Genetic Technology (Precision Breeding) Act 2023

Precision bred confirmation

6 Application for precision bred confirmation

(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.

7 Report by advisory committee

(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.

8 Issue of precision bred confirmation

(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.

9 Revocation of precision bred confirmation

(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;

(b) about the consequences of revoking a precision bred confirmation;

(c) for prescribed information to be included in the register (see section 18).

(3) Provision made by virtue of subsection (2)(b) must secure that the following are treated as revoked by the revocation of a precision bred confirmation relating to an organism—

(a) a precision bred animal marketing authorisation relating to the organism;

(b) any marketing authorisation issued under regulations under Part 3 that was issued in reliance, for the purposes of any requirement imposed by virtue of section 26(3)(a), on the organism being a marketable precision bred organism.

(4) Regulations under this section may confer a function on the advisory committee.

(5) Regulations under this section are subject to the negative procedure.