u.s. fda food safety modernization act (fsma) for customs brokers
DESCRIPTION
Learn about the new regulations under the U.S. FDA Food Safety Modernization Act (FSMA), including new requirements for U.S. Agents.TRANSCRIPT
04/11/23
U.S. FDA Food Safety Modernization Act: Are you
Ready?
Presented by Cornelia Rooks, Senior Regulatory Specialist
Registrar CorpAugust 2012
FDA Food Safety Modernization Act
“FSMA” signed by President Obama 01/04/2011Phased in over time thru 2016Most significant update to food safety laws since 1938
Motivators for FSMA
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food borne diseases
Public health burden that is largely preventable.
High Profile Cases
Imports in the spotlightMelamine in pet foodIllegal antibiotics in aquacultureBetter detection of common pathogens, and strains of new
pathogens.
Imports of FDA-Regulated Food Have Almost Doubled Since 2002
Burden on Manufacturers and Importers
Port-of-Entry inspection cannot handle increase in imported foods
FSMA makes Importers more responsible for quality of products from foreign manufacturers
Vision of FSMA
Prevention
Inspections, Compliance,
and Response
Import Safety
Enhanced Partnerships
NEW FDA REQUIREMENTS CURRENTLY IN EFFECT
Latest Developments
New User Fees- Registration Suspension Administrative Detentions Updated Prior Notice Filings Anti-Smuggling New Dietary Supplements guidance Processed foods and produce pilots to
explore how to quickly trace foods back to source of contamination-
Registration Renewal
Each food facility must renew its U.S. FDA registration every two years (4th quarter of every even-numbered year). Starting October 2012
Low acid and acidified food manufacturers typically must have two separate FDA registrations for each location, • (1) a Food Facility Registration (“FFR”), which all food facilities must
file, regardless of whether they handle low acid and acidified foods, and
• (2) a Food Canning Establishment (“FCE”) registration.
Note: An Update to electronic system on 8/1/12, for new companies entering data into system
The data in these two registrations must match precisely.
United States Agent
Foreign Establishments must notify FDA of the name, business name, address, phone number, and email address of their United States agent.
The US Agent must reside or maintain a place of business in the US.
United States Agent
U.S. Agents have been designated since 2003, and foreign companies have not had to update that information since the initial designation
Since 2003, many customs brokers and importers have allowed foreign companies to designate them as the required “U.S. Agent”
New FDA User Fees
New FDA User Fees Effective October 1, 2011FDA Hourly Rate For Reinspections and
Reconditioning: $221 per hour, domestic $289 per hour for foreign travel
Revision Announced August 1, 2012, effective October 1, 2012
FSMA Reinspection Fees
Invoiced to the foreign facility’s designated “U.S. Agent”
That could be an importer who agreed to act as the U.S. Agent
That could be YOU ----- if you have been designated as the “U.S. Agent” by a foreign food facility’s FDA registration
Reinspection
“Reinspection” is one or more inspections subsequent to such an inspection which identified non-compliance materially related to a food safety requirement.
New FDA User Fees
Reinspection Fees Fee is based on the number of direct hours, including:time spent conducting the physical surveillance at the facility,whatever components of such an inspection are deemed
necessarymaking preparations and arrangements for the reinspection
New FDA User Fees
Reinspection Fees traveling to and from the facilitypreparing any reports,analyzing any samplesexamining any labels if requiredperforming other activities until the facility is in compliance.
New FDA User Fees
“Reconditioning Fees” on Imported Food Fees must be paid by owner of food or importer, depending on
circumstancesFees must be paid at the hourly rate for all expenses in
connection with arranging, conducting, and evaluating the results of examinations and additional examinations of product
New FDA User Fees
“Reconditioning Fees” on Imported Food. Will be charged where reconditioning is required to bring food
into complianceWill be charged if product is destroyed
Fees Related to Import Alerts (DWPE)
Will be charged where food is detained by an Import Alert
No charge if food is detained, not subject to an Import Alert, and Shipper or Importer submits satisfactory proof that food is not adulterated.
Fees Related to Import Alerts (DWPE)
Exporters applying for removal from DWPE must pay FDA's hourly charges for evaluating the application, including the cost of inspecting the foreign facility if necessary.
New FDA User Fees
Not Complying with a Recall Order(1) Not initiating a recall as ordered by FDA(2) Not conducting the recall in the manner specified by FDA(3) not providing FDA with information regarding the recall as
ordered by FDA.An importer who does not comply with a recall order is
responsible for paying the feeThe party paying the fee would be the party that received the
recall order.
Other Recent Changes By FSMA Affecting Customs
Brokers, Freight Forwarders and Importers
Prior Notice
Filers need to indicate whether a food product has been refused entry to another country
Registration Suspension
FDA’s power to suspend the registration of food facilities effectively closes any facility that created, caused, or is responsible for food having a reasonable probability of adverse health consequences to humans or animals.
FDA may also suspend registration of facilities suspected to have prior knowledge or involvement in introducing such food into commerce in the United States.
Registration Suspension
Registration may be held in suspension until U.S. FDA determines the cause to be rectified and that no further health consequences exist.
FDA also announced its right to require “corrective action plans” from suspended facilities as proof that no further health consequences exist.
Administrative Detention
Allows FDA to proactively halt food suspected of adulteration or misbranding at the border instead of being required to wait for a proven health concern.
If FDA suspects food to have been produced or processed in unsanitary conditions, the agency may administratively detain food products for up to 30 days.
Import Safety
Voluntary Qualified Importer Program(VQIP) Implementation was due June 2012FDA must establish a user-fee funded VQIP to expedite entry
into the United States of imported food from eligible, qualified importers.
To be eligible to participate, an importer must offer food for importation from a facility that has a certification by an accredited third party.
FDA will qualify eligible importers to participate in VQIP based on risk considerations.
The new law directs FDA to issue guidance on participation in and compliance with VQIP.
Import Safety
Foreign Supplier Verification Program (FSVP)Regulation was due January 2012FSVP requires all importers to conduct risk-based foreign
supplier verification activities to verify that imported food is not adulterated and that it was produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable.
04/11/23
FSMA and Inspections
FDA Registered Facilities
Domestic registrations: 169,884Foreign registrations: 445,884Total: 615,768
**As of May 22, 2012
Inspections and Detentions
U.S. FDA’s review of a facility or product can have serious impact on business
Reasons for Inspection
Routine scheduleSurveyResponse to reported problemFulfillment of FSMA mandate
FDA’s Foreign Inspection History
FDA’s 2010 Foreign Inspection Totals
FSMA Foreign Facility Inspection Schedule
Double the previous year, minimum of:
Year Foreign Inspections
2011 600
2012 1,200
2013 2,400
2014 4,800
2015 9,600
2016 19,200
04/11/23
One Big Challenge…
Detentions
Shipment Detained?
Shipment arrives, FDA has options: 1. Release
2. Detain –Review – Release
3. Detain – Review – Test – Release
4. Detain – Review – Test – Refuse entry
Phone call in the nightIf importer advises you of detention,
ask for a copy of the “Notice of FDA Action.”
Compliance Issues
Misbranding: FDA has jurisdiction to ensure that food labeling is truthful, non-misleading, and adequate to ensure that foods are safe and effective for their intended uses.
Adulteration: FDA has jurisdiction to ensure that foods are properly processed, meet their specifications and are not contaminated.
Analysis of FDA Detentions
Common Reasons for Detention
Failure to label product correctly – Most of these detentions could have been avoided by pre-shipment label review.
Failure to make required electronic filings – Registrations, Process Filings, Prior Notices…
Food Labeling & Ingredients
A top reason product is detained: Incorrect labeling, unapproved ingredients, prohibited health claims
Easy problems to avoidCommon errors in trying to avoid problems:
Copy other wrong labelsOnly follow part of the regulations
“Notice of FDA Action” Example
http://www.accessdata.fda.gov/scripts/importrefusals
OASIS
FDA Automatic Detention
Products from certain countries, foreign manufacturer, a specific product, or shipper may be placed on “Automatic Detention,” also called DWPE.
Reasons may include: article has been manufactured, processed, or packed under
insanitary conditionsarticle is adulterated, misbranded
Removal from FDA Automatic Detention/DWPE
Not easy: FDA must believe the issue(s) causing the listing have been resolved (i.e. what have you changed?);
A minimum of five consecutive non-violative commercial shipments before the FDA will consider removal;
Shipments should represent routine commercial entries and include certain documentation;
A written petition with documentation must be submitted to FDA for their review/action
Proactive versus Reactive
Numerous regulations already existU.S. offers enormous market potential
and products will only need to comply with specific regulations, not all.
Best advice: stay informed. Many changes are coming over the next 4 years.
Investing in compliance is much cheaper than reacting to a failed inspection or detention in the U.S.
Detentions mean demurrage, laboratory testing fees, warehousing fees, cost to “recondition” product, return freight, possible FDA fees, and loss of a customer.
Compliance to U.S. FDA Regulations
BEFORE first shipment to the U.S is
much cheaper than a single detention.
Think about the various costs of a detention:1. Demurrage: $$$ per day
2. Laboratory testing fees: $$$ per sampling/test
3. Warehousing fees: $,$$$ ?
4. Freight cost to return the product: $,$$$ ?
5. Cost to “recondition” the product (re-label, for example): $,$$$ ?
6. Cost of loosing a client: $$$,$$$ ?
7. FDA Fees $$$?
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Founded in 2003, based in Hampton, Virginia, USA with over 100 employees
All services are fixed fee, no hourly rates25,000 total clients served from more than 150 countries“Live Help” on web site19 overseas offices.
Food & Beverage Services
FDA Food Facility RegistrationsRegistration Renewals in 2012U.S. Agent ServiceFood Labeling ReviewsLow-Acid & Acidified Canned Food RegistrationsPrior Notice FilingsDetention AssistanceAudit Service starting October 2012
Pre-Inspection Audit Service
COMING SOON• As part of our U.S. Agent service, Registrar Corp will dispatch
a food safety expert trained in FDA inspections to facilities to help prepare if a notice of FDA inspection after October 1, 2012 is received.
• This assistance is included at no additional charge other than travel and lodging expenses.
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