Lesson 4: How the Process Works
Topic 4: Prepare a Proposed Rule or Notice
In this topic, you will learn about step four of the U.S. market access process: Preparing the proposed rule or notice.
Objective:
- Identify the purpose and key components of a proposed rule or notice
Both a proposed rule and a notice have two primary jobs: to announce to anyone concerned, through publication in the Federal Register, that APHIS is considering allowing the importation of animals, plants, or their products and to allow the public to comment on the proposed conditions for their importation. Beyond that, a proposed rule and a notice can look quite different.
A proposed rule consists of two principal sections. The Background section describes the proposed requirements and explains why APHIS has determined them to be necessary. The proposed regulatory text shows how the CFR would be changed by the addition of the proposed requirements.
For example, a proposed rule to allow the importation of avocados from any country where quarantine fruit flies are present would probably include a requirement in the proposed regulatory text that fallen fruit be regularly removed from the orchard and not included in fruit meant for export. The Background section would describe this requirement and explain that it is necessary because fallen fruit is more likely to be infested by fruit flies.
In addition, the Background section might be the only place where all the requirements that would apply to the importation of a commodity are presented in full. In lesson 3, we discussed a proposal to amend an existing section (specifically, ยง 319.56-25), which already allowed the importation of papaya from countries in Central America and Brazil, to also allow the importation of papaya from Colombia and Ecuador under similar conditions. Because the existing conditions were already set out in the CFR, the proposed regulatory text simply indicated that Colombia and Ecuador would also be eligible to export papayas to the United States under these conditions. The Background section discussed the conditions and why they would be as effective for papayas from Colombia and Ecuador as they were for papayas from Central America and Brazil.
The risk analysis ultimately determines what is in the Background section and in the proposed regulatory text, and all three should be consistent with each other.
Besides the Background section and the proposed regulatory text, a proposed rule also contains information on APHIS’ compliance with various Executive Orders and statutes, and a summary of the economic analysis APHIS has conducted.
A notice, by contrast, mainly presents the findings of the risk analysis, with little discussion of the reasoning behind those findings. Interested parties can read the risk analysis itself, in which the proposed determination and the reasons for it are presented. The public can comment directly on the findings and conclusions of the risk analysis.
In this topic, you learned about preparing a proposed rule or notice, and the material each type of document typically contains.
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