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The Management of Market Surveillance Systemson Consumer Product Safety

First Graduate Course

Organization ofAmerican States

First Graduate Course

The Management of Market Surveillance Systems onConsumer Product Safety

Washington, D.C.January – March, 2011

Academic coordination:

The Pompeu Fabra University of Barcelona was in charge of the academic coordination of the course, making well known specialists, professors and cutting edge technology tools available for this purpose. It was also in charge of coordinating all the organizational aspects of the academic part of the course.

The organization of this course, as well as the preparation and dissemination of this document have been possible thanks to the funding provided by the Brazilian Government, through its National Health Surveillance Agency (ANVISA), the Department of Consumer Protection and Defense (DPDC), and the National Institute of Metrology, Normalization and Industrial Quality (INMETRO).

The United States Consumer Product Safety Commission supported the organization of the first graduate course by making staff from all its departments available to the Consumer Safety and Health Network at the planning stage, as well as during the first two days of the course in Washington, D.C.

The Generalitat of Catalonia, through the Agencia Catalana del Consum provided funding for the coordination of the course in Barcelona.

The Better Business Bureau (BBB) and the National Institute of Standards and Technology (NIST) of the United States, contributed to the organization of the in-person part of the course.

Consumer Safety and Health Network First Graduate Course:The Management of Market Surveillance Systems on Consumer Product Safety.

All rights reserved, 2011.

Organization of American States17th Street and Constitution Ave, N.W.Washington, D.C 20006, USAwww.oas.org

Secretary GeneralJosé Miguel Insulza

Assistant Secretary GeneralAlbert R. Ramdin

Acting Executive Secretary for Integral Development Jorge Saggiante

Director, Department of Social Development and EmploymentAna Evelyn Jacir de Lovo

Coordinator, Consumer Protection ProgramMarcos Acle

Academic Coordinator of the Graduate CourseJosep Tous

Technical Team, Consumer Protection ProgramAndres Yi ChangKaren Espino-MitchellAnge LiuMelissa Panszi

The reports included in this publication were written within the framework of the Consumer Safety and Health Network first Graduate Course: The Management of Market Surveillance Systems on Consumer Product Safety. The content of the papers transcribed or cited hereby are the sole responsibility of their authors, and in no way represent the opinion of the institutions they belong to or that of the General Secretariat of the OAS, PAHO or any other institution related with the organization of this course.

The preparation and dissemination of this document have been funded by the Brazilian Government.

This document has been designed by the Department of Conferences and Meetings Management of the Organization of American States.

Costa Rica

• Kattia Chaves Matarrita (Technical Support Department)

Ecuador

• Juan Pablo Galán (Consumer Defense Directorate)

• Talia Palacios Campaña (Consumer Defense Directorate)

El Salvador

• Diana Burgos (Consumer’s Defense Office)

Guatemala

• Gladys Arreola (Food Regulation and Control Department)

Mexico

• Dinora Pliego Citalán (Federal Commission for the Protection against Sanitary Risk)

Peru

• Hamilton García Díaz (Health Promotion Directorate)

• Angel Escandón Villa (General Environmental Health Directorate)

• Evelyn Edith Chumacero Asención (INDECOPI)

Dominican Republic

• Fidel del Rosario (National Consumer Rights Protection Institute)

• Natanael De los Santos (National Consumer Rights Protection Institute)

Consumers International

• Hubert Linders

Organization of American States

• Marcos Acle Mautone (Department of Social Development and Employment)

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Introduction

The graduate course “The Management of Market Surveillance Systems on Consumer Product Safety” is a part of the Consumer Safety and Health Network for the Americas (CSHN), which is coordinated by the General Secretariat of the Organization of American States (OAS) in collaboration with the Pan American Health Organization (PAHO).

The CSHN is the first Inter-American effort to contribute to the integration and consolidation of national and regional market surveillance systems for consumer product safety, and it is the result of a commitment of the American States to efficiently protect the rights of consumers, as well as to promote safe consumption, as expressed in the OAS General Assembly Resolutions AG/RES. 2494 (XXXIX-O/09), 2549 (XL-O/10), and 2682 (XLI-O/11).

The overall objective of the CSHN is to ensure the consumption of safe goods and services, thus protecting the health of the population of the Americas. In order to achieve such objective, one of the short-term goals set has been to build the capacity of the States to monitor and control the safety of consumer products, by means of personnel training and an efficient information exchange among relevant national authorities.

In this context, one of the main pillars of the CSHN is the design and implementation of activities to build the institutional capacity of the OAS Member States to implement or strengthen efficient national alert systems that will react rapidly upon the entry of unsafe products into their markets.

Objective

The objective of this graduate course is to contribute to the technical training of the authorities of the Region through the study of the fundamentals of product safety administrative management, mainly in Europe and North America, in order to analyze and compare the realities of these countries against the realities and the needs of the participants’ countries. This will enable the States of Latin America and the Caribbean to enrich their perspective and to improve their market surveillance models, based upon a risk management strategy that is coherent with their administrative structure and their legal framework, and to be able to advance towards implementing an inter-American rapid alert system for product safety.

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Authors of the Essays

The reports referenced in the publication were written within the framework of the first graduate course. The content of the papers summarized above are the sole responsibility of their authors, and in no way represent the opinion of the institutions they belong to or that of the General Secretariat of the OAS, PAHO or any other institution related with the organization of this course.

Argentina

• Alejandro Rupnik (Sub-Secretariat of Consumer Defense)

• José Luis Laquidara (Sub-Secretariat of Consumer Defense)

Belize

• Kenisha Stuart (Belize Bureau of Standards)

Brazil

• Adriana Mattos Menezes (Superintendence of Consumer Protection and Defense – Procon Bahia)

• Amaury Martins de Oliva (Superintendence of Consumer Protection and Defense – DPDC)

• Cristiana Menezes Santos (Superintendence of Consumer Protection and Defense – Procon Bahía)

• Isabella B. Barreto Baptista (Superintendence of Consumer Protection and Defense – Procon Bahía)

• José Agenor A. Da Silva (National Health Surveillance Agency – ANVISA)

• Neilton Araújo de Oliveira (National Health Surveillance Agency – ANVISA)

• Paulo Coscarelli ((National Institute of Metrology, Normalization and Industrial Quality)

CHILE

• Ximena Castillo Faura (SERNAC)

• Ana María Becerra Puebla (SERNAC)

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Structure

The course consisted of a four-week online phase with a 7-12 hour workload per week for each student, with feedback and an online follow-up of the students’ progress by specialists from the Pompeu Fabra University of Barcelona, as well as practical exercises to consolidate the lessons learned.

After the four weeks of long-distance education, in-person activities were held in Washington, D.C. These included the presentation of proposals by students and a debate on the conclusions drawn, as well as practical exercises and presentations by experts and an intensive study of the consumer product safety system for non-food consumer products in the United States, led by officials of the United States Consumer Product Safety Commission (CPSC).

The final papers submitted at the end of the course were an analysis of the issues within the students’ own countries, including specific proposals to improve the product safety surveillance management.

The final assessment in order to pass the course and obtain the corresponding graduate diploma issued by the Pompeu Fabra University was based on the students’ participation during the online activities and the in-person sessions, as well as on the results of the examinations of each module and the practical exercises.

Organization

The course was coordinated by the General Secretariat of the OAS through its Department of Social Development and Employment. The Pompeu Fabra University of Barcelona was in charge of the academic aspects, making distinguish specialists and cutting edge educational technology available to the CSHN.

Contributions

Financial support from the Brazilian Government, through its National Health Surveillance Agency (ANVISA), the Department of Consumer Protection and Defense (DPDC), and the National Institute of Metrology, Normalization and Industrial Quality (INMETRO); and from the Generalitat of Catalonia, through the Catalan Consumer Agency, made this course possible.

The contribution of the Pompeu Fabra University of Barcelona was also crucial, as it made available not only specialists and professors, but also its technological tools, and it coordinated all the organizational aspects of the academic part of the course.

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Peru

Systems • N/A Legal framework

• Constitution Art. 65 • Consumer Protection and Defense Code

Institutions • National Institute for the Defense of Competition and Intellectual Property (INDECOPI)

Current actions

• Verification of compliance with labeling regulations • Control campaigns in toy centers • Reactive surveillance • Inspection visits and consumer education and awareness‐raising

campaigns Obstacles • Reactive attitude of consumption authorities upon complaints

• Lack of coordination between the sectors involved in surveillance • Lack of sources of information

Challenges • Acknowledging the prevention authority • Educating the consumer for surveillance

Areas of action/Actions for improvement

• Defining areas for joint action • Developing consumer education plans • Promoting the supplier’s active role • Disseminating the surveillance models learned • Designing a joint‐action program • Proposing a work agenda with the consumption authorities

Future plans • Designing a surveillance strategy • Implementing communication mechanism between the authority and the

consumer • Implementing risk analysis

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Likewise, the United States Consumer Product Safety Commission made staff from all its departments available in the planning stage, as well as during the first two days of the course in Washington, D.C., when they shared the US expertise on the subject with the Region’s specialists.

Finally, it is worth mentioning the support received from the Better Business Bureau (BBB) and the National Institute of Standards and Technology (NIST) of the United States, which contributed to the organization of the in-person part of the course in Washington, D.C.

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Mexico Systems • N/A Legal framework

• Federal Law on Consumer Protection and the corresponding Regulations • Federal Law on Metrology and Normalization and the corresponding

Regulations • Official Mexican Regulation • General Health Law • General Labor Control Law • Law on Biosafety of Genetically Altered Organisms

Institutions • Ministry of Finance – Office of the Federal Prosecutor for the Consumer (PROFECO)

• Health Secretariat ‐ Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

Current actions

• Development of sanitary regulation, control and outreach activities • Health risk assessment • Regulatory and non‐regulatory prevention and control • Setting guidelines and criteria for product classification • Assessment, verification, and supervision visits • Analysis and control of sanitary conditions • Sanitary check visits

Obstacles • Late response capacity • Confusion in the development of new products • Lack of legal instruments for enforcement • Lack of specific tests • Lack of information to the population

Challenges • Access to information on risk assessment • Access to common databases


• Collecting information • Identifying priorities based on the information available • Using international standards • Widening the scope through other agencies

Future plans • Creating mechanisms to share information • Training specialists

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Common Identified Challenges to Strengthen Market Product Safety

As part of the graduate course, each one of the participating delegations analyzed the situation in their country, identifying the key aspects to understand the development and progress of consumer protection and the right of consumers to safe consumption. This included reviewing the legal frameworks in force, the institutions in charge, the actions being taken, the challenges on this issue, and future plans.

The participants’ work is the result of studying over 300 pages of materials containing thorough explanations of the North American and European market surveillance systems, as well as time devoted to debating each topic, and the comparative analysis of the corresponding national legal frameworks. In the course of seven weeks of intense work, the participants reflected on a way to match consumer safety in their countries to the administrative structures and the legal frameworks in force, and on a way to find synergies in the cooperation between consumption, health and industry administrations, and among administrations in different countries within the Americas.

Despite the fact that each essay focuses on a specific national reality, they all share several common aspects, which constitute a core of challenges and similar opportunities within the framework of the CSHN to keep promoting consumer protection in the hemisphere, as shown below.

Specialized structures or areas

To begin with, most participants acknowledge the lack of structure, coordination and exchange of information between sectors, authorities, and government agencies-both at a local and regional level, as well as at a national and international level-which frequently have concurrent jurisdictions and undefined hierarchies. This also results in a lack of competence and duplication of efforts, which may result in inefficient market surveillance management.

In some countries, this challenge lies in elaborating a strategic plan, redesigning and reassessing their operative and administrative structure, as well as carefully designing regional public policies. The definition of roles and specific competences both, at the organizational and individual level, has also been deemed necessary. Thus, work should be done towards the long-term goal of standardizing laws and regulations at a continent level within a common legal framework, or at least towards the compatibilization of this kind of regulation.

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• Enforcing regulations and rules on suppliers • Creating a consumer product safety detection and assessment system • Creating an information system for the surveillance of potential incidents • Creating an early alert system • Establishment of cooperation mechanisms with other countries


• Harmonization of regulatory and legal frameworks • Coordination, communication and information exchange between authorities

• Strengthening and unification of product safety control and surveillance • Financial assistance • Strengthening the capacity of the competent authorities • Coordination with Customs • International cooperation

Future plans • Strengthening the work carried out by the CSHN • Replicating a technical training experience • Coordinating efforts to consolidate the Inter‐American Rapid Alert System

Guatemala Systems • N/A Legal framework

• Decree 90‐97 Code and Health • Government agreement 969‐99 on Food Safety Regulations • Health Code, Foodstuffs, Food retail facilities

Institutions • Ministry of Health and Social Assistance • General Regulation, Surveillance and Health Control Directorate • Food Regulation and Control Department • National Health Laboratory

Current actions

• Market surveillance by sampling • Verification of product identity

Obstacles • Lack of financial, infrastructure, and human resources

Challenges • Management of relevant resources


• Managing support from international organizations • Designing an action plan to set parameters in the country • Creating an action plan for the National Health Laboratory • Implementing the annual training plan

Future plans • Launching surveillance activities in the departments of Quetzaltenango and Chiquimula

• Increasing the number of samples taken

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Regulatory frameworks for consumer product safety

Another aspect brought up by several participants was the current lack of legal instruments to regulate and enforce the law, and the inefficiency and obsoleteness of the legal procedures, added to the inefficiency of generic penalties.

All these result in a loophole in the legal framework at the national level and also across borders, as well as a lack of leading organisms in this area. There are also very few cases in which there is systematic coordination between consumer protection agencies and health ministries, for instance. In order to address this problem it is necessary to foster political will and to educate the authorities in charge of making decisions on the relevance of the issue.

Information-gathering and communication policies on product safety

Another issue is the lack of systems to gather and disseminate information on consumer product safety among institutions and to and from the public. This is usually accompanied by inefficient procedures to capture, process, and channel such information.

The participants expressed the need to implement systems to report the results of market surveillance activities, as well as to work towards involving and raising awareness within the private sector, seeking alliances that will be beneficial to and that will encourage consumer safety. It is also crucial to raise awareness among the general public about the importance of the role they play in terms of the consumer product market safety.

All of the above must be combined with a policy that fosters fluent communication with the different stakeholders involved, and that also helps to verify the accuracy and reliability of the information provided by suppliers, consumers, and all the intermediaries who take part in commercial transactions.

Budget limitations

Another challenge pointed out on several occasions is budget limitations and the need to make a sustainable and transparent plan for the adequate management of the funds available to national agencies responsible for consumer product safety market surveillance. Progress in this area is hindered by the lack of qualified, experienced, and competent staff. It is thus necessary to train other relevant stakeholders, such as those from the private sector, in order to foster the mainstreaming of the issue, and to obtain a larger commitment from all the stakeholders involved.

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• Issuing market surveillance reports


• Improving market surveillance • Creating a coordination unit • Creating an entity and a regulation to regulate risk assessment • Developing a system to register harm to consumers • Developing a system to report imported products that breach regulations • Implementing a safe consumption network to alert authorities

Future plans • Creating an entity to coordinate the institutions carrying out surveillance tasks.

El Salvador Systems • National System for Consumer Protection Legal framework

• Constitution Art. 1 and 110 • Consumer Protection Law • National Consumer Protection Policy • Health Code • Organic Law of the General Customs Directorate • CONACYT Law • Central‐American Technical Regulations

Institutions • Ministry of Health (MINSAL) • General Customs Directorate • National Science and Technology Council • Consumer’s Defense Office

Current actions

• International alert systems monitoring • Establishment of normalization processes to make the Obligatory Salvadorian Regulations and the Central‐American Technical Regulations

• Implementation of the Salvadorian Quality and Productivity System • Participation in the CHSN

Obstacles • Scope limited to foodstuffs • Lack of financing, training of personnel, laws and regulations, infrastructure and surveillance

• Breach of laws • Weak institutional coordination and information exchange systems • Lack of systems to disseminate information • Lack of a surveillance and early alert system

Challenges • Strengthening the existing regulatory frameworks • Increasing funding

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• Enforcing regulations and rules on suppliers • Creating a consumer product safety detection and assessment system • Creating an information system for the surveillance of potential incidents • Creating an early alert system • Establishment of cooperation mechanisms with other countries


• Harmonization of regulatory and legal frameworks • Coordination, communication and information exchange between authorities

• Strengthening and unification of product safety control and surveillance • Financial assistance • Strengthening the capacity of the competent authorities • Coordination with Customs • International cooperation

Future plans • Strengthening the work carried out by the CSHN • Replicating a technical training experience • Coordinating efforts to consolidate the Inter‐American Rapid Alert System

Guatemala Systems • N/A Legal framework

• Decree 90‐97 Code and Health • Government agreement 969‐99 on Food Safety Regulations • Health Code, Foodstuffs, Food retail facilities

Institutions • Ministry of Health and Social Assistance • General Regulation, Surveillance and Health Control Directorate • Food Regulation and Control Department • National Health Laboratory

Current actions

• Market surveillance by sampling • Verification of product identity

Obstacles • Lack of financial, infrastructure, and human resources

Challenges • Management of relevant resources


• Managing support from international organizations • Designing an action plan to set parameters in the country • Creating an action plan for the National Health Laboratory • Implementing the annual training plan

Future plans • Launching surveillance activities in the departments of Quetzaltenango and Chiquimula

• Increasing the number of samples taken

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de Salud

The whole continent also faces a challenge in terms of the difficulty to move around for field operations and the lack of adequate infrastructure. In some particular cases, this will imply creating government units or organisms that specialize in consumer protection, information management, industries, health, articulation, standards, among others.

Strengthening national surveillance and consolidating regional cooperation

Finally, it was deemed necessary to create a plan in the countries to establish a national prevention system to emphasize the education of consumers as watchdogs and the acknowledgement of prevention authorities as such.

In today’s globalized world, governments must have a global perspective, and this demands cooperation and unity. It is thus necessary to develop similar criteria and action plans that will allow for rapid joint action. This process will obviously not be automatic; it will be necessary to articulate and harmonize the mechanisms available in each country to protect the health and safety of its citizens. This articulations will depend on the country’s legal framework, its capacity to devote funds, its administrative structure, and even its political sensitivity, meaning that each country will work at its own pace.

This is why the participants have pointed out the need to consolidate the Consumer Safety and Health Network and, within this framework, to create or strengthen efficient and specialized market surveillance, rapid alerts, and logistics (data gathering and generation of reliable statistics) systems to solve the problem of the late response of stakeholders. This will enable them to share information about incidents and hazardous market products in a rapid and secure manner in each country. This system should also serve as a cooperation mechanism with other markets that will allow to advance towards a legal framework compatible with all the different realities of the hemisphere.

All of these challenges must be faced considering the analysis of successful experiences and good practices, in order for them to be replicated and improved, if possible. Likewise, a fully comprehensive plan must be drawn, with a defined surveillance and prevention strategy, and which uses risk analysis tools that will allow for a broader perspective on the issue.

This wide variety of challenges that the Continent currently faces, are also a unique opportunity to work jointly and to foster mutual cooperation between countries and regions. In the light of these circumstances, which are sometimes adverse, it is worth noting that despite the different realities, there is optimism among the countries, and they have all expressed their willingness to advance and keep working towards an American continent where the rights of consumers are respected above all.

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• Development of a centralized database Future plans • Organizing forums to inform about the issue and to make an action plan

• Raising awareness about the need for a timely and rapid information system

• Strengthening the bonds between official institutions • Designing and implementing an integrated data and information system

Ecuador Systems • Ecuadorian Quality System Legal framework

• Constitution Art. 42 • Constitution Art. 281 • National Development Plan for Good Living • Production Code • Organic Law on Consumer Defense • Ecuadorian Quality System Law • Organic Law of the National Health System

Institutions • Consumer Defense Directorate (DIDECO) • Ministry of Industry and Productivity (MIPRO) • Ministry of Public Health • National Quality Council • Ecuadorian Normalization Institute (INEN) • Ecuadorian Accreditation Agency (OAE)

Current actions

• Establishment of the Inter‐Ministry Quality Committee • Surveillance of industries after claims or identification of damages through MIPRO • Annual surveillance plan and ex‐post registration of foods by the Ministry of Health

Obstacles • Establishment of an efficient market surveillance system • Lack of competence and duplication of efforts of the entities in charge • Lack of coordination among authorities • Lack of access to information • Lack of communication with the consumer

Challenges • Reinforcing information exchange at institutional level • Coordinating the different entities involved in market surveillance • Improving the complaint filing system • Improving the efficiency of the market surveillances system • Creating an evaluation unit in the Ministry of Industry and the Ministry of Health

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• Issuing market surveillance reports


• Improving market surveillance • Creating a coordination unit • Creating an entity and a regulation to regulate risk assessment • Developing a system to register harm to consumers • Developing a system to report imported products that breach regulations • Implementing a safe consumption network to alert authorities

Future plans • Creating an entity to coordinate the institutions carrying out surveillance tasks.

El Salvador Systems • National System for Consumer Protection Legal framework

• Constitution Art. 1 and 110 • Consumer Protection Law • National Consumer Protection Policy • Health Code • Organic Law of the General Customs Directorate • CONACYT Law • Central‐American Technical Regulations

Institutions • Ministry of Health (MINSAL) • General Customs Directorate • National Science and Technology Council • Consumer’s Defense Office

Current actions

• International alert systems monitoring • Establishment of normalization processes to make the Obligatory Salvadorian Regulations and the Central‐American Technical Regulations

• Implementation of the Salvadorian Quality and Productivity System • Participation in the CHSN

Obstacles • Scope limited to foodstuffs • Lack of financing, training of personnel, laws and regulations, infrastructure and surveillance

• Breach of laws • Weak institutional coordination and information exchange systems • Lack of systems to disseminate information • Lack of a surveillance and early alert system

Challenges • Strengthening the existing regulatory frameworks • Increasing funding

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The participants have given positive feedback on this first edition of the course, and they have requested the Department of Social Development and Employment of the OAS to increase the coordination of this kind of efforts within the framework of the CSHN; particularly by organizing further editions of this graduate course, as well as supplementary training activities.

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Dominican Republic Systems • N/A Legal framework

• General Health Law 42‐01 • General Law on Environment and Natural Resources No. 64‐00 • Law No. 602‐1977 General Law on Quality Regulations and Systems • Law No 4030‐1955 on animal health • Law No 4990‐1958 on plant health • Law No. 358‐05 General law on Protection of Consumers or Users Rights

Institutions • Ministry of Public Health and Social Assistance • Ministry of Agriculture • Ministry of Industry and Commerce • General Directorate of Quality Standards and Systems • National Consumer Rights Protection Institute

Current actions

• Product surveillance upon claims • Control of misleading publicity • Tax collection for products • Creation and monitoring of animal and digital quarantine facilities in

ports and airports • Product inspection and quality control • Verification of claims • Metrological verification • Verification of advertising and deals • Price monitoring • Seizure of expired or damaged products

Obstacles • Budget and logistic limitation • Weak coordination among institutions • Weak information capture, processing, and channeling systems • Lack of infrastructure to analyze products • Lack of competent staff

Challenges • Creating a specialized unit • Redesigning data gathering instruments • Creating a regulating office for the National Information System • Strengthening product surveillance and safety • Redesign of an operative and administrative structure • Making a strategic plan • Designing regional public policies


• Reassessment of the organizational structure of institutional agencies in charge of surveillance activities

• Reassessment of the competence and skills of the inspection staff • Development of a strategic work plan • Creation of periodic program assessment mechanisms

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• Development of a centralized database Future plans • Organizing forums to inform about the issue and to make an action plan

• Raising awareness about the need for a timely and rapid information system

• Strengthening the bonds between official institutions • Designing and implementing an integrated data and information system

Ecuador Systems • Ecuadorian Quality System Legal framework

• Constitution Art. 42 • Constitution Art. 281 • National Development Plan for Good Living • Production Code • Organic Law on Consumer Defense • Ecuadorian Quality System Law • Organic Law of the National Health System

Institutions • Consumer Defense Directorate (DIDECO) • Ministry of Industry and Productivity (MIPRO) • Ministry of Public Health • National Quality Council • Ecuadorian Normalization Institute (INEN) • Ecuadorian Accreditation Agency (OAE)

Current actions

• Establishment of the Inter‐Ministry Quality Committee • Surveillance of industries after claims or identification of damages through MIPRO • Annual surveillance plan and ex‐post registration of foods by the Ministry of Health

Obstacles • Establishment of an efficient market surveillance system • Lack of competence and duplication of efforts of the entities in charge • Lack of coordination among authorities • Lack of access to information • Lack of communication with the consumer

Challenges • Reinforcing information exchange at institutional level • Coordinating the different entities involved in market surveillance • Improving the complaint filing system • Improving the efficiency of the market surveillances system • Creating an evaluation unit in the Ministry of Industry and the Ministry of Health

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Opening speech of the activities of the course

February 28th, 2011Washington D.C.

José Miguel InsulzaSecretary General

In the name of the Organization of American States, I would like to welcome you to our headquarters, and to this opening session of the in-person activities of “The Management of Market Surveillance Systems on Consumer Product Safety” course. I would also like to greet our partners in this task: Welcome to the OAS, we are very happy that you are here and we thank you for your support. I would also like to greet our friends from PAHO, with whom we have joined forces to work on countless activities; among which this current one stands out as particularly significant for all of us. Also the representatives of the Brazilian Government, who have not only provided financial support for this activity, but have also provided their support in managing all the work. I would also like to greet the Catalan Consumer Agency and the Pompeu Fabra University of Barcelona. I have not forgotten Consumers International; I left it for the end because I wanted to tell you that my first contact with consumer issues was about 17 years ago when my wife worked in an organization then called “International Organization of Consumer Unions” in Santiago, Chile, which later became Consumers International, and that is were I met my friend the Secretary for Juridical Affairs of the OAS, Jean Michele Arrighi, who was legal council to that international organization of Consumer Unions. So much has changed since, but I am also glad to see that Juan Trimboli is still there, and I send him my best regards.

This is probably the reason why we wanted to organize a program on consumption ever since I came to the OAS. In my opinion, the issue of consumers is intimately linked to our vision of democracy, to our exercise of citizenship. Indeed, citizens play several roles in modern society, one of which is that of consumers, a role that we all play, which we cannot stop playing. The way we do it, and the way in which we are allowed to play it, has a direct impact on the idea of citizenship, and on the quality of a modern democratic society.

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• Mainstreaming and public responsibility • Coordinating surveillance plans and actions and improving the

regulations • Developing objective points of reference • Creating and taking a cross‐border perspective • Promoting consumer culture

Future plans • Regulatory support to the legislation • Positioning the issue with the relevant authorities • Consolidating a coordinated, expeditious, and efficient work system • Developing sources of information • Implementing the system within the country and abroad

Costa Rica Systems • N/A Legal framework

• Constitution Art. 46 • Law No. 7472 Promoting Competitiveness and Effective Consumer Defense

• Article 45 Law No. 7472 Institutions • Consumer Support Directorate (DAC)

Current actions

• Withdrawal of products unsafe for consumption • Voluntary withdrawal procedure

Obstacles • Controlling the entry of products withdrawn in other countries Challenges • Combining efforts to reach an agreement with the National Children’s

Hospital • Training the retail sector in international withdrawals


• Establishing an agreement with the National Children’s Hospital • Creating a case management system • Improving consumer communication strategies • Cooperating to share information with other organizations that Costa Rica is an active member of

Future plans • Coordination with the Director of the National Children’s Hospital • Building a module to generate statistics in the DAC • Cooperating to share information with international organizations

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In our democracy we are entitled to have our own opinion, but as someone said: “we are entitled to our own opinions, but many times we are not entitled to our own facts”; and this is the case because in a complex society with a high flow of information, most of that information is not aimed at convincing us of what the best option is, but to convince us of the option chosen by whoever is sending the message. This might be dangerous for the role of the citizen, but it is even more dangerous in the case of the consumer, because in that case things are not exactly what they seem.

The effort we have been making for a long time and in several places is to ensure that in a modern and democratic society consumers not only have a right to a fair price, but also to choose from several options, not only that they know the product, but that they also have the right to choose a product that will not harm their health. This is the goal, and the consumer issue is therefore central as it is stated in the Charter of the Organization of American States, as one of the issues that this organization that works for democracy, must cater for.

Nevertheless, it has only been possible to materialize this effort or the idea that we have had since I started my mandate in the OAS in the last two years, and I would like to thank Evelyn for the wonderful work she has done to make this possible. Her background is linked to consumer organizations in her native El Salvador, and her work here has not only been very coherent, but also very expeditious. The first resolution was only passed in 2009; in 2010 we received a mandate from the Assembly, and the network is now fully operational, and I think this is very important. The presence of all of you is also significant, it forces us to make a commitment, and we feel very optimistic to make this a central task in the future.

I hope that you will participate in the development of this Network since, as is the case with all other activities of the OAS, the main protagonists are the countries, the Member States, and that is why we have an institutional obligation to honor such participation. As part of this activity, as with many others involving human rights, protection of women, corruption, etc., we have also involved the civil society, represented in this case by Consumers International, and we also hope that the civil society will also be represented in each one of your countries. I am sure that this will be the case. This is a fundamental task that we need to carry out with our partners, since international organizations preach about the need for coordination, and it is a good thing that we practice it ourselves; it is our hope that this Network will develop further.

I have been tracking the progress of a rapid alert system for products that is under development on our webpage, and I find it very stimulating. I think we are doing a very good job, and I hope that we will have the resources necessary to continue to carry out this task from both, our member countries, and those who cooperate

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improvement

Future plans • Establishment of the Brazil Safe Consumption and Health Work Group, setting the foundations for a unified system, consolidating the CSHN’s actions

• Strengthening State Systems • Training in safe consumption and health • Improvement of regulatory field measures for product withdrawal

(regulations currently under public consultation)

Chile Systems • N/A Legal framework

• Constitution Art. 19 • Law No. 19496 Protection of Consumers’ Rights

Institutions • Ministry of Health • Ministry of Transport and Telecommunications • Ministry of Energy • Ministry of the Environment • National Consumer Protection Service • Public Health Institute • Superintendence of Electricity and Fuels • Superintendence of the Environment

Current actions

• Raising awareness and socialization of the issue • Surveillance of products for children • Regulatory improvements and updates • Diagnosis of the existing information and qualitative behavior study in

homes • Development of institutional workshops • Promotion of voluntary initiatives

Obstacles • Lack of a coordination structure among State agencies • Legal loopholes • Lack of a guiding agency • Lack of means to materialize goals • Obsolete and inefficient legal procedures • Inefficient generic sanctions

Challenges • Developing sources of information • Fostering private investment • Developing structures, coordination and regulations to configure the

system across borders • Strengthening the National Safety Measures System

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• Mainstreaming and public responsibility • Coordinating surveillance plans and actions and improving the

regulations • Developing objective points of reference • Creating and taking a cross‐border perspective • Promoting consumer culture

Future plans • Regulatory support to the legislation • Positioning the issue with the relevant authorities • Consolidating a coordinated, expeditious, and efficient work system • Developing sources of information • Implementing the system within the country and abroad

Costa Rica Systems • N/A Legal framework

• Constitution Art. 46 • Law No. 7472 Promoting Competitiveness and Effective Consumer Defense

• Article 45 Law No. 7472 Institutions • Consumer Support Directorate (DAC)

Current actions

• Withdrawal of products unsafe for consumption • Voluntary withdrawal procedure

Obstacles • Controlling the entry of products withdrawn in other countries Challenges • Combining efforts to reach an agreement with the National Children’s

Hospital • Training the retail sector in international withdrawals


• Establishing an agreement with the National Children’s Hospital • Creating a case management system • Improving consumer communication strategies • Cooperating to share information with other organizations that Costa Rica is an active member of

Future plans • Coordination with the Director of the National Children’s Hospital • Building a module to generate statistics in the DAC • Cooperating to share information with international organizations

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with us. Human capital is the main resource; I insist on the fact that we must all be convinced that consumer-related issues are within an area where public power is obliged to guarantee our full citizen’s rights, as it happens in other areas. The more people we convince, the higher our chances to improve the lives of our people and our children.

I thank you for being here. I wish you every success in your studies, work and management, and above all, I wish you success in your future efforts to support this Network within your own countries.

Thank you.

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Future plans • Passing the necessary legislation • Signing access to information agreements • Investing in training • Signing an agreement with Customs

Brazil Systems • National Consumer Defense System (SNDC)

• National Sanitary Surveillance System (SNVS) • Legal Metrology and Quality Network of Brazil

Legal framework

• Consumer Defense Code (Law No. 8078/90) • Organic Healthcare Laws (No. 8080 and No. 8142)

Institutions • Ministry of Health • National Health Surveillance Agency • National Institute of Metrology, Normalization and Industrial Quality

(INMETRO) of the Ministry of Development, Industry and Commerce • Brazilian National Transit Department (DENATRAN), of the Ministry of

Cities • Department of Consumer Protection and Defense of the Ministry of

Agriculture and the Ministry of Justice • PROCONS

Current actions

• Inclusion of the concept of “defect” and the “Theory of Quality” into the legislation

• Implementation of recalls • Payment of indemnities for damages to affected consumers • Complaint processing and investigation of irregularities • Assessment of unfair trade • Creation of a group to research on consumption accidents (GEPAC) • Monitoring international databases • Cooperation agreement between government and international agencies • Surveillance of consumption accidents by means of databases • Communication with the population through the dissemination of

information Obstacles • Coordination between local, regional, and national agencies with

concurring jurisdictions and without a defined hierarchy Challenges • Overcoming the fragmentation of knowledge and duplication of efforts

• Increasing communication with the population • Harmonization of surveillance mechanisms

Areas of action/Actions for

• Coordination between the sectors involved • Dissemination of early alerts to the population through the CSHN portal

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improvement

Future plans • Establishment of the Brazil Safe Consumption and Health Work Group, setting the foundations for a unified system, consolidating the CSHN’s actions

• Strengthening State Systems • Training in safe consumption and health • Improvement of regulatory field measures for product withdrawal

(regulations currently under public consultation)

Chile Systems • N/A Legal framework

• Constitution Art. 19 • Law No. 19496 Protection of Consumers’ Rights

Institutions • Ministry of Health • Ministry of Transport and Telecommunications • Ministry of Energy • Ministry of the Environment • National Consumer Protection Service • Public Health Institute • Superintendence of Electricity and Fuels • Superintendence of the Environment

Current actions

• Raising awareness and socialization of the issue • Surveillance of products for children • Regulatory improvements and updates • Diagnosis of the existing information and qualitative behavior study in

homes • Development of institutional workshops • Promotion of voluntary initiatives

Obstacles • Lack of a coordination structure among State agencies • Legal loopholes • Lack of a guiding agency • Lack of means to materialize goals • Obsolete and inefficient legal procedures • Inefficient generic sanctions

Challenges • Developing sources of information • Fostering private investment • Developing structures, coordination and regulations to configure the

system across borders • Strengthening the National Safety Measures System

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Executive Summary1jecutivo

The graduate course “The Management of Market Surveillance Systems on Consumer Product Safety” was held from January through March, 2011 within the framework of the Consumer Safety and Health Network for the Americas (CSHN), coordinated by the OAS in alliance with PAHO.

The aim of these postgraduate courses is to provide technical training to the authorities in the Region involved in product safety. This is done by studying the foundations of product safety administrative management in markets with more advanced systems, and comparing them with the reality and the needs of our region.

The competent authorities in the American states are thus able to enrich their perspectives, enhance their market surveillance models according to their administrative structure and legal frameworks, and they can progress in the future implementation of an inter-American rapid alert system for consumer products which will enable the adoption of preventive and proactive measures when a product is proven to be harmful for human health.

As part of the graduate course, each participanting delegation analyzed the situation in their country, covering key aspects to understand the development and the progress of consumer protection and consumer rights. These aspects included reviewing legal frameworks, the institutions responsible, actions being taken, and future plans.

The following is a succinct summary of the main conclusions drawn by the participants.

Argentina

The most relevant consumer protection regulations and laws are contained in Art. 42 of the Constitution and Law No. 24240, Consumer Defense and the Trade Loyalty Law, No. 22802. Several different organisms of the Ministry of Health, the Ministry of Industry, and the Commerce Secretariat, the Federal Public Income Administration, Customs, among others, work jointly to carry out this task.

Apart from carrying out the tasks they are competent in, these organisms have focused on activities aimed at promoting instances to raise awareness about consumer rights, training authorities, and strengthening government links.

1 The reports referred in the publication were written within the framework of the first graduate course. The content of the papers summarized above are the sole responsibility of their authors, and in no way represent the opinion of the institutions they belong to or that of the General Secretariat of the OAS, PAHO or any other institution related with the organization of this course.

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Challenges • Obtaining safe products and lowering accident rates • Adhesion and commitment from the relevant organizations • Extension of activities through the CSHN • Implementation of an Articulation Unit


• Review and update of the regulations in force • Analysis of successful experiences and good practices • Mass dissemination campaign • Review of the information provided by suppliers

Future plans • Planning meetings with relevant CHSN agencies, work methodology and action plan

• Training program and test run • Launching the “Program”. • CSHN follow‐up and monitoring.

Belize Systems • N/A Legal framework

• Draft Consumer Protection Law

Institutions • Belize Regulations Bureau

Current actions

• Product surveillance is done exclusively for food and restricted to price control

Obstacles • Lack of legal framework • Lack of training and experience of the staff • Lack of financial resources for field work • Lack of vehicles for field work • Lack of information about non‐food products • Lack of prevention in a system that has a purely reactive approach

Challenges • Increasing the political commitment of authorities • Obtaining financial resources • Persuading the public to play an active role • Access to information about local and imported products • Signing a cooperation agreement with Customs • Creating a regional information system • Passing a Consumer Protection Law


• Establishing a legal framework • Increasing the number of staff and training them • Defining the roles of institutions and agencies • Establishing a relationship of reciprocity with Customs • Signing regional agreements with consumer protection agencies

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Future plans • Passing the necessary legislation • Signing access to information agreements • Investing in training • Signing an agreement with Customs

Brazil Systems • National Consumer Defense System (SNDC)

• National Sanitary Surveillance System (SNVS) • Legal Metrology and Quality Network of Brazil

Legal framework

• Consumer Defense Code (Law No. 8078/90) • Organic Healthcare Laws (No. 8080 and No. 8142)

Institutions • Ministry of Health • National Health Surveillance Agency • National Institute of Metrology, Normalization and Industrial Quality

(INMETRO) of the Ministry of Development, Industry and Commerce • Brazilian National Transit Department (DENATRAN), of the Ministry of

Cities • Department of Consumer Protection and Defense of the Ministry of

Agriculture and the Ministry of Justice • PROCONS

Current actions

• Inclusion of the concept of “defect” and the “Theory of Quality” into the legislation

• Implementation of recalls • Payment of indemnities for damages to affected consumers • Complaint processing and investigation of irregularities • Assessment of unfair trade • Creation of a group to research on consumption accidents (GEPAC) • Monitoring international databases • Cooperation agreement between government and international agencies • Surveillance of consumption accidents by means of databases • Communication with the population through the dissemination of

information Obstacles • Coordination between local, regional, and national agencies with

concurring jurisdictions and without a defined hierarchy Challenges • Overcoming the fragmentation of knowledge and duplication of efforts

• Increasing communication with the population • Harmonization of surveillance mechanisms

Areas of action/Actions for

• Coordination between the sectors involved • Dissemination of early alerts to the population through the CSHN portal

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Notwithstanding, there still remains a lot to be done, particularly in terms of revising and updating the regulations in force, reviewing the information provided by product suppliers, and mass dissemination campaigns.

Belize

Belize is in a very difficult context; it is still waiting for Congress to pass its draft Consumer Protection Law. As long as there is no legal framework, it will be difficult for the country to advance towards an efficient consumer protection.

This is one of the main challenges, although it is also necessary to capacitate the staff, and to define the roles each institution and organization will play, as well as to establish regional agreements with consumer protection agencies. Political will and public opinion will be two key factors in determining the speed at which progress will be made towards reaching the goals.

Brazil

In its 1988 Constitution, Brazil explicitly incorporated the Right to Healthcare and Consumer Protection. In 1990 it approved a Consumer Defense Code and the Organic Health Laws. Together with these changes, the National Consumer Defense System and the National Sanitary Surveillance System were created, which, together with the metrology and evaluation institutions, have the goal of strengthening institutional cooperation in order to protect the citizens in terms of health and consumption.

The Department of Consumer Protection and Defense, the National Health Surveillance Agency, and the National Institute of Metrology, Normalization and Industrial Quality, are the main agencies in charge of consumer protection.

Brazil has been proactive and it has made progress in terms of product quality surveillance, protecting the quality-safety relationship, recalling products, offering compensation for damages to consumers when needed, receiving and investigating claims and breaches, by monitoring international databases, signing cooperation agreements, and trying to keep the population informed through alerts.

Despite the fact that much progress has been made, there is still work to be done in order to overcome knowledge fragmentation and duplication of efforts among Government agencies. The dissemination of the rapid alert system for the public that appears in the CSHN portal is also among Brazil’s priorities for the future.

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Agriculture, the Ministry of Industry and Trade, the Directorate‐General of Standards and Quality Systems, and the National Consumer Rights Protection Institute.

The main limitations recorded are cross‐institutional coordination, budgetary limitations, lack of infrastructure and competent staff, as well as the need for improvement in the procedures for gathering, processing, and channeling information. For this reason, efforts are being made to reassess the organizational structure and the competence and abilities of the inspectors, as well as to develop a strategic plan and obtain centralized databases.

Argentina Systems • National Regulations, Quality, and Certification Systems Legal framework

• Constitution Art. 42 • Consumer Defense Law No. 24240 • Commercial Loyalty Law No. 22802 • Mandatory Certification Regime

Institutions • Agencies of the Ministry of Health • Agencies of the Ministries of Industry and the Trade Secretariat • Customs • Federal Public Income Administration (AFIP) • Ministry of Foreign Affairs, International Trade and Worship • Ministry of Security • Insurance Superintendence • Occupational risk insurance companies • Province or municipal agencies with similar competences • Hospitals and prepaid healthcare companies

Current actions

• Promoting spaces for the dissemination of information about rights • Training of authorities • Strengthening cooperation in government agencies • Consolidation and development of programs such as “Remediar,” “Plan

Nacional Manos a la Obra,” “Plan Seguridad Alimentaria” and “Plan Familia”

Obstacles • High staff turnover rates • Coordination with other organizations with the same issues

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Current actions






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Current actions






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Current actions






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Comparison Tables

Chile

In spite of having a Law for the Protection of Consumers’ Rights (No. 19496) and Article 19 of the Constitution, which creates a series of rights (articles 1, 8, 9, and 21), the regulations in Chile are still mainly sector-based and specific, giving institutions limited competencies, with no product safety law to set an essential standard for all products.

The main obstacles are, thus, the absence of a coordination structure among the agencies of the State, legal loopholes, and obsolete legal procedures, as well as inefficient generic sanctions. The agencies in charge of facing these challenges are the Ministry of Health, the Ministry of Transport and Telecommunications, the Ministry of Energy, the Ministry of the Environment, the National Consumer Protection Service, among others.

Chile’s future plans to continue working in this area include providing regulatory support to the regulations, involving the relevant authorities, consolidating a coordinated, expedited, and efficient work system, and developing information sources, and implementing a national and international system.

Costa Rica

The agency in charge of consumer defense in Costa Rica is the Consumer Support Directorate (DAC), and the regulations in force are Art. 46 of the Constitution and Law No. 7472 on Promoting Competitiveness and Effective Consumer Defense. Currently, its main activity consists in voluntary withdrawal of products from the market, and the main challenge is controlling incoming products that have been withdrawn in other countries.

An agreement with the Children’s Hospital is in process, with the objective of providing an open channel to safeguard children’s safety. It is also trying to build a module to generate statistics in the DAC, as well as to share information with the organizations it belongs to. It also seeks new media to promote and disseminate information to the consumer.

Ecuador

Consumer protection in Ecuador is regulated under Arts. 42 and 281 of the Constitution, as well as the National Development Plan for Good Living, the Production Code, the Organic Law on Consumer Defense, the Ecuadorian Quality System Law, and the Organic Law of the National Health System.

Work has been done in Ecuador, which has resulted in the establishment of the Inter-Ministry Quality Committee, that not only controls quality, but also carries out surveillance activities upon claims or identifies damages, apart from executing an

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Dominican Republic

The Dominican legal framework for consumer protection and rights include: General Health Law 42-01, the General Law on Environment and Natural Resources 64-00, Law 602-1977 General Law on Quality Regulations and Systems, and others. The entities responsible for surveillance and consumer protection are the Ministry of Public Health and Social Assistance, the Ministry of Agriculture, the Ministry of Industry and Trade, the Directorate-General of Standards and Quality Systems, and the National Consumer Rights Protection Institute.

The main limitations recorded are cross-institutional coordination, budgetary limitations, lack of infrastructure and competent staff, as well as the need for improvement in the procedures for gathering, processing, and channeling information. For this reason, efforts are being made to reassess the organizational structure and the competence and abilities of the inspectors, as well as to develop a strategic plan and obtain centralized databases.

annual surveillance and control plan after the registration of food products. The main challenges it faces are: the reinforcement of information exchange among institutions, the articulation of the existing responsible entities, the improvement of the complaint system, the creation of an efficient market surveillance system, the creation of an assessment system, and the elaboration of surveillance reports.

The organizations authorized for said tasks are: the Consumer Defense Directorate (DIDECO), the Ministry of Industry and Productivity (MIPRO), the Ministry of Public Health, the National Quality Council, the Ecuadorian Normalization Institute and the Ecuadorian Accreditation Agency.

El Salvador

El Salvador has a National Consumer Protection System in place, and there are four organizations with competence in product safety market surveillance: the Ministry of Health, the General Customs Directorate, the National Science and Technology Council, and the Consumer Defense Bureau.

El Salvador monitors alerts in international systems, it has its own normalization processes for making the Obligatory Salvadorian Regulations and the Central-American Technical Regulations, and it implements the Salvadorian Quality and Productivity System. However, its scope is currently limited to food and it lacks funding, staff training, infrastructure, and surveillance capacity. Apart from trying to overcome these obstacles, its action plan includes creating an early alert system, strengthening weak institutional coordination, and expanding its mechanisms of cooperation with other countries.

There are also plans to reinforce the legal framework, which currently consists of Arts. 1 and 100 of the Constitution, the Consumer Protection Law, the Health Code, the National Consumer Protection Policy, among others.

Guatemala

Actions taken in Guatemala are mainly limited to market surveillance through sampling and verification of the identity of the products on store shelves. These activities are carried out mainly in the capital city, since the financial, human, and infrastructure resources available are not enough to take them to the rest of the country. The regulations currently in force are Decree 90-97 (Code and Health), the Food Safety Regulations, and the Health Code, Foodstuffs, Food retail facilities.

The main challenge for Guatemala is deemed to be managing the adequate resources. Support from international organizations is sought, as is the establishment of a national action plan and training the staff of the Ministry of Health and Social Assistance, the General Regulation, Health Control and Surveillance Directorate, the Food Control and Regulation Department, and the National Health Laboratory.

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Mexico

Product safety surveillance in the Mexican market is in the hands of the Ministry of Finance and the Ministry of Health, through the Office of the Federal Prosecutor for the Consumer (PROFECO) and the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), respectively. These organizations carry out regulation, control and health promotion activities, assess health risks, carry out prevention and control, both, regulatory and non-regulatory prevention and control, define product guideline and classification criteria, and make assessment, verification and supervision visits.

The institution’s response capacity is not rapid enough, and the legal instruments available, such as the Federal Consumer Protection Law, the Federal Law on Metrology and Normalization, the Official Mexican Regulations, the General Health Law, etc., are not enough for adequate regulation.

Moreover, the population has been proven to lack adequate access to information. The main challenges are, thus, to have access to information and to inform consumers. These agencies try to achieve this by means of agreements, by sharing information with other organizations, through information collection and training their personnel in order to have their own specialists.

Peru

Consumer defense in Peru is in the hands of the National Institute for the Defense of Competition and Intellectual Property (INDECOPI), and it is regulated under Art. 65 of the Constitution and the Consumer Protection and Defense Code.

Consumer protection in Peru is mainly reactive, although INDECOPI’s activities include the verification of the enforcement of labeling regulations, the organization of consumer education campaigns, inspection visits, etc.

As well as in the other countries, one of the challenges in Peru is coordination among the sectors involved in surveillance, and lack of sources of information, and that is where the current efforts are centered at. Likewise, there is willingness to raise the number of prevention and consumer education activities, as well as to consolidate communication mechanisms between consumers and authorities.

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