E3C4C5Part VI Genetically Modified Organisms

Annotations:
Extent Information
E3

Pt VI: for extent of this Part see s. 164(4) below.

Modifications etc. (not altering text)
C4

Pt. VI (ss. 106-127): transfer of functions (16.2.2000) by S.I. 2000/253, art. 2, Sch. 1

Preliminary

E1I1106 Purpose of Part VI and meaning of “genetically modified organisms” and related expressions.

F11

This Part has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms.

2

In this Part the term “organism” means any acellular, unicellular or multicellular entity (in any form), other than humans F2, human embryos or human admixed embryos ; and, unless the context otherwise requires, the term also includes any article or substance consisting of or including biological matter.

3

For the purpose of subsection (2) above “biological matter” means anything (other than an entity mentioned in that subsection) which consists of or includes—

a

tissue or cells (including gametes or propagules) or subcellular entities, of any kind, capable of replication or of transferring genetic material, or

b

genes or other genetic material, in any form, which are so capable,

and it is immaterial, in determining if something is or is not an organism or biological matter, whether it is the product of natural or artificial processes of reproduction and, in the case of biological matter, whether it has ever been part of a whole organism.

F33A

For the purposes of subsection (2) above—

a

“human embryo” means an embryo within the meaning given in the provisions of the Human Fertilisation and Embryology Act 1990 (apart from section 4A) by virtue of section 1(1) and (6) of that Act, and

b

“human admixed embryo” has the same meaning as it has in that Act by virtue of section 4A(6) and (11) of that Act.

C1C24

For the purposes of this Part an organism is “genetically modified” if any of the genes or other genetic material in the organism—

F4a

have been artificially modified, or

b

are inherited or otherwise derived, through any number of replications, from genes or other genetic material (from any source) which were so modified.

F54A

Genes or other genetic material in an organism are “artificially modified” for the purposes of subsection (4) above if they are altered otherwise than by a process which occurs naturally in mating or natural recombination.

This subsection is subject to subsections (4B) and (4C) below.

4B

For the purposes of subsection (4) above—

a

genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this paragraph;

b

genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this paragraph.

4C

An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description.

4D

In subsections (4B) and (4C) above “prescribed” means prescribed by regulations made by the Secretary of State F6or, in relation to Wales, the National Assembly for Wales.

5

F7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

F7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

In this Part, where the context permits, a reference to “reproduction”, in relation to an organism, includes a reference to its replication or its transferring genetic material.

E2I1106 Purpose of Part VI and meaning of “genetically modified organisms” and related expressions.

F81

This Part has effect for the purpose of ensuring that all appropriate measures are taken to avoid damage to the environment which may arise from the escape or release from human control of genetically modified organisms.

2

In this Part the term “organism” means any acellular, unicellular or multicellular entity (in any form), other than humans F2, human embryos or human admixed embryos ; and, unless the context otherwise requires, the term also includes any article or substance consisting of or including biological matter.

3

For the purpose of subsection (2) above “biological matter” means anything (other than an entity mentioned in that subsection) which consists of or includes—

a

tissue or cells (including gametes or propagules) or subcellular entities, of any kind, capable of replication or of transferring genetic material, or

b

genes or other genetic material, in any form, which are so capable,

and it is immaterial, in determining if something is or is not an organism or biological matter, whether it is the product of natural or artificial processes of reproduction and, in the case of biological matter, whether it has ever been part of a whole organism.

F33A

For the purposes of subsection (2) above—

a

“human embryo” means an embryo within the meaning given in the provisions of the Human Fertilisation and Embryology Act 1990 (apart from section 4A) by virtue of section 1(1) and (6) of that Act, and

b

“human admixed embryo” has the same meaning as it has in that Act by virtue of section 4A(6) and (11) of that Act.

C34

For the purposes of this Part F9, subject to subsection (4C) below, an organism is “genetically modified” if any of the genes or other genetic material in the organism—

F10a

have been artificially modified, or

b

are inherited or otherwise derived, through any number of replications, from genes or other genetic material (from any source) which were so modified.

F114A

subject to subsections (4B) and (4C) below, genes or other genetic material in an organism are “artificially modified” for the purposes of subsection (4) above if they are altered otherwise than by a process which occurs naturally in mating or natural recombination.

4B

For the purposes of subsection (4) above–

a

genes or other genetic material shall be taken to be artificially modified if they are altered using such techniques as may be prescribed for the purposes of this paragraph;

b

genes or other genetic material shall not be regarded as artificially modified by reason only of being altered by the use of such techniques as may be prescribed for the purposes of this paragraph.

4C

An organism shall be taken not to be a genetically modified organism for the purposes of this Part if it is an organism of a prescribed description.

4D

In subsections (4B) and (4C) above, “prescribed” means prescribed by regulations made by the Scottish Ministers.

5

F12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

F12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

In this Part, where the context permits, a reference to “reproduction”, in relation to an organism, includes a reference to its replication or its transferring genetic material.