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

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.

Re-Inspection 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:

1. Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition).  This guidance document contains helpful questions and answers regarding food facility registration.
2. 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.

New Center of Excellence & Expertise to Arrive in Miami 2013!

DHS Secretary Janet Napolitano addresses a crowded audience at the 2012 East Coast Trade Symposium while CBP Deputy Commissioner David V. Aguilar listens.
Photo Credit: James Tourtellotte

U.S. Customs and Border Protection (CBP) Deputy Commissioner David V. Aguilar announced at the East Coast Trade Symposium the expansion of the Centers of Excellence and Expertise (Centers), which will create six new Centers in 2013 for the Agriculture & Prepared Products; Apparel, Footwear & Textiles; Base Metals; Consumer Products & Mass Merchandising; Industrial & Manufacturing Materials; and Machinery industries. CEE's are "virtual "one-stop shops" that provide centralized processing for importers that volunteer to participate. TheCenters are also already a source of information for the entire trading community. Centers are virtual organizations, managed from a strategic location, that link CBP trade personnel by industry to authoritatively facilitate trade."

CBP's goal is to eventually cover the full range of imported goods. For now, the Centers to be established in FY 2013 are:

1. Agriculture & Prepared Products: Miami
2. Apparel, Footwear & Textiles: San Francisco
3. Base Metals: Chicago
4. Consumer Products & Mass Merchandising: Atlanta
5. Industrial & Manufacturing Materials: Buffalo
6. Machinery: Laredo

These virtual centers will provide one-stop processing to lower the Trade’s cost of business, provide greater consistency and predictability and enhance CBP enforcement efforts. The Centers represent CBP’s expanded focus on "Trade in the 21st Century," transforming customs procedures to align with modern business. The Centers will also serve as resources to the broader trade community and to CBP’s U.S. government partners. The current Centers are Electronics in Long Beach; Pharmaceuticals, Health & Chemicals in New York City; Automotive & Aerospace in Detroit; and Petroleum, Natural Gas & Minerals in Houston.

Resources to learn more about the CEE's:

• Customs created a new 8 minute video advising on additional benefits the CEE's provide, including being a "common sense trade processing system," and discussing the assistance with administrative detentions of merchandise the CEE's can provide.
• PowerPoint Presentation on CEE's.
• CEE's FACT SHEET.

C-TPAT and ISA members are given priority to apply for admission into CEE's.  CEE's are supposed to provide the uniform decision making the importing community craves. Import Specialists will eventually all belong to a specific CEE and utilize their specialized knowledge to provide consistent admissibility decisions around the country. I very much look forward to seeing and reporting on how the Miami CEE progresses.

Jennifer Diaz Joins Governor Rick Scott in Addressing Businesses in Bogota

On December 4, 2012, I will address companies in Bogota, Colombia to discuss the "Top 10 Tips When Importing into the U.S. to Ensure Compliance." My particular topic will go into depth on the top costly mistakes I've seen importers make, and most importantly, how to avoid them. I will go into compliance with the newly enacted Free Trade Agreement and compliance with other federal government agencies (like U.S. Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC), and more. Importantly, I will address how to effectively deal with the U.S. government, should you have trouble while importing.

The conference is in conjunction with Enterprise Florida's Trade Mission to Colombia led by Florida's Governor Rock Scott. The purpose of the half day conference is to address the current environment of big business opportunities in Florida, especially in light of the new U.S.-Colombia Free Trade Agreement (FTA).

Other panels include: The U.S. Economy and Investment Opportunities; Rules of Origin & Trade Facilitation (Compliance with the new FTA); Business Opportunities in Infrastructure and Utilities. All panelists will be available for question and answer sessions as well.

Colombia is the fifth largest economy in Latin America, with a population of approximately 45 million. During the last decade, improvements in security and political stability have fostered economic growth and a secure business climate. With 4 percent GDP growth in 2010 and an estimated 4.6 percent growth in 2011, the Colombian market presents unbounded opportunities for Florida companies.

You may register and view the agenda here.

See you in Bogota!

Don't Let Your Currency be Seized When Traveling Internationally - TOP TIPS

The holidays are approaching... Do you intend to carry "monetary instruments" when traveling internationally? Read on, these TOP 5 Tips when carrying "monetary instruments" above $10,000 can save you a U.S. Customs Seizure Case.

Here are your top tips to assure you get it right, and you're not screaming U.S. Customs Seized my Money, Oh No!

CBP Symposium Postponed Due to Weather

Hurricane Sandy is busy disrupting the sunshine state as well as D.C. Breaking news from CBP, the CBP Symposium, due to start this coming Monday, is now postponed. CBP's message is below. This is a great opportunity for CBP to join the C-TPAT conference with the symposium. I hope they do. I'll keep you advised when the CBP symposium is back on.

Dear Registrants,

Due to concerns over participant safety and potential travel disruptions related to Hurricane Sandy, U.S. Customs and Border Protection has decided to postpone the East Coast Trade Symposium that had been scheduled for Monday and Tuesday.

We apologize for this inconvenience, but due to the strength and breadth of this storm we believe this postponement is the appropriate decision. We do not want to risk the safety of our participants, many of whom would be traveling to Washington D.C. to attend.

The nature of the storm is such that the agency’s emergency response protocols have been activated and must take precedence.

CBP will provide additional information regarding the registration for this event at a later date. The new date and location within the Washington DC Metropolitan Area for the symposium will be announced as soon as possible. CBP officials apologize for this inconvenience and will reschedule this important event in the near future.

Your Chance to Meet Some of CBP's TOP Officials



Have you met CBP's Chief Operating Officer, Thomas Winkowski (pictured left)? How about the Director of Field Operations in Miami, Vernon Foret? Or, CBP's Senior Advisor for Private Sector Engagement, Maria Luisa O’Connell?

Start thinking of what questions you have for CBP, because you'll have the chance to meet them this month.

Assistant Commissioner Al Gina recently shared his thoughts on CBP's Priority Trade Initiatives with NCBFAA. See them here. The seven hot topics are:

1. Role of the Broker;
2. ACE,The agency’s automated cargo processing system;
3. The Centers of Excellence and Expertise,
4. Simplified Entry-Air Cargo Advanced Screening,
5. Trusted trade partnerships;
6. Trade intelligence, and
7. One U.S. Government at the Border.

Here's your chance to ask questions about CBP's progress with implementation of its priorities. I for one want to hear CBP's progress in ensuring the Centers of Excellence are yielding a more uniform decision making process for CBP at all ports of entry.

You are invited to attend a round table discussion on U.S. Customs and Border Protection’s (CBP) trade transformation initiatives. This meeting will provide a great opportunity to have an open discussion with Chief Operating Officer, Thomas Winkowski; Director of Field Operations (Miami) Vernon Foret; and Senior Advisor for Private Sector Engagement, Maria Luisa O’Connell. There will be two meetings held at different times, on October 24, 2012, but will contain the same information.
Due to limited seating, CBP requests that only ONE representative from each company sign up for one of the meetings. Your choices are:

• Wednesday, October 24, 2012 from 10:00 – 11:00 a.m. at the Cargo Clearance Center (CCC), Conference Room 264, 6601 NW 25th Street, Miami, FL 33122. Since space is limited, online registration is required. Click here to register for this time slot. RSVP's must be in by close of business October 18, 2012.
• Wednesday, October 24, 2012 from 1:30 – 2:30 p.m. at the Cargo Clearance Center (CCC), Conference Room 264, 6601 NW 25th Street, Miami, FL 33122. Click here to register for this time slot.

You will receive a confirmation email with further details regarding the meeting. If for some reason you need to cancel your registration, please click here.

In addition, if you have specific questions you would like addressed during the meeting, please forward them to Phyllis Ratliff: Phyllis.Ratliff@dhs.gov no later than October 18th. Please limit your response to two (2) questions.

What are your questions? See you there?

Biennal Registration Requirement is Up and Running!

Biennial Registration Renewal for Food Facilities is now available, as of October 22, 2012. 

Here's what you need to know about FDA's new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. 

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I've summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn't lapse.  If your not re-registered by December 2012, FDA will cancel your Bioterrorism Act registration and your importations will be delayed.

New Biennial Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 22– December 2012 registration renewal period.

U.S. Agent

FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

1. live or maintain a place of business in the U.S. and
2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders. 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 steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?

The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

Want to Reap Benefits From TSA When Traveling?

If you travel often, read on, you'll be glad you did. When was the last time you had the ability to go through security WITH YOUR SHOES ON? Without taking out your laptop? WITH your jacket on? Without having to take out your liquids? If this appeals to you, which it definitely did for me, you'll be pleased to know the Transportation Security Administration (TSA) is partnering with U.S. Customs and Border Protection (CBP) for TSA Pre-Check, an initiative that allows eligible passengers to qualify for expedited screening at participating airports.

U.S. citizens, who are members of a CBP Trusted Traveler program, including Global Entry, SENTRI, and NEXUS are automatically eligible to participate and receive expedited screening benefits for domestic travel through the TSA Pre-Check initiative. TSA Pre-Check benefits include keeping shoes, light outerwear and belts on, keeping laptops in their cases, and leaving the 3-1-1 compliant liquids/gels bag in one’s carry-on during screening through TSA security checkpoints.
Members interested in participating in TSA Pre-Check through their Trusted Traveler program membership must enter their PASS ID into the ‘Known Traveler’ field when booking a flight reservation or saving their PASS ID to their airline’s frequent flyer profile. Members can find their PASS ID either online by accessing their GOES account, or on the back of their membership card in the top-left corner.

When traveling on one of the TSA Pre-Check participating airlines, CBP Trusted Traveler members should remember to provide the airline with their full name, date of birth, and PASS ID exactly as it appears in their CBP Trusted Traveler program online account to ensure they are properly considered for TSA Pre-Check.

To learn more, visit www.globalentry.gov or www.tsa.gov, you'll be glad you did!

Disclaimer, I've been displeased as this is not sure proof. Don't expect it to work 100% of the time, it doesn't... But, when it does, you'll be ecstatic!

DR-CAFTA: Si o No? ( Yes or No?)

Co-authored by Carlos Gimenez.

Just because you are importing a product from a party to the DR-CAFTA Free Trade Agreement, does not necessarily mean that the product will be granted DR-CAFTA treatment by U.S. Customs & Border Protection ("CBP"). Even if 95% of the product is made from components that all originate from DR-CAFTA party nations, that still may not be enough.

If the product has one component that originates outside of DR-CAFTA parties, whether or not the product will receive DR-CAFTA treatment will rely heavily on General Note 29(n), Chapter 61, Chapter rule 2, which states:

For purposes of determining whether a good of this chapter is originating, the rule applicable to that good shall only apply to the component that determines the tariff classification of the good and such component must satisfy the tariff change requirements set out in the rule for that good. If the rule requires that the good must also satisfy the tariff change requirements for visible lining fabrics listed in chapter rule 1 to this chapter, such requirement shall only apply to the visible lining fabric in the main body of the garment, excluding sleeves, which covers the largest surface area, and shall not apply to removable linings.

Case in point, a client requested an alaysis of whether DR-CAFTA would apply to a garment produced of components that all originated in DR-CAFTA party countries, with one exception, the lace that was used to create a decorative front panel. The lace portion of the garment originated in Korea and it only accounted for roughly 17% of the material used overall. In this case, the analysis hinged upon whether or not the lace was the "component that determines the tariff classification", and whether the lace provided the "essential character" of the garment. In this case, the determination was that the lace was in fact the essential character, DR-CAFTA treatment was precluded, and a tariff of 16.5% was applied. If the garment was subject to DR-CAFTA treatment, rate of duty would have been FREE.

The moral of this story, if you want to ensure that the product imported is entitled to DR-CAFTA treatment, do not add any components that would jeopardize that treatment without seeking and receiving an expert opinion and/or a Binding Ruling from CBP. The worst thing that could happen is to work so hard to avail yourself of DR-CAFTA treatment, only to have to pay a double digit tariff for not doing your homework.

Don't Let Your Bioterrorism Act Registration Lapse

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I've summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn't lapse.

New Biannual Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biannual registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

  

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent

FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

1. live or maintain a place of business in the U.S. and
2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders. 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 steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required. 

Need a U.S. Agent?

The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

CBP Symposium Registration is OPEN (for now)!

REGISTRATION IS NOW OPEN!

Registration opened on August 29, 2012 at 1:00 pm eastern standard time.

The CBP Symposium will take place from October 29-30, 2012 at the Renaissance DC Downtown Hotel in Washington, DC.

To register, click here.  For those of you that don't want to travel to DC, webinar is an option, and that registration is available here.  The full agenda may be found here.

If you're going, send me an email at jdiaz@becker-poliakoff.com!  Let's meet in DC!



CBP Symposium Date Change & C-TPAT Conference Postponed

Originally CBP planned to hold the East Coast CBP Symposium right after the C-TPAT conference from September 24-28th in DC. I thought that was a great idea and hope it works in the future. For now, the C-TPAT conference is postponed and the CBP Symposium has a new date.

So mark your calendars for the CBP Symposium titled "Transforming Trade for a Stronger Economy", it is now October 29-30 in Washington, DC. CBP is limiting attendance to 3 representatives per company, so plan accordingly. Registration has not yet been announced - but, I will say, you need to act fast, it's sold out within a day typically. It's an excellent opportunity to meet with all levels at CBP - take advantage! The Symposium already took place on the West Coast, for a sneak peak at what to expect in DC, see the agenda here. Questions for CBP about the symposium may be sent to tradeevents@dhs.gov.

CBP advised all member of C-TPAT that "C-TPAT will not be holding its 2012 Conference in September due to scheduling and logistics challenges. We are currently working to revise the planning in order to bring you the conference material at a later date. We will provide updated information as we get it on both the www.cbp.gov website and through email messages on the C-TPAT Portal. We apologize for any inconvenience this has caused."

See you at the CBP Symposium!

TTB Issues Interim Policy for Labeling Gluten-Free Spirits

On May 24, 2012, U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an Interim Policy on Gluten Content Statements in the Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages (TTB Ruling 2012-2).

Currently, there is no Food and Drug Administration (FDA) regulation that defines the term “gluten-free” (despite the GF communities outcry for one!).

FDA proposed to define gluten free as:

• an ingredient that is a species of wheat, rye, barley, or a crossbred hybrid of these grains;
• an ingredient derived from these grains and that has not been processed to remove gluten;
• an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 or more parts per million (ppm) gluten in the food; or
• 20 ppm or more gluten.

Pending the issuance of a final rule by FDA, TTB is providing interim guidance on the use of the term “gluten free” on alcohol beverage labels and advertisements subject to TTB’s authority. 

Alcohol Products Made from Gluten-Free Materials

TTB’s position is that the term “gluten-free” will be interpreted by consumers of alcohol beverages to mean that the product contains no gluten. TTB provided the example of wine fermented from grapes, or vodka distilled from potatoes. If there are good manufacturing practices – meaning no cross-contamination, no additives, no yeast, and no storage materials with gluten – a ‘gluten-free’ claim in the labeling of the alcohol beverage will be permissible in the interim period awaiting FDA’s final rule.

Alcohol Products Made from Gluten-Containing Materials 

FDA and TTB both assert that there are currently no scientifically valid testing methods to determine the gluten content of fermented products. This includes companies that undertake a process to remove the gluten from its alcohol beverages.

  

TTB’s position is that these methods cannot be used to substantiate a “gluten-free” claim at this time. Further, a “gluten-free” statement on labeling for a product made from gluten would be misleading.

However, the following statement is permissible: "Processed/Treated/Crafted to Remove Gluten". This statement must be accompanied with a conspicuous qualifying statement informing the consumer:

“Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten. The gluten content of this product cannot be verified, and this product may contain gluten.”

  

- OR -

  

“This product was distilled from grains containing gluten, which removed some or all of the gluten. The gluten content of this product cannot be verified, and this product may contain gluten.” 

The full interim policy can be found here. 

For more information regarding your company's strategy for remaining in compliance with FDA and TTB in order to break into the gluten-free consumer market, contact attorney Jennifer Diaz at (305) 260-1053 or by email at JDiaz@becker-poliakoff.com.

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.

China Sourcing Fair - How to Solve U.S. Customs Issues When Importing From China

 The rewards of sourcing from China are well known, but succeeding at it is far from simple. With a sluggish global economy resulting in unpredictable market changes, cost-effective sourcing is important.

To help you build or sharpen your China sourcing strategies, I am thrilled to be part of a new series of "How to Source from China" conferences at the China Sourcing Fair (July 10-12, Miami)!

The conferences are led by industry experts, and reveal real-life sourcing risks in China. We will share actionable knowledge at every step as the project moves from concept to delivery, and the conference will offer in-depth insights and practical tips on do's and don'ts of China sourcing. Whether you're a beginner or veteran buying professional, the FREE conference program is your chance to learn how to source efficiently and effectively from the "world's factory".

Register now to enhance your importing skills and knowledge today! Conference seats are limited and are on a first-come, first-served basis.

I will be speaking on "How to Solve U.S. Customs Issues When Importing From China".

Intellectual property rights (IPRs) are a priority trade initiative for U.S. Customs. Most confiscated China imports violated US Customs' IPR laws, which should serve as a reminder when buying from China.

In my seminar, we will look at ways of preventing and dealing with these issues. In particular, we will cover:

• Trademark / copyright violations (What U.S. Customs looks for)
• Top compliance tips in advance of importation (What you need to know before your goods go!)
• Statistics of seizure cases (concentrating on China statistics)
• How cases progress with U.S. Customs

Join this session and you'll leave with a better understanding!

Register now to confirm your seat!

Free Trade Zones Expanding in Miami-Dade County

PortMiami wants free trade zones (FTZ’s) throughout Miami-Dade county.

As we know, PortMiami is currently dredging to 50 feet in pursuit of the post Panamax ships, and wants to prepare for the massive amounts of cargo PortMiami looks forward to receiving as a result of the dredging project.  In preparation, PortMiami is looking to the South Florida business community to get engaged and prepared as well.

Under PortMiami's plan, any business north of Southwest Eighth Street could apply for free-trade status (under FTZ 281) and be exempt from import duties (for example, for cargo heading abroad). There are many benefits to an FTZ, ultimately resulting in duty savings.

The Miami Herald reported that PortMiami’s application is expected to receive approval by the summer (UPDATE - PortMiami has officially been approved and operates FTZ 281), which will allow local businesses the opportunity to apply for foreign-trade zone status, enabling them to utilize their FTZ for duty savings, as goods shipped into a FTZ that are destined for export are exempt from paying CBP duties.  Many companies use South Florida as a transhipment hub, purchasing goods from China, using South Florida as a distribution center, and then selling those goods to customers in South America.  Using a FTZ saves the importer from having to pay customs duties on imports for exports.

The Beacon Council – Miami-Dade County's official economic development partnership – has coined trade/logistics and aviation as two of the ‘seven pillars’ of Miami-Dade County in the One Community, One Goal (OCOG) initiative. The others include International Banking & Finance, Education, Creative Design, Hospitality & Tourism, Information Technology, and Life Sciences & Health Care.

In 2010, Miami-Dade County had $95,380,550,601 in International Trade revenue (both import and export). Wholesale trade alone accounts for 9,383 businesses in Miami-Dade County, employing 62,407 people with an average salary of $64,984. With these proposed FTZ expansions, these numbers are only going to grow... If you want to take advantage and get your application in for your FTZ, please contact Jen Diaz at (305) 260-1053 or by email at JDiaz@bplegal.com.

CBP's Pointers on Exporting Used Vehicles

Last week, I attended a seminar hosted by U.S. Customs & Border Protection (CBP) at the Miami Free Zone regarding exportation of used vehicles such as cars and automobiles. Here are the highlights:

CBP's '72-Hour Rule'

CBP regulations require the exporter of a vehicle to submit all export documents to the port of entry from which the vehicle will be exported at least 72 hours prior to export. Documentation for U.S.-titled vehicles include an original certificate of title. For used, self-propelled vehicles a current Certificate of Title or a Salvage Title issued by any jurisdiction in the United States is required.

What if the car has 'Foreign Title'?

For vehicles that are registered or titled abroad, the owner must provide to CBP the original document that provides satisfactory proof of ownership (with an English translation of the text if the original language is not in English), and two complete copies of that document (and translation, if necessary). Important Note: Failure to have translated copies on hand will result in CBP delaying your importation.

What if it’s a 'Junk' car?

Junk Cars mean vehicles not to be sold as a whole. Junk cars require salvage title or a certificate of destruction. Destruction documentation is provided on the state level. Note: Certificates of destruction can only be reassigned twice in the State of Florida.

What if there is a 'Lien'?

If the car has an issue with title, like a lien, the interested third-party (lien holder’s) must provide a letter of authorization. The letter may be either signed or a stamp is acceptable. Note: You cannot import or export an automobile with a lien without this documentation.

  

CBP Emphasized the following: To import a vehicle under 19 C.F.R. §192, the vehicle must be:

1. Used;
2. Self Propelled; and
3. Sold to someone other than a dealer. 

What qualifies as ‘Used’?

Used” refers to “any self-propelled vehicle the equitable or legal title to which has been transferred by a manufacturer, distributor, or dealer to an ultimate purchaser”. Note: Do not use the phrase ‘dealer to dealer’ when communicating with CBP because once a vehicle is classified as used once, CBP will never define it as ‘new’ again.

But what IS a ‘Self-Propelled’ vehicle’?

Self-propelled includes any automobile, truck, tractor, bus, motor home, self-propelled agricultural machinery, self-propelled construction equipment, self-propelled special use equipment, and any other self-propelled vehicle used or designed for running on land but not on rail. Snowmobiles, ATV’s, and motorcycles are also vehicles under CBP regulations.

What is NOT a 'Self-Propelled' vehicle?

Jet skis and boats fall under ‘watercraft’, and are not required to be presented as used vehicles under 19 CFR § 192. CBP does not consider trailers vehicles because they are not self-propelled. Trailers must be attached to a self-propelled vehicle to qualify. Trains are not considered vehicles, either.

What does “Someone Other Than a Dealer” mean?

A ‘dealer’ is defined at the state level in state laws. The ultimate purchaser cannot be a dealer. “Ultimate purchaser” means the first person, other than a dealer purchasing in his capacity as a dealer, who in good faith purchases a self-propelled vehicle for purposes other than resale. The thing to remember here is the ultimate purchaser cannot be a dealer. Note: A dealer cannot reassign title to itself. Further, Non-dealers cannot reassign Manufacturer’s Statement of Origin (MSO). If you are a dealer, you can reassign the same MSO over and over again and it is okay. More information on CBP’s vehicle importing regulations can be found here.

For more information regarding the requirements for exporting used vehicles and solutions to CBP compliance issues, contact attorney Jennifer Diaz at (305) 260-1053 or JDiaz@becker-poliakoff.com.

Jennifer Diaz is the Chair of the Customs and International Trade Department at Becker & Poliakoff, P.A. She earned her J.D. from Nova Southeastern University Shepard Broad Law Center. Jennifer is admitted to practice law in the state of Florida and is board-certified in International Law by the Florida Bar.

Don't Fry Day: FDA Delays Enforcement of Sunscreen Requirements

Today, May 25, 2012 is officially designated as Don’t Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn’t want you to fry either. On June 18, 2012 the FDA’s new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013.

Here are some major changes you should see as a result of the new requirements:

1. The terms "sunblock", "sweatproof", "waterproof", "all‐day", "instant protection", and "extended wear" will be eliminated from your beach-going vocabulary. The FDA found these claims to be false and misleading to consumers and they are now prohibited for sunscreen labeling. A word of caution: these or similar claims will cause the product to be misbranded under section 502 of the FD&C Act (21 U.S.C. 352).
2. A plain statement of "water resistant" is not going to be sufficient, either. There are newly required label statements regarding the length of time a sunscreen product is truly water resistant. This is to ensure that the consumer is aware of how long the sunscreen will last in the water. But how will a manufacturer know how much water resistance is provided in terms of time? There are new FDA effectiveness testing requirements to determine water resistant sunscreen times.
3. Are you used to buying the sunscreen with the highest SPF number? A combined ‘‘Broad Spectrum SPF’’ statement is now required on the principal display panels [PDP’s] for sunscreen products. If the sunscreen does not pass the broad spectrum test, or it is broad spectrum with an SPF value of less than 15, the product will bare a required skin cancer and skin aging warning label in bold, indicating the adverse consequences of spending time in the sun. What does that mean for consumers? The broad spectrum labels and warnings will make shopping for sunscreen more apples-to-apples. It will be easier to determine which different types of sunscreen are really protecting your skin from the sun the way you need them to, and which ones don’t go the distance.

For more information regarding all the new changes to sunscreen product testing and labeling, please visit Federal Register’s "Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use".

For assistance in complying with these new requirements, please contact Jennifer R. Diaz, Chair of the customs and international trade department of Becker & Poliakoff, P.A. at (305) 260-1053, or by email at JDiaz@becker-poliakoff.com.

Here’s to not frying this Memorial Day weekend! 

2012 CBP Symposium Announced!

CBP announced May 10, 2012 as the date for CBP's Trade Symposium - "Transforming Trade for a Stronger Economy."  It will take place in Long Beach California, and registration starts March 20, 2012!

How I Helped Release $2.5 Million Stuck in Customs

Before beginning a career in international trade, I did not ever stop to think that the t-shirt I was wearing or dishes I was using were likely made elsewhere, and went through a long complicated logistics supply chain in order to reach my local store. Little did I know that when anything goes wrong in that complicated supply chain, it would be my job to help. Recently, a client had over 2.5 million dollars worth of electronic merchandise on hold by U.S. Customs and Border Protection (Customs) for alleged intellectual property rights violations. In plain English, Customs was under the impression my client was trying to import goods with trademarks or logos they did not have the authorization to import.

When you see these symbols, make sure you think about LICENSES to use them!!

For this client, this was a lot of money at stake, and it could have put them out of business if we did not come up with a quick solution. Instead of thinking of the band aid type solution, to solely fix this issue, we came up with a compliance plan for the client to use going forward, that would also help solve the current issue.

U.S. Customs & Border Protection Seized My Goods - Oh No!

U.S. Customs & Border Protection (CBP) seizes merchandise EVERY day (and there is a LOT you can do to get your merchandise back!).  Check out the latest 2011 stats on intellectual property rights enforcement and seizure statistics.

What some don't know is the merchandise does NOT even have to be destined for the U.S. for CBP to seize it.  Yes, it's true.  CBP detains and physically inspects cargo daily. CBP is supposed to issue timely detention notices and the detention notices are supposed to include the specific reason for the detention, anticipated length of the detention; nature of the tests or inquiries to be conducted; and nature of any information which, if supplied to U.S. Customs may accelerate the disposition of the detention.  I wish I had a dollar for every importer that told me they never received one, or where the rationale for detention was blank, or said IPR (intellectual property rights)!

HOW TO GET OFF THE FDA BLACK LIST (Import Alert List)

What is the Black List?

The United States Food and Drug Administration (FDA) has authority from Congress to place an importer, manufacturer, shipper, grower, geographic area, or country on a “detention without physical examination” (DWPE) list (aka the FDA’s black list). To check if a company you are doing business with is on such a list, check FDA’s Import Alert page, you can search by country, company, etc. If your company is on this list, any merchandise you import may be detained as soon as it is offered for entry into the United States. You will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days. The company/country, etc. will remain on this black list, until information is presented to the FDA that proves the merchandise is no longer violative.

How to Get Off the Black List

Do You Know the TOP 10 COMPLIANCE TIPS?

If you import, you need to!

On behalf of the Organization of Women in International Trade (OWIT-South Florida), I am hosting an informal round table where members OWIT will have the opportunity to get to know one another and learn all about compliance with U.S. Customs and Border Protection (CBP)!

Yes, men are welcome!

This session is especially important for importers and brokers and those in involved in international trade.

Attendees will receive a special "cheat sheet" providing great resources to utilize when importing, including the top 10 compliance tips.

Space is limited to OWIT members! Become a member of OWIT here (it is only $100 for a YEAR of benefits including these FREE IBR's), and assure your spot by sending in your RSVP today!

Please email Jennifer Diaz with any questions!

Importing into the United States in Compliance with U.S. Customs & Border Protection (CBP)

Do you want to learn the Top 10 Tips When Importing to Ensure Compliance?  What about the Importance of CBP Rulings for Classification, Valuation and Country of Origin?

How about Cost Savings practices like utilizing Free Trade Agreements?

Well you can learn this and hot topics like:

- Importance of protecting Intellectual Property Rights

- Basic customs concepts and terms

- What to do if you encounter a CBP detention and/or seizure case

- Learn when to submit a Prior Disclosure to CBP

Join my webinar with Compliance Online, January 27, 2012, at 1:00 pm eastern. 

You can join the live session and ask questions! 

If you import merchandise into the U.S., you may not realize, but, you are the responsible party! In this presentation, we will discuss how to comply with U.S. Customs and Border Protection’s (CBP) vast laws and regulations. By the end of the Seminar you will know and understand the importance of tariff classification, Customs valuation, Country of origin marking, intellectual property rights and Free Trade Agreements. 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.