Lab to Field

The Crop Pesticide Process:

The Discovery Process

Primary Biological Screening:

Testing is conducted to determine if the proposed chemical has any potential applications for use as a pesticide.

Secondary Biological Screening:

Chemicals that show promise as an active ingredient in a pesticide go through additional testing.

Toxicology Screening:

Registrants conduct tests to generate a toxicological profile for the chemical.

Market Research:

The time and cost of a pesticide lab to label the life cycle, coupled with evolving regulations and consumer demand, creates volatility for businesses. To mitigate the risk associated with developing new pesticides, market research is conducted to target consumers’ needs when developing pesticides and other factors such as the size of the potential market and competitors. Information can be collected from sales representatives, pesticide dealers, university scientists, or advisory councils.

Patent Review:

Patents are reviewed to determine if there is a defensible claim or exclusive patent for the pesticide. If there is an existing patent, is patent licensing an option?

The Development Process

The Decision to Develop:

Based on market research and cost-benefit analysis, a determination is made on whether or not to bring the pesticide to market.

Large-Scale Field Testing:

Evaluated under field conditions, pesticides are tested to examine how pests and plants respond to the pesticide application and the timing and dose of the pesticide application.

Expanded Toxicology and Environmental Testing:

Additional testing is conducted to see how the pesticide responds to different soil types, secondary pests that respond to the pesticide, and persistence and/or accumulation in the environment (soil, water, food, humans, or wildlife).

Label Development:

Before the EPA’s evaluation, information collected during the field testing is used to develop the label for the pesticide. Any remaining information not on the label will be developed during the EPA evaluation.

Registration Package Submission:

When submitting a pesticide for registration, 12–15 forms will need to be submitted as part of the application.

The Registration Application and Review Process

EPA Evaluation:

Data is reviewed to evaluate the human and environmental risks posed by the pesticide. In addition, a risk assessment and peer review are conducted, which ultimately inform regulatory and management decisions.

Manufacturing Preparation:

The product begins to be developed while also being actively marketed to consumers in preparation for distribution.

State Review and Registration:

Each state leads pesticide agency reviews and approves pesticide’s federal registration for use within the state. Many states have additional data and review requirements that consider local conditions that have to be met for these products to be registered.

Pesticide Applicator Certification:

Professional applicators must be certified through training and testing to apply pesticides, and they must participate in continuing education to keep their licenses. Private applicators (farmers) also must be tested to be certified, and purchase certain pesticide products that require higher levels of management to ensure they are used correctly.

Pesticide Safety Educators:

Most states have pesticide safety education coordinators who are responsible for the certification of applicators and the dissemination of information to ensure that pesticides are used properly. They also develop state-specific information on local needs and coordinate their efforts with colleagues in other states through the American Association of Pesticide Safety Educators.

EPA Sets Residue Tolerances:

As part of pesticide registration, the EPA sets residue tolerance levels for fruits, vegetables, and other foods for each pesticide applied to food crops (these levels are many times greater than what would potentially cause any harm).

FDA Enforces Pesticide Tolerances:

The U.S. Food and Drug Administration (FDA) employs a three-fold strategy to enforce the EPA’s tolerances for pesticide chemical residues in human and animal foods. In its regulatory pesticide residue monitoring program, the FDA selectively tests a broad range of imported and domestic commodities for approximately 800 pesticide residues. The FDA may also carry out focused sampling surveys for specific commodities or selected pesticide chemical residues of special interest. In addition, FDA monitors the levels of pesticide chemical residues in foods prepared for consumption in its Total Diet Study (TDS), an ongoing program that monitors contaminants and nutrients in the average U.S. diet. If residues exceed the established tolerance level, the FDA pursues enforcement action.

USDA Also Monitors Pesticide Residues:

USDA’s Pesticide Data Program (PDP) samples, tests, and reports on pesticide residues on agricultural commodities, emphasizing commodities that are highly consumed by infants and children. PDP enables the EPA to assess dietary exposure, facilitates the global marketing of U.S. agricultural products, and provides guidance for FDA and other governmental agencies to make informed decisions.

Requirements to Report Negative Impacts:

Under FIFRA Section 6(a)(2), pesticide producers must report information concerning unreasonable adverse effects of their products on people or the environment. The EPA investigates this information to determine if any changes need to be made in the way the product is used to address concerns.

State regulatory oversight:

Every state-lead pesticide regulatory agency operates as a co-regulator with the EPA in helping to ensure that pesticides are used properly. In this role, they inspect pesticide retail establishments, investigate complaints of misuse, and take appropriate enforcement actions. They also proactively support stewardship efforts and training for applicators. The state regulators coordinate their efforts with EPA through the Association of American Pesticide Control Officials.

Regional Enforcement:

Each of the ten EPA Regional Offices around the country has personnel dedicated to the enforcement of pesticide laws.

Manufacturing Facilities

Where pesticide products are produced, they must be registered with the EPA and must report to the EPA the annual production of all products. These facilities are subject to periodic inspection by EPA personnel.