Animal Cloning: A Draft Risk Assessment - Biotechnologie.de

Chapter I: Executive Summary 10
animals pose no additional risks. It relies on the comparison of individual components of
edible products, and the identification of the appropriate comparators.
Assessing the safety of food products from animal clones and their progeny is best
accomplished by using both approaches: prospectively drawing on our knowledge of
biological systems in development and maturation, and in retrograde, from an analysis of
food products. Subtle hazards and potential risks that may be posed by animal clones
must, however, be considered in the context of other mutations and epigenetic changes
that occur in all food animal populations. No adverse outcomes have been noted in clones
that have not also been observed in animals derived via other ARTs or natural mating that
enter the food supply unimpeded.
Because the value of clones lies in their genetics, CVM anticipates that animal clones
might enter the food supply as meat if removed from the herd due to injury or
senescence, but these would likely be animals near the end of their reproductive lives.
Milk from clones, however, might enter the food supply. Progeny of clones are more
liked to be reared as animals intended primarily for food use.
2. Conclusions Regarding Potential Food Consumption Risks
Based on this review of the body of data on the health of animal clones, the composition
of meat and milk from those animals and corresponding information on clone progeny,
CVM has drawn the following conclusions:
a. Cattle Clones
Edible products from perinatal bovine clones may pose some very limited human food
consumption risk.
The underlying biological assumption in place for this age cohort is that perinatal clones
may be fragile at birth due to residual incomplete or inappropriate reprogramming of the
donor nucleus. The data are consistent with that assumption; some perinatal clones do not
survive for several reasons, including poor placentation, LOS, and in some cases, frank
malformations. Although surviving clones can be fragile for a period of time, survivors
tend to adjust to life outside the womb within a relatively short period, either on their
own or with assistance from caregivers. A significant proportion of perinatal clones
survives gestation and is born without significant health problems. Laboratory measures
of key physiological functions do not indicate that surviving animals are very different
from conventional newborns. It is therefore unlikely that food consumption risks have
been introduced into these animals or that rendering these clones will pose risks in animal
feed or to humans consuming animals fed material derived from the clones.