Genetic Technology (Precision Breeding) Act 2023

Part 1 — Precision breeding: definitions

Precision bred organism

1

• (1) In this Act “precision bred organism” means a precision bred plant or a precision bred animal.

• (2) For the purposes of this Act an organism is “precision bred” if—

• (a) any feature of its genome results from the application of modern biotechnology,

• (b) every feature of its genome that results from the application of modern biotechnology is stable,

• (c) every feature of its genome that results from the application of modern biotechnology could have resulted from traditional processes, whether or not in conjunction with selection techniques, alone, and

• (d) its genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology.

• (3) In this Act “modern biotechnology” means any technique mentioned in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443).

• (4) A feature of an organism’s genome is “stable” if it is capable of being propagated whenever the organism is reproduced, whether by sexual or asexual reproduction.

• (5) In determining whether a feature of an organism’s genome could have resulted from traditional processes, no account is to be taken of—

• (a) the copy number of the feature,

• (b) its epigenetic status, or

• (c) its location in the genome.

• (6) In this section “traditional processes” means—

• (a) in relation to plants—

• (i) sexual fertilisation,

• (ii) spontaneous mutation,

• (iii) in vitro fertilisation,

• (iv) polyploidy induction,

• (v) embryo rescue,

• (vi) grafting,

• (vii) induced mutagenesis, or

• (viii) somatic hybridisation or cell fusion of plant cells of organisms which are capable of exchanging genetic material by a process within sub-paragraphs (i) to (vii);

• (b) in relation to animals—

• (i) sexual fertilisation,

• (ii) spontaneous mutation,

• (iii) artificial insemination,

• (iv) in vitro fertilisation,

• (v) embryo transfer,

• (vi) polyploidy induction, or

• (vii) recovery and transfer of primordial germ cells.

• (7) An “artificial modification technique” means any technique by which genes or other genetic material can be artificially modified within the meaning of Part 6 of the Environmental Protection Act 1990 (as it has effect from time to time).

• (8) If the category of techniques by which, or circumstances in which, genes or other genetic material are taken to be, or not to be, artificially modified for the purposes of Part 6 of the Environmental Protection Act 1990 changes by virtue of—

• (a) regulation 5 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443) being modified, or

• (b) regulations being made under subsection (4B) or (4C) of section 106 of the Environmental Protection Act 1990,

regulations may modify this section so as to make corresponding changes (with or without variation) to the definition of “modern biotechnology”.

• (9) Regulations under subsection (8) are subject to the affirmative procedure.

• (10) An organism to which subsection (11) applies does not fail to be precision bred merely because it does not meet the condition in subsection (2)(d).

• (11) This subsection applies to an organism which, for the purposes of Part 6 of the Environmental Protection Act 1990, is to be taken not to be a genetically modified organism by virtue of—

• (a) paragraph (3) of the regulation referred to in subsection (8)(a), or

• (b) regulations under subsection (4C) of section 106 of that Act.

Meaning of “plant” and “animal”

2

• (1) In this Act “plant” means an organism in the taxonomic group—

• (a) Archaeplastida, or

• (b) Phaeophyceae.

• (2) In this Act “animal” means an organism in the taxonomic group Metazoa, other than a human (or a human admixed embryo).

• (3) In subsections (1) and (2), references to an organism—

• (a) include an embryo and all subsequent developmental stages of the organism;

• (b) in the case of a plant, also include a seed or a vegetative propagule;

• (c) do not include a gamete.

• (4) In this Act “gamete”—

• (a) does not include an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo, but

• (b) otherwise includes a mature germ cell capable of initiating fusion with a germ cell of the opposite sex.

• (5) In this section—

• “embryo” includes an egg that is in the process of fertilisation or is undergoing any other process capable of resulting in an embryo;

• “human” includes a human embryo and all subsequent developmental stages of a human;

• “human admixed embryo” has the same meaning as it has in the Human Fertilisation and Embryology Act 1990 by virtue of section 4A(6) and (11) of that Act.

Part 2 — Precision bred organisms: release, marketing and risk assessments

Release

Restrictions on release of precision bred organism in England

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• (1) A person who has a precision bred organism under their control must not release the organism in England unless—

• (a) the following apply—

• (i) the notification requirements are satisfied in relation to the release (see section 4),

• (ii) the person is a person specified in the release notice under section 4(2), and

• (iii) the release is carried out in accordance with the release notice, or

• (b) the organism is—

• (i) a marketable precision bred organism (see section 5(2)), or

• (ii) the qualifying progeny of a marketable precision bred organism (see section 24).

• (2) For the purposes of this Act an organism is under a person’s “control” if the person keeps it contained by measures designed to—

• (a) limit its contact with humans and the environment, and

• (b) prevent or minimise the risk of adverse effects as regards the health of humans or the environment.

• (3) For the purposes of this section and section 4, a person “releases” an organism under their control by deliberately causing or permitting it to—

• (a) cease to be under their control or the control of anyone else, and

• (b) enter the environment.

Release of precision bred organism: notification requirements

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• (1) The notification requirements are satisfied in relation to the release of an organism if—

• (a) a person has given a notice (a “release notice”) to the Secretary of State in relation to the release, accompanied by—

• (i) any required information (see subsection (3)(b)), and

• (ii) any fee required by regulations under section 39, and

• (b) any minimum period prescribed by regulations has elapsed since paragraph (a) was satisfied.

• (2) A release notice must specify one or more persons, or descriptions of person, in relation to the release.

• (3) Regulations may—

• (a) make provision about the form and content of a release notice (but subject to subsection (2));

• (b) prescribe information which must accompany a release notice (“required information”).

• (4) Regulations under subsection (3) may, in particular, prescribe whom a person may specify under subsection (2) when giving a release notice.

• (5) For the meaning of “release” see section 3(3).

• (6) Regulations under subsection (1)(b) are subject to the negative procedure.

• (7) Regulations under subsection (3) are subject to the affirmative procedure.

Marketing

Restrictions on marketing of precision bred organism in England

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• (1) A person must not market a precision bred organism in England unless—

• (a) it is a marketable precision bred organism, or

• (b) it is the qualifying progeny of a marketable precision bred organism.

• (2) In this Act “marketable precision bred organism” means a precision bred organism in respect of which—

• (a) a precision bred confirmation is in force, and

• (b) if it is a relevant animal, a precision bred animal marketing authorisation is in force.

• (3) For the purposes of this Act—

• (a) a precision bred organism is “marketed” by a person when products consisting of or including—

• (i) the precision bred organism, or

• (ii) its gametes,

are made available to other persons, whether or not for consideration, and

• (b) the marketing occurs in England so far as those products are made available for delivery in England.

• (4) For provision about the following terms used in subsections (1) and (2) see—

qualifying progeny	section 24
precision bred confirmation	section 8(1)(a)(i)
relevant animal	section 10
precision bred animal marketing authorisation	section 13(1).

• (5) For the purposes of subsection (2), a precision bred confirmation or precision bred animal marketing authorisation is “in force” if it has been issued and not revoked, and, in the case of an authorisation, is not suspended.

Precision bred confirmation

Application for precision bred confirmation

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• (1) A person (the “notifier”) may apply for a precision bred confirmation in relation to an organism by giving a notice (a “marketing notice”) to the Secretary of State.

• (2) Regulations may—

• (a) make provision about the form and content of a marketing notice, and

• (b) prescribe information which must accompany a marketing notice (“required information”).

• (3) As soon as practicable after receiving—

• (a) a marketing notice,

• (b) any required information, and

• (c) any fee prescribed by regulations under section 39,

the Secretary of State must refer the marketing notice to the advisory committee (see section 22(1)) by sending the committee the marketing notice and any required information that accompanied it.

• (4) Regulations under subsection (2) are subject to the affirmative procedure.

Report by advisory committee

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• (1) This section applies where the Secretary of State refers a marketing notice to the advisory committee.

• (2) Within 90 days after the marketing notice is referred to it, the advisory committee must provide a report to the Secretary of State stating—

• (a) whether it considers the organism to be precision bred, and

• (b) its reasons for reaching that conclusion.

• (3) Before the end of that period, the committee may by notice (“an information notice”) request the notifier to provide further information to the committee.

• (4) The committee’s report to the Secretary of State must be accompanied by any information provided to the committee as the result of an information notice.

• (5) Subsection (2) is subject to regulations under section 23.

Issue of precision bred confirmation

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• (1) As soon as practicable after receiving a report from the advisory committee under section 7(2), the Secretary of State must—

• (a) if satisfied that the organism is precision bred—

• (i) issue a statement to that effect (a “precision bred confirmation”), and

• (ii) give notice of it to the notifier;

• (b) if not satisfied, give notice to the notifier of that fact.

• (2) A notice under subsection (1)(b) must state the reasons for not issuing a precision bred confirmation.

Revocation of precision bred confirmation

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• (1) Regulations may make provision conferring power on the Secretary of State to revoke a precision bred confirmation relating to an organism if the Secretary of State is no longer satisfied that the organism is precision bred.

• (2) Regulations made under this section must make provision—

• (a) for the procedure that is to be followed where the Secretary of State proposes to revoke a precision bred confirmation, which must include provision for—

• (i) requiring notice of a proposal to revoke a precision bred confirmation to be published in any way that the Secretary of State considers appropriate to bring it to the attention of those affected by it, and

• (ii) permitting persons affected by the proposal to make representations about it;