The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019

Regulation 3(24)

SCHEDULE 1 S NEW SCHEDULE 1 TO BE INSERTED

Commencement Information

I1 Sch. 1 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Regulation 6(1) and schedule 2

“SCHEDULE 1 S PRINCIPLES FOR ENVIRONMENTAL RISK ASSESSMENT

Introduction

1.— (1) This schedule describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment.

(2) In this schedule—

“cumulative long-term effects” means the accumulated effects of consents on human health and the environment, including among other things flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics,

“delayed effects” means the effects on human health or the environment which may not be observed during the period of the release of the genetically modified organism, but become apparent as a direct or indirect effect either at a later stage or after termination of the release,

“direct effects” means the primary effects on human health or the environment which are a result of the genetically modified organism itself and which do not occur through a causal chain of events,

“immediate effects” means the effects on human health or the environment which are observed during the period of the release of the genetically modified organism. Immediate effects may be direct or indirect, and

“indirect effects” means the effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management (observations of indirect effects are likely to be delayed).

(3) A general principle for environmental risk assessment is that an analysis of the cumulative long-term effects relevant to the release and the placing on the market of genetically modified organisms is to be carried out.

PART A S OBJECTIVE

2.   The objective of an environmental risk assessment is, on a case by case basis, to identify and evaluate potential adverse effects of the genetically modified organism, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or the placing on the market of genetically modified organisms may have. The environmental risk assessment should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used.

PART B S GENERAL PRINCIPLES

3.   In accordance with the precautionary principle, the following general principles should be followed when performing the environmental risk assessment—

(a) identified characteristics of the genetically modified organism and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations,

(b) the environmental risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data,

(c) the environmental risk assessment should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the genetically modified organisms concerned, their intended use and the potential receiving environment, taking into account, among other things, genetically modified organisms already in the environment, and

(d) if new information on the genetically modified organism and its effects on human health or the environment becomes available, the environmental risk assessment may need to be readdressed in order to—

(i) determine whether the risk has changed, and

(ii) determine whether there is a need for amending the risk management accordingly.

PART C S METHODOLOGY

CHAPTER C.1 S GENERAL AND SPECIFIC CONSIDERATION FOR THE ENVIRONMENTAL RISK ASSESSMENT

Step 1: Intended and unintended changes

4.— (1) As part of the identification and evaluation of the potential adverse effects referred to in Part A of this schedule, the environmental risk assessment must identify the intended and unintended changes resulting from the genetic modification and must evaluate their potential to cause adverse effects on human health and on the environment.

(2) Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.

(3) Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.

(4) Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.

Step 2: Long-term adverse effects and cumulative long-term adverse effects in the environmental risk assessment of applications to which Part 3 of these Regulations applies

5.— (1) Long-term effects of a genetically modified organism are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a genetically modified organism or from an extensive use of a genetically modified organism in time and space.

(2) The identification and evaluation of the potential long-term adverse effects of a genetically modified organism on human health and on the environment must take into account the following—

(a) the long-term interactions of the genetically modified organism and the receiving environment,

(b) the characteristics of the genetically modified organism which become important on a long- term basis, and

(c) data obtained from repeated deliberate releases or placings on the market of the genetically modified organism over a long period.

(3) The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introduction of this schedule must also take into account the genetically modified organisms deliberately released or placed on the market in the past.

Step 3: Quality of the data

6.— (1) 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.

(2) 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.

(3) 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.

(4) Data provided in the environmental risk assessment for applications to which Part 3 of these Regulations applies, must comply with the following requirements—

(a) 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—

(i) if carried out in the United Kingdom, retained EU law relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances,

(ii) if carried out in a member State of the EU, 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

(iii) if carried out elsewhere, the ‘OECD Principles on Good Laboratory Practice’,

(b) where studies other than toxicological studies are provided in the environmental risk assessment, they must—

(i) comply with the principles of Good Laboratory Practice laid down in retained EU law, where relevant, or

(ii) be conducted by organisations accredited under the relevant ISO standard, or

(iii) in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards,

(c) 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,

(d) the applicant must specify, where possible, the size of effect that each study performed intends to detect and justify it,

(e) 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

(f) 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.

Step 4: Stacked transformation events in applications to which Part 3 of these Regulations applies

7.   The following must apply to the environmental risk assessment of a genetically modified organism containing stacked transformation events in applications to which Part 3 of these Regulations applies—

(a) the applicant must provide an environmental risk assessment for each single transformation event in the genetically modified organism or refer to already submitted applications (or equivalent notifications) for those single transformation events,

(b) the applicant must provide an assessment of the following aspects—

(i) the stability of the transformation events,

(ii) the expression of the transformation events, and

(iii) the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events, and

(c) where the progeny of the genetically modified organism can contain various sub-combinations of the stacked transformation events, the applicant must provide a scientific rationale justifying that there is no need to provide experimental data for the concerned sub-combinations, independently of their origin, or, in the absence of such scientific rationale, must provide the relevant experimental data.

CHAPTER C.2 S CHARACTERISTICS OF THE GENETICALLY MODIFIED ORGANISM AND OF THE RELEASES

8.— (1) The environmental risk assessment must take into account the relevant technical and scientific details regarding characteristics of—

(a) the recipient or parental organism(s),

(b) the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor,

(c) the genetically modified organism,

(d) the intended release or use including its scale,

(e) the potential receiving environment(s) into which the genetically modified organism will be released and into which the transgene may spread, and

(f) the interaction(s) between these characteristics.

(2) Relevant information from previous releases of the same or similar genetically modified organisms and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, must be considered in the environmental risk assessment, subject to regulations 11(2) and 16(3).

CHAPTER C.3 S STEPS IN THE ENVIRONMENTAL RISK ASSESSMENT

9.   The environmental risk assessment must be conducted for each relevant area of risk referred to in Chapters D.1 and D.2 of Part D of this schedule in accordance with the following six steps.

Step 1: Problem formulation including hazard identification

10.— (1) The problem formulation must—

(a) identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the genetically modified organism with those of the chosen non-genetically modified comparator under corresponding conditions of release or use,

(b) identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under sub-paragraph (1)(a),

(c) identify relevant assessment end-points,

(d) identify and describe the exposure pathways or other mechanisms through which adverse effects may occur,

(e) formulate testable hypotheses, and define relevant measurement end-points, to allow, where possible, a quantitative evaluation of the potential adverse effect(s), and

(f) consider possible uncertainties, including knowledge gaps and methodological limitations.

(2) For the purposes of sub-paragraph (1)(b)—

(a) potential adverse effects must not be discounted on the basis that they are unlikely to occur,

(b) potential adverse effects will vary from case to case, and may include—

(i) effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,

(ii) altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors,

(iii) compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine,

(iv) effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,

(v) disease affecting humans, including allergenic or toxic reactions, and

(vi) disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate, and

(c) where potential long-term adverse effects of a genetically modified organism are identified, they must be assessed in the form of desk based studies using, where possible, one or more of the following—

(i) evidence from previous experiences,

(ii) available data sets or literature, or

(iii) mathematical modelling.

(3) For the purposes of sub-paragraph (1)(c), the potential adverse effects that could impact the identified assessment end-points must be considered in the next steps of the risk assessment.

(4) For the purposes of sub-paragraph (1)(d), adverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include—

(a) the spread of the genetically modified organism(s) in the environment,

(b) the transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not,

(c) phenotypic and genetic instability,

(d) interactions with other organisms, and

(e) changes in management, including, where applicable, in agricultural practices.

Step 2: Hazard characterisation

11.— (1) The magnitude of each potential adverse effect must be evaluated. This evaluation must assume that such an adverse effect will occur. The environmental risk assessment must consider that the magnitude is likely to be influenced by the receiving environment(s) into which the genetically modified organism is intended to be released and by the scale and conditions of the release.

(2) Where possible, the evaluation must be expressed in quantitative terms.

(3) Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) must be used and an explanation of the scale of effect represented by each category must be provided.

Step 3: Exposure characterisation

12.— (1) The likelihood or probability of each identified potential adverse effect occurring must be evaluated to provide, where possible, a quantitative assessment of the exposure as a relative measure of probability, or otherwise a qualitative assessment of the exposure. The characteristics of the receiving environment(s) and the scope of the application must be taken into consideration.

(2) Where the evaluation is expressed in qualitative terms, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the exposure must be used and an explanation of the scale of effect represented by each category must be provided.

Step 4: Risk characterisation

13.— (1) The risk must be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.

(2) Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk must be provided. In that case, a categorical description (‘high’, ‘moderate’, ‘low’ or ‘negligible’) of the risk must be used and an explanation of the scale of effect represented by each category must be provided.

(3) Where relevant, the uncertainty for each identified risk must be described and, where possible, expressed in quantitative terms.

Step 5: Risk management strategies

14.— (1) Where risks are identified that require, on the basis of their characterisation, measures to manage them, a risk management strategy must be proposed for each risk.

(2) The risk management strategies must be described in terms of reducing the hazard or the exposure, or both, and must be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the environmental risk assessment

(3) The consequent reduction in overall risk must be quantified where possible.

Step 6: Overall risk evaluation and conclusions

15.— (1) A qualitative and, where possible, quantitative evaluation of the overall risk of the genetically modified organism must be made taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty.

(2) The overall risk evaluation must include, where applicable, the risk management strategies proposed for each identified risk.

(3) The overall risk evaluation and conclusions must also propose specific requirements for the monitoring plan of the genetically modified organism and, where appropriate, the monitoring of the efficacy of the proposed risk management measures.

(4) For applications to which Part 3 of these Regulations applies, the overall risk evaluation must also include an explanation of the assumptions made during the environmental risk assessment and of the nature and magnitude of uncertainties associated with the risks, and a justification of the risk management measures proposed.

PART D S CONCLUSIONS ON THE SPECIFIC AREAS OF RISK OF THE ENVIRONMENTAL RISK ASSESSMENT

16.   Conclusions on the potential environmental impact in relevant receiving environments from the release or the placing on the market of genetically modified organisms must be drawn for each relevant area of risk listed in Chapter D.1 for genetically modified organisms other than higher plants or, as the case may be, Chapter D.2 for genetically modified higher plants, on the basis of an environmental risk assessment carried out in accordance with the principles outlined in Part B of this schedule and following the methodology described in Part C of this schedule, and on the basis of the information required pursuant to schedules 2 and 3.

CHAPTER D.1 S GENETICALLY MODIFIED ORGANISMS OTHER THAN HIGHER PLANTS

Areas of risk

17.— (1) Likelihood of the genetically modified organism becoming persistent and invasive in natural habitats under the conditions of the proposed release(s).

(2) Any selective advantage or disadvantage conferred to the genetically modified organism and the likelihood of this becoming realised under the conditions of the proposed release(s).

(3) Potential for gene transfer to other species under conditions of the proposed release of the genetically modified organism and any selective advantage or disadvantage conferred to those species.

(4) Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism and target organisms (if applicable).

(5) Potential immediate and/or delayed environmental impact of the direct and indirect interactions between the genetically modified organism with non-target organisms, including impact on population levels of competitors, prey, hosts, symbionts, predators, parasites and pathogens.

(6) Possible immediate and/or delayed effects on human health resulting from potential direct and indirect interactions of the genetically modified organism and persons working with, coming into contact with or in the vicinity of the genetically modified organism release(s).

(7) Possible immediate and/or delayed effects on animal health and consequences for the feed/food chain resulting from consumption of the genetically modified organism and any product derived from it, if it is intended to be used as animal feed.

(8) Possible immediate and/or delayed effects on biogeochemical processes resulting from potential direct and indirect interactions of the genetically modified organism and target and non-target organisms in the vicinity of the genetically modified organism release(s).

(9) Possible immediate and/or delayed, direct and indirect environmental impacts of the specific techniques used for the management of the genetically modified organism where these are different from those used for non-genetically modified organisms.

CHAPTER D.2 S GENETICALLY MODIFIED HIGHER PLANTS

Areas of risk

18.— (1) Persistence and invasiveness of the genetically modified higher plants, including plant to plant gene transfer.

(2) Plant to micro-organisms gene transfer.

(3) Interactions of the genetically modified higher plants with target organisms.

(4) Interactions of the genetically modified higher plants with non-target organisms.

(5) Impacts of the specific cultivation, management and harvesting techniques.

(6) Effects on biogeochemical processes.

(7) Effects on human and animal health.”

Regulation 3(29)

SCHEDULE 2 S NEW SCHEDULE 5A TO BE INSERTED

Commencement Information

I2 Sch. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(2)(b)

Regulation 16(2)(g) and schedule 4

“SCHEDULE 5A S MONITORING PLAN

Introduction

1.   This schedule describes in general terms the objective to be achieved and the general principles to be followed in the design of the monitoring plan referred to in regulations 16(2)(g) and 28(f).

PART A S OBJECTIVE

2.   The objective of a monitoring plan is to—

(a) confirm that any assumption regarding the occurrence and impact of potential adverse effects of the genetically modified organism or its use in the environmental risk assessment are correct, and

(b) identify the occurrence of adverse effects of the genetically modified organism or its use on human health or the environment which were not anticipated in the environmental risk assessment.

PART B S GENERAL PRINCIPLES

3.— (1) Monitoring takes place after the consent to the placing of a genetically modified organism on the market.

(2) The interpretation of the data collected by monitoring should be considered in the light of other existing environmental conditions and activities. Where changes in the environment are observed, further assessment should be considered to establish whether they are a consequence of the genetically modified organism or its use, as such changes may be the result of environmental factors other than the placing of the genetically modified organism on the market.

(3) Experience and data gained through the monitoring of experimental releases of genetically modified organisms may assist in designing the post marketing monitoring regime required for the placing on the market of genetically modified organisms as or in products.

PART C S DESIGN OF THE MONITORING PLAN

4.   The design of the monitoring plan should—

(a) be detailed on a case by case basis taking into account the environmental risk assessment,

(b) take into account the characteristics of the genetically modified organism, the characteristics and scale of its intended use and the range of relevant environmental conditions where the genetically modified organism is expected to be released,

(c) incorporate general surveillance for unanticipated adverse effects and, if necessary, (case-)specific monitoring focusing on adverse effects identified in the environmental risk assessment—

(i) whereas case-specific monitoring should be carried out for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed or indirect effects which have been identified in the environmental risk assessment, and

(ii) whereas surveillance could, if appropriate, make use of already established routine surveillance practices such as the monitoring of agricultural cultivars, plant protection, or veterinary and medical products. An explanation as to how relevant information collected through established routine surveillance practices will be made available to the consent-holder should be provided,

(d) facilitate the observation, in a systematic manner, of the release of a genetically modified organism in the receiving environment and the interpretation of these observations with respect to safety to human health or the environment,

(e) identify who (applicant, users) will carry out the various tasks the monitoring plan requires and who is responsible for ensuring that the monitoring plan is set into place and carried out appropriately, and ensure that there is a route by which the consent holder and the Scottish Ministers will be informed on any observed adverse effects on human health and the environment (time points and intervals for reports on the results of the monitoring must be indicated), and

(f) give consideration to the mechanisms for identifying and confirming any observed adverse effects on human health and environment and enable the consent holder or the Scottish Ministers, where appropriate, to take the measures necessary to protect human health and the environment.”