FDA hosted three webinars after the release of the Food Safety Modernization Act (FSMA) Final Rules on Preventive Controls. These rules will set new safety requirements for facilities that manufacture, process, pack or hold human food and animal food.

1. Preventive Controls Rules:
Coverage and Farm
Definition
http://www.fda.gov/fsma
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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
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3. Farms
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• 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)
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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.
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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
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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.
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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
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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.
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10. Secondary Activities Farm
• The definition also allows certain, limited
additional manufacturing/processing,
packing, and holding
– Same as those for a primary production farm
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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)
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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.
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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)
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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
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• “Holding” includes activities performed for the safe
or effective storage of RACs (e.g., drying, screening,
fumigating)
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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
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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.
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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)
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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)
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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
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