BPI Quarantine Administrative Order No. 02, Series of 2008 on Rules and Regulations for the Importation, Exportation and Domestic Movement of Irradiated Plants and Plant Products and the use of Irradiation as Phytosanitary Treatment

Republic of the Philippines D epartment of Agricu/ıure BUREAU OF PLANT INDUSTRY Manila Df eARTM ENT OF AGRICULTURE IUlI/U L,IUII IJI ,lw u lm 'll 'fi "'l ııı re p ly tn g p ts t ire tn l$ t Ode For $i pnaı ure : S -OS.O g. 0185 ReçelV' Ci : 0 6f15/2OO6 1:):3 3 A"I 2 San Andres sı., alate. Mani la ıilippines mail: bup lant@yahoo.com BP I QUARAl'.'TTh'E ADMTh'lSTRATlVE ORDER No. ~ Series of 200S TeL. N o. 525-79-09 525-78-57 521-29-87 52 1-91-35 Fax No . 521-76-50 SUBJECT: RULES AND REGULATIONS FOR THE IMPORTATION, EXPORTATION AND DOMESTIC MOVEMENT OF IRRADIATED PLANTS AND PLANT PRODUCTS AND THE USE OF IRRADIATION ASPHYTOSANITARYTREATME~'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 of plants and plant products, and to promote appropriate measures for their control. WHERRAS, contracting parties of the IPPC adopts International Standards for Phytosanitary Measures (ISPMs) which are standards, guidelines and recommendations recognized as the basi s for phytosanitary measures by World Trade Organization (WTO) members under the Agreement on th e Application of Sanitary and Phytosanitary (SPS Agreement). ' \'HEREAS, in 2003 the Interim Commission on Phytosanitary Measures (ICPM) of the IPPC approved ISPM No. i S, providing technical guidance on the specific procedures for the application of ionizing radiation as a phytosanitary treatment for regulated pests or articles. WHEREAS, the Bureau of Plant Industry (BPI), being the National Plant Protection Organization (NPPO), is responsible for the phytosanitary aspec ts of evaluation, adoption and use of irradiation as a phytosanitary measure, and to the extent necessary, should coope rate with other national 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 as cobalt-60 and cesium-137 and the Bureau of Health Devices and Techno logy (BHDT) which has th e mandate to regulate irradiation facilit ies using radiation emitted by. electronic and electrical devices 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 quarantine purposes. 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 of irradiation 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 a specified targct. The Si unit is gray (Gy) A type of plant , plant product , or other artiel e being moved for trade or other purpose A quantity of plants, plant products and/or other art ielcs bcing moved 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 the country Measurement of the absorbed dose distribution within a process load through the use of dosimcters placed at specific locations within thc process load A device that , when irradiated exhibits a quantifiable change in same property of the device which can be related to the absorbed dose in a given matcrial using appropriate analytical instrumentation and techniqucs A system used for detemıining absorbed dose, consis ting of dosimeters, measuremcnt instru ments and their associated referencc standards, and procedures for the system 's use A defined, measurable and reproducib le effect by a preseribed treatment The act of transport ing coınmodities from a local port to a foreign port Unit of absorbed dose where i gray (Gy) ıs equivalent to thc absorption 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 for planting, corısumption, manufacturing, domestication or fo r any other 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 2 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 ISPM NPPO PNRI Charged partic1es and c1ectromagnetic wav es that as a result of ph ysical interaction create ions by eithcr primary or secondary processes Treatment with any typ e of ioni zing radiation A number of units of a single commodity, identi fia ble by its homogencity of composition, origin, etc ., forming part of a eonsignment The loealized minimum absorbed dose (Dmin) within the proecss load A pest of quarantine importance that is not known be neutralized by the irradiation Any species, strain or biotype of plant,animal or pathogenic agent injurious to plants and plant products Use of phytosanitary procedures leading to the issuance of a Phytosanitary Certificatc Unmanufuctured material of plant ongin (inc1udin g grain) and those ınanufactured products that, by their nature or that of thcir proccssing, may create a risk for the introduction and spread ofpests Living plants and paıts thereof, inc1ueling seeds and germplasm A pest of quarantine significance that will be neutralized by the approved dose Official procedure for thc killing, inaetivation or removal of pests, or for rendering pests infertilc or for devitalization Bureau of Plant Industry Bureau of Health Devices and Technology International Plant Protection Convention International Standard for Phytosanitary Measures National Plant Protection Organization Philippine Nuclear Research Institute PQS Plant Quarantine Service 3 Seetion 2 Coverage This Order eovers the (a) importation, exportation and domestic mavement of irradiated living plants, and parts thereof, plant products or unmanufactured materiaI of plant origin and semi-processed plant products or manufactured products that, by their nature or that of their processing, may create a risk for the introduction and spread of pests, and (b) the use of irradiation as a phytosarıitary treatment . IMPLEMENTATION RULE Seetion 3 Irradiation Facility Approval Irradiation fucility should be approved by the NPPO in the country where the facility is located prior to applying phytosanitary treatments. it covers both local and foreign facility, both for import, export and local trade. A. Requirements for Approval ı. Local Facility a. Documentary requirements ı. Duly accomplished application form Il . Copy of Security and Exchange Commission (SEe) Registration or Department of Trade and Industry (DTI) Business Permit, whichever is applicable ııı. Copy of Mayor' s Permit rv. Company / facility profile v. Tax IdentificatiorıNumber (TıN) and latest Ineome Ta" Return (ITR) where applicable vı. Locatiorı map of the treatment facility vii. License from PNRI (if using radioactive source such as cobalt-60 and cesium-137) or BHDT ( if using electrically generated radiation such as electron beam or X-ray) vııı . Documented Standard Operating Procedures describing in detail the treatment facility system and procedures including all processes from handling, 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 officer c. Passed the actual facility testing to be supervised by a BPI authorized officer d. Facility compliaııce agreemeııt completed and sigııed by all appropriate officials e. Other requirements that maybe decmed necessary 2. Foreign Facility a. Letter of intent for facility approval from the NPPO where the facility is located b. Certificate ofapprovaI by the NPPO of the country where the facility is located c. Philippine verificatiorı of the facility and final approva! 4 i B. Pmcedure for Facility Approval i. Local Facility a. Intcrested local facility i company should file an application for facility approval to the BPI b. Original and photocopy of the above-mentioned requirements should be presented c. Interested Ioeal facility leompany should request for faeility inspection and testing at the BPI-PQS d. A duly authorized Plant Quararıtine Offieer/lnspector shall inspeet and evaluate the treatment facility and shall eonduct aetual testing e. The Plant Quarantine Officer/lnspeetor shall submit a report of the inspeeted facil iıy and the result of the aetual testing conducted to the Chief of the Plant Quarantine Service f Signing of Faci!ity Complianee Agreement. The agreement shall be concluded between 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 BPI Director 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 shall endorse the application for facility approval to the BPI. The BPI shall reviewand evaluate the application and if necessary shall conduct an actual visit of the facility for verification and final approval. C. Treatment The use of irradiaıion as a phytosanitary measure shall prevent the introduction or spread of 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 to reproduce (e.g. sterility), or inactivation. lonizing radiation may be provided by radioactive isotopes (gamma rays from cobalt-60 or 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 through bilateral agreement between Philippincs and its trading partner. For local trade, the NPPO shaLl issue and "'O~ go idelines for specific target pest that rrıay be developed in ili, future.~' 5 The followin g are the treatment requirements : • • • • • D. Dosimetry Treated commodities sball be ccrtificd and released only after dosimetry measurements 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 Plant Industry Treatment sha ll be done in the presence ofa Plant Quaranıine Officerr Iuspcctoı Dose rate. treatment time , temperature, humidity, and venti latiorı should be carefully cons idered when conducting treatments ı. Calibration • All components of the dosirnctry system shall be İn accordance with international dosimetry standards BPI shall assess perfornıancc of the dos iınetry system 2. Dose mapping • • • Dose mappi ng shall be done in accordance with docume nted standard operating procedures. Dose mapp ing sball be conducted to fully cbaraeterize the dose distribution within the irradiation charnbers and commodity, and demonstrate that the treatment consistently meets the preseribed reqnirements under defined and controlled conditions . Independent dose mapping sball be done for ineomplete as well as first and last process loads (for continuous irradiation) to determine if the absorbed-dose distribution is signi ficarıtly different from a routine load and to adjust the treatment accordingly. 3. Routine Dosimetry • As part of the verification process, an accurate measurement of absorbcd dose in a consignment should be ensured to dctermine and monitor treatment cfficacy , • The required number, location and frequency of the measurements should be preseribed based on the specific equipment, proccsses, commodities, relevant standards and phytosanitary requirements . • Dosimeters verification sball be carried out to cvaluate for stability against the effects of variables such as light, temperature, humidity, storage time, and the type and timing of analyses required. 6 =---''-- -=-..c~~ ~ , - - E. Pııckaging and Labeling i. Packaging In ordcr to avoid infcstation after irradiation, commodities sbould be packed in materials that provide an effective barrier to re-infestation. Packaging shall conforın to the requirements of the NPPO of the importing country . The size and shape of containers are determined, in part, by the operating characteristics of the irradiation facility . Thes e characteristics include the product transport systems and the irradiation source, as they affect the dose distribution within the containcr. 2 . Labeling Packagesi 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 quantity treatment facility code packing facility idcntification number and location treatment facility identification number and locatian grower/production area code treatment lot numbers pre seribed treatment date of packing treatment dat e radura 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 and audit of facil ity tr eatm ent records that include , direct treatment oversight. The level of oversight should 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 ent facilit 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 as required. 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; 7 ~ .. . ~..2...-==C--= . • eontingeney plans and eorreetive aetions to be taken in the event of treatment failure 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 for review when necessary and shall be kept for at least one year. Records that maybe required 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 or paekages; date of treatment; and any observed dcviation from treatment speeifieation. SECTION 4 Aecreditation of Exporter and Packing Facility All exporters intending to export irradiatcd plants and plant produets shall apply for accreditaıion at the nearest Bureau of Plant Industry-Plant Quarantine Service (BPI-PQS) office with the following requirements and procedure: A. Requirements for Aecreditation I. Doeumentary Requirements i. Duly aeeomplished applieation form ll . Copy of Seeurity and Exchange Commission (SEC) Registration or Department of Trade and Industry (DTI) Business Permit, whiehever is applieable ıı ı. Copy of Mayor's Permit i v. Company i faeility profile v. Ta" ldentifieation Number (TıN) and Latest Ineome Tax Return (ITR) where applieable v ı. Location map of the packing faeility 2. Standard Operating Procedure of the packing house 3. Other requirements that maybe deemed necessary B. Prucedure for Accreditation I. All interested exporters shall file aıi applieation for accreditation to the ncarest BPI PQS with the above-mentioned requirements. 2. BPI shall validate the applieation and whenover necessary, the BPI-PQS shall conduet an interview whieh shall eover Plant Quarantine Lawand Rules and Regulations. 8 .=. - 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 opening to prevent entry of pests ; Packing house must have sufficient water supply for cleaning; Packers should wear hairnets within the packing house; and Packing house should have sufficient lighting. 5. The Plant Quarantine OfficerlInspector shall submit areport of the inspected packing hous 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 of Accreditation shall be revoked. Re-accreditation shall only be possible upon compliance of all corrective measures based on thorough plan t quarantinc investigation . SEcnON5 Suspension 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 standards and regulations shall result to suspension of the facility Problems 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 the operational procedures that may substantially affect any aspeet of the treatment process 9 - ~- -- ------ -- .- 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 6 Inspection and Phytosanitary Certification A. Export Inspection ı. Packinghouse Facility a. 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 Facility a. 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. 10 C. Import Inspection Import inspecti on shall be earried out in accordance with bilateral agreement betwc eu Philippines and the exporting country taking in considcration the following: • • • target pest/s non-target pest verification of efficacy of the treatment I . All importers shou ld apply for inspection/clearance at least 24 hours prior to arrival of the consignment for all commoditics treared with irradiation. 2. Upon arrival, commodities shall be subjeeted to inspeetion and elearance by the Plant Quarantine 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 failure resulting 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 not norrnally 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 into consideration the effeet of treatment on the non-target pest(s) • Cons ignmerıt maybe detained :and an y appropriate action may be taken by the BPI D. Not ification of Non-Compliance and Emergency Actions 111e BPI should immediately notify the NPPO of the exporting eountry if they have idcntified non-compliance with speeified phytosanitary requirements. This is to give the exporting country an'opportunity to invesıigaıe instances of apparent non-compliance, and correct as necessary. The following maybc considered as significant failures : • Failure to eomply with documentary requirements, ineluding: a . Absence of phytosanitary certificates b . Uncert ified alteratiorıs or erasures to phytosanitary certificates c. Serious deficiencies in information on phytosanilary certifi cates d. Fraudulent phytosanitary certificates i i • Prohibited consignment s • Evidcnce of failure of speeified treatments And other signifieant failures Notilıcalion should include information as slipulated in ISPM No. 13 "Guidelinesfor the Noıification ofNon-compliance and Emergency Action" . For non-cornp liance, the exporting eountry should investigate significant instances of non-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 current phytosanitary situation of the consignrncnt. APPENDICES Bilateral agrcements and dctailed proeedures (eg. Operaticnal Work Plan and official forms) shall form part of this Order. LEGAL SANCTlONS Any dcficiencies in eomplying with the rules and regulat ions for the movement of irradiatcd plants and plant produets and the use of irradiation as phyto sanitary treatment or an y vioIations of any pro visions of this Administrative Ordcr shall be ground for the imposilion of fines, 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 er of general ciroulation . ' APPRr ART~RC. Y~ Secrctary ~ il plt~ 08 Aııgııst 2008 ı<~ırs:. RUDl NAS, C ESO IV BPI 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 lll1 In r ep lyl n ıı p\ı clte th iı code For Signature: 5 08 08 0185 Rec.lved : 08/1612008 -o.aa AM 12 - o - - •