Kraig Biocraft Laboratories Inc (KBLB)

[Gyalogtank]

"If you have any information on requirements of the FDA for GMO's that are not eaten, that would be helpful."

GM-cotton for instance. https://en.wikipedia.org/wiki/Bt_cotton

And GM-silkworms are regulated by the FDA:
https://www.loc.gov/law/help/restrictions-on-gmos/usa.php

"The FDA also asserts jurisdiction over genetically engineered animals, pursuant to its authority to regulate “new animal drugs” (NADs) under the FFDCA.[52] Under the FFDCA, NADs are deemed generally unsafe unless the FDA has approved a New Animal Drug Application (NADA) for the particular use of the drug.[53] Except in cases in which the FDA exercises discretion to decline to require compliance,[54] or where the drug is only for investigational use and thus need only conform to specified exemptions,[55] the FDA requires a genetically engineered (GE) animal to be the subject of an approved NADA based on a demonstration that it is safe and effective for its intended use.[56] A NADA for a GE animal must include information on the animal’s identification; chemistry; clinical purpose; labeling; components and composition; manufacturing methods, facilities, and controls; safety and effectiveness; environmental impact; and other information.[57]"


"Do you think they currently aren't producing GMO's in the U.S.? "

Yes, they are producing GM-silkworms. In limited quantities in research laboratories. Experimentally under umbrella licences research institutes or companies have on GMOs which are not sold on the market. And some GMOs are produced commercially with the approval of the FDA.

"They produced enough for the Army to send them shoot pack panels."

How much did they sell those panels? Experimental, scientific, research uses are widespread, but selling GMOs is a completely different matter. For our purely selfish reasons we are only interested in silk if it can be sold for money to generate revenue.

"Would this require approval?"

A much looser approval for research and development uses which can be obtained easily.

"Do you think they didn't have that approval, if required for non-edibles? "

Most likely the experimental rearing of silk moths was approved. The commercial production of them not.

"All GMO's on the list of approved GMO's are edibles. "

Actually there are several strains of alfalfa and cotton on the approved GMO list none of them edible. https://www.ncbi.nlm.nih.gov/pubmed/28230933

"If I remember correctly, KBLB has a statement from the FDA that says approval is not required."

Highly unlikely.

Let me tell you a story from the same source: https://www.ncbi.nlm.nih.gov/pubmed/28230933

"BOX 3-2 The ProdiGene Incident: Noncompliance with Regulatory Processes
The production of plant-based pharmaceutical or industrial proteins has two main components: the GE
crop and the bioprocess to achieve the final product. ProdiGene was a private biotechnology company
based in College Station, Texas, that focused on the use of GE plants to produce proteins, enzymes, and
molecules for pharmaceutical and industrial applications. In 1997, ProdiGene began field trials for GE
maize plants in Nebraska, Texas, and Iowa. The company’s largest trial was conducted in 2001 to produce
a combination of proteins in about 22 hectares of maize. 1
In mid-2002, the company entered into an agreement with Sigma-Aldrich Fine Chemicals to
manufacture recombinant trypsin using ProdiGene’s GE plant system. The GE maize expressed trypsin
genes from domestic cow in the grain (USDA-APHIS, 2004). The process promised to be scalable and
profitable for both sides because of a high demand for animal-free products; traditional commercial
production of trypsin involves animal systems (Wood, 2002). However, during field trials of commercial
production of recombinant proteins in GE plants (maize), the company was faced with a series of
noncompliance events that led to punitive action.
In September 2002, inspectors from the U.S. Department of Agriculture (USDA) found volunteer 2
maize growing in an Iowa soybean field that had been a field-test site for ProdiGene’s GE maize during the
previous growing season. ProdiGene failed to notify USDA, in accordance with permit conditions, about
volunteer maize plants with tassels within 24 hours of their discovery. After the discovery by the
inspectors, ProdiGene destroyed some 61 hectares of maize seed and plant material within 400 meters of
the previous year’s test plot under the inspectors’ supervision.
In October 2002, USDA inspectors again found volunteer GE maize with tassels from the previous
year’s Nebraska test sites growing in a soybean field. The company was ordered to remove all the volunteer
maize to prevent its harvesting with the soybeans. However, the company failed to remove the volunteer
maize, and about 500 bushels of soybeans were harvested and sent to a grain elevator, where they were
mixed with another 500,000 bushels of soybeans. At that point, all soybean movement at the elevator was
stopped, and USDA destroyed all 500,000 bushels of soybeans.
After an investigation by USDA’s Investigative and Enforcement Services and a formal administrative
proceeding, ProdiGene was issued a $250,000 penalty. In an additional consent decision, ProdiGene agreed
to reimburse USDA for the cost of buying, moving, and incinerating 500,000 bushels of soybeans and to
post a $1 million bond to demonstrate financial responsibility for any future violations. USDA provided an
interest-free loan to ProdiGene for the full $3.75 million penalty and clean-up cost. When International
Oilseed Distributors, Inc. bought ProdiGene in August 2003, it assumed the unpaid portions of the USDA
loan.
In 2004, a USDA inspector found volunteer maize in baled oats that had been grown in the fallow zone
alongside a ProdiGene test field that contained a maize variety engineered to produce pharmaceutical or
industrial compounds. The baled oats were to be used as on-farm animal feed. The inspector found
volunteer maize growing and flowering in the fallow zone surrounding the test field and in a nearby
sorghum (Sorghum bicolor) field planted within a 1.6-km isolation distance. As part of its remedial action,
ProdiGene destroyed all volunteers in the isolation zone and plowed under the sorghum field under USDA
supervision; all suspect oat bales were quarantined and later destroyed.
In a July 26, 2007, settlement with USDA, ProdiGene, Inc. paid a $3,500 civil penalty and agreed that
neither it nor “its successors in interest” would ever again apply to USDA for a notification or permit to
introduce GE products."