Lecture notes for Life Sc III yr -Regulating the use of biotech

Regulating the use of biotech

Regulation is done by - NIH- RAC (recombinant DNA advisory comittee)

Everyone knows why biotech should be regulated other wise evil scientists will create new Frankensteins.
(Read it yourself - Glick - Last chapter)

Regulation needs to be done in 3 major areas:

1Food ( Chymosin or rennin, Tryptophan, Bovine somatotrophin)
2Environment (Ice-minus Pseudomonas syringae)
3Medical (Human gene therapy)

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Brief explaination of these areas is as under:

1Food:
a) Chymosin (rennin) : this enzyme breaks casein protein which is present in milk. thus it helps in cuddling of milk which is helpful in cheese making. The enzyme has been synthesized in E. coli by rDNA tech.

FDA (food and drug administrations) asked the company to do many tests before it could be used. e.g
*To ensure that synthetic rennin was similar to natural one they were asked to prove it. so they did:
restriction mapping
SBH
sequencing

**To ensure that synthetic rennin doesn't contain E.coli contamination they were asked to prove it. so they explained purification:

the rChymosin was purified from inclusion bodies.
further the strain is non-pathogenic and non-toxigenic to humans.

b) Tryptophan
This amino acid was also produced by rDNA. However it caused disease - EMS - eosinophilia myalgia -syndrome (severe muscle pain).
It was caused by EBT (ethylene (bis) tryptophan) which is an intermediate of Trp.

It was banned by FDA

c) Bovine somatotropin (growth hormone)

Used to increase the size of mammary glands and thus increased milk production.

Major concerns: 1 -Mastitis (infection of mammary glands) - however FDA did not find any corelation with it. 2 - lameness in cattle.

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2 Environment ( release of GMO's)
GMO release is prohibited by EPA (environmental protection agency)

An example: Ice-Minus Pseudomonas syringae

In nature Ice-Plus strain is found. Which causes frost bite. By secreting a protein which forms ice crystal. The researches made an Ice-Minus strain which lack the gene for the protein and don't cause frost bite.

However permission was not granted to use it. Trials were held out in court and field which was a very time -consuming process.

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3 Human gene therapy

It is of two types:
a) somatic gene therapy - can be performed under guidelines
b) Germ line gene therapy - not permitted - due to accumulation of defective or unantural genes.

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P.S: details will be discussed in the class.