COMPILATION OF PAPERS ON Better Technical Regulations in

NATIONAL QUALITY INFRASTRUCTURE PROJECTFunded by the European Union and implemented by UNIDO

COMPILATION OF PAPERS ON

Better Technical Regulationsin Nigeria

An assessment of Technical Regulations regime against best International Practices and WTO requirements

2

BACKGROUND ANDBASELINE REPORTS

SECTION 1

AWARENESS MEETINGS ON BETTER REGULATIONS

TRAINING/WORKSHOP ON RISK MANAGEMENT IN REGULATORY FRAMEWORKS

CONSULTATIVE MEETINGS WITH THE WORKING GROUP ON TECHNICAL REGULATIONS

November 2014

December 2014

January 2015

ASSESSMENT OF NIGERIA TR REGIME AND THE EFFECTIVENESS OF THE RELEVANT MARKET SURVEILLANCE AUTHORITIES

January 2015

WORKSHOP ON THE ESTABLISHMENT OF A WORKING GROUP ON TECHNICAL REGULATIONS (WG-TRs)

INAUGURATION OF THE WORKING GROUP ON TECHNICAL REGULATIONS (WG-TRs)

CATEGORIZATION, HARMONIZATION AND STREAMLINING OF TECHNICAL REGULATIONS IN NIGERIA

VALIDATION OF THE CATEGORIZATION, HARMONIZATION AND STREAMLINING OF TECHNICAL REGULATIONS IN NIGERIA

February 2015

March 2015

April 2015

June 2015

4

5

NATIONAL QUALITY INFRASTRUCTURE PROJECT (NQIP)

COMPONENT 1- PROMULGATION OF A NATIONAL QUALITY POLICY AND ENSUING LEGISLATION FOR THE NATIONAL QUALITY INFRASTRUCTURE

REPORT OF THE AWARENESS MEETINGS WITH TECHNICAL REGULATORY

INSTITUTIONS ON BETTER REGULATIONS NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND

The Nigeria Quality Infrastructure Project is supporting the development of the missing

standards and accredited testing and certification bodies within the framework of the National

Quality Infrastructure (NQI) in order to improve the quality of products and services exchanged

in the Nigerian, regional and international markets.

The project will achieve its objectives through the following:

Promulgation of a National Quality Policy and ensuing legislation for the NQI;

Establishment of a National Accreditation Body;

Development of a National Metrology Institute;

Improvement of Organized Private Sector (OPS) patronage of the NQI and their

capacities to create and support conformity assessment bodies (CAB) and;

Enhancement of the consumer protection role on quality issues as well as increased

capacities of consumer associations to lift up the quality offer/culture of Nigerian

enterprises.

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The National Expert on Technical Regulation is expected to organize awareness meeting with

key technical regulatory institutions on better regulations, intimate them with the need for the

creation of a working group on technical regulations and market surveillance authorities.

This is the report of the outcome of the interactive meetings with the different institutions.

2.0 REGULATORY INSTITUTIONS

The different institutions in Nigeria were accessed from the relevant website which included

Http://services.gov.ng/directory a portal of the Nigerian government, Ministries Departments

and Agencies, Commissions, Institutions and others. A suitable search engine was used to

access each institution’s home page from where the Act, Mandate and/or Mission were found.

All institutions with specific Act/Mandate on technical regulations were selected and other

institutions which may not be considered as having mandate on technical regulation but may

contribute to the realization of the project in terms of services were also included.

3.0 VISITS AND ASSESSMENT OF THE DIFFERENT INSTITUTIONS

A total of 31 institutions were selected for the visit (Annex I). Letters introducing the NQI

project, the purpose for the visit and request for an appointment within a given time were

prepared and dispatched. This was followed with phone calls and e-mails. Following the

objectives of the NQIP awareness meetings were held with the various stakeholders within

Abuja to assess their conformance to practices relating to better technical regulations and their

market surveillance.

The Institutions were visited on the dates given in Annex 2. Awareness meetings were held

with 23 of the institutions. Four (4) institutions (CRFFN, ICRC, NASENI and NERC) scheduled

appointment dates that could not be contained within the timeline for this assignment. Visiting

two (2) of the institutions (SON and NBTE) required traveling out of Abuja for the meeting; this

however could not be contained within the given timeline. There was no response from CPC

and BPP (Annex 2). At the end of the exercise, 17 institutions (Annex 1, Group A) were regarded

as relevant and further recommended for the upcoming training/workshop on risk

management on better regulation. Fourteen institutions (Annex 1 Group B) do not have

mandates on technical regulations. For some of the institutions regarded as relevant to the

7

NQIP, even though interactive meeting could not be held, information required was gathered

online, from their Act/Mandate.

4.0 FINDINGS AND OBSERVATIONS

It was observed that some of the institutions have Legal framework/mandate relating to

technical regulations. The regulations were adopted from International bodies with related

operations. From the interactive meetings, all regulations were adapted to suit the Nigerian

culture and environment.

While some had the power and tool to carry out the enforcement, others revert to offices in

the state MDAs’, stakeholders, manufacturers and the industrialist for the monitoring and

enforcement of their mandate. The fundamental challenge is the attitude of Nigerians and

deliberate refusal to comply with stipulated regulations.

There were some conflicts and frictions in the execution of mandates partly due to ill-defined

responsibilities and gaps created by poor understanding of the limits of the mandate. The

challenges varied. Some of the institutions with the relevant mandate with regard to technical

regulations requested for better funding and capacity building for the effective and efficient

UNIDO Expert on TR with staff of NAQS (Coordinating Director 4th from left)

UNIDO Expert on TR with staff of Nigerian Custom Services, Trade and Tariff Unit (Mr. Nsofor, focal person, 4th from left)

8

delivery on their mandates. Some requested for tools for effective market surveillance. The

laboratories, where needed, were reported to be few, ill-equipped and below the required

international standard.

A few others had the mandate without the enabling power for the enforcement. Conflicts

between the regulatory institutions were apparent and this requires some resolution. The

current situation of the borders was of great concern. While there may be some meaningful

and direct control at the sea and air ports, controls at the land borders were of great concern.

Checks varied from strict and overzealous official checks to complete total lack of it. Effective

control of sub-standard products appeared suppressed within the country. These limitations

were attributed to poor consumer awareness and the inefficiency of some regulatory

institutions. Some of the printed documents collected during the visits are listed in Annex 3.

UNIDO Expert on TR with NAFDAC staff (Director, Food Directorate and Applied Nutrition, 3rd from left)

UNIDO CTA and Expert on TR with staff of Trade Department, FMITI (Director of Trade, FMITI 1st from left)

9

5.0 WAY FORWARD

There is the need for a training workshop to institutionalize necessary changes amongst the

regulatory bodies. This will comprise the institutions visited and the screened enlarged group

obtained from the Department of Trade FMITI. It is hoped that the workshop will address the

challenging issues as indicated in this report; particularly areas of conflicts and setbacks in the

regulatory framework.

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ANNEX 1

INSTITUTIONS LISTED

GROUP A

1. DEPARTMENT OF WEIGHTS AND MEASURES (W&M)

2. DEPARTMENT OF FEDERAL PRODUCE AND INSPECTION (FPIS)

3. CONSUMER PROTECTION COMMISSION (CPC)

4. NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC)

5. NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS ENFORCEMENT AGENCY

(NESREA)

6. NIGERIA AGRICULTURAL QUARANTINE SERVICES (NAQS)

7. NIGERIA CUSTOM SERVICES (NCS)

8. INSTITUTE OF PUBLIC ANALYST OF NIGERIA (IPAN)

9. PHARMACISTS COUNCIL OF NIGERIA (PCN)

10. NATIONAL AGENCY FOR SCIENCE AND ENGINEERING INFRASTRUCTURE (NASENI)

11. MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)

12. STANDARD ORGANISATIONS OF NIGERIA (SON)

13. BUREAU OF PUBLIC PROCUREMENT (BPP)

14. MANUFACTURERS ASSOCIATION OF NIGERIA (MAN)

15. DEPARTMENT OF WEIGHTS AND MEASURE FMITI

16. NIGERIAN COMMUNICATIONS COMMISSION (NCC)

17. NIGERIAN EXPORT PROMOTION COUNCIL (NEPC)

GROUP B

1. ENERGY COMMISSION OF NIGERIA (ENC)

2. NIGERIA ELECTRICITY REGULATORY COMMISSION (NERC)

3. ASSOCIATION OF FOOD BEVERAGE AND TOBACCO EMPLOYERS (AFBTE)

4. NIGERIAN UNIVERSITY COMMISSION (NUC)

5. NATIONAL SUGAR DEVELOPMENT COUNCIL (NSDC)

6. NATIONAL EMERGENCY MANAGEMENT AGENCY (NEMA)

7. COUNCIL FOR THE REGULATION OF ENGINEERING IN NIGERIA (COREN)

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8. NATIONAL BOARD FOR TECHNICAL EDUCATION (NBTE)

9. NIGERIA ATOMIC ENERGY COMMISSION (NAEC)

10. INFRASTRUCTURE CONCESSION REGULATORY COMMISSION (ICRC)

11. NATIONAL INFORMATION TECHNOLOGY DEVELOPMENT AGENCY (NITDA)

12. COUNCIL FOR THE REGULATION OF FREIGHT FORWARDING IN NIGERIA (CRFFN)

13. COUNCIL OF NIGERIAN MINING ENGINEERS AND GEOSCIENTISTS (COMEG)

14. NIGERIAN SHIPPERS COUNCIL (NSC)

ANNEX 2 INSTITUTIONS VISITED WITH DATES

DATE INSTITUTIONS VISISTED ACHIEVEMENTS REMARKS

13th Nov. DEPARTMENT OF WEIGHTS AND MEASURES (W&M)

DEPARTMENT OF FEDERAL PRODUCE AND INSPECTION (FPIS)

CONSUMER PROTECTION COMMISSION (CPC)

NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC).

Successful meetings were held with the Directors and the team members in the Departments of W&M and FPIS. Meeting was held with the Project Officer II Department and the Assistant Director of Trade (WTO/SPS) a larger meeting to meet with the Director was scheduled.

Mail was delivered to CPC but expected response to the mail never came.

Mail could not be delivered to the NAFDAC office. The staff members were on an industrial action.

17th Nov. NATIONAL ENVIRONMENTAL STANDARDS AND REGUALTIONS ENFORCEMENT AGENCY NESREA

ENERGY COMMISSION OF NIGERIA (ENC)

NIGERIA ELECTRICITY REGULATORY COMMISSION (NERC)

NIGERIAN COMMUNICATIONS COMMISSION (NCC)

NIGERIAN EXPORT PROMOTION COUNCIL (NEPC)

Successful meeting was held with the Director, Partnership and Education of NESREA, Director and Deputy Director, Product Development of NEPC and Technical Assistant to the Executive Commissioner (SM)of NCC

NERC: there was no qualified officer present

ECN declined the interactive meeting because it is not a regulatory body

http://en.wikipedia.org/wiki/Nigerian_Export_Promotion_Council

http://en.wikipedia.org/wiki/Nigerian_Export_Promotion_Council

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18th Nov. NIGERIA AGRICULTURAL QUARANTINE SERVICES (NAQS)

NIGERIA ELECTRICITY REGULATORY COMMISSION (NERC) (A REPEAT VISIT)

A successful meeting was held with the Coordinating Director of the Quarantine Services and seven other members were present for the interactive meeting.

A repeat visit was made to NERC. All the officers scheduled for the meeting were out of station and will not be back till second week in December.

19th Nov. NIGERIAN UNIVERSITY COMMISSION (NUC)

NATIONAL SUGAR DEVELOPMENT COUNCIL (NSDC

NIGERIA CUSTOM SERVICES (NCS)

NATIONAL EMERGENCY MANAGEMENT AGENCY (NEMA)

Successful meeting was held with Deputy Director (UG Accreditation) of Department of Quality Assurance) NUC and Special assistant to the Executive Secretary, NSDC.

Appointments with NCS and NEMA were re-scheduled

20th Nov. NIGERIA CUSTOM SERVICES (NCS) (a re-visit)

NATIONAL EMERGENCY MANAGEMENT AGENCY (NEMA) (a re-visit)

COUNCIL FOR THE REGULATION OF ENGINEERING IN NIGERIA (COREN)

Department of trade (a re-visit)

NATIONAL BOARD FOR TECHNICAL EDUCATION (NBTE)

Held successful interactive meetings with officer in charge, Tariff and Trade NCS; Director Planning Research and Focusing NEMA; Head of Engineering Regulation, COREN and Director and six others of Department of TRADE.

There was no senior officer at the Abuja NBTE’s Liaison office to interact with.

21st Nov. NIGERIA ATOMIC ENERGY COMMISSION (NAEC)

INFRASTRUCTURE CONCESSION REGULATORY COMMISSION (ICRC)

NATIONAL INFORMATION TECHNOLOGY DEVELOPMENT AGENCY (NITDA)

Successful interactive meetings were held with the Executive Vice Chairman NAEC, and President IPAN

Appointment to re-visit ICRC and NITDA was re-scheduled for Monday 24th Nov.

NBTE: Interactive meeting can only be held with the Director at the

http://en.wikipedia.org/w/index.php?title=National_Sugar_Development_Council&action=edit&redlink=1

http://en.wikipedia.org/w/index.php?title=National_Sugar_Development_Council&action=edit&redlink=1

http://en.wikipedia.org/w/index.php?title=Infrastructure_Concession_Regulatory_Commission&action=edit&redlink=1



http://en.wikipedia.org/w/index.php?title=National_Information_Technology_Development_Agency&action=edit&redlink=1



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INSTITUTE OF PUBLIC ANALYST OF NIGERIA (IPAN)

NATIONAL BOARD FOR TECHNICAL EDUCATION (NBTE) (a re-visit)

Head office, Kaduna.

24th Nov. PHARMACISTS COUNCIL OF

NIGERIA (PCN)

NATIONAL AGENCY FOR SCIENCE AND ENGINEERING INFRASTRUCTURE (NASENI)

NATIONAL INFORMATION TECHNOLOGY DEVELOPMENT AGENCY (NITDA)

MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)

COUNCIL FOR THE REGULATION OF FREIGHT FORWARDING IN NIGERIA (CFFRN)

INFRASTRUCTURE CONCESSION REGULATORY COMMISSION (ICRC)

COUNCIL OF NIGERIAN MINING ENGINEERS AND GEOSCIENTISTS (COMEG)

A successful meeting was held with the Registrars of PNC, MSLCN, COMEG and senior officer of NITDA;

NASENI, CFFRN and ICRCA: Suitable time for the re-scheduled meeting could not be reached within the given timeline.

26th Nov. NIGERIAN SHIPPERS COUNCIL (NSC),

NAFDAC

The meeting was held with Deputy Director (ALO) of NSC, the main office is in Lagos.

A successful interactive meeting was held with the Director Food Directorate and Applied Nutrition and two other Deputy Directors of NAFDAC.

STANDARD ORGANISATIONS OF NIGERIA (SON)

BUREAU OF PUBLIC PROCUREMENT (BPP)

SON: Requested the interactive meeting be held in Lagos. This

http://cdnetng.org/?q=node/4905


http://en.wikipedia.org/wiki/National_Agency_For_Science_and_Engineering_Infrastructure












http://en.wikipedia.org/w/index.php?title=Bureau_of_Public_Procurement&action=edit&redlink=1

http://en.wikipedia.org/w/index.php?title=Bureau_of_Public_Procurement&action=edit&redlink=1

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trip could not be contained within the given timeline

BPP: There was no response to the mail sent to BPP.

ANNEX 3

LIST OF DOCUMENTS COLLECTED

INSTITUTION DOCUMENTS COLLECTED

Department of weights and measure

The Laws of the Federation Of Nigeria in force on the 31st day of December 2002

Weights and Measures (Replacement of fifth schedule) Order 2012; (B269-280): in Federal republic of Nigeria official gazette, No. 25 Vol. 99.

Weights and Measures (Legal Metrology Related Services) Regulations 2012; (B263-268): in Federal republic of Nigeria official gazette, No. 24 Vol. 99.

Nigeria Customs Service Import Guidelines, Documentations Requirement Under The Destination Inspection Scheme In Nigeria

Council of Nigerian Mining Engineers and Geoscientists (COMEG).

COMEG ACT No 40, 1990.

The GEM, official magazine of COMEG, vol. 3 (3), 2013

National Emergency Management Agency (NEMA)

(NEMA) Act 1999

Annual reports (two issues)

FEDERAL PRODUCE INSPECTION SERVICE (FPIS)

A flier titled “All about Federal Produce Inspection Service”

Institute of Public Analysts f Nigeria (IPAN) ACT CAP.116 LFN 2004

IPAN ACT CAP.116 LFN 2004

IPAN’S REPORT of the laboratory inspection committee, presented to the Presidential committee meeting, October 2014

National Sugar Development Council (NSDC)

Nigerian Sugar Master Plan 2

Nigeria Agricultural Quarantine Service

The bill for an act to Establish Nigeria Agricultural Quarantine Service

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REPORT OF THE TRAINING/WORKSHOP ON RISK MANAGEMENT IN REGULATORY

FRAMEWORKS Venue: Bolton White Hotel Abuja

Date: 9TH-12 & 15TH-17TH DECEMBER 2014

NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152

1.0 BACKGROUND AND OBJECTIVES

The Nigeria Quality Infrastructure Project is supporting the development of the missing

standards and accredited testing and certification bodies within the framework of the National

Quality Infrastructure (NQI) in order to improve the quality of products and services exchanged

in the Nigerian, regional and international markets.

The project will achieve its objectives through the following:

Promulgation of a National Quality Policy and ensuing legislation for the NQI;

Establishment of a National Accreditation Body;

Development of a National Metrology Institute;

Improvement of Organized Private Sector (OPS) patronage of the NQI and their

capacities to create and support conformity assessment bodies (CAB) and;

Enhancement of the consumer protection role on quality issues as well as

increased capacities of consumer associations to lift up the quality offer/culture

of Nigerian enterprises.

16

In line with the first component of the objectives and the related output which is ‘The technical

regulation regime be assessed against best international practices and WTO requirements,’ one

of the activities required to achieve this is, the ’Assessment of the current Nigerian technical

regulations package and of the effectiveness of related market surveillance authorities’.

Already completed tasks under this activity are:

- Identification of key technical regulatory institutions in Nigeria,

- Organization of awareness meeting in collaboration with key technical regulatory

institutions on better regulations for the working group, regulators and market surveillance

authorities,

The next task, a training/workshop on ‘Risk management in Regulatory frameworks- Towards

a better management of risks’ was conducted. The specific objective of the workshop was to

establish a better regulatory framework for the regulators, standardization bodies,

conformity assessment bodies and market surveillance authorities.

This report highlights the outcome of the training/workshop.

2.0 HIGHLIGHTS OF THE TRAINING AND WORKSHOP

Nineteen institutions participated in the training/workshop on better framework on technical

regulations. Selection of the different institutions was based on the outcome of the

consultative meetings previously held to assess their relevance with regard technical

regulations. The sectors covered in the selection of the institutions are:

- Regulatory

- Standardization

- Accreditation

- Business

- Market surveillance

The training was conducted for 2 separate groups, the first group was on the 9th and 10th Dec.

and second group on the 11th and 12th Dec. 2014 (Annex A).

The training was facilitated by the International Expert, Valentin Nikonov and the national

expert on technical regulations Abimbola Uzomah. The training program was based on the

effective regulations aimed at protecting the health, safety and environment while supporting

growth, investment, innovation and market openness.

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During the first week, the international expert, Valentin Nikonov used different models to

illustrate the risk management functions as listed below:

Setting the objectives of the regulatory system

Management of assets (traceability provisions)

Risk identification

Risk analysis and evaluation: understanding the most important risks

Choosing risk treatment strategies

Implementing risk treatment strategies

Contingency planning and crisis management (including developing a plan to deal with

disruption-related risk)

Monitoring, reviewing and improving the risk management process

Well laid out reference models to illustrate the risk-based regulatory system for these functions

were used. Supportive references such as ISO 31000, ISO 9001, ISO 14001 and other relevant

management standards were also given.

At the end of the training, sub-groups were created. Equipped with the template for the

development of ‘Risk Management’ each sub group developed a regulatory framework on risk

management using specific familiar cases such as;

Building a house within the commercial center

Production of a wedding cake

Soup preparation

Sailing in a boat for a holiday

Taking a business trip from Abuja to Lagos by air

Importing of vehicles from overseas

With the set objectives of the specific case, each sub-group deliberated on the step-by-step

risk management functions. The presentation from each sub-group at the end of the exercise

was quite interactive and informative as the representative of each sub-group gave the analysis

of the risk management framework of their selected case study. The idea was to use the same

concept in the development of the regulatory framework for the different institutions with

mandate on technical regulations in Nigeria.

The training ended with an examination that evaluated the individual’s understanding of the

training. A survey of the general overview of the training course was also conducted.

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As a follow up 3-day workshop based on the knowledge acquired from the training was

conducted from the 15th-17th Dec., 2014. This was to launch a risk management plan of some

specific sectors namely food, environment and energy (Annex B) being the tree sectors that

appeared to have greater impact on the Nigerian society. Institutions representing each sector

were National Agency for Food and Drugs Commission (NAFDAC) for food; National

Environmental Standards and Regulations Enforcement Agency (NESREA) for environment and

Electricity Management Services Limited (EMSL) for energy. The Standards Organisation of

Nigeria (SON) as the standardization body and IPAN a Conformity Assessment Institution also

participated in the workshop (Annex B). The workshop took each sector through the risk

management regulatory framework in line with their respective regulatory objective(s) by

applying the United Nations Economic Commission for Europe (UNECE) reference model,

function by function:

-How it is done

-Start doing what is not done

-Plan how it will be done

3.0 SURVEY RESULT OF THE TRAINING PROGRAM

A survey to evaluate the training program was conducted. The design and the results are

presented in Annex C. In Group 1, Part 1 of the survey, >80% of the participants strongly agreed

with all the statements listed. Some boxes were left blank, maybe by error of omission, while

very few, on four points stated ‘neither agree nor disagree’. In Part 2, >90% of the participants,

spread their rating between ‘Good’, ‘Very Good’ and ‘Excellent’. The survey result of group 2

had similar trend (ANNEX C). The positive response under the column, ‘Strongly disagree’ in

group 2 probably came from a participant who may have mistakenly read the first column as

‘Strongly agree’ because the same participant marked ‘Excellent’ in the Part 2 of the

questionnaire. However, this low score may not be regarded as significant when compared

with the other scores. Worthy of note is the response to ‘Item l’ of group 2, which stated thus

“I would recommend this to other organizations”. Organizations suggested in response to this

statement were the Nigerian Customs Services and Nigerian Immigration. No reason was given

for this suggestion. A participant from SON, recommended 4-day instead of the 2-day training.

The overall rating of the training program from all the participants was very good.

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4.0 CONCLUSION

The outcome of the training workshop showed that the regulatory framework of institutions

in Nigeria require thorough review with a view to update and harmonize so as to conform with

the international best practices. These issues will be addressed in the other activities detailed

in the work plan for the NQI project.

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ANNEX A

INSTITUTIONS THAT PARTICIPATED IN THE TRAINING PROGRAM

GROUP 1; DAY 1

1. Bureau of Public Procurement (BPP)

2. Federal Produce Inspection Services (FPIS)

3. Institute of Public Analysts of Nigeria (IPAN)

4. National Agency For Science and Engineering Infrastructure (NASENI)

5. Nigeria Export Processing Zones Authority (NEPZA)

6. Nigeria Agricultural quarantine Services (NAQS)

7. Nigeria Export Promotion Council (NEPC)

8. Standards Organisation of Nigeria (SON)

(Two representatives from each institution and six from SON)

GROUP 2: DAY 2

1. Consumer Protection Council (CPC)

2. Department of Trade FMITI

3. Department of Weights and Measures FMITI

4. Manufacturers Association of Nigeria (MAN)

5. Medical Laboratory Science Council of Nigeria (MLSCN)

6. National Agency for Food And Drugs Commission (NAFDAC)

7. National Environmental Standards and Regulations Enforcement Agency (NESREA)

8. Pharmacists Council of Nigeria (PCN)

9. Standards Organisation of Nigeria (SON)

(Two representatives from each institution and four from SON)

ANNEX B: INSTITUTIONS SELECTED FOR THE WORKSHOP

DAY INSTITUTION SECTOR

1 NAFDAC and SON Food

2 NESREA and IPAN Environment

3 EMSL and SON Energy


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ANNEX C: RESULT OF THE SURVEY ON A 100% SCALE

GROUP 1

Part 1

Item STATEMENT Strongly disagree

Neither agree nor disagree

Strongly agree

NA Blank

a. The facilitator was well organized

100

b. The facilitator made good use of time allotted

8 92

c. The facilitator demonstrated good knowledge of Risk Management

8 92

d. Facilitators’ presentation style was effective in helping me learn

8 92

e. The presentation methods used were appropriate for the audience

8 92

f. The materials provided will be useful to me

83 17

g. The materials provided will be useful to my organization

83 17

h. I understood the concept as presented in the training

100

i. The meeting improved my understanding of risk management

100

j. The training improved my understanding of how relevant risk management can be to my organization

100

k. The knowledge I learned will be useful me in my job

100

l. I would recommend this to other organizations

75 25

m. I would attend other trainings offered on Risk Management

100

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Part 2

S/No. PARAMETER Excellent Very good Good Fair Poor Blank

1 Visuals 25 58 17

2 Acoustics 17 75 8

3 Meeting place 75 17 8

4 Handouts/Memory Stick 17 35 33 8 7

5 Overall assessment 33 50 17

GROUP 2

Part 1

S/NO STATEMENT Strongly disagree


Strongly agree

NA Blank


7 93


7 7 86

c. The facilitator demonstrated good knowledge of Risk Management

7 93


7 7 86


7 7 79 7


7 7 86

g. The materials provided will be useful to my organization

7 13 80

h. I understood the concept as presented in the training

7 13 73 7

i. The meeting improved my understanding of risk management

7 7 86

j. The training improved my understanding of how relevant risk management can be to my organization

7 93

23

k. The knowledge I learned will be useful me in my job

7 93

l. I would recommend this to other organizations

7 67 13 13

m. I would attend other trainings offered on Risk Management

7 86 7

Part 2

S/No.

Parameter Excellent

Very good

Good Fair Poor Blank

1 Visuals 50 36 14

2 Acoustics 29 36 28 7

3 Meeting place 43 21 29 7

4 Handouts/Memory Stick 29 21 36 7 7

5 Overall assessment 29 57 14

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NATIONAL QUALITY INFRASTRUCTURE PROJECT (NQIP) COMPONENT 1- PROMULGATION OF A NATIONAL QUALITY POLICY AND ENSUING

LEGISLATION FOR THE NATIONAL QUALITY INFRASTRUCTURE

REPORT OF CONSULTATIVE MEETINGS WITH THE WORKING GROUP ON TECHNICAL REGULATIONS

DATE: 19TH – 23RD, 26TH & 28TH JANUARY, 2015

NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND

One of the activities mapped out for the establishment of the Office of Technical Regulation

for the NQP includes the creation of the working group on technical regulations (WGTR). The

group will be responsible for the assessment and review of the current technical regulations

(TR) and the effectiveness of related market surveillance authorities in line with international

best practice.

In order to achieve this, consultative meetings were held with the relevant institutions, with

the primary aim of creating awareness for the establishment of the Working group on

Technical Regulations. This will be followed by the workshop on technical regulations based on

WTO-TBT-SPS requirements. This report is on the outcome of the consultative meetings held

with the respective institutions.

2.0 PRE-CONSULTATIVE MEETING ACTIVITIES

Within the first 15 days of January 2015, each institution to be visited was contacted through

emails, phone calls and text messages. Each institution was requested to make available their

technical regulations for the visit. Appointments were fixed for specific days between 19th and

28th January 2015.

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3.0 REPORT OF THE CONSULTATIVE MEETINGS

The regulatory bodies visited are listed in Annex 1. The main objective of the visit was to create

awareness for the establishment and inauguration of the Working Group on Technical

Regulations and to intimate them on the proposed workshop on good regulatory practices.

Information regarding the various regulatory activities of each institution was obtained during

the visit and a copy of their Act was collected, where it was made available. The information

so obtained was used to assess the institutions in their regulatory activities. The

awareness/consultative meetings took place from the 19th to 23rd, 26th and 28th January (Annex

3.1 REPORT OF THE DAILY ACTIVITIES

i. Day 1

Three departments in the Federal Ministry of Industries, Trade and Investment (FMITI) were

visited. The Trade Department and FPIS did not make available their mandate. According to

the focal persons, they are covered under the same Act that established the Ministry. The

Trade Department is the focal point for the WTO, their mission is basically same as that of the

Ministry, which is to implement policy programs to attract investment, boost industrialization,

increase trade and export and develop enterprises. The Department for Weights and Measures

has legislation that covers metrology as contained in the Acts. The hard copy of this was made

available.

ii. Day 2

NESREA and NAQS were visited on the second day. The information gathered were same with

what was already obtained online. The list of 28 regulations on environmental issues already

published by NESREA was made available but not the Act that established the agency. NAQS

gave a list of its functions and activities, but lacked the enforcement power because the bill for

its establishment has not been assented to.

iii. Day 3

The meeting with Standards Organisation of Nigeria (SON) took place on the third day (Annex

3A). The functions/mandates were as stated in the Acts already obtained online. The regulatory

activities and mandates were discussed and areas of overlaps with the other regulatory

agencies were highlighted. SON is involved in regulatory, conformity assessment, and market

surveillance and consumer complaints. The contact person gave a strong defense for the

involvement of SON in all these activities as covered in their mandate. The need for SON to

27

disengage from some of these activities was discussed. Other document obtained was the soft

copy of SON catalogue that contained over 1000 standards for Nigerian products.

The focal person for NCC was not available for the meeting.

iv. Day 4

The meeting with NAFDAC was held with the deputy director on regulations and quality with 8

other members in the same unit (Annex 3B). The activities which covered the regulation of

packaged food, water, drugs, cosmetics, and medical devices were briefly discussed. Some of

the activities involved pre- and post-market surveillance of the regulated products, licensing of

premises and product certification. The role of NAFDAC, as secretariat of the WGTR was

mentioned to let the officers know their relevance in the project.

The appointments scheduled for MAN did not hold because the focal person was not available.

v. Day 5

The visit to CPC was brief; the focal person was not available but a junior officer made available

the Act that established CPC. The focal person for EMSL requested that the meeting be shifted

to Monday the 26th Feb (Day 6).

vi. Day 6

Two departments in the Federal Ministry of Agriculture were visited. The Director, Department

of Animal Husbandry and Pest Control gave the scope of their coverage and regulatory

activities. The meeting was brief, because the Director needed to excuse himself to attend to

the challenges of a new outbreak of the Avian Flu. He made available the soft copy of their Act.

The Director Department of Fisheries elaborated on their market surveillance activities in the

regulation of the frozen fish business. Cases of destruction of spoilt fish still being housed in

cold rooms for sale to the public were mentioned. He also elaborated on the control of fishing

practices. He made available the hard copy of their Act.

The appointment with the focal person from EMSL, did not hold. He had an emergency that

prevented him from keeping the appointment. The information needed from him concerning

the regulatory activities was obtained from their website.

vii. Day 8

.The NASC oversees the seed production in Nigeria and the development of quality seeds for

the farmers. They also oversee the production and packaging of seeds for export. This include

maintenance of good storage conditions for the seeds and proper labeling after packaging with

special note for traceability. They regulate the importation and exportation of seeds. All the

28

cocoa industries in Nigeria are under their watchful eye. The success of all seed production in

Nigeria is closely linked to the good supervision of this council. The soft or hard copy of the Act

was not made available.

29

ANNEX 1

LIST OF THE INSTITUTIONS VISITED FOR THE CONSULTATIVE MEETINGS


2. DEPARTMENT OF TRADE, (FMITI)

3. DEPARTMENT OF WEIGHTS AND MEASURES, FMITI

4. FEDERAL DEPARTMENT OF ANIMAL PRODUCTION AND HUSBANDRY SERVICES

(FDAPHS), (FMARD)

5. FEDERAL DEPARTMENT OF FISHERIES, (DF), FMARD

6. FEDERAL PRODUCE INSPECTION SERVICES (FPIS)

7. NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL

(NAFDAC)

8. NATIONAL AGRICULTURE SEED COUNCIL (NASC)

9. NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS ENFORCEMENT

AGENCY (NESREA)


11. STANDARD ORGANIZATION OF NIGERIA (SON)

ANNEX 2

WORK PLAN FOR THE CONSULTATIVE MEETINGS

DAY DATE INSTITUTION ACTIVITIES

JAN

1 19 TRADE, W&M, FPIS CONSULTATIVE MEETINGS

2 20 NESREA, NAQS

3 21 SON, NCC

4 22 NAFDAC , MAN

5 23 CPC, EMSL

6 26 FDAPHS, DF

7 27 NFSMC INAUGURATION of the NFSMC & PAPER PRESENTATION

8 28 NFSMC,

NASC

BREAKOUT SESSIONS

CONSULTATIVE MEETING

30

ANNEX 3B VISIT TO SON

ANNEX 3B VISIT TO NAFDAC

31

ANNEX 3C

VISIT TO NASC

32

33



REPORT OF THE ASSESSMENT OF NIGERIA TR REGIME AND THE EFFECTIVENESS

OF THE RELEVANT MARKET SURVEILLANCE AUTHORITIES NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND

The national Quality Infrastructure Project is set to achieve five cardinal goals one of which is

to promulgate a National Quality Policy and ensuing legislation. The expected output under

this component is the Assessment of the current Nigerian technical regulations (TR) package

and of the effectiveness of related market surveillance authorities. This will be achieved by:

- Awareness and training of the working group and regulators on best practices in technical

regulations. Actions required are:

Organize awareness meetings;

Carry out external consultations and regional workshops;

Report on the meetings, consultations and workshops.

The awareness and training of the working group and regulators on best practices in technical

regulations was conducted and the reports have been submitted.1

The next output is the Identification of technical regulations, the review and ensuing

recommendations. This is a report of the activities undertaken to achieve this targeted output.

2.0 REPORTS OF THE ASSESSMENT OF THE REGULATORY INSTITUTIONS

1The reports expected included: (a) Organize awareness meetings; (b) Report on the consultative meetings, the training/workshop and the creation of a Technical Regulations Working Group (TRWG) have been submitted and available.

34

2.1 SELECTION OF THE WORKING GROUP

The technical regulations working group (TRWG) was selected from the list of participants at

the training/workshop held on 9-14 December 2014 (ANNEX I). Selection was based on the

information made available during the consultative meetings, the Act establishing the

institution and/or mandate/functions. The Law library Ministry of Justice, Imo State was visited

on 6th, 7th, 8th and 12th January 20152 for publications to assist in this exercise. Some materials

were obtained during the consultative meetings while some were accessed online. The

information available from these sources was used to review their technical regulations regime

and the effectiveness of the market surveillance authorities.

3.0 HIGHLIGHTS OF THE ASSESSMENT OF THE REGULATORY INSTITUTIONS

3.1 NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS ENFORCEMENT AGENCY

(NESREA)

The National Environmental Standards and Regulations Enforcement Agency (NESREA), is a

parastatal of the Federal Ministry of Environment. It was established to replace Federal

Environmental Protection Agency (FEPA) through Decree 58 of 1988 and 59 (amended) of

1992. The Act establishing NESREA was passed by the National Assembly, signed into law and

published in the Federal Republic of Nigeria Official Gazette No. 92. Vol. 94 of 31st July, 2007.

Act empowers the Agency to be responsible for enforcing all environmental laws, guidelines,

policies, standards and regulations in Nigeria, as well as enforcing compliance with provisions

of international agreements, protocols, conventions and treaties on the environment to which

Nigeria is a signatory.

NESREA has responsibility for the protection and development of the environment, biodiversity

conservation and sustainable development of Nigeria's natural resources in general and

environmental technology including coordination, and liaison with, relevant stakeholders

within and outside Nigeria on matters of enforcement of environmental standards, regulations,

rules, laws, policies and guidelines with several functions.3 Source of the regulations is the ISO

2 The latest information available for the materials sourced from the library was in 2004 3 Some functions of the Agency, amongst others include to: enforce compliance with guidelines, and legislation on sustainable management of the ecosystem, biodiversity conservation and the development of Nigeria’s natural resources; conduct environmental audit and establish data bank on regulatory and enforcement mechanisms of environmental standards other than in the oil and gas sector; create public awareness and provide environmental education on sustainable environmental

35

standards on environment. The multilateral environment agreements are stepped down to

the level attainable in Nigeria depending on the services under consideration. These are then

developed (to take cognizant of the culture and environmental differences) i.e. streamline to

Nigeria situation. NESREA focuses her regulatory work on individuals or organizations whose

activities pose threat to the environment. This is carried out through the development of

regulations and standards, and implementation of various environmental enforcement

program and activities which include:

Development of Environmental Regulations;

Interception and Arrest of Vessels carrying E-waste to Nigeria;

Regulating the Telecom Sector;

Regulating the Illegal traffic in endangered species of Fauna and Flora;

Controlling Environmental Degradation by Quarry Operations

The enforcement programs are coordinated by four technical departments4. There are 28

regulations published by NESREA.

Observations

Two of the major problems encountered by NESREA for effectiveness are:

The attitude of Nigerians towards cleanliness of the environment.

Lack of adequate skilled man power

Occasional conflicts with NCC with regards the erection of the Telecommunication mast

and other telecommunication issues.

3.2 STANDARDS ORGANISATION OF NIGERIA (SON)

SON was established by an Enabling Act Number 56 of December 1971 – (Act cap 412 of the

laws of Federal Republic of Nigeria. The Act has since had three amendments: Act Number

20 of 1976, Act Number 32 of 1984 and Act Number 18 of 1990.

management; promote private sector compliance with environmental regulations other than in the oil and gas sector; prohibit processes and use of equipment or technology that undermine environmental quality; conduct field follow-up of compliance with set standards and take procedures prescribed by law against any violator; and establish mobile courts to expeditiously dispense cases of violation of environmental regulation. 4Inspection and enforcement, Environmental and quality control, Legal department and Partnership and education

36

The mandate includes; preparation of Standards relating products, measurements, materials,

processes and services amongst others and their promotion at National, Regional and

International levels; Certification of products, assistance in the production of quality goods

and services; and Improvement of measurement accuracies and circulation of information

relating to standards. Other function5 of SON is to undertake necessary investigations of the

quality of facilities and products manufactured in Nigeria and imported, so as to establish a

Quality Assurance system including certification of factories, products and laboratories;

Activities for the effective coordination of these functions are carried out by the various

directorates, departments and units.

SON membership of International Standards Bodies includes:

• International Organization for Standardization (ISO)

• International Electrochemical Commission (IEC)

• African Organization for Standardization (ARSO)

Other responsibilities of SON are stated below:

i. Laboratory Services: SON is involved in the testing and implementation of standards.

Samples tested are usually obtained from routine inspection enforcement, product

registration and consumer complaints or samples submitted by customers who want

to ascertain the quality of their products or those obtained at various ports/borders

during inspection.

ii. Product Certification: SON ensures that a product conforms to the requirements

stipulated in the relevant specifications or standards. This is a conformity assessment

exercise which involve factory inspections, testing, certification, auditing and

surveillance, among others. (Product certification are in four categories, MANCAP,

5Other functions of the SON include the following: Ensuring compliance with Standards designated and approved by SON Governing Council; Ensuring reference standards for calibration and verification of measures and measuring instruments; Compiling an inventory of products requiring standardization and the catalogue of Nigerian Industrial Standards (NIS) specification; Fostering interest in the recommendation and maintenance of acceptable standards by industry and the general public; Developing methods for testing of materials, supplies and equipment, including items purchased for use of all the MDAs (Ministries, Departments and Agencies); Prescribe standards for mandatory status; Undertake preparation and distribution of standards samples; Establish and maintain laboratories for its functions; Compile and publish general scientific or other data; Advise on specific problems relating to standards specifications; Sponsor appropriate national and international conferences; Co-ordinate all activities relative to its functions prescribed for it under the Act.

37

SONCAP, Certification for export and Collaboration (the fourth one is an administrative

role)

iii. Trainings: SON organizes conferences and training for industries (Importers,

Manufacturers and Exporters etc.). The management system training include the

implementation of standard, internal and lead auditors for the standard.

The trainings cover ISO 9000, ISO 14000, ISO 22000, ISO/IEC 17025, ISO/IEC 15189,

ISO/IEC 27000 management systems

iv. Market surveillance: SON carries out Ports and Border Operations, for the import

inspection of goods and quality assessment and other enforcement activities to identify

substandard products

Observations

The SON is the focal point in Nigeria for all the International organizations with

regard standards of all the products in Nigeria and thus serves as the only National

standardization body in Nigeria. Every other regulatory agency, organization,

institution derives their standards and guidelines on regulated products and

services from SON.

SON is involved in elaborate market surveillance of all products along with other

organization, SON has desk at airports, seaports and land borders

SON is involved in laboratory accreditation and certification.

SON makes provision for consumer complaints and legal actions are taken where

necessary.

SON mounts programs for the different industrial auditors and issue certificate for

the mounted program

SON is thus multi-functional body covering all matters related to standardization, regulation,

conformity assessment, market surveillance and many more.

3.3 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC)

The National Agency for food and Drug Administration and Control (NAFDAC) was established

by Act 15 of 1993 as amended by Act 19 of 1999 now known as Act Cap N1 Laws of the

Federation of Nigeria 2004. The Miscellaneous Provisions are the Counterfeit and Fake drugs

38

and Unwholesome Processed Foods (Miscellaneous Provisions) Act 25 of 1999 now as Act C34

LFN 2004 and Food and Drug & Related products (Registration etc.) Act pg. of 1993 now known

as Act Cap F33 LFN 2004

The mandate is to safeguard the public health by ensuring that only the right quality food,

drugs and other regulated products are manufactured, exported, imported, advertised, sold

and used.

The scope is to regulate, protect and promote public health by ensuring the wholesomeness,

quality, safety and efficacy (as applicable) of food, packaged water, drugs, cosmetics, medical

devices, chemicals and detergents (referred to as regulated products) consumed in Nigeria.

NAFDAC has published 33 regulations for the guidance of the different directorate. There 19

functions carried out by the agency.6 The regulatory activities7 defined within these functions

cover: Licensing and registration of food premises and Importation & exportation of food.

Thus NAFDAC generally can be classified as;

A regulatory body

Marketing and surveillance authority

Conformity assessment body

NAFDAC chairs the General Purposes Technical Committee of the National Codex Committee

and is a member of the Nigerian delegate to Codex meetings and thus play important role in

6Some of NAFDAC functions listed herein were accessed from wwww.nlipw.com/functions-of-the-agency/ accessed on 2nd

Feb 2015

(a) Regulate and control the importation, exportation, manufacture, advertisement,, distributions, sale and use of food,

drugs, cosmetics, medical devices, bottled water and chemicals (NAFDAC REGULATED PRODUCTS (NRP)), (b)Conduct

appropriate tests and ensure compliance with standard specifications for the effective control of NRP, their raw materials

and production processes. (c) Undertake appropriate investigations into the production premises for NRP and establish

relevant assurance systems, including certificates of the site and the product (d) Undertake inspection of the NRP and

establish relevant quality assurance systems (certification of the product and the site). (e) Compile standard specifications

and guidelines for NRP. (f) Undertake registration for NRP. (g) Control exportation and issue certificate for NRP intended for

exports. (h) Establish and maintain relevant laboratories. (i) Undertake measures that the use of narcotic drugs and

psychotropic substances are limited to medical scientific purposes. (j) Undertake and coordinate research programs on the

storage, adulteration, distribution and rational use of NRP; and (k) Issue guidelines on, approve and monitor the

advertisement of NRP. 7 Other activities of NAFDAC accessed from www.nafdac.gov.ng on 2nd Feb 2015: (a) Labeling of food, (b) Advertisement of food, (c) Sampling procedures, (d) Closure of unhygienic food premises, (e) Health control of food handlers, (f)Irradiation of food, (g) Marketing of Breast milk substitutes, (h) Ante-mortem and/or post-mortem examination of food animals, and (i)Quarantine measures.

http://www.nafdac.gov.ng/

39

the WTO (SPS) enquiry point in Nigeria and INFOSAN Focal Point/INFOSAN Emergency Contact

Point in Nigeria.

Observations

NAFDAC has well defined regulatory guidelines for their technical regulations for the

protection of human health and economic promotion. However, there are apparent overlaps

of legislations, functions/mandate with other agencies and parastatals which include SON, CPC,

Department of Physical and life sciences, Pharmaceutical Council of Nigeria and Medical

Science Laboratory Council of Nigeria.

In spite of all the programs mounted to control NAFDAC REGULATED PRODUCTS (NRP),

NAFDAC still has some challenges, some of which are;

Fake/inadequate documentations (false information) by manufactures,

Importation of banned and substandard products,

Unsatisfactory manufacturing processes GMP,

Inadequate and false claim on labels,

weak co-ordination and communication among Nigerian food regulators ,

Poor control of the border entry points and

Consumer ignorance

3.4 CONSUMER PROTECTION COUNCIL (CPC)

Consumer Protection Council was enacted by the Act no 66 of 1992 now amended as Act

chapter 25C Law of the Federation of Nigeria (LFN) 2004. It has the mandate to be a dynamic,

effective and responsible apex of consumer protection agency of the Federal Government of

Nigeria, championing the cause of fully sensitized consumers to achieve a caring and

consumer-friendly community. CPC has many functions8, the major function is to provide

speedy redress to consumers' complaints through negotiation, mediation and conciliation.

8Other functions that are quite numerous include the following: (a) Seek ways to remove from the market hazardous products and causing offenders to replace such products with safer and more appropriate alternatives;(b) Publish the list of products the consumption and sale of banned, withdrawn, severally restricted or not approved by the Federal Government or foreign governments; (c) Cause an offending company, firm, trade, association or individual to protect, compensate, and provide relief and safeguards to injured consumers or communities from adverse effects of technologies that are inherently harmful, injurious, violent or highly hazardous; (d) Organize and undertake campaigns leading to increased public consumer awareness; (e) Encourage trade, industry and professional associations to

40

CPC also has a committee in each State of the federation, mandated to carry out functions

relating to the consumer complaints, power to establish laboratories, assign and empower

inspecting officers for market surveillance amongst others. These rules and regulations have

been clearly defined by the other agencies (e.g. SON and NAFDAC). CPC relies on the guidelines

on technical regulations mapped out by some other agencies.

Observations

The resultant effect of numerous functions is over-regulation which does not necessarily

promote their effectiveness in protecting the consumer or promoting investment and/or

international trade.

3.5 FEDERAL DEPARTMENT OF LIVESTOCK

This is the government department for animal diseases information, monitoring, quarantine

services, veterinary public health, livestock development and the implementation of related

livestock special project. The Department is the nation’s livestock industry, for the control of

livestock pests and crops adjudged for economic importance.

Document made available by this department on technical regulations was the Act for the

disease control enacted in 1988, (ANIMAL DISEASE (CONTROL), ACT No 10 1988 LFN) and

contains 24 sections. Section 21 specifies the regulations that can be drafted to safe guard the

animal health.

Observation

Some of the functions listed by this department are also carried out by NAQS.

develop and enforce in their various fields quality standards designed to safeguard the interest of consumers; (f) Issue guidelines to manufacturers, importers, dealers and wholesalers in relation to their obligation under this Act; (g) Encourage the formation of voluntary consumer groups or associations for consumers, well-being; (h) Ensure that consumers' interests receive due consideration at appropriate forums and provide redress for obnoxious practices or the unscrupulous exploitation of consumers by companies, firms, trade associations or individuals; (i) Encourage the adoption of appropriate measures to ensure that products are safe for either intended or normally safe use; (j) Apply to court to prevent the circulation of any product which constitutes an imminent public hazard; (k) Compel a manufacturer to certify that all safety standards are met in their products;(l) Cause, as it deems necessary, quality tests to be conducted on a consumer product; (m) Demand production of labels showing date and place of manufacture of a commodity as well as certification of compliance; (n) Compel manufacturers, dealers and service companies, where appropriate, to give public notice of any health hazards inherent in their products; (o) Ban the sale, distribution, advertisement of products which do not comply with safety or health regulations.

41

3.6 DEPARTMENT OF FISHERIES’

There are the Sea Fisheries Act which provides for the control, regulation and protection of sea

fisheries in the territorial waters of Nigeria, 1992 No 71 and the Inland Fisheries Act which

provides for the licensing of fishing craft and the regulation of fishing on the inland waters of

Nigeria, 1992 No 108.

The main function9 is to ensure the achievement of self-sufficiency in fish production through

the provision of appropriate infrastructure to enhance fish production and utilization by the

private sector.

Observation

Similar regulatory roles were also listed for NAQS.

3.7 Nigeria Agricultural Quarantine Services (NAQS)

Approval to establish NAQS was given by the Federal Executive Council in 2001. Up till 2007,

the agricultural quarantine activities were handled by 3 different units in the ministry of

agriculture, Plant, Veterinary and Fish Quarantine services. Each operated under different

mandate and was domicile under the Department of Livestock and Pest Control Services and

The Federal Department of Fisheries respectively.

The harmonization of the 3 units into NAQS was approved in 2007; the Bill was passed but yet

to be assented to. The Bill provides the legal backing to the creation of NAQS as an Agency and

the legal framework for enforcement of quarantine activities in Nigeria.

9Other functions include: (a) The development and modernization of the means of production, processing, storage, and marketing of fish and shell fish Monitoring, control and surveillance of Nigeria’s marine and freshwater fisheries resources for the achievement of resource conservation in partnership with relevant research institutes, Law enforcement agencies; (b) Transfer of appropriate and modern fisheries technology to end users and extensionists in linkage with relevant State based extension Agencies; (c) Fish quality assurance and value addition to enhance foreign exchange earnings from exported shell fish and fin fish (Promotion of export trade in shrimps and fish products as a means of earning foreign exchange from non-oil sources; (d) Provision of fishing inputs to fishermen for increased fish production. Improvement on the quality of life in fishing villages; (e) Reduction of post-harvest fish losses; (f) Provision and Improvement of employment opportunities in the rural fishing communities; and (g) Acceleration and adoption of research in all aspects of fisheries.

42

The mandate of Nigeria Agricultural Quarantine Services (NAQS) is to ensure that all plants,

animals and aquatic produce / products leaving the shores of the country under the

stipulated international standards for enhanced trade.

The main objectives of the Nigeria Agricultural Quarantine Service are to prevent the

introduction, establishment and spread of exotic pests and diseases of all agricultural

products in international trade. NAQS sets out to provide an effective Science - based

regulatory service for quality assurances of agricultural products through consistent

enforcement of sanitary and phytosanitary measures for promoting a secured and

sustainable agricultural and economic development.

The legal tools for the operation of the NAQS is derived from Animal Disease (Control) Decree

1988 and the Plant (Control of Importation) Regulations, 1964, now Agriculture (Control of

Importation) Act 31st march 1964. The Act was enacted to make provisions for the regulation

and the importation of articles for the purpose of controlling plant diseases and pests.

Presently, NAQS coordinates the activities of the plant, animal and aquatic resources including

snails, ornamental fish, composite fish and life fish. The regulations are based on SPS, IPPC, and

OIE. The regulations are for imports and exports at sea ports, air ports, land, post offices and

other carrier hubs. It has four zones for the operations, South West (Lagos), South East (Port

Harcourt), North West (Kano), North East (Maiduguri) and border stations. Certificates are

issued after inspection.

Observations

Similar roles and functions are carried out by the Departments of Livestock and Pest control

and Department of Fisheries. Federal Produce Inspection Services (FPIS) is also responsible for

the exports of agricultural commodities. Even though the functions of FPIS10 are more specific.

The ill-defined roles of these agencies are usually the major sources of conflicts in the

regulatory systems.

10 It assesses products on a standard 3% sample for quality, weight, fumigation and packaging (QWFP). If the product is in compliance, FPIS issue a quality assurance certificate. There will also be a grader number, which identifies the grader and the warehouse. Mandates that all exporters be registered with Nigeria Export Promotion Council and have the QWFP certification

43

3.8 NIGERIAN COMMUNICATIONS COMMISSION (NCC)

The Nigerian Communications Commission Act was established in 2003. The primary objective

of this Act is to create and provide a regulatory framework for the Nigerian communications

industry and all matters related thereto. Some of the other specific objectives are listed11.

The functions and the technical regulations of NCC which have close relation to the

objectives are available online www.nigeria-

law.org/Nigerian%20Communications%20Commission%20Act%202003.htm

Some of the technical codes in the regulatory system include:

Requirements for network interoperability, including the provision of certain network

capabilities such as calling line identification capability and pre-selection capability,

Promotion of safety of network facilities,

Provision of network facilities or services, including requirements for qualified

providers and installers,

Provision of customer equipment and cabling, including requirements for qualified

installers,

Approval of customer equipment and other access devices and

Adoption of technical standards promulgated by international bodies.

Observations

Some of the challenges for this institution are; poor consumer awareness; poor monitoring of

imported goods particularly products from China. The conflict is usually with NESREA with

11 (a) Promote the implementation of the national communications or telecommunications policy; (b) establish a regulatory framework for the Nigerian communications industry; (c) promote the provision of modern, universal, efficient, reliable, affordable and easily accessible communications services and the widest range thereof throughout Nigeria; (d) encourage local and foreign investments in the Nigerian communications industry and the introduction of innovative services and practices in the industry in accordance with international best practices and trends; (e) ensure fair competition in all sectors of the Nigerian communications industry; (f) Encourage participation of Nigerians in the ownership, control and management of communications companies and organizations; and (g) encourage the development of a communications manufacturing and supply sector within the Nigerian economy

44

regards the position of the mast and other electronic junks (used electronic wares) that end

up as e-waste, constituting a major problem for NESREA.

3.9 DEPARTMENT OF WEIGHTS AND MEASURES (W&M)

The W&M act of 1962 was repeal and re-enacted in 1975 with additional provision to facilitate

the change to the metric system. Weights and Measures Act chapter W3, 1974, No. 32 consist

of 51 sections/schedules, some of which are;

The regulations relating to weighing or measuring for trade

Provision of weighing and measuring instruments for use by inspectors

Examination of weights

Powers of inspection and sealing of premises

A review of the Table of Fees has been published, no. 85, vol. 101, S. I. No.10, Weights and

measures (Replacement of fifth schedule) Order, 2012, B 269-280. On the legal metrology and

related services No. 24, vol. 99, S. I. No.9, 2012, B263-268 and B 407-408.

Observations

Controls of the weights and measures of goods have suffered much set back. Market

surveillance is rarely carried out due to the lack of skilled staff and required tools. The major

conflict is with the Department of Petroleum Resources.

3.10 INSTITUTE OF PUBLIC ANALYSTS OF NIGERIA (IPAN) (SERVICE PROVIDER)

The Act establishing IPAN was in 2004, LFN CAP 16. Major function is to determine the

standards of knowledge and skill of persons seeking to practice as Public Analysts and

managing those standards from time to time as circumstance may permit. IPAN also co-

operates with relevant organizations whose objectives border on: Standardization of consumer

products and Control of regulated products such as Food, Drugs, Cosmetics, Medical Devices,

Water and Chemicals, including Protection of the environment from hazardous substances and

participation in National Planning and Development.

45

Other functions include:

Training and registration of Pubic Analysts;.

Regulation of the practice of Public Analysts by issuing guidelines on ethics and

professional practice.

Registration and regulation of analytical laboratories

Standardization of analytical methods and development of new ones.

Observations

IPAN is a private accreditation body recognized by the government, SON and NAFDAC and also

regulates the practices of the public analysts in Nigeria.

3.11 NIGERIA EXPORT PROCESSING ZONES AUTHORITY (NEPZA)

The Act establishing NEPZA was enacted by Decree 63 of 1992. Some of the functions

conferred on the Authority by the Decree include:-

The administration of the Authority and management of all the Export Processing

Zones;

The approval of development plans of the Authority and the Zones annual budgets in

respect to infrastructures, administrative buildings, promotion of Zones, the provision

and maintenance of services and facilities;

The establishment of customs, police, immigration and similar posts in the Zones;

The supervision and co-ordination of the functions of various public sector and private

sector organizations operating within the Zones and resolving any dispute that may

arise amongst them;

The resolution of trade disputes between employers and employees in the Zone in

consultation with the Federal Ministry of Employment, Labour and Productivity;

The adaptation of investment promotion strategies in the Zones, including the opening

of Investment Promotion Offices abroad;

The recommendation to the Federal Military Government of additional incentive

measures for the Zones;

The establishment and supervision of Zonal Administrators for the purpose of

managing the Zones and the grant

46

Observations

The major responsibility of NEPZA is administrative. There was no indication of any conflict

with other institutions. The effectiveness of the organization or lack of it, was not readily

measurable from information gathered.

3.12 ELECTRICITY MANAGEMENT SERVICES LIMITED (EMSL)

The EMSL is a technical and professional agency established and incorporated in accordance

with the provision of Part 1 section 8 of the Electricity Power Sector Reform Act 2005 and the

Supplementary Regulations number 46/40 (B499-452), gazette no. 374, 2010.

The vision of EMSL is to be an efficient world class technical services provider ensuring

standardization, specification, quality, safety and competence for the Nigerian Electricity

Industry. Her mandates include:-

Ensuring that

Electrical materials, equipment, instruments used in Nigeria Electricity Supply Industry

(NESI) are of the right quality, standards and specification;

The power systems and networks put in place have been properly planned, designed

and executed before use and to ensure that such systems are capable of delivering safe

reliable and regular electricity supply to the consumers nationwide;

The safety of lives and property within the grid and off-grid networks is guaranteed;

That electric meters and instruments are of the right type, class and accuracy for proper

accountability of energy produced, delivered, supplied and utilized by the consumers;

Certification and advancing the skill and expertise of all technical personnel engaged in

practice of electrical installations along the value chain and utilization in NESI

Observations

The service delivery to consumers’ needs improvement. The market surveillance is inadequate

The design and mechanism for the implementation of the mandate should be modernized.

47

4.0 GENERAL OBSERVATIONS

The following observations were made during the course of the consultative meetings and

from the documents available

i. Each institution has statutory right in pursuing the mandate for which it was

established;

ii. There were obvious overlaps of mandates and this contradicts the WTO for trade

promotion;

iii. Uncoordinated activities of the different regulators, resulting in avoidable duplications

of activities and a waste of man-hour;

iv. There were multiple certification bodies on the same or similar standards;

v. The private sector is overweighed with demands to meet the different stipulated tariffs

and thus become vulnerable to activities of corrupt government agents who tend to

take undue advantage of the lapses within the system. Consequently, the quality of

service deliveries/products are compromised;

vi. The incentive for exportable goods in a country endowed with lots of natural resources

is low. Most of the products do not meeting the exportable standards;

vii. Some of the regulatory agencies do not have the required skilled man power;

viii. Due to the large population size of the country and diversities of locally produced

goods, the demand on the few conformity assessment bodies is high and their ability

for a sustainable and appropriate market surveillance exercise and enforcement of

compliance is weak;

ix. Effective monitoring and implementation cannot be readily validated because of the

obvious gap between the ‘law’ and the ‘practice’

x. Lack of effective contributory roles of the private sector and the consumers in the

regulatory structure;

xi. There is need for the reformation and strengthening of the regulatory structure to

ensure the quality of the services and goods provided;

xii. All the regulatory institutions are dependent on the government for sustenance and

maintenance and as such, performance of the chief executive may be affected by

changes in the political structure;

48

xiii. Poor or lack of revenue generation to augment the subventions from the government.

5.0 RECOMMENDATIONS

In order to solve these problems associated with the regulatory issues in Nigeria, the under

listed recommendations may be applied:

i. Identification of effective policy objectives for the restructuring of the institutional

regulatory framework (in accordance with Article 2.2 of the WTO TBT12 Agreement) by

being able to protect the health and safety of the community, while keeping regulatory

intervention to a minimum, necessary to achieve the regulatory objective and not stifle

innovation and competition amongst businesses and thereby ensure benefits to

consumers and to the community in general.

ii. Establish central organization to oversee the development/review of the current

regulations and adopt standardized, systematic analytical tools that can aid the

decisions in relation to the review. The organization will also be responsible for the

vetting of future regulatory proposals to avoid overlaps.

iii. Review the act establishing each institution in conformity with the WTO guidelines to

eliminate overlaps and reflect good regulatory practice. This may require the adoption

and implementation of risk management system (ISO 31000).

iv. Review the technical regulations to be Performance-Based in line with Article 2.8 of the

WTO TBT Agreement13. This specifies the desired objective and at the same time

allowing the regulated entity to determine their own technique for achieving the

outcome.

v. The design of the technical regulations should be tailored towards the elimination of

technical barriers to trade (WTO TBT Agreement14) and the elimination of different

qualities of products for local and international markets. This will be cost effective and

will encourage competitiveness.

vi. Government financial support to the institutions must be adequate.

12 Ensuring that technical regulations are not prepared, adopted or applied with the view to or with the effect of creating unnecessary obstacles to international trade. For this purpose technical regulation shall not be more trade restrictive than necessary to fulfil a legitimate objective. 13 Wherever appropriate Members shall specify technical regulations based on product requirements in terms of performance rather than design or descriptive characteristics 14 TBT Agreement states that where technical regulations are prepared, adopted or applied in accordance with the relevant international standards, there shall be a presumption that the regulations do not create an unnecessary obstacle to international trade.

49

vii. Employment of skilled and capable human resources must be encouraged with plans

for periodic trainings for new technological developments.

viii. Consideration should also be given to ‘equivalent standards’ as they relate to the

ECOWAS community. This will reduce the burden on industry and trade within the

terms of the WTO TBT Agreement15 .

ix. Regulatory measures on conformity assessment must contain compliance strategies

which ensure the greatest degree of compliance at the lowest level of government

intervention. This will include the pre-market’ conformity assessment regimes and the

supplier declaration regime.

x. In the choice of conformity assessment regime, special consideration should be given

to the specifics such as the number of licenses, certifications, approvals, authorities etc.

These should be kept to the minimum required to achieve regulatory objectives.

xi. The technical competence of the conformity assessment body must meet international

standards, the essential WTO TBT principles of transparency and non-discrimination.

xii. The regulations must be subject to review. This will help maintain flexibility and

adaptability to changes.

15 Members shall give positive consideration to accepting as equivalent technical regulations of other Members. Even if these regulations differ from their own, provided they are satisfied that these regulations adequately fulfil the objectives of their own regulations.

50

ANNEX 1

LIST OF THE MEMBERS OF WORKING GROUP ON TECHNICAL REGULATIONS (WG-TR)


2. DEPARTMENT OF TRADE, FMITI


4. ELECTRICITY MANAGEMENT SERVICES LIMITED (EMSL)

5. FEDERAL DEPARTMENT OF FISHERIES, FMARD

6. FEDERAL DEPARTMENT OF LIVESTOCK AND PEST CONTROL, FMARD

7. FEDERAL DEPARTMENT OF VETERINARY AND PEST CONTROL, FMARD


9. INSTITUTE OF PUBLIC ANALYSTS OF NIGERIA (IPAN)




13. NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION COUNCIL (NAFDAC)


AGENCY (NESREA)

15. NIGERIA EXPORT PROCESSING ZONES AUTHORITY (NEPZA)


17. NIGERIAN COMMUNICATIONS COMMISSION (NCC)


http://en.wikipedia.org/wiki/Nigerian_Communications_Commission

51



REPORT OF THE WORKSHOP ON THE ESTABLISHMENT OF A WORKING GROUP ON

TECHNICAL REGULATIONS (WG-TRs)

Venue: Reiz Continental Hotel, Abuja

Date: 10 &11 Feb., 2015


One of the goals of the National Quality Infrastructure Policy (NQIP) is to develop a National

Quality Policy to aggregates stakeholders’ resolutions in a framework that is operative within

the current economic environment and in line with the international best practice.

Consequently, the regulatory regime must be reviewed and updated.

The current technical regulations in Nigeria have been assessed to be fragmented with many

overlaps and non-compliant with WTO-TBT requirements. There is a wide gap between the law

and the practice. To substantiate this, a proper review of all the technical regulations in Nigeria,

with a view to streamline and harmonize using the international guidelines as provided by the

WTO-TBT-SPS requirements should be carried out.

This is a report on the outcome of a 2-day workshop on the establishment of the WGTR, their

roles and responsibilities as detailed within the terms of reference. It also seeks a means of

evaluating the Act/Functions of Regulatory institutions in Nigeria using the guidelines provided

by WTO, TBT and SPS. It will also develop a road map for the production of a green paper for

the establishment of a Technical Regulation Office for better Technical Regulation. This will be

guided by the following main objective:

52

Establish the Working Group on Technical Regulations, define the terms of

reference to the group and outline a roadmap for the harmonization of regulatory

systems.

And the under listed expected outcomes:

Establishment of WG-TRs

Development of a roadmap for mainstreaming the Nigerian Technical Regulations

in conformity with WTO, TBT and SPS agreements.

2.0 REPORT

Fifteen members (82% attendance) of the WG-TRs (Annex 1) were present for the workshop.

The meeting was chaired by the Director Weights and Measure (Engr. O. J. Sikuade). There

were 3 presentations during the two-day workshop.

1st Presentation: INSTITUTIONAL ASSESSMENT OF TECHNICAL REGULATORS AND

MARKET SURVEILLANCE AUTHORITIES.

2nd Presentation: OVERVIEW OF WTO, TBT AND SPS AGREEMENTS IN THE

FRAMEWORK OF THE NQI PROJECT

3rd Presentation: WTO AGREEMENTS ON TBT AND SPS AS INSTRUMENTS OF BETTER

REGULATORY FRAMEWORK: MYCOTOXINS CONTROL

The 1st presentation reported the result of the review of the technical regulatory institutions

in Nigeria. The details of this report were captured in my last report.The presentation

highlighted;

The WTO definitions and the roles of the Regulatory agencies

The difference between SPS and TBT agreements and

The use of the Tool-box of instruments for regulatory co-operation/elimination of TBTs.

The problems with technical regulations in Nigeria were highlighted. It also discussed

the general regulatory problems as obtained in other economies and outlined the

ensuing recommendations

53

The 2nd presentation further highlighted the definitions, functions and responsibilities of

regulators (the standardization, conformity assessment, regulator the market surveillance

bodies) within the WTO conditions.

The 3rd presentation was an overview of the regulatory practices of other world economies.

Different cases with regards international trade (TBT) were presented. The case of

MYCOTOXINS in food products in some African countries and Brazil and its deterrent to trade

was elaborated. Steps taken in Brazil which involved good regulatory practices (WTO and SPS

requirements) and the inputs from the private sector were presented. The export figure before

the application of the WTO measures was below 1 million tons annually. Peanut production

rose to the neighborhood of 197,000 tons per year as against that of India (4 million tons),

China (1.9 million), and United States (1.7 million).

These presentations were tailored towards initiating a good evaluation of the Nigerian

situation by the participants and steering their minds towards the adoption of an effective,

sustainable and credible regulatory framework in line with international best practices.

Part of the activities of the second day was a self-evaluation of the individual technical

regulatory mandate; this was followed by group evaluation of each mandate using the WTO

conditions earlier (Annex 2). A template was provided for the exercise. The result of the

exercise is tabulated in Annex 3.

3.0 ANALYSIS OF THE ASSESSMENT

The overall assessment of the exercise is shown in Annex 4 and summarized below. Individual

and group assessment showed that the scores were within close range (except

standardization) suggesting that all did regulatory activities, market surveillance and

conformity assessment at about the same level. This is a clear indication of overlaps in the

regulatory systems. The individual evaluation showed more than one standardization body,

but this was checked off with the group assessment. This result supports the earlier statement

on the need to a review mandates of the regulatory institutions in Nigeria for streamlining and

harmonization.

54

CATEGORIZATION OF THE REGULATORY INSTITUTIONS

S/No ORGANIZATION OVERALL

EVALUATION

1. CPC RM

2. EMSL C

3. FISHERIES DEPT R

4. FPIS RC

5. IPAN R

6. MAN MC

7. MLSCN R

8. NAQS RC

9. NEPZA MC

10. NESREA RM

11. SON S

12. TRADE DEPT RM

13. VET SERVICES RM

14. WEIGHTS AND

MEASURE

DEPT

M

AVERAGE RATING OF INDIVIDUAL AND GROUP ASSESSMENT OF ALL REGULATORY ACTIVITIES

ASSESSOR STANDARDIZATION

(S)

REGULATORY

(R)

MARKET

SURVEILLANCE

(M)

CONFORMITY

ASSESSMENT

(C)

INDIVIDUAL 13.5 34 25.5 27

GROUP 4.7 32.7 31.3 31.3

S STANDARDIZATION

R REGULATORY

M MARKET SURVEILLANCE

C CONFORMITY ASSESSMENT

55

4.0 WAY FORWARD

The way forward was therefore mapped out. The activities, given below, were agreed upon

towards the development of good regulatory practices and the production of a green paper on

technical regulations:

i. Take inventory of all agency mandate involved in the NQI project

ii. Identify overlaps by mandate and streamline

iii. Notify stakeholders involved towards harmonization of technical regulation

concerned.

iv. Draft and sign MOU by all the concerned bodies. The MOU shall reflect the following

Collaboration and

Harmonization of activities in relation to best practices for the technical

regulation

v. Draw up a green paper for public dissemination for Federal Executive Council (FEC)

approval

56

CROSS-SECTION OF THE WORKSHOP

57

ANNEX I

THE TECHNICAL WORKING GROUP (WG-TR)






6. FEDERAL DEPARTMENT OF LIVESTOCK AND PEST CONTROL, FMARD

7. FEDERAL DEPARTMENT OF VETERINARY AND PEST CONTROL, FMARD






AGENCY (NESREA)




ANNEX 2

MAIN FUNCTIONS AND RESPONSIBILITIES OF THE REGULATORY AGENCIES

Standardization bodies:

i. Could be private or public sector

ii. The standard could be for national purpose or international for free flow of trade

iii. The functions include proposal, development, establish, monitor and coordinate

voluntary/mandatory standards

Regulatory bodies:

i. The body Set up by Act of Parliament

ii. Control specified sector

iii. May impose legal sanctions

58

Market surveillance bodies:

i. Set up by Act of Parliament or Memorandum of Association

ii. Monitor market performance

iii. Flag irregularities

Conformity assessment bodies:

i. Public or private sector, domestic or international

ii. Assess products, processes or personnel

iii. Issue certificates of conformance

iv. Participation is voluntary

WTO CONDITIONS

i. A standardization body cannot be a regulator or market surveillance

ii. A standardization body can be classified as a conformity assessment body provided it

is under a separate management

iii. A regulator can also be classified as a market surveillance only

iv. A conformity assessment body may be classified as a market surveillance

v. Market surveillance can also be a conformity assessment body

59

ANNEX 3 RATING OF THE REGULATORY INSTITUTION

S/No

ORGANIZATION

% ACTIVITY STANDARDIZATION

(S)

% ACTIVITY REGULA

TORY (R)

% ACTIVITY MARKET

SURVEILLANCE (M)

% ACTIVITY

CONFORMITY

ASSESSMENT (C)

INDIVIDUAL EVALUATION

GROUP EVALUATION

GP 1

GP 2

GP 3

1. CPC 10 50 20 20 R MC RM RM

2. EMSL 20 10 30 40 MC RC RC C

3. FISHERIES DEPT

20 60 10 10 R RM RC RMC

4. FPIS 10 5 15 70 MC MC RM MC

5. IPAN 10 50 - 40 R nr nr nr

6. MAN - 25 75 M MC D

7. MLSCN 10 40 40 10 RM RC RC R

8. NAQS - 60 10 80 C RC RM R MC

9. NEPZA - - 50 50 MC MC RM C

10. NESREA 10 85 3 2 MC R RM nr

11. SON 55 40 2 3 SR S nr nr

12. TRADE DEPT

25 25 25 25 SRM R RM SMC

13. VET SERVICES

5 15 40 45 R MC RM RMC

14. WEIGHTS AND MEASURE DEPT

50 100 100 50 RM nr RM SMC

nr: Not Rated

60

ANALYSIS OF THE TOTAL ASSESSMENT

S/No ORGANIZATION % ACTIVITY STANDARDI

ZATION (S)

% ACTIVITY REGULATORY

(R)

% ACTIVITY MARKET

SURVEILLANCE (M)

% ACTIVITY CONFORMITY ASSESSMENT

(C)

OVERALL CATEGORIZATION

1. CPC 43 43 14 RM

2. EMSL 29 14 57 C

3. FISHERIES DEPT 50 25 25 R

4. FPIS 14 43 43 RC

5. IPAN 100 R

6. MAN 50 50 MC

7. MLSCN 57 14 29 R

8. NAQS 37.5 25 37.5 RC

9. NEPZA 14 43 43 MC

10. NESREA 40 40 20 RM

11. SON 75 25 S

12. TRADE DEPT 23 33 33 11 RM

13. VET SERVICES 37.5 37.5 25 RM

14. WEIGHTS AND MEASURE DEPT

14 28 44 14 M

61



INAUGURATION OF THE WORKING GROUP ON TECHNICAL REGULATIONS (WG-TRs)

Venue: Transcrop Hilton Hotel, Abuja Date: 10 &11 March, 2015


As a follow up to the previous reports on this project, the National Quality Policy (NQP)

within the concept of the National Quality Infrastructure Policy seeks to develop a

framework for the regulatory bodies that is operative within the current economic

environment and in line with the international best practice. Part of the strategies to

achieve this, is to establish a Working Group on Technical Regulations (WGTR) to operate

within a well-defined terms of reference. Part of the task of the WGTR is to

review/update the regulatory regime in line with WTO-TBT-SPS requirements and

establish the technical regulation office in line with the proposed milestone from the last

workshop.

This document reports the Inauguration of the WGTR and the outcome of their activities

during the working sessions on the proposed milestone. The working session herein

addressed:

i. The review of agencies mandate involved in the NQI project to identify overlaps,

gaps and harmonize/streamline the technical regulation.

ii. The drafting of MOU to reflect collaboration and harmonization of activities in

relation to best practices for the technical regulation

62

iii. Development of procedure to establish the Office of Technical Regulations (OTR)

toward the production of a green paper for public dissemination for Federal

Executive Council (FEC) approval on NQP.

Two papers were presented before the inauguration ceremony. The highlights of both

papers are given hereunder.

2.0 OPENING

The Opening ceremony was held on the 10th of March, 2015. Present were Dr. Patrick

Kormawa, UNIDO Country Representative and Regional director; Representative of the

European Union Delegation, Mr. Juan Casla; Permanent Secretary, FMITI, Ambassador

Abdulkadir Musa and members of the Working Group on Technical Regulations. Some

media men were also present.

The program was chaired by the Permanent Secretary, FMITI who represented the

Honourable Minister, FMITI, who was initially scheduled to chair the meeting but was

unavoidably absent. The Welcome Speech was delivered by Dr. Patrick Kormawa, UNIDO

Representative and Regional Director. In his speech, he expressed his gratitude to the

support given by the European Union to the NQI project and the FMITI. Making reference

to the NQI project, the achievements so far, he laid emphasis on the future plans in the

implementation of the Nigeria Industrial Revolution Plan. He also pointed out the roles

of the WGTR in the actualization of this project and the need for the establishment of

the OTR. The Permanent Secretary, FMITI gave the Keynote Speech. He expressed the

importance of the project to the Federal Government and gave credence to the

European Union for their support. He also affirmed the continual support of the Federal

Government of Nigeria towards the successful completion of the project. In his remarks,

he reminded members present of the main objective of the NQI project towards

improving quality, safety, integrity and marketability of Nigerian goods and services and

the removal of technical barriers to trade. He laid strong emphasis on the onerous task

and the responsibilities ahead for the members of the WGTR to actualize the vision of

the Federal Government in turning around the economy of the nation by the year 2020.

The highlight of the day was on the implementation of Better Technical Regulations

which requires a regulatory framework with the establishment of the WGTR. On this

note, the Permanent Secretary formally inaugurated the WGTR (Annex 1), after reading

63

the Terms of Reference (TOR) and its adoption as a working document. Before the

adoption, the Chairman reiterated Section 10 of the TOR which was on ‘Remuneration’.

He made it clear that apart from the Daily Subsistence Allowance (DSA) and transport

costs to members who have to travel from other cities than the one hosting the WGTR

meetings, no member should expect any other payment. Members adopted the TOR as

a working document. A group photograph (Annex 2) led by the Perm Sec, UNIDO

Representative, EU Delegate and members of the WGTR was taken after the

inauguration. The Director Trade Department FMITI was appointed as the Chairman of

the WGTR.

3.0 PAPER PRESENTATION

The first paper was delivered by UNIDO Technical Expert on Regulations16. This was the

result of analysis of the individual and third party assessment of the mandates of the dif

ferent institutions. The mandates were also assessed against the WTO-TBT-SPS- conditi

ons. The summary of the result is presented in the table below:

INSTITUTION ASSESSMENT (%)

Individual Third party WTO-TBT-SPS

STANDARDIZATION BODY

13.5 4.7 4.1

REGULATORY BODY 34.0 32.7 42.4

MARKET SURVEILLANCE

25.5 31.3 37.5

CONFORMITY ASSESSMENT

27 31.3 16

The following can be deduced from this analysis:

i. There are overlaps of mandates;

ii. Uncoordinated activities resulting in duplication of roles and responsibilities;

iii. Multiple certification bodies on the same or similar standards;

iv. Wide gaps between the ‘law’ and the ‘practice’

v. Effective contributory roles of the private sector and the consumers in the

regulatory structure is lacking;

In conclusion and wat forward, the following points were emphasized;

16 ABIMBOLA UZOMAH

64

i. Need for the reformation and strengthening of the regulatory structure to

ensure the quality of the services and goods provided;

ii. Restructuring of the institutional regulatory framework;

iii. Review the Act establishing each institution in conformity with the WTO

guidelines to eliminate overlaps, gaps and to reflect good regulatory practice.

iv. The review of Technical Regulations towards the elimination of technical

barriers to trade (WTO, TBT Agreement) and upgrading the quality of locally

produced goods to meet the standards of international markets.

The second paper was delivered by the CTA UNIDO17 who gave a brief introduction of

the NQI project, an overview of the WTO-TBT-SPS agreement, the proposed milestone

and their timeline within the NQI Project and the achievements so far as outlined below:

i. The assessment of Nigerian Technical regulation regime, the review of the

different institutional mandates;

ii. National consultations held on 8 Dec 2014

iii. Training/workshop on better regulations (9 to 19 December 2014)

iv. Printing and circulation of the National Food Safety Policy and its

Implementation Strategy document

v. The inauguration and launching of the National food Safety Management

Committee

vi. Regional consultations in 6 geo-political zones

vii. National consultations on 8 Dec 2014

17 CHARLES MALATA

65

4.0 WORKING SESSIONS ON THE WGTR MILESTONES

On day 2 of the workshop, members of the WGTR were split into three groups (Annex

3a-3c) each to handle different parts of the milestone.

4.1 Group 1

The group used the report of the last WGTR meeting to take inventory of agencies

involved in the NQIP and identify mandate overlaps and gaps. The group was to

streamline and harmonize the mandate in line with WTO, TBT and SPS agreements.

4.1.1 Submission

The group was able to deliberate on some of the enabling Acts of NAFDAC18, SON19,

Weights & Measures, CPC20 and MLSCN21. The details of the mandates were analyzed. It

was observed that SON has no provision for standards on drugs. The mandate of CPC was

found to overlap with that of NAFDAC and Weights & Measures. Similarly, MLSCN’s

mandate materially conflicted with that of NAFDAC in the regulation of medical

devices/kits, reagents and chemicals. Due to time constraint other institutions could not

be assessed. To that extent, the assignment was in-conclusive and it was agreed that the

group should re-convene on the 23rd of April to finish the task.

4.2 Group 2

Group 2 was given the task to draw up stakeholders’ engagement strategy to notify all

concerned bodies towards the implementation of the draft MOU to achieve

collaboration, harmonization and technical regulation best practice.

4.2.1 Submission

The strategy for the engagement of the members of the WGTR towards fulfilling the

terms of the MOU was divided under the following headings:

i. Correspondence

ii. Consultative stakeholders’ meeting

iii. Schedule of responsibility

iv. Establishment of a clerk office in all the stakeholders

v. Publicity/sensitization

18 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL 19 STANDARD ORGANISATIONS OF NIGERIA 20 CONSUMER PROTECTION COMMISSION 21 MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA

66

vi. Courtesy visits

vii. Monitoring and evaluation

Follow-up detailed action, timeline, funding and responsible agent were clearly defined

for each activity (Annex 4). UNIDO NQIP was included as the sole funding body for all

the activities and NAFDAC was made the secretariat.

4.2.2 Amendment

There was no major amendment of the MOU except for ARTICLE 3 (Utilization of

funds), this was amended to read;

“The UNIDO (NQIP) will provide DSA and transport cost to members who have to travel

from another city than the one hosting the WG-TR meeting. While sitting allowance

shall be paid to committee members that are present at each meeting.”

This was amended to replace:

“The UNIDO (NQIP) will provide DSA and transport costs to members who have to

travel from another city than the one hosting the WGTR meetings. Outside this, no

other expenses shall be allowed as remuneration or otherwise.”

4.2.3 Adoption

On the amended paragraph, the chairman reminded members of the TOR which clearly

stated that there will be no sitting allowance for members, but that the DSA and other

logistics will be taken care off. On this note, the amended clause was dropped, and the

previous statement was retained. The submission was thereafter adopted as a working

document. Members also signed the MOU.

4.3 Group 3

The tasks for group 3 are outlined below;

i. Recommend fundamental pillars of the office of the Technical Regulations on

Better Technical Regulation using the WTO, TBT and SPS agreements.

ii. Recommend a roadmap for disseminating the green paper to the public and

submissions to,

67

Federal Executive council

Ministry of Justice

National Assembly

4.3.1 Submission

Members of group 3 outlined the functions of the Office of Technical Regulations (OTR)

as follows:

i. Shall be responsible for the harmonization of the functions of all regulatory and

standardization agencies/bodies.

ii. Shall coordinate the activities of the standardization and regulatory bodies.

iii. Shall review and update existing standards/regulations in line with WTO

agreements.

iv. Shall recommend to national body the adoption of new standards/regulations.

v. The OTR shall serve as the secretariat for the national body and report to the

same body.

vi. Shall be responsible for the preparation of quarterly briefs for the national

body.

vii. Shall be responsible for the creation of awareness with regard to existing and

new standards/regulations among stakeholders.

viii. On behalf of the standardization/regulatory bodies OTR shall liaise with relevant

international organizations to obtain current updates on standards.

ix. The OTR shall in addition to the above carry out any other function that will

enable them achieve its mandate.

OTR is recommended for either the office of:

Vice President or

Chief of staff to the President or

Secretary to the Government of the Federation or

Chief Economic Adviser.

It is expected that the establishment of OTR in any of the suggested office shall be by

‘Executive Order’ or ‘Executive Fiat’. The duration should be between two to three

months after the Executive Order

68

Resources needed

The resources needed shall be classified under the following;

Structured office (office space)

Office equipment

Human resources

Adequate funding

The exact budgetary allocation could not be fixed at this stage

4.3.2 Amendment/Adoption

Members requested the group to include the timeline for each activity within the

stated two to three months. This was inserted as presented below and the submission

was thereafter adopted.

Timeline for the procedure

PROCEDURE WEEK MONTH

From To 1 2 3 4 5 6 1 2

WGTR Steering Committee

Steering committee

FMITI

FMITI22 FEC

FEC23 MoJ

MoJ24 NAAS25

The total duration for the working group to develop the green paper and pass same to

the National Assembly (NAAS) was estimated to be 14 weeks as indicated above.

22 FEDERAL MINISTRY OF INDUSTRY, TRADE AND INVESTMENT 23 FEDERAL EXECUTIVE COUNCIL 24 MINISTRY OF JUSTICE 25 NATIONAL ASSEMBLY

69

ANNEX 1

THE MEMBERS OF THE WORKING GROUP ON TECHNICAL REGULATIONS (WGTR)





5. FEDERAL DEPARTMENT OF ANIMAL PRODUCTION AND HUSBANDRY

SERVICES FMARD


7. FEDERAL DEPARTMENT OF VETERINARY AND PEST CONTROL SERVICES,

FMARD

8. FEDERAL MINISTRY OF INDUSTRY, TRADE AND INVESTMENT (FMITI)


10. HOUSE COMMITTEE ON INDUSTRY




14. NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND

CONTROL (NAFDAC)

15. NATIONAL AGRICULTURE SEED COUNCIL (NASC)

16. NATIONAL ASSEMBLY

17. NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS

ENFORCEMENT AGENCY (NESREA)

18. NATIONAL PLANNING COMMISSION (NPC)



21. NIGERIAN BAR ASSOCIATION (NBA)

22. NIGERIAN COMMUNICATION COMMISSION (NCC)

23. NIGERIAN LAW REFORMS COMMISSION (NLRC)

24. SENATE COMMITTEE ON TRADE


70

ANNEX 2

MEMBERS OF THE WGTR WITH PERMANENT SECRETARY FMITI UNIDO COUNTRY REPAND EU REPRESENTATIVES

ANNEX 3: GROUPS 1, 2 AND 3 DURING THE WORKING SESSION

ANNEX 3A: WGTR GROUP 1

ANNEX 3B: WGTR GROUP 2

71

Annex 3C: WGTR GROUP 3

ANNEX 4

SUBMISSION FROM GROUP 1

NAME OF ORGANIZATION

MAIN FUNCTION OVERLAPS OF FUNCTION

GAPS RECOMME-NDATION

NAFDAC -Test, inspect, certify, regulate and compile standards for food products. -Control manufactured goods their importation and exportation. - Regulated products include, packaged food, drug, cosmetics, medical devices, chemicals and bottled water.

72




SON -Establish the approved standards, including metrology, materials, commodity, structure and processes. -In commerce and industry, SON provides measures. -In quality control of raw materials and product conformity, provides overall policy. - Organize tests to ensure compliance. -Establish quality assurance of the systems. -Certification of premises, products and laboratories. -Ensure preference of calibration and verification. -Compile the Nigeria standard specifications. -Register and regulate standard marks, scientific and general data. -Advice MDAs’

No standards for drugs

Weights and Measures

-Primarily in charge of metrological standards Traceability. -Empowered to test and enforce compliance

CPC -Provide speedy redress to consumers' complaints; -Seek ways and means of removing or eliminating from the market hazardous products and causing offenders to replace such products; -Publish, from time to time, the list of products banned or not approved by the Federal Government or foreign governments; -Cause an offending company to protect, compensate, and provide relief to injured consumers -Organize campaigns to increase public and consumer awareness; -Safeguard the interest of consumers; -Has power to establish laboratory or collaborate with an existing one

Overlaps of functions and conflicts with other regulatory agencies such as NAFDAC, Weights and Measures

73




Medical Laboratory Council

-Regulate medical laboratory -Inspect, regulate and accredit laboratory practices -Regulate production, importation and sales of laboratory reagents and chemicals

Conflicts with provisions of NAFDAC Act on medical devices/kits, reagents and chemicals

74

ANNEX 5

SUBMISSION FROM GROUP 2

S/N

Activities Follow-up detail action

Time line Funding

Define schedule of responsibility

Remarks

1 Correspondence

Letters dispatched Emails Text messages (SMS)

Continuous UNIDO FMITI

2 Consultative stakeholders’ meeting

Meeting to be held once a month

continuous until the project is finished

UNIDO NAFDAC (secretariat)

3 Schedule of responsibility

Each working group will determine the schedule of duty for every member

Continuous UNIDO All committee

The scheduled responsibility be assigned to the working group subject to review in the course of the implementation

4 Establishment of a clerk office in all the stakeholders

Each stakeholder should establish a desk office that will serve as a contact and an internal facilitator on the project

Continuous All agencies involved

5 Publicity/sensitization

Print and electronic media: Newspaper Television Seminars and workshops

Regularly or occasionally

UNIDO The working group

The sensitization is very important and must be regular

6 Courtesy visits Chief executives to solicit their buy-in and to ensure the implementation

Date for the visit will be determined by the working group

UNIDO

75

S/N

Activities Follow-up detail action

Time line Funding

Define schedule of responsibility

Remarks

7 Monitoring and evaluation

A team will be constituted to ensure proper follow-up on the total activity

As agreed by the committee

76

77



REPORT OF THE WORKING SESSION ON THE CATEGORIZATION, HARMONIZATION AND STREAMLINING OF TECHNICAL REGULATIONS IN

NIGERIA

Venue: Channel View Hotel, Calabar

Date: 23 & 24 April, 2015


Towards the promulgation of a National Quality Policy and ensuing legislation for the

NQI, a Working Group on Technical Regulation (WGTR) was inaugurated by the Minister

FMITI, ably represented by the Permanent Secretary FMITI on the 10th of March 2015.

At a previous meeting before the inauguration, the group had identified some

milestones in order to establish the Office of the Technical Regulation and the

development of good regulatory practice. The draft copy of the MOU for the WGTR was

adopted and signed as a working document and the details for the establishment of the

office of the technical regulations were stated and adopted by members. The mandate

review could not be completed at the same time; the task was therefore rescheduled

for 23rd and 24th of April, 2015.

The expected outputs of this workshop are:

Compiled inventory of MDAs mandates and policy instruments in Nigeria that is

involved in the NQIP.

78

Identify overlaps of mandate and policy instruments of MDAs involved in NQIP

Harmonize and streamline mandates, in line with WTO SPS and TBT agreements.

This is the report of the review of the mandates which involved the categorization of the

regulatory bodies as standardization, regulatory, conformity assessment and market

surveillance based on the WTO-TBT-SPS definitions.

2.0 PREAMBLE

The work session was preceded by a paper presentation26 to elaborate on the definition

of the key terms required for better understanding of technical regulations and to

introduce the work process on the review and harmonization/streamlining of mandates.

Participants were members of the sub-group 3 of WGTR (Annex 1). The necessary

mandates and templates for the different activities were provided. The participants were

broken into four groups to categorize each institution based on the definitions of the

regulatory bodies as provided by WTO-TBT-SPS agreement and as highlighted during the

paper presentation.

3.0 CATEGORIZATION OF INSTITUTIONS

The 16 institutions were categorized as given below (Annex 2):

Standardization bodies:

NCC, NEMSA, NESREA, SON, TRADE, VPSC AND W&M

Conformity Assessment:

CPC, FISHERIES, FPIS, IPAN, MAN, MLSCN, NAFDAC, NASC, NCC, NEMSA, NEPZA.

NESREA. SON and W&M

Market Surveillance:

26 PRESENTATION: WTO FRAMEWORK AND WORK PROCESS FOR WGTR ON REVIEW OF MANDATES by ABIMBOLA UZOMAH

79

CPC, FISHERIES, FPIS, MAN, NAFDAC, NASC, NCC, NEMSA, NESREA. SON, and

W&M

Regulatory body:

CPC, FISHERIES, MLSCN, NAFDAC, NASC, NCC, NEMSA, NESREA, SON, and

W&M

3.2 OBSERVATION

All the institutions (except TRADE and VPSC) categorized as Standardization

bodies by their mandate were also involved in all the other aspects of technical

regulations. This included regulatory, market surveillance and conformity

assessment.

A significant number of those categorized as Regulatory bodies were also market

surveillance bodies. This is in line with WTO provisions. The exception here is

MLSCN, who by their Mandate were Regulatory and Conformity Assessment

bodies but not market surveillance. This suggests that, their regulatory roles are

limited as they do not have the enforcement power over the products and

services they regulate.

IPAN and NEPZA were categorized only as Conformity Assessment bodies.

FPIS and MAN do not have any Standardization or Regulatory role in their

Mandate

4.0 REVIEW OF MANDATE OVERLAPS AND OVERSIGHT

Participants reviewed the mandates of each institution for overlaps, oversights and gaps.

Recommendations for streamlining and/or harmonization were suggested.

80

4.1 MANDATE OVERLAPS

4.1.1 MARKET SURVEILLANCE

4.1.1.1 OVERLAPS BETWEEN FPIS and NASC

FPIS27

o Inspection and quality control of all agricultural produce to ensure

compliance with international, prescribed, grades and standards for

export.

NASC28

o To analyze and propose programs, policies and actions regarding seed

development and the seed industry in general, including legislation and

research on issues relating to seed testing, registration, release,

production, marketing, distribution, certification, quality control, supply

and use of seeds in Nigeria, importation and exportation of seeds and

quarantine regulations relating thereto;

RECOMMENDATIONS

i. FPIS should be the focal institution for ensuring compliance with international

standards for all agricultural produce.

ii. NASC should let go of the role of analyzing and proposing programs, policies and

actions regarding seed quality control and use of seeds in Nigeria.

4.1.1.2 OVERLAPS BETWEEN NCC and TRADE Department (FMITI)

NCC29

o The promotion of fair competition in the communication industry and

protection of communication services and facilities

o providers from misuse of market power or anti-competitive and unfair

practices by other service or facilities providers or equipment suppliers

27 FPIS Mandate section 1 28 NASC ACT, section 3a 29 NCC ACT 2003, Section 4 (1) (a)

81

TRADE DEPT (FMITI) MANDATE

o Create an enabling environment to stimulate domestic investment.

RECOMMENDATION

i. Setting standards with regard to market powers should be carried out solely by

the National Standards body (domicile in FMITI) for all forms of

investors/investments..

4.1.1.3 OVERLAPS BETWEEN SON and CPC

SON30

o The Director-General may, upon being satisfied that the quality, purity or

potency of any product (whether or not the subject of a mandatory

industrial standard) is such as to be detrimental or hazardous to life and

property, apply to the magistrate's court having jurisdiction in the area

for an order-

-to seize, destroy or prohibit any person from selling or offering

for sale such

-product; or seal up the premises where such product is

manufactured or stored; or

-direct the manufacturer to rectify the deficiency in the case of

low product

CPC31

o Seek ways and means of removing or eliminating from the market

hazardous products and causing offenders to replace such products with

safer and more appropriate alternative.

30 SON ACT. Section 17, 1 a. b &.c 31 CPC ACT, Part 1: section 2: sub-section b.

82

RECOMMENDATION

i. SON should strictly be a standardization /conformity assessment body. Their

activities should strictly be directed towards the manufacturer while the CPC

should pay more attention to the goods already in the market.

4.1.1.4 MANDATE STREAMLINE

The functions and powers of NAFDAC as stipulated in the ACT was reviewed and

recommendations as to the limitations of its functions and powers were suggested

NAFDAC (Function & Powers of the agency)32

o (c) undertake appropriate investigations into the production premises

and raw materials for food, drugs, cosmetics, medical devices, bottled

water and chemicals and establish relevant quality assurance systems,

including certification of the production sites and of the regulated

products;

o (d) undertake inspection of imported food, drugs, cosmetics, medical

devices, bottled water and chemicals and establish relevant quality

assurance systems, including certification of the production sites and of

the regulated products;

RECOMMENDATION

i. NAFDAC should confine their market surveillance operations to products specified

within their mandate with the exception of chemicals. It was recommended that

another capable institution should handle the regulations of chemicals. The reason is

to reduce the expansive activities of NAFDAC and for better efficiency.

32 Part II Paragraph:5, Sub section: C & d

83

4.1.2 REGULATORY BODY

4.1.2.1 OVERLAPS BETWEEN NASC AND NAQS

NAQS BILL33

o Enforce compliance with regulations on the importation and exportation of

fishes and fish products, animals and animal products, biological, plants

products, wild life trophies and wood products

NASC ACT34

o To analyze and propose program, policies and actions regarding seed

development and the seed industry in general, including legislation and

research on issues relating to seed testing, registration, release, production,

marketing, distribution, certification, quality control, supply and use of seeds

in Nigeria, importation and exportation of seeds and quarantine regulations

relating there to.

RECOMMENDATION

The group decided on having one national institution overseeing the activities of

plant quarantine as done internationally. The suggested institution was NAQS.

4.1.2.2 OVERLAPS BETWEEN CPC AND SON

SON35

o The Director-General (SON) may, upon being satisfied that the quality,

purity or potency of any product (whether or not the subject of a

mandatory industrial standard) is such as to be detrimental or hazardous

to life and property, apply to the magistrate's court having jurisdiction in

the area for an order-

- To seize, destroy or prohibit any person from selling or offering

for sale such product; or

33 NAQS BILL, Part 11, sub-section 1 (f) 34 NASC ACT, Section3 (a) 35SON ACT, Section 17 (1)

84

- Seal up the premises where such product is manufactured or

stored; or

- Direct the manufacturer to rectify the deficiency in the case of

low product.

CPC36

o Compel a manufacturer to certify that all safety standards are met in their

products

RECOMMENDATION

i. All safety standards are regulated by SON and should be left within their purview.

4.1.2.3 OVERLAPS BETWEEN DEPARTMENT OF FISHERIES DEPARTMENT AND NAFDAC

Both have the mandate to regulate packaged frozen fish. (Fisheries Act37)

RECOMMENDATION

No recommendation was suggested for this overlap

4.1.2.4 OVERLAPS BETWEEN NAFDAC AND CPC

Both institutions have related activities with respect to advertisement, distribution and

sale or products.

NAFDAC stipulated guidelines for advertisement of different categories of products

covered under her mandate, whereas, CPC indicated the liability of advertising

medium38.

RECOMMENDATION

i. It was recommended that both institutions should maintain the provision in their law

but where it relates to activities under NAFADC’s mandate, CPC should work in

collaboration.

36 CPC, Section 3 (b) 37 SEA FISHERIES (FISH INSPECTION AND QUALITY ASSURANCE) REGULATIONS [S .1. 22 of 1995.) Section 4 (1),(5) &(6) 38 CPC DECREE, 1992; PART II, SECTION 20

85

4.1.3 CONFORMITY ASSESSMENT

4.1.3.1 OVERLAPS BETWEEN NAFDAC, SON AND CPC

NAFDAC39

o Conduct appropriate tests and ensure compliance with standard

specifications designated and approved by the Council for the effective

control of the quality of food, drugs, cosmetics, medical devices, bottled

water and chemicals and their raw materials as well as their production

processes in factories and other establishments;

SON40

o To undertake investigations as necessary into the quality of facilities,

materials and products in Nigeria, and establish a quality assurance system

including certification of factories, products and laboratories

CPC41

o Cause as it deems necessary, quality tests to be conducted on a product

RECOMMENDATION

Laboratory Test and Quality Control to be streamlined between NAFDAC and CPC.

SON laboratory activities should be streamlined to support standardization activities.

All must use accredited laboratories.

4.1.3.2 OVERLAPS BETWEEN CPC AND FISHERIES DEPARTMENT

CPC42

o Seek ways and means of removing or eliminating from the market hazardous

products and causing offenders to replace such products with safer and more

appropriate alternatives

39 Part 11,Paragragh5,subsection b) 40 Part 5,section 1b 41 Decree 66,section 3c 42 Decree 66,Secion 2(b)

86

FISHERIES43

o e) provide for the inspection of buildings and premises used for the curing,

preservation, storage or sale of fresh, cured or preserved fish;

o f) provide for the seizure and destruction of any fresh, cured or preserved fish

that is unfit for human or animal consumption

RECOMMENDATION

i. The two institutions should work and collaborate with the Regulatory Agencies

responsible for goods and services including removal and disposal of hazardous

products in the market and at the production premises

4.1.3.3 OVERLAPS BETWEEN SON and NAFDAC

SON44,

o To undertake investigations as necessary into the quality of facilities,

materials and products in Nigeria, and establish a quality assurance

system including certification of factories, products and laboratories.

NAFDAC45

o (d) Undertake inspection of imported food, drugs, cosmetics, medical

devices, bottled water and chemicals and establish relevant quality

assurance systems, including certification of the production sites and of

the regulated products;

43 Cap S4, Section 14(2), e and f 44 SON ACT Part 5,Section 1b 45 Part 11,paragraph5,Subsection(d)

87

RECOMMENDATION

i. SON should certify factories and products only, while NAFDAC retains her regulatory

roles over food, drugs, cosmetics, medical devices and packaged water.

4.1.4 STANDARDIZATION BODY

4.1.4.1 OVERLAPS BETWEEN SON AND NCC

SON46

o (d) To compile an inventory of products requiring standardization.

o (e) To compile Nigerian standards specifications

o (f) to foster interest in the recommendation and maintenance of

acceptable standards by industry and the general public;

NCC47

o (h) the development and monitoring of performance standards and

indices relating to the quality of telephone and other communications

services and facilities supplied to consumers in Nigeria having regard to

the best international performance indicators ;

o (l) proposing, adopting, publishing and enforcing technical specifications

and standards for the importation and use of communications equipment

in Nigeria and for connecting or interconnecting communications

equipment and systems ;

o (m) the formulation and management of Nigeria’s inputs into the setting

of international technical standards for communications services and

equipment ;

RECOMMENDATION

i. NCC Acts 2003 should be reviewed to subject their developed standards to the

validation by the National standards body to avoid conflicts.

46 SON Act, Section 5, d, e, & f 47 NCC ACT 2003 Sections 4 (h); (l); (m)

88

4.1.4.1 OVERLAPS BETWEEN VPCS AND SON

VPCS48

SON49

RECOMMENDATION

i. Mandate of VPCS should be reviewed to subject the developed standards to

validation by a National Standard body.

4.1.4.2 OVERLAPS BETWEEN NEMSA AND SON

NEMSA Bill,50

o (e) to specify technical standards for electrical plants, electric lines and

connectivity to the grid;

o (f) to specify safety requirements for construction, operation and

maintenance of electrical power plants, transmission system, distribution

networks and electric lines;

SON51 Act

RECOMMENDATION

i. NEMSA’s Bill should be reviewed to subject developed standards to validation by a

National standards body to avoid conflicts

4.1.4.3 OVERLAPS BETWEEN SON AND W&M DEPARTMENT

SON Act52

Weights and Measures Act53

(1) The Minister shall maintain secondary and tertiary standards in

accordance with the provisions of this section which shall be known

collectively as "the Nigerian trade standards"

48 Mandate: Para C2 & Para D2 49 SON Act, Section 5, d, e, & f 50 Part 2. Section 6 e & f; 51 SON Act, Section 5, d, e, & f 52 SON Act, Section 5, d, e, & f 53 CAP W3 LFN 2003, Section 3 Sub section:1,2

89

(2) The secondary standards shall consist of standards of all the measures set

out in Parts I and IV and all the weights set out in Part V of the Third Schedule

to this Act (other than capacity measures of more than ten liters); and any

such standard shall be constructed and, while it remains in use, from time to

time at intervals not exceeding five years, have its value re-determined, by

reference to such one or more of the Nigerian primary standards as may

appear to the Minister to be appropriate.

RECOMMENDATION

i. W&M Act should be reviewed to subject developed standards to validation by a

National standards body

5.0 ANALYSIS OF THE EVALUATION EXERCISE OF THE WORKSHOP

The result of the evaluation of the workshop by the participants is summarised in Annex

3. The overall assessment may be regarded as excellent as most of the criteria were

highly rated 80-100% by the participants.

6.0 WAY FORWARD

The output of this working group with all the recommendations must be presented to

other members of WGTR to validate for subsequent compilation of TRs and the

establishment of the office of the technical regulations.

ANNEX 1: LIST OF PARTICIPANTS

INSTITUTION NAME

1. CPC Fatima Ojo

2. FDAP&HS/FMARD Barr. Innocent U. Okonkwo

3. FMITI Babangida Abbare Aliyu

4. FMITI Gyang Demitta

5. IPAN Adebayo Ademilola

6. MBA Mirabel Mosugu-Gabriel

7. MLSCN Lawrena Okoro

8. NAFDAC Nneka Offiah

9. NAFDAC Stella Denloye

10. NAQS Onukwuba Nnamdi

90

11. NPC Kayode Ayobola.M

12. SON Udeme Udom

13. WEIGHTS AND MEASURES, FMITI

Salim Muktar Mohammed

Cross sections of the breakout sessions

91

ANNEX 2: CATEGORIZATION OF THE INSTITUTIONS

S/No INSTITUTION STD C A

MS REG

1 CPC

2 FISHERIES

3 FPIS

4 IPAN

5 MAN

6 MLSCN

7 NAFDAC

8 NASC

9 NCC

10 NEMSA

11 NEPZA

12 NESREA

13 SON

14 TRADE

15 VPSC

16 W&M

ANNEX 3 ANALYSIS OF THE EVALUATION OF THE WORKSHOP (assessed on % scale)

PART1

Item STATEMENT Strongly disagree


Strongly agree

NA Blank


100


10 90

c. The facilitator demonstrated good knowledge of technical regulation

100


100


100


20 30 50

92

g. The provided my understanding of categorisation of standards, Regulations, Conformity Assessment, Market Surveillance bodies

20 80

h. I appreciate the knowledge acquired in understanding WTO conditions for good practice in technical regulations

10 80 10

PART 2

S/No. PARAMETER Excellent Very good

Good Fair Poor Blank

1 Visuals 20 50 10 20

2 Acoustics 30 40 10 20

3 Meeting place 30 40 10 20

4 Handouts/Memory Stick

30 20 30 20

5 Overall assessment

40 40 20

93



REPORT OF THE WORKING SESSION ON THE VALIDATION OF THE CATEGORIZATION, HARMONIZATION AND STREAMLINING OF TECHNICAL

REGULATIONS IN NIGERIA AND

THE REVIEW OF THE DRAFT POLICY ON THE OFFICE OF TECHNICAL REGULATIONS

Venue: Monty Hotel, Uyo

Date: 24th & 25th June, 2015


Towards the promulgation of a National Quality Policy and ensuing legislation for the

NQI, a Working Group on Technical Regulation (WGTR) was inaugurated by the Minister

FMITI, ably represented by the Permanent Secretary FMITI on the 10th of March 2015.

The draft copy of the Memorandum of Agreement for the members of the WGTR was

presented, adopted and signed as a working document and the details for the

establishment of the Office of the Technical Regulation OTR were presented and

adopted by members.

In line with the set milestones for the WGTR is the harmonization and streamlining of

mandates of MDAs’ with relevance to technical regulations. A sub-group of the WGTR

reviewed the mandates of the relevant institutions at the meeting of the WGTR at Uyo

on 23rd and 24th of April, 2015. The overlaps and oversights of mandates were identified

94

and recommendations were provided. The zero draft of the policy document for the

establishment of the Office of Technical Regulations was prepared and circulated

amongst the WGTR.

The expected outputs of the workshop were to:

i) Validate the reviewed mandates by all the members of WGTR

ii) Review of the Draft Policy Document on the Office of Technical

Regulations

And the expected outcome were:

i) Harmonized and review of mandates on technical regulations

available

ii) Policy Document on the Office of Technical Regulations available for

public dissemination

This is the reports of the validation exercise of the reviewed Acts/mandates on technical

regulations and the review of the draft policy document on the Office of Technical

Regulations.

2.0 PREAMBLE

A brief overview of the key terms required for better understanding of technical

regulations was presented and the reports of the sub-group that met at Uyo on 23rd and

24th of April, 2015, were provided. WGTR (ANNEXES 1&2) was broken into four working

sessions to assess the recommendations provided on the mandates review. Members

were expected to ‘Accept’ or ‘Revise’ the recommendations as provided.

95

3.0 VALIDATION OF THE REVIEWED MANDATE

3.1 MARKET SURVEILLANCE

3.1.1 OVERLAPS BETWEEN FPIS54 and NASC55

SUB-GROUP RECOMMENDATION:

iii. FPIS should be the focal institution for ensuring compliance with international

standards for all agricultural produce.

iv. NASC should let go of the role of analyzing and proposing programs, policies and

actions regarding seed quality control and use of seeds in Nigeria.

OBSERVATION AND RECOMMENDATION OF WGTR

Recommendations were rejected, the mandates of each institution was considered

appropriate and no overlap existed between them

3.1.2 OVERLAPS BETWEEN NCC56 and TRADE Department (FMITI)57

SUB-GROUP RECOMMENDATION

ii. Setting standards with regard to market powers should be carried out solely by

SON, the National Standards body for all forms of investors/investments.

FINAL DECISION OF THE WGTR

The mandate for each institution was considered appropriate and there was no overlap

between NCC and TRADE Department (FMITI)

54 FPIS Mandate section 1: Inspection and quality control of all agricultural produce to ensure compliance with international, prescribed, grades and standards for export. 55 NASC ACT, section 3a: To analyze and propose programs, policies and actions regarding seed development and the seed industry in general, including legislation and research on issues relating to seed testing, registration, release, production, marketing, distribution, certification, quality control, supply and use of seeds in Nigeria, importation and exportation of seeds and quarantine regulations relating thereto 56 NCC ACT 2003, Section 4 (1) (a): The promotion of fair competition in the communication industry and protection of communication services and facilities providers from misuse of market or anti-competitive and unfair practices by other services or facilities providers or equipment suppliers. 57 Mandate: Create an enabling environment to stimulate domestic investment.

96

3.1.3 OVERLAPS BETWEEN SON58 AND CPC59

RECOMMENDATION OF THE SUB-GROUP

SON should strictly be a standardization/conformity assessment body. Their activities

should strictly be directed towards the manufacturer while the CPC should pay more

attention to the goods already in the market.


Recommendation was upheld though WGTR did not find any overlap between the two

institutions.

3.1.4 MANDATE STREAMLINE: NAFDAC60

RECOMMENDATIONS OF THE SUB-GROUP

The functions and powers of NAFDAC as stipulated in the ACT was reviewed and

recommendations as to the limitations of its functions and powers were suggested as

given below

ii. NAFDAC should confine their market surveillance operations to products specified

within their mandate with the exception of chemicals. It was recommended that

other capable institution should handle the regulations of chemicals so as to reduce

the expansive activities of NAFDAC and for better efficiency.


Recommendation of the sub group was upheld.

58 SON ACT, Section 17, 1a, b, &c: The Director-General may, upon being satisfied that the quality, purity or potency of

any product (whether or not the subject of a mandatory industrial standard) is such as to be detrimental or hazardous to

life and property, apply to the magistrate's court having jurisdiction in the area for an order -to seize, destroy or prohibit

any person from selling or offering for sale such product; or seal up the premises where such product is manufactured or

stored; or direct the manufacturer to rectify the deficiency in the case of low product 59CPC ACT, Part1: Section 2: sub-section b: Seek ways and means of removing or eliminating from the market hazardous products and causing offenders to replace such products with safer and more appropriate alternative. 60Part II Paragraph 5, sub-section c & d: NAFDAC (Function & Powers of the agency); (c) undertake appropriate investigations into the production premises and raw materials for food, drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products; (d) undertake inspection of imported food, drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products.

97

3.2 REGULATORY BODY

3.2.1 OVERLAPS BETWEEN NASC61 AND NAQS62


RECOMMENDATION

The sub-group recognized NAQS as the national institution that should oversee all

the quarantine activities including those carried out by NASC.


Members observed that NAQS oversees the quarantine activities of importation and

exportation of plants, aquatic and animal products while NASC mandate covers the

quarantine of imported seeds for research and for multiplication. Hence, both

institutional mandates were not considered to be overlapping. The recommendation was

rejected.

3.2.2 OVERLAPS BETWEEN SON63 AND CPC64


RECOMMENDATION

i. All safety standards are regulated by SON and should be left within her purview.


No overlaps could be established between SON and CPC While SON is the only recognized

national standardization body, other standardization bodies may exist, but their activities

must be within the purview of SON. The certification activities of CPC should be

considered under Conformity Assessment and not as a Regulatory body

61 NASC ACT, Section3 (a); To analyze and propose programs, policies and actions regarding seed development and the seed industry in general, including legislation and research on issues relating to seed testing, registration, release, production, marketing, distribution, certification, quality control, supply and use of seeds in Nigeria, importation and exportation of seeds and quarantine regulations relating thereto. 62 NAQS BILL, Part 11, sub-section 1 (f) : Enforce compliance with regulations on the importation and exportation of fishes and fish products, animals and animal products, biological, plants products, wild life trophies and wood products

63 SON ACT, Section 17 (1): The Director-General (SON) may, upon being satisfied that the quality, purity or potency of any product (whether or not the subject of a mandatory industrial standard) is such as to be detrimental or hazardous to life and property, apply to the magistrate's court having jurisdiction in the area for an order to seize, destroy or prohibit any person from selling or offering for sale such product; or seal up the premises where such product is manufactured or stored; or direct the manufacturer to rectify the deficiency in the case of low product. 64 CPC, Section 3 (b): Compel a manufacturer to certify that all safety standards are met in their products

98

3.2.3 OVERLAPS BETWEEN DEPARTMENT OF DEPARTMENT OF FISHERIES65 AND NAFDAC


Both have the mandate to regulate packaged frozen fish.

No recommendation was suggested for this overlap.


Regulation of all packaged and labeled fish and fish products should be considered under

NAFDAC

3.2.4 OVERLAPS BETWEEN NAFDAC AND CPC66


NAFDAC and CPC have related activities with respect to advertisement, distribution and

sale of products that do not comply with safety and health regulations

Both institutions have related activities with respect to advertisement, distribution and

sale or products.

NAFDAC stipulated guidelines for advertisement of different categories of products

covered under her mandate, whereas, CPC indicated the liability of advertising medium.

RECOMMENDATION

It was recommended that both institutions should maintain the provision in their law but

where it relates to activities under NAFADC’s mandate, CPC should work in collaboration.


Each institution should retain the provisions on advertisements, distributions and sale in

their laws, but CPC should work in collaboration with NAFDAC where it relates to

products regulated under the mandate of NAFDAC.

65 SEA FISHERIES (FISH INSPECTION AND QUALITY ASSURANCE) REGULATIONS [S .1. 22 of 1995.) Section 4 (1),(5) &(6) 66 CPC DECREE, 1992; PART II, SECTION 20

99

3.3 CONFORMITY ASSESSMENT

3.3.1 OVERLAPS BETWEEN NAFDAC67, SON68 AND CPC69


i. Laboratory Test and Quality Control to be streamlined between NAFDAC and CPC.

SON laboratory activities should be streamlined to support standardization activities.

All must use accredited laboratories.


No overlap was found, but WGTR indicated that all laboratory test and quality control

should be carried out only in accredited laboratories.

3.3.2 OVERLAPS BETWEEN CPC70 AND FISHERIES71 DEPARTMENT

RECOMMENDATIOD OF THE SUB-GROUP

ii. The two institutions should work and collaborate with the Regulatory Agencies

responsible for goods and services including removal and disposal of hazardous

products in the market and at the production premises


There was no overlap between the two bodies. The recommendation of the sub group

was however upheld.

67 Part 11,Paragragh5,subsection b); Conduct appropriate tests and ensure compliance with standard specifications designated and approved by the Council for the effective control of the quality of food, drugs, cosmetics, medical devices, bottled water and chemicals and their raw materials as well as their production processes in factories and other establishments; 68 Part 5,section 1b: To undertake investigations as necessary into the quality of facilities, materials and products in Nigeria, and establish a quality assurance system including certification of factories, products and laboratories 69Decree 66, Section 2(b): Cause as it deems necessary, quality tests to be conducted on a product. 70 Decree 66, section 2 (b) Seek ways and means of removing or eliminating from the market hazardous products and causing offenders to replace such products with safer and more appropriate alternatives 71 Cap S4, Section 14(2), e and f: (e) provide for the inspection of buildings and premises used for the curing, preservation, storage or sale of fresh, cured or preserved fish; (f) provide for the seizure and destruction of any fresh, cured or preserved fish that is unfit for human or animal consumption

100

3.3.3 OVERLAPS BETWEEN SON72 and NAFDAC73


ii. SON should certify factories and products only, while NAFDAC retains her regulatory

roles over food, drugs, cosmetics, medical devices and packaged water.


SON should utilize the services of an independent and accredited conformity

assessment body in carrying out part 5 section 1(b) of its mandate on standardization.

While NAFDAC’S role under this mandate should be seen as a conformity assessment

body for regulatory purposes. Is was also recommended that NAFDAC should use the

services of an independent and accredited conformity assessment body in carrying out

her regulatory activities.

72 SON ACT Part 5, Section 1b: To undertake investigations as necessary into the quality of facilities, materials and products in Nigeria, and establish a quality assurance system including certification of factories, products and laboratories. 73 Part 11,paragraph5,Subsection(d): Undertake inspection of imported food, drugs, cosmetics, medical devices, bottled water and chemicals and establish relevant quality assurance systems, including certification of the production sites and of the regulated products;

101

3.4 STANDARDIZATION BODY

3.4.1 OVERLAPS BETWEEN SON74 AND NCC75; VPCS76; NEMSA77 & W&M78


ii. The Act/Mandate of each institution should be reviewed to subject their developed

standards to the validation by SON, the National standards body to avoid conflicts.


This recommendation was upheld by WGTR

5.0 VALIDATION

All the recommendations suggested were unanimously validated by all the members of

WGTR. The mandates were harmonized and streamlined in line with the WTOTBT SPS

condition

6.0 CATEGORIZATION EXERCISE

The categorization exercise was reviewed by WGTR, 5 more institutional mandates were

further reviewed and listed. A total of 21 institutions were categorized as given below:

74 SON Act, Section 5, d, e, & f : (d) To compile an inventory of products requiring standardization; (e) To compile Nigerian standards specifications: (f) to foster interest in the recommendation and maintenance of acceptable standards by industry and the general public; 75 NCC ACT 2003 Sections 4 (h); (l); (m): (h) the development and monitoring of performance standards and indices relating to the quality of telephone and other communications services and facilities supplied to consumers in Nigeria having regard to the best international performance indicators ; (l) proposing, adopting, publishing and enforcing technical specifications and standards for the importation and use of communications equipment in Nigeria and for connecting or interconnecting communications equipment and systems ; (m) the formulation and management of Nigeria’s inputs into the setting of international technical standards for communications services and equipment ; 76 Mandate: Paragraph c2 & d2: Development of standards and guidelines leading to good animal welfare practices’; Setting of Sanitary Standards; Harmonization of sanitary and SPS measures to be consistent with international Standards 77 Part 2. Section 6 e & f; (e) to specify technical standards for electrical plants, electric lines and connectivity to the grid; (f) to specify safety requirements for construction, operation and maintenance of electrical power plants, transmission system, distribution networks and electric lines; 78 CAP W3 LFN 2003, Section 3 Sub section: 1, 2: (1) The Minister shall maintain secondary and tertiary standards in accordance with the provisions of this section which shall be known collectively as "the Nigerian trade standards”. (2) The secondary standards shall consist of standards of all the measures set out in Parts I and IV and all the weights set out in Part V of the Third Schedule to this Act (other than capacity measures of more than ten liters); and any such standard shall be constructed and, while it remains in use, from time to time at intervals not exceeding five years, have its value re-determined, by reference to such one or more of the Nigerian primary standards as may appear to the Minister to be appropriate.

102

CLASSIFICATION SUB-GROUP CATEGORIZATION

WGTR CATEGORIZATION

Regulatory body

CPC, FISHERIES, MLSCN, NAFDAC, NASC, NCC, NEMSA, NESREA, SON, and W&M

CPC, MLSCN, NAFDAC, NASC, NAQS, NCC, NEMSA, NESREA, SON, and W&M

Market Surveillance body

CPC, FISHERIES, FPIS, MAN, NAFDAC, NASC, NCC, NEMSA, NESREA, SON, and W&M

CPC, FPIS, MAN, NAFDAC, NASC, NCC, NESREA, SON, NEPZA, TRADE, DVPC, DAPHS, NAQS, NEPC and W&M

Standardization body NCC, NEMSA, NESREA, SON, TRADE, VPSC, W&M

NCC, SON, TRADE, VPSC AND W&M

Conformity assessment body

CPC, FISHERIES, FPIS, IPAN, MAN, MLSCN, NAFDAC, NASC, NCC, NEMSA, NEPZA. NESREA. SON and W&M

CPC, FISHERIES, FPIS, IPAN, MAN, MLSCN, NAFDAC, NASC, NCC, NEMSA, NEPZA. NESREA. SON and W&M

The mandate review was carried out with reference to the respective categorization for

each institution.

7.0 REVIEW OF THE DRAFT POLICY

The zero draft of the policy document was presented and the under listed amendments

were suggested

i. Section 1.2 EXISTING INSTITUTIONS WITH REGULATORY MANDATE, Table 1:

The table should include the following departments

Dept. of Animal Production & Husbandry Services (DAPHS)

Dept. Veterinary and Pest Control Services (VPCS), and

Dept. of Fisheries

ii. Section 3.3.3, Sanctions

The last line that reads “Regulatory authorities are not entitled to demand or collect

the payment of fines.” was deleted.

Reason: Members insisted that demand for fines should always be part of their

mandate.

iii. Section 5.6 TECHNICAL REGULATIONS MANAGEMENT BOARD (TRMB)

The part containing the main beneficiary institutions was deleted i.e.

103

“This shall include the main beneficiary institutions such as

a. Standards Organisation of Nigeria (SON),

b. Weights and Measures Department of Federal Ministry of Industry,

c. Trade and Investment (FMITI),

d. National Agency for Food & Drug Administration and Control (NAFDAC),

e. Conformity Assessment Bodies (including private CABs),

f. Organized private sector (NACCIMA, MAN, NASME, etc.),

g. Small and Medium Enterprises Development

h. Agency of Nigeria (SMEDAN),

i. Nigerian Export Promotion Council (NEPC),

j. Consumers Protection Council (CPC) and Consumer Associations.

k. Nigerian Electricity Management Services Agency (NEMSA)”

Reason: Members commented that the list is subject to change from time to time

and the selected few may not be a good representative of the expected beneficiary

institutions, hence this list should be left open.

8.0 NATIONAL QUALITY AWARD PROGRAMME FOR NIGERIA (NQAPN)

The National program for quality award was introduced, this will involve an integrated

approach of nine core elements, namely: leadership, strategic quality planning, human

resource management, processes management, resource management, customer and

market focus, quality and business performance and impact on society. Through the

implementation of these nine components, any company can achieve extraordinary

excellence in the overall business performance. This called for the creation of National

Working Group for NATIONAL QUALITY AWARD PROGRAMME FOR NIGERIA (NQAPN)

which will be seated under the Office of Technical Regulations. Five members of the

WGTR were nominated and an open ballot system was conducted. Three of the

nominees, Lawrena Okoro (MLSCN), Mohammed Muktar Salim (Weights and Measure)

and Ambrose Oruche (MAN) with the highest scores were elected to be members of the

National Working Group for National Quality Award.

104

9.0 CONCLUSION

The mandate review showed that the overlaps and gaps that existed between the

different institutions may be largely due to improper categorization of the different

regulatory institutions and lack of adequate understanding/interpretation of the

mandates by personnel charged with the responsibilities of implementation of the

mandate. The WGTR, guided by the WTO-TBT-SPS conditions and within the scope

provided, was able to harmonize and streamline the different mandates on technical

regulations as presented in this document. The information generated from this report

will be compiled to develop the database on technical regulations.

ANNEX 1 LIST OF THE MEMBERS OF WGTR

S/NO NAME INSTITUTION

1 Usman Abdulahi FMITI

2 Ademilola Adebayo IPAN

3 Benegna Agim NAFDAC

4 Chinyere Akujobi DVPCS

5 Aliyu Tukur EMSL

6 Ambrose Oruche MAN

7 Abbare Aliyu Babangida FMITI

9 I. S. Dafang FPIS

10 Fatima Ojo CPC

11 Innocent U. Okonkwo FDAP&HS, FMARD

12 Jerry Bakut NEPZA

13 Lawrena Okoro MLSCN

14 Nneka Offiah NAFDAC

15 Olusegun Adesayo EMSL

16 Nnamdi Onukwuba NAQS

17 Salim Muktar Mohammed WEIGHTS AND MEASURES, FMITI

18 Udeme Udom SON

105

ANNEX 1 CROSS SECTION OF THE MEMBERS OF THE WGTR DURING THE WORKING SESSION

106

PRESENTATION MADE DURINGWG-TR MEETINGS & WORKSHOPS

SECTION 2

CONSULTATIVE MEETING OF THE TECHNICAL REGULATIONS WORKING GROUP

INSTITUTIONAL ASSESSMENT OF TECHNICAL REGULATORS AND MARKET SURVEILLANCE

WTO AGREEMENT ON TBT AND SPS AS INSTRUMENT OF BETTER REGULATORY FRAMEWORK: MYCOTOXINS CONTROL

February 2015

February 2015

February 2015

CLASSIFCATION OF REGULATORY BODIES WITHIN WTO TBT - SPS CONDITIONSMarch 2015

GUIDE TO THE CLASSIFICATION OF REGULATORY AGENCIES April 2015

CONSULTATIVE MEETING OF THE TECHNICAL REGULATIONS WORKING GROUP

Reiz Hotel, Abuja10 & 11 February 2015

1

NIGERIA QUALITY INFRASTRUCTURE PROJECT

Presentation outline:

2

Brief Introduction: NQI Project components

Presentation on:

WTO Agreements - “TBT and SPS”

Work plan - “Technical Regulations”

Issues - “Better Regulations”

Proposal: “Road map to OTR”

Question & Answers

Brief Introduction of Project Area:

NATIONAL QUALITY INFRASTRUCTURE PROJECT FOR NIGERIAThis NQI project contributes to the overall Federal Government of Nigeria’s developmental programme with the €12 million funding from the EU towards supporting the development of the missing standards and quality control bodies within the framework of the NQI. The aim is to improve the quality of products and services exchanged in the Nigerian market and abroad.The project has five (5) outcomes as follows:

3

Brief Introduction of Project Area (cont’d):

1. A National Quality Policy (NQP) is promulgated and ensuing legislation for the National Quality Infrastructure (NQI) is improved.

2. A National Accreditation Body (NAB) is established in coherence with the West African accreditation system and is internationally recognized.

3. A National Metrology Institute (NMI) is developed to ensure calibration of instruments and traceability of measurement to international standards

4. Improved capacity of the Organised Private Sector (OPS) to create and/or support Conformity Assessment Bodies (CABs).

5. Improved capacity of Consumer Protection Council (CPC) and other consumer associations to raise awareness and promote quality for better consumer protection.

4

The road to a National Quality Policy for Nigeria:

Projects / Activities What has been Done What we will do QuarterTime line

Roadmap for better Technical regulations

Key Regulators trained on risk management and good regulations

Establish TR Working Group Q1

Draft roadmap for Office of Technical Regulations

Q2-Q3

Roadmap for SPS is designed Food safety policy published and widely distributed

Identify key high risk foods Q1

IMFSC and FSMC inaugurated Train food handlers on GAP, HACCP, Food safety management

Q2-Q3

Prepare Green Paper (National Quality Policy)

Quality policy has been drafted Finalise draft for NSC validation Q1

Quality policy has been peer reviewed Present Draft Green paper to HM FMITI and FEC for endorsement

Q1, Q2

Public consultation have been done in 6 geopolitical zones

Publish National Quality Policy Q2

Improve institutional capacity Engage national coordinator on capacity building Q2

Develop SON management plans and train staff on standardisation

Q2-Q4

5

Quality Infrastructure:

Metrology

Standardization Accreditation

BIPM OIML

ISO IAF ILACITU-TIEC

Science

And

Technology Society

ConformityAssessment

Trade

Supporting Sustainable Development

The World Trade Organization (WTO):

Agreement on the application of Sanitary and Phytosanitary Measures

Sps Agreement

Agreement on

Technical Barriers to Trade

TBT Agreement

WTOSlide 8

“Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.”

TBT Agreement, Annex 1, para 1

Technical Regulation:

WTOSlide 9

“Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines, or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking, or labeling requirements as they apply to a product, process, or production method.”

TBT Agreement, Annex 1, para 1

Standards:

WTOSlide 11

Article 2.4 of the TBT Agreement

WTOSlide 12

“2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations ....”

Article 2.4

WTOSlide 13


Article 2.4

WTOSlide 14

“2.4 ... except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.”

Article 2.4

World-Wide Conformity Assessment:

So far identified how:

• International standards will improve trade when used as a means of compliance

• TBT has preference for international standards as implementation tool for technical regulation

• Regulators should be involved in developing international standards

Now consider also that:

• TBT makes reference to mutual recognition of conformity assessments

• Some factors to consider:• Risk• Cost/benefit• Effects on trade• The future

Conclusion: Technical Barriers to Trade related to Tests, Certificates and similar

requirements can be addressed through the use of international standards on Conformity Assessment.

To facilitate this International Regulatory requirements should:• be performance based• allow for acceptance of Conformity Assessment based on mutual

recognition• Use, reference and promote the international standards and guides on

Conformity Assessment.

Relying on international standards on Conformity Assessment to demonstrate compliance with technical regulation, reconciles public objectives such as safety and security with compliance to the commitments in the WTO TBT(/SPS) Agreement.

Conformity Assessment & the WTO TBT Agreement:“Recognizing the important contribution that international standards and conformity assessment systems can make in this regard by improving efficiency of production and facilitating the conduct of international trade;”

Desiring therefore to encourage the development of such international standards and conformity assessment systems; …


... except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.”

“2.6 With a view to harmonizing technical regulations on as wide a basis as possible, Members shall play a fullpart, within the limits of their resources, in the preparation by appropriate international standardizing bodies of international standards for products for which they either have adopted, or expect to adopt, technical regulations.”

WTO TBT/SPS Agreements:

WTO/SPSsanitary & phytosanitary

measures

WTO/TBTtechnical

regulations & standards

• Reference point to solve disputes in international trade (safety/non-safety matters)

• Reference point to harmonize national

• sanitary & phytosanitary measures • standards & regulations

NationalSanitary & Phytosanitary measures

Technical regulations

WTO SPS Agreement:Sanitary & Phytosanitary Measures –protect human life and health (...) resulting from

• Additives• Contaminants• Veterinary drugs• Pesticides• Pathogen microorganisms + toxins

Harmonized sanitary & phytosanitary measures based on international standards

WTO/TBT Agreement:Cover all aspects of consumer protection not contemplated under the WTO/SPS Agreement• Standards• Technical Regulations• Conformity Assessment Procedures

(Quality Assurance Systems)• Provisions for

• Packaging, • Marking, • Labelling, etc.

Harmonized technical regulations based on international standards

• Protecting consumers health –WTO/SPS - TBT

• Ensuring fair trade practices –WTO/SPS - TBT

• NQI Project coordinating work with regulatory and other MDA stakeholders towards better trade environment

Facilitating international trade

Du

al Ob

jective

WTO SPS Agreement:

• Article 4 – Equivalence

• Equivalence Members shall accept the sanitary or phytosanitary measures of other Members as equivalent even if these measure differ from their own or from those use by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitaryprotection. For this purpose, reasonable access shal be given, upon request, to the importing Member for inspection, testing and other relevant procedures

Article 5 –Assessment of Risk and Determination of the Appropiate Level of

Sanitary or Phytosanitary Protection• 2 In the assessment of risks, Members shall take into account available

scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; [...]

Article 8 –Control, Inspection and Approval Procedures

• Annex C Control, Inspection and Approval Procedures: include inter aliasampling, testing and certification

Annex A – Definitions: • SPS measures include all relevant laws, decrees, regulations, requirements &

procedures including inter alia end product criteria; processes and production methods; testing, inspection, certification and approval processes; [...] provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements related to food safety

What is Conformity Assessment?

WTO:“Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled.”

[TBT Agreement, Annex 1, paragraph 3]

International Standards and Conformity Assessment:

• World Trade Organization and international acceptance of tests and certificates

• Reconciling facilitation of trade and progress in quality, security, health, consumer and environmental protection

• International recognition and acceptance to be based on confidence and good practices

• The way forward: promoting good practices by implementing the International Standards and Guides, based on a double level of consensus, amongst countries and across stakeholders

Risk-based conformance assessment:• Need for transparency & harmonization with

international science-based standard

• Need to ensure consistency between import and domestic requirements

• Consideration of the exporting country’s inspection controls in determining the level of inspection needed at import

• Need for expeditious processing of commodities at import

• Importance of coordination among border control agencies to share information and reduce delays

• Importance of science-based decision-making to:

• identify risk and appropriate inspection

• establish sampling frequencies based on the risk inherent to the product

Basic conformity assessment process

Object Test Attestation

Self-declaration(1st Party)

Contract(2nd Party)

Certification(3rd. Party)Requirements

(Regulations and/orVoluntary International Standards)

Accreditation

Peer assessment

Ex: REGULATORY or MARKET REQUIREMENTS for Products

Enabling Regulators to

meet the

WTO T B T

de facto

and

de jure requirements for

conformity assessment

+

Conformity assessment - The 1-1-1 Dream:

1 Test

1 CONFORMITY ASSESSMENT

1Standard

Acceptedeverywhere

WTO Slide 30

The Agreement on Technical Barriers to Trade

(The TBT Agreement)

Main functions & characteristics of bodies:Standards bodies:• Public or private sector, domestic or

international• Propose, develop, establish, monitor,

and/or coordinate voluntary standards

Regulatory bodies:• Set up by Act of Parliament• Control specified sector• May impose legal sanctions

Conformity assessment bodies:• Public or private sector, domestic or

international• Assess products, processes or personnel• Issue certificates of conformance• Participation is voluntary

Market surveillance bodies:• Set up by Act of Parliament or

Memorandum of Association• Monitor market performance• Flag irregularities

WTO classification of bodies:Standardisation bodies:• Public or private sector, or

domestic/national• Propose, develop, establish, monitor,

and/or coordinate voluntary standards based on international standards

Regulatory bodies:• Set up by central or local governments• Administers regulatory processes and

procedures• May impose legal sanctions

Conformity assessment bodies:• Public or private sector, domestic or

international• Assess products, processes or personnel• Issues certificates of conformance• Participation is voluntary

Market surveillance bodies:• Act of Parliament or Memorandum of

Association• Monitors market performance• Flags irregularities

The Nigerian National Quality Policy (under preparation):

Proposed Way Forward for the Better TR:

Foreseen milestones towards the OTR Review of MDA’s inventory & mandates as recommended in Orosanye’s Report Overlaps identified (and recommendation for streamlining) Stakeholders notified MOU drafted and signed by all stakeholders Green Paper prepared FEC approval received Confirmed status by Ministry of Justice National Assembly approves the OTR

36

… for your attention!

1

INSTITUTIONAL ASSESSMENT OF TECHNICAL REGULATORS AND

MARKET SURVEILLANCE AUTHORITIES

ByABIMBOLA UZOMAH

NATIONAL EXPERT ON TECHNICAL REGULATIONSUNIDO

Reiz Hotel, Abuja10 February 2015

2

INTRODUCTION

BACKGROUND: Ensuring that goods from, imported and traded in Nigeria are designed, produced, packaged, labelled and supplied in accordance with international best practices

INSTITUTIONS ASSESSED FINDINGS

3

FINDINGS

GOVERNMENT AGENCIES (MDAs)• Ill-defined mandate or overlaps of mandate• Occasional conflicts between individual regulators• Weak co-ordination and communication among

Nigerians food regulators • Ceaseless battle against manufacturer who majored in

the production of poor quality product

4

FINDINGS cont’d

OPERATORS OF BUSINESS PREMISES Over-regulation Poor conformance to regulation Corruption Smuggling of fake and sub-standard products through

the loose borders and ports

5

PROBLEMS

SOURCES OF THE PROBLEMS• Subsistence economies and little domestic

manufacturing capacity for finished products; Highly dependent on the quality of imported

products, which is often outside our control; Lack of consumer infrastructure;

6

PROBLEMS cont’d

Under-developed quality assurance, accreditation and legal metrology infrastructure — even basic legal metrology “weights and measures” may not exist;

Lack of implementation systems developed to a level that would facilitate an efficient regime of technical regulation;

7

WHERE DO WE GO FROM HERE?

Set up a National regulatory system that is effective, consistent, sensible, and understandable.

National regulation that can have a positive impact in protecting the environment and the health and safety of all citizens;

Controlled cost of compliance with the regulation

8

Definitions in the WTO Agreement on Technical Barriers to TradeTechnical regulation • Document which lays down product characteristics or their

related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking, or labeling requirements as they apply to a product, process, or production method.

Standard • Document approved by a recognized body, that provides, for

common and repeated use, rules, guidelines, or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking, or labeling requirements as they apply to a product, process, or production method.

9

Definitions in the WTO Agreement on Technical Barriers to Trade Cont’d

Conformity assessment procedures • Any procedure used, directly or indirectly, to determine that

relevant requirements in technical regulations or standards are fulfilled.

• Conformity assessment procedures include, inter alia, procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; registration, accreditation, and approval as well as their combinations

Or • Any procedure used, directly or indirectly, to determine that

relevant requirements in technical regulations or standards are fulfilled.”

Conformity assessment enables buyers, sellers, consumers, and regulators to have confidence that products sourced in d ti d f i k t t ifi i t

10

Definitions in the WTO Agreement on Technical Barriers to Trade Cont’d

Market surveillance Market surveillance is a key component of the

safety and quality infrastructure of a country. This may be accomplished through pre-market assessment and approval systems, or post-market surveillance programs.

11

Market surveillance

Procedure for the market surveillance may include• Inspection and testing of products on the market,• Inspection of the requested marking on products and/or

accompanying documents,• Validation of conformity assessment procedures followed

by the supplier,• Verification of quality systems of the supplier’s

manufacturing processes,• Examination of the supplier’s electronic and paper records,• Mandatory reporting of adverse incidents to the

regulators, and• Corrective actions for non-conforming products.

12

The SPS and TBT Agreements

SPS is defined as any measure applied to: • Protect animal or plant life or health within the territory of the

Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease causing organisms;

• Protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs;

• Protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests;

• Prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests.

13

TBT Agreement

This agreement deals with all technical requirements, voluntary standards and conformity assessment procedures, except when these measures are covered by the SPS Agreement

14

Differences between SPS and TBT Measures

Human life risks from:

additives • contaminants • toxins • plant-, product- or animal-carried disease • disease-causing organisms • pests entering, establishing or spreading

YES ➜SPS

Animal life SPS risks from:

• additives • contaminants • toxins • diseases • plant-, product- or animal-carried disease • disease-causing organisms • pests entering, establishing or spreading

YES ➜SPS

15

SOURCE

Plant life risks from: pests entering, establishing or spreading • diseases • disease-causing organisms

YES ➜ SPS

A country risks from: pests entering, establishing or spreading

YES ➜ SPS

16

NO

Is it a technical regulation, a standard or a procedure for assessing whether a product conforms to a technical requirement?

YES ➜ TBT

NO OTHER

Tool-box of instruments for regulatoryco-operation/elimination of TBTs transparent, predictable and non-discriminatory

17

Nature of action

Different degrees of regulatory co-operation

Example ofagreement

Trans-national arrangements (“Regulatory co-operation”)

6. Recognition of -fully harmonized technical regulation

EU – harmonisedarea


5. Recognition of- product specifications (essential requirementsand standards linked to those requirements)- marking specifications, marks etc.

MACAAPECAUNECE“InternationalModel”RA


4. Recognition of results of conformity assessmentprocedures- certificates of conformity- inspections- test results

MRA

18

Nature of action Different degrees of regulatory co-operation

Example ofagreement


3. Recognition of- common procedures (testing procedures, testreport forms)- accreditation systems

MLA

National practices(“good regulatorypractice”)

2. Observance of principal trade policy provisions- non-discrimination, proportionality, performancebased regulations, use of internationalstandards etc.

TBT agreement

National practices(“good regulatory

ti ”)

1. Information exchange procedures/transparencymeasures

TBT AgreementDirective98/34/EC

19

WHERE DO WE STAND?

WHERE DO WE GO FROM HERE?

SELF APPRAISAL

20

LIST OF SOME ACRONYMS

MRA; Mutual Recognition Agreements ACAA; Agreements on Conformity Assessment and

Acceptance of Industrial Products PECA; Protocol to the European Agreements on

Conformity Assessment and Acceptance of Industrial Products

MLA; Multilateral Recognition agreements between Accreditors

21

2222

1

WTO AGREEMENTS ON TBT AND SPS AS INSTRUMENTS OF BETTER

REGULATORY FRAMEWORK:MYCOTOXINS CONTROL

ByABIMBOLA UZOMAH

NATIONAL EXPERT ON TECHNICAL REGULATIONSUNIDO

Reiz Hotel, Abuja11 February 2015

MYCOTOXINS IN FOODS

Mycotoxins are toxic chemical compounds produced by molds, which can have important consequences in human and animal health

The most important mycotoxin types are i). Aflatoxins B1, B2, G1, and G2; ii). fumonisin B1;T-2 toxin;iii). zearalenone; ochratoxin A; and iv). deoxynivalenol.

MYCOTOXIN IN FOODS

The Food and Agriculture Organization of the United Nations (FAO) has estimated aworldwide loss of about one billion metric tons of foodstuff per year as a result of mycotoxins

MYCOTOXINS Mycotoxins, also regarded as extrolites (secondary

metabolites of fungal origin) are odourless, tasteless and colourless (to the naked eye).

These toxins inflict loss to farmers and render quality of international trade discounted.

In the USA, the economic cost due to 3 mycotoxins (aflatoxins, fumonisins and deoxynivalenol) is estimated to be about USD 900million

International Agency for Research on Cancer, an arm of theWHO, reported that in 2008 liver cancer in sub-Saharan Africa accounted for 43,345 deaths, which is about 10.3% of the total mortality attributable to cancer, some of which may be attributable to aflatoxin consumption.

The IARC had earlier in 1988 placed aflatoxin B1 on the list of human carcinogens.

MYCOTOXINS

Endemic in Africa Of all known extrolites, aflatoxins are very prevalent in

Africa with others like ochratoxin, patulin, fumonisin and zearalenone occurring at varying levels and different regions.

Aflatoxicosis have been reported to affect humans and dogs

During the period January to June 2004, an aflatoxin outbreak in Eastern Kenya resulted in 317 and 125 deaths.

Levels of up to 1020 ppb of aflatoxin were reported on Malawian grains.

Aflatoxins and fumonisin are prevalent on crops in Sierra Leone and Ghana

MYCOTOXINS

Villages in Burkina Faso experienced fumonisincontamination on maize with levels as high as 29,000ppb.

Ghana, Nigeria, Senegal, Togo and Burkina Faso all have a record of contamination due to aflatoxin on sorghum, maize, cotton seeds, ground nut and its products, shelled melon, yam and cassava chips all at varying levels, most time exceeding the EU and FDA standards.

In 1988, some primary school pupils died and this was traced to their consumption of aflatoxin–contaminated ground nut cake called 'kulikuli' in south western Nigeria

INTERNATIONAL COMMERCIAL SCENE

Some countries have established rigid standards for mycotoxins in food and feed that have negatively affected the exports of developing countries.

Very strict standards have been set by some Asian and EU countires (measures stricter than that of CODEX, allowed by SPS)

Country Foodstuffs Total aflatoxins

(µg/kg) Australia / New Zealand

Peanuts

Tree nuts15

Canada Nut and nut products 15

GCC

Nigeria

Peanuts, almonds, shelled Brazil nuts, hazelnuts pistachios intended for further processing

15

Almonds, hazelnuts, pistachios, shelled Brazil nuts, “ready-to-eat”

10

(GCC) Gulf Cooperation Council: Saudi Arabia, United Arab Emirates (UAE), Kuwait, Bahrain, Oman, Yemen and Qatar

India Wheat, maize, jawar (sorghum) and bajra, rice, whole and split pulse (dal) masur(lentil), whole and split pulse urd (mungbean), whole and split pulse moong(green gram), whole and split pulse chana(gram), split pulse arhar (red gram), and other food grains

30

Groundnut kernels (shelled) (peanuts); 30

USA Brazil nuts, peanuts and peanut products, pistachio products 20

South Africa Peanuts 15

BARRIERS FOR EXPORTING COUNTRIES

EU regulation of aflatoxin costs African countries US$670 million each year in export losses (World Bank)

In Brazil, • A maximum of 20 micro-grams of total aflatoxin (B1 + B2 +

G1 + G2) per kilogram of peanuts, peanut butter, maize grain, or maize flour destined for human consumption. 50 microgram for animal feed.

• EU is 15mcg, CODEX is 10mcg (for peanuts subject to further processing)

EFFORTS TO REDUCE THE LEVEL: Initiative by the Public sector New program were introduced by 2001

• activities of monitoring, • control, • inspection, and • tracking of contaminants, including mycotoxins.

Efforts to be implemented throughout the production chain, promoting GMP and HACCP principles in order to certify conformity with national standards for mycotoxins

EFFORTS TO REDUCE THE LEVEL: Initiative by the Public sector In January 2002, Laboratory certification procedures were modified A laboratory authorized assigned by the Ministry must test

for the presence of mycotoxins in food such as peanuts, peanut products, and Brazil nuts, if an importing country requires such tests.

In addition, all batches of peanuts and peanut products, maize and maize products, dried fruits, and popcorn can only be imported after a test for mycotoxins has been conducted.

Importing or exporting companies have to bear the costs for these test

EFFORTS TO REDUCE THE LEVEL: Initiative by the Private sectorDuring the 1960s - 1970s, Peanut production in Brazil was up to 1 million tons annually. It exported in unshelled and shelled form, as pressed meal, and as oil. With aflatoxin problem exports and total peanut production fellBy 2003 Peanut production rose to the neighborhood of 197,000 tons per

year, (India was 4 million tons),China (1.9 million), and United States (1.7 million).

AFLATOXIN:Major concern

The occurrence of aflatoxins Reduced exports of peanuts themselves, raised concerns among Brazilian consumers and businesspeople about their candy industry (sweet and

savory candy).

In 2001, the Brazilian Association of Cacao, Chocolates, Candies and Byproducts Industry (ABICAB) created the “pro-peanut” program, with

the objective of offering safe peanut products to consumers.

ACTIONS TAKEN

Serious market surveillance control of products on the market is carried out in a systematic and

methodical way. Product samples are collected and tested for aflatoxin. The producers whose product does not meet with Brazillian standard may

be notified directly or even denounced to the Ministry of Health.Safe products receive the “ABICAB Peanut Quality” seal.

The ABICAB also disseminates positive information about the product and stimulates the development of new technologies throughout the peanutproduction chain.

Peanut candy found on the Brazilian market bearing the ABICAB seal, thus fulfilling a consumer demand.

ABICAB hopes first to help the national market recover and then to expand exports of peanut products

ACTIONS TAKEN

In 2001/02 Brazil produced 35.3 million tons of maize. The maize used for animal feed is about 65 percent of

national production.

The maize-based animal feed companies, (operating mostly in the domestic market), • carried out mycotoxins analyses, at least for aflatoxin, (which is

subject to government regulation). • They also control levels of unregulated mycotoxins, such as

zearalenone, ochratoxin,T-2, vomitons

ACTIONS TAKEN

• and fumonisins.• They did so because they raised livestock, and mycotoxins

can reduce the efficiency of livestock production.• These companies also invested in broad contaminant controls

to increase their competitiveness and fulfill client demands.

The costs of mycotoxins analyses are very high, with capital investment of about US$55,900, and between US$0.02 and 0.06 per ton of feed per month

POINTS TO NOTE

Both the public and private sectors in Brazil are made concerted effort to control mycotoxins in foods consumed by• both humans and animals

The initiatives were driven by• the international food market and • the domestic food and feed market.

The public and private actors realize that problems arising from mycotoxincontamination can affect the market for an entire production sector and not simply the market for isolated companies that fail to implement adequate food safety controls.

Therefore, incentives exist for industry wide improvement. The public sector has played a significant role in defining standards by

regulating the maximum permitted limits for all mycotoxins that represent a danger to consumer health—an important step in guaranteeing food safety

Control of mycotoxin is from the farm, and through the production chain. It was important for thr government to partner with the private sector, in order to maintain and expand its implementation programs, which include the principles of Good Manufacturing Practices and HACCP.

CLASSIFICATION OF REGULATORY BODIES WITHIN WTO TBT & SPS CONDITIONS)

ABIMBOLA UZOMAH

UNIDO TR EXPERT

Venue: Ogun/Nassarawa Hall, Transcorp Hilton Hotel, Abuja

Date: 10 & 11 March 2015

Time: 09h00 2

CONTENT)

•REGULATORY

•STANDARDIZATION

•MARKET SURVEILLANCE

•CONFORMITY ASSESSMENT

•WTO CONDITIONS•Time: 09h00 3

REGULATORY BODY

Regulatory authorities are commonly set up to enforce standards and safety

Regulatory bodies:

Set up by Act of Parliament

Control specified sector

May impose legal sanctions

TECHNICAL STANDARD

Standards bodies:

Public or private sector, domestic or international

Propose, develop, establish, monitor, and/or coordinate voluntary standards

Document describes

Product characteristics or their related processes

Production methods, including the applicable administrative provisions (SPECIFICATIONS)

Compliance is mandatory.

May include or deal exclusively with terminology such as;• symbols,• packaging, • marking or labeling requirements.

STANDARD

Document describes

Product characteristics or their related processes

Production methods, including the applicable administrative provisions (SPECIFICATIONS)

May include or deal exclusively with terminology such as;

• symbols,

• packaging,

• marking or labeling requirements.

STANDARD

ISO (International Organization for Standardization) is an independent, non‐governmental membership organization

They give world‐class specifications for products, services and systems, to ensure quality, safety and efficiency.

They are instrumental in facilitating international trade.

STANDARD

The standardization body ensure that products and services are safe, reliable and of good quality.

Standards are used as are strategic tools that reduce costs by minimizing waste and errors and increasing productivity.

Standards help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.

Market surveillance bodies

Set up by Act of Parliament or Memorandum of Association

Monitor market performance

Flag irregularities


For the determination of the relevance of technical regulations or standardsConformity assessment are procedures used directly or indirectly to determine that relevant requirements in technical regulations or standards are fulfilled. This may include procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; registration, accreditation and approval as well as their combinations.

Conformity assessment

Conformity assessment (CA) involves a set of processes that show that a product, service or system meets the requirements of a standard.

Main focus of CA are

• Certification• Testing• inspection

Certification is the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. Certification is also known as third party conformity assessment. A demonstration of an effective management system in an industry

CERTIFICATION

CERTIFICATION CONTD’

Certification can be a useful tool to add credibility, by demonstrating that product or service meets the expectations of the customers.

For some industries, certification is a legal or contractual requirement.

Certification...

Standardization body does not perform certification.

Develops Standards, such as the ISO standards, but are not involved in their certification, and do not issue certificates.

Certification is performed by external certification bodies, thus a company or organization cannot be certified by ISO.

TESTING

Testing is the determination of one or more of an object or product’s characteristics and is usually performed by a laboratory.

The required tests are measured against a set of standards

Carried out by accredited laboratory to ensure uniformity in terms of result

There are standard laboratories can follow to help ensure that their results can be trusted.

INSPECTION

Inspection describes the regular checking of a product to make sure it meets specified criteria.

There are developed standards that inspection bodies can follow to help ensure that their work can be trusted.

WTO CONDITIONS

A STANDARDIZATION BODY CANNOT BE A REGULATOR OR MARKET SURVEILLANCE

A STANDARDIZATION BODY CAN BE CLASSIFIED AS A CONFORMITY ASSESSMENT BODY PROVIDED IT IS UNDER A SEPARATE MANAGEMENT

WTO CONDITIONS

A REGULATOR CAN ALSO BE CLASSIFIED AS A MARKET SURVEILLANCE ONLY

A CONFORMITY ASSESSMENT BODY MAY BE CLASSIFIED AS A MARKET SURVEILLANCE

MARKET SURVEILLANCE CAN ALSO BE A CONFORMITY ASSESSMENT BODY

ILLUSTRATIONS

KEY TO CIRCLES

A = STANDARDIZATIONB = REGULATORC = MARKET SURVEILLANCED = CONFORMITY ASSESSMENT BODY

S R

MC

S R

M C

C

S

R

M

INDS= 13.5 %R= 34 %M= 25.5 %C= 27 %

S

R

M

C

C

S

R

M

3rd PartyS= 4.7 %R= 32.7 %M= 31.3 %C= 31.3 %

M

R

C

S

OBSERVATIONS

There were obvious overlaps of mandates and this contradicts the WTO for trade promotion;

Uncoordinated activities of the different regulators, resulting in avoidable duplications of activities and a waste of man‐hour;

There were multiple certification bodies on the same or similar standards;

Most of the products do not meeting the exportable standards;

Effective monitoring and implementation cannot be readily validated because of the obvious gap between the ‘law’ and the ‘practice’

Lack of effective contributory roles of the private sector and the consumers in the regulatory structure;

There is need for the reformation and strengthening of the regulatory structure to ensure the quality of the services and goods provided;

CONCLUSION

Restructuring of the institutional regulatory framework

Review the act establishing each institution in conformity with the WTO guidelines to eliminate overlaps, gaps and reflect good regulatory practice.

The review of the technical regulations should be tailored towards the elimination of technical barriers to trade (WTO TBT Agreement) and the elimination of different qualities of products for local and international markets.

25

GUIDE TO THE CLASSIFICATION OF REGULATORY AGENCIES

ABIMBOLA UZOMAHLEAD EXPERT ON TECHNICAL REGULATIONS, UNIDO

Monty Suites, No 37 Edet Akpan Avenue, UyoDate: 24th & 25th June 2015

51

INTRODUCTIONWTO FRAMEWORK ON TECHNICAL REGULATIONSREVIEW OF MANDATE

CONTENT

BRIEF INTRODUCTION OF THE PROJECT

• 1. A National Quality Policy (NQP) is promulgated and ensuing legislation for the National Quality Infrastructure (NQI) is improved.

• 2. A National Accreditation Body (NAB) is established in coherence with the West African accreditation system and is internationally recognized.

• 3. A National Metrology Institute (NMI) is developed to ensure calibration of instruments and traceability of measurement to international standards

• 4. Improved capacity of the Organised Private Sector (OPS) to create and/or support Conformity Assessment Bodies (CABs).

• 5. Improved capacity of Consumer Protection Council (CPC) and other consumer associations to raise awareness and promote quality for better consumer protection.

3

WTO CONDITIONS

• STANDARDIZATION BODY

• There may be many standardization bodies in a country

• National Standards body: – Is recognized by the government ,

– The national member of one or more of the international apex bodies (WTO), and of the corresponding regional organizations,

– IT’S NORMALLY THE WTO ENQUIRY POINT.

4

• REGULATORY AUTHORITIES

• Set up to enforce standards and safety

• Regulatory bodies:

• Set up by Act of Parliament

• Control specified sector

• May impose legal sanctions

5

This is government body that is empowered to implement laws covering the approval of products and services for reasons of;

• Protection of human safety or health

• Protection of animal and plant life or health

• Protection of the environment

• Prevention of deceptive practices

• National security requirements

6

FIVE ELEMENTS OF A GENERIC TECHNICAL REGULATORY SYSTEMS

• A regulator, in the form of a public body identified to administer technical regulations

• A suite of technical regulations, that normally include both administrative and technical provisions

• A supplier of the product (designer, manufacturer, importer, distributor, retailer) which is responsible for marketing safe products and monitoring their products in the marketplace

•

7


• Government recognized (accredited) body with the competence in carrying out the following activities:

• Sampling and testing;

• Assessment;

• Inspection;

• Auditing;

• Certification;


• Government recognized (accredited) body with the competence in carrying out the following activities:

• sampling and testing; Assessment; inspection; auditing;

certification (accredit) and

• quality management system assessment (including HACCP and food safety management, occupational safety etc).

MAJOR RESPONSIBILITY IS TO CONFIRM THAT PRODUCTS

FULFILL THE REQUIREMENTS LAID DOWN IN REGULATIONS AND STANDARDS (specific characteristics of a product, such as its size, shape, design, functions and performance, or the way it is labeled or packaged before it is put on sale)

9

CONFORMITY ASSESSMENT BODY contd’

• A conformity assessment infrastructure enables the regulator to make decisions

about compliance or noncompliance,

• here is a range of sanctions that can be applied by the regulator in the event of proven noncompliance

10

MARKET SURVEILLANCEMARKET SURVEILLANCE

Includes both pre‐market and post‐market surveillance activities. Has the duty to monitor (surveillance) products

• coming into the market to ensure that they conform to relevant technical regulations and

• Must be competent

The empowering legislation for the market surveillance authority(ies)

• must be in place and operate under updated/complete legislation

• be formally identified,• notified to the public in legislation, and • be granted the necessary powers to perform their functions,

11

MARKET SURVEILLANCE FUNCTIONS INCLUDE

• powers to enter premises or conduct searches at borders (whether on an ad hoc or regular basis),

• take samples, demand product safety files or other information, recall or confiscate and where necessary, dispose of nonconforming goods, order a halt to production, delay or prevent market entry or, in extreme cases, even close down premises

12

WTO GUIDELINES (CONDITIONS)

• A STANDARDIZATION BODY CANNOT UNDERTAKE REGULATORY OR MARKET SURVEILLANCE FUNCTIONS

• A STANDARDIZATION BODY MAY UNDERTAKE CONFORMITY ASSESSMENT FUNCTIONS PROVIDED THE FUNCTIONS ARE UNDER SEPARATE MANAGEMENT

13

WTO CONDITIONS

• A STANDARDIZATION BODY CANNOT BE A REGULATOR OR MARKET SURVEILLANCE

• A STANDARDIZATION BODY CAN BE CLASSIFIED AS A CONFORMITY ASSESSMENT BODY PROVIDED IT IS UNDER A SEPARATE MANAGEMENT

14


• A CONFORMITY ASSESSMENT BODY MAY UNDERTAKE MARKET SURVEILLANCE FUNCTIONS

• A MARKET SURVEILLANCE BODY MAY ALSO UNDERTAKE CONFORMITY ASSESSMENT FUNCTIONS

• A REGULATOR CAN ONLY UNDERTAKE MARKET SURVEILLANCE FUNCTIONS

WTO CONDITIONS

• A REGULATOR CAN ALSO BE CLASSIFIED AS A MARKET SURVEILLANCE ONLY

• A CONFORMITY ASSESSMENT BODY MAY BE CLASSIFIED AS A MARKET SURVEILLANCE

• MARKET SURVEILLANCE CAN ALSO BE A CONFORMITY ASSESSMENT BODY

16

• S= STANDARDIZATION

• R = REGULATOR

• M = MARKET SURVEILLANCE

• C = CONFORMITY ASSESSMENT BODY

S R

MC

IMPORTANT REMINDER

ACT• LAW THAT HAS PASSED THROUGH THE PARLIAMENT

(HOUSE OF REP, SENATE AND SIGNED BY THE PRESIDENT

DECREE• LAW PASSED UNDER THE MILITARY GOVT

• GAZETTEIS AN OFFICIAL PUBLICATION BY THE GOVERNMENT, MAY BE PERIODIC AND CONTAINS MATTERS APPROVED BY THE GOVERNMENT

18

IMPORTANT REMINDER

MANDATE

• AN OFFICIAL INSTRUMENT TO IMPLEMENT AN ACT. IT IS THE ACT THAT GIVES THE MANDATE ITS STRENGTH

A BILL

• IS A DRAFT OF THE LAW YET TO GO THROUGH THE SERIES OF READINGS, AMENDMENT IF NECESSARY, BEFORE BEING ACCENTED TO BY THE PRESIDENT FOR IT TO BECOME A LAW

19

T

H

A

N

K

Y

O

U

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NATIONAL QUALITY INFRASTRUCTURE PROJECTFunded by the European Union and implemented by UNIDO

www.nqi-nigeria.org

Documents

COMPILATION OF PAPERS ON Better Technical Regulations in