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Current FDA Food Requirements
and the New Food Safety Modernization Act
Presented by Registrar Corp January 21st, 2016
About Registrar Corp Registrar Corp is a consulting firm providing regulatory compliance services for companies regulated by the U.S. Food and Drug Administration. The company is made up of 140 people worldwide, with 85 staff based in the U.S., including former U.S. FDA employees, scientists, and Regulatory Specialists. Registrar Corp assists each year over 18,000 companies in more than 160 countries around the world. The company serves all sectors regulated by U.S. FDA, including Food & Beverages, Cosmetics, Medical Devices, Drugs, and Radition-emitting Electronic Devices. More information may be found at http://www.registrarcorp.com
Quick Review: Top Ten Requirements for Manufacturers and Exporters of Food and Beverages to the United States (presented by David Lennarz)
DWPE: the “Dreaded Red” (presented by Mark Prinz) FSMA: New Rules (presented by Edwin VelezRivera) Questions & Answers
Webinar Overview
About our Speaker David Lennarz is a Vice-President at Registrar Corp. Mr. Lennarz is a graduate of the University of Virginia, and has worked for nearly 22 years in FDA-regulated industries in the U.S. and Europe. Mr. Lennarz has conducted seminars on U.S. Food and Drug Administration regulations for Food & Beverages, Drugs, Medical Devices, and Cosmetics for trade associations, trade shows, and governments in more than 30 countries around the world. He served as a Technical Expert for the U.S. Food and Drug Administration’s Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations. He co-founded Registrar Corp in 2003 and is based in Registrar Corp’s head office in Hampton, Virginia.
#10: Good Manufacturing Practices (aka “GMPs”)
#9: Food Safety
HACCP and Preventative Controls • Focuses on the prevention of hazards • HACCP required for Seafood and Juice product
#8: Low-Acid Canned Food (“LACF”) Requirements
#7: Labeling Requirements
#7: Future Changes to Labeling
#6: Product Claims
#5: Facility Registration
#4: Facility Registration Renewal
#3: US Agent for FDA Communications
#2: Prior Notice
#1: New Rules of the FSMA
1/20/2016
U.S. FDA Import Alerts
Mark Prinz, M.S. Senior Regulatory Specialist Thursday, January 21, 2016
Mark Prinz Senior Regulatory Specialist, Import Alerts
Mark Prinz holds a Master of Science degree in Biology from Old Dominion University in Norfolk, Virginia and has experience in both field and analytical research. Mr. Prinz began his career with Registrar Corp in 2010 reviewing the labeling and formulation of hundreds of products for FDA compliance. Since 2013, he has been heading Registrar Corp's Import Alerts department assisting international companies to develop the petitions required for removal or exemption from detention under various FDA Import Alerts.
An Issue of Resource Management
25-30 million entries per year Food, drugs, medical devices, and cosmetics
Over 300 possible ports of entry
1/20/2016
Import Refusals vs. Import Alerts
• Import Refusals result from a
single detention.
• Import Refusals occur when FDA inspects a shipment at its port of entry and determines it is non-compliant. That one specific non-compliant shipment is refused entry into the United States. Once a shipment is refused, it cannot be undone, so companies should carefully monitor their suppliers and the quality of products they ship.
• Import Alerts result in continuous detentions.
• Import Alerts occur when FDA notices a pattern of non-compliance from a particular company, country, or product type. All shipments of products listed on an Import Alert are subject to Detention Without Physical Examination (DWPE). Companies on Import Alert can petition for removal.
What is an Import Alert?
Notice to all entry ports that certain products from specific areas or manufacturers may be violative
Created whenever FDA discovers a pattern of violation that creates a reason to believe that future shipments may be similarly violative
Instructs FDA compliance officers to detain these products
More than 250 active Import Alerts
1/20/2016
Additional Import Alerts Related to Seafood & Other Products
1/20/2016
99-19 (Salmonella) 99-22 (Allergen Labeling) 99-30 (Mislabeling) Etc…
Types of Import Alerts
List Import Alerts: Subject to the alert unless you’re on the Green List
List Import Alerts: Only subject to the alert if you are on the Red List
1/20/2016
Types of Import Alerts
List Import Alerts: Inherently risky products from anywhere in the world
• 16-20 – Puffer Fish (Tetrodotoxin)
Violations common or widespread in certain regions
• 16-07 – Dried or Pickled Finfish from Thailand (Filth) • 16-35 – Raw and Cooked Shrimp from India (Filth/Decomp/Salmonella)
1/20/2016
Types of Import Alerts
List Import Alerts: Based on the nature of the violation or history of the company
16-04 – Misbranded Seafood
16-120 – Foreign Processors Not in Compliance with Seafood HACCP
99-19 – Food Products due to Salmonella
1/20/2016
Detention Without Physical Examination (DWPE)
Shipment will be detained without inspector even looking at it
Works under the premise that the products appear violative based on a history of violation
NOT an automatic refusal The importer must present evidence to FDA that the product is
NOT violative in order to get a shipment released from detention
This process will repeat for ALL shipments for as long as the Import Alert is in effect
1/20/2016
Importers Affected Too
Import Alert # 16-119 “Detention Without Physical Examination of Fish and Fishery Products For Importer And Foreign Processor
(Manuf) Combinations”
Failure to Comply with Seafood HACCP Verification Requirements
1/20/2016
FDA Import Alerts
What can be done if a company finds
themselves subject to DWPE?
PETITION!
1/20/2016
Removal from DWPE
A firm will remain subject to DWPE unless it provides evidence to FDA that it is no longer at risk
Petition sent to Division of Import Operations (DIO) to request removal May be 100+ pages in length Requires extensive documentary evidence
DIO reviews petition, which can take months before a decision is made
1/20/2016
Petition Requirements
Documentary evidence that the problem has been corrected or prevented Will vary depending upon the circumstances (e.g. a revised HACCP plan,
change of suppliers, label revisions, lab analyses of every lot, etc.)
A series of non-violative shipments to verify that the corrective or preventive actions are sufficient Minimum of 5-12 shipments Submission of shipping documents
• US Customs Form 3461 or 7501 • Commercial Invoice • Packing List • Bill of Lading
1/20/2016
Edwin Velezrivera Director of Food Safety
Edwin VelezRivera holds a Master of Science degree in Food Science and Technology from Kansas State University. Mr. VelezRivera has over 21 years of experience in the Food Safety, Auditing, and Food Defense profession. He has taken numerous FDA training courses, including "Good Manufacturing Practices (GMP)," "Food Code," "Inspection Techniques and Evidence Development,” and more. Mr. VelezRivera has been with Registrar Corp since 2012. His team performs mock FDA food facility inspections around the world, reviews and develops HACCP, Food Safety, and Food Defense plans, and executes other food safety related services.
Rules Having Direct Impact on Imports
Preventive Control Rule for Human and Animal Foods Foreign Supplier Verification Program (FSVP) Voluntary Qualified Importer Program (VQIP) Two Additional Rules we will NOT cover today are: Produce Safety Third Party Accreditation
1/20/2016
• Current Good Manufacturing Practice (GMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food • Originally proposed: January 16, 2013 • Supplemental proposal: September 29, 2014 • Public comments: More than 8,000 for the original
proposal; more than 1,300 for the supplemental proposal
• Final rule was published September 17th, 2015 • Implementation starts September 2016
Background: Preventive Control Rule for Human and Animal Foods
Who is Covered? • Facilities that manufacture, process, pack or
hold human food • In general, facilities required to register with
FDA under sec. 415 of the FD&C Act • Not farms or retail food establishments
• Applies to domestic and imported food • Some exemptions and modified requirements
apply
Other Exemptions
• Activities subject to Hazard Analysis & Critical Control Points (HACCP) regulations (i.e., seafood and juice)
• Manufacturing, processing, packing, and holding of dietary supplements
• Alcoholic beverages at certain facilities • Activities subject to low-acid canned food
regulations (microbiological hazards only)
New Food Safety Plan Requirement
• Hazard analysis • Preventive Controls • Monitoring Procedures • Corrective Actions • Verification Procedures • Recordkeeping
New Supply Chain Program Requirement
Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (“supply-chain applied control”).
New Supplier Verification Activities
• Onsite audits (default for serious hazards) • Sampling and testing • Review of relevant food safety records • Review and Monitoring of FDA Compliance
Status of manufacturers
Activity and frequency based on nature of hazard, where it is controlled and supplier
performance.
• Very small businesses and Businesses subject to Pasteurized Milk Ordinance • Less than $1 million in annual food sales • Three years (September 17, 2018)
• Small businesses • Businesses with fewer than 500
full-time employees • Two years (September 17, 2017)
• All other businesses • One year (September 17, 2016)
Compliance Dates for Businesses
Planned Guidance
• Hazard analysis and preventive controls • Environmental monitoring • Food allergen controls • Validation of process controls • A Small Entity Compliance Guide that explains
the actions a small or very small business must take to comply with the rule
Background: Foreign Supplier Verification Program
Foreign Supplier Verification Rule (“FSVP”) Proposed rule: July 29, 2013 Supplemental proposal: Sept. 29, 2014 Public comments: 300+ for proposed rule and 100+
for supplemental Final rule issued: Nov. 13, 2015 Implementation Date starting May 2017
2
Key Principles of FSVP Rule
Requires importers to share responsibility for ensuring safety of imported food
Risk-based (according to types of hazards, importers, and suppliers)
Flexibility in meeting requirements (assessing activities conducted by others)
Alignment with PC supply-chain provisions
51
Purpose of FSVPs
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 to allergen labeling)
52
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.
53
Exemptions from FSVP Firms subject to juice or seafood HACCP regulations Food for research or evaluation Food for personal consumption Alcoholic beverages and ingredients (when importer
uses them to make an alcoholic beverage)
54
FSVP Exemptions (cont.)
Food transshipped through U.S. Food imported for processing and export “U.S. food returned” Meat, poultry, and egg products subject to USDA
regulation at time of importation
55
Importers in Compliance with Preventive Controls
Importers are deemed in compliance with most of FSVP when they: Comply with PC supply-chain provisions Implement preventive controls under PC regulation
for hazards in food they import Are not required to implement a preventive control
under certain PC provisions
56
Use of Qualified Individuals
Must use a qualified individual to perform all required FSVP tasks 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 A company may outsource this expertise
57
Hazard Analysis 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 May assess another’s hazard analysis
58
Evaluation of Food and Foreign Supplier
Must “approve” suppliers and determine appropriate supplier verification activities (may use unapproved suppliers on temporary basis when subject food to verification)
Considerations include: Risk posed by the food (hazard analysis) Entities controlling hazards or verifying control Supplier characteristics (procedures, processes, and practices) FDA compliance status and food safety history
59
Verification Activities (cont.)
Determine appropriate verification activities (and frequency) based on food and supplier evaluation Activities may include: onsite auditing; sampling and testing;
review of supplier records; other appropriate measures Annual onsite auditing is default approach when a
food has a SAHCODHA hazard.
60
Reliance on Verification Activities Conducted by Others
May rely on another entity’s determination or performance of appropriate verification activities (e.g., farm audits conducted by produce distributor)
Must review and assess results of verification activities (importer’s own or others on which it relies)
61
Verification Activities (cont.)
Onsite audits: Must be conducted by “qualified auditor”; may be
government employee Consider applicable FDA food safety regulations (or
laws and regulations of country with comparable or equivalent food safety system)
Substitute results of inspection by FDA or food safety authority in comparable or equivalent food safety system
62
Requirements for Special Circumstances
The food cannot be consumed without application of control (e.g., coffee beans).
Hazard controlled by importer’s customer or subsequent entity in US distribution. Disclosure statement Written assurance Other system to ensure control of hazard at subsequent
distribution step
63
Dietary Supplements
Most standard requirements do not apply when an imported dietary supplement component or packaging meets specifications established in accordance with dietary supplement CGMPs.
Other dietary supplements (including finished supplements): hazard analysis not required; verification standard is compliance with CGMPs.
65
Very Small Importers and Food from Certain Small Suppliers
Very small importer (VSI) Less than $1 million/yr. in human food sales Less than $2.5 million/yr. in animal food sales
Food from certain small suppliers Qualified facility Produce from certain small suppliers that are not covered
farms Shell egg producers with < 3,000 laying hens
66
VSIs and Importers of Food from Small Suppliers (cont.)
Annually document eligibility Verification: Written assurances from suppliers Additional requirements for food from small
suppliers: Evaluate and monitor supplier compliance history Approve suppliers Ensure food is from approved suppliers
67
Countries with Comparable or Equivalent Safety Systems
Most FSVP requirements would not apply when importing certain food from supplier in country whose food safety system FDA has officially recognized as comparable or determined to be equivalent. New Zealand! As of now.
68
FDA Guidance and Outreach
Developing FSVP draft guidance for industry Food Safety Preventive Controls Alliance will develop
course materials for FSVP. Webinars and meetings
69
Voluntary Qualified Importer Program (“VQIP”)
Fast Lane for Food Imports
• Expedited Entry • Expedited Lab Analysis • Dedicated Help Desk
• Not the Same as C-TPAT, but a similar concept.
VQIP
Who Can Participate? “VQIP Importer” term • May be different than Importer of Record and FSVP Importer • May be foreign entity • Three year shipping history is reviewed • Annual Audit by FDA Accredited Auditor • No ongoing FDA proceedings (Import Alerts or other actions) Annual Fee: Estimated First Year Fee = $16,400.00
VQIP
When? • Importers May Apply Annually January – March • VQIP Year Runs From October to September • First Year Anticipated to be 2018
VQIP
Which Foods? • Nothing on Import Alert or Recall • Must be From Supplier Certified by FDA Accredited Auditor • Must Be Identified on VQIP Application
•No Additions During the Year
Summary and Solutions
Key Requirements: GMPs, registration, labeling, FCE, Prior Notice
Import Alerts and DWPE FSMA Main takeaway: Number of existing rules, and more
on the way. Prudent path for importers: Select suppliers carefully,
and be sure to monitor them for FDA issues which may in turn cause detentions or delays at the port
74
Summary and Solutions
Registrar Corp provides a full range of fixed-fee compliance services: Registration & U.S. Agent Service Prior Notice Filings Label, Ingredient, and Product Review LACF and Food Safety Services (Mock FDA Inspections, etc) Detention Assistance DWPE Petition Submissions
76
Questions?
Web Site: www.registrarcorp.com Email: [email protected]
Contact Us
Registrar Corp Headquarters 144 Research Drive Hampton, Virginia
USA 23666 P: +757-224-0177 F: +757-224-0179
www.registrarcorp.com