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All comments can be sent at [email protected]  with copy furnished to [email protected] . Deadline of submission of comments shall be by 26 June 2021.

I. RATIONALE

The Implementing Rules and Regulations of Republic Act 10611 otherwise known as the “Food Safety Act of 2013” states that food safety standards and codes of practice for processed and pre-packaged foods are to be developed, amended/revised, or updated.

Whereas FDA Circular No. 2013-010 or “Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods”, was implemented in 2013, the FDA has not introduced any updated guidelines. Hence, this updated guidelines is hereby issued with the following considerations: 1. Addition of new food categories/products and, 2. Update of references.

The reference criteria for specific food commodities as stated in Tables 1 to 15 now includes pre-packaged tubed and cubed ice, ethnic milk-based confectioneries, and food supplements.

The methods used for the enumeration or detection of specified microorganisms shall be those that have been internationally established. Such methods, as well as the cited specifications were obtained from the following internationally recognized references:

  1. FDA Bacteriological Analytical Manual published by the Association of Official Analytical Chemists International (AOAC)
  2. Compendium of Analytical Methods of the Canadian Health Protection Branch
  3. Compendium of Methods for the Microbiological Examination of Foods compiled by the American Public Health Association (APHA)
  4. Specifications and Standards for Foods, Food Additives, etc., Japan External Trade Organization
  5. Microbiological Guidelines for Food (For ready-to-eat food in general and specific food items), August 2014
  6. Microorganisms in Foods by the International Commission on Microbiological Specifications for Foods (ICMSF)
  7. Codex Alimentarius Commission Guidelines
  8. International Standards Organization (ISO) Microbiological Methods
  9. Australia New Zealand Food Authority (ANZFA)
  10. Philippine National Standards (PNS)
  11. Standard Methods for the Examination of Water and Wastewater (SMEWW)
  12. Canadian Food Inspection Agency
  13. Association of Official Analytical Chemists (AOAC)
  14. American Dehydrated Onion and Garlic Association standards (ADOGA)
  15. Gelatin Manufacturers Institute of America (GMIA)

II. OBJECTIVES

To serve as updated guidelines for the assessment of microbiological quality of certain processed food products and help ensure that food manufacturers comply with Good Manufacturing Practices (GMP).         

III. SCOPE

This Circular covers food establishments engaged in the manufacture, trade, repacking, wholesale, importation and distribution of processed food products in the Philippines.

 IV.  DEFINITION OF TERMS

APC or Aerobic Plate Count as a routine test provides an estimate of the total number of mesophilic aerobic bacteria in a sample without differentiating among the various types. This analysis can be used as a general index of the bacterial population.

Bacillus cereus is a sporulating, Gram-positive organism that grows aerobically and is most commonly isolated from rice, cereals and pasta.

Campylobacter is a microaerophilic organism, Gram-negative, oxidase positive, spiral-shaped rods with flagella. The Campylobacter genus is part of the family Campylobacteraceae.

Clostridium perfringens  is a Gram – positive anaerobic  sporulating  bacillus  unusual  among

Clostridia in being non-motile. Categorised into sub categories dependent upon the toxin produced, it is a key food poisoning pathogen in meat dishes.

Coliform bacteria are organisms and are commonly used as bacterial indicators of sanitary quality in foods and water. They are Gram-negative rods, which can ferment lactose with the production of acid and gas when incubated at 35°C to 37°C.

Commercial sterility means the absence of microorganisms capable of growing in the food at normal non-refrigerated conditions at which the food is likely to be held during manufacture, distribution and storage.

Cronobacter spp. is a Gram-negative, motile, peritrichous non-spore forming, facultative anaerobic bacterium. It is an opportunistic pathogen and has been linked with serious infections in infants.

    E. coli or Escherichia coli are a member of the family Enterobacteriaceae, and are divided into many sub-groups. E. coli is used as an indicator organism in water testing for the presence of faecal coliforms.

   Enterobacteriaceae is a family of gram-negative, non-spore forming bacteria that includes many bacteria that are found in human or animal intestinal tracts, as well as plants and the environment. The family includes a number of foodborne pathogens such as Salmonella, pathogenic E. coli, Shigella and Cronobacter, as well as non-pathogenic bacteria.

   Lactic acid bacteria are Gram-positive, acid tolerant, rods or cocci that usually produce lactic acid as the major metabolic end product of carbohydrate fermentation.

   Listeria are Gram-positive, catalase positive, non spore forming rods with flagella. Listeria monocytogenes and Listeria ivanovii are consistently associated with human illness isolated from soil, vegetation and water.

   Salmonella genus  belongs to  the  family Enterobacteriaceae. Salmonella bacteria are Gram – negative, non spore forming rods. There are approximately 2,500 serovars of Salmonella, which are characterized according to somatic and flagella antigens. Salmonella is one of the most frequent causes of food poisoning and a major public health problem worldwide.

   S. aureus or Staphylococcus aureus is a Gram-positive, non-spore forming cocci bacteria that belongs to the Staphylococcus genus. Several staphylococcal species (coagulase-negative and coagulase-positive strains) have the ability to produce heat-stable enterotoxins that cause gastroenteritis in humans.

   V. parahaemolyticus or Vibrio parahaemolyticus is a Gram-negative, curve-shaped rod naturally present in coastal and estuarine waters. V. parahaemolyticus is halophilic (salt-tolerant) and is lysed almost immediately in freshwater. It is a natural contaminant of seafood (fish, shellfish and crustaceans).

V. GENERAL GUIDELINES

This guidelines shall be used as reference to enhance food safety for the protection of public health.

VI. SPECIFIC GUIDELINES

  1. The responsibility of ensuring the microbiological quality of processed food product(s) and compliance to GMP shall rest upon the establishments or any person involved in the production, sale, handling, packing, transport, distribution, trading and storage of the product.
  2. The guidelines shall be used as reference for the assessment of microbiological quality of processed food products, and as a regulatory tool in post market monitoring and surveillance.

VII.   SEPARABILITY CLAUSE

If any provision of this Circular is declared unauthorized or rendered invalid by any court of law or competent authority, those provisions not affected thereby shall remain valid and effective.

VIII.  PENALTY CLAUSE

Sanctions over violations of any of the provisions of this FDA Circular shall follow the Rules of Administrative Procedure provided in the IRR of RA 9711.

IX. REPEALING CLAUSE

FDA Circular No. 2013-010 “Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods” and other issuances inconsistent or contrary to this Circular are hereby repealed.

 X. EFFECTIVITY

This FDA Circular shall take effect fifteen days (15) after its publication in two (2) national papers of general circulation, Official Gazette, and upon filing submission at the Office of the National Registrar (ONAR) at the UP Law Center, Diliman, Quezon City.

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