Import certification

German Health Authorities may deny import certificate to plasma collectors who make a single error in interdicting shipment of a viral marker reactive unit or properly notifying fractionator... 

Removal of an Argentine inspection body from proposed list based on on-the spot-evaluation. Superseded Further delay in implementing the Third Country list and minor change to the import certificate... 

All medicinal products can be sold after obtaining an import certificate. Before permission for importation is granted by the NDI and after the MA is approved, the first 3 batches of the product should be analyzed. Permissions are given for the next important batches only after presentation of the qucility certificate of the imported batch. 

Is the material in the shipment to be imported an article , or tobacco or tobacco product If yes, an import certification is not required (positive or negative). If no, continue to the next question. 

Is the material in the shipment to be imported a pesticide a source or special nuclear material or by-product a firearm or ammunition or a food, food additive, drug, cosmetic, or device If yes, the material is not subject to TSCA, but a negative TSCA import certification is required unless the shipment is clearly identified as being a pesticide or other chemical not subject to TSCA (e.g., the shipment is accompanied by FDA Form FD701 or EPA (FIFRA) Form 3540-1). If no, continue to the next question. 

Does the shipment contain any chemical substances or mixtures regulated under TSCA Section 5 (including new chemical substances), TSCA Section 6, or TSCA Section 7 If yes, continue to the next question. If no, a positive TSCA import certification can be made. 

Are the chemical substances and/or mixture in the shipment compliant with TSCA Sections 5, 6 If yes, a positive TSCA import certification can be made. If no, import certification cannot be provided and the shipment cannot be imported until the chemical substance and/or mixtures is compliant with all applicable requirements under TSCA Sections 5, 6, and 7. 

After due consideration was given to these various problems, a recommendation was offered whereby export of cannabis resin would be prohibited to any country unless the recipient signed a special import certificate stating that such importation was to be used exclusively for medical or scientific purposes. 

The third part of the regulation is about how the control and certification system works in Turkey. Authorisation for control and certification, necessary documents for the controls of production units and operators, control procedures, principles of certification system and preparation of certification reports handled in this part. Upon demand, raw product, processed product, export or import certificates can be prepared. 

Section 12 (export notification) and 13 (import certification) rules are applicable ... 

In the Q8cA, the EPA asserts that substances that are imported for export only are subject to the rules under 13, which require import certifications. The statutory provision states that substances imported for export are subject only to the requirements of 4 and 8. It is apparent that the EPA does not have authority to require import certifications under 13. However, it seems prudent to comply with the import requirements of 13, although there are persuasive arguments that these requirements cannot be enforced. 

When substances are imported in violation of the PMN rules, the import certification under TSCA 13 will inevitably be incorrect, and penalties can be assessed for the import certification violations in addition to the penalties for the PMN violations. Each nonexempt chemical import must be accompanied by either a positive or negative declaration. The positive declaration states that the substance is subject to TSCA and complies with its rules, and... 

In the Matter of Ashland, Inc is an example of a company resolving EPA s finding that an NOC violation had occurred this was achieved by payment of a fine and the conducting of an audit of compliance with the TSCA 5 rules and the import certification rules. 

The R D exemption is only an exemption from the PMN, Inventory, and SNUR requirements of TSCA. R D substances are subject to the substantial risk reporting requirements of TSCA 8(e), any restrictions that may be issued under 4 or 6, import certifications, export notifications, and all other TSCA programs. 

The polymer exemption is an exemption from the premanufacture notice requirements and not an exemption from all of the many programs under the Toxic Substances Control Act. An exempt polymer is subject to all of the other TSCA programs, including (but not limited to) the substantial risk reporting in 8(e) of the statute, Significant New Use Rules, import certifications, and export notifications. 

FI. Ensuring Compliance with Import Certification Requirements... 

Import Certifications are kept by the Customs Service. Copies of certifications are only forwarded to EPA when Customs suspects a violation. Living with TSCA Q8cA, question 48. 

Pennsylvania Avenue, N.W., Attn TSCA 13 Coordinator, Chemical Control Division, Washington, DC. The addressee can elect to separate the samples, accept one, sign and submit the post importation certificate for that sample, and reject the other. The addressee remains responsible for the cost of returning or disposing of the rejected sample. ... 

To reduce the administrative burden to importers and the EPA, EPA also established a blanket certification procedure that importers can use for repeat shipments of small quantities of chemical substances imported through the mails. The importer must file a 13 import certification with EPA the first time the chemical substance is imported by mail. With this certification, the importer must include a statement of its intent to use a blanket certification for future shipments of the chemical substance. The importer must submit an annual report to EPA, postmarked by January 31 of the following year, for each chemical substance that is imported under a blanket certification, identifying each shipment. The annual report should be sent to the same address as noted in the prior paragraph. ... 

A mixture is any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of chemical reaction except that such term does not include any combination which occurs, in whole or in part, as a result of a chemical reaction if none of the chemical substances comprising the mixture is a new chemical substance and if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined. Each chemical substance in the mixture, other than impurities, must be identified. The import certification applies only to chemical substances intentionally present... 

The import certification regulation currently exempts imported articles themselves, but chemical substances and mixtures in an article that are intended to be removed or released from the article, and have an end use or commercial purpose separate from the article of which they are a part, are subject to import certification requirementsT An example of a chemical substance or mixture that is intended to be released from the article and has a separate end use than the article would be ink in pens. Conversely, transformer fluids in transformers, lighter fluids in cigarette lighters, and crankcase oil in automobiles are not intended to be removed from the articles of which they are a part and have no commercial purpose separate and apart from these articles, and so would not need import certificates. Those same chemical substances, if imported in drums, cans, or other containers, are subject to import certification requirements." ... 

Not all importation onto soil governed by the United States requires import certifications. The Customs Territory of the United States is limited to the fifty states, the District of Columbia, and Puerto Rico. Therefore, TSCA does not regulate imports into Guam and other U.S. protectorates. In addition, certification is not required for chemicals imported under entry for transportation and exportation, such as a product being transported through the United States from Canada to Mexico or for importation into a Foreign Trade Zone. " However, if the substance is later withdrawn from the Foreign Trade Zone for use in the United States, a certification would be required at that time. ... 

The importer should take care to preserve any records which support the position that the original intended use of the product was not covered by TSCA because a change in use subsequent to importation, and inconsistent with the importation certification, can constitute a violation under TSCA. ... 

While the statutory exemption noted above clearly excludes the requirement of making an import certification for chemical substances imported for export only, EPA has taken the position that the requirements of 13 do apply to chemical substances imported for export only. Although there are very good arguments based on the statute itself that these requirements cannot be enforced in the context of import for export only, it seems prudent to make import certifications in this situation. 

EPA recognizes that neither it nor Customs has any authority under TSCA or any other law to place TSCA requirements directly on the foreign exporter, and so has put the onus for compUance on the importer. 45 Fed. Reg. 79730 (Dec. 1,1980). The foreign shipper cannot sign the import certification. Living with TSCA Q8cA, question 45. 

For TSCA purposes, TSCA import certifications should be kept for five years and any documents used in determining the compliance of the substance with TSCA (such as supplier certification letters, MSDS and the Kke) for five years from the date of last import of the product, since the company will be relying on those documents the entire time it imports the product, not just the first time. 

Note that only violations of 15 are potentially criminal. Therefore, using a chemical that was imported without a proper import certification under 13 is not criminal, although wiUful failure to prepare the import certification is criminal. 

It is axiomatic that the EPA must have jurisdiction over any entity that it seeks to bring an enforcement action against. For example, the EPA has said it cannot enforce the import certification requirements against a... 

---