Genetic Technology (Precision Breeding) Act 2023

• (6) In subsection (4), “relevant decision”, in relation to a costs notice, means—

• (a) the decision to issue the notice, or

• (b) the decision as to the amount of the costs.

• (7) Regulations which provide for the issue of a costs notice may make provision—

• (a) for the payment of interest on late payment;

• (b) as to how any amounts payable by virtue of the regulations are to be recoverable.

• (8) Regulations under this section are subject to the affirmative procedure.

Part 5 — General

Fees

39

• (1) Regulations may make provision requiring a fee to be paid to the appropriate authority in respect of the exercise of any function conferred by or under Part 2 or Part 3.

• (2) In this section “appropriate authority” means—

• (a) in relation to a function conferred by or under Part 2, the Secretary of State;

• (b) in relation to a function conferred by or under under Part 3, the Food Standards Agency.

• (3) Regulations which require the payment of a fee must prescribe—

• (a) the amount of the fee, or

• (b) how the amount of the fee is to be calculated.

• (4) In prescribing the amount of a fee in respect of a function (or any other amount by reference to which the fee is to be calculated) the Secretary of State may have regard to the desirability of securing that, as far as practicable and taking one year with another, the following are equal—

• (a) income of the appropriate authority from fees referable to the function, and

• (b) expenditure incurred by—

• (i) the Secretary of State, in the case of a function conferred by or under Part 2, or

• (ii) the Secretary of State, the Food Standards Agency or enforcement authorities, in the case of a function conferred by or under Part 3,

in exercising the function (including a reasonable share of expenditure which is referable only partly or indirectly to the exercise of that function).

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

Notices and documents

40

• (1) Regulations may make provision about—

• (a) how a notice or other document may be issued or given under this Act;

• (b) when such a notice or document is to be treated as being received.

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

Consequential amendments of the Environmental Protection Act 1990

41

• (1) The Environmental Protection Act 1990 is amended as follows.

• (2) After section 106 insert—

(106A) (1) In this Part as it applies in relation to England, references to genetically modified organisms (except in this section and section 127)— (a) do not include references to precision bred organisms; (b) so far as they relate to marketing, also do not include references to gametes of precision bred organisms. (2) For the purposes of subsection (1), this Part applies in relation to England so far as it applies in relation to— (a) importing genetically modified organisms where their destination is in England; (b) acquiring genetically modified organisms which are in England; (c) keeping or releasing genetically modified organisms in England; (d) marketing a genetically modified organism so far as the organism (or, where the organism is marketed by virtue of a product consisting of or including the organism being made available to other persons, that product) is made available for delivery in England. (3) In this section “precision bred organism” and “gamete” have the same meanings as in the Genetic Technology (Precision Breeding) Act 2023.

• (3) In section 124 (advisory committee for purposes of Part 6), in subsection (1), at the end insert—

For other functions of the committee, see Part 2 of the Genetic Technology (Precision Breeding) Act 2023.

Power to make consequential provision

42

• (1) Regulations may make supplementary, incidental or consequential provision in connection with any provision of or made under this Act.

• (2) Regulations under this section may modify legislation.

• (3) Regulations under this section which contain provision modifying primary legislation (with or without other provision) are subject to the affirmative procedure.

• (4) Other regulations under this section are subject to the negative procedure.

Regulations

43

• (1) This section applies to regulations under this Act other than regulations under section 48 (commencement regulations).

• (2) Regulations are to be made by statutory instrument.

• (3) A power to make regulations includes power—

• (a) to make—

• (i) different provision for different purposes;

• (ii) transitional, transitory or saving provision;

• (b) to confer a function involving the exercise of a discretion.

(See section 42(1) for power to make consequential, incidental and supplemental provision.)

• (4) Where regulations under this Act are subject to the affirmative procedure, the regulations may not be made unless a draft of the statutory instrument containing them has been laid before, and approved by a resolution of, each House of Parliament.

• (5) Where regulations under this Act are subject to the negative procedure, the statutory instrument containing them is subject to annulment in pursuance of a resolution of either House of Parliament.

• (6) Any provision that may be made by regulations under this Act subject to the negative procedure may be made in regulations subject to the affirmative procedure.

Interpretation

44

In this Act the following terms have the following meanings—

• “advisory body” means the advisory committee or welfare advisory body;

• “the advisory committee” has the meaning given by section 22(1);

• “the affirmative procedure” has the meaning given by section 43(4);

• “animal” has the meaning given by section section 2(2);

• “compliance notice” has the meaning given by section 33(1);

• “control” is to be read in accordance with section 3(2);

• “enforcement authority” means a body designated as such under section 28(1);

• “enforcement notice” has the meaning given by section 32(3);

• “the environment” includes land, air, water and living organisms supported by any of those media;

• “gamete” has the meaning given by section 2(4);

• “legislation” means— primary legislation, retained direct EU legislation, or subordinate legislation;

• “marketable precision bred organism” has the meaning given by section 5(2);

• “marketing notice” has the meaning given by section 6(1);

• “modern biotechnology” has the meaning given by section 1(3);

• “modify”, in relation to legislation, includes amend, repeal or revoke (and related terms are to be read accordingly);

• “monetary penalty notice” has the meaning given by section 35(1);

• “the negative procedure” has the meaning given by section 43(5);

• “notifier”, in relation to a marketing notice, has the meaning given by section 6(1) (but see section 11(9));

• “organism” (except in section 2) means plant or animal;

• “Part 2 obligation” has the meaning given by section 21;

• “Part 3 obligation” has the meaning given by section 29;

• “plant” has the meaning given by section 2(1);

• “precision bred” has the meaning given by section 1;

• “precision bred animal marketing authorisation” means a marketing authorisation issued under section 13(1);

• “precision bred confirmation” has the meaning given by section 8(1)(a)(i);

• “precision bred organism” has the meaning given by section 1(1);

• “precision bred trait”, in relation to a relevant animal, means a trait of the animal which results from a feature of the animal’s genome that results from the application of modern biotechnology;

• “prescribed” means prescribed by regulations;

• “primary legislation” means— an Act, an Act of the Scottish Parliament, an Act or Measure of Senedd Cymru, or Northern Ireland legislation;

• “progeny”, in relation to a precision bred organism, includes any progeny of the organism, whether resulting from sexual or asexual reproduction;

• “qualifying progeny” has the meaning given by section 24;

• “the register” has the meaning given by section 18;

• “regulations” means regulations made by the Secretary of State;

• “relevant animal” has the meaning given by section 10;

• “relevant breach” has the meaning given by section 31(1);

• “stop notice” has the meaning given by section 34(1);

• “subordinate legislation” means an instrument made under primary legislation or under retained direct EU legislation;

• “the welfare advisory body” has the meaning given by section 22(3).

Financial provisions

45

The following are to be paid out of money provided by Parliament—

• (a) any expenditure incurred under or by virtue of this Act by the Secretary of State or the Food Standards Agency, and

• (b) sums payable out of money so provided under any other Act.

Crown application

46

• (1) This Act binds the Crown.

• (2) If the Secretary of State certifies that it appears to the Secretary of State appropriate in the interests of national security that powers of entry conferred under this Act should not be exercisable in relation to Crown premises specified in the certificate, those powers are not exercisable in relation to those premises.

• (3) In subsection (2), “Crown premises” means premises held, or used, by or on behalf of the Crown.

• (4) No power of entry conferred under this Act may be exercised in relation to land belonging to His Majesty in right of His private estates.

• (5) In subsection (4), the reference to His Majesty’s private estates is to be construed in accordance with section 1 of the Crown Private Estates Act 1862.

Extent and application to sea areas

47

• (1) Subject as follows, this Act extends to England and Wales only.

• (2) Part 1 and section 41 extend to England and Wales and Scotland only.

• (3) Sections 42 to 46, this section and section 48 extend to England and Wales, Scotland and Northern Ireland.

• (4) This Act—

• (a) applies to the territorial sea adjacent to England as it applies in England;

• (b) applies to any area for the time being designated under section 1(7) of the Continental Shelf Act 1964 as it applies in England.

Short title and commencement

48

• (1) This Act may be cited as the Genetic Technology (Precision Breeding) Act 2023.

• (2) Part 1 comes into force on the day on which this Act is passed.

• (3) Parts 2 to 4 and sections 39 and 40 come into force—

• (a) so far as necessary to enable the exercise of any power to make regulations, on the day on which this Act is passed;

• (b) for remaining purposes, on such day as regulations may appoint.

• (4) Section 41 comes into force on such day as regulations may appoint.

• (5) The rest of this Part comes into force on the day on which this Act is passed.

• (6) Regulations under this section may appoint different days for different purposes.

• (7) Regulations may make transitional, transitory or saving provision in connection with the coming into force of any provision of this Act.

• (8) Regulations under this section are to be made by statutory instrument.

Precision bred organism

Meaning of “plant” and “animal”

Restrictions on release of precision bred organism in England

Release of precision bred organism: notification requirements

Restrictions on marketing of precision bred organism in England

Application for precision bred confirmation

Report by advisory committee

Issue of precision bred confirmation

Revocation of precision bred confirmation

Meaning of “relevant animal”

Application for precision bred animal marketing authorisation

Report by welfare advisory body

Issue of precision bred animal marketing authorisation

Precision bred animal marketing authorisations: reporting obligations

Suspension and revocation of precision bred animal marketing authorisation

Reviews and appeals relating to Part 2

Restrictions on importation and acquisition of precision bred organisms in England

Precision breeding register

Inspectors

Monitoring and inspection of Part 2 obligations

Meaning of “Part 2 obligation”

Advisory bodies

Advisory bodies: time limits etc

Meaning of “qualifying progeny”

Precision bred animal marketing authorisation: adverse effects

Regulation of food and feed produced from precision bred organisms

Food and feed marketing authorisations: register

Monitoring and inspection of Part 3 obligations

Meaning of “Part 3 obligation”

Interpretation of Part 3

Meaning of “relevant breach” etc

Enforcement

Compliance notices

Stop notices

Monetary penalty notices

Content of enforcement notices: further provision

Enforcement notices: reviews and appeals

Costs

Fees

Notices and documents

Consequential amendments of the Environmental Protection Act 1990

Power to make consequential provision

Regulations

Interpretation

Financial provisions

Crown application

Extent and application to sea areas

Short title and commencement

Editorial notes