FSMA Preventative Controls Rules: Coverage and Farm Definition 2015

Preventive Controls Rules: Coverage and Farm

Definition

http://www.fda.gov/fsma

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THE FUTURE IS NOW

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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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.

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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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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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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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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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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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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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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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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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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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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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)

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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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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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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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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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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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