Section I Risk Analysis
OPERATIONALIZATION AND CONTROL Section I
Drafting of Complementary Norms of Good Practices
Art. 86. The Agriculture and Livestock Health Care Unified System’s Three Organs shall draft complementary norms of good practices for agri-culture and livestock health, including operating hygiene standard procedures to permit the appli-cation of pest and disease risk analysis principles and of hazard analysis and critical control points consistently with these Regulations.
Paragraph 1. The National Agricultural Pol-icy Council shall approve the national and state complementary norms and determine their pe-riodical review.
Paragraph 2. Said review’s purpose is to en-sure that the complementary norms continue to be objectively applied and to incorporate scien-tific and technologic advances.
Paragraph 3. The national complementary norms’ titles and references shall be published and publicized throughout the national territory.
Paragraph 4. The national complementary norms of good practices shall be drafted for each production chain and with the participation of producers and other agents on the chain, and shall take into consideration pertinent comple-mentary norms of good practices of reference international organizations.
Art. 87. The Intermediate Organs may, at their discretion and keeping in view specific in-terests, draft their own complementary norms of good practices, which shall be submitted to the Ministry of Agriculture, Livestock, and Food Sup-ply as Central and Superior Organ and to other Intermediate Organs for their information.
CHAPTER VI
OPERATIONALIZATION AND CONTROL Section I
Laboratory Control
Art. 88. Analysis methods should meet the following criteria:
I – Accuracy;
II – Applicability (matrix and concentration spectrum);
X – Measurements uncertainty; and
XI – Other criteria that may be chosen as needed.
Paragraph 1. The results indicating the accu-racy referred to in item I above should be obtained through trial of groups of products conducted in accordance with nationally or internationally rec-ognized protocols and, if performance criteria have been established for the analysis methods, accuracy should be based on conformity tests.
Paragraph 2. Results of trial of groups of products shall be published or made available without restriction.
Paragraph 3. Analysis methods uniformly applied to several groups of products shall be preferable to methods applicable only to specific products.
Paragraph 4. Special norms and guidelines aimed at harmonization shall be established for situations in which:
I – The analysis methods can be validated solely at accredited or reference laboratories;
and
II – The performance criteria for the analysis methods are abased on conformity tests.
Art. 89. Analysis methods adapted to these Regulations shall be conceived pursuant to speci-fications and to nationally and internationally recommended analysis methods.
Section II Sampling
Art. 90. Sampling and analysis methods used for official controls should comply with ap-plicable Brazilian norms.
Paragraph 1. The analysis methods should be validated in laboratories in accordance with national norms or with internationally recom-mended protocols.
Paragraph 2. In the absence of internation-ally recognized national norm or protocol, the
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Ministry of Agriculture, Livestock, and Food Sup-ply as Central and Superior Organ shall approve norms or instructions defining appropriate meth-ods for achieving the intended objective.
Paragraph 3. The analysis methods should have the characteristics defined hereunder.
Art. 91. The competent authorities of the Min-istry of Agriculture, Livestock, and Food Supply as Central and Superior Organ shall regulate counter-proof procedures and establish appropriate proce-dures to ensure the right of producers of animals, plants, inputs – including animal feed – and animal and plant products, whose products are subjected to sampling and analysis, to seek the opinion of another accredited expert as prescribed, without prejudice to the competent authorities’ obligation to take prompt measures in emergencies.
Sole Paragraph. Counterproof procedures and second opinions do not apply in case of risks associated with animals, plants, and perishable agricultural and livestock products.
Art. 92. Samples should be properly collect-ed, handlcollect-ed, conditioncollect-ed, identificollect-ed, and trans-ported so as to ensure their validity for analysis.
Section III
Agriculture and Livestock Health Care Unified System’s Controls
Art. 93. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ shall perform general and specific audits in the Intermediate and Local Organs to assess the conformity of their controls and activities with national multi-year control plans.
Paragraph 1. The Ministry of Agriculture, Livestock, and Food Supply as Central and Supe-rior Organ may designate Intermediate and Local Organ experts, if necessary, to perform or support general and specific audits at the other Interme-diate and Local Organs.
Paragraph 2. General and specific audits shall be performed in coordination with and with the cooperation of the competent authorities of the Intermediate and Local Organs.
Paragraph 3. General audits shall be regular-ly performed in accordance with the multi-year control plans.
Paragraph 4. Before general audits, ,
cur-rent information on the sanitary agriculture and livestock controls may be requested at the discre-tion of the Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ.
Art. 94. General audits shall be complement-ed with specific audits and specific inspections in one or more than one specified area.
Paragraph 1. Specific audits and inspections have the following purposes:
I – To assess the implementation of the na-tional multi-year control plan and the enforce-ment of legislation pertaining to animals, plants, inputs – including animal feed – and animal and plant products, and may include, as the case may be, on-site inspection of official services and fa-cilities associated with the production chain sub-jected to the audit.
II – To assess the Intermediate and Local Organs’ operation conditions and their work or-ganization;
III – To identify, evaluate, and propose con-tingency or emergency plans geared to relevant, critical, or recurring problems at the Intermedi-ate and Local Organs; and
IV – To investigate emergency situations, emerging problems, resolution of contingency plans, or improvements at Intermediate and Lo-cal Organs.
Paragraph 2. The Ministry of Agriculture, Livestock, and Food Supply as Central and Supe-rior Organ shall prepare a report on the results of audits in which it participates.
Paragraph 3. The reports should include, as the case may be, recommendations to the Inter-mediate and Local Organs aimed at enhancing compliance with the agriculture and livestock health and inspection legislation.
Paragraph 4. The Ministry of Agriculture, Livestock, and Food Supply as Central and Supe-rior Organ shall submit to the Intermediate and Local Organ’s competent authority the draft re-port, and the competent authority shall submit its opinion and comments within thirty days.
Paragraph 5. The Intermediate and Local Organ’s opinion and comments shall be included in the final report, provided they are submitted by the deadline established in the preceding Paragraph.
41 Paragraph 6. The reports shall be publicized
as determined by the Ministry of Agriculture, Livestock, and Food Supply as Central and Supe-rior Organ.
Art. 95. The Intermediate and Local Organs shall:
I – Participate in general and specific audits performed by the Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ;
II – Perform their own general and specific audits;
III – Adopt corrective measures pursuant to the recommendations stemming from the audits;
IV – Provide all the requisite assistance and all the documentation and any other kind of technical support requested by the Ministry of Agriculture, Livestock, and Food Supply as Cen-tral and Highest Organ; and
V – Grant the auditors of the Ministry of Ag-riculture, Livestock, and Food Supply as Central and Superior Organ access to all the facilities or parts thereof as well as to all requested informa-tion, including information systems, which may be relevant for the audit.
Art. 96. The Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ shall at any time assess the sanitary or phytosani-tary conditions or the consistency between the legislation and the sanitary agriculture and live-stock systems adopted by the Intermediate and Local Organs as pertains the federal agriculture and livestock healt and inspection legislation.
Section IV
Imports and Exports Control
Art. 97. Importers of animals, plants, inputs – including animal feed – and animal and plant products susceptible of presenting the risk of in-troduction and dissemination of diseases or pests are obligated to meet the requirements hereun-der and comply with the norms established by the Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ.
Art. 98. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ shall, on the basis of risk analysis, estab-lish and keep current a list of pests and diseases,
animals, plants, inputs – including animal feed – and animal and plant products that will be subjected to official controls at the points of en-try into the national territory, at the authorities’
discretion.
Art. 99. The competent authorities of the Ministry of Agriculture, Livestock, and Food Sup-ply as Central and Superior Organ shall under-take official controls to verify conformity with the legislation pertaining to importation and expor-tation, as specified hereunder.
Art. 100. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ shall define, under specific norms and by country, special controls prior to the exportation to Brazil of animals, plants, inputs – including animal feed – and animal and plant products to ensure that the requirements and other condi-tions hereunder are met.
Paragraph 1. Approval shall be granted re-garding animals, plants, inputs – including ani-mal feed – and aniani-mal and plant products from countries that have a sanitary agreement with Brazil; approval may be granted to one or more than one product.
Paragraph 2. Should approval be granted pursuant to the preceding Paragraph, the con-trol of the importation of animals, plants, in-puts – including animal feed – and animal and plant products will be simplified and expedited in accordance with the associated risk and the specific rules established by the Ministry of Ag-riculture, Livestock, and Food Supply as Central and Superior Organ.
Paragraph 3. Controls prior to exportation undertaken at the country of origin may be effi-cient, at the competent authority’s discretion, the undertaking of further official controls may be re-quested to confirm the healthiness and quality of the imported animals, plants, inputs – including animal feed – and animal and plant products.
Paragraph 4. The approval referred to in Para-graph 1 above shall be granted, provided that:
I – The audits or official procedures under-taken on the basis of specifications defined by the Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ prove that the animals, plants, inputs – including animal
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feed – and animal and plant products exported to Brazil meet the requirements hereunder or equivalent requirements; and
II – The controls undertaken at the country of origin prior to shipment are deemed suffi-ciently efficient and effective to replace or reduce the documental, identity, and physical control contemplated hereunder.
Paragraph 5. The approval shall identify the competent authority in the country of origin under whose responsibility the controls prior to exportation are undertaken.
Paragraph 6. The competent authority or control organ specified in the approval of the ex-porter country shall be responsible for contacts with the Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ.
Paragraph 7. The competent authority or control organ in the exporting country shall en-sure the official certification of the controlled shipment before the latter’s entry into the na-tional territory.
Paragraph 8. The approval shall specify the certificate forms.
Paragraph 9. Should the official control of imports subject to the aforementioned proce-dure detect any noncompliance with these Regu-lations, the authorities of the Ministry of Agricul-ture, Livestock, and Food Supply as Central and Superior Organ shall broaden inspections and controls, pursuant to the noncompliance’s seri-ousness, and undertake new risk analysis, and shall immediately notify the exporting countries in accordance with the pertinent agriculture and livestock sanitary agreements.
Paragraph 10. Should the noncompliance referred to in Paragraph 9 above persist or should the noncompliance jeopardize the objectives hereunder, including agriculture and livestock health, the application of the simplified or fast control regime shall be immediately suspended.
Art. 101. In addition to the legal ments of the importing countries, the require-ments of these Regulations and of the current sanitary and phytosanitary legislation must be met in connection with the exportation or reex-portation of animals, plants, inputs – including animal feed – and animal and plant products.
Art. 102. The Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ shall establish specific norms for the undertaking of importation control pertaining to the following:
I – Animals and plants without commercial value, whenever international transportation means are used;
II – Exemptions or specific conditions appli-cable to certain processing, industrialization, and immediate exportation procedures;
III – Animal and plant products for supplying crew and passengers of international means of transportation;
IV – Inputs, including animal feed, and animal and plant products ordered by mail, telephone, or the internet, and delivered to the consumer;
V – Animal feed and animal and plant prod-ucts carried by crew and passengers of interna-tional means of transportation;
VI – Shipments from Brazil that are being re-turned by importing countries; and
VI I- Documents that must accompany ship-ments, whenever samples are collected.
Art. 103. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ may at any time evaluate the sanitary con-dition or the equivalence of the legislation and of the agriculture and livestock sanitary systems of exporter and importer countries with the Brazil-ian agriculture and livestock health and inspec-tion legislainspec-tion.
Paragraph 1. The Ministry of Agriculture, Livestock, and Food Supply as Central and Supe-rior Organ may at its discretion designate experts or specialists for the specific tasks referred to in this article’s heading.
Paragraph 2. Evaluations should address the following items, among others:
I – The consistency and coherence of the ex-porter country’s agriculture and livestock health and inspection legislation;
II – The organization and functioning of the exporter country’s official services, and compe-tent authorities and their attributions and au-tonomy;
III – The personnel’s and team’s qualification for the performance of the official controls;
43 IV – The infrastructure in place, including
diagnostic laboratories and facilities;
V – The existence and functioning of control procedures;
VI – The situation of animal health, zoonoses, and sanitary and phytosanitary control, and pro-cedures for the notification of animal and plant disease outbreaks or events; and
VII – The guarantees the exporter countries can offer of compliance with the national re-quirements, or of sanitary equivalence.
Paragraph 3. The frequency of evaluation of the agriculture and livestock sanitary conditions in the countries that export to Brazil shall be de-termined on the basis of the following:
I – Risk analysis of the exported products;
II – Brazilian legal dispositions;
III – Volume and nature of imports from the country in question;
IV – Results of previous evaluations done by the Ministry of Agriculture, Livestock, and Food Supply as Central and Superior Organ;
V – Results of importation controls;
VI – Information received from other or-gans;
VII – Information received from internation-ally recognized sources, such as the World Health Organization, the Codex Alimentarius, the Inter-national Plant Protection Convention, and the World Organization for Animal Health;
VIII – Detection of diseases and pests in the exporting country;
IX – Identification of risks associated with animals, plants, and perishable agricultural and livestock products; and
X – Need to investigate emergency situations in the exporter country.
Art. 104. Should risk analysis identify risks associated with animals, plants, and perishable agricultural and livestock products, the Ministry of Agriculture, Livestock, and Food Supply as Cen-tral and Superior Organ will immediately take the emergency measures contemplated hereunder or under the provisions of current legislation on the protection of agriculture and livestock health.
Art. 105. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ shall issue a report on the results of each
evaluation undertaken, including pertinent rec-ommendations.
Art. 106. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ may request from exporting countries in-formation on the organization and management of their agriculture and livestock sanitary control systems.
Paragraph 1. Said information shall be checked against the exporting country’s control results.
Paragraph 2. Should the exporting country fail to provide said information or should the information provided prove incorrect, Brazil will unilaterally and immediately demand the full application of importation controls, without any concessions.
Paragraph 3. The Ministry of Agriculture, Livestock, and Food Supply as Central and Su-perior Organ shall determine the form whereby information should be collected, compiled, or-ganized, and presented as well as the transition measures meant to give exporter countries time to prepare said information.
Art. 107. The equivalence agreements rec-ognize that measures applied in the exporting country provide guarantees equivalent to those applied in Brazil.
Paragraph 1. For equivalence determination, the following items shall be evaluated:
I – Nature and content of the certificates that must accompany products;
II – Specific requirements applicable to ex-ports to Brazil; and
III – Audit results.
Paragraph 2. The Ministry of Agriculture, Livestock, and Food Supply as Central and Supe-rior Organ shall prepare and keep current a list of regions or establishments whose exports to Brazil will not be permitted, taking into consideration the equivalence system.
Paragraph 3. The recognition of equivalence shall be revoked immediately and unilaterally whenever any of the established conditions is not met.
Art. 108. The Ministry of Agriculture, Live-stock, and Food Supply as Central and Superior Organ is hereby authorized to carry out joint
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tiatives and support neighbor countries in con-nection with the healthiness of animals, plants, inputs – including animal feed – and animal and plant products so as to develop the requisite in-stitutional capability to meet the conditions re-ferred to hereunder.
CHAPTER VII