A presentation about food safety and the potential impacts of the proposed new FSMA rules.

1. Evolution of Produce Safety &
The FDA Proposed
Produce Safety Rule
Gretchen L. Wall
Produce Safety Alliance Coordinator
Farmers Market Managers Conference
February 19, 2015

2. 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”

3. 2006:
Spinach
E. coli O157:H7
2003:
Green Onions
Hepatitis A
2004:
Roma Tomatoes
Salmonella
2005:
Frozen Raspberries
Norovirus
2008:
Cantaloupe/Peppers
Salmonella
A Number of Notable Outbreaks
2009:
Sprouts –Salmonella,
Tomatoes - Salmonella
2010:
Sprouts (2) - Salmonella
Shredded Romaine - E.coli O145
2011:
Cantaloupe - Listeria
Romaine - E.coli O157:H7
2012:
Cantaloupe - Salmonella
Lettuce mix - E.coli O157:H7
Sprouts – E.coli O26
2013:
Cucumbers- Salmonella
2014: Cilantro, Sprouts (2), caramel
apples, Frozen berry mix

4. Outbreaks by Commodity

5. Foodborne Illness Outbreaks

6. Foodborne Illnesses

7. Evolution of Produce Safety
• FDA announces rule plan in Dec 2009
– Voluntary compliance was not working
– Foodborne illnesses associated with fresh
produce still happening

8. 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

9. 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

10. 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
Oct
2015
2016-
2017
2016-
2018
2016-
2019
Public Comment End
November 22, 2013
Supplemental Comments
Due Dec. 15th
Fall
2014
2020+
Wearehere
Add an additional 2
years to each
business size for
compliance with the
water standards

11. 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

12. 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

13. In Scope Out of Scope
In Scope,
but Exempt
Produce Safety Rule
In Scope

14. 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. 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”.

16. Updated: Qualified Exemptions
• Farms may be exempt if they:
 Average gross sales of food sold in
previous 3 years is <$500,000
AND
 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

17. Produce Farms Exempt or Not Covered
by the Produce Rule
189,000
Total Produce
Farms
154,000
Exempt/
Not covered
35,000
Covered

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

19. Foodborne Illnesses Associated
with Fresh Produce Impact…
• Marketability and profitability
• Regulatory action
• Industry standards
• Buyer requirements
• Consumer confidence
and buying preferences

20. "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

21. 21
Non-Exempt Growers
FSMA Requirements

22. 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

23. 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

24. How Often Should You Test
Ground & Public Water Sources?
Source Testing Frequency
Ground
4 times during the growing season
or over the period of a year
Public Water
Source
Copy of test results or certificates
of compliance

25. Post-Harvest Water Quality Criteria
• No change from original proposed rule
• Directly contacts produce after harvest:
– No detectable generic E.coli

26. 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

27. 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

28. 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

29. 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 new
markets
• FSMA regulations

30. • 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

31. 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

32. Questions?
Gretchen L. Wall, M.S.
Produce Safety Alliance Coordinator
glw53@cornell.edu
Elizabeth A. Bihn, Ph.D.
Produce Safety Alliance Director
eab38@cornell.edu
www.producesafetyalliance.cornell.edu