There are many federal agencies that impact the agriculture and food industries. The United States Department of Agriculture is home to 29 of these agencies including the Agricultural Marketing Service, the Farm Credit Administration, the Food Safety Inspection Service, and the Forest Service. Agencies such as the Environmental Protection Agency, the Fish and Wildlife Service, and many others also take actions that impact the agriculture and food industries. This blog post will explain how these agencies have authority to make regulations and will discuss the legal weight of other agency documents.

Separation of Powers & Checks and Balances

Federal agencies are part of the executive branch of government.  However, the other two branches also play a role in the regulatory process. The legislative branch, which consists of the Senate and House of Representatives, enacts laws that create agencies or grant existing agencies the authority to create or amend regulations. Although the President appoints heads of certain agencies, the Senate must approve each of the President’s picks. The judicial branch, which consists of federal courts and the Supreme Court of the United States, hears cases brought by and against the agencies. The authority of each branch of government is granted through the United States Constitution.

Rules and Rulemaking

Generally

The defining characteristics of agency rules (also known as regulations) are that they are usually of “general applicability” and “future effect”.  This is why rules often look like and have the effect of law. “General applicability” means that finalized rules do not apply to single individuals, but instead apply to large groups of people. For example, the rules implementing the Clean Water Act (CWA) apply generally to people who “discharge a pollutant from a point source” and not specifically to a single individual. Rules also often have “future effect” meaning they regulate conduct that has yet to occur. For example, the CWA only applies to those who will discharge or who have discharged a pollutant from a point source after 1972, because that is when the act was passed by the legislature and signed into law by President Nixon. Thus, the Environmental Protection Agency, the agency that administers the CWA, cannot bring an action against someone who discharged a pollutant from a point source prior to 1972.

Rules are codified in the Code of Federal Regulations (CFR). However, agencies cannot simply publish rules in the CFR. Instead, agencies must adhere to the rulemaking process set out in the Administrative Procedure Act (APA). Although the APA is fairly straightforward, the process can be a long and winding road.

As mentioned above, the first step in rulemaking does not actually start with the agency. Before an agency can initiate rulemaking, Congress must first grant the agency authority to do so through enacting legislation. For example, in 2016 Congress amended the Agricultural Marketing Act of 1946 and directed the Secretary of Agriculture to “establish a national mandatory bioengineered food disclosure standard with respect to any bioengineered food and any food that may be bioengineered” and “establish such requirements and procedures as the Secretary determines necessary to carry out the standard.” 7 U.S.C. § 1639b(a). Although Congress directed the Secretary of Agriculture to take this action, the Secretary of Agriculture delegated this task to the Agricultural Marketing Service (AMS) which typically happens.

In its rulemaking process, AMS decided to conduct informal rulemaking, which many people know as “notice-and-comment” rulemaking. Most modern rules are created through an informal rulemaking process, however formal rulemaking is also an option and is used in a few scenarios. Sometimes Congress will direct the agency to conduct a certain type of rulemaking. Other times Congress is silent as to which type of rulemaking it prefers the agency to conduct so it is up to the agency to decide between informal and formal rulemaking.

Informal Rulemaking

The first step of informal rulemaking is publishing what the APA calls a “notice of proposed rulemaking”, but is more commonly known as a proposed rule. However, agencies often conduct research or seek public comment before drafting any sort of regulatory language. Sometimes agencies publish an “Advanced Notice of Proposed Rulemaking” in the CFR to gather public comments from those with expertise on the proposed regulatory topic. The agencies will use this research and any public comments received to draft a proposed rule.

Before publishing its proposed rule for the Bioengineered Food Disclosure Standard, AMS both conducted research and sought public comment. In June 2017, AMS posted 30 questions on its website asking anyone interested or with expertise in bioengineering to comment and answer the questions. In response, AMS received 112,000 comments and answers. AMS also hired a consulting group to study the technological challenges of providing consumers electronic access to the bioengineered disclosures. AMS published the study’s findings in September 2017. For a more recent example, on September 2, 2021, the Food Safety Inspection Service published an Advanced Notice of Proposed Rulemaking to gather more information on how to regulate cell cultured meat labeling.

After conducting research and seeking preliminary public comment, agencies will likely publish a proposed rule. The proposed rule serves two purposes. It notifies the public of agency action, and it gives the public an opportunity to comment. This is why informal rulemaking is known as notice-and-comment rulemaking. AMS published a proposed rule for the Bioengineered Food Disclosure Standard in May 2018. The proposed rule, like most proposed rules, contained draft regulatory language. AMS asked for general comments on what the public thought of the proposed rule and how AMS could improve the rule. Sometimes agencies will ask the public to respond to specific questions or address a particular issue when commenting on a proposed rule. However, AMS did not ask any specific questions in its proposed rule for the bioengineered food disclosure standard.

The APA requires agencies to give interested parties adequate time to read and comment on proposed rules. The APA does not prescribe a particular time period for which comment periods must be open, however, agencies typically set comment periods for 30, 60, or 90 days. As for the Bioengineered Food Disclosure Standard proposed rule, AMS set the comment period at 60 days. Within the 60 days AMS received over 14,000 comments.

After the comment period closes, agencies review the comments and consider which comments to incorporate into a final rule. The APA does not require agencies to publish a final rule according to any particular timeline. After going through the comments, agencies may decide that there is no present need for the proposed rule and simply never publish a final rule. However, statutes other than the APA may require an agency to publish a final rule and to do so within a particular timeframe. For example, when Congress amended the Agricultural Marketing Act directing AMS to create the Bioengineered Food Disclosure Standard, Congress required AMS to establish the standard “not later than 2 years after July 29, 2016”. Thus, AMS was statutorily required to publish a final rule, and was required to publish it by a specific date. AMS missed its deadline by a few months and published the final rule establishing the Bioengineered Food Disclosure Standard on December 20, 2018. However, this missed deadline does not affect the validity of the final rule.

The Bioengineered Food Disclosure Standard offers an example of informal rulemaking that occurred fairly quickly and smoothly, however not all informal rulemaking processes are as smooth. The regulations implementing the National Organic Program offer an example of informal rulemaking that did not move quickly or smoothly. Before AMS published the final rule in December 2000, AMS published multiple proposed rules that were never finalized throughout the 1990 decade.

Formal and Hybrid Rulemaking

Sometimes statutes call for agencies to conduct “notice-and-hearing” rulemaking, instead of “notice-and-comment” rulemaking. Depending on how formal of a hearing is required, this form of rulemaking is either considered formal or hybrid rulemaking. As the term notice-and-hearing suggests, this form of rulemaking requires agencies to publish a proposed rule in the federal register, and then conduct a trial-type hearing. The hearing is usually presided over by an Administrative Law Judge (ALJ) who hears evidence on the record and makes a recommendation or tentative decision. As mentioned earlier, a hallmark of rules is that they apply generally. Thus, a hearing results in a final rule that doesn’t only apply to the parties involved in the hearing, but to everyone who falls under the jurisdiction of the rule.

In the agriculture industry, this form of rulemaking takes place when marketing orders are established. According to AMS, “[m]arketing orders … are initiated by industry to help provide stable markets for dairy products, fruits, vegetables and specialty crops. Each order … is tailored to the individual industry’s needs. Marketing Orders are a binding regulation for the entire industry in the specified geographical area, once it is approved by the producers and the Secretary of Agriculture.” Marketing orders are codified in the CFR at 7 C.F.R. §§ 900-1299.

Other Documents

Other than informal and formal rulemaking, agencies also often publish documents that do not have the force of law. These guidance documents are called many different things such as notices, guidelines, and directives. Although guidance documents are sometimes called “rules”, or non-legislative rules, they do not have the force of law like rules created through notice-and-comment and notice-and-hearing rulemaking. Guidance documents are not codified anywhere and are usually found on the website of the agency who authored the document. Guidance documents usually describe the agency’s current thinking on a topic, express the agency’s view on a statute or rule, or offer the agency’s current policy objectives. Ultimately, guidance documents are usually only viewed as recommendations.

Conclusion

The agriculture and food industries are regulated by many different agencies. Each of these agencies are subject to the APA, meaning they must go through a prescribed rulemaking process before their rules have the force of law. There are two main types of rulemaking: informal rulemaking which is also known as notice-and-comment rulemaking; and formal rulemaking, or notice-and-hearing rulemaking. If an agency wants to publish a document without going through the procedures outlined in the APA, then the agency has the option of publishing a non-binding guidance document. Guidance documents are useful to understand where an agency stands on certain topics, but they do not have the force of law.

 

For the full text of the APA, click here.

To visit the CFR website, click here.

To view recently posted notices, proposed rules, and final rules or to comment on a notice, proposed rule, or final rule, click here.

To read the proposed rule for the Bioengineered Food Disclosure Standard, click here.

To read the final rule for the Bioengineered Food Disclosure Standard, click here.

To learn more about marketing orders, click here.

To view an example of an agency guidance document, click here.

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