Pesticides: Regulating Pesticides

Pesticide producers sometimes inquire about the process for adding new substances to the 25(b) exempted active ingredient list and Permitted Inerts List 4A. The processes for each have similarities but there are also substantial differences, all of which are described in federal law and summarized below.

The Basics

The EPA mission is to protect human health and the environment, and the Agency relies on scientific data to do so. The most basic requirement for adding a substance to the 25(b) and 4A lists is that the substance must be demonstrably safe for the intended use. This means that pesticide producers must demonstrate through the submission of data or scientific studies that a proposed substance is safe. Specific data requirements vary depending on the nature of the substance in question. The only way that EPA can amend the lists is by reviewing data that pesticide producers supply in order to support the Agency's final decision.

Amending FIFRA 25(b)

Because the 25(b) exempted active ingredient list is written in the Code of Federal Regulations, the official rulebook for federal agencies in the United States, making any changes to the list must be done through a process called rulemaking.  Some of the benefits of rulemaking are that it ensures uniformity and fairness in federal regulations, as well as giving stakeholders and the general public an opportunity to comment on proposed rules before federal agencies implement them.  However, anyone considering embarking on a rule-making project should be aware that it is a complex, detail-oriented process.

EPA determines the requirements for adding a chemical or substance to 25(b) on a case-by-case basis once the Agency receives a request to grant an exemption to a substance not already listed. At the very least, the Agency must complete a risk assessment on the proposed substance. The data requirements for adding a minimum risk active ingredient to the 25(b) list are roughly the same as for registering any reduced-risk pesticide. EPA also allows public comment so that interested parties may explain why they support or oppose the proposal. If the results of the risk assessment and public comment periods indicate that use of the substance for pesticidal purposes will not jeopardize public health or the environment, the substance can be added to the 25(b) list. The rulemaking and risk assessment process can take between three and four years.

Those trying to decide if they want to request an amendment to 25(b) should be aware that once an amendment is made, the new active ingredient would be available for all minimum risk pesticide manufacturers to use. Further, unlike data used to support full registration, which is commercially protected for 15 years, data submitted to amend the exempted 25(b) list of active ingredients becomes publicly available as soon as the list is amended in the Code of Federal Regulations.

Amending Permitted Inerts List 4A

Before a substance can be added to List 4A, a pesticide producer or other stakeholder must submit data that demonstrate the safety of the substance. List 4A consists of substances that have undergone a scientific evaluation demonstrating that the proposed substance is safe for use in all pesticide products, subject only to good agricultural or manufacturing practices. Although rulemaking is not required to amend List 4A, proposed substances must be evaluated for safety because EPA does not establish any restrictions on use patterns (how, where, when or in what manner 25(b) pesticides can be used) or limit the amount of a List 4A chemical substance that can be used as an inert ingredient in a pesticide product. Data requirements for proposed List 4A substances vary depending on the nature of the substance, so EPA determines these data requirements on a case-by-case basis. Please contact the Inert Ingredient Assessment Branch at inertsbranch@epa.gov for information about the data requirements, cost, and projected time-frame for an Agency decision to amend List 4A.

Tolerances for Food Uses for Newly Listed Active and Inert Pesticide Ingredients

Tolerance is the term EPA uses to describe the maximum pesticide residue levels allowed on food or feed crops. If it is anticipated that minimum risk pesticide products containing newly listed active or inert ingredients will be used in a manner that may result in residues on food or feed crops, the pesticide producer must either apply for tolerance exemptions or establish new tolerances.

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