18906 Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 

measuring only indaziflam, in or on the 

commodity. 

Commodity Parts per 

million 

Almond, hulls ............................ 0.15 

Fruit, citrus, group 10–10 ......... 0.01 

Fruit, pome, group 11–10 ......... 0.01 

Fruit, stone, group 12 ............... 0.01 

Grape ........................................ 0.01 

Nut, tree, group 14 ................... 0.01 

Olive .......................................... 0.01 

Pistachio ................................... 0.01 

Sugarcane, refined sugar 1 ....... 0.01 

1Tolerance without a corresponding U.S. 

registration. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2011–7774 Filed 4–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0307; FRL–8864–1] 

Mancozeb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mancozeb in 

or on almonds, cabbage, lettuce, 

peppers, and broccoli. Dow 

AgroSciences LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

6, 2011. Objections and requests for 

hearings must be received on or before 

June 6, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2005–0307. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2005–0307 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 6, 2011. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2005–0307, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of November 

30, 2005 (70 FR 71836) (FRL–7747–5), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 3E6536 for 

mandarin oranges/mandarins; PP 

4F4324 for almond nuts and almond 

hulls; PP 4F4333 for broccoli, cabbage, 

lettuce, and peppers) by Dow 

AgroSceinces LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petitions requested that 40 CFR 180.176 

be amended by establishing tolerances 

for residues of the fungicide mancozeb, 

zinc manganese ethylenebis 

dithiocarbamate, in or on mandarin 


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oranges/mandarins at 5.0 parts per 

million (ppm) (PP 3E6536), almond nuts 

at 0.1 ppm and almond hulls at 10.0 

ppm (PP 4F4324); and broccoli at 13.0 

ppm, cabbage at 10.0 ppm, lettuce at 

10.0 ppm, and peppers at 7.0 ppm (PP 

4F4333). That notice referenced a 

summary of the petition prepared by 

Dow AgroSciences LLC, the registrant, 

which is available in the docket, 

http://www.regulations.gov. One 

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is setting 

the tolerances at levels different than 

originally requested in the petitions, 

with the exception of almond. The 

reason for these changes is explained in 

Unit IV.D. The request for mandarin 

oranges has been withdrawn. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for mancozeb 

including exposure resulting from the 

tolerances established by this action. 

Mancozeb is a member of the ethylene 

bisdithiocarbamate (EBDC) group of 

fungicides that also includes the related 

active ingredients maneb and metiram. 

Mancozeb, maneb and metiram, are all 

metabolized to ethylenethiourea (ETU) 

in the body and all degrade to ETU in 

the environment. Therefore, EPA has 

considered the aggregate or combined 

risks from food, water and nonoccupational exposure resulting from 

mancozeb alone and ETU from all 

sources (i.e., the other EBDC fungicides) 

for this action. 

In response to the petitions submitted 

to establish tolerances for residues of 

mancozeb on almond, cabbage, leaf 

lettuce, peppers, and broccoli, EPA 

completed two risk assessments in 2007: 

• A mancozeb risk assessment which 

considered all existing and proposed 

uses for mancozeb, and 

• An ETU risk assessment that 

considered exposure to ETU from all 

sources (mancozeb, metiram, and 

maneb) for all existing and proposed 

uses. 

Although the 2007 mancozeb review 

showed risks that were acceptable, the 

2007 ETU review demonstrated 

unacceptable cancer risks, therefore 

preventing the Agency from acting on 

the petitions for almond, cabbage, leaf 

lettuce, peppers, and broccoli. The 

Agency worked to refine the cancer risk 

assessment for ETU. A refined cancer 

risk assessment for ETU from all sources 

has been completed and the Agency is 

now prepared to act on the proposed 

tolerances for almond, cabbage, leaf 

lettuce, peppers, and broccoli. Because 

the 2010 ETU review dealt strictly with 

refining the cancer risk, the Agency will 

be relying on three risk assessments to 

support this tolerance document. These 

assessments are as follows: 

• A 2007 risk assessment for 

mancozeb for acute, short-term, 

intermediate-term, chronic, and cancer 

risk (refer to risk assessment in the 

Docket EPA–HQ–OPP–2005–0307 titled 

‘‘Mancozeb: Human Health Risk 

Assessment to Support Proposed New 

Uses on Broccoli, Cabbage, Lettuce, 

Peppers and Almonds’’), 

• A 2007 risk assessment for ETU for 

acute, short-term, intermediate-term and 

chronic risk (refer to risk assessment in 

the Docket EPA–HQ–OPP–2005–0307 

titled ‘‘Ethylenethiourea (ETU) from 

EBDCs: Health Effects Division (HED) 

Human Health Risk Assessment of the 

Common Metabolite/Degradate ETU’’), 

• A 2010 addendum to the 2007 ETU 

assessment for cancer risk (refer to risk 

assessment in the Docket EPA–HQ– 

OPP–2005–0307 titled ‘‘Addendum to 

the Aggregate Human Health Risk 

Assessment of the Common Metabolite/ 

Degradate Ethylene Thiourea (ETU) to 

Support New Tolerances on Imported 

Grapes and Bananas for Metiram and for 

New Tolerances for Mancozeb on 

Almonds, Broccoli, Cabbage, Lettuce, 

and Peppers.’’). 

In the Federal Register of April 16, 

2010, (75 FR 19967) (FRL–8822–2) the 

voluntary cancellation of the last 

product containing maneb registered for 

use in the United States was announced 

by the Agency. Therefore, it is important 

to note that since all products for maneb 

have been cancelled and there are 

limited existing stocks for maneb still in 

the channels of trade, the risk 

assessments for ETU likely 

overestimates the exposures to this 

common metabolite. EPA’s assessment 

of exposures and risks associated with 

mancozeb and ETU follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. In addition to 

evaluating mancozeb, EPA also 

evaluated the risks of ETU, a 

contaminant, metabolite and 

degradation product of mancozeb and 

the other EBDC group of fungicides, 

which includes the related active 

ingredients metiram and maneb. 

1. Mancozeb. Mancozeb is not acutely 

toxic via the oral, dermal or inhalation 

routes of exposure. Further, mancozeb is 

not a skin irritant nor is it a skin 

sensitizer, although it does cause mild 

eye irritation. The findings in multiple 

studies demonstrate that the thyroid is 

a target organ for mancozeb. Thyroid 

toxicity was manifested as alternations 

in thyroid hormones, increased thyroid 

weight, and microscopic thyroid lesions 

(mainly thyroid follicular cell 

hyperplasia). These effects are due to 

the ETU metabolite. In a subchronic 

study in the rat, neuropathology was 

seen (injury to peripheral nerves) 

microscopically with associated clinical 

signs (abnormal gait and limited use of 

rear legs) and loss of muscle mass. An 

acute neurotoxicity study with 

mancozeb has been completed and 

reviewed since the 2007 risk 

assessment; neuropathology was not 

observed, and minimal effects upon 

motor activity were observed at high 

doses. The Agency conducted a 

preliminary dietary assessment using a 

point-of-departure from this study and 

found no risk concerns. Other toxicity 

included increases in bilateral 

retinopathy in the chronic rat study. 

Elevated cholesterol and a mild, 

regenerative, anemia occurred in 

subchronic and chronic dog studies. 

Mancozeb is rapidly absorbed and 

eliminated in the urine. In oral rat 

metabolism studies with radiolabelled 


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mancozeb and other EBDCs, an average 

7.5% in vivo metabolic conversion of 

EBDC to ETU occurred, on a weight-toweight basis. Metabolism data indicate 

mancozeb does not bio-accumulate. 

Mancozeb has been tested in a series of 

in vitro and in vivo genotoxicity assays, 

which have shown that it exhibits weak 

genotoxic potential. 

Thyroid follicular cell adenomas and 

carcinomas were increased in high-dose 

males and females in the combined rat 

toxicity/carcinogenicity study with 

mancozeb. Doses in a mouse study were 

too low to assess carcinogenicity, and 

there were no treatment-related changes 

in tumor rates. Historically, mancozeb’s 

potential for carcinogenicity has been 

based on its metabolite ETU, which is 

classified as a probable human 

carcinogen. However, since ETU is 

known to be the chemical causing the 

thyroid tumors observed, the cancer 

assessment has been done only for ETU 

rather than the parent compound. 

Developmental defects in the rat 

developmental toxicity study included 

hydrocephaly, skeletal system defects, 

and other gross defects which occurred 

at a dose causing maternal mortality and 

did not indicate increased susceptibility 

of offspring. Abortions occurred in the 

rabbit developmental toxicity study at 

the high dose which also caused 

maternal mortality, and there was no 

indication of enhanced susceptibility of 

offspring in the rabbit. There was no 

evidence of reproductive toxicity in the 

2-generation reproduction study in rats. 

2. ETU. The thyroid is a target organ 

for ETU; thyroid toxicity in subchronic 

and chronic rat, mouse, and dog studies 

included decreased levels of T4, 

increases or decreases in T3, 

compensatory increases in levels of 

TSH, increased thyroid weight, and 

microscopic thyroid changes, chiefly 

hyperplasia. Overt liver toxicity was 

observed in one chronic dog study. ETU 

is classified as a probable human 

carcinogen based on liver tumors in 

female mice. 

Developmental defects in the rat 

developmental study were similar to 

those seen with mancozeb, and 

included hydrocephaly and related 

lesions, skeletal system defects, and 

other gross defects. These defects 

showed increased susceptibility to 

fetuses because they occurred at a dose 

which only caused decreased maternal 

food consumption and body weight 

gain. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mancozeb as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Mancozeb: Human Health Risk 

Assessment to Support Proposed New 

Uses on Broccoli, Cabbage, Lettuce, 

Peppers and Almonds’’ on pages 13–15 

in docket ID number EPA–HQ–OPP– 

2005–0307. 

Additionally, specific information on 

the studies received and the nature of 

the toxic effects caused by ETU as well 

as the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document titled 

‘‘Ethylenethiourea (ETU) from EBDCs: 

Health Effects Division (HED) Human 

Health Risk Assessment of the Common 

Metabolite/Degradate ETU’’ on pages 

16–17 in docket ID number EPA–HQ– 

OPP–2005–0307. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for mancozeb and ETU used 

for human risk assessment is discussed 

in Unit IV.B. of the final rule published 

in the Federal Register of August 18, 

2010 (75 FR 50902) (FRL–8841–1). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mancozeb, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

mancozeb tolerances in 40 CFR 180.176. 

In evaluating dietary exposure to ETU, 

EPA considered exposure under the 

petitioned-for tolerances discussed in 

this document as well as all existing 

uses of the EBDC group of fungicides 

(maneb, metiram, mancozeb) including 

the uses for which there are maneb 

tolerances even though all maneb 

registrations have been canceled. EPA 

assessed dietary exposures from 

mancozeb and ETU in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for mancozeb and ETU. In estimating 

acute dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). 

a. Mancozeb. The following 

assumptions were made for the acute 

exposure assessments: The Agency 

conducted a highly refined, 

probabilistic acute dietary assessment 

incorporating maximum percent crop 

treated information for new and existing 

uses, field trial or monitoring data, and 

processing and cooking factors. 

b. ETU. The following assumptions 

were made for the acute exposure 

assessments: The Agency conducted a 

highly refined, probabilistic acute 

dietary assessment incorporating 

maximum percent crop treated 

information for new and existing EBDC 

uses, field trial or monitoring data for 

existing EBDC uses, and processing and 

cooking factors. It was assumed that 

commodities would not be treated with 

more than one EBDC in a season, as 

there are label restrictions regarding 

treatment with multiple EBDCs. Percent 

crop treated was estimated by summing 

the percent crop treated for the 

individual EBDCs. For residue values, 

EPA used either market basket survey 

data or field trial data. For a few 

commodities, mancozeb-derived ETU 

from mancozeb field trial data were 

used for both mancozeb and maneb 

because maneb field trial data were not 

available and application rates were 

sufficiently similar to estimate manebderived ETU values. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. 


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a. Mancozeb. The chronic dietary 

exposure and risk assessment for 

mancozeb (non-cancer and cancer) 

incorporated average values based either 

on field trial data or monitoring data 

and average percent crop treated data 

for new and existing uses, as well as 

processing and cooking factors. 

b. ETU. Chronic anticipated residues 

were calculated from field trial data on 

EBDCs or monitoring data for ETU. 

Averages of the field trial and market 

basket survey residues were used. EPA 

also used PCT data. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight-ofthe-evidence from cancer studies and 

other relevant data. If quantitative 

cancer risk assessment is appropriate, 

cancer risk may be quantified using a 

linear or nonlinear approach. If 

sufficient information on the 

carcinogenic mode of action is available, 

a threshold or non-linear approach is 

used and a cancer RfD is calculated 

based on an earlier noncancer key event. 

If carcinogenic mode of action data are 

not available, or if the mode of action 

data determines a mutagenic mode of 

action, a default linear cancer slope 

factor approach is utilized. Mancozeb 

degrades and/or metabolizes to ETU 

which causes thyroid tumors; therefore, 

EPA has historically attributed 

mancozeb’s carcinogenicity to the 

formation of ETU, which is classified as 

a probable human carcinogen. The 

Agency has used the cancer potency 

factor (Q1

*) of 0.0601 (mg/kg/day)-1 for 

ETU (based on liver tumors in female 

mice) for risk assessment. Therefore, 

cancer risk from exposure to mancozeb 

has been calculated by estimating 

exposure to mancozeb-derived ETU and 

using Q1* for ETU. The same approach 

has been taken for the other EBDCs. 

EPA’s estimated exposure to mancozebderived ETU and ETU from other EBDCs 

included ETU residues found in food as 

well as ETU formed by metabolic 

conversion on parent mancozeb in the 

body (conversion rate of 0.075). EPA 

relied on the same estimates used for 

the chronic exposure assessment in 

assessing cancer risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

In the 2007 acute risk assessment for 

mancozeb, the Agency estimated the 

PCT for existing uses as follows: 

Apple, 41%; asparagus, 34%; barley, 

0.9%, beet, sugar, 2.9%; cantaloupe, 

10%; carrot, 13%; casaba, 10%; corn, 

field, 1%; corn, sweet, 22%; cottonseed, 

oil, 0.8%; cucumber, 32%; grape, 14%; 

honeydew melon, 13%; oat, 1%; onion, 

dry bulb, 77%; peanut, 2.3%; pear, 

51%; potato, 50%; pumpkin, 10%; rice, 

1%; rye grain, 1%; squash, summer, 

86%; squash, winter, 10%; tomato, 

80%; watermelon, 30%; wheat, grain, 

2.3%. 

In the 2007 chronic risk assessment 

for mancozeb, the Agency estimated the 

PCT for existing uses as follows: 

Apple, 26%; asparagus, 16%; barley, 

0.2%, beet, sugar, 1.3%; carrot, 9%; 

casaba, 8%; corn, field, 1%; corn, sweet, 

12%; cottonseed, oil, 0.2%; cucumber, 

18%; grape, 9%; honeydew melon, 8%; 

oat, 1%; onion, dry bulb, 38%; peanut, 

0.9%; pear, 32%; potato, 36%; 

pumpkin, 8%; rice, 1%; rye grain, 1%; 

squash, summer, 41%; squash, winter, 

8%; tomato, 49%; watermelon, 28%; 

wheat, grain, 0.9%. 

In the 2007 acute risk assessment for 

ETU the Agency estimated the PCT for 

existing uses as follows: 

Apple, 65%; asparagus, 30%; barley, 

2%; bean, dried, 2.5%; beets, sugar, 

15%; Brussels sprouts, 32%; 

cantaloupe, 12.5%; carrot, 2.5%; casaba, 

12.5%; cauliflower, 15%; celery, 12%; 

chickpea, 2.5%; Chinese waxgourd, 

15%; chive, 20%; collards, 10%; corn, 

field, 2.5%; corn, sweet, 17.5%; 

cottonseed, oil, 3.5%; cranberry, 31%; 

cucumber, 40%; eggplant, 65%; fennel, 

Florence, 12%; fig, 1%; garlic, 25%; 

grape, 81.5%; grape, wine, 81.5%; guar, 

seed, 1%; honeydew melon, 12.5%; 

kale, 5%; leek, 25%; mustard greens, 

5%; oat, 2%; onion, dry bulb, 85%; 

peanut, 3.5%; pear, 55%; potato, 85%; 

pumpkin, 15%; rice, 2.5%; rye grain, 

2%; squash, summer, 35%; squash, 

winter, 0%; tomato, fresh, 80%; tomato, 

processed, 25%; turnip tops, 86%; 

walnut, 37.5%; watermelon, 55%; 

wheat, grain, 3.5%. 

In the 2007 chronic risk assessment 

for ETU the Agency estimated the PCT 

for existing uses as follows: 

Apple, 42%; asparagus, 21%; barley, 

2%; bean, dried, 1%; beets, sugar, 6%; 

Brussels sprouts, 21%; cantaloupe, 6%; 

carrot, 8%; casaba, 6%; cauliflower, 5%; 

celery, 12%; chickpea, 1%; Chinese 

waxgourd, 5%; chive, 10%; collards, 

10%; corn, field, 1%; corn, sweet, 11%; 

cottonseed, oil, 2%; cranberry, 31%; 

cucumber, 20%; eggplant, 45%; fennel, 

Florence, 12%; fig, 1%; garlic, 25%; 

grape, 60%; grape, wine, 60%; guar, 

seed, 1%; honeydew melon, 6%; kale, 

6%; kohlrabi, 1%; leek, 10%; mustard 

greens, 5%; oat, 2%; onion, dry bulb, 

60%; peanut, 2%; pear, 40%; potato, 

63%; pumpkin, 6%; rice, 1%; rye grain, 

2%; squash, summer, 25%; squash, 

winter, 25%; tomato, fresh, 54%; 

tomato, processed, 54%; walnut, 31%; 

watermelon, 10%; wheat, grain, 2%. 

For the 2010 ETU cancer risk 

assessment the Agency estimated the 

PCT for existing uses as follows: 

Apple, 51%; asparagus, 15%; barley, 

1%; bean, dried, 1%; beets, sugar, 3.5%; 

Brussels sprouts, 15%; cantaloupe, 

7.5%, carrot, 5%; cauliflower, 10%; 

chickpea, 1%; collards, 31%; corn, field, 

1%; corn, sweet, 6%; cottonseed, oil, 

11%; cranberry, 45%; cucumber, 30%; 

eggplant, 30%; fig, 5%; flaxseed, 11%; 

garlic, 25%; grape, 6%; grape, wine, 

26%; guar, seed, 1%; kale, 73%; leek, 

15%; mustard greens, 22%; oat, 11%; 

onion, dry bulb, 75%; peanut, 2%; pear, 

35%; potato, 67.5%; pumpkin, 20.5%; 

rice, 1%; rye grain, 11%; safflower, oil, 

11%; squash, summer, 57%; squash, 

winter, 26%; tomato, fresh, 30%; 

tomato, processed, 30%; turnip tops, 

36%; walnut, 36%; watermelon, 45%; 

wheat, grain, 11%. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 


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recent 6 to 7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 1. 

In those cases, 1% is used as the average 

PCT and 2.5% is used as the maximum 

PCT. EPA uses a maximum PCT for 

acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

In the 2007 acute risk assessment for 

mancozeb, the Agency estimated the 

PCT for new uses as follows: 

Almond, 35%; broccoli, 9%; cabbage, 

47%; cabbage, Chinese, 47%; head 

lettuce 66%; leaf lettuce 61%; pepper, 

bell, 48%; pepper, non-bell, 48%. 

In the 2007 chronic risk assessment 

for mancozeb, the Agency estimated the 

PCT for new uses as follows: 

Almond, 35%; broccoli, 7%; cabbage, 

42%; cabbage, Chinese, 42%; head 

lettuce 58%; leaf lettuce 59%; pepper, 

bell, 43%; pepper, non-bell, 43%. 

For the 2007 ETU acute assessment, 

the Agency estimated the PCT for new 

uses as follows: 

Almond, 50%; broccoli, 22%; 

cabbage, 82%; cabbage, Chinese, 82%; 

pepper, bell, 88%; pepper, non-bell, 

88%. 

For the 2007 ETU chronic assessment, 

the Agency estimated the PCT for new 

uses as follows: 

Almond, 45%; broccoli, 17%; 

cabbage, 57%; cabbage, Chinese, 57%; 

pepper, bell, 73%; pepper, non-bell, 

73%. 

For the 2010 ETU cancer assessment, 

the Agency estimated the PCT for new 

uses as follows: 

Almond, 28%; broccoli, 15%; 

cabbage, 62%; cabbage, Chinese, 62%; 

pepper, bell, 74%; pepper, non-bell, 

74%. 

EPA estimates the percent crop 

treated for new uses (PCTn) of a 

pesticide represent the upper bound of 

use expected during the pesticide’s 

initial 5 years of registration. The PCTn 

recommended for use in the chronic 

dietary assessment is calculated as the 

average PCT of the pesticide or 

pesticides that are the market leader or 

leaders, (i.e., the pesticides 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 

market leader included in the 

estimation may not be the same for each 

year since different pesticides may 

dominate at different times. 

Typically, EPA uses USDA/NASS as 

the source data because it is publicly 

available and directly reports values for 

PCT. When a specific use site is not 

reported by USDA/NASS, EPA uses 

proprietary 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, if the production area and pest 

spectrum are substantially similar. 

EPA refines PCTn estimates based on 

approaches other than the market leader 

approach if the previous PCTn estimates 

based on the market leader indicate that 

the chemical exposure potentially poses 

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 highest 

PCT is selected from each year/crop 

combination. Consideration is also 

given to the potential for the 

development of resistance 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 5 years. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which mancozeb may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water—i. Mancozeb. The Agency has 

determined that mancozeb is very shortlived in soil and water, and would not 

reach water used for human 

consumption whether from surface 

water or ground water. 

ii. ETU. ETU is highly water soluble, 

and may reach both surface and ground 

water under some conditions. The ETU 

surface water Estimated Drinking Water 

Concentrations (EDWCs) were generated 

using a combined monitoring/modeling 

approach. Results of a surface water 

monitoring study conducted by the ETU 

Task Force were used to refine the 

outputs of the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM–EXAMS) models; the 

site/scenario modeled was application 

of an EBDC fungicide on peppers in 

Florida, and was chosen to produce the 

highest EDWC acute values. The ground 

water EDWC was detected in a Florida 

community water system intake in a 

targeted ground water monitoring study 

conducted by the EBDC task force from 

1999 to 2003. Both these surface and 

ground water values represent upperbound conservative estimates of the 

total ETU residual concentrations that 

might be found in surface water and 

ground water due to the use of the EBDC 

fungicides. 

Based on the PRZM/EXAMS and 

monitoring studies, the EDWCs of ETU 

acute and chronic exposures are 

estimated to be 25.2 parts per billion 

(ppb), and 0.1 ppb, respectively for 

surface water. The EDWC for chronic 

exposure is estimated to be ppb for 

ground water 0.21. 

Estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 25.2 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment of ETU, the water 

concentration of value 0.21 ppb was 

used to assess the contribution to 

drinking water. For cancer dietary risk 

assessment of ETU, the water 

concentration of value 0.21 ppb was 

used to assess the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonVerDate Mar<15>2010 15:31 Apr 05, 2011 Jkt 223001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\FR\FM\06APR1.SGM 06APR1

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occupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

i. Mancozeb. Mancozeb is currently 

registered for use on the following 

residential sites: Home gardens, golf 

courses, and sod farms (potential 

exposure to mancozeb is from residues 

remaining on transplanted turf). The 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food with short- and 

intermediate-term residential exposures 

to mancozeb. Since residues of 

mancozeb are not expected in drinking 

water, only mancozeb food residues are 

considered. 

The two scenarios that were evaluated 

for mancozeb are the ‘‘short/ 

intermediate-term home garden 

aggregate (adult)’’ which considers 

residential handler exposures 

(inhalation) to adult applicators 

combined with average food exposures 

and the ‘‘short/intermediate-term treated 

turf aggregate (toddler)’’ which considers 

residential incidental oral exposures to 

toddlers combined with average food 

exposures. The only postapplication 

scenario for adults in contact with 

treated turf (golf courses) is via the 

dermal route of exposure. Since no 

dermal endpoints were selected for 

mancozeb, a quantitative risk 

assessment for this scenario is not 

required. 

ii. ETU. ETU non-dietary exposure is 

expected as a result of the registered 

uses of mancozeb and the other EBDCs 

on home gardens, golf courses and sod 

farms. For ETU, aggregate exposure 

sources include food, drinking water, 

home gardening activities and golfing. 

The Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food with short- and 

intermediate-term residential exposures 

to mancozeb. 

The three scenarios that were 

evaluated for ETU are as follows: The 

first is the ‘‘short/intermediate-term 

home garden aggregate’’ which combines 

handler exposures (inhalation and 

dermal) and postapplication garden 

exposures (dermal) plus average daily 

food and drinking water exposure for 

adults and postapplication garden 

exposures (dermal) plus average daily 

food and drinking water exposure for 

youth. The second is the ‘‘short-term 

treated turf aggregate (toddlers)’’ which 

combines treated turf post application 

exposures (incidental oral and dermal) 

plus average daily food and drinking 

water exposure for toddlers. And the 

last is the ‘‘short/intermediate-term 

treated turf aggregate’’ which considers 

short-term residential exposures 

(dermal) plus average daily food and 

drinking water exposure for adults such 

as golfing on treated turf. This 

assessment is protective of adult and 

youth golfers. Although exposure to 

children golfing could be almost twice 

that of the adult golfer because of 

increased surface area/body weight (SA/ 

BW) ratios, younger golfers are not 

expected to use the golf course for the 

same length of time as adolescents and 

adults. The shorter duration on the golf 

course for younger golfers offsets the 

higher SA/BW; therefore, risks from 

short-term post-application exposures to 

young golfers are likely to be similar to 

risks for adult golfers. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

As previously mentioned, the risk 

estimates summarized in this document 

are those that result only from the use 

of mancozeb, and ETU derived from 

mancozeb and the other EBDC 

chemicals, which are all 

dithiocarbamates. For the purposes of 

this action, EPA has concluded that 

mancozeb does not share a common 

mechanism of toxicity with other 

substances. The Agency reached this 

conclusion after a thorough internal 

review and external peer review of the 

data on a potential common mechanism 

of toxicity. 

EPA concluded that the available 

evidence does not support grouping the 

dithiocarbamates based on a common 

toxic effect (neuropathology) occurring 

by a common mechanism of toxicity 

(related to metabolism to carbon 

disulfide). After a thorough internal and 

external peer review of the existing data 

bearing on a common mechanism of 

toxicity, EPA concluded that the 

available evidence shows that 

neuropathology can not be linked with 

carbon disulfide formation. For more 

information, please see the December 

19, 2001 memo, ‘‘The Determination of 

Whether Dithiocarbamate Pesticides 

Share a Common Mechanism of 

Toxicity’’ on the internet at http:// 

www.epa.gov/oppsrrd1/cumulative/ 

dithiocarb.pdf. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity— 

i. Mancozeb. In the rat developmental 

study, developmental effects were 

observed in the presence of severe 

maternal effects, including maternal 

mortality and clinical signs. In the 

rabbit developmental study, 

developmental effects (spontaneous 

abortions) were observed at the same 

dose (80 mg/kg/day) at which maternal 

effects included mortality and clinical 

signs. In the rat reproduction study, no 

effects were observed in offspring, while 

thyroid effects and body weight gain 

decrements occurred in adults. 

ii. ETU. There was evidence of 

increased susceptibility of fetuses to 

ETU in the rat developmental studies 

because hydrocephaly occurred at doses 

below that causing maternal toxicity. 

Acceptable reproductive and rabbit 

developmental toxicity studies were not 

available for ETU. As a result, the 

Agency evaluated the level of concern 

for the effects observed when 

considered in the context of all available 

toxicity data. In addition, the Agency 

evaluated the database to determine if 

there were residual uncertainties after 

establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the ETU risk assessment. 

3. Conclusion—i. Mancozeb. In the 

2007 assessment, EPA retained the 

presumptive 10X FQPA safety factor for 

the protection of children due to the 

absence of a required developmental 

neurotoxicity study. That study has 

recently been received. Neurotoxicity 

was not observed in the study, and the 

young animals did not show 

susceptibility, as compared to the 

adults, for the slight toxicity that was 

observed (reduced body weight gain). 

Additionally, since the completion of 

the 2007 assessment, EPA has imposed 

a new data requirement for 

immunotoxicity data and such data has 


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not been submitted for mancozeb. The 

absence of an immunotoxicity study 

does not raise significant uncertainty. In 

the absence of that study, the available 

toxicity data for mancozeb have been 

thoroughly examined for any 

information which suggests a potential 

for immunotoxicity. The analysis did 

not reveal such information and the 

Agency does not believe that conducting 

the immunotoxicity study will result in 

a point of departure (POD) less than the 

currently selected PODs for risk 

assessment. 

Because EPA is relying on the 2007 

assessment in evaluating acute and 

chronic risks, EPA is retaining the 

children’s safety factor determination in 

that assessment (retain the additional 

10X factor). EPA expects that once that 

determination is revisited, the 

children’s safety factor will be lowered 

or removed entirely due to the 

submission of the DNT study and the 

fact that immunotoxicity is not a 

concern with mancozeb. These changed 

circumstances certainly do not support 

an additional safety factor higher than 

10X. Further, as discussed below, EPA 

believes that the 2007 risk assessment 

does not underestimate exposure to 

mancozeb. Accordingly, EPA concludes 

that the 2007 determination on the 

children’s safety factor protects the 

safety of infants and children. 

ii. ETU. The toxicity database for ETU 

is not complete. EPA lacks the following 

studies: A DNT study; a developmental 

study in rabbits; a 2-generation 

reproduction study; and a comparative 

thyroid study in adults and offspring. 

Given these multiple data gaps for 

studies that directly assess the risk to 

the young, EPA does not have reliable 

data to remove or modify the 

presumptive 10X FQPA safety factor. 

No further safety factor to protect is 

needed for the following reasons. First, 

the Agency determined that the degree 

of concern for the susceptibility seen in 

ETU developmental studies was low. 

The reasons for this conclusion are: 

• The teratogenic effects of ETU have 

been well-characterized in numerous 

studies in the published literature, as 

well as in a guideline study submitted 

by the registrant. In addition, since 

metabolism studies have shown that 

approximately 7.5% of mancozeb 

converts to ETU in mammalian systems, 

the extensive toxicity database with 

mancozeb on developmental effects 

provide extensive information about 

pre- and post-natal toxicity of ETU; 

• There is a clear NOAEL for these 

effects and the dose-response 

relationship, although steep, is well 

characterized in the numerous 

developmental studies in rats. 

• The developmental endpoint with 

the lowest NOAEL was selected for 

deriving the acute RfD. 

• The target organ (thyroid) was 

selected for deriving the chronic RfD as 

well as endpoints for non-dietary 

exposures (incidental oral, dermal, and 

inhalation). Since the ETU doses 

selected for overall risk assessments will 

address the concern for developmental 

and thyroid toxicity, there are no 

residual uncertainties with regard to 

prenatal and/or postnatal toxicity. 

Second, the information on ETU 

gleaned from the extensive mancozeb 

database on effects other than 

development effects also reduces, to a 

degree, the uncertainty arising from the 

significant datagaps for ETU. 

Third, EPA has concluded that the 

exposure assessment, although refined, 

is unlikely to under-estimate potential 

exposures especially considering 

exposure to maneb was included even 

though all maneb products have been 

canceled. In making this judgment, EPA 

has taken into account that it is relying 

on three separate reviews in this Notice: 

• A 2007 risk assessment for 

mancozeb for acute, short-term, 

intermediate-term, chronic, and cancer 

risk, 

• A 2007 risk assessment for ETU for 

acute, short-term, intermediate-term and 

chronic risk, and 

• A 2010 addendum to the 2007 ETU 

assessment for cancer risk—and that the 

percent crop treated estimates differ 

slightly between reviews. 

In comparing the percent crop treated 

information from 2007 and 2010, there 

are some increases in usage for some 

crops, and there are decreases in usage 

for other crops. These differences 

appear to largely offset each other. 

Further, most of the increases are 

attributable to estimated increases in 

maneb usage but, as noted, maneb was 

canceled in 2010 and it is unlikely that 

existing stocks are sufficient to sustain 

prior usage levels much less any 

increased usage. An EPA sensitivity 

analysis of the main contributors to ETU 

exposure showed no significant increase 

in exposure from the changed percent 

crop treated estimated. The percent crop 

treated values used in these risk 

assessments are detailed in the memo 

titled ‘‘Mancozeb. Discussion on Percent 

Crop Treated Values Used in Aggregate 

and Chronic Assessments’’ in docket 

number EPA–HQ–OPP–2005–0307. 

In any event, there are two other 

aspects of the exposure assessment that 

are likely to significantly overstate 

exposure to mancozeb and ETU. First, 

exposure estimates for some crops, 

including bananas, a high-consumption 

food, include the assumption that 

everything consumed in the United 

States has been treated. Second, the 

residue data used in the assessment for 

the proposed commodities and many 

other crops are based on crop field 

trials. Monitoring studies conducted for 

several crops have shown that residues 

on foods close to the point of 

consumption are much lower than the 

residues found in crop field trials. 

For all of these reasons, EPA 

concludes that it has not 

underestimated exposure to mancozeb 

and ETU. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk (Mancozeb). The 

mancozeb acute aggregate assessment 

considers acute exposure to mancozeb 

only and not ETU. Further, this 

assessment is based on residues of 

mancozeb in food only since residues of 

mancozeb are not expected in drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to mancozeb will 

occupy 6.9% of the aPAD for females 

13–49 years of age, the only population 

group of concern. 

2. Acute risk (ETU). Using the 

exposure assumptions discussed in this 

unit for acute exposure, the acute 

dietary exposure from food and water to 

ETU will occupy 87% of the aPAD for 

females 13–49 years of age, the only 

population group of concern. 

3. Chronic risk (Mancozeb). There are 

no long-term residential exposure 

scenarios for mancozeb and there is not 

likely to be residues of mancozeb in 

drinking water. Therefore, the long-term 

or chronic (non-cancer) aggregate risk 

for mancozeb includes contribution 

from food alone. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to mancozeb from 

food will utilize 3.3% of the cPAD for 

children 1–2 years of age, the 

population group receiving the greatest 

exposure. 

4. Chronic Risk (ETU). The aggregate 

chronic risks were calculated using food 


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and water exposure only because golfing 

and toddler transplanted turf exposure 

scenarios were considered to occur only 

on a short term basis. Using the 

exposure assumptions described in this 

unit for chronic exposure, EPA has 

concluded that chronic exposure to ETU 

from food and water will utilize 58% of 

the cPAD for children (1 to 2 years old), 

the population group receiving the 

greatest exposure. 

5. Short-and intermediate-term risk 

(Mancozeb). Short- and intermediateterm aggregate exposure takes into 

account short- and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Mancozeb is currently registered for 

uses that could result in short- and 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food with short- and 

intermediate-term residential exposures 

to mancozeb. The two scenarios that 

were evaluated for mancozeb are the 

following: 

i. Short/intermediate-term home 

garden aggregate (adult). The aggregate 

short/intermediate-term home garden 

MOEs for adults are 110,000. Because 

for mancozeb EPA is concerned only 

with MOEs that are below 1,000, this 

MOE does not raise a risk concern. 

ii. Short-term treated turf aggregate 

(toddler). The mancozeb short-term 

aggregate risk (MOE) for toddlers 

exposed to treated turf is 1,100. Because 

for mancozeb EPA is concerned only 

with MOEs that are below 1,000, this 

MOE does not raise a risk concern. 

6. Short- and intermediate-term risk 

(ETU). Short- and intermediate-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Mancozeb is currently registered for 

uses that could result in short- and 

intermediate-term residential exposure 

to ETU. The 2007 assessment also 

included products containing maneb 

which were expected to result in shortand intermediate-term exposure. As 

previously discussed, these products 

have since been cancelled. The Agency 

determined that it was appropriate to 

aggregate chronic exposure through food 

with short- and intermediate-term 

residential exposures to ETU. The three 

scenarios that were evaluated for ETU 

are the following. 

i. ETU short/intermediate-term home 

garden aggregate. The ETU short/ 

intermediate-term home garden 

aggregate MOEs for adults is 13,000 and 

17,000 for youth, respectively. Because 

for ETU EPA is concerned only with 

MOEs that are below 1,000, this MOE 

does not raise a risk concern. 

ii. ETU short-term treated turf 

aggregate (toddlers). The ETU shortterm treated turf aggregate MOE for 

toddlers is 1,100. Because for ETU EPA 

is concerned only with MOEs that are 

below 1,000, this MOE does not raise a 

risk concern. 

iii. ETU short/intermediate-term 

treated turf aggregate. The ETU shortterm treated turf aggregate MOE for 

golfers is 6,100. Because for ETU EPA is 

concerned only with MOEs that are 

below 1,000, this MOE does not raise a 

risk concern. 

7. Aggregate cancer risk for U.S. 

population (mancozeb and ETU). As 

noted earlier in this document, 

mancozeb degrades and/or metabolizes 

to ETU which causes the same types of 

thyroid tumors as those seen when 

animals are dosed with mancozeb; 

therefore, EPA has historically 

attributed mancozeb’s carcinogenicity to 

the formation of ETU, which is 

classified as a probable human 

carcinogen (B2). 

The cancer risks were aggregated 

using the food and drinking water doses 

for the general population and the food, 

water and recreational doses for golfers, 

home gardeners and athletes. The 

average daily dose was used for food 

and water exposures and the lifetime 

average daily dose was used for the 

recreational exposures. The aggregate 

doses were multiplied times the potency 

factor for ETU, 0.0601 (mg/kg/day)¥1 to 

determine the cancer risks. The risk is 

estimated to be 3 × 10¥6. 

EPA generally considers cancer risks 

(expressed as the probability of an 

increased cancer case) in the range of 1 

in 1 million (or 1 × 10¥6) or less to be 

negligible. The precision which can be 

assumed for cancer risk estimates is best 

described by rounding to the nearest 

integral order of magnitude on the 

logarithmic scale; for example, risks 

falling between 3 × 10¥7 and 3 × 10¥6

are expressed as risks in the range of 

10¥6. Considering the precision with 

which cancer hazard can be estimated, 

the conservativeness of low-dose linear 

extrapolation, and the rounding 

procedure described above, cancer risk 

should generally not be assumed to 

exceed the benchmark level of concern 

of the range of 10¥6 until the calculated 

risk exceeds approximately 3 × 10¥6. 

This is particularly the case where some 

conservatism is maintained in the 

exposure assessment. Although the ETU 

exposure risk assessment is refined, it 

retains significant conservatism in that, 

for leafy greens, field trial data and not 

market basket data on similar crops is 

used in estimating exposure. The leafy 

greens have tended to be among the top 

contributors to the aggregate risk (along 

with water and leaf lettuce). For other 

commodities, market basket data has 

shown reductions in residues one to two 

orders of magnitude lower than field 

trial data. Moreover, the only remaining 

EBDC registration for leafy greens 

(maneb) was canceled in 2010 but the 

exposure assessment does not take this 

into account. Additional conservatism is 

included in the exposure assessment by 

the assumption of 100 percent crop 

treated for many commodities. 

Accordingly, EPA has concluded the 

aggregate cancer risk for all existing 

mancozeb and other EBDC uses and the 

uses associated with the tolerances 

established in this action fall within the 

range of 1 × 10¥6 and are thus 

negligible. 

8. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to mancozeb 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate methods are available for 

the enforcement of tolerances for the 

plant commodities which are the subject 

of this request. The Pesticide Analytical 

Method (PAM) Vol. II lists Methods I, II, 

III, IV, and A for the determination of 

dithiocarbamate residues in/on plant 

commodities. The Keppel colorimetric 

method (Method III) is the preferred 

method for tolerance enforcement. The 

Keppel method determines EBDCs as a 

group by degradation to CS2. The 

analytical methodology for ETU is based 

on the original method published by 

Olney and Yip (JAOAC 54:165–169). 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 


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standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

There are no established or proposed 

Codex MRLs for residues of mancozeb; 

however, Codex limits for mancozeb 

and similar fungicides are grouped 

under dithiocarbamates measured as 

carbon disulfide. There are Codex MRLs 

for almonds; almond hulls; cabbages, 

head; lettuce, head; cos lettuce; peppers, 

sweet. Tolerances for the EBDC 

pesticides are expressed in terms of 

carbon disulfide (CS2), which is the 

same as the Codex tolerance expression. 

The level of 0.1 ppm for almonds is also 

the same as the Codex MRL for 

almonds. However, for the reasons 

indicated below, the tolerance levels 

being established for the other subject 

crops cannot be harmonized with the 

associated Codex MRLs. 

• Based on the calculations in the 

Agency’s tolerance spreadsheet, in 

accordance with the Agency’s 

‘‘Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data,’’ 

the appropriate tolerance level for 

cabbage is 9.0 ppm. The tolerance level 

cannot be harmonized with Codex; the 

highest residue level in the crop field 

trials (6.0 ppm in CS2 equivalents) is 

greater than the Codex MRL for cabbage 

(5 ppm). 

• The available data indicate that the 

appropriate tolerance level for head 

lettuce is 3.5 ppm. The tolerance level 

cannot be harmonized with Codex; the 

highest residue level in the crop field 

trials (2.2 ppm in CS2 equivalents) is 

considerably less than the Codex MRL 

of 10 ppm for head lettuce. 

• The available data indicate that the 

appropriate tolerance level for leaf 

lettuce is 18 ppm. The tolerance level 

cannot be harmonized with Codex; the 

highest residue level in the crop field 

trials (14 ppm in CS2 equivalents) is 

greater than the Codex MRL for Cos 

lettuce (10 ppm). 

• The appropriate tolerance level for 

pepper is 12 ppm. The tolerance level 

cannot be harmonized with Codex as 

the Codex MRL has been established for 

sweet pepper only. 

• The appropriate tolerance level for 

almond hulls is 4 ppm. This value 

cannot be harmonized with Codex as it 

is significantly below the Codex MRL of 

20 ppm. 

C. Response to Comments 

The company Cerexagri, Inc. 

submitted a comment on the initial 

notice of filing in 2006. Cerexagri 

proposed that EPA reject the petitions 

for reasons primarily dealing with 

information included in the risk 

assessment provided by Dow 

AgroSciences in the petitions. The 

Agency conducts its own risk 

assessments and does not rely on those 

provided by registrants. For example, 

Cerexagri did not agree with Dow 

AgroSciences proposal to assume that 

‘‘mancozeb uses will simply replace a 

share of the existing maneb market’’. Nor 

did Cerexagri agree with Dow 

AgroSciences use of market basket data 

to extrapolate expected residues on the 

proposed commodities. The EPA did 

not base PCT estimates for new 

commodities based on the assumption 

that one EBDC will replace another but 

instead used its standard market leader 

approach to determine appropriate PCT 

numbers. Further, the EPA relied on the 

results of the crop field trial data to 

estimate exposure to the proposed 

commodities and many other crops. 

Results of the Market Basket Survey 

were only used for commodities/ 

chemicals associated with the survey. 

Therefore, the objections voiced by 

Cerexagri are not relevant to the 

conclusions reached by the Agency 

regarding these petitions. 

Finally, Cerexagri requested that the 

EPA first engage in a public process that 

would seek the participation of the 

grower community, research community 

and other interested parties before 

determining which new uses of EBDC 

fungicides should be approved because 

approval of the uses requested in this 

petition may preclude the approval of 

other uses. EPA, however, has followed 

all procedural requirements in the 

FFDCA section. Moreover, in the time 

since this petition was submitted, no 

further uses of EBDCs have been 

requested. 

D. Revisions to Petitioned-For 

Tolerances 

All of the tolerance levels being 

established in this document, with the 

exception of almond, are different than 

the levels requested in the original 

tolerance petitions. EPA revised the 

tolerance levels based on analysis of the 

residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s 

‘‘Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data.’’ 

V. Conclusion 

Therefore, tolerances are established 

for residues of mancozeb, zinc 

manganese ethylenebis dithiocarbamate 

in or on almond at 0.1 ppm; almond, 

hulls at 4 ppm; broccoli at 7 ppm; 

cabbage at 9 ppm; lettuce, head at 3.5 

ppm; lettuce, leaf at 18 ppm; and pepper 

at 12 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 


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Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 / Rules and Regulations 18915 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 21, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.176 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.176 Mancozeb; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Almond ...................................... 0 .1 

Almond, hulls ............................ 4 

* * * * * 

Broccoli ..................................... 7 

Cabbage ................................... 9 

* * * * * 

Lettuce, head ............................ 3 .5 

Lettuce, leaf .............................. 18 

* * * * * 

Pepper ...................................... 12 

* * * * * 

* * * * * 

[FR Doc. 2011–7461 Filed 4–5–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0493; FRL–8863–1] 

Ethiprole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

permanent tolerances (without U.S. 

registrations) for residues of the 

insecticide ethiprole [5-amino-1-[2,6- 

dichloro-4-(trifluoromethyl)phenyl]-4- 

[(ethyl)-sulfinyl]-1H-pyrazole-3- 

carbonitrile], including its metabolites 

and degradate, in or on rice and tea. 

Bayer CropScience LP requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

6, 2011. Objections and requests for 

hearings must be received on or before 

June 6, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0493. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Carmen Rodia, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0327; e-mail address: 

rodia.carmen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to, those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 


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