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March 2003 - Issue #12

In This Issue:

24-Hour Advance Manifest Rule for Outbound Sea Shipments
Food Facility Registration and FDA Prior Notice Requirements
U.S. Customs Service and EPA Agree to Share Cargo Information
Brokers, NVOCC's, Importers Now Required to Report NVOCC Bill of Lading Number
C-TPAT Consulting Services
 


Trade Industry News
24-Hour Advance Manifest Rule for Outbound Sea Shipments

U.S. Customs’ 24 Hour Advance Manifest Rule is in place for Inbound/Import sea shipments. The rule will be amended and applied to Outbound/Export sea shipments shortly; it is currently scheduled to be in place no later than October 1, 2003. Traditionally, Vessel Operating Common Carriers (VOCC’s) or the Steamship Lines transmitted the vessel departure manifest data days after the vessel had left the port, which was generally incomplete and inaccurate. The information provided was virtually useless to U.S. Customs in enforcing their targeting strategies.

To correct this, under the new rule, U.S. Customs will require explicit manifest information within 24 hours of vessel departure to allow them to target exports that may be prohibited.   The focus will be initially on transactions and shipments that are suspected of supporting global terrorism, including money laundering schemes, high-tech communication systems and dangerous chemicals. 

When the rule becomes effective, the forwarders/Non-Vessel Operating Common Carriers (NVOCC’s)/ Vessel Operating Common Carriers (VOCC’s) will need the documentation, including commercial invoices reflective of pricing/value, at least 24 hours before the cutoff time/date at the port of departure.   U.S. Customs will also be eliminating the use of the clause “NO SED REQUIRED - NO INDIVIDUAL SCHEDULE B NUMBER VALUED $2500.00 OR MORE, FTSR 30.55(H).”  Customs will now require complete details and values reported for every transaction. 

Please note that none of this information has been finalized. This is simply the first draft of procedures to be provided by Customs. Samuel Shapiro & Company, Inc. will send updates as we receive additional information.

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Food Facility Registration and FDA Prior Notice Requirements

The Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 (the Act) requires the U.S. Department of Health and Human Services (DHHS) to take specific actions to protect the nation’s food supply against terrorist threats.   The Food and Drug Administration is the regulatory arm of DHHS and is responsible for food safety.

The Food and Drug Administration (FDA) has issued proposed regulation to require any domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003. Registration will permit FDA to respond quickly to a threatened or actual terrorist attack on the U.S. food supply; it will also assist FDA in determining the location and cause of a potential threat as well as permit the agency to quickly notify facilities that might be affected.

Each facility’s location must be registered separately, even if previously registered with FDA for any other purpose. Registration is not an endorsement or evaluation of the facility.  Foreign food facilities will appoint a U.S. Agent.  Food facility registration information will not be made available to the public under the Freedom of Information Act.  

FDA strongly encourages electronic registration, via the Internet, as it will be faster and more convenient than paper registration.  A facility registering electronically will receive both its registration number and its confirmation instantaneously once all of the required fields on the registration screen are completed. Registration by mail may take several weeks to several months. FDA plans to have its electronic and paper systems in operation at least two months before the December 12, 2003 statutory deadline.  Therefore, FDA cannot accept registration prior to October 12, 2003. 

Additionally, beginning December 12, 2003, FDA will require that prior notice of food imported or offered for import into the United States, whether for consumption or in-bond transit and export, be received no earlier than five days prior to, and no later than noon of, the day before the imported food arrives at the border crossing or at the first U.S. port of arrival.   It will allow FDA time to review and evaluate information before the commodity actually arrives. It will also provide time to shift resources to target inspections, to intercept contaminated products and to ensure movement of safe, wholesome food to market.

The purchaser or importer, or their qualified agent, who resides or maintains a place of business in the United States, must submit prior notice of the importation of food. In-bond movements may be of particular interest, as the prior notice must be transmitted at the first U.S. port of arrival or the first U.S. border crossing. For instance, an arriving carrier or transporting carrier must submit prior notice in cases of in-bond transit for export. Interested parties should consider the reliability of the information being transmitted. The arriving carrier or transporting carrier may not have sufficient knowledge of the product to transmit all of the elements for prior notice.     

Notices must be submitted electronically through FDA’s web-based Prior Notice System, instead of U.S. Customs’ existing Automated Commercial System (ACS), because the ACS cannot be modified to accommodate the additional data requirements of the prior notice system before the December 12, 2003 statutory deadline.   Customs is in the process of developing the Automated Commercial Environment (ACE) system as a replacement for the ACS. However, the ACE implementation is not expected until 2005.  Once ACE is fully operational, it will be able to receive prior notices.

The FDA web-based Prior Notice System will be available 24 hours a day, seven days a week. If the system is not working, a printed version of the system’s screen must be delivered in person, by FAX or by email to the FDA office with responsibility over the geographical area of the anticipated “first US port of entry/arrival”. Immediate acknowledgment of the submission will be provided. Confirmation of electronically received prior notice is not an evaluation of the goods.

Amendments are accepted once, under limited circumstances, for information regarding product specificity or quantity change that was not available at the time the original prior notice was submitted.  Amendments cannot be used to change the nature of the article of foods.  Intentions to amend the prior notice must be filed at the time of the original electronic submission.  The amendment must then follow.   Amendments must be submitted no later than two hours prior to arrival.  Updates related to anticipated arrival information (a change in port, date or time of arrival) may be filed.   Amendments are product specific.  Updates are arrival specific.

Failure to register each facility and provide timely prior notice may result in the imported product being refused admission and held at the port of entry or other secure location as required by FDA. The purchaser, owner, importer or consignee will be responsible for transportation and storage expenses. Failure to register or provide timely prior notice is considered a prohibited act and may result in civil and criminal penalties.

A critical step is the publication of the proposed rules for public comment. Under U.S. law, proposed regulations are published in the Federal Register to provide interested parties with an opportunity to submit comments, such as suggestions to make the proposal more effective, and questions regarding the agency’s data. It also provides an opportunity to submit information that the agency may not have.  Updated information on the regulatory proposals can be accessed electronically at: 

http://www.fda.gov/oc/bioterrorism/bioact.html

http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0278-npr0001.pdf

http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0276-npr0001.pdf

Comments on the proposed regulation for Registration of Food Facilities (Docket Number 02N-0276) and the proposed regulation for Prior Notice of Imported Food (Docket Number 02N-0278) will be accepted for 60 days from the date it appeared in the Federal Register on February 3, 2003 (Volume 68, Number 22).  Written comments on both proposals can be sent to

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

All comments can be sent electronically to www.fda.gov/dockets/ecomments.  It is important to include the docket number when providing comments.

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    U.S. Customs Service and EPA Agree to Share Cargo Information

    An agreement signed in January 2003 by U.S. Customs Service and the Environmental Protection Agency (EPA) allows the EPA to gain critical access to confidential records regarding incoming vessels calling on more than 301 seaports of entry nationwide. The effort will greatly enhance the abilities of both agencies to better respond to emergencies and potentially hazardous threats.

    Although Customs and the EPA have been sharing data, this agreement allows the EPA regular monthly access, as well as access in cases of emergency when a questionable vessel is identified, to the electronic information database that Customs maintains. According to an Associated Press article written by AP writer Wayne Perry, "former New Jersey governor, Christie Whitman, now an EPA Administrator, said that the EPA will share the information it gleans from the Customs database with state and local governments, for instance, when a shipment of hazardous chemicals is due to arrive at a particular location". In addition, according to the article, Customs Commissioner Bonner reiterated the importance that information is shared freely and quickly among various government agencies in an effort to help the government's emergency response in critical situations.

    Sources: Associated Press Article by Wayne Perry - Associated Press Writer, dated January 15, 2003 appearing on U.S. Customs Website; “Customs and EPA Sign MOU to Share Information on EPA-Regulated Imports" from International Trade Today dated January 21, 2003.

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    Brokers, NVOCC's, Importers Now Required to Report NVOCC Bill of Lading Number

    Under the revised import version of the 24-Hour Advance Manifest Rule, brokers, Non-Vessel Operating Common Carriers (NVOCC's) and importers are now required to show the NVOCC bill of lading number as well as the NVOCC Standard Carrier Alpha Code (SCAC) code on all entry documentation and electronic transmissions if the NVOCC is an operational automated manifest system (AMS) participant.

    U.S. Customs issued Administrative Message 03-0513 on February 6, 2003 outlining the procedures for proper reporting. The NVOCC bill of lading number can no longer be reported as a house bill number. The NVOCC bill of lading number must be reported as the master bill number. In addition, master bills issued by the actual carrier cannot be reported. Under the 24-Hour Rule, automated NVOCC AMS participants should use their own Standard Carrier Alpha Code (SCAC) codes as the issuer code as well as the carrier code.

    Failure to properly report the SCAC code and the master bill of lading number may result in delays obtaining the release of cargo.

    Sources: “Customs Administration Message 03-0513" dated February 6, 2003; "Reporting of Bills of Lading on Entry/Entry Summary when NVOCC is an Operational AMS Participant Under 24-Hour Rule" from International Trade Today dated February 10, 2003.

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    Shapiro Products & Services
    C-TPAT Consulting Services

    Samuel Shapiro and Company, Inc. hosted a successful and very informative half-day seminar in February focusing on the Customs-Trade Partnership Against Terrorism (C-TPAT) program at the World Trade Center in Baltimore, Maryland. (Please see our editorial in this issue on the subject of Requests for Information (CF28) that are being issued by Customs in order to secure CTPAT information from importers.)

    Customs has intensified efforts to encourage all importers to voluntarily participate in the C-TPAT program. Samuel Shapiro & Company, Inc. offers comprehensive C-TPAT assessment and consulting services. For more information, please contact compliance@shapiro.com or 1-800-695-9465, Ext. 281.

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