Oregon s Produce Industries and FSMA

Transcription

1 Oregon s Produce Industries and FSMA January 12 and 13, 2016 Stephanie Page, Oregon Department of Agriculture Lauren Gwin, Oregon State University A big thank you to Dr. Joy Waite-Cusic at OSU for the irrigation water sample slides!

2 Key messages Major final rules are done Produce rule will affect many produce growers Some produce growers will be exempt Some packers & on-farm processors only subject to produce rule Some packers & on-farm processors subject to PC rule Still a lot of details to be worked out Need your input on ODA role

3 FSMA: a short history Federal law passed by Congress FSMA passed in 2011 FDA proposed rules in 2013 Extensive comment and stakeholder involvement FDA tour of the PNW 5 final rules adopted Public meeting in Portland in December 2015

4 Final rules adopted Produce safety rule Human food preventive controls rule Animal food preventive controls rule Imported food rule Third party certification

5 2 more final rules in 2016 Intentional adulteration Transportation

6 Produce rule Agricultural water Biological soil amendments of animal origin Worker health and hygiene Equipment, tools, buildings and sanitation Domesticated and wild animals Growing, harvesting, packing and holding activities Sprouts requirements

7 Produce rule: exemptions Produce for personal or on-farm consumption Produce not a raw agricultural commodity Certain specified produce rarely consumed raw Farms with produce sales of $25,000 per year Produce that will undergo a kill step Farms with less than $500K in annual sales AND majority of food sales to qualified end users

8 Produce rule: key points Applies to farms including: Primary activities farm Secondary activities farm Irrigation rule more flexible Will also require more data/calculations

9 Agricultural water Inspection of water system once per year Keep records of this inspection To extent under your control: Prevent system from being a source of contamination Maintain the system Reduce potential for contamination Standards for treatment of water Post-harvest water must have no detectable E. coli

10 Irrigation water Initial survey for surface water: Minimum of 20 samples As close to harvest as possible Over a minimum of 2 years Over a maximum of 4 years Groundwater: Minimum of 4 samples during growing season or over 1 year This profile must be updated every year after initial survey: 5 samples per year for surface water 1 sample per year for groundwater

11 Irrigation water standards Statistical threshold value 410 Geometric mean 126 If your water does not meet these standards, either: Stop irrigating Treat irrigation water Apply interval between last irrigation and harvest Apply interval between harvest and end of storage Identify & remove source of contamination

12 Covered Produce AND Direct Application SURFACE OR GROUND WATER Water Quality Pro.ile Meets Standards?! Yes! No! Maintain Normal Operations Apply Mitigation Strategy or Discontinue Use Monitor Water Quality

13 What is a Water Quality Profile? Water Quality Pro.ile 20 samples over 2 years Geometric Mean (GM): central tendency MAGIC HAPPENS! Statistical Threshold Value (STV): variability Water Test Results!

14 Farm A s Water Quality Profile Water Quality Pro.ile GM: 12.7! STV: 52.3! Geometric Mean (GM): central tendency MAGIC HAPPENS! Statistical Threshold Value (STV): variability Water Test Results!

15 Farm A s Water Quality Profile Water Quality Pro.ile GM: 12.7! STV: 52.3! Meets Standards?! GM: 125! STV: 410! Yes! No! Maintain Normal Operations Apply Mitigation Strategy or Discontinue Use Monitor Water Quality

16 Water Quality Pro.ile GM: 12.7! STV: 52.3! Monitor Water Quality Year 3:! GM: 33.5! STV: 86.5! All.ine in year 3, but a spike in Y4: Year 4:! GM: 75.3! STV: 417.7! NEW Water Quality Pro.ile

17 Farm A s NEW WQ Profile NEW Water Quality Pro.ile GM: 23.1! STV: 130.8! Geometric Mean (GM): central tendency MAGIC HAPPENS! Statistical Threshold Value (STV): variability Year 2:! Years 3& 4:!

18 Farm A s Water Quality Profile NEW Water Quality Pro.ile GM: 23.1! STV: 130.8! Meets Standards?! GM: 125! STV: 410! Yes! No! Maintain Normal Operations Apply Mitigation Strategy or Discontinue Use Monitor Water Quality Bottom line: The Y4 spike didn t put Farm A out of compliance.

19 Farm B s Water Quality Profile Water Quality Pro.ile GM: 241! STV: 576! Geometric Mean (GM): central tendency MAGIC HAPPENS! Statistical Threshold Value (STV): variability Water Test Results!

20 Farm B s Water Quality Profile Water Quality Pro.ile GM: 241! STV: 576! Meets Standards?! GM: 125! STV: 410! Yes! No! Maintain Normal Operations Apply Mitigation Strategy or Discontinue Use Monitor Water Quality Farm B had too many too-high readings to pass.

21 Apply Mitigation Strategy Time Interval Between Irrigation and Harvest 0.5 log reduction per day! Alternative data! Treat Water Time Interval Between Irrigation and End of Storage Must have supporting data! Recordkeeping! Discontinue Use Goal: Provide same level of public health protection as using irrigation water that met the standard! Inspect! Make changes! Retest! Back to Farm B à 1 day die-off à now compliant GM: 241 à 76! STV: 576 à 182!

22 Biological amendments Interval between application and harvest not included pending further research National Organic Program standards acceptable Raw manure must not contact covered produce during application and minimize contact after application

23 Definitions Primary production farm Under one management General but not contiguous location Growing and harvesting of crops Raising of animals Includes certain on-farm processing activities Secondary activities farm Not located on primary production farm Harvesting, packing, holding Primary production farms that grow a majority of the RACs must own or jointly own a majority interest

24 Preventive controls rule Definitions new farm definition Farm activities exempt from PC rule Certain processing activities on farms ARE subject to part of PC rule distilling, canning, etc. Record keeping Updated Current Good Manufacturing Practice Hazard analysis and risk-based preventive controls

25 Registration & Recordkeeping Facilities subject to PC rule must submit bioterrorism act registration Recordkeeping for qualified facilities required starting January 1, 2016

26 CGMPs Personnel health, cleanliness, hygiene Plant and grounds Sanitary operations Sanitary facilities and controls Equipment and utensils Processes and controls Warehousing and distribution Defect action levels

27 Preventive controls requirements Food safety plan Hazard analysis Preventive controls When preventive controls not required Verification Validation Reanalysis Qualified individual Recall plan Monitoring Corrective actions

28 Exemptions from preventive controls Qualified facilities Small and very small business conducting low-risk on-farm activities Jams/jellies Baked goods Several other activities listed Small business = less than 500 FTE Very small business = less than $1M in annual sales of human food plus value of food produced, packed, held without sale

29 What happens now? Staggered compliance dates FDA received funding for FY 2016 Beyond 2016 funding is unknown Funding levels to states still unknown What should ODA role be in implementation? ODA participation depends on federal funding

30 Conclusion FDA responded to many comments Improvements in flexibility More recognition of business structures Also more complicated Operations may be subject to produce rule, PC rule, or in some cases, both Need your feedback on ODA role