1. 1 Comments and responses from the Public on Biosafety Bill Kenya Biodiversity Coalition (KBioc) PELUM, KEPHIS, KARI, STAK Consortia group Panafric, Individual submissions

2. 2 Scope of the Bill Comments: Bill titled Biosafety Bill but deals only with GMOs Biosafety concerns not limited to GMOs Broaden the scope to cover all aspects of biosafety or change title to GMO Bill Action: The Bill’s purpose to regulate biosafety issues related to GMOs is clear enough, hence no need to revise the title or broaden the scope

3. 3 Part 1 preliminary Comments: review definition of :- Placing into market Biosafety Contained use Introduction into environment Environment Delete Biotechnology is not mentioned in the Bill Genetically modified organisms – delete living or non living Action: comments adopted and revisions proposed

4. 4 Clause 3(2)pharmacueticals Comments: What’s the rationale for this exclusion? The justification should be stated in the Bill Action: No need to state the rationale in the Bill as this is not common practice - rationale: This is a requirement of the Cartegena Protocol; and pharmaceuticals are already regulated in accordance with WHO regulations

5. 5 Clauses 4(a) and4(c) insert /delete underlined comments: 4 (a) delete ‘the risks of harm that may’ 4 (c) Insert ‘transparent science based and predictable’ Action: done

6. 6 Clause 6(1)composition of the board comments (g) delete or his representative nominated in writing (i) Director of medical services to be on the board (j) Director of agriculture be changed to Agriculture secretary and be replaced by PS agriculture (k) Appointment by minister changes to six from five (l) Industry/private sector be representative on the board Action: Department of public health (MOH) is a regulator representative of biotech industry added PS agriculture replaces director of agriculture

7. 7 6(1)composition of the board cont comments 6(4) ex officio members to be specified Action: 6(1) l - corrected to read- a Chief Executive officer appointed under section12 as ex officio member

8. 8 Clause 7(2)c corrections Delete – undertake and Action changed to read – ‘co-ordinate research undertake investigation and surveys’

9. 9 corrections 12 (2) replace employment with service 13(2) CEO to fund raise for the Board 17 replace of any works with arising out of negligence Action : word employment is appropriate 13(2) raising funds is covered under 5(2)d as a function of the Board 17. Retained of any works - word negligence requires proof and is also limiting.

10. 10 clause19 (4) publishing in newspaper Comments: Add electronic media in addition to newspapers Elaborate on introduction into environment Action: electronic media added Section 19 introduction to the environment will be defined as in EMCA

11. 11 Clause 20 approval for imports Comment: written approval to be replaced by written notification because it will delay trade Action: Section 20 approval for imports has been retained as in the Bill to avoid abuse

12. 12 Clause 21 placing into the market Bill to be clear about handling of food aid Action: covered under 5 (g) intended use

13. 13 Clause 22(1)a written approvals for trans-shipments Comments: approval may hinder trade Written notification to be given not approval Action : written approval maintained to avoid abuse

14. 14 Clause 23. advance written comments for import of GMO Comments: To state that – ‘exporters should comply with or meet requirements of exporting countries’ Action: section retained as it is –explained above 22(2) word form replaced with manner

15. 15 Clause 24 withdrawal of applications comments: Bill should make provision for refund of fees for withdrawal of applications Action: There is no justification for a refund of fees should an applicant voluntarily withdraw an application

16. 16 Clause 26(1)screening application for completeness Comments: 30 days too long Should be reduced to 21 days Action: maintained at 30 days for future volumes of applications

17. 17 Clause 27 risk assessment Comment: 27(1)b word if any not necessary 27 (3) report findings should be made public Action all decisions will be made public If any- deleted

18. 18 Clause 29(1)e socio economic considerations Addition made to read - genetically modified organisms on the environment where the decision is for an application under section 19 of the Act

19. 19 Clause 30 (1)decision of approval Comments: 270 days too long Should be reduced to 90 days Action: reduced to 150 days

20. 20 Clause 31(3) publishing of suspension or revoke order Comments: explain publishing at whose cost Action: retained as it is administratively the authority will determine how to recover publishing expenses.

21. 21 Clause 33 corrections Action: 33(1) corrected to read – may review a decision made under section 29 of the Act 33(3) – the word “issue” deleted 33(4) - 150 days replaced with 30 days

22. 22 Clause 34 offence for withholding information Comments: - penalty should be reduced - different comment – penalty should be increased to serve as a deterrent Action: 2 million fine increased to 10 million

23. 23 Clause 35 (1)b qualifications of appeals board members Comments need not necessarily be masters degree holders, experience to be considered Action: retained as it is, technology highly technical, understanding is important

24. 24 Clause 35 (9) added The appeals Board shall communicate its final decision to the appellant within ninety days of the receipt of the appeal application

25. 25 Clause 38 (2) correction Word granted inserted

26. 26 Clause 39 corrections 39 (1)word unintentional should be replaced with unintended Action: - current wording retained 39(2) undertake a risk assessment replaced by mitigate any adverse effects to human and environment 40 letter I added to read 40(i)

27. 27 43 inspection and monitoring Comments: Minister needs to be guided on the appropriate appointments Action: corrected to read – ‘The Minister in consultation with the Authority may by gazette notice –”

28. 28 45(1) powers of the inspectors Comments: excessive powers of the inspectors and unchecked monitoring Need to include provision to appeal against inspectors Action: Clause 35(4) to be revised by inserting a new sub-clause (e) so aggrieved persons can appeal decisions of the inspectors (e) decision of a Biosafety inspector - Also new sub-clause (f) inserted: (f) or any other decision of the Authority

29. 29 Clause 50 packaging and labeling Comments: farmers can not implement this Action: Clause 50 deleted in its entirety - New wording – the minister in consultation with Authority will make regulations for transport, handling packaging and identification of GMOs to be included in current Clause 51

30. 30 Clause 53 Concerns raised with potential liability of “officers” of a corporate body since the term applies in Kenya to several categories of employees who do no necessarily have decision-making authority Action: Clause 53 deleted in its entirety

31. 31 Clause 54 consent of AG of proceedings of an offence comments: This is restricting to the Authority, is confusing and contradicts other clauses needs to be deleted Action: Retained Protection of AG is necessary for government agencies Does not contradict other clauses

32. 32 Clause 56(3) transition Comments- 56(1)Documents held by NCST be handed over and cases be adopted by Authority 56(3)if approval has been applied and granted before why the need for a review? Should be deleted Action: clause 56(3) deleted

33. 33 Second schedule board meetings Four times in the year is too frequent, Two times is suggested Action: Remains as is Quarterly is appropriate, board will need to meet frequently since the approval time has been reduced to 150 days

34. 34 Fourth schedule: information on release into environment 1. replace exporter with Applicant and delete number 2 Indicate scale of release e.g. large scale or small scale Action: The word exporter in number one replaced with Applicant and number 2 deleted

35. 35 Precautionary Principle The precautionary approach is contained in Principle 15 of the 1992 Rio Declaration on Environment. This approach has also been accepted in the United Nations Convention on Biological Biodiversity, (CBD) and has been used in the protocol of the CBD, namely the Cartagena Protocol on Biosafety. This protocol regulates “the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health.” This is the approach upon which our proposed Bill is premised.