Test Requirements

Question 1

What is part 1 of the data requirements for pesticide registration?

Answer 1

Product label for Active ingredient and end use product

Question 2

What is part 2 of the data requirements for pesticide registration?

Answer 2

Product chemistry for AI

Question 3

What is part 3 of the data requirements for pesticide registration?

Answer 3

Product chemistry for end product

Question 4

What is part 4 of the data requirements for pesticide registration?

Answer 4

Toxicology for AI and/or EP

Question 5

What is part 5 of the data requirements for pesticide registration?

Answer 5

Occupational and/or bystander exposure

Question 6

What is part 6 of the data requirements for pesticide registration?

Answer 6

Metabolism and TK studies for AI and/or EP

Question 7

What is part 7 of the data requirements for pesticide registration?

Answer 7

Food, feed and tobacco residues

Question 8

What is part 8 of the data requirements for pesticide registration?

Answer 8

Environmental Chemistry and Fate

Question 9

What is part 9 of the data requirements for pesticide registration?

Answer 9

Environmental Toxicology for EP and/or TGAI

Question 10

What is part 10 of the data requirements for pesticide registration?

Answer 10

Value (Efficacy) for EP

Question 11

What are the four human health studies submitted for the data requirements?

Answer 11

acute, short and long term and special studies

Question 12

What are the required studies submitted for pesticides for acute studies?

Answer 12

primary irritation, and dermal sensitization studies

Question 13

What are the required routes of exposure studies to be submitted in acute studies?

Answer 13

oral, dermal and inhalation

Question 14

What are conditionally required studies to be submitted in an acute toxicity package?

Answer 14

potentiation/interaction and antidotes

Question 15

What are the studies required for short term submission?

Answer 15

oral-rodent and non rodent
dermal-rodent

Question 16

What is the conditional study potentially required for short term submission?

Answer 16

inhalation

Question 17

What are the required studies for long term submission?

Answer 17

chronic and oncogenicity in two rodent species

Question 18

What are conditional studies for long term test submission?

Answer 18

combined chronic/oncogenicity

Question 19

What are the three required special studies data needed for a special study submission?

Answer 19

multigenerational reproduction and developmental tests in rodents
teratogenicity in rodents and non rodents
TK

Question 20

What are the two conditional studies for a special studies submission?

Answer 20

genotox and neurotox

Question 21

What are the potential genotox tests submitted?

Answer 21

microbial and mammalian cell point mutation, in-vitro chromosomal aberrations

Question 22

What species are used in neurotox tests?

Answer 22

rodents and hens

Question 23

What are the minimum and max number of tests needed for just the human health portion of the pesticide submission?

Answer 23

Min-25
Max-35

Question 24

What is the species required for terrestrial and aquatic invertebrates study protion of the enviro tox package?

Answer 24

earthworms and daphnia

Question 25

What are the conditional species tests needed for the enviro tox submission?

Answer 25

bees/pollinators, predators, and parasites

Question 26

What are the two categories that are conditional to test for in enviro tox submissions?

Answer 26

marine invertebrates and wild mammals

Question 27

What tests are performed on marine invertebrates?

Answer 27

acute and chronic tox, shell deposition, embryo/larval and bioconcentration

Question 28

What are the requirements for a fish study submission in enviro tox?

Answer 28

acute tox studies in cold and warm water species

Question 29

What are the conditional studies need in fish studies?

Answer 29

salinity challenges, ELS, full life cycle and bioaccumulation for sublethal and chronic studies

Question 30

What are the required studies for bird studies?

Answer 30

dietary exposure in quail and duck

Question 31

What are the conditional studies for birds?

Answer 31

repro, and special studies for use patterns (e.x. granules)

Question 32

What are the required organisms needed for non target plant studies?

Answer 32

freshwater algae, terrestrial and aquatic vascular plants

Question 33

What are some other studies submitted for the enviro tox data package?

Answer 33

benthic organisms for sediment studies and field studies

Question 34

What is the minimum and max amount of tests needed for the enviro tox portion of the submission?

Answer 34

9 and 38

Question 35

What is the minimum amount of studies submitted including human and environmental health and the actual most likely number?

Answer 35

34 and 50ish

Question 36

How many tests does PMRA require to register a new pesticide?

Answer 36

over 200