Good Agricultural Practices (GAPs) & FSMA Produce Safety Rule Overview

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1 Good Agricultural Practices (GAPs) & FSMA Produce Safety Rule Overview Achyut Adhikari Assistant Professor & Extension Food Safety Specialist School of Nutrition and Food Science Louisiana State University AgCenter

2 Before we start GAPs/GHPs workshops: Two series workshops Series I: This training is intended to improve your understanding of GAPs and to guide assessment of risks and implementation of practices to reduce risks on fresh produce farms. Series II: Workshops on implementation of GAPs and GHPs will be held on dates to be announced later this year.

3 Before we start People who attend both series I & II workshops will be eligible for a program that will reimburse 75 percent of the fees charged for USDA GAPs certification. Taking this training will not result in your farm being "GAPs Certified". GAPs certification is done by a third party (e.g. USDA, Primus, Global GAP) and involves the successful completion of an onfarm audit.

4 Outline Microbial food safety Food safety regulations update Good Agricultural Practices (GAPs)/Good Handling Practices (GHPs)

5 Why Food Safety? Foodborne illness is a significant burden About 48 million (1 in 6 Americans) get sick each year 128,000 are hospitalized 3,000 die Immune-compromised individuals more susceptible Infants and children, pregnant women, older individuals, those on chemotherapy

6 Food Microbiology In foods, microorganisms can be Beneficial Cause spoilage Cause disease (pathogens)

7 Contaminated food that can cause illness are difficult to identify

8 Growth of Microorganisms At optimum growth conditions most of them double at every 20 minutes

9 Foodborne Illness Infection Intoxication Toxin mediated infection

10 Contribution of different food categories to estimated domestically acquired illness and deaths,

11 Outbreaks and illness due to food commodities,

12 Most Frequent Causes of Foodborne Illness in the United States Pathogen Estimated number of illnesses % 5,461, ,027, , , ,148 3 Subtotal 91 (CDC, 2011)

13 Most Frequent Causes of Foodborne Illness in the United States Pathogen Estimated number of illnesses % Norovirus 5,461, Salmonella, nontyphoidal 1,027, Clostridium perfringens 965, Campylobacter spp. 845,024 9 Staphylococcus aureus 241,148 3 Subtotal 91 (CDC, 2011)

14 Foodborne Pathogens Salmonella Diarrhea, fever and abdominal cramp Listeria monocytogenes percent of the clinical infections resulting in death (Ramaswamy et al. 2007) Meningitis, pneumonia, abortion etc. E. coli O157:H7 Low infectious dose: cells Hemolytic-uremic syndrome

15 Natural Habitat for Pathogens of Concern Norovirus Infected humans Salmonella GI tract of animals and human Listeria monocytogenes GI tract of animals and human E. coli O157:H7 GI tract of animals and human Particularly ruminant animals

16 Microbial quality standard based on generic E. coli level Pathogens are present at low levels in the environment Indicator Organisms Same source as of pathogens Indicate the risk of pathogen presence Examples: Total coliforms, Fecal coliforms, Generic E. coli etc.

17 Indicator Organisms Total Coliform Fecal Coliform Generic E. coli E. Coli O157:H7

18 Why are we so concerned about on-farm food safety?

19 Control of Pathogenic Organisms prevent contamination of foods (keep it out) destroy foodborne disease agents (kill it) prevent multiplication of foodborne disease agents (control it)

20 Challenges associated with fresh produce and nuts Once introduced, pathogens are difficult to remove Often Uncooked: eaten raw Associated pathogens have a low infectious dose Internalization: a topic of discussion

21 blog.etq.com

22 FSMA proposed rules Six major preventive control rules: Standards for produce safety Preventive controls for human food Foreign supplier verification program Preventive controls for animal food Food defense rule to address intentional adulteration of food Sanitary transportation of human and animal food

23 Background FDA issued proposed rule on Jan. 16, 2013 Standards for growing, harvesting, packing, and holding of produce Stakeholder Input 3 Public meetings; various outreach efforts Comment period closed on Nov. 22, 2013 Over 15,000 comments received Limited re-opening of docket Comment period closed on Dec. 15, 2014 Over 2,450 comments received Describe FDA s current thinking on certain specific issues FDA

24 Standards for Produce Safety Focus on 5 identified routes of microbial contamination 1. Agricultural water 2. Biological soil amendments of animal origin 3. Worker health and hygiene 4. Equipment, tools, buildings and sanitation 5. Domesticated and wild animals Other requirements Sprouts Growing, harvesting, packing and holding FDA

25 Issues Addressed in Supplemental Proposed Rule Use of raw manure Agricultural water Microbial quality standard for irrigation water and crop protection sprays Frequency of testing Impact on wildlife and animal habitat Withdrawal of qualified exemption Farms excluded from coverage Packing or holding of own others covered produce

26 Agricultural Water Water used in the growing, harvesting, packing of produce where the water is reasonably likely to contact the produce

27 Agricultural water during high risk activities Must test water to ensure there is no detectable generic E. coli woodswine7.blogspot.com

28 Key Revisions: Agricultural Water 2012 Environmental Protection Agency recreational water quality criteria A cultivable generic E. coli level of a Geometrical Mean (GM) of 126 CFU per 100 ml of water and an Statistical Threshold Value (STV) (approximately 90%) of 410 CFU per 100 ml of water

29 Key Revisions: Agricultural Water For water that does not meet microbial standard, alternate options are provided to account for microbial die-off: Apply time interval in days between last irrigation and harvest using 0.5 log/day reduction rate

30 Key Revisions: Agricultural Water 3) Provide an allowance for microbial reduction between irrigation and end of storage. This includes appropriate microbial removal rates during activities such as commercial washing to achieve a (calculated) log reduction of the GM or STV of generic E. coli level below as proposed (must be supported by scientific data and information)

31 Biological soil amendments Must be handled, transported and stored to minimize contamination with: Crops Food contact surfaces Water source/distribution system USDA s National Organic Program standards, which call for a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with soil.

32 Equipment Tools Building and Sanitation Store and maintain equipment and tools properly Buildings (toilets, plumbing, pest control, construction/design)

33 Worker Health and Hygiene Personnel qualification and training Health and personnel hygiene

34 Domesticated and Wild Animals Waiting period between grazing and harvesting Probable animal intrusions

35 No product testing requirement

36 Covered farms Farms that grow, harvest, pack or hold most produce in raw or natural state Farms with annual produce sales of > $25,000 per year

37 Who would not be covered by the produce rule? Produce for personal or on-farm consumption Produce not a Raw Agricultural Commodity, Certain produce rarely consumed raw, e.g. potatoes Produce that will receive commercial processing

38 History 1997 President Clinton s Food Safety Initiative Identified produce as an area of concern Directed to issue guidance on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) for fruits and vegetables

39 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables Published on 1998 Issued by USDA and FDA Not a regulation. but Guidance Buyers are the enforcement branch

40 GAPs/GHPs what is it? Good Agricultural Practices (GAPs) and Good Handling Practices (GHPs) Not a federal regulation but a market driven certification program GAPs cover on farm production and harvesting practices, and GHPs cover packing, storage and distribution of crops

41 USDA GAP & GHP audits verify adherence to the recommendations made in the U.S. Food and Drug Administration s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables and industry recognized food safety practices. What does it focus on? Prevention of microbial food safety hazards When? Growing Packing/Holding Transportation

42 On-farm Route of Pathogen Contamination The 4 W s Water Waste Wildlife Workers

43 Other factors Equipment, tools and building sanitation Growing, harvesting, handling and packing chronicle.augusta.com kickofjoy.com

44 Every segment of the food chain must address food safety to reduce risk of pathogen contamination You cannot eliminate the risk of pathogen contamination, but you can minimize it and ends on the plate

45 Thank you!! Any questions??