The US Food and Drug Administration issued the long delayed and much anticipated Foreign Supplier Verification Rule under the Food Safety Modernization Act (FSMA) today. The highlights of the rule are provided below, including who is covered and when the rule will take effect. There are a number of exemptions and partial exemptions the posts to follow will explore. For now, if you you import food or finished dietary supplements it is imparative you read and understand how the rule will impact your operations.
The proposed rule is in-line with the Preventative Controls Rule and Produce Safety Rule released early this year. All three rules are adapting a widely followed hazard analysis approach to preventing outbreaks and contamination. The same approach used by larger facilities known as HACCP (Hazard Analysis and Critical Control Points). The Rule applies the approach across the playing field, adds record keeping components, and mandates the importer verify hazards are controlled before importing. The risk must be reasonably foreseeable as reasonably likely to occur and there are two options on how risks should be controlled.
The rule explains the difference in approaches:
Under Option 1 of this c, onsite auditing of the foreign supplier would be required for hazards to be controlled by the foreign supplier when there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death. Onsite auditing also would be required under Option 1 for microbiological hazards in certain raw agricultural commodities (RACs) that are fruits or vegetables. Audits could be conducted by auditors that are accredited in accordance with the accreditation system that FDA is developing to implement section 307 of FSMA, but the proposal would not require the use of accredited auditors. Also, instead of an onsite audit, an importer could rely on the results of an inspection of the foreign supplier conducted by FDA or the food safety authority of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
For other hazards, including less serious hazards and hazards that the foreign supplier verifies have been controlled by its supplier, importers would have the flexibility under Option 1 to choose the verification activity or activities that will provide sufficient assurance that the hazards are adequately controlled. These activities could include onsite auditing of the foreign supplier, periodic or lot-by-lot sampling and testing, periodic review of the supplier’s food safety records, and any other procedure that an importer has established as being appropriate to verify adequate control of a hazard.
Option 2 of the co-proposal would allow importers to choose from among these verification activities for all types of hazards not controlled by the importer or its customer. In determining the appropriate verification activities and how frequently they should be conducted, the importer would need to consider the risk presented by the hazard, the probability that exposure to the hazard will result in serious harm, and the food and foreign supplier’s compliance with U.S. food safety regulations.
More to come in the days to follow as Food Court has more time to read the rule in detail.
Highlights of the Proposed Rule
All importers must establish and follow an FSVP, unless otherwise exempted. An importer of food under the proposed FSVP regulations is the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. Under the proposed FSVP regulations, an importer would be required to develop, maintain, and follow an FSVP for each food it imports, which, in general, would need to include the following:
Compliance Status Review: Importers would be required to review the compliance status of the food and the potential foreign supplier before importing the food and periodically thereafter. Such review would need to include any FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act).
Hazard Analysis: Importers would be required to analyze the hazards associated with each food they import. The hazard analysis would identify the hazards that are reasonably likely to occur for each type of food imported, and evaluate the severity of the illness or injury if such a hazard were to occur.
Verification Activities: Importers would be required to conduct activities that provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled. Verification activities could include: onsite auditing of foreign suppliers; periodic or lot-by-lot sampling and testing of food; and periodic review of foreign supplier food safety records; or other appropriate risk-based procedures. Verification activities applicable to all FSVPs, regardless of identified hazards, include maintaining a written list of foreign suppliers from which food is imported, and establishing and following adequate written procedures for conducting verification activities.
Corrective Actions: Importers would be required to review complaints they receive concerning the foods they import, investigate the cause or causes of adulteration or misbranding in some circumstances, take appropriate corrective actions, and revise their FSVPs when they appear to be inadequate.
Periodic Reassessment of the FSVP: Importers would be required to reassess their FSVPs within three years of establishing the FSVP or within three years of the last assessment. However, importers would have to reassess the effectiveness of their FSVP sooner if they become aware of new information about potential hazards associated with the food. Examples of such information might include information on changes to the source of raw materials or to product formulation.
Importer Identification: Importers would be required to obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number for their company and to ensure that, for each food product offered for importation into the United States, their name and DUNS number are provided electronically when filing for entry with Customs and Border Protection.
Recordkeeping: Importers would be required to keep certain records, including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations and corrective actions, and FSVP reassessments.
Control of Hazards
The FDA is proposing a flexible, risk-based approach to foreign supplier verification. The proposed regulation focuses on foreseeable food safety risks identified through a hazard assessment process, rather than all risks covered by the adulteration provisions in the FD&C Act. Because the principle of hazard assessment is well accepted and understood throughout the food industry, the FDA believes that it provides the most effective way to implement a risk-based framework in which importers can evaluate potential products and suppliers and conduct appropriate verification efforts.
The requirements for supplier verification in the proposed rule on FSVP are primarily based on who is to control the hazards that are reasonably likely to occur with a particular food and the nature of the hazard. In the proposed rule, the FDA is proposing two options for the supplier verification activities for hazards that the foreign supplier will control or that the foreign supplier verifies are being controlled by its raw material or ingredient supplier.
Under Option 1 of the proposal, if the foreign supplier controls the hazard at its establishment and there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required to conduct or obtain documentation of onsite auditing of the foreign supplier. Onsite auditing would also be required for microbiological hazards in certain raw agricultural commodities. For non-SAHCODHA hazards that the foreign supplier controls, the importer would be required to conduct one of more of the verification activities mentioned above (onsite auditing, sampling and testing, review of the supplier’s food safety records, or some other appropriate procedure) before using or distributing the food and periodically thereafter. In determining the appropriate verification activities, the importer must consider the risk presented by the hazard and the food and foreign supplier’s compliance status.
Under Option 2 of the proposal, for all hazards that the foreign supplier will either control or verify that its supplier is controlling, importers would need to choose a verification procedure from among onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure. In determining the appropriate verification activities and how frequently they should be conducted, the importer would need to consider the risk presented by the hazard, the probability that exposure to the hazard will result in serious harm, and the food and foreign supplier’s compliance status.
If the importer, rather than the foreign supplier or its supplier, will be responsible for controlling a hazard that it has identified as reasonably likely to occur, the proposed rule would require the importer to document, at least annually, that it has established and is following procedures that adequately control the hazard. If the importer’s customer will be controlling a hazard identified by the importer, the importer would need to obtain written assurance, at least annually, that its customer has established and is following procedures (identified in the written assurance) that adequately control the hazard.
The proposed rule also states the FDA’s intent to align the supplier verification provisions in the FSVP regulations with any supplier verification provisions that are included in the final rules on preventive controls for human and animal food. This would avoid imposing duplicative requirements on entities that would be subject to both the FSVP and preventive controls regulations (because the entity is both a food importer and a registered food facility).
Modified Requirements and Exemptions
Under the proposed rule, modified FSVP requirements would apply in certain circumstances, including the following:
Importation of a dietary supplement or dietary supplement component;
Importation of food by a very small importer or importation of food from a very small foreign supplier; and
Importation of food from a foreign supplier in good compliance standing with a food safety system that FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
The proposed rule would exempt the importation of the following from the FSVP requirements:
Juice and seafood from facilities that are in compliance with the Hazard Analysis & Critical Control Points (HACCP) regulations, which contain their own supplier verification provisions;
Food imported for research or evaluation purposes;
Food imported for personal consumption;
Alcoholic beverages; and
Food that is transshipped or imported for further processing and export.
Effective and Compliance Dates
The FDA is proposing that the FSVP regulations become effective 60 days after the final rule is published in the Federal Register, but FDA is proposing to provide additional time before importers would be required to come into compliance. The compliance dates would vary depending on the circumstances. In general, the compliance date would be 18 months after the publication date of the final FSVP regulations. However, recognizing that the FSVP proposed rule is closely tied to the proposed rules on preventive controls and produce safety, the compliance dates for importers in many cases would depend on the compliance dates for those rules. In general, the importer would be required to comply with the FSVP regulations six months after the foreign supplier of the food is required to comply with the new FSMA preventive controls regulations.