Attachment II - Page 8 
50862 Federal Register / VoL 49, No. 252 / Monday, December 31, 1984 / Notices 
NOTES 
Interprets mandatory statutory 
requirements. 
Pesticides defined to include liv- 
ing organisms. n>A Review period 
could vary from one to several 
years. Fourteen microbial pesti- 
cides (noo-engineered) have been 
approved. 
120 day review period; can be 
extended. 
Higher plants and animals and 
certain pheromone attractants have 
been exempted. 
Includes data requirements for 
microbial pesticides. Testing 
requirements are tiered, with more 
complicated tests required where 
certain criteria are met. Addi- 
tional requirements for genetically 
modified and other microbial pesti- 
cides determined on a case-by-case 
basis. 
CROSS-REFERENCES 
EPA sets tolerance 
levels for pesticide 
residue in the food 
chain which EDA and 
USDA-FSIS enforce. 
USD A has responsibil- 
ity for higher plants 
and animals that are 
considered pesticides 
(40 CFR 162.5(c) (4) ) . 
Section 3 of FI FRA 
AFFECTED 
AGENCIES 
EPA, 
agencies 
that manu- 
facture 
"new 
ctiemi cal 
sub- 
stances" 
for com- 
mercial 
purposes. 
EPA, 
USDA-FSIS, 
HHS-EDA 
EPA 
EPA 
EPA, 
USD A- APHIS 
EPA 
AFFECTED 
PRODUCTS 
OR 
PROCESSES 
TSCA Chemical* 
Biological 
pesticides 
(e.g., micro- 
organisms or 
their chemical 
products) . 
Includes INA 
bacteria. 
Microbial 
pesticides 
DESCRIPTION 
PEN requirements 
Requires registration of 
pesticides before distribut ion 
or use (pesticide broadly 
defined as "any substance or 
mixture. .. intended for pre- 
venting, destroying, repelling 
or mitigating any pest, and 
...intended for use aa a plant 
regulant, defoliant, or 
dessicant.") 
Authorizes EPA to publish 
"guidelines" specifying kinds 
of information needed for 
registration. 
Authorizes EPA to issue 
experimental use permits for 
limited uses before registra- 
tion. 
Authorizes EPA to exempt a 
pesticide from registration. 
Data requirements for pesti- 
cide registration including 
genetically modified microbial 
pesticides 
AUTHORITY 
OR 
GUIDELINE 
Regulations: 
40 CFR 720 
Federal Insecticide, 
Fungicide and 
Rodent icide Act 
(FI FRA) 
(7 USC 136-136y) 
Sectioo 3 (c) (2) (A) 
Section 5 
Section 25 (b) 
Regulations: 
40 CFR 158 
[ 362 ] 
