Product Safety Throughout Processing

1. Product Safety Throughout Processing SCOTT MARCIANO Manager, Quality & Safety JEFF REIDMILLER Microbiologist/Assistant Winemaker November 18, 2008

2. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 East Coast Operations: Background • Canandaigua Winery (Canandaigua, NY) and Widmer’s Wine Cellars (Naples, NY) • Canandaigua Winery – largest winery east of the Mississippi • Full-time staff of 300 employees, plus seasonal hiring • Annual production of approximately 30 million gallons (10 million 9.0 liter cases)

3. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 East Coast Operations: Background (continued) • Unlike California and most other winemaking regions, juice is stored after crush, and fermented throughout the year. • East Coast has 12 bottling lines that bottle sizes ranging from 187 ml to 4.0 liter glass bottles, and one bag-in-box line that can bottle sizes from 4.0 to 18.0 liter bag-in-box. • Currently bottle still wines, artificially carbonated wines, and champagne. • Distribution of finished goods includes three warehouses – one at each winery and a remote warehouse in Geneva, New York. • Both wineries are ISO 9001:2000 certified.

4. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 What are the risks to the winery? • Pesticides on the grapes • Incoming ingredient contamination and tampering • Microorganism contamination (yeast, mold, bacteria) • Foreign material (glass, carton dust, machine parts, airborne contamination, rodent infestation) • Final product safety

5. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Pesticides • Grapes have a number of herbicides, fungicides, and pesticides applied to prevent crop damage. • How does Constellation know that growers are adhering to New York State Department of Conservation (DEC) and Environmental Protection Agency (EPA) application requirements? • Are the growers adhering to periods of harvest? • Are they using approved pesticides?

6. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 How do we control/monitor pesticides? • The Grower Relations team utilizes “Track Grape”, a program developed by the Cornell Cooperative Extension. • All growers under contract are required to enter their spray data into this program. • The program only allows approved chemicals in the system and monitors periods of harvest based on application data. • All records are reviewed by the Director of Grower Relations.

7. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Incoming Ingredients East Coast Operations receives a number of raw ingredients by rail, tanker truck, or drum (such as high proof alcohol, flavors, sugar, and juice concentrate). How do we control incoming ingredients? • Assumes okay at supplier • All tankers and rail cars are sealed. Winemaking/Cellar verify seal numbers against original Bill of Lading that contains the seal number. Once verified, the truck can be opened and a sample taken. • Certificates of Analysis are received for each lot of ingredients such as alcohol, sugar, and concentrate. • Samples are tested analytically for key product characteristics identified by the Winemaking team. • Samples are also analyzed organoleptically. • Once approved, products are unloaded to a tank in the winery or released from hold. • Every ingredient is given a unique material and/or lot number and is tracked in a winemaking database.

8. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Winery Sanitation and Microbiological Monitoring • Product safety from juice in the wine cellar to finished, bottled product • Proactive versus reactive sanitation and laboratory methods • Utilizes internal and external resources for latest technology and best practices for our facility • One size does not fit all: facilities, tanks, bottling lines, product

9. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Sanitation • Successful bottling line sanitation begins in the wine cellar: • - Dirty tanks and transfer hoses can undo a stellar sanitation of the bottling lines. • - In our environment, yeast are everywhere because we ferment 52 weeks out of the year. • Minimum, primary goal: • - Certainty that the wine in the bottle is free from contamination by microorganisms that can cause degradation of wine quality. • Maximum goal: • - An entire winery that is free of microorganisms that are harmful to the wine’s quality and shelf life, and meets consumer expectations.

10. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Cellar Sanitation Process Measured/Monitored • Basic tools to monitor sanitation in wine cellar: • Swabbing after sanitizing equipment (bioluminescence) • Titrations to verify chemical concentrations (i.e. tank rinse) • Pre-bottling plating of product in bottle-ready tank • Filter sanitation and integrity testing

11. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Bottling Sanitation Process Defined • What process is going to be used (i.e. full chemical, chlorine, or hot water). • - Canandaigua Winery utilizes a four-step CIP sanitation (wash, rinse, sanitize, rinse) • All bottling sanitation is documented in SOPs, Work Instructions, and Master Sanitation Schedules – all defined in the Quality Management System.

12. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Bottling Sanitation Process Monitored/Measured • Basic tools to monitor sanitation in Bottling: • Chart/document critical temperature and hold times • Titration to verify chemical concentrations • Swabbing of equipment • Microbiology of finished product throughout the run (at start, at end, and at defined intervals between) • - Set internal limits on microbiological analysis; need to be defined and realistic.

13. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Microbiological Monitoring Throughout Processing • Tank samples (pre-bottle): • - Monitor low alcohol (6% to 14%) products on a daily basis • - Getting proper samples that are representative of product in tank • - Response to high microbial loads (filter selection) • Filler valve stem analysis after sanitation • Sanitation line checks • - bottling equipment • - bottle rinsers • - bottling dust covers • - filler and capper location • - bottle warmer • - air quality • - Incoming bottles (random)

14. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Microbiological Monitoring Throughout Processing • Utilizing technology beyond the standard swabs and agar plates • Biofilms and biofouling in bottling lines • - Adhesion of microorganisms onto the surfaces of solution-handling systems • - Once established, removal by physical and/or chemical means is difficult and expensive • - Early detection of biofouling is key to controlling and preventing it in the future • Biofouling assessment by Ethox International • - Installed fouling cell housings containing stainless steel discs in multiple locations of two separate bottling lines • - Discs exposed to product and cleaning flows and chemistries for 1, 4, and 8 weeks • - Analyze discs for biofouling by FTIR and epifluorescence microscopy • - Provides a benchmark of our CIP process

15. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Microbiological Monitoring of Bottled Product • Establish limits on plate counts for each product • - Dieback time and yeast challenge experiments • - Two types of medium, categorize growth as yeast, mold, or bacteria • - Product holds and replate procedure using “holdback” samples • - Consumer complaints: testing product left in bottle • Zygosaccharomyces – wine spoilage yeast • - Zygo has high alcohol and preservative tolerance • - Creates sediment in bottle and can cause secondary fermentation in the bottle • - Once Zygo is present in winery, it is difficult to eliminate; containment is key • - Primary reservoirs in winery for Zygo are the difficult to sanitation locations in processing lines • - Monitor daily in finished product

16. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Other Foreign Material • Sanitizing is not just cleaning the fillers; there are numerous sources of contamination: • Airborne exposure to open, unfilled bottles and filled, unsealed bottles • Product contact surfaces, bottles, caps and/or corks • Non-product contact surfaces – bottle cleaners, fillers, closure equipment, conveyors • Breakage on bottling lines poses a physical hazard • Maintenance work done to areas of product contact should be sanitized appropriately after work has been completed (i.e. filler stems) • Rodent/pest control

17. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 How do we control foreign material? Minimize the time the bottle is left open after being filled and prior to capping.

18. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Other Foreign Material (continued) • Bottles are rinsed with air, water (5 ppm iodine solution) and/or both to control carton dust and foreign material. • After rinsing and filling prior to capping, • NYS Agriculture and Markets requires us • to have dust covers over our conveyors • to prevent foreign material from entering • bottles. • Standard operating procedures for breakage • in our fillers and cappers. • Standard operating procedures for product • contact areas that have had maintenance • work done (i.e. sanitized filler stems).

19. Example: WJJJYYLL HH:MM Year Hour Winery of production Line Minute Julian date code PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Package Safety How do we prevent product tampering? • All capped products have pilfer rings: • Every bottle that is shipped is date coded for traceability (Ag & Markets and FDA requirement):

20. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 How do we track/trace or recall? • By utilizing the bottling date code provided on the individual bottles, we can obtain the bottling date and lot of wine (lot serial number) used in that bottling date. • Utilizing the recall program in our operation system (JDEdwards) we can obtain a report of all customers that were sent the products in question, along with the quantities they received. • From that lot serial number we can drill down to the wine work order and track/trace the wine ingredients that were used that lot. • Commercial wine industry is a three-tiered system. • Documented standard operating procedure for recalls is required by the FDA.

21. PRODUCT SAFETY THROUGHOUT PROCESSING November 2008 Benefits of ISO 9001:2000 Certification • Provides consistency in work practices and final product • Gets away from “tribal” knowledge procedures • Defines responsibilities and accountability; includes supplies • Strengthens organization and customer confidence • Continuous improvement • Validation of new product design