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Iowa Grain Quality Initiative

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Iowa Grain Quality Initiative ...

    OWA GRAIN QUALITY INITIATIVE I

    AGRIBUSINESS ASSOCIATION OF IOWA

    U. S. Food and Drug Administration

    Raw Agricultural Commodities, Animal Feed

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (also

    know as the Bioterrorism Act) was signed into law in June 2002. It gives the FDA the

    responsibility for protecting the nation’s food supply and tracing incidents of adulteration of food

    by bio-terrorism or natural causes to their source.

Agribusinesses in Iowa and the Nations ( elevators and feed mills ) which receive, hold and

    distribute raw agricultural commodities, or receive, manufacture, hold and distribute animal feed

    and pet feed for consumption by human or animals are affected by this Act. There are two

    Sections of the Act which elevators and feed mills must take action on to compliant with the law.

    Section 305 requires registration and Section 306 requires record maintenance.

Section 305 Registration

    ? Registration of facilities went into effect on December 12, 2003.

    ? Registrations requirements apply to facilities that manufacture, process, pack, or hold

    food for human or animal consumption.

    ? Food includes raw agricultural commodities for use as food or components of food, and

    animal feed and pet feed.

    ? All agribusiness companies with one or multiple locations which meet one of the criteria

    listed must register that location.

    ? Registration is best done on line at http://www.access.fda.gov/

    ? For help, contact furls@fda.gov, 800-216-7331 or 301-575-0156.

    ? If there is a question about the facility registration call 800-216-7331 and information will

    be disseminated under FDA guidelines.

    ? If registration information changes, the registration must be updated within 60 days.

    ? Failure to register is a “prohibited act”.

Section 306 Record Maintenance

    ? Record maintenance applies to all registered facilities

    ? Record maintenance compliance began for businesses with 500 full-time employees or

    more on December 9, 2005.

    ? Record maintenance compliance will begin for businesses with 11 to 499 full-time

    employees on June 9, 2006, and 10 or fewer full-time employees on December 11, 2006.

    ? Records must be established and maintained by a person ( including individuals,

    partnerships, corporations, and associations ) which manufacture, process, pack,

    transport, distribute, receive, hold or import food, and persons who place food directly in

    contact with its finished container.

Section 306 Record Maintenance Excluded from these regulations

    ? Farms.

    ? Persons how do one of these (previous listed) activities, for personal consumption.

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    Section 306 Record Maintenance Non-transporters of food ? Non-transporters are persons (defined earlier) who own food or who hold, manufacture,

    process, pack, import, receive, or distribute food for the purpose other than

    transportation.

    ? Non-transporters must identify, establish and maintain records on two sources of food

    movement through there businesses. Those sources are the immediate previous source

    and the subsequent recipient of all food received and released.

    ? Records to establish Immediate non-transporter previous sources of all food received. Sources are; farm, transportation company, dog food manufacturer

    o Name of firm, contact person, address, telephone number, fax number and e-

    mail address

    o Type of food brand name variety; soybean low-linolenic; dog food brand-x

    dog food.

    o Date received

    o Quantity and type of packaging soybean 3400 lbs.; dog food 50 lb. bags

    o Food received from persons who manufacturer, process, or pack must include

    the lot or code number or other identifier.

    o Records to establish the food received is based on one step back who

    transported the food to your business and who produced the raw agricultural

    commodity or who supplied the ingredient or meal for the animal feed or who

    manufactured the dog food.

    ? Records to establish Immediate non-transporter subsequent recipients of food released. Recipients are: who was the grain shipped to and who received the animal

    feed.

    o Name of firm, contact person, address, telephone number, fax number and e-

    mail address

    o Type of food brand name variety

    o Date received

    o Quantity and type of packaging

    o Food released from persons who manufacturer, process, or pack must include

    the lot or code number or other identifier.

    o Finished product records must identify the specific source of each ingredient that

    was used to make each lot of the food.

    o Records to establish the food released is based on one step forward who

    transported the food from the business and who received the raw agricultural

    commodity or who received the animal feed or who received the dog food.

    Section 306 Record Maintenance Transporters of food ? Records to establish Transporter of food

    o A transporter is a person who has possession, custody or control of food

    o Name of transporters previous source and subsequent recipient source.

    o Origin and destination points

    o Date shipment received and date released

    o Number of packages

    o Description of freight

    o Route of movement during the time the food was transported

    o Transfer points through which the shipment moved

    Section 306 Record Maintenance Records retention

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? Type of food raw agricultural commodities

    o Non-transporter 2 years from date received

    o Non-transporter 2 years form date released

    o Transporter 1 year form date received and 1 year from date released

    ? Type of food animal food, including pet food

    o Non-transporter 1 year from date received

    o Non-transporter 1 year from date released

    o Transporter 1 year form date received and 1 year form date released

    Section 306 Record Maintenance Records availability ? When FDA has a reasonable belief that an article of food is adulterated and present a

    threat of serious adverse health consequences or death to humans or animals.

    ? An inspection request after meeting reasonable belief is as soon as possible but not to

    exceed 24 hours from official request.

    ? If required records are not established and maintained.

    o Failure to establish and maintain the required records or failure to make them

    available to FDA is a prohibited act

    o The Federal government can bring a civil action or criminal action in Federal

    court.

    Section 303 Detention

    ? Authorize FDA to order the detention of food if an officer or qualified FDA employee finds,

    during an inspection, examination or investigation, credible evidence or information

    indication the article presents a threat of serious adverse health consequences or death

    to humans or animals

    Acknowledgements

    ? U.S. Food and Drug Administration

    o http:/www.fda.gov/oc/bioterrorism/bioact.html

    ? Iowa State University Extension

    o Iowa Grain Quality Initiative www.iowagrain.org ? Iowa State University of Science and Technology Copyright ? 2006 all rights

    reserved

    Questions and contact

    ? Howard E Shepherd Iowa State University Extension Iowa Grain Quality Initiative

    515-294-3137 howard@iastate.edu

    ? Training Module on FDA Record Maintenance at Iowa Grain Quality Initiative Web site

    on raw agricultural commodities and animal and pet feed.

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