1. Preventive Controls Rules: Coverage and Farm Definition http://www.fda.gov/fsma 1 THE FUTURE IS NOW

2. Who is Covered by Preventive Controls? In general, facilities that manufacture, process, pack or hold food –Facilities required to register with FDA under sec. 415 of the FD&C Act –Not farms or retail food establishments Applies to domestic and imported food There are some exemptions and modified requirements for certain facilities 2

3. Farms 3 A farm is exempt from FDA’s food facility registration requirement. Facilities that do not have to register with FDA are not subject to the preventive controls requirements. −Depending on certain factors, farms may be subject to the forthcoming Produce Safety rule. PCHF revises the farm definition to reflect modern farming practices.

4. Evolution of Farm Definition First defined as part of Implementation of the Bioterrorism Act of 2002, for registration and recordkeeping regulations (21 CFR Part 1, subparts H and J) Regulatory significance of facility/farm distinction has increased in subsequent years (e.g., reportable food registry, mandatory recall, preventive controls) 4

5. Evolution of Farm Definition In September 2014, in response to stakeholder input, FDA proposed a revised farm definition for public comment. –A farm would no longer be required to register as a food facility if it packs or holds RACs grown on another farm under different ownership. –In general, on-farm packing or holding of produce would fall under produce safety rule. 5

6. Evolution of the Farm Definition The final Preventive Controls for Human Food rule clarifies the definition and expands it further to cover two kinds of farming operations: − Primary production farm − Secondary activities farm 6

7. Primary Production Farm An operation under one management in one general, but not necessarily contiguous, location Devoted to the growing of crops, the harvesting of crops, the raising of animals, or any combination of these activities –The definition has been expanded to include operations that just grow crops and operations that just harvest crops. 7

8. Primary Production Farm In addition to these activities, a primary production farm can: –Pack or hold RACs (regardless of who grew or raised them) –Manufacture/process, pack, or hold processed foods so long as: all such food is consumed on that farm or another farm under the same management; or the manufacturing/processing falls into limited categories 8

9. Secondary Activities Farm An operation not located on a primary production farm that is devoted to harvesting, packing, and/or holding RACs. The primary production farm(s) that grow, harvest, and/or raise the majority of those RACs must own or jointly own a majority interest in the secondary activities farm. 9

10. Secondary Activities Farm The definition also allows certain, limited additional manufacturing/processing, packing, and holding –Same as those for a primary production farm 10

11. Activities That Do Not Fall Under Farm Definition Activities that do not fall within the farm definition include manufacturing/ processing that goes beyond what falls within the farm definition. As examples: –Pitting dried plums, chopping herbs –Making snack chips or flours from legumes –Roasting peanuts, tree nuts, or seeds (e.g., pumpkin, sunflower, or flax seeds) 11

12. Activities that Do Not Fall Under Farm Definition FDA expects to issue guidance on activities that fall within the farm definition and activities that do not in the near future. 12

13. Other Exemptions Activities subject to Hazard Analysis & Critical Control Points (HACCP) regulations (i.e., seafood and juice) Manufacturing, processing, packing, and holding of dietary supplements Alcoholic beverages at certain facilities Activities subject to low-acid canned food regulations (microbiological hazards only) 13

14. Other Exemptions Certain storage facilities such as grain elevators and warehouses that store only raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing “Holding” includes activities performed for the safe or effective storage of RACs (e.g., drying, screening, fumigating) 14

15. Other Exemptions Farm mixed-type facilities are establishments that are farms that also conduct activities outside the farm definition that require registration. Certain low-risk manufacturing/processing, packing, and holding activities conducted on specific foods by small/very small businesses on farms are exempt from PCs 15

16. Modified Requirements Qualified facilities (includes very small businesses) Facilities, such as warehouses, that only store packaged foods that are not exposed to the environment PCAF: Certain human food by-products used for animal food These will be discussed in greater detail in subsequent webinars on the specific rules. 16

17. Coverage of CGMPs: PCHF CGMPs apply to the manufacturing, processing, packing, and holding of food. But not: –Farms and activities of farm mixed-type facilities that fall within the farm definition (one exception) –Fishing vessels not required to register –Establishments solely engaged in holding and/or transportation of one or more RACs –Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing) 17

18. Coverage of CGMPs: PCAF CGMPs apply to the manufacturing, processing, packing, and holding of animal food. But not: –Establishments, including farms, that are not required to register –Establishments solely engaged in holding and/or transportation of one or more RACs –Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts and hulls (without manufacturing/processing) –Establishments solely engaged in ginning of cotton (without manufacturing/processing) 18

19. For More Information Web site: http://www.fda.gov/fsma Subscription feature available To contact FDA about FSMA and find the new online form for submitting questions: http://www.fda.gov/Food/GuidanceRegulation/FSMA /ucm459719.htm 19