Dr. Francis Nang’ayo

Mr. Abed K. Mathagu

AATF

5th ANNUAL NATIONAL BIOSAFETY CONFERENCE

AUGUST 15-18, 2016

KSMS, NAIROBI, KENYA,

“Strengthening global, regional, national collaboration, partnerships and

capacity towards meeting international obligations in Biosafety”.

Data Portability:

Experience with Application for Commercial

Release of Bt Maize in Kenya

1. Data Requirements for Environmental release of a characterized event 2. Data Requirements and Portability 3. Biology documents 4. Permissibility of data portability 5. Data Sharing and the CPB 6. What we should share 7. Data Available with regulators 8. Role of GLP labs and facilities 9. Considerations when re-generating data 10. How much data is available for characterised events

Outline

Product

Formulation

• Broker & negotiate for appropriate technologies to reach SHF Identify Technologies

Product

Development

Product

Deployment

• Work with national research organizations to adapt technologies

• Business plan, baseline study, communication strategy, risk management

• Support policy efforts for testing and uptake

• Ensuring product development complies with existing regulations, laws and requirements

• Contracting seed production • Sub-licensing of seed companies and other groups to test and

deploy technologies • Product stewardship • Capacity building of stakeholders

African Agricultural Technology Foundation

13 Countries

11 Projects

6 Crops

Kenya

Ethiopia

Burkina Faso

Ghana

Nigeria

South Africa

Mozambique

Zambia

Tanzania

Uganda

Zimbabwe Malawi

Senegal

Seeds 2B

OFAB

Hybrid Rice

CAMAP

Aflatoxin Control in Maize and Peanuts

NEWEST

Bacterial Wilt Resistant Banana

PBR Cowpea

WEMA

Striga control in Maize

KEY

Where we work

Resolve of ANBAA

……….. it is expected that the action of the new

association will reduce hurdles in sharing data and

information between countries by promoting regional

and bilateral agreements between countries ….

At the Launch of the Association of National Biosafety

Agencies in Africa in March 2016, The resolve was….

Data Sharing - Portability

- Data sharing is central to all scientific communities.

- Nobody wants to re-invent the wheel

- Innovations build on primary data generated in different

places.

- Need for sharing Biotechnology data and the data

portability grows from:

- Lab Confinement,

- Through Confined Field trials

- and there is unique need for data Portability

during Commercial Release.

We focus attention on the subject of a well characterized

event during variety release of a product of modern

biotechnology.

Adequate filling of the Application dossier

Applicants MUST adequately and accurately fill

information required in the prescribed forms.

Enormous data is available for well characterized and

widely used events such as Cry1Ab, Cry1Ac, EPSPS

etc.

The Big question is..

.. whether all the information required in the

prescribed form should be generated afresh

… and how much of the publicly available data is

admissible.

Data Requirements for Environmental release of a characterized event

• Data requirements differ from Application to

Application

• However there are general sets of data that are

required Universally that can be shared for different

regions and purpose.

• A number of events proceeding to

commercialization will already be well

characterized and the host organism as well as the

donor organism will be well understood.

Data Requirements and Portability Data Details Comment

Applicant’s

Information

- Contact

- Institution

- Representative

- Data is unique to each

application

Objectives/purpose

of application

- Area of release

- Use of the event

- Data is unique to each

application

Biology of the Host - Reproduction Biology

- Existing wild relatives

- Existing landraces

- Agronomic practices

- Center(s) of genetic diversity

- Data is universal

- Biology/ Consensus

documents have been or can

be developed

Biology of Donor - Many donors such as Bacillus

thuringiensis are well studied and

enormous data exists

- Regulatory elements such as

promoters and terminators have

been well documented

- Vectors used

- Data is universal

- Biology/ Consensus

documents have been or can

be developed

- Vectors are generally well

understood and data is

portable.

Data Requirements and Portability

Data Details Comment

Method of

Modification

Published methods exists

- Gene gun

- Agrobacterium mediated

- No need to re-invent

- There may be parts of processes that are

patented by developers

- These are treated as CBI

Characterization of

the modification

Molecular characterization

-Protein expression levels

-Transformation event

- These are very detailed studies that

should not be repeated if well done.

Safety & Risk

Assessment

Food/Feed safety

- Toxicology

- Allergenicity potential

- Weediness/Invasiveness potential

- Gene flow concerns

- Potential effects on Non target

- Compositional differences

Environmental safety

- Ecological effects

- Gene flow effects

History and results of previous

environmental releases

- Standard methods of risk assessment

and safety assessment have been agreed

on at CODEX , OECD and through the

CPB mechanism

- Numerous sets of safety or risk

assessment data exist at the BCH and

among the competent Authorities.

- Universal data exists on previous

releases

Biology documents

Is data portability permissible?

Section 28. of the Kenyan Biosafety Act. No 2 of 2009.&

Regulation 8. Environmental release regulations.

Non-assessment of risks

The NBA may opt not to undertake a risk assessment … where

it determines that sufficient experience or information exists…

Reg 5(3) of the Environmental release regulations

An applicant may—

(a) refer to data or results from an application previously

submitted by another applicant;

- provided the information, data and results are non-

confidential or such applicants have given their agreement

in writing.

Data Sharing – Key Pillar of the CPB

The Protocol establishes a BCH to Facilitate exchange of information - laws, scientific data, risk assessments, decisions, etc. COP-MOP/3: - among other things requested the Secretariat to: (i) Make easily available decisions and other

information on LMOs-FFP, risk assessments and decisions taken under the AIA procedure;

(ii) Continue to develop non-Internet based mechanisms for countries to access information in the BCH

What should we share Portable data MUST be credible and reliable

Peer reviewed

From regulatory authorities

From previous approvals

From Competent research or authorities

Data Available with regulators

This data should be made available or applicants should be

made aware of

- National and International databases such as the NBCH

- Existing bilateral treaties for data sharing

- Previous approvals and decisions

- Previous Risk assessment reports

- Existing compositional data

- Existing traited varieties and products

National Authorities can generate data of national interest

and make it available for decision making

- Consumption trends

Role of GLP labs and facilities

Most data will be generated either during conduct of filed

trials, laboratory research and also in GLP labs

When universal procedures are

applied such as:

• ISO

• NIH

• JRC

Data should be used any where

such procedures are accepted.

Considerations when re-generating data

Authorities may want data repeated in their

jurisdictions.

Key Considerations should include:

- Clear rationale and the expected outcome.

- Why conducting a CFT is necessary for example

- Cost of repeating

- Animal studies for instance take a long time and

costs ordinarily are commissioned by the

countries with clear outcomes.

How much do we know about Cry1Ab - MON 810?

How much data is available publicly on Bt

The gene elements Bt Efficacy against stem borers?

Bt Maize MON 810: 1996 to February 2016 Se

pt

19

96

Thank you