REGULATIONS ON RISK ANALYSIS FOR ENTRY ANIMALS AND ANIMAL PRODUCTS
(Promulgated by AQSIQ Order No. 40 on December 31, 2002; amended pursuant to GACC Order No. 238 of April 28, 2018)
Chapter I General Provisions
Article 1 These Regulations are formulated to standardize risk analysis for entry animals and animal products, prevent the introduction of animal diseases, safeguard agricultural, livestock and fishery production, and protect human health and the ecological environment, in accordance with the Law of the People's Republic of China on the Entry and Exit Animal and Plant Quarantine and its implementing regulations and with reference to the WTO SPS Agreement.
Article 2 Risk analysis under these Regulations includes risk analysis for imported animals, animal products, animal genetic materials, feeds of animal origin, biological products and animal pathological materials.
Article 3 GACC shall uniformly administer risk analysis for entry animals and animal products.
Article 4 Risk analysis shall comply with Chinese laws and regulations and follow the principles of scientific basis; implementation of or reference to relevant international standards, guidelines and recommendations; transparency, openness and non-discrimination; and avoidance of disguised restrictions on international trade.
Article 5 Where international standards, guidelines or recommendations cannot achieve the level of protection necessary for China's agricultural, livestock and fishery production, human health or ecological environment, GACC may adopt measures providing a higher level of protection based on risk analysis.
Article 6 The risk-analysis process shall include hazard identification, risk assessment, risk management and risk communication.
Article 7 Risk analysis shall result in a written report covering background, methods, procedures, conclusions and management measures.
Chapter II Initiation and Hazard Identification
Article 8 Risk analysis may be initiated in response to an application for market access; proposed importation of a new animal or animal product; changes in the animal-health situation of an exporting country or region; emergence of a new disease or changes in the epidemiology of a known disease; repeated interceptions or serious quarantine problems; changes in relevant international standards or scientific information; or other circumstances requiring assessment.
Article 9 GACC shall define the purpose and scope of the analysis and collect relevant information.
Article 10 Hazard identification shall determine pathogenic agents or other hazards that may be introduced through the animal or animal product concerned and may cause adverse consequences in China.
Article 11 Information may include disease status and surveillance, veterinary administration and laboratory capacity, production and processing systems, vaccination and control programs, animal identification and traceability, slaughter and processing conditions, trade pathways and relevant scientific data.
Article 12 The competent authority of the exporting country or region shall provide relevant technical information as requested. Insufficient information may result in suspension or delay of the analysis.
Chapter III Risk Assessment
Article 13 Risk assessment shall evaluate the likelihood of entry, exposure and establishment or spread of identified hazards and the biological and economic consequences that may result.
Article 14 Entry assessment shall consider prevalence at origin, susceptibility of source animals, production and processing conditions, survival of pathogens, transportation and existing control measures.
Article 15 Exposure assessment shall consider pathways by which susceptible animals, humans or the environment in China could be exposed to the hazard after entry.
Article 16 Consequence assessment shall consider animal health, public health, production losses, control and eradication costs, trade effects and ecological impacts.
Article 17 Risk estimation shall integrate the results of entry, exposure and consequence assessments and describe uncertainty.
Article 18 Qualitative or quantitative methods may be used according to the nature of the issue and availability of scientific data.
Chapter IV Risk Management
Article 19 GACC shall determine appropriate sanitary measures based on risk-assessment results.
Article 20 Measures may include recognition of disease-free countries, zones or compartments; requirements concerning farms, slaughterhouses, processing or storage establishments; vaccination or disease-control requirements; testing, quarantine, treatment or processing; official certification; designated ports; entry inspection and quarantine; restricted use; post-entry quarantine; suspension or prohibition of imports; or other necessary measures.
Article 21 Measures shall be scientifically justified, feasible and commensurate with the level of risk and shall not constitute unnecessary restrictions on international trade.
Article 22 GACC may conduct on-site assessment of the veterinary health system, establishments, laboratories or control programs of the exporting country or region.
Article 23 Where equivalent measures proposed by an exporting country or region can achieve China's appropriate level of protection, GACC may recognize such measures following evaluation.
Article 24 Risk-management measures may be reviewed and adjusted in light of changes in disease status, scientific evidence, trade conditions or implementation results.
Chapter V Risk Communication and Supplementary Provisions
Article 25 Risk communication shall be conducted as appropriate among risk assessors, risk managers, competent authorities, experts and other relevant parties throughout the risk-analysis process.
Article 26 Important risk-analysis matters may be submitted to the China Entry-Exit Animal and Plant Quarantine Risk Analysis Committee for deliberation.
Article 27 GACC is responsible for interpretation of these Regulations.
Article 28 These Regulations shall be implemented in accordance with their promulgation and amendment provisions and other applicable customs rules.
Unofficial Translation. For reference only. Please kindly understand.
非官方翻译，请理解。
