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: Permits@aphis.usda.gov

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: foia.officer@aphis.usda.gov

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

laura.a.jeffers@aphis.usda.gov

Questions?