What is FSVP
What is the Foreign Supplier Verification Program (FSVP)?
FSVP is a law, and one of a number of laws that implement the provisions of the 2011 Food Safety Modernization Act (FSMA). FSVP focuses on safe food practicesis and has fundamentally changed the way that US food importers conduct business.
Put simply, FSVP is a set of FDA food-safety regulations that require all US importers bound by this law to verify that the food and food-related products they import from foreign suppliers are being produced in a manner that provides the same level of public health protection as those produced domestically.
What/who does FSVP apply to?
FSVP applies to all importers and imports of food and food-related products, with some exceptions:
Imports intended for food research purposes or personal consumption are exempt. Imports of juice and some of juice’s raw ingredients are exempt. Imports of certain meat, poultry, and egg products are exempt. Imports of alcoholic beverages and some of the raw ingredients intended for use in alcoholic beverages are exempt. And imports of seafood are exempt.
It is important to mention that although the framers of this law have allowed for specific exceptions, there are many caveats to those exceptions. I strongly recommend that each importer conduct a thorough review of FSVP’s applicability with respect to their individual circumstances.
When does FSVP come into effect?
It depends. The FDA has been rolling out FSVP compliance dates since May of 2017. Factors such as an importer’s annual sales, number of people the employed, the size of their foreign supplier(s), and the type of imported food are all used to determine the appropriate compliance date.
To determine your company’s specific compliance deadline, fill out this breif questionnaire.
What are the penalties for non-compliance?
Those that fail to meet the new requirements can face penalties ranging from a warning to imprisonment. The FDA is currently conducting regulatory audits and has made this new initiative their priority.
What/who is a “foreign supplier”?”
The FDA defines a Foreign Supplier as “… for an article of food, the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.”
Is United Safety Agents’ coverage nationwide?
Yes, United Safety Agents acts as the FSVP Agent for entires made at all U.S. ports.
How much does your service cost?
United Safety Agents’ (USA) services are priced to enable all companies, regardless of their size, access to our customized solutions. Instead of charging large upfront fees, or arbitrary monthly dues, we charge primarily for usage. Our pricing model provides a flexible and affordable FSVP compliance solution.
To learn more and request a customized solution click here.
How long does the process take?
Generally speaking, the process can be accomplished within 5-7 business days – once USA is in receipt of all necessary food-safety documentation.
Am I the “FSVP importer”?
You are the FSVP importer if you are the U.S. owner or consignee of an article of food that is being offered for import into the United States. If the goods are not sold at the time of U.S. entry, the FSVP importer is the U.S. agent of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.
Must the FSVP importer be in the United States?
Yes. The FSVP Importer/Agent must be physically located within the United States with minimally one full-time staff employee. This FSVP Importer/Agent must have been trained and have a good knowledge of the FSVP regulation.
What does “U.S. owner or consignee” mean?”
A U.S. owner or consignee is person or entity in the United States who, at the time of entry of an article of food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food.
What is meant by “time of U.S. entry”?”
Time of U.S. entry is the time when the entry documentation for an individual imported food is submitted to Customs and Border Protection (CBP).
Is the FSVP importer the same person as the importer of record recognized (IOR) by CBP for import entry?”
The FSVP Importer can be the same person as the IOR. But most of the time it not the case.
The FSVP importer is responsible for verifying that the imported food are produced in accordance with applicable U.S. food safety requirements. In contrast, the IOR might be an express consignment operator with little to no knowledge of the safety regulations applicable to the products for which they obtain clearance from CBP.
Is a FSVP Agent the same as a U.S. food facility registration agent?
No. The FSVP Agent or representative of a foreign owner or consignee for FSVP purposes is responsible for meeting all applicable requirements under the FSVP regulation. These responsibilities and duties are qualitatively different from serving as a communications link with a foreign facility.
When is a U.S. Agent or representative required under the FSVP regulation?
If there is no U.S. owner or consignee of an article of food at the time of entry, the foreign owner or consignee of the food must designate a U.S. agent or representative to serve as the importer of the food for FSVP purposes. A U.S. agent or representative of a foreign supplier of a food is a person in the United States who is designated by the foreign owner or consignee of a food as the agent or representative for purposes of meeting the requirements of the FSVP regulation, as confirmed in a signed statement of consent to serve as the FSVP importer.
This requirement ensures that there is an entity located in the United States who takes responsibility for the food.
Who is the foreign supplier of a food?
The foreign supplier of a food is the establishment that manufactures/processes the food is exported to the United States without further manufacturing/processing by another establishment.
What are the requirements for an FSVP?
In general, the FSVP regulation requires that, for each imported food, the FSVP Importer/Agent must develop, maintain, and follow a Foreign Supplier Verification Program that provides adequate assurances that the foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as required by FDA rulls like any US manufacturer in the same category of products.
The FSVP Importer/Agent must also ensure that the foreign supplier is producing the food in compliance with adulteration requirements, as well as regulations regarding misbranding with respect to labeling of human food for the presence of major food allergens.
Who is a qualified individual?
A qualified individual is a person who has the education, training, or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation, and can read and understand the language of any records that the person must review in performing this activity. A qualified individual may be, but is not required to be, an employee of the importer. You might also rely on non-employees such as a consultant or a designated FSVP agency.
• Establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted;
• Determine and conduct appropriate foreign supplier verification activities, such as onsite auditing, sampling and testing, and review of supplier food safety records; and
• Review and assess the results of verification activities and, if necessary, take appropriate corrective action.
For some of these activities, you may rely on other qualified entities to perform the activity provided that you review and assess documentation of the performance of these activities.
What are the requirements when there is no U.S. owner or consignee at the time of entry?
If there is no U.S. owner or consignee of the food at the time of entry, the foreign owner or consignee must designate a U.S. agent or representative as the importer of the food responsible for compliance with the FSVP requirements. The designated agent must be a person who resides in the United States, or maintains a place of business in the United States. An agent must be physically present, as it is not sufficient to merely have a mailbox, answering service, or some other place in the United States where the. If you hired an FSVP importer as third paty, you must have a signed agreement to validate that he is the designate a U.S. agent or representative for the purpose of meeting the definition of FSVP importer. At any time, FDA may request to see the signed statement of consent.
How does the FDA verify that I have a valid FSVP importer at entry?
When a food product under FDA oversight is offered for entry into the United States, your Custom Broker must send many documents and electronic codes prior to the entry. One of the automatic code indicate if your products are subject to FSVP regulation. And your custom invoice to US Customs. All the coordinates of your FSVP importer must appear on this document to cross the bord.
What are some consequences if I do not comply with the applicable FSVP requirements?
In the event that you do not comply with all applicable FSVP requirements for the specific food item you are attempting to import, the FDA may refuse admission into the United States of the food item in question. In addition, importing or offering for importation a food into the United States without having an FSVP is a prohibited act. The United States can bring both a civil action in federal court to enjoin a person who commits a prohibited act as well as a criminal action in Federal court to prosecute a person who is responsible for the commission of a prohibited act. The FDA can also seek debarment of any person who has been convicted of a felony relating to importation of food into the United States. In addition, false representations to the U.S. government, including falsely identifying a U.S. agent or representative, may result in criminal prosecution of those involved
What are the consequences if I do not respond to an FDA request for records?
If you do not respond to the FDA’s request for records relating to your FSVP, the FDA will consider that a violation of your obligations. The FDA will consider such a refusal to be a violation of FSVP requirements if the refusal is made when the request records at your place of business or if the refusal is made in response to a written request from the FDA to send records to the Agency electronically or through other prompt means . The FDA will consider taking enforcement action if you do not respond to a request for records as required.
What will happen if the FDA has determined that I am not in compliance with FSVP and places the food on Import Allert?
If a food you offer for importation into the United States is listed on an FSVP import alert because you did not comply with the FSVP requirements for that food, FDA may detain the food without physical examination when you offer it for importation. FDA will then issue a Notice of FDA Action, which will state the reason for detention. The notice will also specify a place and a period of time during which you will have an opportunity to introduce testimony demonstrating that you are in compliance with FSVP with respect to the food. Such testimony may be introduced orally or in writing. If you do not wish to introduce testimony, you can choose to waive your right to introduce testimony and export or destroy the product. If you do respond but FDA determines that your response is inadequate, FDA may refuse entry of the food. In such a case, we will issue a Notice of FDA Action informing you that your entry has been refused. The food must then be exported or destroyed.