Lesson 3: Basic Requirements of the U.S. Regulatory System
Topic 2: Rulemaking or Notice-Based Process
This topic covers the notice-based processes that APHIS has introduced for some importation-related actions, and compares and contrasts the notice-based process with the typical rulemaking process described in the Administrative Procedure Act.
Objectives:
- Describe the conditions when APHIS would use rulemaking to authorize importation of plant and animal products
- Describe the conditions when APHIS would use the notice-based process to authorize importation of plant and animal products, and explain the procedural benefits of using this process
- Compare and contrast the APHIS rulemaking and notice-based processes
As discussed in the last topic, the Administrative Procedure Act governs the rulemaking process. However, for certain types of actions, APHIS has promulgated rules that set up a framework for taking public comment on market access requests without going through the rulemaking process. Instead, APHIS publishes notices in the Federal Register to make risk analysis available for public review and comment. APHIS then takes action based on the conclusions of the assessments and in accordance with the processes set up in the regulations. These processes are commonly referred to as “notice-based processes”.
Both the rulemaking process and the notice-based process fulfill the SPS Agreement’s requirement to provide notification to WTO members of sanitary and phytosanitary regulations. They also both give WTO members an opportunity to comment on such regulations. At the same time that the rule or notice is made available for public comment, APHIS makes it available through the IPPC or OIE. Since APHIS makes all of its regulations available for public comment, and since foreign competent veterinary authorities and NPPOs may comment on all actions, APHIS’ processes go above and beyond the requirements of the SPS Agreement. In adopting a notice-based process for some of its import-related decision-making, APHIS is working within local legal structures (i.e., the Administrative Procedure Act) to resolve market access requests in the quickest way possible.
In the United States, rulemaking is subject to a large number of procedural requirements that are not related to animal or plant health risk mitigation. These requirements are discussed in more detail in Lesson 5 of this module. Notices typically are not subject to many of these requirements, so they can be published in less time. APHIS still takes comments on notices and respond to those comments in a subsequent notice, maintaining the open process, which is described in the next topic in this lesson.
Currently, APHIS has two main notice-based processes. The first applies to the importation of fruits and vegetables.
If the Administrator of APHIS determines that the application of one or more of five designated phytosanitary measures are sufficient to mitigate the phytosanitary risk associated with the importation of a fruit or vegetable, APHIS publishes a notice in the Federal Register. This notice makes the pest risk analysis that led to that determination available for public comment. The five phytosanitary measures are:
- Inspection at port of entry
- Importation from a pest-free area
- Phytosanitary treatment
- Pre-export inspection for a specific pest
- Importation in commercial consignments
APHIS chose these measures for use in the notice-based process because they are widely used, and their efficacy is well understood. If mitigating the risk associated with the importation of a fruit or vegetable requires any measures other than those five, APHIS must use the rulemaking process. Let us look at two real examples from Colombia and Peru.
APHIS is able to apply the notice-based process to the importation of a fruit or vegetable when one or more of the five designated phytosanitary measures are sufficient to mitigate the risk associated with the importation of the fruit or vegetable. Otherwise, the rulemaking process must be used.
The other major notice-based process applies to the determination of the animal disease status of a country or region. The process applies to most of the diseases whose introduction into the United States APHIS seeks to prevent, including foot-and-mouth disease (FMD), highly pathogenic avian influenza, and classical swine fever.
Under this process, APHIS conducts a risk assessment to determine whether a country or region qualifies for a change in disease status. If it does, APHIS publishes a notice in the Federal Register, asking for public comment on the change. If it is determined that the country or region is free of that disease, then the notice-based process may be used to authorize importation.
APHIS is seeking to expand its use of notice-based processes in the future. Increased use of notice-based processes will allow APHIS to respond more promptly to market access requests. Once market access requirements are established, the notice-based process will also speed up responses to new scientific evidence or changes in pest conditions.
The notice-based process requires APHIS to take comments on its actions, but it is not subject to the same procedural requirements that the rulemaking process is. Accordingly, APHIS hopes to expand its use of the processes.
To continue, select Topic 3 from the Topics menu above or click here.