Transcript Revisions to Permit Policies

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
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
1910: A Gift from Japan
USDA Inspection of Cherry Trees
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
1910: USDA Burns Cherry Trees
due to Insect pests and Diseases
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
Total Number of Permits Issued 2003 = 9716
Cotton = 31 (<1%)
Fruits & Vegatables = 1493
(15%)
Pest = 3279 (35%)
Basic/Post Entry
= 1602 (16%)
Misc. = 255 (3%)
General = 822 (8%)
Canadian= 198 (2%)
Departmentals
= 238 (2%)
Soil, 250, 3%
Log and Lumber
= 1548 (16%)
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Types of PPQ Permits
• Fruits & Vegetables (Part 319.56)
• Nursery Stock, Plants, Roots, Bulbs, Seeds, etc. (Part 319.37)
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
• Canadian (Part 319.37)
Departmental (for prohibited plant material, various regulations)
Plant Pests (Part 330.200) (~ 35%)
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 CFR
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Average Permit Issuance Times
Type of Permit
No. days (2003)
Post Entry
2.2
Timber and Timber Products
2.1
Departmental
2.2
Soil
5.0
Canadian
3.5
Corn
1.8
Sugercane
1.0
Rice
1.0
Cotton
5.0
Brass
1.0
Transit
1.6
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
BTS ISO 9001 Certification:
Plant and Plant Product Permits
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Seed Permits
84 % of total U.S. imports of seeds for
planting come from:
Chile
Netherlands
China
Finland
Denmark
Mexico
Argentina
Japan
Australia
India
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
“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
Plant Pest Permits
and
Select Agent Registration
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Laws & Regulations: Possession
and Transfer of Plant Pathogens
Law/Statute
Regulation
Written by U.S.
Congress
Written by USDA (as
directed by Congress)
Plant Protection Act of
2000
7 CFR 330
Plant Pest Permitting
Agricultural Bioterrorism 7 CFR 331
Protection Act of 2002
“Select Agent” Program
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
General Comparison of Permitting
and Select Agent Registration
Permit:
7 CFR Part 330
• Import or interstate
movement of all plant
pests and pathogens
• Most permits require
laboratory inspection
• Provides for deregulation
of specific regulated
articles
Registration:
7 CFR Part 331
• Possession, use, or transfer
of listed Select Agents
• All registrations require
laboratory inspection
• Certain exemptions
• All staff need FBI Security
Risk Assessment
• Security and biosafety plans
required
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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)
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
Plant Pest Permits Required for:
• 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 diagnosis
• Intrastate movement of plant pests if
the pest was moved originally into
state under permit
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Total Number of Pest Permits Issued, 2003 = 3279
Weeds = 102
(3%)
Pathology = 978
(30%)
Entomology = 2199 (67%)
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Plant Pest Permits: Recent
Change Stimuli
(in chronological order)
• PPQ Safeguarding Report
• Self-imposed ISO-9000 discipline
• 9-11 terrorist activities
• Anthrax letters
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Responses to Change Stimuli:
Issuance of Plant Pest Permits
• Applicant must sign permit conditions
• Increased Laboratory Inspections
• Essential 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
Responses to Change Affecting
Issuance of Plant Pest Permits
• Shipping Labels:
• Now… account for labels
• Future… Bar-Code tracking of packages (ePermits,
Release 2)
• Permitted material must enter through PPQ
(Plant) Inspection Stations
• New law: Agriculture Bioterrorism Protection
Act of 2002 (ABPA)
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Permits Issuance:
A Few Operating Philosophies
•
•
•
•
•
First in, first out
Consistency (with caveats)
Transparency
Science-based
Risk-based
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Some Pest Permit Statistics
Year
2004
Number of
Permits
3596
(July)
Average
Issuance, days
41
2003
4368
62
2002
4832
55
2001
4344
60
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Permit Statistics:
Pathogen Permits
Year
2004
# Permits
829
(July)
# Pending
Av. Days
391
70
2003
1180
91
98
2002
1071
20
117
2001
922
2
102
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Steps We’re Taking to Improve
Efficiency and Response Time
•
ePermits (current data base = JPS)
• For the first time – a single APHIS Permit Data Base
(PPQ, VS, BRS, other USDA Agencies ??)
• ISO 9001
• Currently certified: Plant & Plant Products
• Currently preparing for audit:
•
•
•
•
Plant Pest Permits
PPQ’s Select Agent Program
NIS’ “Urgent” Process
Transit Permits
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Steps We’re Taking to Improve
Efficiency and Response Time
• Permits 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)
• Creation of New Permitting Process for WPP
• State pre-approval
• only for interstate movement of domestic isolates not
intended for field studies
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Permit Requirements (in part)
• PPQ Form 599 Label on Exterior of All
Packages
• Package addressed to inspection station
identified on 599 label for PPQ
Inspection/Clearance
• Adequate Packaging to Contain Enclosed
Organisms
• Valid Permit
• Valid delivery address as identified on
permit
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Plant Pest Permit
Shipping Label:
PPQ Form 599
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
PPQ Form 599: Reverse side
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Import of Plant Pests:
DHS-CBP Role
• Administrative Processing Only – Not
Inspection
• Risks associated with most permits – CBP
instructed not to open in unsecured location.
• All Permitted Packages Held for USDA
Clearance (BEFORE) Customs Clearance
• PPQ Inspection Station Routing Critical
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Import of Plant Pests:
Carrier Expectations/Processing


FedEx does not include permit information on manifest
• we would like this info on manifest to facilitate
clearance
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,
delays
• Will not guarantee overnight delivery when routed
to PPQ Inspection Station – 1 to 2 day delay
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Additional Challenges
• CBP’s Automated Targeting System
• CBP targets USDA permitted material
• Fish and Wildlife Service Inspectors
• Food and Drug Administration
Inspectors
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
The Act Required USDA-APHIS and HHSCDC 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
- Plant Protection & Quarantine
•
9 CFR Part 121
- Veterinary Services
•
42 CFR Part 73
- Centers for Disease Control and Prevention
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
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
PPQ’s Select Agent Program
Ten “Select Agents” (all plant pathogens)
• 4 Fungi, 5 Bacteria, 1 Virus
Fungus
Disease
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
PPQ’s Select Agent Program
Bacterium
Disease
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
citrus variagated chlorosis strain
Virus
Disease
Plum Pox Potyvirus
Plum pox
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Exemptions
Diagnostic and Clinical Facilities, as long as
they…
• Report identification:
• Verbally within 24 hr
• On Form 2044 within 7 days
• Inactivate 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
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))
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
Transfers
• Both sender and receiver must be
registered or exempt
• Transfer must be submitted and
approved prior to transfer
• Applies to both Intra- and Interstate
Transfer, and Import
• At this point, no regulatory
requirements regarding export
(under OGC review)
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
New USDA-APHIS Forms
• APHIS Form 2040: Application for
Laboratory Registration
• APHIS Form 2041: Report of Transfer
• APHIS Form 2042: Request for Exemption
• APHIS Form 2043: Report of Theft, loss, or
Release
• APHIS Form 2044: Report of Identification
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services
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
_______________________________________________________________________
APHIS, PPQ, Plant Health Programs - Biological and Technical Services