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
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
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)
15
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
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
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 [email protected]
Elizabeth A. Bihn, Ph.D.Produce Safety Alliance [email protected]
www.producesafetyalliance.cornell.edu