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                Food Safety Modernization Act (FSMA)

Food Safety Modernization Act (FSMA)

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          Guidance & Regulation (Food and Dietary Supplements)
          Food Safety Modernization Act (FSMA)
          FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and AnimalsFood Safety Modernization Act (FSMA) FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
  
  	
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    Print**About the Final Rule**
  The FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that:
  The food is produced in a manner that provides the same level of public health protection as section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs) of the FD&C Act (21 U.S.C. 350g and 350h), if applicable;
    The food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and
    The human food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (concerning food allergen labeling).The final rule went into effective January 26, 2016.
  Federal Register Notice
    Docket Folder FDA-2011-N-0143 provides the full text of the rule
    FSVP for Food Importers Regulation (21 CFR part 1, subpart L)
    Final Rule At-A-Glance
    What Foreign Supplier Verification Programs Mean for ConsumersIndustry Assistance
	The FDA is committed to helping importers comply with the FSVP requirements. To facilitate compliance, the FDA provides guidance, outreach and training.
  To assist importers determine the FSVP records they should develop and maintain, the FDA has made available a **list of records required by the FSVP regulation**. To help importers submit their FSVP records, FDA launched the **Importer Portal for FSVP Records Submission**.
  The  following information will assist importers with compliance with the FSVP rule:
  What Do Importers Need to Know?
    Am I Subject to FSVP? [Am I Subject to FSVP? (for Black & White Printing)]
    What to Do if You're Covered by Both PC and FSVP Rules
    FSVP Regulation Records Requirements
    Recognition of Acceptable Unique Facility Identifier (UFI) for the FSVP Regulation
    What to Expect During a FSVP Inspection
    FSVP and Produce Inspections
    Supplier Evaluation Resources
    Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsThe FDA has established the FSMA Technical Assistance Network, to provide a central source of information for questions related to the FSMA rules, programs, and implementation strategies. In addition, FDA has collaborated with the Food Safety Preventive Controls Alliance (FSPCA) to develop training materials for importers and others who wish to obtain additional information on implementation of the FSVP regulation. These materials are available on the FSPCA website.
  The following are additional resources for industry:
  FSVP List of Participants
    FSMA Inflation Adjusted Cut Offs
    Third-Party Audits & FSMA
      Accredited Third-Party Certification Program Voluntary Audit Templates
        Industry Resources on Third-Party Audit Standards and FSMA Supplier Verification Requirements
    FSMA Questions & Answers
    FDA Data Dashboard
    Final Regulatory Impact Analysis
  
  Key Requirements
	Download the Key Requirements in PDF
  1. Scope
  Who is covered by the rule?
      For the purposes of FSVP, 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. See Am I Subject to FSVP? for more information.
        There are exemptions discussed below.
    What is an FSVP? It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
    Importers are responsible for actions that include (and are explained further below):
      Determining known or reasonably foreseeable hazards with each food
        Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
        Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
        Conducting supplier verification activities
        Conducting corrective actions
    Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
    Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. Similarly, if the importer obtains many different foods from a single supplier, a separate FSVP would be required for each food.
    Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if
      they are in compliance with the supply-chain program requirements under the preventive controls rules;
        they implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or
        they are not required to implement preventive controls under those rules in certain specified circumstances. Examples of such circumstances include when the type of food (e.g., such as coffee beans) could not be consumed without application of a preventive control, or when the customer will be significantly minimizing or preventing identified hazards) and they comply with requirements for disclosures and written assurances.
    The evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance.
    Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements. FDA has extended the compliance date for obtaining these written assurances for two years. However, as required by the final rule, importers must disclose in documents accompanying the food that the food is not processed to control the identified hazard.2. Hazard Analysis
  What do we mean by ‘hazard’? An importer is required to identify and evaluate—based on experience, illness data, scientific reports and other information—the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control. These include:
      Biological hazards, including parasites and disease-causing bacteria
        Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens
        Physical hazards, such as glass
    They may be hazards reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, such as substituting a less costly ingredient.
    The analysis must assess the probability that these hazards will occur in the absence of controls and the severity of the illness or injury that could occur.
    The evaluation would have to consider factors that include the:
      Formulation of the food
        Condition, function and design of the establishment and equipment of a typical entity that produces the food
        Raw materials and other ingredients
        Transportation practices
        Harvesting, raising, manufacturing, processing and packing procedures
        Packaging and labeling activities
        Storage and distribution
        Intended or reasonably foreseeable use
        Sanitation, including employee hygiene
    An importer can rely on another entity to conduct the hazard analysis, so long as the importer reviews and assesses the relevant documentation.3. Evaluation of Food Risk and Supplier Performance
  What evaluation must be done of the risk posed by an imported food and a supplier’s performance? An importer must evaluate:
      The hazard analysis
        The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier
        A foreign supplier’s procedures, processes and practices related to the safety of food,
        Applicable FDA food safety regulations, and information regarding the foreign supplier’s compliance
        The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems
        Other factors as necessary, including storage and transportation practices
    The importer can rely on another entity (other than the foreign supplier) to perform the evaluation of risk, so long as the importer reviews and assesses the relevant documentation.4. Supplier Verification
  What supplier verification activities must be conducted? Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.
    Importers have the flexibility to tailor supplier verification activities to unique food risks and supplier characteristics. The options include:
      Annual on-site audits of the supplier’s facility. This is generally required when there is a reasonable probability that exposure to a hazard controlled by the foreign supplier will result in serious adverse health consequences or death to humans or animals (called a SAHCODHA hazard). However, the importer can choose another means of verification provided that the importer documents that the alternate choice is appropriate and provides adequate assurances that the foreign supplier is producing the food in accordance with applicable U.S. safety standards.
        Sampling and testing
        A review of the supplier’s relevant food safety records
    An importer can rely on another entity (other than the foreign supplier) to determine and perform appropriate supplier verification activities, so long as the importer reviews and assesses the relevant documentation.5. Corrective Actions
  What if something goes wrong? Importers must promptly take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required under the produce safety and preventive controls regulations, as applicable, or that the supplier produces food that is adulterated or misbranded with respect to allergen labeling.
      The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.6. Exemptions and Modified Standards
  The requirements for dietary supplements vary according to a number of factors, including whether the import is a finished product or an ingredient/component.
      Importers who establish and verify compliance with certain specifications (concerning dietary supplement components and packaging) required under the separate, pre-existing dietary supplement Current Good Manufacturing Practices (CGMP) regulation. will not be required to comply with most of the standard FSVP requirements.
        The same would apply to importers whose customer is required to establish such specifications and verify that they are met, except that the importer would have to obtain written assurance that its customer is complying with those requirements.
        Importers of other dietary supplements, including finished products, would be required to comply with most of the standard FSVP requirements (except the hazard analysis requirement), but their verification activities would focus on compliance with the dietary supplement CGMP regulations.
    Modified FSVP requirements are established for very small importers and importers of food from certain small suppliers. (An example of these modified requirements is that certain importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.)
      The definition of very small importer is consistent with the definition of very small business in the preventive controls rules: $1 million for human food and $2.5 million for animal food of annual sales (averaged over three year period) combined with the U.S. market value of food that is imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee).
        Importers of certain small foreign suppliers are subject to modified FSVP requirements. Those small suppliers are:
          Facilities subject to modified requirements under the preventive controls rules because they are qualified facilities
            Farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption
            Shell egg producers with fewer than 3,000 laying hens
            Each of these types of producers is either exempt from their underlying FDA food safety regulations or subject to modified requirements, mostly, and in some cases entirely, because of the size of these firms.
    There are modified requirements for certain foods from a foreign supplier in a country whose food safety system has been recognized as comparable or determined to be the equivalent of the United States’ system.
    Additionally, certain categories of imported food are not covered by FSVP. These include:
      Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations.
        Food for research or evaluation
        Food for personal consumption
        Alcoholic beverages and certain ingredients for use in alcoholic beverages
        Food that is imported for processing and future export
        Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards).
        Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation7. Unique Facility Identifier
  The final FSVP rule requires that an importer provide its name, electronic mail address, and unique facility identifier (UFI) recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States.
    The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.
    DUNS numbers, assigned and managed by DUN & Bradstreet, are available free of charge to importers by visiting FDAdunslookup.com.
    FDA issued updated guidance in April 2022 that removes the temporary policy of permitting the use of the entity role code “UNK” in lieu of a DUNS number.  The guidance states that beginning on July 24, 2022, FSVP importers must comply with the requirement in 21 CFR 1.509(a) of providing a unique facility identifier recognized as acceptable by FDA (i.e., DUNS number) when filing entry with CBP.
  
  Compliance Dates
	All compliance dates have passed.
  Read more on:
  **Compliance Dates for the FSVP Final Rule**
    **Compliance Date Extensions and Clarifications for FSMA Final Rules**
  
  Related Guidance
	Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
    Guidance for Industry: Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions
    Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19
    Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals
    Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide
    Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities
    Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507
    Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
    Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food
    Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA
    Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation
    Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation
    Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs
  
  Public Meetings & Webinars
	July 2021 Webinar: FDA and USDA/FAS Outreach Webinars for Industry Stakeholders on the Produce Safety Rule (PSR) and Foreign Supplier Verification Program (FSVP)
    June 2016 Public Meeting Series: FDA Food Safety Modernization Act: Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs 
      Report on Regional FSMA Import Safety Meetings (PDF)
    March 2016 Public Meeting: FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation
    November 2015 Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
    November 2015 Industry Call: Discussion on the Foreign Supplier Verification and Third-party Accreditation Final Rules Audio (MP3) and Transcript (PDF)
    November 2014 Public Meeting: Supplemental Notices of Proposed Rulemaking
  
  Translations
	Translations of the Key Requirements Fact Sheet
  العربية (Arabic) (PDF: 227KB)
    中文 (Simplified Chinese) (PDF: 202KB)
    英語 (Traditional Chinese) (PDF: 456KB)
    Français (French) (PDF: 167KB)
    न्दी (Hindi) (PDF: 185KB)
    Italiano (Italian) (PDF: 161KB)
    日本語 (Japanese) (PDF: 453KB)
    한국어 (Korean) (PDF: 327KB)
    Português (Portuguese) (PDF: 165KB)
    Русский (Russian) (PDF: 184KB)
    Español (Spanish) (PDF: 157KB)
    แบบไทย (Thai) (PDF: 306KB)Translations of *Am I Subject to FSVP?*
  中文 (Simplified Chinese) (PDF: 370KB)
    英語 (Traditional Chinese) (PDF: 415KB)
    Français (French) (PDF: 74KB)
    Italiano (Italian) (PDF: 71KB)
    न्दी (Hindi) (PDF: 223KB)
    日本語 (Japanese) (PDF: 196KB)
    한국어 (Korean) (PDF: 280KB)
    Português (Portuguese) (PDF: 74KB)
    Русский (Russian) (PDF: 141KB)
    Español (Spanish) (PDF: 74KB)Translations of the At-A-Glance
  Français (French) (PDF: 30KB)
    Español (Spanish) (PDF: 30KB)
  
  Contact Us
	The FDA has established the FSMA Technical Assistance Network, to provide a central source of information for questions related to the FSMA rules, programs, and implementation strategies.

                                                                                  Content current as of:
      07/13/2023
              
              
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