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PRODUCT AND COMPANY AUDITS

TSG has conducted due diligence audits to support the acquisition of both products and entire companies, audits of compliance with adverse incident reporting, audit of compliance with product labeling and manufacture, and general compliance audits under EPA's Audit Policy.

DUE DILIGENCE

In a Due Diligence Audit of a candidate acquisition it is necessary to confirm that the product and its labeling conform to the most recent federal and state approvals. This requires a review of commercial labels and the manufacturing batch records and a comparison to the federal and state approved labels and the approved formula. Consideration of label improvement programs, Reregistration Eligibility Documents, and PR Notices also need to be considered. Where the acquisition of a company is being considered, an audit of the company's systems and compliance with recordkeeping and reporting must also be considered.

FIFRA 6(a)(2) REPORTING OF ADVERSE INCIDENTS

Registrants are required to report to EPA any information it has or receives that may impact adversely the terms of its registration. The registrant must have a process by which such reports are received and considered for the need to report such information to EPA under the adverse incident regulations. It must make reports in a timely fashion as outlined in the regulations.

IMPORT AND EXPORT REGULATIONS

Chemicals and biologicals intended for use in pesticide products may be subject to FIFRA or TSCA and their import must comply with the appropriate regulations. Notice of Arrival forms must be provided to facilitate entry. Experimental samples must be properly labeled.

The export of pesticide products is likewise subject to regulation. Labeling accompanying the product must be in the language(s) of the receiving, and transshipment, countries, and Foreign Purchaser Acknowledgement Statement are required for the export of pesticide products not registered in the U.S.

TSG is well suited to provide audits of all types. We have federal and state registration personnel. TSG also has chemists and toxicologists that can address issues of human or environmental toxicity and risk. Many of our staff have first-hand industry experience in dealing with these issues.