&DĂŬĞƐ>ŽǁͲƌŝƐŬĞƚĞƌŵŝŶĂƟŽŶĨŽƌWƌŽĚƵĐƚƐ
ĨƌŽŵ'ĞŶŽŵĞͲĞĚŝƚĞĚĞĞĨĂƩůĞ
dŚĞh͘^͘&ŽŽĚĂŶĚƌƵŐĚŵŝŶŝƐƚƌĂƟŽŶĂŶŶŽƵŶĐĞĚDĂƌĐŚ
ϳŝƚŚĂƐŵĂĚĞĂůŽǁͲƌŝƐŬĚĞƚĞƌŵŝŶĂƟŽŶĨŽƌƚŚĞŵĂƌŬĞƟŶŐŽĨ
ƉƌŽĚƵĐƚƐ͕ŝŶĐůƵĚŝŶŐĨŽŽĚ͕ĨƌŽŵƚǁŽŐĞŶŽŵĞͲĞĚŝƚĞĚďĞĞĨĐĂƩůĞ
ĂŶĚƚŚĞŝƌŽīƐƉƌŝŶŐĂŌĞƌĐŽŶĐůƵĚŝŶŐƚŚĞŝŶƚĞŶƟŽŶĂůŐĞŶŽŵŝĐ
ĂůƚĞƌĂƟŽŶĚŽĞƐŶŽƚƌĂŝƐĞĂŶLJƐĂĨĞƚLJĐŽŶĐĞƌŶƐ͘
dŚĞ/'ƌĞƐƵůƚƐŝŶƚŚĞĞƋƵŝǀĂůĞŶƚŐĞŶŽƚLJƉĞ;ŐĞŶĞƟĐŵĂŬĞͲ
ƵƉͿĂŶĚƐŚŽƌƚͲŚĂŝƌĐŽĂƚƚƌĂŝƚƐĞĞŶŝŶƐŽŵĞĐŽŶǀĞŶƟŽŶĂůůLJďƌĞĚ
ĐĂƩůĞ͕ŬŶŽǁŶĂƐĂ͞ƐůŝĐŬ͟ĐŽĂƚ͘dŚŝƐŝƐƚŚĞ&͛ƐĮƌƐƚůŽǁͲƌŝƐŬ
ĚĞƚĞƌŵŝŶĂƟŽŶ ĨŽƌ ĞŶĨŽƌĐĞŵĞŶƚ ĚŝƐĐƌĞƟŽŶ ĨŽƌ ĂŶ /' ŝŶ ĂŶ
animal for food use.
͞dŽĚĂLJ͛Ɛ ĚĞĐŝƐŝŽŶ ƵŶĚĞƌƐĐŽƌĞƐ ŽƵƌ
ĐŽŵŵŝƚŵĞŶƚƚŽƵƐŝŶŐĂƌŝƐŬĂŶĚƐĐŝĞŶĐĞͲ
ďĂƐĞĚ͕ĚĂƚĂͲĚƌŝǀĞŶƉƌŽĐĞƐƐƚŚĂƚĨŽĐƵƐĞƐŽŶ
ƐĂĨĞƚLJƚŽƚŚĞĂŶŝŵĂůƐĐŽŶƚĂŝŶŝŶŐŝŶƚĞŶƟŽŶĂů
genomic alterations and safety to the
ƉĞŽƉůĞ ǁŚŽ ĞĂƚ ƚŚĞ ĨŽŽĚ ƉƌŽĚƵĐĞĚ ďLJ
these animals,” said Steven M. Solomon,
ĚŝƌĞĐƚŽƌ ŽĨ &͛Ɛ ĞŶƚĞƌ ĨŽƌ sĞƚĞƌŝŶĂƌLJ
DĞĚŝĐŝŶĞ͘͞/ƚĂůƐŽĚĞŵŽŶƐƚƌĂƚĞƐŽƵƌĂďŝůŝƚLJ
ƚŽ ŝĚĞŶƟĨLJ ůŽǁͲƌŝƐŬ /'Ɛ ƚŚĂƚ ĚŽŶ͛ƚ ƌĂŝƐĞ
ĐŽŶĐĞƌŶƐĂďŽƵƚƐĂĨĞƚLJ͕ǁŚĞŶƵƐĞĚĨŽƌĨŽŽĚ
ƉƌŽĚƵĐƟŽŶ͘tĞĞdžƉĞĐƚƚŚĂƚŽƵƌĚĞĐŝƐŝŽŶ
ǁŝůůĞŶĐŽƵƌĂŐĞŽƚŚĞƌĚĞǀĞůŽƉĞƌƐƚŽďƌŝŶŐ
ĂŶŝŵĂů ďŝŽƚĞĐŚŶŽůŽŐLJ ƉƌŽĚƵĐƚƐ ĨŽƌǁĂƌĚ
ĨŽƌ ƚŚĞ &͛Ɛ ƌŝƐŬ ĚĞƚĞƌŵŝŶĂƟŽŶ ŝŶ ƚŚŝƐ
ƌĂƉŝĚůLJĚĞǀĞůŽƉŝŶŐĮĞůĚ͕ƉĂǀŝŶŐƚŚĞǁĂLJĨŽƌ
ĂŶŝŵĂůƐĐŽŶƚĂŝŶŝŶŐůŽǁͲƌŝƐŬ/'ƐƚŽŵŽƌĞ
ĞĸĐŝĞŶƚůLJƌĞĂĐŚƚŚĞŵĂƌŬĞƚƉůĂĐĞ͘͟
ĂƐĞĚ ŽŶ ƚŚĞ ĂŐĞŶĐLJ͛Ɛ ƌĞǀŝĞǁ ŽĨ
ƐĐŝĞŶƟĮĐ ĚĂƚĂ͕ & ŚĂƐ ĚĞƚĞƌŵŝŶĞĚ ƚŚĂƚ
ƚŚĞƉƌŽĚƵĐƚŝƐůŽǁͲƌŝƐŬĂŶĚĚŽĞƐŶŽƚƌĂŝƐĞ
any safety concerns, and FDA does not
ĞdžƉĞĐƚƚŚĞƉƌŽĚƵĐƚĚĞǀĞůŽƉĞƌŽĨƚŚĞ/'ƚŽ
ƉƵƌƐƵĞ&͛ƐĂƉƉƌŽǀĂůƉƌŝŽƌƚŽŵĂƌŬĞƟŶŐ
;ĞŶĨŽƌĐĞŵĞŶƚ ĚŝƐĐƌĞƚŝŽŶͿ͘ dŽ ĚĂƚĞ͕ ƚŚĞ
&ŚĂƐŵĂĚĞůŽǁͲƌŝƐŬĚĞƚĞƌŵŝŶĂƟŽŶƐĨŽƌ
ĞŶĨŽƌĐĞŵĞŶƚĚŝƐĐƌĞƟŽŶǁŝƚŚŵĂŶLJŽƚŚĞƌ
/'ƐŝŶĂŶŝŵĂůƐĨŽƌŶŽŶĨŽŽĚƵƐĞƐĂŶĚŚĂƐ
ĂƉƉƌŽǀĞĚ ĂƉƉůŝĐĂƚŝŽŶƐ ĨŽƌ ĨŝǀĞ /'Ɛ͗ ŝŶ
ŐƌŽƵƉƐŽĨŐŽĂƚƐ͕ĐŚŝĐŬĞŶƐ͕ƐĂůŵŽŶ͕ƌĂďďŝƚƐ
and, most recently, in a line of pigs.
/'Ɛ ĂƌĞ ĂůƚĞƌĂƚŝŽŶƐ ŵĂĚĞ ƵƐŝŶŐ
molecular technologies that introduce
changes to the genome of an animal. The
/'ŝŶƚŚĞƐĞĐĂƩůĞ͕ŬŶŽǁŶĂƐWZ>ZͲ^>/<
ĐĂƩůĞ͕ ǁĂƐ ŝŶƚƌŽĚƵĐĞĚ ƵƐŝŶŐ Ă ŐĞŶŽŵĞͲ
ĞĚŝƟŶŐ ƚĞĐŚŶŝƋƵĞ ŬŶŽǁŶ ĂƐ Z/^WZ͘ dŚĞ
/'ĐĂŶďĞƉĂƐƐĞĚŽŶƚŽŽīƐƉƌŝŶŐ͕ĂůůŽǁŝŶŐ
ƚŚĞƚƌĂŝƚƚŽďĞƐŚĂƌĞĚƚŚƌŽƵŐŚĐŽŶǀĞŶƟŽŶĂů
ďƌĞĞĚŝŶŐ͘ dŚĞƌĞ ĂƌĞ ĐŽŶǀĞŶƟŽŶĂůůLJ ďƌĞĚ
ĐĂƩůĞǁŝƚŚŶĂƚƵƌĂůůLJŽĐĐƵƌƌŝŶŐŵƵƚĂƟŽŶƐ
ƚŚĂƚ ƌĞƐƵůƚ ŝŶ ƚŚĞ ƐĂŵĞ ĞdžƚƌĞŵĞůLJ ƐŚŽƌƚ͕
ƐůŝĐŬͲŚĂŝƌĐŽĂƚ͘
ZĞƉŽƌƚƐŝŶƐĐŝĞŶƟĮĐůŝƚĞƌĂƚƵƌĞŝŶĚŝĐĂƚĞ
ĐĂƩůĞǁŝƚŚƚŚŝƐĞdžƚƌĞŵĞůLJƐŚŽƌƚ͕ƐůŝĐŬͲŚĂŝƌ
ĐŽĂƚ ĂƌĞ ƉŽƚĞŶƚŝĂůůLJ ĂďůĞ ƚŽ ďĞƚƚĞƌ ǁŝƚŚƐƚĂŶĚ ŚŽƚ ǁĞĂƚŚĞƌ͘
ĂƩůĞƚŚĂƚĂƌĞĐŽŵĨŽƌƚĂďůĞŝŶƚŚĞŝƌĞŶǀŝƌŽŶŵĞŶƚĂƌĞůĞƐƐůŝŬĞůLJ
ƚŽ ĞdžƉĞƌŝĞŶĐĞ ƚĞŵƉĞƌĂƚƵƌĞͲƌĞůĂƚĞĚ ƐƚƌĞƐƐ ĂŶĚ ŵĂLJ ƌĞƐƵůƚ ŝŶ
ŝŵƉƌŽǀĞĚĨŽŽĚƉƌŽĚƵĐƟŽŶ͘ůƚŚŽƵŐŚWZ>ZͲ^>/<ĐĂƩůĞŚĂǀĞĂŶ
ĞƋƵŝǀĂůĞŶƚƚƌĂŝƚƚŽƚŚŽƐĞǁŝƚŚĂŶĂƚƵƌĂůůLJŽĐĐƵƌƌŝŶŐƐŚŽƌƚŚĂŝƌ
coat, they are not currently in commerce. The product developer
ƉůĂŶƐƚŽƵƐĞƚŚĞŐĞŶĞƟĐƉƌŽĚƵĐƚƐĨƌŽŵƚŚĞƐĞƚǁŽĂŶŝŵĂůƐƐŽŽŶ
ǁŝƚŚƐĞůĞĐƚĐƵƐƚŽŵĞƌƐŝŶƚŚĞŐůŽďĂůŵĂƌŬĞƚĂŶĚĂŶƟĐŝƉĂƚĞƐŵĞĂƚ
ƉƌŽĚƵĐƚƐǁŝůůďĞĂǀĂŝůĂďůĞĨŽƌƉƵƌĐŚĂƐĞďLJŐĞŶĞƌĂůĐŽŶƐƵŵĞƌƐŝŶ
as early as two years. R
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