Lesson 4: How the Process Works
Topic 2: Prepare Risk Analysis
In this topic, you will learn about step two of the U.S. market access process: Preparing a risk analysis.
Objective:
- Describe how the risk analysis, which is prepared to examine the potential importation of plant or animal products, shapes the subsequent action that regulates the importation of those products
The preparation of the risk analysis will be discussed extensively in future modules in this training, and we will not go into detail on that topic here. With regard to market access, the conclusions of the risk analysis shape the subsequent regulatory action. When looking at market access requests for fruits and vegetables, for example, the mitigation measures that the pest risk analysis recommends will determine whether the importation of the fruit or vegetable is authorized through a notice-based process or through rulemaking, as discussed earlier. If the pest risk analysis leads to rulemaking, the mitigations recommended in the pest risk analysis will be reflected in the proposed rule.
On the animal side, decisions on country disease status usually indicate one of two statuses, unlike decisions to authorize the importation of fruits and vegetables: either a country is affected with a disease or it is not. However, again, the risk analysis drives the subsequent action. If a risk assessment indicated that a country could not be declared to be free of a specific disease or could only be declared free of that disease with vaccination APHIS may allow the importation of animals or animal products from that country, subject to certain requirements. The requirements would be described in the risk management section of the risk analysis, and those requirements would, in turn, be incorporated into the proposed action.
In this topic, you learned about how APHIS’ risk analyses drive the subsequent regulatory process.
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