In short, it’s FDA’s new tool to ensure that the imported food meets the U.S. standards and is safe to U.S. consumers. FSVP is a risk-assessing program developed under to FDA’s Food Safety Modernization Act of 2011, also known as “FSMA”. FSVP requires verification of the foreign suppliers of food items entering to the U.S., and it demands conduction of procedures and actions to assure the safety of food exported to the United States. FSVP basic rules include:
- Appointment of an “FSVP Importer”, or also known as FSVP agent, for food shipments entering to the U.S.
- The party identified as “FSVP importer” is responsible to establish and maintain the FSVP procedures to verify that foreign suppliers are taking the safety measures that can reassure the food item is being produced with, at least, same level of public health protection standards defined in U.S. Federal Food, Drug and Cosmetic Act (Hazard Analysis and Risk-based Preventative Controls, HARPC & Standards of Produce Safety).
- The FSVP importer must be a U.S. party and, according to FDA, is primarily considered the owner or consignee of the food item being entered to the United States. However, if the food item has no owner or consignee at the point of entry, a U.S. based agent or representative can take the role of FSVP agent as long as a written statement of consent is being signed by the FSVP agent (FSVP agent should not be mistaken by FDA food facility registration U.S. agent or customs broker agent).
- The signed statement will contain FSVP agent’s, name, address, contact info and DUNS number and such data will be provided to U.S. Customs through Automated Commercial Environment or ACE at the point of entry of the food item to the U.S.
Is everyone subject to FSVP?
There are some exemptions to the FSVP program. For example:
- Juice and seafood products that are subject to FDA’s Hazard analysis and Critical Control Point regulations (HACCP)
- Meat, poultry and egg products that are regulated by USDA
- Alcoholic beverages and some ingredients used in alcoholic beverages
- Food entered U.S. for research purposes or personal consumptions.
FDA has published a
factsheet of coverage and exemptions that helps you identify if your company is subject to FSVP program. Beware, exemptions in this flowchart are limited and if you find your company exempted you might still indirectly be subject to FSVP program. For example, some foreign dietary supplement manufacturers exempted due to Current Good Manufacturing Practice or CGMP exclusion, as well as seafood and juice manufacturing facilities subject to HACCP and are still subject to Hazard Analysis and Risk-based Preventative Controls-HARPC and therefore subject to FSVP. You can consult us for further understanding of the such regulations.
Remember, the compliance dates for importers subject to FSVP differ according to several considerations, including; size of the foreign supplier, nature of the importer and whether the foreign supplier is already subject to other programs such as HACCP, CGPM or Standards of Produce Safety. The compliance dates for final rule of FSVP program can be found on
FDA website.
What can FDA Listing Inc. offer to foreign exporters of food to the U.S.?
If you are a trader, broker or manufacturing company and need an FSVP agent to take the responsibility of the FSVP program for a food shipment, depending on the nature food items entering the U.S., we can serve as FSVP agent for your company. Prior to engagement as your FSVP agent will need to make assessment of the food items and review the documents relating to the safety and quality of the food products being entered to the United States. If you need assistance,
get in touch with us.
By doing so your company transfers the responsibility of FSVP compliance to FDA Listing Inc. and FDA’s FSVP-related inquires will be directed to our office. In such cases, we will undertake all required activities and maintain necessary documentations for the FSVP compliance program. All required documentations from the foreign supplier can be conveniently uploaded, stored and shared via an online portal for mutual access.
What can FDA Listing Inc. offer to U.S. importers?
Under FSVP, U.S. importers must take certain FSVP compliance actions and keep the following records for FDA review, upon FDA inspection.
- Records of documents that substantiates a Qualified Individual that is capable to understand, oversee and follow the FSVP regulations
- Records of compliance of foreign suppliers (separate for each foreign supplier) with FDA food safety regulations
- Records of Food Safety Plan & Food Safety Hazard Analysis and risk assessments
- Records of corrective action plan when necessary
- Records of Good Manufacturing Practice or GMP System
FDA Listing Inc.’s trained food safety experts can act as the Qualified Individuals to review and streamline U.S. importers’ current FSVP program or develop a new FSVP from scratch. We can assist you to establish FSVP record keeping systems to stay in compliance with U.S. FDA and CBP as required.
Get in touch for assistance.
How about Standards of Produce Safety?
The Produce Safety Rule is also part of the FDA Food Safety Modernization Act (FSMA) of 2011. This regulation sets the standards, both for domestic and foreign farms, regarding the production, harvesting, and handling of fruits and vegetables, to prevent microbial contamination and reduce foodborne disease associated with fresh produce. Standards of Produce Safety is consisting of standards relating to:
- Worker’s health, hygiene and training
- Equipment, building and sanitation
- Agricultural water
- Soil amendments
- Production of sprouts
If you need assistance with understanding if the rules apply to you or complying with FDA Standards of Safety rules you can
contact us here.
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