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 […]

FDA Biennial Registration 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 […]

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 […]

Why all the guesswork?

There are so many questions, with an even greater amount of potential answers when importing goods into the United States.  What is the HTS classification? Are the product labels marked correctly for entry?  What is the product’s country of origin?  Should the product receive NAFTA, DR-CAFTA, GSP or some other duty-free treatment?  What is more important is that the answers to these questions mean real money!  For example, if the product you are importing is eligible for duty-free treatment, it could mean the difference between paying a double-digit tariff versus none at all.

Answering these questions is not always so simple, and are often subject to interpretation.  An importer could assume that their own guesses are correct, but, taking that leap places in jeopardy the profitability of the venture, especially as profit margins become ever so tight.  What’s worse is that a wrong guess could potentially subject the company to fines if Customs and Border Protection (CBP) simply does not agree with the interpretation you have used in the past. CBP statute of limitations is five years – that translates into a multitude of entries potentially subjected to CBP fines if you have been guessing wrong.

How do you eliminate the guesswork? Submit a Binding Ruling Request!  Put simply, a Binding Ruling Request is an official request to CBP that includes relevant information, and often a sample of the product, for CBP to review and respond as to the following:

(1)          HTS Classification
(2)          Marking/Labels Ruling
(3)          Country of Origin Determination
(4)          Valuation Rulings
(5)          Applicability of […]

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.

On a daily basis, different companies call me to discuss issues they are having with U.S. Customs and Border Protection (CBP). For instance, today, a company called me discussing a CBP 28 – Request for Information, and thereafter a CBP 29 – Notice of Action received from CBP. The issue was an underlying classification issue. Bottom line, they had never done any Pre-Compliance on the Harmonized Tariff Schedule’s (HTS) they were using for their imported merchandise. They said the infamous line – that’s why I hired a broker. Important to note that this just does not cut it with CBP.

CBP publishes really great Informed Compliance Publications for Importers – too few importers have read them, and too small a percentage of importers know they exist. For new importers, CBP has a great resource titled Basic Importing and Exporting. Included […]

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