Evolution of Produce Safety & The FDA Proposed

Produce Safety Rule

Gretchen L. WallProduce Safety Alliance Coordinator

Farmers Market Managers ConferenceFebruary 19, 2015

Evolution of Produce Safety• 1998 FDA Guide to Minimize Microbial Food

Safety Hazards in Fresh Fruits and Vegetables

– CDC shows fresh produce is making people sick

– Recommendations for voluntary compliance

• Winter 1999-2000 farmers start to get letters from buyers asking about food safety practices

– Food safety practices become industry driven

– Inconsistent requests, no premium for practices and other issues make implementation “optional”

2006:SpinachE. coli O157:H7

2003:Green Onions Hepatitis A

2004:Roma TomatoesSalmonella

2005:Frozen RaspberriesNorovirus

2008:Cantaloupe/PeppersSalmonella

A Number of Notable Outbreaks2009:Sprouts –Salmonella, Tomatoes - Salmonella

2010:Sprouts (2) - Salmonella Shredded Romaine - E.coli O145

2011:Cantaloupe - ListeriaRomaine - E.coli O157:H7

2012:Cantaloupe - SalmonellaLettuce mix - E.coli O157:H7Sprouts – E.coli O26

2013:Cucumbers- Salmonella

2014: Cilantro, Sprouts (2), caramel apples, Frozen berry mix

Outbreaks by Commodity

Foodborne Illness Outbreaks

Foodborne Illnesses

Evolution of Produce Safety

• FDA announces rule plan in Dec 2009

– Voluntary compliance was not working

– Foodborne illnesses associated with fresh produce still happening

FDA Food Safety Modernization Act & Proposed Produce Safety Rule

• Draft released 1-4-13• First comment period closed 11-22-13• Supplemental released 9-29-14• Proposed Produce Rule:

Focus on the growing, harvesting, and post-harvest handling of produce

• Focus is on the prevention, not detection of issues

Proposed Produce Safety Rule Supplemental

• Over 15,000 comment received during the first open comment period

• Key provisions reopened for comment on September 29, 2014, including: Water quality standards Raw manure and compost Mixed use facilities Procedures for withdrawing the qualified

exemption for certain farms

• Comments due by December 15, 2014 Docket Folder FDA-2011-N-0921

FSMA Time Frame…in Theory!

Draft Rule Released

Final rule published in Federal Register

Large growers (>$500K) comply -

2 years

Small growers ($250-500K)

comply - 3 years

Very small growers ($25-250K) comply -

4 years

Jan 2013

Nov 2013

Oct2015

2016-2017

2016-2018

2016-2019

Public Comment EndNovember 22, 2013

Supplemental Comments Due Dec. 15th

Fall 2014

2020+

We

are

he

re

Add an additional 2 years to each

business size for compliance with the

water standards

Produce Rule: Areas of Focus

–Agricultural water

–Biological soil amendments

–Domesticated and wild animals

–Personnel qualifications, training, and health and hygiene

– Equipment, tools, buildings, and sanitation

A Note About What’s NOT Required

• Participation in third party audits e.g. USDA GAPs, Primus, GlobalGAP, etc.

Unless the buyer requires, then the grower must participate if they want to supply

• A written farm food safety plan (for farmers)• A good idea regardless, gets growers moving in

the right direction

• Seems to be the way small market venues are moving currently

In Scope Out of Scope

In Scope, but Exempt

Produce Safety RuleIn Scope

Updated: Proposed Exemptions

1. Produce rarely consumed raw

2. Produce destined for ‘kill-step’ processing

3. Produce for personal/on-farm consumption

4. Make <$25,000 in all food sales (3 year average)

4. Make <$25,000 in all produce sales(3 year average)

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FSMA Exempt Farmers & Labeling Requirements

– “Must prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business, or, in the case of Internet sales, in an electronic notice”.

Updated: Qualified Exemptions

• Farms may be exempt if they:

Average gross sales of food sold in previous 3 years is <$500,000AND

Sell to qualified end users either*:

A. Direct to consumer

B. Restaurant, retail food establishment in same state or within 275 miles of where produce was grown

Produce Farms Exempt or Not Covered by the Produce Rule

189,000Total Produce

Farms

154,000Exempt/

Not covered

35,000Covered

Growers may be exempt from the regulation, but not from the market place.

Foodborne Illnesses Associated with Fresh Produce Impact…

• Marketability and profitability

• Regulatory action

• Industry standards

• Buyer requirements

• Consumer confidence and buying preferences

"It's a good thing I had a bag of Marijuana instead of a bag of spinach.

I'd be dead by now."

- Willie Nelson

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Non-Exempt GrowersFSMA Requirements

Updated: Agricultural Water Standards & Testing Requirements

• Originally proposed for surface water:

– <235 CFU/100ml generic E.coli single sample or a rolling geometric mean <126 CFU

– Test once every 7 days during growing season

• Supplemental for surface water:

– <126 CFU/MPN generic E. coli per 100 ml, geometric mean (n=5) AND a statistical threshold value of <410 CFU/MPN generic E. coli per 100 ml

– Testing dependent on water quality profile

How Often Should You Test Surface Water?

Source:Surface Water

Testing Frequency

Baseline 20 samples over 2 years

Annually Minimum 5 samples per year

If annual test does not support water

quality profile

Current annual survey, combined with new data for a

total of 20 samples

How Often Should You Test Ground & Public Water Sources?

Source Testing Frequency

Ground4 times during the growing season

or over the period of a year

Public Water Source

Copy of test results or certificatesof compliance

Post-Harvest Water Quality Criteria

• No change from original proposed rule

• Directly contacts produce after harvest:

– No detectable generic E.coli

Updated: Soil Amendments

• FDA has proposed deferring action on the use of raw soil amendments and has proposed to remove the 9 month application interval

• FDA will be working with USDA ARS to facilitate research, risk assessment, and incentivizing composting practices

Updated: Definition of a ‘Farm’ and ‘Farm Activities’

• Why does the definition of a ‘farm’ matter?

On-farm packing and holding of produce are not subject to PC Rule unless they meet the definition of processing or manufacturing

Farms that pack or hold produce from another farm are not subject to the PC Rule

A farm would no longer need to register as a food facility merely because it packs or holds raw agricultural commodities grown on another farm under different ownership

NY GAPs Training Opportunities

Visit gaps.cornell.edu

• February 26-27 in Kingston, NY

• March 9-10 in Millbrook, NY

• March 10-11, 2015 in Canton, NY

• March 24-25, 2015 in Plattsburgh, NY

• Trainings that already happened:

– Middletown, NY December 2014

– Geneva, NY January 2015

– Canajoharie, NY February 2015

– Holtsville, NY February 2015

Top 3 Reasons for GAPs Implementation

1. Personal commitment to food safety

2. Maintain market access

3. Reduce liability

Other reasons:

• To gain access to newmarkets

• FSMA regulations

• Cooperative agreement between Cornell University, FDA, and USDA

• Established in 2010

• Focused on outreach and education to assist growers with meeting regulatory and market food safety requirements

Produce Safety Alliance

The PSA Website producesafetyalliance.cornell.edu

• Provides a way for people to join and be involved with the PSA

• All progress, updates, and outcomes are available for review

• Easy way to reach us!

• Continues to evolve and improve

Questions?

Gretchen L. Wall, M.S. Produce Safety Alliance Coordinatorglw53@cornell.edu

Elizabeth A. Bihn, Ph.D.Produce Safety Alliance Directoreab38@cornell.edu

www.producesafetyalliance.cornell.edu