Miscellaneous International Trade Notices
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Control of Residual Solvents in Drug Products Marketed in the United States." To ensure that the FDA considers comments before it begins work on the final version of the guidance, comments should be submitted by October 6, 2008. (FDA notice, D/N FDA-2008-M-0208, FR Pub 08/07/08, available at http://edocket.access.gpo.gov/2008/pdf/E8-18127.pdf.)
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1. FDA Draft Guidance on Residual Solvents in Drug Products
2. FDA Seeks Comments, to Hold Meeting on Nanotechnology
FDA is announcing a public meeting, on September 8, 2008, and a request for comments, including available data, to gather information that will assist it in further implementing the recommendations of the Nanotechnology Task Force Report relating to the development of FDA guidances. Comments must be submitted by October 24, 2008. (FDA notice, D/N FDA-2008-N-0416, FR Pub 08/07/08, available at http://edocket.access.gpo.gov/2008/pdf/E8-18132.pdf.)
3. Advisory Committee on Microbiological Criteria for Food Re-Chartered
The Food Safety and Inspection Service issued a notice announcing the re-chartering of the National Advisory Committee on Microbiological Criteria for Foods by the Secretary of Agriculture on June 5, 2008. (FSIS notice, D/N FSIS-2008-0023, FR Pub 08/07/08, available at http://edocket.access.gpo.gov/2008/pdf/E8-18137.pdf.)
4. Certain Sodium Heparin from China Recalled, Etc.
According to the Food and Drug Administration's weekly Enforcement Report, Scientific Protein Laboratories, LLC is recalling certain Heparin Sodium, USP (Porcine Intestines) manufactured by Changzhou SPL Company, Ltd., Changzhou, China due to the presence of foreign substance, etc. Also, certain Sandoz, Estradiol Valerate Injections are being recalled by Sandoz, Inc. that were manufactured by Sandoz Canada, Inc. for exceeding the unknown impurity specification during stability testing. See report for additional recalls. (FDA Enforcement Report 08-31, dated 08/06/08, available at http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01067.html.)
5. FAS' Global Agriculture Information Network Reports
FAS issued the following GAIN reports:
Argentina Grain and Feed: Lock-Up Report
Argentina Planting Seeds: Annual
Argentina Fresh Deciduous Fruit: Semi-Annual
Argentina Grain and Feed: Lock-Up Report
Venezuela Agricultural Situation: Government Temporarily Stops Some Food Imports
Australia FAIRS Country Report: Annual
Belgium-Luxembourg Frozen Potato Products: Benelux
Belgium-Luxembourg Agricultural Situation: Belgian Minister of Agriculture
Canada Agricultural Situation: This Week in Canadian Agriculture, Issue 22
Chile Dried Fruit: Raisin Annual
China Agricultural Situation: Grain and Oilseed Market Situation Update
Egypt Trade Policy Monitoring: Trade Policy
Egypt FAIRS Country Report: Annual
France HRI Food Service Sector: Annual Report
Israel FAIRS Country Report: Annual
Japan Bio-Fuels: Bio-Fuels Annual Report
Korea Product Brief: Almonds, Walnuts, and Pistachios
Korea FAIRS Country Report: Annual
Malaysia Oilseeds and Products: Update (July)
Mexico Oilseeds and Products: July Update Oilseeds
Mexico Grain and Feed: Update on Grain & Feed
New Zealand FAIRS Country Report: Annual
Russian Federation Grain and Feed: August Monthly Update
Ukraine FAIRS Country Report: Annual Update
Venezuela FAIRS Country Report: Annual
6. EC to Connect EU with UN Carbon Credit Registry before December
The European Commission, Member States and the United Nations Framework Convention on Climate Change (UNFCCC) Secretariat have successfully completed all the testing required for connecting to the UN's international carbon credit registry. The EU's Community Independent Transaction Log (CITL) and Member State registries will be connected to the UN's International Transaction Log (ITL) before December 2008 at the latest. The link will mean carbon credits issued under the Clean Development Mechanism can be transferred to the registries of EU Member States. (EC press release IP/08/1246, dated 08/06/08, available at http://europa.eu/rapid/pressReleasesAction.do?reference=IP/08/1246&format=HTML&aged=0&language=EN&guiLanguage=en.)
5. Iran and Iraq Sign Customs Cooperation Agreement
The governments of Iran and Iraq have signed a customs cooperation agreement. The customs agencies of the two countries are ready to exchange information regarding the transporting or warehousing of goods, means of transportation and customs houses, new methods of combating customs offences and smuggling and other related electronic or paper based data. (Iran Customs Administration press release, dated 08/13/08, available at http://www.irica.gov.ir/English/news/NewsViewEn.aspx?ID=223.)
6. OPIC Approves $127 Million for New Investment Funds for Africa
The Board of Directors of the Overseas Private Investment Corporation (OPIC) approved $127 million for two new private equity investment funds for Africa. The first fund will invest in pan-African companies with exceptional growth prospects, the second is designed to strengthen African capital markets by investing in innovative financial instruments such as mezzanine and convertible debt. (OPIC press release, dated 08/05/08, available at http://www.opic.gov/news/pressreleases/2007/pr080508.asp.)
7. BIS Significant Export Enforcement Cases for August 2008
The Bureau of Industry and Security has issued a notice announcing its most significant export enforcement cases for the month of August 2008:
| Entity | Action/Violation/Alleged Violation |
|---|---|
| Cryostar SAS | Sentenced to a $500,000 criminal fine and two years of probation for its involvement in a conspiracy to illegally export U.S. origin cryogenic submersible pumps to Iran. |
| Tah Wei Chao | Pled guilty to conspiracy and violating the International Emergency Economic Powers Act for conspiracy to export, exporting, and attempting to export thermal imaging cameras to China without the required licenses. |
| Euro Optics Inc. | Sentenced to a $10,000 corporate fine, $800 special assessment and five years of corporate probation, for violating the International Emergency Economic Powers Act and the International Trafficking in Arms Regulations in the export of Commerce and State Department-controlled rifle scopes to various countries without the required licenses. |
| Allied Telesis Labs | Sentenced to a $500,000 fine and two years of supervised probation for conspiracy to export high-speed telecommunication equipment to Iran without U.S. Government authorization. |
| Donald Wayne Hatch and Rigel Optics Inc. | Pled guilty to one count of making false statements, and also entered a guilty plea on behalf of the corporation to one count of violating the Arms Export Control Act for selling night vision optical equipment to various foreign customers. |
(BIS notice, dated August 2008, available at http://www.bis.doc.gov/complianceandenforcement/mcl082008.pdf)