fsma produce rule basics and purdue food safety update...november 2015 - final produce rule...
TRANSCRIPT
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
July 2016
Scott MonroeFood Safety Educator
FSMA Produce Rule Basics and Purdue Food Safety Update
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
What have you heard???
Produce Food Safety
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
CDC estimates that each year:• 48 million Americans sick from
foodborne illness• 1 in 6 people• 128,000 hospitalizations• 3,000 deaths
A significant proportion of foodborne illnesses have been
attributed to fresh produce
Source: http://www.cdc.gov/foodborneburden/
http://ww
w.cdc.gov/foodborneburden/attribution-im
age.html#foodborne-illnesses
Produce Food Safety
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•Americans buying more fresh produce•Range of consumer health (immuno-compromised)•Better detection and reporting systems•Microbes newly associated with produce
– (E. coli, Salmonella, Norovirus)
Produce Related Illnesses
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Bacteria – Single-celled organisms that live independently.Parasites – Intestinal worms or microscopic protozoa that live in a host animal or human
Viruses – Small particles that live and can only replicate in a host
Microbial Causes of Illness
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Three most common microbesSalmonella
E. coli O157:H7Listeria monocytogenes
24 Hours
1 Cell 17 Million CellsUnder ideal growing conditions
Microbial Causes of Illness
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SoilPeopleWaterManureLivestockPetsWildlife
On-Farm Microbial Sources
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E. coli on lettuce
Salmonella on muskmelon
Photo credits: E. Maynard, Peter Cooke, Stephen Ausmus, Scimat Science Photo Library, Institute of Food Technologists
Washing Safe
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Potatoes Spinach Lettuce
Winter Squash Sweet Corn Cucumbers
Zucchini Beets Radish
Eggplant Kale Microgreens
Tomatoes
Apples
Berries
Garlic
Herbs
Onions
Cooked ?Both? Raw
Microbial ‘kill step’ Wash step
Cooked vs. Raw Consumption
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Field Wash/Pack Cooling/Storage Transportation Market Consumer
Consider Farm to Fork Risks
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GAPs are the conditions, growing practices, and harvesting practices recommended for minimizing risk of microbial contamination to produce safe and wholesome fruits and vegetables.
National GAPs Programwww.gaps.cornell.edu
Using Good Agricultural Practices
Reduce on-farm Risks
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ALL growers who introduce produce into the public food supply should be concerned
about food safety!
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Regulation of on-farm food safety
Federal Government (FDA)(FSMA)
Indiana State Department of Health (ISDH)
Industry
County Health Departments
Farmers’ Market Rules
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January 2011 - Signed into Law
November 2015 - Final Produce Rule Published
January 2016 – New Produce Rule Became Law
FSMA = Food Safety Modernization Act
https://en.wikipedia.org/wiki/FDA_Food_Safety_Modernization_Act
Food Safety Modernization Act
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Seven rules in process by FDA
Preventive Controls for Human Foods (final)
Preventive Controls for Food for Animals (final)
Produce Safety (final)
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (final)
Accreditation of Third-party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (final)
Sanitary Transportation of Human and Animal Food (final)
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (final)
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FSMA Terminology
Covered – One is held to and obligated to comply with the produce rule.
Exempt – One is not obligated to comply with the produce rule.
Qualified Exemption – One is exempt from the produce rule provided that certain conditions (qualifiers) are met.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
FSMA Produce Rule –
Am I Covered???
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Am I a FARM or a FACILITY???
https://slowhappyliving.files.wordpress.com/2014/11/img_1784.jpg
Photo: J. Obermeyer
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
FarmFSMA Produce Rule
Good Agricultural Practices (GAPs)
FacilityFSMA Preventive Controls Rule
Applies if required to register with FDAChopping, grinding, and pelletizing may constitute “manufacturing”
Mixed-type FacilityAn entity that engages in both farming and processing
https://slowhappyliving.files.w
ordpress.com/2014/11/im
g_1784.jpg
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Photo: J. Obermeyer
FarmMinimal processing
DryingBalingVacuum packing
***No significant alterations
FacilityBeyond minimal processing
Pelletizing***Significant alterations
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FSMA Produce Ruledefinition of “farm”
• Farms are not required to register as a food facility merely because they pack or hold raw agricultural commodities grown on another farm under a different ownership.– Such activities are subject to the produce
safety rule rather than the preventive controls rule for human food.
– One can still pack for a neighbor!
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
FSMA Produce Rule – Am I Covered???
Farms or farm mixed-type facilities with an average annual monetary value of produce
sales of $25,000 or less are not covered.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
AsparagusBeans
BlackGreat NorthernKidneyLimaNavyPinto
BeetsGarden (roots and tops)Sugar
CashewsSour CherriesChickpeasCocoa Beans
Coffee BeansCollardsSweet CornCranberriesDatesDill
SeedsWeed
EggplantsFigsHorseradishHazelnutsLentilsOkraPeanuts
PecansPeppermintPotatoesPumpkinsWinter SquashSweet PotatoesWater Chestnuts
Commodities Rarely Consumed Raw
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Food Grains
Barley AmaranthCorn Quinoa
Dent BuckwheatFlint Oilseeds
Sorghum CottonOats FlaxRice RapeRye SoyWheat Sunflower
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Processing crops receive a qualifiedexemption if:
A. They receive commercial processing that adequately reduces the presence of microorganisms of public health significance.
B. Accompanying documents disclose that the food is “not processed adequately to reduce the presence of microorganisms of public health significance”.
C. Written assurances from the buyer are obtained annually.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
If I’m exempt,does this really matter???
FSMA Produce Rule
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Remember!!!While individuals may be exempt
from regulations,
One is NEVER exempt from liability!
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Who Sales Time to ComplyFarms >$500,000 food sales/year 2 yearsSmall Farms $500,000 - $250,000 food sales/year 3 yearsVery Small Farms $250,000 - $25,000 food sales/year 4 years
In addition to compliance times, all will receive an additional two years to comply with water testing requirements.
Compliance Timeline
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Agricultural Water “Water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces, including water used in growing activities (including irrigation water applied using direct water applicationmethods, water used for preparing crop sprays, and water used for growing sprouts) and in harvesting, packing, and holding activities (including water used for washing or cooling harvested produce and water used for preventing dehydration of covered produce).”FSMA Produce Rule – Section 112.3(c)
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Direct Water Application Method“Using agricultural water in a manner whereby the water is intended to, or is likely to, contact covered produce or food contact surfaces
during use of the water.”
ProduceDefined, in part, as the harvestable part of a crop.
FSMA Produce Rule – Section 112.3(c)
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1. Is my farm covered by the produce rule?
2. Is this particular crop covered by the produce rule?
3. Will I be applying water, as irrigation or crop sprays, to the harvestable part of the crop?
Water Questions to Ask
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Surface water applied directly to harvestable part during growing20 samples within two years to establish a baseline5 samples per year thereafter
Underground water applied directly to harvestable part during growing4 samples in the first year1 sample thereafter
Sources: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm415226.htm#water and PSA Curriculum Resources
Produce RuleAgricultural Water Standards
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Produce RuleAgricultural Water Standards
(con’t)
For all water sources:Geometric Mean <126 CFU generic E. coli /100 mlStatistical Threshold Value <410 CFU generic E. coli / 100 ml
Sources: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm415226.htm#water and PSA Curriculum Resources
Produce Rule Training Requirement
One person from each covered farm must complete training in the APPROVED GAPs curriculum.
The approved curriculum is the Produce Safety Alliance Curriculum
The training and registrations will be managed by the Association of Food and Drug Officials (AFDO)
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Purdue ExtensionFood Safety Activities and Programming
Produce Safety Alliance (PSA) curriculum team8 individuals certified as trainers in approved curriculumTeam is currently seeking “lead trainer” certification.
Training sponsored by NC SARE
Produce Food Safety for Direct Marketers2 hour program for produce direct marketers.
Presented at Small Farms Conference, statewide webinar, and various countiesPresented program in over 30 counties
Program supported by USDA Specialty Crops Block Grant through ISDA
Produce Food Safety Website Developed through USDA Specialty Crops Block Grant through ISDA
Includes GAPs resources, blog, and event calendarhttps://ag.purdue.edu/hla/foodsafety
Food Safety Plan Writing Series4 session series delivered over internet (June/July 2015)
Supported by USDA Specialty Crops Block Grant through ISDA
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Food Safety Activities and Programming (con’t)
Continue work with Cantaloupe IndustryPre-harvest workshops
ECGA unannounced audits (2014/2015)
Mock AuditingProvide mock audits for vegetable growers in advance of 3rd party audits
Staff Development Programs2 day GAPs training program for educators conducted December 2015
ResearchSummer/Fall 2015 Rapid Response Flood Project supported by Center for Produce Safety, et. al.
Testing of novel sanitizer productsWorking toward manure project in 2016/17
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Flood Research (2015)
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How soon can I replant???
What can be done to speed the process???
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Answering flood-related questions
AND
Making lemonade out of lemons
SWPAC Flood Remediation Project
Funded by the Center for Produce Safety et. al.
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Randomized Complete Block Design6 Treatments
ControlTillageCover CropBrassicaClear Plastic MulchBlack Plastic Mulch
4 Replications
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Soil Samples are periodically taken from plots
Samples are then analyzed for microbial populations
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To estimate the rate of microbial die-off after a flood event
And
To determine if treatments significantly alter microbial die-off rates
Goals of the Flood Remediation Study
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Results –Data from this work
suggested that doing nothing was best
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Extension Food Safety Personnel
Scott MonroeFood Safety Educator
Amanda DeeringClinical Assistant ProfessorFresh Produce Food Safety
Amanda’s Picture Here
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Amanda DeeringClinical Assistant Professor
Department of Food Science
Email: [email protected]: 765-494-0512
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Scott MonroeFood Safety Educator
Purdue Extension
Southwest Purdue Agricultural Center4369 N. Purdue Rd.
Vincennes, IN 47591(812)886-0198 (Office)(765)427-9910 (Cell)
[email protected]://ag.purdue.edu/hla/foodsafety
Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.
Questions???