Paragraph 6 Step 3: Quality of the dataF1
In order to carry out an environmental risk assessment for an application to which Part 3 of these Regulations applies, the applicant must collate already available data from scientific literature or from other sources, including monitoring reports, and must generate the necessary data by performing, where possible, appropriate studies. Where applicable, the applicant must justify in the environmental risk assessment why generating data by studies is not possible.
The environmental risk assessment for applications to which Part 2 of these Regulations applies must be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the applicant.
Where data generated outside the United Kingdom is provided in the environmental risk assessment, its relevance to receiving environment(s) in the United Kingdom must be justified.
Data provided in the environmental risk assessment for applications to which Part 3 of these Regulations applies, must comply with the following requirements—
where toxicological studies carried out to assess risk to human or animal health are provided in the environmental risk assessment, the applicant must provide evidence to demonstrate that they were conducted in facilities which comply with—
if carried out in a member State of the EU F4or in Northern Ireland, EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances, or
if carried out elsewhere, the ‘OECD Principles on Good Laboratory Practice’,
where studies other than toxicological studies are provided in the environmental risk assessment, they must—
comply with the principles of Good Laboratory Practice laid down in F5assimilated law, where relevant, or
be conducted by organisations accredited under the relevant ISO standard, or
in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards,
information on the results obtained from the studies referred to in sub-paragraphs (a) and (b) and on the study protocols used must be reliable and comprehensive and must include the raw data in an electronic format suitable for carrying out statistical or other analysis,
the applicant must specify, where possible, the size of effect that each study performed intends to detect and justify it,
the selection of sites for field studies must be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the genetically modified organism may be released. The selection must be justified in the environmental risk assessment, and
the non-genetically modified comparator must be appropriate for the relevant receiving environment(s) and must have a genetic background comparable to the genetically modified organism. The choice of the comparator must be justified in the environmental risk assessment.
Annotations
Textual amendments
- F1
Sch. 1 inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), reg. 1(2)(b), sch. 1; 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in sch. 1 para. 6(4)(a)(i) substituted (2.2.2023) by The Agriculture (Retained EU Law and Data) (Scotland) Act 2020 (Consequential Modifications) and Agricultural Products, Aquatic Animal Health and Genetically Modified Organisms (EU Exit) (Amendment) Regulations 2022 (S.S.I. 2022/361), regs. 1, 14(2)(i)
- F3
Word in sch. 1 para. 6(4)(a)(i) substituted (1.1.2024) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) (Scotland) Regulations 2023 (S.S.I. 2023/374), reg. 1(1), sch. 2 para. 2(4)
- F4
Words in sch. 1 para. 6(4)(a)(ii) inserted (2.2.2023) by The Agriculture (Retained EU Law and Data) (Scotland) Act 2020 (Consequential Modifications) and Agricultural Products, Aquatic Animal Health and Genetically Modified Organisms (EU Exit) (Amendment) Regulations 2022 (S.S.I. 2022/361), regs. 1, 14(2)(ii)
- F5
Word in sch. 1 para. 6(4)(b)(i) substituted (1.1.2024) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) (Scotland) Regulations 2023 (S.S.I. 2023/374), reg. 1(1), sch. 2 para. 2(5)