SCHEDULE 3 S INFORMATION TO BE INCLUDED IN APPLICATIONS FOR CONSENT TO RELEASE OR MARKET ORGANISMS OTHER THAN GENETICALLY MODIFIED HIGHER PLANTS

PART II S INFORMATION RELATING TO THE ORGANISMS

Characteristics of donor, parental and recipient organisms S

1.   

3.  Scientific name and taxonomy. S

4.  Usual strain, cultivar or other name. S

5.  Phenotypic and genetic markers. S

6.  The degree of relatedness between donor and recipient or between parental organisms. S

7.  The description of identification and detection techniques. S

8.  The sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques. S

9.  The description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, prey, parasites and competitors, symbionts and hosts. S

10.  The organisms with which transfer of genetic material is known to occur under natural conditions. S

11.  Verification of the genetic stability of the organisms and factors affecting that stability. S

12.  The following pathological, ecological and physiological traits:– S

(a) the classification of hazard according to [F1 [F2 assimilated] law] concerning the protection of human health and the environment;

(b) the generation time in natural ecosystems, sexual and asexual reproductive cycle;

(c) information on survivability, including seasonability and the ability to form survival structures, including seeds, spores and sclerotia;

(d) pathogencity, including infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms and possible activation of latent viruses (proviruses) and ability to colonise other organisms;

(e) antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy; and

(f) involvement in environmental processes, including primary production, nutrient turnover, decomposition of organic matter and respiration.

Textual Amendments

F1 Words in sch. 3 para. 12(a) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(26); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in sch. 3 para. 12(a) 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(6)

13.  The sequence, frequency of mobilisation and specificity of indigenous vectors, and the presence in those vectors of genes which confer resistance to environmental stresses. S

14.  The history of genetic modifications. S

Characteristics of the vector S

2.   

15.  The nature and source of the vector. S

16.  The sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organisms and to make the introduced vector and insert function in those organisms. S

17.  The frequency of mobilisation, genetic transfer capabilities and/or methods of determination of the inserted vector. S

18.  Information on the degree to which the vector is limited to the DNA required to perform the intended function. S

Characteristics of the modified organisms S

3.   

19.  The methods used for the modification. S

20.  The methods used– S

(a) to construct inserts and to introduce them into the recipient organism; and

(b) to delete a sequence.

21.  The description of any insert and/or vector construction. S

22.  The purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function. S

23.  The methods and criteria used for selection. S

24.  The sequence, functional identity and location of the altered, inserted or deleted nucleic acid segment or segments in question, and in particular any known harmful sequence. S

Characteristics of the genetically modified organisms in their final form S

4.   

25.  The description of genetic traits or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed. S

26.  The structure and amount of any vector or donor nucleic acid remaining in the final construction of the modified organism. S

27.  The stability of the organism in terms of genetic traits. S

28.  The rate and level of expression of the new genetic material in the organism, and the method and sensitivity of measurement of that rate and level. S

29.  The activity of the expressed protein. S

30.  The description of identification and detection techniques, including techniques for the identification and detection of the inserted sequence and vector. S

31.  The sensitivity, reliability (in quantitative terms), and specificity of detection and identification techniques. S

32.  The history of previous releases or uses of the genetically modified organisms. S

33.  In relation to human health, animal health and plant health– S

(a) the toxic or allergenic effects of the organisms and/or their metabolic products;

(b) the comparison of the modified organism to the donor, recipient or (where appropriate) parental organism regarding pathogenicity;

(c) the capacity of the organisms for colonisation;

(d) if the organism is pathogenic to humans who are immunocompetent–

(i) diseases caused and mechanism of pathogenicity including invasiveness and virulence;

(ii) communicability;

(iii) infective dose;

(iv) host range and possibility of alteration;

(v) possibility of survival outside of human host;

(vi) presence of vectors or means of dissemination;

(vii) biological stability;

(viii) antibiotic resistance patterns;

(ix) allergenicity; and

(x) availability of appropriate therapies; and

(e) the other product hazards.