The following information was provided to the Agribusiness Association from Iowa State University staff, Dr. Charlie Hurburgh and Howard Shepherd.
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.
Please click here for a pdf file with more information. Press the next button below for answers to 17 common questions.
1. I receive raw agricultural commodities, corn and soybeans and FDA says I have to keep records of the commodities received starting 9 June 2006. What records must I keep?
The records of the received commodities for consumption by human or animals must include.
•The immediate previous source where the commodity came from, name of the farm or elevator, the contact person, that farm or elevator address, the telephone number of the farm or elevator, the fax number of the farm or elevator, and the e-mail address of the contact person.
•The commodity information must be recorded, corn, the date received, the amount received.
•The immediate previous transporter of the commodity, the name of the firm, the contact person, the address of the transportation company, the telephone number of the company, the fax number of the company, and the e-mail address of the contact person.
To receive more information on FDA recordkeeping go to www.iowagrain.org
2. On 9 June 2006 FDA requires I keep records of commodities received. How long must I keep the records?
The records for the commodity received must be kept – 2 years – from the date received at the elevator.
To receive more information on FDA recordkeeping go to www.iowagrain.org
3. The FDA says I have to keep records of commodities received. Do I have to be registered to receive raw agricultural commodities?
Yes, the facility where raw agricultural commodities are received stored and shipped from and will be used for consumption by humans or animals must be registered with FDA. If there are question on registration of a facility, call 800-216-7331.
To receive more information on FDA recordkeeping go to www.iowagrain.org
4. I am a Farmer, and I store corn and soybeans on my farm. Do I have to register or keep records for FDA?
Farms are exempted for the FDA registration and recordkeeping requirements. But, when the grain is delivered to the elevator or feed mill or alcohol plant, the farm information must be given to the receiving facility.
To receive more information on FDA recordkeeping go to www.iowagrain.org
5. I receive raw agricultural commodities at several business locations. Do I have to register each location or can one registration cover all locations?
A business which receives raw agricultural commodities at several locations, must register each location. The business may want to create a business registration with all facilities under one contact by knowing the registration numbers for each location and placing them under a business registration folder. Go to and access [email protected] and it will direct the business contact how to get all company locations in the folder.
To receive more information on FDA recordkeeping go to www.iowagrain.org and view the FDA information under Recent Topics.
6. My company has a FDA registration, but several personal changes in our organization have occurred since registration was required on 12 December 2003. Does the original registration still apply?
If there is a change in any information required in the registration, that information must be changed within 60 days of the change. That includes the contact person, a change in receiving, storing or shipping raw agricultural commodities or animal feed or pet food into and out of the facility.
To receive more information on FDA recordkeeping go to www.iowagrain.org and view the FDA information under Recent Topics.
7. My business has facilities which receive raw agricultural commodities, and I record received information at the scale in an electronic format at some locations and on hand written scale ticket at other locations. What information do I need to capture on the scale ticket to satisfy FDA recordkeeping requirements?
The scale ticket is a legal document for receipt and shipping for commodity warehousing of grain. The only information from the scale ticket FDA will need for trace back will be the commodity – corn, the date received, and the amount received. The scale ticket must be linked to data which will capture the name of the farm or company where the grain came from, the contact person, the address, the telephone number, a fax number and email address if available.
To receive more information on FDA recordkeeping go to www.iowagrain.org and view the FDA information under Recent Topics.
8. My company receives raw agricultural commodities and I do not believe I need to register any facilities.
If a company receives raw agricultural commodities for use as food for human or animal consumption the facility must register with FDA. The consequences of not registering the facility are a “Prohibited Act” and this means compliance is based on litigation not a fine.
To receive more information on FDA recordkeeping go to www.iowagrain.org and view the FDA information under Recent Topics.
9. My company receives raw agricultural commodities at several locations, and grain is transferred to one distribution location with a rail head. Contract drivers and company employee drivers move the grain to the rail head elevator. Do I have to capture any information on the transfer of the grain, and the drivers moving the grain?
# 1.Movement of grain by a company employee in vertical integration of grain in a company and the movement of grain from one location to another is internal transfer company records (and should be recorded thus) because the grain has not left the control of the company.
# 2.The contract driver is a different person having control of the grain and is subject to recordkeeping rules. First the company which ships the grain from one location to another must record who they turned the grain over to for shipment. Second the company must then record where the grain was received by who delivered the grain to the rail head elevator. Third the contract driver must keep records of where he picked up the grain and where he delivered the grain.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
10. My company has FDA registration information for each location where raw agricultural commodities are received. What kind of security is needed for paper or electronic document information?
The FDA registration documentation falls under the company security plan. The registration is unique to the company location and should be considered a security required document. This registration guarantees the responsible person at the company will receive any notification of an act targeting there facility or food products received and distributed by the company. These documents should be secured properly.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
11. I have heard the term “co-mingling” of raw agricultural commodities (grain). How does this impact the record keeping requirements when grain is received at our company which has three 300,000 bushel capacity and five 100,000 bushel capacity bins?
The information on the grain received must be captured as producer information. The grain received is “co-mingled with other producer grain in one or more bins. The bins could be turned over many times because of moisture or quality, again “co-mingling. Grain taken form a bin is shipped to the recipient of the grain and the recipient information must be captured. The “co-mingling” process may have 1500 number names in the shipment out of the elevator to the recipient, and if that is the best the records can define for “co-mingling” that is what is acceptable today.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
12. I am a consultant who consults a large farmer who produces commodity crops and stores them on his farm. He also buys commodity crops from other farmers and transports to his farm and stores the crop before delivery to the elevator. Is this farmer exempt from FDA registration and recordkeeping compliance?
1. First if he is buying commodities from other farmers he needs a license. This has nothing to do with FDA.
2.He is exempt for FDA registration and recordkeeping for the crops he produces and stores on his own farm.
3.The farmer becomes a grain dealer when he buys commodities and receives, stores, and delivers grain. He will have to register his storage facility as an commercial elevator in town would have to do, and must also comply with the recordkeeping requirements.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
13. I farm and grow alfalfa. I dry and chop the alfalfa and sell the alfalfa to another person for use as animal feed. Does this fall under the farm exemption?
The recordkeeping requirements apply to this farm because the act of drying and chopping are post harvest activities, which are considered manufacturing or processing. Record must be established and maintained for the foods received and released.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
14. Section 173.315(m) of the HMR states that a nurse tank must meet the requirements of the edition of the ASME Code in effect at the time the cargo tank was manufactured and be marked accordingly. What requirements apply to the maintenance and repair of nurse tanks?
The ASME Code establishes design and construction requirements for cargo tanks, but does not include repair, maintenance, or requalification requirements. However, in order for a non-specification tank to continue to be marked to indicate that it conforms to the ASME Code, repairs that require welding must be performed in accordance with the National Board Inspection Code. The National Board requires welding on cargo tanks to be performed by a facility holding an “R” stamp.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
15. What requirements apply to nurse tanks in states that have not adopted National Board standards? The State of Iowa, for example, permits facilities that do not hold an “R” stamp to perform welding repairs on nurse tanks?
As noted above, in order for a nurse tank to continue to be marked that it conforms to the ASME code, welding repairs on the nurse tank must be performed in accordance with the National Board Inspection Code. The HMR require nurse tanks to be marked to indicate conformance with the ASME Code. Thus, irrespective of state requirements, to maintain the ASME Code marking required by 173.315(m)(1) of the HMR, welding repairs on nurse tanks must be performed in accordance with the National Board Inspection Code.
To receive more information on FDA recordkeeping go to www.iowagrain.org.
16. Is the entry for anhydrous ammonia in the table in 173.315(a) applicable to anhydrous ammonia transported in nurse tanks?
No. The requirement for transporting anhydrous ammonia in nurse tanks are in 173.315(m) of the HMR.
17. I own, a feed store and small feed mill, how much do I have to sell to meet the FDA recordkeeping requirements, and do I have to be registered?
Answer – information from FDA – Registration of Food Facilities and Establishment – November 2003, and Establishment and Maintenance of Records – December 2004
1. Retail food establishments, such as groceries and roadside stands, that sell food directly to consumers as their primary function, meaning that annual food sales directly to consumers are of are of greater dollar value than annual sales to other buyers do no have to register.
2. Registration of Food Facilities went into effect on December 12, 2003.
3. Registration of Domestic facilities is required if the facility manufactures, processes, packs or holds food for human or animal consumption.
4. Food includes –
1. Raw agricultural commodities for use as food or components of food and
2. Animal feeds and pet food.
5. The Feed mill is required to be registered under the guide lines it receives raw agricultural commodities to manufacture, process, pack and hold animal feeds for animal consumption and the retail store is part of the business and does not have to be registered.
6. Failure to register a Food Facility is a Prohibited Act.
7. Small Feed Mills with less than 11 employees will have to comply with Establishment and Maintenance of Records starting 11 December 2006.
8. The Feed Mill will have to establish and maintain records because it manufactures, processes, packs, transports, distributes, receives, and holds food (animal feed).
9. The Feed Mill records must include – where food came from
a. Name of the firm, address, telephone number, fax number and email address.
b. Type of food – raw agricultural commodity – corn, oats, soybean.
c. Date received.
d. Quantity and type of packaging.
e. Transporter who brought the food – firm name, address, telephone number, fax number and email address
10. The Feed Mill records must in include – where the animal feed went to
a. Name of firm, address, telephone number, fax number and email address
b. Animal feed – brand name and lot number or identifier.
c. Date released.
d. Quantity and type of packaging.
e. Ingredient sources used in each lot of finished product.
f. Transporter who delivered the feed – firm name, address, telephone number, fax number and email address.
11. The Retail store is part of the Feed Mill, is what is called vertically integrated. The records captured in the Feed Mill can be used by the Retail store. The bill of sale is the record for the customer who has a pet as an end user. The bill of sale record for the customer who uses the feed for animals which will be sold for human consumption will need to include the name of the firm, address, telephone number, fax number and email address and quantifying information.
To receive more information on FDA recordkeeping go to www.iowagrain.org
18. SPILLS – What Should a Retailer Do?
AAI is recommending that retailers call the DNR 24-hour spill hotline in the event any volume is released. Any spill amount which creates a “hazardous condition” must be reported to IDNR within six hours of occurrence. “Due to a recently expanded interpretation of “hazardous conditions we recommend you contact the DNR immediately.” There will be times when the IDNR staff comes to your facility and other times, they will just take the information on the phone discussing your clean up procedures with you. The number is 515-281-8694. See attached IDNR Spill guide for further information. Local IDNR field offices can also be called during working hours. For your local field office go to: http://www.iowadnr.gov/fo/index.html