question /answer forum what you need to know about fsvp · 08/11/2018 · •compliance with...
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QUESTION/ANSWER FORUM:WHAT YOU NEED TO KNOW ABOUT FSVP
www.scarbrough-intl.com
THE SCARBROUGH GROUP
Freight Forwarding &U.S. Customs Brokerage
Regional Asset-Based Trucks
NVOCC Operations & Consolidation Services
North American Truck Brokerage
www.scarbrough-intl.com
1984
1988
2003
2014
2015
2018
Freight Forwarding &Mexico Customs Brokerage
Customs & Supply Chain Consulting
Alfredo Iniguez-Garcia, CSO U.S. Food and Drug Administration [email protected]
ABOUT THE SPEAKERS
www.scarbrough-intl.com
Caleb HallScarbrough International, Ltd.
Patrick J. Caulfield, Esq.GDLSK LLP
Tracey Topper Gonzalez, Esq.GDLSK LLP
ABOUT FSVP
FOOD SAFETY MODERNIZATION ACT (FSMA): IMPORT SAFETY
http://www.fda.gov/fsma
FOR MORE INFORMATION
• Subscription feature available• To submit a question about FSMA, • visit www.fda.gov/fsma and go to Contact Us
http://www.fda.gov/fsma
FINAL RULE ON
FOREIGN SUPPLIER VERIFICATION PROGRAMS
http://www.fda.gov/fsma
http://www.fda.gov/fsma
BACKGROUND
• FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations.
• Final rule published: Nov. 27, 2015
• Food safety Central role
http://www.fda.gov/fsma
KEY PRINCIPLES OF FSVP RULE
• Establishes explicit responsibility for importers to ensure the safety of imported food
• Risk-based (according to types of hazards, importers, and suppliers)
• Alignment with PC supply-chain provisions• Flexibility in meeting requirements (assessing
activities conducted by others)
http://www.fda.gov/fsma
PURPOSE OF AN FSVP
• 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 (as it relates to allergen labeling)
http://www.fda.gov/fsma
WHO MUST COMPLY?
• “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.
http://www.fda.gov/fsma
FSVP EXEMPTIONS
• Firms subject to juice or seafood HACCP regulations• Food for research or evaluation• Food for personal consumption• Alcoholic beverages and alcoholic beverage
ingredients
http://www.fda.gov/fsma
FSVP EXEMPTIONS (CONT.)
• Food transshipped through U.S.• Food imported for processing and export• “U.S. foods returned”• Meat, poultry, and egg products subject to USDA
regulation at time of importation• Low acid canned food facilities (microbiological
hazards only)
http://www.fda.gov/fsma
USE OF QUALIFIED INDIVIDUALS
• Must use a qualified individual to perform required FSVP activities– 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
http://www.fda.gov/fsma
STANDARD FSVP REQUIREMENTS
• Develop FSVP • Conduct Hazard Analysis• Evaluate Risks Posed by a Food and Performance
of the Foreign Supplier• Approval of Foreign Supplier• Foreign Supplier Verification Activities• Corrective Actions• Maintenance of Records
http://www.fda.gov/fsma
HAZARD ANALYSIS: 1.504
• Known or reasonably foreseeable hazards requiring a control– Biological, chemical, radiological, and physical hazards– Naturally occurring, unintentionally introduced, or
intentionally introduced for economic gain
• May review and assess another entity’s hazard analysis
http://www.fda.gov/fsma
EVALUATION FOR APPROVAL
• Evaluation of risks posed by a food and performance of foreign supplier
• Evaluation is basis for:– Approval of foreign suppliers – Determination of verification activities
http://www.fda.gov/fsma
AND VERIFICATION ACTIVITIES: 1.505
FOREIGN SUPPLIER VERIFICATIONACTIVITIES: 1.506
• Establish and document use of written procedures to ensure the:– Use of approved suppliers or unapproved foreign
suppliers on a temporary basis– Appropriate verification activities are conducted
with respect to the imported food
http://www.fda.gov/fsma
APPROPRIATE VERIFICATION ACTIVITIES
• Must document determination, performance, conduct, review and assessment of results
• Verification activities include: – Onsite audits (qualified auditor), sampling and testing of
the food, a review of foreign supplier relevant food safety records, other appropriate activities
http://www.fda.gov/fsma
ONSITE AUDITS & SAHCODHA
• Hazard controlled by foreign supplier• Serious Adverse Health Consequence Or Death to
Humans or Animals (SAHCODHA)• Must conduct or obtain documentation of onsite
audit• Prior to importing food and annually thereafter• Exception - written determination of other activities
http://www.fda.gov/fsma
RELIANCE ON ANOTHER ENTITY
• May rely on another entity to:– Conduct hazard analysis– Perform evaluation of food and supplier– Establish written procedures for the use of approved or
unapproved foreign suppliers– Determine and conduct verification activities
• Must document review and assessment, including use of a qualified individual
http://www.fda.gov/fsma
MODIFIED REQUIREMENTS
• Certain importers may choose to comply with the modified FSVP requirements
• Only certain verification activities must be conducted
• Applies to sections 1.507, 1.511, 1.512, and 1.513
http://www.fda.gov/fsma
HAZARDS CONTROLLED OR CONTROLLED AFTERIMPORTATION: 1.507
• Foods intended for further manufacturing or processing and hazards will be controlled after importation
• Foods imported in the raw state; cannot be consumed raw
• Not required to conduct an evaluation of the food and supplier or verification activities if hazards requiring a control are identified and any of the circumstances apply
http://www.fda.gov/fsma
DIETARY SUPPLEMENTS: 1.511
• Applies to importers of certain dietary supplements/components intended for further manufacturing, processing, or packaging
• Must establish and comply with certain dietary supplement cGMPs
• “Other importers” ex. finished dietary supplements– Hazard Analysis not required
http://www.fda.gov/fsma
VERY SMALL IMPORTERS: 1.512
• Must meet definition as a very small importer • Less than $1 million/year in human food sales• Less than $2.5 million/year in animal food sales• Annually documentation of eligibility
http://www.fda.gov/fsma
IMPORTERS OF CERTAIN FOODSFROM CERTAIN SMALL FOREIGN SUPPLIERS: 1.512
• Small foreign suppliers:– Qualified facility– Produce from certain small suppliers that are not
covered farms– Shell egg producers with < 3,000 laying hens
http://www.fda.gov/fsma
COUNTRIES WITH COMPARABLE OREQUIVALENT SAFETY SYSTEMS: 1.513
• Importers of certain food from a foreign supplier in a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent.
• Systems Recognition Countries (SRC)• Applies to food that is not intended for further
manufacturing or processing
http://www.fda.gov/fsma
OTHER FSVP REQUIREMENTS
• Corrective Actions: 1.508 or applicable section
• Importer Identification at Entry: 1.509
• Maintenance of Records: 1.510 or applicable section
http://www.fda.gov/fsma
COMPLIANCE DATES
• The final FSVP rule was published on November 27, 2015
• First compliance date: May 30, 2017 • Last compliance date: July 27, 2020• Compliance Dates:
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm
http://www.fda.gov/fsma
GUIDANCE AND OUTREACH
• Webinars and meetings• FSVP Fact Sheets; FSVP At-a-Glance • Supplier Evaluation Resources • Technical Assistance Network (TAN)Under development:• FSVP guidance for industry• Collaboration with FSPCA to develop FSVP training course
materials• “FDA Data Dashboard”
http://www.fda.gov/fsma
VOLUNTARY QUALIFIED IMPORTERPROGRAM (VQIP)
OVERVIEW OF DRAFT GUIDANCE
http://www.fda.gov/fsma
WHAT IS VQIP?
• FDA required to establish a program to provide for the expedited review of food imported by voluntary participants.
• Eligibility is limited to importers who demonstrate a high level of control over the safety and security of their supply chains.
http://www.fda.gov/fsma
DEFINITION OF VQIP IMPORTER
• Section 806(g) defines “importer” as “the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.” – Can include manufacturers, consignees and importers
of record for food for humans and animals– May or may not be the FSVP importer
32http://www.fda.gov/fsma
DRAFT VQIP GUIDANCE ELIGIBILITY CRITERIA
• Quality Assurance Program (QAP) • Assurance of compliance with the supplier
verification and other importer responsibilities under the applicable FSVP or HACCP regulations
• Current facility certification, including farms, issued under FDA’s Accredited Third-Party Certification regulations for each foreign supplier of food in VQIP
http://www.fda.gov/fsma
DRAFT VQIP GUIDANCE ELIGIBILITY CRITERIA
• 3+ year history of importing food to the United States
• No ongoing FDA administrative or judicial action (e.g., import alert, injunction, recall), or other history of non-compliance with food safety regulations by the importer, other entities in the supply chain (e.g., foreign suppliers, filers/brokers, and FSVP and HACCP importers), or food
http://www.fda.gov/fsma
DRAFT ELEMENTS OF A QAP
• Corporate Quality Policy Statement • Organizational structure and individual responsibilities• Food defense system to protect against intentional
adulteration• Experience and training requirements for employees
responsible for implementing the QAP• Written procedures for establishing and maintaining
records relating to the structure and implementation of the QAP
http://www.fda.gov/fsma
DRAFT ELEMENTS OF A QAP (CONT.)
• Policies and procedures to ensure food safety from source to entry (e.g., temperature and storage controls), including procedures regarding:
• Compliance with supplier verification procedures in the FSVP or HACCP rules, if applicable, and maintenance of current facility certifications under FDA’s Accredited Third-Party Certification Program,
• Communication of information about potential health hazards to FDA and others
• Corrective actions to address food and foreign supplier non-compliances that pose a risk to public health
http://www.fda.gov/fsma
DRAFT BENEFITS OF VQIP
• Expedited entry into the U.S. for all foods included in an approved VQIP application
• Examination and/or sampling generally limited to “for cause” situations in which there is a potential threat to public health
• Any sampling or examination done at destination or another location chosen by the importer
http://www.fda.gov/fsma
DRAFT BENEFITS OF VQIP (CONT.)
• Expedited laboratory analysis of any samples • VQIP Importers Help Desk • Public posting on the FDA’s VQIP web page of
approved VQIP importers, if desired
http://www.fda.gov/fsma
OTHER ELEMENTS OF THE DRAFT GUIDANCE
• Application Process (e.g., elements, timing, FDA review)
• Revocation Process• Reinstatement Process• FDA Oversight• User Fees
http://www.fda.gov/fsma
COMMENTS RECEIVED
• The requirement for ‘3-year history of importing food into the United States‘ should be more flexible to account for mergers and divestitures between companies.
• DUNS numbers are difficult to obtain, do not offer any security, and are not the best option to identify importers.
• FDA should provide flexibility for VQIP participants to readily add products throughout the year.
http://www.fda.gov/fsma
COMMENTS RECEIVED (CONT.)
• In order for the Help Desk to provide value, the employees need to be vested with the authority to make decisions and take action.
• When possible, providing a “may proceed” in advance of arrival in the U.S. would add value because it would allow importers to pre-arrange logistics and facilitate faster border transitions.
http://www.fda.gov/fsma
STATUS OF VQIP
• Notice of Availability published in Federal Register June 5, 2015– Draft Guidance Document– Guidelines in Consideration of the Burden of the VQIP Fee
on Small Business– 75 Day Comment Period
• Anticipate Final Guidance Summer 2016
http://www.fda.gov/fsma
TIMING OF VQIP PROGRAM
• Informal Fee Estimate in 2017• A formal fee will be published no later than August 1,
2018• Anticipate first applications January 1, 2018• Anticipate first benefit period to begin October 1,
2018
http://www.fda.gov/fsma
QUESTIONS
www.scarbrough-intl.com
Alfredo Iniguez-Garcia, CSO U.S. Food and Drug Administration [email protected]
ABOUT THE SPEAKERS
www.scarbrough-intl.com
Caleb HallScarbrough International, Ltd.
Patrick J. Caulfield, Esq.GDLSK LLP
Tracey Topper Gonzalez, Esq.GDLSK LLP