UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON. D.C. 20460

SEP 1 6 2010

OFFICE OF CHEM!CA.L SAFETY

AND POlLUTION PREVENTION

MEMORANDUM

SUBJECT:

FROM:

T HRU :

TO:

Percent Crop Treated for New Uses (PC'Tn) of Mancozeb on Almonds, Broccoli,

Cabbage, Peppe r, Pwnpkin, and Winter Squash, PC Cnde: 014504; DP Barcnde:

360397; Lettuce, both Head and Other; PC Cnde: 014504; DP Barcnde: 364745,

NON PRIA, Parent DP: 635267; and Percent Crop Treated wi th Maneb for

Collards. Mustard Greens, TurnipGreens, and Kale

Jihad Alsadek, Ph.D., Economist T~'WA--- . .A-i~c;/ Science lnfonnation & Analysis Branch

Biological and Economic Analysis Division (7503P)

Carl Chen, Ph.D., Plant Pathologist

Biological Analysis Branch

Biological and Economic Analysis Division (7503P)

Science

Diann Sim

Inf

s, C

orm

h

ation

ief

an

A'i

d nalysis

.~

Brane

Biological and Economic Analysis Division (7503P)

Arnet Jones, Chief ::Jl~ Biological Analysis Branch

Biological and Economic Analysis Division' 503P)

Lisa Jones, Risk Manager Reviewer

Fungicide Branch

Registration Division (7505P)

Christine Olinger, Senior Chemist

Risk Assessment Branch VII

Health Effects Division (7509P)

Office of Pesticide Programs

PRP Review: August 4, 2010

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I. SUMMARY

HED requested that BEAD provide refined percent crop treated (PCT) value s for use of

mancozeb on almonds, broccoli, cabbage, pepper, pumpkin, winter squash and lettuce, both head

and other. Additionally, HED requested PCT values for use ofmaneb on collards, mustard and

turnip greens, and kale. HED also provided the ED BCIETU Task Force Study (February, 2010)

for BEAD's review. The EBDC Task Force (TF) submitted a study proposal to develop

information on the maneb cancellation, refinements to the RED risk assessments, and the impact

of these refinements on the EBDCs IETU cumulative and aggrega te risk assessment. Their

proposal also included data sources and methods to refine PCTn for the crops in the mancozeb

petitions, and to calculate the PCT for the leafy green Brassicas

BEAD reviewed the most recent available usage data and, through this memo, is

providing refinements of the projected percent crop treated (PPCT) values (new use) previously

provided for almonds, broccoli, cabbage, pepper, pumpkin, and winter squash (Alsadek and

Chen, 2009a) and lettuce, both head and other (Alsadek and Chen, 2009b). The term "PCTn"

has been recentl y used for percent crop treated for new uses (Doucoure and Chen, 2010), and is

used in this memo referring to previous PPCTs. BEAD is also providing PCT values for maneb

on collards, mustard and turnip greens, and kale. A summary of the previous, refined, and

proposed (EBDC Task Force) mancozeb PCTn values are shown in Table l. Table 2 presents

the refined P'Cf n values, both chronic and acute for mancozeb for almonds, broccoli, cabbage,

pepper, pumpkin, winter squash, head lettuce and other lettuce. PCTs for collards, mustard and

turnip greens, and kale are presented in Table 3. BEAD has considered all available relevant

information and believes it is unlik ely that these value s will be exceeded during the next five

years for these crops.

II. FEDERAL REGISTER LANGUAG E

For the market leader approach, EPA estimates the percent crop treated for new uses

(PCTn) of a chemical repre sent the upper bound of use expected durin g the pesticide's initial

five years of registration; that is, PCTn for this chemical is a threshold of use that EPA is

reasonably certain will not be exceeded for each registered use site. The PCTn recommended for

use in the chronic dietary assessment is calculated as the average percent crop treated (PCT) of

the mark et leader or leaders, (i.e., the one(s) with the greatest PCT,) on that site over the three

most recent years of available survey data. The PCTn recommended for use in the acute dietary

assessment is the maximum observed PCT over the same period. Comparisons are only made

among pesticides of the same pesticide types (e.g., the market leader for fungicides on the use

site is selected for comparison with a new fungicide). The mark et leader included in the

estimation may not be the same for each year since different pesticid es may dominate at different

times.

Typically, EPA uses USDAINASS as the source data because it is publicly available and

directly reports values for PCT. When a specific use site is not reported by USDAINASS, EPA

uses propri etary data and calculates the PCT given reported data on acres treated and acres

grown. If no data are available, EPA may extrapolate PCTn from other crops, ifthe production

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area and pest spectrum are substantially similar.

EPA refines PCTn estimate s based on approaches other than the market leader approach

ifthe previous PCTn estimates based on the market leader indicate that the chemical exposure

potentially pose a risk of concern. EPA considers the pest or pest spectrum targeted by the

chemical for the new uses and identifies other pesticides already registered on that crop that

target the same pest or pest spectrum. The PCTn is calculated based on the data from the three

most recently available pesticide usage surveys. If multiple chemicals are identified that target

the same pest spectrum, then the one with the highe st PCT is selected from each year/crop

combination. Consideration is also given to the potential for the development ofresistance for

each chemical using data available from the Resistance Action Committees.

EPA has considered all available relevant information and concludes that it is unlikely

that the PCTn values will be exceeded during the next five years.

III. Refinemen t of Mancozeb's PCTn Values for Almonds, Broccoli, Ca bbage, Pepper,

Pumpkin, Winter Squash, Head Lettuce, and Other Lettuce.

Previous Pc 'Fnvalues were derived by using the market leader approach. The market

leader approach is supported by an analysis that the new pesticide or new use of a registered

pesticide is not likely to overtake the market leader for the pesticide type, fungicide in this case.

These values were derived by averaging the three most recent years of available data for the

pesticide type market leader and crop to obtain the chronic PCTn value for manco zeb and by

selecting the highest observed from the three years of data for the acute PCTn value.

BEAD refines estimates based on approaches other than the market leader approach

where PCTn estimates provided based on the market leader indicate that the chemical exposure

poses a risk of concern and reliable information shows that the market leader estimates would

overstate future chemical use. This approach relies heavily on either a detail ed chemical-specific

analysis or a general analysis based on historical data. Because the previous Pe Tn estimates

based on the market leader indicate that the chemical exposure potentially pose a risk of concern,

BEAD attempted to further refine these Pf'Tn values beyond the market leader approach.

Mancozeb is a broad spectrum fungicide with a low potential for the development of

resistance. Other chemicals that target the same general pest spectrum, also with low potential

for the development ofresistance, include copper compounds, chlorothalonil, sulfur, and other

EBDCs.

BEAD first considered the pest or pest spectrum targeted by the chemical for the new

uses. Next, BEAD identified other pesticide s already registered on that crop that target the same

pest or pest spectrum. BEAD then calculated a PCfn based on the data from the three most

recently available surveys. The data sources used in the refinement included USDA NASS

(2002, 2004, 2006), Cal DPR (2006, 2007, 2008), and proprietary data (GtK Kynetec). If

multipl e chemicals were identified that target the same pest spectrum, then the one with the

highest peT was selected from each year/crop combination. Consideration was also given to the

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potential for the development of resistance for each chemical using data available from the

Resistance Action Committees. Should additional reliable information become ava ilable, BEAD

may be able to further refine the PCTn estimate.

Tab le 1 is a summary of the previously calculated PCTn values using the market leader

approach, the refined PCTn values and the Task Force proposed mancozeb PCTn values for

almonds, broccoli, cabbage, pepper, pumpkin, winter squash, head lettuce, other lettuce. Table 2

presents the refined PCTn Value s, both chronic and acute for mancozeb for almonds, broccoli,

cabbage, pepper, pumpkin, winter squash, head lettuce and other lettuce

Table 1. Summary of Previously Calculated PCTn Va lues Using the Market Leader

Appr oa ch, the Refined PCTn Va lues, and the Task Force's Pr oposed Mancozeb PCTn

Values for Almonds, Broccoli, Cabbage, Pepper, Pumpkin, Winter Squash, Head Lettuce,

and Other Lettuce.

Crop BEAD Market BEAD Refined Task Force

Leade r Approach Chronic PCTn+ Pro posed PCTs***

Chronic PCTn*/**

Almonds 31 18 10

Broccoli 8 5 10

Cabbage 42 42 15

Pepper 46 44 30

Pumpkin 45 45 6

Winter Squash 47 47 25

Head lettuce 67 67 67

Other lettuce 62 62 62

+. See Table 2 for more details on how the refined PCTn were calculated

Sou rces:

*Mancozeb PPCT Memo by J. Alsadek, and C. Chen, 4/2/2009.

**Man cozeb PPCT Memo by J. Alsadek, and C. Chen, 6/21/2009.

***EBDCIETU Task Force Response to EPA's June 14,2007 Memorandum, February 5, 2010

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Ta ble 2. Refinement of PCTn Values, Both Chro nic and Acute, for Mancozeh based on

PCTs from Market Leaders for Almonds, Broccoli, Ca bbage, Pepper, Pumpkin, Winter

Squash, Head Lettuce, and Other Lett uce.

Crop ' Ma rket Leader Years Annual Avg. PCT of Max. PCT of

(ML) PCTof ML(Chronic) ML(Acute)

ML

Almonds Copper Hydroxide 2006 25 18 25

Copper Hydroxide 2007 14

Copper Hydroxide 2008 16

Broccoli Mancb 2002 5 5 6

Chlorothalonil 2004 6

Chlorothalonill 2006 3

Maneb

Cabbage Chlorothalonil 2002 33 42 47

Chlorothalonil 2004 47

Chlorothalonil 2006 47

Peppers Copper Hydroxide 2002 48 44 48

Sulfur 2004 40

Maneb 2006 45

Pumpkin Chlorothalonil 2002 31 45 57

Chlorothalonil 2004 57

ChlorothaloniI 2006 48

Winter Chlorothalonil 2002 42 47 54

Squash Chlorothalonil 2004 54

Chlorothalonil 2006 45

Head Maneb 2002 66 67 75

Lettuce Maneb 2004 59

Maneb 2006 75

Other Maneb 2002 61 62 66

Lettuce Maneb 2004 59

Maneb 2006 66

Sources:

GfK Kynetec. (1998-2008) Proprietary data.

Agricultural Chemical Usage (2002, 2004, and 2006) Vegetables Summary, NASS, USDA.

California DPR (2006·2008)

1CA data are used for almonds and broccol i. Almonds and broccoli acreage treated with the market leader(s)

divided by total CA acreage for the years 2006, 2007,and 2008 for almonds. and for the years 2002, 2004, and 2006

for broccoli and multiplying by 100 to get a percentage for each year and then averaging the three percentages to get

a mancozeb refined PCT value. Average PCT values are used for chronic and maximum values are used for acute

risk assessment.

2 2002, 2004, and 2006 NASS data are averaged for each market leader to get refined mancozeb peT values for

peppers, pumpkins, and winter squash. Average peT values are used for chronic risk assessment and maximum

values are used for acute risk assessment.

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IV. Percent Crop Treated with Maneb for the Hrassica Crops (collards, mustard greens,

turnip greens, and kale)

Maneb is labeled for collards, mustard greens, and turnip greens, only in Georgia and

Tennessee, while it is labeled for use on kale in all states except California. PCT values for these

crops arc summarized in Table 3.

BEAD calculated the P'C'Ts for collards, mustard greens, and turnip greens using the most

recent agricultural census data (2007). BEAD identified the available crop acreage harvested in

Georgia and Tennessee for each crop and divided the relevant acreage by the total U.S area

harvested for that crop, and then multiplied by 100. This method assumes 100 percent maneb

treatment for the three crops in Georgia and Tennessee. Where there were no available harvested

acres data for Tennessee, BEAD used the ratio of TN farms to US farms multiplied by the

national harvested acreage as a surrogate for TN harvested acres. GA and TN harvested acreage

is divided by total US harvested acres and then multipli ed by 100. The result is used as a

surrogate for percent crop treated for collards, mustard greens, and turnip greens. These

percentages for collards, mustard greens, and turnip greens are used by IlED to refine their risk

assessment. This assumes 100 percent maneb treatment on collards, mustard greens, and turnip

greens in Georgia and Tennessee.

To calculate the PCT value for maneb 's use on kale, BEAD subtracted the CA harvested

acreage from the national harvested acreage. The result is divided by the national harvested

acreage and multiplied by 100. This method assumes 100 percent maneb treatment on kale in all

states but California.

The TF approach differs from BEAD's in the following areas: 1) BEAD used most

recent data, 2007 agricultural census data, while TF used relatively old data, 2003 NASS data,

and 2) observed maneb labeled crops in certain states differ from the TF study, especially kale

which is labeled nationwide except for California.

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Table 3. PCTs for Brassica Crops (Collards, Mustard Greens, Turnip Greens, and Kale),

Treated wit h Mancb.

Crop Year States Acreage Harvested Total US BEAD Task Force

Acres Calculated Proposed

Harvested PCTs PCTs

Collards 2007 GA&TN 3,451(3 ,320+131' ) 11,223 31% 53%

Mustard 2007 GA&TN 1,786(1,585+201' ) 8,323 22% 23%

Greens

Turnip 2007 GA&TN 3,371 (2,777+594' ) 9,365 36% 48%

Greens

Kale 2007 All Except CA 2,917" 3,994 73% 10%

Source.

hnp:Nwww.agcensus.usda.gov/Publicationsl2007IFull Report/us v I.pdf

• • According to the source, acres harvested in Tennessee (TN) were withheld to avoid disclosing data for

individual fanns. BEAD used the ratio ofTN farms to national number of farms, multiplied by the national acres

harvested to be the acreage for TN. This acreage was added to the GA acreage and divided by the total national

acreage to get the percent of acreage in GA and TN harvested . This percentag e is used as a surrogate for percent

crop treated for each of these three crops, assuming 100 percent maneb treatment.

• • • California harvested acreage was subtracted form the total US harvested acreage. BEAD divided this result by

the total US harvested acreage, and multiplied by 100 to get the percent of kale treated with maneb

V, ADDITIONAL BIOLOGICAL FACTORS

There are three main biol ogical factors BEAD considers in evaluating the likelihood that

use of a newly registered chemical or a new use will exceed the peT for new uses or new

chemicals: (1) the extent of pest pressure on the crops in question; (2) the pest spectrum of the

new pesticide in comparison with the market leaders as well as whether the market leaders are

well-established for this use; and (3) resistance concerns with the new pesticide and the market

leaders. High pest pressure with the lack of registered controls could indicate significant demand

for a new chemical. Emergency exemptions under section 18 of FIFRA are a good indicator in

regard to these situations. On the other hand, it would he relatively diffi cult for a new active

ingredient to gain a large portion of the market if a) it competes with the market leader(s) or

others that have been extensivel y used for pest control including the same target pest(s), b) its

new use is limited, for example, registered only for a single pest, and/or c) it is labeled for pest(s)

of minor eco nomic concern. Finally, ifthe target pests are developing resistance to the market

leader(s), it co uld indicate an advantage for the new active ingredient in the market.

Both maneb and mancozeb are EBDCs and are co nsidered to be broad spectrum

fungicides with low risk for resistance. Whi le the Task Force assume s that mancozeb would

replace maneb on a one-to-one basis, BEAD does not have data that would indicate that this

would occur, or whether another broad-spectrum fungicide would be selected by the growers.

The refore BEAD has selected the broad-spectrum fungici de with the greatest PCT to estimate

the PCTn, and concludes that it is unlikely that the use ofmancozeb will exceed the refmed

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PCTn estimates on any crop identified in Table 2. It is mainly because 1) for mancozeb to

compete with the leading fungicide(s) that have been used extensively for similar functions such

as broad spectrum and low risk in resistance, it will take time to build market share, which will

unlikely happen in the time frame ofthis assessment; and/or 2) existing maneb stocks are likely

to reduce the usage of mancozeb. If more than one EBDC product is used on the same crop

during the same growing season, the maximum seasonal poundage may not exceed that allowed

for a single product.

In addition, NASS PCT data are not available for the four leafy green Brassicas. Maneb

PCTs in Tennessee were estimated, when compared to other leafy green fungicide uses in the

state, as 45% for collards, 45% for kale, 70% for mustard greens, and 60% for turnip greens

(Tennessee Greens Profile, 2008). Maneb is labeled for use on kale in all U.S. except California,

and other three greens in Georgia and Tennessee only. This memo assumes 100% maneb usage

on collards, mustard greens, or turnip greens in Georgia and Tennessee and kale in all states

except California. It is a conservative estimate and no analysis on additional factors is needed.

Because these greens are also grown in other states that are not labeled for maneb use, TF

proposed that " [fJor the purposes ofrisk assessment, it can be assumed that conservatively 100%

of the Georgia collard crop was treated with maneb. Therefore, the proposed %CT for maneb on

collards is 53%." (Task Force Study. 2010) For another example - mustard greens, TF

calculated that " 100% ofthe Georgia crop, representing 23% ofthe US acreage, is a fair estimate

of the total US %CT, resulting in 23% CT for maneb." Beside the agreement on the approach

used for these greens, there are differences between this memo and the TF proposal (Table 3).

First, 2007 Census ofAgriculture data are used. Second, Tennessee is included, which is also

labeled for maneb use, in spite of relatively small acreage. And third, the same assumption and

calculation is applied to all four greens in this memo, but was not applied to kale in TF' s

proposal.

VI. CONCLUSIONSIRECOMMENDATIONS

BEAD recommends that the total refined EBDCs PCTn values for almonds, broccoli,

cabbage, pepper, pumpkin, winter squash, and head/other lettuce, and the maneb PCTs for

collards, kale, mustard greens, and turnip greens be used in the chronic and/or acute dietary risk

assessment. BEAD has considered all available relevant information and believes it is unlikely

that the above PCTn and PCT values will be exceeded during the next five years for these crops.

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VII. REFERENCES

Agricultural Chemical Usage (2002, 2004, and 2006) Vegetables Summary .

Alsadek J, Chen C. 2009a. Proj ected Percent Crop Treated (PPCT) for the Fungicide Mancozeb

on Six New Crops: Almonds, Bell Pepper, Broccoli, Cabbage, Pumpkin, Winter

Squash, and Percent Import Share for Mandarin! Oranges. PC Code : 014504; DP

Barcode: 360397; Decision #: 2994 14.

Alsadek J, Chen C. 2009b. Proj ected Percent Crop Treated (Pl'C'I') for the Fungicide Mancozeb

on Lettuce (Head, and Other). PC Code : 014504; DP Barcode : 360397; NON PRIA,

Parent DP:635267; Dec ision #: 302667.

BEA D Memo. 12/14/2006. BEAD's Approach to Provid ing Projected Percent Crop Treated

(Pl'C'I} Estimates for Use in Dietary Risk Assessment in OP?

Census of Agriculture . 2007. United States Department of Agriculture National Agricultural

Statistics Service.

http: //'WV.'W.agcenslls.llsda.gov/Publications/2007/Full Reportlusv I.pdf.

Comments to Maneb Cancellat ion. 2010. Summary of Comments to Proposed Rule of May 26,

20 I0: Maneb To lerance Revocations.

Cucurbits Fact Sheet. 1987. Anthracnose of Cucurbits. Cornell University Department of Plant

Pathology Vegetable MD Online Fac tsheets. Accessed on Jul y 28, 2010.

http://vegetablemdonline .ppath.cornel l.edulfactsheets/Cucurbit_List.htrn

Doucoure C, Chen C. 2010. Percent Crop Treated for New Uses (PCTn) with the New Chemical,

Fluopyrarn, PC#080302, DP# 370371.

GtK Kynetec. 1998-2008. Proprietary Data.

Task Force Study. 2010. EBDCIETC Task Force Response to EPA's June 14,2007

Memorandum "Ethylenethiourea (ETU) from EBDCs: Health Effects Division (HED)

Human Health Risk Assessment ofthe Common Metabolite/Degradate ETU" and EPA's

April 17,2007 Memorandum "PP#9#6006 PP#4F4324 ad 4F4333 Aggregate Dietary

Assessment of the Common MetabolitelDegradate Ethylene Thiourea (ETU) to Support

New Tolerances on Imported Grapes and Bananas for Metiram and for New Tolerances

for Mancozeb on Almonds, Borccoli, Cabbage, Lettuce, and Peppers". Janet Ollinger.

February 5, 2010.

Tennessee Greens Profile. 2008. Crop Profile for Leafy Greens in Tennessee. University of

Tennessee Extension Service.

http://www.iprncenters.orgicropprofiles/docsrrNleafygreens.pdf

cc: M. Waller; C. Olinger

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