I. RATIONALE
Pursuant to Republic Act No. 9711 otherwise known as “The Food and Drug Administration Act of 2009”, the FDA is mandated to “develop and issue policies, standards, regulations, and guidelines that would cover establishments, facilities and health products”. Further, the Implementing Rules and Regulations of Republic Act No. 10611 otherwise known as the “Food Safety Act of 2013” states that the FDA shall be responsible for developing, adopting and/or amending/revising food safety standards and codes of practice for processed and prepackaged foods. This is aligned with the end goal of ensuring the safety and quality of processed food products available for the general public.
Large and small food companies introduce an estimated 15,000 new food products every year. Hence, there is a need to update existing food policies to keep up with innovations in processed food. FDA Circular No. 2013-010 or “Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods” was implemented in 2013, and it was reviewed by the Common Services Laboratory (CSL) and Center for Food Regulation and Research (CFRR) of the FDA to consider the addition of new food categories and update the microbiological specifications of certain food products. The methods to be used for the enumeration or detection of specified microorganisms shall be those that have been adopted from locally and internationally established references as provided in Annex B.
This Circular is hereby issued to repeal FDA Circular No. 2013-010 entitled “Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods” and to provide the updated guidelines on the microbiological requirements and assessment of certain prepackaged processed food products.
II. OBJECTIVES
The objectives of this Circular are the following:
A. To revise and update the guidance document in the assessment of microbiological quality of prepackaged processed food products.
B. To align the guidelines on the microbiological requirements and assessment of prepackaged processed food products with local and international standards.
III. SCOPE
This Circular covers imported and locally produced prepackaged processed food products under the jurisdiction of the FDA.
IV. DEFINITION OF TERMS
A. Aerobic Plate Count (APC) 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, and to obtain the general information on the sanitary quality of products, manufacturing practices, raw materials, processing conditions, handling practices & shelf-life.
B. Bacillus cereus is an aerobic, sporulating, Gram-positive, motile, catalase positive bacterium that is commonly found in soil, on vegetables, and in many raw and processed foods. cereus food poisoning may occur when foods are prepared and held without adequate refrigeration for several hours before serving. Foods incriminated in past outbreaks include cooked meat and vegetables, boiled or fried rice, vanilla sauce, custards, soups, and raw vegetable sprouts.
C. Campylobacter are microaerophilic, non-sporulating, Gram-negative, motile bacteria. The species of greatest interest in foods is jejuni, and, to a lesser extent, C. coli. C. jejuni is not an environmental organism but rather is one that is associated with warm-blooded animals. A large percentage of all major meat animals has been shown to contain these organisms in their feces, with poultry being prominent
D. Clostridium perfringens is a strictly anaerobic, sporulating, Gram-positive, non-motile, catalase negative bacterium. Food poisoning due to perfringens may occur when foods such as meat or poultry are cooked and held without maintaining adequate temperature before serving. The presence of small numbers of C. perfringens is not uncommon in raw meats, poultry, dehydrated soups and sauces, raw vegetables, and spices
E. Coliforms refer to a group of facultative anaerobic, Gram-negative, rod-shaped bacteria that ferments lactose to produce acid and gas within 48 h at 35°C. Its
detection is used as an indicator of sanitary quality of water or as a general indicator of sanitary condition in the food-processing environment.
F. Commercial sterility means the absence of microorganisms capable of growing in the food at normal nonrefrigerated conditions at which the food is likely to be held during manufacture, distribution and storage.
G. Cronobacter are facultative anaerobic, non-sporulating, Gram-negative, motile, catalase positive bacteria. They are opportunistic pathogens that have been linked with serious infections in infants.
H. 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 coli, Shigella and Cronobacter, as well as non-pathogenic bacteria.
I. Escherichia coli is a facultative anaerobic, non-sporulating, Gram-negative bacterium, which belongs to the family Enterobacteriaceae. It is widely distributed in the intestine of humans and warm-blooded animals and is used to indicate recent fecal contamination or unsanitary processing.
J. Fecal streptococci are coccoid-shaped, chain forming, Gram positive bacteria of intestinal origin. The normal habitat of this microorganism is the intestinal tract of human beings and warmblooded animals and their presence in water indicates fecal contamination.
K. Heterotrophic Plate Count (HPC) – formerly known as standard plate count, is a procedure for estimating the number of live, culturable heterotrophic (use organic compounds as energy sources in their metabolism) bacteria in water.
L. High-risk population – certain group of people more likely to get sick and to have a more serious illness. These groups are composed of adults aged 65 and older, children younger than 5 years, people with weakened immune systems and pregnant women.
M. 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.
N. Listeria is a genus of facultative anaerobic, non-sporulating, Gram-positive, motile or non-motile bacteria. Among the six species under it, only monocytogenes is commonly associated with human listeriosis. The psychrotrophic nature of L. monocytogenes is a problem for the food industry. Post-process re-contamination is one of the most common causes of L. monocytogenes in the final product. Foods that have been associated with the transmission of L. monocytogenes include raw milk, inadequately pasteurized milk, chocolate milk, soft fresh cheeses, sorbets, raw
vegetables, bovine and poultry meats, meat products (sausages raw fermented sausages, hot dog type sausages), raw and smoked fish and seafood.
O. Lot refers to a set of units of a product which has been produced and/or manufactured and/or packaged under similar conditions. A lot can consist of several batches.
P. Mesophilic bacteria – microorganisms that grows at moderate temperatures between 20°C and 45°C and with an optimum temperature in the range of 30-39°C.
Q. Osmophilic yeasts – yeast that are capable of growing in high concentrations of organic solutes, particularly in sugars. Osmophilic yeasts are usually the cause of spoilage of high-sugar foods, including jams, honey, concentrated fruit juices, chocolate candy with soft centers etc.
R. Process hygiene indicators – criteria applied to the finished product (powder form) or any other previous point that provides the information for the purpose of verification. The criteria is intended to be used by the manufacturer as a means of on-going assessment of their hygiene programs.
S. Pseudomonas aeruginosa – gram negative, non-spore forming rod which is oxidase and catalase positive. It is an opportunistic pathogen of man that is capable of growth in water at very low nutrient concentrations.
T. Salmonella is a genus of facultative anaerobic, non-sporulating, Gram-negative bacterium, which also belongs to the family Enterobacteriaceae. Members of this genus are infectious pathogens capable of initiating clinical symptoms in humans. It is one of four key global causes of diarrheal diseases. The disease is generally contracted through the consumption of contaminated foods of animal origin (meats, poultry, eggs, milk and dairy products, fish, shrimp) but fresh produce (fruits and vegetables such tomatoes, peppers and cantaloupes) and low-moisture foods (such as spices) also have been implicated in transmission.
U. Staphylococcus aureus is a Gram-positive, non-sporulating, non-motile, catalase-positive, and coagulase-positive bacterium. The production of coagulase is considered as an indication of pathogenicity among the species of Staphylococcus. aureus is predominantly associated with the skin, skin glands and mucous membranes of warm-blooded animals. Thus, the presence of this bacterium or its enterotoxins in processed foods or on food processing equipment is generally an indication of poor sanitation.
V. Thermophilic spores – spores from thermophilic bacteria (thermophiles) or bacteria that grow optimally at 55°C but can grow up to 65°C.
W. Vibrio parahaemolyticus is a facultative anaerobic, Gram-negative, non-sporulating, motile, halophilic bacterium. parahaemolyticus is a curve-shaped rod naturally present in coastal and estuarine waters. It is halophilic (salt-loving) and is lysed almost immediately in freshwater. It is a marine microorganism native in estuarine
waters throughout the world. Its pathogenic strains cause disease worldwide, although most common in Asia and the United States. Molluscan shellfish, such as oysters, clams, and mussels raw or undercooked are the most common foods associated with V. parahaemolyticus infection.
X. Water activity (Aw) is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. It is an indication of the amount of free water in food that supports microbial growth, and participates in and supports chemical and enzymatic reactions and spoilage processes.
Y. Yeast-like fungi also known as dimorphic fungi corresponds to fungi that can change from yeast form to mycelial form in response to changes in environmental factors. May be basidiomycetes such as Cryptococcus neoformans or ascomycetes such as Candida albicans
V. GUIDELINES
A. All food business operators and market authorization holders shall adhere to these guidelines for the microbiological specifications of prepackaged processed food products. Compliance of the finished product to Annex A of this Circular ensures the safety and quality of the processed food product.
B. The guidelines shall be the basis for evaluation of microbiological properties of food products during application for product registration. The details on how to apply for and obtain a Certificate of Product Registration (CPR) are stated in FDA Circular No. 2020-033 or “Procedure for the Use of the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food Products Repealing FDA Circular No. 2016-014 “Procedure for the Use of Electronic Registration System for Prepackaged Processed Food Products” or its future amendments.
C. The guidelines contain reference criteria as prescribed in Tables 1-14. The tables contain descriptions of the food group to which specific criteria apply, the required test(s) for microorganisms considered, and the number of samples that should conform to the limits. New food categories such as pre-packaged tubed and cubed ice, ethnic milk-based confectioneries, and instant noodles, among others, have been added.
VI. PENALTY CLAUSE
Any food product that are non-compliant to, or in violation of, the reference criteria shall be deemed not in conformity with the applicable food quality or safety standard or either adulterated, misbranded, mislabelled or both, as the case may be. Accordingly, the authorized sanctions shall be imposed following Republic Act No. 3720, as amended by
Executive Order No. 175 and Republic Act No. 9711 or Republic Act No. 10611, as far as applicable, and following the proceedings under Book III of the Implementing Rules and Regulations of R.A. No. 9711.
VII. SEPARABILITY CLAUSE
If any provision of this Circular is declared unauthorized or rendered invalid by any court of law, the provisions not affected thereby shall remain valid and effective.
VIII. 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.
IX. EFFECTIVITY
This Circular shall take effect fifteen (15) days after its publication in the Official Gazette or in any newspaper of general circulation and upon filing with the University of the Philippines Law Center Office of the National Administrative Register.