US FDA Food Safety Modernization Act-Future Impact on Asia

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Presented at the Conference section of Food & Hotel Singapore, 9 April 2014

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US FDA Food Safety Modernization Act-Future Impact on Asia

  1. 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. 2 Current & Future Requirements  Background  Motivation and Concept  Proposed Rules  Effects on Foreign Manufacturers  Questions & Answers
  3. 3. 3 FDA Food Safety Modernization Act: Facts 2011 1938
  4. 4. 4 FDA Food Safety Modernization Act: Facts
  5. 5. 5 U.S. Regulation Overview
  6. 6. 6 Federal Register Citation
  7. 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. 8 Code of Federal Regulations
  9. 9. 9 Motivators for FSMA: Facts 48,000,000 Americans get sick 128,000 are hospitalized 3,000 die
  10. 10. High Profile Cases Imports in the spotlight over past decade:
  11. 11. 11 United States Imports
  12. 12. 12 Import Statistics Medical Devices Drugs Foods
  13. 13. 13 Burden on Importers and Foreign Manufacturers FSMA makes importers more responsible for quality of products from foreign manufacturers
  14. 14. 14 Vision of FSMA: Prevention
  15. 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. 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. 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. 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. 19. What is a Food Safety Plan?  Conduct a Hazard Analysis  Establish Preventative Controls  Monitoring  Corrective Actions  Verification Activities  Recordkeeping Prevention 19
  20. 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. 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. 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. 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. 24. Vision of FSMA: Inspections, Compliance and Response 24
  25. 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. 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. 27. Foreign Facility Inspection Schedule Inspections, Compliance, & Response 0 5000 10000 15000 20000 25000 2011 2012 2013 2014 2015 2016 Inspections Year 27
  28. 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. 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. 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. 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. 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. 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. 34. Vision of FSMA: Import Safety 34
  35. 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. 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. 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. 38. Foreign Supplier Verification Program for Importers of Food Import Safety All importers must establish, maintain, and follow a FSVP 38
  39. 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. 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. 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. 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. 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. 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. 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. 46 Vision of FSMA: Enhanced Partnerships
  47. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 58
  59. 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. 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. 61 Questions?

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