1. APTECA GOOD MORNING - WELCOME
Aflatoxin Proficiency Testing and Control in
Africa, Asia, Americas and Europe
GOOD MORNING - WELCOME
PUBLIC-PRIVATE SECTOR COLLABORATION TO MANAGE AFLATOXIN RISK
2 March, 2017

2. AGENDA INTRODUCTIONS MEETING OBJECTIVES CO-REGULATION – AN OVERVIEW
BREAKOUT GROUP DISCUSSIONS
BREAKOUT GROUP FEEDBACK TO PLENARY
WAY FORWARD

4. MEETING OBJECTIVES
AGREEMENT TO FORMALISE A NATIONAL PUBLIC-PRIVATE SECTOR PARTNERSHIP TO MANAGE AFLATOXIN RISK
DEVELOPMENT OF A ROADMAP TO GET THERE – WITH ROADBLOCKS IDENTIFIED

5. 19-01-2017 MEETING INSIGHTS Hon. Adan Noor:
There is need to develop a standard framework to be followed by every institution
There is need for specialized laboratories for food safety
A checklist must be developed to determine minimum requirements for a testing laboratory in terms of equipment, training of personnel
Coordination among and between Agencies should be complementary rather than competitive
Capacity building is required – technology, training dynamics
Funding is needed for our research institutions as we look forward and hope for a permanent solution for Aflatoxin management in the country
…. There is a total need for private – public sector partnership

6. 19-01-2017 MEETING INSIGHTS Hon. Kareke Mbiuki:
A strategy needs to be established on how to regulate Posho Mills because they serve almost 60% of the Kenyan Population
Small scale farmers also need to be included in the efforts to manage Aflatoxin risk

7. MEETING OBJECTIVES
DEVELOPMENT OF A ROADMAP TO FORMALISE A NATIONAL PUBLIC-PRIVATE SECTOR PARTNERSHIP TO MANAGE AFLATOXIN RISK – WITH ROADBLOCKS IDENTIFIED
CO-REGULATION AS THE GUIDING FRAMEWORK

8. Co-regulation as a governance option to manage aflatoxin risk Second High Level Breakfast Meeting March 2, 2017
Co-regulation as a governance option to manage aflatoxin risk offers greater coverage is protecting animal, human and market health than other forms of regulation, based on my experience as the chief regulatory official in Texas with responsibility for managing aflatoxin risk.
Tim Herrman, Ph.D. Texas State Chemist and Professor

9. Generic List of Governance Options
Co-regulation is one of a list of generic governance options ranging from direct regulation to no intervention. The state of Texas, where I serve as state chemist and director of the Office of the Texas State Chemist, is the government regulatory agency responsible for managing aflatoxin risk. Our agency transitioned to a co-regulation model for aflatoxin risk in Co-regulation is a public private partnership. It requires commitment from both parties to fulfill their respective responsibilities in conformance with standards. I describe this as a transaction where, if a firm achieves rightness with respect to implementing the standard, I extend legal certainty to that firm. This type of relationship protects consumers and also fosters economic growth by protecting the marketplace. This type of regulatory approach reduces both food safety risk and market risk, leaving a level playing field where entrepreneurs differentiate themselves in the marketplace based on their competitiveness, innovation, and execution of their business strategy. This type of regulation creates a marketplace that attracts investment and growth. While the industry I regulate is mature, we have observed steady growth with tonnage feed tonnage in the state increasing from 12 to 20 million tons since 2005 and a dramatic increase in register products and licensed firms.
National Research Council 2013; FIGURE 4-1. Options for assigning private-public responsibility to ensure food safety.
SOURCE: Adapted from Garcia-Martinez et al. (2007).

10. Aflatoxin Risk Management Cycle
Roadmap Forward
Questions
Is there anything in the laws, rules, or policy that prevent adoption of co-regulation as a governance option (Inter-agency, Inter-Ministry, Government-Private)
Financial gains and losses in adopting and implementing co-regulation, are they quantifiable, how will it impact regional markets?
Who will drive the partnership, how will it be coordinated?
Identify performance indicators, objectives, an parameters needed for co-regulation to manage aflatoxin risk?
First High Level
Gap Identification
Lack of harmonization and equivalency in testing including sampling and analysis
Legal backing for a public-private partnership
Education and analyst qualification for measuring aflatoxin
How to share data
Minimum sampling and testing criteria
Labelling to designate testing and aflatoxin safe approval
Government support to manage aflatoxin risk
Prevention
Resistant hybrids
Cultural practices
Storage
Technology
and Policy
Solutions
Training
&
Qualification
Proficiency & Verification Process
Management
& Recordkeeping
Monitoring & Corrective Actions
Risk Management
Government Sector
Risk Management
Informal Sector
The aflatoxin risk management cycle depicted on this slide represents the different sectors in the market beginning with field production, next the informal sector, formal sector and government sector. Each has a critical role in managing aflatoxin risk beginning with production and storage practices, grain handling, transportation and marketing, processing and delivery to consumers and government regulatory oversight of the process. Super-imposed on the aflatoxin risk management cycle is a quality cycle, adapted form the Shewart cycle known as plan, do, check and act. In this diagram, the inter-related steps to implementing a system to manage aflatoxin risk include establishing good technology and policy solutions as a foundation, that is accompanied by training and qualification of analysts who accurately sample, prepare and analysis for aflatoxin, verification of analyst testing accuracy through proficiency testing and re-analyzing some of the retained samples to ensure testing accuracy, managing the system including document control, and monitoring of the entire process and taking corrective actions as need. During the first high level meeting this group listed questions that were discussed and captured in the meeting minutes. Today, we will focus on answering these questions and identify actions items in 4 questions designed to capture last meetings deliberation and move us forward to our goal of realizing co-regulation as a governance option to manage aflatoxin risk.
Risk Management
Formal Sector
Co-regulation

11. Co-regulation Roadmap to a Government- Private Partnership to Manage Aflatoxin Risk
Vision
A public-private partnership will manage aflatoxin risk through a connected transparent market place that delivers aflatoxin safe food and feed to all Africans
Objectives
Facilitate adoption of a quality systems approach to accurately measure aflatoxin and other mycotoxins
Work with all sectors of the food chain to identify gaps and deliver affordable solutions to manage aflatoxin risk
Deliver globally an accredited aflatoxin proficiency testing program and certified reference material
Formalize a government-private partnership that facilitates policy solutions and communicate these solutions to stakeholders including general public
Achieve sustainability
To capture our progress to date, I have listed a vision and some objectives as follows:

12. Texas has a serious aflatoxin problem, similar to Kenya, east Africa, the COMESA and all of Africa. We have successfully implemented co-regulation as a governance option to manage aflatoxin risk using a public private partnership. The program is endorsed by our Texas Farm Bureau and Texas Corn Growers Board. It is also endorsed by the American Farm Bureau and National Corn Growers Association. However, national adoption of this approach has not been realized, in part due to a lack of commitment by my counterparts in other states and the federal government.

13. One-Sample-Strategy
In Texas we call our co-regulation program the one-sample-strategy because a single sample collected, prepared, and analyzed correctly can be used for multiple purposes including purchasing the maize, crop insurance and regulatory monitoring. This approach, though no less expensive than direct regulation, has increased our oversight 30-fold, improving food safety and reducing fraud.

14. Approval Process Sampling & Testing Plan Training to review criteria
Background check
Proficiency evaluation
Approved as a designee of OTSC
There is an approval process including preparation of a sampling and testing plan, training on the program preventive control points (or performance indicators), objectives and control parameters, background check, evaluating analysts ability to produce the correct results, an finally approval, where I extend my authority as state chemist to the designee who is credentialed and issues official results on behalf of our agency.

15. OTSC Monitoring Employee performance Equipment performance
Grinder check
Lab scale calibration record
OTSC control standard record
HPLC analysis of verification samples
During the harvest, our field investigators evaluate conformance to the OSS performance indicators through monitoring including grinder check, lab scale calibration, record review to ensure the control standard measurement is within the correct limits, and retained samples are collected and some are reanalyzed at our headquarter lab for verification.

16. OTSC Corrective Actions
Oversee adjustment or repair of equipment
Oversee retraining of personnel
Report missing or non-compliant equipment
Report records that are missing, inaccurate, or appear to reflect poor performance
Suspend or remove an employee or firm
If a deviation occurs, there is corrective action. I would note that in any quality system, this occurs even in our own lab.

17. Outbound Seals Certificate of Analysis
Full Participant
All incoming loads are sampled & grain is always segregated. Seal is attached to outbound documentation.
Firms may issue an official certificate of analysis for crop insurance and full participants in the program may designate product using a seal so it is no longer inspected in the marketplace.

18. Texas Industry Performance
The problem in accurately measuring and managing aflatoxin in Texas was tremendous prior to the implementation of our co-regulation program and these problems have diminished and are under control.

19. C0-reguation managed Aflatoxin risk through adoption of a quality systems approach
Which leads to my final point about why co-regulation is a best practice in terms of governance option to manage aflatoxin risk, you can’t improve what you do not control, you can’t control what you do not measure, and you can’t measure what you do not define.

20. BREAKOUT GROUP DISCUSSION
QUESTIONS
Is there anything in the Law, policy or the regulations that prevents adoption of co-regulation as a governance option? What legal/policy support is required to enable adoption?
Consider inter-Agency, inter-Ministry, Government-Private Sector, EAC and COMESA
List the financial gains/losses in adopting and implementing co-regulation. Are they quantifiable? How will co-regulation impact regional trade?
What are the objectives, performance indicators and parameters needed for a co-regulation model?
Who will drive the partnership? How will it be coordinated?
What other stakeholders?

21. PLENARY DISCUSSION

22. WAY FORWARD

23. THANK YOU REMEMBER … “COMING TOGETHER IS A BEGINNING,
STAYING TOGETHER IS PROGRESS, AND
WORKING TOGETHER IS SUCCESS”
Henry Ford
THANK YOU