Pecan Production and the Food Safety Modernization Act (FSMA)

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1 Pecan Production and the Food Safety Modernization Act (FSMA) William McGlynn Department of Horticulture and Landscape Architecture / Robert M. Kerr Food and Agricultural Products Center

2 What s the risk? Nuts have traditionally been assumed to be a low food safety risk. But Outbreaks have led many buyers / brokers to consider requiring producers to have a food safety plan Retailers increasingly require processors to have a food safety plan

3 What do we mean by food safety? Any food safety plan is fundamentally about minimizing hazards in food products.

4 How do we define a hazard? A hazard is anything that introduces a risk of harm to a consumer. Three main types of hazards in foods are: Chemical Physical Biological

5 Biological Hazards Biological hazards include bacteria, viruses, fungi, and parasites. The main organisms of concern in pecans are bacteria, especially E. coli O157:H7 and Salmonella.

6 Methods of contamination Contamination of pecans can occur before or after harvest by contact with: Contaminated water. Contaminated soil. Direct contact with animal manure. Contaminated equipment or facilities. Contaminated animals (including humans).

7 Elements of a Food Safety Plan GAPs (Good Agricultural Practices). Minimizing risks in the orchard. GHPs (Good Handling Practices). Minimizing risks after harvest.

8 FSMA UPDATE

9 What is the Food Safety Modernization Act (FSMA)? Five Proposed Rules: Produce Safety Standards - Published Jan. 2013, Modified Nov (applies to non-exempt pecan growers) Preventive Controls for Human Food - Published Jan (applies to non-exempt pecan shellers) Foreign Supplier Verification Program Preventive Controls for Animal Food Accredited Third Party Certification

10 PREVENTIVE CONTROLS FOR HUMAN FOOD

11 When do I become a processor? Anything that alters the natural state of an agricultural product is usually considered processing This excludes any handling that is a normal part of harvest and packing. In Oklahoma, for pecans processing basically means cracking and shelling. Note: FDA does not consider shelling your own nuts to be processing.

12 What does it mean if I m a processor Processors must comply with additional regulations, including: Facility registration Facility inspection / minimum requirements Purchase required licensing Product processing / handling requirements Product packaging / labeling requirements Written food safety plan per FSMA unless exempt.

13 When is a label required for pecans? Custom cracked pecans require a special label in Oklahoma. Pecans pre-packaged for retail sale require a complete food product label. Pecans sold out of bulk bins and then packaged for buyers do not require labeling unless package bears the name or address of the seller.

14 What is required on a food label? A standard food label has up to seven required pieces of information: Statement of Identity. Declaration of net weight, volume, or contents. Ingredients List. Allergen Statements. Name and Address. Nutrition Facts. Warning or safe Handling Statements. Country of Origin.

15 Country of origin labeling: Raw Commodities Raw pecans, shelled or unshelled, are required to bear country of origin labeling whether they are domestic or international in origin. Applies to pre-packaged or bulk pecans. Pre-packaged raw pecans must have country of origin information somewhere on the package. No specific labeling schemes are mandated for bulk items. May be a placard, sign, etc.

16 Basic Exemptions from FSMA preventive controls standard for pecan shellers Very small businesses that are engaged in low-risk processing or low-risk on-farm handling of raw agricultural commodities. Very small business is defined as annual food sales of less than $1,000,000 Shelling of tree nuts is defined as a low-risk activity.

17 Basic FSMA requirements for shellers who are not exempt Must have written food safety plan that incorporates basic components of a HACCP plan. May include general requirements for product / environmental testing.

18 PRODUCE SAFETY STANDARD

19 FSMA Produce Safety Standard covers Produce Produce is defined as fruits and vegetables Produce includes mushrooms, sprouts, herbs and tree nuts Produce does not include grains There are some limitations on the type of produce that is covered

20 Basic exemptions from FSMA produce safety rules Produce for personal consumption Produce intended for commercial processing with a kill step e.g. canning; grower will need to keep sales records. Produce typically not consumed raw (FDA will compile a list) e.g. potatoes Produce that is not defined as a raw agricultural commodity (RAC) Processed products, e.g. fresh-cut produce.

21 As a pecan grower you are exempt if: Your farm has a 3-year average of < $25k in annual produce sales. Your farm has a 3-year average of < $500k in annual produce sales, and a majority of the food (by value) is sold directly to qualified end-users Qualified End-User means: the consumer of the food ( consumer is not a business) or a restaurant or retail food establishment that is located: in the same State as the farm that produced the food; or not more than 275 miles from the farm that produced the food.

22 What do the proposed FSMA produce standards cover? Five key areas that focus on commonly identified routes of microbial contamination of produce: Agricultural water Farm worker hygiene Manure and other soil amendments Animals in production areas Equipment, tools and buildings There are also specific proposed standards for sprouts.

23 WATER

24 Agricultural water defined One type: Irrigation water that comes in direct contact with edible portions of produce. Water used in sprays that come in direct contact with edible portions of produce. Second type: Water used to wash or cool produce during/after harvest. Water used to make compost tea or other agricultural teas. Water used for hand washing or cleaning food contact surfaces, e.g. harvest totes or packing sheds.

25 FSMA testing requirements for agricultural water Treated (sanitized) water does not require routine testing. Untreated surface water: Baseline established by taking a minimum of 20 samples collected as close as practical to harvest over two growing seasons. After baseline established, five samples per growing season must be tested. Untreated ground water: Baseline established by taking a minimum of 4 samples collected as close as practical to harvest over a single growing season. After baseline established, one sample per growing season must be tested.

26 Test limits for agricultural water Irrigation and spray water: The average of all samples should not exceed 126 CFU of generic E.coli per 100 ml of water and no more than 10% of the samples tested may exceed 410 CFU of generic E.coli in 100 ml of water. Packing shed, hand washing, produce cooling/washing, and/or tea water: No detectable generic E.coli per 100 ml of water.

27 Options if water fails testing Stop using water source, treat water and re-test. Apply an interval of days between last irrigation and harvest, using a microbial die-off rate of 0.5 log (logarithmic dilution) per day. Apply an interval of days between harvest and the end of storage using appropriate microbial die-off or removal rates, provided there is adequate supporting data. Apply appropriate microbial removal rates during such activities as washing, provided there is adequate supporting data.

28 FARM WORKER HYGIENE

29 GAPs -Worker Hygiene FSMA does not provide detailed prescriptions for worker hygiene requirements. Plan would be expected to address: Teaching workers about food safety Effective training results in better employees and safer produce Providing clean restrooms with soap, water, and single-use towels and enforcing use of facilities

30 MANURE AND OTHER SOIL AMENDMENTS

31 Soil amendments Untreated manure: For now: 120-day interval between the application of manure and harvest for crops in contact with the soil and 90 days for crops not in contact with the soil. Compost: No minimum application interval if: Compost is processed to meet a microbial standard specified in the Produce Safety rule. It is applied in a manner that minimizes the potential for contact with produce during and after application.

32 Specific approved composting methods Static composting that maintains aerobic (i.e., oxygenated) conditions at a minimum of 131 F (55 C) for 3 days and is followed by adequate curing, which includes proper insulation. Turned composting that maintains aerobic conditions at a minimum of 131 F (55 C) for 15 days, with a minimum of five turnings, and is followed by adequate curing, which includes proper insulation.

33 ANIMALS IN PRODUCTION AREAS

34 GAPs Animals in Production Areas FSMA does not provide detailed prescriptions for controlling animals in the orchard. Plans would be expected to address: Any efforts at animal exclusion, especially timetable for removal of cattle: 120 days prior to harvest Any procedures for removing animal manure prior to harvest and/or identifying and excluding grossly contaminated nuts from harvest

35 EQUIPMENT, TOOLS, AND BUILDINGS

36 GAPs Equipment, Tools, and Buildings FSMA does not provide detailed prescriptions for cleaning / sanitizing equipment and facilities. Plans would be expected to address the areas described on the following slides.

37 GAPs During Harvest Develop a cleaning and maintenance schedule for equipment Assign to reliable workers Clean and sanitize storage facilities prior to harvest Clean and sanitize harvest bins and machinery daily or as practical Avoid standing in harvest bins Don t haul pecans in contaminated or dirty bins

38 GAPs In the Sorting/cleaning/packing Shed Have schedule to inspect handling/packing areas and remove any dirt, debris, or culls Have schedule to clean and sanitize: Handling/packing areas and equipment Floors Drains Waste receptacles Bathrooms

39 Document Facility Cleaning Clean and sanitize the cleaning/sorting shed, pecan storage areas, bathrooms, and any pecan handling equipment as feasible Inspect and dry-clean equipment and areas that cannot be wet-cleaned. Keep all surfaces which contact pecans as clean as possible.

40 Document pest control efforts Exclusion Baiting oyourownpes tcontrol.com/ miceglueboa rd.htm Sanitation Trapping L. LaBorde, Penn State

41 More information on specific proposed requirements: Further information on the specific proposed standards for each of the five focus areas can be found here: FSMA Facts Farmer s Toolkit Regulation/FSMA/UCM pdf

42 Documentation is Essential Any food safety practices implemented should be documented in order to prove good faith efforts and due diligence. Proper documentation is an essential part doing business in today s world. For legal purposes, if there is no record then it never happened. Even the most minimal record of cleaning procedures is better than no record at all.

43 Recordkeeping In general, records need to be kept to document that certain standards are being met, such as: Agricultural water microbial testing results Composted manure microbial testing results Worker training efforts Building and/or equipment cleaning/sanitizing program Records that are already being kept for other purposes need not be duplicated

44 Traceback establishes a chain of custody Develop lot identification scheme for loads of pecans as they are harvested. Record harvest date, and orchard of origin for each lot. Maintain records of lot numbers for all loads of pecans shipped out. Record the identity of the buyer of each lot.

45 Implementation timeline Effective Date for FSMA rules: 60 days after a final rule is published (court-mandated deadline for publishing final produce rule is October 31, 2015). Very Small Businesses (3-year average of more than $25K and less than $250K in annual produce sales) 4 years after effective date for most requirements, 6 years for some water-related testing and record-keeping requirements Small Businesses (3-year average of more than $250K and less than $500K in annual produce sales) 3 years after effective date for most requirements, 5 years for some water-related testing and record-keeping requirements All Others 2 years after effective date for most requirements, 4 years for some water-related testing and record-keeping requirements

46 PRODUCE SAFETY ALLIANCE (PSA) UPDATE

47 FDA Partner Produce Safety Alliance is a broad-based partnership charged with developing a national education and training program for farmers, packers, and regulatory personnel Housed at Cornell University s National GAPs Program and funded by the U.S. Department of Agriculture (USDA) and the FDA Has in-state partners in most states, including Oklahoma Currently working on USDA-FDA approved training curriculum Web site:

48 Draft Curriculum Title: Produce Safety On-Farm Preventive Controls Training Introduction to Preventive Controls Module 1: Worker Health, Hygiene, and Training Preventive Controls Module 2: Soil Amendment Preventive Controls Module 3: Wildlife and Domestic Animal Preventive Controls Module 4.1: Production Water Preventive Controls Module 4.2: Postharvest Water Preventive Controls Module 5: Postharvest Handling and Sanitation Preventive Controls Module 6: How to Develop a Farm Food Safety Plan

49 Sample Training Module Module 5: Postharvest Handling and Sanitation Preventive Controls Assessment of Risk Objective 1: Identify potential routes of contamination associated with harvesting, washing, packing, storage, and transportation activities and key attributes of the buildings, produce contact surfaces, employee practices, equipment, and tool design that may be pose a potential risk for contaminating produce. Good Agricultural Practices Objective 2: Identify key sanitary practices that can be implemented and maintained to reduce identified risks in produce handling areas. Objective 3: Identify the steps involved in cleaning and sanitizing food contact surfaces. Objective 4: Define key parts of a pest control program that will reduce or eliminate rodents, birds, insects, and other pests from postharvest handling areas. Objective 5: Describe key practices for transporting fresh produce that will minimize any risk of contaminating the product. Monitoring Objective 6: List key practices that need to be monitored during postharvest handling to assure sanitary practices are in place and properly completed including adherence to schedules established in the farm s SOPs. Corrective Actions Objective 7: Describe postharvest handling practices that could contribute to contamination of fresh produce and corrective actions that could be taken to reduce the risk of contaminating produce. Record Keeping Objective 8: Identify key records to document sanitary postharvest handling practices to help prevent the contamination of fresh produce.

50 Future Plans Training modules were finalized (2014) Train the trainer sessions will be conducted ( ) Grower training workshops (1-2 days) will be conducted (2016) Note: the timeline of any future plans depends a great deal on when FSMA rules are actually finalized

51 Additional online resources FAPC Developing a Food Safety Plan for Your Fresh Produce Operation: FAPC Fresh Produce Production Food Safety Plan Logs and Worksheets: Guide to Minimize Microbial Hazards for Fresh Fruits and Vegetables: Cornell University Good Agricultural Practices Publications: includes: Food Safety Begins on the Farm a grower s guide Food Safety Begins on the Farm a grower s self-assessment

52 Questions? Oklahoma State University Division of Agricultural Sciences and Natural Resources