On February 1, 2013 Many Food Facilities Face Suspension

The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S.

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, alcoholic beverages, and/or dietary supplements 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.

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 (which FDA extended until January 31, 2013, as renewals did not start until October 22).

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 22– January 31, 2013 extended 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. 

Contact Jennifer Diaz with any questions and ensure your importation are not delayed come February 1, 2013.

What You Missed at the C-TPAT Conference

The Customs-Trade Partnership Against Terrorism is a voluntary government-business initiative that builds cooperative relationships that strengthen and improve overall international supply chain and U.S. border security. C-TPAT is widely recognized as one of the most effective means of providing the highest level of cargo security through close cooperation with international supply chain businesses such as importers, carriers, consolidators, licensed customs brokers, and manufacturers. At CBP's C-TPAT Conference held on January 8-9, 2013, CBP announced major updates to C-TPAT – lucky for you, I’ve recapped the highlights for you below.


Trusted Trader Program

• CBP proposes to combine CBP’s ISA program with C-TPAT. Additionally, if importers choose to be part of the Trusted Trader Program, they can take advantage of “joint validations” with other government agencies (OGA’s). CBP and TSA have already been performing joint validations for 9 months. Trade is concerned that OGA’s will go on fishing expeditions while validating and no guarantees have been made from CBP that OGA’s won’t. This is a major concern for some (rightfully so!).

• CBP is seeking comments regarding its new Trusted Trader Program. Please email any comments here.

Internal Conspiracies

Top conspiracy indicators to look for are:

• Anyone taking photos of entrances, fencing, hours of operation, etc..

• Anyone interested in stow plans, employee schedules, transit routes, and GPS

• Anyone in financial distress

• Anyone attempting to access a system that they have no authorization to access

• Anyone showing up to work on a day off or with large bags

• Anyone entering restricted zones without access

Container Inspection

Use the VVTT process:

• View seal and container locking hardware

• Verify seal #

• Tug on seal to make sure it is on right

• Twist and turn seal to make sure it doesn’t unscrew.

Most Common Areas of Failed Criteria:

• Conveyance Security – tracking an monitoring 51%

• Container Security – sealing/ container inspection 49%

• Business Partners – screening and subcontracting 46%

• Personnel Security – background checks 31%

SW Border Strategies

• 86% of the time the drivers are responsible and have some involvement in conspiracies

• There were 41 seizures representing C-TPAT companies in 2012

• There are 160 underground tunnels from Mexico the U.S. or Canada to the U.S.

Evidence of Implementation

Suspensions and removals from January 2002-November 2012:

• 403 importers suspended due to validation issues

• 339 were removed from C-TPAT

CBP expects:

• C-TPAT Manuals including all minimum security procedures

• Documentation of audits, checklists, appropriate training

• Assurance that all documentation is uploaded into the portal

• Checklists to be uploaded that are filled out (blank forms will no longer be acceptable)

• Photo and video evidence of implementation may be requested

• If you DON’T contact your CBP Supply Chain Security Specialist (SCSS) when illegal activity is detected, it is a STRIKE against you

Visitor logs

• Only for unknown visitors

• Don’t let visitors sign themselves in!

C-TPAT Portal 2.0

• Expect changes to the portal in the summer, it’s in early prototype stages now

• You will not have to be a C-TPAT member to create a user account

• SVI numbers will go away, tracking will be done using a business name and type

• Members will have the ability to share documents

• The new structure will give you the ability to combine common security practices, this is beneficial if you have more than one user account

Thomas Winkowski, Acting COO of CBP

• Over 55% of goods entering the U.S. are from C-TPAT certified partners

• CBP is pushing for more Mutual Recognition Agreements (MRA’s)

• CBP currently has 7 MRA’s in place

• MRA’s on the horizon with Taiwan, China, Israel and Mexico

Kevin McAleenan, Acting Assistant Commissioner, Office of Field Operations (OFO)

• CBP is working on advancing benefits to C-TPAT members

• New CBP Director Lauren Koffer was announced!

Dan Baldwin, Executive Director

Currently CBP has:

• 10,452 certified partners

• 158 – CBP staffing level

• 328 – Tier 3 IOR’s

• 22,223 – Total Validations Completed since inception

Concern regarding budget and number of validations CBP will be able to complete for FY13

• In 2012 there were 822 new companies that applied for C-TPAT & 693 of those were certified

Barry Brandman, President, Danbee Investigations

Top 5 best practices:

1. Must enlist senior management support

2. Culture and security excellence (Don’t meet standards, exceed them)

3. Apply checks and balances throughout (Anticipate that your first line of defense will fail)

4. Strategically utilize security technology

5. Diligently audit safeguards to expose weaknesses

If you have questions regarding submitting a C-TPAT application, C-TPAT validations, advancing in tier status, or any pending C-TPAT program changes, feel free to contact me.