Pursuant to Sections 62, 65 (l) and 67 (c) of R.A. No. 8550, this guideline on the implementation of the Hazard Analysis Critical Control Point is hereby issued for the information and guidance of all concerned.

Section 1. Definition. - The terms as used in this Order, shall be construed as follows:

1. Accreditation - A procedure wherein BFAR gives a formal recognition to a fish processing plant as having the competency to carry out the HACCP program.
   
   
2. Corrective Action Request (CAR) - Issued to the company to correct serious deficiencies noted during inspection.
   
   
3. Critical Control Point (CCP) - A process step in which control can be applied to prevent, eliminate, or reduce food safety hazards.
   
   
4. Control Point (CP) - A step, process and/or an operation in the manufacturing process from raw material to its final consumption.
   
   
5. Critical Limit (CL) - One or more prescribed tolerances that must be met to control hazards at the critical point which separates acceptability from unacceptability.
   
   
6. Fish - includes all fish and other aquatic species such as crustaceans (Crabs, prawns, shrimps and lobsters), cephalopods (squid, cuttlefish and octopus) and mollusks (clams, mussels, scallops, oyster, snail and gastrophods).
   
   
7. Fish processing plant - The facility where fish and fishery products are prepared, processed, chilled, frozen, packaged and stored.
   
   
8. Fishery Products - include all seawater or freshwater animals or other products of aquatic living resources or parts thereof, e.g., seaweeds, invertebrates, etc.
   
   
9. Food safety - The assurance that the food is processed properly and when consumed will not be harmful.
   
   
10. Good Manufacturing Practices (GMP) - The set of rules implemented in the processing plant which includes adherence to existing rules and regulations in force respecting plant construction, personnel hygiene and sanitation that supports company ™s policy and standards.
    
    
11. Hazard Analysis Critical Control Point (HACCP) - A preventive food quality management system which identifies, evaluates and controls the hazards significant to food safety specific to a product.
    
    
12. HACCP plan - A written document delineating the formal procedure to be followed in accordance with the seven HACCP principles in order to ensure food safety specific to a product.
    
    
13. HACCP compliance certificate - A written document issued by BFAR attesting that the fish processing plant is HACCP compliant.
    
    
14. International standards - Standards established by the Codex Alimentarius Commission.
    
    
15. Monitor - The act of conducting a planned sequence of observations or measurements of control parameters at the CCP.
    
    
16. Prerequisite program - involves or is composed of Good Manufacturing Practices and Sanitation Standard Operating Procedures.
    
    
17. Processors - are the people engaged in the commercial or institutional processing of fish and fishery products for export and the domestic market.
    
    
18. Satellite fish processing plant - Fish processing plant/s owned and operated by a single company located in different areas where fish and fishery products are processed.
    
    
19. Sanitation Standard Operating Procedures (SSOP) - A set of rules and guidelines on hygiene and sanitation established by processing plant to achieve the goal of food safety.

Sec. 2.    Fish inspection. - The Bureau of Fisheries and Aquatic Resources shall be the primary agency responsible in implementing the HACCP-based fish inspection and, in consonance thereto, shall have the following functions.

1. Inspect, monitor, assess/audit fish processing plants;
   
   
2. Inspect fish and fishery/aquatic products coming into or going out of the country;
   
   
3. Document and authorize the movement or trade of fishery products to ensure compliance to the requirements of the national and international market;
   
   
4. Conduct monitoring and surveillance of imported fish and fishery products to verify its intended use;
   
   
5. Issue voluntary product certificate for the export of fish and fishery/aquatic products as required by the importing countries;
   
   
6. Impose sanctions on accredited fish processing plants not complying with national/international standard rules and regulations;
   
   
7. Provide laboratory services to the industry on product testing and analysis;
   
   
8. Dispose of fish and fishery products found to be adulterated, decomposed or unsafe for human consumption;
   
   
9. Upgrade the skill and competence of personnel performing regulatory assessment of fish and fishery products and including fish processing plants; and
   
   
10. Provide training and advisory services to the industry.

Sec. 3. Qualification of HACCP Inspector. - The HACCP system Inspector/Auditor shall have the following qualifications:

1. A degree in fisheries, food science or allied courses;
   
   
2. Experience of at least two years in inspection and quality assurance activities;
   
   
3. Trained on HACCP and has acquired competency and skills required in conducting the inspection/audit; and
   
   
4. Has knowledge and understanding of the national and international standards and regulatory requirements.

Sec. 4.    Purpose of HACCP-based inspection. - The inspection shall be carried out to establish the capability of fish processing plants to manufacture and/or distribute safe food and obtain evidence that the HACCP system is effectively implemented.  The inspection may be applied in a mandatory or voluntary basis.

1. Mandatory inspection shall be conducted to enforce relevant national and international legislation and regulations and assess fish plant compliance.
   
   
2. Voluntary inspection shall be conducted upon request in writing by the management of the fish processing plant for appropriate guidance, technical assistance and development of expertise in the HACCP implementation.

Sec. 5.    Scope. - HACCP-based inspection shall cover the following:

1. Fish and fishery/aquatic products intended for human consumption, to include
   
   1)      Raw fish intended as raw material for processing or distribution;
   
   2)      Locally processed or manufactured fish and fishery products;
   
   3)      Imported fish and fishery/aquatic products; and
   
   4)      Fish and fishery/aquatic products intended for export.
   
   
2. Fish processing plants. - Registered and licensed fish plants and their satellite plants, processing fish and fishery/aquatic products for the domestic and export markets.

Sec. 6.    Requirement for inspection. - Fish plants including those processing fish and fishery/aquatic products for export to countries with which the Philippines has entered into an agreement, which BFAR has been tasked to implement, shall be subject to mandatory inspection.

Sec. 7.    Application for inspection. - Operators of fish processing plants shall file the application with BFAR containing the following information together with the HACCP documents required including the plant ™s SSOP and GMP:

1. Name and address of the fish processing plant;
   
2. Type of fish product/s processed at the plant;
   
3. Operation for which inspection is being sought.

Sec. 8.    Conduct of inspection. - Inspection of fish processing plants shall be carried out by an authorized fish inspector to ensure that:

1. Prerequisite programs are properly implemented and the objectives conform with written standard procedure;
   
   
2. Documented GMP procedures are up to date and properly implemented to meet the objectives set in the documents; and
   
   
3. The written HACCP plan satisfactorily addresses food safety and has been properly implemented and maintained.

Sec. 9.    Nature of inspection. - The Director of BFAR or his duly authorized representative shall determine the frequency, intensity and type of inspection to be conducted.  An inspection may be unannounced. For announced inspection, notice shall be given at least five (5) days before the inspection.

Sec. 10.  Assistance to inspectors. - The plant management shall provide assistance to the inspectors including access to areas necessary in carrying out the inspection by making available documents and records relating to HACCP, and interview of concerned personnel when necessary.

Sec. 11.  Requirements of pre-requisite program. - Processors of fish and fishery products shall develop and implement a set of written rules and guidelines on the following:

1. SSOP - Processors and importers shall monitor the following specific conditions and practices and keep records thereof, that will be made available during inspection:
   
   1)      Safety of water used in the processing and in the manufacture of the ice;
   
   2)      Condition and cleanliness of food contact surfaces, pieces of equipment and containers used during the processing;
   
   3)      Application of measures to prevent cross-contamination of the food, packaging material and contact surfaces;
   
   4)      Proper maintenance of hand washing, hand sanitizing, and toilet facilities;
   
   5)      Protection of product, packaging material and contact surfaces from adulteration;
   
   6)      Proper labeling, storage and use of toxic compounds;
   
   7)      Assurance of personnel health condition through specific health program to prevent contamination of the product, packaging materials and contact surfaces; and
   
   8)      Implementation of a pest control program in the plant.
   
   
2. GMP - The processors and importers shall also monitor specific requirements in the proper maintenance of plant premises and facilities and equipment and the record thereof shall be kept and be made available to fish inspectors.
   
   
3. Training - Plant personnel performing activities related to implementation of the HACCP system shall be trained pursuant to a HACCP Training Program to be developed and implemented by management.  A record of the training shall be kept and be made available for verification.

Sec. 12.  HACCP plan requirements. - Processors shall prepare and implement a HACCP plan based on the seven HACCP principles of:

1. Identifying significant food safety hazards whether product- or process-related that must be controlled;
   
   
2. Identifying CCPs in the processing steps where control measures can be applied;
   
   
3. Establishing critical limits or criteria to be met at the CCPs identified;
   
   
4. Setting up procedures and instituting a frequency schedule in monitoring the CCPs identified;
   
   
5. Establishing a corrective action plan and a set of procedures to be followed when deviation occurs;
   
   
6. Developing verification procedures and frequency plan to assess effectiveness identified; and
   
   
7. Establishing a record keeping system to document all necessary information in the HACCP plan.

The HACCP plan shall be signed and dated by the plant manager prior to its implementation. Periodic reassessment of the plan shall be implemented and any modification and/or revision shall undergo the same process.

The written HACCP plan shall also include a complete product description and its intended use, a verified product flow process, a HACCP plan table and a detailed background information on the product to be processed.

Sec. 13.  HACCP plan review. - All HACCP documents including the plant SSOP and GMP submitted shall be reviewed prior to the on-site inspection based on the following:

1. Adequacy of information on the product and the process description including the operation and intended use of the product;
   
   
2. Completeness of the process flow diagram noting the information of when, how, and who confirmed the same;
   
   
3. Presence of all required elements in the plan and proof that these are addressed adequately;
   
   
4. Assessment of the management.  The plant management shall be assessed on the level of commitment and compliance based on their -
   
   1)      Compliance history
   2)      Training and its application
   3)      Technical knowledge available
   
   
5. Determination of completeness of information of pre-requisite program

Sec. 14.  Revision of documents. - The plant management shall be notified of the documents identified with shortcomings or areas for improvement during the review and shall be returned with the comments and proper guidance.  The documents upon completion of the revision shall be resubmitted to BFAR for the on-site inspection and verification.

Sec. 15.  Issuance of CAR. - The inspector shall issue the Corrective Action Request for non-compliance or lapses noted during the inspection, specifying the date within which the defects shall be rectified, on the following bases:

1. HACCP document submitted not identical with actual processing step verified during the on-site inspection;
   
   
2. Non-compliance with legislation and government regulations;
   
   
3. Failure to identify and address food safety hazard;
   
   
4. Non-compliance with established food control program;
   
   
5. Evidence of non-conformance with the submitted HACCP plan especially on the identified critical factors in processing steps; and
   
   
6. Failure to adhere to established procedures in the pre-requisite programs.

Sec. 16.  Plant's obligation towards CAR issued. - Plants shall rectify the defect/s identified on or before the action date specified whereupon the inspector may propose in writing to amend or cancel the CAR or extend the corrective action date.

Sec. 17.  Inspection report. - The inspector shall issue a summary report at the conclusion of the inspection together with the CAR issued and shall discuss the report with the management.  The inspector shall provide oral or written advice and recommendations to improve the implementation and effectiveness of the system.

Sec. 18.  Certification for GMP and HACCP. - The fish processing plant may be issued a GMP and/or HACCP certification on the basis of compliance to food safety regulation and legislation, including conformance to the minimum requirement on the pre-requisite programs.

Sec. 19.  Requirement for HACCP certification. - Fish processing plants may be incorporated to the official list of HACCP certification upon meeting the following requirements:

1. The written HACCP plan satisfactorily addresses food safety;
   
   
2. The actual procedures comply with the documented procedure submitted;
   
   
3. On-site inspection show evidence that the HACCP plan/s are actually implemented as documented and are functioning;
   
   
4. All the required elements in the HACCP plan are present and addressed adequately; and
   
   
5. The overall program satisfactorily maintains food safety.

Sec. 20.  Requirement for GMP compliance certification. - Any fish processing plant may be issued GMP compliance certification which meets the following requirements:

1. Pre-requisite programs are properly implemented to address the scope and objectives of food safety;
   
   
2. Documented GMP procedures are up to date and properly implemented to meet the objectives set in the document;
   
   
3. Personnel responsible in the implementation of the program are fully aware of their duties and functioning in the monitoring of the hygiene and process control of the plant; and
   
   
4. The GMP program is effectively monitored, controlled and recorded.

Sec. 21.  Application for Certification. - A certification may be issued after an application therefor has been filed and the application fee of one hundred (P100.00) pesos has been paid, and such other charges for administrative and technical services rendered.  A separate charge for the microbiological examination and other laboratory tests conducted may be imposed when such examination are deemed necessary,

Sec. 22.  Certification for exported fish products. - Exported fish and fishery/aquatic products shall be certified on the basis of compliance to specific national and international regulations and after having met the following requirements:

1. The product has been processed in the fish processing plant that has been GMP and HACCP certified;
   
   
2. The export product complies with the food safety requirement of the importing countries on the basis of laboratory analysis and the specified criteria.

Sec. 23.  Repeal. - All orders, rules and regulations or parts thereof, which are inconsistent with this Order, are hereby repealed or modified accordingly.

Sec. 24.  Effectivity. - This Order shall take effect fifteen (15) days after its publication in the Official Gazette and/or in two (2) newspapers of general circulation, and fifteen (15) days after registration with the Office of the National Administrative Register.

Adopted: 17 May 2001

(SGD.) LEONARDO Q. MONTEMAYOR Secretary
Recommended by:
(SGD.) MALCOLM I. SARMIENTO, JR.	(SGD.) CESAR M. DRILON, JR.
Director, Bureau of Fisheries and Aquatic Resources	Undersecretary for Fisheries and concurrently Chairman, NFARMC