FSMA Implementation -Foreign Supplier Verification
Programs
National Confectioners Association
January 2016
Webinar #4
Robert Hahn
Olsson Frank Weeda Terman Matz PC
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Disclaimer
• These webinars are for informational purposes
only and are not intended to provide legal
advice
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FSMA Final Rules
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CGMPs and Preventive Controls/Human Food
CGMPs and Preventive Controls/Animal Food
Foreign Supplier Verification Programs (FSVP)
Accreditation of Third-Party Certification
Bodies
• Produce Safety
• Voluntary Qualified Importer Program (VQIP)
– draft guidance document
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Additional Resources
• FDA plans to issue:
– A draft guidance document on FSVP rule
– Course materials on FSVP rule
• FSMA Technical Assistance Network (TAN)
– http://www.fda.gov/Food/GuidanceRegulation/FS
MA/ucm459719.htm
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FOREIGN SUPPLIER VERIFICATION
PROGRAMS (FSVP)
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FSVP Rule
• Basic requirement:
– Importers must develop, maintain, and follow a
Foreign Supplier Verification Program
• Purpose:
– To ensure foreign supplier is complying with
Preventive Controls or Produce Safety rule, if
applicable, and is producing food that is not
adulterated or misbranded (with regard to
allergen labeling)
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Definitions
• “Importer” – The US owner or consignee of
the article of food offered for import
– “US owner or consignee” – The person in the US who, at
time of entry, owns the food, has purchased the food, or
has agreed in writing to purchase the food
– If no US owner or consignee, the importer is the US agent
or representative of the foreign owner or consignee, as
confirmed in a signed statement of consent
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Definitions
• “Foreign supplier” – The establishment that
manufactures/processes the food, raises the
animal, or grows the food (without further
manufacturing/processing of more than a de
minimis nature)
• “Food” – Food as defined in FD&C Act, except
excludes pesticides
– NB: Food contact substances included. So, an importer’s
FSVP must address imports of food packaging.
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Standard FSVP Requirements
• Conduct a hazard analysis for imported food
• Conduct an evaluation of the food and foreign supplier (and a
reevaluation
• Determine appropriate verification activities
• Conduct verification activities and review and assess the
results
• Take appropriate corrective actions
• Approve foreign suppliers and ensure that food is imported
only from approved foreign suppliers (with limited exceptions)
• Identify importer at time of entry
• Keep required records
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Hazard Analysis
• Identify and evaluate known or reasonably
foreseeable hazards for each type of food
imported, to determine if any are hazards
requiring a control
– Based on experience, illness data, scientific reports, and
other information
– Hazard requiring a control is a hazard that a person
knowledgeable about food safety would establish controls
or measures to significantly minimize or prevent
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Hazard Analysis
• Hazard identification
– Biological, chemical (including radiological), and
physical hazards
– Naturally occurring, unintentionally introduced, or
intentionally introduced for economic gain (i.e.,
economically motivated adulteration)
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Hazard Analysis
• Hazard Evaluation
– Must consider probability and severity of hazard
– Must consider environmental pathogens if a RTE
food is exposed to the environment before
packaging and packaged food does not receive a
lethality treatment or include a control (e.g.,
formulation) that will control the pathogen
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Hazard Analysis
• Hazard evaluation (cont’d)
– Must consider:
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Product formulation;
Condition, function, and design of facility and equipment;
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; and
Any other relevant factors (e.g., weather that might affect levels of
natural toxins)
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Hazard Analysis
• Importer must do separate a hazard analysis
for each food it imports from each foreign
supplier
– But, may do one hazard analysis for different
foods of the same type from the same foreign
supplier (e.g., different varieties of same fruit),
provided all foods of that type have a similar
hazard profile
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Hazard Analysis
• Importer not required to do evaluation or
foreign supplier verification activities if there
are no hazards requiring a control
– FDA says that certain imported foods may have no
hazard requiring a control, including salt, some
food-grade chemicals, many types of candy (e.g.,
hard candy, fudge, maple candy, taffy, toffee),
honey, molasses, sugar, syrup, and
jams/jellies/preserves from acid fruits
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Hazard Analysis
• Importer not required to do evaluation or
foreign supplier verification activities if:
– Importer determines and documents that the type
of food cannot be consumed without application
of appropriate control (e.g., cocoa beans, coffee
beans);
– Importer controls the identified hazard; or
– Importer relies on its customer or a subsequent
entity in the US supply chain to control the
identified hazard
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Hazard Analysis
• If importer relies on its customer or a
subsequent entity to control hazard:
– Importer must disclose that food is “not
processed to control [identified hazard]”; and
– Annually obtain from its customer a written
assurance
• Content of written assurance depends on who is
controlling hazard
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Evaluation of Food and Foreign
Supplier Performance
• Importer must evaluate the food and foreign
supplier performance
• This evaluation is the basis for:
– Approving foreign suppliers; and
– Determining appropriate foreign supplier
verification activities
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Evaluation of Food and Foreign
Supplier Performance
• Importer must consider the following factors:
– The hazard analysis for the food (including the nature of
the hazards requiring a control);
– The entity controlling the identified hazards; and
– The foreign supplier’s performance, including:
• Its food safety processes and practices;
• Applicable food safety regulations and its FDA compliance history
(including any FDA Warning Letters and Import Alerts);
• Its food safety history (e.g., results of testing, audit results,
responsiveness in correcting problems); and
• Other appropriate factors (e.g., storage and transportation
practices)
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Reevaluation
• Importer must conduct a re-evaluation if it
becomes of aware of new information about
any of those factors, and at least every 3 years
– If concerns about safety of imported food,
importer must promptly determine whether it is
appropriate to continue importing food from that
foreign supplier and whether foreign supplier
verification activities need to be changed
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Approval of Foreign Suppliers
• Importer must establish and follow written
procedures to ensure food is imported only
from approved foreign suppliers
– May use unapproved foreign suppliers on a
temporary basis when necessary, provided food is
subjected to verification activities before it is
imported
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Foreign Supplier Verification
Activities
• Importer must establish and implement written
procedures to ensure appropriate verification
activities are conducted
– Verification activities must provide assurance that the
hazards requiring a control identified in the hazard analysis
are significantly minimized or prevented
– Verification activities are directed to the entity or entities
that are controlling the hazards or verifying their control
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Verification Activities
• Importer must determine appropriate verification
activities (and their frequency) based on the
evaluation of the food and foreign supplier
• Importer must establish and implement written
procedures to ensure appropriate verification
activities are conducted
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Verification Activities
• Appropriate verification activities include:
– Onsite audits;
– Sampling and testing of food;
– Review of foreign supplier’s food safety records; and/or
– Other appropriate verification activities
• Verification activities must provide assurance that the hazards
requiring a control identified in the hazard analysis are
significantly minimized or prevented
• Verification activities are directed to the entity or entities that
are controlling the hazards or verifying their control
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Verification Activities
• If there is a reasonable probability the hazard
in the imported food would cause serious
adverse health consequences or death to
humans or animals (SAHCODHA), annual
onsite auditing is required…….
– Unless importer determines (and documents) that
other verification activities or less frequent audits
are adequate to control the hazard
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Verification Activities
• Onsite Audits
– Must be conducted by a qualified auditor
– Not required to be done by an accredited thirdparty certification body (CB)
• Even if done by third-party CB, audit not subject to Third-Party
Certification Body rule (e.g., submission of audit report to FDA)
– If food is subject to FDA food safety regulations,
audit must consider those regulations and review
foreign supplier’s food safety plan and its
implementation
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Verification Activities
• Onsite Audits (cont’d)
– GFSI and other audit schemes
• FDA implies these schemes will need to be updated to
be consistent with FDA food safety requirements
• “Until such time, if an importer choses to use a GFSI,
GAP, or other similar audit, the importer might need to
supplement that audit to meet the requirements of
[the FSVP rule] or otherwise determine that the audit
meets the requirements of [the FSVP rule].” 80 Fed.
Reg. at 74288.
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Verification Activities
• Onsite Audits (cont’d)
– In lieu of an onsite audit, the importer may rely on
a food safety inspection by:
• FDA;
• Other federal, state, local, tribal, or territorial agency;
or
• The food safety authority of a country whose food
safety system FDA has officially recognized as
comparable or equivalent to the US system
– Provided the inspection is done within 1 year of the date
an onsite audit would have been required
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Verification Activities
• Importer must promptly review and assess
results of verification activities to determine
whether the hazards in food from that foreign
supplier are being adequately controlled
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Corrective Action
• If importer determines foreign supplier is not
following procedures that provide same level
of protection as FDA requirements, it must
take appropriate corrective actions
– If importer learns of problem by means other than
verification activities or re-evaluation of food and
foreign supplier, importer must investigate and
determine whether FSVP needs to be modified.
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Identification of Importer
• Importer must ensure that, for each line entry,
the following information is provided to
Customs:
– Importer’s name;
– Importer’s email address; and
– A unique facility identifier acceptable to FDA
• FDA will issue a guidance document on acceptable
identifiers, which will include the DUNS number
• Importer should provide DUNS number for the facility
at which it keeps its FSVP records
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Identification of Importer
• FDA will use this importer information to:
– Create a list of all FSVP importers to be posted on
FDA’s website, as required by FD&C Act § 805(g)
– Identify and locate importers for inspection
– Prevent “port shopping”
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Recordkeeping and FDA Access
• Extensive required records
• Must be made available to FDA upon request during
inspection and must be submitted to FDA
electronically (or other prompt means) upon written
request
• Records not required to be in English, but importer
must provide English translation within a reasonable
time upon request
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Training
• Must use a qualified individual to develop
FSVP and perform all required FSVP tasks
– QI must have education, training, or experience
(or combination thereof) necessary to perform the
activity
– QI must be able to read and understand the
language of any records reviewed in performing a
required task
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Training
• Must use a qualified auditor to conduct onsite
audits of foreign supplier
– QA is a QI who has technical expertise to perform
audit function obtained through education,
training, or experience (or combination thereof)
• But, must have at least some actual audit experience
– May be a government employee or audit agent of
an accredited third-party certification body
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Reliance on Other Entities
• May rely on another entity for certain tasks:
– Hazard analysis
– Evaluation of food and foreign supplier (not foreign
supplier)
– Verification activities (not foreign supplier, except for
sampling/testing of food)
• Importer must review and assess documentation, and
document its review and assessment (including documenting
that the task was done by a qualified individual)
• Only the importer may approve foreign suppliers
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Exemptions
• Food imported for research or evaluation
• Food imported for transshipment
• Food imported for processing and future
export
• US food returned without further
manufacturing/processing
• Meat, poultry, and egg products subject to
USDA jurisdiction
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Exemptions
• If importer is also a “receiving facility” under
Preventive Controls rule and is in compliance with
supply-chain program requirements, it is deemed to
be in compliance with FSVP rule
– Importer still subject to requirement to identify
FSVP importer at time of entry
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Not Exempt
• Imports where importer and foreign supplier
are part of same corporate family
– But, may take this into account in evaluating food
and foreign supplier performance and in
determining appropriate foreign supplier
verification activities
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Modified Requirements
• Food imported by a very small importer
– <$1 million in average annual sales of human food
plus market value of human food manufactured,
processed, packed, or held without sale
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Modified Requirements
• Very small importer must:
– Annually document eligibility
– Obtain written assurance (before importing food and every
2 years thereafter) from foreign supplier that producing
food with same level of public health protection as FD&C
Act and that food is not adulterated or misbranded with
regard to allergen labeling
• Not required: hazard analysis, evaluation of food and foreign
supplier performance, foreign supplier verification activities
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Modified Requirements
• Food imported from the following small
foreign suppliers:
– Qualified facility as defined in Preventive Controls rule
(includes a very small business, i.e., a business with <$1
million in average annual sales of human food);
– Farm that grows produce and that is not a covered farm
under the Produce Safety rule (e.g., <$25,000 in average
annual sales) or that has a qualified exemption; or
– Shell egg producer with < 3,000 laying hens
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Modified Requirements
• Importer must:
– Annually document eligibility of foreign supplier
– Obtain written assurance (before importing food and every
2 years thereafter) from foreign supplier – content of
written assurance depends on type of small foreign
supplier
• Not required: hazard analysis, foreign supplier
verification activities
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Modified Requirements
• Certain food imported from a foreign supplier
in a country whose food safety system FDA
has officially recognized as comparable or
equivalent
– Systems recognition agreement
– Applies only to food that will not be processed
further (e.g., finished packaged food, RACs that
will not be commercially processed)
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Modified Requirements
• Importer must document (before importing
food and annually thereafter) that:
– Foreign supplier is under oversight of comparable
or equivalent food safety system;
– Food is within scope of official recognition or
equivalence determination; and
– Supplier is in good compliance standing with the
foreign food safety authority
• Not required: hazard analysis, evaluation of food and foreign
supplier performance, foreign supplier verification activities
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Compliance Dates
• Importers must comply by the latest of the
following:
– May 27, 2017 (18 months after final rule);
– If foreign supplier is subject to Preventive Controls
or Produce Safety, 6 months after foreign supplier
is required to comply with the relevant rule; or
– If importer is also a “receiving facility,” the date
the importer is required to comply with the
supply-chain program provisions of the Preventive
Controls rule
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ACCREDITATION OF THIRD-PARTY
CERTIFICATION BODIES
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Accreditation Program
• FDA will recognize accreditation bodies
• Accreditation bodies (ABs) will accredit thirdparty certification bodies
• Accredited third-party certification bodies
(CBs) will audit foreign eligible entities and
issue food and facility certifications
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When Certification Required
• Two situations:
– FDA requires certification as an additional
condition of admission under FD&C Act 801(q)
– To be eligible to participate in VQIP, importer must
have a current facility certification for each foreign
supplier of food it intends to import under VQIP
• Foreign suppliers and importers may also use
accredited CBs to conduct audits under FSVP
rule, but not required to
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Audits
• When performing audits under this program, an
accredited CB must:
– Perform facility audits unannounced (during a 30-day
window)
– Audit for compliance with FDA regulatory requirements,
not GFSI or other benchmarked schemes
– Notify FDA immediately if discover a condition that could
cause or contribute to a serious risk to public health
– Prepare audit report within 45 days after the audit
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Regulatory Audits
• Must be sufficiently rigorous to ensure entity
likely to remain in compliance for at least 12
months after the audit
• Audit report must be submitted to FDA
electronically, regardless of whether a
certification is issued
• A certification may be issued only after a
regulatory audit
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Consultative Audits
• A food safety audit of an eligible entity:
– To determine compliance with FDA requirements
and industry standards and practices;
– For internal purposes only; and
– Conducted in preparation for a regulatory audit
• Audit report must be maintained in records, not sent
to FDA. FDA may access only under FD&C Act
section 414 (based on reasonable belief food is
adulterated and poses a risk of SAHCODHA).
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Certifications
• Have a maximum term of 12 months
• FDA may refuse to accept certification if
agency determines it is not valid or reliable
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FDA Notification Requirement
• CB must notify FDA immediately if discovers a
condition that could cause or contribute to a serious
risk to public health
• Requirement applies to both regulatory and
consultative audits
• But, because consultative audits must be
unannounced and must be done in anticipation of a
regulatory audit, an audit that does not meet this
definition is not a “consultative audit” and is not
subject to notification requirement
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Effective Date
• Effective date is January 26, 2016
• However, program will not launch until the
final user fee rule takes effect
• At that time, accreditation bodies may apply
for FDA recognition
− Third-party certification bodies may seek
accreditation after one or more FDA-recognized
accreditation bodies begin accepting applications
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VOLUNTARY QUALIFIED IMPORTER
PROGRAM (VQIP)
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VQIP
• VQIP draft guidance document (June 2015)
– Explains how VQIP will work and how importers
can qualify
– A voluntary program
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Definitions
• “Importer” – The person who causes the food to be
imported into the customs territory of the US
– Can be importer of record, owner, manufacturer, etc.
• “Foreign supplier” – Same definition as in FSVP
rule
• “Food” – Food as defined in FD&C Act, except
excludes pesticides and food contact substances
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Eligibility Criteria
• At least 3 year history of importing food
• Current facility certification for each foreign supplier
whose food importing under VQIP (by an accredited
third-party certification body)
• Annual non-refundable fee paid by Oct. 1
– FDA estimates the annual fee will be $16,400
• No food imported by the importer is the subject of
an Import Alert or Class I recall
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Eligibility Criteria (cont’d)
• Importer and “non-applicant entities” may not be
the subject of any ongoing FDA administrative or
judicial action (e.g., Import Alert, injunction,
debarment, suspension of registration) or have a
history of significant non-compliances (e.g., Class I
recall, OAI inspection with no corrective action).
– Non-applicant entities – foreign supplier, FSVP or
HACCP importer (if different than VQIP importer),
customs broker
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Eligibility Criteria (cont’d)
• Importer may not be the subject of any CBP
penalties, forfeitures, or sanctions related to safety
or security of FDA-regulated products during
preceding 3 years
• FSVP or HACCP importer must be in compliance with
importer requirements under those regulations
• Importer must use paperless filers/brokers that have
received a passing rating during their last FDA Filer
Evaluation
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Eligibility Criteria (cont’d)
• Importer must have a Quality Assurance
Program (QAP), including:
– A corporate policy statement on food safety and security
throughout supply chain;
– Training/experience requirements for employees;
– Food safety policies and procedures (including procedures
for reporting to FDA foreign supplier non-compliance that
poses a risk to public health);
– Food defense policies and procedures;
– QAP implementation procedures; and
– Recordkeeping procedures and required records
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Annual Application Process
• Importer submits Notice of Intent between Jan. 1 and May 31
• Importer submits application, copy of QAP, and labels of each
food to be imported under VQIP to FDA
• FDA will review application and usually inspect the importer
• Importer must pay annual fee by Oct. 1
• Importer must promptly amend application if removes a food,
removes/replaces a foreign supplier, removes/adds a food
label, updates QAP, removes/replaces a FSVP or HACCP
importer, removes/adds a filer/broker, etc.
• Importer identifies food as VQIP food at entry
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Benefits of Participation
• PREDICT screening system will recognize VQIP foods
and immediately release, unless need to examine or
sample for public health reasons
• FDA will not examine or sample except “for cause,”
surveillance assignment, or VQIP audit
• If examine or sample shipment, FDA will do so at
destination or other location chosen by importer
• Any lab tests will be expedited “to extent possible”
• If re-export necessary, FDA will work with CBP to
export food from port preferred by importer
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Concerns
• Costs may outweigh benefits
– GMA estimates annual cost of participation at
least $85,000 (annual fee plus cost of regulatory
audits for 20 foreign suppliers)
• GMA comments requested:
– FDA issue May Proceed or notice of examination/sampling
at least 5 days before shipment arrives in US
– FDA should allow VQIP importer to choose lab
– FDA should decrease frequency of inspections of foreign
suppliers
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THANK YOU
Bob Hahn
rhahn@ofwlaw.com
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