Document ID: EPA-HQ-OPP-2007-0536-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-23T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		August 13, 2009

Subject:	FENARIMOL.  Re-Assessment of Harmonization of Proposed
Tolerance of Fenarimol on Hops with CODEX MRL.  

PC Code:  	206600	DP Barcode:	368101

Decision No.:	367682	Registration No.:	10163-273

Petition No.:	6E7074	Regulatory Action:	Section 3

Assessment Type:	None	Registration Case No.:	None

TXR No.:	None	CAS No.:	60168-88-9

MRID No.:	None	40 CFR:	§180.421

  SEQ CHAPTER \h \r 1 From:		  SEQ CHAPTER \h \r 1 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:		  SEQ CHAPTER \h \r 1 John Redden, Team Leader

				ARIA

				RIMUERB/RD (7505P)

		

				AND

		

				Jack Arthur, Acting Branch Chief

			Risk Assessment Branch 5 (RAB5)

			Health Effects Division (HED; 7509P)

To:	Laura Nolen/Barbara Madden/Dan Rosenblatt, RM Team 05 

			RIMUERB/RD (7505P)

	  SEQ CHAPTER \h \r 1 

Following the risk assessment for fenarimol considering the proposed
new use on hops, dried cone (DP# 330714, B. Hanson, 30/JUL/2009), it was
determined that there was an existing CODEX MRL on the commodity, hops,
dried cone at the level of 5.0 ppm for the chemical fenarimol. 
Currently the tolerance recommendation from ARIA is 1.2 ppm.

Since there is an existing CODEX MRL, the question of harmonization has
been re-examined for the use of fenarimol on hops.  Based on use
pattern, residue definition, resulting dietary and aggregate risks and
exposures, ARIA has concluded that no significant increase in harm to
any population or population subgroup would result from the
harmonization of the US EPA tolerance in/on hop, dried cones to 5.0 ppm.

With increased foreign trade, especially with the hops commodity, the
ability to harmonize, when possible is an advantage to both the US and
our foreign partners.  The following arguments will demonstrate the
dietary exposure and risks as well as the aggregate exposure and risks
associated with raising the proposed tolerance on hop, dried cones from
1.2 ppm to 5.0 ppm.

1.  The use patterns of fenarimol on hops for the US and European
community are similar with the following directions for use:

1) application rate of approximately 0.054 lb ai/A, with a maximum of 4
applications; 2) 14-day retreatment interval (RTI); and 3) 10 day
preharvest interval (PHI).

2.  The residue definition for tolerance is also equivalent between the
US EPA and CODEX.

3.  Below, in Table 1, is a summary of the risk and exposure of
fenarimol use with the residue level for hops set at 1.2 ppm and 5.0
ppm.  Notice that the most highly exposed population subgroup is all
infants (<1 year old) at 76% of the chronic population-adjusted dose
(cPAD).  Table 1 also summaries the change in dietary (food + water)
risk and exposure as a result of harmonizing the hops tolerance to 5.0
ppm.

Table 1.  Summary of Chronic Dietary Exposure and Risk for Fenarimol
with 1.2 ppm or 5.0 ppm Residue for Hops, dry cone.  

Population Subgroup1	DEEM Chronic Dietary Analysis

	Hops Residue = 1.2 ppm	Hops Residue = 5.0 ppm

	Exposure (mg/kg/day)	% cPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.001402	23	0.001429	24

All Infants (< 1 year old)	0.004570	76	0.004570	76

Children 1-2 years old	0.002080	35	0.002080	35

Children 3-5 years old	0.001942	32	0.001942	32

Children 6-12 years old	0.001337	22	0.001337	22

Youth 13-19 years old	0.001010	17	0.001020	17

Adults 20-49 years old	0.001315	22	0.001362	23

Adults 50+ years old	0.001374	23	0.001392	23

Females 13-49 years old	0.001300	22	0.001316	22

1 Values for the population with the highest risk for each type of risk
assessment are bolded.  

2 NA = Not Applicable; no acute dietary endpoint was identified for
these population subgroups.

4.  Because no appropriate endpoint was available to determine the aRfD
for the general population or any population subgroup, an acute dietary
or aggregate risk assessment was not performed.  

≥ 1000 is required since a lowest-observable adverse-effect level
(LOAEL) was used for risk assessment (i.e., a no-observable
adverse-effect level (NOAEL) was not established in the critical study).
 Note: A level of concern (LOC) of a MOE of 300 was previously used but
has since been raised to 1000 (DP#: 331611, C. Swartz, 3/22/2007).

Table 2.  Short-Term Aggregate Risk for Fenarimol

Population	NOAEL	Food + Drinking Water	Dermal	LOC	MOE Aggregate

EXP	EXP

Adults 20-49 years old	35	0.001362	0.0026	1000	8800

Dermal Exposure = TTR (1.53 µg/cm2) x TC (500 cm2/hr) x conversion
factor (1 mg/l,000 µg) x exposure time (4 hrs golfing) x Dermal
Absorption Factor (5/100) / body weight (60 kg adult).  Short-term MOEs
were calculated using DAT 0 residue values.

TTR turf transferable residue

DAT days after treatment

6.  Since intermediate/long-term exposures are not anticipated, an
intermediate-term aggregate risk assessment was not necessary.  Hence, a
rise in the level of residues of hops used in the human health risk
assessment will have no impact.

7.  Since the chronic aggregate risk assessment includes exposure from
food and drinking water only, and the chronic dietary analysis that was
performed included both, no further calculations are necessary.  With
EFED’s suggestions for restricting fenarimol use on turf to
professional stadia and golf course tees, greens, and fairways at the
currently proposed application rates (resulting in an EDWC of 66 ppb)
the chronic dietary and, therefore, chronic aggregate risks are below
ARIA’s and HED’s level of concern.

8.  Because fenarimol is “not likely to be carcinogenic to humans”,
an aggregate cancer risk assessment was not required.