The Food Safety Modernization Act (FSMA), signed into law in 2011, was designed to improve public health by strengthening the food safety system. The law provided authority to the U.S. Food and Drug Administration (FDA) to write and enforce regulations that focus on preventing food safety issues. The law also directs FDA to enforce food safety standards for foods imported from other countries, with the intent that these foods meet the same safety standards as those grown or processed in the U.S. FDA regulated foods that are grown, manufactured, or processed outside the U.S. are therefore covered under several FSMA regulations including the Produce Safety Rule, the Preventive Controls for Human Foods Rule, and the Preventive Controls for Animal Foods Rule. The Foreign Verification Program Rule (FSVP) requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.
One of the first challenges for food importers is determining if a particular food falls under FSMA or is excluded. There are many foods imported into the U.S. that may be excluded from FSMA coverage because pre-existing regulation are already in place. These include foods regulated under previously enacted FDA regulations for seafood and juice products. Foods that fall under USDA jurisdiction, specifically meat and poultry products, are excluded because USDA has established its own import regulations. There are also exclusions for imported foods that will not be consumed in the U.S., as well as foods imported solely for test purposes. A general rule to remember is that if a food that is not excluded, it will fall under one or more of the FSMA rules.
A key point for importers to understand is that all foods that are brought into the U.S., and then consumed in the US, must meet U.S. food safety standards. This means that fresh fruits and vegetables grown in another country for export to the U.S. must be grown, harvested, packed, and held under the standards established in the Produce Safety Rule. Foods (human or animal) or food ingredients imported into the U.S. for further processing by U.S. manufacturers will fall under the food safety requirements written in the Preventive Controls Rule for Human Foods or the similar rule for animals food. Imported foods that will not be processed by the importer such as those directly sold through retail entities must assume responsibility, in conjunction with their foreign supplier for the safety the product by developing a plan by to ensure that the safety of the product is properly controlled by the foreign supplier. It is the importer’s responsibility to understand the requirements of this rule and implement necessary measures to ensure that their foreign supplier has adequate food safety controls in place.
In some cases, the determination of who the importer is is not easy. Imported foods may by touched by a number of different entities as they make their way into the U.S. The key part of the regulation is to make sure that the importer is identified before the food enters the U.S. FDA requires this in order to assign responsibility for the imported product to that entity. This responsible entity must have a U.S. address where the proper documentation will be kept.
The designated FSVP importer is required, through development of a hazard analysis, to determine what potential hazards, if any, represent a potential risk for the given imported food. For those identified hazards having significant potential risk, the importer must ensure, or verify, that the foreign supplier has adequate controls to prevent or eliminate that risk. As a means of verification, importers can use one or more ways, including implementing testing requirements, conducting food safety audits, and collecting pertinent documentation. Verification must take place beforehand as part of a supplier approval process, and then monitored on an ongoing basis.
Individuals tasked with writing and implementing an a Foreign Supplier Verification Program must be qualified through training to do the task. This can be accomplished through attending a FSVP training course developed by the Food Safety and Preventive Control Alliance (FSPCA) and which is offered by Penn State. This training is not just necessary for those who import foods and therefore must write a FSVP plan. It is also important for U.S. food processors, retailers, and other food businesses who buy food from foreign sources; because in the end, they will also pay a price for a foreign supplier’s inadequate food safety program.
As you can see, the FSVP is complex and requires training to understand how the rule could affect your food operation. Visit the Penn State Extension FSMA website at extension.psu.edu/fsma for more information on the FSVP Rule and when and where Penn State will be offering training.
Links.
Registration site for the Penn State Foreign Supplier Verification Workshop
https://extension.psu.edu/foreign-supplier-verification-workshop
FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm
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