USDA STATEMENTS
Select the appropriate statement according to the category which applies to your
samples.
A) Recombinant Microbes/Proteins et al
1. Name of protein, etc.
2. Produced by recombinant microbial expression in (name the microbe, E. coli)
which is considered not pathogenic for livestock or avian species and does not
contain genes or express antigens of livestock or poultry disease agents.
3. Does not originate from facilities where work with exotic disease agents affecting
livestock or avian species is conducted.
4. Preparation does not contain any animal derived additives, such as albumin.
5. or declaration identifying the additives and stating that the PRODUCT WILL BE
USED ONLY IN VITRO.
B) Cell lines, monoclonal antibodies
1. Monoclonal antibody raised against ________________(name immunogen).
2. For in vitro use only.
3. Material does not come from a facility where work with exotic viruses affecting
livestock and avian species is conducted.
4. Material is recombinant but contains no genes and expresses no products of exotic
livestock or poultry disease agents. ---OR--5. Material is not recombinant.
6. Human pharmaceuticals/vaccines, ready for use, not containing live animal or
poultry viruses as the vector.
C) Blood or tissue from lab animals (ie: mice, rats)
1. Samples are from healthy grown in the laboratory animals. The animals were not
exposed to or inoculated with any livestock or poultry disease agents exotic to the
United States and did not originate from a facility where work with exotic disease
agents affecting livestock or avian species is conducted. The samples contain no
other animal products such as Bovine Serum Albumin.
2. If antisera, must identify the immunogen.
D) Pharmaceuticals/bulk raw product/test kits
a) Pharmaceuticals, synthetic compounds, reagents
1. Name of drug.
2. Material Safety Data Sheet (MSDS), if available.
3. Material is chemically synthesized.
4. Material does not contain any animal or cell culture derived products or additives
such as albumin or serum.
5. Lab testing only (or the FDS IND#).
6. Not subject to TSCA (Toxic Substances Control Act).
b) Gelatin (if not of animal origin)
1. Finished human pharmaceutical in final dosage form.
2. Ready for human use.
c) Gelatin (if it is of animal origin-most gelatin is made from animal hide)
1. Requires USDA permit.
d) Test kits (not containing any drug)
1. Test kits and/or kit components are not intended to be used to diagnose infectious
diseases of animals.
2. Test kits and/or kit components are pre-packaged and ready for use.