Document ID: EPA-HQ-OPP-2005-0061-0182
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-10-20T04:00Z

September 22, 2006

Mr. James B. Gulliford

Assistant Administrator

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, N. W.  (7101M) 

Washington, DC 20460

Dear Mr. Gulliford:

The U.S. Apple Association (USApple) is the national trade association
representing all segments of the apple industry.  Members include 36
state apple associations representing 7,500 apple growers throughout the
country, as well as over 300 individual firms involved in the apple
business.

USApple collaborates with apple growers, university scientists and its
member organizations to provide information to government agencies on
regulatory and agricultural policies.  The Northwest Horticultural
Council (NHC) is a USApple member, and collaborated in development of
this letter.  We appreciate this opportunity to respond to your request
for new data that will help you and your staff make a fair decision
regarding the future use of azinphos methyl.

Apple Growers Need Azinphos Methyl

There are over 40 insects that plague apple growers across the United
States.  This wide variety of pests makes apple pest management one of
the most challenging and complex of all agricultural crops.  Broad
spectrum insecticides, such as azinphos methyl, have helped apple
growers manage a range of harmful insects, while allowing growers the
opportunity to enter their orchards to perform important horticultural
activities such as pruning, thinning and tree training.

Azinphos methyl is one of the most valuable insecticides to apple
growers, because it is economical and dependable.  It is also compatible
with Integrated Pest Management programs that foster growth of
populations of beneficial insects that prey on harmful insects.  Growers
use azinphos methyl to control pests, such as codling moth, oriental
fruit moth and plum curculio, that can destroy an entire apple crop in a
matter of hours.  Since the risk of crop loss is so great, apple growers
prefer to use azinphos methyl, because they know it will control harmful
insects.

If apple growers lose azinphos methyl they will be forced to adopt other
alternatives that are more difficult to use, and may not be as effective
under high pest populations.  The current alternatives are not effective
on all insect life stages, they must be applied in more specific time
windows and they require more precise application.  When weather events
have such a great potential to dictate application timing, growers lose
flexibility in timing their applications.  As a result, the potential
for missing critical windows is much greater, and the risk of crop loss
is greater.  Apple growers prefer to use azinphos methyl because it is
dependable and economical.  However, they also use other tactics to
control import pests.

In the Pacific Northwest and California, growers use mating disruption
in combination with a range of insecticides to control codling moth. 
However, mating disruption is not economically feasible in most Eastern
and Midwestern orchards, because multiple pest species must be
controlled simultaneously.  Pesticide applications would be necessary to
control the full range of pests even if mating disruption effectively
controlled one harmful insect species.

Azinphos methyl is also an important tool that helps growers avoid
dependence on any particular class of chemistry.  USApple is concerned
that the removal of azinphos methyl will result in a growing dependence
on available alternatives in the neonicotinoid class of chemicals that
could lead to insect resistance to those alternatives.  If resistance
develops, growers will be forced to use more pesticides to control pests
than if azinphos methyl were still available. 

Apple Impact Assessment

The U.S. Environmental Protection Agency’s (EPA) azinphos methyl
impact assessment estimates that apple growers would sustain losses
totaling as much as $81 million if azinphos methyl were cancelled. 
USApple has submitted comments to EPA explaining that the impact is
underestimated, because the agency’s chemical cost estimates were low,
miticide applications were not included in the estimate, and the agency
did not factor in anticipated damage from the use of alternatives and
the expected increases in orchard monitoring costs.  However, even if
EPA’s estimate were not underestimated, an $81 million cost to apple
growers would be an enormous financial burden. 

Apple pest management is extremely complex and diverse across all
production regions.  It is difficult to capture the impact of EPA’s
underestimate of the impact from the loss of azinphos methyl.  However,
a specific example is explained below to represent the value of azinphos
methyl to apple growers.

Washington State Impact Assessment Example

In a recent visit to Washington state, EPA officials visited Olsen
Orchards located in the town of Buena, Washington in the heart of Yakima
County, the largest apple-producing county in the United States.  There
are approximately 55,000 acres of apples in Yakima County which makes it
larger than any other apple producing state in the nation with the
exception of Washington state in aggregate.  The Olsen orchard is
located in an area of Yakima County with steadily increasing codling
moth pressure.

Below is a treatment-by-treatment breakdown of the spray program in
Olsen orchards  The program illustrates that apple growers are already
using other alternative insecticides besides azinphos methyl.  In this
particular situation, mating disruption is being used in combination
with acetamiprid and novaluron, which are two of the alternatives EPA
suggest could be used in place of azinphos methyl.  This program clearly
shows that azinphos methyl is needed in combination with other
alternatives to attain effective control.  Removing azinphos methyl from
this program would be more expensive and it could lead to greater insect
resistance if several more applications of acetamiprid and novaluron are
used.  Washington growers continue to state that phosmet is not
considered a one for one replacement for azinphos methyl and it costs
more than azinphos methyl.

 

Mr. Olsen is also suffering increased codling moth damage that is highly
visible in the orchard.  He has also used had to use an additional
insecticide treatment to control mites, because use of acetamiprid
disrupted his biological mite control.  More applications of acetamiprid
would likely further exacerbate mite problems.  If this pressure
continues without respite, current alternatives, given that they are
less effective for codling moth control, would not provide adequate
codling moth control if azinphos methyl were phased-out.  While the
highest codling moth pressure is now limited to the south-central region
of Washington state, broader areas of the state are likely to experience
greater codling moth pressure as the economic conditions that have lead
to poorly managed orchards persist.

Table 1.  2006 Codling Moth Control Program in Olsen Orchards	 	 	 

Date	Insecticide	rate/acre	units	$ per unit	$ per acre	$ per application
Total Cost ($)/Acre

15-Apr	Isomate C+	200	ties	0.28	56	20	76

4-May	Pyriproxyfen	5	Oz.	9.25	46.25	17.35	63.6

25-May	Acetamiprid	3.4	Oz.	14.95	50.83	17.35	68.18

16-Jun	Azm	2	lbs.	12.4	24.8	17.35	42.15

29-Jun	Pyridaben	6.6	Oz.	6.95	45.87	17.35	63.22

6-Jul	Azm	2	lbs.	12.4	24.8	17.35	42.15

26-Jul	Novaluron	16	Oz.	1.59	25.44	17.35	42.79

9-Aug	Azm	2	lbs.	12.4	24.8	17.35	42.15

30-Aug	Methoxyfenozide	16	Oz.	2.34	37.44	17.35	54.79

 	 	 	 	 	 	Total	495.03

 	 	 	 	 	 	 	 

1 application	Phosmet	5	lbs.	9.6	48	17.35	65.35

 	 	 	 	 	 	 	 

Ecological Risk is Overestimated

USApple has commented on several occasions that the ecological risk
assessment overestimates the potential risk from the use of azinphos
methyl, because overly conservative scenarios are used to model
potential risk.  In the Western scenario, the agency uses a site with an
average annual rainfall of 36 inches, when the primary apple production
region receives annual rainfall of 6 inches.  The modelers go beyond
that to use an annual value of 39.7 inches to capture the 90th
percentile of the maximum annual peak concentration in 30 years to
calculate the risk.

In the Eastern Scenario, the agency’s model estimates the 90th
percentile of annual erosion to be 121 tons/ha. (49 tons/acre).  The
U.S. Department of Agriculture’s (USDA) National Resources
Conservation Service (NRCS) estimates average annual erosion from
Pennsylvania orchards from 2.1 tons/acre in average soils to 5.9
tons/acre in highly erosive soil in Adams County, Pennsylvania using its
widely accepted universal soil erosion model.,  Additionally, the 2003
NRCS National Resources Inventory Survey estimates New England/Mid
Atlantic average soil erosion to be 3.2 tons/acre.  If average erosion
in Pennsylvania is 4 tons/acre, EPA’s estimate would be 12 times
greater than the NRCS estimate.  Using the national inventory estimate
of 3.2 tons/acre, EPA’s estimate would be 15 times greater.

These are two examples that demonstrate how unrealistic assumptions
exaggerate the potential ecological risk from azinphos methyl use.  The
orchards visited by EPA staff during the week of Sept. 11, 2006 clearly
demonstrate that virtually continuous sod cover crops in these orchards
are playing a major role in reducing run-off.  We would argue that a
continuous cover crop in orchards and between orchards and the water
body offer significant protection when compared to the agency’s model
which greatly underestimates this protection.

Monitoring Data Conflict with EPA’s Ecological Model Results

USApple has also commented to EPA that its predictions of azinphos
methyl concentrations in water conflict with actual measurements from
water monitoring data.

EPA’s STORET (STOrage and RETrieval Database) and U.S. Geological
Survey (USGS) monitoring data indicate azinphos methyl concentrations
are mostly 1 ppb or less, with two peak values of less than 4 ppb
between 1990 and 2005.  After 2001, the highest concentrations from
actual monitoring data were 0.75 ppb in Oregon and less than 0.05 ppb in
Pennsylvania.  However, EPA’s predictive model estimates the
concentrations to be 9.9 ppb in Oregon and 15.1 ppb in Pennsylvania.

USApple maintains EPA’s modeled predictions are significantly
overestimated, because of the use of overly conservative assumptions
that do not represent real environmental or orchard conditions. 
Additionally, USApple believes the real concentrations are likely to
diminish over time because of the industry’s voluntary mitigation,
which proposes to reduce total annual applications from 8 lbs. to 6 lbs.
of formulated product.  USApple understands EPA used water monitoring
databases in its modeling process, but only up to 2001.  However,
monitoring data through 2001 would not capture the impact of significant
azinphos methyl mitigation that was implemented in 2002 and 2003. 
USApple has documented the impact of apple specific azinphos methyl
mitigation in previous comments.

U.S. Department of Agriculture statistics demonstrate that azinphos
methyl use decreased 31 percent from 2003 to 2005.  The average number
of applications decreased from 2.8 applications per acre in 2003 to 2.4
applications per acre in 2005 and the percent of apple acreage treated
declined from 73 percent in 2003 to 63 percent in 2005.  The apple
industry’s voluntary mitigation is expected to result in even less use
of azinphos methyl in the future.

Studies Targeting Azinphos Methyl Use Support Monitoring Data Results

Attached for your consideration is a study titled “Pesticide Use and
Toxicity Assay in Mission, Bender and Yaksum Creeks” prepared in 2003
by the Chelan County Conservation District.  This report examines
pesticide concentrations in small flowing streams before and after
applications of azinphos methyl and other orchard chemicals.  The
concentration detected appears to be well below the 0.4 ug. a.i./L level
that was shown to cause negative effects in a 21-day chronic toxicity
study.  Additionally, this study demonstrates that even in streams near
orchards where azinphos methyl was used, no daphnia, which represents
the most sensitive aquatic group, were found to be harmed by the
applications.  

Since the concentrations in the Chelan County study were measured in
flowing streams, any small azinphos methyl concentrations quickly
disappeared after the spraying event, which virtually eliminates the
likelihood of chronic toxicity at the levels predicted by EPA’s model.

The results of other field studies recently presented to the agency have
also documented very low levels of azinphos methyl in Northwest rivers
and creeks.  Monitoring of the Sulphur Creek Wasteway indicate that
maximum concentrations of azinphos methyl ranged from 0.023 ppb in 2003
to 0.14 ppb in 2005.  The highest of these values is still 70 times less
than the agency’s calculated value of 9.9 ug. a.i./L.  Additionally,
there is no evidence there is any significant persistence of the active
ingredient in Northwest waterways.

An analysis of the Lower Neel Creek in Oregon during the period of
summer azinphos methyl use indicates that average concentrations of
azinphos methyl were reduced from approximately 0.33 ppb to 0.02 ppb in
2005.  The 2005 average, based on actual monitoring data, would be 495
times less than the 9.9 ug. A.i./L predicted by EPA’s model.

While we understand the agency’s rationale for using an ecological
risk model to predict pesticide concentrations in water, we believe the
agency should utilize more realistic orchard practices and validate its
model predictions using monitoring data.

New aquatic concentration information, collected by diverse public
agencies in the west, suggests EPA’s model is not adequately refined
and should not be used as the solitary indicator of ecological risk. 
Additionally, there is no evidence that fish or wildlife are being
harmed by legal azinphos methyl applications based on routine monitoring
practices.

Farm Worker Risk

Recently the Washington Department of Labor and Industries released the
results of their 2006 workplace investigations which are conducted when
cholinesterase depressions are reported in the Washington Cholinesterase
Monitoring Program.  Review of these investigation summaries indicates
that only three cases involved cholinesterase (ChE) inhibition when
azinphos methyl alone was used in the previous 30 days.  We emphasize
that these reports include depressions from potential exposure to a
variety of chemicals.  However, only three cases involve ChE inhibition
where azinphos could be the only possible exposure.  The ChE depression
noted in these cases were 20.35 percent, 22.66 percent and 25.72
percent, respectively.  Additionally, no illness was reported in any of
these cases.

These reports demonstrate that Washington state pesticide applicators
are applying azinphos methyl with relative safety.  In every case, even
beyond the three cases involving azinphos methyl, worker and workplace
safety practices have been implicated as the probable cause of the
possible exposure.  The tree fruit industry of the Pacific Northwest
plans to continue to work with its members and their employees to
improve safe use of crop protection tools.

A summary of the 2005 Washington Cholinesterase Monitoring Program
conducted by the USDA’s Office of Pesticide Policy indicates that in
2005 only one agricultural handler of 611 workers tested had
significantly depressed ChE levels resulting from potential azinphos
methyl exposure.  Only two workers out of 580 workers tested in 2004 had
significantly depressed ChE levels resulting from potential azinphos
methyl exposure.  Additionally the summary states that a California
Department of Pesticide Regulation report noted there were no illnesses
reported by California physicians associated with the use of azinphos
methyl from 1999 to 2002 and none in 2004, but there was one possible
illness in 2003. These facts respute the assertion that farm workers are
being exposed to unreasonable risks from azinphos methyl applications.  

Summary

USApple, including NHC, believes they have raised substantive and
credible issues regarding the ability of the agency to rely solely on
its ecological risk model to accurately estimate the potential risk of
azinphos methyl to the environment.  While significant monitoring data
and several independent studies indicate azinphos methyl concentrations
in water are not adversely impacting the environment, it would be
inappropriate for EPA to make a final decision to cancel azinphos
methyl, especially when such an action would be so harmful to apple
growers.

Additionally, cholinesterase monitoring data in Washington and
California indicate farm workers are not being exposed to unreasonable
risks.

EPA indicated in its azinphos methyl decision document that it would be
willing to reassess the proposed phase out if it determined in 2010 that
more time would be needed to establish maximum residue levels (MRL) in
international markets for certain azinphos methyl alternatives.  While
the MRL issue is certainly a future uncertainty, there are other
significant uncertainties that merit reassessment in 2010. 

It is respectfully proposed that the agency remove the proposed phase
out, and make a commitment to reassess azinphos methyl in 2010.  Such an
approach would provide an opportunity for the registrants to generate
additional data that could clarify issues regarding ecological risk and
farm worker risk.  A collaborative process with stakeholders over the
next four years could help refine the ecological risk model and provide
adequate time to revisit many of the unanswered questions regarding
human studies and the current review process.

While these issues are being addressed, the apple industry is willing to
reduce total annual per acre applications from 8 lbs. to 6 lbs. of
formulated product, observe the proposed 100 foot buffer from permanent
bodies of water and discuss labeling options to ensure azinphos methyl
use is only used when absolutely necessary.

We appreciate this opportunity to provide the agency new data that may
inform its final decision.

Please contact Jim Cranney by telephone at (800) 781-4443 or via e-mail
at   HYPERLINK "mailto:jcranney@usapple.org"  jcranney@usapple.org  or
Mike Willett by telephone at (509) 453-3193 or via email at   HYPERLINK
"mailto:willett@nwhort.org"  willett@nwhort.org  if you have questions
or need additional information.

     

Sincerely yours,

	

James R. Cranney, Jr.					Dr. Michael J. Willett

Vice President 					Vice President for Scientific Affairs

U.S. Apple Association				Northwest Horticultural Council

							105 So. 18th Street, Suite 105

							Yakima, Washington 98901

							Tel: (509) 453-3193

							  HYPERLINK "mailto:willet@nwhort.org"  willet@nwhort.org 

 

 U.S. Apple Association Strategic Pest Management Plan, April, 16, 2001.

 Washington State University, Guide to Codling Moth Damage
Identification, W.E. Jones, J.F. Brunner and D. Fabion, 2006.

 U.S. Apple Association Comments, Azinphos Methyl Ecological Risk
Assessment, Grower Impact Assessments;    Notice of Availability; Docket
Identification Number EPA-HQ-OPP-2005-0061, Feb. 6, 2006.

 Grower Pesticide Application Report, Olsen Orchard Visit, Sept. 13,
2006.

 U.S. Apple Association Comments, EPA-HQ-OPP-2005-0061 Azinphos Methyl
Proposed Reevaluation Decision, Aug. 8, 2006.

 U.S. Department of Agriculture, Natural Resources Conservation Service,
RUSLE2 Erosion Calculation Record, Ardentsville Soil Scenario, Sept. 21,
2006.

 U.S. Department of Agriculture, Natural Resources Conservation Service,
RUSLE2 Erosion Calculation Record, Catoctin Soil Scenario, Sept. 21,
2006.

 U.S. Department of Agriculture, Natural Resources Conservation Service,
National Resources Inventory 2003 Annual NRI, May 2006.

 U.S. Apple Association, Azinphos Methyl Ecological Risk Assessment
Letter to Ms. Deborah Edwards, March 31, 2006.

 Makhteshim Agan, Reductions in AZM Use Since 1997, Sept. 2006.

 Pesticide Use and Toxicity Assay in Mission, Brender and Yaksum Creeks,
WRIA 45 Watershed Planning – Supplemental Water Quality Planning 2003;
Burgoon, Peter S., Rickel, Michael; July 15, 2003.

Sulphur Creek Wasteway Pesticide Detections, Cowles Jim, Washington
Department of Agriculture, Pesticide Management Division, Sept. 13,
2006.

 Pesticide Stewardship Partnerships, Oregon Department of Environmental
Quality, Foster, Gene, Grand, Fenix, Sievers et al., Sept. 13, 2006.

 Washington Department of Labor and Industries, 2006 Cholinesterase
Monitoring Season Consultation Activity Summaries, Sept. 2006.

 U.S. Department of Agriculture, Office of Pesticide Policy, Summary of
Ag Handler Exposure Monitoring in the State of Washington and reported
Pesticide related Illnesses in California, Sept. 2006.

703 442-8850

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fax 703 790-0845

Web site www.usapple.org

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