Posts Tagged ‘FDA’


 

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.

You can stay informed by signing up to our email newsletter. These emails consist of general trade information, regulatory updates and event notifications. Click the button below to stay informed on the latest trade information, regulatory updates and Pacific Customs Brokers events.

Sign Up for PCB's Newsletter

Your Designation Maintenance Begins with our Professional Development Courses

Image: Seminar Room

 

Your Professional Development starts with Pacific Customs Brokers! If you have never attended one of our Professional Development Courses, the following information might help you decide on attending the next one.

Professional Development Courses – Seminars and Workshops

At our in-person courses you learn the best practices of being a compliant importer and/or exporter which will help you expedite your commercial shipments to and avoiding costly delay triggers. Our experts share their knowledge and stories on international and cross-border shipping regulations to keep you current with customs and partner government agency requirements.  Benefits of attending an in-person seminar or workshop include:

  • All day access – Get our experts to answer your questions one-on-one
  • Case studies and real-life examples – Examine other attendees’ trade compliance hurdles
  • Cost-effectiveness – More affordable than industry standards
  • Range of topics – Choose from a wide variety of topics
  • Certificate of Completion – Receive a certificate for each course you attend
  • Handouts – Take home your own set of course material
  • Industry accreditation – Earn points towards maintenance of your industry designations
  • Networking – Connect with other like-minded professionals

Professional Development Courses – On-Demand *COMING SOON*

Our on-demand library is designed to meet the demands of the global trade community. These sessions are a convenient way for trade professionals to stay ahead of new regulations with international trade and gain additional knowledge in key areas. Benefits of attending an on-demand course include:

  • Global accessibility – Travel is removed from the equation for companies with multiple locations or branches
  • Convenience – Attend from the comfort of your desk or home at any time that is best for you
  • Concise training – In a fast-paced industry, efficiency becomes just as important as staying compliant, watch in parts or “binge” on the full course
  • Industry accreditation – Earn points towards maintenance of your industry designations

 

Taking any of our courses may earn you maintenance points, credits, and hours towards a variety of professional designations. Some examples of eligible designations are:

  • Certified Customs Specialist (CCS)
  • Certified Trade Compliance Specialist (CTCS)
  • Certified Export Specialist (CES)
  • Designate with the Law Society of British Columbia (LSBC)
  • Accounting Professional

Registration for Fall 2018 is now open!

Review and plan your professional development maintenance for the second half of 2018 by clicking on the hyperlinked course names below. 

  CSCB NEI LSBC
Course Name CCS CTCS CCS CES  
How To Import Into Canada Part 1 5 5
How To Import Into Canada Part 2 5 5 3
How To Import Into Canada (Series) 5 5 3
How To Classify A Product 5 6 4
How To Import Into The US Part 1 5 5 3
How To Import Into The US Part 2 5 5 3 3
How To Import Into The US (Series) 5 5 3
How To Value A Product For Customs 5 5
*How To Choose The Best Incoterm 5 3 3
*How To Import CFIA Regulated Goods 5 5
*How To Import FDA Regulated Goods 5 5 3

 

*Registration for spring 2019 courses coming soon.

 

 

Have questions or comments about any of our courses? Call 888.538.1566 or email us today!

Trade Talk | This week in HS Tariff Changes

Trade Talk | This week in HS Tariff Changes

Trade – New 2017 Customs HS Tariff Codes in Effect NOW!

What we know for sure: HS Tariff changes

Getting your HS Tariff Code right is really important! The HS Tariff changes have been coming for quite a while and most are well known to customs brokers however let’s ensure that you, the vendors, are clear!

The current updates announced by the World Customs Organization (WCO) that came into effect as of January 22, 2017, are still being digested by most organizations. Our Trade Compliance Advisors have been on top of this for several months and are prepared to offer support where your company might need it.

If you are a client of ours, rest assured that we have already implemented the required changes and addressed all prior rulings that needed updating. If however, you are not a client of ours, we recommend you either contact your customs broker to ensure your tariff classifications and rulings are correct or contact our Trade Compliance Advisors. We are available 24/7 to provide this service on your company’s behalf.

What we are talking about:

The HS Tariff Changes had a large focus food products.

“The majority of the new changes to the HS have been broached by the FAO (Food and Agriculture Organization of the United Nations).

The HS 2017 amendments for fish and fishery products are to further enhance the coverage of species and product forms which need to be monitored for food security purposes and for better management of resources. The split by more detailed product forms for crustaceans, molluscs and other invertebrates is motivated by the importance of trade and consumption of these species in the various product forms.

The amendment for cuttlefishes and squids is to extend the coverage of the present codes, in order to have all those species grouped. At present, a significant share of cuttlefish and squid trade is recorded under residual codes for molluscs.”

With the final actions and rulings in regards to Forestry Products we are also talking about the amendments on this section of the WCO amendment announcement:

“The amendment for forestry products aims at one main area: enhancement of the coverage of wood species in order to get a better picture of trade patterns, including endangered species. In particular, separating the data on tropical wood trade will both serve to focus attention on the important issue of tropical wood use and clarify data on non-tropical hardwoods. The HS 2017 amendments also include the creation of new subheadings for the monitoring and control of certain products of bamboo and rattan, requested by the International Network for Bamboo and Rattan (INBAR).”

What we think:

We have been ensuring over recent months that our clients rulings are up to date with the changes and requirements laid out in the 2017 Customs Tariff. We are confident that our clients will, and have, found the transition to the 2017 Customs tariff seamless.

What we advise:

If you have a ruling on a classification we advise you to ensure that it is upheld under the 2017 customs tariff amendments, if you are not sure we highly recommend you contact a customs broker as soon as possible to avoid penalties, fines or worse, holdups of your company’s goods at border crossings.

Here is a great excerpt from our blog Your Broker Knows blog which covers tips on how to correctly classify your goods using the H.S. Tariff:

Key Reasons Why “Getting It Right” Is So Important: (The full article is here: http://bit.ly/2kagZzd)

Let us start with the area that everyone is aware:

  1.   Duty rates: The tariff classification has a direct correlation to the duty rate that you will be expected to pay (and no, it is not a matter of “finding the one that says FREE”).
  2.   NAFTA: This is very important as one of the first steps in determining if goods qualify under NAFTA is to find the tariff classification for the product and to then check under the NAFTA Specific Rules of Origin to determine how the goods might qualify. A common misconception is that products will “automatically” qualify if they are made in Canada, the U.S. or Mexico.
  3.   Anti-Dumping Duty (ADD): If a government decides that they need to protect a domestic industry, they can impose an anti-dumping duty on specific imports. This is also driven by the harmonised tariff classification. Pay close attention to this area as anti-dumping duty rates are always very high – usually double or sometimes triple digit percentages. For a full list of Canadian imports subject to dumping duties visit this link » Goods subject to anti-dumping or countervailing duties
  4.   Exporting to countries other than the U.S. where the shipment value exceeds $2,000.00? You or your freight forwarder will be required to complete a B13A export document (or electronic equivalent), and you will need the eight-digit harmonised system export code or the Canadian 10-digit import code for each product. Once again, export restrictions and permits governed by Foreign Affairs are driven by the tariff classification. The above topics are the primary reasons for determining the correct tariff classification. In addition, we should also include the controls through other governmental agencies, such as the Canadian Food Inspection Agency, Free Trade Agreements with other countries, and also the effects on Canada’s trade statistics.

Remember – If your company’s name is indicated as the importer on any customs documents, you (not your customs broker) are looked upon as the responsible party to ensure all declarations are correct. You may be able to avoid any future problems by getting it right the first time!

What we are reading:2017 Customs Tariff Amendments

The WCO has published the accepted amendments to the Harmonized System (HS) Nomenclature that went into force on 1 January 2017. It includes 233 sets of amendments, divided as follows: agricultural sector 85; chemical sector 45; wood sector 13; textile sector 15; base metal sector 6; machinery sector 25; transport sector 18; other sectors 26.

Link: http://bit.ly/2kI8prv

Along with the announcements and information shared on the WCO website, we are and have been, reading and disseminating the new Customs Tariff Documentation as you can see in this image – all 4 inches thick of it!

 

ACE Transition | Changes to FDA Entry Filing

Update

The U.S. Food and Drug Administration (FDA) has now completed its transition to the Automated Commercial Environment (ACE). As a result, all goods regulated by the FDA must be transmitted via ACE effective June 15, 2016 and will no longer be accepted in the previous Automated Commercial System (ACS). Additional information is now required when filing entries and corresponding entry summaries for FDA regulated goods.

What additional information will be mandatory?

  • Commodity details and intended use
  • Description of how the commodity is processed
  • Product state (i.e. fresh, frozen, shelf stable, etc.)
  • FDA product code
  • Country of production or source
  • Full and detailed invoice description
  • Full name and address of the:
    • Manufacturer
    • Shipper
    • Importer
    • Consignee
    • Consolidator
    • Farmer/grower (if applicable)
    • Processing plant (if applicable)
  • FDA registration number(s)
  • Port of entry
  • Quantity
  • Weights (actual, rather than estimated)
  • Packaging type
  • Product line value
  • Arrival date and time

Certain commodities may require additional information. Please contact Pacific Customs Brokers for additional details.

How will this affect my entry?

Pacific Customs Brokers may contact importers to obtain any mandatory information required for the entry filing with ACE and FDA.

As CBP and FDA implement this mandatory filing requirement entry filing delays are to be expected. It is imperative to note that missing information will result in additional processing delays.

Have questions or comments regarding the potential processing delays you may experience? Have tips for minimizing shipment delays? Share your thoughts with us. Leave them in the comments section below or email Ask Your Broker.

Biennial FDA Food Facility Re-registration Now Open

FoodAbout the Food Safety Modernization Act (FSMA) program:

The Food Safety Modernization Act (FSMA) improves the registration process by ensuring, among other things, that the FDA has accurate contact information for each facility. The new registration form also includes new categories of foods. These new categories will help FDA rapidly communicate with the right facilities in the event of an emergency. Food producers and manufacturers have long been required to register with the Food and Drug Administration. Facilities can register online, via mail or fax. If your company is not domestic (not located within the U.S.) you will be required to assign a U.S. agent in your registration. See below for more information on assigning a U.S. agent.

 

Read more in our blog: Food Modernization Safety Act – Re-Registering your Facility with the FDA

The U.S. Food and Drug Administration (FDA) issued further information and guidance regarding registration requirements for domestic and foreign manufacturers, processors, packers or holders of food for human or animal consumption based on changes made by the FDA Food Safety Modernization Act (FSMA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Biennial registration renewal for food facilities began at 12:01 AM on October 1, 2014. The updated food facility registration system is accepting food facility registration renewals.

Who must register?

Under the Food Safety Modernization Act (FMSA), all domestic and foreign facilities that manufacture, pack or store food, food ingredients, pet foods or dietary supplements are required to renew their registration with the FDA before the end of 2014 and to re-register every two years thereafter. This represents a change from the previous registration requirement for food facilities. The re-registration form contains new food categories, and requires more detailed and updated contact information.

 Read more in our blog: U.S. Food Safety Modernization Act – Does It Affect Me?

How to re-register a domestic company?

To submit a registration renewal to FDA, a food facility is required to submit required registration information to FDA, including the additional registration information. If you are affected by the new regulations, you may re-register your food facility online.

How to re-register if not a domestic company?

Pacific Customs Brokers offers the following services:

  • Act as your U.S. Agent
  • Assist with FSMA re-registration
  • Answer your queries regarding FDA requirements

Note: Pacific Customs Brokers does not have to be your U.S. customs broker in order to assist your company with FSMA re-registration.   Contact Pacific Customs Brokers for assistance with food facility registrations or the FSMA. To stay current on this topic, you may also want to subscribe to Pacific Customs Brokers weekly trade newsletter.   Do you have questions on the FDA food facility re-registration? Share them in our comments section below.