FAO-WHO Global Forum of Food Safety Regulators

Agenda Item 4.4 a) GF 01/13

FAO/WHO Global Forum of Food Safety Regulators
Marrakesh, Morocco, 28-30 January 2002

Brazil Institutional Experience for the Implementation of Risk Analysis

Antonia Maria de Aquino
Ministry of Health, Brazil

I. General Considerations
II. Institutional Experiences

I. General Considerations

The National Agency for Sanitary Surveillance (NASS) of the Ministry of Health (MH) was established in January, 1999. The mission of the Agency is "to protect and promote health ensuring sanitary safety of products and services", especially for food and their corresponding manufacturing units. It is worth noting that the actions for food sanitary control in Brazil are shared by the health and agriculture sectors.

Both experiences, which will be discussed here, were managed by the NASS.

The initiatives of the food sector of the Agency to set risk analyses in motion have been directed towards the improvement of control and sanitary inspection systems for certain products.

The Risk Analysis process seeks to estimate the risk for human health associated with the presented scenario as well as to select and implement the appropriate measures to control such risks with the aim to ensure safe food for the population. The impact on human health is the main concern of the risk analysis process.

Considering the three components interacting to integrate the risk analysis process, NASS has proceeded as follows:

Risk evaluation is based upon existing official epidemiological data, upon analytical results of the specific product, and upon the analysis of the food manufacturing process with a view towards identifying the critical stage, which requires systematic control;

Risk management involves the updating of sanitary norms, technical training for inspectors, and the implementation of national programs for sanitary inspection and monitoring of food sanitary quality;

Risk communication is achieved by disseminating in the media information on the foodborne risks posed by a given product; by warnings in product labels; and by delivering instructive material to raise public awareness of the risks coming from a certain food.

The risk analysis process is achieved through the participation of the different parties involved -as recommended by the Codex Alimentarius directives- including health and agriculture official institutions, representative entities from the productive sector, teaching and investigation institutions, and consumers' protection organizations, all of them essential to ensure the transparency of the whole process as well as of decision-making.

Issues to deal with following the risk analysis process have mainly emerged from epidemiological data and food control program outcomes which indicate a risk situation coming from the combination food-agent.

II. Institutional Experiences

Botulism in Canned Palm Heart

Since the occurrence of three cases of canned palm heart-associated botulism in 1997, 1998 and 1999, risk analysis was started and the Technical Group was established, formed by different interested parties or stakeholders, such as the scientific community, e.g., the Food Technology Institute (FTI) and the Adolfo Lutz Institute (ALI); members of representative entities of the productive sector - Brazilian Association of Food Industries (BAFI), members of the Brazilian Environment Institute (BEI), members of Sanitary Surveillance from the States, the National Agency for Sanitary Surveillance (NASS), Epidemiological Surveillance, and consumers' representatives -Consumers' Protection Institute (CPI).

As described above, the warning label was an emergency measure adopted provisionally, since after the results from the National Program for Sanitary Inspection of Canned Palm Heart Industry, the companies approved were exempted from wearing the warning label in their products. The registration of the products from companies which did not meet the requirements was cancelled, and the authorization to process such products was withdrawn.

Due to the emergency nature of the situation and the remarkable virulence of the toxin Clostridum botulinum, a Warning to the Population was published in the most popular newspapers of the country; also, an official release was made to the Sanitary Surveillance Bodies of the States, recalling the brands which have caused the outbreak and it was decided to carry out laboratory analyses to monitor if the pH, considered the Critical Control Point of the product, was within the 4.5 limit in all the batches available in the market.

Following the Warning to the Population, the official press published the resolution that canned palm hearts should be labeled in a clear and readable way for the consumers, with the following warning: "For safety, this product should only be consumed after being boiled either in the can fluid or in freshwater for 15 minutes". This warning was elaborated from scientific studies developed by the Food Technology Institute (FTI).

The Consumers' Protection Institute played a crucial role in communication since it carried out a market research collecting samples from 15 (fifteen) separate brands of canned palm heart. The outcome of this study was made known through an interview about canned palm heart-associated botulism in the most important television network during prime time. Brands were prohibited and their batches released only after an additional laboratory analysis was performed.

As the hazard has been clearly identified and characterized, risk evaluation was based upon the study of the productive process, specifically upon identification of the canned palm heart processing stages considered critical for Clostridium botulinum control. As a result of the study, the stages of product acidification and thermal treatment were identified.

Based upon the studies carried out, Resolutions RDC NASS Nbr. 17 and 18/1999 for Canned Palm Heart Standard and Good Manufacturing Practices, respectively, were endorsed. According to the information emerging from the Regulations, the Technical Group elaborated directives for the National Program of Sanitary Inspection for the Canned Palm Heart Industry. The resolutions established a term of 180 (one hundred and eighty) days for the companies to implement Good Manufacturing Practices (GMP) and monitoring of Critical Control Points of the productive process. To meet these requirements, companies should also train a specialist in GMP.

NASS asked the Brazilian Supermarket Association to buy only canned palm hearts having the warning label while this provision was still in effect -29 April, 1999 to 19 February, 2000. After February 2000, the companies could not continue marketing the canned palm heart with the warning label, they should buy and distribute only products with registration and brand authorized by Sanitary Surveillance.

By that time, the population was informed through the media they could consume canned palm heart without the warning label, since the products commercially available had been authorized at the sanitary inspection. NASS offered a site in the Internet including all the brands, industries, and numbers of approved registrations after they have been gazetted (Boletín Oficial de la Unión).

Due to the occurrence of cases of canned palm heart-associated botulism, risk communication showed the need to re-organize the Sanitary and Epidemiological Surveillance Systems in Brazil. To pay better attention to cases, epidemiological surveillance of the major State of the country, São Paulo, established a Reference Center for Botulism. This national-scope center is in operation 24 hours a day, available through a toll-free line (0800) telephone line and has a technical team trained in giving orientation and advice to health professionals regarding diagnosis, treatment, and research on the different signs and symptoms of the disease. The Reference Center for Botulism comprises the Institute Butantan, also located in São Paulo, which has the technical conditions to produce and have the anti-botulinic serum for the whole country and for Latin America.

The setting up of the inspection program within industries was the responsibility of sanitary surveillance bodies of the states, jointly with NASS, and was achieved by sensitizing sanitary inspectors on the importance of product control, and training of 62 (sixty two) inspectors regarding Good Manufacturing Practices for canned palm heart, the productive process safety evaluation, and harmonization of technical-legal procedures.

Only industries (including new industries, in-operation industries, and industries exporting palm heart to Brazil) controlling the critical points of the productive process defined by risk assessors, and meeting other requirements established by the aforementioned Resolutions, were approved during sanitary inspection. There were nearly 519 (five hundred and nineteen) industries when the Program was started; this figure dropped to 120 authorized industries in September 2001. Also, 267 (two hundred and sixty seven) product registrations were cancelled.

Since the implementation of the Program, routine sanitary inspection was established as well as the commitment of the productive sector regarding the product safety.

Although risk communication was, in principle, an experience which had an effect on the productive sector and decreased product consumption in the country, communication was found to be extremely positive, considering the following aspects:

training of 62 inspectors from NASS and the 27 surveillance agencies from the States regarding GMP for canned palm heart;

enhancement of sanitary inspection at producing premises and stores;

organization of the productive sector in associated entities;

mandatory implementation for industries to have a trained technician in GMP in canned palm heart;

creation and availability in the internet of a data base on brands, registrations and industries authorized by sanitary surveillance and those whose registrations had been cancelled;

encouragement for the creation of a Reference Center for Botulism, what allowed for the re-organization of the flow of notification and sanitary, epidemiological, and laboratory investigation of the disease

Since the risk communication as of April 1999, no other case of canned palm heart-associated botulism was observed in Brazil.

Iodine Deficiency Disorders in salt for human consumption

Risk analysis was developed after the establishment of an inter-institutional commission in November, 1999, which gathered all interested parties, stakeholders. The commission was formed by the Ministry of Health, represented by the Department of Health Policy, Sanitary Surveillance, Epidemiological Surveillance; the Ministry of Agriculture, the United Nations Children's Fund (UNICEF) and representative associations and consortiums of the productive sector. This Committee gathered periodically ensuring exchange of information among the involved parties.

The committee decided that the Department of Health Policy would take part in the Thyromobil Project, developed by the International Council for the Control of Iodine Deficiency Disorders (ICCIDD), to evaluate goiter prevalence among 1,977 school children (6-12 years old) from 06 units of the Federation, as well as the level of iodine in the salt consumed in the children's homes. The result of the project showed the prevalence of goiter to be approximately 2%, that is, a value lower than 5%, the normal limit established by the World Health Organization. Regarding iodine content in the salt consumed in the children's homes, the total average obtained was 48.3 ppm, this value being within the limits legally established in the country (40-100 ppm). The outcomes showed a high standard deviation among samples, more precisely, a 29 ppm. average. The analysis of samples of salt intended for human consumption carried out routinely by the sanitary surveillance services confirm the standard deviation obtained by the Thyromobil Project.

Based on the Thyromobil Project results, more specifically, considering iodine high standard deviation in salt samples collected from the children's homes, the inter-institutional commission verified the need to adopt measures to ensure the standard deviation control during the processing of salt for human consumption.

In that sense, the National Agency for Sanitary Surveillance elaborated Technical Regulations, Resolution NASS RDC Nbr. 28/2000, defining Good Manufacturing Practices for salt for human consumption, highlighting which controls should be carried out by each establishment to ensure appropriate iodine levels in the end product. At the same time, with the publication of such technical regulations, NASS established the "National Program for Sanitary Inspection of Establishments Producing Salt for Human Consumption" with the purpose of inspecting 100% of national companies. According to the directives of the Program, salt establishments go through a first inspection step during which salt processing conditions are evaluated. When the Program identifies an establishment which does not meet all the requirements of the technical regulations, it is given a term of 180 days to proceed to adaptation.

After the expiration of this term, establishments will be re-inspected, and only those which fully meet the requirements of the Technical Regulations will be authorized. It was also stated that only establishments approved in the National Program will be authorized for the commercialization of salt for human consumption. With the aim to ensure risk communication to the productive sector, the National Service for Industrial Learning (NSIL) was included in the National Program in order to disseminate in the sector the control measures regulated by NASS, and the reasons for their adoption, and also to provide companies with technical assistance to put these measures into effect.

This National Program is at the end of its initial stage of sanitary inspection, with 122 establishments inspected up to the present.

Apart from the need to establish measures to manage the high deviation of iodine content in salt for human consumption, as revealed by the Thyromobil Project, the inter-institutional commission highlighted the need to inform the consumers about the risks from iodine deficient consumption as well as the importance of iodine salt for the control of Iodine Deficiency Disorders (IDD). Therefore, advertising campaigns were elaborated for television and radio, apart from the informative material delivered to schools, and urban and rural areas.

During the risk communication process, we highlight the importance of the health community agent. This agent is a community member trained by the Ministry of Health in basic health measures, forming a network of 144,000 members all over the Federative Units of Brazil. According to the Control Program of Iodine Deficiency Disorders, these agents took part in the risk communication to the population through house calls explaining the importance of the consumption of iodine salt and the appropriate conditions of product storage.

Among the results obtained through the exchange among involved entities, it is worth mentioning the re-evaluation of analytical methodology used by official laboratories after the account of the productive sector experiences, the recognition of the need to establish an expiration date for iodine salt, and the learning about salt consumption habits in low-income rural populations.



Agenda Item 4.4 a)	GF 01/13
FAO/WHO Global Forum of Food Safety Regulators Marrakesh, Morocco, 28-30 January 2002 Brazil Institutional Experience for the Implementation of Risk Analysis Antonia Maria de Aquino Ministry of Health, Brazil I. General Considerations II. Institutional Experiences I. General Considerations The National Agency for Sanitary Surveillance (NASS) of the Ministry of Health (MH) was established in January, 1999. The mission of the Agency is "to protect and promote health ensuring sanitary safety of products and services", especially for food and their corresponding manufacturing units. It is worth noting that the actions for food sanitary control in Brazil are shared by the health and agriculture sectors. Both experiences, which will be discussed here, were managed by the NASS. The initiatives of the food sector of the Agency to set risk analyses in motion have been directed towards the improvement of control and sanitary inspection systems for certain products. The Risk Analysis process seeks to estimate the risk for human health associated with the presented scenario as well as to select and implement the appropriate measures to control such risks with the aim to ensure safe food for the population. The impact on human health is the main concern of the risk analysis process. Considering the three components interacting to integrate the risk analysis process, NASS has proceeded as follows: Risk evaluation is based upon existing official epidemiological data, upon analytical results of the specific product, and upon the analysis of the food manufacturing process with a view towards identifying the critical stage, which requires systematic control; Risk management involves the updating of sanitary norms, technical training for inspectors, and the implementation of national programs for sanitary inspection and monitoring of food sanitary quality; Risk communication is achieved by disseminating in the media information on the foodborne risks posed by a given product; by warnings in product labels; and by delivering instructive material to raise public awareness of the risks coming from a certain food. The risk analysis process is achieved through the participation of the different parties involved -as recommended by the Codex Alimentarius directives- including health and agriculture official institutions, representative entities from the productive sector, teaching and investigation institutions, and consumers' protection organizations, all of them essential to ensure the transparency of the whole process as well as of decision-making. Issues to deal with following the risk analysis process have mainly emerged from epidemiological data and food control program outcomes which indicate a risk situation coming from the combination food-agent. II. Institutional Experiences Botulism in Canned Palm Heart Since the occurrence of three cases of canned palm heart-associated botulism in 1997, 1998 and 1999, risk analysis was started and the Technical Group was established, formed by different interested parties or stakeholders, such as the scientific community, e.g., the Food Technology Institute (FTI) and the Adolfo Lutz Institute (ALI); members of representative entities of the productive sector - Brazilian Association of Food Industries (BAFI), members of the Brazilian Environment Institute (BEI), members of Sanitary Surveillance from the States, the National Agency for Sanitary Surveillance (NASS), Epidemiological Surveillance, and consumers' representatives -Consumers' Protection Institute (CPI). As described above, the warning label was an emergency measure adopted provisionally, since after the results from the National Program for Sanitary Inspection of Canned Palm Heart Industry, the companies approved were exempted from wearing the warning label in their products. The registration of the products from companies which did not meet the requirements was cancelled, and the authorization to process such products was withdrawn. Due to the emergency nature of the situation and the remarkable virulence of the toxin Clostridum botulinum, a Warning to the Population was published in the most popular newspapers of the country; also, an official release was made to the Sanitary Surveillance Bodies of the States, recalling the brands which have caused the outbreak and it was decided to carry out laboratory analyses to monitor if the pH, considered the Critical Control Point of the product, was within the 4.5 limit in all the batches available in the market. Following the Warning to the Population, the official press published the resolution that canned palm hearts should be labeled in a clear and readable way for the consumers, with the following warning: "For safety, this product should only be consumed after being boiled either in the can fluid or in freshwater for 15 minutes". This warning was elaborated from scientific studies developed by the Food Technology Institute (FTI). The Consumers' Protection Institute played a crucial role in communication since it carried out a market research collecting samples from 15 (fifteen) separate brands of canned palm heart. The outcome of this study was made known through an interview about canned palm heart-associated botulism in the most important television network during prime time. Brands were prohibited and their batches released only after an additional laboratory analysis was performed. As the hazard has been clearly identified and characterized, risk evaluation was based upon the study of the productive process, specifically upon identification of the canned palm heart processing stages considered critical for Clostridium botulinum control. As a result of the study, the stages of product acidification and thermal treatment were identified. Based upon the studies carried out, Resolutions RDC NASS Nbr. 17 and 18/1999 for Canned Palm Heart Standard and Good Manufacturing Practices, respectively, were endorsed. According to the information emerging from the Regulations, the Technical Group elaborated directives for the National Program of Sanitary Inspection for the Canned Palm Heart Industry. The resolutions established a term of 180 (one hundred and eighty) days for the companies to implement Good Manufacturing Practices (GMP) and monitoring of Critical Control Points of the productive process. To meet these requirements, companies should also train a specialist in GMP. NASS asked the Brazilian Supermarket Association to buy only canned palm hearts having the warning label while this provision was still in effect -29 April, 1999 to 19 February, 2000. After February 2000, the companies could not continue marketing the canned palm heart with the warning label, they should buy and distribute only products with registration and brand authorized by Sanitary Surveillance. By that time, the population was informed through the media they could consume canned palm heart without the warning label, since the products commercially available had been authorized at the sanitary inspection. NASS offered a site in the Internet including all the brands, industries, and numbers of approved registrations after they have been gazetted (Boletín Oficial de la Unión). Due to the occurrence of cases of canned palm heart-associated botulism, risk communication showed the need to re-organize the Sanitary and Epidemiological Surveillance Systems in Brazil. To pay better attention to cases, epidemiological surveillance of the major State of the country, São Paulo, established a Reference Center for Botulism. This national-scope center is in operation 24 hours a day, available through a toll-free line (0800) telephone line and has a technical team trained in giving orientation and advice to health professionals regarding diagnosis, treatment, and research on the different signs and symptoms of the disease. The Reference Center for Botulism comprises the Institute Butantan, also located in São Paulo, which has the technical conditions to produce and have the anti-botulinic serum for the whole country and for Latin America. The setting up of the inspection program within industries was the responsibility of sanitary surveillance bodies of the states, jointly with NASS, and was achieved by sensitizing sanitary inspectors on the importance of product control, and training of 62 (sixty two) inspectors regarding Good Manufacturing Practices for canned palm heart, the productive process safety evaluation, and harmonization of technical-legal procedures. Only industries (including new industries, in-operation industries, and industries exporting palm heart to Brazil) controlling the critical points of the productive process defined by risk assessors, and meeting other requirements established by the aforementioned Resolutions, were approved during sanitary inspection. There were nearly 519 (five hundred and nineteen) industries when the Program was started; this figure dropped to 120 authorized industries in September 2001. Also, 267 (two hundred and sixty seven) product registrations were cancelled. Since the implementation of the Program, routine sanitary inspection was established as well as the commitment of the productive sector regarding the product safety. Although risk communication was, in principle, an experience which had an effect on the productive sector and decreased product consumption in the country, communication was found to be extremely positive, considering the following aspects: training of 62 inspectors from NASS and the 27 surveillance agencies from the States regarding GMP for canned palm heart; enhancement of sanitary inspection at producing premises and stores; organization of the productive sector in associated entities; mandatory implementation for industries to have a trained technician in GMP in canned palm heart; creation and availability in the internet of a data base on brands, registrations and industries authorized by sanitary surveillance and those whose registrations had been cancelled; encouragement for the creation of a Reference Center for Botulism, what allowed for the re-organization of the flow of notification and sanitary, epidemiological, and laboratory investigation of the disease Since the risk communication as of April 1999, no other case of canned palm heart-associated botulism was observed in Brazil. Iodine Deficiency Disorders in salt for human consumption Risk analysis was developed after the establishment of an inter-institutional commission in November, 1999, which gathered all interested parties, stakeholders. The commission was formed by the Ministry of Health, represented by the Department of Health Policy, Sanitary Surveillance, Epidemiological Surveillance; the Ministry of Agriculture, the United Nations Children's Fund (UNICEF) and representative associations and consortiums of the productive sector. This Committee gathered periodically ensuring exchange of information among the involved parties. The committee decided that the Department of Health Policy would take part in the Thyromobil Project, developed by the International Council for the Control of Iodine Deficiency Disorders (ICCIDD), to evaluate goiter prevalence among 1,977 school children (6-12 years old) from 06 units of the Federation, as well as the level of iodine in the salt consumed in the children's homes. The result of the project showed the prevalence of goiter to be approximately 2%, that is, a value lower than 5%, the normal limit established by the World Health Organization. Regarding iodine content in the salt consumed in the children's homes, the total average obtained was 48.3 ppm, this value being within the limits legally established in the country (40-100 ppm). The outcomes showed a high standard deviation among samples, more precisely, a 29 ppm. average. The analysis of samples of salt intended for human consumption carried out routinely by the sanitary surveillance services confirm the standard deviation obtained by the Thyromobil Project. Based on the Thyromobil Project results, more specifically, considering iodine high standard deviation in salt samples collected from the children's homes, the inter-institutional commission verified the need to adopt measures to ensure the standard deviation control during the processing of salt for human consumption. In that sense, the National Agency for Sanitary Surveillance elaborated Technical Regulations, Resolution NASS RDC Nbr. 28/2000, defining Good Manufacturing Practices for salt for human consumption, highlighting which controls should be carried out by each establishment to ensure appropriate iodine levels in the end product. At the same time, with the publication of such technical regulations, NASS established the "National Program for Sanitary Inspection of Establishments Producing Salt for Human Consumption" with the purpose of inspecting 100% of national companies. According to the directives of the Program, salt establishments go through a first inspection step during which salt processing conditions are evaluated. When the Program identifies an establishment which does not meet all the requirements of the technical regulations, it is given a term of 180 days to proceed to adaptation. After the expiration of this term, establishments will be re-inspected, and only those which fully meet the requirements of the Technical Regulations will be authorized. It was also stated that only establishments approved in the National Program will be authorized for the commercialization of salt for human consumption. With the aim to ensure risk communication to the productive sector, the National Service for Industrial Learning (NSIL) was included in the National Program in order to disseminate in the sector the control measures regulated by NASS, and the reasons for their adoption, and also to provide companies with technical assistance to put these measures into effect. This National Program is at the end of its initial stage of sanitary inspection, with 122 establishments inspected up to the present. Apart from the need to establish measures to manage the high deviation of iodine content in salt for human consumption, as revealed by the Thyromobil Project, the inter-institutional commission highlighted the need to inform the consumers about the risks from iodine deficient consumption as well as the importance of iodine salt for the control of Iodine Deficiency Disorders (IDD). Therefore, advertising campaigns were elaborated for television and radio, apart from the informative material delivered to schools, and urban and rural areas. During the risk communication process, we highlight the importance of the health community agent. This agent is a community member trained by the Ministry of Health in basic health measures, forming a network of 144,000 members all over the Federative Units of Brazil. According to the Control Program of Iodine Deficiency Disorders, these agents took part in the risk communication to the population through house calls explaining the importance of the consumption of iodine salt and the appropriate conditions of product storage. Among the results obtained through the exchange among involved entities, it is worth mentioning the re-evaluation of analytical methodology used by official laboratories after the account of the productive sector experiences, the recognition of the need to establish an expiration date for iodine salt, and the learning about salt consumption habits in low-income rural populations.