Document ID: EPA-HQ-OPP-2008-0478-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-07-08T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460      

	OFFICE OF PREVENTION, PESTICIDES

                                                                        
                   AND TOXIC SUBSTANCES

	

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  		12/JUN/2009

SUBJECT:	Pyrimethanil;  Amended: Section 3 Registration Request to
Register New Postharvest Uses on Stone Fruit, Crop Group 12 and a
Preharvest Use on Lemon.  Summary of Analytical Chemistry and Residue
Data.

  

PC Code:  288201	DP Barcode:   D366080

Decision No.: 393117	Registration No.: 400-168

Petition No.: 8E7353	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  70852-53-8

MRID No.:  NA	40 CFR:  40 CFR §180.231

	         									

FROM:	Debra Rate, Ph.D., Biologist

		Alternative Risk Integration and Assessment (ARIA) Team

		Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

		Registration Division (RD) (7505P)

				

THROUGH:	John Redden, Team Leader

		ARIA/RIMUERB/RD (7505P)

AND

			George F. Kramer, Ph.D., Senior Chemist

Risk Assessment Branch 1 (RAB1)

			Health Effects Division (HED; 7509P)

	

TO:	Susan Stanton, Environmental Specialist

	IR-4 Team/RIMUERB/RD (7505P)

		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 

		

Upon reconsideration, ARIA, in consultation with RAB1, ChemSAC, and OGC,
has determined that changes are required for the previous memorandum,
DP# 361301, D. Rate, 05/MAR/2009.  

In order to remain in compliance with CFR40 §180.1(h), ARIA has
recommended for revisions to the previous recommendations in DP# 361301
(D. Rate, 05/MAR/2009).  The following amendments to tolerance
recommendations will have no negative impact on dietary (acute and
chronic) risk and, in fact, the recent human health risk assessment (DP#
353181, D. Rate, 25/MAR/2009) can be considered to be more conservative
with the amended recommendations. 

The purpose of this memorandum is to make revisions to the conclusion,
regulatory recommendations, residue chemistry deficiencies and proposed
tolerance sections of DP# 361301.  

No changes in the original document other than those explicitly set
forth here are necessary.

I.	 CONCLUSIONS

Regulatory Recommendations 

Provided that a revised Section B, label (see requirements under
Directions for Use) and Section F (see requirements under Proposed
Tolerances) are submitted in addition to the submission of analytical
reference standards to replace expired samples; there are no residue
chemistry issues that would preclude granting a registration for uses of
pyrimethanil (Penbotec® 400SC (EPA Reg. No. 43813-32-2792) and Scala®
SC (EPA Reg. No. 264-788)) on stone fruit and citrus fruit.  ARIA
recommends for the following permanent tolerances:

Fruit, stone, group 12	10 ppm

Fruit, citrus, group 10, except lemon, postharvest    	10 ppm

Lemon, preharvest and postharvest	11 ppm

ARIA recommends for the removal of the following tolerances
concomitantly with the establishment of the above tolerances:

Fruit, stone (except cherry), group 12	3.0 ppm

Fruit, citrus group 10 (postharvest)	10 ppm

Residue Chemistry Deficiencies

860.1200 Directions for Use

The label should be revised to prohibit the use of adjuvants with
Scala® SC in the preharvest treatment of lemons.  The submitted label
for Penbotec® 400SC states that stone fruit can be treated by high
volume spray, drench or dip; however, only stone fruit (except cherries)
may be treated with low-volume spray.  A revised Section B should be
submitted which accurately reflects the field trial data and label
instructions for both products.  

860.1550 Proposed Tolerances

A summary of the recommended tolerances along with recommendations for
commodity definitions are presented in Table 9.  The petitioner should
submit a revised Section F to reflect these tolerance and commodity
definitions.

860.1650 Submittal of Analytical Reference Standards

The petitioner should submit new analytical standards for pyrimethanil,
to replace the expired samples.  

860.1500 Crop Field Trials

Lemon

47425604.der.doc, D. Rate, 03/NOV/2008. (Lemon)

Table 4.  Summary of Residue Data from Crop Field Trials with
Pyrimethanil.

Commodity	Total Applic. Rate

 (lb ai/A)	PHI 

(days)	Sample size (n)	Residue Levels (ppm)

Min.	Max.	HAFT*	Median	Mean	Std. Dev.

Lemon	0.690 – 0.817	7	10	0.068	0.31	0.27	0.22	0.20	0.080

*HAFT = Highest Average Field Trial

IR-4 submitted field trial data to support the establishment of a
tolerance for residue of pyrimethanil in or on lemon.  Five field trials
were conducted for this study during the 2004 – 2005 growing season in
CA (Region 10).  At each trial, one foliar air blast application of
Scala( SC (54.6 % pyrimethanil) with no adjuvants or additives was made
at a rate of approximately 0.70 lb ai/A.  Mature lemons were harvested 7
days after the application.

Residues of pyrimethanil were analyzed in the IR-4 Western Region
Laboratory, Davis, CA.  The procedure used for the analysis was derived
from the AgrEvo UK Limited method 140/01/012, “Fruit and Vegetables:
Analytical Method for the Determination of Residues (Improved Version),
Pyrimethanil, Active Substance.”  Pyrimethanil residues in lemon were
extracted by homogenization with acetone.  An aliquot of the extract was
acidified then washed with hexane before adding base to enable solvent
partition.  Final clean-up was by silica SPE, with determination by
GC/MSD.

Based on recoveries of samples fortified at the LLMV, 0.05 ppm, the LOD
and LOQ were calculated as 0.017 ppm and 0.052 ppm, respectively.  No
residue decline data was submitted.

Conclusions:  In combination with previously reviewed data and the
established tolerance of 10 ppm for postharvest treatment of citrus
fruit, ARIA recommends for a tolerance in/on fruit, citrus, group 10,
except lemon, postharvest at 10 ppm and a tolerance in/on lemon,
preharvest and postharvest at 11 ppm.  Concomitant with the
establishment of the recommended tolerance, ARIA recommends for the
removal of the current 10 ppm tolerance on fruit, citrus, group 10
(postharvest).

860.1550 Proposed Tolerances

The Agency has determined that the residue of concern for the purpose of
tolerance expression in plants is parent only.  The residues of concern
for tolerance expression in ruminant tissues are parent + Metabolite
AEC614276, and for milk are parent + Metabolite AEC614277; see Figure 1
(Attachment 1) for chemical names and structures of these regulated
compounds.  The tolerance expressions proposed by the petitioner in its
submission of Section F are consistent with the tolerance definitions
for pyrimethanil in 40 CFR §180.518.

A summary of the recommended tolerances for the commodities addressed in
the current petition is listed in Table 9.

The recommended tolerance of 10 ppm for stone fruits (crop group 12) is
adequate and is supported by the submitted residue data.  When the
maximum residues from all routes of pyrimethanil exposure to stone
fruits (crop group 12) are considered (i.e., postharvest by high-volume
spray, drench or dip, or low-volume spray + preharvest application), the
total residues (ppm) are expected to be below the recommended tolerance.

The proposed tolerance of 10 ppm in/on fruit, citrus, group10, except
lemon, postharvest is adequate and is supported by previously reviewed
residue data reflecting the proposed use pattern (DP#   SEQ CHAPTER \h
\r 1 284001 and 284870,   SEQ CHAPTER \h \r 1 J. Morales and   SEQ
CHAPTER \h \r 1 G. Kramer,   SEQ CHAPTER \h \r 1 12/JAN/2004).  The
proposed tolerance in/on lemon, preharvest and postharvest at 11 ppm is
also supported by previously reviewed data in combination with the
submitted studies.  Thus, ARIA recommends to establish the proposed
tolerances.

Codex maximum residue limits (MRLs) have been established for
pyrimethanil per se in/on plant commodities.  Codex MRLs are listed for
citrus fruit at 7 ppm (postharvest); cherry (postharvest), peach and
nectarine at 4 ppm; apricot at 3 ppm; and plum at 2 ppm.  Presumably due
to differences in application and use patterns, harmonization is not
feasible at this time.

A Canadian MRL for citrus fruit (Calamondins, citrus citron, citrus
hybrids, grapefruits, kumquats, lemons, limes, oranges, pummelos,
satsuma mandarins, tangerines) is established at 10 ppm and for stone
fruit (apricots,  nectarines, peaches, plumcots, plums, prune plums)
established at 3 ppm.  There are no Mexican MRLs established for
residues of pyrimethanil in commodities associated with this review.  

An International Residue Limit (IRL) form is appended to this Summary
Document and follows this section.

Table 9.  Tolerance Summary for Pyrimethanil.

Commodity	Proposed / Established Tolerance (ppm)	Recommended Tolerance
(ppm)	Comments; Correct Commodity Definition

40 CFR §180.518 (a)(1)

Stone Fruits (Crop Group 12) 	10	10	Fruit, stone, group 12

Fruit, citrus (except lemon), group 10 (postharvest)		10	10	Fruit,
citrus, group 10, except lemon, postharvest

Lemon	11	11	Lemon, preharvest  and postharvest

Fruit, stone (except cherry), group 12	3.0	Remove

	Fruit, citrus, group 10 (postharvest)	10	Remove

	

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