Attachment 1: STFG Guidance Document

Appendix 1: Decision Tree for Seed Treatment (Excluding Potato Seed-Piece Treatment)

Maximum Theoretical Residue in
Harvested RACs (Food And Feed)
<5 ppb?

No

Foliar Use Also Registered or
Proposed?

Yes

NF, No Data Required

Yes

No

ROC Same for Foliar And Soil
Treatments? (Compare Foliar
Metabolism Data with Confined
Rotational Crop Data)

<

Additional Data May Be Required On A Case-

By-Case Basis (E.G., Residue Data for Soil
Metabolites, Residue Data For Seed + Foliar
Application)

No

t

Definitions:

NF

Non-Food

LOQ

Limit of Quantification

ROC

Residues of Concern.



Note that if there is no



characterization/identification of



theTRR (total radioactive



residues), then the ROC = TRR.

Total Foliar + Seed Rate < 125% Foliar
Rate

(Label Restriction On the Foliar End-
Use Product May Be Required)

K

No Additional Data Required. Foliar
Tolerances Cover Seed Treatment.

Radiotracer Study Available?

No

Yes

Are Adequate Plant Metabolism
Data Available to Determine ROC?

Yes

Rate >10 g ai/100 kg Seed?

No

Conduct Radiotracer
Study

Then I

Yes I

For Human Foods, No Field Trial Data

Are Required and A LOQ-Level
Tolerance Is Set; For RACs That Are
Only Livestock Feed Items, A 50%
Reduction In The Number Of Trials
Can Be Applied.

Conduct
Radiotracer Study

Then I

Conduct FTs for
Tolerance Setting

TRR/ROC <5 ppb in All RACs (food
and feed) in IX Radiotracer Study?

No

Ye^f

nS

NF, No Additional Data Required. No
Tolerances Required.

OPTIONAL for Both Food/Feed Items:

ROC 5 ppb in
the Radiotracer Study. Tolerances Set (LOQ Level for RACs in Which ROC <5
ppb). For RACs that are Only Livestock Feed Items, a 50% Reduction in the
Number of Trials can be Applied. Note that Livestock Metabolism (and
Possibly Feeding) Studies Will Be Required and that Adequate Plant
Metabolism Should Be Available.

Yes

Food Use, No Additional Data
Required. Tolerances Set at LOC
Level for All RACs.

Notes: 1) For highly toxic chemicals, the 5 ppb ROC threshold value may be
reduced; 2) If the ROC are <5 ppb in radiotracer studies conducted on five
representative crops (small grain, radish or garden beets (analyze both root and
tops), leaf lettuce, soybeans, and a short season fruiting or cucurbit vegetable),
then seed treatment uses on all crops will be considered NF; 3) If the ROC in wheat
forage, hay, grain, and straw are all <5 ppb, then the seed treatment can be
considered nonfood for the following crops: wheat, barley, oats, rye, triticale,
buckwheat, sorghum, rice, and millet. Also, if the ROC is <5 ppb in all wheat and
corn RACs, then uses on all cereal grains can be classified as NF; 4) For uses on
soybeans and peanuts (or other legumes that are not grown as livestock feeds)
where ROC >5 ppb in soybean forage/hay and peanut hay, but <5 ppb in seeds or
nutmeats, the uses are classified as food uses and field trials required unless the
petitioner chooses to restrict feeding of the foliage parts of these crops. This
restriction would eliminate the need for crop field trials on the foliage, but a LOQ-
level tolerance would still be needed for the seeds or nutmeats; 5) If tolerances
are needed, then a validated enforcement method will always be required; 6) A
minimum of three trials are required for tolerance setting; 7) In cases where field
trials are waived for a human food RAC, a processing study will also not be
required.

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