1. Lecture 5 Good Manufacturing Practices (GMPs) for Food (1) Part 110 of 21 CFR http://vm.cfsan.fda.gov/~lrd/gmp-insp.html http://vm.cfsan.fda.gov/~lrd/cfr110.html http://www.cfsan.fda.gov/~dms/cgmps.html

2. Student Learning Outcomes  Understand which section of the Food, Drug, and Cosmetic Act is the basis for GMPs.  Understand sections of GMPs that affect food safety and quality.  Assessment by instructor:  Be able to develop a specific GMP for a feed mill, flour mill, bakery, or any food plant given a scenario about a particular plant, its surroundings, production process, and handling of finished foods. This is your first laboratory assignment.

3. Reasons for Establishing GMPs  Food produced should be safe  Food should not cause injury or should be free of defects  Consumers cannot tell whether food is injurious  Trust is placed in those who manufacture foods (producers, processors, and handlers)  FFDCA (1938) gives FDA authority to ensure food safety  In the US 76 million food-borne illnesses are reported, resulting in 325,000 hospitalizations, and 5,000 deaths (CDC 1999)  Illnesses are costly because of medical care, lost wages, or productive employment

4. FDCA (1938) Sections  342 (a) (1). Prohibits deleterious or poisonous substances in food  Basis for HACCP  342 (a) (2) (3) & (4). Food is adulterated if it may have been rendered injurious to health by the conditions under which it was prepared, packed, or held  Basis for GMPs

5. Legal Basis for GMPs  Sec. 342 (a) (4)  Food does not have to contain filth or be injurious to health  The food does not have to cause actual illness, injury, or death; only psychological discomfort  GMP regulations were finalized in April 1969  GMPs are broad and apply generally to all foods  Specific GMPs have been developed for LACF (Part 113), AF (Part 114), bottled water (Part 129), and infant formula (Parts 106 & 107)

6. Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food  21 CFR Part 110  Subparts:  Part A-General provisions  Part B-Buildings and facilities  Part C-Equipment  Part D-Reserved  Part E-Production and process control  Part F-Reserved  Part G-Defect action levels

7. Subpart A-General Provisions

8. Definitions Sec. 110.3  Acid foods or acidified foods (pH, 4.6 or below)  Batter (semi-fluid substance)  Blanching (prepackaging heat treatment of peanuts/treenuts)  Critical Control Points - lack of control creates hazard, filth or decomposition  Food contact surface – direct or drainage  Lot - identified by specific code  defined by batch or time  Microorganisms - yeasts, molds, bacteria, viruses  that cause or indicate adulteration  Undesirable microorganisms-Public health significance

9. Definitions (continued)  Pest - any objectionable animals or insects  Plant - facility for manufacturing, packaging, storage, labeling, etc.  Quality control operation - systematic procedure to prevent adulteration  Rework - clean unadulterated food  Safe moisture level – prevents microbial growth  Water activity (a w : measure of free moisture in food. Vapor pressure of food/vapor pressure of pure water at the same temperature)

10. Definitions (continued)  Sanitize - treat to destroy vegetative cells w/o adverse effects on product quality  Shall - mandatory  Should - recommended

11. Personnel Sec. 110.10  Responsibility of plant management  Disease control  personnel with communicable disease or illness should not be allowed to work  personnel with open sores should not be allowed to work or contact food  personal cleanliness  protective apparel  education and training  supervision

12. Exclusions Sec. 110.19  Operations that are engaged solely in harvesting, storing, or distributing raw agricultural commodities are not subject to GMPs, unless such regulations are necessary to protect the public

13. Subpart B-Buildings and Facilities

14. Plant and Grounds Sec. 110.20  Remove waste, grass, weeds etc.  remove all harborage or breeding places  Maintenance of roads, yard, parking lots  Adequate drainage  Waste treatment and disposal  Design, size and construction for sanitation  prevent potential for contamination of food or food surfaces  Ventilation for odors and fumes  Lighting

15. Sanitary Operations Sec. 110.35  Physical facilities kept in good repair and in good sanitary condition  Proper cleaning and sanitation of food contact surfaces- frequency  food contact surface free of microorganisms  use and storage of toxic chemicals  pest control - rodenticides, insecticides  dry processes must stay dry  wet processes - clean after every interruption  sanitizing agents adequate and safe  storage of cleaned portable equipment

16. Sanitary Facilities and Controls Sec. 110.37  Water supply - food and cleaning  Plumbing - sufficient water, avoid contamination  Adequate floor drains  Avoid backflow - cross contamination  Toilets - adequate and accessible  sanitary and good repair  self closing doors - not directly into process areas  hand washing, sanitizing, towel service, valve design, signs, refuse disposal

17. Subpart C-Equipment

18. Equipment and Utensils Sec. 110.40  Designed for ease of sanitation  non-corrosive food surfaces  Properly maintained  Installation facilitates cleaning  Must not contribute to adulteration  lubricants, fuel, metal fragments, other contaminants

19. Equipment  Seams - smoothly bonded  Non-food contact surface cleanable  Holding, conveying systems  Freezers/refrigerators  temperature measuring and recording  automatic controls to regulate temperature  Instruments for pH, a w, and temperature must be properly maintained  Compressed air for food use

20. Subpart E-Production and Process Controls

21. Process and Controls Sec. 110.80  All operations will support sanitation  receiving  inspection  transporting, segregating, preparing  manufacturing  packaging  storing or warehousing  Shipping

22. Process and Controls  Supervision of sanitation - competent personnel  Testing procedures established and used  identify sanitation failures  identify possible food contamination  Adulterated or contaminated food will be rejected  treatment to eliminate contamination  sifting, heat treatment, inspection

23. Warehousing and Distribution Sec. 110.93  Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as deterioration of the food and the container

24. Subpart G-Defect Action Levels

25. Defect Action Levels Sec. 110.110  Natural or unavoidable defects that at low levels are not hazardous to health  Revised as new data becomes available  FDA does not excuse unsanitary conditions, despite compliance with the DAL  Mixing foods above DAL with one below DAL is illegal and such food is considered adulterated under Sec. 342 (a) (3) of the FDCA

26. Questions  Which section of adulterated food is the basis for GMPs?  Where can you find GMPs described?  Why are GMPs generic and not specific?  GMPs cover issues both outside and inside the facility. Explain possible reasons behind these GMPs?  As a supervisor, what would you do to ensure that GMPs are being followed?  Develop an outline for a GMP training program in your facility?