1. PPQ’s Biological and Technical Services (BTS) Michael J. Firko, Ph.D. Director, Biological and Technical Services (301) 734-8760 ASTA/APHIS Meeting 10 November, 2004 10 November, 2004 _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

2. Some Early Historical Items Pertinent to PPQ’s Mission  1862 – Creation of USDA  Late 1800’s-early 1900’s – Efforts to establish Plant Protection Legislation  within USDA and elsewhere  1910 – First shipment of Cherry Trees from Japan APHIS, PPQ, Plant Health Programs - Biological and Technical Services _______________________________________________________________________

3. 1910: A Gift from Japan USDA Inspection of Cherry Trees APHIS, PPQ, Plant Health Programs - Biological and Technical Services

4. _______________________________________________________________________ 1910: USDA Burns Cherry Trees due to Insect pests and Diseases due to Insect pests and Diseases APHIS, PPQ, Plant Health Programs - Biological and Technical Services

5. Some Early Historical Items Pertinent to PPQ’s Mission  1912 – Plant Quarantine Act, Create Federal Horticultural Board  1928 – Create Plant Quarantine and Control Administration (PQCA)  1957: Federal Plant Pest Act  2000: Plant Protection Act APHIS, PPQ, Plant Health Programs - Biological and Technical Services _______________________________________________________________________

6. APHIS, PPQ, Plant Health Programs - Biological and Technical Services

7. Types of PPQ Permits Fruits & Vegetables (Part 319.56)Fruits & Vegetables (Part 319.56) Nursery Stock, Plants, Roots, Bulbs, Seeds, etc. (Part 319.37)Nursery Stock, Plants, Roots, Bulbs, Seeds, etc. (Part 319.37) Canadian (Part 319.37)Canadian (Part 319.37) Departmental (for prohibited plant material, various regulations)Departmental (for prohibited plant material, various regulations) Plant Pests (Part 330.200) (~ 35%)Plant Pests (Part 330.200) (~ 35%) Honeybees and honeybee semen (Part 322)Honeybees and honeybee semen (Part 322) Exotic bee diseases and parasites (Part 319.76)Exotic bee diseases and parasites (Part 319.76) Khapra Beetle / Brassware (Part 319.75)Khapra Beetle / Brassware (Part 319.75) General / CITES (Part 355)General / CITES (Part 355) Log and Lumber, etc. (Part 319.40)Log and Lumber, etc. (Part 319.40) Soil (Part 330.300)Soil (Part 330.300) Noxious Weeds (Part 360)Noxious Weeds (Part 360) Corn (Parts 319.24 and 319.41)Corn (Parts 319.24 and 319.41) Sugercane (Part 319.15)Sugercane (Part 319.15) Cotton (Part 319.8)Cotton (Part 319.8) Citrus (Part 319.28)Citrus (Part 319.28) Rice (Part 319.55)Rice (Part 319.55) Transit (Part 352)NOTE: All Parts from 7 CFRTransit (Part 352)NOTE: All Parts from 7 CFR _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

8. _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services Type of Permit No. days (2003) Post Entry 2.2 Timber and Timber Products 2.1 Departmental2.2 Soil5.0 Canadian3.5 Corn1.8 Sugercane1.0 Rice1.0 Cotton5.0 Brass1.0 Transit1.6 Average Permit Issuance Times

9. _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services BTS ISO 9001 Certification: Plant and Plant Product Permits

10. Seed Permits 84 % of total U.S. imports of seeds for planting come from: ChileMexico NetherlandsArgentina ChinaJapan FinlandAustralia DenmarkIndia _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

11. “Phyto” Requirements Phytosanitary certificates issued by a PQ Official in originating country Valid for not more than 15 days Is addressed to PPQ Must contain description of restricted article Must certify that seeds have been inspected thoroughly and found free of injurious plant diseases, etc. Contains any additional specific declarations required under regulations _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

12. Plant Pest Permits and Select Agent Registration _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

13. Laws & Regulations: Possession and Transfer of Plant Pathogens Law/Statute Written by U.S. Congress Regulation Written by USDA (as directed by Congress) Agricultural Bioterrorism Protection Act of 2002 7 CFR 331 “Select Agent” Program _______________________________________________________________________ Plant Protection Act of 2000 7 CFR 330 Plant Pest Permitting APHIS, PPQ, Plant Health Programs - Biological and Technical Services

14. General Comparison of Permitting and Select Agent Registration Permit: 7 CFR Part 330 Import or interstate movement of all plant pests and pathogensImport or interstate movement of all plant pests and pathogens Most permits require laboratory inspectionMost permits require laboratory inspection Provides for deregulation of specific regulated articlesProvides for deregulation of specific regulated articles _______________________________________________________________________ Registration: 7 CFR Part 331 Possession, use, or transfer of listed Select AgentsPossession, use, or transfer of listed Select Agents All registrations require laboratory inspectionAll registrations require laboratory inspection Certain exemptionsCertain exemptions All staff need FBI Security Risk AssessmentAll staff need FBI Security Risk Assessment Security and biosafety plans requiredSecurity and biosafety plans required APHIS, PPQ, Plant Health Programs - Biological and Technical Services

15. Regarding possession, use, and transfer of listed agents: “…7 CFR 331.13(a)… incorporate(s) the existing permit requirements under the plant pest regulations in 7 CFR part 330.” (Preamble to 7 CFR 331, p.76918) (Preamble to 7 CFR 331, p.76918) _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

16. From the U. S. Congress Plant Protection Act, 2000 (language carried over from Plant Pest Act, 1957) “… “… no person shall import, enter, export, or move in interstate commerce any plant pest, unless the importation, entry, exportation, or movement is authorized under general or specific permit…” _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

17. Plant Pest Permits Required for: All import and interstate movement of any plant pest or disease, including…All import and interstate movement of any plant pest or disease, including… Plant material and specimens being moved for the purpose of pest or disease diagnosisPlant material and specimens being moved for the purpose of pest or disease diagnosis Intrastate movement of plant pests if the pest was moved originally into state under permitIntrastate movement of plant pests if the pest was moved originally into state under permit _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

18. _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

19. Plant Pest Permits: Recent Change Stimuli (in chronological order) PPQ Safeguarding ReportPPQ Safeguarding Report Self-imposed ISO-9000 disciplineSelf-imposed ISO-9000 discipline 9-11 terrorist activities9-11 terrorist activities Anthrax lettersAnthrax letters _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

20. Responses to Change Stimuli: Issuance of Plant Pest Permits Applicant must sign permit conditionsApplicant must sign permit conditions Increased Laboratory InspectionsIncreased Laboratory Inspections Essential prohibition on “Hand Carry” for importationsEssential prohibition on “Hand Carry” for importations NOTE: PPQ is in the process of drafted “new” permitting regulations (7 CFR Part 330) _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

21. Responses to Change Affecting Issuance of Plant Pest Permits Shipping Labels:Shipping Labels: Now… account for labelsNow… account for labels Future… Bar-Code tracking of packages (ePermits, Release 2)Future… Bar-Code tracking of packages (ePermits, Release 2) Permitted material must enter through PPQ (Plant) Inspection StationsPermitted material must enter through PPQ (Plant) Inspection Stations New law: Agriculture Bioterrorism Protection Act of 2002 (ABPA)New law: Agriculture Bioterrorism Protection Act of 2002 (ABPA) _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

22. Permits Issuance: A Few Operating Philosophies First in, first out First in, first out Consistency (with caveats) Consistency (with caveats) Transparency Transparency Science-based Science-based Risk-based Risk-based _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

23. Some Pest Permit Statistics _______________________________________________________________________Year Number of Permits Average Issuance, days 2004 3596 (July) 41 2003436862 2002483255 2001434460 APHIS, PPQ, Plant Health Programs - Biological and Technical Services

24. Permit Statistics: Pathogen Permits _______________________________________________________________________Year # Permits # Pending Av. Days 2004 829 (July) 39170 200311809198 2002107120117 20019222102 APHIS, PPQ, Plant Health Programs - Biological and Technical Services

25. Steps We’re Taking to Improve Efficiency and Response Time ePermits (current data base = JPS) ePermits (current data base = JPS) For the first time – a single APHIS Permit Data Base (PPQ, VS, BRS, other USDA Agencies ??)For the first time – a single APHIS Permit Data Base (PPQ, VS, BRS, other USDA Agencies ??) ISO 9001ISO 9001 Currently certified: Plant & Plant ProductsCurrently certified: Plant & Plant Products Currently preparing for audit:Currently preparing for audit: Plant Pest PermitsPlant Pest Permits PPQ’s Select Agent ProgramPPQ’s Select Agent Program NIS’ “Urgent” ProcessNIS’ “Urgent” Process Transit PermitsTransit Permits _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

26. Steps We’re Taking to Improve Efficiency and Response Time Permits for Widely Prevalent Plant PathogensPermits for Widely Prevalent Plant Pathogens Agreements with APS (American Phytopathological Society) for construction of State-by-state lists of widely prevalent pathogens (WPP, fungi, viruses, bacteria and mycoplasmas)Agreements with APS (American Phytopathological Society) for construction of State-by-state lists of widely prevalent pathogens (WPP, fungi, viruses, bacteria and mycoplasmas) Creation of New Permitting Process for WPPCreation of New Permitting Process for WPP State pre-approvalState pre-approval only for interstate movement of domestic isolates not intended for field studiesonly for interstate movement of domestic isolates not intended for field studies _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

27. Permit Requirements (in part) PPQ Form 599 Label on Exterior of All PackagesPPQ Form 599 Label on Exterior of All Packages Package addressed to inspection station identified on 599 label for PPQ Inspection/ClearancePackage addressed to inspection station identified on 599 label for PPQ Inspection/Clearance Adequate Packaging to Contain Enclosed OrganismsAdequate Packaging to Contain Enclosed Organisms Valid PermitValid Permit Valid delivery address as identified on permitValid delivery address as identified on permit APHIS, PPQ, Plant Health Programs - Biological and Technical Services _______________________________________________________________________

28. APHIS, PPQ, Plant Health Programs - Biological and Technical Services _______________________________________________________________________ Plant Pest Permit Shipping Label: PPQ Form 599

29. APHIS, PPQ, Plant Health Programs - Biological and Technical Services _______________________________________________________________________ PPQ Form 599: Reverse side

30. Import of Plant Pests: DHS-CBP Role Administrative Processing Only – Not InspectionAdministrative Processing Only – Not Inspection Risks associated with most permits – CBP instructed not to open in unsecured location.Risks associated with most permits – CBP instructed not to open in unsecured location. All Permitted Packages Held for USDA Clearance (BEFORE) Customs ClearanceAll Permitted Packages Held for USDA Clearance (BEFORE) Customs Clearance PPQ Inspection Station Routing CriticalPPQ Inspection Station Routing Critical _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

31. Import of Plant Pests: Carrier Expectations/Processing FedEx does not include permit information on manifest FedEx does not include permit information on manifest we would like this info on manifest to facilitate clearancewe would like this info on manifest to facilitate clearance FedEx will not guarantee port of entry FedEx will not guarantee port of entry If package not addressed to Inspection Station Fedex must reroute for USDA clearance, then back to port of entry for Customs clearance – costs, delaysIf package not addressed to Inspection Station Fedex must reroute for USDA clearance, then back to port of entry for Customs clearance – costs, delays Will not guarantee overnight delivery when routed to PPQ Inspection Station – 1 to 2 day delayWill not guarantee overnight delivery when routed to PPQ Inspection Station – 1 to 2 day delay APHIS, PPQ, Plant Health Programs - Biological and Technical Services _______________________________________________________________________

32. Additional Challenges CBP’s Automated Targeting SystemCBP’s Automated Targeting System CBP targets USDA permitted materialCBP targets USDA permitted material Fish and Wildlife Service InspectorsFish and Wildlife Service Inspectors Food and Drug Administration InspectorsFood and Drug Administration Inspectors _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

33. Public Health Security and Bioterrorism Preparedness Response Act of 2002 Signed into law June 12, 2002 _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

34. The Act Required USDA-APHIS and HHS- CDC to Write and Implement New Regulations Within About Two Months Interim Final Rules: Possession, Use and Transfer of Biological Agents and Toxins 7 CFR Part 331 7 CFR Part 331 - Plant Protection & Quarantine 9 CFR Part 121 9 CFR Part 121 - Veterinary Services 42 CFR Part 73 42 CFR Part 73 - Centers for Disease Control and Prevention _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

35. Public Health Security and Bioterrorism Preparedness Response Act of 2002 Purpose: To improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies - Title II, Subtitle B cited as… Agricultural Bioterrorism Protection Act of 2002 _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

36. Mandate to Create a List of Select Agents (from ABPA) “LIST OF BIOLOGICAL AGENTS AND TOXINS. — The Secretary of Agriculture shall by regulation establish and maintain a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products.” _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

37. PPQ’s Select Agent Program Ten “Select Agents” (all plant pathogens) 4 Fungi, 5 Bacteria, 1 Virus4 Fungi, 5 Bacteria, 1 Virus _______________________________________________________________________FungusDisease Peronosclerospora philippinensis Philippine downy mildew of corn Phakopsora pachyrhizi Soybean rust Sclerophthora rayssiae var. zeae Brown stripe downy mildew of corn Synchytrium endobioticum potato wart APHIS, PPQ, Plant Health Programs - Biological and Technical Services

38. PPQ’s Select Agent Program BacteriumDisease Liberobacter africanus Citrus greening disease Liberobacter asiaticus Citrus greening disease Ralstonia solanacearum, race 3, biovar 2 Brown rot of potato Bacterial wilt of potato Xanthomonas oryzae pv. oryzicola Bacterial leaf streak of rice Xylella fastidiosa, citrus variagated chlorosis strain citrus variagated chlorosis _______________________________________________________________________VirusDisease Plum Pox Potyvirus Plum pox APHIS, PPQ, Plant Health Programs - Biological and Technical Services

39. Exemptions Diagnostic and Clinical Facilities, as long as they… Report identification:Report identification: Verbally within 24 hrVerbally within 24 hr On Form 2044 within 7 daysOn Form 2044 within 7 days Inactivate or transfer agent to registered entityInactivate or transfer agent to registered entity NOTE: Facilities maintaining viable agents as positive controls must register _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

40. Exemptions The Administrator may grant a specific exemption upon a showing of good cause (and written request) and upon his or her determination that such exemption is consistent with protecting animal or plant health, and animal or plant products (7 CFR Part 331.4(b) and 9 CFR 121.5(f))The Administrator may grant a specific exemption upon a showing of good cause (and written request) and upon his or her determination that such exemption is consistent with protecting animal or plant health, and animal or plant products (7 CFR Part 331.4(b) and 9 CFR 121.5(f)) _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

41. Transfers Both sender and receiver must be registered or exemptBoth sender and receiver must be registered or exempt Transfer must be submitted and approved prior to transferTransfer must be submitted and approved prior to transfer Applies to both Intra- and Interstate Transfer, and ImportApplies to both Intra- and Interstate Transfer, and Import At this point, no regulatory requirements regarding export (under OGC review)At this point, no regulatory requirements regarding export (under OGC review) _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

42. Civil & Criminal Penalties  Violation of any provisions of the regulations: up to $250,000 (civil or criminal) for an individual and up to $500,000 (criminal) for any other person (i.e., an entity)  Transfer of an agent or toxin listed in 7 CFR 331, 9 CFR 121, and/or 42 CFR 73 to an unregistered person: civil money penalty listed above and/or imprisonment for up to 5 years (10 yrs if criminal)  Unregistered persons possessing an agent or toxin listed in 7 CFR 331, 9 CFR 121, and/or 42 CFR 73: civil money penalty listed above and/or imprisonment for up to 5 years (10 yrs if criminal) _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

43. New USDA-APHIS Forms APHIS Form 2040: Application for Laboratory RegistrationAPHIS Form 2040: Application for Laboratory Registration APHIS Form 2041: Report of TransferAPHIS Form 2041: Report of Transfer APHIS Form 2042: Request for ExemptionAPHIS Form 2042: Request for Exemption APHIS Form 2043: Report of Theft, loss, or ReleaseAPHIS Form 2043: Report of Theft, loss, or Release APHIS Form 2044: Report of IdentificationAPHIS Form 2044: Report of Identification _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

44. Web Information www.aphis.usda.gov/ppq/permits Contact Information Biological and Technical Services, PPQ, APHIS 4700 River Road Unit 133 Riverdale, MD 20737-1236 Phone (301) 734-5519 Fax (301) 734-8700 _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services

45. _______________________________________________________________________ APHIS, PPQ, Plant Health Programs - Biological and Technical Services