Compliance with export notification

D. Ensuring Compliance with Export Notification Requirements... 

Before designing the audit protocol, it is important to determine the purpose of the audit. For example, an audit of compliance with export notification requirements will have a different group of functions involved than an audit of how a laboratory manages compliance with the research and development exemption to the PMN requirements. 

If there are exports, then the seller s compliance with export notification requirements should be evaluated. 

The notice of inspection may limit the inspection to one TSCA program. For example, the inspection could be limited to compliance with 8(e) requirements to submit notices of significant risk information, it could be directed to the premanufacture notification requirements of 5, or it could cover all TSCA requirements. The letter will typically specify the kinds of documentation that the inspectors will want to inspect. It is advisable to review these materials in advance to see exactly what the inspector will see, and avoid the element of surprise if there is a violation on the face of a document. It will often be possible to refute any inference of a violation, and all the arguments should be marshaled at this point. For example, if the inspection notice states that all notices of export under 12(b) should be assembled, and a quick review shows that some letters were not submitted until after the export may have taken place, it may be possible to gather documentation showing that the exports occurred later than expected and the notices were indeed timely. 

B. Phase 2 Development The Development Representative will ensure the screening of product candidates. External evaluation by selected customers (technical partners) may be initiated to obtain early performance feedback, especially in areas where the company is unable to perform the key tests necessary, or to obtain early vahdation of company test results. In Phase 2 there is no commitment to commercialization. The Director of Marketing of the Business Unit responsible for the experimental product area must approve in writing sampling an R D substance outside of the company and shall ensure compliance with Procedure Number Lab. 5, Sampling R D Substances to Third-Parties. If sampling is to a destination outside of the United States, the Director of Marketing shall inform the MRC who shall determine if the substance is subject to the export notification requirements ofTSCA 12(b). 

Cosmetics are not subject to registration or notification, there are pre-shipment testing procedures in force, based on mandatory SASO standards applied equally to both imported and domestically produced products. These encompass the protection of health, safety, national security, public morals, the environment and prevention of deceptive practices. For imported cosmetics, procedures to ensure conformity to the appUcable Saudi standards are enforced by the Ministry of Commerce and Industry, which implements the International Conformity Certification Program (ICCP) as a combined conformity assessment, inspection and certification scheme, on the basis of which goods are allowed entry into the KSA. Compliance with the relevant Saudi standards, or approved equivalent international alternatives, leads to the issue of a Certificate of Conformity (CoC) prior to shipment by Country Offices or Regional Licensing Centres. The ICCP apphes to all consumer products exported to the KSA (KSA, 2004). Samples may be selected for minimum verification tests as a part of annual routine inspections. Periodic pre-shipment inspection will be performed. 

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