date from which the decision shall have effect

6. Appeals

6.1 The Representation and Appeals Procedure

We propose to modify the representation and appeals procedures so that-

a) seed merchants, seed processors, seed packers, licensed crop inspectors, licensed seed samplers and licensed seed testing stations have similar rights to make written representation (but not oral representations) against decisions made under the Regulations (e.g. decisions to vary, suspend or revoke licences or registrations).

b) rights of appeal to the independent Plant Varieties and Seeds Tribunal against decisions made under the Regulations are retained in respect of decisions in respect registrations and are extended to decisions affecting licensed crop inspectors, seed samplers and licensed seed testing stations who currently have no independent appeal rights (there shall be no appeal against refusal to grant or vary, or a decision to revoke or vary, a licence by reason that there has been a failure to pass an examination of competence).

6.2 Conditions where the Right of Appeal is not Applicable

There are new conditions where the right of appeal is not applicable. There shall be no right of appeal to the Tribunal where the Scottish Ministers-

a) have refused to grant an application for a crop inspector's licence or a seed sampler's licence for the sole reason that the applicant has failed to pass the relevant examination for the grant of the licence;

b) have refused to vary a crop inspector's licence for the sole reason that the licence holder has failed to pass the relevant examination for the variation of the licence; or

c) have decided that a licensed crop inspector is no longer competent to inspect crops or a licensed seed sampler is no longer competent to sample seed and have varied, suspended or revoked the licence for the sole reason that the licence holder has failed to pass an examination which required to be undertaken and passed as a condition of the licence.

d) have decided that the Analyst in Charge is no longer competent to carry out the functions for the sole reason that the Analyst in Charge has failed to pass an examination which is required to be undertaken and passed, as a condition of the licence.

The Scottish Ministers shall take such steps as are necessary on their part to give effect to any decision of the Tribunal which constitutes the final determination of an appeal.

7. Record Keeping

There will be a statutory requirement to keep records for a period of six years.

8. Transitional Arrangements for Licences

An administrative exercise will be carried out shortly after the coming into force of the Regulations which will involve licences issued under the 1985 Regulations being replaced by licences granted under the new Regulations. The new licences will be subject to new conditions and we will be consulting upon these shortly. The consultation period will be the opportunity for views to be expressed thereon.

SEERAD

EPHAS - Seeds

28 February 2006

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