Regulatory Roadmap for Farmer s Market Vendors. Faith Critzer

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2 Regulatory Roadmap for Farmer s Market Vendors Faith Critzer faithc@utk.edu

3 Rules for All Food Manufacturers to Play By

4 Good Manufacturing Practices Manufactured in a sanitary environment adhering to Good Manufacturing Practices (GMPs)- 21CFR Part 110 Process controls (proper cooking time and temperature) Ingredient handling/storage Pest control Cleaning and sanitation Sanitary equipment and utensil design Allergen control Personal hygiene

5 Good Manufacturing Practices TDA currently working to adopt subpart B of the Preventative Controls Regulation 21 CFR Part 117

6 GMP Training & Resources Cornell GMP Online Training Very Comprehensive course $50 UT Publications Getting Started in a Food Manufacturing Business in Tennessee Adding Value to Agriculture Through Commercial Food Processing Enterprises

7 UTK FST Extension>Publications

8 Product Labeling The Four Must Haves Product name Manufacturers name and address Or name, city and zip if listed in white pages Net weight of product in English and Metric units e.g. ounces/pounds and gram weight equivalent or milliliters/liters and fluid ounces Complete list of ingredients in order of predominance by weight

9 Allergens Food Allergen and Consumer Protection Act January 1, 2006 Any of the Big 8 allergens properly identified in ingredient statement Wheat Soy Milk Eggs Fish Shellfish Peanuts Tree nuts (e.g. almonds, cashew, brazil nuts) Statement after ingredients Contains:

10 Allergens

11 Advisory Labeling Statements Advisory Labeling May contain Made on shared equipment Made in a facility that

12 Product Name Name of Distributor or Manufacturer with Street Address

13 Weight in grams and ounces

14 Did we miss anything? Ingredients: apples, honey, apple cider, citric acid, salt, spices

15 Nutrition Facts Panels Small Business Exemption File notice with FDA Sales of less than 100,000 units AND <100 full-time employees Notice does not need to be filed with FDA Gross sales of less than $500,000

16 Nutrition Facts Panels Two Methods 1) Laboratory Based Nutritional Analysis Require a physical sample of the product The samples are then prepped and analyzed in the laboratory using various scientific instruments and techniques to yield data that is specific and unique to the product. Laboratory based nutritional analysis can be used for virtually any food type.

17 Nutrition Facts Panels Two Methods 2) Nutritional Database Analysis Requires the formula for the product Detailed information about each ingredient and product processing information No physical sample is required to be submitted Database analysis can be used for products that have common ingredients. Not recommended: Products that have unique or exotic ingredients, Products with ingredients for which there is no nutritional data available, or Products that undergo extensive processing. This method can only be used for human foods.

18 Nutrition Facts Panels Two Methods 1) Laboratory Based Nutritional Analysis Approx $800-1,500 Refer to outside testing lab 2) Nutritional Database Analysis $ Online as well as outside testing labs

19 Acidified Foods

20 Acidified Foods Foods with >10% by weight in particulates that are low acid (ph >4.6) Vegetables Eggs Nuts Examples: salsa, pickles, chow-chow

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22 Acidified Foods Must adhere to GMPs as well as acidified food regulations Manufactured in commercial facility Community kitchen - rent time Rent time from a restaurant/cater while closed Co-packer- another company manufacturer your product Require minimum batch sizes Build their own Inspected and permitted as commercial food manufacturer

23 What are the additional requirements for acidified foods? 1) One time educational course

24 Better Process Control School Educates manufactures of the acidified food requirements Microbiology- food safety Process controls- cook time/temperature Product measurements ph Records

25 What are the additional requirements for acidified foods? 1) One time educational course 2) Register your facility with FDA

26 Registering Your Facility Form 2541 Just file one time for each location you process A/ReportsManualsForms/Forms/UCM pdf

27 What are the additional requirements for acidified foods? 1) One time educational course 2) Register your facility with FDA 3) Work with a processing authority to establish a scheduled process for each product

28 Who is a Processing Authority? Someone with expertise knowledge in microbiology and thermal processing Charge a fee per recipe to establish process May need to come on site while you manufacture to collect data

29 What are the additional requirements for acidified foods? 1) One time educational course 2) Register your facility with FDA 3) Work with a processing authority to establish a scheduled process for each product 4) File Scheduled Process with FDA

30 Filing a Scheduled Process with FDA FDA Form 2541a NOW 2541e Specific to the product Documents critical factors established by processing authority

31 What are the additional requirements for acidified foods? 1) One time educational course 2) Register your facility with FDA 3) Work with a processing authority to establish a scheduled process for each product 4) File Scheduled Process with FDA 5) Keep accurate records documenting all critical factors each time you process

32 Examples of Records Thermal processing records Cook time, temperature Finished product ph Fill weights Solid fill weight

33 Acidified Food Resources Factsheet to assist acidified food manufacturers

34 FDA Resources and Guidance Documents ulation/foodfacilityregistration/acidifiedl ACFRegistration/ucm htm ulation/guidancedocumentsregulatoryin formation/acidifiedlacf/default.htm

35 Formulated Acid Foods

36 Formulated Acid Foods Foods with natural ph <4.6 Usually Less than 10% by weight particulate low acid foods Most of our sauces and dressings fall into this category BBQ sauce, mayonnaise and marinades

37 Formulated Acid Foods Still recommend review of product formulation and processing steps Must adhere to GMPs Manufactured in a commercial kitchen DO NOT have additional requirements for acidified foods Can voluntarily submit 2541e to FDA for review

38 Formulated Acid Foods Materials Factsheet to assist formulated acid food manufacturers

39 Cottage Food Laws

40 Cottage Food Industry Growing support for home-made products Allows producers to add value to fruit and vegetable crops they raise A start to your business- not the end game Applies ONLY to non-potentially hazardous foods? Varies from state to state

41 What are non-potentially hazardous foods? Good question! These foods don t support the growth of bacteria that can be harmful

42 Can I get a list of nonpotentially hazardous foods? No! Wide range of products Fruit jams and jellies Apple butters Dried pumpkin and spinach pasta Dried herbs Contact me to determine if your product fits into this category

43 Domestic Kitchen Rules In May 2012, law was passed which allows manufacturers to opt-out of inspection and permitting by the Tennessee Department of Agriculture

44 Opting Out Allows manufacturers to sell direct to consumers They must display an 8.5-by-11-inch sign with 0.75-inch font at the place of sale stating, "These food products were made in a private home not licensed or inspected."

45 Domestic Kitchen Products Must be properly labeled Product name Manufacturers name and address Net weight of product in ounces/pounds and gram weight equivalent Complete list of ingredients in order of predominance by weight Warning label: This Product was made in a private home not licensed or inspected Any of the Big 8 allergens properly identified- wheat, soy, milk, eggs, fish, shellfish, peanuts, tree nuts,

46 What are the benefits to being inspected? Can sell through multiple retail outlets Some farmers markets sill require inspected/permitted domestic kitchen manufacturers Do not have to display warning sign and include this information on label If not properly trained, you don t know what proper practices are

47 What is required if I get inspected? 1) Adhere to modified Good Manufacturing Practices (GMPs)

48 How are GMPs modified? No pets, no pets, no pets At least inside No domestic duties Childcare, cooking dinner Separate refrigerator/ingredient storage Cross contamination Break resistant lighting- teflon coated bulbs No requirement for separate handwashing sink Can use home bathroom

49 What is required if I get inspected? 1) Adhere to modified Good Manufacturing Practices (GMPs) 2) One time passage of a course that covers information pertinent to Domestic Kitchen Manufacturers- offered both online and in person

50 Domestic Kitchen Course Online- extol Certifications $ students since Feb. of /category.php?id=25 In person classes on demand- 10 people minimum $100 8 hours

51 What is required if I get inspected? 1) Adhere to modified Good Manufacturing Practices (GMPs) 2) One time passage of a course that covers information pertinent to Domestic Kitchen Manufacturers- offered both online and in person 3) Permitted and Inspected by the Tennessee Department of Agriculture

52 Other Food Types

53 Retail Meat Sales Animals processed, meat packaged and labeled at USDA inspected facility Transported in a secure manner - freezer operated by inverter is acceptable No re-freezing of product refrigerated product maintained at or below 41F Retail Meat Sales Permit from TDA

54 Retail Meat Sales Labeling Requirements Product name. Name and address of the place of business of the manufacturer, packer or distributor ( packed for or distributed by are acceptable). USDA mark of inspection/establishment number. Net weight. Safe handling instructions. Ingredients (if more than a single ingredient product). Price per pound (non-frozen, random weight packages only). Total price (non-frozen, random weight packages only). Optional Code date or lot number. (Recommended not required.) Special statement and claims. (Require approval by USDA.)

55 Retail Meat Sales

56 Poultry Producer/Grower Exemption <20,000 birds/year Exempt from inspection May sell to consumer, hotel, retail stores, and restaurants/institutions Labeling: The shipping containers, when distributed in intrastate commerce, (instead of all the required features of a label for inspected product) bear: The processor s name The address Net weight The statement, Exempt P.L Safe handling instructions

57 Exemption Provisions The poultry is healthy when slaughtered; The slaughter and processing are conducted under sanitary standards, practices, and procedures that produce poultry products that are sound, clean, and fit for human food (not adulterated); The poultry is not misbranded is identified as exempt product and labeled;

58 Exemption Provisions The business operates under only 1 exemption during calendar year; Product cannot bear the Official USDA mark of inspection; and Poultry products do not move in inter-state commerce. The business slaughters and processes no more than 20,000 birds/carcasses in a calendar year under the exemption. Facility used to slaughter or process poultry is not used to slaughter or process another person s poultry unless the Administrator of FSIS grants an exemption [9 CFR (b)(2)].

59 Dairy Products EXCEPTIONS: Milk, cream and mixes must be pasteurized in properly operated and designed equipment in a licensed and permitted dairy plant 1. Raw milk hard cheese processed in dairy facility cheese aged 60 days 2. Ice cream made from pasteurized mix, cheese balls, cheese cake etc.

60 Eggs No permit/inspection required <3,000 birds Limit of 50 cases (30 doz per case) of unclassified eggs per year= 18,000 eggs >18,000 eggs must be graded Must be from own flock- no distributors Cleaned and sanitized Unused containers Must be labeled Unclassified Name of producer Eggs deemed adulterated may not be offered for sale Store at or below 41ºF

61 Honey No permit/inspection required <150 gallons per year Only sell product you produce Must be labeled Honey Comb honey Cut comb honey, Honey with comb, Chunk honey Name, address, & net weight

62 Newly Defined Standard of Identity TCA chapter Honey and any flavoring, spice or other added ingredient Processed in such a way that a modification to honey occurs that materially changes the flavor, color, viscosity or other material characteristics Must be distinguished in the food name from honey by declaration of the food additive or modification.

63 Sorghum Molasses Must be labeled Name, address, & net weight 100% Pure Sorghum Molasses Not Pure Sorghum Molasses - Include ingredient listing Inspected by TDA

64 Fresh Cut and Shelled Produce or Nuts Fresh produce that has been cut, shredded, sliced, chopped, torn, or shelled Maintain cut produce at 41 F or less during storage and display Will need to be processed in a facility inspected and permitted by TDA

65 Weights And Measures "Fresh fruits and vegetables may be sold by either weight, count. head/bunch, dry measure, or a combination of these methods of sale as specified in NIST Handbook 130".

66 Weights And Measures Scales used for retail sale must meet appropriate standards & inspected by TDA Nat l Type Evaluation Program (NTEP) Annual TDA inspection & permit fees - <2500 lbs. - $5.00 Non-compliant scales must be repaired by registered service company TDA has a list Net Wt. only lbs. ozs. & grams. Questions Bob Williams or robert.g.williams@tn.gov

67 Tennessee Department of Agriculture Consumer and Industry Services Mike Brown Outreach Coordinator (615) Will send packet for you to complete and send back for their review Inspector will inspect at least once a year

68 University of Tennessee County Extension Office Department of Food Science & Technology Faith Critzer

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