The United States Environmental Protection Agency (EPA) requires the registration of all pesticides distributed or sold in the country. This ensures that these substances will not pose unreasonable risks to human health or the environment.
Protheragen-ING Lab has a proven track record of providing innovative solutions and efficient, practical and cost-effective EPA consulting support for pesticide registration. By working with us, you will get your pesticide products to market in a timely and cost-effective manner.
EPA pesticide assessment guidelines
OCSPP 830.1700: Storage Stability
The guideline focuses on the storage stability of pesticide formulations. It is essential to demonstrate that the pesticide remains effective and stable over time under specified storage conditions. Key aspects include:
| Test Duration | Typically, the storage stability test should cover a period of at least one year. |
| Storage Conditions | The test should reflect conditions that the product will likely encounter in the marketplace. |
| Parameters to be Monitored | The parameters to be evaluated during the stability test include physical and chemical properties, such as pH, active ingredient concentration, and the presence of any degradation products. |
OCSPP 830.1800: Certification of Limits
The guideline pertains to the certification of limits for active ingredients and significant impurities within a pesticide product. The objective is to ensure that the product consistently meets the specifications provided in the registration. Key points include:
| Active Ingredient Limits | The certified limits must reflect the acceptable range of active ingredient concentrations. |
| Impurity Limits | Significant impurities must be identified, and their acceptable concentration ranges must be specified. |
| Analytical Methods | Validated analytical methods must be used to determine the concentrations of active ingredients and impurities. |
40 CFR Part 158OPPTS
Compliance with 40 CFR Part 158OPPTS is mandatory for all pesticide registrations. This section of the Code of Federal Regulations outlines the data requirements for pesticide registration, which include:
| Product Chemistry | Detailed information on the product's chemical composition, including the identity and quantity of all ingredients. |
| Toxicology | Data on the potential health effects of the pesticide, including acute, subchronic, and chronic toxicity studies. |
| Environmental Fate | Information on how the pesticide behaves in the environment, including degradation and accumulation studies. |
| Ecological Effects | Assessment of the pesticide's impact on non-target organisms, such as birds, fish, and beneficial insects. |
Our comprehensive pesticide registration services
Protheragen-ING Lab provides consulting services on all aspects of EPA pesticide registration to meet our clients’ needs from early product development to regulatory approval and product management of the final pesticide product. Our pesticide registration services and support include:
- Registration of new company numbers and establishment numbers
- Development of registration strategies
- Preparation of application with all necessary documents
- New active substance registration
- EPA new pesticide product/similar product registration
- Data gap analysis, fee assessment, and exemption analysis
- EPA pesticide data compensation assessment and fee assessment
- EPA pesticide device registration
- EPA pesticide additives and disinfectant registration
- Minimum risk pesticide compliance
- Pesticide registration compliance analysis report
- Communication with EPA and responding to EPA comments and questions
- Preparation of amendments and notification submissions
- Annual report submission
- Assisting clients with adverse-effects reporting
- Preparation of product registrations and data rights transfers
- Comprehensive regulatory consulting and training services
Why choose our EPA registration service?
- Regulatory Expertise.
- Data Management.
- Quality Assurance.
For more information on our EPA Pesticide Registration Service or to start your registration process, please contact us. Ensure the success of your pesticide product registration with our professional and reliable services. Reach out to us today!