Table 1 Protocol used and comparison to existing assessment and to non-mandatoryregulatory tests

Animals measured/group/sex

10/10 SD rats (200 rats measured)

10/20 SD rats (200 rats measured/total 400)

At least 10 rodents

Duration in months

24 (chronic)

3 (subchronic, 13 weeks)

3

Doses by treatment

3

2

At least 3

Treatments + controls

GMO NK603, GMO NK603 + Roundup, Roundup, and closest isogenicmaize

GMO NK603 + Roundup, closest isogenic maize, and 6 other maize linesnon substantially equivalent

GMOs or Chemicals (in standard diet or water)

Animals by cage (same sex)

1 to 2

1

1 or more

Monitoring/week

2

1

1 or more

Organs and tissues studied

For high dose and controls

Organs weighted

10

7

At least 8

Histology/animal

34

17/36

At least 30

Electronic microscopy

Yes

No

No

Feed and water consumptions

Measured

For feed only

At least feed

Behavioral studies (times)

2

1 (no protocol given)

1

Ophthalmology (times)

2

0

2

Blood parameters

31 (11 times for most)

31 (2 times)

At least 25 (at least 2 times)

Plasma sex steroids

Testosterone, estradiol

No

No, except if endocrine effects suspected

Number of blood samples/animal

11, each month (0 to 3) then every 3 months

2, weeks 4 and 13

1, at the end

Urine parameters studied

16

18

7 if performed

Number of urine samples

11

2

Optional, last week

Liver tissue parameters

6

0

0

Roundup residues in tissues

Studied

Not studied

Not mandatory

Microbiology in feces or urine

Yes

Yes

No

Transgene in tissues

Studied

Not studied

Not studied