161.34—Flagging of studies for potential adverse effects.
(a)
Any person who submits a study of a type listed in paragraph (b) of this section to support an application for new or amended registration, or to satisfy a requirement imposed under FIFRA sec. 3(c)(2)(B), must submit with the study a statement in accordance with paragraph (c) of this section.
(b)
The following table indicates that 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.
| Toxicity studies | Pesticide assessment guidelines No. | Criteria | Reporting code |
|---|---|---|---|
| Oncogenicity [or combined oncogenicity/chronic feeding study] | 83-2 | Treated animals show any of the following: | |
| or | |||
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Code of Federal Regulations
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| Subchronic feeding study | 82-1 | An incidence of neoplasms in male or female animals which increases with dose; | 1 |
| or | |||
| A statistically significant (p ≤0.05) incidence of any type of neoplasm in any test group (male or female animals at any dose level) compared to concurrent control animals of the same sex; | 2 | ||
| or | |||
| An increase in any type of uncommon or rare neoplasms in any test group (male or female animals at any dose level) compared to concurrent control animals | 3 | ||
| or | |||
| A decrease in the time to development of any type of neoplasms in any test group (male or female animals at any dose level) compared to concurrent control animals | 4 | ||
| Teratogenicity | 83-3 | When compared with concurrent controls, treated animals show a dose-related increase in malformations (or deaths) on a litter basis in the absence of significant maternal toxicity at the same dose levels | 5 |
| Neurotoxicity | 81-7 | When compared with controls, treated animals show a response indicative of acute delayed neurotoxicity | 6 |
| Chronic feeding study or combined chronic feeding/oncogenicity study | 83-1 | Cholinesterase inhibition NOEL less than 10 times the current existing ADI | 7 |
| or | |||
| General (systemic) toxicity NOEL less than 100 times the current existing ADI | 8 | ||
| Reproduction study | 83-4 | Reproductive effects NOEL less than 100 times the current ADI | 9 |
| Subchronic feeding study | 82-1 | Cholinesterase inhibition NOEL less than 100 times the current existing ADI | 10 |
| or | |||
| General (systemic) toxicity NOEL less than 1000 times the current existing ADI | 11 | ||
(c) Identification of studies.
For each study of a type identified in paragraph (b) of this section, the applicant (or registrant in the case of information submitted under FIFRA sec. 3(c)(2)(B)) 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)
“I have applied the criteria of 40 CFR 161.34 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)
“I have applied the criteria of 40 CFR 161.34 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.]”