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Produce Food Safety and the Food Safety Modernization Act

Presented by:Scott Monroe Michael O’DonnellFood Safety Educator Extension Educator, ANRSouthwest Purdue Ag Center Delaware County

Purdue University is an Equal Opportunity/Equal Access Institution

Produce Food SafetyWhat have you heard???

Produce Food SafetyWhy is this an issue???

Fruits and Vegetables are Good For You!“Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases.”

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://www.cdc.gov/foodborneburden/attribution-image.html#foodborne-illnesses

Produce Food Safety•We're eating more fresh produce •New packaging methods with less room for error•New microbes associated with produce•Distribution is very wide in many cases•More people with suppressed immune systems•Better detection, reporting

Why the Increase in Produce-Related Illness?

Photos: J. Ellett

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The Biggest Challenge With Fresh Produce -

NO KILL STEP!!!

Cooked vs. Raw ConsumptionPotatoes Spinach Lettuce

Winter Squash Sweet Corn CucumbersZucchini Beets RadishEggplant Kale Microgreens

TomatoesApplesBerriesGarlicHerbs

Onions

Cooked ?Both? RawMicrobial ‘kill step’ Wash step

Photos: J. Ellett

ALL growers who introduce produce into the public food supply should be concerned about food safety!

On-farm Microbial SourcesSoilPeopleWaterManureLivestockPetsWildlife

Microorganisms That Cause Foodborne Illness

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.

Three most common microbesSalmonella

E. coli O157:H7Listeria monocytogenes

24 Hours1 Cell 17 Million CellsUnder ideal growing conditions

Microbial Causes of Illness

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Pathogenic Viruses• Norovirus most common cause of foodborne illness• Hepatitis A• Others

Norovirus capsid protein cryo electron microscope image.

Source: http://www.plospathogens.org/article/info:doi/10.1371/journal.ppat.1002921 via https://secure.flickr.com/photos/ajc1/8102307987/

Hepatitis A and Norovirus Transmission • Person-to-person through oral-fecal route• Contaminated food and water • Contaminated surfaces

Washing hands is an effective way to reduce spread.

Parasites Associated with Foodborne Illness and Produce• Cryptosporidium• Cyclospora• Giardia• Entamobea• Toxoplasma• Sarcocystis• Isospora• Helminthes

• Nematodes (e.g. Ascaris lumbricoides) and Plathelminthese (Fasciola hepatica)

Purdue University is an Equal Opportunity/Equal Access institution.

Produce associated with illness caused by Cyclospora. USDA.

Washing SafeE. coli on lettuce

Salmonella on muskmelon

Photo credits: E. Maynard, Peter Cooke, Stephen Ausmus, Scimat Science Photo Library, Institute of Food Technologists

It will Take a Farm to Fork ApproachFarm Packing facility

Transport Cooling/StorageDistribution

Repacking

TransportRetail

Direct Market

Home/Restaurant

Fork

Good Agricultural PracticesGAPs 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

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Good Agricultural PracticesGAPs focus on four main areas of production

WaterWasteWildlifeWorkers

Good Agricultural PracticesCertification ProcessFarm Self Assessment

Written Farm Food Safety Plan

Third Party AuditCertification

Plan Implementation

GAPs Awareness and Training

Your GAPs or Mine?

Various GAPs guidelines are in use –similar but not identical•USDA GAPs/GHPs•Harmonized GAPs

•Global Food Safety Initiative•GlobalGAP•PrimusGFS

Benefits of On-Farm Food Safety PlanningPublic health

Longer shelf-lifeHigher quality produce

Due diligenceReduce liability risk

Industry StandardsFSMA

Federal Government (FDA)Indiana State Health Department (ISDH)

County Health DepartmentsFarmers’ Market Rules

Regulation of on-farm food safetyJanuary 2011 - Signed into LawNovember 2015 - Final Produce

Rule PublishedJanuary 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 FDAPreventive 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 (proposed)Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (proposed)

FSMA Produce Rule –Am I Covered???

FSMA Produce Ruledefinition of “farm”

• Farms are not required to register as a food facility merely because it packs or holds 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!

FSMA Produce Rule – Am I Covered???

Farms or farm mixed-type facilities with an average annual monetary value of producesales of $25,000 or less are not covered.

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AsparagusBeans BlackGreat NorthernKidneyLimaNavyPintoBeets Garden (roots and tops)SugarCashewsSour CherriesChickpeasCocoa Beans

Coffee BeansCollardsSweet CornCranberriesDatesDill SeedsWeedEggplantsFigsHorseradishHazelnutsLentilsOkraPeanuts

PecansPeppermintPotatoesPumpkinsWinter SquashSweet PotatoesWater Chestnuts

Commodities Rarely Consumed Raw

Food GrainsBarley AmaranthCorn QuinoaDent BuckwheatFlint OilseedsSorghum CottonOats FlaxRice RapeRye SoyWheat Sunflower

Processing crops receive a qualified exemption if:A. They receive commercial processing that adequately reduces the presence of microorganisms of public health significance.

B. Accompanying documents must 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.

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What about Food Hubs, Produce Auctions, and CSA’s???

FSMA Produce Rule

If I’m exempt,does this really matter???

ExemptionsRemember!!!

While individuals may be exempt from regulations, one is NEVER

exempt from liability!

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 yearsIn addition to compliance times, all will receive an additional two years to comply with water testing requirements.

Compliance Timeline

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Produce Rule Water StandardsSurface water applied directly to produce during growing

20 samples within two years to establish a baseline5 samples per year thereafter

Underground water applied directly to produce during growing4 samples in the first year1 sample thereafter

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 RequirementOne person from each covered farm must complete training in the APPROVED GAPs curriculum.The approved curriculum is the Produce Safety Alliance CurriculumThe training and registrations will be managed by the Association of Food and Drug Officials (AFDO)

2013 2013

2013 2013

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2013 2013

2013

Food Safety Activities and Programming from Purdue ExtensionProduce Safety Alliance (PSA) curriculum team

8 individuals certified as trainers in approved curriculumTeam is currently seeking “lead trainer” certification.Training sponsored by NC SARE

Produce Food Safety for Direct Marketers2 ½ hour program for direct marketers.Will be available in March for use in countiesWill also be presented statewide via WebEx or other distance technologyProgram supported by USDA Specialty Crops Block Grant through ISDAProduce Food Safety Website

Developed through USDA Specialty Crops Block Grant through ISDAIncludes GAPs resources, blog, and event calendarhttps://ag.purdue.edu/hla/foodsafetyFood Safety Plan Writing Series4 session series delivered over WebExSupported by USDA Specialty Crops Block Grant through ISDA

Food Safety Activities and Programming (con’t)Continue work with Indiana Melon Industry

Mock AuditingProvide mock audits for vegetable growers in advance of 3rd party auditsProvide unannounced audits for Eastern Cantaloupe Growers

Staff Development ProgramsMock Audit Program for Educators – in developmentGAPs training program for educators conducted December 2015

Extension Food Safety Personnel

Scott MonroeFood Safety EducatorAmanda DeeringClinical Assistant ProfessorFresh Produce Food Safety

Amanda’s Picture Here

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Amanda DeeringClinical Assistant ProfessorDepartment of Food ScienceEmail: adeering@purdue.eduPhone: 765-494-0512

Scott MonroeFood Safety Educator

Purdue Extension

Southwest Purdue Agricultural Center4369 N. Purdue Rd.

Vincennes, IN 47591(812)886-0198 (Office)(765)427-9910 (Cell)jsmonroe@purdue.edu

https://ag.purdue.edu/hla/foodsafety

Questions???