FOOD SAFETY REGULATIONS

FOOD SAFETY FAQ

WHAT ARE ACIDIFIED FOODS REGULATIONS?

Acidified foods are low-acid foods to which acid(s) or acidic ingredients are added to produce a food with a pH level of 4.6 or below, preventing the growth of harmful bacteria such as Clostridium botulinum, which can lead to botulism, a potentially fatal illness. These products require a scheduled process that is reviewed and approved by a process authority—a qualified person with expertise in thermal processing or acidification. The process authority ensures that the process is scientifically validated to produce a safe, shelf-stable product. The Scheduled Process must be filed with the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) before distribution of the product. This involves submitting Form FDA 2541 and other relevant forms outlining the process used to ensure the safety of the product. Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF) | FDA

WHAT IS A SCHEDULED PROCESS?

Scheduled process is a set of specific, documented procedures that a food manufacturer must follow to ensure the safety of a food product, particularly for certain high-risk, shelf-stable foods that are preserved through methods like canning. It is designed to control hazards like microbial contamination. The process involves carefully controlling factors like temperature, pH, pressure, and time to ensure the food is processed safely. After the scheduled process is developed, food manufacturers must adhere to it strictly. They must also monitor critical control points, like time, temperature, or pH, during production to ensure the process is followed correctly and maintain records documenting that the scheduled process was followed during production.

WHAT ARE COMMON FOOD SAFETY MANUFACTURING TERMS?

• Better Process Control School (BPCP) is specialized food training required by the FDA for supervisors of acidified and low-acid food processing operations.

• Critical Control Points (CCP) are specific stages in the food production or handling process where controls can be applied to prevent, eliminate, or reduce a food safety hazard to an acceptable level. An example of a CCP is to monitor cooking a food to ensure it reaches a predetermined temperature that kills harmful microorganisms.

• Hazard Analysis And Critical Control Points (HACCP) pronounced as "Hassip" (sounds like "has-sip"). HACCP is a systematic approach to food safety that focuses on identifying, evaluating, and controlling biological, chemical, and physical hazards in the food production process. Foods that require a HACCP plan are in high-risk food categories, such as: seafood and fish products, juice products, low-acid and acidified canned foods, and certain meat and poultry products (under state jurisdiction).

• Hazard Analysis and Risk-Based Preventive Controls (HARPC) pronounced as "H-A-R-P-C" (each letter is pronounced individually, like "H-A-R-P-C"). Food safety requirements mandated by the FDA under the Food Safety Modernization Act (FSMA) HARPC is a proactive approach designed to ensure that food facilities identify potential hazards in their operations and implement preventive controls to minimize or prevent those hazards, ensuring food safety throughout the production process.

WHAT IS A PROCESS AUTHORITY?

A Process Authority (typically a food safety expert or microbiologist) must scientifically validate and develop the scheduled process for the food product. They determine the exact parameters (time, temperature, pH, etc.) required to safely process the food and ensure the destruction of harmful pathogens. Process Authority can also help with product development such as recipe development to improve shelf-life and packaging selection.

WHAT FOODS REQUIRE A SCHEDULE PROCESS?

• Acidified Foods: Low-acid foods (pH above 4.6) to which acids or acid foods are added to reduce the pH to 4.6 or below, making them shelf-stable. Examples: Pickled vegetables, salsas, some sauces, and dressings.

• Low-Acid Canned Foods (LACF): Foods with a pH above 4.6 and a water activity above 0.85 that are packaged in hermetically sealed containers (like cans, jars, or pouches) and are shelf-stable. Examples: Vegetables, meats, and fish products packed in cans or jars.

• Juice Products: Some juices and juice blends that are not pasteurized or have undergone certain treatments may require a scheduled process to ensure microbial safety.

• Other Specialty Products (certain meat, poultry, and seafood products).

WHAT IS REQUIRED ON A FOOD LABEL?

Principal Display Panel (PDP): Part of the label most likely to be seen by consumers at the time of purchase. This shows the Statement of Identity: (the name of the food)

Net Quantity of Contents: Listed in both metric (grams, kilograms, milliliters, liters) and US Customary System (ounces, pounds, fluid ounces) terms.

Font Size and Legibility: All required information must be prominently placed and in a font size and style that is easy to read.

Standards of Identity: Certain foods must meet specific standards regarding their composition and production to be labeled with particular names.

Claims on Labels: Any health claims, nutrient content claims, or structure/function claims must comply with FDA regulations and be substantiated by scientific evidence.

Code Dating: Each container must be marked with an identifying code with the year, day, and period during which it was packed. Coupled with the manufacturer address, this coding facilitates traceability and is essential for food safety management.

Nutrition Facts Labeling: Serving Size and Servings Per Container: Reflects the amount people typically consume. Caloric Information: Total calories per serving. Nutrient Details: Amounts of total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, total sugars, added sugars, protein, and certain vitamins and minerals. Instructions can be found at What’s on the Nutrition Facts Label | FDA

Information Panel: located adjacent to the PDP. This includes Nutrition Facts, Ingredient List, Allergen Declaration, Name, Address of Manufacturer, Packer, or Distributor, and County of Origin, if imported.

Nutrition Facts are not required for Small Business that apply and qualify for a labeling exemption but are a good idea especially for selling on-line.

WHAT IS A NYS AG & MARKETS 20C LICENSE?

NYS Ag & Markets 20C license regulations focus on local issues, such as specific food safety practices, local ingredient sourcing, labeling specific to state standards, and adherence to New York’s environmental and business regulations. 20C licensing allows Ag & Markets to conduct regular inspections of the facility and enforce corrective actions and fines. The 20C license covers a wide range of food processing activities, including manufacturing, repacking, warehouses and selling food products at retail or wholesale.

New York law mandates that all food processors, except those that qualify for an EXEMPTION, obtain a 20C license. All food processors, exempt and not exempt are required to meet Current Good Manufacturing Practices (cGMP). For certain products, New York requires a hazard plan known as HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP).

• Unless the product qualifies for an EXEMPTION, operating without a 20C license in New York, even if FDA-registered, is illegal and could result in penalties, fines, or the shutdown of the business.

• To apply for a 20C license go to: Food Business Licensing | Agriculture and Markets (ny.gov). Fees range from $0 to $400 depending on the type of facility and number of employees.

• The license fee is waived for two years for a first-time applicant that processes food in a kitchen incubator food processing facility, which is a food processing facility used by multiple small and emerging food processing businesses, including both full-time facility tenants and businesses that rent space on a temporary basis.