Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations 2019

• Jurisdiction: Ireland
• Citation: IR SI 506/2019
• Year: 2019

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 18th 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 20181 , hereby make the following regulations:

1. These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations 2019.

2. In these Regulations -

“Agency” means the Environmental Protection Agency;

“Principal Regulations” means the Genetically Modified Organisms (Deliberate Release) Regulations 2003 ( S.I. No. 500 of 2003 ).

3. The Principal Regulations as in force immediately before the coming into operation of these Regulations shall continue to apply to -

(a) a notification received by the Agency under Article 14 or Article 29 of the Principal Regulations before the coming into operation of these Regulations and a consent granted by the Agency on foot of such a notification, or

(b) a consent granted by the Agency under Part II or Part III of the Principal Regulations before the coming into operation of these Regulations.

4. Article 3 of the Principal Regulations is amended -

(a) by the substitution, in sub-article (1), of the following definition for the definition of “the Directive”:

“ ‘the Directive’ means Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC2 as amended by -

(a) Regulation (EC) No. 1829/2003 of the European Parliament and of the Council of 22 September 20033 ,

(b) Regulation (EC) No. 1830/2003 of the European Parliament and of the Council of 22 September 20034 ,

(c) Directive 2008/27/EC of the European Parliament and of the Council of 11 March 20085 ,

(d) Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 20156 , and

(e) Commission Directive (EU) 2018/350 of 8 March 20181 ;”, and

(b) by the insertion of the following sub-article after sub-article (2):

“(2A) A word or expression that is used in these Regulations and is also used in the Directive has, unless the contrary intention appears, the same meaning in these Regulations that it has in the Directive.”.

5. The Second Schedule to the Principal Regulations is amended -

(a) by the substitution of the text set out in Part 1 of Schedule 1 for Part C of the Second Schedule to the Principal Regulations,

(b) by the substitution of the text set out in Part 2 of Schedule 1 for the title and first paragraph of Part D of the Second Schedule to the Principal Regulations, and

(c) by the substitution of the text set out in Part 3 of Schedule 1 for Part D.2 of the Second Schedule to the Principal Regulations.

6. The Third Schedule to the Principal Regulations is amended -

(a) by the substitution of the text set out in Part 1 of Schedule 2 for the text appearing before Part I of the Third Schedule to the Principal Regulations, and

(b) by the substitution of the text set out in Part 2 of Schedule 2 for Part II of the Third Schedule to the Principal Regulations.

7. The Fourth Schedule to the Principal Regulations is amended -

(a) by the substitution of the text set out in Part 1 of Schedule 3 for point 1 of Part I of the Fourth Schedule to the Principal Regulations, and

(b) by the substitution of the text set out in Part 2 of Schedule 3 for point 7 of Part I of the Fourth Schedule to the Principal Regulations.

Schedule 1

Regulation 5

Part 1

“C. Methodology

Guidance issued by the European Food Safety Authority is available for the implementation of this Part for notifications under Part C of the Directive.

C.1. General and specific considerations for the environmental risk assessment

1. Intended and unintended changes

As part of the identification and evaluation of the potential adverse effects referred to in Part A, the environmental risk assessment shall identify the intended and unintended changes resulting from the genetic modification and shall evaluate their potential to cause adverse effects on human health and on the environment.

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

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

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

2. Long-term adverse effects and cumulative long-term adverse effects in the environmental risk assessment of Part III notifications

Long-term effects of a GMO are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a GMO or from an extensive use of a GMO in time and space.

The identification and evaluation of the potential long-term adverse effects of a GMO on human health and on the environment shall take into account the following:

(a) the long-term interactions of the GMO and the receiving environment;

(b) the characteristics of the GMO which become important on a long-term basis;

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

The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introductory part of the Second Schedule shall also take into account the GMOs deliberately released or placed on the market in the past.

3. Quality of the data

In order to carry out an environmental risk assessment for a notification under Part III, the notifier shall collate already available data from scientific literature or from other sources, including monitoring reports, and shall generate the necessary data by performing, where possible, appropriate studies. Where applicable, the notifier shall justify in the environmental risk assessment why generating data by studies is not possible.

The environmental risk assessment for notifications under Part II shall 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 notifier.

Where data generated outside Europe is provided in the environmental risk assessment, its relevance to receiving environment(s) in the European Union shall be justified.

Data provided in the environmental risk assessment for notifications under Part III shall 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 notifier shall provide evidence to demonstrate that they were conducted in facilities which comply with:

(i) the requirements of Directive 2004/10/EC7 ; or

(ii) the “OECD Principles on Good Laboratory Practice” (GLP), if carried out outside the European Union;

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

(i) comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC2 , 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 points (a) and (b) and on the study protocols used shall be reliable and comprehensive and shall include the raw data in an electronic format suitable for carrying out statistical or other analysis;

(d) the notifier shall 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 shall be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the GMO may be released. The selection shall be justified in the environmental risk assessment;

(f) the non-genetically modified comparator shall be appropriate for the relevant receiving environment(s) and shall have a genetic background comparable to the GMO. The choice of the comparator shall be justified in the environmental risk assessment.

4. Stacked transformation events in Part III notifications

The following shall apply to the environmental risk assessment of a GMO containing stacked transformation events in Part III notifications:

(a) the notifier shall provide an environmental risk assessment for each single transformation event in the GMO or refer to already submitted notifications for those single transformation events;

(b) the notifier shall provide an assessment of the following aspects:

(i) the stability of the transformation events;

(ii) the expression of the transformation events;

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

(c) where the progeny of the GMO can contain various sub-combinations of the stacked transformation events, the notifier shall 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, shall provide the relevant experimental data.

C.2. Characteristics of the GMO and of the releases

The environmental risk assessment shall take into account the relevant technical and scientific details regarding characteristics of:

• the recipient or parental organism(s),

• the...