genetic technology original
genetic technology original
genetic technology original
Genetic Technology
(Precision Breeding) Act 2023
2023 CHAPTER 6
An Act to make provision about the release and marketing of, and risk
assessments relating to, precision bred plants and animals, and the marketing
of food and feed produced from such plants and animals; and for connected
purposes. [23rd March 2023]
BE IT ENACTED by the King’s most Excellent Majesty, by and with the advice and consent of
the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by
the authority of the same, as follows:—
PART 1
(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.
Genetic Technology (Precision Breeding) Act 2023 (c. 6) 3
Part 2 – Precision bred organisms: release, marketing and risk assessments
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(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.
PART 2
Release
Marketing
(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.
(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.
(4) Before the end of the reporting period, the body may by notice (“an information
notice”) request the notifier to provide further information to the body.
(5) The body’s report to the Secretary of State must be accompanied by any information
provided to the body as the result of an information notice.
(6) Subsections (2) and (3) are subject to regulations under section 23.
(7) Regulations under subsection (3) are subject to the negative procedure.
(2) The regulations must, in particular, in relation to each of the decisions mentioned in
subsection (3)—
(a) secure that any person prescribed by the regulations may—
(i) require the Secretary of State to review the decision, and
(ii) if not satisfied with the outcome of any such review, appeal against
the decision,
(b) secure that the grounds on which a review may be required or an appeal
brought include the following—
(i) that the decision was based on an error of fact,
(ii) that the decision was wrong in law, and
(iii) that the decision was unreasonable for any reason, and
(c) make provision for such an appeal to be brought in the First-tier Tribunal.
(3) Those decisions are—
(a) a decision under section 8 not to issue a precision bred confirmation;
(b) a decision under section 9 to revoke a precision bred confirmation;
(c) a decision under section 13 not to issue a precision bred animal marketing
authorisation;
(d) a decision under section 15 to suspend or revoke a precision bred animal
marketing authorisation.
(4) Regulations may make provision as to—
(a) the Secretary of State’s functions on a review of a decision under this Part;
(b) the powers of the First-tier Tribunal on an appeal by virtue of this section.
(5) Regulations under this section are subject to the negative procedure.
Risk assessments
(4) Provision that may be made by virtue of subsection (3) includes provision requiring
persons carrying out risk assessments to obtain advice from prescribed persons.
(5) For the purposes of this section—
(a) “acquire”, in relation to precision bred organisms, includes any method by
which such organisms may come to be in a person’s possession, other than
by their being imported;
(b) “damage to the environment” is caused by the presence in the environment
of a precision bred organism which is no longer under anyone’s control (see
section 3(2)) and is capable of causing adverse effects as regards the health
of humans or the environment.
(6) Regulations under this section are subject to the negative procedure.
Register
(6) Regulations may make provision for the keeping of the register.
(7) Regulations under subsection (1) are subject to the affirmative procedure.
(8) Regulations under subsection (6) are subject to the negative procedure.
19 Inspectors
(1) The Secretary of State may appoint inspectors for the purposes of this Part.
(2) An inspector appointed under this section is not liable in any civil or criminal
proceedings for anything done in the purported exercise of the inspector’s functions
under section 20 or Part 4 if the court is satisfied that the act was done in good faith
and that there were reasonable grounds for doing it.
(3) Relief from liability of an inspector under subsection (2) does not affect any liability
of any other person in respect of the inspector’s act.
(4) In this Part “inspector” means an inspector appointed under this section.
(i) for the purposes of this Part or Part 6 of the Environmental Protection
Act 1990, or
(ii) for prescribed purposes relating to safeguarding the health and
welfare of animals.
(4) Regulations under this section are subject to the affirmative procedure.
22 Advisory bodies
(1) References in this Act to the advisory committee are to the committee appointed by
the Secretary of State under section 124(1) of the Environmental Protection Act 1990.
(2) The advisory committee must, at the request of the Secretary of State, provide advice
on any matter relevant to the Secretary of State’s functions under sections 6 to 9
(precision bred confirmation).
(3) References in this Act to the welfare advisory body are to such committee or other
body as may be designated by regulations.
(4) A body designated by regulations under subsection (3) may be—
(a) a committee appointed by the Secretary of State for the purposes of this Part,
or
(b) a body—
(i) established by or under any other Act, or
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PART 3
(b) for food and feed marketing authorisations to be issued subject to conditions
and limitations;
(c) for varying or cancelling conditions or limitations that apply to food and feed
marketing authorisations, or imposing new ones;
(d) about revocation of food and feed marketing authorisations;
(e) about publication of information relating to applications for food and feed
marketing authorisations.
(5) In subsection (4), references to applications for food and feed marketing authorisations
include references to applications to vary or cancel conditions or limitations that apply
to marketing authorisations.
(6) Provision that may be made by virtue of subsection (4) includes provision conferring
functions on the Food Standards Agency, which may include provision—
(a) for requiring the Food Standards Agency, in carrying out a function conferred
by the regulations—
(i) to obtain advice or information from, or consult, persons of prescribed
descriptions;
(ii) to carry out risk assessments;
(b) relating to any risk assessment required by the regulations.
(7) Regulations which, by virtue of subsection (6)(a)(i), impose an obligation on any
person other than the Food Standards Agency may provide that the obligation is not
a Part 3 obligation (see section 29).
(8) Regulations made by virtue of subsection (2)(a)—
(a) may prescribe who is authorised to place food and feed on the market by virtue
of a food and feed marketing authorisation, which may, in particular, be—
(i) only the person who applied for the authorisation,
(ii) any person, or
(iii) any person of a prescribed description, and
(b) may provide for any provision made by virtue of paragraph (a) to be subject, in
the case of a particular food and feed marketing authorisation, to any limitation
to which the authorisation is subject.
(9) Regulations under this section are subject to the affirmative procedure.
(4) Regulations under subsection (1) are subject to the affirmative procedure.
30 Interpretation of Part 3
(1) In this Part—
“feed” has the meaning given by Article 3(4) of the Food Regulation;
“food” has the same meaning as in the Food Regulation (see Article 2 of
that Regulation);
“food and feed marketing authorisation” means a marketing authorisation
issued under regulations under section 26 in relation to a precision bred
organism;
“the Food Regulation” means Regulation (EC) No 178/2002 of the
European Parliament and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, establishing the European
Food Safety Authority and laying down procedures in matters of food safety;
“inspector” means a person appointed as such under regulations under
section 28;
“traceability”, in relation to food or feed produced from a precision bred
organism, means the ability to trace and follow the organism and the food or
feed through all stages of production, processing and distribution.
(2) For the purposes of this Part, food or feed is produced “from” a precision bred
organism if it contains or consists of, or is otherwise derived from, the precision bred
organism.
(3) References in this Part to food or feed being placed on the market are to be read in
accordance with Article 3(8) of the Food Regulation.
20 Genetic Technology (Precision Breeding) Act 2023 (c. 6)
Part 4 – Enforcement
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PART 4
ENFORCEMENT
32 Enforcement
(1) Regulations may make provision for—
(a) an inspector to issue either of the following—
(i) a compliance notice (see section 33);
(ii) a stop notice (see section 34);
(b) the Secretary of State or an inspector to issue a monetary penalty notice (see
section 35);
to a person in relation to a relevant breach.
(2) Regulations may provide for a requirement imposed by a stop notice to be enforceable,
on the application of the Secretary of State, by injunction.
This does not affect the enforcement of the requirement (or power to make provision
for its enforcement) in any other way (whether by monetary penalty notice or
otherwise).
(3) In this Act “enforcement notice” means—
(a) a compliance notice,
(b) a stop notice, or
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Enforcement notices
33 Compliance notices
(1) In this Act “compliance notice” means a notice requiring the person to whom it is
issued to take specified steps within a specified period.
(2) Regulations which provide for the issue of a compliance notice must secure—
(a) that a compliance notice may be issued only where the inspector issuing the
notice is satisfied that the person to whom it is issued has committed or is
committing a relevant breach,
(b) that the steps specified under subsection (1) are steps that the inspector
considers will ensure that the relevant breach does not continue or recur, and
(c) that the period specified under subsection (1) is not less than 14 days
beginning with the day on which the notice is received.
(3) Sections 36 and 37 make further provision about compliance notices.
(4) In this section “specified”, in relation to a compliance notice, means specified in the
notice.
34 Stop notices
(1) In this Act “stop notice” means a notice prohibiting the person to whom it is issued—
(a) from carrying on a specified activity, or
(b) from doing so until the person has taken specified steps.
(2) Regulations which provide for the issue of a stop notice must secure—
(a) that a stop notice may be issued to a person only where the inspector issuing
the notice reasonably believes that the person to whom it is issued has
committed or is likely to commit a relevant breach, and
(b) that the steps specified under subsection (1)(b) are steps that the inspector
issuing the notice considers will ensure that the specified activity will be
carried on in a way that does not involve the person committing a relevant
breach.
(3) Sections 36 and 37 make further provision about stop notices.
(4) In this section “specified”, in relation to a stop notice, means specified in the notice.
(3) Regulations which provide for the issue of a monetary penalty notice must secure that
the Secretary of State or an inspector may issue a monetary penalty notice only where
satisfied that the person to whom it is issued has committed a relevant breach.
(4) Regulations which provide for the issue of a monetary penalty notice must require the
notice to state—
(a) how payment may be made,
(b) the period within which payment must be made, and
(c) the consequences of late payment or failure to pay.
(5) Regulations which provide for the issue of a monetary penalty 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.
(iv) in the case of a stop notice, that the person to whom it was issued had
not committed the relevant breach and would not have done so had
the notice not been issued,
(v) in the case of a monetary penalty notice, that the amount of the penalty
was unreasonable, and
(vi) that the decision was unreasonable for any other reason,
(c) make provision for such an appeal to be brought in the First-tier Tribunal, and
(d) make provision for suspending the operation of a compliance notice or
monetary penalty notice where an appeal is brought under the regulations in
relation to the notice pending the outcome of the appeal.
(2) Regulations which provide for the issue of an enforcement notice may make provision
as to—
(a) the Secretary of State’s functions on a review of a decision to issue an
enforcement notice, or
(b) the powers of the First-tier Tribunal on an appeal by virtue of this section.
Costs
38 Costs
(1) Regulations may make provision for an appropriate authority, by notice (a “costs
notice”) to require a person to pay the costs incurred by the authority in relation to an
enforcement notice up to the time of its issue.
(2) In this section, “appropriate authority”, in relation to an enforcement notice, means—
(a) in relation to a Part 2 obligation, the Secretary of State;
(b) in relation to a Part 3 obligation, an enforcement authority.
(3) In subsection (1), “costs” includes, in particular—
(a) investigation costs;
(b) administration costs;
(c) costs of obtaining expert advice (including legal advice).
(4) Regulations which provide for the issue of a costs notice to a person must secure that—
(a) the notice specifies the amount required to be paid,
(b) the person to whom the notice is issued may require the person issuing it to
provide a detailed breakdown of the amount,
(c) the person to whom the costs notice is issued is not liable to pay any costs
which that person shows to have been unnecessarily incurred,
(d) the person to whom the notice is issued may—
(i) require the Secretary of State to review a relevant decision, and
(ii) if not satisfied with the outcome of any such review, appeal against
that decision, and
(e) the grounds on which a review may be required or an appeal brought include—
(i) in the case of a decision as to the amount of the costs, that the amount
includes any amount referable to any costs unnecessarily incurred,
(ii) that the decision was based on an error of fact,
(iii) that the decision was wrong in law, and
(iv) that the decision was unreasonable for any other reason.
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(5) Regulations which provide for the issue of a costs notice to a person must also make
provision—
(a) for an appeal under the regulations to be brought in the First-tier Tribunal, and
(b) for suspending the operation of a costs notice where an appeal is brought under
the regulations pending the outcome of the appeal.
(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
39 Fees
(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.
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43 Regulations
(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.
44 Interpretation
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—
(a) primary legislation,
(b) retained direct EU legislation, or
(c) 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);
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45 Financial provisions
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.
46 Crown application
(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
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