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Operational Requirements for use
of Phytosanitary Irradiation on
Imports
Laura A. Jeffers
National Operations Manager
Plant Protection and Quarantine
Animal and Plant Health Inspection Services
United States Department of Agriculture
• Regulatory summary
• Facility approval &
certification
• Packaging & process
configuration approval
• Importer requirements
• Resources
Outline
Irradiation Program Types
Preclearance and Offshore Programs
Offshore irradiation of US imports
Port of Entry Program
Domestic irradiation of US imports
Domestic Quarantine Program
Irradiation for domestic movement
Export Program
Irradiation of US exports
• Market access
• Framework equivalency work
plan
• Trust fund
• Operational work plan
• Commodity-specific addendum
Import Regulatory Summary
• Facility approval
• Facility certification
• Importer compliance agreement
• Importer permit
• Packaging approval
• Process configuration approval
Regulatory Summary
Facility Approval
• Facility location
• License information
• Irradiator information
• Safety information
• Standard operating procedures (SOP)
• Personnel information
• Dosimetry information
• Facility diagrams
Facility Certification
• Tour of the facility
• SOP review
• Delivery of phytosanitary dose
• Calibration of dosimetry system
• Process configuration approval
• Database training
• Safeguarding requirements
• Facility compliance agreement
Validation of facility application information
Tour of the Facility
• Facility familiarization
• Follow commodity path
• Meet facility personnel
• Address outstanding issues from facility
approval
• Identify additional safeguarding issues
• Identify additional operational issues
SOP Review
• Address outstanding issues from facility approval
• Data collection (paperwork)
• Record storage
• Flow of commodity through facility
• Practices for storage of treated, untreated,
improperly packaged, and improperly irradiated
goods
• Emergency plans
• Are SOPs specific enough for phytosanitary
treatments?
Process Configuration
Packaging
• Approval of components
• Configuration arrangement
• Pest-proof packaging
Commodity
• Article weights
• Box weights
As mortality is not the target response for APHIS
treatments, live insects may remain after treatment
Pest Proof Packaging
Process Configuration
Dose Mapping
• Place dosimeters throughout
load
• Focusing on areas expected
to receive high and low
absorbed doses
• Includes a reference location,
Rf
IRADS Training
Irradiation Reporting and
Accountability Database
• Tracks irradiation
treatment and trace-
back data
• Creates treatment
certificates
• Modules for import and
export treatments
Recertification Re-certification of a facility is initiated by the
following
• Problems with treatment process identified by
APHIS or NPPO
• Change in facility management
• Significant operational or structural changes at the
facility
• Replenishment, rearrangement or change of the
radiation-producing source
Annual recertification is NOT necessary.
Preclearance & Offshore Facilities
India
Krushak
Vietnam
Son Son
An Phu Irradiation
Mexico
Sterigenics
Benebión
Thailand
Thai Irradiation Center
Synergy Health
South Africa
HEPRO
Australia
Steritech
Preclearance & Offshore Facilities
Port of Entry Facilities
Sadex
Sioux City, IA
National Center for Electron
Beam Research*
College Station, TX
Gateway America*
Gulfport, MS
Southern Tier Rule
http://www.gpo.gov/fdsys/pkg/FR-2012-07-20/pdf/2012-17725.pdf
Southern Tier Rule
As of July 2012, establishment of port of entry
phytosanitary irradiation facilities are allowed in the
Southern U.S. states.
Additional Requirements:
• Approval by state representative to the National
Plant Board (State Plant Regulatory Official)
• Refrigerated conveyance of commodity
• Maps of surrounding agricultural production areas
• Pest trapping or monitoring
• Additional facility safeguarding
Importer Requirements
Compliance Agreement
• Agreement between APHIS and Importer
• Routing Information and Maps
• Procedures and Contact Information
• Recordkeeping Requirements
Permit
• Allows Importer to Bring Commodity into U.S.
• Commodity and Country of Origin
• Port of Entry
• Required Certification for Entry
• Transportation Conditions
Please contact Permit Services for more
information:
http://www.aphis.usda.gov/permits/ppq_eperm
its.shtml
Telephone (301) 851-2046 or (877) 770-5990
Fax (301) 734-4300
Email: [email protected]
Permit Services
PPQ Stakeholder Registryhttps://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new
PPQ Treatment Manualhttp://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf
• Import-driven Manual
• Treatment Schedules
• Irradiation Overview
• Pest Specific/Generic Doses
• Facility Certification
• Facility Audits
• Dosimetry
• Dose Mapping
FOIAhttp://www.aphis.usda.gov/foia/how_to_submit_a_foia_request.shtml
All FOIA requests must be submitted in writing through mail, fax, email, or the web.
Indicate that you are making a request under FOIA, and send the request to the
following address:
VIA MAIL:
Animal and Plant Health Inspection Service
Director, Freedom of Information and Privacy Act Staff
4700 River Road, Unit 50
Riverdale, MD 20737
VIA FACSIMILE: 301-734-5941
VIA E-MAIL: [email protected]
VIA Web Request Form: Click here to submit your FOIA Request Online.
PPQ Irradiation Treatment Sitehttp://www.aphis.usda.gov/wps/portal/aphis/ourfocus/planthealth?1dmy&urile=wcm%3apath%3a%2Faphis_content_li
brary%2Fsa_our_focus%2Fsa_plant_health%2Fsa_import%2Fsa_quarantine_treatments%2Fct_irradiation_treatment
“I am interested in having an irradiation facility
certified by APHIS to apply quarantine treatments
for fresh fruits and vegetables.
Where can I get more information?”
Facility Approval and Certification
Laura Jeffers
(919) 855-7455
Questions?