PPQ’s Biological and Technical Services (BTS) Michael J. Firko, Ph.D. Director, Biological and Technical Services (301) 734-8760 ASTA/APHIS Meeting 10

PPQ’s Biological andPPQ’s Biological andTechnical Services Technical Services (BTS)(BTS)

Michael J. Firko, Ph.D.Michael J. Firko, Ph.D.Director, Biological and Technical ServicesDirector, Biological and Technical Services

(301) 734-8760(301) 734-8760

ASTA/APHIS MeetingASTA/APHIS Meeting

10 November, 200410 November, 2004

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

Some Early Historical Items Some Early Historical Items Pertinent to PPQ’s MissionPertinent to PPQ’s Mission

1862 – Creation of USDA1862 – Creation of USDA

Late 1800’s-early 1900’s – Efforts Late 1800’s-early 1900’s – Efforts to establish Plant Protection to establish Plant Protection LegislationLegislation

within USDA and elsewhere within USDA and elsewhere

1910 – First shipment of Cherry 1910 – First shipment of Cherry Trees from JapanTrees from Japan


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1910: A Gift from Japan1910: A Gift from JapanUSDA Inspection of Cherry TreesUSDA Inspection of Cherry Trees


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1910: USDA Burns Cherry Trees1910: USDA Burns Cherry Trees due to Insect pests and Diseasesdue to Insect pests and Diseases


Some Early Historical Items Some Early Historical Items Pertinent to PPQ’s MissionPertinent to PPQ’s Mission

1912 – Plant Quarantine Act, 1912 – Plant Quarantine Act, Create Federal Horticultural BoardCreate Federal Horticultural Board

1928 – Create Plant Quarantine 1928 – Create Plant Quarantine and and Control Administration (PQCA)Control Administration (PQCA)

1957: Federal Plant Pest Act1957: Federal Plant Pest Act

2000: Plant Protection Act2000: Plant Protection Act


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Total Number of Permits Issued 2003 = 9716

Log and Lumber= 1548 (16%)

General = 822 (8%)

Basic/Post Entry= 1602 (16%)

Fruits & Vegatables = 1493 (15%)

Cotton = 31 (<1%)

Canadian= 198 (2%)

Departmentals= 238 (2%) Soil, 250, 3%

Misc. = 255 (3%)

Pest = 3279 (35%)


Types of PPQ PermitsTypes of PPQ Permits• Fruits & Vegetables (Part 319.56)Fruits & Vegetables (Part 319.56)• Nursery Stock, Plants, Roots, Bulbs, Nursery Stock, Plants, Roots, Bulbs, SeedsSeeds, etc. (Part 319.37), etc. (Part 319.37)

• Canadian (Part 319.37)Canadian (Part 319.37)• DepartmentalDepartmental (for prohibited plant material, various regulations) (for prohibited plant material, various regulations)• Plant PestsPlant Pests (Part 330.200) (Part 330.200) (~ 35%)(~ 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 WeedsNoxious Weeds (Part 360) (Part 360)• CornCorn (Parts 319.24 and 319.41) (Parts 319.24 and 319.41) • Sugercane (Part 319.15)Sugercane (Part 319.15)• CottonCotton (Part 319.8) (Part 319.8)• Citrus (Part 319.28) Citrus (Part 319.28) • RiceRice (Part 319.55) (Part 319.55)• Transit (Part 352)Transit (Part 352) NOTE: All Parts from 7 CFRNOTE: All Parts from 7 CFR

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Type of PermitType of Permit No. days (2003)No. days (2003)

Post EntryPost Entry 2.22.2

Timber and Timber ProductsTimber and Timber Products 2.12.1

DepartmentalDepartmental 2.22.2

SoilSoil 5.05.0

CanadianCanadian 3.53.5

CornCorn 1.81.8

SugercaneSugercane 1.01.0

RiceRice 1.01.0

CottonCotton 5.05.0

BrassBrass 1.01.0

TransitTransit 1.61.6

Average Permit Issuance Times

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BTS ISO 9001 Certification:Plant and Plant Product Permits

Seed PermitsSeed Permits

84 % of total U.S. imports of seeds for planting come from:

Chile MexicoNetherlands ArgentinaChina JapanFinland AustraliaDenmark India

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““Phyto” RequirementsPhyto” 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

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Plant Pest PermitsPlant Pest Permits

andand

Select Agent RegistrationSelect Agent Registration

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Laws & Regulations: Possession Laws & Regulations: Possession and Transfer of Plant Pathogensand Transfer of Plant Pathogens

Law/StatuteLaw/StatuteWritten by U.S. Written by U.S. CongressCongress

RegulationRegulationWritten by USDA (as Written by USDA (as directed by Congress)directed by Congress)

Agricultural Bioterrorism Agricultural Bioterrorism Protection Act of 2002Protection Act of 2002

7 CFR 3317 CFR 331

““Select Agent” ProgramSelect Agent” Program

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Plant Protection Act of Plant Protection Act of 20002000

7 CFR 3307 CFR 330

Plant Pest PermittingPlant Pest Permitting


General Comparison of Permitting General Comparison of Permitting and Select Agent Registrationand Select Agent Registration

Permit: Permit: 7 CFR Part 3307 CFR Part 330 • Import or interstate Import or interstate

movement of all plant movement of all plant pests and pathogenspests and pathogens

• Most permits require Most permits require laboratory inspectionlaboratory inspection

• Provides for deregulation Provides for deregulation of specific regulated of specific regulated articlesarticles

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Registration: Registration: 7 CFR Part 3317 CFR Part 331• Possession, use, or transfer Possession, use, or transfer

of listed Select Agentsof listed Select Agents

• All registrations require All registrations require laboratory inspectionlaboratory inspection

• Certain exemptionsCertain exemptions

• All staff need FBI Security All staff need FBI Security Risk AssessmentRisk Assessment

• Security and biosafety plans Security and biosafety plans requiredrequired


Regarding possession, use, and Regarding possession, use, and transfer of listed agents:transfer of listed agents:

“…“…7 CFR 331.13(a)… incorporate(s) 7 CFR 331.13(a)… incorporate(s) the existing permit requirements the existing permit requirements under the plant pest regulations in 7 under the plant pest regulations in 7 CFR part 330.” CFR part 330.”

(Preamble to 7 CFR 331, (Preamble to 7 CFR 331, p.76918)p.76918)

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From the U. S. Congress From the U. S. Congress Plant Protection Act, 2000Plant Protection Act, 2000

(language carried over from Plant Pest Act, 1957)(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…”

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Plant Pest Permits Required for:Plant Pest Permits Required for:• All import and interstate movement All import and interstate movement

of any plant pest or disease, of any plant pest or disease, including…including…

• Plant material and specimens being Plant material and specimens being moved for the purpose of pest or moved for the purpose of pest or disease diagnosisdisease diagnosis

• Intrastate movement of plant pests if Intrastate movement of plant pests if the pest was moved originally into the pest was moved originally into state under permitstate under permit

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Total Number of Pest Permits Issued, 2003 = 3279

Weeds = 102(3%)

Pathology = 978(30%)

Entomology = 2199 (67%)


Plant Pest Permits: Recent Plant Pest Permits: Recent Change StimuliChange Stimuli

(in chronological order)(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

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Responses to Change Stimuli: Responses to Change Stimuli: Issuance of Plant Pest PermitsIssuance of Plant Pest Permits

• Applicant must sign permit conditionsApplicant must sign permit conditions

• Increased Laboratory InspectionsIncreased Laboratory Inspections

• Essential prohibition on “Hand Carry” for Essential prohibition on “Hand Carry” for importations importations

NOTE: PPQ is in the process of drafted “new” NOTE: PPQ is in the process of drafted “new” permitting regulations (7 CFR Part 330)permitting regulations (7 CFR Part 330)

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Responses to Change Affecting Responses to Change Affecting Issuance of Plant Pest PermitsIssuance of Plant Pest Permits

• Shipping Labels: Shipping Labels: • Now… account for labelsNow… account for labels

• Future… Bar-Code tracking of packages (ePermits, Future… Bar-Code tracking of packages (ePermits, Release 2)Release 2)

• Permitted material must enter through PPQ Permitted material must enter through PPQ (Plant) Inspection Stations(Plant) Inspection Stations

• New law: Agriculture Bioterrorism Protection New law: Agriculture Bioterrorism Protection Act of 2002 (ABPA)Act of 2002 (ABPA)

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Permits Issuance:Permits Issuance:A Few Operating PhilosophiesA Few Operating Philosophies

• First in, first outFirst in, first out• Consistency (with caveats)Consistency (with caveats)• TransparencyTransparency• Science-based Science-based • Risk-basedRisk-based

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Some Pest Permit StatisticsSome Pest Permit Statistics

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YearYearNumber of Number of

PermitsPermitsAverage Average

Issuance, daysIssuance, days

20042004 3596 3596 (July)(July) 4141

20032003 43684368 6262

20022002 48324832 5555

20012001 43444344 6060


Permit Statistics:Permit Statistics:Pathogen PermitsPathogen Permits

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YearYear # Permits# Permits # Pending# Pending Av. DaysAv. Days

20042004 829 829 (July)(July) 391391 7070

20032003 11801180 9191 9898

20022002 10711071 2020 117117

20012001 922922 22 102102


Steps We’re Taking to Improve Steps We’re Taking to Improve Efficiency and Response TimeEfficiency and Response Time

• ePermits (current data base = JPS)ePermits (current data base = JPS)• For the first time – a single APHIS Permit Data Base For the first time – a single APHIS Permit Data Base

(PPQ, VS, BRS, other USDA Agencies ??)(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

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Steps We’re Taking to Improve Steps We’re Taking to Improve Efficiency and Response TimeEfficiency and Response Time

• Permits for Widely Prevalent Plant Permits for Widely Prevalent Plant PathogensPathogens

• Agreements with APS Agreements with APS (American Phytopathological (American Phytopathological

Society)Society) for construction of State-by-state for construction of State-by-state lists of widely prevalent pathogens (WPP, lists of widely prevalent pathogens (WPP, fungi, viruses, bacteria and mycoplasmas)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 only for interstate movement of domestic isolates not

intended for field studiesintended for field studies

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Permit RequirementsPermit Requirements (in part)(in part)

• PPQ Form 599 Label on PPQ Form 599 Label on ExteriorExterior of All of All PackagesPackages

• Package addressed to inspection station Package addressed to inspection station identified on 599 label for PPQ identified on 599 label for PPQ Inspection/ClearanceInspection/Clearance

• Adequate Packaging to Contain Enclosed Adequate Packaging to Contain Enclosed OrganismsOrganisms

• Valid PermitValid Permit• Valid delivery address as identified on Valid delivery address as identified on

permitpermit


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Plant Pest Permit Shipping Label: PPQ Form 599


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PPQ Form 599: Reverse side

Import of Plant Pests:Import of Plant Pests:DHS-CBP RoleDHS-CBP Role

• Administrative Processing Only – Not Administrative Processing Only – Not InspectionInspection• Risks associated with most permits – CBP Risks associated with most permits – CBP

instructed not to open in unsecured location.instructed not to open in unsecured location.• All Permitted Packages Held for USDA All Permitted Packages Held for USDA

Clearance (BEFORE) Customs ClearanceClearance (BEFORE) Customs Clearance• PPQ Inspection Station Routing CriticalPPQ Inspection Station Routing Critical

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Import of Plant Pests:Import of Plant Pests:Carrier Expectations/ProcessingCarrier Expectations/Processing

FedEx does not include permit information on manifestFedEx does not include permit information on manifest• we would like this info on manifest to facilitate we would like this info on manifest to facilitate

clearanceclearance FedEx will not guarantee port of entryFedEx will not guarantee port of entry

• If package not addressed to Inspection Station If package not addressed to Inspection Station Fedex must reroute for USDA clearance, then back Fedex must reroute for USDA clearance, then back to port of entry for Customs clearance – costs, to port of entry for Customs clearance – costs, delaysdelays

• Will not guarantee overnight delivery when routed Will not guarantee overnight delivery when routed to PPQ Inspection Station – 1 to 2 day delayto PPQ Inspection Station – 1 to 2 day delay


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Additional ChallengesAdditional 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 Food and Drug Administration

InspectorsInspectors

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Public Health Security and Public Health Security and Bioterrorism Preparedness Bioterrorism Preparedness

Response Act of 2002Response Act of 2002Signed into law June 12, 2002Signed into law June 12, 2002

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The Act Required USDA-APHIS and HHS-The Act Required USDA-APHIS and HHS-CDC to Write and Implement New CDC to Write and Implement New

Regulations Within About Two MonthsRegulations Within About Two Months

Interim Final Rules: Possession, Use and Interim Final Rules: Possession, Use and Transfer of Biological Agents and ToxinsTransfer of Biological Agents and Toxins

• 7 CFR Part 3317 CFR Part 331- Plant Protection & Quarantine- Plant Protection & Quarantine

• 9 CFR Part 1219 CFR Part 121 - Veterinary Services- Veterinary Services

• 42 CFR Part 7342 CFR Part 73- Centers for Disease Control and Prevention- Centers for Disease Control and Prevention

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Public Health Security and Bioterrorism Public Health Security and Bioterrorism Preparedness Response Act of 2002Preparedness Response Act of 2002

Purpose: To improve the ability of the Purpose: To improve the ability of the United States to prevent, prepare for, and United States to prevent, prepare for, and respond to bioterrorism and other public respond to bioterrorism and other public health emergencieshealth emergencies

- - Title IITitle II, Subtitle B cited as…, Subtitle B cited as…

Agricultural Bioterrorism Agricultural Bioterrorism Protection Act of 2002Protection Act of 2002

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Mandate to Create a List of Mandate to Create a List of Select Agents (from ABPA)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.”

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PPQ’s Select Agent ProgramPPQ’s Select Agent Program

Ten “Select Agents” (all plant pathogens)Ten “Select Agents” (all plant pathogens)• 4 Fungi, 5 Bacteria, 1 Virus4 Fungi, 5 Bacteria, 1 Virus

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FungusFungus DiseaseDiseasePeronosclerospora Peronosclerospora philippinensisphilippinensis

Philippine downy mildew of Philippine downy mildew of corncorn

Phakopsora pachyrhiziPhakopsora pachyrhizi Soybean rustSoybean rust

Sclerophthora rayssiaeSclerophthora rayssiae var. var. zeaezeae

Brown stripe downy mildew of Brown stripe downy mildew of corncorn

Synchytrium endobioticumSynchytrium endobioticum potato wartpotato wart


PPQ’s Select Agent ProgramPPQ’s Select Agent ProgramBacteriumBacterium DiseaseDiseaseLiberobacter africanusLiberobacter africanus Citrus greening diseaseCitrus greening disease

Liberobacter asiaticusLiberobacter asiaticus Citrus greening diseaseCitrus greening disease

Ralstonia solanacearumRalstonia solanacearum, ,

race 3, biovar 2race 3, biovar 2Brown rot of potato Brown rot of potato

Bacterial wilt of potato Bacterial wilt of potato

Xanthomonas oryzaeXanthomonas oryzae

pv. oryzicolapv. oryzicolaBacterial leaf streak of rice Bacterial leaf streak of rice

Xylella fastidiosaXylella fastidiosa,,

citrus variagated chlorosis citrus variagated chlorosis strainstrain

citrus variagated chlorosiscitrus variagated chlorosis

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VirusVirus DiseaseDiseasePlum Pox PotyvirusPlum Pox Potyvirus Plum poxPlum pox


ExemptionsExemptions

Diagnostic and Clinical Facilities, as long as Diagnostic and Clinical Facilities, as long as they…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 Inactivate or transfer agent to registered entityentity

NOTE: Facilities maintaining viable agents as NOTE: Facilities maintaining viable agents as positive controls must registerpositive controls must register

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ExemptionsExemptions

• The Administrator may grant a The Administrator may grant a specific exemption upon a showing of specific exemption upon a showing of good cause (and written request) and good cause (and written request) and upon his or her determination that upon his or her determination that such exemption is consistent with such exemption is consistent with protecting animal or plant health, protecting animal or plant health, and animal or plant products and animal or plant products (7 CFR (7 CFR Part 331.4(b) and 9 CFR 121.5(f))Part 331.4(b) and 9 CFR 121.5(f))

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TransfersTransfers• Both sender and receiver must be Both sender and receiver must be

registered or exemptregistered or exempt• Transfer must be submitted and Transfer must be submitted and

approved prior to transferapproved prior to transfer• Applies to both Intra- and Interstate Applies to both Intra- and Interstate

Transfer, and ImportTransfer, and Import• At this point, no regulatory At this point, no regulatory

requirements regarding export requirements regarding export (under OGC review)(under OGC review)

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Civil & Criminal PenaltiesCivil & Criminal Penalties Violation of any provisions of the regulations:Violation of any provisions of the regulations: up up

to $250,000 (civil or criminal) for an individual to $250,000 (civil or criminal) for an individual and up to $500,000 (criminal) for any other and up to $500,000 (criminal) for any other person (person (i.e.,i.e., an entity) an entity)

Transfer of an agent or toxin listed in 7 CFR 331, Transfer of an agent or toxin listed in 7 CFR 331, 9 CFR 121, and/or 42 CFR 73 to an unregistered 9 CFR 121, and/or 42 CFR 73 to an unregistered person:person: civil money penalty listed above and/or civil money penalty listed above and/or imprisonment for up to 5 years (10 yrs if criminal)imprisonment for up to 5 years (10 yrs if criminal)

Unregistered persons possessing an agent or Unregistered persons possessing an agent or toxin listed in 7 CFR 331, 9 CFR 121, and/or 42 toxin listed in 7 CFR 331, 9 CFR 121, and/or 42 CFR 73:CFR 73: civil money penalty listed above and/or civil money penalty listed above and/or imprisonment for up to 5 years (10 yrs if criminal)imprisonment for up to 5 years (10 yrs if criminal)

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New USDA-APHIS FormsNew USDA-APHIS Forms

• APHIS Form 2040:APHIS Form 2040: Application for Application for Laboratory Laboratory

RegistrationRegistration

• APHIS Form 2041:APHIS Form 2041: Report of Transfer Report of Transfer

• APHIS Form 2042:APHIS Form 2042: Request for Exemption Request for Exemption

• APHIS Form 2043:APHIS Form 2043: Report of Theft, loss, or Report of Theft, loss, or Release Release

• APHIS Form 2044:APHIS Form 2044: Report of Identification Report of Identification

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Web InformationWeb Information

www.aphis.usda.gov/ppq/permitswww.aphis.usda.gov/ppq/permits

Contact InformationContact InformationBiological and Technical Services, PPQ, APHISBiological and Technical Services, PPQ, APHIS

4700 River Road Unit 1334700 River Road Unit 133

Riverdale, MD 20737-1236Riverdale, MD 20737-1236

Phone (301) 734-5519Phone (301) 734-5519

Fax (301) 734-8700Fax (301) 734-8700

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Documents

PPQ’s Biological and Technical Services (BTS) Michael J. Firko, Ph.D. Director, Biological and Technical Services (301) 734-8760 ASTA/APHIS Meeting 10