SPS Module 2 Logo. SPS Module 2 Logo.
SPS Online.
Principles of the SPS Agreement.
APHIS and the General Approval Process.
Overview.
PPQ, VS and IS.
Other Agencies.
Plants and Plant Products.
Request to Export or Import.
Enterable Commodities.
Denial and Risk Assessment Determination.
Risk Assessment.
Entry with Inspection.
Mitigating Risk.
The Rulemaking Process.
Animals and Animal Products.
Regionalization.
Regionalization Request.
Regionalization Approval.
Risk Classification and Management.
Argentine Beef Example.
Conclusion.
Handouts.
Rulemaking Process.
Request Requirements.
Approval Process.

Animals and Animal Products

Risk Classification and Management

The risk classification system mentioned in the proposed regionalization docket is benchmarked to allow regions to evaluate their export status. The system consists of five benchmark risk levels classified as negligible, slight, low, moderate and high risk. There was previously a three-category system that did not include what is now described as low and moderate risk benchmarks.

The low-prevalence benchmark complies with WTO-SPS requirements to recognize regions of low prevalence. The low risk benchmark may be thought of as free-with-vaccination, and the moderate risk benchmark as regions where the disease is known to exist but at a low prevalence. VS determination is based on a case-by-case risk assessment.

The six risk classifications:

  • RN (Negligible Risk)
  • R1 (Slight Risk)
  • R2 (Low Risk)
  • R3 (Moderate Risk)
  • R4 (High Risk)
  • RU (Unknown or Unclassified Risk)

RN: This classification will be assigned to physically isolated regions with strict border controls and a sound animal health infrastructure, not adjacent to affected regions and are unaffected and unexposed with respect to the restricted disease agent being classified. Importations into the United States from RN regions present negligible animal health concern.

Risk Classes R1 through RU: Regions placed in risk classifications other than RN must meet increasingly stringent risk-mitigation requirements to reduce risk of their importations to acceptable levels as those of RN-classified regions.

The risk management options for achieving negligible risk status are:
  • Point of origin certification;
  • Testing and/or inspecting animals or animal products;
  • Testing and/or inspecting premises or herds of origin;
  • Treatment of animals or processing of animal products;
  • Quarantine procedures; and
  • Restricted use or movement of imported animals.

  • The burden of demonstrating that a particular region is pest or disease-free or of limited pest or disease prevalence rests with the exporting country. The responsibility of the importing country is to be transparent, as is the intent with the United States Regionalization Rule, in how it will evaluated a pest or disease-free request.