The Genetic Manipulation Regulations 1989

Citation and commencement

1.  These Regulations may be cited as the Genetic Manipulation Regulations 1989 and shall come into force on 1st November 1989.

Interpretation

2.—(1) In these Regulations, unless the context otherwise requires— “approved” means approved for the time being in writing by the Health and Safety Executive for the purposes of these Regulations; “genetic manipulation” means the propagation of combinations of heritable material by the insertion of that material, prepared by whatever means outside a cell or organism, into a cell or organism in which it does not occur naturally, either—

(a) directly; or

(b) into a virus, microbial plasmid or other vector system which can then be incorporated in the cell or organism; “genetic manipulation safety committee” means a committee established under regulation 6(2); “intentional introduction into the environment” means the intentional introduction into the environment (that is outside provision for containment) of a live cell or organism which was produced or modified by genetic manipulation, in vitro cell fusion or other in vitro technique, to form combinations of heritable material which do not occur naturally in that cell or organism; “organism” means any biological entity capable of replication (whether microscopic or not); “pathogen” means any of the following—

(a) an organism which falls into one of the hazard groups numbered 2, 3 and 4 in Schedule 1;

(b) an animal pathogen within the meaning of Article 3 of the Importation of Animal Pathogens Order 1980(1); or

(c) a plant pest within the meaning of Article 3 of the Plant Health (Great Britain) Order 1987(2).

(2) In these Regulations a reference to “an activity involving genetic manipulation” shall be taken as a reference to an activity involving—

(a) the construction or modification of a cell or organism by genetic manipulation;

(b) the use of a cell or organism constructed or modified by genetic manipulation; or

(c) intentional introduction into the environment,but shall not include a reference to the supply or use of a cell or organism as a finished product for routine use if the construction or modification of that cell or organism by genetic manipulation has been notified under regulation 5.

(3) In these Regulations, references to “containment levels” and to “good large-scale practice” shall be treated as references to those terms as further described in the method of risk assessment approved for the purpose of regulation 6(1).

(4) In these Regulations, unless the context otherwise requires—

(a) a reference to a numbered regulation or Schedule is a reference to the regulation or Schedule in these Regulations so numbered; and

(b) a reference to a numbered paragraph is a reference to the paragraph so numbered in the regulation or Schedule in which that reference appears.Meaning of “work” and “at work”

3.  For the purpose of these Regulations and Part I of the Health and Safety at Work etc. Act 1974 the meaning of the word “work” shall be extended to include an activity involving genetic manipulation and the meaning of “at work” shall be extended accordingly.Modification of section 3(2) of the Health and Safety at Work etc. Act 1974

4.  Section 3(2) of the Health and Safety at Work etc. Act 1974 shall be modified, in relation to an activity involving genetic manipulation, so as to have effect as if the reference to a self-employed person included a reference to any person who is not an employer or an employee in relation to that activity.Notification of activities involving genetic manipulation

5.—(1) Subject to paragraphs (4) and (6), no person shall carry out an activity involving genetic manipulation unless, before commencing that activity, he has notified the Health and Safety Executive of his intention to do so at least—

(a) in the case of an activity involving an intentional introduction into the environment, 90 days in advance;

(b) in any other case, 30 days in advance; or

(c) in either case, such shorter time in advance as the Executive may agree.

(2) Subject to paragraph (4), the notification required by paragraph (1) shall be in an approved form and shall comprise—

(a) a notification of an intention to carry out activities involving genetic manipulation which shall contain the particulars specified in Schedule 2; and

(b) a notification of each individual activity involving genetic manipulation which shall contain the particulars specified in Schedule 3.

(3) Where a person has made a notification in accordance with paragraph (2)(a) and subsequently makes a significant change in the activities to which the notification relates which would affect the particulars notified (including the cessation of those activities), he shall forthwith notify the Executive of that change.

(4) In the case of an activity involving genetic manipulation specified in paragraph (5), it shall be sufficient compliance with paragraph (1) if the person who intends to carry out the activity—

(a) notifies the Executive in accordance with paragraphs (1) and (2)(a); and

(b) as soon as is reasonably practicable after the end of each calendar year sends the Executive a list of the activities carried out during that year containing the particulars specified in Schedule 4.

(5) Paragraph (4) shall apply to an activity involving genetic manipulation (other than intentional introduction into the environment) which, when assessed for risk in accordance with regulation 6(1), is assigned to containment levels 1 or 2 or as warranting only the use of good large-scale practice, as the case may be.

(6) Paragraph (1) shall not apply where the only activities involving genetic manipulation consist of self-cloning activities (namely the application of genetic manipulation to rearrange the genome of an individual species) except where they involve a pathogen or an intentional introduction into the environment.

Risk assessment

6.—(1) For the purpose of notifying an individual activity involving genetic manipulation under regulation 5(2)(b) or determining whether the activity is to be assessed as falling into containment levels 1 or 2 or as warranting only the use of good large-scale practice as the case may be and is therefore an activity to which regulation 5(4) applies, the person carrying out the activity shall carry out a risk assessment of the intended activity by the approved method.

(2) The person carrying out the activity shall establish a committee for the purpose of advising him in relation to any risk assessment mentioned in regulation 6(1).

Application outside Great Britain

7.  These Regulations shall apply to any work outside Great Britain to which sections 1 to 59 and 80 to 82 of the Health and Safety at Work etc. Act 1974 apply by virtue of the Health and Safety at Work etc. Act 1974 (Application outside Great Britain) Order 1989(3) as they apply to work within Great Britain.

Exemption certificates

8.—(1) Subject to paragraph 2, the Health and Safety Executive may, by a certificate in writing, exempt any person or class of person or any activity or class of activities from all or any of the requirements or prohibitions imposed by these Regulations and any such exemption may be granted subject to conditions and to a limit of time and may be revoked by a certificate in writing at any time.

(2) The Executive shall not grant any such exemption unless, having regard to circumstances of the case and in particular to—

(a) the conditions, if any, which it proposes to attach to the exemption; and

(b) any other requirements imposed by or under any enactments which apply to the case,it is satisfied that the health and safety of persons who are likely to be affected by the exemption will not be prejudiced in consequence of it.

Revocations and savings

9.—(1) The Health and Safety (Genetic Manipulation) Regulations 1978(4) are hereby revoked.

(2) In the case of an activity involving genetic manipulation commenced—

(a) before the date on which these Regulations come into force it shall be sufficient compliance with regulation 5(1) if the intention to carry out that activity was notified under the said Regulations of 1978;

(b) on or after the date on which these Regulations come into force it shall be sufficient compliance with regulation 5(1) (in so far as it requires a notification referred to in regulation 5(2)(a)) if the intention to carry out that activity was notified under the said Regulations of 1978.

Signed by order of the Secretary of State.

Patrick Nicholls

Parliamentary Under Secretary of State,

Department of Employment

3rd October 1989