Lesson 4: How the Process Works

Topic 3: Prepare Other Required Analyses

In this topic, you will learn about step three of the U.S. regulatory process: Preparing other required analyses.

Objective:

  • Explain the purpose of other analyses that might need to be prepared in order to successfully authorize the importation of plant or animal products into the United States

Once APHIS has an idea of what the risk analysis recommends, APHIS can begin the preparation of other required analyses, most often an economic analysis, an environmental analysis, and a paperwork burden statement. These analyses will be discussed in more detail in Lesson 5 of this module. For now, it is important to remember that they need to be prepared at the same time as the proposed rule or notice, so that they can accompany the proposed rule or notice through the clearance process.

An economic analysis identifies the economic effects of a proposed rule, with emphasis on its effects on small economic entities. An economic analysis is only required for rules and not for notices. The economic analysis concentrates on direct effects. For example, an action authorizing the importation of grapes from a new country would consider the potential effects on U.S. grape producers, importers, and other handlers of grapes. Since many grapes sold in the United States are imported, the analysis would take into account potential displacement of existing imports. Similarly, for an action authorizing the importation of swine from a country declared free of classical swine fever, the analysis would focus on U.S. swine producers and importers.

The environmental analysis is required for all Federal government actions, not just market access requests. The purpose of the environmental analysis is to help agencies identify the potential effect on the environment of the actions it takes. Environmental analyses for market access requests mostly document that there are mitigations for any potential animal or plant health risks associated with the importation, although sometimes they evaluate the potential impact of the use of a chemical treatment or the introduction of a disease.

In addition, APHIS must prepare a description of the burden of complying with the rule (known as the “paperwork burden”). This analysis examines the amount of time that affected entities, such as producers, NPPOs, and importers, must spend filling out paperwork (or electronic forms) to comply with APHIS regulations.

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In this topic, you learned about the other analyses that may be required to proceed with the U.S. market access process. These analyses will be discussed in more detail in Lesson 5 of this module.

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