Attachment V - Page 1 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
RECOMBINANT DNA ADVISORY COMMITTEE 
SUBGROUP OF WORKING GROUP ON RELEASE INTO THE ENVIRONMENT 
MINUTES OF MEETING 
SEPTEMBER 14, 1984 
A subgroup of the Vforking Group on Release into the Environment net by telephone 
conference call fran 11:00 a.m. to 12:10 p.m. on September 14, 1984, to attempt 
to develop a document dealing with points to consider in data submissions for 
experiments involving field testing of microorganisms. Drs. George Lacy, Thomas 
Pirone, Sue Tolin, Anne Vidaver, and Elizabeth Milewski participated. 
Dr. Milewski began the discussion by calling the attention of the working 
group to a seminal document developed by Dr. Vidaver (Attachment I). 
Dr. Milewski asked Dr. Vidaver what definition of "microorganism" was used in 
developing the document, and whether this document was intended to apply only 
to plant associated microorganisms. Dr. Vidaver said she conceived of the 
document as applying to all microorganisms, i.e., bacteria, fungi, viruses. 
She did not see her proposed language as being restricted to plant associated 
microorganisms, although currently RAC is receiving proposals on plant associated 
microorganisms . 
Dr. Pirone offered the example of rumen bacteria as a type of agricultural 
proposal involving animals and microorganisms. He predicted such experiments 
would be reviewed by RAC in the near future. 
Dr. Tolin of ferred the example of livestock vaccines as uses of microorganisms 
which might be reviewed in the near future; she said such vaccines might be 
based on (1) live attenuated viruses or (2) a coat protein vaccine. 
Dr. Vidaver said she had also envisaged the document as applying to organisms 
used in mining or leaching ores vhen she ccmposed her proposed language. 
Dr. Pirone called the working group's attention to some of the data requirements 
in the document Points to Consider in the Preparation of TSCA Premanufacture 
Notices for Genetically Engineered Microorganisms frcm the Environmental Protec- 
tion Agency (EPA) (Attachment II). He suggested the following items in the E3?A 
document might be useful to consider: 
"3. Patholoaical, ecological, physiological traits of source organisms: 
a. Nature and degree of pathogenicity, infectivity, or toxicity 
to humans, other animals, plants, or microorganisms; host range; 
[ 43 ] 
