2 Dec 2015
FSMA Final Rule on FSVP for Importers of Human and Animal Food
On November 13, 2015 the United States Food and Drug Administration (US FDA) released the final rule on the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. It will be published in the US federal register on November 27, 2015, and all compliance dates will be based on that publication date.
This rule applies to all importers of human and animal foods, and additives, including food packaging and other food contact materials, into the United States. There are some exemptions and modified requirements “An importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.”
Importers will be responsible for determining known or reasonably foreseeable hazards with each food. These hazards can be physical or chemical including radiological and microbial in nature. Importers must evaluate the risk of each food, based on hazard analysis and the foreign supplier’s performance. Based on this information, the importer is to approve the suppliers and establish the appropriate supplier verification activities. The importer is responsible for conducting supplier verification activities and for the corrective actions for any non-conformance of these activities. These procedures must be documented and be followed by the importer. FSVP programs will be specific to each food and supplier. This program must be revaluated every three years, or when new information about a hazard or the supplier’s performance is made known.
The hazard analysis performed is to be based on the hazards reasonably likely to occur, whether the hazard is natural, unintentionally introduced or intentionally introduced for economic gain. The analysis must assess the probability that the hazard will occur in the absence of controls and the severity of illness or injury that may occur. The importer can rely on another firm to conduct this hazard analysis, providing the importer reviews the relevant documentation.
Evaluation of Risk
In the evaluation of risk the importer is to use hazard analysis, as well as how the supplier is minimizing or preventing the hazard, including the US FDA food safety regulations, the supplier’s food safety history and other factors affecting food safety such as storage and transportation. The importer can rely on another firm to conduct this evaluation of risk, providing the importer reviews the relevant documentation.
The importer will determine which supplier verification activities are appropriate, based on the evaluation of the risk. One of these activities, the annual onsite audits of the supplier’s facility, is generally required when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences, or death to humans or animals. When the hazard is not this type of risk, the importer can use onsite audits, sampling and testing, the review of food safety records or other appropriate verification procedures. The importer can rely on another firm to conduct this supplier verification, providing the importer reviews the relevant documentation.
If some problem does occur, the importer must take appropriate corrective actions. Depending on the circumstances, such as the product being adulterated or misbranded, the appropriate corrective action may be to stop using the supplier until the problem has been properly addressed.
Exemptions and Modified Standards
Importers of dietary supplements and/or ingredients may be required to comply with most of the FSVP requirements, excluding the hazard analysis but the verification procedure would require evaluation of the facility’s compliance to the dietary supplement cGMP regulations. There are modified requirements for certain foods from foreign suppliers from countries which have an equivalent program, as determined by the US FDA. There are modified requirements for very small importers whose sales ceiling is $1 million USD for human food, and $2.5 million for animal food. Importers for certain types of small supplier will also have modified requirements. These firms are qualified facilities as per the preventive control rules or produce rule, farms not covered by the produce rule and shell egg producers with fewer than 3,000 laying hens.
Exempt from the FSVP are juice, fish and fishery products (all subjected to HACCP regulations), as well as food for research or evaluation, food for personal consumption, alcoholic beverages and certain ingredients used in them. Also exempt is food imported for processing and future export, low acid can food regarding microbial hazards and certain meat, poultry and egg products as regulated by the United States Department of Agriculture Food Safety Inspection Service.
The importer must comply with whichever is the latest compliance date, which is 18 months from date of publication (May 27, 2017), 6 months after the supplier is required to comply with the preventive control rule or produce safety rule. If the importer is also a manufacturer or processor that is to adhere to the supply-chain part of the preventive control rule, instead of the FSVP, then the date required by the rule is the compliance date.
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