Postharvest Care of Produce: When Does a Farm Become a

Purdue University Cooperative Extension Service is an equal access/equal opportunity institution.

January 22, 2013r

Katie Clayton

Food Science Extension Outreach Specialist

Postharvest Care of Produce: When Does a Farm Become a „Facility‟?


Public Health Security and Bioterrorism Preparedness and Response Act of 2002


Bioterrorism Act of 2002

• Directed Food and Drug Administration (FDA)

to protect public from threatened or actual

terrorist attack on U.S. food supply

• FDA established regulations

– Domestic and foreign facilities that

manufacture/process, pack or hold food for

human or animal consumption in the United

States must register with FDA

– Original deadline: December 12, 2003

– Allow FDA better traceability for potential or

actual bioterrorism act


What qualifies as “FOOD”?

• Dietary supplements and dietary ingredients

• Infant formula

• Beverages – Alcohol & bottled water

• Fruits and vegetables

• Fish and seafood

• Diary products and shell eggs

• Raw agricultural commodities for use as food or components of food

• Canned and frozen foods

• Bakery goods, snack food, candy

• Live food animals

• Animal feeds and pet food


Who Must Register?

Domestic or foreign facility:

• Owner

• Operator

• Agent in Charge

• OR individual authorized by one of above

• Domestic facility

• Must register regardless if food enters interstate commerce

• Foreign facility

• Must designate a U.S. agent (ex: importer or broker) with a

U.S. address


Renewal? Fees? Updates?

• Bioterrorism Act of 2002

– Required registration once

• Existing: by December 12, 2003

• New: before beginning manufacturing/processing, packing or holding operations

– No renewal

– Only required updates of changes

• No fee for registration

• When to update

– Change of owner, operator in charge, or U.S. agent

• Within 60 days

– Out of business

• Registration must be canceled


Food Safety Modernization Act Changes

(enacted January 4, 2011)

• Registration must be renewed every other year

– October 1 through December 31 of even-numbered years

• FDA permitted to inspect facility

• FDA has authority to suspend registration

– If food manufactured, processed, packed, received, or held in facility has

“reasonable probability” of causing serious adverse health

consequences or death to humans or animals


Exemptions

Facilities that do NOT have to register:

• Private residences of individuals

• Non-bottled water, drinking water collection and distribution establishments and structures (i.e. municipal water systems)

• Transport vehicles that hold food only in the usual course of their business as carriers

• Farms

• Restaurants

• Retail food establishments

• Nonprofit food facilities

• Fishing vessels that do not process fish

• Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture


Do I Qualify for the FARM Exemption?

“Farms – facilities in one general location devoted to growing and harvesting crops (washing, trimming outer

leaves, and cooling produce are part of harvesting) and/or raising animals (including seafood).

The term “farm” includes facilities that pack or hold food, provided that all food used in those activities is grown, raised

or consumed on that farm or another farm under the same ownership, as well as facilities that manufacture/process

food, provided that all food used in such activities is consumed on that farm or another farm under the same

ownership”

http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/UCM332657.pdf





Production Systems








ownership”






“Growing/Harvesting”

• Washing

• Trimming outer leaves

• Cooling

• Example: Is use of chlorinated water to wash lettuce on a

farm considered “processing” necessitating registration of

the farm?

– Washing - If use public or municipal water that is chlorinated for

other purposes

– Washing – If chlorine is added at 50-200ppm (at pH of 6.0-7.5) to

control microbiological quality of water as recommended in FDA

GAPs guidance

– Manufacturing/processing – If chlorine added above 200ppm,

considered “treating” a food


“Packing/Holding”

For sole purpose of transporting harvested food off the farm:

• Sorting

• Grading

• Wrapping

• Boxing

• Example: Does placing stickers on fruit or veggies

constitute “processing” ?

– Packing - If all fruit is grown OR consumed on that farm or a farm

under same ownership

• Example: Does a farm need to register if it grows its own

produce, harvests it, wraps it and places it into cartons for

the sole purpose of transporting food off the farm?

– No need to register – considered “packing”


“Manufacturing/Processing and Packaging”

• Manufacturing/Processing - “making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients”

– Must involve some sort of change to or manipulation of food

• Packaging – “placing food into a container that directly contacts the food and that the consume receives”

– Considered an example or step of manufacturing and processing

• Example: A farm that simply places a raw agricultural commodity (ex: strawberries) into containers such as clamshells. Do they need to register? – No – this is not “manufacturing/processing” and is “packing”

rather than “packaging”

• Due to no change in the strawberries

vs.


A: Fresh B: Fresh Cut – “processing”

Fresh vs. Fresh Cut

Produce


“Mixed-Type Facility”

• Mixed-Type Facility – an establishment that engages in both activities that are exempt from registration and activities that require the establishment to be registered.

• Example: A farm that grows oranges and processes them into orange juice for sale to a distributor. Are they required to register?

– Yes – because this farm processes fruit into juice which is not covered by the farm definition

• Example: Are maple syrup producers “farms” and thus exempt from registering? – Yes – exempt if ONLY gather sap from maple trees –

“harvesting”

– No – not exempt if gathering and concentrating by heating – “manufacturing/processing”


Location, Location, Location…








ownership”






“One General Location”

Example: Produce grown on a farm is picked and trimmed

and then sent to be packed at a packing shed that is owned

by the same person that owns the farm. The packing shed is

not in the same general physical location as the farm. The

packaged produce is then shipped by the farmer to a

distributor. Does the packing shed have to be registered?

– Yes. Because farm is defined in terms of location and the

packing shed is at a different physical location the shed is not a

“farm” • Farm definition extends to facilities in the same general physical location as

the farm (i.e. on the farm) that pack or hold food, provided all food used in

such packing or holding is grown, raised or consumed on that farm or

another farm under the same ownership

• Farm also extends to facilities located on the farm that manufacture/process

food if ALL food used in such processing is CONSUMED ON that farm or

another under same ownership


“Under the Same Ownership”

Example: If a farm receives produce from other farms not under

the same ownership for packing, does the farm receiving

produce have to register?

– Yes. All produce was not grown on farm under the same

ownership therefore do not qualify for “farm” exemption


“Mobile Units”

Example:

• As vegetables are harvested they are transferred to

a truck mounted operation in the field where it is

packed and cooled.

• The mobile unit is NOT permanently located at the

farm (moves from farm to farm). Packed product

then transferred to truck for transport off the farm.

Does the farm or truck mounted

packaging/processing unit or both need registered?

– Neither. Considered “packing” not

“manufacture/processing/packaging”

– No. The truck that transports the workers and filled

containers off the farm is not a facility that is required to

be registered because it is holding the food only in its

usual course of business as a carrier.


“Mobile Units”

Example: A truck mounted operation under separate ownership

from the farm cuts produce frown on the farm (e.g. chops carrots)

and places them into consumer-ready bags before transporting off

farm. Does the farm or truck mounted packaging/processing unit

or both need registered?

– Truck, Yes. • Truck is preforming “manufacture/processing/packaging” operations and does not

meet definition of “farm”

• Separately owned thus not the same establishment

• Should register using fixed address for the owner, operator or agent in charge of the

mobile facility

– Farm, No.


“Mobile Units”

Example: A truck mounted operation travels from

one vineyard to another and bottles wine made

from grapes grown and processed into wine at

the vineyard. Does the truck mounted

packaging/processing unit need registered?

– Yes.

• FDA considers bottling “packaging”

• Placing wine into bottles involves manipulation of

the wine because it is preserving the manufactured

condition of the wine by vacuum-sealing it and

corking it


Selling Produce on the Farm/Roadside Stand

Example: A farm grows tomatoes and sells them directly to

consumers from a roadside stand located on the farm. Does

the farm have to be registered?

– No. If primary activity of roadside stand is selling food (including

tomatoes directly to consumers, it is exempt by FDA as a retail

food establishment.


Online Registration

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/OnlineRegistration/default.htm





Resources/References

• October 2003: Fact Sheet on FDA'S New Food Terrorism Regulation: Interim Final Rule - Registration of Food Facilities – http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistratio

n/ucm081610.htm

• December 2012: Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide

– http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm331957.htm

• December 2012: Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) – http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Guid

anceDocuments/FoodDefenseandEmergencyResponse/ucm331959.htm

http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/ucm081610.htm



http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm331957.htm







Questions?

Contact Me: Katie Clayton

765-494-3726

[email protected]

mailto:[email protected]

