Question 1

Specific Question?

Accepted Answer

The following FAQs provide answers to common questions. If you have a specifc question, please feel free to reach out via phone or email. Alternatively, you may reserve a time that works best for your schedule.    We hope that you find the following FAQs useful. If not, we look forward to hearing from you.

Question 2

What is the Foreign Supplier Verification Program (FSVP)?

Accepted Answer

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.

Question 3

What/who does FSVP apply to?

Accepted Answer

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.

Question 4

When does FSVP come into effect?

Accepted Answer

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.

Question 5

What are the penalties for non-compliance?

Accepted Answer

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.

Question 6

What/who is a "foreign supplier"?"

Accepted Answer

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.”

Question 7

Is United Safety Agents' coverage nationwide?

Accepted Answer

Yes, United Safety Agents acts as the FSVP Agent for entires made at all U.S. ports.

Question 8

How much does your service cost?

Accepted Answer

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.

Question 9

How long does the process take?

Accepted Answer

Generally speaking, the process can be accomplished within 5-7 business days - once USA is in receipt of all necessary food-safety documentation.

Question 10

Am I the "FSVP importer"? "

Accepted Answer

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 there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the FSVP importer is the U.S. agent or representative 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.

Question 11

Must the FSVP importer be in the United States?

Accepted Answer

Yes. The FSVP Importer/Agent must be located within the United States.   That is to say: 01) they must have a physical U.S. location (e.g. an office), 02) they must have at least one employee staffed at the location full-time, and 03) they must be "qualified" under FSVP. This applies whether they are the U.S. owner or consignee of the food at the time of entry or the U.S. agent or representative of the foreign owner or consignee at the time of entry. It would not be sufficient to merely have a mailbox, answering service, or some other place in the United States where the importer is not physically present.

Question 12

What does "U.S. owner or consignee" mean?"

Accepted Answer

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.

Question 13

What is meant by "time of U.S. entry"?"

Accepted Answer

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).

Question 14

Is the importer, as defined in the FSVP regulation, the same person as the importer of record recognized by CBP for import entry?"

Accepted Answer

The importer of a food for purposes of FSVP may be, but is not necessarily, the importer of record for customs and border patrol (CBP) purposes. Under the FSVP regulation, the importer is the person who is responsible for verifying that the imported food was produced in accordance with applicable U.S. food safety requirements. In contrast, the CBP importer of record of the imported food 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.

Question 15

When is a U.S. Agent or representative required under the FSVP regulation?

Accepted Answer

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 owner or consignee’s 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 is responsible for developing and implementing an FSVP, as well as take responsibility for the food.

Question 16

Is a FSVP Agent the same as a U.S. food facility registration agent?

Accepted Answer

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. U.S. FSVP Agent or representatives for FSVP purposes serves a different role than a U.S. agent named in the FDA registration of a foreign food facility.

Question 17

If I comply with the FSVP requirements for a food I import, is the food exempt from the prior notice requirements?"

Accepted Answer

No. Although both the FSVP and prior notice regulations help FDA ensure the safety of foods imported into the United States, each has a distinct purpose. FSVP focuses on ensuring that the food is safe before arrival at U.S. ports of entry. Under FSVP, the importer must perform risk-based foreign supplier verification activities to ensure that the foreign supplier produces the food using processes and procedures that provide the same level of public health protection as those required in the United States, as applicable to the individual imported food, and that the food is not adulterated or misbranded with respect to allergen labeling. Prior notice is notification to FDA that an article of food is being imported or offered for import in advance of the arrival of the article of food.Prior notice of import shipments allows FDA, with the support of CBP, to protect the nation’s food supply.

Question 18

Who is the foreign supplier of a food?

Accepted Answer

The foreign supplier of a food is 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.

Question 19

What are the general requirements for an FSVP?

Accepted Answer

TheFSVP 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 those required under the following, if applicable to the imported food: Section 418 of the FD&C Act regarding hazard analysis and risk-based preventive controls for certain foods and the implementing regulations for human food, and for animal food; or Section 419 of the FD&C Act regarding standards for produce safety and the implementing regulation.   The FSVP Importer/Agent must also ensure that the foreign supplier is producing the food in compliance with adulteration reqquirements, as well as regulations regarding misbranding with respect to labeling of human food for the presence of major food allergens.

Question 20

Who must develop and perform activities required for my FSVP?

Accepted Answer

A qualified individual must be the one to develop your FSVP and perform all required actions under the FSVP regulation.

Question 21

Who is a qualified individual?

Accepted Answer

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.

Question 22

What is the purpose of a hazard analysis?

Accepted Answer

The purpose of a hazard analysis is to determine the food safety concerns that might be posed by an imported food. For each type of food, the FSVP Importer/Agent must conduct a hazard analysis to identify potential food safety hazards that must be managed through controls. The FSVP Importer/Agent must also assess the probability that the hazards will occur in the absence of controls and assess the severity of the illness or injury to humans or animals from the hazard if the hazard were to occur.

Question 23

What basic requirements apply to a hazard analysis?

Accepted Answer

A hazard analysis must identify and evaluate the illness data, scientific reports, and other information as a means to recognize the known or reasonably foreseeable hazards in each food you import to determine whether there are any hazards that require measures to control such hazard . Even if you determine that there are no hazards that require a control, a qualified individual must compose a hazard analysis.

Question 24

What types of hazards should I consider in the hazard analysis?

Accepted Answer

Your hazard analysis must consider known or reasonably foreseeable hazards in each food you import. Such hazards include:  •Biological hazards, including microbiological hazards such as parasites, viruses, environmental pathogens, and other pathogens; •Chemical hazards, including radiological hazards, pesticide and drug residues, natural  toxins, decomposition, unapproved food or color additives, food allergens, and, in animal food, nutrient deficiencies or toxicities; and •Physical hazards, including stones, glass, and metal fragments. Your hazard analysis must include known or reasonably foreseeable hazards that: • Occur naturally, • May be unintentionally introduced, and • May be intentionally introduced for purposes of economic gain

Question 25

May I rely on a hazard analysis conducted by another entity?

Accepted Answer

Provided the hazard analysis was conducted by a qualified individual, you may rely on another entity's hazard analysis.

Question 26

What must I consider when approving a foreign supplier and determining the appropriate supplier verification activities that must be conducted for the foreign supplier?

Accepted Answer

When approving a foreign supplier and determining the appropriate supplier verification activities, you must evaluate the foreign supplier’s overall performance as well as the risk posed by the specific food you are wishing to import. To properly do so, you must considering the following factors: • The hazard analysis of the food, including the nature of the hazard requiring a control. • The entity or entities that will be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, such as the foreign supplier, the foreign supplier’s raw material or other ingredient supplier, or another entity in your supply chain. • Foreign supplier performance, including:            o The foreign supplier’s procedures, processes, and practices related to the safety of                the food;            o Applicable FDA food safety regulations and information relevant to the foreign                          supplier’s compliance with those regulations, including whether the foreign supplier                is the subject of an FDA warning letter, import alert, or other FDA compliance                        action related to food safety (or, when applicable, the relevant laws and regulations                of a country whose food safety system FDA has officially recognized as                comparable or determined to be equivalent to that of the United States, and                          information relevant to the supplier’s compliance with those laws and regulations);            o The foreign supplier’s food safety history, including available information about               results from testing foods for hazards, audit results relating to the safety of the food,               and responsiveness of the foreign supplier in correcting problems. • Any other factors as appropriate and necessary, such as storage and transportation practices.

Question 27

What information about applicable FDA food safety regulations and a potential foreign supplier’s compliance with those regulations should I consider and how should I evaluate it?

Accepted Answer

You should determine what FDA food safety regulations a potential foreign supplier is subject to, such as the requirements for preventive controls, produce safety, dietary supplement CGMP, LACF, acidified foods, infant formula, or BSE. Having an understanding of applicable FDA food safety regulations and information relevant to a foreign supplier’s compliance with those regulations can help you determine whether the supplier has a demonstrable history of supplying acceptable products and meeting all industry and regulatory requirements. In evaluating the supplier’s compliance with the applicable regulations, you should consider whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety (e.g., mandatory recall). You should at least consider such compliance-related information that is publicly available  or that you have obtained by other means. FDA has searchable online databases for compliance-related documents such as warning letters, import alerts, import refusals, recall notices, inspections, and notices of suspensions of facility registrations.

Question 28

What foreign supplier verification and related activities must I conduct under my FSVP before importing a food from a foreign supplier?

Accepted Answer

You will need to conduct the following supplier verification and related activities to remain in accordance with all relative legislation:  • Establish and follow written procedures to ensure that you use approved suppliers (or, when necessary and appropriate, unapproved suppliers on a temporary basis when you subject foods from such suppliers to adequate verification activities before importing the food); • 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.

Question 29

May I rely on someone else to determine what foreign supplier verification activities I must conduct?

Accepted Answer

Yes, you may rely on a determination of appropriate foreign supplier verification activities made by a qualified individual.

Question 30

What are the requirements when there is no U.S. owner or consignee at the time of entry?

Accepted Answer

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. Please note that in order to validly designate a U.S. agent or representative for the purpose of meeting the definition of FSVP importer, the U.S. agent or representative’s role must be confirmed in a signed statement of consent to serve as the importer under the FSVP regulation. At any time, FDA may request to see the signed statement of consent.

Question 31

How may I transmit the required importer identification information at entry?

Accepted Answer

When a food product under FDA oversight is offered for entry into the United States, the CBP Automated Commercial Environment (ACE) system will prompt the filer to transmit the following code:   • An entity role code “FSV,” which will send a signal to the ACE system indicating the entry line is subject to the FSVP regulation   Transmission of entity role code “FSV” will trigger a request for the FSVP importer’s name, email address, and DUNS number as the UFI recognized as acceptable by FDA.

Question 32

What are some consequences if I do not comply with the applicable FSVP requirements?

Accepted Answer

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

Question 33

What are the consequences if I do not respond to an FDA request for records?

Accepted Answer

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.

Question 34

May FDA refuse admission if I do not identify the FSVP importer at entry?

Accepted Answer

Yes. The FDA may refuse admission of a food if identification of the FSVP importer is required, but not provided. Importer identification is a mandatory declaration requirement when filing entry with CBP. In addition, the FDA may refuse admission of a food if the foreign owner or consignee of the food at the time the food is offered for entry has not appropriately designated a U.S. agent or representative to serve as the FSVP importer. If there is no U.S. owner or consignee, a foreign owner or consignee must designate a U.S. agent or representative to serve as the FSVP importer, or entry will be barred.

Question 35

How will FDA inform me if I am not in compliance with the FSVP requirements when FDA reviews my records?

Accepted Answer

If the FDA investigator observes potential violations of the FSVP requirements during a review of your records, the investigator will provide you with a written summary of the observations on an official FDA Form. The FDA may also discuss the observations with you. In a discussion of the observations, you may inform the investigator or other Agency personnel of corrections you have made or that you plan to make. The FDA will explain how you can submit your response, including any other corrections you may make, through the FDA/FURLS portal system, the U.S. Postal Service (e.g., certified mail), or a commercial delivery service. The FDA  will take any corrective actions into account when determining whether to take enforcement action (e.g., warning letter or FDA import alert).

Question 36

What is a warning letter?

Accepted Answer

A warning letter is a letter to an individual or firm relating to violations of FDA-enforced requirements that the FDA may have recognized. The FDA's position on the matter is that warning letters are issued only for violations of regulatory significance. A warning letter identifies the violation or violations, and makes clear that the individual or firm must correct mentioned violations. The letter provides directions and a timeframe to inform FDA of its plans for correction. Following distribution of the letter, the FDA will then check that such corrections have been made in the timeframe given.

Question 37

What is an import alert?

Accepted Answer

An import alert provides information to FDA field staff for instances where the Agency has sufficient evidence or other information to refuse admission of future shipments of FDA-regulated products that are imported or offered for import. If an import alert is applicable, FDA field staff may use the information in the alert, along with other information about the article being imported, to determine whether FDA should detain the article. FDA is not required to refuse admission. If the FDA detains an article that appears violative, they will provide notice to the importer of the nature of the violation and the right to present testimony regarding the admissibility of the article. Depending on the information submitted by the importer, the article may either be permitted or refused entry into the United States.

Question 38

What will happen if the FDA has determined that I am not in compliance with FSVP and places the food on Import Allert?

Accepted Answer

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.

FOREIGN SUPPLIER VERIFICATION PROGRAM

FOREIGN SUPPLIER VERIFICATION PROGRAM

FOREIGN SUPPLIER VERIFICATION PROGRAM

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