S.I. No. 506/2019 - Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations 2019

1. Information relating to the recipient plant or, where appropriate, to the parental plants

(a) Complete name

(i) family name

(ii) genus

(iii) species

(iv) subspecies

(v) cultivar/breeding line

(vi) common name.

(b) Geographical distribution and cultivation of the plant within the European Union.

(c) Information concerning reproduction

(i) mode(s) of reproduction

(ii) specific factors affecting reproduction, if any

(iii) generation time.

(d) Sexual compatibility with other cultivated or wild plant species, including the distribution in the European Union of the compatible species.

(e) Survivability

(i) ability to form structures for survival or dormancy

(ii) specific factors affecting survivability, if any.

(f) Dissemination

(i) ways and extent of dissemination;

(ii) specific factors affecting dissemination, if any.

(g) Where a plant species is not normally grown in the European Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.

(h) Potential interactions of the plant, that are relevant to the GMHP, with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.

2. Molecular characterisation

(a) Information relating to the genetic modification

(i) Description of the methods used for the genetic modification.

(ii) Nature and source of the vector used.

(iii) Source of the nucleic acid(s) used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.

(b) Information relating to the genetically modified plant

(i) Description of the trait(s) and characteristics which have been introduced or modified

(ii) Information on the sequences actually inserted or deleted

• size and copy number of all detectable inserts, both partial and complete, and methods used for its characterisation,

• the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format,

• in case of deletion, size and function of the deleted region(s),

• subcellular location(s) of the insert(s) (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination,

• in the case of modifications other than insertion or deletion, function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification,

• sequence information in a standardised electronic format for both 5? and 3? flanking regions at each insertion site,

• bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes,

• all Open Reading Frames, (hereafter referred to as “ORFs”) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA. ORF is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame,

• bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects,

• primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein,

• bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.

(iii) Information on the expression of the insert

• method(s) used for expression analysis together with their performance characteristics,

• information on the developmental expression of the insert during the life cycle of the plant,

• parts of the plant where the insert/modified sequence is expressed,

• potential unintended expression of new ORFs identified under the seventh indent of point (ii), which raise a safety concern,

• protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown.

(iv) Genetic stability of the insert and phenotypic stability of the GMHP.

(c) Conclusions of molecular characterisation

3. Comparative analysis of agronomic and phenotypic characteristics and of composition

(a) Choice of conventional counterpart and additional comparators.

(b) Choice of sites for field studies.

(c) Experimental design and statistical analysis of data from field trials for comparative analysis

(i) Description of field studies design

(ii) Description of relevant aspect of the receiving environments

(iii) Statistical analysis.

(d) Selection of plant material for analysis, if relevant.

(e) Comparative analysis of agronomic and phenotypic characteristics.

(f) Comparative analysis of composition, if relevant.

(g) Conclusions of comparative analysis.

4. Specific information for each area of risk

For each of the seven areas of risk referred to in Part D.2. of the Second Schedule, the notifier shall first describe the pathway to harm explaining in a chain of cause and effect how the release of the GMHP could lead to harm, taking into account both hazard and exposure.

The notifier shall submit the following information, except where it is not relevant in view of the intended uses of the GMO

(a) Persistence and invasiveness including plant to plant gene transfer

(i) Assessment of the potential for the GMHP to become more persistent or invasive and the adverse environmental effects thereof;

(ii) Assessment of the potential for the GMHP to transmit transgene(s) to sexually compatible relatives and the adverse environmental effects thereof;

(iii) Conclusions on the adverse environmental effect(s) of persistence and invasiveness of the GMHP including the adverse environmental effect(s) of plant-to-plant gene transfer.

(b) Plant to micro-organism gene transfer

(i) Assessment of the potential for transfer of newly inserted DNA from the GMHP to microorganisms and the adverse effects thereof;

(ii) Conclusions on the adverse effect(s) of the transfer of newly inserted DNA from the GMHP to microorganisms for human and animal health and the environment;

(c) Interactions of the GMHP with target organisms, if relevant

(i) Assessment of the potential for changes in the direct and indirect interactions between the GMHP and target organisms and the adverse environmental effect(s);

(ii) Assessment of the potential for evolution of resistance of the target organism to the expressed protein (based on the history of evolution of resistance to conventional pesticides or transgenic plants expressing similar traits) and any adverse environmental effect(s) thereof;

(iii) Conclusions on adverse environmental effect(s) of interactions of the GMHP with target organisms.

(d) Interactions of the GMHP with non-target organisms.

(i) Assessment of the potential for direct and indirect interactions of the GMHP with non-target organisms, including protected species, and the adverse effect(s) thereof.

The assessment shall also take into account the potential adverse effect(s) on relevant ecosystem services and on the species providing those services.

(ii) Conclusions on adverse environmental effect(s) of interactions of the GMHP with non-target organisms.

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

(i) For GMHPs for cultivation, assessment of the changes in the specific cultivation, management and harvesting techniques used for the GMHP and the adverse environmental effect(s) thereof;

(ii) Conclusions on adverse environmental effect(s) of the specific cultivation, management and harvesting techniques.

(f) Effects on biogeochemical processes

(i) Assessment of the changes in the biogeochemical processes within the area in which the GMHP is to be grown and in the wider environment, and the adverse effects thereof;

(ii) Conclusions on adverse effects on biogeochemical processes.

(g) Effects on human and animal health

(i) Assessment of potential direct and indirect interactions between the GMHP and persons working with or coming into contact with the GMHPs, including through pollen or dust from a processed GMHP, and assessment of the adverse effects of those interactions on human health;

(ii) For GMHPs not destined for human consumption, but where the recipient or parental organism(s) may be considered for human consumption, assessment of the likelihood of and possible adverse effects on human health due to accidental intake;

(iii) Assessment of the potential adverse effects on animal health due to accidental consumption of the GMHP or of material from that plant by animals;

(iv) Conclusions on the effects on human and animal health.

(h) Overall risk evaluation and conclusions.

A summary of all the conclusions under each area of risk shall be provided.

The summary shall take into account the risk characterisation in accordance with steps 1 to 4 of the methodology described in Part C.3. of the Second Schedule and the risk management strategies proposed in accordance with step 5 of Part C.3. of the Second Schedule.

5. Description of detection and identification techniques for the GMHP.

6. Information about previous releases of the GMHP, if applicable.”.

Schedule 3

Regulation 7

Part 1

“1. proposed commercial names of the products and names of GMOs contained therein, and a proposal for a unique identifier for the GMO, developed in accordance with Commission Regulation (EC) No 65/2004 . After the consent any new commercial names should be provided to the competent authority.”.

Part 2

“7. methods for detection, identification and, where appropriate, quantification of the transformation event; samples of the GMO(s) and their control samples, and information as to the place where the reference material can be accessed. Information that cannot be placed, for confidentiality reasons, in the publicly accessible part of the register(s) referred to in Article 31(2) of the Directive should be identified.”.

GIVEN under my Official Seal,

7 October, 2019.

RICHARD BRUTON,

Minister for Communication, Climate Action and Environment.

1 OJ No. L 67, 9.3.2018, p. 30

2 OJ No. L 106, 17.4.2001, p.1

3 OJ No. L 268, 18.10.2003, p.1

4 OJ No. L 268, 18.10.2003, p.24

5 OJ No. L 81, 20.3.2008, p.45

6 OJ No. L 68, 13.3.2015, p.1

1 OJ No. L 67, 9.3.2018, p. 30

7 OJ No. L50, 20.2.2004, p.44

2 OJ No. L 106, 17.4.2001, p.1

7. Effects on human and animal health.”.

Schedule 2

Regulation 6

Part 1

“

INFORMATION REQUIRED IN NOTIFICATIONS

Articles 14 and 30

Notifications referred to in Part II or Part III of these Regulations shall, as a rule, include the information set out in Part I of this Schedule, for GMOs other than higher plants, or in Part II of this Schedule, for genetically modified higher plants.

The provision of a given subset of information listed in Parts I and II of this Schedule shall not be required where it is not relevant or necessary for the purposes of risk assessment in the context of a specific notification, in view especially of the characteristics of the GMO, of the scale and conditions of the release or of its intended conditions of use.

The appropriate level of detail for each subset of information may also vary according to the nature and the scale of the proposed release.

For each required subset of information, the following shall be provided

(i) the summaries and results of the studies referred to in the notification, including an explanation about their relevance to environmental risk assessment, where applicable;

(ii) for notifications referred to in Part III of these Regulations, Annexes with detailed information on those studies, including a description of the methods and materials used or the reference to standardised or internationally recognised methods and the name of the body or bodies responsible for carrying out the studies.

Future developments in genetic modification may necessitate adapting this Schedule to technical progress or developing guidance notes on Annex III to the Directive. Further differentiation of information requirements for different types of GMOs, for example perennial plants and trees, single celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the European Union.”.

Part 2

“INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)

I. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 14

A. General information

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

18

th October,

2019.

I, RICHARD BRUTON, Minister for Communications, Climate Action and Environment, in exercise of the powers conferred on me by sections 6 and 111 of the

Environmental Protection Agency Act 1992

(No. 7 of 1992) and for the purpose of giving effect to Commission Directive (EU) 2018/350 of 8 March 2018

1

, hereby make the following regulations