Pesticide Regulation – Registration of a Pesticide

What is a pesticide?

The term pesticide includes a variety of product ingredients, such as insect repellants, weed killers, disinfectants, and swimming pool chemicals which are designed to prevent, destroy, repel or reduce pests of any sort. Pesticides are found in nearly every home, business, farm, school, hospital and park in the United States.

What are the United States Federal Pesticide Laws?

EPA regulates pesticides under broad authority granted in two major statutes, which were amended by the Food Quality Protection Act of 1996.

• Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - requires all pesticides sold or distributed in the United States (including imported pesticides) to be registered by EPA. EPA can authorize limited use of unregistered pesticides or pesticides registered for other uses to address emergencies and special local needs.
• Federal Food, Drug and Cosmetic Act (FFDCA) - Requires EPA to set pesticide tolerances for all pesticides used in or on food. A tolerance is the maximum permissible level for pesticide residues allowed in or on commodities for human food and animal feed.

Pesticides that meet the registration requirements are granted a license or "registration" that permits their distribution, sale, and use according to specific use directions and requirements identified on the label.

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What data is required for pesticide registration?

In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product. The producer of the pesticide must provide data from tests done according to EPA guidelines.

These tests evaluate whether a pesticide has the potential to cause harmful effects on humans, wildlife, fish, and plants, including endangered species and nontarget organisms, as well as possible contamination of surface water or ground water from leaching, runoff, A pesticide cannot be legally used if it has not been registered with EPA's Office of Pesticide Programs.

The data requirements for registration are intended to generate data and information necessary to address concerns pertaining to the identity, composition, potential adverse effects and environmental fate of each pesticide. EPA's requirements for data are listed in the Code of Federal Regulations, Chapter 40, Part 158. The Office of Prevention, Pesticides and Toxic Substances (OPPTS) has developed guidelines that provide testing guidance recommended by EPA.

The OPPTS harmonized guidelines are organized in the following 10 series:

• 810 - Product Performance Test Guidelines
• 830 - Product Properties Test Guidelines
• 835 - Fate, Transport and Transformation Test Guidelines
• 840 - Spray Drift Test Guidelines
• 850 - Ecological Effects Test Guidelines
• 860 - Residue Chemistry Test Guidelines
• 870 - Health Effects Test Guidelines
  • Test Guidelines/Acute Toxicity - Acute Oral Toxicity
    Up-And-Down-Procedure
• 875 - Occupational and Residential Exposure Test Guidelines
• 880 - Biochemicals Test Guidelines
• 885 - Microbial Pesticide Test Guidelines

Following are four groups of tests that may be required:

1. Product Performance

This data requirement provides a mechanism to ensure that pesticide products will control the pests listed on the label and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including disinfectants used to control microorganisms infectious to humans in any area of the inanimate environment and those pesticides used to control vertebrates (such as rodents, birds, bats and skunks) that may directly or indirectly transmit diseases to humans.

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2. Product Properties / Product Chemistry

Data submitted to meet the requirements for product chemistry fall into two major categories:

1. Information on product identity, composition, and analysis
   (OPPTS Guideline#)
   
   

   Product Identity and composition	830.1550
   Description of materials used to produce the product	830.1600
   Description of production process	830.1620
   Description of formulation process	830.1650
   Discussion of formation of Impurities	830.1670
   Preliminary analysis	830.1700
   Certified limits	830.1750
   Enforcement analytical method	830.1800
   Submittal of samples	830.1900

   
   • Information on specific physical and chemical characteristics of pesticide chemicals and products.
   
   

   Color	830.6302
   Physical state	830.6303
   Odor	830.6304
   Melting point/melting range	830.7200
   Boiling point/boiling range	830.7220
   Density/relative density/bulk density	830.7300
   Water solubility: Column elution method; shake flask method	830.7840
   Water solubility, generator column method	830.7860
   Vapor pressure	830.7950
   Dissociation constant	830.7370
   Petition coefficient (n-octanol/water), shake flask method	830.7550
   Petition coefficient (n-octanol/water), generator column method	830.7560
   Petition coefficient (n-octanol/water), estimation by liquid chromatography	830.7570
   pH 63–12	830.7000
   Stability to normal and elevated temperatures, metals and metal ions	830.6313
   Oxidation/reduction: chemical incompatibility	830.6314
   Flammability	830.6315
   Explodability	830.6316
   Storage stability	830.6317
   Viscosity	830.7100
   Miscibility	830.6319
   Corrosion characteristics	830.6320
   Dielectric breakdown voltage	830.6321
   UV/visible absorption	830.7050

2. Listed below are some of the reasons for regulatory requirements to product chemistry data:
   
   
   1. Identification and characterization of each ingredient in pesticide products.
   2. Risk assessment.
   3. Environmental Fate assessment.
   4. Reentry determination and labeling precautions pertaining to worker protection.
   5. Labeling directions pertaining to tank mixes and spray applications.
   6. Labeling ingredient statement, precautionary statements, the physical or chemical hazards statement, and the storage and disposal statement.
   7. Expressing a product's composition and some properties on the Confidential Statements of Formula (CSFs).
   8. Developing the Reregistration Eligibility Decisions (REDs).
   9. Public inquiry: chemical spills, injuries to the flora and fauna, uses, contamination to various compartments of the environment, still birth, drift, degradation, efficacy, fish kills, leaching, runoff, marketing, storage, disposal, transportation, analytical methods, flammability, corrosivity, explodability, etc.
      
      
3. Protection of Humans and Domestic Animals
   
   
   • Acute Toxicity
   • Sub Chronic Toxicity
   • Chronic Toxicity
   • Teratogenicity and Reproduction Studies
   • Mutagenicity Studies
   • Animal Metabolism Studies
   • Reentry Protection
   • Pesticide Spray-Drift Evaluation
   • Hazard to Non-Target Organism
   • Short-Term Acute and Subchronic toxicity
   • Long-Term Toxicity
     
     
4. Protection of Environment
   
   
   • Residue Chemistry
   • Environmental Fate
   • Degradation Studies
   • Plant and Soil Metabolism Studies
   • Mobility Studies
   • Dissipation Studies
   • Accumulation Studies

Once all data has been reviewed by EPA:

EPA Makes Decision on Pesticide Registration

• Does the proposed pesticide use meet EPA's standards for human health protection?
• Does the proposed pesticide use meet EPA's standard for worker protection?
• Does the proposed pesticide use meet EPA's standard for protecting the environment?

If the application fails to meet these standards, EPA:

• Notes the need for more or better data
• Notes any labeling modifications
• Notes any use restrictions
• Communicates the deficiencies to the applicant

If approved, EPA:

• Establishes a tolerance if the pesticide is intended for use on food
• Approves the registration, possibly with risk mitigation
• Publishes a notice in the Federal Register, the official publication of the Executive Branch

Types of Registrations Under FIFRA
There are several types of registration actions through which pesticides may be used in the United States:

Federal Registration Actions: Under Section 3 of FIFRA, EPA can register pesticides for use throughout the United States. Some pesticides are registered by EPA for more limited use in certain states. In addition, States, Tribes and Territories can place further restrictions on pesticides, EPA-registered products used or sold within their own jurisdictions.

Experimental Use Permits (EUPs): Under Section 5 of FIFRA, EPA can allow manufacturers to field test pesticides under development. Manufacturers of conventional pesticides are required to obtain experimental use permits before testing new pesticides or new uses of pesticides if they conduct experimental field tests on 10 acres or more of land or one acre or more of water. Biopesticides also require EUPs when used in experimental settings.

Emergency Exemptions: Under Section 18 of FIFRA, EPA can allow State and Federal agencies to permit the unregistered use of a pesticide in a specific geographic area for a limited time if emergency pest conditions exist. Usually, this arises when growers and others encounter a pest problem on a site for which there is either no registered pesticide available, or for which there is a registered pesticide that would be effective but is not yet approved for use on that particular site. Also, exemptions can be approved for public health and quarantine reasons.

State-Specific Registrations, Under Section 24(c) of FIFRA, States can register a new pesticide product for any use, or a federally-registered product for an additional use, as long as there is both a demonstrated "special local need," and a tolerance, exemption from a tolerance, or other clearance under FFDCA. EPA can disapprove a State's special local need registration.

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