January 26, 2006

Docket No. 2002N-0273
Division of Dockets Management [HFA-305]
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

The Association of Food and Drug Officials (AFDO) is pleased to comment on U.S. Food and Drug Administration’s (FDA) proposal to amend their regulations and prohibit the use of certain cattle origin materials in the food or feed of all animals. The intent of the amendments is to strengthen existing safeguards that help prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle.

AFDO is a 109-year old organization that represents Federal, state and local government regulatory officials and industry associates. A number of the state food safety program managers active in AFDO oversee the BSE inspection program in their state and are very interested in this matter.

AFDO applauds FDA for its careful consideration of previous comments received. We recognize the attention FDA will give to risk assessments, reports of the scientific steering committee of the European Union, and recommendations made by the International teams who reviewed the BSE cases in North America, as well as other sources of information, before releasing the current proposal for rule amendment. AFDO fully supports the removal from the animal food and feed chain of cattle origin materials specified in the proposal, and offers the following comments for consideration:

1) While one can be reasonably assured that regulatory officials monitoring the removal of Specified Risk Materials (SRM) from human food verify the effective removal of cattle materials prohibited in animal feed (CMPAF), this is not the case with custom slaughter and certain other animal processors that are not continually monitored by U.S. Department of Agriculture (USDA) or equivalent authorities. An aggressive approach needs to be taken by authorized regulatory agencies to ensure that the impacted parties will follow the provisions of current proposals, once adopted and in effect. This is particularly important since there are no definitive tests available that would verify cattle, that have not been inspected and passed for human consumption and whose brain and spinal cord have not been removed, have not entered distribution systems.

2) Consistency and clarity of rule provisions are essential for effective understanding and management. There is a significant volume of younger cattle that are not processed through the continually monitored USDA slaughter facilities. These animals are therefore subject to the proposed rule. The brain and spinal cord from cattle under 30 months of age appear to be of very low, if any, infectivity. As proposed, the brain and spinal cord will have to be removed from uninspected cattle less than 30 months, if intended for animal feed. This is inconsistent with the removal of SRMs from human foods. Distal ileum, by contrast, from younger cattle (under 30 months) appears to be of higher risk compared to brain and spinal cord but there is no requirement for excluding it from animal feeds. Additionally, the removal of distal ileum or the entire intestine from the younger cattle requires less labor-intensive efforts than removal of brain and spinal cord. We realize there would be a greater volume of tissues requiring disposal if the entire intestine was to be removed from all cattle of any age not inspected and passed for human consumption. However, the magnitude of the associated risk should be the determining factor. If the character of the regulation is risk, keep risk considerations consistent.

3) AFDO is concerned that if the amendment to the rules is adopted CMPAF may be potentially used as fertilizers. If there are risks associated with consumption of CMPAF by cattle through direct crop exposure, this issue needs to be addressed in a coordinated effort with the agencies that have jurisdiction over the distribution and/or use of fertilizers. Prevention of crop contamination is critical as it is now suspected that as little as 0.001g of infected material can transmit BSE to cattle. FDA should provide clear guidance on approved methods for disposal of the CMPAF to ensure that they will not contaminate any animal feed and that they do not accumulate in the environment to become a source of contamination in the future.

4) The Canadian Food Inspection Agency has proposed amendments to the Canadian federal regulations that will strengthen their existing animal feed controls. However, the Canadian definition of Specified Risk Materials is different from FDA’s definition of CMPAF. Because of the open trade between the two countries and the similar level of risks associated with BSE, we would encourage a harmonization of the amendments to the current rules in the United States, as much as possible, with those of Canada.

5) Finally, with regard to international distribution of feeds of animal origin, FDA must consider the complications of receiving materials from low BSE risk countries that contain, or may contain, CMPAFs. While the risk of exposure from these materials is low, the potential for these materials to interfere with compliance verification is high. Until there are valid methodologies to identify CMPAF and other prohibited animal proteins, control officials will have to rely upon physical inspection of processes and records. Not having controls over all materials only makes the burden of compliance monitoring more complicated.

On behalf of AFDO I would like to thank the Food and Drug Administration for the opportunity to provide these comments for your consideration.

Sincerely,

Marion F. Aller, President
Association of Food and Drug Officials