Embed Size (px)
Citation preview
Passed by Congress on December 21, 2010 FDA now has a legislative mandate to require
comprehensive, prevention based controls across the food supply
Reason: 1 in 6 people in the U.S. suffer from foodborne illness each year
Transforms the FDA approach from investigating outbreaks to preventing outbreaks
2
• Twelve finalized rules, one proposed, and one “advanced notice of proposed rulemaking”
• Four rules directly affecting producers:• Produce Rule• Preventive Controls for Human Food• Preventive Controls for Animal Food• Sanitary Transportation of Human and Animal
Food
3
4
5
Final rule: November 27, 2015 Very similar to Good Agricultural Practices (GAPs) Main differences:
• GAPS: Voluntary• Produce Rule: Mandatory (maybe not if you’re exempt). More
recordkeeping and water tests Goal is the same: minimizing risk of foodborne
pathogens on food
Focus on… 4 W’sWaste
WildlifeWater
Worker
• Some growers may be excluded based on:• Commodities grown (e.g., rarely consumed raw)• Average annual produce sales
• Some growers may be exempt based on:• Processing activities that include a ‘kill step’• Average annual food sales and to ‘qualified end users’
• But really, all growers should understand and take action to reduce food safety risks on the farm
6
Almonds, apples, apricots, apriums, artichokes-globe-type, Asian pears, avocados, babacos, bananas, Belgian endive, blackberries, blueberries,
boysenberries, brazil nuts, broad beans, broccoli, Brussels sprouts, burdock, cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), cantaloupes,
carambolas, carrots, cauliflower, celeriac, celery, chayote fruit, cherries (Sweet), chestnuts, chicory (roots and tops), citrus (such as clementine,
grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniqfruit), cowpea beans, cress-garden, cucumbers, curly endive, currants,
dandelion leaves, fennel-Florence, garlic, genip, gooseberries, grapes, green beans, guavas, herbs (such as basil, chives, cilantro, oregano, and parsley), honeydew, huckleberries, Jerusalem artichokes, kale, kiwifruit, kohlrabi, kumquats, leek, lettuce, lychees, macadamia nuts, mangos, other melons
(such as Canary, Crenshaw, and Persian), mulberries, mushrooms, mustard greens, nectarines, onions, papayas, parsnips, passion fruit, peaches, pears,
peas, peas-pigeon, peppers (such as bell and hot), pine nuts, pineapples, plantains, plums, plumcots, quince, radishes, raspberries, rhubarb,
rutabagas, scallions, shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung bean), strawberries, summer squash (such as patty pan,
yellow and zucchini), sweetsop, Swiss Chard, taro, tomatoes, turmeric, turnips (roots and tops), walnuts, watercress, watermelons, and yams
7
Produce that is rarely consumed raw, specifically:
Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts
8
1. Worker Health, Hygiene, and Training2. Soil Amendments3. Wildlife, Domesticated Animals, and Land
Use4. Agricultural Water Part 1: Production Water5. Agricultural Water Part 2: Postharvest Water6. Post-harvest Handling and Sanitation
9
Worker training• Reporting
injuries/illnesses• Recordkeeping• Personal hygiene
Bathroom and handwashing facilities
Training records
10
The PSA Grower Training manual is a great resource Cornell signage and training DVD’s GAPs is very similar
11
Manure versus compost
Application intervals
Recordkeeping
12
There are currently no application intervals for raw manure outlined in the FSMA Produce Safety Rule
Untreated Soil Amendments • Generally following NOP 120 (soil contact) and 90
(no soil contact) day application to harvest rule for raw manure
• FDA is currently pursuing further research to support application intervals for raw manure
• Raw manure must not be directly applied to the harvestable portion of the crop
Treated Soil Amendments• Zero day application interval for compost treated by
a scientifically validated process
13
The Produce Safety Alliance’s Grower Training manual outlines this with great detail• What soil amendments are okay• What records you need• Application intervals• Approved soil amendment treatment protocols
14
Only pertains to covered produce grown in an open area Conducting pre-harvest risk assessment of fields
• Observation of animals• Fecal matter in field• Crop destruction
If you determine that there is a risk of contamination then have a plan in place for harvesting your crop safely
15
16
Three main impact points for produce safety risks related to production water are:
1. Production water source and quality2. Application method (irrigation)3. Timing of application
17
Testing is the only way to quantitatively evaluate the microbial quality of the water
The water quality profile can help you:• Understand the long-term quality of source
water• Understand appropriate uses for each source• Determine if corrective measures are needed
18
Each source of production water must be tested to evaluate whether its water quality profile meets the following criteria:o 126 or less colony forming units (CFU) generic E.
coli per 100 mL water geometric mean (GM)
AND
o 410 or less CFU generic E. coli per 100 mL water statistical threshold value (STV)
19
Source Testing RequirementPublic Water
SupplyCopy of test results or current certificates of
compliance
Ground Water
4 or more times during the growing season or over one year then 1 or more times each year
Surface Water
20 or more times over 2 – 4 years then 5 or more times each year
Profile samples must be representative of use and must be collected as close in time as
practicable to, but before, harvest20
Three types of corrective measures are allowed if the microbial water quality profile does not meet water quality criteria:
1. Apply a time interval for microbial die off2. Re-inspect the water system, identify problems, and
make necessary changes and confirm effectiveness3. Treat the water
21
22
Cannot eliminate every food safety risk in the field
Postharvest water has the potential to spread contamination widely
23
• Water used for the following must have no detectable generic E. coli per 100 mLsample– Direct contact with covered produce
during or after harvest– Direct contact with food contact surfaces– To make ice– For handwashing
• Untreated surface water may not be used for these purposes
24
Source Testing Requirements
Untreated Ground Water
4 or more times during the growing season or over the period of a year;1 or more tests/year after first year
Public Water Supply
Copy of test results or current certificatesof compliance
25
Every season you should be inspecting your water system• Nature of your water source (well, pond, municipal, etc.)• Extent of your control over water source• Degree of protection of each water source• Likelihood of contamination of water• Need for any maintenance/repairs• Reduce potential for contamination of covered produce with pooled
water Recordkeeping
• Records of annual inspections• Water tests• Scientific data/info you use to support your water treatment method• Water treatment monitoring results• Documents to support any microbial die-off rate used
26
This part is the toughest, and the most different from GAPs.
Online and/or downloadable geometric mean and statistical threshold value calculators http://wcfs.ucdavis.edu/• Western Center for Food Safety’s Excel spreadsheet • University of Arizona Cooperative Extension “Ag
Water App”• University of Arizona Cooperative Extension “Online
Calculator• PSA to come out with their own “by hand calculator”
27
AgroLab, Inc. 101 Clukey DriveHarrington, DE 19952Phone: 302-566-6094, Fax: 888-412-0873Email: [email protected]
Chesapeake Environmental Lab, Inc.P.O. Box 946Stevensville, MD 21666Phone: 800-300-TEST (toll free), 410-643-0800 (local), Fax: 410-643-0801 www.chesapeakeenvironmentallab.comMaryland Certified Lab #181
Enviro-chem Laboratories Inc.47 Loveton Circle Suite KSparks, Maryland 21152Phone: 410-472-1112, Fax: 410-472-1116http://www.enviro-chem.net/index.htmlMaryland Certified Lab #192
Fountain Valley Analytical Laboratory, Inc.1413 Old Taneytown RoadWestminster, MD 21158Phone: 410-848-1014, 410-876-4554, Fax: 410-848-0298Email: [email protected]://www.fval.com/Maryland Certified Lab #133
Fredericktowne Labs, Inc.3039C Ventrie CourtMyersville, MD 21773Phone: 800-332-3340 (toll-free), 301-293-3340 (local), Fax: 301-293-2366Email: [email protected]://www.fredericktownelabs.com/index.htmMaryland Certified Lab
Microbac Laboratories, Inc. 2101 Van Deman StreetBaltimore, MD 21224Phone: 410- 633-1800Email: [email protected] Certified Lab #334
28
Penn State Agricultural Analytical Services LaboratoryPenn State UniversityTower RoadUniversity Park, PA 16802 Phone: 814-863-0841, Fax: 814-863-4540Email: [email protected]://www.aasl.psu.edu/Water.html
Trace Laboratories, Inc.Wastewater and Drinking Water Sampling and Analysis5 North Park DriveHunt Valley, MD 21030 Phone: 410-584-9099 Fax: 410-584-9117 Email: [email protected]://www.tracewatertesting.com/index.htmMaryland Certified Lab
Water Testing Labs of Maryland, Inc.Several locations across the statePhone: 800-200-5323, Local phone numbers listed onlinehttp://www.wtlmd.com/Maryland Certified Lab # 104, 134, 214
29
Keep covered produce separate from non-covered produce Do not distribute drops Use cleanable or single-use food-packing and packaging
materials Tools and equipment must be:
• Cleanable and working properly and stored to prevent contamination
• Inspected regularly• Cleaned and sanitized as often as possible
Take measures to control pests Records of dates and methods of cleaning and sanitizing
30
31
Business Size Compliance Time
Very small $25,000 - $250,000 produce sales annually*
4 years
Small$250,000 - $500,000 produce sales annually*
3 years
All other farms 2 years
*Three year average;Compliance times start from final rule date: January
2016 with 2 extra years for water testing
32
• All farms that grow, harvest, or pack fresh produce intended to be eaten raw and with more than $500,000 in annual produce sales*
• Farms with less than $25,000 in annual produce sales* are NOT covered.
*Averaged over the previous three years
More than half of the average annual monetary value of the food the farm sold was directly to qualified end-users (in previous 3 years)
a) the consumer of the food (consumer does not include a business); or
b) a restaurant or retail food establishment that is located:i. In the same State or the same Indian reservation as the farm that
produced the food; orii. Not more than 275 miles from such farm
ANDThe average annual monetary value of all food the farm sold during the 3- year period preceding the applicable calendar year was less than $500,000
33
34
MDA was awarded a grant from the FDA Cooperative agreement that MDA can take
charge of Produce Rule implementation in Maryland
MDA working closely with UMD and UME USDA grant awarded to Dr. Rohan Tikekar
(UMD) and myself to supplement costs for combined Produce Rule and Preventive Controls Rule for Human Food trainings
35
February 8-11, 2017 at Baltimore County extension office, Cockeysville, MD
February 22-25, 2017 at Wye Research and Education Center, Queenstown, MD
March 8-11, 2017 at Western Maryland Research and Education Center, KeedysvilleMD
$20 for produce safety training only, $40 for PC rule training only, and $50 for both
Contact Rohan Tikekar [email protected] to register(space is limited)
36
