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techniques. These firms include those producing substances and materials to be used as or in
biologics, drugs, or devices for use in humans and those producing substances used as or in
veterinary biologics and all research institution involved in biotechnology.
Guidance Recommendations
There are diverse guidelines outlined in the guidance. First, under the Investigation New
Animal Drug (INAD) recommends, that producer and developers of animals with intentionally
modified genome should ensure that investigational animals and/or their products are used only
for research purposes in order to prevent release of unsafe animals and their products into the
market. Second, there is need to ensure all shipments of investigational animals and/or their
products must be labeled correctly indicating edible products from the animal and those that
require certification and authorization of FDA to warrant consumption. In addition, proper
labeling materials of particular animals with modified DNA must be sort from the FDA to ensure
the animals are seed for the intended purpose.
The third recommendation is to ensure non-edible foods from animals with intentionally
modified genome are not supplied to the market without FDA’s approval to ascertain the safety,
genotypic and phenotypic stability of the animals. Approval of Investigational Food Use
Authorization must be sort before introducing any investigational animals and products into the
food market and an environmental assessment should be conducted as per the set regulations on
the implication of introducing the investigational animals and products in the environment to
ascertain the potential health, animal environmental risks. Fourth, ensure surplus investigational
animals and/or their products are buried or incinerated and ensure proper storage of appropriate
identification and deposition documentation.
