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Enforcement

Best PracticesCustoms BrokerEventsFDA IssuesFoodFSMAImportSpeaking

FREE World Trade Month Seminar on FDA/FSMA COMPLIANCE for Importers

posted by Jennifer Diaz April 24, 2017 4 Comments

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In celebration of World Trade Month, Diaz Trade Law is hosting a World Trade Month Seminar Series for Compliance Professionals featuring U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) speakers.

Food Importers, here is your chance to learn practical tools for trade! We are providing the trade community a valuable opportunity to speak direct with FDA, Brokers, and legal experts to address any concerns relating to food importations and discuss the upcoming Foreign Supplier Verification Program (FSVP) requirement under the Food Safety Modernization Act (FSMA).

The TOP reasons you should attend? 

  1. For a limited time, registration is FREE!
  2. You have the ability to hear DIRECTLY from FDA.
  3. We want the seminars to be informative and all of your questions answered. In that vain, we are currently taking ANY questions you have related to food importation/FSMA for the FDA. Please email your questions today to info@diaztradelaw.com!

You have a limited time to RSVP to this event for FREE!!! Yes, for FREE. We find this information to be invaluable so Diaz Trade Law is sponsoring this event, to bring it to you for FREE. RSVP today! Our full event agenda including the who, what, when, and where is below. Don’t miss it!

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CBPCustoms BrokerImport

BEWARE – Liquidated Damages WILL be Imposed for 10+2 Violations

posted by Jennifer Diaz July 18, 2013 0 comments

For those who thought CBP’s “measured and commonsense” approach for those that weren’t fully complying with the Importer Security Filing (ISF or 10+2) rules would last forever, think again!

Effective, July 9, 2013, CBP advised it would start the liquidated damages phase of the Importer Security Filing (ISF) enforcement process. CBP will now make use of the newly activated cargo holds in the Automated Cargo Environment (ACE) system to address non-compliance with the ISF rule. CBP may also withhold the release or transfer of non-compliant ISF shipments at the terminal until the required ISF is filed. For carrier violations of the vessel stow plan requirement, CBP may refuse to grant a permit to unlade the merchandise. Once the ISF data is received and a security assessment is made, additional enforcement actions including a Non-Intrusive Inspection (NII) and/or intrusive exams may be initiated.

Liquidated Damages

CBP may also assess liquidated damages of up to $5,000 per violation for the submission of an inaccurate, incomplete or untimely filing. CBP Dec. 09-26 discusses “Guidelines for the Assessment and Cancellation of Claims for Liquidated Damages for Failure to Comply with the Vessel Stow Plan, Container Status Message, and Importer Security Filing Requirements.”  First violations may be mitigated to $1,000-$2,000 – depending on the presence of aggravating or mitigating factors.  Some mitigating factors for the failure to file a complete, accurate and timely ISF include evidence of progress in the implementation of ISF during the “flexible enforcement period,” small number of violations compared to number of shipments, Tier 2 and 3 C-TPAT status, remedial action….  CBP has advised that “no relief will be granted if CBP determines that law enforcement goals were compromised by the violation.”  Aggravating factors include multiple errors on your ISF!  If you do receive a Liquidated Damages claim, it is important you consult with an expert to file a timely, persuasive Petition to CBP and address all relevant mitigating factors to assure you receive the maximum reduction possible.

What’s ISF Again?

The ISF rules require importers and vessel-operating carriers to provide additional advance trade data on cargo shipments to CBP 24 hours prior to vessel lading, pursuant to Section 203 of the Security and Accountability for Every Port (SAFE Port Act) of 2006.

Importers must report the following 10 data elements on each ISF:

  1. Manufacturer (or supplier) name and address
  2. Seller (or owner) name and address
  3. Buyer (or owner) name and address
  4. Ship-to name and address
  5. Container stuffing location
  6. Consolidator (stuffer) name and address
  7. Importer of record number/foreign trade zone applicant identification number
  8. Consignee number(s)
  9. Country of origin
  10. Commodity Harmonized Tariff Schedule (HTS) number

From the carrier, 2 data elements are required:

  1. Vessel stow plan – required for arriving vessels with containers.
  2. Container status messages – required for containers arriving via vessel.

Hence, 10+2!

For shipments consisting entirely of freight remaining on board (FROB) cargo or goods intended to be transported in-bond as an immediate entry or transportation and exportation entry, the following 5 data elements are required:

  1. Booking party name and address
  2. Ship-to name and address
  3. Commodity Harmonized Tariff Schedule (HTS) number
  4. Foreign Port of Unlading
  5. Place of delivery

In order to avoid liquidated damages and untimely delays with your cargo, full ISF compliance is now required.  Since we’re talking compliance, do you have your pre-compliance plan established?  If not… Let’s talk!

If you have any questions on the listed requirements, need assistance with cargo detained as a result of this new enforcement phase, getting your C-TPAT application in ASAP (and getting to Tier 2 quickly!), or any other compliance or enforcement question, please feel free to contact Diaz Trade Law at info@diaztradelaw.com and we would be happy to assist you!

FoodFSMA

FDA Extends Until January 31 for Food Facilities to Re-Register

posted by Jennifer Diaz December 20, 2012 2 Comments

 Below are the latest and greatest updates  regarding compliance with the FDA’s Food Safety Modernization Act (FSMA). It includes background on FSMA, an update from FDA with 2 new guidance documents, FDA’s extension to file biennial registrations, and an update on FDA using its enforcement power to suspend a facilities registration – meaning they can NOT import into the U.S.

FSMA Background

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d]. The registration requirements in section 415 of the FD&C Act apples to domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 102 of FSMA amended section 415 of the FD&C Act in relevant part to provide that food facilities required to register with FDA must renew their registrations with FDA every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year, otherwise, their registration will be cancelled by the FDA.

Reinspection Fees

Importantly, please note that facilities will be charged reinspection fees by the FDA. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required. U.S. Agents will be responsible to assure these fees are collected.

FDA Extension

Because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA’s guidance document advised that FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.

FDA Published 2 Guidance Documents:

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition). This guidance document contains helpful questions and answers regarding food facility registration.

Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide. Thus guide was updated to reflect FSMA amendments to the FD&C Act, and discusses: who is required to register pursuant to the Bioterrorism

Suspension of Registration

FSMA also amended section 415 of the FD&C Act to provide FDA with the authority to suspend a food facility’s registration in certain circumstances involving food that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA already used this power and suspended the registration of Sunland, a producer of nuts. The full story may be read here.

Export

New Export Enforcement Priorities Come with New Names at the Bureau of Industry and Security

posted by Customs & International Trade Law Blog April 17, 2011 0 comments

On April 14, 2011, in Washington, D.C., David Mills, the new Assistant Secretary for Export Enforcement, Bureau of Industry and Security (BIS), U.S. Department of Commerce, and his Special Advisor, Bob Rarog, explained the enforcement priorities of BIS. These priorities were established by Eric Hirschhorn, who was just sworn in as Under Secretary of the U.S. Commerce Department’s Bureau of Industry and Security (BIS) on April 2, 2010, after being appointed by President Obama. This event was part of the American Bar Association’s Section of International Law’s Export Controls and Economic Sanctions Committee.

David Mills, who has an excellent perspective from recently being a private practicing attorney, and was formerly the Chief of Licensing at the Office of Foreign Assets Control (OFAC), identified the three primary initiatives of export enforcement by the BIS.

1.  Efficiency – process administrative cases faster.

2.  Education – outreach program to exporting companies.

3.  Enforcement – going for the $250,000 maximum penalty or twice the value of the transaction, whichever is greater.

David Mills stated that where both OFAC and BIS have jurisdiction over a violation, it is best to file voluntary self disclosure simultaneously with both agencies.  Generally, Special Agents from the BIS’ Office of Export Enforcement will conduct the investigation thereafter.  Another interesting point was that the Obama Administration remains focused on Iran, preventing the proliferation of weapons of mass destruction (WMD), and prohibiting any transactions with Specially Designated Nationals (SDNs). This is consistent with the U.S. Department of Justice’s recent National Counter-Proliferation Initiative to increase the detection and prosecution of export control violations. For the past two years since this Initiative started, the number of criminal and civil cases targeting violations of the ITAR, EAR and trade sanctions have greatly increased. Federal agents from the FBI, Justice, BIS, ICE, OFAC, State and Defense have investigated and prosecuted companies and individuals for illegally exporting goods and technology not only to countries such as Iran, China and Cuba, but also to close allies such as Canada, Mexico, Taiwan and Israel. 

What surprised many of the legal experts listening to David Mills who practice in the area of export controls was the statement by Mr. Mills that the filing of voluntary self disclosure by the company with BIS will not necessarily protect the employees of that company. Mr. Mills was sending a message:

Willful or knowing, as opposed to inadvertent,  violations by individuals will be punished.

Mr. Mills clearly set forth a new policy:

Special Agents of BIS are directed to focus on investigating culpable individuals for criminal prosecution or civil penalties.

He also stated that it is often an appropriate action for the company to terminate the employee who violates the laws of the United States.