U.S. CUSTOMS & BORDER PROTECTION, FDA AND DEPT. OF COMMERCE CENSUS UPDATE

1. U.S. CUSTOMS & BORDER PROTECTION, FDA AND DEPT. OF COMMERCE CENSUS UPDATE WMTA NOV. 19, 2011

2. C-TPAT UPDATE Details of C-TPAT Portal's New "Adjusted" Validation Scorecard, Etc. • U.S. Customs and Border Protection recently posted information on improvements to the C-TPAT Portal (Release 65 - Adjusted Scorecard Post Response) that deployed on November 12, 2011. Among other things, this release includes a new "Adjusted Scorecard" that provides points to C-TPAT participants that implement required actions or recommendations during the response period for CBP's Validation Report.

3. C-TPAT (A C-TPAT validation is a process through which the CBP C-TPAT program officials meet with Partner company representatives and visit selected domestic and foreign sites to verify supply chain security processes and procedures that a company voluntarily agrees to verify or perform under the auspices of the C-TPAT program. Validation visit findings are documented in a Validation report (which includes the Validation Scorecard) and is forwarded to the C-TPAT participant. If significant supply chain security weaknesses are found that are not corrected during the Validation report’s 90-day response period, a participant’s C-TPAT benefits may be suspended.

4. FDA PREDICT PROGRAM FDA - PREDICT Program Starts at Southern Ports of Entry  (Predictive Risk Risk-based Evaluation for Dynamic Import Compliance) • The Food and Drug Administration is in the mist of rolling out the PREDICT system (Predictive Risk Risk-based Evaluation for Dynamic Import Compliance) all along the southern border between November & December 2011, and fully implemented by the end of 2011 in the entire USA for Human Foods, House wares and Food related goods, Cosmetics, Medical Devices and Drugs it will be phased in during 2012. • PREDICT went live: on 11/1/11 at the Nogales, San Luis ports of entry, 11/08/2011 in Calexico, Otay Mesa on 11/14/2011,  El Paso and Laredo by the end of November with the ALL  of SWID ports by 12/6/11! • The purpose of this program is to segment risk of commodities regulated by FDA and establish intelligent screening for Import activity.

5. FDA PREDICT continued  The screening will be based on the following categories: •  Importer of Record • Exporter and or Shipper • Commodity • Industry A combined score per say will be derived based on data being provided at the time of entry to keep track of the accuracy of the data and constancy of what is filed with FDA and actually recorded with FDA.  PREDICT facilitates the processing of entries by measuring the quality of data being provided to the filers (brokers) then to FDA.

6. FDA PREDICT continued  What FDA has encountered with the use of PREDICT is that the time of processing and reviewing entries is far more efficient, effective and expeditious where the number of MAY PROCEEDS have increased.  Thereby allowing FDA to focus on the entries that require more effort and time to verify data accuracy and completeness. • FDA personnel are currently being trained on the new entry review system. Due to the nature of the new system, expect some delays as personnel become more acquainted on the new system. • It will become more imperative for Import Filers to input all the necessary data required to avoid any further delays. • This is the link to the detailed information and video from  FDA on PREDICT and the rest of the presentations that FDA is utilizing to train the FDA officers and sharing with the importing community. http://www.fda.gov/ForIndustry/ImportProgram/ucm172743.htm#.Tqs8gVX6IQ8.email

7. FDA PREDICT continued • PREDICT assists FDA in expediting the clearance of lower-risk cargo if accurate and complete data are provided by importers and entry filers. FDA Import Operations would like to stress the importance of providing the correct information in the electronic transmission of entries in order to reduce delays. • As a rule, each entry must stand on its own regardless of the history of similar entries. Entries that do not contain the correct information will be forwarded to manual reviewers. If documents are requested, it is often due to a deficiency in the transmitted information. Predict matches the affirmations of compliance with the product code provided so it is imperative that the correct product codes be used. • When corrections need to be made on electronic entries, PREDICT scores for the importer and brokerage firms will both increase. Higher PREDICT scores can result in entries being held, manually reviewed, and examined. To expedite the entry review process, please ensure that the most valid, up-to-date, and correct information is provided with each line of their entry.

8. FDA PREDICT Checklist to ensure that the correct and adequate documents are provided. • The entry contains goods of US origin. • The documents provide a reason why the US goods are being returned. -A statement of intended use addressed to FDA Investigator and signed/dated by the Cnee/Importer is included. It answers what the product is and how it will be used. -There are brochures and labeling of the [final] product(s) within the documents. • The entry contains devices. • The necessary device listing and registration numbers have been verified and are included. (See AofC codes for Medical Device and Radiation Emitting Products) • The entry contains radiation emitting devices. • There is a signed FDA form 2877 noting the AWB/Entry # and Accession Number. • The entry contains OTC drugs. • The necessary drug registration numbers have been verified and included (NDC). • The entry contains Rx drugs. • The necessary drug registration numbers have been verified and are included. (NCD + NDA/ANDA or IND). • The entry contains canned food products. • The documents contain unit packaging information and net weight. • The documents contain FCE and SID# with can dimensions expressed in whole inches and any fractions expressed in 16ths of an inch (not decimals).

9. U.S. DEPARTMENT OF COMMERCE BUREAU OF THE CENSUS / EXPORT You Must Comply with the Foreign Trade Regulations • How does the Foreign Trade Regulations (FTR) affect your export business? • It is imperative that you understand the FTR so you can avoid possible penalties and seizure of your export shipments.

10. EXPORT COMPLIANCE SEMINARS AND WORKSHOP Seminar: Tuesday, November 15, 2011 (Irvine) Address: FDA (Food and Drug Administration (District Office) 19701 Fairchild Irvine, CA 92612 • Seminar: Wednesday, November 16, 2011 (Los Angeles) Address: Sheraton Gateway Los Angeles Hotel 6101 West Century Blvd. Los Angeles, CA 90045 Cost: $199.00 Workshop: Thursday, November 17, 2011 Address: Long Beach City College 4900 E. Conant St. BLDG 2 Long Beach, CA 90808 Cost: $60.00