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UPDATE: Permits, Registrations, Imports, and Manuals

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UPDATE: Permits, Registrations, Imports, and Manuals

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    2. OUTLINE PHP/PRI/PRIM Reorganization Introduce Sam Johnson ASTA Requests Plant Pest Permits Issues Interceptions “Departmental Permit” update ePermits update

    4. Introduction Sam (Robert Samuel) Johnson, Ph.D. Permit Services Branch Chief (Deborah Knott’s replacement)

    5. ASTA Requests Guidelines for “Diagnostic Labs” Permit Conditions for Seed Testing Labs Centralization of Facility Information Interception Data Widely Prevalent Pathogen Permits

    6. Guidelines for “Diagnostic Labs” The term “Diagnostic Labs” is used by different people to mean different things PPQ’s original intent/usage Purely diagnostic… receive sample, all work in vitro, and within containment… destruction of sample Permittee’s usage… As above, but also… Koch’s postulates (plant inoculations) Seed plantings for pathogen tests, etc. Retaining identified pathogens for collections

    7. Permit Conditions for Seed Testing Labs Not purely “diagnostic” in the PPQ use of the term: Seeds from foreign countries Possible presence of foreign pathogens, intended or not Sometimes contaminants are present Soil, other plant species, etc. Lab work Plant inoculations Greenhouse work

    8. Centralization of Facility Information There is a single repository for facility information related to Plant Pest Permitting Lack of clarity regarding requirements of: PPQ’s Plant Pest Permitting Regulations 7 CFR Part 330, pursuant to the Plant Protection Act PPQ’s Select Agent Regulations 7 CFR Part 331, pursuant to the Agricultural Bioterrorism Protection Act

    9. Common Interceptions on Seeds (Slide from April Meeting) 2000-2005 938 host/country/pest combinations Some with multiple interceptions (e.g., 70) Most (~60%) on “consumption” seeds About 40% on seeds for propagation

    10. Categories of Interceptions made on shipments of Seed (1 of 3) Seed itself is prohibited Federal noxious weeds (7 CFR 360) Parasitic plants (7 CFR 330) Quarantine significant - often depends on country of origin (because they are known hosts of serious diseases or other difficult-to-detect plant pests)

    11. Categories of Interceptions made on shipments of Seed (2 of 3) Prohibited quarantine-significant seeds, examples: Corn and corn relatives (7 CFR31.24, 7 CFR 319.41) Bamboo (7 CFR 319.37-2a) Rice (7 CFR319.55) Peanut (7 CFR 319.37-2a)

    12. Categories of Interceptions made on shipments of Seed (3 of 3) Actionable contaminants in seed soil plant pests, (insects, mites, nematodes, mollusks, pathogens, parasitic plants) quarantine significant seeds if prohibited from the country of origin Federal noxious weed seeds

    13. Certain Restrictions on Seed Shipments Coated or pelleted seeds are prohibited because they cannot be inspected However PPQ has designed a protocol where a sample can be drawn according to International Seed Testing Association (ISTA) requirements Authorized officials draw official seed sample from each lot before the seed is processed in the country of origin Sealed sample will accompany the shipment of coated or pelleted seed for inspection by PPQ at the port of entry

    14. Examples of seeds that require treatment as a condition of entry Citrus family (Rutaceae) Cotton (Gossypium) Flatpea, roughpea, sweet pea or peavine (Lathyrus spp.) Hibiscus (Hibiscus spp.) and Kenaf (Hibiscus cannabinus) Niger (Guizotia abyssinica)

    15. Permits for Widely Prevalent Pathogens (WPP) (Slide from April) Agreements with APS (American Phytopathological Society) for construction of State-by-State lists of widely prevalent pathogens: fungi, viruses, bacteria and mycoplasmas) Creation of New Permitting Process for WPP State pre-approval only for interstate movement of domestic isolates NOT for field study permits

    16. Widely Prevalent Pathogen Permits Concern about statements on WPP permits related to “no field release”

    17. Widely Prevalent Pathogen Permits Distinction between: Expedited permits for WPP Lab work, no further distribution Standard conditions “Preconcurrence by State” Permits for pathogens on the WPP list when the intent is other than above (e.g., propagation for field release) These permits are issued, but instead of being handled by a Permit Specialist or Program Assistant, one of our scientists reviews and issues the permit, and the State reviews each application

    18. “Departmental” Permits (Slide from April) For prohibited articles Original intention… research, by USDA Current usage… various, insufficient oversight Strategy for improvement: Phase 1 (now): More appropriate conditions, and more involvement of State Officials Phase 2: Modify name to “Research”, expand beyond USDA Proposed Rule (draft) to modify existing regulations Phase 3: Create new classes of permits (intended use) Example, commercial development

    19. “Departmental” Permits, Currently: Still in Phase 1 (no new regulatory developments) Revising “sets” of permits (e.g., Departmental Permits for Chrysanthemums) Additional conditions Increased oversight by PPQ field and State No new Departmentals for Chrysanthemums Limited duration All with same expiration date for coordinated changes

    20. A web-based, user interface that supports electronic: creation of permit applications & notifications submission to APHIS processing by APHIS State review permit issuance by APHIS tracking… by all appropriate stakeholders role-based access

    21. Safeguarding Recommendations GPEA, Government Paperwork Reduction Act - eGov initiatives mandatory Need for consistency among programs - PPQ, VS, BRS Transparency and tracking by all Magnitude of APHIS permitting system - PPQ Example…

    22. Types of PPQ Permits (All issued by PRI) Fruits & Vegetables (Part 319.56) Nursery Stock, Plants, Roots, Bulbs, Seeds, etc. (Part 319.37) Departmental (“Research”, for prohibited plant material, various regulations) Plant Pests (Part 330.200) Honeybees and honeybee semen (Part 322) Exotic bee diseases and parasites (Part 319.76) Khapra Beetle / Brassware (Part 319.75) General / CITES (Part 355) Log and Lumber, etc. (Part 319.40) Soil (Part 330.300) Noxious Weeds (Part 360) Corn (Parts 319.24 and 319.41) Sugercane (Part 319.15) Cotton (Part 319.8) Citrus (Part 319.28) Rice (Part 319.55) Transit (Part 352) NOTE: All Parts from 7 Code of Federal Regulations (CFR)

    23. Types of PPQ Permits (All issued by PRI) Fruits & Vegetables (Part 319.56) Nursery Stock, Plants, Roots, Bulbs, Seeds, etc. (Part 319.37) Departmental (“Research”, for prohibited plant material, various regulations) Plant Pests (Part 330.200) ~35% of PPQ permits Honeybees and honeybee semen (Part 322) Exotic bee diseases and parasites (Part 319.76) Khapra Beetle / Brassware (Part 319.75) General / CITES (Part 355) Log and Lumber, etc. (Part 319.40) Soil (Part 330.300) Noxious Weeds (Part 360) Corn (Parts 319.24 and 319.41) Sugercane (Part 319.15) Cotton (Part 319.8) Citrus (Part 319.28) Rice (Part 319.55) Transit (Part 352) NOTE: All Parts from 7 Code of Federal Regulations (CFR)

    24. Entomology (~ 65 %) Insects Mites Mollusks (snails, slugs) Other Invertebrates Noxious weeds ( ~ 5 %) Plant Pathogens ( ~ 30 %) Nematodes Bacteria Viruses Fungi

    25. Entomology (~ 65 %) Insects Mites Mollusks (snails, slugs) Other Invertebrates Noxious weeds ( ~ 5 %) Plant Pathogens ( ~ 30 %) Nematodes Bacteria Viruses Fungi

    26. Genera of Fungi Permitted for Import: Jan-Jun ‘05 Acremonium Alternaria Amauroderma Armillaria Aspergillus Athelia Bipolaris Botrytis Bremia Ceratocystis Cercospora Chondrostereum Cladosporium Claviceps Cochliobolus Colletotrichum Corynespora Dactyliochaeta Diaporthe Didymella Diplocarpon Dothidea Drechslera Elsinoe Epichloe Epicoccum Erysiphe Erythricium Exserohilum Fulvia Fusarium Ganoderma Geotrichum Gloeophyllum Glomerella Glomus Guignardia Helminthosporium Heterobasidion Kabatiella Leptodontium Leptographium Leptosphaerulina Leveillula Macrophomina Monilinia Mycogone Mycosphaerella Ophiostoma Penicillium Peronospora Phacidiopycnis Phaeoisariopsis Phellinus Phialophora Phoma Phomopsis Phytophthora Plasmopara Peltaster Pleospora Podosphaera Polymyxa Postia Potebniamyces Pseudocercosporella Pseudoperonospora Puccinia Pyrenochaeta Pyrenophora Pyricularia Pythiogeton Rhizoctonia Rhizophlyctis Rhizophydium Rhynchosporium Saccharomyces Sclerotinia Sclerotium Septoria Sphaerobolus Sphaerotheca Spizellomyces Stagonospora Stemphylium Thecaphora Thyrostroma Tilletia Tolyposporium Trametes Trichoderma Uncinula Uromyces Ustilago Venturia Verticillium Zygophiala n = 97

    27. Origin Countries, Fungi Permits: Jan-Jun 2005 Argentina Australia Belize Bolivia Brazil Bulgaria Cameroon Canada Chile China Colombia Costa Rica Egypt El Salvador France Fed. States of Micronesia Germany Great Britain India Indonesia Ireland Israel Italy Japan Korea Madagascar Malaysia Mali Mauritius Mexico Micronesia Netherlands New Zealand Nigeria Palau Papua New Guinea Peru Philippines Russia Rwanda Scotland South Africa Spain Switzerland Taiwan Uganda Yap Yemen Yugoslavia Zambia Zimbabwe n = 51

    28. Permitted Genera, Fungi/Bacteria, Interstate, 3/05 - 6/05 Septoria Sphaeropsis Sporisorium Stagonospora Steinernema Thielaviopsis Tilletia Trametes Trichoderma Urocystis Uromyces Ustilago Venturia Verticillium Xanthomonas n = 66

    29. ePermits will address delays in Permit Issuance… Example Currently… many permit applications are not complete, or they have errors: e.g., ~ 5% have no phone number Scientific names not provided Scientific names spelled incorrectly Use of unapproved synonyms ePermits applications require these data to be entered, and entered correctly

    32. ePermits Release Plan

    33. ePermits Release 2 – 2005 Accomplishments BRS, PPQ, VS - Requirements/Design & Build Web-enabled 9 forms - BRS Notification and BRS 2000; PPQ 526, 585, 587, 588, and 621; VS 16-3 and 16-7 Applicant Portal Automated Workflow Infrastructure completed Automated User Fee online credit card transactions eAuthentication at Level 2 Barcode Shipment Tracking; Interview Engine Installed new hardware and deployed ePermits at NITC External User Groups – Beta testing Full Deployment December – C&A phase 2 Users Applicants APHIS HQ personnel and APHIS Port Inspectors DHS – Read access

    34. ePermits Planned Release 3 – 2006 Focus Web-enable forms - PPQ 546 & 525; VS 2005, VS 17-129 Amendments and Renewals Multi-level eAuthentication Integration with other APHIS systems (HCARTS, VSPS) Historical Data migration Deployment Sept. ‘06 Users Additional Applicants and APHIS Specialists State and Regional Regulatory Partners Port Officials including DHS-CBP

    35. Focus Containment Facility Inspections database Integration with USDA Shared Services Portal Enhanced reporting capabilities Integration with US Customs ITDS Users Other USDA and Federal Agencies (e.g. AMS, FSIS, CDC, FDA, IES) ePermits Planned Release 4 – 2007

    36. ePermits Stakeholder Outreach

    37. ePermits Architecture

    39. ePermits: eAuthentication eAuthentication required for use of ePermits Pest permits (and most other PPQ permits) will require eAuthentication Level 2 eAuthentication Level 2 requires (in order): On line application and establishment of ID and password “In-person” certification of ID with “LRA” (Local Registration Authority)

    40. ePermits: eAuthentication eAuthentication (LRA) service available: At Farm Service Administration (FSA) offices “In all counties in the United States” in Riverdale (PRI + ?) Other APHIS Offices in the future ?? SPHD offices ? VS field offices ?

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