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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
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
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.
6
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.
10
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)
11
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
12
DATE INSTITUTIONS VISISTED ACHIEVEMENTS REMARKS
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
13
DATE INSTITUTIONS VISISTED ACHIEVEMENTS REMARKS
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
14
DATE INSTITUTIONS VISISTED ACHIEVEMENTS REMARKS
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
15
NATIONAL QUALITY INFRASTRUCTURE PROJECT (NQIP)
COMPONENT 1- PROMULGATION OF A NATIONAL QUALITY POLICY AND ENSUING LEGISLATION FOR THE NATIONAL QUALITY INFRASTRUCTURE
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.
17
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.
18
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.
19
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.
20
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
21
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
22
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
Neither agree nor disagree
Strongly agree
NA Blank
a. The facilitator was well organized
7 93
b. The facilitator made good use of time allotted
7 7 86
c. The facilitator demonstrated good knowledge of Risk Management
7 93
d. Facilitators’ presentation style was effective in helping me learn
7 7 86
e. The presentation methods used were appropriate for the audience
7 7 79 7
f. The materials provided will be useful to me
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
25
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.
26
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
1. CONSUMER PROTECTION COMMISSION (CPC)
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)
10. NIGERIA AGRICULTURAL QUARANTINE SERVICES (NAQS)
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
33
NATIONAL QUALITY INFRASTRUCTURE PROJECT (NQIP)
COMPONENT 1- PROMULGATION OF A NATIONAL QUALITY POLICY AND ENSUING LEGISLATION FOR THE NATIONAL QUALITY INFRASTRUCTURE
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.
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)
1. CONSUMER PROTECTION COMMISSION (CPC)
2. DEPARTMENT OF TRADE, FMITI
3. DEPARTMENT OF WEIGHTS AND MEASURES, 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
8. FEDERAL PRODUCE INSPECTION SERVICES (FPIS)
9. INSTITUTE OF PUBLIC ANALYSTS OF NIGERIA (IPAN)
10. MANUFACTURERS ASSOCIATION OF NIGERIA (MAN)
11. MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)
12. MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)
13. NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION COUNCIL (NAFDAC)
14. NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS ENFORCEMENT
AGENCY (NESREA)
15. NIGERIA EXPORT PROCESSING ZONES AUTHORITY (NEPZA)
16. NIGERIA AGRICULTURAL QUARANTINE SERVICES (NAQS)
17. NIGERIAN COMMUNICATIONS COMMISSION (NCC)
18. STANDARD ORGANIZATION OF NIGERIA (SON)
51
NATIONAL QUALITY INFRASTRUCTURE PROJECT (NQIP)
COMPONENT 1- PROMULGATION OF A NATIONAL QUALITY POLICY AND ENSUING LEGISLATION FOR THE NATIONAL QUALITY INFRASTRUCTURE
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
NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND
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
57
ANNEX I
THE TECHNICAL WORKING GROUP (WG-TR)
1. CONSUMER PROTECTION COMMISSION (CPC)
2. DEPARTMENT OF TRADE, FMITI
3. DEPARTMENT OF WEIGHTS AND MEASURES, 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
8. FEDERAL PRODUCE INSPECTION SERVICES (FPIS)
9. INSTITUTE OF PUBLIC ANALYSTS OF NIGERIA (IPAN)
10. MANUFACTURERS ASSOCIATION OF NIGERIA (MAN)
11. MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)
12. NATIONAL ENVIRONMENTAL STANDARDS AND REGULATIONS ENFORCEMENT
AGENCY (NESREA)
13. NIGERIA EXPORT PROCESSING ZONES AUTHORITY (NEPZA)
14. NIGERIA AGRICULTURAL QUARANTINE SERVICES (NAQS)
15. STANDARD ORGANIZATION OF NIGERIA (SON)
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
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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
INAUGURATION OF THE WORKING GROUP ON TECHNICAL REGULATIONS (WG-TRs)
Venue: Transcrop Hilton Hotel, Abuja Date: 10 &11 March, 2015
NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND
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)
1. CONSUMER PROTECTION COMMISSION (CPC)
2. DEPARTMENT OF TRADE, FMITI
3. DEPARTMENT OF WEIGHTS AND MEASURES, FMITI
4. ELECTRICITY MANAGEMENT SERVICES LIMITED (EMSL)
5. FEDERAL DEPARTMENT OF ANIMAL PRODUCTION AND HUSBANDRY
SERVICES FMARD
6. FEDERAL DEPARTMENT OF FISHERIES, FMARD
7. FEDERAL DEPARTMENT OF VETERINARY AND PEST CONTROL SERVICES,
FMARD
8. FEDERAL MINISTRY OF INDUSTRY, TRADE AND INVESTMENT (FMITI)
9. FEDERAL PRODUCE INSPECTION SERVICES (FPIS)
10. HOUSE COMMITTEE ON INDUSTRY
11. INSTITUTE OF PUBLIC ANALYSTS OF NIGERIA (IPAN)
12. MANUFACTURERS ASSOCIATION OF NIGERIA (MAN)
13. MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA (MLSCN)
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)
19. NIGERIA AGRICULTURAL QUARANTINE SERVICES (NAQS)
20. NIGERIA EXPORT PROCESSING ZONES AUTHORITY (NEPZA)
21. NIGERIAN BAR ASSOCIATION (NBA)
22. NIGERIAN COMMUNICATION COMMISSION (NCC)
23. NIGERIAN LAW REFORMS COMMISSION (NLRC)
24. SENATE COMMITTEE ON TRADE
25. STANDARD ORGANIZATION OF NIGERIA (SON)
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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
NAME OF ORGANIZATION
MAIN FUNCTION OVERLAPS OF FUNCTION
GAPS RECOMME-NDATION
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
NAME OF ORGANIZATION
MAIN FUNCTION OVERLAPS OF FUNCTION
GAPS RECOMME-NDATION
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
77
NATIONAL QUALITY INFRASTRUCTURE PROJECT (NQIP)
COMPONENT 1- PROMULGATION OF A NATIONAL QUALITY POLICY AND ENSUING LEGISLATION FOR THE NATIONAL QUALITY INFRASTRUCTURE
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
NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND
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.
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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)
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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.
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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
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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
Neither agree nor disagree
Strongly agree
NA Blank
a. The facilitator was well organized
100
b. The facilitator made good use of time allotted
10 90
c. The facilitator demonstrated good knowledge of technical regulation
100
d. Facilitators’ presentation style was effective in helping me learn
100
e. The presentation methods used were appropriate for the audience
100
f. The materials provided will be useful to me
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
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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 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
NAME: ABIMBOLA UZOMAH POSITION: NATIONAL EXPERT ON TECHNICAL REGULATION CONTRACT REFERENCE NUMBER: 12152 1.0 BACKGROUND
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.
OBSERVATION AND RECOMMENDATION OF WGTR
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.
OBSERVATION AND RECOMMENDATION OF WGTR
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.
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3.2 REGULATORY BODY
3.2.1 OVERLAPS BETWEEN NASC61 AND NAQS62
RECOMMENDATIONS OF THE SUB-GROUP
RECOMMENDATION
The sub-group recognized NAQS as the national institution that should oversee all
the quarantine activities including those carried out by NASC.
OBSERVATION AND RECOMMENDATION OF WGTR
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
RECOMMENDATIONS OF THE SUB-GROUP
RECOMMENDATION
i. All safety standards are regulated by SON and should be left within her purview.
OBSERVATION AND RECOMMENDATION OF WGTR
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
RECOMMENDATIONS OF THE SUB-GROUP
Both have the mandate to regulate packaged frozen fish.
No recommendation was suggested for this overlap.
OBSERVATION AND RECOMMENDATION OF WGTR
Regulation of all packaged and labeled fish and fish products should be considered under
NAFDAC
3.2.4 OVERLAPS BETWEEN NAFDAC AND CPC66
RECOMMENDATIONS OF THE SUB-GROUP
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.
OBSERVATION AND RECOMMENDATION OF WGTR
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
RECOMMENDATIONS OF THE SUB-GROUP
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.
OBSERVATION AND RECOMMENDATION OF WGTR
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
OBSERVATION AND RECOMMENDATION OF WGTR
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
RECOMMENDATIONS OF THE SUB-GROUP
ii. SON should certify factories and products only, while NAFDAC retains her regulatory
roles over food, drugs, cosmetics, medical devices and packaged water.
OBSERVATION AND RECOMMENDATION OF WGTR
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
RECOMMENDATIONS OF THE SUB-GROUP
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.
OBSERVATION AND RECOMMENDATION OF WGTR
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
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
“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 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; …
“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 ....”
... 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
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
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
Trans-national arrangements (“Regulatory co-operation”)
5. Recognition of- product specifications (essential requirementsand standards linked to those requirements)- marking specifications, marks etc.
MACAAPECAUNECE“InternationalModel”RA
Trans-national arrangements (“Regulatory co-operation”)
4. Recognition of results of conformity assessmentprocedures- certificates of conformity- inspections- test results
MRA
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Nature of action Different degrees of regulatory co-operation
Example ofagreement
Trans-national arrangements (“Regulatory co-operation”)
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
CONFORMITY ASSESSMENT
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 %
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.
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
CONFORMITY ASSESSMENT
• Government recognized (accredited) body with the competence in carrying out the following activities:
• Sampling and testing;
• Assessment;
• Inspection;
• Auditing;
• Certification;
CONFORMITY ASSESSMENT
• 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
CONFORMITY ASSESSMENT
• 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
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