Overview of the Foreign Supplier Verification Programs Rule
FSMA
What is the Foreign Supplier Verification Programs Rule?
(FSVP)
This presentation will provide you with an overview of Foreign Supplier Verification Programs, and what they include.
For a thorough understanding of the programs and the rule take the official FSPCA FSVP Training Online, Self-Paced:
Introduction to FSMA
The FSVP rule is about ensuring that imported foods meet the same food safety standards that are required of food produced in the United States.
It is helpful to understand how the Foreign Supplier Verification Program (FSVP) fits into FSMA, and what food safety standards are required.
Foreign Supplier Verification Program
The purpose of the FSVP rule is to ensure that foreign suppliers of human and animal food that will be consumed in the U.S. are meeting the same level of public protection as those required under FSMA rules.
- It is the responsibility of the Importer to verify the suppliers are meeting their food safety obligations.
- Foreign suppliers are not regulated by the FDA. The U.S. Importer will need to ask foreign suppliers to provide information to help demonstrate that the U.S. Importer has met their obligations.
How does FSMA apply to:
They are regulated under:
- Preventive Controls for Human Food
- Preventive Controls for Animal Food
- Produce Safety
- Other related rules
U.S. Importers are regulated under:
- Foreign Supplier Verification Program
Foreign Suppliers are not regulated by the FDA.
However, the U.S. Importer will need to ask foreign suppliers to provide information to help demonstrate that the U.S. Importer has met their obligations.
What responsiblities are assigned to each of these types of facilities?
These companies must prepare a food saftey plan made up of a hazard analysis, preventive controls, monitoring and measuring, corrective actions, documented procedures, records, and a recall plan.
U.S. Importers must verify that foreign suppliers produce food using processes and procedures that provide the same level protection required of U.S Producers and that the food is not adulterated or misbranded (allergens).
The foreign supplierwill need to provide information to the U.S. Importer so they can demonstrate that the food was produced with the same level of public protection as the Preventive Controls or Produce Safety Rule.
General Requirements
What foreign supplier verification program must I have?
The U.S Importer is required to develop, maintain, and follow an FSVP for each type of food they import.
An FSVP is not one specific thing. It is everything that the FSVP Importer has done to comply with the FSVP requirements.
Click on each tab for an overview of the required activities, and then we will look at them each in more detail.
Hazard Analysis
The FSVP starts with Hazard Analysis. Hazard analysis identifies all the reasonably foreseeable hazards associated with the food or ingredient to determine if they require a control. You must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards.
- Biological, chemical (including radiological), and physical hazards, and
- Hazards that are naturally occurring, unintentionally introduced, or intentionally introduced for economic gain.
The hazard analysis must be documented by a qualified individual employed or contracted the FSVP Importer.
Evaluation and Approval
The FSVP Importer must evaluate each foreign supplier's performance, including:
- Processes and procedures for ensuring food safety, and
- Its history of compliance with food safety requirements
The FSVP Importer must approve each foreign supplier and have written procedures to ensure use of approved foreign suppliers only.
- They may use an unapproved supplier on a temporary basis if necessary. The food must be verified as safe.
Verification Activities
- Select and conduct one or more appropriate verification activities to verify that the hazards required to be controlled by their suppliers have been significantly minimized or prevented.
- Verification activities are required for all hazards requiring a control.
- FSVP Importers must determine, not only appropriate verification activities, but also the frequency of those activities based on food risk and supplier evaluations.
Identify the U. S. FSVP Importer
For each line entry of food product offered for importation into the United States, your name, electronic mail address and unique facility identifier must be provided electronically when filing entry with the U.S. Customs and Border protection.
Document Activities
All documentation that is required by the FSVP rule must be complete, must be kept for at least two years, and must be made available to FDA upon request.
- Records are required for each requirement of the FSVP rule.
- FDA will be checking the records.
- Records must be kept for at least 2 years.
Hazard Analysis
What hazard analysis must I conduct?
The U.S. FSVP Importer must conduct a hazard analysis to identify the known or reasonably foreseeable hazards. This can be done either:
- By a qualified individual that is an employee of the importer, or
- By an outside expert (a qualified individual) hired by the importer to do the analysis.
- Or, by reviewing a hazard analysis prepared by the foreign supplier or other entity. We will see more detail on the requirements for this later.
Identify Potential Hazards
The first step in the FSVP process is to identify hazards associated with the food that you are importing. The Qualified Individual must sign the Hazard Analysis.
A hazard is something in the food that could cause illness or injury to humans or animals that eat the food. For example:
- Biological
- Chemical
- Physical
The hazard analysis must identify all of these types of hazards that are associated with the food.
Biological Hazards
Biological hazards can be found in air, dirt, water, skin, hair, plants, saliva and other sources.
Biological hazards include certain:
- Pathogenic Bacteria, Viruses, Protozoa, Yeasts, Molds, Prions
- Environmental pathogens are a concern when ready-to-eat food is exposed to the environment before packaging
Chemical Hazards
Chemical hazards include:
- Naturally occurring chemicals including allergens, mycotoxins and decomposition by-products.
- Contaminants such as pesticides, industrial chemicals, heavy metals, drug residues or radiological hazards.
- Chemicals used in the product formula that are hazardous at a certain level such as food additives, color additives or preservatives.
Physical Hazards
Physical hazards include any potentially harmful physical contamination not normally found in the food. Physical hazards can cause:
- Choking hazards
- Injury to the mouth or other adverse effects
Sources of physical contamination include:
- Glass or brittle material
- Plastic
- Metal
- Stones
- Wood
- Other sources
Economically Motivated Adulteration
Hazards may also be introduced because of economically motivated adulteration. This is when a product is adulterated for economic gain. In some cases, this adulteration also causes a food safety hazard. Examples include:
- Melamine added to diluted dairy products
- Peanuts added to Cumin spice
- Dye containing lead added to spices or candy
Hazard analysis must include evaluating hazards that have had a pattern of economically motivated adulteration in the past.
Evaluate the Hazards
Hazard evaluation includes assessing each known or foreseeable hazard that was identified during hazard analysis. The evaluation must determine
- The probability of the hazard occurring if it is not controlled
- The severity of the illness or injury if the hazard occurs
This evaluation identifies where controls are needed, and what type of controls should be in place.
Review of Another's Hazard Evaluation
The U.S. FSVP Importer may also meet the requirement for hazard analysis by reviewing a hazard analysis prepared by another entity using a qualified individual. For example, reviewing the hazard analysis prepared by the foreign supplier.
- The review must be done by the importer's qualified individual
- Records must show the review, assessment and completion by the qualified individual.
Evaluate the Supplier
What evaluation for foreign supplier approval and verification must I conduct?
to approve a foreign supplier, you must evaluate:
- The result of the hazard analysis
- The hazard requiring a control and the entities that will be applying the control
- The foreign supplier's Performance
- Storage and transportation practices or other relevant factors
The approval will be based on this evaluation and be documented.
Entity that will control the Hazard
Controls may be applied at the foreign supplier or by another entity in the food chain. For example, a supplier to the foreign supplier may control the hazard.
Foreign Supplier Performance
Evaluate the foreign supplier's performance.
- What food safety procedures, processes and practices do they have in place?
- Has the FDA issued any warning letters, import alerts or other compliance action?
- What is the foreign supplier's food safety history?
- Testing results
- Audit results
- Responsiveness in correcting problems
Document the Evaluation
Maintain records of the evaluation and conclusions, as well as the qulifications of the person performing the review.
Approve the Supplier
Approve each of your foreign food suppliers based on the information from the Hazard Analysis, the foreign supplier's performance and based on who is controling the hazard.
This information may have been conducted by another entity, you must do the approval of the foreign supplier.
The suppliers must be approved before your food is imported.
Reevaluate the Supplier
FSVP Importers must regularly reevaluate their hazard analysis and foreign supplier performance at least every three years to see if their FSVP is still valid.
Importers must also promptly reevaluate thei FSVP if they become aware of a food safety problem with the food they import, including a food safety problem they discover as the result of a verification activity.
Review of Other's Evaluation
The review must be performed by a qualified individual. If the hazard analysis is done by the supplier or other entity, it must still be done by a qualified individual, and reviewed by your qualified individual. This means a review of the entire hazard analysis, not just being informed of the hazards.
The hazard analysis must address biological, chemical and physical hazards and address the probablity of the hazard occurring if it is not controlled, and the severity of the hazard.
FSVP Activities
What foreign suppliers verification and related activities must I conduct?
Once you have completed hazard analysis and evaluation and approved a supplier, verification activities need to be planned and carried out. This includes:
- Procedures to ensure you import only from approved foreign suppliers
- Verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented.
Use Approved Foreign Suppliers
You must have written procedures that define the process used to make sure only approved foreign suppliers are used and keep records to show that you follow the process.
The procedure may include a process for using an unapproved supplier on a temporary basis if you subject the food to adequate verification activities.
Identify Verification Activities
written procedures are also required foe ensuring that foreign supplier verification procedures are in place and followed to provide assurance that the hazard in the food have been significantly minimized or prevented. Activities may include:
- On-site audits
- Sampling and testing of the food
- Review of the foreign supplier's food safety records
- Other activities you identify as appropriate
The procedures must identify the frequency required for the verification activities.
Verification for Serious Hazards
When hazard in the food could cause serious adverse consequences or death to humans or animals, an on-site audit is required before importing the food and annually ongoing.
- Obtain documentation of an on-site audit or inspection
- Conduct an on-site audit
- Audit must be performed by a qulified auditor
- Maintain documentation including audit procedures, dates, conslusions, corrective actions and documentation to show that te audit was conducted by a qulified auditor.
Reliance on Others
You may rely on entities other than the foreign supplier for verification activities. To do this you must:
- Review and assess whether their determination regarding the appropriate activities is appropriate.
- Document the review and assessment.
- Show that the determination of appropriate verification activities was made by a qulified individual.
Perform Verification
Conduct and document the verification activities that you identified as appropriate for the food before importing and according to your plan ongoing. This may include:
- Performing required sampling and testing
- Performing required review of documentation
- Performing required on-site audits
- Performing other verification activities as identified.
Review Results of Verification
Promptly review the results of verification activities that you conduct or obtain from others.
- Document your review and assessment of the results.
- If they do not provide adequate assurance that the hazards have been significantly minimized or prevented, take corrective action.
Take Corrective Action
If an importer determines that its foreign supplier is not producing food in a manner that provides at least the same level of public protection as U.S safety standards, such as the Preventive Controls rules, the importer must document and correct any deficiencies.
Appropriate corrective action will depend on the circumstances but could include discontinuing use of the foreign supplier. Actions must be intended to correct the problem for the long term.
- FSVP importers must document any corrective action they take.
For each line entry of food product offered for importation into the United States, your name, electronic mail address and unique facility identifier must be provided electronically when filing entry with the U.S. Customs and Border protection.
- Obtain a Unique Facility Identifier (UFI) by requesting a DUNS number from Dun & Bradstreet at no charge.
- At this time a DUNS number is the only recognized UFI.
https://fedgov.dnb.com/webform/newReq.do
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm
A guidance document is available that provides information on how you may comply with FDA's requirement to identify yourself as the importer of food at entry to the U.S. for the FSVP regulation.
- How to identify yourself as the U.S. Importer
- What to do if you do not have a DUNS number in time for compliance.
Documents & Records
What records will I need to keep to demonstrate compliance
FSVP Records
The U.S. FSVP Importer must maintain required documents and records of FSVP activities. These include:
- The hazard analysis
- Foreign supplier performance evaluation
- Procedures for approving foreign suppliers
- Foreign supplier approval
- Procedures to assure use of only approved foreign suppliers
- Determination of verification methods and frequency
- Performance of verification activities
- Any necessary corrective action
- Reevaluations of your FSVP every 3 years or for cause
Records Requirement
You must document and maintain records for every FSVP activity you are required to perform. The records may be:
- Original Records or true copies
- Electronic records
- In a language other than English
Records must be signed and dated upon completion and after any modification of the FSVP. They must be:
- Legible
- Recorded at the time of the activity
- Detailed enough to demonstrate compliance
Records Availablity
Records must be made available to the FDA upon request foe inspection and for copying. If requested by the FDA:
- You must send records to the FDA electronically or by another method of prompt delivery
- An English translation of records must be provided within a reasonable amount of time.
Records may be stored off-site if they can be retrived and provided on-site within 24 hours.
Records Retaintion
- Records that relate to your processes and Procedures for any required activities, including the results of evaluations and verifications must be maintained for at least 2 years after discontinuing use.
- All other records must be maintained for 2 years after creating or obtaining the records.
Existing Records
If existing records contain required information for FSVP purposes you can use them.
- If they do not contain some of the required information you must obtain the new information and maintain it either separately or combined with the existing records.
What if the U.S. FSVP importer buys from a distributor or broker, and does not know what supplier is used?
The FSVP Importer is responsible for assuring that all FSVP requirements are met. But the rule allows others to perform some functions.
Other entities, such as the broker, may provide the information needed to meet FSVP requirements
- Hazard analysis
- Evaluation
- Verifications
The functions must be performed by a qualified individual and reviewed by the Importers qualified individual.
The FSVP importer still makes the approval decision.
There is one exception to be aware of:
- The FSVP Importer cannot rely on an audit conducted by the supplier themselves.
U.S. FSVP Importers
The best way to understand the FSVP Rule is to take a course that uses the FSPCA standard curriculum.
We offer this course Online as a Self-Paced Course, following the official FSPCA curriculum and offering the FSPCA Certificate upon completion.
This Course will explain the Foreign Supplier Verification Program (FSVP) requirements, your responsibilities as an importer and how to comply with the law.
Click for Information
It is important for all Importers to have a thorough understanding of the rule and what is required in an FSVP.
Take the official FSPCA Course:
Foreign Supplier Verification Programs (FSVP)
Definitions
The following definitions apply to words and phrases as they are used for Foreign Supplier Verification Programs. Other definitions of these terms may apply when they are used in other subparts of CFR 21.
Adequate means that which is needed to accomplish the intended purpose in keeping with good public practice.
Audit means the systematic, independent, and documented examination (through observation, investigation, discussions with employees of the audited entity, records review, and, as appropriate, sampling and laboratory analysis) to assess an audited entity's food safety processes and procedures.
Dietary supplement has the meaning given in section 201(ff) of the Federal Food, Drug, and Cosmetic Act.
Dietary supplement component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Dietary supplement components include dietary ingredients (as described in section 201(ff) of the Federal Food, Drug, and Cosmetic Act) and other ingredients.
Environmental pathogen means a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens for the purposes of this part include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria.
Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of subpart H of this part.
Farm means farm as defined in § 1.227.
Farm mixed-type facility means an establishment that is a farm but that also conducts activities outside the farm definition that require the establishment to be registered under section 415 of the Federal Food, Drug, and Cosmetic Act.
Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act, except that food does not include pesticides (as defined in 7 U.S.C. 136(u)).
Food allergen means a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act.
Foreign supplier means, for an article of food, the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.
Good compliance standing with a foreign food safety authority means that the foreign supplier -
(1) Appears on the current version of a list, issued by the food safety authority of the country in which the foreign supplier is located and which has regulatory oversight of the supplier, of food producers that are in good compliance standing with the food safety authority; or
(2) Has otherwise been designated by such food safety authority as being in good compliance standing.
Harvesting applies to applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots, or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.
Hazard means any biological, chemical (including radiological), or physical agent that is reasonably likely to cause illness or injury.
Hazard requiring a control means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the probability that the hazard will occur in the absence of controls or measures and the severity of the illness or injury if the hazard were to occur), establish one or more controls or measures to significantly minimize or prevent the hazard in a food and components to manage those controls or measures (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the control or measure and its role in the facility's food safety system.
Holding means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
Importer means the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart.
Known or reasonably foreseeable hazard means a biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with a food or the facility in which it is manufactured/processed.
Lot means the food produced during a period of time and identified by an establishment's specific code.
Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, extruding (of animal food), formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, pelleting (of animal food), rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
Microorganisms means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens.
Packing means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
Pathogen means a microorganism of public significance.
Qualified auditor means a person who is a qualified individual as defined in this section and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function as required by § 1.506(e)(1)(i) or § 1.511(c)(5)(i)(A). Examples of potential qualified auditors include:
(1) A government employee, including a foreign government employee; and
(2) An audit agent of a certification body that is accredited in accordance with subpart M of this part.
Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under this subpart, and can read and understand the language of any records that the person must review in performing this activity. A qualified individual may be, but is not required to be, an employee of the importer. A government employee, including a foreign government employee, may be a qualified individual.
Raw agricultural commodity has the meaning given in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.
Receiving facility means a facility that is subject to subparts C and G of part 117 of this chapter, or subparts C and E of part 507 of this chapter, and that manufactures/processes a raw material or other ingredient that it receives from a supplier.
U.S. owner or consignee means the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food.
Very small importer means:
(1) With respect to the importation of human food, an importer (including any subsidiaries and affiliates) averaging less than $1 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee); and
(2) With respect to the importation of animal food, an importer (including any subsidiaries and affiliates) averaging less than $2.5 million per year, adjusted for inflation, during the 3-year period preceding the applicable calendar year, in sales of animal food combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee).
You means a person who is subject to some or all of the requirements in this subpart.
