1. Natural Resource Concerns

2. In 2007 there were a number of food borne illness attributed to fresh produce People became sick Business’s lost market share Lawyers became rich

4.  Stakeholders and policy makers came together…

6. Produce Safety Standards - Published Jan. 16, 2013 Preventive Controls for Human Food - Published Jan. 16, 2013 Foreign Supplier Verification Program Preventive Controls for Animal Food Accredited Third Party Certification

7.  Confirm industry’s primary role on food safety  Risk-based and flexible Burden commensurate with risk  Address small business issues Additional time for small farms, businesses, to comply  Extensive government, stakeholder Input

9.  Considers risk posed by practices, commodities, conditions  Science- and Risk-based Focus on identified routes of microbial contamination Excludes certain produce rarely consumed raw Excludes produce to be commercially processed  Flexible Additional time for small farms to comply Variances Alternatives for some provisions

10.  Framework considers many factors associated with produce farming community Examples include diversity of operations and broad range of crops and practices  Proposing integrated approach that draws on past experiences Examples include CGMPs, HACCP, shell egg regulation

11.  One way or another just about every producer is impacted by this rule  Scale and risk based Exemptions under Produce Rule  Scale and Risk based Exemptions under Preventative Controls

12.  “Produce” defined as fruits and vegetables  Produce includes mushrooms, sprouts, herbs and tree nuts  Produce does not include grains  Some limitations on covered produce

13.  Produce for personal or on-farm consumption  Produce not a Raw Agricultural Commodity  Certain produce rarely consumed raw  Produce that will receive commercial processing  Farms with sales of ≤ $25,000 per year  Qualified exemption and modified requirements

14. 1. Agricultural water 2. Biological soil amendments of animal origin 3. Worker health and hygiene 4. Equipment, tools, buildings and sanitation 5. Domesticated and wild animals Focus on 5 identified routes of microbial contamination Other requirements Growing, harvesting, packing and holding activities

16. Agricultural water: water used in covered activities on covered produce, where water is likely to contact covered produce.  Direct contact Irrigation water  Crop spraying  Washing and cooling of covered produce  Cleaning food contact surfaces  Hand during and after harvest activities

17.  Overhead Irrigation : 235 GEC per 100ml  Harvesting operations: 0 detectable GEC Dump tanks, cooling, ice, flumes, hydrocoolers  Hand Washing: 0 detectable GEC  Drip Irrigation : Not Ag water as defined by FSMA (Subject to FD& C act)

18.  Public Water System (SDWA) No Testing  Private Well: Every 3 months  Rivers or natural lakes: once every 7 days  On farm man made reservoir: monthly (if not subject to run off)

19.  Require treatment of agricultural water that you use if you know or have reason to believe that the water is not safe and of adequate sanitary quality for its intended use, including requirements for treatment methods, treating such water, and monitoring its treatment (proposed § 112.43);

20.  Alternatives  You may establish and use alternatives to the requirements established in proposed § 112.44(c) for testing water, and taking action based on test results, when agricultural water is used during growing operations for covered produce …using a direct water application method, provided you have adequate scientific data or information to support a conclusion that the alternative would provide the same level of public health protection as the § 112.44(c) requirements and would not increase the likelihood that your covered produce will be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.

21.  If you want to water your crops with overhead irrigation from a pond, stream or river, you will test that water at least once per week, per source throughout the growing season.  No more wash tanks or flumes in the pack shed, continuous or recirculated sanitized flow only  If you want to do something different show us a science based alternative (FDA will not review just tell us you have it)

22.  FDA defines a farms purpose as producing and preparing its own “raw agricultural commodities” for commerce.  Anything beyond that and the farm becomes a facility (biosecurity act) and may fall under the Preventive Controls Rule.

23.  FSMA will drive up farms annual costs. Estimates from $14,000 annually for a small farm. Significantly more if farm falls under Preventative Controls  FSMA will place new demands on NRCS  FSMA may drive some farms out of business and lead to increased development pressure resulting in degraded water quality

24.  Educate our cooperators and partners  Comment on the rules by May 16 2013  Ask and hope we can get an extension through Dec 2013  Demand FDA perform an Environmental Impact Statement on the rule