This document provides an overview of the U.S. Food and Drug Administration's Food Safety Modernization Act and its future impact on food importers and manufacturers in Asia. It discusses key components of the act related to prevention, inspections and compliance, import safety, and enhanced partnerships. The act aims to shift the U.S. food safety focus from response to prevention. It establishes standards for food production and imports and increases inspections of domestic and foreign facilities. Foreign manufacturers will face greater oversight and responsibility to meet new food safety requirements.

1. The U.S. Food and Drug
Administration’s Food Safety
Modernization Act:
Future Impact on Asia
David Lennarz
Vice President, Registrar Corp
April 2014
114/04/2014

2. 2
Current & Future Requirements
 Background
 Motivation and Concept
 Proposed Rules
 Effects on Foreign Manufacturers
 Questions & Answers

3. 3
FDA Food Safety Modernization Act: Facts
2011
1938

4. 4
FDA Food Safety Modernization Act: Facts

5. 5
U.S. Regulation Overview

6. 6
Federal Register Citation

7. 7
Code of Federal Regulations
 The Food, Drug, and
Cosmetic Act is detailed
in what we call the Code
of Federal Regulations or
“CFR”
 The CFR is a codification
of the general and
permanent rules published
in the “Federal Register”

8. 8
Code of Federal Regulations

9. 9
Motivators for FSMA: Facts
48,000,000 Americans get sick
128,000 are hospitalized
3,000 die

10. High Profile Cases
Imports in the spotlight over past decade:

11. 11
United States Imports

12. 12
Import Statistics
Medical Devices Drugs
Foods

13. 13
Burden on Importers
and Foreign Manufacturers
FSMA makes importers more responsible for quality of
products from foreign manufacturers

14. 14
Vision of FSMA: Prevention

15. 15
Key Components
Prevention
 Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for
Human Food
• Proposed Rule Released January 4, 2013
• Comment period ended on November 22, 2013
 Standards for the Growing, Harvesting, Packing and
Holding of Produce for Human Consumption
• Proposed Rule Released January 4, 2013
• Comment period until November 22, 2013
Prevention

16. Mandatory Preventative
Controls for Food
• Two parts –
• New provisions requiring Hazard Analysis and Risk-based
Preventative Controls
• Revises existing CGMPs in 21 CFR part 110 and places
both new requirements into a new Part 117
• Affects all firms required to register under the
Bioterrorism Act, with exemptions
Prevention
16

17. Hazard Analysis and Risk-
based Preventative Controls
• Science and risk-based to prevent hazards to public
health
• Flexible in that firms develop these to fit their products
and operations in order to significantly minimize or
prevent all food safety hazards reasonably likely to
occur
• Similar to HACCP currently required by FDA for
seafood and juice and is common practice in many
companies worldwide
Prevention
17

18. How does this differ from
HACCP?
 Differs from HACCP in that preventative controls may
be required at points other than at critical control points
and critical limits would not be required for all
preventative controls.
 A written Food Safety Plan must be developed and
implemented
Prevention
18

19. What is a Food Safety Plan?
 Conduct a Hazard Analysis
 Establish Preventative Controls
 Monitoring
 Corrective Actions
 Verification Activities
 Recordkeeping
Prevention
19

20. Components of a
Food Safety Plan
• Must be prepared by a “Qualified Individual”
• “Qualified Individual” has training in standardized
curriculum, or be otherwise qualified through job
experience to develop and apply a food safety system
• Prepares plan, develops hazard analysis,
validates preventative controls, reviews
records, and conducts reanalysis of food
safety plan
Prevention
20

21. Mandatory Produce Safety
Standards –Proposed Rule
 Establishes science-based standards for growing,
harvesting, packing, and holding produce on domestic
and foreign farms
 Identifies routes of microbial contamination
• Agricultural water;
• biological soil amendments of animal origin;
• health and hygiene;
• animals in the growing area;
• equipment, tools, and buildings
Prevention
21

22. Mandatory Produce Safety
Standards – What’s Covered?
Prevention
22
• Covers fruits and vegetables in raw or
natural (unprocessed) state
• Exemptions include agricultural
commodities rarely consumed raw and
products that will be commercially
processed (such as canned)

23. Mandatory Produce Safety
Standards – When?
 Of all FSMA rules, Produce Safety is most contentious
 Public meetings with farmers has shed light on practical
problems
 FDA itself has publically stated final rule will likely look very
different than proposed rule
Prevention
23

24. Vision of FSMA: Inspections,
Compliance and Response
24

25. Key Components
Inspections, Compliance, and Response
• Mandated Inspection Frequency - Immediate
• Records Access – Immediate
• Registration Renewal: Each food facility must renew its U.S.
FDA registration every two years -- October 2012 – December
2012 (extended until January 31, 2013)
• Mandatory Recall - Immediate
• Expanded Administrative Detention - Effective July 2011
• Suspension of Registration - Effective June 2011
Inspections,
Compliance,
& Response
25

26. Mandated Inspection
Frequency
 Based on Risk, numbers to increase
 Foreign facilities: within one year of the bill’s signing,
FDA is to increase inspections of foreign facilities, and
then increase that number every year for five years.
Inspections,
Compliance,
& Response
26

27. Foreign Facility
Inspection Schedule
Inspections,
Compliance,
& Response
0
5000
10000
15000
20000
25000
2011 2012 2013 2014 2015 2016
Inspections
Year
27

28. Registration Renewal
 Required for both domestic and foreign facilities
 “Facility” is a location that manufactures, processes, packs, or
warehouses food or beverages for human or animal
consumption
 Required between October 1st and December 31st of
every even year starting in 2012
Inspections,
Compliance,
& Response
28

29. Registration Statistics
Inspections,
Compliance,
& Response
0
50000
100000
150000
200000
250000
300000
Foreign Facility Domestic Facility
Registrations
Facility Type
Registrations prior to December 31, 2012
29

30. Registration Statistics 2/19/14
 FDA purged database of those that failed to renew in
early 2013
 New February 19, 2014 statistics now show:
 81,575 US Facilities
 115,753 Non-U.S. Facilities
TOTAL: 197,328 versus +/- 430,000 in 2012
Approximately 50% of all registrations were deleted
Inspections,
Compliance,
& Response
30

31. Registration Statistics 2/19/14
 China: 10,180 USA: 81,575
 Japan: 13,296 France: 9,952
 Korea: 3,805 Italy: 9,243
 India: 3,133 Mexico: 8,465
 Taiwan: 1,874 Canada: 6,533
 Thailand: 1,555 Spain: 4,426
 Vietnam: 1,385 Chile: 2,603
 Indonesia: 970 Germany: 2,287
 Malaysia: 903 Singapore: 743 (2009)
Inspections,
Compliance,
& Response
31

32. Registration Renewal
 Facilities that failed to renew must now re-register
 A new number is issued
 Failure to renew will prevent issuance of a Prior Notice
Confirmation Number, therefore preventing the
submission (the FFRM and PNSI are now linked)
Inspections,
Compliance,
& Response
32

33. Suspension of Registration
 FDA may by order suspend the
registration of a facility
 reasonable probability of causing
serious adverse health consequences
or death to humans or animals
 If the registration of a facility
is suspended
 no person can import or export food
into the United States from that
facility
Inspections,
Compliance,
& Response
33

34. Vision of FSMA: Import Safety
34

35. Key Components
Import Safety
• Voluntary Qualified Importer Program
• Guidance Document Not Yet Released
• Foreign Supplier Verification Program
• Proposed Rule Released July 26, 2013
• Comment Period ended on January 27, 2014
Import
Safety
35

36. Voluntary Qualified Importer
Program (VQIP)
 FDA to establish a Voluntary Qualified Importer Program
(VQIP) to expedite entry into the United States of
imported food from eligible, qualified importers.
 FDA will qualify eligible importers to participate in
VQIP based on risk considerations.
Import
Safety
36

37. Voluntary Qualified
Importer Program
 FDA will charge a User Fee for importers wishing to
enroll in the program
 Guidance document has not yet been issued
 Similar to C-TPAT?
 Will large importers and retailers embrace VQIP?
 Will small importers be excluded by cost or complexities
of the program?
Import
Safety
37

38. Foreign Supplier Verification
Program for Importers of Food
Import
Safety
All importers must
establish, maintain, and
follow a FSVP
38

39. Foreign Supplier Verification
Program for Importers of Food
 Proposed regulations vary based on type of food
(processed, produce, dietary supplements)
 Important: the obligations are placed on the importer,
which in turn will place some obligations on the foreign
manufacturer
Import
Safety
39

40. Foreign Supplier Verification
Program for Importers of Food
Key components:
 Importer to maintain list of foreign suppliers
 Perform supplier compliance status review
 Conduct hazard analysis through verification activities
 Conduct investigative & corrective actions (as needed)
 Reassess FSVP periodically
 Supply importer identification (DUNs Number)
 Maintain Records
Import
Safety
40

41. Conduct Compliance Status
Review
 Importers required to review compliance status of the
food and foreign supplier before importing.
 FDA Warning Letters
 Import Alerts
 Certification requirements
 What does this mean for
you? Importers will be
watching you more closely.
Import
Safety
41

42. Periodic Reassessment of the
FSVP
 Importers required to reassess their FSVP within three
years of establishing the plan
 Sooner if they become aware of new information about potential
hazards associated with the food
 How does that affect you? Importers will look to you for
updated information on hazards
Import
Safety
42

43. Modified FSVP Requirements
 Proposed rule defines “very small importer” and “very
small foreign supplier” as having annual food sales of no
more than $500,000
 Eligibility would have to be documented annually and
importers would have to obtain written assurances every 2
years that their suppliers are complying
Import
Safety
43

44. Modified FSVP
Requirements
 Food from a foreign supplier in good compliance
standing with a food safety system that FDA has
officially recognized as comparable or equivalent
 New Zealand has been recognized
 Perhaps the European Union and Canada next?
Import
Safety
44

45. Modified FSVP
Requirements
 Modified FSVP requirements for
 Juice and seafood from facilities compliant with HACCP
 Alcoholic beverages
 Food imported for research or evaluation purposes;
 Food imported for personal consumption; and
 Food that is transshipped or imported for further processing and
export.
Import
Safety
45

46. 46
Vision of FSMA: Enhanced Partnerships

47. Key Components
Enhanced Partnerships
• Third Party Audits / Certification
• Proposed Rule Released July 26, 2013
• Comment Period ended January 27, 2014
• Capacity Building
• Outreach through training
• Establishment of overseas offices
• China offices of FDA established
Enhanced
Partnerships
47

48. Third Party Audit Concept
 Allows FDA to leverage industry audits
 A credible third-party program will help to facilitate entry
of certain imported foods under VQIP
 A comprehensive third-party program will create a new
path for working with foreign governments
Enhanced
Partnerships
48

49. Third-Party Audits
 Proposed Rule covers development of a program to
establish Accreditation Bodies and Third Party Auditors
seeking recognition by the FDA. Encompasses:
 The monitoring and oversight of participating accreditation
bodies and auditors
 The auditing and certification of foreign food facilities
 Notifying the FDA of conditions in an audited facility that could
cause or contribute to a serious risk to the public health.
Enhanced
Partnerships
49

50. Capacity Building
 FSMA directs FDA to develop a comprehensive plan to
expand the technical, scientific, and regulatory food
safety capacity of foreign governments and their
respective food industries
Enhanced
Partnerships
50

51. New User Fees under
FSMA
 New FDA User Fees: October 1, 2011
 FDA Hourly Rates for Fiscal Year 2014:
 $237 per hour, domestic
 $302 per hour, foreign activities
 Charged for:
 DWPE Petition Review
 Reconditioning
 Re-Inspections
 VQIP
Enhanced
Partnerships
51

52. New User Fees under
FSMA
 Re-inspection Fees are calculated for:
 Traveling to and from the facility
 Preparing reports
 Analyzing samples
 Examining labels
 Thus far, FDA has not issued re-inspection fees
 Guidance document pending
Enhanced
Partnerships
52

53. New User Fees under FSMA
 Re-inspection Fees
 Will be charged to the facility’s U.S. Agent listed in Section 7 of
the food facility registration module
 An importer who was listed as the U.S. Agent in a foreign
registration may be liable even if they were listed in 2003 and no
longer conduct business with the foreign facility
Enhanced
Partnerships
53

54. U.S. Agent Responsibilities
 US Agent is designated in
Section 7, FFRM
 US Agent must:
 Reside in USA
 Be available 24/7
 Answer questions as
though they are
answering for registrant
 Should know how to
deal with FDA.
Enhanced
Partnerships
54

55. Takeaways…
 FSMA phased in over years
 New rules will have a great impact on Asian and firms
worldwide
 Final Rules likely to be different than proposed rules,
especially for Produce
 Smaller manufacturers who ignore rules will likely face
greater risk of Import Alert
55

56. In Summary…
 U.S. remains a market of volume and high value
 Dedicate resources now to food safety to avoid expensive
problems later
 FSMA is phased in over time, final rules yet to be
announced.
 Once final rules are released, Registrar Corp will offer a
range of services to help foreign manufacturers comply
with FSMA.
56

57. About Us
 Registration & US Agent Service
 FDA Prior Notice Submissions
 Labeling and Ingredient Reviews
 LACF Registration & Process Filing Submissions
 Detention Assistance & Removal from DWPE
 Mock FDA Inspections
 HACCP and Food Safety Plan Development
57

58. 58

59. Contact Us: USA Office
Registrar Corp Headquarters
144 Research Drive
Hampton, Virginia
USA 23666
P: +757-224-0177
F: +757-224-0179
E: info@registrarcorp.com
www.registrarcorp.com
16/10/2013 59

60. 60
Registrar Corp Office in China
Registrar Corp's Office in China
(美国FDA REGISTRAR公司深圳代表处隶属于
Registrar Corp公司,负责其在中国境内相关业务。)
Room 606-608, Block A, Rongchao Binhai Building,
No. 5 Xinghua 1st Road, Bao'an CBD
Shenzhen City
People's Republic of China 518101
Phone: 400-860-0210 / +86-755-82070649
Fax: +86-755-82070866
Mobile: +86-18926783540 / 13794462358
Email: china@registrarcorp.com
www.registrarcorp.com

61. 61
Questions?