(a) Any applicant who submits a study of a type listed in paragraph (b) of this section must submit with the study a statement in accordance with paragraph (c) of this section.
(b) The following table indicates the study types and the criteria to be applied to each. Column 1 lists the study types by name. Column 2 lists the associated Pesticide Assessment Guideline number. Column 3 lists the criteria applicable to each type of study. Column 4 lists the reporting code to be included in the statement specified in paragraph (c) of this section when any criterion is met or exceeded.
Table--Flagging Criteria----------------------------------------------------------------------------------------------------------------
Criteria: Treated animals show Criteria
Study Type(s) Guideline No. any of the following: No.----------------------------------------------------------------------------------------------------------------Carcinogenicity or combined carcinogenicity/ 870.4200 An incidence of neoplasms in 1
chronic feeding study 870.4300 males or females which increases
with dose (positive trend
p<=0.05); or
A statistically significant 2
(pairwise p<=0.05) increase of
any type of neoplasm in any test
group, males or females at any
dose level, compared to
concurrent control animals of
the same sex; or
An increase in any type of 3
uncommon or rare neoplasms in
any test group, males or females
animals at any dose level,
compared to concurrent controls
of the same sex; or
A decrease in the time to 4
development of any type of
neoplasms in any test group,
males or females at any dose
level, compared to concurrent
controls of the same sex.----------------------------------------------------------------------------------------------------------------Prenatal developmental toxicity 870.3700 When compared to concurrent 5Reproduction and fertility..................... 870.3800 controls, treated offspring showDevelopmental neurotoxicity.................... 870.6300 a dose-related increase in
malformations, pre- or post-
natal deaths, or persistent
functional or behavioral changes
on a litter basis in the absence
of significant maternal toxicity
at the same dose level.----------------------------------------------------------------------------------------------------------------Neurotoxicity 870.6100 When compared to concurrent 6
870.6200 controls, treated animals show a
statistically or biologically
significant increase in
neuropathological lesions or
persistent functional or
behavioral changes.----------------------------------------------------------------------------------------------------------------Chronic feeding 870.4100 The no observed adverse effect 7Carcinogenicity................................ 870.4200 level (NOAEL) from one of theseReproduction and fertility..................... 870.3800 studies is less than the NOAELPrenatal developmental toxicity................ 870.3700 currently used by the Agency asDevelopmental neurotoxicity.................... 870.6300 the basis for either the acuteAcute or 90-day neurotoxicity.................. 870.6200 or chronic reference dose.----------------------------------------------------------------------------------------------------------------
(c) Identification of studies. For each study of a type identified in paragraph (b) of this section, the applicant shall include the appropriate one of the following two statements, together with the signature of the authorized representative of the company, and the date of signature:
(1) Study does not meet or exceed criteria.
I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study neither meets nor exceeds any of the applicable criteria.
(2) Study meets or exceeds criteria.
I have applied the criteria of 40 CFR 158.34 for flagging studies for potential adverse effects to the results of the attached study. This study meets or exceeds the criteria numbered [insert all applicable reporting codes].