Genetic Technology (Precision Breeding) Act 2023

Part 2: Precision Bred Organisms, Release, Marketing, and Risk Assessments

Release

3: Restrictions on release of precision bred organisms in England

36. This section sets out the conditions under which a person who has a precision bred organism under their control may release that organism into the environment in England.
37. Subsection (1) outlines that a person who has a precision bred organism under their control must not release a precision bred organism in England unless the notification requirements set out in section 4 have been satisfied in relation to the release, the person is specified in the notification and the release is carried out in accordance with the notice; or the organism is either a marketable precision bred organism (as defined in section 5(2) is the qualifying progeny of a marketable precision bred organism). "Qualifying progeny" is defined in section 24.
38. Subsection (2) describes the circumstances in which a precision bred organism can be considered under a person’s control.
39. Subsection (3) describes the circumstances in which a precision bred organism is considered to be released.

4: Release of precision bred organism: notification requirements

40. This section sets out the notification requirements for the release of a precision bred organism in England.
41. Subsection (1) sets out the legal requirements for a notification of release of a precision bred organism. The notification requirements are satisfied in relation to the release if a person gives the Secretary of State a notice of the intention to release an organism (with any required information) and if the person has paid the fees required by regulations made under section 40, and any minimum period required by regulations has elapsed between satisfying the requirements and releasing the organism.
42. Subsection (2) requires the notice to specify persons in relation to the release.
43. Subsection (3) sets out a power to make regulations to make provisions for the details of the release notification form, such as the form and content of the release notice, and any other required information.
44. Subsection (4) provides that these regulations may prescribe who can be specified in relation to a notice.
45. Subsection (5) provides that the meaning of "release" is as in section 3(3).
46. Subsection (6) specifies that regulations under subsection (1)(b) are subject to the negative procedure.
47. Subsection (7) specifies that regulations under subsection (3) are subject to the affirmative procedure.

Marketing

5: Restrictions on marketing of precision bred organisms in England

48. This section sets out the notification requirements for the marketing of a precision bred organism in England.
49. Subsection (1) contains restrictions on the marketing of precision bred organisms in England: a person must not market a precision bred organism in England unless the organism is a marketable precision bred organism or is the qualifying progeny of a marketable precision bred organism.
50. Subsection (2) defines a "marketable precision bred organism" as one which will have to have received a precision bred confirmation (under section 8(1)(a)), and, for a relevant animal, have an animal marketing authorisation.
51. Subsection (3) explains what it means to market precision bred organisms in England, for the purposes of this Act.
52. Subsection (4) sets out where relevant definitions can be found in the Act.
53. Subsection (5) explains what is meant by a confirmation or authorisation being "in force".

Precision bred confirmation

6: Application for precision bred confirmation

54. This section describes the application process for a precision bred confirmation.
55. Subsection (1) establishes that a person may apply for confirmation, from the Secretary of State, that an organism is a precision bred organism by giving a notice (a "marketing notice") to the Secretary of State.
56. Subsection (2) provides for regulations that may be used to establish the form and content of the marketing notice and the required information that must accompany it.
57. Subsection (3) requires the Secretary of State to refer the marketing notice and any required information that accompanied it to the advisory committee as soon as practical after receiving this information and after receiving any fee that is required under section 36.
58. Subsection (4) specifies that regulations made under this section are subject to the affirmative procedure.

7: Report by advisory committee

59. This section sets out the requirements for the report of the advisory committee.
60. Subsection (1) establishes this section applies where a marketing notice has been referred to the advisory committee by the Secretary of State.
61. Subsection (2) establishes a period of 90 days as the timeframe in which the advisory committee must provide a report to the Secretary of State. This report must outline whether the advisory committee considers the organism to be precision bred and its reasons for that conclusion.
62. Subsection (3) provides that the committee may request further information from the notifier under an ‘information notice’ request, if they deem it necessary in order to assess and report if an organism is precision bred.
63. Subsection (4) provides that the committee report must contain any information provided by the notifier as a result of an information notice.
64. Subsection (5) provides for the committee report to be subject to regulations made under section 23 regarding time limits.

8: Issue of precision bred confirmation

65. Subsection (1) of this section provides for the Secretary of State, upon receipt of the advisory committee report, to issue the notifier with a precision bred confirmation and provide the notifier notice of it if the Secretary of State is satisfied the organism is precision bred. If not satisfied the organism is precision bred, the Secretary of State must give notice to the notifier of that fact, stating the reasons for such notice as required by subsection (2).

9: Revocation of precision bred confirmation

66. This section provides for the revocation of a precision bred confirmation.
67. Subsection (1) enables regulations to provide to the Secretary of State a power to revoke a precision bred confirmation if no longer satisfied that the organism is precision bred.
68. Subsection (2) provides that the Secretary of State must, in those such regulations, outline the procedures which must be followed in order to revoke a precision bred confirmation. Regulations must include provisions for publication of such revocation, allowing the persons affected by the revocation to make representation about it, the consequences of such revocation, and the details of information which will be published on the PB Public Register.
69. Subsection (3) provides that if a precision bred confirmation is revoked, any marketing authorisations issued under regulations under Part 3 (Food and feed produced from precision bred organisms) in reliance on the organism being a marketable precision bred organism, and for relevant animals a precision bred animal marketing authorisation relating to the animal cease to have effect.
70. Subsection (4) enables regulations under this section to confer a function on the advisory committee, for instance to provide the Secretary of State with advice relating to the revocation of a precision bred confirmation.
71. Subsection (5) specifies that regulations made under this section are subject to the negative procedure.

Relevant animals: precision bred animal marketing authorisation

10: "Relevant animal"

72. This section defines what a "relevant animal" is.
73. Subsection (1) explains that a "relevant animal" for the purposes of this Act is a vertebrate.
74. Subsection (2) provides that regulations may be made in order to extend the definition of a "relevant animal" if the definition in the Animal Welfare Act 2006 is extended to include invertebrates of any description.
75. Subsection (3) explains that the meanings of "vertebrate" and "invertebrate" are set out in the Animal Welfare Act 2006, as follows: "vertebrate" means any animal of the Sub-phylum Vertebrata of the Phylum Chordata and "invertebrate" means any animal not of that Sub-phylum.
76. Subsection (4) specifies that regulations made under this section are subject to the draft affirmative procedure.

11: Application for precision bred animal marketing authorisation

77. This section sets out the application process for a precision bred animal marketing authorisation.
78. Subsection (1) explains that this section applies where the Secretary of State has received a marketing notice relating to an animal.
79. Subsection (2) explains that the person who gave a marketing notice in respect of an animal who wishes to obtain a precision bred animal marketing authorisation for that animal can apply to the Secretary of State.
80. Subsection (3) sets out that when making an application for a precision bred animal marketing authorisation the applicant must include an animal welfare declaration.
81. Subsection (4) lists the information requirements and fees which must accompany an application for a precision bred animal marketing authorisation.
82. Subsection (5) allows for the form and content of an application for a precision bred animal marketing authorisation and related documentation to be set out in regulations and allows for regulations to require additional information to be provided with the application.
83. Subsection (6) explains that the Secretary of State must refer an application for a precision bred animal marketing authorisation and any related information to the welfare advisory body.
84. Subsection (7) sets out that when the Secretary of State must refer the application to the welfare advisory body and allows the Secretary of State to decide to wait until a confirmation of precision breeding is issued in relation to the relevant animal.
85. Subsection (8) explains that the duty to refer the application to the welfare advisory committee does not apply if the Secretary of State decides not to issue a precision breeding confirmation in relation to the relevant animal.
86. Subsection (9) allows for regulations to set out when a person other than the notifier can apply for a precision bred marketing authorisation for a precision-bred animal.
87. Subsection (10) specifies that regulations made under subsection (5) are subject to the affirmative procedure.
88. Subsection (11) specifies that regulations made under subsection (9) are subject to the negative procedure.

12: Report by welfare advisory body

89. This section refers to the report by the welfare advisory body.
90. Subsection (1) explains that this section applies where the Secretary of State refers a precision bred animal marketing authorisation to the welfare advisory body.
91. Subsection (2)(a) to (c) outlines what must be included in the report from the welfare advisory body to the Secretary of State and that the report must be provided within a set timeframe.
92. Subsection (3) explains that the timeframe for the reporting period will be set out in regulations, and that it will begin on the day the application is referred to the welfare advisory body.
93. Subsection (4) enables the welfare advisory body to request further information from a person submitting an application under an ‘information notice’ before the end of the reporting period set out in subsection (3).
94. Subsection (5) sets out that the advisory body’s report to the Secretary of State must be accompanied by any information that the body was provided with after issuing an information notice.
95. Subsection (6) confirms that subsections (2) and (3) are subject to regulations under section 23 on Advisory bodies and time limits.
96. Subsection (7) specifies that regulations made under this section are subject to the negative procedure.

13: Issue of precision bred animal marketing authorisation

97. This section sets out the process for issuing a precision bred marketing authorisation.
98. Subsection (1) (a) to (c) explains what the Secretary of State must do when he receives a report from the welfare advisory body. It sets out that he must decide if a precision bred animal marketing authorisation can be issued and notify the applicant of his decision, including any reasons for not issuing the authorisation.
99. Subsection (2) (a) to (b) sets out that the Secretary of State must consider whether the notifier’s declaration explains the traits produced by precision breeding in the animal and identifies any risks to the health or welfare of the animal or its qualifying progeny (as defined in section 24) associated with those traits. This subsection explains that if he is satisfied with how these elements have been considered, the Secretary of State may issue a precision bred animal marketing authorisation.

Protection of relevant animals following issue of marketing authorisation

14: Precision bred animal marketing authorisations: reporting obligations

100. This section provides for reporting obligations concerning precision bred marketing authorisations.
101. Subsection (1) (a) to (b) and (2) set out that draft affirmative regulations may make provisions to require the notifier, or any other person specified, to report information to the Secretary of State about the welfare of the relevant animal and its qualifying progeny (as defined in section 24). This subsection also provides that when the relevant animal is supplied to another person, the notifier may be required to take steps to collect that health and welfare information, or enable it to be collected, from the other person.
102. Subsection (3) provides for the periods during which reporting obligations would apply.
103. Subsection (4) specifies that regulations made under this section are subject to the draft affirmative procedure.

15: Suspension and revocation of precision bred animal marketing authorisation

104. This section provides for the suspension and revocation of a precision bred marketing authorisation.
105. Subsection (1) (a) to (c) sets out that regulations made under this section can enable the Secretary of State to suspend or revoke a precision bred animal marketing authorisation, either because of new information about animal health or welfare, or because of a failure by any person to comply with a legal requirement to report information about a relevant animal’s health and welfare.
106. Subsection (2) (a) to (c) explains that Regulations made under this section must set out the procedure to be followed if the Secretary of State plans to suspend or revoke a precision bred animal marketing authorisation – including who should be notified and who can appeal, what the effect of the suspension or revocation is and what changes should be made to the register of precision bred organisms.
107. Subsection (3) confirms that regulations under this section can also confer a function to the welfare advisory body as part of the process if needed.
108. Subsection (4) confirms that nothing in this section affects the power to make provision in relation to a failure to comply with regulations under section 14.
109. Subsection (5) specifies that regulations made under this section are subject to the negative procedure.

Reviews and appeals relating to Part 2

16: Reviews and appeals relating to Part 2

110. This section provides for reviews and appeals relating to Part 2.
111. Subsection (1) requires the Secretary of State to make regulations for reviews and appeals against decisions made under this part.
112. Subsection (2) provides that regulations must secure that the appellant has the rights to require the Secretary of State to review, and then to appeal to the First-tier Tribunal against the decisions made under Part 2 of this Act and provides for the grounds on which that review or appeal can be made. These are that the decision was based on an error of fact, was wrong in law, unreasonable or on any other grounds prescribed by regulations.
113. Subsection (3) describes the decisions an appellant is able to request a review or appeal against: a decision not to issue or to revoke a precision bred confirmation; or a decision not to issue, to revoke or to suspend a precision bred animal marketing authorisation.
114. Subsection (4) provides that additional provisions concerning appeals may be made by regulations, including the powers of the First-tier Tribunal on an appeal.
115. Subsection (5) specifies that regulations made under this section are subject to the negative procedure.

Risk assessments

17: Restrictions on importation and acquisition of precision bred organisms in England

116. This section provides for restrictions on importation and acquisition of precision bred plants and animals in contained use conditions.
117. Subsection (1) provides that regulations may be made requiring a person to carry out an environmental risk assessment for precision bred organisms that are imported to a place in England or that are acquired in England. The Government intends that this should have limited application in that it envisages it only applying to precision bred animals and plants before they are released into the environment or marketed (after which point, they are subject to the regulatory provisions on release and marketing in this Act). It provides for existing requirements placed on Genetically Modified Organisms and Precision Bred plants and animals in contained use conditions (such as laboratories) to be maintained. In the majority of cases, a mixture of Genetically Modified and Precision Bred organisms will be present in laboratories and other contained use facilities and this subsection will provide for the current regulations on environmental risk assessment to continue to apply. These are proportionate and science based.
118. Subsection (2) establishes the meaning of an environmental risk assessment for the purposes of any regulations that are made under subsection (1).
119. Subsection (3) establishes the provisions that may be made in regulations for environmental risk assessments, including keeping them under review and keeping records for provision to the Secretary of State.
120. Subsection (4) makes provision requiring persons carrying out environmental risk assessments to obtain advice from prescribed persons.
121. Subsection (5) defines the terms ‘acquire’ and ‘damage to the environment’.
122. Subsection (6) specifies that regulations made under this section are subject to the negative procedure.

Register

18: Precision breeding register

123. This section refers to the Precision Breeding Register. Subsection (1) requires the Secretary of State must establish and maintain a register and prescribes the information the register must contain.
124. Subsection (2) provides for the Secretary of State not to include information in the register if they determine that such information is commercially confidential, subject to subsection (4).
125. Subsection (3) explains the circumstances of the requirements in subsection (2) cease to apply when the Secretary of State determines that the information is no longer commercially confidential.
126. Subsection (4) provides that neither the name of any person giving the notices and required information mentioned in subsection (1)(a) nor the general description of any precision bred organism are considered to be commercially confidential.
127. Subsection (5) provides for the Secretary of State to ensure the register is accessible to the public, free of charge, in electronic form. 
128. Subsection (6) enables the Secretary of State to make regulations for the keeping of the register.
129. Subsection (7) specifies that regulations made under subsection (1) are subject to the affirmative procedure.
130. Subsection (8) specifies that regulations made under subsection (6) are subject to the negative procedure.

Monitoring and inspection

19: Inspectors

131. This section refers to monitoring and inspection powers.
132. Subsection (1) provides for the Secretary of State to appoint inspectors for the purposes of Part 2 of this Act.
133. Subsection (2) provides for the inspectors appointed under this section to not be liable in any civil or criminal proceedings for anything done in the purported exercise of their functions if the court deems in was done in good faith and there were reasonable grounds for doing it.
134. Subsection (3) does not cover any liability of any other person in respect to the inspector’s act.
135. Subsection (4) defines what an "inspector" is for the purposes of Part 2 of this Act.

20: Monitoring and inspection of Part 2 obligations

136. This section provides for monitoring and inspections in respect of Part 2 obligations.
137. Subsection (1) enables the Secretary of State to make regulations for monitoring compliance with the obligations under this Part and investigate compliance failures.   
138. Subsection (2) provides for the Secretary of State to make regulations regarding the appointment of inspectors and their functions and provides for a non-exhaustive list of what these regulations might cover.
139. Subsection (3) establishes that regulations made under this section may not create criminal offences, confer power of entry into private dwellings except under a warrant or authorise the use of force on power of entry. Regulations must also prohibit inspectors from wider use or disclosure of information obtained under them.
140. Subsection (4) specifies that regulations made under this section are subject to the draft affirmative procedure.

21: Meaning of "Part 2 obligation"

141. This section describes the meaning of an obligation under Part 2 in relation to release, marketing and risk assessments of PBOs.
142. Su bsection (1) defines a "Part 2 obligation" as an obligation imposed under Part 2 (except for those circumstances described in subsection (2)), or a requirement arising from a stop notice or compliance notice issued in connection with Part 2.
143. Subsection (2) establishes that a Part 2 obligation is not one imposed by an information notice or any obligation of the Secretary of State, an advisory body, or an inspector.
144. Subsection (3) allows regulations to provide that a failure to comply with a Part 2 obligation can also relate to the provision of misleading or false information in relation to a Part 2 obligation or an authorisation.
145. Subsection (4) defines "requirement" to include "prohibition".
146. Subsection (5) specifies that regulations made under section (3) are subject to the draft affirmative procedure.

Release and marketing: general provisions

22: Advisory bodies

147. This section sets out the advisory bodies for Part 2 of this Act.
148. Subsection (1) establishes the advisory committee referenced in this Part is the same committee established under section 124 (1) of the Environmental Protection Act 1990.  
149. Subsection (2) places a duty on the advisory committee to give advice on applications, reports and the issuing and revocation of precision breeding confirmation as required by the Secretary of State.  
150. Subsection (3) defines "welfare advisory body" for the purposes of this Part as the body so designated by regulations.
151. Subsection (4) allows the welfare advisory body to be a committee appointed by the Secretary of State for the purposes of this Part, or a body which was established previously by or under any other Act or which exercises functions of a public nature.
152. Subsection (5) places a duty on the welfare advisory body to provide advice to the Secretary of State on any matter relevant to the Secretary of State’s functions under sections 11 to 15.
153. Subsection (6) establishes that subsections (7) and (8) apply to the welfare advisory committee if it is appointed by the Secretary of State under subsection 4(a).
154. Subsection (7) enables members of the committee to hold and vacate office in accordance with the terms of their appointment.
155. Subsection (8) enables the Secretary of State to pay members of the committee remuneration and allowances, as decided by the Secretary of State.
156. Subsection (9) specifies that regulations made under section (3) are subject to the affirmative procedure.

23: Advisory bodies: time limits etc

157. This section sets out additional provisions for the advisory bodies.
158. Subsection (1) allows for Secretary of State to make regulations for the notification to be treated as paused while information requested by an information notice has not been provided and withdrawn if the requested information is not provided to the advisory body’s satisfaction within a prescribed period.
159. Subsections (2) and (3) define "information notice", "relevant application", and "reporting period" for these purposes.  
160. Subsection (4) specifies that regulations made under this section are subject to the negative procedure.

24: "Qualifying progeny"

161. This section establishes the meaning of a "qualifying progeny" of a marketable precision bred organism.

25: Precision bred animal marketing authorisation: adverse effects

162. Subsection (1) enables the Secretary of State to specify in regulations subject to the affirmative procedure when the health or welfare of a precision bred animal or its qualifying progeny is, or is not, considered to be adversely affected by a trait which results from precision breeding. This would allow the Secretary of State to establish thresholds for assessing risk or exceptions which may need to be considered as part of the decision to issue, suspend, or revoke a precision bred animal marketing authorisation.
163. Subsection (2) specifies that regulations made under this section are subject to the draft affirmative procedure.