Guidelines on the Accreditation of Plant Food Testing Laboratories

May 6, 2016

DA DEPARTMENT CIRCULAR NO. 03-16

 

Pursuant to Republic Act No. 10611, also known as "Food Safety Act of 2013"; Republic Act No. 7394 or the "Consumer Act of the Philippines"; Executive Order No. 292, series of 1987, also known as "Administrative Code of 1987"; and relevant international agreements to which the Philippines is a signatory, the following guidelines on accreditation of food testing laboratory is hereby issued:

ARTICLE I

General Provisions

SECTION 1. Objective. — This circular aims to establish and detail the requirements and procedures in the accreditation of plant food testing laboratories.

SECTION 2. Definition of Terms. —

2.1 Accreditation is the formal recognition by an independent body, generally known as an accreditation body that a certification body is capable of carrying out certification. Accreditation is not obligatory but it adds another level of confidence, as 'accredited' means the certification body has been independently checked to make sure it operates according to international standards. In the Philippines, the official accreditation body is the Philippine Accreditation Bureau (PAB). Food Safety Regulatory Agencies can provide Official Accreditation which is the procedure by which a government agency having jurisdiction formally recognizes the competence of an inspection and/or certification body to provide inspection and certification services.

2.2 Applicant refers to any person who, during the duration of the accreditation has control over the laboratory and shall ensure compliance with all the requirements in this Circular and the conditions in the relevant certificate.

 An applicant shall be:

2.2.1 Any department or agency of the Philippine government.

2.2.2 A private company registered with the Securities and Exchange Commission or the Department of Trade and Industry.

2.3 Audit refers to the systematic and functionally independent examination to determine whether activities and related results comply with planned objectives.

2.4 Certification means the procedure by which official certification bodies or officially recognized certification bodies provide written or equivalent assurance that foods or food control systems conform to food safety requirements. Certification of food may be, as appropriate, based on a range of inspection activities which may include continuous online inspection, auditing of quality assurance systems, and examination of finished products. Official Inspection and Certification Systems are administered by government agencies having jurisdiction.

2.5 Inspection refers to the examination of food, food production facilities or establishments, and the management and production systems of food businesses, including the examination of documents, finished product testing and registration, and of the origin and destination of production inputs and outputs to verify compliance with legal requirements by an agency mandated to perform food safety regulatory and/or enforcement functions. cSaATC

2.6 Laboratory Accreditation means an attestation conveying formal demonstration of a laboratory's competence and capability to carry out specific scientific and technical tests or analytical service with respect to food products.

2.7 Plant food refers to food coming from plants except those that are under the jurisdiction of commodity agencies such as sugar, coconut, rice, corn and other grains.

2.8 Plant food testing refers to the different tests conducted on plant food that will determine if they are fit for human consumption such as but not limited to test on pesticide residue, microbiological contamination like salmonella and coliform, mycotoxins, and heavy metals.

2.9 Testing Laboratory means a legal entity that engages in the business of conducting tests, assay, examination measurements, or analytical services with respect to fresh and processed food products and farm inputs.

SECTION 3. Scope. — This Circular shall govern the accreditation of testing laboratories, both public and private, engage in conducting test, calibration, assay, examination measurements, or analytical services with respect to primary production and post-harvest stages of food supply chain and foods locally produced or imported in this category except laboratories of the Bureau of Plant Industry (BPI).

ARTICLE II

Accreditation of Laboratories

SECTION 4. Requirements. — Applicants applying for accreditation under this Circular must comply with requirements prescribed in this Section which will be treated confidentially.

4.1 Documentary Requirements. The following documentary requirements must be submitted to the BPI:

4.1.1. Letter of Intent addressed to the Director signed by the applicants; Authorized representative;

4.1.2. Accomplished Application Form;

4.1.3. Valid Business or Mayor's Permit

4.1.4. Department of Trade and Industry (DTI) or Securities and Exchange Commission (SEC) Registration, for Single Proprietorship or Corporation/partnership, respectively;

4.1.5. Hazardous Waste Generator Registration from DENR-EMB if applicable;

4.1.6. License to handle controlled precursor and essential chemicals from PDEA and/or other permits/licenses necessary to manage restricted chemicals;

4.1.7. Board Resolution or Special Power of Attorney, where appropriate, authorizing the applicant's representative to apply for accreditation. For public laboratories, Authorization Letter from the head of agency.

4.2 Technical Requirements. The following technical data and information must be provided to the BPI:

4.2.1. Profile of Laboratory

4.2.1.1. Name;

4.2.1.2. Address;

4.2.1.3. Organizational chart;

4.2.1.4. Contact person;

4.2.1.5. Function; and

4.2.1.6. Responsibilities.

4.2.2. Scope of analysis

4.2.3. Certificate of accreditation for ISO 17025 from Philippine Accreditation Bureau, if any

4.2.4. Method of analysis

4.2.5. List of major analytical equipment

4.2.6. Lay-out of office/laboratory

4.2.7. Laboratory personnel including trainings

4.2.8. Copy of documents from local or international body certified to conduct Proficiency Test demonstrating evaluation of laboratory performance in the scope applied for

4.2.9. Manual of Operations

SECTION 5. Creation of BPI-Plant Product Safety Services Division (BPI-PPSSD) Inspection Team. — The BPI-PPSSD shall create inspection teams tasked with the following functions:

5.1 Evaluate the accomplished application together with the required supporting documents.

5.2 Conduct on-site inspection of the laboratory.

5.3 Endorse the result of evaluation and recommend appropriate action to the Chief of PPSSD.

5.4 Conduct audit.

SECTION 6. Procedure. — The procedure for accreditation shall be as follows:

6.1. Application

6.1.1. The applicant shall submit to the BPI-PPSSD a Letter of Intent and the documentary and technical requirements specified in Section 4 hereof. For public laboratories, all documentary requirements referred to in Section 4 except (4.1.3) and (4.1.4) are required in addition to the technical requirements. cHDAIS

6.1.2. Upon submission, the designated staff shall immediately check the submitted documents for completeness of required documents. Applications with incomplete requirements shall be returned to applicant stating the reason.

6.2. Orientation

 Within five (5) days from receipt of complete application, the applicant shall attend an orientation conducted by the BPI on the following topics:

• Food Safety Act of 2013

• CODEX and its roles

• Duties and responsibilities of applicant

• Requirements of the importing countries

• Grounds for suspension and revocation of laboratory accreditation

• Reasons for approval or disapproval of application

• Other relevant function, as may be needed

6.3 Evaluation of Application

6.3.1 Within sixty (60) days, the BPI-PPSSD Inspection team shall evaluate the submitted application form together with the required supporting documents.

6.3.2 As part of the evaluation of application, the Inspection team shall make an on-site inspection of the laboratory including interview of the head of the laboratory and its analysis, check documents like standard operating procedures, work instructions, logbooks, calibrations records, and control graphs. During inspection, the applicant shall be informed of any non-compliance and shall recommend corrective measures. The Inspection team shall conduct additional on-site inspection, if necessary, to check that the corrective measures are undertaken.

6.4 Endorsement. The BPI-PPSSD Chief shall endorse the result of evaluation to the BPI Director for appropriate action.

6.5 The Director shall approve or deny the application for accreditation based on the evaluation submitted. If approve, the Director issues the Certificate of Accreditation. All applications that are not favorably considered shall be returned to the applicant with reason for denial.

6.6 An appeal shall be entertained at the latest fifteen days after the return of the application.

SECTION 7. Certificate of Accreditation. — The Certificate of Accreditation shall contain, among others, the following:

7.1. Unique Accreditation Code issued by BPI;

7.2. Name of Laboratory;

7.3. Address of the Laboratory;

7.4. Scope of Accreditation;

7.5. Name/s of authorized signatories and their specimen signature; and,

7.6. Date of issuance and expiration.

SECTION 8. Validity of the Certificate of Accreditation. — The Certificate of Accreditation shall be valid only for three (3) years reckoned from the date of approval/issuance subject to periodic audit.

SECTION 9. Procedure for Renewal of Accreditation. — The procedure outlined in Section 6 hereof shall be observed in processing application for renewal of accreditation. Moreover, the following measures shall be complied with:

9.1 The Office of the Director shall issue a Certificate of Renewal of Accreditation to distinguish from new applicants.

9.2 For laboratories that did not renew their accreditation three (3) months before the expiry date, the following procedure shall apply:

9.2.1 After expiry date, the laboratory shall be delisted from the list of accredited laboratories;

9.2.2 In case, the laboratory applies for re-accreditation after the expiry date or after delisting from the roll, the applicant shall be considered as a new applicant;

9.2.3 The previously assigned Accreditation Code shall be used in the Certificate of Accreditation.

9.3 At anytime, the Director may authorize the conduct of on-site audit and monitoring of the accredited laboratory.

SECTION 10. Criteria for Evaluation of Application. — The application for accreditation shall be evaluated based, among other, on the following:

10.1 Legitimacy of the operation of the applicant;

10.2 Completeness of the documents required to be submitted;

10.3 Accreditation is in accordance to international standards;

10.4 Methods of analysis used are internationally approved or validated;

10.5 Methods of analysis are regularly verified; and,

10.6 Analysts/staff are competent

ARTICLE III

Audit

SECTION 11. Scope of Audit. — The audit shall cover the scope of accreditation granted by the BPI.

SECTION 12. Audit Period. — An audit is conducted by BPI-PPSSD Inspection team about six (6) to eight (8) months after the issuance of Certificate of Accreditation and again twelve (12) to eighteen (18) months after. An audit may be conducted when there are detections/notifications in the country of destination for the commodities/shipments they have certified or when authorized by the BPI Director. ISHCcT

SECTION 13. Audit Procedure. — The procedure for the conduct of audit is as follows:

13.1 A NOTICE OF AUDIT shall be given the laboratory at least one (1) month before the scheduled audit. The Notice includes the following:

13.1.1 Date of Audit;

13.1.2 Scope of audit;

13.1.3 Names of the inspection team, at least three (3), who will conduct audit.

13.2 A program or schedule of audit shall be given the laboratory at least one (1) week before the scheduled audit and shall include the following:

13.2.1 Opening meeting where the team leader will introduce the whole team, the scope and the schedule of audit;

13.2.2 Audit proper;

13.2.3 Team deliberation;

13.2.4 Exit meeting where the team leader will present the findings and discuss the findings with the applicant and all concerned.

13.3 The applicant, all authorized signatories and all concerned analysts shall be present during the conduct of audit.

13.4 The applicant shall receive the audit findings from the inspection team.

13.5 The applicant shall submit to BPI Director through the BPI-PPSSD a Report of corrective and preventive actions on all findings within thirty (30) days.

13.6 BPI-PPSSD shall evaluate submitted Report of corrective and preventive actions, prepares results of evaluation.

13.7 BPI-PPSSD Chief shall endorse the results of evaluation to the BPI Director for appropriate action.

13.8 The Director shall recommend the continuation of the accreditation if pass, and suspension of accreditation if failed and shall be confidential.

ARTICLE IV

Fees and Charges

SECTION 14. Pursuant to the provisions of SECTION 36 of RA 10611, the DA, the DOH and the LGUs, where applicable, shall be allowed to collect fees for the inspection of food products, production and processing facilities, issuance of import or export certificates, laboratory testing of food samples and other fees as maybe deemed necessary.

14.1 The following fees shall be collected:

 Certificate of Accreditation — P5,000.00 (inclusive of Application fee of P1,000.00)

 Certificate of Renewal of Accreditation — P2,500.00 (inclusive of Application fee of P1,000.00)

ARTICLE IV n

Sanctions and Penalty

SECTION 15. Suspension of Accreditation. — The following are grounds for suspension of the accreditation after due process:

15.1 Proof of non-compliance established during audit and the corrective measures not undertaken within the prescribed time as directed by the BPI Director; or,

15.2 Three (3) detections/notifications in the country of destination for the commodities/shipments they have certified.

ARTICLE V

Repealing Clause

SECTION 16. All existing administrative orders, rules and regulations or parts thereof, which are inconsistent with the provisions of this Circular are hereby repealed or modified accordingly.

ARTICLE VI

Separability Clause

SECTION 17. If any portion of this circular is declared unconstitutional or invalid, the other portions thereof which are not affected thereby shall continue to be in full force and effect.

ARTICLE VII

Effectivity

SECTION 18. This Circular shall take effect fifteen (15) days after the publication in two (2) newspapers of general circulation and its filing with the National Administrative Register, U.P. Law Center.

 

(SGD.) PROCESO J. ALCALASecretary

n Note from the Publisher: Copied verbatim from official copy. Duplication of Article IV.

Published in The Philippine Star on June 6, 2016.