Notification Retention Requirements

While there is no specific recordkeeping requirement under TSCA 12(b), TSCA generally requires that records be kept for five years. However for notifications that are one time only, likely those notifications should be kept for at least five years after the most recent export of the same substance to the same country to be able to prove that the required 12(b) notice was made for the first export. If the first notice cannot be located, it would be prudent to file again before the next export of the same substance to the same country. 

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Once the information is compiled, the next step is to make sure that the people who are responsible in the company for exports, including through the mails or courier services, perform their functions consistently with the requirements for export notifications. As always, the best way to do this depends on what the company does and how it does it. For companies that seldom export, training the export speciaHst, or having a written procedure requiring the export specialist to check the product fist manually each time she makes an export may be sufficient. Someone in the organization, either the regulatory specialist or the export specialist, must enter onto the list the history of notifications made for each chemical substance. A copy of the notification must also be maintained in accordance with appropriate record retention requirements for at least five years after the most recent export of the substance to the same country. 

Some contract laboratories and professional consultants (e.g., veterinary ophthalmologists and pathologists), may not be familiar with the GLP regulations. In such cases, mere notification of a requirement to provide GLP-compl3dng services may not be sufficient. It is advisable to spend time with contractors and professional consultants to review in detail the GLP requirements that will apply to the work they will perform. It is especially important to review with them the GLP requirements for documentation and document retention. 

Step 5. If the product is being exported to a particular destination for the first time in the calendar year, the ES checks the Product Database to determine if the product requires an annual TSCA 12(b) export notice to the particular destination, or if the product requires a one-time TSCA 12(b) notification to the particular destination, and if such notification has already been made. If the appropriate notification has not already been made, the ES informs the Manager of Regulatory Compliance(MRC). The MRC shall make all required notifications within seven days of receipt of an order in the Order Processing System, but no later than the date of export. (Another alternative might be to have form letters for this purpose available to the ES to use to make the notifications within the required timeframe, and to send a copy of the notification to the MRC for retention.) (There should be a procedure which demonstrates how the MRC reviews new and existing products for 12(b) designation, how this field is kept current in the Product Database, and how the 12(b) notifications are made and retained.)... 

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