International Travelers Beware - U.S. Customs WILL Seize Your Money...

International travelers often contact me with the same distraught face as the man pictured to my left, after their money is confiscated by U.S. Customs and Border Protection (CBP) as a result of not properly declaring currency on hand. Declaration Form 6059B will look familiar to all international travelers as you fill it out when entering the U.S. Many times, the rationale for seizure is that parties traveling together split their currency, and even though together they have over the $10,000 minimum, the travelers advise they are each carrying less then the $10,000 minimum requirement for reporting (in question 13 of Form 6059B), resulting in ALL of the currency on hand being seized. Recently, CBP seized $82,000 of currency, and arrested the female driver, after discovering three packages of bulk currency hidden within a vehicle as a female driver attempted to exit the U.S. and enter Mexico. During this holiday season, this post will tell you what you need to know to assure it's NOT YOU that has their currency seized when traveling internationally!

Take 2 - Registration Now Opens For CBP's Symposium in DC

Mark your calendars - the CBP 2014 East Coast Trade Symposium is back on and scheduled for March 6-7, 2014, at the Washington Hilton Hotel in Washington, D.C.

The theme remains the same - “Increasing Economic Competitiveness Through Global Partnerships and Innovation”. Based on the overwhelming interest received by CBP for participation at the Symposium, CBP is limiting attendance to three (3) participants per company to afford equal representation from all members of the international trade community. If a company exceeds the limitation, subsequent registrations will automatically be placed on the waiting list.

Registration for onsite participation has increased to $128, and will open TODAY, December 18, 2014 at 12:00 p.m. EST. Act fast, this event is usually sold out typically within a day! Attendance at the Symposium is an excellent opportunity to meet with all levels at CBP, so take advantage of this opportunity!

See you at the CBP Symposium!

PortMiami and CBP Join Forces to Bring Back (and Expedite) Transshipment

PortMiami has been working feverishly to bring back transshipment to Miami.

Step one was PortMiami's outreach to U.S. Customs and Border Protection (CBP).  PortMiami Director Bill Johnson wrote a letter to Acting CBP Commissioner, Thomas Winkowski, dated June 26, 2013, asking CBP to develop a pilot program, "with a transshipment inspection protocol pilot for PortMiami."

Large Seizure by CBP Highlights High Margins of Counterfeiting, and Necessity of Recordation

Co Authored by Michael De Biase 

One of CBP's latest news releases, dated September 27, 2013, noted that more than 16,000 counterfeit Hermes handbags were seized by Customs and Border Protection (“CBP”) because Hermes took the extra step of recording their intellectual property with CBP.   Not surprisingly, when you analyze the difference between the alleged value of the counterfeit products (reported to CBP) as compared to the suggested retail price of the genuine goods, you have a grave difference. In this case, $295,665 (value of counterfeit goods) compared to $210,785,475 (value of genuine goods).  That’s over $210 million worth of potential profits for the counterfeiters, at the expense of Hermes – a crime in every sense. Because Hermes recorded its intellectual property with CBP, CBP seized this infringing merchandise, and will also have the ability to issue a penalty for the MSRP of the merchandise. Yes, that means a penalty in the amount of $210,785,475 will be coming to the counterfeiters!

Most often, counterfeiters target large luxury brands whose goodwill and name recognition has a certain element of exclusivity.  While some may not sympathize with profitable companies, what they fail to realize is that counterfeiting hurts in a variety of other ways. Counterfeiting hurts consumers who buy products under the false impression that they are genuine, companies whose goodwill is tarnished by the inferior quality of the counterfeit products bearing their brands, and it hurts those who worked hard to build something of substantial value.  In this case, Hermes lost out on, potentially, more than $210 million dollars in revenue.  That is not only felt by Hermes the corporation, it hurts the retail stores and the malls they’re in, the shipping companies, the raw materials developers, and the families of the employees for all of these parties.

Luckily for importers and consumers, CBP recognizes the importance of intellectual property protection and provides assistance in stopping the infringing products at our borders.  CBP’s Intellectual Property Rights Recordation (“IPRR”) system allows holders of registered trademarks and copyrights to record their registration with CBP, so that CBP can police the borders for infringing goods.  Once recorded, it is entered into a online search system named IPRS. According to the news released mentioned above regarding catching counterfeiting Hermes at the border, once intellectual property is recorded with CBP,

CBP officers are trained to identify and interdict counterfeit goods, and this is a great example of how their training and expertise are employed every day in our ports of entry,” said CBP Director of Field Operations in Los Angeles Todd C. Owen

Considering the incentives for counterfeiters along with the potential losses for intellectual property rights holders, companies that import merchandise must consider recordation a necessity. Importantly, when you record your marks, you must go to an expert in this area - as this is your opportunity to train CBP on the methods of policing your mark - and only trained experts can work on this proficiently so you have the best results with CBP, like Hermes did. To learn more about the top four benefits of recording your intellectual property, review this article.

To get started on recording your intellectual property, or if you have any questions on how to best have CBP police your recorded trademarks and copyrights, please contact me.

Impact of Government Shutdown

Co Authored by Omar Franco 

The impact of the federal government shutdown, which began October 1, 2013, will be deeply felt by importers and exporters alike. Most government services deemed "essential" by the federal agencies will continue, but “non-essential” services will be discontinued until funding is restored.

This early on, there is no obvious resolution of the budget dispute to tie the FY-2014 government funding to Affordable Care Act (ACA) reforms. Both the House and Senate are entrenched in their positions and they are not scheduled to negotiate any time soon. One side will have to capitulate or bipartisan negotiations will have to lead to a resolution. We feel that negotiations will probably not occur this week as both sides need to assess how the markets and voters will respond to the federal government shutdown. Depending on the public response, we will see movement by one side, probably by Republicans, if the reaction is seen as damaging. As of today, the Dow was up, so the market reaction has been subdued. The reaction from voters is still unknown, but if it is subdued as well, the shutdown will be prolonged. We anticipate the shutdown will last through this week at a minimum.

Some lawmakers are considering broadening the debate by including the debt ceiling. Pressure from resolving the government shutdown could also resolve the debt ceiling issue. The longer the shutdown continues, the more likely the resolution will be tied to the debt ceiling. We do foresee a resolution emerging, however, we do not have any real idea as to what the time frame will be.

To get a glimpse of the impact on the importing and exporting community, we've included updates from the BIS and ITC below.

For example, on the export side, the Department of Commerce's Bureau of Industry and Security (BIS) has this note on its website -- they are completely SHUT DOWN, and not accepting licenses - except for emergencies.  See more here:

The Federal Government is currently shut down due to a funding lapse. As a result, the Department of Commerce's Bureau of Industry and Security (BIS) is no longer accepting export license applications, classification requests (CCATS), encryption reviews, encryption registrations, or advisory opinion requests. Similarly, BIS will not be issuing any final determinations. The SNAP-R application on BIS's Website is not available and will not reopen until the Federal Government shutdown ends. All pending export license applications, commodity classification requests, encryption reviews, encryption registrations, and advisory opinion requests will be held without action by BIS until the shutdown ends.
Applicants may request emergency processing of export license applications for national security reasons by submitting email requests to Deputy Assistant for Export Administration Matthew Borman.

The subject line of the email should read "Request for Emergency License" and the email must identify the applicant (including point of contact), intermediate and ultimate consignees, and end user(s), items, end use, and national security justification for the emergency processing.

On the import side, the impacts are distinctly felt with the U.S. International Trade Commission (ITC).  The interactive HTS that I love is not active - and ADD/CVD investigations are tolled.  CUSTOMS Info Global Data Mining has taken the opportunity to present a PDF copy of the HTSUS during the ITC's hiatus here (note you will have to provide your contact information).
See the latest from the ITC's website:

The U.S. International Trade Commission will shut down its investigative activities for the duration of the absence of appropriation. These activities include, but are not limited to, proceedings conducted under the authority of Title VII of the Tariff Act of 1930, including antidumping and countervailing duty investigations and reviews; investigations and ancillary proceedings conducted under the authority of section 337 of the Tariff Act of 1930; and investigations conducted under the authority of section 332 of the Tariff Act of 1930.

Investigations tolled 

During shutdown, the schedules and deadlines for all investigative and pre-institution activities will be tolled. All hearings and conferences will be postponed, subject to the exceptions described below. Once the Commission receives funding and the period of the shutdown ends, all schedules will resume starting with the day on which the Commission recommences operations. For example, if the shutdown lasts four days (e.g., October 1-4), then the deadline for the filing of any document on October 4 would be extended four days to October 8. If a rescheduled deadline falls on a nonbusiness day, the deadline will be extended to the next business day. The agency may reconsider schedules after resuming operations.

Exceptions

Notwithstanding the general tolling of schedules:
The staff conferences in preliminary phase antidumping and countervailing duty investigations scheduled to take place on October 7, 2013 and October 9, 2013 will take place as scheduled if the Commission resumes operations by October 3, 2013. Should the shutdown not end before October 3, 2013, all conferences will be rescheduled pursuant to the general tolling provisions described above.

The hearing in the Hot-Rolled Steel five-year reviews scheduled for October 3, 2013 will take place as scheduled if the Commission resumes operations by October 2, 2013. Otherwise, this hearing will be rescheduled upon further notice.

The hearing for Investigation No. 332-541, Trade Barriers that U.S. Small and Medium-Sized Enterprises Perceive as Affecting Exports to the European Union, scheduled to take place on October 8, 2013 will take place as scheduled if the Commission resumes operations by October 3, 2013. Otherwise, this hearing will be rescheduled upon further notice.

Website

During shutdown, the online services provided on the Commission's World Wide Web site, at www.usitc.gov, will be unavailable. This includes:

• USITC website
• EDIS
• DataWeb
• HTS Online Reference Tool
• All phone communication with USITC staff
• Restoration of service is expected as quickly as possible after appropriations become available.

If you have an questions on how the shutdown will impact your business contact Omar or me anytime.

FDA Finally Issues Definition of "GLUTEN FREE"!

FDA issued the update below DEFINING the term "Gluten Free".   As a Celiac, this is extremely exciting news! The reason this is a HUGE deal?  Us Celiac's need to know we can trust food products that are labeled "gluten free".  If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers...

My sincere hope is FDA will now test imported products that make "GLUTEN FREE" claims, and assure these companies are legitimately using the gluten free claim.  Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim!  The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA's own laboratories to check the parts per million of gluten in the product.  If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product - meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA's Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The "Compliance Date" for this final rule is August 5, 2014. If consumers see products labeled "gluten free" we should be able to TRUST that those products legitimately do not contain gluten. Now, we have a standard. Products labeled gluten free must contain LESS than 20 parts per million of gluten to be legitimately labeled so.

This is a fantastic start!!! Here's what the FDA had to say, and the actual FINAL RULE is included as a hyperlink at the end.

FDA defines “gluten-free” for food labeling
New rule provides standard definition to protect the health of Americans with celiac disease
The U.S. Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The regulation was published in the Federal Register.

Join FDA in Miami to Discuss Major FSMA Proposed Rules

The U.S. Food and Drug Administration (FDA) announced it will hold two additional public meetings to discuss the Food Safety Modernization Act (FSMA) Proposed Rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies. 

The two proposed rules are designed to strengthen assurances that imported food meets the same safety standards as food produced domestically.  The FSVP proposal provides requirements for importers to verify that their foreign suppliers are implementing the modern, prevention-oriented food safety practices called for by the FSMA, and achieving the same level of food safety as domestic growers and processors. This will create a new burden for importers to know and trust their manufacturers.  I believe we can expect to see enforcement and penalties from FDA - if you have not met your manufacturer yet, now is the time!

The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies provides for the strengthening of quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains.

The purpose of the FDA’s public meetings is to solicit public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.

If you are interested in commenting on these proposed rules, contact me to discuss the process. Please note the timeline below to submit comments to the FDA. 

These two added meetings will take place in Miami, FL and Long Beach, CA.

Register here!

• Miami meeting - October 10-11, 2013, at the Hyatt Regency Miami, 400 SE Second Avenue, Miami, FL 33131.

October 10, 2013

8:30 a.m. – 5:00 p.m.

October 11, 2013

8:30 a.m. – 12:30 p.m.  

• Long Beach meeting - October 22-23, 2013, at the Hilton Long Beach & Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA  90831

October 22, 2013

8:30 a.m. – 5:00 p.m.

October 23, 2013

8:30 a.m. – 12:30 p.m.

Please note the following important dates for the meetings in Miami, FL and Long Beach, CA:

• Meeting in Miami, FL
  
  
  
  • September 24, 2013: Closing date for request to make oral comment
  
  
  • September 24, 2013: Closing date to request special accommodation due to a disability
  
  
  • October 1, 2013: Closing date for advance registration

• Meeting in Long Beach, CA
  
  
  
  • October 1, 2013: Closing date for request to make oral comment
  
  
  • October 1, 2013: Closing date to request special accommodation due to a disability
  
  
  • October 8, 2013: Closing date for advance registration

• November 26, 2013: Closing date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Foreign Supplier Verification Programs, see Docket No. FDA-2011-N -0143. For the proposed rule on Accreditation of Third-Party Auditors/Certification Bodies, see Docket No. FDA-2011-N-0146.

If you manufacture or import food products you MUST stay on top of FSMA and the new rules FDA will implement.  For assistance in commenting on these important new changes, contact me.  See you at the Miami meeting.

REGISTRATION OPENS for CBP's 2013 East Coast Trade Symposium in D.C.

Mark your calendars for the CBP 2013 East Coast Trade Symposium, scheduled for October 24 – 25, 2013, at the Washington Hilton Hotel in Washington, D.C. This year’s theme is “Increasing Economic Competitiveness Through Global Partnerships and Innovation”.

Based on the overwhelming interest received by CBP for participation at the Symposium, CBP is limiting attendance to three (3) participants per company to afford equal representation from all members of the international trade community. If a company exceeds the limitation, subsequent registrations will automatically be placed on the waiting list.

Registration for onsite participation is $108, and is open as of September 18, 2013 at 12:00 p.m. EST. Act fast, this event sells out quickly!

Attendance at the Symposium is an excellent opportunity to meet with all levels at CBP, so take advantage of this opportunity! For a sneak peak at what to expect in DC, see the agenda here. See you at the CBP Symposium!

An added bonus:

• As a special opportunity for U.S. citizens participating in this year’s CBP 2013 East Coast Trade Symposium, U.S. Customs and Border Protection (CBP) will be on-site to conduct interviews for those interested in enrolling in the Global Entry program. Act within the next week, in order to be eligible for on-site enrollment. This offer is only available to those who have completed the online application, paid the $100 application fee, and are pre-approved through the Global Online Enrollment System.
• Interested attendees must apply for Global Entry by Friday, October 10.
• When applying, be sure to only select the Global Entry option. Global Entry is extremely popular with frequent international travelers because approved travelers use a kiosk to enter the U.S. rather than waiting in line to see an officer. For U.S. travelers, Global Entry approval also allows you to enroll in the Transportation Security Administration’s (TSA) PreCheck trusted traveler program, which expedites screening through TSA checkpoints at participating airports.

This is a terrific benefit I hope you will take advantage of.  I am a HUGE advocate of the TSA PreCheck program, check out my blog post regarding this wonderful program here.

Jen Diaz Honored as Rising Star by DBR

On July 18, 2013, the Daily Business Review (DBR) announced the 40 young Florida lawyers chosen as 2013 Rising Stars by a panel of DBR judges. I'm proud to announce I have been selected as one of the 40 Rising Stars!
The article stated:

Our panel carefully reviewed more than 125 nominations of attorneys 40 years old and under who have established themselves as top contributors to the practice of law and their communities, and are in a position to become tomorrow's top lawyers and leaders.

See the list of the 40 Rising Star honorees.

Profiles of all the Rising Stars will appear in a DBR special section on Wednesday, Sept. 18, and an event honoring their accomplishments will be held that night from 6 p.m. to 9 p.m., at the Bankers Club in downtown Miami, One Biscayne Tower, Biscayne Room, 14th Floor.
For those who wish to attend the event to honor the Rising Stars, please contact Andre Sutton at asutton@alm.com or (757) 721-9020. The event's main sponsor is Ice Legal.

Congratulations to the 2013 Rising Stars.

-David Lyons, Editor in Chief
-Chris Mobley, Publisher

I'm honored to have been selected and invite you to join me as we celebrate on September 18th at the Bankers Club.

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

For those who thoughts 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 or need assistance with cargo detained as a result of this new enforcement phase, please feel free to contact me, and I'm happy to assist you with any ISF or CBP related question!  

Say Goodbye to GSP, ATPA and ATPDEA

The question of the day... Will GSP be extended?  Yes, no, maybe??

July 31, 2013 is the date when the expiration of the Generalized System of Preferences (GSP), Andean Trade Preference and Act  (ATPA) and the Andean Trade Promotion and Drug Eradication Act (ATPDEA) will take place.

Read on to ensure that you get your refunds expeditiously when/if GSP is renewed, likely after July 31, 2013.

CBP's notice today states:

Barring Congressional action, the Generalized System of Preferences (GSP), special program indicator (SPI) “A” and “A+,” the Andean Trade Preference Act (ATPA), SPI “J,” and the associated Andean Trade Promotion and Drug Eradication Act (ATPDEA), SPI “J+,” are due to expire for goods entered or withdrawn from warehouse after midnight, July 31, 2013.

Special Procedures for GSP-Eligible Goods:

• Importers should pay the normal trade relations (column 1) duty rate but continue to flag GSP-eligible importations with the applicable SPI (“A” or “A+” until further notice. If the program is renewed with a retroactive clause, use of the SPI will allow CBP to process automatic duty refunds. No corresponding procedure is available for the ATPA or ATPDEA programs. [MAKE SURE YOU DISCUSS THIS WITH YOUR BROKER AND DO SO!]

Clarification for African Growth and Opportunity Act (AGOA) Eligible Goods:

• Goods eligible for preference under African Growth and Opportunity Act (AGOA) may continue to receive preference on tariff items displaying SPI “A,” “A+” or “D” in the “Special” column of the Harmonized Tariff Schedule of the United States (HTSUS).

To receive AGOA preference on a good with SPI “D” in the “Special” column of the HTSUS, the importer will continue to file the entry summary with SPI “D” and without duty. To receive AGOA preference on a tariff item with the SPI “A” or “A+” in the “Special” column of the HTSUS (and thus no “D”), the importer will file the entry summary with the SPI “A” but without duty.

Impact on the Merchandise Processing Fee (MPF): 

• The expiration of GSP has no impact on the payment/non-payment of the merchandise processing fee (MPF).

OTI's - July 31 is Deadline to Voice Opinion on FMC's Proposed Changes

Now's the time to apply to become a non vessel operating common carrier (NVOCC) and/or ocean freight forwarder (OFF).  FMC has proposed major changes to its regulations and application requirements for Ocean Transportation Intermediaries (OTIs).   Get your application in now to avoid those changes, and/or, learn the changes and spend the time to comment on them while you can.  Detailed summaries of those changes are below.  July 31, 2013 is the cutoff to have your voice heard!

FMC issued an Advanced Notice of Proposed Rulemaking (ANPRM) that would significantly amend the regulations governing the licensing, bonding and duties of NVOCCs and ocean freight forwarders. The ANPRM is 117 pages long!! You can review the ANPRM in FMC’s Docket No. 13-05, Amendments to Regulations Governing Ocean Transportation Intermediary Licensing and Financial Responsibility Requirements, and General Duties. 

The major changes are:

• Qualifying Individual (QI) Changes – Included in the proposed changes are changes to many definitions - this one impacts what it will take to become a QI.  The standards will be tougher.  For one, the QI’s 3 years of relevant experience will only qualify if one has worked for a licensed, bonded, registered OTI. Experience obtained while the individual was employed by a licensed domestic OTI, a vessel operator, or a registered foreign-based NVOCC would be acceptable.
• All Owners will now be Vetted – Background checks will now not be limited to the QI, all owners will go through background checks (and my two cents, your application will take that much longer to be processed with every additional owner)..
• All Licenses will now be Online – FMC proposes to go green in its application process.  Application fees are much cheaper online, $250 vs. the paper application fee of $850.   
• License Renewal Every 2 Years! – All licenses, both forwarder and NVOCC, be renewed every two years, regardless of how long a company has held a license. As part of that renewal process, the licensee would be required to pay a filing fee in an amount yet to be determined. As proposed, the information to be provided would include the name of the current Qualifying Individual, all shareholders, officers and directors (and, their social security numbers), and require the production of corporate good standing certificates. Each company would be required to submit an application for renewal at least 60 days prior to the scheduled expiration dateof its current license. 
• Suspension/Revocation of Licenses – Under the current regulations, a license can be suspended or revoked for failing to respond to a lawful order, making materially false or misleading statements, or failing to have a current tariff or bond. The ANPRM now proposes to also subject licenses to revocation if the OTI “knowingly and willfully accepts cargo from, processes, books, or transports cargo” for, an NVOCC that is either unlicensed or fails to have the required bond. The Commission also proposes to“streamline” the appeals process for any revocation of licenses by eliminating an OTI’s right for a full evidentiary hearing. Indicating that such proceedings are “often lengthy and expensive,” the ANPRM proposes to establish a procedure by which appeals could be handled by a hearing officer on a written record, without any apparent right of discovery concerning matters that may be in the Commission’s files.
• Foreign Registered NVOCCs – The ANPRM would require foreign registered NVOCCs to submit a detailed registration form and a filing fee, with those registrations only valid for a period of two years. Under current regulations, and as is the case with existing OTI licenses, registrations are valid for an indefinite period. The foreign NVOs would be required, in their registration forms, to provide their legal name, any trade names, their principal business address with contact information, a contact person with an email address, and their U.S. resident legal agent.
• Increase Bond Requirements - Citing incidents in which two NVOCCs went out of business owing significantly more than the $75,000 bond, which meant that claimants were unable to recover all monies owed, the ANPRM proposes to increase all OTI bonds as follows: Ocean Forwarder $50,000 $75,000, Licensed NVOCC $75,000 $100,000, Registered NVOCC $150,000 $200,000, Group Bond $3 Million $4 Million
• Tiers for Claims on Bonds - The ANPRM would establish three tiers of payment priorities for claims against the bond.
• FMC Website Publication of Claims - The Commission would publish these notices and claims on its website, which would be available to the general public as well as the various sureties. 
• Prohibit Surety From Payment of 20%+ of Bond - Another proposal would prohibit the surety from paying any claims that amount to more than 20 percent of the face amount of the bond for a period of at least five months after the date the claim is received.
• License Revocation when Bond Termination Occurs – In this proposed rule, FMC licenses and registrations could be revoked “without hearing or other proceeding” in the event the required bond is terminated.
• New Class of NVOCCs for Household Goods – The commission seeks comments on such a change, not an actual proposal at this time.

How do you feel about these changes?  Think they are fair?  Want to comment to the FMC?  Make sure you speak up before July 31! Ready to submit your application? Contact me today at jdiaz@becker-poliakoff.com.  

Do You Know the Top 10 Tips When Importing?

Do you know the top 10 tips when importing to ensure compliance? If not, here's why you should listen to my Compliance Online webinar that took place on June 27, 2013 at 10:00 a.m., EST.

If you import merchandise into the U.S., you are the responsible party and must be aware your requirements and potential liability. In this presentation, we will discuss how to comply with U.S. Customs and Border Protection’s (CBP's) vast laws and regulations. By the end of the webinar you will know and understand the importance of:

• Tariff classification;
• Customs valuation;
• Country of origin marking;
• Intellectual Property Rights (IPR) Protection and CBP Enforcement; and
• Free Trade Agreements (FTA) you should be taking advantage of.

You will also learn basic customs concepts and terms like:

• CBP Form 3461 & CBP 7501;
• Protests;
• Seizure cases;
• Liquidated damage claims, Penalties/Fines;
• Prior disclosure; and
• FP&F Petition Process.

Learn key best practices and hear real life case studies. Learn what to do, and more importantly, what NOT to do, and what the consequences are for non compliance.

To hear the recorded version of this webinar, that took place on June 27, 2013, click here.

Florida Companies Convicted and Sentenced

Co Authored by Robert Becerra

In another example of the government’s continuing use of the criminal justice system to enforce international trade laws, three Florida companies and their management were recently convicted and sentenced for importing smuggled toys from China containing lead and containing counterfeit trademarks.

LM Import-Export, Inc., Lam’s Investment Corp., and LK Toys Corp., Hung Lam and Isabella Kit Yeung plead guilty to charges of conspiracy to traffic and smuggle toys containing hazardous substances such as lead, and one count of trafficking in counterfeit goods, in violation of 18 U.S.C. Secs. 371 and 2320, respectively. Co-defendant Yeung plead guilty to one misdemeanor count of submitting a false country of origin label, in violation of 19 U.S.C. Sec. 1304(a). The information, or charging document filed in court, against all defendants, as well as the plea agreements for each defendant can be found on the website of the District Court for the Southern District of Florida. (If you have trouble getting these documents, email me and I'd be happy to share them with you).
The facts underlying the charges, as stated in court documents, are that from April, 2000, until May 2011, a span of 11 years, the corporate defendants conspired to sell children’s products imported from China in violation of the Consumer Product Safety Act 15 U.S.C. Sec. 2068, and the Federal Hazardous Substances Act, 15 U.S.C. Sec. 1263. Some of the toys contained lead, while others presented various hazards such as choking, aspiration or ingestion. The products were imported using false statements on Customs declaration forms and with false country of origin labeling.

Hung Lam was sentenced to 22 months incarceration, 3 years of supervised release and a $10,000 fine. The corporations were sentenced to 5 years of probation. Yeung was sentenced to 1 year probation and a $1,000 fine. An order was entered mandating the forfeiture to the government of $862,500 and all products imported by the defendants that were seized by the government. The press release from the Consumer Products Safety Commission and Department of Justice discussing the case can be found here and here respectively.

This case is extremely important for importers to be familiar with and understand that:

1. It is vital for importers to retain counsel to assist with pre-compliance before you import.
2. When you receive any violation notice from the federal government, retain counsel immediately and be sure to address all violations with remedial action and enhanced compliance procedures in an attempt to keep administrative penalties or forfeiture cases from turning into potential criminal matters.
3. Resolving a civil action through a consent decree with the government does not absolve you of criminal liability.
4. Once contacted by government officials, retain counsel immediately. Any evidence you provide or any statements you make will be used against you in court.
5. Repeated misconduct and federal regulatory law violations over a period of years will often result in criminal prosecution of both companies and their individual employees, resulting in federal prison sentences and substantial fines and forfeitures.

Export Regulations and Cloud Computing...Beware!

Co Authored by Perry Sofferman

Forrester Research predicts that the global market for cloud computing services will have increased from $40.7 billion dollars in 2011 to approximately $241 billion dollars by 2020. You can see the ZDNet article here. This figure includes the Platforms as a Service, Infrastructure as a Service and Business Process as a Service delivery models. What this information reveals is that while cloud computing is already a significant part of operational strategy for many businesses (as well as governmental agencies), we should expect it to not only grow as a market but to become even more intertwined with the way we conduct business and store data on a daily basis. Consequently, businesses in general and export compliance officers in particular need to be vigilant and make sure that their use of this important technology is consistent with US export regulations. 

When using cloud services, the user is uploading data to available servers in the cloud provider’s server facility(ies). The type of data uploaded and the location of the server where that data is stored can potentially trigger export compliance issues for the user. In fact, the ultimate location of the particular server used to hold the user’s data may be unknown to either the user or the cloud provider. Data can be redirected to various servers in different countries in order to properly allocate server space based on fluctuations of usage in different time zones. It should be noted that this is only one example of several possible scenarios where the actual export of restricted data could occur inadvertently by the user.

Based on Advisory Opinions issued by the Bureau of Information and Security (“BIS”), there is guidance indicating that in scenarios where exports take place through means of cloud computing:

• (i) the cloud computing provider is not the exporter (the user is) and
• (ii) if foreign nationals employed by the provider access restricted data there may well be a deemed export of such data to such foreign national on the part of the user.

If, however, a cloud computing service provider is aware that the service will be used to support certain proscribed activities, then the provider will be obligated to properly acquire the necessary license. Neither the Directorate of Defense Trade Controls (DDTC) nor the Office of Foreign Asset Controls (OFAC) have yet provided substantive guidance on the subject of export regulations in relation to cloud computing, although OFAC has provided some limited guidance related to exports to Iran involving software and services incidental to personal communications. “Cloud Computing” remains an undefined term in the EAR, ITAR and OFAC regulations.

Top 5 Tips for Export Compliance Professionals in Regard to Cloud Computing  

1. It is critical for compliance officers and others involved in export control management, including providers of cloud computing services, to take steps to better familiarize themselves with the many complex issues at play in this area. A good start would be a detailed review of the BIS advisory opinions, which can be found here.
2. In addition, users of cloud services should think about how to approach this issue with their providers. Users might consider gaining a good understanding of where their provider’s servers are located and whether the providers have instituted any safeguards to address export compliance issues. Likewise, providers may want to delve more deeply into the ITAR regulations with particular emphasis placed on the relation between cloud computing services and “brokering” activities.
3. Compliance officers should make sure that members of their organizations are aware that export regulations are applicable to cloud services and that while the storage of data in the cloud might feel virtual, the penalties for export regulation violations remain brick and mortar.
4. While exporters remain liable for violations of export regulations, compliance officers should work with their IT departments when negotiating terms to agreements with cloud services providers. For example, require the service provider to notify you in the event servers are added in geographic locations that might be problematic for you. See if it is possible to obtain a right to terminate in such instance. In addition, try to get the provider to indemnify you in the event there is an export violation as a result of a provider’s action or inaction.
5. Make sure a review of how your organization uses cloud services is part of your standard compliance self-audit so as to identify any possible problems or lapses before they become significant.

In a speech in 2012, Under Secretary of Industry and Security, Eric Hirschorn, noted that a future project for the Bureau might be a review of “for clarification’s sake – the rules regulating cloud computing.” For both users and providers, such a review should be anxiously awaited.

June 10 - FSMA Rules Will be Released!

The U.S. Food and Drug Administration (FDA) has been court ordered to set firm dates for FSMA's implementation.  Details of the court case forcing FDA to set these dates, and the organization that sued the FDA to make this happen follow.
Background
The Center for Food Safety (CFS), a national non-profit public interest and environmental advocacy organization, filed a lawsuit against the FDA on August 29, 2012.  The complaint alleged FDA failed to promulgate 7 food safety regulations required by the Food Safety Modernization Act (FSMA).  Congress enacted the FSMA – which was signed into law on January 4, 2011 – to modernize food safety laws and regulations by mandating science-based standards and controls; by providing the FDA with greater authority to prevent and address food safety hazards by taking steps to prevent them from occurring; by strengthening the FDA’s inspection and enforcement powers; and by improving coordination among federal, state, and foreign food safety agencies. CFS documented the foodborne illness outbreaks since FSMA was signed into law, January 4, 2011.

Court Order
The court case is being heard by Judge Phyllis Hamilton, in the U.S. District Court for the Northern District of California.  Yesterday, May 21, 2013, Judge Hamilton ordered that the FDA and CFS have an extended deadline of June 10, 2013 to file a joint statement with a mutually agreeable proposed schedule for the outstanding food safety rules.

Rationale for Suit and Missed Deadlines
The ongoing battle between the CFS and FDA to complete this process has lasted for several months. On August 2012, the CFS filed a suit against the FDA Commissioner after the FDA missed a series of deadlines for publishing the regulations mandated by the Food Safety Modernization Act. After numerous deadlines went by without the release of the mandated rules, CFS went to court to try to force FDA to adhere to these time constraints. Following the court appearance, Judge Hamilton ruled that the FDA must come up with a new schedule for issuing the proposed rules by May 20.  This extension came about as a result of the inadequacy in time provided for the FDA and CFS to resolve their differences regarding the schedule FDA suggested to issue the proposed rules.

The FDA sent its updated schedule to CFS on May 15; however, CFS was not satisfied with the proposed timeline. Due to the fact that there were only five days left until the deadline expired, the parties filed a Joint Stipulation for Extension of Time. This extension was granted by Judge Hamilton.

New Rules Released by FDA & What's to Come
Since CFS filed its complaint last year, FDA has released some of the key FSMA mandated rules it failed to publish on time, including preventive controls for human food and standards for produce safety, both released in early January. However, there are some rules that are yet to be released. Among them is the foreign supplier verification program (section 301).  This program is set to overhaul import safety, an establishment of regulations to ensure the safe transport of food products and a rule ensuring neutrality of third-party audits.  I think of it akin to C-TPAT (Customs-Trade Partnership Against Terrorism).  It's a self-policing and auditing type program that includes functions like  monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.

I look forward to seeing and reporting on FDA's implementation of FSMA.

Do You Keep Your Manifest Information CONFIDENTIAL?

Did you know importers and consignees can request that U.S. Customs and Border Protection (CBP) keep your manifest information confidential?

If you are currently letting your competitors know your source, read on, and learn how to keep your private data private!
Pursuant to the privacy statute, 19 C.F.R. § 103.31 (d) the public is allowed to collect manifest data (e.g., bills of lading) at every port of entry. This information is limited to vessel manifests. Air, rail, and truck manifests are not available to the general public in any form.

Websites such as panjiva.com, datamyne.com and importgenius.com (to name a few) collect and publish the names of importers, suppliers, and manufacturers from vessel manifest data. This can be troubling for some, as your competitors are able to access information related to the sourcing and/ or manufacturing of your products. However, an importer/shipper may make a request to CBP for confidentiality. The confidential protection is valid for 2 years, thereafter, you have to renew your request.

The public may obtain manifest data at every port of entry. However, Section 103.31 states that

Only the name and address of the shipper, general characteristics of the cargo, number of packages, gross weight, name of the vessel, port of exit, port of destination, and country of destination may be copied and published.

The regulation also states that

An importer or consignee may request confidential treatment of its name and address contained in inward manifests, to include identifying marks and numbers. In addition, an importer or consignee may request confidential treatment of the name and address of the shipper or shippers to such importer or consignee.

It is essential that you send in renewal requests 60 days prior to the expiration of the 2 year confidentiality period. The importer will receive a response when the confidentiality request has been granted and it will state the effective time period.

CBP sent a message to trade on Feburary 7, 2013 (CSMS #13-000064), titled "improperly formatted ACE ocean manifest data resulting in release of confidential data." CBP made it clear that after an importer requests confidentiality, and its granted by CBP, the importer must be sure the commercial party names submitted to CBP always match - CBP will not grant confidentiality if you use any variation of the name originally requested. One incorrect keystroke by an individual who is processing the information can result in a new variation of company information that is not covered by the grant of confidentiality. CBP has stated that the release of confidential data is strictly the result of improper data entry by users and not by CBP programming or system errors.

To assure you send an effective request for confidentiality and so your competitors don't have access to your private data, contact me today!

File Your Petitions Timely, Or Else...

As of January 9, 2013, Customs and Border Protection (CBP) is making procrastinators pay the price for filing untimely petitions that seek relief from liquidated damages. CBP amended it’s guidelines for the cancellation and mitigation of claims for liquidated damages in cases where petitioners are late in filing claims for relief. Additionally, CBP also changed the formula for calculating late petition mitigation.

Current Rule for Timely Petitions

Under the existing regulatory authority, in order to be considered timely, petitions for relief in response to claims for liquidated damages must be filed:

•A. By bond principals within 60 days from the date of mailing of the notice of liquidated damages (see 19 C.F.R. 172.3(b)) or any lawful extension thereof; or

•B. By sureties within 60 days of the demand for payment by CBP (see 19 C.F.R. 172.4) or any lawful extension thereof.

When circumstances so warrant, extensions of the time period to file a petition may be granted by the FP&F Officer (FPFO) if such an extension of time is requested during the 60-day period available for timely filing a petition (see 19 C.F.R. 172.3(c)). The amendment to the current rule does not allow a petition for relief to be considered if it is filed after (a) the commencement of sanctioning action against the bond principal or (b) the issuance of a notice to show cause against the surety.

A party responsible for a liquidated damages claim may submit an offer in compromise to CBP pursuant to 19 U.S.C. § 1617 and 19 C.F.R. 161.5. These new guidelines, which will be applicable to all liquidated damages claims for which a late petition is filed on or after Jan. 9, are applicable only to petitions for relief and do not apply to offers in compromise submitted pursuant to 19 U.S.C. 1617 and 19 C.F.R. 161.53.

Consequently, the new mitigation guidelines concerning untimely petitions will impose a more stringent standard. Untimely petitions will be accepted or considered only if the petitioner is able to demonstrate the existence of extraordinary circumstances that prevented the petitioner from filing a timely petition or timely seeking a lawful extension of time in which to file a petition. What does that mean? The FPFO will exercise his or her discretion in determining whether circumstances existed so as to warrant CBP’s consideration or acceptance of a late petition.

Untimely Petitions will NO longer be Accepted

Subject to the permitted exceptions, no untimely petition will be accepted in any circumstance if it is filed:

a. More than 180 days after the date of mailing of the notice of claim to the bond principal, or in the case of a surety, the date of mailing of the first demand on surety;

b. After the petitioner has previously submitted a petition in the same case and/or been offered mitigation in the same case, and such mitigation amount was not paid within the prescribed period;

c After the claim has been referred to Office of Chief Counsel for collection action;

d. After the commencement of sanctioning action against the bond principal; or

e. After the issuance of a notice to show cause against a surety.

CBP notes that (a) an untimely petition is not a supplemental petition described in 19 C.F.R. 172.41, (b) a supplemental petition must be timely filed following a decision on an original petition filed in accordance with the established regulatory time frames, (c) the rejection of an untimely petition does not constitute a “decision” for purposes of 19 C.F.R. 172.41, and (d) petitions that are filed untimely and not accepted for consideration will be rejected. A party responsible for a liquidated damages claim may submit an offer in compromise to CBP pursuant to 19 U.S.C. § 1617 and 19 C.F.R. 161.5.

The Exceptions…

However, untimely petitions for relief of liquidated damages claims issued for the late filing of an entry summary, the late payment of estimated duties (including under the periodic monthly statement test), the late payment of passenger processing fees or the late filing or late payment of reconciliation entries may be accepted without regard to the limitations expressed in paragraphs a and b above at any time prior to the circumstances described in paragraphs c through e.

New Mitigation Calculation for Late Petitions

CBP has also implemented a new calculation for mitigating liquidated damages for untimely petitions. In calculating the mitigated amount on a late petition, CBP will first determine the base amount (i.e., the amount of mitigation that would have been afforded on a timely petition). CBP will then determine the “additional mitigation amount” by multiplying the full assessed amount of the claim by 0.1 percent (.001) and then multiply by the number of days the petition is late (i.e., .001 times the number of days late times the full assessed claim amount.) The product will be the additional amount which will be added to the base amount to produce the mitigated amount applied to the untimely filed petition. In no case will the additional mitigated amount to be added to the base amount be less than $400. For example, a $100,000 liquidated damages claim for which a petition is filed 30 days late will be mitigated to the amount provided by the guidelines plus an additional amount calculated by the new formula (30 days late x .001 = .03 x 100,000 = $3,000 added charge.)

Bottom line, assure you have an expert Customs attorney assisting you to fight for mitigation of Liquidated Damages claims, and file your Petitions TIMELY!

Seizure Averted - Why a Customs Lawyer is Essential at Detention

Sitting with your head down moping about U.S. Customs and Border Protection (CBP) holding your goods is never the right answer!

Two days ago, a potential client called and explained that a valuable shipment was detained by CBP. The potential client asked if I could help recoup the goods from CBP, during this detention phase, or if they should wait.

When I get this question, I always want to scream, NOW!!  This is the most essential time an importer has.  Here's the real question - do you want an expert in Customs law to assist you before your goods are guaranteed to be stuck in CBP for months, or work on getting them back for you NOW?!

I always request pertinent information about the commodity and the supposed rationale for the detention (if you don't have this information yet, I help you get it). In this case, the potential client adamantly stated that the goods were legitimate, gray market goods; however, CBP was skeptical.

I advised the potential client that obtaining my services at this point would be the BEST option so I could clearly determine and explain to CBP the legitimacy of the merchandise and demand the release. After being hired, I immediately began working on the case due to the exigency of the circumstances. My tasks were to understand the basics of the commodity, learn the history of the product, and prove the legitimacy of the goods before CBP made a decision to seize them.

The consequences of not taking these immediate actions would be the potential seizure of the goods. More importantly, if the goods are seized by CBP, it could take several months (sometimes years) before they may be released.  The great news is within 1 business day I was able to convince CBP that the goods were in fact legitimate gray market goods, and they were released.  Waiting an extra week to get me involved would have been the difference between a detention by CBP (and release of the goods) or CBP's seizure of the goods, and many months (or years) before the goods were released (with storage fees to pay!).

Thereafter, I worked with this client and discussed pre-compliance - which is especially important to understand why the detention occurred in the first place and how to avoid a similar situation from re-occurring.

Hiring an expert in CBP laws, prior to the seizure of the merchandise saved this client much time and a considerable amount of expenses. If your business is going through a similar issue with CBP, contact me during the detention phase, preferably before the seizure notice is issued!

Band-Aid or Stitches? What's Your Compliance Approach?

When you get a deep cut, do you simply put on a band-aid or do you go to the hospital to get stitches that you really need? Stitches take time and are more costly - but, your bleeding will stop and your cut is less likely to re-open. With a band-aid - you're likely to re-open your wound and/or get an infection. You get stitches if you know what's good for you!

Compliance is similar in that there may be a quick fix for the current issue; however, if you don't stop the bleeding and get stitches, you will be in trouble in the long-run, and the bleeding won’t stop.

FDA Discusses TOP Reasons for Detention of Goods

At today’s Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA’s Joint Team 488 – which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows, as I feel this is of most value to you to know and is arranged by commodity.

Food Products Top Rationales for Detention

•Manufacturer (processor, packer or person holding food product) is not registered with the FDA pursuant to the Bioterrorism Act. (You can Register with the FDA here: www.FDA-USA.com)

•Low Acid Canned Foods (LACF) are imported without establishment registration (FCE #) or scheduled process (SID #)

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve food labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Incorrect or missing statement of identity

3.Failure to list allergens

4.Failure to declare ingredients

5.Failure to include a proper “Nutrition Facts” label (incorrect formats for Nutrition Facts labeling is also common) required by 21 C.F.R. 101.9

6.Color additives are not declared correctly (or at all) on the label or not certified

7.Food additives are unsafe or not declared on the label

Dietary Supplements Top Rationales for Detention

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve dietary supplement labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1. Label is not in English

2.Unauthorized health claims

3.Undeclared active ingredients

4.Lacks a “Supplement Facts” panel required by 21 C.F.R. 101.36

5.Failure to list the name of product and “Dietary Supplement” or “Herbal Supplement” on the label

6.Failure to list the appropriate disclaimer necessary when claims are made

Cosmetics Top Rationales for Detention

•The cosmetics are subject to an Import Alert (for example IA 66-38 for cosmetics labeled with drug claims)

•The cosmetics are contaminated and unsafe to use

•The cosmetics are manufactured under unsanitary conditions

•The cosmetics contain a non-permitted color additive

•Product labeling is not compliant (FDA does not pre-approve cosmetic labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1. Label is not in English

2.Labeling is missing ingredients

3.Label lacks warnings and adequate directions for use

4.Missing the net quantity of contents

5.Cosmetic contains a “drug” claim

Drugs Top Rationales for Detention

•The cosmetics are subject to an Import Alert (for example IA 66-41 – Unapproved new drugs)

•Drugs are not registered or listed with the FDA

•Product labeling is not compliant (FDA does not pre-approve drug labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Label does not contain adequate directions for use

3.Active Pharmaceutical Ingredients (API) is not properly labeled or listed

4.Drug contains a “new” chemical or a different dosage making the product a “new drug”

Medical Devices Top Rationales for Detention

•The manufacturers is not registered with the FDA

•The initial importer is not registered with the FDA

•The device is not listed with the FDA

•The product does not contain a 510k or PMA

•Product labeling is not compliant (FDA does not pre-approve medical device labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Label is false or misleading

Bottom line, as you can see, it is up to you, the importer to perform pre-compliance and assure you get compliance right before you import. FDA expects you to know the requirements and has little mercy if you don’t. Assure you stay compliant and avoid the top rationale for FDA to detain your goods by hiring someone that is extremely knowledgeable with FDA’s laws and regulations and continually stays up to date with the constant changes.  Contact me with any questions!

CBP Brings Seizure & Forfeiture Notices to the 21st Century

Co Authored by Michael DeBiase

U.S. Customs and Border Protection (“CBP”) has published a final rule (the “Rule”) providing CBP with the ability to publish seizure and forfeiture notices on the Department of Justice (“DOJ”) forfeiture website. CBP believes that such notices will reach a broader range of the public, at less cost, than the current local print publications or customhouse postings.

You know what? CBP is right, and kudos to them for this added efficiency that goes into effect on February 28 of this year.

Pursuant to the Rule, CBP will post all seizure and forfeiture notices for thirty (30) consecutive days on the DOJ’s site. Thereafter, CBP may still publish notice in print form when it deems such additional outreach appropriate.

The beauty of the Rule is that it provides a vehicle by which both the government and the party interested in the seized goods to share in the greater efficiency, streamlined procedures, and reduction in costs offered by giving electronic notice. This will also make it easier for the interested parties to assert claims for the seized property.

This is a change that needed to happen, and although the process and site will surely experience “growing pains”, the efficiency and cost savings should prove well worth it.

If you do receive a seizure notice, remember, you must file a Petition within 30 days of the seizure notice or, if seeking judicial review of the seizure, file a claim and cost bond equal to 10% of the value of the seized merchandise, up to a maximum of $5,000.

For a summary of the seizure process, review our blog "U.S. Customs Seized My Merchandise, Now What?"

We leave you with our top 3 tips:

1. Perform Pre-Compliance PRIOR to importing merchandise into the U.S. Assure the merchandise you will import is compliant with applicable laws/regulations.
2. If CBP detains your products, contact a knowledgeable customs attorney or customs broker to actively demonstrate that there is no violation. Getting the case resolved in the detention phase is essential. Otherwise, the seizure case will be much more costly and timely.
3. If CBP seizes your products, make sure your customs attorney knows the policies, procedures, and practices of CBP to effectively pursue the release of the merchandise.

Significant New Food Safety Rules are Coming

The FDA has proposed two new rules issued under the Food Safety Modernization Act (FSMA) that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods. If you want your voice heard, you have until May 16, 2013 to submit your comments to the FDA on the proposed rule. The FDA does take comments seriously, we're here to help if you want assistance in drafting your comments. This rule is expected to be published shortly following the conclusion of the comment period on May 16, 2013.

 The proposed rules would apply to facilities that manufacture, process, pack or hold human food. The rules focus on commonly identified routes of microbial contamination of produce, including:

(1) agricultural water

(2) farm worker hygiene

(3) manure and other additions to the soil

(4) animals in growing areas, and

(5) equipment, tools and buildings.

In general the facilities that are required to register include manufacturers, processors, warehouses, storage tanks, and grain elevators. However, there are a number of exemptions and modified requirements. We would be pleased to assist you in determining whether or not your facility may be exempt from these requirements.

Below is a recap of the proposed rules.

Rule #1 - Preventative Controls for Human Food. The rule proposes firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

• hazard analysis;
• risk based preventive controls;
• monitoring procedures;
• corrective actions;
• verification; and
• recordkeeping

Do you have your written plan in place yet?

Rule #2 - Produce Safety. The second rule proposes enforceable science- and risk-based safety standards for growing, harvesting, packing and holding fruits and vegetables on foreign and domestic farms. These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:

• Irrigation and other agricultural water
• Farm worker hygiene
• Manure and other additions to the soil
• Intrusion of animals in the growing fields.
• Sanitation conditions affecting buildings, equipment and tools

The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.

The rules still to come are:

• Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
• Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
• Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.

As FDA implements more of FSMA, we will keep you informed.

Do you need assistance in submitting a comment to FDA? Does your company need training on FSMA? If so, contact me anytime.