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Current FDA Requirements
& the New Food Safety
Modernization Act
Presented by Registrar Corp
February 23rd, 2016
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Thailand & the U.S. – Why export?
A short history of the FDA
Review of current FDA requirements
The Food Safety Modernization Act (FSMA)
FDA Import Refusals and Detention Without Physical
Examination (DWPE)
FDA Inspections
Summary and Q&A
Seminar Overview
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2/23/2016
Why Export to the U.S.?
Thai – U.S. Relations & Trade
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Why Export to the U.S.?
The United States is the world's largest economy and the
largest exporter and importer of goods and services
GDP of $16.77 trillion
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In 2015, the U.S. imported an estimated…
Seafood: $17.2 billion
Fruits & Frozen Juices: $14.2 billion
Vegetables: $9.9 billion
Meat products: $11.9
Bakery products: $8.7 billion
And much more…
Total U.S.-imported food: $116.8 billion
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The U.S. Market
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317 million consumers
Large variety of ethnicities, ages, climates, etc.
Diversity of tastes and incomes provides a market for
any product
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Multiple Distribution Opportunities
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Large Grocery Stores
E-Commerce
Specialty Stores
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U.S. – Thai Relationships
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Imported Thai goods totaled $26.2 billion in 2013
Thailand ranks as the U.S.’s 19th largest supplier of
goods imported in 2013
Trans-Pacific Partnership – possible ratification
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Before you export…
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The U.S. is a regulated market, so many rules apply
Not complying with U.S. Food and Drug
Administration regulations has negative consequences
Prepare in advance to avoid costly mistakes
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2/23/2016
The U.S. Food and Drug
Administration
A Short History
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Beginnings - 1906
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Pre-1906: No regulation
Upton Sinclair’s The Jungle
Pure Food and Drug Act of
1906
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Creation of the FDA - 1938
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President Franklin
Delano Roosevelt signs
the Food, Drug, and
Cosmetic Act in 1938
after over 100 people die
from taking Elixir
Sulfanilamide
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The Modern Age
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In the 1960s, the Pillsbury
Corporation developed the
first Hazard Analysis and
Critical Control Point
system for NASA
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Toward the Future: FSMA
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President Obama signed the Food Safety
Modernization Act into law on January 4th, 2011
FDA calls it the “most sweeping reform of our food
safety laws in more than 70 years”
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FDA’s Current Structure
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2/23/2016
Current FDA Regulation
A Brief Review
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The Bioterrorism Act of 2002
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September 11th, 2001
Requires food facilities to:
Register with the FDA
Designate a U.S. agent for
communication
Give prior notice on food
shipments
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Food Facility Registration
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Food facilities engaged in
“manufacturing, processing,
packaging, or holding of
food” must register with the
FDA
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Food Facility Registration
• Thailand – 1,530
• Myanmar – 11
• Cambodia – 76
• Vietnam – 1,536
• Laos - 33
• China – 26,743
• Indonesia – 2,598
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U.S. Agent
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Foreign food facilities must also designate a U.S. agent
as a point of contact for FDA
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Prior Notice
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Foreign food facilities are required to give FDA “prior
notice” on shipments to the US
Prior Notice must be filed before a shipment arrives
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Food Labeling
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• A top reason product is detained: Incorrect labeling, unapproved ingredients, prohibited health claims
• Common errors in trying to avoid problems:
• Copy other wrong labels
• Only follow part of the regulations
• Nutrition Facts chart formatting is critical and will soon change
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Requirements for Low-Acid/Acidified
Canned Foods (LACF)
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• Low-Acid, Acidified, Thermally Processed Foods
• Typically produced in Cans, Bottles, Jars, or Tetra-Paks
• Food Canning Establishment (“FCE”)
• Registration required
• Process Filings (Submission Identifies or “SID”) for each product, each size
• Important factors are pH and Water Activity
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HACCP
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• Focuses on the prevention of hazards
• Can be applied throughout the food chain
• “From farm to table.”
• Currently required for
• Seafood (21 CFR§123)
• Juice (21 CFR§ 120)
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Current Good Manufacturing Practices
(cGMPS)
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• Guidelines and conditions which must be met by every food facility to ensure production of safe and wholesome foods.
• GMPs required for all food and beverages are found in 21 CFR §110
• GMPs required for dietary supplements are found in 21 CFR §111
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cGMP – 21 CFR § 110
GMP requirements include:
Sanitation
Employee hygiene and hygienic practices
Equipment construction, maintenance and calibration
Pest Control
Facility construction
Water quality
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FSMA Changes to Current FDA
Requirements
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Registration
Food facilities must renew their registration every
even-numbered year (2016, 2018, 2020, etc.)
Must include the U.S. agent email address on their
registration renewal
Prior Notice
Food facilities must state if a food offered for import
to the U.S. was refused entry at the port of another
country
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LACF System Changes
• In October 2015 FDA changed a number of features
in the LACF system. Major changes include:
• New access roles determine who can file and see
filings, and who can have access in general.
• New forms have replaced forms used for the past
30+ years
• New features within the actual submission process.
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2/23/2016
Food Safety
Modernization Act
(FSMA)
What You Need to Know
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Motivators for FSMA: Facts
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High Profile Cases
Imports in the spotlight over past decade:
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High Profile Cases
High profile food scandals originating in the U.S.
as well:
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Imports on the Rise
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FSMA Places Burden on Importers
and Foreign Manufacturers
•Increase in exports to the U.S.; too many ports; not enough
FDA inspectors.
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Progress with the FSMA
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Progress with the FSMA
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FSMA: Four Areas
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FSMA: Who Can Be a “Qualified Individual”?
• 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
Manufacturers/Importer must use a Qualified Individual
for required FMSA tasks
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FSMA: Preventive Control (PC) Rule
Food Safety Plan
• Hazard analysis
• Preventive controls
• Supply-chain program
• Recall plan
• Procedures for monitoring
• Corrective action procedures
• Verification procedures
• Recordkeeping
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FSMA: Preventive Control (PC) Rule
Food Safety Plan
• Food plan based on “Hazard Analysis and Risk-
based Preventive Controls” (HARPC)
• Looks at which foods offer which hazards and
evaluates risks
• HACCP vs. HARPC
• Must be written by a qualified individual
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FSMA: PC Rule
Who Must Comply?
• 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
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FSMA: PC Rule
Who’s exempt?
• 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)
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• Very small businesses• Less than $1 million in annual food sales
• Three years: September 17th, 2018
• Small businesses• Businesses with fewer than 500 full-time employees
• Two years: September 17th, 2017
• All other businesses• One year: September 17, 2016
PC Rule: Compliance Dates for Businesses
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FSMA: Foreign Supplier Verification Program (FSVP)
• 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
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Purpose of FSVP
•Importers must 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
-and-
• Food is not adulterated or misbranded (as to
allergen labeling)
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FSVP: How’s it Work?
General Requirements of the FSVP
A “Qualified Person” Must Perform the Following:
• Hazard Analysis
• Supplier Verification Activities (including
compliance status review of foods and suppliers)
• Corrective Actions
• Periodic Reassessment of FSVP
• Importer Identification at Entry
• Record-keeping
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FSVP: 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 entity’s hazard
analysis
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FSVP: Approved Suppliers
To approve suppliers and determine appropriate
supplier verification activities
Importers must consider:
• Risk posed by the food (hazard analysis)
• Entities controlling hazards or verifying control
• Supplier characteristics (procedures and practices;
FDA compliance history, including Warning Letters,
Import Alerts, etc.)
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FSVP: Verification Activities
• Onsite audits (default for serious hazards)
• Sampling and testing
• Review of relevant food safety records, including
monitoring a supplier for FDA Warning Letters or Import
Alerts
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FSVP: Supplier Verification Activities
• May rely on another entity’s determination or
performance of appropriate verification activities (e.g.,
farm audits conducted by produce distributor, BRC
audit, etc.)
• Must review and assess results of verification activities
(importer’s own or others on which it relies)
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FSVP: Supplier Verification Activities
Modified Requirements
• If the food cannot be consumed without application of
control (e.g., coffee beans)…
or
• The hazard is controlled by importer’s customer or
subsequent entity in US distribution…
• The importer must include a disclosure statement with the
food and/or obtain written assurance from the subsequent
entity in the supply-chain that they will control the hazard
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FSVP: Corrective Actions
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FSVP: New DUNS Requirement?
• Importers will have to include:
DUNS number?
Email address at time of
entry
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FSVP: Recordkeeping
• Importers must document their activities related to:
Approving suppliers
Supplier verification activities
Corrective actions
• Importers must retain these
records for at least two years
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FSVP: Who Must Comply?
• “Importer”: defined as
owner or consignee
• If there is no US owner or
consignee, the “Importer” is the
U.S. agent or representative of
the foreign owner or consignee,
as confirmed in a signed
statement of consent
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FSVP: Who’s Exempt?
• 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)
• 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
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FSVP: Who’s Exempt?
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 (same $ as VSI)
• Produce from certain small suppliers that are not
covered farms
• Shell egg producers with < 3,000 laying hens
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VSI and Importers of Foods from Small Suppliers
• Annually document eligibility
• Verification: Written assurances from suppliers
• Additional requirements for food from small suppliers:
Evaluate supplier compliance history
Approve suppliers
Ensure food is from approved suppliers
Attestation
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FSVP: Compliance Dates
• Importers must comply with this rule:
• May 27th, 2017 (18 months after publication of
final rule)
OR
• 6 months after supplier must comply with
Preventive Controls or Produce Safety
• For exporters:
• Exporters must make sure they comply with the
appropriate FSMA rules to continue doing business
with companies in the U.S.
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FSMA: Accredited Third Party
Certification Rule
FDA
FDA would recognize accreditation bodies (ABs) based on certain
criteria such as competency and impartiality.
Accreditation Bodies
ABs would accredit qualified third-party certification bodies (CBs).
Third-Party Certification Bodies
Third-party CBs would audit and issue certifications for foreign
facilities and foods.
Foreign Facilities
Foreign facilities may choose to be audited by an accredited CB.
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FSMA: Voluntary Qualified
Importer Program (VQIP)
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VQIP: Eligibility, Part 1
Food importer (in U.S. or abroad)
Can be different from CBP “importer of record”
Three-year history of importing food into the U.S.
DUNS number
Use paperless filer/broker with passing rating during last
FDA Filer Evaluation
No food is subject to an import alert or Class 1 recall
(whether or not food is brought in under VQIP)
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VQIP: Eligibility, Part 2
No ongoing FDA administrative or judicial action
No history of significant non-compliances with food
safety (e.g., “Official Action Indicated”)
Each foreign facility has current certification
VQIP Quality Assurance Program (QAP)
Within past three years, no CBP penalties
Pay annual VQIP user fee before Oct. 1st
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VQIP: Certification
To obtain food from foreign suppliers under VQIP, each
foreign facility must have a current food facility
certification issued by a third-party auditor/certification
body accredited by FDA
Annual recertification
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VQIP: Application
Submit “Notice of Intent to Participate in VQIP”
between January 1st and May 31st for the next fiscal year
A VQIP Application must include:
Applicant info and firm information
FSVP Responsible Contact
VQIP Quality Assurance Program
Filer/Broker Information
Foreign Supplier Facility and Products
Fee - $16,400
Resubmission
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VQIP: QAP
The VQIP Quality Assurance Program must include:
Corporate Quality Policy Statement
Organization Structure and Functional Responsibilities
Food Safety Policies and Procedures
Food Defense Policies and Procedures
Training for VQIP Employees
Implementation Procedures
Records
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VQIP: After Approval
FDA will “ordinarily conduct a VQIP inspection” after
the application has been approved
After approval, the FDA will reevaluate eligibility every
three years
Application may be amended to add/remove certain
items each year, but not new food
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VQIP: After Approval
FDA can revoke your VQIP participation if:
You cannot meet the VQIP eligibility requirements (no refund)
Evidence of participation in smuggling or fraudulent activities
FDA will send a “Notice of Intent to Revoke” and allow
the importer 30 days for corrective action
FDA will share revocation with other federal agencies
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VQIP: Pros and Cons
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FSMA: Produce Safety
70
FDA has finalized its Produce Safety rule under FSMA
Under this rule, foreign and domestic agricultural
facilities must ensure that their practices are up to FDA
standards, especially:
Agricultural water
Biological soil amendments of animal origin (fertilizers)
Employee training
Employee health and hygiene
Equipment, tools, buildings, and sanitation
Sprouts
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FSMA: Produce Safety
71
Who is affected?
Domestic and imported produce
Produce for human consumption
Who is exempt?
Less than $25,000 in produce
Produce rarely consumed raw
Produce for personal or on-farm consumption
Who has modified requirements?
Produce with a “kill step”
<$500,000 in all food sales, majority to “qualified end-user”
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FSMA: Produce Safety
72
What are variances?
A foreign government may petition to have a “variance” from
a particular provision under the produce safety law
The petition must include:
Why the variance is necessary, i.e. local growing
conditions, local climate
How the hazard will be controlled under the variance
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FSMA: Produce Safety
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FSMA: Sanitary Transportation
74
Final rule due by March 31st, 2016
Establishes requirements for:
Vehicles and transportation equipment
Transportation operations
Employee training
Records
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FSMA: Sanitary Transportation
75
Does it apply to me?
Does not apply to transportation wholly in another
country (i.e., transportation of food solely in
Thailand)
Applies to transportation that enters the U.S.
Exceptions for shippers/carriers with less than
$500,000 in annual sales
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FSMA: Intentional Adulteration
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Final rule due by May 31st, 2016
Requires food facilities to:
Develop a written food defense plan
Identify possibilities for intentional adulteration
Create mitigation strategies
Monitor
Corrective action
Verification
Training personnel
Records
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FSMA: Intentional Adulteration
77
Does it apply to me?
Exemptions for “qualified facilities”
<$10,000,000 in sales
Holding food
Alcohols
Produce rule
Animal food
Only packing
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FSMA Summary
2015 saw significant progress in implementing FSMA
FDA is set to have adequate funding to actually
implement FSMA
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2/23/2016
U.S. FDA
Import Alerts and Use of
DWPE
How to Petition FDA
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An Issue of Resource Management
25-30 million entries per year Food, drugs, medical devices, and cosmetics
Over 300 possible ports of entry
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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 without physical examination (DWPE)
More than 250 active Import Alerts
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36 Seafood-Specific Import Alerts
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Additional Import Alerts
Related to Seafood & Other Products
99-19 DWPE for presence of Salmonella
99-22 DWPE for lack of allergen labeling
99-39 DWPE for misbranding/nutrition labeling
45-02 DWPE for containing illegal colors
Etc…
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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
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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)
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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
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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
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16-22
Canned Shrimp from Thailand
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16-22
Canned Shrimp from Thailand
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16-47
Red Snapper from Thailand
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Thailand’s Import Alerts
Thailand is currently subject to 46 import alerts
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FDA Import Alerts
What do you do if you find yourself or your
supplier subject to DWPE?
PETITION!
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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
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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
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2/23/2016
FDA Inspections
Why & How to Prepare
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Why Me and Why Now?
• You consent to FDA inspections with your food facility registration
• Facility’s risk profile:
• Commodity specific
• Manufacturing process
• Compliance history
• Could be as simple as you are located near another facility FDA will inspect
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High Risk Foods
•Acidified Foods
•Low-Acid Foods
•Seafood
•Custard Filled Bakery
Product
•Modified Atmosphere
Packaging
•Dairy Products
•Soft; Semi-soft; Soft Ripened
Cheese and Cheese Products
•Unpasteurized Juices
•Sprouts Ready-to-Eat
•Fresh Fruits and Vegetables
•Processed Fruits and
Vegetables
•Spices
•Shell Eggs
•Sandwiches
•Prepared Salads
•Infant Formula
•Others
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Inspection Process:
“Notice of Inspection”
• Notice is sent by email to
registrant’s email as
indicated in the food
facility’s FDA registration
• Notice is also sent to U.S.
Agent via email
• Email will come from:
@fda.hhs.gov
• Key Points:
• 5 Days to Respond
• Provide additional
data
• Refusal to respond or
refusal to allow an
inspection may cause
“increased sampling,
refusal of admission,
or other regulatory
action.”
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Inspection Process: “Factory Profile
Information” Form
• Once you reply, FDA’s Office of Regulatory Affairs
will contact you:
• May take days, weeks, or months (or never)
• Coordinate inspection date
• Ask you to complete and return a “Factory Profile Information”
form to FDA
• FDA will then come back with name of investigator, their flight
info, ask you to make hotel reservations, and maybe even ask you
to provide ground transportation.
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Inspection Process: Day 1
• Inspection is typically 2 days
• Day 1:
• Introductions
• Opening Meeting
• Quick Tour
• Document Review
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Inspection Process: Day 2
• Day 2:
• Most time spent in factory
• Closing meeting with management
• Delivery of form “483” “Inspectional
Observations”
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Inspection: Focuses
• Focus on processes
• HACCP/HARPC (in future, Food Safety Plan)
• Focus on personnel
• Focus on facility construction & grounds
• Focus on sanitation
• Focus on equipment & utensils
• Focus on warehouse/distribution
• Focus on records
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Applicable FDA Regulations
A single inspection may focus on multiple
requirements
For example, canned sardines may be inspected for
compliance with:
Seafood HACCP (21 CFR 123)
Low Acid Canned Foods (21 CFR 113)
Current GMP (21 CFR 110)
Food Labeling (21 CFR 101)
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End of Inspection
• Closing Meeting: Discussion of observations with
management (CEO, Plant Manager, QA / QC Managers)
• Opportunity to have corrective actions of the
deficiencies identified by FDA Investigator reviewed
before inspector departs
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End of Inspection
• Inspector departs with no
observations
or…
• Form FDA 483 (Inspectional
Observations) is issued
• Outlines Observations /
Deficiencies
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After the Inspection
• Facility responds to FDA
483
• FDA reviews response to
FDA 483
• FDA issues an
Establishment Inspection
Report (“EIR”)
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After the Inspection
• FDA will eventually classify the
inspection:
• No Action Indicated (NAI)
• Voluntary Action Indicated (VAI) -
• Official Action Indicated (OAI)
• FDA discloses the final inspection
classification in an online database
• http://www.accessdata.fda.gov/scripts/inspsearch/
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OAI Actions
• Warning Letter (which
you could respond to) and
perhaps a “Close Out
Letter”
• Detentions at the port
• Registration suspension
• Re-inspection under
FSMA
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Inspection Process: Summary
Notice of Inspection
Request for more information
Inspection
FDA Form 483 issued
Corrective Action
Response
Establishment Inspection
Report
Classification
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2/23/2016
Summary & The Year Ahead
What’s in Store for 2016
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Common Themes for 2016
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Common Themes for 2016
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Common Themes for 2016
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Labeling Changes for 2016
FDA has issued two proposed rules and one
supplemental proposed rule related to nutrition
labeling.
Final rule is scheduled to be published in March 2016.
Industry will have two years to comply after the
effective date stated in the final rule.
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Highlights of the Proposed Rules
Calories and Serving Sizes made more prominent
Percent Daily Values moved to the left side of the label
Potassium and Vitamin D must be declared; Vitamins A and C
now optional
Calories from Fat declaration removed
Update to the daily values for certain nutrients
Declaration of Added Sugars and %DV (10% of total calories)
Changed the current footnote to "*The percent daily value (%DV)
tells you how much a nutrient in a serving of food contributes to a
daily diet. 2,000 calories a day is used for general nutrition
advice."
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Highlights of the Proposed Rules
Replace "Total Carbohydrate" with "Total Carbs"
Change "Amount Per Serving" to "Amount Per [actual size]" e.g.,
Amount Per ½ cup
Revision of serving sizes to reflect what Americans actually
consume
Require certain packaged foods be labeled as a single serving if
typically eaten in one sitting (e.g., 20 oz soda)
Require dual column labels on certain packages for products that
could be consumed in one or multiple sittings ("per serving" and
"per package")
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Original vs. Proposed Charts
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Common Theme for 2016:
FDA Compliance Monitoring
FSMA requires firms to “monitor” the FDA compliance
of their suppliers
Preventative Control Rule
Foreign Supplier Verification Program
Voluntary Qualified Importer Programs
Concept is simple: importers must check the compliance
of their suppliers, foreign and domestic
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FDA & Your Company’s Digital Footprint
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FDA Compliance Monitor
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Summary, Solutions, and Questions
Registrar Corp provides a full range of fixed-fee
compliance services:
Registration & U.S. Agent Service
FSMA Compliance Package (includes FSVP audit)
Prior Notice Filings
Label, Ingredient, and Product Review
LACF and Food Safety Services (Mock FDA Inspections, etc)
Detention Assistance
DWPE Petition Submissions
FDA Compliance Monitor
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FSMA Compliance Package
FDA Foreign Supplier Compliance Package
Food Safety Plan Review (up to three products)
FDA Compliance Monitoring (up to 50 facilities)
Onsite Food Safety Audit (FSVP Audit) (excludes travel and
lodging)
Food Defense Plan Creation or Review
Labeling and Ingredient Review (up to three products)
FCE-SID Process Filings (unlimited)
Food Facility Registration and U.S. Agent Service (as required
under 21 CFR §1.225)
Detention Assistance
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Contact Us
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +1-757-224-0177
F: +1-757-224-0179
www.registrarcorp.com
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Registrar Corp Worldwide Offices
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