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.