Republic of the PhilippinesD epartment of Agricu/ıure

BUREAU OF PLANT INDUSTRYManila

Df eARTM ENT OF AGRICULTURE

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mail: bup lant@yahoo.com

BP I QUARAl'.'TTh'E ADMTh'lSTRATlVE ORDERNo. _~Series of 200S

TeL. N o. 525-79-09525-78-57521-29-8752 1-91-35

Fax No . 521-76-50

SUBJECT: RULES AND REGULATIONS FOR THE IMPORTATION,EXPORTATION AND DOMESTIC MOVEMENT OF IRRADIATEDPLANTS AND PLANT PRODUCTS AND THE USE OF IRRADIATIONASPHYTOSANITARYTREATME~'T

WHEREAS, the Philippines is a member of the International Plant Protection Convention(IPPC), an international treaty securing action to prevent the spread and introduction of pests ofplants and plant products, and to promote appropriate measures for their control.

WHERRAS, contracting parties of the IPPC adopts International Standards for PhytosanitaryMeasures (ISPMs) which are standards, guidelines and recommendations recognized as the basi sfor phytosanitary measures by World Trade Organization (WTO) members under the Agreementon th e Application of Sanitary and Phytosanitary (SPS Agreement).

' \'HEREAS, in 2003 the Interim Commission on Phytosanitary Measures (ICPM) of the IPPCapproved ISPM No. i S, providing technical guidance on the specific procedures for theapplication of ionizing radiation as a phytosanitary treatment for regulated pests or articles.

WHEREAS, the Bureau of Plant Industry (BPI), being the National Plant ProtectionOrganization (NPPO), is responsible for the phytosanitary aspec ts of evaluation, adoption and useof irradiation as a phytosanitary measure, and to the extent necessary, should coope rate with othernational or international regulatory agencies such as the Phil ippine Nuclear Research Institute(pNRI) which has the mandate to regulate irradiation facilities using radioactive sources such ascobalt-60 and cesium-137 and the Bureau of Health Devices and Techno logy (BHDT) which hasth e mandate to regulate irradiation facilit ies using radiation emitted by. electronic and electricaldevices such as electron beam and X-ray.

WHEREAS, irradiation is increasingly accepted internationally as a quarantine treatment,providing effe ctive means of disinfesting/disinfecting plants and plant products for quarantinepurposes.

NOW , THEREFORE, pursuant to the provisions of Seetion 17 of the Presidenti al Decree No.1433, the Director of Bureau of Plant Industry hereby issue this Order govem ing the importation,exportation and domestic movement of irrad iated plants and plant produ cts and the use ofirradiation as phytosanitary treatment.

GENERAL PRovısıoNS

Seetion ı

Defini tion of Terms and Abbreviations

The fol1owing terms when used in this Administrativc Order shall mean as follows:

Absorbed dose

Commodity

Consignment

Domestic movemerıt

Dosc mapp ing

Dosimeter

Dosimetry

Efficacy

Exportation

Gray (Gy)

Kilogray (kGy)

lmportation

Inspcction

Quantity of radiation energy absorbed per unit of mass of aspecified targct. The Si unit is gray (Gy)

A type of plant , plant product , or other artiel e being moved fortrade or other purpose

A quantity of plants, plant products and/or other art ielcs bcingmoved from one count ry to arıother and covered, when require d,by a single phytosanitary ccrtificate

Movemcnt of commodity from one locality to arıother within thecountry

Measurement of the absorbed dose distribution within a processload through the use of dosimcters placed at specific locationswithin thc process load

A device that , when irradiated exhibits a quantifiable change insame property of the device which can be related to the absorbeddose in a given matcrial using appropriate analyticalinstrumentation and techniqucs

A system used for detemıining absorbed dose, consis ting ofdosimeters, measuremcnt instru ments and their associatedreferencc standards, and procedures for the system 's use

A defined, measurable and reproducib le effect by a preseribedtreatment

The act of transport ing coınmodities from a local port to aforeign port

Unit of absorbed dose where i gray (Gy) ıs equivalent to thcabsorption of i joule per kilogram

Unit ofabsorbcd dose which is equivalent to 1,000 gray (Gy)

The act of bringing into the country foreign commoditics forplanting, corısumption, manufacturing, domestication or fo r anyother purpose

Official visual examination of plants, plant products or other ,regulated artieles to determine if pests are prescnt and/or to •deıcrminc cornpliance with phytosanitary regulation

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loni zing radiatiorı

Irraeliation

Lot

Minimum absorbed dose

Non-Targer Quarantine Pest

Pest

Phytosanitary eertifieation

Plant produets

Plants

Target Quarantine Pest

Treatment

Abbreviations:BPI

BHDT

IPP C

ISPMNPPO

PNRI

Charged partic1es and c1ectromagnetic wav es that as aresult of ph ysical interaction create ions by eithcrprimary or secondary processes

Treatment with any typ e of ioni zing radiation

A number of units of a single commodity, identi fia ble byits homogencity of composition, origin, etc ., formingpart of a eonsignment

The loealized minimum absorbed dose (Dmin) withinthe proecss load

A pest of quarantine importance that is not known beneutralized by the irradiation

Any species, strain or biotype of plant,animal orpathogenic agent injurious to plants and plant products

Use of phytosanitary procedures leading to the issuanceof a Phytosanitary Certificatc

Unmanufuctured material of plant ongin (inc1udin ggrain) and those ınanufactured products that, by theirnature or that of thcir proccssing, may create a risk forthe introduction and spread ofpests

Living plants and paıts thereof, inc1ueling seeds andgermplasm

A pest of quarantine significance that will be neutralizedby the approved dose

Official procedure for thc killing, inaetivation orremoval of pests, or for rendering pests infertilc or fordevitalization

Bureau of Plant Industry

Bureau of Health Devices and Technology

International Plant Protection Convention

International Standard for Phytosanitary MeasuresNational Plant Protection Organization

Philippine Nuclear Research Institute

PQS Plant Quarantine Service

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Seetion 2Coverage

This Order eovers the (a) importation, exportation and domestic mavement of irradiatedliving plants, and parts thereof, plant products or unmanufactured materiaI of plant origin andsemi-processed plant products or manufactured products that, by their nature or that of theirprocessing, may create a risk for the introduction and spread of pests, and (b) the use ofirradiation as a phytosarıitary treatment .

IMPLEMENTATION RULE

Seetion 3Irradiation Facility Approval

Irradiation fucility should be approved by the NPPO in the country where the facility islocated prior to applying phytosanitary treatments. it covers both local and foreign facility, bothfor import, export and local trade.

A. Requirements for Approval

ı. Local Facilitya. Documentary requirements

ı. Duly accomplished application formIl . Copy of Security and Exchange Commission (SEe) Registration or

Department of Trade and Industry (DTI) Business Permit, whichever isapplicable

ııı. Copy of Mayor' s Permitrv. Company / facility profilev. Tax IdentificatiorıNumber (TıN) and latest Ineome Ta" Return (ITR)

where applicablevı. Locatiorı map of the treatment facilityvii. License from PNRI (if using radioactive source such as cobalt-60 and

cesium-137) or BHDT ( if using electrically generated radiation such aselectron beam or X-ray)

vııı . Documented Standard Operating Procedures describing in detail thetreatment facility system and procedures including all processes fromhandling, treatment, and post treatment safeguarding of commodity

ıx , List of probable commodities to be treated at the facility

b. Passed the facility inspectiorı conducted by a BPI authorized officerc. Passed the actual facility testing to be supervised by a BPI authorized officerd. Facility compliaııce agreemeııt completed and sigııed by all appropriate officialse. Other requirements that maybe decmed necessary

2. Foreign Facility

a. Letter of intent for facility approval from the NPPO where the facility is locatedb. Certificate ofapprovaI by the NPPO of the country where the facility is locatedc. Philippine verificatiorı of the facility and final approva!

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B. Pmcedure for Facility Approval

i. Local Facility

a. Intcrested local facility i company should file an application for facility approvalto the BPI

b. Original and photocopy of the above-mentioned requirements should bepresented

c. Interested Ioeal facility leompany should request for faeility inspection andtesting at the BPI-PQS

d. A duly authorized Plant Quararıtine Offieer/lnspector shall inspeet and evaluatethe treatment facility and shall eonduct aetual testing

e. The Plant Quarantine Officer/lnspeetor shall submit a report of the inspeetedfacil iıy and the result of the aetual testing conducted to the Chief of the PlantQuarantine Service

f Signing of Faci!ity Complianee Agreement. The agreement shall be concludedbetween the company/facility and the BPI which shall include the following:

• BPl's approval of the facility;• Monitoring programıne administered by BPI;• Audit provisions including unannouneed visits;• Free access to documentation and record of the treatment facility; and• Correetive action to be takerı in cases of non-cornpliarıce .

g. Reeommendation by the PQS Chief prior to the final approval of the BPIDirector

h. Certificate of Approval shall be issued with the assigned code

2. Foreign Facility

For foreign facility, the NPPO of the country where the facility is located shallendorse the application for facility approval to the BPI. The BPI shall reviewandevaluate the application and if necessary shall conduct an actual visit of the facility forverification and final approval.

C. Treatment

The use of irradiaıion as a phytosanitary measure shall prevent the introduction or spreadof regulated pcsts. This may be realized by achieving certain responses in the targeted pest(s)such as: mortality, preventing successful development (e.g. non-emergence of adults), inability toreproduce (e.g. sterility), or inactivation.

lonizing radiation may be provided by radioactive isotopes (gamma rays from cobalt-60or cesium-137), electrons generated from machine sources (up to 10 MeV) and X-ray machine(up to 5MeV).

Treatment dose for a specific commodity must be determined based on science throughbilateral agreement between Philippincs and its trading partner. For local trade, the NPPO shaLlissue and "'O~ go idelines for specific target pest that rrıay be developed in ili, future.~'

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The followin g are the treatment requirements :

•

•

•

•

•

D. Dosimetry

Treated commodities sball be ccrtificd and released only after dosimetrymeasurements confirm that thc Dmin was met

Re-treatment of consignments may be allowed, provided that thc maxımum

absorbed dose is within the limits a1lowed by the importing country

Treatment shall be done only by facilitie s approved by the Bureau of PlantIndustry

Treatment sha ll be done in the presence ofa Plant Quaranıine Officerr Iuspcctoı

Dose rate. treatment time , temperature, humidity, and venti latiorı should becarefully cons idered when conducting treatments

ı. Calibration

•

All components of the dosirnctry system shall be İn accordance with internationaldosimetry standardsBPI shall assess perfornıancc of the dos iınetry system

2. Dose mapping

•

•

•

Dose mappi ng shall be done in accordance with docume nted standard operatingprocedures.Dose mapp ing sball be conducted to fully cbaraeterize the dose distributionwithin the irradiation charnbers and commodity, and demonstrate that thetreatment consistently meets the preseribed reqnirements under defined andcontrolled conditions .Independent dose mapping sball be done for ineomplete as well as first and lastprocess loads (for continuous irradiation) to determine if the absorbed-dosedistribution is signi ficarıtly different from a routine load and to adjust thetreatment accordingly.

3. Routine Dosimetry

• As part of the verification process, an accurate measurement of absorbcd dose ina consignment should be ensured to dctermine and monitor treatment cfficacy ,

• The required number, location and frequency of the measurements should bepreseribed based on the specific equipment, proccsses, commodities, relevantstandards and phytosanitary requirements .

• Dosimeters verification sball be carried out to cvaluate for stability against theeffects of variables such as light, temperature, humidity, storage time, and thetype and timing of analyses required.

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E. Pııckaging and Labeling

i. Packaging

In ordcr to avoid infcstation after irradiation, commodities sbould be packed in materialsthat provide an effective barrier to re-infestation. Packaging shall conforın to the requirements ofthe NPPO of the importing country . The size and shape of containers are determined, in part, bythe operating characteristics of the irradiation facility . Thes e characteristics include the producttransport systems and the irradiation source, as they affect the dose distribution within thecontaincr.

2 . LabelingPackagesi boxes shall be rnarked with at least the fo llowing identifying features to allow

identification of treatment lots and trace-back:

••••••••

•

name of product and quantitytreatment facility codepacking facility idcntification number and locationtreatment facility identification number and locatiangrower/production area codetreatment lot numberspre seribed treatmentdate of packingtreatment dat eradura symbol (optional),

All packages should be labeled "Treated with Radiation" or " Treated by Irradiation ".

F. Verification

.Adequac y of treatment facilities and processes shall be verified throu gh monitoring andaudit of facil ity tr eatm ent records that include , direct treatment oversight. The level of oversightshould be sufficient to detect and correct deficieneies promptly.

G. Documentation by the treatment Facility

BPI shall be responsible for monitoring records and documentation of the treatm entfacilit y and ensuring that records are available to concemed parties .

1. Documenıaıion ofprocedures

Documented procedures heJp ensure that comm odities are consi stent!y treated asrequired. At a minimum, an agreed writterı procedure should address the foll owing :

• consignment handling procedure before, during and after treatment ;• orientation and configuration of the commodity during treatment;• critica! process parameters and the means for their monitoring;• dos imetry;

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• eontingeney plans and eorreetive aetions to be taken in the event of treatmentfailure or problem with eritieal treatment processes;

• procedurcs for handling rejeeted lots; and• labcling, recordkecping, and documentation requirements.

2. Faeility records and traeeability

Treatment facility operators shall keep records whieh shall bc available to BPI forreview when necessary and shall be kept for at least one year. Records that mayberequired include:

minimum and maximum absorbed doses (target and measured);name of ciients and thcir details;eommodity treated;purpose of treatment;lot size, volurnc and identification, including number of .articles orpaekages;date of treatment; andany observed dcviation from treatment speeifieation.

SECTION 4Aecreditation of Exporter and Packing Facility

All exporters intending to export irradiatcd plants and plant produets shall apply foraccreditaıion at the nearest Bureau of Plant Industry-Plant Quarantine Service (BPI-PQS) officewith the following requirements and procedure:

A. Requirements for Aecreditation

I. Doeumentary Requirements

i. Duly aeeomplished applieation formll . Copy of Seeurity and Exchange Commission (SEC) Registration or

Department of Trade and Industry (DTI) Business Permit, whiehever isapplieable

ıı ı. Copy of Mayor's Permiti v. Company i faeility profilev. Ta" ldentifieation Number (TıN) and Latest Ineome Tax Return (ITR) where

applieablev ı. Location map of the packing faeility

2. Standard Operating Procedure of the packing house3. Other requirements that maybe deemed necessary

B. Prucedure for Accreditation

I. All interested exporters shall file aıi applieation for accreditation to the ncarest BPI­PQS with the above-mentioned requirements.

2. BPI shall validate the applieation and whenover necessary, the BPI-PQS shallconduet an interview whieh shall eover Plant Quarantine Lawand Rules andRegulations.

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3. Irıterested exporters should request for packing facility inspection to BPI-PQS .4 . A duly authorized Plant Quarantine OfficerlInspector shal l inspect and evaluate the

packing house facility .

••

•

•••

Packing house facility should be in good condition;Packing house should be hygienically maintained and sprayed with insecticides;to include surrounding premises so as to exclude the ent ry ofpests;Packing house must be equipped with net (less than 1.6x1. 6mm) for any openingto prevent entry of pests ;Packing house must have sufficient water supply for cleaning;Packers should wear hairnets within the packing house; andPacking house should have sufficient lighting.

5. The Plant Quarantine OfficerlInspector shall submit areport of the inspected packinghous e facility to the Chief of the Plant Quarantine Service.

6. Recommendation by the Chief PQS for fina! approval of the BPI Director.7 . Upon completion of the abovementioned requirements , BPI-PQS will issue a

Ccrtificate of Accreditation with assigned code.8. Any accredited exporter who violates the Plant Quarantine Law, rules and regulations

of this protoco! will be delisted as an accredited exporter and its Certificate ofAccreditation shall be revoked. Re-accreditation shall only be possible uponcompliance of all corrective measures based on thorough plan t quarantincinvestigation .

SEcnON5Suspension and Reinstatement of Facility

A. Suspension

The following are the grounds for suspens ion:

i. Exporter i Packing Facility

• Non compliance with the set standards for a packing house facility• Taıııperinglalterations of the Phytosanitary Certificate• Taıııperinglalterations oflabels of the packages or boxes intended for export• Probl ems detected by the Plant Quarantine Officer during audit.• Failnre to inform the BPI-PQS of the changes madc in the packing facility and in

the operational procedures that may substantially affect thc export• . Packing of commodity witho ut the presence of the Plant Quarantine Offi cer

2. Treatment Facility

•

•••

Repeated non-cornpliance (twice) of treatment facilities with the set standardsand regulations shall result to suspension of the facilityProblems detected by the Plant Quarantine Officer during audit.Conduct of treatment without the presence of the Plant Quarantine Officer.Failurc to inform the BPI-PQS of the changes made in the facility and in theoperational procedures that may substantially affect any aspeet of the treatmentprocess

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B. Re-ins tatement of Facility

Rc-instatcment of the packing house and treatment facility shall only be granted when

corrective measures have been undertaken.

C. Prncedure for re-ins tatement

1. The packing/treatment faeility shall request for re-instatement to the BPI.2. BPI shall reviewand evaluate the request,3. BPI shall visit the faeilit y (packinghouse and/or treatment faeility) and eonduet

inspeetion .4. BPI shall eonduet actual testing of the treatment facility (calibration, dose

mapping and routine dosimetry) for certification .5. Approval ofBPI for re-instatement .

Seet ion 6Inspection and Phytosanitary Certification

A. Export Inspection

ı. Packinghouse Facilitya. A BPI Plant Quarantiııe Officer shall be assigned to inspect the packing process at

the packing area.b. BPI Plant Quarantine officer shall verify that all cartons are properly packed,

sealed and Iabelcd.c. The BPI Plant Quarantine Officer shall carry out inspeetion on specified samplc

size based on protoco l agreed with a trading partner.

2. Irradiation Facilitya. Treated commodities shall be separated from non-treated commodities.b. Treated commodities shall be safeguarded in holding rooms to prevent

unauthorized eııtry and re-infestation.c. Documentation verification shall be done by the BPI to check for completeness

and accuracy as the basis for certifyiııg the treatment.d. Treated commoditi es shall be properly labeled and must bear the appropr iate

markings prior to release.

B. Phytosanitary Certificat ion

BPI shall issue Phytosanitary Certificate signed by a deputized Plant Quarantine Officer

upon compliance with the requirements.

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C. Import Inspection

Import inspecti on shall be earried out in accordance with bilateral agreement betwc euPhilippines and the exporting country taking in considcration the following:

•••

target pest/snon-target pestverification of efficacy of the treatment

I . All importers shou ld apply for inspection/clearance at least 24 hours prior to arrival of theconsignment for all commoditics treared with irradiation.

2. Upon arrival, commodities shall be subjeeted to inspeetion and elearance by the PlantQuarantine Officer / Inspeetor.

3. All shipıuent should ha ve the proper label/markings.4 . The following measures shall be follow ed in the event of the following situations:

Detection oftarget pest(s) when mortality is not the required response

• Deteetion of live stages of target pests should not be considered treatment failureresulting in non-compliance, urıless the integrity of the treatment system is

inadequate• Laboratory or other anal yses may be performed on surviving target pest(s) to

verify treatment efficacy

Detection of target pest(s) when mortality is the required response

• Live target pcsts maybe found when transport times are short, but should notnorrnally result in consignment refusal, uııless the established mortality time has

bcen exceeded

Detection of pests other than target pest(s)

• Should be assessed for risk posed and appropriate measures done , taking intoconsideration the effeet of treatment on the non-target pest(s)

• Cons ignmerıt maybe detained :and an y appropriate action may be taken by theBPI

D. Not ification of Non-Compliance and Emergency Actions

111e BPI should immediately notify the NPPO of the exporting eountry if they haveidcntified non-compliance with speeified phytosanitary requirements. This is to give theexporting country an'opportunity to invesıigaıe instances of apparent non-compliance, and correctas necessary. The following maybc considered as significant failures :

• Failure to eomply with documentary requirements, ineluding:a . Absence of phytosanitary certificatesb . Uncert ified alteratiorıs or erasures to phytosanitary certificatesc. Serious deficiencies in information on phytosanilary certifi catesd. Fraudulent phytosanitary certificates

i i

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• Prohibited consignment s• Evidcnce of failure of speeified treatments

And other signifieant failures

Notilıcalion should include information as slipulated in ISPM No. 13 "Guidelinesfor theNoıification ofNon-compliance and Emergency Action" .

For non-cornp liance, the exporting eountry should investigate significant instances ofnon-c ornp liance to determine the possibl c eause with a view to avoid rccurrcncc. Upon reque st ,the rcsult of the invesligation should be provided to the BPI.

Emcrgency aelions maybe undertakcıı by the Philipp ines based on the currentphytosanitary situation of the consignrncnt.

APPENDICES

Bilateral agrcements and dctailed proeedures (eg. Operaticnal Work Plan and officialforms) shall form part of this Order.

LEGAL SANCTlONS

Any dcficiencies in eomplying with the rules and regulat ions for the movement ofirradiatcd plants and plant produets and the use of irradiation as phyto sanitary treatment or an yvioIations of any pro visions of this Administrative Ordcr shall be ground for the imposilion offines, suspensiorı or revocation of the accreditation after due notic e.

REPEALING CLAUS E

All cxisting rules and rcgulatiorıs inconsistcnt with this Ordcr are hcreb y modifıed,

revoked or repealed aeeordingly.

EFFE CTlVIT Y

Thi s Order shall tak c cffcct fiftecn (15) days after its publieation in a national newspap erof general ciroulation . '

APPRrART~RC. Y~

Secrctary ~ il

plt~08 Aııgııst 2008

---ı<~ırs:. RUDl NAS, C ESO IVBPI DIRE CTO R

. OfP ARTf',IENl Of AGR.ıCU I..TURE

1 IIIIIIlIU"IlII 'l llI lliU\lU ll lıl l\lI IIı,~ IIlII ~'\III1I\ lIl lll1In r ep lyl n ıı p\ı clte th iı code

For Signature: 5_08_08_0185

Rec.lved : 08/1612008 -o.aa AM

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