50902 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

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: August 6, 2010. 

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. In §180.920, in the table, add 

alphabetically the following inert 

ingredient to read as follows: 

§ 180.910 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

Diethylene Glycol 

(CAS No. 111– 

46–6) 

Without 

limitation 

Solvent, 

stabilizer 

and/or 

antifreeze 

* * * * * * * 

[FR Doc. 2010–20318 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0541; FRL–8841–1] 

Mancozeb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mancozeb in 

or on multiple commodities which are 

identified and discussed later in this 

document. The Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). In 

addition, this action establishes a timelimited tolerance for residues of 

mancozeb in or on walnuts in response 

to the approval of a specific exemption 

under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing the use of 

mancozeb on walnuts to control walnut 

blight. This regulation establishes a 

maximum permissible level of residues 

of mancozeb in walnuts. The timelimited tolerance on walnuts expires 

and is revoked on December 31, 2013. 

Also, this action revises the 

introductory text of paragraphs (a) and 

(b). 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 2010, 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–2005–0541. 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–2005–0541 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 October 18, 2010. 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–2005–0541, 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), 


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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50903 

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 March 15, 

2006 (71 FR 13389) (FRL–7767–3), 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 3E4173, 5E4570, 

9E5054, and 9E5061) by the 

Interregional Research Project Number 4 

(IR-4), 681 US Highway No. 1 South, 

North Brunswick, NJ 08902–3390. 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 the following 

commodities: (PP 3E4173) cucurbit 

vegetable crop group 9 at 4.0 parts per 

million (ppm); (PP 5E4570) mango, star 

apple (caimito), canistel, mamey sapote, 

sapodilla, and white sapote at 15.0 ppm; 

(PP 9E5054) ginseng at 2.0 ppm; (PP 

9E5061) sugar apple, cherimoya, 

atemoya, custard apple, and sweetsop at 

3.0 ppm. The notice included a 

summary of the petitions prepared by 

Dow AgroSciences, the registrant. 

However, in the Federal Register of 

September 16, 2009, (74 FR 47504) 

(FRL–8431–4) in a document titled 

‘‘Mancozeb, Maneb, Metiram, and 

Thiram; Proposed Tolerance Actions,’’ 

EPA proposed establishing tolerances 

for ginseng at 1.2 ppm, removing the 

existing tolerances for cucumber, melon 

and summer squash and establish a 

tolerance for the vegetable, cucurbit 

group 9 at 2.0 ppm, and revising the 

tolerance expression in § 180.176. The 

reasons why EPA determined the 

tolerances for ginseng and cucurbit 

vegetable crop group 9 should be 

different from the original IR-4 petition 

as well as the rationale for changing the 

tolerance expression are explained in 

Unit V.D. 

EPA did not receive comments on the 

notice of March 15, 2006 but comments 

were received on the proposed rule of 

September 16, 2009. EPA’s response to 

these comments is discussed in Unit 

V.C. 

EPA is not establishing a tolerance for 

sweetsop. The reason why is explained 

in Unit V.D. 

Separate from the actions being taken 

in response to the IR-4 petitions, EPA is 

also establishing a time-limited 

tolerance for residues of mancozeb in or 

on walnuts at 0.015 ppm in connection 

with an emergency use of mancozeb 

approved under FIFRA. This tolerance 

expires and is revoked on December 31, 

2013. 

III. Emergency Exemption for 

Mancozeb on Walnuts and FFDCA 

Tolerances 

Walnut blight is a bacterial disease 

caused by Xanthomonas campestris 

pv.juglandis. It can result in severe 

economic losses due to undeveloped 

walnuts or early walnut-drop when the 

pathogen is present with free moisture 

during flowering and early nut 

development. Historically, walnut blight 

was managed by the application of 

copper products. Copper-resistant 

pathogens were found in some orchards 

and walnut losses in these orchards 

increased. Maneb was found to 

effectively manage walnut blight, and 

thus reduce walnut losses, where 

copper-resistant populations occurred 

and EPA has allowed use of maneb on 

walnut under an emergency exemption 

on a longstanding basis in the State of 

California. However, registrants have 

requested all products containing the 

active ingredient maneb be cancelled. 

Additionally, the Agency has been 

notified by the EBDC Task Force that 

there are no existing stocks of products 

containing maneb available for use on 

walnuts during 2010. Therefore, for the 

2009-2010 growing season, the State of 

California requested an emergency 

exemption for use of mancozeb. This is 

the first time that California has 

requested mancozeb for this use. It 

represents an equivalent agricultural 

tool since mancozeb and maneb are 

related compounds. 

After having reviewed the 

submission, EPA determined that an 

emergency condition exists for 

California, and that the criteria for 

approval of an emergency exemption are 

met. EPA has authorized a specific 

exemption under FIFRA section 18 for 

the use of mancozeb on walnuts for 

control of walnut blight in California. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of mancozeb in or on walnuts. 

In doing so, EPA considered the safety 

standard in section 408(b)(2) of FFDCA, 

and EPA decided that the necessary 

tolerance under section 408(l)(6) of 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although this time-limited tolerance 

expires on December 31, 2013, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on walnuts after that 

date will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether mancozeb 

meets FIFRA’s registration requirements 

for use on walnuts or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

mancozeb by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance by itself serve as the 

authority for persons in any State other 

than California to use this pesticide on 

the applicable crops under FIFRA 

section 18 absent the issuance of an 

emergency exemption applicable within 

that State. For additional information 

regarding the emergency exemption for 

mancozeb, contact the Agency’s 

Registration Division at the address 

provided under FOR FURTHER

INFORMATION CONTACT. 

IV. 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 


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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. 

EPA completed the Reregistration 

Eligibility Decision (RED) for mancozeb 

in September, 2005 (http:// 

www.epa.gov/oppsrrd1/REDs/ 

mancozeb_red.pdf). The Agency 

determined that most uses for the active 

ingredient mancozeb were eligible for 

reregistration provided that the risk 

mitigation measures identified in the 

RED were adopted and labels were 

amended to reflect these measures. 

Certain uses (foliar use on cotton, use on 

pineapple seed pieces, use on 

residential lawns/turf, use on athletic 

fields/turf, and use on pachysandra) 

were not eligible for reregistration and 

have since been voluntarily canceled by 

mancozeb registrants and deleted from 

all mancozeb labels. 

In assessing mancozeb risk for the 

RED, EPA included the uses associated 

with the petitions submitted by IR-4 to 

establish tolerances for residues of 

mancozeb on cucurbit vegetable crop 

group 9 (PP 3E4173), mango, star apple, 

canistel, mamey sapote, sapodilla, white 

sapote (PP 5E4570), ginseng (PP 

9E5054), sugar apple, cherimoya, 

atemoya, custard apple, and sweetsop 

(PP 9E5061). Additionally, EPA 

considered exposure to residues of 

mancozeb on walnut in connection with 

a pending petition (PP 5F4582) 

submitted by the registrant. No action 

was taken on these petitions until the 

mitigation measures outlined in the RED 

were implemented and existing stocks 

for the cancelled uses moved through 

the channels of trade. The registrant 

later withdrew the petition request to 

establish tolerances for mancozeb on 

walnuts. 

While these mitigation measures were 

being implemented several things 

changed regarding the mancozeb/ETU 

risk profile. First, EPA determined that 

it was appropriate to retain the 10X 

FQPA Safety Factor for acute dietary 

risk due to lack of the developmental 

neurotoxicity study. Second, the 

registrant submitted additional petitions 

in 2004 that were not considered in the 

RED to establish tolerances for residues 

of mancozeb in or on almond (PP 

4F4324), cabbage, leaf lettuce, peppers 

and broccoli (PP 4F4333). Therefore, 

based on these changes, EPA conducted 

an additional risk assessment in 2007 

for mancozeb which assessed all uses 

(refer to risk assessment in the Docket 

EPA–HQ–OPP–2005–0541 titled 

‘‘Mancozeb: Human Health Risk 

Assessment to Support Proposed New 

Uses on Broccoli, Cabbage, Lettuce, 

Peppers and Almonds’’). 

To date, EPA is still working to refine 

the risk assessment for ETU which 

incorporates the pending new uses for 

mancozeb that were submitted to EPA 

in 2004 (almond, cabbage, leaf lettuce, 

peppers and broccoli). In the meantime, 

EPA is moving forward to establish a 

time-limited tolerance on walnut to 

support the emergency exemption as 

well as establish permanent tolerances 

for cucurbit vegetable group 9, mango, 

star apple, canistel, mamey sapote, 

sapodilla, white sapote, ginseng, sugar 

apple, cherimoya, atemoya, and custard 

apple. EPA is relying on an assessment 

conducted for mancozeb in 2007 (refer 

to risk assessment in the Docket EPA– 

HQ–OPP–2005–0541 titled ‘‘Mancozeb: 

Human Health Risk Assessment to 

Support Proposed New Uses on 

Broccoli, Cabbage, Lettuce, Peppers and 

Almonds’’), an assessment for ETU from 

2007 (for short- and intermediate-term 

aggregate exposures; refer to risk 

assessment in the Docket EPA–HQ– 

OPP–2005–0541 titled 

‘‘Ethylenethiourea (ETU) from EBDCs: 

Health Effects Division (HED) Human 

Health Risk Assessment of the Common 

Metabolite/Degradate ETU’’), and the 

assessment completed in the RED for 

exposures to ETU since that is still valid 

and accounts for exposure to all of the 

commodities discussed in this rule 

(refer to risk assessment in the Docket 

EPA–HQ–OPP–2005–0176 titled ‘‘ETU 

from EBDCs: Health Effects Division 

(HED) Human Health Risk Assessment 

of the Common Metabolite/Degradate 

ETU to Support Reregistration’’). Since 

the 2007 ETU assessment includes the 

use on almond, cabbage, leaf lettuce, 

peppers and broccoli, uses for which 

tolerances do not exist and are not being 

established at this time, the estimates 

for short- and intermediate-term 

aggregate risk for ETU are likely 

overestimates. 

It is also important to note that since 

most products for maneb have been 

cancelled or will be shortly and there 

are limited existing stocks for maneb 

still in the channels of trade, the risk 

assessments for ETU likely overestimate 

the exposures to this common 

metabolite. Additionally, the risk 

estimates for mancozeb include uses for 

which tolerances do not exist and are 

not being established at this time, and 

therefore, the numbers reported are an 

over estimate of the potential risks. 

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 


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Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 50905 

reviewed since the last 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 

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 toxic 

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 

www.regulations.gov in the document 

titled ‘‘Mancozeb: Human Health Risk 

Assessment to Support Proposed New 

Uses on Broccoli, Cabbage, Lettuce, 

Peppers and Almonds,’’ pp. 13-15 in 

docket ID number EPA–HQ–OPP–2005– 

0541. 

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 

www.regulations.gov in document titled 

‘‘ETU from EBDCs: Health Effects 

Division (HED) Human Health Risk 

Assessment of the Common Metabolite/ 

Degraduate ETU to Support 

Reregistration. Chemical ID No. 600016. 

DP Barcode No. D305129,’’ pp. 9-11 in 

docket ID number EPA–HQ–OPP–2004– 

0078. 

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 shown in 

Tables 1 and 2 of this unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MANCOZEB FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for Risk 

Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13–50 years of age) 

NOAEL = 128 milligrams/kilograms/ 

day (mg/kg/day) 

UFA =10x 

UFH = 10x 

UFDB=10x 

Acute RfD = 0.13 mg/kg/ 

day 

Acute PAD = 0.13 mg/kg/ 

day 

Developmental Toxicity in the rat 

LOAEL = 512 mg/kg/day based on 

hydrocephaly and other malformations 

Acute dietary 

(General population including infants and children) 

No appropriate endpoint was identified from oral toxicity studies. 


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50906 Federal Register / Vol. 75, No. 159 / Wednesday, August 18, 2010 / Rules and Regulations 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MANCOZEB FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for Risk 

Assessment Study and Toxicological Effects 

Chronic dietary 

(All populations) 

NOAEL= 4.83 mg/kg/day 

UFA = 10x 

UFH = 10x 

UFDB=10x 

Chronic RfD = 0.005 mg/ 

kg/day 

Chronic PAD = 0.005 mg/ 

kg/day 

Toxicity/Carcinogenicity in the rat 

LOAEL = 30.9 mg/kg/day based 

thyroid toxicity (changes in thyroid hormone levels, microscopic 

thyroid changes and changes in 

thyroid weights) 

Incidental oral short- or intermediate 

term 

(1 to 30 days) 

NOAEL= 9.24 mg/kg/day 

UFA = 10x 

UFH = 10x 

UFDB=10x 

LOC for MOE = 1,000 Subchronic Toxicity Study in the rat 

LOAEL = 17.82 mg/kg/day based 

on decreased T4 

Dermal short- and intermediate 

term 

(1 to 30 days) 

Mancozeb has low dermal absorption. No systemic toxicity observed via the dermal route at 1,000 mg/ 

kg/day. Developmental effects were noted at doses much higher than those where systemic toxicity 

was observed in the maternal animals (in oral studies) indicating that developmental effects will not 

occur below 1,000 mg/kg/day the limit dose, from dermal exposure. 

Dermal long-term Dermal (or oral) study NOAEL= 

4.83 mg/kg/day (dermal absorption rate = 1% 

UFA = 10x 

UFH = 10x 

UFDB=10 

LOC for MOE = 1,000 Toxicity/Carcinogenicity in the rat 

LOAEL = 30.9 mg/kg/day based on 

thyroid toxicity (changes in thyroid hormone levels, microscopic 

thyroid changes and changes in 

thyroid weights) 

Inhalation short-, intermediate-, or 

long-term 

NOAEL = 0.079 mg/L [equivalent to 

21 mg/kg/day] 

UFA = 10x 

UFH = 10x 

UFDB=10x 

LOC for MOE = 1,000 Subchronic Inhalation in the rat 

LOAEL = 0.326 mg/L based on thyroid hyperplasia and decreased 

T4 (females) 

Cancer 

(Oral, dermal, inhalation) 

Mancozeb’s potential for carcinogenicity is due to the formation of the metabolite ETU which is classified as a probable human carcinogen. Mancozeb’s cancer risk is calculated by estimating exposure to 

mancozeb-derived ETU and using the ETU cancer potency factor (Q1*) of 6.01 x 10-2 (mg/kg/day)-1 to 

provide a quantitative estimate of risk. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETU FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13–50 years of age) 

NOAEL = 5 milligrams/kilograms/day 

(mg/kg/day) 

UFA = 10x 

UFH = 10x 

UFDB=10x 

Acute RfD = 0.005 

mg/kg/day 

Acute PAD = 0.005 

mg/kg/day 

Developmental Toxicity in the rat 

(Khera Study, MRID No. 45937601) 

LOAEL = 10 mg/kg/day based on developmental defects of the brain 

Acute dietary 

(General population including infants 

and children) 

No appropriate endpoint attributable to a single exposure (dose) was identified. 

Chronic dietary 

(All populations) 

NOAEL= 0.18 mg/kg/day 

UFA = 10x 

UFH = 10x 

UFDB= 10x 

Chronic RfD = 

0.0002 mg/kg/ 

day 

Chronic PAD = 

0.0002 mg/kg/ 

day 

Chronic Oral Toxicity in the dog. 

LOAEL = 1.99 mg/kg/day based on 

thyroid toxicity (increased thyroid 

weight and macroscopic changes in 

the thyroid – hypertrophy, follicular 

dilation) 

Incidental Oral (Short- and Intermediate-Term) NOAEL= 7 mg/kg/day 

UFA = 10x 

UFH = 10x 

UFDB=10x 

Residential LOC = 

1,000 

4 week range-finding dog study 

LOAEL = 34 mg/kg/day based on thyroid toxicity (decreased levels of 

thyroid hormones, gross thyroid lesions) 


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TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETU FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Dermal (Short- and Intermediate-Term) NOAEL = 5 mg/kg/day 

DA = 26% 

UFA = 10x 

UFH = 10x 

UFDB= 10x 

LOC for MOE = 

1,000 

Developmental Toxicity in the rat 

(Khera Study, MRID No. 45937601) 

LOAEL = 10 mg/kg/day based on developmental defects of the brain 

Dermal (Long-Term) NOAEL = 0.18 mg/kg/day 

DA = 26% 

UFA = 10x 

UFH = 10x 

UFDB= 10x 

LOC for MOE = 

1,000 

Chronic Oral Toxicity in the dog 

LOAEL = 1.99 mg/kg/day based on 

thyroid toxicity (increased thyroid 

weight and macroscopic changes in 

the thyroid – hypertrophy, follicular 

dilation) 

Inhalation (Short- and IntermediateTerm) Inhalation (or oral) study NOAEL= 5 

mg/kg/day 

UFA = 10x 

UFH = 10x 

UFDB= 10x 

Inhalation toxicity is assumed to be 

equivalent to oral toxicity. 

LOC for MOE = 

1,000 

Developmental Toxicity in the rat 

(Khera Study, MRID No. 45937601) 

LOAEL = 10 mg/kg/day based on developmental defects of the brain 

Inhalation (Long-Term) NOAEL = 0.18 mg/kg/day 

UFA = 10x 

UFH = 10x 

UFDB= 10x 

Inhalation toxicity is assumed to be 

equivalent to oral toxicity. 

LOC for MOE = 

1,000 

Chronic Oral Toxicity in the dog 

LOAEL = 1.99 mg/kg/day based on 

thyroid toxicity (increased thyroid 

weight and macroscopic changes in 

the thyroid – hypertrophy, follicular 

dilation) 

Cancer 

(Oral, dermal, inhalation) 

Q1* = 6.01 x 10 -2 (mg/kg/day)-1ETU is classified as a probable human carcinogen. Cancer risk is 

quantitified with a linear low-dose extrapolation approach based on liver tumors in female mice. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. DA = Dermal Absorption. 

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 discussed in this document 

including additional proposed uses that 

the Agency is not establishing 

tolerances for at this point (almonds, 

cabbage, lettuce, broccoli, and pepper) 

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). 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. 

The Dietary Exposure Evaluation 

Model (DEEM(TM)) analysis evaluated 

the individual food consumption as 

reported by respondents in the 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 proposed uses 

that the Agency is not establishing 

tolerances at this time (almonds, 

cabbage, lettuce, broccoli, and pepper) 

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 uses, 

field trial or monitoring data, 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 Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994-1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII). 

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 proposed uses that the Agency is not 


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establishing tolerances at this time 

(almonds, cabbage, lettuce, broccoli, and 

pepper) and existing uses, as well as 

processing and cooking factors. 

b. ETU. Chronic anticipated residues 

were calculated from field trial 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 of the 

evidence from cancer studies and other 

relevant data. Cancer risk is quantified 

using a linear or non-linear 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 non-cancer 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 the 

Q1* for ETU. The same approach has 

been taken for the other EBDCs. EPA’s 

estimated exposure to mancozebderived ETU 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 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. 

For mancozeb the Agency estimated 

the PCT for existing uses as follows: 

Cantaloupes 5%; pumpkins 5%; sugar 

beets 5%; tobacco 5%; cucumber 10%; 

garlic 10%; sweet corn 10%; grapes 

15%; squash 15%; asparagus 20%; 

eggplant 20%; tomatoes 25%; apples 

30%; cranberries 30%; watermelons 

35%; pears 40%; onions 50%; and 

potatoes 54%. Beans, green; carrots; 

cherries; corn (field); cotton; oranges; 

peaches; peanuts; pecans; prunes, 

plums; strawberries; walnuts; and wheat 

all average less than 1%. 

For ETU the Agency estimated the 

PCT for existing uses of mancozeb, 

maneb and metiram. 

a. Mancozeb. For mancozeb, the PCT 

was identical to that listed in this unit. 

b. Maneb. For maneb, the Agency 

estimated the PCT for existing uses as 

follows: 

Almonds 10%; apples 1%; dry beans 

1%; green beans 5%; broccoli 5%; 

Brussels sprouts 21%; cabbage 15%; 

carrots 1%; cauliflower 5%; celery 5%; 

collards 10%; field corn 1%; eggplant 

55%; garlic 25%; grapes 1%; mustard 

greens 5%; kale 5%; lettuce 65%; 

onions; 10%; pears 1%; peppers 30%; 

potatoes 5%; pumpkins 5%; spinach 

15%; squash 5%; sugar beets 1%; sweet 

corn 1%; tomatoes 5%; walnuts 30%; 

watermelons 5%; wheat 5%. 

c. Metiram. For metiram, the Agency 

estimated the PCT for existing uses as 

follows: 

Apples 15%; asparagus 1%; peaches 

1%; potatoes 10%; squash 1%. 

The PCT estimates for mancozeb and 

maneb on walnuts reflect usage of 

maneb on walnuts under an emergency 

exemption prior to the cancellation of 

maneb products and establishment of 

the emergency exemption use on 

walnuts for mancozeb. Going forward, 

EPA expects mancozeb use on walnuts 

to replace maneb. However, for this 

present action, EPA concludes it is 

reasonable to use the risk assessment 

that relied upon the PCT estimates in 

this unit for walnuts because: EPA does 

not expect mancozeb use on walnuts to 

be higher than the prior maneb use; 

mancozeb residues on walnuts and the 

consumption level of walnuts are 

insignificant compared to residue and 

consumption levels of other mancozebtreated commodities (e.g., melons and 

apples); and ETU residues from maneb 

and macozeb are equivalent. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 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 

one. 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%. 

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 


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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. The values are listed in 

Table 3 of this unit. 

TABLE 3.— SURFACE AND GROUND

WATER VALUES. 

Acute Chronic Cancer 

Surface 

Water 

EDWC 

0.1 to 

25.2 

ppb 

0.10 ppb 0.10 

ppb 

Ground 

Water 

EDWC 

0.21 ppb 0.21 ppb 0.21 

ppb 

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 0.21 ppb for 

ground water. 

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 nonoccupational, 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. 

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 dietary 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 the Short/ 

Intermediate-Term Home Garden 

Aggregate which combines handler 

exposures (inhalation and dermal) and 

post application garden exposures 

(dermal) plus average daily food and 

drinking water exposure for adults and 

post application garden exposures 

(dermal) plus average daily food and 

drinking water exposure for youth, 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 Short/IntermediateTerm Treated Turf Aggregate (Adults 

‘‘Golfers’’) which considers short-term 

residential exposures (dermal) plus 

average daily food and drinking water 

exposure for adults such as golfing on 

treated turf. 

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 in Unit IV., 

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. 


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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. The 

toxicity database for mancozeb is not 

complete. The new requirement for an 

immunotoxicity study has not been met. 

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. A developmental 

neurotoxicity (DNT) study has been 

submitted, and EPA has recently 

completed a review of this study. 

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). 

Since the review of the DNT was 

completed after the most recent risk 

assessment was finished, EPA has not 

had the opportunity to re-evaluate the 

need for an FQPA factor. For this 

assessment, EPA has retained the 

presumptive 10X FQPA safety factor for 

the protection of children, but will revisit the need for the safety factor for the 

next tolerance action. 

No additional FQPA Safety Factor is 

needed beyond the 10X database 

uncertainty factor applied to account for 

the data gap for a developmental 

neurotoxicity study with mancozeb. The 

reasons for this conclusion are: 

a. There is a lack of evidence of preand/or postnatal susceptibility resulting 

from exposure to mancozeb 

b. There are no residual uncertainties 

concerning toxicity, and 

c. The exposure assessment, although 

refined, is unlikely to under-estimate 

potential exposures. 

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-generaltion 

reproduction study; and a comparative 

thyroide study in adults and offspring. 

Given these multiple datagaps 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: 

a. 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 provide extensive 

information about toxicity of ETU; 

b. 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. 

c. The developmental endpoint with 

the lowest NOAEL was selected for 

deriving the acute RfD. 

d. The target organ toxicity (thyroid 

toxicity) 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 pre- and/or post-natal toxicity. 

Second, the information on ETU 

gleaned from the extensive mancozeb 

database 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. 

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 

per se from food only since residues of 

mancozeb per se 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 dietary (food only) exposure alone. 

Using the exposure assumptions 

described in this unit for chronic 

exposure, EPA has concluded that 


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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 

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). Since there 

are no dermal endpoints selected for 

mancozeb, the home garden aggregate 

risk assessment does not include dermal 

exposure. Further, since residues of 

mancozeb are not expected in drinking 

water, only mancozeb food residues are 

considered. This assessment combines 

residential handler exposures 

(inhalation) to adult applicators plus 

average food exposures. The exposure 

value used for food represents the 

highest exposure found from all adult 

populations in the mancozeb chronic 

dietary exposure assessment. 

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). Since there are no dermal 

endpoints selected for mancozeb and no 

likelihood of residues in drinking water, 

the mancozeb short-term treated turf 

aggregate risk assessment for toddlers 

combines residential incidental oral 

exposures with average food residues. 

The exposure value used for food 

represents the highest exposure found 

from all child populations in the 

mancozeb chronic dietary exposure 

assessment. 

With a 5–day interval between 

application and transplant for the sod 

farm use, which is now on the registered 

label, 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 and maneb are currently 

registered for uses that could result in 

short- and intermediate-term residential 

exposure to ETU and the Agency has 

determined that it is 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 combines handler inhalation 

and dermal exposures and post 

application garden dermal exposures 

plus average daily food and drinking 

water for adults exposed to ETU. For 

youth exposed to ETU, the assessment 

combines post application garden 

dermal exposures with average food and 

drinking water. Only mancozeb is 

registered for use in home garden 

settings. Average food and drinking 

water exposure values reflect the most 

highly exposed adult or youth 

subpopulation from the average daily 

dietary assessment, and consider ETU 

derived from mancozeb, metiram, and 

maneb applications. The existing and 

proposed food uses were included in 

the food and drinking water exposure 

estimates. 

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 short-term 

treated turf aggregate risk assessment 

combines treated turf post application 

incidental oral and dermal exposures 

with average daily food and drinking 

water exposure for toddlers. Maneb and 

mancozeb are both registered for 

applications to sod farms. Average food 

and drinking water exposure values, 

including all sources of ETU, reflect the 

most highly exposed children’s 

subpopulation from the chronic dietary 

assessment. 

The ETU short-term 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 (Adults 

‘‘Golfers’’). The short/intermediate-term 

treated turf aggregate risk assessment 

combines dermal exposures for adults 

golfing on treated turf exposed to ETU 

with average daily food and drinking 

water exposures. Only mancozeb uses 

are relevant for this scenario. 

The ETU short-term treated turf 

aggregate MOE for adults (‘‘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 Unit IV.C.iii., 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 2.3 x 10-6. 

EPA generally considers cancer risks 

in the range of 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 log 

scale; for example, risks falling between 

3 x 10-7 and 3 x 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, 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 x 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 


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market basket data on similar crops is 

used in estimating exposure. 

Accordingly, EPA has concluded the 

cancer risk for all existing mancozeb 

uses and the uses associated with the 

tolerances established in this action fall 

within the range of 1 x 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 

and/or ETU residues. 

V. 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 carbon 

disulfied (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 

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 maximum residue limits for 

residues of mancozeb per se; however, 

Codex limits for 

dimethyldithiocarbamates fungicides 

are grouped under dithiocarbamates. 

There are Codex MRLs for cucumber (2 

ppm), melons (0.5 ppm), pumpkins (0.2 

ppm), and summer squash (1 ppm). 

C. Response to Comments 

As discussed in Unit II. of this 

document, in the Federal Register of 

September 16, 2009, EPA proposed 

tolerance actions for mancozeb. EPA did 

receive comments on the proposed rule; 

however, many of those comments are 

not related to the uses proposed in this 

action. Therefore, EPA is only 

responding to the comment received 

that directly addresses issues that 

pertain to this action. EPA will respond 

to the additional comments in a future 

rule. 

Comment. The Natural Resources 

Defense Council (NRDC) commented 

about the FQPA Safety Factor and the 

risks to infants of low iodide women. 

NRDC is concerned about the effects of 

the EBDC fungicides on women of 

child-bearing age. All of the EBDC 

fungicides have shown effects on the 

thyroid. They have noted that a decrease 

in thyroxine in pregnant and lactating 

women, such as has been observed in 

laboratory animals exposed to the EBDC 

fungicides, can result in neurodevelopmental problems in their 

children. NRDC has specifically 

inquired whether the Agency 

considered the risks to the infants of 

low-iodide women, and has 

recommended that the Agency retain 

the FQPA factor of at least 10X, and 

possibly more. 

Agency Response. EPA agrees with 

NRDC that protection from adverse 

effects in the thyroid in women of childbearing age is important to protect the 

developing fetus from adverse 

outcomes. An adverse effect, even in the 

case of women with iodine deficiency, 

is not expected for the following 

reasons. 

The mode of action for thyroid 

toxicity from the EBDCs is understood. 

ETU, which is the common metabolite 

of the EBDCs, acts by inhibiting thyroid 

peroxidase, an enzyme used in the 

synthesis of thyroid hormone. This 

enzyme inhibition ceases when 

exposure to ETU is removed and there 

is no subsequent change in enzyme 

function The other thyroid effects (organ 

weight and microscopic changes), are 

secondary to this enzyme inhibition as 

the body attempts to increase 

production of thyroid hormone by 

stimulating the thyroid in 

compensation. 

People are protected from the enzyme 

inhibition because the EBDCs are 

regulated from the NOAEL for thyroid 

effects, which is below the dose at 

which there are thyroid effects in 

animals. Further, the EBDCs were tested 

in rats, which are much more sensitive 

to thyroid perturbations than are 

humans. Rats are more sensitive than 

humans because the serum half-life of 

the thyroid hormone, thyroxine, is 

much shorter in rats (less than 1 day) 

than in humans (5-9 days). The 10X 

interspecies uncertainty factor applied 

to the EBDCs to account for the 

possibility that humans are more 

sensitive than the test animals is 

therefore more than adequate to protect 

humans. The 10X intraspecies factor 

accounts for variability in sensitivity 

among species and gives protection for 

women with iodine deficiency. The 

combination of these factors is therefore 

expected to be protective for the fetus 

and pregnant women with regard to 

possible iodine deficiencies. The 

Agency has requested a comparative 

thyroid assay for ETU which will 

provide additional information on the 

potential susceptibility of developing 

organisms, including the developing 

fetus, to thyroid perturbation, and has 

retained an FQPA safety factor of 10X to 

account for the uncertainties associated 

with these missing data. 

D. Revisions to Petitioned-For 

Tolerances 

EPA is not establishing a tolerance for 

sweetsop because it is the same 

commodity as sugar apple. The Agency 

is establishing the tolerance on sugar 

apple because it is the preferred term for 

this commodity. 

The ginseng tolerance is a reduction 

from the proposed 2.0 ppm to 1.2 ppm 

based on conclusions reached in the 

RED. The 2.0 tolerance recommendation 

is on a mancozeb per se basis; however 

EPA is now recommending for a 

tolerance on a carbon disulfide 

equivalents basis thus resulting in a 

tolerance recommendation of 1.2 ppm. 

In regards to the cucurbit tolerance, 

based on available field trial data that 

showed mancozeb residues as high as 

2.1 ppm on cucumber, 2.7 ppm on 

melons, and 1.75 ppm on summer 

squash, the Agency determined that 

individual tolerances should be set at 

3.0 ppm, 3.0 ppm, and 2 ppm, 

respectively, which when converted to 

carbon disulfide equivalents using a 

rounded conversion factor of 0.6X is 

calculated as 1.8 ppm, 1.8 ppm, and 1.2 

ppm, respectively. Because the 

representatives for crop group 9 include 

cucumber, muskmelon, and summer 

squash, EPA believes that these 

tolerances should be combined into a 

single crop group tolerance and 

decreased from their current individual 


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tolerance levels of 4 ppm to 2 ppm. EPA 

proposed these changes in the Federal 

Register of September 16, 2009, in a 

document proposing multiple changes 

to the mancozeb tolerances. 

E. Revisions to Tolerance Expression 

EPA is also in this action changing the 

mancozeb tolerance expression as 

proposed in the Federal Register of 

September 16, 2009. Currently, 

tolerances for mancozeb are established 

in 40 CFR 180.176(a) for residues of the 

fungicide mancozeb, a coordination 

product of zinc ion and maneb 

(manganese 

ethylenebisdithiocarbamate) and 

calculated as zinc 

ethylenebisdithiocarbamate (zineb). 

Mancozeb is a member of the class of 

dithiocarbamates, whose decomposition 

releases CS2. In order to allow 

harmonization of U.S. tolerances with 

Codex Maximum Residue Limits 

(MRLs), the Agency determined that for 

the purpose of tolerance enforcement, 

residues of mancozeb should be 

calculated as carbon disulfide. 

Therefore, EPA is revising the 

introductory text containing the 

tolerance expression in 40 CFR 

180.176(a) and (b). 

VI. Conclusion 

Therefore, tolerances are established 

for residues of mancozeb, zinc 

manganese ethylenebis dithiocarbamate 

in or on cucurbit vegetable crop group 

9 at 2.0 ppm; mango, star apple, 

canistel, mamey sapote, sapodilla, and 

white sapote at 15.0 ppm; ginseng at 1.2 

ppm; sugar apple, cherimoya, atemoya 

and custard apple at 3.0 ppm; and a 

time-limited tolerance in or on walnut 

at 0.015 ppm. 

VII. 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 tolerance 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 

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) (Public Law 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). 

VIII. 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: August 10, 2010. 

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 as 

follows. 

i. In paragraph (a), revise the 

introductory text; 

ii. In paragraph (a), in the table, 

remove the commodities Cucumber, 

Melon, and Summer squash and 

alphabetically add the following 

commodities; 

iii. In paragraph (b), revise the 

introductory text; 

iv. In paragraph (b), in the table, 

alphabetically add Walnut. 

The amendments read as follows: 

§ 180.176 Mancozeb; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of mancozeb (a 

coordination product of zinc ion and 

maneb (manganese 

ethylenebisdithiocarbamate)), including 

its metabolites and degradates, in or on 

the commodities in the following table. 

Compliance with the tolerance levels 

specified in this paragraph is to be 

determined by measuring only those 

mancozeb residues convertible to and 

expressed in terms of the degradate 

carbon disulfide. 

Commodity Parts per 

million 

* * * * * 

Atemoya ...................................... 3.0 

* * * * * 

Canistel ....................................... 15.0 

* * * * * 

Cherimoya .................................. 3.0 

* * * * * 

Custard apple ............................. 3.0 


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Commodity Parts per 

million 

* * * * * 

Ginseng ...................................... 1.2 

* * * * * 

Mango ......................................... 15.0 

* * * * * 

Sapodilla ..................................... 15.0 

Sapote, mamey .......................... 15.0 

Sapote, white .............................. 15.0 

Commodity Parts per 

million 

* * * * * 

Star apple ................................... 15.0 

Sugar apple ................................ 3.0 

* * * * * 

Vegetable, cucurbit, group 9 ...... 2.0 

* * * * * 

(b) Section 18 emergency exemptions. 

Time limited tolerances are established 

in connection with use of the pesticide 

under a section 18 emergency 

exemption granted by EPA for residues 

of mancozeb (a coordination product of 

zinc ion and maneb (manganese 

ethylenebisdithiocarbamate)), including 

its metabolites and degradates, in or on 

the commodities in the following table. 

Compliance with the tolerance levels 

specified in this paragraph is to be 

determined by measuring only those 

mancozeb residues convertible to and 

expressed in terms of the degradate 

carbon disulfide. The tolerances will 

expire and are revoked on the dates 

specified in the following table. 

Commodity Parts per million Expiration/revocation 

date 

* * * * ** *

Walnut ...................................................................................................................................... 0.015 12/31/13 

* * * * * 

[FR Doc. 2010–20453 Filed 8–17–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0099; FRL–8836–2] 

Flubendiamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

reassesses, modifies and revokes 

tolerances for residues of 

flubendiamide, N2-[1,1-dimethyl-2- 

(methylsulfonyl)ethyl-3-iodo-N1-[2- 

methyl-4-[1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in/on multiple 

food and livestock commodities which 

are identified, and will be discussed in 

detail later in this document. Bayer 

CropScience, LP in c/o Nichino 

America, Inc. (U.S. subsidiary of Nihon 

Nohyaku Co., Ltd.) requested these 

tolerances under the Federal Food, Drug 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 18, 2010. Objections and 

requests for hearings must be received 

on or before October 18, 2010, 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–2007–0099. 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 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; fax number: 

(703) 308–0029; 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 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–2007–0099 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 


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