Learn about the new regulations under the U.S. FDA Food Safety Modernization Act (FSMA), including new requirements for U.S. Agents.

1. U.S. FDA Food Safety
Modernization Act: Are you
Ready?
Presented by Cornelia Rooks,
Senior Regulatory Specialist
Registrar Corp
August 2012
11/01/12

2. FDA Food Safety Modernization Act
“FSMA” signed by President Obama 01/04/2011
Phased in over time thru 2016
Most significant update to food safety laws since 1938

3. 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.

4. High Profile Cases
Imports in the spotlight
Melamine in pet food
Illegal antibiotics in aquaculture
Better detection of common pathogens, and strains of new
pathogens.

5. Imports of FDA-Regulated Food Have
Almost Doubled Since 2002

6. 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

7. Vision of FSMA
Prevention
Inspections,
Enhanced
Compliance,
Partnerships
and Response
Import Safety

8. NEW FDA REQUIREMENTS
CURRENTLY IN EFFECT

9. 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-

10. 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.

11. 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.

12. 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”

13. New FDA User Fees
New FDA User Fees Effective October 1, 2011
FDA 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

14. 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

15. Reinspection
“Reinspection” is one or more inspections subsequent to
such an inspection which identified non-compliance
materially related to a food safety requirement.

16. 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
necessary
making preparations and arrangements for the reinspection

17. New FDA User Fees
Reinspection Fees
traveling to and from the facility
preparing any reports,
analyzing any samples
examining any labels if required
performing other activities until the facility is in compliance.

18. New FDA User Fees
“Reconditioning Fees” on Imported Food
Fees must be paid by owner of food or importer, depending on
circumstances
Fees 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

19. New FDA User Fees
“Reconditioning Fees” on Imported Food.
Will be charged where reconditioning is required to bring food
into compliance
Will be charged if product is destroyed

20. 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.

21. 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.

22. 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 fee
The party paying the fee would be the party that received the
recall order.

23. Other Recent Changes By
FSMA Affecting Customs
Brokers, Freight Forwarders
and Importers

24. Prior Notice
 Filers need to indicate whether a food product has been refused entry to
another country

25. 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.

26. 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.

27. 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.

28. Import Safety
Voluntary Qualified Importer Program(VQIP)
Implementation was due June 2012
FDA 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.

29. Import Safety
Foreign Supplier Verification Program (FSVP)
Regulation was due January 2012
FSVP 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.

30. FSMA and Inspections
11/01/12

31. FDA Registered Facilities
Domestic registrations: 169,884
Foreign registrations: 445,884
Total: 615,768
**As of May 22, 2012

33. Inspections and Detentions
U.S. FDA’s review of a facility or product can have
serious impact on business

34. Reasons for Inspection
Routine schedule
Survey
Response to reported problem
Fulfillment of FSMA mandate

35. FDA’s Foreign Inspection History

36. FDA’s 2010 Foreign Inspection Totals

37. 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
11/01/12

38. One Big Challenge…

39. Detentions

40. 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 night
If importer advises you of detention,
ask for a copy of the “Notice of FDA Action.”

41. 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.

42. Analysis of FDA Detentions

43. 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…

44. Food Labeling & Ingredients
A top reason product is detained:
Incorrect labeling, unapproved ingredients, prohibited
health claims
Easy problems to avoid
Common errors in trying to avoid problems:
Copy other wrong labels
Only follow part of the regulations

45. “Notice of
FDA Action”
Example

46. OASIS
http://www.accessdata.fda.gov/scripts/importrefusals

47. 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 conditions
article is adulterated, misbranded

48. 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

49. Proactive versus Reactive
 Numerous regulations already exist
 U.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.

50. 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): $,$$$ ?
6. Cost of loosing a client: $$$,$$$ ?
7. FDA Fees $$$?


51. About Registrar Corp
Expertise in Food & Beverages, Medical Devices,
Cosmetics, Radiation Emitting Devices, and Drugs
Founded in 2003, based in Hampton, Virginia, USA
with over 100 employees
All services are fixed fee, no hourly rates
25,000 total clients served from more than 150 countries
“Live Help” on web site
19 overseas offices.

52. Food & Beverage Services
FDA Food Facility Registrations
Registration Renewals in 2012
U.S. Agent Service
Food Labeling Reviews
Low-Acid & Acidified Canned Food Registrations
Prior Notice Filings
Detention Assistance
Audit Service starting October 2012

53. 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.

54. Need Additional Assistance?
US Agent and Detention Services
 Drug Products
 Establishment Registration
 Product Listing
 Label & Ingredient Reviews
 Drug Master Files (DMF)
 Medical Devices
 Establishment Registration
 Device Listings
 510(k) Administrative Review
 Medical Device Master Files (MAF)

55. About Registrar Corp
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +757-224-0177
F: +757-224-0179
E: info@registrarcorp.com

56. Questions & Answers
info@registrarcorp.com