FOOD SAFETY MODERNIZATION ACT GOOD AGRICULTURAL PRACTICES EDUCATIONAL OUTREACH SEMINARS

Transcription

1 FOOD SAFETY MODERNIZATION ACT GOOD AGRICULTURAL PRACTICES EDUCATIONAL OUTREACH SEMINARS March 1-3, 2016

2 TODAY, YOU WILL LEAVE WITH AN UNDERSTANDING OF: What is FSMA? Why was FSMA created? Exemptions & Compliance Dates What does FSMA require? How does GAP stack up to FSMA? How to get GAP certified

3 WELCOME FROM TOM BELLAMORE Welcome from Tom Bellamore 3

4 WHAT IS FSMA?

5 FOOD SAFETY MODERNIZATION ACT FSMA became law on January 26th, 2016 FSMA places the responsibility for the safety of fresh produce and meat sold in the U.S. on the FDA (including offshore production) FSMA focuses on mitigating risk of microbial contamination through identified possible routes FSMA = policies and procedures to uphold science-based standards 5

6 FSMA IDENTIFIED POSSIBLE ROUTES FOR MICROBIAL CONTAMINATION People worker hygiene and health Water hand washing, drinking, irrigation, application mixes, run off Soil soil amendments, prior uses, adjacent uses, contamination Animals wild or domestic 6

7 FSMA INCLUDES FIVE SEPARATE RULES Preventive Controls for Human Food Rule Preventive Controls for Food for Animals Rule Standards for Produce Safety Rule Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Rule Accredited Third-Party Certification Rule 7

8 FSMA PRODUCE SAFETY RULE: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Rule): This Rule covers the production and harvesting of raw commodities for all produce sold in the United States, including produce grown internationally. This Rule includes avocados grown for commercial purposes. 8

9 WHY WAS FSMA CREATED?

10 HISTORY OF HIGH-PROFILE FOOD SAFETY INCIDENTS Spinach 2006, E. coli 3 deaths/199 sickened Peanut butter 2008, Salmonella 9 deaths/714 sickened Cantaloupes 2011, Listeria monocytogenes 33 deaths/146 sickened Incidents continue Cucumbers, 2014/15, Salmonella 4 deaths/838 sickened Cilantro, 2015, Cyclospora 546 sickened Packaged salad, 2015/16, Listeria monocytogenes 1 death/17 hospitalized 10

11 INCREASING CONCERN FOR FOOD SAFETY Buyers Federal Government Consumers 11

12 WHO CARES? RETAILERS & FOOD SERVICE CARE 12

13 WHO CARES? CONSUMERS CARE Consumers care Consumer Trust in the Food System study shows, Every sector of the food system, whether farmers, grocery stores or restaurants, is under ever-increasing pressure to demonstrate they are operating in a way that is consistent with stakeholder values and expectations. 13

14 WHO CARES? WE SHOULD FDA Avocado Sampling Assignment Began in ,600 samples (480 domestic/1,120 imported) Samples taken at handler facilities, ports of entry, and retailers Testing for Salmonella and Listeria Rationale: multiple foodborne illness outbreaks associated with consumption of guacamole 11 positives for Salmonella on U.S. avocados 14

15 FOOD SAFETY IS OUR BUSINESS Avocados are low risk but not zero risk Yes, a food safety outbreak could happen to avocados Everything from worker hygiene to water sources could be a factor 15

16 IMPACT OF A FOOD SAFETY INCIDENT Market disruption Damage to reputation, nutrition message and image Litigation 16

17 IMPACT OF A FOOD SAFETY INCIDENT 17

18 GUILTY BY ASSOCIATION? 18

19 GUILTY BY ASSOCIATION? 19

20 GUILTY BY ASSOCIATION? The best way to deal with a food safety incident is to not have one! 20

21 FSMA EXEMPTIONS & COMPLIANCE DATES

22 FSMA EXEMPTIONS The Rule does not apply to: Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less 22

23 FSMA EXEMPTIONS The Rule also provides a qualified exemption and modified requirements for certain farms. To be eligible for a qualified exemption, the farm must meet two requirements: The farm must have food sales averaging less than $500,000 per year during the previous three years; and The farm s sales to qualified end-users must exceed sales to all others combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away. 23

24 FSMA COMPLIANCE DATES The following are final compliance dates under the Rule based on business size: Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period: four years (January 26, 2020) Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: three years (January 26, 2019) All other farms: two years (January 26, 2018) 24

25 HOW WILL FDA ENFORCE? Monumental undertaking for FDA Sheer scale of responsibility may mean economies of scale? Larger operations higher on list? $50MM appropriated for verification/ auditing First handler of fruit? States possibly assist (CDFA?) Lots of questions 25

26 WHAT DOES FSMA REQUIRE?

27 FSMA REQUIREMENTS FSMA = policies and procedures to uphold science-based standards 27

28 FIVE SECTIONS OF THE RULE Worker Training and Health and Hygiene Agricultural Water (Quality and Testing) Biological Soil Amendments (Raw Manure and Compost) Domesticated and Wild Animals Equipment, Tools and Buildings 28

29 HOW DOES GAP STACK UP TO FSMA? Generally FSMA requirements are consistent with GAP certification Two major exceptions: Windfall Fruit Agricultural Water Testing requirements 29

30 HARVEST OF WINDFALL FRUIT Dropped covered produce ( ) This section of FSMA prohibits the distributing of produce that drops to the ground before harvesting The CDFA acknowledges that federal law will preempt state law on this subject and that a change in California law will be forthcoming 30

31 AGRICULTURAL WATER REQUIREMENTS FSMA identifies Agricultural Water as water used in activities on produce, including water used in growing activities Hand washing during harvest Cleaning food contact surfaces (clipper blades) Irrigation water applied using direct water application methods (micro-sprinklers) Water used for preparing crop sprays 31

32 AGRICULTURAL WATER REQUIREMENTS FSMA requires greater testing frequency to establish a microbial water quality profile Based on two criteria: geometric mean (GM) and the statistical threshold (STV) The utilization of GM and STV for the creation of a Dataset is not part of the Commission s current GAP program More on this later 32

33 WHAT ARE GOOD AGRICULTURAL PRACTICES (GAPS)?

34 WHAT IS THE PURPOSE OF GAPS? To assure customers that thought and action have gone into minimizing the potential for contamination by pathogens Go beyond just government requirements Protect people Ensure the public that our practices are safe Often just need to document current practices Risk assessment vs. Passing an audit inspection Practice what we preach culture 34

35 COMMISSION S ROLE Get ahead of FSMA compliance dates; maintain dialogue with retailers and regulators Provide uniform tools to help majority of growers achieve certification Oversee this voluntary program to assist the industry in becoming GAP certified 35

36 GREAT PROGRESS IN FOUR YEARS We re making great progress! Launched in Nov Voluntary 50-60%+ of industry certified Important to support Premium Avocado brand 36

37 HOW TO GET GAP CERTIFIED

38 GROWERS WORK WITH CAC AND HANDLERS Review food safety practices at meetings and in CAC materials Inform handler you d like to become GAP certified Complete pre-audit review Adjust practices as needed Schedule audit 38

39 GROWER AUDIT EXPERIENCE Handler schedules audit Day of audit, auditor reviews paperwork, drives perimeter, checks common problem areas Average price $350-$400 GAP certification good for one year 39

40 AUDIT FAILURE WILL OCCUR IF An immediate food safety risk is present when produce is grown, processed, packed or held under conditions that promote or cause the produce to become contaminated Observation of employee practices (personal or hygienic) that jeopardize or may jeopardize the safety of the produce Falsification of records 40

41 PRE-SEASON RISK ASSESSMENT

42 PRE-SEASON RISK ASSESSMENT Ground History Flooding; grazing lands Adjacent Land Use Runoff from livestock; manure Fertilizer/Crop Nutrition Raw/composted manure; fertilizers 42

43 PRE-SEASON RISK ASSESSMENT Irrigation/Water Use Sources; microbial testing; system condition Employee Hygiene Toilets/hand washing facilities; employee training Necessary Records PCA/QAL licenses; pesticide use report; water testing; maintenance logs; NUOCA (Notice of Unusual Occurrence and Corrective Action) 43

44 PREPARATION SHEET FOR PRIMUSLABS RANCH/FARM AUDIT

45 PREPARATION SHEET 45

46 THE GAP MANUAL

47 GAP BINDER SECTIONS 1. General Information 2. Field Sanitation 3. Agricultural Inputs 4. Worker Health & Hygiene 5. Food Security 6. Food Safety & Security Training 7. Forms & Logs 47

48 KEY AREAS TO WATCH Hand washing Worker training Restrooms Water quality Illness 48

49 SECTION ONE: GENERAL INFORMATION

50 SECTION ONE: GENERAL INFORMATION Ranch Information Traceability Soils & Land Use 50

51 SECTION ONE: GENERAL INFORMATION Examples of Necessary Records: Ranch history and prior use Grove identification, size and layout Water source and testing results Detailed harvest records Contact information for owners, managers Pest management Worker trainings Sanitary facility inspection and cleaning 51

52 SECTION TWO: FIELD SANITATION

53 SECTION TWO: FIELD SANITATION Livestock, Wildlife and Pets Animal presence poses contamination risk Monitor for high concentrations Discourage Their Presence Removing fecal material and dead animals Take corrective action if necessary 53

54 SECTION THREE: AGRICULTURAL INPUTS

55 SECTION THREE: FERTILIZERS & COMPOST Only composted manure and Class A biosolids should be used in the grove Letter of Guarantee for all fertilizer and compost shipments Document the rates, dates and locations of applications Store materials in a way that prevents leaching Cover manure piles to prevent wind scatter 55

56 SECTION THREE: CROP PROTECTION MATERIALS Product Use Reports required Letters of Guarantee from the applicator who applies material Store materials safely 56

57 SECTION THREE: WATER USAGE DOES NOT FULLY MEET FSMA REQUIREMENTS 57

58 FSMA AGRICULTURAL WATER CRITERIA Water directly applied to produce must meet certain criteria The geometric mean of samples must be 126 or less Colony Forming Units (CFU) of generic E. coli per 100 ml of water The statistical threshold (STV) of samples is 410 CFU or less of generic E. coli in 100 ml of water 58

59 FSMA AGRICULTURAL WATER CRITERIA FSMA requires water meet potable standards no detectable generic E. coli when it is reasonably likely that potentially dangerous microbes, if present, would be transferred to produce through direct or indirect contact (e.g. water used for washing hands during and after harvest and water used on food-contact surfaces like clipper blades) FSMA prohibits use of untreated surface water for any of these purposes 59

60 FSMA AGRICULTURAL WATER CRITERIA Geometric mean (GM) is an average and is intended to determine the average amount of E. coli in water source Statistical threshold (STV) reflects the amount of variability in the water quality (indicating E. coli levels when adverse conditions come into play like rainfall or high river stage that can wash waste into rivers or canals) Best described as 90% of samples are below the value 60

61 FSMA AGRICULTURAL WATER CRITERIA If water does not meet these criteria, corrective actions are required as soon as possible, but no later than the following year Allowing time for microbes to die off Treating the water 61

62 FSMA AGRICULTURAL WATER TESTING REQUIREMENTS Surface Water (ponds, reservoirs, canals, rivers ditches): Initial survey, minimum of 20 samples, over the course of 2-4 years Findings are used to calculate the GM and STV = microbial water quality profile After initial survey, annual survey of 5 samples per year Added to most recent 15 samples Creates a rolling dataset of 20 samples to confirm quality by recalculating GM and STV 62

63 FSMA AGRICULTURAL WATER TESTING REQUIREMENTS Untreated ground water (wells): when it is directly applied to growing produce (e.g. irrigation, fertigation, foliar applications) Initial survey, minimum of 4 samples, as close as practical to harvest, during the growing season or over 1 year Findings are used to calculate the GM and STV = microbial water quality profile After initial survey, annual survey of 1 sample per year Added to most recent 3 samples Creates a rolling dataset of 4 samples to confirm quality by recalculating GM and STV 63

64 FSMA AGRICULTURAL WATER TESTING REQUIREMENTS Untreated ground water (wells): when it is used for purposes for which no detectable E. coli is allowed (e.g. washing hands, cleaning equipment) Initial survey, minimum of 4 samples during the growing season or over 1 year If the 4 samples meet the no detectable generic E. coli criterion, testing can be done once per year thereafter If a test fail, resume testing 4 times per growing season until all have no detectable generic E. Coli 64

65 Credit Western Growers Association

66 FSMA AGRICULTURAL WATER TESTING REQUIREMENTS Public Water Systems: There is no requirement to test agricultural water that is received from public water systems The FDA is exploring the development of an online tool that farms can use to input their water sample data and calculate these values 66

67 SECTION FOUR: WORKER HEALTH & HYGIENE

68 SECTION FOUR: WORKER HEALTH & HYGIENE Hygienic practices can be taken for granted Important to establish policies and procedures for workers (GAP manual) Provide training for workers quarterly 68

69 SECTION FOUR: WORKER HEALTH & HYGIENE Hand Washing Potable water is available to all employees to drink and wash hands Employees must wash hands with soap and water at the beginning of the workday, after using the toilet, after eating, and after breaks Water testing records must be available (district water?) 69

70 SECTION FOUR: WORKER HEALTH & HYGIENE Restrooms Employees must use a proper restroom facility every time NO EXCEPTIONS Restroom facility doesn t necessarily have to be located on the grove (see current Cal- OSHA requirements) 70

71 EXISTING CAL-OSHA REQUIREMENTS

72 SECTION FOUR: WORKER HEALTH & HYGIENE Illness Employees must report incidences of illness or bleeding Ill or injured workers should be kept out of the production area First-aid kits and emergency numbers should be available 72

73 SECTION FIVE: FOOD SECURITY

74 SECTION FIVE: FOOD SECURITY Physical Security Gates are locked (where necessary) No trespassing signs Water Source Security Designed to prevent tampering (monitored) 74

75 SECTION FIVE: FOOD SECURITY Chemical Security Inventory records Chemicals kept in locked storage Employee Security Personal materials kept away from harvest operations Employees trained on food security 75

76 SECTION SIX: FOOD SAFETY AND SECURITY TRAINING

77 SECTION SIX: FOOD SAFETY AND SECURITY TRAINING Worker training New employees must be trained before they enter the grove Continued training quarterly Connection between microorganisms and food handling, importance of illness reporting Personal hygiene toilet use, hand washing (failure to use is grounds for dismissal) Supervisors should be aware of food borne illness symptoms fever, diarrhea, vomiting 77

78 SECTION SEVEN: FORMS & LOGS

79 SECTION SEVEN: FORMS & LOGS Forms & Logs Mock Recall Form NUOCA (Notice of Unusual Occurrence & Corrective Action) Form Worker Training Chemical Log Inventory Log Others 79

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81 THANK YOU.QUESTIONS? Online at: Ken Melban Food Safety shouldn t be seen as a COST of doing business it IS our business. 81