FEDERAL OFFICIAL GAZETTE 
Federative Republic of Brazil  National Printing Press 
 
DATE: 10 / 12 / 2010  PAGE: 71 
 
 
Ministry of Fisheries and Aquaculture 
 
MINISTER’S OFFICE 
 
NORMATIVE ACT Nº 14 OF DECEMBER 9, 2010 
 
THE STATE MINISTER OF FISHERIES AND AQUACULTURE, in the exercise of his authority and duties, taking into consideration article 87 of the Federal Constitution and in 
accordance with the provisions of article 27, item XXIV, sub item ( e), of Law nº 10.683 of 
May 28, 2003, amended by Law nº 11.958 of June 26, 2009, jurisdiction regulated by Decree Nº 7.024 of December 07, 2009, and consider ing the need for protection regarding the 
introduction, into national territory, of disease agents that pose a threat to the country’s sanitary conditions, the sustainability of produc tive chains and the Brazilian aquatic fauna, 
has decided: 
 
 Art. 1 To establish the General Procedures for carrying out Import Risk Analysis (IRAs) of fish, fish products and aquatic animals and their respective reproductive materials, 
cells, organs and tissues, taking into account the impact of imports on the Brazilian aquatic 
animal health.   
 Art. 2 To govern how IRAs are conducted and ratified. 
  
 Sole paragraph. The Secretaria de Monitoramento e Controle da Pesca e Aquicultura – 
SEMOC ( Secretariat for the Monitoring and Control of Fisheries and Aquaculture), through the Coordenação Geral de Sanidade Pesqueira – CGSAP (General Coordination Office for 
Aquatic Animal Health), is responsible for conducting and developing the IRAs, as well as 
developing regulations supplementing this Normative Act.   
 
FEDERAL OFFICIAL GAZETTE 
Federative Republic of Brazil  National Printing Press 
 
 
 
CHAPTER 1 
DEFINITIONS 
 
Art. 3  The IRA is the basic method for defining sanitary condition requirements for 
the importation of fish and fish products and aquatic animals, their respective reproductive 
materials, cells, organs and tissues, and for the implementation of risk management procedures that ensures the adequate level of protection established for the identified potential 
hazards.  
 Art. 4  The following shall be taken into consideration in the development of Import 
Risk Analyses: 
 I – concepts and references that are internationally harmonized and have been 
approved in agreemen ts signed by Brazil; 
 II – recommendations from the World Organization for Animal Health (OIE); 
 
III – the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS 
Agreement) of the World Trade Organization (WTO); 
 
IV – other criteria, on the condition they ar e science-based, that can help establish 
methodologies to supplement international requirements. 
 
  
CHAPTER II 
PROCEDURES 
 
 
Art. 5  Any country wishing to export to Brazil, for the first time, certain fish and fish 
products or aquatic animals and their respective reproductive materials, cells, organs and 
tissues, must request the sanitary  requirements for such a process to the Ministry of Fisheries 
and Aquaculture (MPA).  
 § 1º  The MPA will issue its opinion on th e need to conduct an IRA to determine the 
sanitary risk associated with the importation of  the product(s) from the country in question;  
  
 
FEDERAL OFFICIAL GAZETTE 
Federative Republic of Brazil  National Printing Press 
 
 
 § 2º  In case it is determined that an IRA is not necessary, the MPA must provide 
information about the sanitary requirements to be met by the exporting country;  
 
 § 3º  The potential hazards to the aquatic animal health in the country associated with 
the importation of the commodity shall be li sted in a technical report, which will be 
publicized and forwarded to the exporting country.  
 
Art. 6  The MPA may, at any time, and if it deems it necessary, issue a technical report 
on the need to conduct an IRA to determine the sanitary risk pertaining to the entry of fish and 
fish products or aquatic animals and their respective reproductive materials, cells, organs and tissues that have previously entered Brazil.  
 
Art. 7  If there are no potential hazards listed in the technical report, and it therefore 
indicates there is no need to conduct an IRA,  the sanitary import requirements shall be 
forwarded to Ministério da Agricultura, Pecuária e Abastecimento   - MAPA [ the Brazilian 
Ministry for Agriculture, Livestock and Food Supply ], so the Ministry can take any 
appropriate action under its responsibility.  
 
Art. 8  The MPA is also responsible for encouraging, at any time, the regulation or 
revision of the sanitary requirements for importation of fish and fish products and aquatic 
animals, and their respective reproductive materials, cells, organs and tissues that it deems as 
posing a sanitary risk to Brazil. 
 
Sole paragraph. In case there is a sanitary emergency in any given exporting country, 
the MPA may request the MAPA to suspend all imports of fish and fish products and aquatic animals, and their respective reproductive mate rials, cells, organs and tissues, until later 
definition of mitigating measures.  
 Art. 9  The MPA shall be responsible for advertising these procedures as well as 
maintaining an updated information list of the Import Risk Analyses on the Ministry’s Web 
site . 
Art. 10  The Import Risk Analyses are cl assified into the two following types: 
 
I – qualitative; or 
 II – quantitative. 
 
  
 
FEDERAL OFFICIAL GAZETTE 
Federative Republic of Brazil  National Printing Press 
 
Art. 11  The Import Risk Analysis (IR A), regardless of type, must include the 
following steps: 
 
I – Identification of the hazards associated with the import requested, taking into 
account: 
 
a) available scientific data; 
b) relevant processes and production methods; 
c) relevant testing, sampling and inspection procedures; 
d) prevalence of specific diseases; 
e) existence of disease-free countries, zones or compartments; 
f) quarantine procedures. 
 
II – Risk estimation by evaluating the release and exposure assessments associated with the hazards identified as well as the extent and the scope of their consequences. It 
is the responsibility of the CGSAP/SEMOC/MPA to request the following: 
 a) additional information from the sanitary  authorities of the country of origin; 
b) the cooperation of national and international experts; or 
c) a public consultation.  
 
III – Risk management associated with the hazards identified, while considering the 
possibility of establishing mitigating measures;  
IV –Final report preparation, with the subsequent communication of risks and 
disclosure of outcomes.   
Art. 12  The results of the IRAs will be posted on the MPA Web site and forwarded 
via official communication to MAPA  and to the exporting country.  
 Art. 13  This Normative Act comes into effect on the date of its publication. 
 Art. 14  Normative Act (MPA) no. 12 of August 20, 2010, is hereby repealed. 
 
 
 
ALTEMIR GREGOLIN