Genetic Technology (Precision Breeding) Act 2023.
Type of law
Legislation
Abstract
The Genetic Technology (Precision Breeding) Act 2023 regulates the release and marketing of, and risk assessments relating to, precision bred plants and animals (Part 2), including derived food and feed (Part 3).
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. The Act defines “Modern biotechnology” as any technique mentioned in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002, and specifies that modern biotechnology is different from "artificial modification technique” defined as 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. The Act also clarifies what "Traditional processes” means and distinguishes in relation to plants and to animals (sexual fertilization, spontaneous mutation; in vitro fertilization; polyploidy induction; embryo rescue; grafting; induced mutagenesis, or somatic hybridization or cell fusion of plant cells or recovery and transfer of primordial germ cells).
Part 2 (Release, marketing and risk assessments), establishes that a person who has a precision bred organism under their control must not release the organism in England unless a) the notification requirements are satisfied in relation to the release (see section 4), the person is a person specified in the release notice under section 4(2), and the release is carried out in accordance with the release notice, or (b) the organism is a marketable precision bred organism (see section 5(2)), or the qualifying progeny of a marketable precision bred organism (see section 24). Similarly for marketing, the Act establishes that a person must not market a precision bred organism in England unless it is a marketable precision bred organism, or it is the qualifying progeny. In this Act “marketable precision bred organism” means a precision bred organism in respect of which a precision bred confirmation is in force (see sections 7 to 9), and if it is a relevant animal, a precision bred animal marketing authorization is in force (see sections 10 to 15). Provisions consider for authorization animal welfare. Section 17 regulates Environmental Risk Assessment and restrictions on importation and acquisition of precision bred organisms in England when this can cause damage to the environment in England. Further provisions regulate inspections, monitoring, data collection and reporting, register, role of advisory bodies, etc.
Part 3 concerns Food and feed produced from precision bred organisms; The Act establishes that Regulations may make provision for regulating the placing on the market in England of food and feed produced from precision bred organisms. Regulations may prohibit any person from placing food or feed produced from a precision bred organism on the market in England except in accordance with a marketing authorization issued by the Secretary of State under the regulations in relation to the organism, and impose requirements for the purpose of securing traceability in relation to food or feed produced from precision bred organisms that is placed on the market in England. Further Regulations may make provision for establishing and regulating a public register; may make provision for designating one or more bodies as enforcement authorities with functions of monitoring compliance and investigating powers. Part 4 is Enforcement.
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. The Act defines “Modern biotechnology” as any technique mentioned in regulation 5(1)(a) or (b) of the Genetically Modified Organisms (Deliberate Release) Regulations 2002, and specifies that modern biotechnology is different from "artificial modification technique” defined as 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. The Act also clarifies what "Traditional processes” means and distinguishes in relation to plants and to animals (sexual fertilization, spontaneous mutation; in vitro fertilization; polyploidy induction; embryo rescue; grafting; induced mutagenesis, or somatic hybridization or cell fusion of plant cells or recovery and transfer of primordial germ cells).
Part 2 (Release, marketing and risk assessments), establishes that a person who has a precision bred organism under their control must not release the organism in England unless a) the notification requirements are satisfied in relation to the release (see section 4), the person is a person specified in the release notice under section 4(2), and the release is carried out in accordance with the release notice, or (b) the organism is a marketable precision bred organism (see section 5(2)), or the qualifying progeny of a marketable precision bred organism (see section 24). Similarly for marketing, the Act establishes that a person must not market a precision bred organism in England unless it is a marketable precision bred organism, or it is the qualifying progeny. In this Act “marketable precision bred organism” means a precision bred organism in respect of which a precision bred confirmation is in force (see sections 7 to 9), and if it is a relevant animal, a precision bred animal marketing authorization is in force (see sections 10 to 15). Provisions consider for authorization animal welfare. Section 17 regulates Environmental Risk Assessment and restrictions on importation and acquisition of precision bred organisms in England when this can cause damage to the environment in England. Further provisions regulate inspections, monitoring, data collection and reporting, register, role of advisory bodies, etc.
Part 3 concerns Food and feed produced from precision bred organisms; The Act establishes that Regulations may make provision for regulating the placing on the market in England of food and feed produced from precision bred organisms. Regulations may prohibit any person from placing food or feed produced from a precision bred organism on the market in England except in accordance with a marketing authorization issued by the Secretary of State under the regulations in relation to the organism, and impose requirements for the purpose of securing traceability in relation to food or feed produced from precision bred organisms that is placed on the market in England. Further Regulations may make provision for establishing and regulating a public register; may make provision for designating one or more bodies as enforcement authorities with functions of monitoring compliance and investigating powers. Part 4 is Enforcement.
Attached files
Web site
Long title of text
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.
Date of text
Repealed
No
Source language
English
Legislation Amendment
No