The small business compliance deadline for the U.S. Food and Drug Administration (FDA) Preventive Controls Rule for Human Food passed on September 18, 2017. Under the Foreign Supplier Verification Program (FSVP) Rule, many U.S. importers have six months from this deadline (until March 19, 2018) to implement FSVPs for foreign suppliers of human food that qualify as small businesses (defined as having fewer than 500 full-time equivalent employees).
FSVPs consist of documenting several detailed components for each foreign supplier and each category of their imported food products (i.e. chocolate confectionary, bottled oils, etc.) In order to ensure compliance before the deadline, Registrar Corp urges importers to begin creating their FSVPs now.
What do I need to develop FSVPs?
FDA requires the following, among other things, of importers covered by the March deadline.
Documentation of supplier compliance:
Importers are required to ensure that they import from suppliers whom they have evaluated and approved through various methods that outline the potential health risks their products pose. A covered importer must ensure that a supplier is compliant with preventive controls rules, including the implementation of a food safety plan, and allergen labeling rules. The importer must also monitor the supplier’s FDA compliance history.
Should an approved supplier be found non-compliant, FDA requires importers to take corrective actions. These may involve facilitating the development of the supplier’s Food Safety Plan or ceasing business with them until they become compliant.
Hazard analysis of food products:
The FSVP rule requires importers to document a detailed hazard analysis of each category of food products they import from a given supplier. The analysis should identify any known or reasonably foreseeable hazards that could pose illness or injury, as well as the potential risks involved in the supplier’s handling of the food during manufacturing procedures, storage, and transport.
The data obtained by this hazard analysis should be used to determine appropriate supplier verification activities relative to the level of risk these products pose, such as sampling or onsite audits of a food facility.
Why should I begin building my FSVPs now?
Developing the required documentation can be a lengthy process. A single supplier may need multiple FSVPs. Importers should make efforts to ensure they comply in time to be prepared for possible inspection. Registrar Corp saw evidence of FSVP inspections occurring within three months following the May 2017 FSVP compliance date.
Registrar Corp provides a variety of services to assist U.S. importers and their suppliers with requirements under the Food Safety Modernization Act (FSMA). Registrar Corp’s Food Safety Team consists of Qualified Individuals who are well-versed in the development of FSVPs and Food Safety Plans. Additionally, Registrar Corp’s FDA Compliance Monitor provides a simple solution to monitoring and approving suppliers as required under FSVP. Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
This article was originally published as a press release.