| Comment Record|
Ms. Jamie Clover Adams ||
2001-11-20 15:30:46 |
Kansas Department of Agriculture |
| Comments for FDA General |
1. General Comments
November 19, 2001
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
RE: Kansas Department of Agriculture Comments on Docket No. 01N-0423
The Kansas Department of Agriculture’s Agricultural Commodity Assurance Program (ACAP) conducts both federal and state prohibited material inspections in the state of Kansas. ACAP inspectors routinely inspect feed mills to determine compliance with federal and state rules pertaining to the proper handling, labeling and record keeping of prohibited materials used in animal feed.
The Food and Drug Administration (FDA) has solicited information in the form of 17 questions regarding its present feeding rule. The main question posed is if the current rules are adequate to provide public health controls. We believe that overall the current rules are sufficient in scope to provide adequate controls to ensure safe animal feed. However, minor changes to the rules may provide even better safeguards than are now in place.
FDA has asked if they should require dedicated facilities and transportation for feed containing mammalian protein to decrease the possibility of commingling during production and transportation (questions four and five). While these measures certainly would decrease the possibility of commingling it may not be necessary to require dedicated facilities and transportation to further minimize the possibility of commingling. Instead, if FDA defined what are adequate clean-out procedures and set some minimum standards, then the possibility of commingling would be further reduced from current levels.
Currently, adequate clean-out procedures must be written and used, but there is no standard for what is an “adequate clean-out procedure.” Consequently, clean-out procedures may vary from facility to facility and transport to transport with no objective measures to determine their effectiveness. We are forced to rely on the facility or transporter to decide if their clean-out procedures are adequate.
Our agency could sample the feed and have it analyzed at our laboratory to determine the presence of mammalian protein, but that then leads to another question. Does the current rule require that animal feed be 100 percent free of prohibited materials (zero-tolerance) or is there a level in which prohibited material can be in feed and yet the feed considered safe? These are not simply hypothetical situations or questions, but have been posed in response to actual enforcement activities conducted by our program.
Defining adequate clean-out procedures and setting minimum standards for clean-out is not an easy task, but it would provide guidance to manufacturers and transporters of feed and to regulatory officials. This would then provide better safeguards against commingling and provide the regulatory official with the tools to easily identify inadequate clean-out procedures. The current rules would be strengthened and provide better assurance without requiring the use of dedicated facilities or transportation.
Question nine asks if FDA should remove the exemption for pet foods from labeling with the precautionary statements. We believe the exemption for pet foods should be removed because of the potential for feeding prohibited materials to ruminants. Under the current rule we must rely on the salvager of the pet food to properly label it with a cautionary statement. The salvager may or may not know if the product contains prohibited materials and may or may not properly label it.
Producers of cattle and other ruminants have been educated to look for the cautionary statement before feeding animal feeds. Without the cautionary statement on pet food the producer may erroneously believe that the pet food does not contain prohibited materials and feed it to their cattle or other ruminants. Requiring that pet foods be labeled with a cautionary statement would provide the necessary information to producers without depending on the salvager to label the product.
FDA has asked about removing other exemptions or expanding the list of prohibited materials. We do not have any comments on this issue other than FDA should continue to study these products and any changes should be based on scientific data. We urge FDA to continue to study bovine spongiform encephalopathy (BSE), to continue funding enforcement efforts and to use science-based evidence to make necessary changes to its animal feed regulations.
If you have any further questions, please do not hesitate to contact Constantine Cotsoradis, ACAP manager at (785) 862-2415.
Jamie Clover Adams
Kansas Secretary of Agriculture
Kansas Department of Agriculture
109 SW 9th Street
Topeka, Kansas 66612