Foreign Supplier Verification Programs [FSVP]

Foreign Supplier Verification Programs [FSVP]

FDA Food Safety Modernization Act (FSMA)

Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA

DRA050 Rev.1.0 Effective:01/212016

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FOREIGN SUPPLIER VERIFICATION PROGRAMS BACKGROUND Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 2


• Food Safety Modernization Act (FSMA) Sec.301 requires importers to have Foreign Supplier Verification Programs (FSVPs) and FDA to issue regulations.

• Proposed rule: July 29, 2013• Supplemental proposal: Sept. 29, 2014• Final rule issued: Nov. 13, 2015

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FOREIGN SUPPLIER VERIFICATION PROGRAMS PURPOSE Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 4


• To provide adequate assurances that:• Foreign suppliers produce food using processes and procedures

providing same level of public health protection as FSMA preventive controls or produce safety provisions,

• Food is not adulterated or misbranded.

In two words:

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FOREIGN SUPPLIER VERIFICATION PROGRAMS KEY PRINCIPLES Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 6


• Foreign Supplier Verification Programs (FSVP) applies to all imported food, beverages, and dietary supplements/ingredients unless the importer or foreign supplier is exempted by FSMA, or it the food is under the exclusive jurisdiction of USDA.

• FSVP Rule requires importers to share responsibility for ensuring safety of imported product!• “Importer” is U.S. owner or consignee of a food at time of U.S. entry.

• If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent.



• Importers must be able to demonstrate, through their Vendor Qualification Program, that their foreign manufacturers supply products that:

• Are made, processed, packed and stored using processes that “provide the same level of public health protection” as Hazard Analysis and Risk-Based Preventive Controls (HARPC) and the Standards of Produce Safety Requirements,

• Comply with the Major Food Allergen Labeling requirements, and

• Are not adulterated



• Failure to implement the FSVP requirements, leading to FDA Import Refusals and Import Alerts targeting both the Foreign Suppliers and the Importers.

• Placement onto an FDA Import Alert red list will significantly increase the costs of importing.



• Prior to FSVP, the U.S. Food and Drug Administration (FDA) had to find some evidence that imported product appeared to violate the law before it could reject or refuse admission to the imported product.

• Under FSVP, for a company to import product, it must have a program in place to verify that both the imported product and the foreign supplier comply with U.S. law.

• If it appears the importer does not have an adequate FSVP, FDA can stop the importation of that importer’s shipments, even if the product and the foreign supplier are in compliance.

• The law does not require FDA to prove the importer violates FSVP to stop the importation of a product. Instead, FDA only has to prove that it appears the importer violates FVSP.



FOREIGN SUPPLIER VERIFICATION PROGRAMS IMPORTERS IN COMPLIANCE Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 11


• Importers are deemed in compliance with most of Foreign Supplier Verification Programs (FSVP) when they:

• Comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) supply-chain provisions,

• Implement preventive controls under Preventive Control regulation for hazards in food they import, and

• Are not required to implement a preventive control under certain Preventive Control provisions.



• Importers must use a qualified individual to perform all required Foreign Supplier Verification Programs (FSVP) tasks.

• Qualified individual(s) must:• Must have education, training, or experience (or combination

thereof) necessary to perform the activity,

• Must be able to read and understand the language of any records reviewed in performing an activity.



• Importers must implement risk-based Hazard Analysis and Verification Activities.• Evaluate known or reasonably foreseeable hazards to determine if they

require a control,• Biological, chemical (including radiological), and physical hazards,• Naturally occurring, unintentionally introduced, or intentionally introduced

for economic gain.

• Evaluate a Product and there Foreign Supplier – cross-functional risk assessment strategy:• Risk posed by the food/product (hazard analysis),• Entities controlling hazards or verifying control ,• Supplier characteristics

•procedures, •processes, and practices,•FDA cGMP compliance •food safety and regulatory compliance history.



FOREIGN SUPPLIER VERIFICATION PROGRAMS SUPPLIER VERIFICATION ACTIVITIESObvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 15


• Importers must implement written procedures to ensure product/material is obtained from approved suppliers (e.g., sourcing, procurement and inventory control SOP),

• May use unapproved suppliers on temporary basis when subject food to verification

• Importers must determine appropriate verification activities (and frequency) based on product and supplier evaluation and implement written procedure (e.g. Vendor qualification, monitoring and disqualification SOP).

• Importers may rely on another entity’s determination or performance of appropriate verification activities,

• Importers must review and assess results of verification activities (importer’s own or others on which it relies).



• Activities may include: • Onsite Auditing,

• Audits must be conducted by “qualified auditor”,• Audits must be designed to consider applicable FDA food safety

regulations (or laws and regulations of country with comparable or equivalent food safety system),

• Onsite audits may substitute results of inspection by FDA or food safety authority in comparable or equivalent food safety system

• Annual onsite auditing is default approach when a food has a Serious Adverse Health Consequences or Death to Humans or Animals (SAHCODHA) hazard.

• Sampling and testing,• Review of supplier records, and• Other appropriate measures based on product/vendor risk level.



FOREIGN SUPPLIER VERIFICATION PROGRAMS HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS [HARPC] Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 18


Sec. 103 of the Food Safety Modernization Act describes HARPC in the following way:

“The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.



• HARPC requires every ingredient and/or food manufacturer, packer, bottler and storage facility to:

• identify food safety and adulteration risks associated with their foods and processes,• implement controls to minimize the risks, • verify that the controls are working, and • design and implement corrective actions to address any deviations from the controls that might arise.• improve controls (implement preventive actions) based on investigation of any deviations from the controls to prevent reoccurrence.



1) Identify Hazards• Identify hazards that might arise due to the specific foods or ingredients

in the product or due to the various processing, manufacturing, packing, and holding steps applied to the product.

• Biological, chemical, physical and radiological hazards

• Natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives

• Naturally occurring hazards or unintentionally introduced hazards

• Intentionally introduced hazards (including acts of terrorism)



• Intentionally introduced hazards brings into play aspects of Good Manufacturing Practices (GMP)

• facilities - the physical plant, security measures to prevent potential bioterrorism events,

• personnel - screening and controls, • entire supply chain - ingredients/components (raw materials, packaging,

dyes, labels, etc.),• the finished product received and delivered and shipped.

• Once ALL hazards identified, companies must create a written analysis of the ALL hazards and include both an identification of the risks as well as an analysis of the risks as they pertain (or could pertain) to the facility and the foods or food ingredients it handles.



2) Risk-based Preventive Controls• HARPC that requires companies to develop and implement a series of risk-

based controls at the critical points of the manufacturing process where the identified hazards must be prevented or minimized to ensure safety of the finished product.

• These critical manufacturing points are called “Critical Control Points” (CCPs).

• The facility must designate control measures at each CCP to ensure the greatest level of risk prevention or mitigation is achieved by normal operation of that manufacturing, processing, packing or storage step.

• Per the statutory language, these Control Measures must significantly minimize or prevent the identified hazards.

• The law defines CCPs as “a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level”



• The HARPC provision in the FSMA also provides a list of examples of types of preventive controls:• Sanitation procedures at food surface contact points• Sanitation of utensils and equipment• Staff hygiene training• Environmental monitoring program (for pathogen controls)• Food allergen control program• Recall plan• Current Good Manufacturing Practices (cGMPs)• Supplier verification activities



3) Monitoring of Effectiveness• HARPC requires the food facility to implement a monitoring program, which

ensures the firm is conducting regular evaluations of the facility’s control measures to determine whether the preventive controls are working.

• HARPC requires the facility to establish and implement this monitoring program.



4) Corrective Preventive Actions• As the risk-based preventive controls and control measures in a

properly designed HARPC system are monitored any instances of deviation from the control measures must be identified, evaluated with respect to cause, and corrected.

• HARPC requires facility owners and operators to identify and fix “out of control” processing steps and to evaluate processed foods for safety and adulteration risks.

• The Corrective Preventive Action steps of HARPC will involve. • Identification of weak spots in the controls• Identification of ineffective controls• Identification of new hazards• Performing necessary steps to reduce the likelihood of recurrence• Evaluating the processed food for safety• Prevention of adulterated food from entering commerce



5) Verification• HARPC requires food facilities to design and implement verification

steps to ensure that their HARPC plans (the hazard identification and analysis, preventive controls and control measures, monitoring and corrective action steps) are operating correctly to prevent or minimize food safety and adulteration hazards.

• This step is designed to verify that: • The selected preventive controls are adequate• Monitoring is occurring properly as defined in the plan• Appropriate corrective actions are taken• Potential food and food processing hazards are reduced• Periodic reviews are conducted at appropriate intervals so the HARPC plan remains

relevant and takes into account new and emerging risks and hazards.



6) Recordkeeping and Documentation• Previously, under the Bioterrorism Act, FDA could only require a food

company to maintain records that enabled food to be traced through the supply chain (one up / one back identification records).

• Now, HARPC requires that records and documents related to food hazards and process control systems be established and maintained for no less than 2 years to cover the following HARPC steps:• The monitoring of the preventive controls• All instances of deviation or processing nonconformance that could be material to food

safety• Testing results and other verification steps designed to ensure the preventive controls

are effectively minimizing or preventing hazards• All instances where corrective actions became necessary• Demonstrating of effectiveness of a food facility’s preventive controls and corrective

actions



7) Requirement to Reanalyze• After developing and implementing an adequate HARPC plan, the food

facility must periodically evaluate its food safety HARPC system.

• Under HARPC the facility must reanalyze its plan:• Whenever there is a significant change at the facility that might increase a known

hazard or introduce a new one• Every 3 years (if no other significant changes occur)All instances of deviation or

processing nonconformance that could be material to food safety

• HARPC requires the facility to perform a new hazard analysis and implement any new, necessary preventive controls before operational changes occur.• Demonstrating of effectiveness of a food facility’s preventive controls and corrective

actions



FOREIGN SUPPLIER VERIFICATION PROGRAMS EXEMPTIONS Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 30


• FSVP explicitly exempts firms that import food from foreign facilities that are in compliance with any of the following:

• Seafood Hazard Analysis Critical Control Points (“Seafood HACCP”),

• Juice Hazard Analysis Critical Control Points Program (“Juice HACCP”),

• Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, • Importantly, this exemption only applies to microbiological

hazards



• Food for research or evaluation,• Food for personal consumption,• Alcoholic beverages and ingredients (when importer uses them to

make an alcoholic beverage),• Food transshipped through U.S.,• Food imported for processing and export,• “U.S. products returned”, and• Meat, poultry, and egg products subject to USDA regulation at time

of importation.

However, these exemptions are limited!



Many foreign facilities that are already subject to these other food and beverage safety requirements will still be subject to Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Standards of Produce Safety.

Therefore, U.S. Importers bringing products from such suppliers will still be subject to FSVP.

The exemptions are essentially illusory because these other food safety programs do not cover all food safety hazards or all elements of food adulteration, both of which are required by HARPC, Standards of Produce Safety and FSVP.



WHY OBVIUM Q ?Obvium*Q LLC | www.obviumq.com |e-mail: [email protected] | phone: (844) SOS 4 FDA 34


Don’t wait to hire Obvium Q until your company is faced with some type of FDA regulatory enforcement action or your import product/material is placed on FDA Import Alert red list!

Obvium Q LLC is the fastest growing cGMP and Quality Assurance consulting firm, specializing in regulatory and scientific affairs within the dietary supplement, homeopathic medicine, food, beverage, cosmetic and OTC industries.

The comprehensive expertise and experience of our team in addressing some of the most complex and highly publicized FDA enforcement matters, has yielded positive results and high client satisfaction, positioning Obvium Q as one of the top consulting firms in the dietary supplement industry.



FSVP requires• Importers must use a qualified

individual.• We are a team of the ASQ Certify

Quality Auditors with an extensive hands-on GMP experience in FDA regulated industries.


Obvium Q provides

• Qualified individuals must be able to read and understand the language of any record reviewed in performing an activity.

• Our staff is multilingual and fully trained to asses your supplier verification documents with professional language proficiency.

• Importers must implement written procedures to the ensure product/material is obtained from approved suppliers.

• In collaboration with your supply chain, we would assess your current supply management practices, “tweak” to meet regulatory requirements, if needed, and develop custom SOPs that fits to your business.

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FSVP requires• Importers must implement written

procedures to ensure product/material is obtained from approved suppliers.

• Our team of ASQ Certified Quality Auditors would develop custom written risk-based vendor qualification, monitoring and disqualification procedures, train your personnel and provide you with the tools to quickly and effectively assess vendor risk level and select appropriate verification activities.


Obvium Q provides

• Onsite Audits • With over 150 audit days conducted worldwide (Japan, China, India, Russia, Germany, Belgium, Holland, Spain, Canada, Brazil, Mexico, etc.) in just 2015, our team of the ASQ Certified Quality Auditors is fully trained to satisfy all your auditing needs from the field. through processing, to finished product manufacturing, packaging and distribution. 37


That’s not all, we can do much more!Give us a call and let us help you secure your business and your

investment!


Before FDA calls, you call us!

(844) SOS 4 FDA (844) 767 4332

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Foreign Supplier Verification Programs [FSVP]

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