Introduction to Phytosanitary Irradiation

Woodward D Bailey

Laboratory Director Miami, FL US

Science and Technology Plant Protection and Quarantine Animal and Plant Health Inspection Service United States Department of Agriculture

•Irradiation History •Definitions and

Concepts

•ISPM 18

•ISPM 28

Phytosanitary Irradiation

•1986. US FDA approves irradiation of fruits and vegetables for insect disinfestation •1989. Approval of Hawaii papaya; 1

st

rule phytosanitary irradiation treatment •1995. Hawaii produce exported with special permit •1996. USDA APHIS approves phytosanitary irradiation against fruit flies on any commodity

2002. Irradiation approved for all admissible fruits and vegetables from all countries to US 2004. Australian mangos to New Zealand 2006. USDA APHIS approves generic doses 2007. Thai mango to United States 2011. First Port of Entry Irradiation Treatment 2012. Southern State Rule

Definitions & Concepts

Irradiation-The exposure of a substance to ionizing energy (radiation) for the purpose of achieving some desired technical benefit Dose vsAbsorbed Dose-Dose refers to the amount of ionizing radiation delivered; Absorbed dose refers to the quantity of radiating energy (in gray) absorbed per unit of mass of a specified target Gray (Gy)-a unit of absorbed dose where 1 Gy is equivalent to the absorption of 1 joule per kilogram of the specified material (1 Gy = 1 J/kg)

Desired Outcomes:

Mortality •Sterilization •Inactivity or devitalization •Inability to emerge or fly Since mortality isusuallynot the targetresponse for irradiation, liveinsects may remain aftertreatment

Phytosanitary Irradiation

IPPC International Plant Protection Convention (IPPC) is multilateral treaty for international cooperation in plant protection The IPPC is a global instrument for the harmonization of phytosanitary measures The Commission on Phytosanitary Measures (CPM) is the governing body of the IPPC

ISPM

International Standards for Phytosanitary Measures (ISPMs) are adopted by the CPM

ISPMs are guidelines and recommendations concerning many aspects of plant health

List of all ISPMs is available at https://www.ippc.int

ISPM 18: Guidelines for the use of irradiation as a phytosanitary

measure

This standard provides technical guidance on procedures for the application of ionizing radiation as a phytosanitary treatment for regulated pests or articles ISPM 18

This does not include treatments used for: Production of sterile organisms for pest control (SIT) •Sanitary treatments (food safety or animal health) •Preservation or improvement of commodity quality •Inducing mutagenesis ISPM 18

ISPM 18-Guidelines

•Authority •Treatment Objective •Treatment •Dosimetry •Approval of Facilities •Phytosanitary System Integrity •Documentation by the Treatment Facility •Inspection and Phytosanitary Certification by the NPPO •Research

ISPM 18-Authority

The NPPO is responsible for the phytosanitary aspects of evaluation, adoption, and use of irradiation as a phytosanitary measure Additionally, it is the NPPO responsibility to cooperate with other regulatory agencies and to avoid overlapping, conflicting, inconsistent, or unjustified requirements

ISPM 18-Treatment Objective

The objective of using irradiation as a phytosanitary measure is to prevent the introduction and spread of plant

pests

This can be realized by achieving certain responses in the target pest(s) such as: mortality •preventing development •sterility •inactivation

ISPM 18-Treatment

Ionizing radiation may be provided by: Radioactive isotopes (gamma rays from Co60 or Cs137) •Electrons generated from machine sources (up to 10 MeV) •X-rays (up to 5 MeV) The unit of measurement for absorbed dose is the Gray (Gy)

Source Types

Gamma: Cobalt 60 orCesium 137 emitsphotons during decay E-beam: High energy electronspropelled (particle beam) froman electron gun X-ray: High energy electronsare converted to X-rays (photons)

ISPM 18-Treatment

When implementing treatments, the following variables should be considered: Dose rate •Treatment time •Temperature •Humidity •Ventilation •Modified atmospheres

Irradiation can be applied: As an integral part of packing operations •To bulk unpackaged commodities •At centralized locations such as the port of embarkation When feasible, treatment can also be applied: At the point of entry •A designated location in a third country •A designated location within the country of final destination

ISPM 18-Dosimetry

Dosimetry ensures that the required Dminis delivered to all parts of the consignment Additionally, dosimetry ensures that variations are accounted for Density and composition of the material treated •Variations in shape and size •Variations in orientation of the product (stacking, volume, and packaging)

All components of the dosimetry systems should be calibrated in accordance with international (or national)

standards

Dose mapping studies should be conducted to characterize the dose distribution within irradiation chambers and commodity Routine dosimetry is critical to monitor efficacy for every irradiation treatment

ISPM 18-Facility Approval

Treatment facilities should be approved by relevant nuclear regulatory authorities Treatment facilities should be subject to approval (qualification, certification, accreditation) by the NPPO Phytosanitary re-approval should be conducted on a regular basis (as appropriate) Dose mapping should be repeated following repairs, modifications, or adjustments in equipment or processes

ISPM 18-PI System Integrity

Confidence is based on assurance that the treatment is effective against the pest of concern and that the commodity has been adequately safeguarded Treated commodities should be adequately segregated, clearly identified, and handled under conditions that will safeguard against

re

-infestation, or misidentification

Packages should be labeled with treatment lot numbers and other identifying features allowing the identification of treatment lots and trace-back (i.e. packing and treatment facility identification and location, dates of packing and treatment).

ISPM 18-Documentation by Facility

Documentation of procedures (SOPs) Consignment handling procedures •Orientation and configuration of the commodity Critical process parameters and monitoring Dosimetry •Contingency plans and corrective actions •Treatment processes

Facility Records and Traceability Facility and responsible parties •Commodity •Target regulated pest(s) •Packer and grower information •Lot description and quantity •Identifying markings •Absorbed doses (target and measured) •Date of treatment •Observed deviations from treatment specification

ISPM 18-Inspection & Certificate

Export inspections ensure the consignment meets the phytosanitary requirements of the importing country Documentation verification •Examination for non-target pests Phytosanitary certification should include: Treated lots •Date of Treatment •Target minimum dose •Verified Dmin

NPPOs should clearly identify the contingency actions to be taken if live pests are found during import inspections: Target pests-no action unless the required response was not achieved Non-target regulated pests- no action if the treatment is believed to have been effective Non-target regulated pests- action if there is insufficient data on efficacy or the treatment is not known to be effective; Non-target, non-regulated pests-no action

ISPM 18-Additional Items

•Annex 1: Specific Approved Treatments •Annex 2: Checklist for Facility Approval •Appendix 1: Estimated Minimum Absorbed Doses for Certain Responses for Selected Pest Groups •Appendix 2: Research Protocol

IPPC recognizes certain treatments as international standards to achieve harmonization, enhance recognition of treatment efficacy, and facilitate trade

NPPO or RPPO can submit data for the evaluation of treatments to the IPPC Secretariat

ISPM 28

The requirements for submitting treatment research data are described in ISPM 28: Phytosanitary Treatments for Regulated Pests ISPM 28

Submissions are reviewed by the Technical Panel on Phytosanitary Treatments which makes recommendations to the CPM The CPM either adopts or rejects the treatment as an international

standard

If the standard is adopted, it is added as an annex to ISPM 28 ISPM 28

NPPOs are not obliged to used treatments that are adopted as international standards (even for the same pest and regulated article) Treatments are adopted only for the commodities, target pest(s), and conditions under which they were tested, unless there is sufficient data for extrapolation ISPM 28

Summary Information Treatment name •NPPO/RPPO contact information •Treatment description –commodity, target pest(s), parameters •Reason for submission •Credentials of those conducting research

ISPM 28-Required Information

Efficacy Data Source of data •Lifecycle/stage of target pest(s) •Statistical level of confidence •Methods used •Dose/efficacy curves (if applicable) •Additional information to support extrapolation (if applicable)

Pest Information Species, strain, biotype, etc. (if applicable) •Conditions under which pests are cultured/reared •Weight •Stage of development •Health •Method of infestation/infection •Most resistant life stage

Commodity Information Type of regulated article •Intended use •Size/shape/weight •Stage of maturity (if applicable) •Storage conditions after harvest/quality (if applicable)

Experimental Parameters Facilities used •Equipment used •Calibration of equipment and

accuracy of measurements

•Experimental design •Level of confidence •Conditions •Critical parameters •How effectiveness was

measured

•Dosimetry (if irradiation)

ISPM 28-Feasibility and Applicability

Ease of use Risk to operators •Technical complexity •Training/expertise required •Equipment/facilities required •Cost of treatment facility •Commercial relevance •Phytotoxicitydata •Effects on humans, non-target organisms, and environment •Resistance management •Have other NPPOs approved the treatment •Stand alone treatment or part of a systems approach •Versatility of treatment

Questions?

US Phytosanitary Irradiation Program

Woodward D Bailey

Laboratory Director Miami, FL US

Science and Technology Plant Protection and Quarantine Animal and Plant Health Inspection Service United States Department of Agriculture

“Any policy is a success by sufficiently low standards and a failure by sufficiently high standards.” -Thomas Sowell

•PPQ Mission •PPQ Organizational Structure •General Information •Regulatory Overview •Program Types •Close up on Preclearance •Additional Resources

Outline

Regulate the movement of any commodity capable of harboring invasive, threatening plant pests, including noxious weeds, in order to protect the “agriculture, environment, and economy of the United States” Facilitate import, export, and interstate commerce of agricultural products and other commodities that pose a risk of harboring certain plant pests Plant Protection Act of 2000

PPQ Mission

PPQ Organizational Structure

Phytosanitary Irradiation

•APHIS treatments require an absorbed doses between 60-400 Gy •FDA limits fresh fruit and vegetable treatments to

1000

Gy •Irradiated food products must bear the Radura

Treatment response options: •Mortality •Sterilization •Inactivity or Devitalization •Inability to Emerge/Fly Mortality is usually not the target response for APHIS treatments and live insects may remain after treatment

Pest Proof Packaging

Pest Proof Packaging

•Packages with no holes can be used; all package seams must be

taped

•Packages with holes can be used; pest proof mesh must cover all holes in; the mesh must be glued to the holes; all box seams must be

taped

•Packages with or without holes can be used; commodity can be placed in pest proof bags inside of package; pest proof bag must be heat sealed or knotted •Packages with or without holes can be used; package/pallet can be placed in pest proof bag; pest proof bag must be heat sealed or knotted (Preclearance Program Only)

•Pest Proof Packaging must have mesh of size <0.6 x 0.6mm, or pore size <0.8mm (for largest dimension, i.e. the hypotenuse) •Pest Proof Packaging cannot create a modified atmosphere around the commodity

Phytosanitary Irradiation

There are threeapprovedsourcefor phytosanitary irradiation treatments •Gamma: Cobalt

60

orCesium

137

emitsphotons during decay •E-beam: High energy electrons propelled froman electron gun •X-ray: High energy electrons are converted to X-rays (photons)

•Market Access Granted •Framework Equivalency Work Plan Signed •Trust Fund Established •Operational Work Plan Signed •Commodity-Specific Addendum Signed

Regulatory Summary

•Facility Plan Approved •Facility Certified •Importer Compliance Agreement Signed •Importer Permit Granted •Packaging Approved •Process Configuration Approved

Irradiation Program Types

Preclearance

Offshore Irradiation of U.S. Imports Port of Entry Domestic Irradiation of U.S. Imports Domestic Quarantine Treatment for Domestic Movement Exports Irradiation of U.S. Exports (in development)

Preclearance: India

Krushak

First Overseas Facility •Certified 2007 •Re-certified 2010 •Co

60

•Mango

Synergy Health Ltd

Certified 2008 •Re-Certified 2009 •Co

60

•Mangosteenand Longan Thai Irradiation Center Certified 2007 •Re-Certified 2012 •Co

60

•Mangosteenand Longan

Preclearance: Thailand

Preclearance: Vietnam

An PhuIrradiation

•Certified 2009 •Re-Certified 2012 •Co

60

•Dragon Fruit and Rambutan Son SonCorporation •Certified 2008 •E-beam •Dragon Fruit and Rambutan

Preclearance: Mexico

Sterigenics

Certified 2008 •Re-Certified 2012 •Co

60

•Guava and Chile Manzano Benebión Certified 2011 •Co

60

•Guava, Chile Manzano, Mango, and Sweet Lime

Preclearance: South Africa

High Energy Processing

(HEPRO)

Certified 2012 •Co

60

•Grape

Preclearance Totals

(in kg)

Port of Entry

SadexCorporation

Certified 2009 •Sioux City IA •Pakistan Mangos •E-beam

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

Southern States: Port of Entry

NCEBR

Certified 2012 •College Station TX •Mexican Exports •E-beam Gateway America Certified 2013 •Gulfport MS •South African Persimmon •Co

60

Domestic Movement

Hawaii Pride

1

st

PPQ-Certified Facility •X-ray •Sweet Potato and Tropical Fruits Pa’inaHawaii •Certified 2012 •Co

60

•Sweet Potato, Tropical Fruits and Herbs

U.S. Exports

Food Technology Service

Inc.

Mulberry FL •Certified 2011 •Co

60

•Stone Fruit Exports to Mexico •Domestic Movement of Grapefruit and Guava to Texas and California

U.S. Exports

Gateway America

Gulfport MS •Stone Fruit Exports to Mexico •SAGARPA is considering recognizing the PPQ certification for their own program

Thailand Preclearance Program

Synergy Health Ltd

Certified 2008 •Re-certified 2009 •Co60

Thai Irradiation Center (TIC)

Certified 2007 •Co60

It’s all about the “COOPERATOR.”

The “Perks”

Thailand Preclearance Program

Eligible Commodities

Dragonfruit •Litchi

•Longan

•Mango

•Mangosteen

•Pineapple •Rambutan

POP Officer Duties

Treatments

Inspection-commodity, packaging and conveyance •IRADS-certificate issuance

Packaging approval-data collection

Process configuration-data collection

Packinghouse inspections

Packing House Inspections

Thailand Preclearance Program

Treatment Duties

Inspection Commodity •Packaging •Conveyance

Review NPPO/exporter paperwork

IRADS Approve treatment data •Certificate issuance

Inspection

Inspection-Longans

Thailand Preclearance Program

Inspection-Mangosteen

Inspection-Conveyance

Paperwork…

Review Treatment Data on IRADS

…paperwork…

Thai Phytosanitary Certificate Exporter Forms

…and more paperwork…

PPQ 203

World’s Tiniest Snowman

First and Last Thai Snowman

Process Configuration Approval

•Dimensions •Material •Insect-proofing •Stored in IRADS FDA maintains a list of approved materials for irradiation treatments

PPQ Irradiation Treatment Site

http://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 want to use irradiation as a treatment to import a commodity. Where do I start?

•FAVIR •Commodity Import Request Process I checked FAVIR. The commodity is eligible for entry, but irradiation is not listed as an approved treatment.

What do I do?

•Requires treatment-Paul Gadh(301) 851-2046 •Does not require treatment-Permit Services (301)

851

-2046

PPQ Irradiation Treatment Site

I checked FAVIR. The commodity is eligible for entry, and irradiation is an approved treatment.

What are my options?

Option 1-Irradiation in the country of origin under an established preclearance program Preclearance programs-VedpalMalik (301)

851

-2278

Option 2-Irradiation conducted at the Port of Entry in the United States Importer Compliance Agreements-Roger Holman (919) 855-7336 •Import Permits-Permit Services (301) 851-2046 •Packaging Logistics-Laura Jeffers (919) 855-

7455

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

Are there non-phytosanitary import requirements that I should be aware of?

Food and Drug Administration: http://www.fda.gov/ •Department of Homeland Security, Customs and Border Protection Agency: http://www.cbp.gov/ •Agricultural Marketing Service: http://www.ams.usda.gov/

Questions?

Irradiation Facility Certification for Phytosanitary Treatments

Woodward D Bailey

Laboratory Director Miami, FL US

Science and Technology Plant Protection and Quarantine Animal and Plant Health Inspection Service United States Department of Agriculture

Outline

•Regulatory Summary •Resources •Facility Approval •Certification Preparation •Facility Certification •Facility Recertification

•Market Access Granted •Framework Equivalency Work plan Signed •Trust Fund Established (Preclearance) •Operational Work Plan Signed •Commodity-Specific Addendum Signed

Import Regulatory Summary

•Facility Plan Approved •Facility Certified •Importer Compliance Agreement Signed •Importer Permit Granted •Packaging Approved •Process Configuration Approved

PPQ Treatment Manual

http://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

PPQ Stakeholder Registry

https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new

PPQ Stakeholder Registry

PPQ Irradiation Treatment Site

http://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

PPQ Trade Team

Country Trade Directors Karen Ackerman (301) 851-2111, Oceania •Jo-Ann Bentz-Blanco (301) 851-2091, Central America, South America, Caribbean •Terri Dunahay(301) 851-2369, Canada •Dennis Martin (301) 851-2033, Africa, Middle East •Marie Martin (301) 851-2107, Mexico •Brendon Reardon (301) 851-2223, Europe •Vacant, China, India, Pakistan •Vacant, Japan, Korea, Taiwan, ASEAN

as of 8/29/14

So you want an irradiation facility?

Step 1. In what program type are you interested?

Depending on the program type, your requirements may differ.

•Preclearance •Port of entry •Domestic •Export

•India •Laos •Malaysia •Mexico •Pakistan •Peru •Philippines •South Africa •Thailand •Vietnam Countries with signed Framework Equivalency Workplanwith the U.S.

as of 8/29/14

FEWP

Step 2. If your facility is in the USA, contact CPHST (Laura Jeffers) for a Facility Plan Approval Application. She will tell you who else to keep informed of your progress (State Plant Health Director (SPHD), State Plant Regulatory Official (SPRO), PPQ Trade Directors, etc.).

Step 2 cont. If your facility is outside of the USA, contact Laura Jeffers for a Facility Plan Approval Application. It is imperativeto contact to the PPQ Country Trade Director to make sure that the appropriate agreements/work plans are in place.

Step 3. Prepare and turn in an electronic copy of your Facility Plan Approval Application to CPHST (Laura Jeffers), ensuring the appropriate people are copied.

Please send the signed hard copy directly to CPHST.

Step 4. CPHST reviews application. Depending on condition of application, review can take 1 -3 months.

Step 5. CPHST schedules call with facility to discuss facility application and collects additional information (if needed). CPHST issues facility approval letter.

Step 6. CPHST schedules call with facility and other PPQ staffs to discuss and schedule certification visit.

Depending on identified issues, certification visit usually occurs 2-3 months after approval.

Step 7. During interim, facility prepares for PPQ certification visit.

Step 8. PPQ (CPHST, Field Operations or Preclearance) conducts facility certification. PPQ issues facility certificate (Form 482).

Southern US States only: A letter supporting the establishment of a port of entry irradiation facility signed by the State Plant Regulatory Official (SPRO) must be submitted beforefacility approval.

Facility Approval

•Facility Location •License Information •Irradiator Information •Safety Information •Standard Operating Procedures (SOP) •Personnel Information •Dosimetry Information •Facility Diagrams

Facility Location

License Information

Irradiator Information

Safety Information

SOP Outlines

SOP Outlines (cont.)

Personnel Information

Dosimetry Information

Dosimetry

6 Dosimetry Systems in Use (all have ASTM standards for practice) Alanine(Pellets and Film) •Ceric-cerousSulfate •RadiochromicFilm •Polymethylmethacrylate •Ethanol-Chlorobenzene •LiFPhoto Fluorescent Film

All dosimetry systems used in APHIS Programs must be traceable to National Standards Lab (NIST) Irradiate NIST dosimeters (transfer) alongside facility dosimeters (adjustment factor is calculated and applied to facility dosimetry system) •NIST calibration of facility dosimeters (calibration curve is calculated and applied to facility dosimetry system)

Facility Diagrams

Facility Diagrams (cont.)

Missing Items

Just when you thought it was safe to go back in the water….

CPHST is revising the Facility Plan Approval Application

Get ready for us!

What should the facility do to prepare for the certification inspection?

•Test process configurations to be sure they meet the quality and volume goals of the facility, boxing and shipping requirements of the exporters, and APHIS dose requirements.

•Be sure there are enough dosimeters on hand to perform dose mapping work.

•Work with fruit suppliers to be sure fruit in the appropriate boxes is available

Facility Certification

•Tour of the Facility •SOP Review •Delivery of Phytosanitary Dose •Calibration of Dosimetry System •Process Configuration Approval •Database Training 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?

Calibration of Dosimetry System

All dosimetry systems used in APHIS programs must be traceable to NIST Irradiate NIST dosimeters alongside facility dosimeters (adjustment factor is calculated and used with dosimetry system) •NIST calibration of facility dosimeters (calibration curve is calculated and applied to dosimetry system)

Process Configuration

Packaging Approval of Components •Configuration Arrangement •Pest-Proof Packaging Commodity Article Weights •Box Weights

Dose Mapping Place dosimeters throughout load •Focusing on areas expected to receive high and low

absorbed doses

•Includes a reference location, R

f

•Absorbed doses for 3 replicates are entered into workbook •Determination of R

min

and R

max

(applied to R

f

•Configuration details entered into IRADS

Process Configuration Testing

Issues with Current Process Time Consuming •Cost Prohibitive (Destructive) •Overly Conservative What Do We Need?

•Non-Destructive Testing •Immediate Release of Commodity

Alternate Processes

Several facilities approached CPHST with alternative process configuration approval

procedures

Port of Entry Program Approval upon arrival •Approval pest proof packaging in advance •Validation of facility timing methodologies

Process Configuration Approval

To date, no E-beam or X-ray facilities have approached CPHST with a proposal.

CPHST will work with previously-certified Co

60

facilities to approve alternate methodologies.

In the future, methods for process configuration testing will be addressed during approval and certification.

Process Configuration Testing

US Imports: 2013 MB Usage

Condition of Entry Treatment

Emergency Action at Port of Entry

IRADS Training

Irradiation Reporting and Accountability Database Tracks irradiation treatment and traceback data •Creates treatment certificates •Modules for import and export treatments

Descriptions of the CTIS treatment databases

Links to helpful treatment sites and documents

Links to the CTIS treatment databases

Links to the CTIS treatment training sites

CPHST staff enters treatment news

Treatment Information Systems

Recertification

Re-certification of a facility is initiated by the following Problems with treatment process identified by APHIS or NPPO (i.e. unmitigated pest interceptions) •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.

Facility Audits

On-Site Audit Review: •Treatment Processes •Dosimetry and Dose Mapping •Safeguarding Measures •Recordkeeping Electronic Audit Review: •Routine Dosimetry Data; checking for significant variation in dose •Treatment Failures

APHIS Certified Domestic Facilities

•Food Technology Service Inc. (FTSI) •Sadex •National Center for Electron Beam Research •Gateway America •Hawaii Pride • Pa’inaHawaii

APHIS Certified International Facilities

•Krushak, India •Synergy Health, Thailand •Thai Irradiation Center, Thailand •Son SonCorporation, Vietnam •An PhuIrradiation, Vietnam •Benebion, Mexico •Sterigenics, Mexico •Hepro, South Africa

Final Thoughts

Questions

COLOMBIAN EXPORTS

Location

Gateway America Air Cargo Perishable Treatment Center Interstate Access: 3 minutes from I-10 45 minutes from I-59 1 hour from I-65 2.5 hours from I-20 Ports: 5 minutes from Port of Gulfport 1 hour from Port of Mobile 1.5 hours from Port of New Orleans

Gateway America is a Primus Lab Certified Global Food Safety Initiative Facility (GFSI)

In April of 2013 Gateway America

was approved for

treatments including:

PORT OF ENTRY

EXPORTS

DOMESTICS

On-Site Facility Features

Customs & Customs Agriculture

USDA-APHIS-PPQ

USDA-APHIS-PPQ Identifier

Cold Storage and Staging

20,000sq.ft. of cold storage

Gateway America offers 3 cold chain atmospheres

All dock doors are equipped with Kelly Door seals and vehicle restraint systems

Our entire cold chain process is regulated, recorded, and monitored by Siemens Apogee system

Ocean Cargo

Ports Serviced:

Port of New Orleans, LA Port of Gulfport, MS Port of Pascagoula, MS Port Bienville, MS Port of Mobile, AL Port of Houston, TX

Food Irradiation Fumigation Pre-Cooling Track & Trace 3

rd

Party Logistics Re-Pack Cross Docking Labeling Specialty Sorting Aircraft Ground Handling Nation Wide Trucking Freight Forwarding Foreign Trade Zone No. 92

Facility Services:

Direct Air Cargo

Gateway America Equipment:

400 X 400sq.ft. Air Cargo Ramp •(2) FMC Main deck Loaders (40,000lbs) capacity •(1) Lantis Lower deck loader (20,00lbs) capacity •33,000lbs capacity Caterpillar Forklift •Cargo dollies •Tugs •TLD Dual Output Ground Power Unit •(2) Air Stairs (MD-11) & B737-B747 •Rice Lake 10’ X 8’ 20,000lbs capacity scale with printer

Incentive Programs for Air Cargo:

Foreign Trade Zone 92 •Tax free bonded fuel for international flights •Aircraft ground handling •Waived landing and takeoff fees •Waived ramp fees

Indirect Air Cargo

Gateway America works with Customs, USDA, and our Customers to import commodities for Port of Entry Treatments. Many of these are passenger aircraft with belly hold capacity others are freighter operations.

Following airports are currently being used for Port of Entry: Atlanta Hartsfield International ( ATL ) DELTA AIRLINES Dallas Fort Worth ( DFW ) AMERICA AIRLINES Houston Intercontinental ( IAH ) UNITED AIRLINES

Produce Irradiation

Fresh produce will generally tolerate doses of 1kGy of irradiation although variation exists.

Not only does our customer meet the regulatory requirement for importing product into the U.S.

they generally see added shelf-life extension due to the elimination of spoilage bacteria

Framework Equivalency Work Plan (FEWP) Operational Work Plan (OWP)

Gateway America works with: Host Countries National Plant Protection Organization (NPPO) USDA- APHIS To establish the necessary dialog to build and implement their Framework Equivalency Work Plan (FEWP). This is a basic trade reciprocity agreement.

Once that is complete we will work with the growers and importers to establish the Operational Work Plan (OWP). This is a simple document stating intentions and project overview.

This covers: Packaging materials / Pest Proof Packing (PPP) Routing Logistics

Compliance Agreements

Once the framework equivalency work plan (FEWP) and operational work plan (OWP) are completed we can move on to Compliance Agreements.

USDA now works directly with the treatment facility to setup Compliance Agreements for new importers.

First step in setting up a Compliance Agreement is to send the boxes to Gateway America at the following address: Gateway America 4300 Air Cargo Rd.

Gulfport, MS. 30501 Once that is complete we will build a customer profile. We will discuss your routing and logistics options.

Information needed for compliance agreements

Thank you for your interest to import commodities using irradiation upon arrival.

Please provide the following information:

1.

Name (and Company) 2.Mailing address 3.Phone number 4.Fax number 5.Commodity for import 6.Country of origin 7.Port of entry. Note: No cargo can enter into CA or FL at this time.

8. Route to treatment facility. Note: No cargo can travel through CA or FL at this time. You must use a sealed, refrigerated conveyance to carry commodity to treatment facility. After leaving the port of entry, commodity cannot be trans-loaded into another means of conveyance.

Before the compliance agreement will be issued, PPQ must receive notice from the treatment facility that they are prepared to irradiate your product. Please contact the facility to ensure that there is an APHIS approved package (this includes pest proofing material) and process configuration for your commodity. The facility will contact PPQ if a new package or process configuration approval is needed.

Pest Proof Packaging

Listed below are the regulations for Pest Proof Packaging:

For pest proof packaging (PPP), PPQ requires a mesh size of <0.6 x 0.6 mm, or a pore size <0.8mm (for largest dimension, i.e. the hypotenuse). If PPP bags are used, the PPP must be knotted or heat sealed (folding or rolling bag is not sufficient). If PPP mesh is used to cover holes and openings on boxes, the PPP must be glued to the box (there can be no gaps between the box and PPP). If cardboard boxes with no openings or holes are used, then box seams can be taped shut.Packaging and PPP cannot create modified atmospheres with O2 concentrations < 18%.

Please keep in mind that the NPPO will work with USDA to while setting up the Operational Work Plan to establish the specific Pest Proof Packaging regulations, these are the general guidelines.

Import Permits

1.Go to the USDA eAuthentication web site https://identitymanager.eems.usda.gov/registration/index.aspx 2.You will apply for a level 2 permit.

3.Next we will help you find qualified Customs Broker that specializes in Perishables Imports for Ocean or Air cargo. Gateway America will help locate the best Customs Broker for your operation.

4.If you need any help with during your permitting process please feel free to contact us anytime.

Port of Entry Treatments

Due to some of the complexities of handling (POE) treatments it is important to understand some of the steps and actions to be taken.

For many of our importers this may be the first time they have ever imported product into the US. We work with the importer and USDA to ensure that all of the protocol steps are followed such as: eAuthentication and applying for level 2 access for ePermits Routing, Compliance Agreements, and Permitting Finding the Customs Broker that fits their needs Labeling Requirements Logistics Distribution Planning and Execution

For Gateway America understanding the entire process is key. If one small piece of the puzzle is overlooked it could delay an importer by months and could delay the import until the next growing season.

Example: One of our customers at Port of Origin forgot to mark one of their pallets as a SAMPLE PALLET. US Customs came very close to reexporting that entire shipment which was about 39,500 lbs. Thankfully Gateway America ad USDA were able to work with US Customs to resolve the issue.

Interesting Link http://www.freshplaza.com/article/159372/Mexico-Puebla-achieves-recordbreaking-pitahaya-exports

Gateway America, LLC. 4300 Air Cargo Rd. Gulfport, MS 39501 Office: (228) 331-1473 ops@gatewayamerica.net

Connect with Gateway America

Ryan Hollingsworth VP Of Operations Wireless: (228) 547-6546 Ryan@gatewayamerica.net

Frank Benso

President

Wireless: (217) 621-3140 Frank@gatewayamerica.net

PHYTOSANITARYIRRADIATION FOR CONTROL OF INSECT PESTS IN HAWAII

Peter Follett, Research Entomologist USDA-ARS U.S. Pacific Basin Agricultural Research Center Hilo, Hawaii

Agricultural trade transports quarantine pests

Overview

Phytosanitary treatments

Insect pests Treatment options Market access

Phytosanitary irradiation

USA and Australia Commercial use in Hawaii

Video

Phytosanitary insect pests

Internal pests

Surface pests

Hitchhikers

Irradiation may be required, or used as “insurance”

Comparison of quarantine treatments

•Cold •Heat •Fumigation •Systems approach •Irradiation •12-22 d treatment time •Quality reduced •Toxic •Complicated •Retailer reluctance -- Fast, no quality loss, non-toxic, simple

Treatment typeShortcoming

Phytosanitary irradiation

Advantages

Broadly effective Good product tolerance Extend shelf-life Competitive cost Treatment is fast Treat in final packaging Treat at any temperature Bilateral trade Generic treatments

Regulations key to the adoption of irradiation

US FDA approved irradiation doses up to 1000 Gy for preservation and disinfestation of fresh fruits and vegetables (1986) USDA APHIS approved generic irradiation doses for quarantine disinfestation of fresh commodities (2006).

150 Gy tephritid fruit flies 400 Gy all insects except Lepidoptera Export approvals

To United States

Many quarantine pests

Thailand –7 tropical fruits –400 Gy India, Pakistan –mango –400 Gy Vietnam –dragon fruit, rambutan–400 Gy Mexico –guava, mango, citrus –70 or 150 or 400 Gy South Africa –table grapes, lychee, persimmon, sweet cherries

–400 Gy

2007 2008 2009 2010 2011 2012 2013 2014

Million kg

0

2

4

6

8

10

12

14

16

From Australia

Queensland fruit fly

Domestic (2003) –23 fruits and vegetables –150 Gy New Zealand –mango, capsicum, tomatoes –250 or 400 or 500 Gy Vietnam –mandarin, orange , table grapes –400 Gy Indonesia –14 fruits –150 Gy Malaysia –mango, lychee–300 Gy United States–mango, lychee–400 Gy

Hawaii’s commercial irradiators

AWAII RIDE

E-beam/X-ray source Opened in 2000 Designed for fresh produce Expensive

Pa’ina

AWAII

Cobalt source Started in 2013 Designedfor fresh produce Relatively inexpensive

Hawaii Pride –X-ray irradiator

Pa’ina Hawaii –cobalt Irradiator

Hawaii exports to U.S. mainland

Fruit flies and other pests

Fruits

Papaya Dragon fruit Mango Longan Banana Rambutan Abiu Atemoya Breadfruit

Vegetables

Sweet potato Bell pepper Eggplant Long bean Moringa Squash Tomato

Cherimoya Guava Jackfruit Lychee Mangosteen Melon Pineapple Sapodilla Star fruit

Hawaii Pride export volumes (million lbs)

2.3

3.9

0.6

0.040.03

11.8

0.6

0.2

0.05

7.5

0.6

0.2

0

2

4

6

8

10

12

14

PapayaSweet potatoExoticsOther

2005

2010

2014

Economically important fruit flies in Hawaii

•Melon Fly

(Bactrocera cucurbitae) 1895

•Oriental fruit fly

(B. dorsalis) 1945

•Solanaceousfruit fly

(B. latifrons) 1983

•Mediterranean fruit fly

(Ceratitiscapitata) 1910

Dose Uniformity Ratio

Lowering the dose for pests or commodities

US FDA approved irradiation doses up to 1000 Gy(1 kGy) for preservation and disinfestation.

DUR = Maximum / minimum dose typically 1.5-3.0 400 Gy(generic dose) x 2.5 = 1000 Gy Advantageous to lower the dose: Avoid problem of 1 kGylimit Cost Capacity Quality

Phytosanitaryirradiation Research to lower doses

Hawaii irradiation research

Lowering the dose for pests

Pest

Fruit flies (3) Sweet potato pests (3) Mango seed weevil Litchi fruit moths (2) Armored scales (2) Banana moth Ants (4) Light brown applemoth Spotted wing drosoph.

Coffee berry borer

Dose (Gy)

150

150

300

250

150

150

100

150

80

100

Rough sweetpotato weevil

Quarantine pest

Discovered on Hawaii island in 2014 From SE Asia External feeder Difficult to raise in the lab Large sweetpotato industry in U.S.

Irradiation Adult most tolerant stage Sterilized at <50 Gy

Coffee berry borer

Quarantine pest

Discovered in Hawaii in 2010 On island of Hawaii but not Kauai Inter-island movement restricted Fumigation used Irradiation Adult most tolerant stage So far, sterilized >1,000 adults at 100 Gy

Latin America

Phytosanitaryirradiation

Latin America to U.S.

Lower doses for specific pests

Pest

Anastrepha ludens Anastrepha obliqua Anastrepha serpentina Anastrepha suspensa Ceratitis capitata Copitarsia declora Brevipalpus chilensis European grape vine

moth

Dose (Gy)

70

70

100

70

100

100

300

200 (in progress)

U.S. to Latin America

Bilateral trade

Example: Sweet cherries Spotted wing drosophila Western cherry fruit fly Codling moth Peach twig borer Oriental fruit moth Oriental fruit fly and other fruit flies

(outbreaks)

Irradiation dose (Gy) 80

150

200

200

200

150

COPA AMERICA Colombia 2 –0 USA

Sweet potato irradiation Video

Effect of Irradiation on Food

Anuradha Prakash

Ionizing energy

www-naweb.iaea.org

earthobservatory.nasa.gov

Three modalities

Gamma

Electron Beam X-ray

www.saicabtech.com

www.nde-ed.org

www.steritech.com.au

How it works?

Proteins: peptide radicals leading to fragmentation and re-aggregation, limited denaturation Carbohydrates: depolymerization Lipids: autoxidation Vitamins: Thiamin, vitamin C, folic acid, carotenoids, vitamin E are sensitive

http://www.mapfre.com/fundacion/html/revistas/seguridad/n134/en/article2.html

Effect on microorganisms

www.radiation-scott.org/radsource/4341-3.gif www.molecularexpressions.com

Commercial Food Uses

DosePurposeExamples

0.05-0.15 kGyInhibit sproutingGarlic, onions, potatoes 0.15-0.40 kGyInsect disinfestation Mangoes, dragonfruit, rambutan, capsicum, etc

1.0- 7.0 kGyPathogen reduction Groundbeef, frozen frog legs, shellfish 7.0-25.0 kGyPathogen reduction Spices

44 kGySterilizationNASA meals

Food Safety

Spices Ground beef Chinese products Frog legs Pet treats NASA irradiated meals Meals for immunocompromised patients

Microbial efficacy and food quality

Greater microbial reduction at higher temperatures but lower temperatures maintain better quality Greater microbial reduction at higher moisture contents thus, dry products need higher dose treatment E. coli, Listeria, Salmonella spp, and parasites -easily destroyed Spores and viruses –more resistant

Shelf-life extension

Parsley and cilantro 14 days

Inhibition of sprouting

Onions Potatoes in Japan

http://www.laradioactivite.com/en/site/pages/Food_Processing.htm

www.global-peace.go.jp Krushak, Nasik, India

Elimination of Plant Pests

International Standards for Phytosanitary Measures

ISPM 18 (2003): GUIDELINES FOR THE USE OF

IRRADIATION AS A PHYTOSANITARY MEASURE

ISPM 28 (2007): PHYTOSANITARY TREATMENTS

FOR REGULATED PESTS

… reducing trade barriers

Quality factors in fresh produce that may be affected by irradiation

Spoilage organisms Appearance

•Peel damage •Interior

Electrolyte leakage Texture

•Pecticsubstances

Color

•Chlorophyll •Anthocyanins •Carotenoids

Flavor and aroma

•Organic acids

Wound response

•Respiration rate •Ethylene •Phenol biosynthesis Scald (apples and pears) Lipid oxidation Nutritional factors

www.toucano.com/irradiation.html

Vegetables Control 1 kGy Broccoli 8.5a 8.5a Red cabbage 8.4a 8.2a Endive 5.8b 6.5a Parsley 6.2b 7.6a Green leaf lettuce 5.4a 7.1b Cilantro 5.5a 6.2a Iceberg lettuce 6.8a 6.2a Spinach 5.0a 6.9b Romaine lettuce 6.8a 6.0a Alfalfa sprouts 7.8a 8.0a Carrots 8.5a 8.5a Red leaf lettuce 4.0a 4.3a Green onion 3.7a 5.3b Celery 3.9a 4.9b

Visual Quality of Nonirradiated (Control) and Irradiated (1 kGy) Freshcut Vegetables after 14 days storage at 4°C.

9 =excellent, 1=unusable.

Fan and Sokorai 2005.

Effect on nutritional value

Folic acid Thiamin Vitamin C Vitamin A (carotenoids) Vitamin E Phenolics

Day 1 Day 14

0 kGy 1 kGy 0 kGy 1 kGy

Broccoli926 902 855 855

Cilantro528 538 115 157

Red leaf

lettuce

74 39 34 15.7

Spinach265 199 198 69

Vitamin C content (µg/g fresh weight) Fan and Sokorai. J. Food Science. 2008.

Process Optimization

% Effect

0

10

20

30

40

50

60

70

80

90

100

Maximum tolerance level for detriment

Minimum acceptable level for desired benefit

Process optimization may move dose response for detriment Process optimization may improve dose response for benefit

D

max

must be less than thisD

min

must be greater than this

Acceptable range

Dose

Dose response for beneficial effects

Dose response for detrimental effects

The illustrated D

min

and D

max

represent the ‘allowed’ range of dose. The ‘actual’ range delivered by the irradiator must fall within the ‘allowed’ range.

Figure courtesy Joseph Borsa, MDS Nordion

Process Control

Dose measured using dosimeters Dose uniformity ratio (DUR) = Dmax/Dmin Dmincannot fall below minimum level needed to achieve a particular goal Dmaxshould not exceed a certain maximum due to effects on quality and to stay under maximum dose allowed by regulations Need to consider optimal dose delivery and processing efficiency

Safety of Irradiated Food

Toxicological Radiolytic

2 alkylcyclobutanones Furans

Regulations

Defined as food additive FDA has main regulatory responsibility, also USDA (FSIS and APHIS) Labeled with a radura (no size specification) and the words “Treated with irradiation” or “Treated by irradiation” Required for retail, finished products or foods destined for further processing, not required for minor ingredients

Consumer Acceptance

Growers Consumers

Retailers

Will consumers will buy irradiated product?

Does the product taste good?

Is it reasonably priced?

Will retailers will stock irradiated food?

Distributors

Will retailers stock the product?

Product focus

Consumers respond positively when informed People purchase irradiated food Insect quarantine applications with produce are expected to grow Focus on the product and its benefits, rather than the technology Most (but not all) will buy when given the opportunity

Courtesy Bill Gerlach, Melissas

Phytosanitary Irradiation Research Needs

Woodward D Bailey

Laboratory Director Miami, FL US

Science and Technology Plant Protection and Quarantine Animal and Plant Health Inspection Service United States Department of Agriculture

•Facility, packaging and process configuration

approval

•PPQ policy and standard development (CFWG) •Research proposal review and/or development •Cooperator research project management •Irradiation database management and QA •Field and hub staff training •International and domestic outreach •Methods development (quality, MAP, generic & specific pest doses)

S&T Irradiation Efforts

Current Research Efforts

•Upon Arrival Process Configuration Approval •Quality Studies •Generic Doses •Modified Atmosphere Packaging •Treatment Verification Tool •Odds n Ends

Dose Mapping

It is important to know what the absorbed dose range will be throughout the configuration Dose mapping Identify areas of high and low absorbed dose •Determine R

f

(reference dose)

Process Configuration Testing

Packaging approval and process configuration testing and approval has to occur before commodity is shipped to the US from the country of origin Issues with current process: Time consuming Cost prohibitive (destructive) Overly conservative Very difficult for Port of Entry Irradiation Program

Process configuration testing on Thai longan

Industry requested APHIS to help develop procedures: Non-destructive testing Immediate release of commodity PPQ has validated industry proposals from 3 facilities

Process Configuration Testing

PPQ will work with previously-certified Co

60

facilities to approve alternate methodologies In the future, methods for process configuration testing will be addressed during approval/certification In addition to saving exporters and participating facilities considerable time and money, this is a large step towards using phytosanitary irradiation as a methyl bromide alternative for emergency actions (quarantine pest found on commodity)

Methyl Bromide Alternative

US Imports: 2013 MB Usage

Condition of Entry Treatment

Emergency Action at Port of Entry

Quality Work

PPQ Irradiation Programs

Preclearance •Offshore irradiation of U.S. imports Port of Entry •Domestic irradiation of U.S. imports Domestic Quarantine •Treatment for domestic movement Exports •Domestic irradiation of U.S. exports

Quality Work

Most fruit can be irradiated with 150-600 Gray with no adverse effects Increased shelf life •Improved quality

Joseph Borsa, MDS Nordion

Joint Project (Chapman University, FTSI, and PPQ) Peaches irradiated 250, 400, 700, and 1000 Gy •Analysis performed 1,7,and 14 days after treatment •Shelf life, pH, Brix, and weight loss

Quality Work -Peaches

Quality Work

Irradiation positively affected the liking/acceptability of all peach varieties tested Shelf life, pH, Brix, and weight loss were not negatively affected by irradiation (variety and age play a bigger role)

Effect of phytosanitary irradiation on the quality and shelf-life of citrus

Determine whether or not phytosanitary irradiation is a feasible treatment for Chinese citrus imports

•Kishumandarin and Chandler pummelos •Irradiated 150, 400, and 1000 Gy •Analysis performed 2, 21,and 28 days after treatment •Shelf life, titratableacidity, firmness, organic acids

Quality Work -Citrus

Joint Project (Chapman University, PPQ)

Kishumandarin did not tolerate irradiation Dark coloration on peel 2 days after irradiation at 400 and 1000 Gy Chandler pummelos No change in color, pH, sugars, juice content •Quality compromised at 1000 Gy, but acceptable at 150 Gy

Quality Work

Generic Absorbed Doses

Generic Absorbed Doses Pest-Specific Absorbed Doses

Generic Absorbed Doses Facilitate Trade

If a risk analysis of a new commodity demonstrates that no pupae or adult Lepidoptera follow a pathway, then export approval can happen without further research.

Generic Absorbed Doses

•Develop doses for quarantine Lepidoptera (adults and pupae) not covered by the generic treatment •Develop generic dose for mites (not included in generic 400 Gy dose) •Reduction of dose levels for specific pests and commodities to shorten treatment time and minimize deleterious effects •Development of generic doses below 400 Gy for important groups of quarantine arthropods (other than fruit fly) •IAEA Working Group

The Evolution of Pest Proof Packaging

MAP is a process that alters the gas composition surrounding a commodity.

•prolongs the shelf-life of perishablegoods •slows the speed of aerobic microorganisms In the past few years, requests to use MAP for phytosanitary treatments have dramatically increased.

Modified Atmosphere Packaging

The generation of free radicals from oxygen and water cause tissue damage.

Most MAP creates a low O

2

environment.

Insect respiration slows, resulting in reduced O

2

concentrations in the hemolymph.

In hypoxic environments, higher absorbed doses may be necessary to achieve same physiological effects.

Anoxic environment reduce efficacy of irradiation treatments In hypoxic environments, higher absorbed doses may be necessary to achieve same physiological effects Current policy requires a minimum concentration of 18% O

2

in MAP (very conservative)

Mexican Guava

No irradiation •Simulate treatment facility conditions •Record the O

2

concentrations before and after “treatment”

Modified Atmosphere Packaging

Before Treatment After Treatment

19.8% 5.6%

Modified Atmosphere Packaging

Add 1 mm perforations to packaging

Modified Atmosphere Packaging

Before Treatment After Treatment

20.9% 20.9%

Requires insect proof packaging

CPHST is funding University of Florida research to characterize the effects of modified atmospheres on irradiation treatments.

Determine whether irradiation in modified atmospheres affects survival or fertility (Lepidopteranpests)

In the event that CBP intercepts a live pest within the pest proof packaging, PPQ needs a tool to verify that an irradiation treatment has occurred.

Ideally, the Treatment Verification Tool Would: Provide Immediate Y/N answer •Be Inexpensive •Be Easy to Use •Not Require Hazardous Reagents •Have Low-Maintenance Storage Requirements •Work for Multiple Insect Families

Treatment Verification Tool

CPHST is working with the University of Florida to develop a diagnostic assay to verify that a phytosanitary irradiation treatment was performed.

Incremental Dosing

CPHST is working with facilities to show that it is possible to achieve required minimum doses using incremental doses CPHST is working with facilities to allow program commodities to run through the irradiation cell in immediate succession

Reworking Procedures

CPHST is working with facilities to develop procedures to re-treat under-dosed commodity

Cobalt Reloading

CPHST is working with facilities to develop procedures to confirm the validity of previouslyapproved process configurations after reloading

Final Thoughts

Questions

CABINET X-RAY MACHINE AND SMALLSCALE IRRADIATION

Peter Follett, Research Entomologist USDA-ARS U.S. Pacific Basin Agricultural Research Center Hilo, Hawaii

Overview

Who wants small scale irradiators?

In-line cabinet X-ray irradiator Radsource’s 4-Pi X-ray tube Comet’s X-ray emitter

Potential for E-beam

Hawaii pride X-ray irradiator

Phytosanitary irradiation

What is the feasibility of in-line irradiation?

Airport baggage screening

Cabinet X-ray irradiators

Why growers might be interested…

Costs a fraction of a stand alone facility (<$1 million) Treat fruit the same day it’s packed –no transportation Moveable -ready-made for domestic quarantines Under grower’s control

Methyl bromide alter.

Can treat fruit cold Simple solution Potential application: Sweet cherries to Australia and Mexico

(spotted wing drosophila)

Requirements

Good penetration Different box types Good dose uniformity ratio At 400 Gy, <1 kGy maximum Sufficient throughput Gentle on commodity

Low cost Portable, self-shielded Reliable during continuous use Two candidates:

X-ray emitter

4-P1 X-ray tube

In-line cabinet X-ray irradiator

XBA-180 X-ray emitter

Concept design: Dominique Cloetta Comet AG

XBA-180 X-ray emitter

Comparison to conventional X-ray tube

Geometry not optimal Small angle of radiation Low dose rate –1/r

2

Large surface emitter Broad radiation beam Higher dose rate >1/r

Simulation for papaya box

Dr. Dominique Cloetta (Comet)

Y

M

At 180kV, 4.5kW and 10cm/min conveyor speed: Min. dose: 78Gy, max. dose: 109Gy DUR: 1.4

at 5cm/min: Min. dose: 156Gy, max. dose: 218Gy at 1.95cm/min: Min. dose: 400Gy, max. dose: 559Gy at 1.09cm/min: Min. dose: 716Gy, max. dose: 1000Gy

X-ray emitter Papaya test

Comet AG Flamatt, Switzerland

DUR

Flat = 1.9 Upright = 1.2

X-ray emitter

In-line cabinet x-ray irradiator

4-Pi x-ray tube

Concept design: Randy Kirk

Applied

Energy Devices

4-pi X-ray tube

12

Transportable Container

Upender

Shipping Container

Pneumatic Actuator Pneumatic Actuators

Portable X-ray Irradiator

VENT

Lead 26”

60”

Power Supplies

ECS CoolerCoolerCooler

7’

= x-ray tube

13’

New x-ray tube design

Dan Gorzen X-ray and Specialty Instruments Inc.

160 kV, 20 mA 35 cm radiation field 10% variation

Cabinet x-ray machine

Under construction

Inside portable container Self shielded (lead) Computer interface Irradiates box from bottom then top Throughput varies by dose

Potential for electron beam

Ex: Prima Frutta, Linden, CA High volume 15,000 boxes per day 1 box per 4 sec Short harvest 2 months Continuous use Treat in cold room

Sweet cherry packing houseSingle layer of fruit

Potential for E-beam

Ex: Prima Frutta, Linden, CA High volume 15,000 boxes per day 1 box per 4 sec Short harvest 2 months Continuous use Treat in cold room

Sweet cherry requirementsIn-line e-beam

Size versus performance

Boxes DUR

1.5

Throughput 100s lbs/hr Cost $1 million

Carrier DUR 1.5-2.0

Throughput 1000s lbs/hr Cost $3-10 million

SmallMediumLarge

Pallet DUR 2.5-3.0

Throughput 10,000s lbs/h Cost $10-30 million

Exito de la Irradiación como Tratamiento Fitosanitario México

Maria Emilia Bustos Griffin

Frutos Mexicanos Irradiados para el Comercio Internacional

Tecnología desde 2008

Implementación de una Tecnología

1. Factibilidad Técnica

2. Factibilidad Económica

3. Factibilidad Financiera

4. Factibilidad Politica

5. Factibilidad Social

Tecnología

Tratamientos Cuarentenarios

Primera propuesta por Koidsumi para mover fruta de la Isla de Formosa (hoy Taiwan) 1930

¿Por qué llevo tantos años la tecnología de irradiación para el tratamiento fitosanitario? y ¿cuál fue el trabajo de México?

1930

Primera Propuesta

Implementación

2008

México

Investigación

Promoción y Estudios económicos

Marco Legal

Reglamentos y normas?

Seguridad?

Grandes Preguntas

Cos

to?

Tecnicas de Deteccion?

Para alimento? Para plaga?

Seguridad de Alimentos Irradiados

“Aditivo” clasificado por el GEIA, 1964 Formación Productos Radiolíticos •1970-1982 Karlsruhe, FRG

CONCLUSION

•Un alimento irradiado hasta una dosis de 10 kGy* NO hay riesgo toxicológico •NO hay problemas nutricionales •NO hay problemas microbiológicos

*Gy = Joule/kg, kGy= 1000Gy

Norma Codex

Situación en México

Década de los 70 investigaciones en diferentes tipos de frutas con el objetivo de incremtentar la vida de Anaquel.

1980 ININ

Irradiador Comercial JS6500

Problema

•EPA en 1982 anuncia suspensión del DBE •comercio de citricos y mango ???

•México exportaba

Información

•Encuestas a industriales y productores de alimentos Alimento Industria( Granos 0

Pollo

12 Fresa 6 Cítricos 5 Mangos 6 Camarón 4 A. animales14 Especias 70

Investigaciones

•Estudios Entomológicos •Dmin en 4 especies de mosca de la fruta de importancia económica para México •A. ludens, serpentina , obliqua, y C. capitata •ARS protocolo efectividad en base al valor Probit-9.

Dosimetría

Parámetro principal del proceso

Selección y colocación Medición y Distribución de dosis en caja y contenedor

Nuevo Concepto

No se requiere alcanzar la mortalidad Rango de respuesta variables.

Inhabilidad de volar o emerger adultos •Esterilidad •Inactivación.

Cambio de mentalidad

Inspectores cambio de actitud hacia una plaga viva, entender que la plaga irradiada no presenta riesgo.

Estudios de Calidad

Pruebas de Transporte

Mango var Kent Irradiada en Mexico y via aerea a E.U.

Dosis de 150, 300 y 375 Gy.

Oficiales del USDA reciben la fruta para cruzar la frontera.

Almacenada en laboratorios del ARS en Weslaco, Texas

Estudio de Factibilidad Economica

1984 OIEA

Conclusión: Costo de Irradiación es mínimo, comparado con el costo del empaque Tratamiento de Irradiación economicamente factible

Normas y Reglamentos

Reconomiento Estados Unidos

FAO/IAEA. Evaluación de la IF para resolver problems de cuarentena en el comercio de frutas ( 1970).

Mexico miembro GCIIA.

Recibe apoyo para implementar la IF.

NAPPO. Reconoce la Irradiación Fitosanitaria

(1989)

1986

FDA Reglamento Autoriza la irradiación para alimentos .

•frutos Dmax 1KGy

•1989

•APHIS Autoriza Irradiar papaya de Hawaii a Guam, Puerto Rico e Islas Virgenes, 150Gy

Nuevo Concepto. Inhabilidad del insecto a volar.

Reacción de Productores Mexicanos

A pesar de ….

Productores deciden utilizar el tratamiento de agua caliente para exportar mango. Y el Bromuro de Metilo para tratar cítricos

Promoción

Seminarios Exposiciones

Cursos Regionales Conferencias

Problemas

La suspensión del Bromuro de Metilo MB Protocolo de MONTREAL (1992) –Daños al ambiente. Destruye la capa de ozono.

Tratamientos Alternativos, presentaban problemas de calidad y muy específicos solo a determinados productos..

Reglamentos

México

Secretaria de Energía Autoriza la irradiación de alimentos.

Secretaria de Salud NOM 033- SSA1- 1993 (publicada Marzo 7, 1995) autoriza la importación y consumo de alimentos irradiados.

Estados Unidos

APHIS 1996. Notice Police

APHIS 1997 Litchee carambolo, mango 250 Gy from Hawaii

27

Irrradiador del ININ

Trabajando casi a su máxima capacidad 1993

Estudio Económico

Factibilidad Financiera

–Inversión U.S $4.6 million –Promedio en 10 años –Ingreso neto US $ 2,185,000 –Retorno Inversion 18% –Retorno Ventas 43%

Organizaciones Regionales

•EPPO •APPC •COSAVE •OIRSA •NAPPO. Norma Regional. “Guías para el uso de la Irradiación como tratamiento Fitosanitario” (1997) •Esta norma sirvio de base para el desarrollo de la norma internacional adoptada por la CIMF Abril 2003

Trabajo con Empresas

•México cede de la reunion anual del

(ICGFI)

•SE anuncia la construcción de una planta de irradiación por la empresa privada •1997

MIAS-ININ-14-07-2011

Planta Sterigenics

36

Fuente Sterigenics

Inició en abril del año 2000 Superficie l 11,160 m2 Planta Multipropósito Capacidad 45 Totes , 440 kg El blindaje 5,000 kCi operación bajo estándares, ISO 11137

Camino al comercio de IF

2000 Industria Inicia operacion la nueva planta de Irradiacion

Crece el interes de la Industria por utilisar el tratamiento.

En planes la Construccion del Irradidor para IF

Reglamentos

APHIS 2002

Autoriza el uso de la Irradiacion como tratamiento Fitosanitario para frutas y vegetales importados a E.U

Secrataria de Agriculatura reconoce IP y accede a elaborar la Norma respectiva NOM-000-FITO-2000

Normas Internacionales

2003 NIMF N°18

“Directrices para utilizar la irradiación como medida fitosanitaria”.

Comercio en 2004

México United States El mundo

DGSV

–USDA iniciaron la Elaboración del documento para el comercio bilateral de productos irradiados en apego a la Norma Internacional para Medidas Fitosanitarias NIMF

18

E.U. establece el Plan de trabajo de Equivalenencias FEWP) para importación

Embarque comercial de mangos irradiados

Australia a New

Zealand

REGLAMENTO

APHIS 2006

•Dmin para 13 plagas comunes de

plantas

Concepto de dosis genérica 150 Gy para moscas de las frutas y 400 Gy para otras plagas excepto pupas de Lepidópteros.

Plan de trabajo para un acuerdo General de Equivalencia

(Framework Equivalency Workplan FEWP) Establece los requisitos generales para pemitir el comercio bilateral de productos vegetales irradiados entre Mexico y Estados Unidos Firmado por DGSV y APHIS Abril 2006

Describe los requerimientos para implementar la irradiación en productos vegetales.

Describe las organizaciones participantes de ambos países así como las responsabilidades de cada una de ellas:

Documento suscrito, octubre 2007 autoridades DGSV y USDA

Plan de trabajo Operacional

•Certificación de huertos y de la instalación de irradiación

•Acuerdo de cumplimiento

•Aplicación del tratamiento

•Seguridad

•Registros y monitoreos

•Responsabilidades de los participantes

•Acuerdo financiero

•Adendas

I.

Requisitos para el programa de irradiación

•USDA- APHIS-PPQ

ONPF DEL PAIS EXPORTADOR (DGSV)

COOPERADOR

PRODUCTORES

EMPACADORES

PERSONAL DE LA INSTALACION

II PARTICIPANTES DEL PROGRAMA

•DGSV Punto focal para la cooperación en el Plan de Trabajo del Marco de Equivalencia (FEWP) y el Plan de Trabajo Operativo (OWP) .

El Cooperador . organización que representará a los exportadores, empacadores y plantas de tratamiento y firmará (con APHIS) el Acuerdo de Cooperación y el plan financiero para la administración del sistema contable.

III Responsabilidades

Norma Oficial Mexicana Tratamiento Fitosanitario

NOM-022-FITO-1995, Requisitos y especificaciones que deben cumplir las personas morales para la prestación de servicios de tratamientos fitosanitarios.

TRATAMIENTO POR IRRADIACIÓN Tratamiento a BasedeFrío Tratamiento Hidrotérminco Tratamiento con aire caliente húmedo forzado.

(Publicadalamodificación alanorma 8deagosto2008)

Certificación y Envio

Sterigenics Mexico

Primera planta de Irradiación para tratamiento

fitosanitario

Certificada USDA y APHIS Octubre 2008 Envía el primer embarque de guayaba irradiada (Noviembre, 2008)

Planta Benebion

Cd. De Matehuala, SLP - inaguracion julio 2011

Procesamiento frutas y vegetales frescos,

de Cobalto 60 •Blindaje de hasta 1.5 MCi •Tarimas industriales

•Movilización Nacional 2015

REGLAMENTO

APHIS 2012

Cambio a la regulación

Autoriza la Irradiación en el Puerto de Entrada de los Estados Unidos

Gran oportunidad para los países exportadores

No cuenten con un irradiador

Volúmenes pequeños

Irradiación en Destino

Octubre 2014 Primer embarque irradiado en destino a)National Center for Electron Beam Research, College Station, Texas b)Gateway America, Gulfport Mississippi

Adendas al plan de trabajo

A partir del 2007 irradiación y Exportación de

mango naranja toronja mandarina lima dulce guayaba chile manzano carambola pitaya granada

Fuente DGSV

Irradiadores

Sterigenics

ININ UNAM

College Station Gulport Mississipi

Benebion

Fruit

Year (tons)

2008 20092010 2011 2012 201320142015

Guava

26535645345 5027 6611 77438302

9709

Grapefruit19

Mango213 1002 771 774 781

Sweet lime21 42 1024 5

Tangerine 257 10

Pomegranate49 135

Carambola327

Fig8

Pitaya66

Manzano pepper97 315 523 595 898 982

Totals26535645912 5636 8178 9240 10030 11713

Tons of irradiated fruit exported by Mexico per

year

(ASEFIMEX 2015)

Importación

Duraznos de Georgia y South Carolina

Gateway America, Gulport Mississippi

2015

•Exportación de fruta que no tienen establecido un tratamiento fitosanitario como: Zapote (Pouteria campechiana), Guanábana (Annona muricata L.), Arrayán (Psidium sartorianum).

•Apertura de mercado con otros Países: Chile -mango.

•Australia -mango y guayaba.

•Nueva Zelandia -mango y guayaba.

DGSV, 2015

Futuro

RADIOFÍLICOS

EN COMERCIO

HIGO

RADIOFÍLICOS II

Flores

Toleran 400 –600 Gy •Clavel, Alstromeria,Gladiolus,Tulip •Statice,Stock,Dendrobium,Prairie.

•Gentian. Oncidium, Campanula •Gloriosa, Fern, Gysophila, Fresin •Lobelia, Tritelia, Lisianthus, Eustoma, Grandiflorum, Gerbera

Radiodelicatus

•Frutas: cítricos chabacano, chirimoya, níspero, maracuyá, pera, piña , ciruela, tangelo, guanábana, ciruela negra.

Radiofóbicos

Frutos:

Aguacate

•Vegetales: Brócoli, coliflor, pepino, ejotes, vegetales de hoja.

Siguiente Proyecto

ICA

INVIMA

InvestigaciónConsumidor