FDA Produce Rule 101 WSDA Produce Safety Program Jill Wisehart, MEd - - PowerPoint PPT Presentation

FDA Produce Rule 101

WSDA Produce Safety Program Jill Wisehart, MEd

Outline

• What is FSMA?
• FDA Produce Rule Background
• 5 Key Parts of FDA Produce
• Small Farm Exemptions
• WSDA Produce Safety Program/Legislative Updates
• Training

Preventive Controls for Human Food Produce Safety Rule Produce Safety Rule Preventive Controls for Animal Food Foreign Supplier Verification Programs Sanitary Transportation

• f Human and

Animal Food Accredited Third Party Certification Rule Sanitary Transportation

• f Food

Produce Safety Rule Intentional Adulteration of Food Accredited Third Party Certification Rule Preventive Controls for Human Food

FDA Focused on Prevention over Response

http://www.chicagotribune.com/business/ct-biz-bright-farms-recall-20171023-story.html

48 million sick

128,000 hospitalized

3,000 die

year

First Federal Rule for Produce Farms

1938 Federal Food, Drug, and Cosmetic Act 2015 Produce Rule

Adulterated Food - Impure, unsafe, unwholesome or

• therwise unfit for human consumption

FDA Farm Definition

• Under one management
• One general location
• Grow crops, harvest

crops and/or raise animals

• Included activities
• Pack
• Hold
• Label
• Dry/dehydrate
• Treat to reduce ripening
• A majority interest
• wned, or jointed
• wned, by primary

production farm(s) that grow, harvest and/or raise the majority of raw produce

• Harvest, pack and/or

hold raw produce

• Different location than

primary farm

Primary Production Farm Secondary Production Farm

FDA Farm Definition & Covered Activities

grow harvest pack hold

• cool
• field core
• filter
• gather
• hull
• remove stems/husks
• shell
• sift
• thresh
• trim outer leaves
• wash (intact produce)
• sort
• cull
• grade
• label
• weigh
• coat with

wax/oil/resin

• store food
• fumigate
• dry/dehydrate
• break down

pallets

• distribution

Covered Produce

• Fruits or vegetables, including mushrooms, sprouts, peanuts,

tree nuts, and herbs

• Not including food grains (ex: barley, corn, sorghum, oats, rice,

rye, wheat, amaranth, quinoa, buckwheat, oilseeds)

Excluded Produce

• Personal or on-farm consumption
• Commercial processing

[provided method and documentation as per §112.(b)(2) – (b)(6)]

• Foods rarely consumed raw (exhaustive list):

asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts

How to prevent foodborne illness?

• 1. Keep pathogens off the food
• 2. Keep pathogens from spreading
• 3. Keep pathogens from growing

https://www.researchgate.net/figure/275949688_fig6_Fig-14-Bacteria- from-the-faeces-of-wild-animals-may-contaminate-spinach-leaves-by

Produce

Tools Compost Water Animals Humans * Excluding sprouts

5 Key Parts

#1 Humans (Subpart D: Worker Health, Hygiene and Training)

Train employees in food safety practices adequate to farm duties RECORD = Training time, personnel, topics

Monitor animal activity for contact with produce. Produce contaminated

• r damaged by animals cannot be harvested and sold.

#2 Animals (Subpart I: Domestic & Wild Animals)

RECORD = Monitoring and corrective actions

Recommend time interval between raw manure and animal byproduct application and harvest.

#3 Compost (Subpart F: Biological Soil Amendments)

RECORD = Compost application type, timing and method

Agricultural Water: used in covered activities on covered produce that is intended to or likely to contact covered produce or food contact surfaces 1. Inspect all agricultural water sources at least once annually

• 2. Test production and post-harvest agricultural water for generic E.coli

#4 Water (Subpart E: Agricultural Water)

RECORD = Water Monitoring; Test Results; Corrective Actions

Ag Water Standards

Geometric Mean (GM): ≤ 126 CFU generic E. coli / 100 mL H2O Standard Deviation (STV): ≤ 410 CFU generic E. coli / 100 mL H2O Zero detectable E. coli in 100 mL

• f agricultural water
• Produce washing
• Food contact surfaces
• Cooling/Hydrating
• Hand washing
• Treated agricultural tea
• Irrigating sprouts

Production Water Post-Harvest Water

Standard

• Irrigation
• Fertigation
• Crop sprays
• Cooling
• Frost protection
• Dust abatement

Clean and sanitize equipment adequate for use.

#5 Tools (Subpart L: Equipment Tools, Buildings & Sanitation)

RECORD = Cleaning and sanitation schedules

Is your farm “covered” by FSMA?

Small Farm Exemptions

≤ $25,000 average annual produce sales (in previous 3 years) Exempt Qualified Exempt < $500,000 average annual food sales (in previous 3 years) and A majority (by value) sold directly to “qualified end-users” [112.3(c)]:  Consumer (not a business)  Restaurant or retail food establishment:

• in the same state or reservation, or
• within 275 miles of farm

Qualified Exempt Requirements

1)

Records claiming status (EFFECTIVE NOW)

• Sales records including farm info, product, date and buyer
• Annual review with signature and date from farm manager

2) Food packaging label (by 2020)

• Farm name
• Complete business address where food grown
• Displayed “prominently and conspicuously” on label, poster, sign, placard,

documents or electronic invoice

FDA’s Compliance Timeline

Business Size

(based on annual produce sales)

Sprouts Compliance Dates Most Produce Compliance Dates Water Compliance Dates Qualified Exemption Labeling Compliance Date Qualified Exemption Record Retention Compliance Date All other businesses (>$500K)

1/26/17 1/26/18 1/26/22 1/1/20 1/26/16

Small businesses (>$250-500K)

1/26/18 1/28/19 1/26/23

Very small businesses (>$25-250K)

1/26/19 1/27/20 1/26/24

Update: Agricultural Water Requirements

• Update as of Sept. 2017:

– FDA extending compliance dates 2-4 years (Jan. 2022, Jan. 2024)- see handout – 8 additional water testing methods from EPA- see handout

WSDA Produce Safety Program

Mission Statement: Implement the Produce Safety Program within the 5-yr FDA grant period in order to ensure the safety and economic vitality of Washington produce.

 5-year FDA grant to implement Produce Safety Rule in WA.  4 FTEs; 3 based in Olympia, 1 based in Seattle  Self-assessment & Strategic Planning

Timeline: 2017 & Beyond

• Now - May 2018: WSDA seeking state authority to

conduct inspections

• January – December 2018: WSDA conducting “On Farm

Readiness Reviews”

• Summer - Fall 2018: WSDA hiring and training produce

inspectors

• January 2019: official start of FDA-required inspections
• March - June 2019: joint WSDA/FDA produce

inspections

Produce Rule Training Requirement

Next PSA Grower Workshop: Dec. 9th at Viva Farms in Mt. Vernon

At least one supervisor or responsible party for your farm must successfully complete a food safety training recognized as adequate by the FDA

PSA: Grower & Train-the-Trainer Courses

Grower Course:

– Taught by Produce Safety Alliance certified trainers – ~7 hours of instruction time covering all parts of the PSR – Attendees receive certificate to verify required course completion – Attendance cost varies

Train-the-Trainer Course:

– Taught by Produce Safety Alliance certified lead trainers – 2-day course that includes Grower curriculum, principles of adult education, developing partnerships, trainer expectations, etc. – Attendees receive certificate to verify required course completion as well as option to apply for Lead Trainer status – Attendance cost varies

On Farm Readiness Reviews (OFRR)

Group Discussion: Biggest vs Smallest Concerns

• A. Training Workers
• B. Keeping Animals Off Produce
• C. Water Source & Quality
• D. Compost Type & Application
• E. Equipment Cleaning & Sanitation
• F. Harvest & Post-Harvest Practices

Questions?

Jill Wisehart, MEd

Management Analyst jwisehart@agr.wa.gov (360) 902 - 1930

Resources

• PSA Records:

https://producesafetyalliance.cornell.edu/sites/producesafetyalliance. cornell.edu/files/shared/documents/Records-Required-by-the-FSMA- PSR.pdf

• Water Testing Method Alternatives:

https://www.fda.gov/downloads/Food/FoodScienceResearch/Laborat

• ryMethods/UCM575255.pdf
• Coverage & Exemption Flowchart:

https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/U CM472499.pdf

• Compliance Dates: https://producesafetyalliance.cornell.edu/food-

safety-modernization-act/produce-safety-rule-compliance-dates- timeline (chart version)