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.