Posts Tagged ‘CBP’


 

Foreign Supplier Verification Program Frequently Asked Questions

FSVP Produce


What is the Foreign Supplier Verification Program (FSVP)?

FSVP is a program set in place by the Food and Drug Administration (FDA). This requires U.S. buyers to make sure they are importing from foreign producers that are manufacturing under the same standards as domestically made foods. It consists of various information retained by the U.S. importer such as hazard analysis of the producers, controls, monitors programs, and specific record keeping requirements.

What is the FSVP compliance date for importers subject to the Produce Rule?

All Importers whose large foreign suppliers are required to be compliant with the Produce Rule will also be required to be compliant with FSVP on July 26th, 2018.

Who is subject to the Produce Rule?

Growers and Manufacturers of vegetables and fruits that are normally consumed raw and that are fresh or minimally processes, such as cut and washed, are subject to the produce rule, such as tomatoes, cucumbers, and blueberries. This does not include frozen fruit or vegetables or items that need to undergo further processing (such as a process to minimize contamination or cooking). This would include squash, coffee beans, and navy beans.

What new information must I include on my invoices?

For your Customs Broker to clear your entry with the FDA, they will now need to know who the FSVP Importer is, the FSVP importer’s DUNS number, and the FSVP importers IRS number. Without this information, the entry will be held.

Who is the FSVP Importer?

The FSVP Importer must be a U.S. Company. When items have been sold this is usually the U.S. buyer of the goods. If there is not buyer, then it is the receiver of the goods in the U.S. If there is no final receiver, such as items going to a fulfillment facility, you can have a U.S. FSVP Agent indicated on the documents, who agrees to take on the responsibilities of the FSVP Importer.

How does this affect Foreign suppliers?

Although the FSVP Importer is technically the U.S. company, there is a large amount of information that the FSVP Importer is required to have on file and verified regarding your manufacturing facility. These can range from lab results, your food safety plans, and other information. If you do not have these available, but they are a requirement for the U.S. company to buy your goods and bring them into the state, they may move on to purchasing from someone who has provided them the required information.

Also, as the foreign supplier, if you are the Importer of Record as well, you will need to make sure you speak with your buyers to confirm with them that they are aware of the FSVP rule, are working to be in accordance with it before July 26th, and that they have provided you their DUNS number and email address.

What does the FDA consider a Large Foreign Supplier?

FDA considered a large facility a facility that is neither a small or very small supplier. This would be a business (including any subsidiaries and affiliates) employing 500 full-time equivalent employees or more.

FDA also lists the definition of full-time equivalent as: “a term used to represent the number of employees of a business entity for the purpose of determining whether the business qualifies for the small business exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours × 52 weeks). If the result is not a whole number, round down to the next lowest whole number.”

Where can I ask more questions regarding the Foreign Supplier Verification Program?

You can call us anytime to find out more information on importing produce into the U.S. and all the subsequent regulations and governing authorities such as the FDA.

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What You Need to Know to Get Your FDA Regulated Products Across the Border

Customs clearing food products through the U.S. border can be challenging if you do not know how the U.S. Food and Drug Administration (FDA) works. Shipments of FDA regulated products cross the border and get delivered to U.S. consignees daily. Just because the shipment gets delivered does not mean it has been released by FDA. Let’s begin by reviewing what is required by the FDA, the entry process at the border and the different reviews a shipment may undergo before release.

Information Required by FDA for the Import of Food Products:

When sending shipments of FDA regulated products to the U.S. you need to provide the following information:

  • The FDA requires that all food facilities register. Once registered, all shipments must declare the FDA Food Facility Registration Number.
  • Imports of food products require the name, address, and FDA registration number for:
    • Manufacturer
    • Last place the product was packaged, processed or stored
  • It is also recommended that you provide the following to your customs broker for clearance:
    • Copy of label
    • Ingredient list

The Entry Process:

When a shipment of FDA regulated product crosses the border, a Customs entry is submitted by the customs broker. If regulated by the FDA, FDA Information and if required Prior Notice is submitted to FDA. The Prior Notice must be submitted at least two hours prior to the shipment arriving at the border so FDA can review the entry and decide if the product crossing is something they want to further examine.

It is important that your shipment crosses the border during normal FDA hours of operation to allow FDA to review or examine the shipment while it is at the port.

If you have a shipment under FDA Review, you should notify your customer to hold the product intact. Failure to follow FDA procedure can result in a penalty of up to three times the value of the product and/or refusal to enter the commerce of the United States.

Types of FDA Reviews:

There are a few types of FDA Reviews that shipments can undergo:

  1. FDA Review –  FDA analyzes the information that has been submitted electronically. As long as all the required information has been provided at the time of entry, typically FDA will release the shipment without further review.
  2. FDA Hold or Documents Required – What this means is FDA has analyzed the electronic submission and is now requesting further information. FDA will require physical copies of the documents. You would need to submit a commercial invoice, packing list, label copies and any other pertinent product information.
  3. FDA Exam Sample – This is the most thorough type of FDA review and can mean a variety of things such as FDA has examined or intends to examine the shipment. This results in a physical sample of the product or the product’s labeling.

 

No matter what type of FDA review, your shipment is not released until you receive  a “May Proceed” message from FDA after which your products may be distributed and consumed in the USA.

 

Don’t Risk Your FDA Goods Being Held Up at the Border

Gain a better understanding of how the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) interact. Attend an upcoming FDA Seminar and get an overview of FDA prior notice, required documentation, penalties and other pertinent topics. Sign up for our next FDA Seminar today!

 

Post your thoughts or questions on shipping food products into the USA in our comments section below or email us at Ask Your Broker.

U.S. FDA Requirements for Regulated Goods

What Is The FDA?

The Food and Drug Administration (FDA) is a federal agency of the United States which ensures food is safe, clean and correctly labeled for human and pet consumption.

What Does The FDA Regulate?

The FDA regulates over 90 industries. Most commonly they regulate biologics, food, cosmetics, vitamins, human drugs, veterinary products, medical devices, in-vitro diagnostics, and non-medical radiation emitting products.

What Does The FDA Not Regulate?

What the FDA does not regulate is advertising of products, alcohol, consumer products, illegal drugs, health insurance, meat, poultry, pesticides, restaurants and grocery stores.

FDA Food Facility Registration

Any food facility who manufactures, processes, packs or holds food must register as an FDA food facility. You must have a physical presence in the U.S. for purposes of registration. Biennial Re-registration is required every even year (2016, 2018, 2020 etc.).  You are able to re-register from October 1st to December 31st, and you must be registered to be able to import any product regulated by the FDA.

FDA Video

A short video explaining the commodities regulated by the U.S. FDA, requirements to clear FDA regulated goods across the border and the types of FDA reviews.

 

 

To assist importers in becoming aware of their requirements and implications of regulations involved with importing FDA regulated goods into the USA, Pacific Customs Brokers regularly hosts FDA related seminars and webinars. Visit the Trade Compliance Education section of our website to see a list of seminars and webinars currently being offered. For more information on how Pacific Customs Brokers can help you commercially import food products into the USA, please contact us.

 

Do you have questions regarding FDA regulated products? Leave them in our comments section below or email  Ask Your Broker.

 

Related Blog Articles:

 

Video: The Importance of Complying with U.S. Customs Regulations

Licensed Customs Broker and Certified Customs Specialist, April Collier, walks importers through the importance of complying with U.S. Customs regulations and what they can do to assure they are meeting all of the requirements governing the movement of commercial goods

 

 

As customs brokers, we make every effort to provide the trade community with the right tools and information to ensure that your company is as proactive as possible with the CBSA and CBP. As part of our ongoing efforts, we offer a number of  Trade Compliance Seminars and Webinars throughout the year on compliance and customs audit among other subjects. Our upcoming U.S. Customs Audit Seminar might be of particular interest. This seminar will focus on the differences between voluntary and enforced compliance, the expectation of “reasonable care”, the potential cost risks of non-compliance, and best practices. For more details on this seminar and registration visit – U.S. Customs Audit Seminar.

Whether you are just starting out or have an existing business, our experienced trade compliance specialists can assist you. To learn how Pacific Customs Brokers’ customs trade compliance and customs audit consulting can help your business; speak with one of our trade compliance specialists today.

 

Is your company trade compliant? Do you have questions about complying with U.S. Customs regulations? Drop us a comment or question below or email  Ask Your Broker.

Additional Resource:

 

Another Successful Carrier Appreciation Reception

Pacific Customs Brokers would like to extend their gratitude to all guests who attended the 3rd Annual Carrier Appreciation and Cross-Border Reception held at Eaglequest Coyote Creek Golf Course in Surrey, B.C. A special thank you to Canada Border Services Agency, U.S. Customs and Border Protection and Commercial Vehicle Safety and Enforcement for their participation. We would also like to thank the B.C. Trucking Association in showing their support by attending this function.

Greg Timm, President of Pacific Customs Brokers says:

“Pacific Customs Brokers considers carriers key partners and allies in our effort to service importers. We spend a great deal of our thought and energy advancing the concerns of carriers to make their cross-border journey faster and simpler. We thank the government stakeholders who engaged with our guests, and especially we thank all of the good people in the trucking industry who joined us for our Carrier Appreciation and Cross- Border Information Event”.  

View the Carrier Reception photo gallery here >>

The event drew a large crowd of owners, general managers, operation managers, customs managers, dispatch administrators, shipping coordinators, and self-carrying importers from the transportation sector.

It was an evening of networking among industry partners with live music and great food! Guests traveled as far as California, Oregon, Michigan, Washington, Vancouver Island and the central interior of British Columbia.

Government Officials from Canada Border Services Agency, U.S. Customs Border and Protection and the Commercial Vehicle Safety and Enforcement were on-hand to field questions related to cross-border topics. It was well worth their time as the guests asked many thought provoking questions.

Congratulations to Arek Koscinski of MC Freight Systems; this year’s lucky winner of an iPad Mini!

Thank you again for everyone’s continued participation for another successful event. We hope to see all of you again next year!

View the Carrier Reception photo gallery here >>

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