Federal Regulatory Support:
Compliance Audit - FIFRA

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires that pesticide registrants and manufacturers adhere to approved manufacturing processes, maintain books and records, fulfill reporting obligations, label pesticide products in compliance with their registration, and maintain registrations. State governments also require that products be registered. In addition, manufacturing facilities may be subject to other statutes governing releases to water, air and soil, as well as the Chemical Facility Anti-Terrorism Standards. All of these responsibilities might give rise to inspections or audits by state or federal inspectors.

Pesticide Producing Establishments are facilities which manufacture, formulate, package, re-package, label or re-label pesticide products. These facilities are required to be registered, maintain books and records, and file annual production reports. EPA, or designated state agencies, may inspect these facilities either for cause or as part of routine scheduled inspection visits. Inspectors may ask to see these records.

EPA may also require registrants to conduct compliance audits when possible violations of law have been identified, such as selling misbranded or adulterated products on the market, or failure to submit required information such as adverse incidents.

Registrants can benefit from conducting voluntary audits when it believes that routine procedures may have strayed from the norm, when changes in the law or regulations may not have been fully implemented, or as a periodic examination of the procedures in place to ensure compliance. Registrants frequently employ independent auditors for this task because it does not divert employees from their regular tasks, and allows for an objective review of company practices to ensure FIFRA systems compliance. Moreover, registrants can benefit from EPA’s Audit Policy “Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations” when potential violations are identified and disclosed to EPA by the registrant. These fines and/or penalties can be avoided or limited when the registrant establishes internal procedures to eliminate and prevent future violations.

If EPA discovers an apparent violation of a product’s registration or a registrant’s FIFRA compliance, EPA may require that the registrant hire a third party to conduct a compliance audit of the products and practices believed to be in violation. A successful audit followed by institution of measures to correct and prevent future violations may be used to negotiate reductions in fines.

TSG’s significant FIFRA experience allows us to perform an audit tailored to a company’s specific compliance needs. Our FIFRA compliance services include comprehensive registration assistance, label compliance, manufacturing in compliance with formulation, ensuring that 6(a)(2) adverse incident issues are properly documented and submitted, state registrations, and import/export issues for records and proper filing.

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