Guidance on Vessel Diversions for Hanjin Shipping Lines Cargo
U.S. Customs & Border Protection
Hanjin Shipping Co., one of the world’s largest shipping lines, filed for court receivership in South Korea on Wednesday. The South Korean company made the filing with the Seoul Central District Court after its banks withdrew their backing, viewing a plan to tackle Hanjin’s debt as insufficient. In anticipation of possible disruptions due to Hanjin Shipping vessels or cargo arriving to U.S. ports, CBP is providing the attached (below) processing scenarios to help trade and CBP identify procedures to follow to prevent disruptions.
Scenario 1: Vessel Diverted to Foreign Port and Discharged: A Hanjin vessel does not arrive in the intended U.S. port and diverts to a foreign port to discharge freight.
- The manifest and Importer Security Filing (ISF) must be deleted.
- All bills of lading need to be deleted (not cancelled)
- Entries and entry summaries need to be cancelled.
- For cargo subsequently entering the U.S. through land border or other means, a new entry should be filed at the appropriate port of entry.
- For shipments subject to Food and Drug Administration (FDA) requirements, filers must request deletion and a new Bio-Terrorism Act (STA) prior notice submission should be transmitted along with the new entry if the cargo subsequently enters the U.S.
Scenario 1a: Hanjin Vessel Diverted to Foreign Port Not Discharged: A vessel diverted to a foreign port of entry is not discharged but cargo is transferred to an alternative conveyance (i.e. barge) for arrival and discharge at the original intended U.S. port of entry.
- This should be used only in limited situations.
- No change is needed to the manifest, bill of lading, ISF, or pre-filed entries.
- A new FDA prior notice is not required.
- The arrival date will reflect the date the conveyance arrives at the intended U.S. port to be offloaded.
Scenario 2: Hanjin Vessel Diverted to Another U.S. Port and Discharged: This includes any scenario where shipments manifested for one U.S. port are discharged in a port other than the manifested port.
- Manifest and bill information should be updated to reflect the port code where the freight will actually be discharged.
- No change is needed to the ISF. However, ISF filers should monitor the ISF disposition codes to ensure that any changes to the manifest and bill information did not cause the original bill match to drop.
- Change pre-filed entries to reflect the actual port code of discharge. The filer may opt for any of the following:
- Using ACE Cargo Release corrections capability, to change pre-filed entries to reflect the actual port code of discharge. As long as the shipment is not held or arrived/released, this process should be fully automated with minimal CBP intervention.
- Initiate an electronic in-bond movement or use a 7512 to allow for inter-modal transport of the goods to the original intended U.S. port for processing by CBP.
- Entries may be cancelled and refiled for the new port of entry.
- A new FDA prior notice is not required; filers can retransmit a corrected/updated prior notice.
In all cases under this scenario, manifest and bill information should be updated, but no change is needed to the ISF. Please note that without updating the bills of lading, the shipments cannot be arrived at the first port of arrival which will prevent entries from releasing. Changes in entry process with ACE Cargo Release has linked the entry release to the manifest arrival to increase the number of fully paperless transactions. Without this, paper entries and other documents will be needed for shipments not requiring examination or further processing with ACE. In addition, since shipments being held for examination or document review will need to be amended in any scenario, this process provides a standard process with most compliant transactions requiring minimal CBP intervention.
Scenario 2a: Hanjin Vessel Diverted to Another U.S. Port Not Discharged: When a vessel is diverted to another U.S. port of entry but not discharged, no change is needed to the bill of lading or entries. The arrival date for the vessel will reflect the date the ship returns to the intended U.S. port to be offloaded.
Scenario 3: Hanjin Vessel Rests at Anchor and Not Diverted: A vessel arrives in port but due to work stoppage rests at anchor until freight can be discharged.
- The carrier must continue to provide advance notification to local CBP ports of theirpending arrival (CBP Form 3171).
- When a vessel arrives at a U.S. port (within CBP territory) and comes to rest whether at anchor, dock, or harbor, carriers must notify local CBP vessel processing personnel.
- After initial arrival, a change to the vessel’s arrival status should be considered (vessel unarrived) to avoid automated cargo release and general order issues.
- The carrier and vessel agents should maintain close communication with local CBP port vessel processing office to share information, updates, instructions, and portspecific guidance.
- CBP will work with the carrier on a case-by-case basis so the actual arrival date and time at the first U.S. port closely reflects the actual date/time the vessel begins to unlade the cargo.
- CBP will also take into consideration situations where cargo has been unladen butdue to work stoppage cannot be moved from the dock.
Scenario 4: In-bond (IT and T&E) cargo already in the U.S. moving under Hanjin’s bond to U.S. port for entry or export. This cargo must be arrived to process the entry and allow release. Customs brokers and others using ABI functions QP/WP can arrive and/or export any in-bond at destination. As an alternative, the in-bond document (or information as appropriate) can be delivered to CBP and in-bond destination in order to be manually arrived/exported.
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USITC Institutes Section 337 Investigation of Certain Athletic Footwear - U.S. International Trade Commission
The U.S. International Trade Commission (USITC) has voted to institute an investigation of certain athletic footwear. The products at issue in the investigation are athletic running and training footwear with specific sole technology.
The investigation is based on a complaint filed by Reebok International Ltd. of Canton, MA, and Reebok International Limited of London, England, on August 10, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain athletic footwear that infringe patents asserted by the complainants. The complainants request that the USITC issue a limited exclusion order and cease and desist orders.
The USITC has identified the following as respondents in this investigation:
TRB Acquisitions LLC of New York, NY;
RBX Active 01 LLC of New York, NY;
RBX DIRECT LLC of New York, NY;
RBX.COM LLC of New York, NY; and
Elite Performance Footwear, LLC, of New York, NY.
By instituting this investigation (337-TA-1018), the USITC has not yet made any decision on the merits of the case. The USITC’s Chief Administrative Law Judge will assign the case to one of the USITC’s administrative law judges (ALJ), who will schedule and hold an evidentiary hearing. The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.
The USITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation. USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.
FCBP Hosts 5th Annual CTAC OpsExpo to Plan for the Future - U.S. Customs & Border Protection
U.S. federal agencies meet to discuss import safety
With the end of the fiscal year only a few weeks away, members of the Commercial Targeting and Analysis Center, better known as CTAC, gathered in Washington, D.C., on Tuesday, to discuss their plans for the future. The 11-partner government agencies that have joined forces to focus on import safety met at the 5th annual OpsExpo operational planning meeting hosted by U.S. Customs and Border Protection.
“One of the most important things that we do in getting ready for a new year is planning and trying to decide what we want to accomplish,” said Executive Assistant Commissioner of CBP’s Office of Trade Brenda Smith, who welcomed the nearly 100 attendees and gave the opening remarks. “This session is absolutely critical for that.”
Smith noted that one of the reasons that CTAC is so impressive is because the group represents diverse authorities, resources, missions, skills, and has access to a wide variety of information. “In the last 10-15 years, one of the things the government has recognized is that we can accomplish a lot more if we are organized and flexible enough to work together,” said Smith.
But she said, the challenges are twofold. “One is being flexible enough to understand that there may be a different way to do things or that someone else’s priority ought to take precedence over your own. The other is being smart enough to organize ourselves so that we leverage those things that we have available to us.”
Smith challenged the group further, asking them to look beyond the next 12 months and make plans for the next five years. “We’ve got a lot of change coming at us. We’ve been working together for the last two to three years to implement the Single Window. We’ve been working not only to drive the automation, but to understand and take advantage of the opportunities for our business processes. You all have a wealth of information coming at you now in electronic form that you can use to target, to assess risk, and to take operational action,” she said. “We need to take the long view and develop a vision for five years down the road and actually implement that vision.”
Bruce Foucart, the director of the National Intellectual Property Rights Coordination Center, which is managed by U.S. Immigration and Customs Enforcement’s Homeland Security Investigations, or HSI, shared some of the results that have occurred because of the CTAC’s efforts. One example he spoke about was Operation Pangea, which involves shutting down online pharmacy websites that sell counterfeit goods and illicit medical equipment. HSI worked in tandem with CBP, the U.S. Food and Drug Administration and Interpol on the operation.
“Just last year alone Operation Pangea led to 393 arrests worldwide and the seizure of $53 million worth of illegal medications. Within the United States, HSI initiated 73 investigations related to counterfeit pharmaceuticals, making 35 arrests, receiving 38 indictments, and 38 convictions. We could not have done that without the intelligence provided from those of you who are in this room,” said Foucart.
CTAC, which was created in October 2009, initially focused solely on import safety. Since that time, environmental crimes that threaten the country’s natural resources and wildlife trafficking have been added. “There are a number of partner agencies that have approached us about joining CTAC that don’t necessarily have an import safety focus,” said Christopher Robertson, CTAC’s branch chief, who said that the center might broaden its scope again. “These agencies focus on items that pose national security risks or are related to economic security.”
Among those attending was Mario Jorquera, a senior engineer in the air enforcement division of the U.S. Environmental Protection Agency, EPA. “This is my third OpsExpo,” said Jorquera. “We are always interested in future targeting opportunities and the fact that we can do that with CTAC is very important for us.” Jorquera explained that the EPA uses the targeting information to enforce the Clean Air Act. “All vehicles and engines in the U.S. have to be certified to show that they have met emission standards to prevent air pollution,” he said.
In the coming year, Jorquera said the EPA would like “to replicate the great success we’ve had during the past two years in targeting illegal vehicles and engines coming into the country. Having intelligence ahead of time so that we know when these goods are coming into the ports is important for us. It used to be that we were reactive. The shipments came in and we had to scramble to figure out if there was a problem,” said Jorquera. “Now we can see ahead of time if we need to be wary of something or simply let it go because it’s not a problem.”
Other attendees such as Richard Lower from the U.S. Department of Agriculture’s Agricultural Marketing Service came to the OpsExpo with the intent of joining CTAC. “We’re trying to get onboard as soon as possible,” said Lower, who explained that his agency is responsible for regulating the quality of certain imported fruits and vegetables. “We often work with other government agencies such as the FDA. There are certain commodities such as raisins, olives, peanuts, pistachios and dates that both FDA and USDA regulate and share the same concerns about. Being a part of CTAC would increase the cooperation and transparency between our agency and the FDA. It helps them and it helps us. That kind of cooperation is invaluable.”
FDA Requires Strong Warnings for Opiod Analgesics, Prescription Opiod Cough Products, and Benzodiazepine Labeling Related to Serious Risks and Death from Combined Use - Food & Drug Administration
Action to better inform prescribers and protect patients as part of Agency’s Opioids Action Plan
After an extensive review of the latest scientific evidence, the U.S. Food and Drug Administration announced today that it is requiring class-wide changes to drug labeling, including patient information, to help inform health care providers and patients of the serious risks associated with the combined use of certain opioid medications and a class of central nervous system (CNS) depressant drugs called benzodiazepines.
Among the changes, the FDA is requiring boxed warnings – the FDA’s strongest warning – and patient-focused Medication Guides for prescription opioid analgesics, opioid-containing cough products, and benzodiazepines – nearly 400 products in total – with information about the serious risks associated with using these medications at the same time. Risks include extreme sleepiness, respiratory depression, coma and death. Today’s actions are one of a number of steps the FDA is taking as part of the agency’s Opioids Action Plan, which focuses on policies aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.
“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf, M.D. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks.”
Given the importance of reaching health care professionals and the public with information about the risks of using these products together, today the FDA also issued a Drug Safety Communication. Through the Drug Safety Communication and by requiring patient Medication Guides, the agency also provides information for anyone who is taking, or who knows someone taking, either of these types of medications and encourages them to better understand the risks of taking them together; and, when it is medically necessary, for health care providers to be careful to prescribe them as directed, without increasing the dose or dosing frequency for either drug.
Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone, and morphine, among other drugs, under both brand and generic names. Certain other opioid medications are also approved to treat cough. Opioid analgesic misuse and abuse have increased significantly in the United States over the past two decades, and represent major public health concerns due to the risk of coma and fatal respiratory depression associated with opioid analgesic overdose. Benzodiazepines are drugs typically prescribed for the treatment of neurological and/or psychological conditions, including anxiety, insomnia and seizure disorders. Both classes of drugs depress the central nervous system (“CNS depressants”); however, each has unique pharmacology, safety risks, and labeling information related to its use. Therefore, the FDA is requiring opioid analgesics, prescription opioid cough products, and benzodiazepines to have slightly different labeling. Additionally, due to the unique medical needs and benefit/risk considerations for patients undergoing medication-assisted therapy treatment (MAT) to treat opioid addiction and dependence, the FDA is continuing to examine available evidence regarding the use of benzodiazepines and opioids used as part of MAT.
The FDA’s data review showed that physicians have been increasingly prescribing them together, and this has been associated with adverse outcomes. Among the data reviewed by the FDA, the agency concluded that from 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths (from taking prescribed or greater than prescribed doses) involving both drug classes nearly tripling during that period. Additionally, the number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.
Clinical guidelines from the U.S. Centers for Disease Control and Prevention (CDC) and existing labeling warnings regarding combined use caution prescribers about co-prescribing opioids and benzodiazepines to avoid potential serious health outcomes. The actions of the FDA today are consistent with the CDC.
In February 2016, the FDA received a citizen petition from numerous local and state public health officials and other stakeholders asking the agency to make certain changes to the existing labeling for benzodiazepines and opioid analgesics. The FDA had already initiated a review of the scientific information on concomitant use of these two drug classes when the agency received the petition, and was encouraged that these public health officials shared the agency’s concerns. Today, the FDA also responded to the citizen petition.
Working with the health care community and federal and state partners to help reduce opioid misuse and abuse and improve appropriate opioid prescribing, while ensuring that patients in pain continue to have appropriate access to opioid analgesics, is a top priority for the FDA and part of HHS’ targeted approach focused on prevention, treatment, and intervention. The agency is committed to continuing to monitor these products and take further actions as needed.
The FDA, an Agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.