1. Those Elusive FDA Import Requirements: FSMA, PREDICT & the New FDA October 26, 2011 Sponsored by:

2. Mr. Benjamin L. England is an attorney and the founder of Benjamin L. England & Associates, LLC., and FDAImports.com, LLC. Mr. England routinely represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. Mr. England received many distinguished service awards from the Department of Health and Human Services and FDA during his 17-years of public service. Sponsored by:

3. Those Elusive FDA Import Requirements: FSMA, PREDICT & the New FDA Benjamin L. England Benjamin L. England & Associates, LLC & FDAImports.com, LLC blengland@fdaimports.com 410-740-3403

4. FDA Imports “Normal” Importation Authorities and Processes The “New Normal” – PREDICT – FSMA Questions and Answers

5. FDA Imports “Normal” Importation Authorities and Processes

6. FDA Imports: Authorities Importation from Foreign Sources FDCA Chapter 8; Title 21: FDA's import & export authorities and the Public Health Service Act (PHSA) FDA's broadest regulatory authority affecting interstate distribution of articles FDA retains all other enforcement options at all times while product is in or entering commerce

7. Principal Import Authorities o Sampling Authority – FDA has authority to sample imported products; subject to notice to importer, owner or consignee who may give testimony regarding admissibility of imported products Covers import examinations, inspections, label reviews, records reviews and physical sampling and testing

8. Broad Power to Prevent Entry Refusal Authority Under the statute, if it “appears” from the examination of samples “or otherwise” that: o (1) Imported article was manufactured, processed, packed under insanitary conditions o (2) Imported article is forbidden or restricted in sale in the country in which it was produced or from which it was exported o (3) Imported article is adulterated, misbranded or unapproved Then such article shall be refused admission Refused goods shall be destroyed unless exported

9. “Appearance” and “Or Otherwise” FDA need not prove that a food item is misbranded or is adulterated or is unapproved – just that it appears to be o “Burden of proof”: More than a hunch FDA need not even obtain the evidence it uses from the shipment it is refusing – but can obtain it from any credible source. FDA is turning to new places to get its evidence

10. FDA Import Processes Let's see how FDA does this and how PREDICT will affect what FDA does Then we will look at the FSMA

11. FDA Import Process FDA receives electronic entry data from U.S. importer’s customs broker re: imported product FDA Prior Notice and Customs/FDA Entry data Description of product o FDA Product code (Hx Screened) o Manufacturer and shipper (exporter) (Hx Screened) o FDA Registration numbers of manufacturer o FCE/SID information, if applicable o Commercial and Customs documents (if requested)

12. FDA Import Process (2) FDA Entry Reviewer reviews information and decides whether to: o May Proceed or Release (FDA Entry Reviewer) o Inspect shipment, examine or sample product and its labeling (FDA Investigator) o Detain based upon info supplied (perhaps based upon an Import Alert) (FDA Compliance Officer) o Release shipment based upon inspection, examination, sampling/testing, or based upon the information supplied at the initial declaration (FDA Investigator or Compliance Officer)

13. FDA Import Process (3) If FDA determines the article “may be subject to refusal” (i.e., it “may appear to be” in violation) FDA will detain the shipment, issue a notice, opportunity for importer to correct problems or prove that the problems do not exist o Importer might provide evidence that the violation does not exist (e.g., submit FCE/SID numbers, submit lab reports) o Importer might request permission to do something to remove the violation that does exist (cook it, segregate and retest it, relabel it): Reconditioning

14. FDA Import Process (4) FDA has authority to refuse imported products if the imported food or the manufacturer “appears” to be in violation of the law FDA evidence can come from: Documents provided at entry Inspections of foreign facility Sampling and testing imported food or reviewing label Reviewing prior shipments of food from the same manufacturer (e.g., Import Alert) After FDA refusal, Customs demands redelivery of shipment

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16. FDA Imports Enter: PREDICT

17. PREDICT PREDICT: Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting:  (Cir. 2002, Fados, Washington, DC) o Will replace OASIS system for admissibility decisions o Purpose-Improve import screening & targeting of imported o food sampling and examination to prevent entry of adulterated, misbranded, or otherwise violative goods o Expedite the entry of non-violative goods o NOT Marcs/Oasis Entry Review or Prior Notice

18. PREDICT (2) Purpose:  Improves FDA import targeting on a line-by-line basis based upon RISK factors  Intended to increase the violation rate on FDA examination or inspection basis  Thus reducing the number of negative, or non-violative FDA examinations  Increases the bang of FDA's import-inspection buck  Why important?

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20. PREDICT (3) Purpose:  Ensures visibility and accountability in risk-based decision making  Entry reviewers (and witnesses before congressional panels) can understand why PREDICT may-proceeded or released a line  Not a Black Box  Significantly increases the SOURCE and VARIETY of data FDA can use to assess risk  Why important?

21. PREDICT (4) Source of RISK data:  Historically, FDA (OASIS) used a combination of rules-based and randomized targeting  But FDA screened on INVOICE data only  Primary data:  FDA Product Code (imprecise)  MID (duplicative)  Sometimes Country Code  That's it, but with PREDICT...

22. PREDICT (5) Source of RISK data:  Using automated data-mining and pattern discovery, results feedback, reinforcement, recognition and then prediction  Some might call that “learning”  More like “evolving” rule sets  Using Open Source Intelligence  Some automated queries of Center databases  Registration, Listing, 510(k), NDA, etc.  Substantially more robust – and proven

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25. FDA Imports FSMA

26. FSMA (very) Generally Hazard Analysis & Risk Preventive Controls Foreign Supplier Verification Program Qualified Importer Program (Voluntary) Facility Inspections (increased – domestic but esp. foreign!) 600 U.S. inspections by 01/04/2012, 19,200 foreign by 01/04/2017 Mandatory Recall Authority – will rarely be used Reportable Food Registry – Facility Registrations – Renewals Every Two Years FEES $$$

27. Akin to the already established HACCP standards Requirements: Conduct hazard analysis, develop and implement preventive controls, and monitor the control’s effectiveness Develop a written plan for controlling hazards Reanalyze for potential hazards at least every three years Verify the effectiveness of the controls Maintain records of the verification process

28. Every Importer Must Establish a Plan That Verifies: That the foreign supplier complies with HARPC That the food is not adulterated or misbranded by failing to disclose major food allergens Importer must maintain records for no less than 2 years Noncompliance is grounds for refusal of an imported article Effective date Jan 4, 2013

29. FDA must establish voluntary program in order to expedite importation. Eligibility is determined by overall safety of food offered for import. Importers must obtain certification by third-party auditors (designated by FDA). Regulations due by January 4, 2012

30. FDA’s Authority to Collect Fees Mandatory Food Recalls Reinspection of a Food Facility Reinspection of an Imported Article Qualified Importer Program

31. FDA Imports Questions and Answers

32. Benjamin L. England Benjamin L. England & Associates, LLC & FDAImports.com, LLC blengland@fdaimports.com 410-740-3403 Those Elusive FDA Import Requirements: FSMA, PREDICT & the New FDA

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