Lesson 3: Basic Requirements of the U.S. Regulatory System

Topic 3: Open Process - "Notice and Comment" (Executive Order 13563)

An important feature of the U.S. regulatory process is that it is open to the public, which can review and to comment on regulatory actions. This topic will describe what an open process is, specify how APHIS’ process is an open process, and describe how anyone can get involved in an APHIS action through the website Regulations.gov.

Objectives:

  • Describe what an “open process” means
  • Identify and describe the two primary advantages of using an open process
  • Describe how APHIS meets the requirements of the Administrative Procedure Act and Executive Order 13563 by publishing in the Federal Register
  • Identify APHIS’ rules and notices on Regulations.gov and discuss supporting and related materials and comments associated with those documents

The U.S. government has made the development of an open regulatory process for its agencies a major priority since 2002. There are two key components to an open regulatory process. First, any individual must be able to easily access an agency’s decisions and the material on which those decisions are based. Second, an individual must be able to easily comment on any published rule or notice. This process helps build cooperative relationships with the industries APHIS regulates and gives consumers equal access to the decision-making process as well.

There are two major advantages to making the regulatory process as open as possible.

  1. The collective knowledge of the U.S. public can provide valuable insights in regulatory decision-making. Commenters regularly provide additional perspectives on issues that APHIS did not consider when developing rules and notices. APHIS takes those comments into consideration to make actions more efficient and effective.
  2. The open process increases legitimacy. Interested parties have access to the materials and analysis the agency uses to make its judgments. Allowing review of those materials creates transparency regarding the agency’s rationale. The open process provides a means for people to formally express any disagreement, and requires the agency to fully respond.

As noted previously, the APA requires notices of proposed rulemaking to be published in the Federal Register. The U.S. Supreme Court ruled in 1947 that publication in the Federal Register constitutes official proclamation to the public — anyone can be presumed to know about something that has been published in the Federal Register.

To access the Federal Register in 1947, an interested person would have had to go to a library that stocked the printed copies. In addition, if there were any other documents associated with a rulemaking, such as a supporting risk analysis or public comments, the person would have had to travel to Washington, D.C., to access the agency’s official file. This meant that only people who could afford to have representation in Washington, D.C., were able to meaningfully participate in the regulatory process.

The U.S. government developed the Web site Regulations.gov to allow people to comment electronically on any proposed rule or notice. In 2005, Regulations.gov was upgraded to allow agencies to make all of their regulatory information, including rules and notices, supporting analyses, and comments, available on a single web site. Thus, people from the United States and around the world can meaningfully participate in the regulatory process.

In January 2011, President Obama issued Executive Order 13563, which requires agencies to use Regulations.gov or some other electronic docket to ensure an open process. Besides statutes, agencies also operate under executive orders, which are orders issued to the agencies by the President. Executive Order 13563 directs agencies to:

“…afford the public a meaningful opportunity to comment through the Internet on any proposed regulation, with a comment period that should generally be at least 60 days. To the extent feasible and permitted by law, each agency shall also provide, for both proposed and final rules, timely online access to the rulemaking docket on Regulations.gov, including relevant scientific and technical findings, in an open format that can be easily searched and downloaded. For proposed rules, such access shall include, to the extent feasible and permitted by law, an opportunity for public comment on all pertinent parts of the rulemaking docket, including relevant scientific and technical findings.”

Executive Order 13563.

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Using an open process for regulatory actions is important to ensure the process’ legitimacy and to improve the quality of its results. APHIS ensures that the public has an opportunity to participate in the regulatory process by publishing in the Federal Register and making its regulatory documents available on Regulations.gov.

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