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Comments of Consumers Union to US Food and Drug Administration on Docket No. 2003N-0573, Draft Animal Cloning Risk Assessment April 27, 2007

Prepared by Michael Hansen, Ph.D.


Consumers Union, publisher of Consumer Reports1, welcomes the opportunity to comment on the Food and Drug Administration’s (FDA’s) Draft Animal Cloning Risk Assessment. We believe this Risk Assessment is inadequate and should be withdrawn. The major shortcomings which would have to be addressed before it could be considered valid are:

  • 1.

    Insufficient data on composition of milk and meat from cloned animals and their offspring. The conclusions of safety appear to be based on data on milk from 43 cow clones, and data on beef from 16 cow clones, and 5 pigs. There are no data at all from other species. These are insufficient data on which to base a conclusion of safety for all milk and meat from cows, pigs, and goats, all breeds, under all husbandry and management conditions. Milk and meat from clones could have altered quality and nutritional characteristics. At lease one study recommends further investigation of potential to cause allergic reactions.

  • 2.

    Failure to consider effects of poor health of clones on food safety and public health. Poor clone health, documented in the Risk Assessment, could result in increased antibiotic use, increased antibiotic resistance, and wider dispersal of dangerous pathogens such as E. coli 01578:H7. These possibilities must be considered in deciding whether cloning is a safe technology for humans.

  • 3.

    Failure to consider the possibility that sick and/or unsafe animals may not always be removed from the food supply during antemortem inspection.

  • 4.

    Failure to conclude that the technology is unsafe for animals, despite extensive data presented as to very high rates of illness, death and deformities in clones. The data show that a vast majority of clones die shortly after birth. The Risk Assessment should assess the safety of the technology for animals, not just humans.

1 Consumers Union (CU) is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers. CU publishes Consumer Reports, which has over 4 million subscribers to the print edition and over 1.5 million subscribers to the online edition ConsumerReports.org To maintain our independence and impartiality, Consumers Union accepts no outside, no free test samples, and has no agenda other than the interests of consumers. Consumers Union supports itself through the sale of our information products and service, individual contributions, and a few noncommercial grants.

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