Food2Market South Carolina Food Regulations and Food Safety Education for Food Entrepreneurs Kimberly A. Baker, MS, RD, LD Food Safety Associate Food2Market A food entrepreneur assistance program Coordinates product testing with faculty in the Clemson Food, Nutrition and Packaging Science Department Educates entrepreneurs on food regulations that their products must adhere to General food safety education related to the food entrepreneur and producing safe food products for sale Food Safety Workshop for Food Entrepreneurs Seafood HACCP Certification Workshops www.clemson.edu/extension/food2market The Idea I make the best.. You make the best you should sell it. 1
What is Your Measure of Success? 1. Hobby 2. Income Financial Support Spending Money The Product Finalize recipe appropriate for production scale What is the market form (refrigerated, frozen, shelf stable, etc.) Where will product be sold? Where will product be produced? What is the competition? What is the market value? Profit margin? Food Regulation Requirements Determine who will regulate food product(s) What are the requirements of the regulatory authority? 2
Regulatory Overview Type of Product Regulatory Agency Retail Prepare and serve product onsite (restaurant) SC DHEC Food Safety Division Prepare and sell product directly to the public (retail) only Wholesale Contains >3% raw or >2% cooked beef, pork, chicken or lamb SC DHEC Food Safety Division *SCDA or SC Meat and Poultry Inspection Dept. may be involved depending on the product type SC Meat and Poultry Inspection Department Cheese, grade A dairy, soft drinks or water products Seafood products Contains >7% alcohol All other food products SC DHEC Dairy Division SC Department of Agriculture Alcohol, Tobacco, Firearms Tax and Trade Bureau SC Department of Agriculture SC Department of Agriculture Regulations 1. Produce product in an approved facility 2. Product testing (if applicable) 3. Label reviewed by SCDA 4. Apply for RVC 5. Comply with regular inspections What is an Approved Facility? Generally: Must meet all required regulations and be suitable for the type of product you will be producing. A facility may be approved on your property, if local zoning law allows. Cannot be your domestic-use kitchen Must have a separate entrance. Shared Facility Co-packer Restaurant Kitchen 3
Product Testing Primarily for shelf stable ( canned ) foods Data is written into a Process Control Letter Official documentation for SCDA and FDA Classifies product as acid, acidified or low acid OR Classifies product as a TCS or Non-TCS food Provides additional information to produce product safely Form and factsheets found on the Food2Market website Product Testing ph Water activity (A w ) Nutrition label ph A scale of 1-14. ph is the measure of hydrogen ion concentration in foods, which directly correlates to the acid content of the food. A food with a ph of 4.6 or lower is classified as an acid/acidified food. Foods with a ph of greater than 4.6 are classified as a low acid food. 4
The ph Scale Scale of 1-14 1 = strong acid 7 = neutral 14 = strong alkali Bacteria grows most rapidly between ph 5-9 The ph Scale The ph of Common Foods Food ph Vinegar 2.0-3.4 Lemons 2.2-2.4 Strawberries 3.0-3.5 Oranges 3.1-4.1 Jam/Jelly 3.1-3.5 Dill Pickles 3.2-3.5 Sauerkraut 3.4-3.6 Honey 3.9 Tomato 4.2-4.9 Cucumber 5.1-5.7 Beef 5.1-6.2 Food ph Peppers 5.15 Bread 5.3-5.8 Onion, yellow 5.4-5.6 Okra 5.5-6.4 Rice, white 6.0-6.7 Flour 6.0-6.3 Cabbage, white 6.2 Milk 6.3-8.5 Chicken 6.5-6.7 Eggs, whole 7.1-7.9 http://www.fda.gov/food/foodborneillnesscontaminants/causesofillnessbad BugBook/ucm122561.htm 5
ph Meters ph Growth Ranges for Specific Pathogens Pathogen Minimum ph for Growth Optimum ph for Growth Maximum ph for Growth Clostridium 5.5-5.8 7.2 8.0-9.0 perfringens Bacillus cereus 4.9 6.0-7.0 8.8 Campylobacter 4.9 6.5-7.5 9.0 Clostridium 4.6 8.5 botulinum Staphylococcus 4.0 6.0-7.0 10 aureus Escherichia coli 4.4 6.0-7.0 9.0 Listeria 4.39 7.0 9.4 monocytogenes Salmonella 4.2 7.0-7.5 9.5 http://www.fda.gov/food/foodscienceresearch/safepracticesforfoodproces ses/ucm094145.htm Acid Classifications Acid Foods - Foods which have a natural ph of 4.6 or below. A processed food is classified as an acid food if the final product ph is similar to the ph of the predominate ingredient. This classification must be determined by a process authority. 6
Acid Classifications Acidified Foods - Foods are classified as acidified when the predominate ingredient(s) are low acid and the final product has been processed or prepared to have a final ph of 4.6 or lower. When foods are classified as an acidified food, the manufacturer must file a schedule process established by a competent process authority and the operation must be under the supervision of an individual who has successfully completed an FDA approved course on processing acidified foods (Better Process Control School). Processors of acidified foods are also required to complete and submit an establishment registration form (Form FDA 2541). Acid Classifications Low Acid Foods - Foods with a ph of greater than 4.6. Vegetables and meats are common low acid foods. Low acid canned foods are at risk for the growth of clostridium botulinum if not canned properly. Water Activity Also written as a w. The measure of water in a product that is bound to food. Pathogens need water to grow. The more water in a product that is bound, the least likely those pathogens can grow and survive. Most pathogens cannot grow in foods with a a w of 0.85 or less. 7
Water Activity Values Values on AW Effects on Microorganisms Scale 0.99 Rapid Bacterial Growth (Most Common Bacteria) 0.97 Limit of growth for common spoilage bacteria 0.95 Many pathogens cease to grow 0.85 Approximate lower value for growth of Staphylococcus aureus 0.60 No growth below this value Chart courtesy of Dr. Paul Dawson, Clemson University Water Activity of Common Foods Food Approximate Water Activity Fresh and Canned Fruits, Vegetables 0.95 and Meat; Bread Hard Cheese (Cheddar, Swiss, 0.91 Provolone) Sponge Cakes 0.87 Salami 0.82 High Sugar Cakes, Syrup, Flour, Soy 0.80 Sauce Jam, Preserves, Marshmallows 0.75 Peanut Butter 0.70 Dried Fruits, Honey 0.60 Water Activity Limits for Pathogen Growth Pathogen Water Activity Limit for Growth Bacteria 0.91 Yeast 0.88 Mold 0.80 Halophillic Bacteria (Salt Loving) 0.75 Xerophilic Mold (Dry Loving) 0.65 Osmophillic Yeast (Affinity for High 0.60 Osmotic Pressure/High Sugar Concentration) 8
PHF vs Non-PHF (TCS vs Non-TCS) Potentially Hazardous Foods - Foods that have the potential to harbor and grow pathogens that cause foodborne illness. These include foods that have a ph of greater than 4.6 and a water activity (a w ) greater than 0.85. Non-Potentially Hazardous Foods - Foods that have low risk in sustaining the growth of pathogens. These foods usually have a ph less than or equal to 4.6 and a water activity (a w ) less than 0.85. ph and Water Activity Growth Ranges for Pathogens ph a w Bacteria 4.5-7.5 >0.9 Yeast 3.0-8.5 >0.8 Molds 2.0-11.0 >0.7 What Does the ph and a w Values Tell Me About a Food Product? Aw values ph values 4.6 or less >4.6-5.6 >5.6 0.92 or less Non-PHF Non-PHF Non-PHF >0.92-0.95 Non-PHF Non-PHF PH >0.95 Non-PHF PH PH Aw values ph values <4.2 4.2-4.6 >4.6-5.0 >5.0 <0.88 Non-PHF Non-PHF Non-PHF Non-PHF 0.88-0.90 Non-PHF Non-PHF Non-PHF PH >0.90-0.92 Non-PHF Non-PHF PH PH >0.92 Non-PHF PH PH PH 9
Required Certifications Better Process Control School Required to produce acidified and low acid foods for sale Register with FDA (product and facility) Required to obtain RVC from SCDA if producing an acidified or low acid product Seafood HACCP Required to process/store seafood and seafood products for wholesale Required to obtain RVC from SCDA Juice HACCP Required for production of juice products Required to obtain RVC from SCDA Nutrition Facts Panel Nutrient Analysis of product s formulation/recipe Sent as a word and pdf file to be incorporated onto product s label Label Requirements Four Basic Requirements based on the Fair Packaging and Labeling Act: 1. Statement of Identity (Product Name) 2. List of ingredients in descending order by weight 3. Name and address of manufacturer, packer or distributor 4. Net weight Follow font and layout requirements 10
What is an RVC? Registration Verification Certificate Given by the SC Department of Agriculture Certificate to Sell Received after initial inspection and product and process meets requirements. Cottage Food Law Exemption For non-potentially hazardous (Non-TCS) baked goods and candy Product testing necessary to determine if Non-TCS Products can be made in the home Sold direct to consumer only Follow label requirements Not for Resale Processed and prepared by a home-based food production operation that is not subject to South Carolina s Food Safety Regulations. Sell no more than $15,000 per year Exemption application on the SCDA website Honey Regulations Regulated by the SC Department of Agriculture ALL honey must be properly labeled (must be reviewed by SCDA) If sold by public sale (at roadside markets, retail stores, etc.) must register with SCDA and have honey house inspected and approved by SCDA. If you sell your honey directly to end consumer (i.e. at Farmers markets) and produce no more than 400 gallons (4,800lbs.) you can apply for registration and inspection exemption. You must file for exemption. A home kitchen cannot be used to produce honey for sale to the public. For more info: http://agriculture.sc.gov/foodsafetyandcompliance 11
Egg Guidelines Regulated by the SC Department of Agriculture No requirements if sold at the farm where eggs are gathered. Must be washed according to guidelines. To sell at Farmers Markets, Stores, Restaurants, etc.: Must complete and sign the Egg Application to Distribute Eggs and proof of label to SCDA. Wash according to guidelines Refrigerate according to guidelines Grade and size eggs according to guidelines Meet labeling requirements For more info: http://agriculture.sc.gov/foodsafetyandcompliance Questions? www.clemson.edu/extension/food2market 12