UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

MAR n5 2010

OFFICE Of

PREVE NTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

SUBJ ECT:

FROM :

Review of a Label Amendment Requestfor Azinphos-methyl, including Public

Comments (DP #373559) n . . ~{

Donald Atwood, Entomologist . ...o/IV I 3 -4 _:}o DavidBrassard, SeniorEntomologist D,lJN\AI

Nikhil Mallampalli, Entomologist ANI;{ Ji.t~ 3/'t/ z 0 I 0

Bio logical Analysis Branch

Stephen Smeannan, Economist

T J Wyatt, Senior Econom ist

Economic Analysis Branch

Biological and Economic Analysis Division (7503P)

TU RU: Arnet Jones, Chief

Biological Analysis Branch

Timothy Kiely, Chief (;:+ VV\ :Y-P

Economic Analysis Branch "J ,-~ Biological and Economic Analysis DiVision (7503P)

,

TO: Thomas Harris

Insecticide and Rodenticide Branch

Registration Division (7505P)

Katie Weyrauch, Chemical Review Manager

Margaret Rice, Chief

Risk Management and Implementation Branch 2

Pesticide Re-evaluation Division (7508P)

BEAD Product Review Panel date: March 3, 2010

Page 1 of 17
Summary

Under the cancellation agreement for azinphos-methyl (AZM ), EPA and the registrant agreed to

a detailed phase-out schedule for several fruit crops, including apples, blueberries, cherries, and

pears. Under the phase-out, seasonal application rates are reduced in stages, beginning in 2009,

with use of AZM fully cancelled after the 2012 growing season. In 2009, the registrant

submitted an applica tion for a label amendment that would maintain seasonal application rates at

the 2009 level through the phase-out period on the grounds that impacts to growers will be

sizeab le. BEAD evaluated the registrant's submission and comments from university extension

personnel, individual growers and grower associations received in response to the application.

The information and data submitted generally support the conclusions of the assessments

evaluating the impact of cancelling AZM, which were conducted by BEAD in 2005 . As the

seasonal rates are lowered, these impacts have begun to manifest themselves. However, none of

the information or data submitted provides compelling evidence that BEAD's 2005 assessments

underestimated the impacts of cance lling AZM, much less underestimate the impacts of a lower

seasonal application rate. Many comments noted that the rates permitted under the final years of

the phase-out would limit growers to a single application of AZM per season. In fact, from a

biological and economic perspective, the step-wise reduction in seasonal application rates was

designed to encourage, and even require, adoption of alternative control regimes while also

providing a "safety net" for growers unaccustomed to new products. Delaying these reductions

would discourage growers from trying new pest control regimes and would likely result in more

uncertainty about the best pest management practices to adopt when AZM is fully withdrawn in

2012.

Background

As part ofthe re-evaluation of azinphos-methyl (AZM), EPA and the registrant agreed to a

detailed phase-out schedule for several fruit crops, including apples, blueberries, cherries, and

pears. Under the phase-out, annua l maximum application amounts are to be reduced in stages,

beginning in 2009, and aerial application is to be prohibited in blueberries after 2009. All

registrations ofthis chemical are to be terminated as of September 30, 2012. This agreement was

forma lized on AZM product labels. In June 2009, the registrant for AZM, Makhteshim Agan

North America (MANA), submitted an application to amend the labels to maintain previous label

rates through the end ofthe comment period. MANA also submitted a detailed paper (MANA,

2009) in support of the application, which described the impacts of cance lling AZM use in the

crops. The paper presents research in key AZM using regions (Washington and Michigan), and

makes the general argument that reductions in application rates (and the elimination of aerial

application in blueberries) should be delayed in order to avoid significant yield losses in all the

crops involve d.

In a July 2009 notice in the Federal Register, EPA solicited public comment on MANA's

application with an emphasis on obtaining data that would show whether or not the impacts on

agriculture and agricultural production would be substantially more severe than those described

in several asse ssments conducted in 2005. These documents are located in docket EPA-HQOPP-2005-006 1 at www.regulations.gov, and are as follows:

Page 2 of 17
• 2005 Grower Impact Assessment ofAzinphos-methyl Use on Blueberries (lowbush and

highbush). Document ID # EPA-HQ-OPP-2005-006 1-0033.

• 2005 Grower Impact Assessment ofAzinphos-methyl Use on Tart Cherries. Document

ID # EPA-HQ-OPP-2005-0061-004 1.

• 2005 Grower Impact Assessment ofAzinphos-methyl Use on Sweet Cherries. Document

ID # EPA-HQ-OPP-200 5-0061-0036.

• 2005 Grower Impact Assessment of Azinphos-methyl Use on Apples. Document ID #

EPA-HQ-OPP-2005-006 1-0043.

• 2005 Assessment for Azinphos-methyl Use in Pear Production in the United States.

Document ID # EPA-llQ-OPP-2005-0061-0039.

• Initial Examination ofMaximum Residue Levels on Exported Fruit for Selected

Insecticide Alternatives to Azinphos-methyI. Document ID # EPA-HQ-OPP-2005-0061-

0142.

In this memo, BEAD responds to and evaluates the MANA paper and other comments submitted

in support of the application. For each crop, BEAD explains the conditions of the phase-out and

summarizes the conclusions ofthe 2005 impact assessment. BEAD outlines the key issues

raised by the MANA submission and public comments regarding the impacts of following the

conditions of the phase-out. BEAD then evaluates the comments and any supporting data to

determine if impacts are likely to be substantially different than previously estimated. If there

were reasons to believe impacts are greater than were anticipated at the time of the decision,

EPA may wish to revisit the scheduled rate reductions.

Blueberry (Hi gh bush varieties only)

Through 2009, highbush blueberry growers could use AZM at a rate of 1.5 Ibs active ingredient

(a.i.) per acre per year. Multiple applications were allowed and applications could be made both

aerially and by ground equipment. Beginning in 2010 and continuing through the end of the

phase-out in 2012, aerial applications are prohibited and the application rate is limited to 0.75 lbs

a.i. per acre per year.

Summary ofBEAD 's 2005 impact assessment

BEAD concluded that highbush blueberry growers in the North Central region (primarily

Michigan) would have to use more treatments of a set of alternative insecticides to substitute for

the average of approximately 2 sprays of AZM they had recently been using. A likely set of

insecticides is comprised oftebufenozide, esfenvalerate, and a miticide to control secondary

pests associated with the use of synthetic pyrethroids. Similarly, growers in the other major

blueberry producing region, the Eastern US (represented by New Jersey in BEAD's assessment,

since that is the largest production area), would also have to use multiple alternatives to achieve

acceptable control of the target pests. In both regions, BEAD expected that pest management

costs would rise, while yield and quality losses would occur at the approximately the same level

as was estimated in BEAD's 2001 assessment, i.e., 1-2% yield and 1-2% quality losses.

Therefore, for both regions, losses ranging from $51 to $1 16 per acre at the grower level (in

terms of returns above variable costs per acre) were predicted, ranging between 5 and 14% of net

Page 3 of 17
operating returns. (Net operating returns do not account for the fixed costs of production and

may underestimate the impact on growers' income, particularly small producers who have fewer

acreage in production across which to spread fixed costs.) At the regional level aggregate losses

of approximately $2.3 million were expected. BEAD also noted that alternatives could interfere

with biological control and that use of some alternatives might not be feasible because some

countries importing U.S. blueberries had not set Maximum Residue Levels (MRLs) for these

pesticides. MRLs set maximum residue levels permitted on imported commodities and if MRLs

have not been established, any detected residues would lead to rejection of entire shipments.

BEAD did not quantify the impact ofthese potential export restrictions because they depend on

individual marketing strategies, which can change with prices and exchange rates.

Key Issues Raised by AJANA Submission

MANA (2009) requests that the seasonal rate be set at 1.0 lb a.i. per acre per year and that aerial

applications be allowed through the phase out. The request states that, despite continuing

research, alternative programs remain less reliable and more costly than AZM and that ground

applications are often infeasible due to wet conditions. Further, the request asserted that the

prohibition of aerial applications would disproportionally affect small producers.

The reque st discusses recent research conducted into alternat ives to AZM. In this work, a

transitional program used tebufenozide with two applications of AZM. An alternative program

used tebufenozide with two applications of esfenvalerate. An "advanced IPM" program used

methoxyfenoxide, spinetoram, and acet amiprid, all of which were registered on this crop after

2005. The request indicates that all three programs provide equivalent control of the primary

fruitworm pests although it is noted that the esfenvalerate-based program has been shown to

result in mite problems, probably because populations of beneficial arthropod predators are

reduced. The AZM-based program costs about $40/acre. The esfenvalerate-based program costs

$SS-60/acre due to increased use of miticides and the advanced IPM program costs about

$110/acre. MANA's request adapts BEAD's 200S analysis to estimate that the se programs result

in losses of S-12% of growers' net operating revenue compared to an AZM regime. MANA

further notes that use of pyrethroids have been implicated in the appearance of secondary pests

such as Putnam scale and gall midge.

In addition, the request notes that insecticides like tebufenozide and methoxyfenozide act by

interfering with the insect's biochem ical growth regul ators. Research cited in the request shows

that, as result ofthis mode of action, the timing of applications ofthese chemicals is much more

critical than for AZM, which can make control more variable.

MANA also presents data from a report by Isaacs (undated), showing that 2,230 acres of

Michigan blueberries were treated at annual rates of more than 0.7Slbs a.i.lacre. This comprises

approximately 17% of the total Michigan blueberry acreage treated with AZM that year. The

original source of the se data is a 2007 survey by USDA-NASS ofMichigan blueberry growers

Finally, MANA notes that some of the chemicals in the advanced IPM program cannot be used

on blueberries bound for the export market because importing countri es have not yet established

Maximum Residue Levels (MRLs) for these pesticides.

Page 4 of 17
Regarding the impact of prohibiting aerial applications, MANA states that small farms are less

likely than large farms to invest in spray equipment and are thus more reliant on custom

applicators. MANA presents data from the 2007 USDA-NASS survey that show 28 farms of

less than 30 acres aerially appli ed AZM while only three farms with more than 100 acres applied

AZM by air. Eighteen farms of between 30 and 100 acres applied AZM by air. MANA

therefore concludes that the prohibition on aerial applications will have a disproportionate impact

on small fanners.

Other Comments

A number of comments were submitted to EPA that provided testim onials to the value of AZM

and/or reiterated points raised in the MANA submission while supporting continued rates of 1.5

lbs a.i.lacre/year (Anthony, 2009; Kamphuis, 2009; Lautensleger, 2009; Maslyn, 2009; Nye,

2009). Other comments supported an annu al rate of2.0 lbs a.i.lacre, claiming 1.5 Ibs a.i.lacre

was insufficient (Hartmann, D., 2009; Hartmann, P., 2009; Hartmann, S., 2009; Trinka, 2009).

A submission from a crop dusting service in Van Buren County, Michigan, indicated that the

service treats about 1500 acre s of blueberry with AZM each year, covering 130 blueberry farms

(Helms, 2009). Helms states that alternatives have higher application costs, in addition to higher

direct costs, but did not indicate how much more expensive application costs may be.

It should be noted that the MANA submission on blueberry draws heavily from a report by

Isaacs (undated), summarizing the results of the USDAINASS survey of Michigan blueberry

growers.

BEAD Response to Comments

BEAD appreciates the data submitted and the intense research activity undertaken in response to

the AZM phase-out. BEAD's 200 5 assessment of the cancellation of AZM indicated that the

impacts to individual growers could be high. The information presented in the MANA

submission largely supports BEAD 's findings but does not indicate that the impacts are

substantially greater than estimated.

The alternative spray programs describ ed in the MANA request were found to provid e fruitworm

control equivalent to that resulting from a conventional spray program that included AZM. It

was noted, however, that alternative chemistries may be more sensitive to timing of application

than is AZM. It was due to this sensitivity that BEAD evaluated a yield loss of 1-2% and a shift

in quality from fresh to processed fruit of ano ther 1-2%. The additional costs noted in MANA' s

submission are similar to those used in BEAD 's 2005 assessment and the results that growers

could face losses of7-12% of net operating revenue are within the bounds of BEAD's results.

In its 2005 assessment, BEAD mentioned that there existed the possibility that minor pests might

become more serious as they are released from the long-lasting broad-spectrum control offered

by AZM. Some comments indicated that this has happened in some blueberry fields. For

example, the MANA request states that Putnam scale and gall midge have been seen more often,

Page 5 of 17
probably as a result ofincreased pyrethroid use. However, the comments did not characterize the

geographical extent or quantify the effects on yield and/or quality.

BEAD is also aware of the problem of acceptance of some alternative pesticides in importing

countries, due to a lack of established Maximum Residue Levels (MRLS). BEAD recognizes

that this situation complicates growers' pest control decisions and increases the management

burden. However, this factor was also recognized in the 2005 assessments.

BEAD has also acknowledged that aerial applications may be needed when conditions are not

favorable for ground applications. MANA claims that an aerial prohibition would have a

disproportionate effect on small farms compared to large farms, based on survey results from

2007, showing more farms of 30 acres or less applying AZM by air than larger farms (MANA,

2009). However, as shown in Table I, the 2007 Census ofAgriculture (USDA NASS, 2008)

shows that there are many more small farms producing blueberry than large farms.

Proportionately, farms of less than 30 acres apply AZM by air no more frequently than do farms

of more than 100 acres. Mid-range farms appear to rely more heavily on aerial applications than

do small or large farms.

Table 1. 2007 Aerial An lication of AZM bv Blueberrv Farm Size

Farm Size # App lyin g AZM by # of Farms I 0/0 of Farms

Air Applying AZM by

Air

More than 100 acres 3 50 6.0

30 to 99 acres 18 50 - 127 14.2 - 36.0

Less than 30 acres 28 663 - 740 3.8 - 4.2

Total 49 840 5.8

Source: MANA, 2009 (Table 7): USDA NASS, 2008

I TheCensus of Agriculture provides data on farms of 25 acres or less and on farms between 25 and

100 acres.

BEAD impact assessments are conducted on a per-acre basis. Impacts are measured relative to

net operating costs, which do not include fixed costs. Thus, impacts as a proportion of grower

income could be understated for small producers, who have fewer acres over which to spread

their fixed costs. However, BEAD's estimated impacts are more representative of mid-range

farms.

As shown in Table 2 of MANA's submission, blueberry acreage has increased substantially

between 2004 and 200S. Further, the submission indicates that the gross value of production per

acre has also increased substantially, from about $6,200/acre in 2004, to over $S,900/acre in

200S. This would suggest that net operating revenue is also increasing, which would tend to

reduce the impact of cancelling AZM as a proportion of grower revenue.

BEAD acknow ledges that as the phase-out takes effect and seasonal rates are reduced, some

growers will begin to feel the impacts ofthe loss of AZM. This is not unexpected. However,

given MANA's submission and the associated comments, BEAD concludes that the extent of the

impacts is unlikely to be substantially greater than was estimated in 2005.

Page 6 of 17
Tart and Sweet Cher ry

Under the phase-out to date, tart and sweet cherry growers had been able to use AZM at a rate of

l.5lbs active ingredient (a.i.) per acre per year. Multiple applications are allowed. Beginning in

2010 and continuing through the end ofthe phase-out in 2012, the application rate is limited to

0.75 lbs a.i. per acre per year.

Summary of BEAD 's 2005 impact assessments

Tart Cherry

Based on the availability of efficacious alternatives to AZM to control plum curculio and cherry

fruit fly in tart cherries, BEAD believed that the benefits derived from the use of AZM were

likely to be small. In the absence of AZM, growers would most likely use pho smet to maintain

the local, state, and federal mandated zero tolerance for these pests. BEAD concluded that use of

phosmet would likely raise production costs by around $10 to $25 per acre. This could amount

to two to four percent of a grower's net cash returns (gross revenue minus operating costs).

However, BEAD also noted at the time that recent increases in the price oftart cherries may

mean that the benefits of AZM as a percent of net cash returns would be smaller. BEAD also

noted that MRLs were not yet in place for all the likely alternatives at the time of assessments,

which could affect producers targeting export markets.

Sweet Cherry

Given the available alternatives and efficacy data, BEAD concluded that grower-level (per acre)

impacts of the loss of AZM for eastern sweet cherry growers could be as high as 11% loss in net

cash return s, while in Washington such losses are approximately 2%. It appeared that effective

new pest control alternatives (such as thiamethoxam, multiple sprays of synthetic pyrethroids,

and spinosad) existed , and that should allow growers to meet the stringent quality standards

required by the sweet cherry market. Howeve r, BEAD also concluded that incre ases in

production costs were potentially significant for individual growers, at least in the eastern U.S.

Calculated losses reflected the increased production costs incurred by the need to apply multiple

treatments ofsome alternatives or the much higher costs of other materials. DEAD also noted

that MRLs were not yet in place for all the likely alternatives at the time of assessments which

could affect producers targeting export markets.

Key Issues Raised by MANA Submission

MANA (2009) requests that the seasonal rate remain at 1.5 lbs a.i. per acre per year. The request

indicates that , despite continuing research, alternative programs remain less reliable and more

costly than AZM.

MANA's request included discus sion of research conducted in Michigan between 2004 and 2008

involving 40 trials of various pest control strategies that do not rely on organophosphate (OP) or

synthetic pyrethroid pesticides. The se trials appear to have been conducted on tart cherry, but

may be applicable to sweet cherry as well. The request states these strategies failed in 13 trials,

Page 7 of 17
including eight failures of control for the plum curculio, four failures due to fruit fly, and one

failure due to the Japanese beetle. AZM-treated trials had no insect control failures. MANA did

not define what constituted a failure in these trials.

According to the submission, phosmet is a valuable late-season tool in tart cherry, but is not an

acceptable earl y and mid-season alternative to AZM due to a shorter period ofresidual activity

and does not penetrate the fruit to kill larvae before they develop. Further, MANA points out

that phosmet is phytotoxic to sweet cherry. MANA also points out that the non-OP strategies

that were studied are more expensive than AZM by more than $50 per acre. MANA adapts

BEAD' s 2005 analysis to estimate that these programs result in losses in tart cherry of 13% of

growers' net operating revenue compared to an AZM regime.

MANA notes that the Washington State University's 2009 Crop Protection Guide recommends

AZM, at a rate of O.75 1bs a.i. per acre, for control ofthe western cherry fruit fly, the primary

pest in western sweet cherry production. The 2010 seasonal rate for AZM would limit growers

to a single application, but two applications are often necessary because the insect emerges over

an eight week period .

The research cited by MANA indicates that conventionally-treated orchards maintain higher

diversity of beneficial insects than do orchards treated with alternative strategies. MANA

concludes that a rate of 0.75 lbs a.i. per acre per year will limit growers to a single application of

AZM, which will be inadequate to maintain a safety net in case an alternative strategy fails.

MANA also notes that MRLs for many alternatives have not been established by countries

representing important export markets.

Other Comments

Several commenters expressed support for the requested label amendments, without providing

additio nal data or information (Anthony, 2009; Maslyn, 2009; Nye, 2009). Hubbell (2009)

expressed opposition to the entire phase-out of AZM.

Korson (2009a) noted that processors have zero tolerance for cherry fruit fly and plum curculio

in tart cherry and that there is no method for identifying and sorting infested fruit prior to

delivery by the grower to the processor. He stated that the Cherry Marketing Institute had tested

several alterna tives but none provided excellent control ofthe two key pests and that phosmet

does not control plum curculio. No data were submitted, however.

Korson (2009b) and Willet (2009 ) pointed out that MRLs have not been established for all

potential AZM alternatives in all export destinations and that where MRLs have been established

they may be lower than tolerances allowed in the U.S.

Whalon (2009) provided the most extensive comments, which covered both sweet and tart

cherry. Several other comments reiterated the basic conclusions ofWhalon ' s research (Fox,

2009; Nugent, 2009; Peterson, 2009). Dr. Whalen's comments make several points about both

the benefits and risks of AZM, and BEAD will focus only on those that are relevant to the

Page 8 of 17
impacts of the AZM phaseout. In his introductory statements, Dr. Whalon asserts that EPA's

estimates of the impact of cancelling AZM "severely misrepresented and underestimated the

economic impacts the loss of AZM will have on the industry.... the processed cherry industry

received a pretty poor determination ofthe economic impacts ofthis decision." Whalon makes

the following points, based on his research on pest control in cherry orchards at Michigan State

University:

• Costs of pest control using "reduced risk" and non-OP alternatives are typically around

$55 per acre more than pest control costs in a conventional system.

• Phosmet has significantly lower effi cacy that AZM.

• Research trials over the last six years have shown more "failures' in fields treated with

reduced risk alternatives such as thiamethoxam, spinosyn, and indoxac arb, as compared

to fields treated with AZM. Failure is defined as any detection of one ofthe key pests,

especially plum curculio and cherry fruit fly, or a situation where the grower resorted to

an application of AZM or phosmet.

Whalon concludes that there are no suitable and effective pesticides available to replace AZM.

BEAD Response to Comments

BEAD appreciates the information on those export markets of key importance for cherry

growers. MRLs for these markets are being tracked by the Agency and it appears that there are

levels established for some, but not all, AZM alternatives in many countries importing U.S.

cherries. BEAD noted this concern for the feasibility of using some alternatives by growers

targeting the export market but was not able to quantify the impact. The comments provide no

basis to quantify the impacts now.

BEAD 's 2005 impact assessme nt estimated that costs to tart cherry growers of cancelling AZM

could range from $10 to $25 per acre depending on the alternatives that could be utilized. This

estimate is less than half the cost increases estimated by Dr. Whalon. However, BEAD notes

that the pest control regimes studied by Dr. Whalon do not include all potential alternatives

identified by BEAD. The reduced risk and organophosphate alternative compounds, for

example, do not include either phosmet or synthetic pyrethroids. BEAD's 2005 assessment

acknowledged that phosmet was less effective than AZM and may require multiple applications

and that synthetic pyrethroids may reduce populations of beneficial insects. However, recent

studies on cherry fruit fly control in tart cherries showed that alternatives such as fenpropathrin

and phosmet provided 100% infestation-free fruit at harvest (TNRC, 2009). Dr. Whalon's

submission states that some growers used phosmet instead of AZM for pest control when trials

'failed.' Phosmet and synthetic pyrethroids may have disadvantages relative to AZM, but failure

to include them as possible control measures overestimates the impacts ofthe loss ofAZM .

BEAD' s 2005 impact assessment found that the processed sweet cherry industry typical of

Michigan production would be face greater impacts than would the production of fresh sweet

cherry in the Pacific Northwest and California. The 2005 assessment found that costs to

Michigan sweet cherry growers could range from $20 to $60 per acre depending on the

alternatives that could be utilized. BEAD notes that cost increases estimate d by Dr. Whalon fall

within these bounds. As noted above, the pest contro l regimes studied by Dr. Whalon do not

include the use ofsynthetic pyrethroids.

Page 9 of 17
Regarding Dr. Whalon's comments on the failures of AZM alternatives in research trials, BEAD

highlights two caveats as to the utility of the information as it was described:

1) A lack of infonnation on the exact details of the "paired comparisons" between AZM and

the reduced risk alternatives means that BEAD cannot use the data to see if the 2005

assessment of the utility of likely combinations of such alternatives along with other

conventional materials (such as lambda-cyhalothrin, a synthetic pyrethroid) was

significantly incorrect.

2) Based on the information provided in the comment, it is not possible to extrapolate from

the number of failure s seen in research trials ofreduced risk materials to the larger

grower community in a reasonable manner. For example, how can the results be used to

determine the freque ncy of such failures in commercial production, especially where

combinations ofreduced risk and conventional insecticides are likely to be used?

BEAD notes that the data on incidents of failures in commercial cherry production with likely

combinations of AZM alternatives do not account for the continued availability of AZM, albeit

at a reduced seasonal rate, until 2012. Nothing in Dr. Whalon's comment suggests that the

current rate is inadequate to serve as a rescue treatment in case ofsimilar incidents. More

generally, BEAD does not see how the comments received for this crop significantly alter its

earlier conclusions.

Apple

Under the phase-out , apple growers may currently use AZM at a rate of 3.0 lbs active ingredient

(a.i.) per acre per year. Multiple applications are allowed. In 2010, the rate is limited to 2.0 Ibs

a.i, per acre per year and, in 2011 and 2012, the application rate is limited to 1.5 lbs a.i. per acre

per year.

Summary ofBEAD 's 2005 impact assessment

Nationally, BEAD concluded that the impacts depend upon the alternative pest management

scenario considered. Losses as a proportion of net of operating revenues (gross revenue minus

operating expenses, but not accounting for fixed costs) for apple acres treated with AZM could

range from 5% to 18% or $63-243 per acre. Extrapolating to the national level, losses could

range from $17.7 million to $68 million. The upper range represents a scenario in which four

applications of phosmet replace three AZM applications and included both increases in control

costs and yield and quality impacts. The lower range ofloss was estimated from a scenario

where a combination of thiacloprid, novaluron, and acetarniprid would replace AZM. Under a

third scenario, where pheromone mating disruption plus a single (vrescue'') application of AZM

are employed in place ofthree AZM applications, losses were estimated to be about $155 per

acre or $43.8 million nationally and represent 12% of an average grower's revenues net of

operating revenues.

Page 10 of 17
Regionally, the Western growers were expec ted to realize greater reductions in net revenue

primarily because operating costs are higher, and yield and quality impacts have greater impact

on fresh market apples in the West than in the East. Effective new alternatives under the second

and third scenarios give growers more treatment options and could be useful for resistance

management when rotated with phosmet. However, per acre application costs are much higher

than with phosmet or with AZM. BEAD also noted that MRLs were not yet in place for all the

likely alternatives at the time of assessments, which influences the feasibility of use on apples

targeting export markets.

Key Issues Raised by AlANA Submission

MANA requests that the seasonal rate be set at 2.0 lbs a.i. per acre per year through the end of

the phase-out period. The request is intended to provide growers with a "safety net" to use AZM

to deal with heavy infestations or failures of other strategies.

The MANA submission summarizes research conducted in the Eastern United States on various

alternative pest control strategies that do not rely on organophosphate, synthetic pyrethroid, or

carbamate insecticides. According to the submission, insect pest damage was at acceptably low

levels with no statistically significant differences betwee n the AZM-treated blocks and blocks

employing alternative strategies. However, the costs ofthe alternative strategies are greater than

with AZM, ranging from $58 to $188 per acre more, where the upper bound employs pheromo ne

mating disruption. MANA adapts BEAD's 2005 analysis to estimate that these programs result

in losses of6-18% of growers' net operating revenue compared to an AZM regime. The added

costs do not include the increase in management time required for alternative strategies that

require more precise application timing.

MANA also notes that orchards using AZM alternatives experience an increase in secondary

pests including spider mites, San Jose scale, and wooly apple aphids.

In 2005, BEAD estimated that, without AZM, growers in the Western United States would rely

on phosmet. applying it more frequently and incurring some loss in fruit quality, or use a

combination ofthiacloprid, novaluron and acetamiprid. MANA claims that phosmet is not an

effective alternative for AZM because of a short residual and lower efficacy. MANA also claims

that thiacloprid, novaluron and acetamiprid are not viable options because these products destroy

beneficial insects and result in serious disruptions ofmite controL Moreover, MRLs have not

been established in all countries for these insecticid es.

Further, the submission states that Washington State University only recommends AZM at a rate

of 1.0 lb a.i.Zacre, for the control ofthe green fruitworm. A reduction in the seasonal rate to 1.5

lbs a.iJacre would preclude growers with infestations of green fruitwonn from using AZM later

in the season for control ofthe grape mealybug or the codling moth.

Page 11 of 17
Other Comments

Several commenters expressed support for the requested label amendments, without providing

additional data or information (Anthony, 2009; Donohoe, 2009; Drake , 2009; Girardin, 2009;

Mas1yn, 2009; Nye, 2009; Sharp, 2009). Hubbell (2009) expressed opposition to the entire

phase-out of AZM.

A comment from the Northwest Horticultural Council Willet (2009) states that two AZM

applicati ons are "most appropriate" for control of "an entire generation of codling moth" in the

Pacific Northwest. He also attached a table showing MRLs for AZM and most of its alternatives

in several apple export markets, and asserts that the lack ofMRLs for all alternatives in "key

markets" (undefined) will prevent their use.

Seetin (2009 ) reiterates the importance oftwo AZM applications, and the MRL situation. He

also provided information on the change in prices for processing apples, showing a decrease

from over $13 to $7.50 per hundredweight. He concludes, therefore, that the impacts of

cancelling AZM would be about twice that estimated by BEAD in 2005 .

BEAD Response to Comments

BEAD notes that MANA's estimated impact to growers of6-18% of net operating revenue is in

keeping with BEAD's 2005 estimates ofimpact of 5-22% of net operating revenue. BEAD also

notes that the 2005 assessment accounted for a loss in quality due to lesser pest control with

AZM alternatives while the data submitted by MANA indicate that there is no difference in

efficacy between AZM and the alternatives. Impacts appear to be solely a function of increased

pest control costs.

BEAD acknowledges the drop in the price impacts on processing apple s in 2009 due to the

current economic downturn noted by Seetin (2009). However, in 2005, BEAD estimated the

price for processed apples at $136 per ton or $6.80 per hundred weight. This is below the 2009

average processing price of $7.50. Thus, the estimate BEAD made in 2005 ofthe impact of the

cancellation of AZM remains relevant.

BEAD acknowledged the MRL issues in the 2005 assessment. BEAD notes that there are

additional MRLs now established for the top two export markets (Mexico and Canada), which

together accounted for approximately 40% ofthe apple export market based (Smeannan and

Mallampalli, 2006). It appears that there are now 4 additional alternati ves that were not

available when the MRL assessment was conducted in 2006 and that there are now MRLs

established in major markets such as Hong Kong that were not identified in 2006.

BEAD also notes that none ofthe commenters provided new data on the comparative efficacy or

cost of newer chemistries in apple production.

Insum, BEAD cannot identify in these comments compelling new data to make the case that

previous assessments underestimated the impacts of cancelling AZM nor the impacts of a lower

seasonal application rate.

Page 12 of 17
Pear

Under the phase-out, pear growers in 2009 and 2010 can use AZM at a rate of 2.0 Ibs active

ingredient (a.i.) per acre per year, reduced from 3.0 lbs a.i. per acre per year in 2008. Multiple

applications are allowed. In 2011 and 2012, the yearly rate is limited to 1.5 lbs a.i. per acre per

year.

Summary ofBEAD 's 2005 impact assessment

BEAD's conclusion was that no yield or quality losses were to be expected if AZM was not

available for use on pears. BEAD noted that alternative pest control scenarios (phosmet or

acetamiprid and methoxyfenozide) are more expensive than AZM. Nationally, these increased

control costs were estimated to decrease the value of production by less than 1% for pear

growers. Regionally, BEAD concluded that the Pacific Northwest would experience the greatest

losses with a reduction in per acre net revenues from 1.5% to 1.6% if AZM is not avai lable. In

addition, BEAD stated that effective new alternatives would give growe rs more treatment

options and could be useful for resistance management when rotated with phosmet, the primary

alternative to AZM . BEAD also noted that MRLs were not yet in place for all the likely

alternatives at the time of assessments.

Key Issues Raised by MANA Submission

MANA requests that the seasonal rate remain at 2.0 lbs a.i. per acre per year through the end of

the phase-out period. The request is intended to provide growers with a "safety net" to use AZM

to deal with heavy infestations or failures of other strategies.

MANA states that, in 2005 , BEAD estimated that, without AZM, growe rs in the Western United

States would rely on phosmet, applying it more frequently, or use a combination ofthiacloprid,

novaluron and acetamiprid. [BEAD actuall y found that a combination ofmethoxyfenozide and

acetimiprid was a likely alternative for AZM .] MANA claims that phosmet is not an effective

alternative for AZM because ofa short residual and lower efficacy . Further, MANA questions

why quality losses were not projected for pears as they were for apples. MANA also claims that

thiacloprid, novaluron and acetamiprid are not viable options because these products destroy

beneficial insects and result in serious disruptions of mite control. Moreover, MRLs have not

been established in all countries for these insecticides, particularly Canada and Mexico, which

are the major markets.

According to the submission, Washington State University recommends AZM for the control of

codling moth and grape mealybug in pear production. The scheduled rate reduction would limit

AZM to a single, late-season application, primarily as a reserve in case of codling moth control.

Pheromone mating disruption and other alternatives are not effective against the grape mealybug.

MANA also anticipates damage in Eastern pear orchards, which cannot easily use pheromone

treatments due to small and fragmented acreage .

Page 13 of 17
Other Comments

Two commenters expre ssed support for the reque sted label amendments, without providing

additional data or information (Anthony, 2009 ; Maslyn, 2009) .

Willet (2009) reiterates the Northwest Horticultural Council's position on apple that two AZM

applications is "most appropriate" in order to control "an entire generation of codling moth" in

pears as well. He also attached a table showing MRLs for AZM and most of its alternatives in

several pear export markets, and asserts that the lack ofMRLs for all alternatives in "key

markets," which are not defined, will prevent their use.

BEAD Response to Comments

BEAD acknowledged in the 2005 assessment that phosmet is not as effective as AZM due to a

shorter residual period. As a result, BEAD concluded that an additional application of phosmet

would have to be made to compensate, resulting in higher chemical control costs, but equivalent

pest control. MANA has not submitted data to the contrary. In fact, the data submitted by

MANA on apple suggests that equivalent efficacy can be achieved, such that no loss in yield or

quality would be expected for apple. That is, BEAD may have overestimated the impact of

cancelling AZM on apple, but it did not underestimate the impact of cancellation on pear.

BEAD acknowledges that outbreaks ofsecondary pests, such as mites, may occasionally occur

with the use of some AZM alternatives. MANA did not list this as a constraint for two out ofthe

three most likely alternatives cited in BEAD' s assessment, phosmet and methox yfenozide. Nor

did MANA include or cite data verifying such outbreaks that would enable BEAD to verify or

quantify the frequency or magnitude ofthis constraint. BEAD' s search of the available literature

revealed one reference which summarized the results of20 field trials conducted over a five year

period investigating the effects of acetamiprid, thiacloprid, phosmet, and azinphos-methyl on

spider mite and predatory mite populations (Beers et al., 2005). This study reported that multiple

(4 to 8) applications of acetamiprid, clothianidin, and thiacloprid resulted in spider mite

populations above the economic threshold of 5 mites per leaf in 43%, 17%, and 11% ofthe

comparisons respectively. Azinphos-methyl applications resulted in spider mite populations

above the economic threshold in 2% ofthe comparisons and phosmet treatments never resulted

in spider mite populations higher than those in the control plots. BEAD acknowledges that

growers experiencing secondary outbreaks ofspider mites may have to apply an acaricide to

avoid yield losses, which would increase the impacts felt by the cancellation of AZM.

As regards the point made by Willett (2009 ) on the need for MRLs, BEAD note s that there are

new MRLs now establ ished for the two export markets identified by MANA as accounting for

about 75 % ofthe pear export (MANA 2009). BEAD 's 2005 assessment addressed this issue

qualitatively, indicating that growers targeting the export market would not find alternatives

lacking MRLs to be feasible alternatives.

BEAD also notes that neither comment provided new data on the comparative efficacy or cost of

newer chemistries in pear production.

Page 140f1 7
In sum, BEAD cannot identify in these comments compe lling new data to make the case that

previous assessments underestimated the impacts of cancellin g AZM on pear producers not the

impacts of a lower seasonal application rate.

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