February 26, 2007

Division of Dockets Management (HFA-305)

United States Food & Drug Administration (FDA)

5630 Fishers Lane, Rm. 1061

Rockville, MD  20852

Docket No. 2003N-0573

Comments on Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability

Official Comments from the Association of Food and Drug Officials (AFDO)

The Association of Food & Drug Officials (AFDO) is a national organization representing the interests of state, local, and Federal regulatory officials, with industry belonging as associate members. AFDO has been in existence for over 110 years and is recognized for its leadership in promoting uniformity and coordination among government officials at all levels. We are pleased to offer our comments on the three documents pertaining to the safety of animal cloning.

Draft Risk Assessment

FDA’s draft risk assessment concludes that meat and milk from cloned adult cattle, pigs, and goats is as safe to eat as those from other animals bred by conventional means. AFDO does not disagree with the methods employed by FDA in evaluating appropriate data in this matter or the conclusions reached. These conclusions parallel those of the National Academies of Science in 2002.

AFDO has always believed that national leadership in the sciences and setting of standards was a primary responsibility of the federal government. This, after all, is a cornerstone for policy-making and allowing food safety government officials at all levels to work in a coordinated and unified fashion. In the ever-changing world of food safety, the establishment of science-based standards is critical to all involved. We must look to our national infrastructure for guidance, but insist they utilize the utmost caution in establishing standards or accepted policy. We believe it is very wise to request that industry not market cloned animal products until all positions may be heard. We are concerned about how this voluntary moratorium can be verified, however, since the selling of a cloned animal goes very easily unnoticed by unsuspecting purchasers. It is very plausible that cloned animal meat will become part of our food supply without anyone knowing, and before all food safety concerns are considered.

AFDO recommends FDA consider the following circumstances concerning cloned animal foods:

• Is stress of offspring animals a concern?
• Is the high rate of birth defects associated with cloning an issue?
• Are there nutritional differences associated with cloned animal products?
• Should a registration or monitoring system for cloned animals be developed?

AFDO believes these questions and all other concerns should be satisfied prior to lifting the voluntary moratorium for cloned animals to be used in the nation’s food supply. As with other new technologies, labeling will need to be a consideration as well. A consumer’s right-to-know and organic designation will certainly become issues that must be considered.

Proposed Risk Management Plan

FDA’s proposed risk management plan marks the beginning of collaborative work to be accomplished with members of the scientific community, along with individuals actively involved with the cloning process. It appears that a majority of Americans now either oppose, or are uncertain about, cloning.  Instituting a risk management plan to address animal health and other uncertainties is an appropriate response. As with the other mentioned concerns, AFDO believes that until this issue can be resolved, cloned animals should not be allowed for foods.

Draft Guidance for Industry

FDA indicates that almost all of the food that will come from cloned animals will come from offspring, and not from clones themselves. Further, they request data from producers and breeders of clones on the health of these animals and composition of food products derived from them. This seems very wise in order to adequately participate in an important debate on clones and food safety. It is another debate which seems very similar to the controversial GMO in foods debate that occurs worldwide. That debate has caused great international non-uniformity as a result. AFDO would recommend that FDA prevent this from happening in this matter concerning food safety of cloned animals, if at all possible.

In conclusion, AFDO accepts FDA’s current thinking relative to animal cloning and supports the follow-up efforts to be taken. We do caution, however, against any rush to judgment by the agency until an extensive review of the comments and evaluation of the risk management plan has been fulfilled. FDA has no authority to prevent the marketing of food from cloned animals, which we view as a substantial issue here. Food safety is so much more important than any economic gains to be made by industry through the cloning process.

We appreciate this opportunity to offer our comments to FDA on this important matter.

Respectfully,

Charlene Bruce, President

Association of Food and Drug Officials