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FDA Circular 2022-012: Microbiological Requirements and Assessment of Prepackaged Processed Foods

• Repeals FDA Circular No. 2013-010.
• Provides updated guidelines for microbiological requirements and assessment of certain prepackaged processed food products.
• Issued 13 DEC 2022.

Rationale

• FDA is mandated to develop and issue policies, standards, regulations, and guidelines for facilities and health products as per Republic Act No. 9711 (The Food and Drug Administration Act of 2009).
• FDA will develop, adopt, amend, and revise food safety standards and codes of practice for processed and prepackaged foods, according to the Implementing Rules and Regulations of Republic Act No. 10611 (The Food Safety Act of 2013).
• The purpose of both acts is to ensure the safety and quality of processed food products for the general public.
• There is a need to update policies to keep up with innovations in processed food, with an estimated 15,000 new food products introduced yearly by large and small food companies.
• FDA Circular No. 2013-010, or "Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods," was implemented in 2013 but was reviewed by the Common Services Laboratory (CSL) and Center for Food Regulation and Research (CFRR) of the FDA to include new food categories and updated microbiological specifications.
• Methods for microorganism enumeration or detection shall be adopted from locally and internationally established references, as stated in Annex B.

Objectives

• To revise and update the guidance document in the assessment of microbiological quality of prepackaged processed food products.
• To align the guidelines on the microbiological requirements and assessment of prepackaged processed food products with local and international standards.

Scope

• Covers both imported and locally produced prepackaged processed food products under the jurisdiction of the FDA.

Definition of Terms

• Aerobic Plate Count (APC): A routine test measuring the total number of mesophilic aerobic bacteria in a sample without differentiating types, used as a general index of sanitary quality, manufacturing practices, raw materials, processing conditions, handling practices, and shelf-life.
• Bacillus cereus: An aerobic, sporulating, Gram-positive, motile, catalase-positive bacterium commonly found in soil, vegetables, and various raw and processed foods.
• Bacillus cereus food poisoning can occur if foods are prepared and held without adequate refrigeration for several hours before serving; outbreaks have involved cooked meat, vegetables, boiled or fried rice, vanilla sauce, custards, soups, and raw vegetable sprouts.
• Campylobacter: Microaerophilic, non-sporulating, Gram-negative, motile bacteria. The species of greatest interest in foods include C. jejuni and C. coli.
• C. jejuni associates with warm-blooded animals, with a large percentage of animals containing these organisms in their feces.
• Clostridium perfringens: A strictly anaerobic, sporulating, Gram-positive, non-motile, catalase-negative bacterium.
• Food poisoning due to C. perfringens occurs when foods like meat or poultry are cooked and held without adequate temperature maintenance.
• Small numbers of C. perfringens are common in raw meats, poultry, dehydrated soups and sauces, raw vegetables, and spices.
• Coliforms: A group of facultative anaerobic, Gram-negative, rod-shaped bacteria that ferments lactose to produce acid and gas within 48 hours at 35°C, and as such is used as an indicator of sanitary quality in water or the general food-processing environment.
• Commercial sterility: Absence of microorganisms able to grow in food under normal nonrefrigerated conditions during manufacture, distribution, and storage.
• Cronobacter spp.: Facultative anaerobic, non-sporulating, Gram-negative, motile, catalase-positive bacteria that are opportunistic pathogens linked to serious infections in infants.
• Enterobacteriaceae: A family of gram-negative, non-spore-forming bacteria found in human and animal intestinal tracts, plants, and the environment.
• This family features foodborne pathogens like Salmonella, pathogenic E. coli, Shigella, and Cronobacter, plus non-pathogenic bacteria.
• Escherichia coli: Facultative anaerobic, non-sporulating, Gram-negative bacterium in the Enterobacteriaceae family, which is widely distributed in the intestines of humans and warm-blooded animals. It serves as an indicator of fecal contamination or unsanitary processing.
• Fecal streptococci: Coccoid-shaped, chain-forming, Gram-positive bacteria of intestinal origin. Its presence in water indicates fecal contamination.
• Heterotrophic Plate Count (HPC): Formerly known as the standard plate count, it is a procedure for estimating the number of live, culturable heterotrophic bacteria in water.
• High-risk population: Individuals more likely to get sick and have serious illnesses, including adults 65 and older, children younger than 5 years, people with weakened immune systems, and pregnant women.
• Lactic acid bacteria: Gram-positive, acid-tolerant, rods or cocci that usually produce lactic acid.
• Listeria: A genus of facultative anaerobic, non-sporulating, motile or non-motile bacteria. Only L. monocytogenes is associated with human listeriosis.
• Psychrotrophic nature of L. monocytogenes is a problem for the food industry, with post-process re-contamination being a main cause.
• Foods linked to L. monocytogenes transmission 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.
• 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.
• Mesophilic bacteria: Microorganisms growing at moderate temperatures between 20°C and 45°C, with an optimum temperature between 30-39°C.
• Osmophilic yeasts: Yeasts capable of growing in high concentrations of organic solutes, usually spoiling high-sugar foods like jams, honey, concentrated fruit juices, and chocolate candy with soft centers.
• Process hygiene indicators: Criteria applied to the finished product (powder form) or any previous point for verification purposes, used by the manufacturer to assess hygiene programs.
• Pseudomonas aeruginosa: Gram-negative, non-spore forming rod which is oxidase and catalase positive. An opportunistic pathogen of man that can grow in water with very low nutrient concentrations.
• Salmonella: A genus of facultative anaerobic, non-sporulating, Gram-negative bacterium in the Enterobacteriaceae family, known as an infectious pathogen.
• Salmonella is one of four key global causes of diarrheal diseases, usually contracted from animal origin foods (meats, poultry, eggs, milk, dairy, fish, shrimp), but also from fresh produce (tomatoes, peppers, cantaloupes) and low-moisture foods (spices).
• Staphylococcus aureus: A Gram-positive, non-sporulating, non-motile, catalase-positive, and coagulase-positive bacterium. Coagulase production indicates pathogenicity in Staphylococcus species
• S. aureus is predominantly associated with the skin, skin glands, and mucous membranes of warm-blooded animals; its presence in processed foods or on food processing equipment points to poor sanitation.
• Thermophilic spores: Spores from thermophilic bacteria (thermophiles) that grow optimally at 55°C but can grow up to 65°C.
• Vibrio parahaemolyticus: Facultative anaerobic, Gram-negative, non-sporulating, motile, halophilic bacterium naturally present in coastal and estuarine waters, which lyses almost immediately in freshwater.
• It is a marine microorganism and is native in estuarine waters throughout the world.
• Its pathogenic strains cause disease worldwide, although most commonly in Asia and the United States. Most common foods associated with V. parahaemolyticus infection are molluscan shellfish (oysters, clams, mussels), raw or undercooked.
• Water activity (Aw): The quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature, indicating the amount of free water that supports microbial growth, chemical and enzymatic reactions, and spoilage processes.
• Yeast-like fungi: Also known as dimorphic fungi, these can change from yeast form to mycelial form in response to environmental changes.
• May be basidiomycetes such as Cryptococcus neoformans or ascomycetes such as Candida albicans etc.

Guidelines

• All food business operators and market authorization holders must comply with these guidelines for microbiological specifications of prepackaged processed foods; compliance with Annex A ensures safety and quality.
• The guidelines act as the basis for evaluating the microbiological properties of food products during product registration.
• Application details for a Certificate of Product Registration (CPR) are 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."
• Guidelines contain criteria prescribed in Tables 1-14, which describe food groups, the required microorganism tests, 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 are added.

Penalty Clause

• Any food product that does not comply with the reference criteria is non-conforming with food quality or safety standards, or is considered adulterated, misbranded, or mislabeled.
• Authorized sanctions will be imposed following Republic Act No. 3720, as amended by Executive Order No. 175, Republic Act No. 9711, or Republic Act No. 10611.

Separability Clause

• If any provision is declared unauthorized or invalid by a court, the remaining provisions will remain valid and effective.

Repealing Clause

• FDA Circular No. 2013-010, "Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods,” and other inconsistent issuances are repealed.

Effectivity

• This Circular takes effect fifteen (15) days after publication in the Official Gazette, or in any general circulation newspaper, and upon filing with the University of the Philippines Law Center Office of the National Administrative Register.