44444 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: July 17, 2013. 

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 § 180.651, in paragraph (a), add 

alphabetically the following 

commodities to the table to read as 

follows: 

§ 180.651 Imazosulfuron; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Melon subgroup 9A ...................... 0.02 

*****

Vegetable, tuberous and corm, 

subgroup 1C ............................. 0.02 

* * * * * 

[FR Doc. 2013–17823 Filed 7–23–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0628; FRL–9393–2] 

Mancozeb; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mancozeb in 

or on walnuts and tangerines. United 

Phosphorus requested the tolerance for 

walnuts and Dow AgroSciences 

requested the tolerance for tangerines 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

24, 2013. Objections and requests for 

hearings must be received on or before 

September 23, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0628, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 eCFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

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– 


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Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations 44445 

OPP–2012–0628 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 September 23, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0628, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

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

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 2, 2012 

(77 FR 25954) (FRL–9346–1), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7935) by United 

Phosphorus, Inc., 630 Freedom Business 

Center, King of Prussia, PA 19406. The 

petition requested that 40 CFR 180.176 

be amended by establishing tolerances 

for residues of the fungicide mancozeb 

in or on walnuts at 0.75 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared by United Phosphorus, the 

registrant, which is available in the 

docket (EPA–HQ–OPP–2012–0044), 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

In the Federal Register of September 

28, 2012 (77 FR 59578) (FRL–9364–6), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 2E8062) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petition requested that 40 CFR 180.176 

be amended by establishing tolerances 

for residues of the fungicide mancozeb 

in or on tangerine at 10 ppm. The 

proposed tolerance supports imports of 

mandarins, tangerines, and clementines. 

That document referenced a summary of 

the petition prepared by Dow 

AgroSciences, the registrant, which is 

available in the docket (EPA–HQ–OPP– 

2012–0628) http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the level at which the 

tolerance is being established for 

walnut. The reason for this change is 

explained in Unit IV.C. 

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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 ingredient metiram, the only 

other registered EBDC. A third EBDC, 

maneb, is no longer registered for use. 

Mancozeb and metiram are metabolized 

to ethylenethiourea (ETU) in the body 

and both 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’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 

ingredient metiram. 

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 is 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 

microscopically (injury to peripheral 

nerves) with associated clinical signs 

(abnormal gait and limited use of rear 

legs) and loss of muscle mass. Decreased 

motor activity occurred in the acute 

neurotoxicity study. In the 

developmental neurotoxicity study, 

there was no maternal toxicity and pup 

effects were limited to decreased body 

weight. 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 radiolabeled 

mancozeb and other EBDCs, an average 

7.5% in vivo metabolic conversion of 

EBDC to ETU occurred, on a weight-toVerDate Mar<15>2010 15:33 Jul 23, 2013 Jkt 229001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\24JYR1.SGM 24JYR1

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weight 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. 

There was evidence of sensitivity in the 

developmental neurotoxicity study with 

mancozeb with decreased pup body 

weight observed in the absence of 

maternal toxicity; the selected 

endpoints are protective for these pup 

effects. 

An immunotoxicity study has been 

reviewed and mancozeb did not show 

any immunotoxicity potential. 

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 thyroxine 

(T4), increases or decreases in 

triiodothyronine (T3), compensatory 

increases in levels of thyroid 

stimulating hormone (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. 

An immunotoxicity study on ETU did 

not show any immunotoxicity potential. 

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 

Section 3 Uses on Walnuts and 

Tolerances for Imported Tangerines’’ on 

pages 70–75 in docket ID number EPA– 

HQ–OPP–2012–0628. 

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 the document 

titled ‘‘Ethylene Thiourea (ETU); 

Aggregate Human Health Risk 

Assessment of the Common Metabolite/ 

Degradate Ethylene Thiourea (ETU) to 

Support Proposed New Section 3 Use on 

Walnuts and Tolerance for Imported 

Tangerines’’ on pages 30–33 in docket 

ID number EPA–HQ–OPP–2012–0628. 

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 (Adult Males, Females > 49, and Children ≥ 6 

years).

NOAEL = 500 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 5 mg/kg/day ............................................................

aPAD = 5 mg/kg/day 

Acute neurotoxicity 

study in the rat. 

LOAEL 1,000 mg/kg/ 

day based on decreased motor activity. 

Acute dietary (Children < 6 

years).

NOAEL = 500 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF UFDB = 

10x 

Acute RfD = 5 mg/kg/day ............................................................

aPAD = 0.5 mg/kg/day 

Acute neurotoxicity 

study in the rat. 

LOAEL 1,000 mg/kg/ 

day based on decreased motor activity. 


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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 

Acute Dietary (Females 13–49 

years).

NOAEL = 1.28 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF UFDB = 

10x 

Acute RfD = 1.3 mg/kg/day .........................................................

aPAD = 0.13 mg/kg/day 

Developmental toxicity study in the 

rat. 

LOAEL = 512 mg/kg/ 

day based on 

hydrocephaly and 

other malformations. 

Chronic dietary (Adult Males, 

Females > 49, and Children 

≥ 6 years).

NOAEL = 4.83 mg/ 

kg/day.

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.16 mg/kg/day ....................................................

cPAD = 0.16 mg/kg/day 

Toxicity/Carcinogenicity in the rat. 

LOAEL = 30.9 mg/ 

kg/day based on 

thyroid toxicity. 

Chronic dietary (Females 13–49 

years and Children < 6 years).

NOAEL = 4.83 mg/ 

kg/day.

UFA = 3x 

UFH = 10x 

FQPA SF UFDB = 

10x 

Chronic RfD = 0.16 mg/kg/day ....................................................

cPAD = 0.016 mg/kg/day 

Toxicity/Carcinogenicity in the rat. 

LOAEL = 30.9 mg/ 

kg/day based on 

thyroid toxicity. 

Inhalation all durations (Adult 

Males, Females > 49 years, 

and Children ≥ 6 years).

Inhalation study 

NOAEL = 0.079 

mg/L (21 mg/kg/ 

day).

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 30 ...................................................................... Subchronic Inhalation in the rat. 

LOAEL = 0.326 mg/L 

based on thyroid 

toxicity. 

Inhalation all durations (Females 13–49 years and Children < 6 years).Inhalation study 

NOAEL= 0.079 

mg/L (21 mg/kg/ 

day).

UFA = 3x 

UFH = 10x 

FQPA SF UFDB = 

10x 

LOC for MOE = 300 .................................................................... Subchronic Inhalation in the rat. 

LOAEL = 0.326 mg/L 

based on thyroid 

toxicity. 

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 × 10¥2 (mg/kg/day)¥1 to quantitate risk. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). 

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 (General population including infants and 

children).

A study with acute 

toxicity applicable 

to the general population was not 

identified.

Acute Dietary (Females 13–49 

years).

NOAEL = 5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF UFDB = 

10x 

Acute RfD = 0.05 

mg/kg/day.

aPAD = 0.005 mg/ 

kg/day 

Developmental Rat Toxicity. 

LOAEL = 10 mg/kg/day, based on hydrocephaly and other malformations. 


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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 

Chronic dietary (Adult Males, 

Females > 49, and Children 

≥ 6 years).

NOAEL = 0.18 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 

0.0018 mg/kg/day.

cPAD = 0.0018 mg/ 

kg/day 

Dog Chronic Oral Toxicity. 

LOAEL = 1.99 mg/kg/day based on thyroid toxicity. 

Chronic dietary (Females 13–49 

years and Children < 6 years).

NOAEL = 0.18 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF UFDB = 

10x 

Chronic RfD = 

0.0018 mg/kg/day.

cPAD = 0.00018 mg/ 

kg/day 

Dog Chronic Oral Toxicity. 

LOAEL = 1.99 mg/kg/day based on thyroid toxicity. 

Dermal short and intermediateterm (Children < 6 years old).Oral study ................

NOAEL = 7 mg/kg/ 

day (dermal absorption rate = 

26%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

LOC for MOE = 

1,000.

4-Week Range-Finding Dog Study. 

LOAEL = 34 mg/kg/day based on thyroid toxicity. 

Dermal short and intermediateterm (Adult Males, Females.

> 49 years, Children ≥ 6 

years).

Oral study ................

NOAEL = 7 mg/kg/ 

day (dermal absorption rate = 

26%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 4-Week Range-Finding Dog Study. 

LOAEL = 34 mg/kg/day based on thyroid toxicity. 

Dermal short- and intermediateterm (Females 13–49 years 

old).

Oral study ................

NOAEL = 5 mg/kg/ 

day (dermal absorption rate = 

26%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

LOC for MOE = 

1,000.

Developmental Rat Toxicity. 

LOAEL = 10 mg/kg/day, based on hydrocephaly and other malformations. 

Inhalation short- and intermediate-Term (Children < 6 

years of age).

Oral study ................

NOAEL = 7 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF UFDB = 

10x 

LOC for MOE = 

1,000.

4-Week Range-Finding Dog Study. 

LOAEL = 34 mg/kg/day based thyroid toxicity. 

Inhalation short- and intermediate-term (adult males, 

females > 49 years, children 

≥ 6 years).

Oral study ................

NOAEL= 7 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 4-Week Range-Finding Dog Study. 

LOAEL = 34 mg/kg/day based thyroid toxicity. 

Inhalation short- and intermediate-term (Females 13– 

49 years old).

Oral study ................

NOAEL = 5 mg/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

LOC for MOE = 

1,000.

Developmental Rat Toxicity. 

LOAEL = 10 mg/kg/day, based on hydrocephaly and other malformations. 

Cancer (Oral, dermal, inhalation).ETU is classified as a probable human carcinogen. ETU’s cancer potency factor 

(Q1

*

) is 6.01 × 10¥2 (mg/kg/day)¥1. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). 

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 


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(mancozeb and metiram). 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 for both 

mancozeb and ETU, EPA used food 

consumption information from the 

2003–2008 food consumption data from 

the U.S. Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). 

a. Mancozeb. The Agency conducted 

a highly refined, probabilistic acute 

dietary assessment incorporating field 

trial or monitoring data from the EBDC/ 

ETU Market Basket Survey, percent crop 

treated (PCT) information, and 

processing study results to assess the 

established uses of mancozeb. The 

monitoring data were used for several 

commodities (corn, cucumber, onion, 

pumpkin, potato, squash, starfruit, 

tomato, meat, and milk). For evaluation 

of the proposed new uses and 

tolerances, field trial data, processing 

factors, PCT data based on section 18 

usage for walnuts, and percent imported 

commodity in domestic consumption 

data on tangerines for mancozeb were 

used to refine residue estimates. The 

entire distributions of residue data from 

field trials or monitoring data were used 

to generate residue distribution files 

(RDFs) for commodities that are 

considered to be not blended or 

partially blended. For commodities 

considered to be blended, the average 

residues incorporating the likely 

maximum estimated PCT was used as a 

point estimate. 

b. ETU. The Agency conducted a 

highly refined, probabilistic acute 

dietary assessment incorporating field 

trial or monitoring data from the EBDC/ 

ETU Market Basket Survey, PCT 

information, and processing study 

results to assess exposures to ETU from 

the established uses of mancozeb and 

metiram. The monitoring data were 

used for several commodities (corn, 

cucumber, onion, pumpkin, potato, 

squash, starfruit, tomato, meat, and 

milk). For evaluation of the proposed 

new uses and tolerances, field trial data, 

processing factors, PCT data based on 

section 18 usage for walnuts, and 

percent imported commodity in 

domestic consumption data on 

tangerines for mancozeb were used to 

refine residue estimates. The entire 

distributions of residue data from field 

trials or monitoring data were used to 

generate residue distribution files 

(RDFs) for commodities that are 

considered to be not blended or 

partially blended. For commodities 

considered to be blended, the average 

residues incorporating the likely 

maximum estimated PCT was used as a 

point estimate. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

for both mancozeb and ETU, EPA used 

food consumption information from the 

2003–2008 food consumption data from 

the USDA NHANES/WWEIA. 

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 PCT data for new and 

existing uses, as well as processing and 

cooking factors. Averages of the field 

trials were used for the walnuts and 

tangerines, while field trial and market 

basket survey data were used for 

established uses. 

b. ETU. Chronic anticipated residues 

were calculated using average values 

based either on field trial data or 

monitoring data and average PCT data 

or average projected PCT as well as 

processing and cooking factors. 

Averages of the field trials were used for 

the walnuts and tangerines, while field 

trial and market basket survey data were 

used for established uses. 

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. 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 

nonlinear 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. 

The cancer risks were aggregated 

using the food and drinking water doses 

for the general population and the food, 

water and recreational doses for home 

gardeners (considered protective of 

other residential scenarios). 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. 

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). 

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 and ETU derived from 

mancozeb, the following maximum PCT 


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estimates were used in the acute dietary 

risk assessment for the following crops: 

Apples: 45%; asparagus: 30%; barley: 

2.5%; cantaloupes: 15%; carrots: 2.5%; 

celery: 2.5%; corn: 2.5%; cranberries: 

20%; cucumbers: 50%; grapes: 20%; 

oats: 1%; onions: 70%; peanuts: 2.5%; 

pears: 50%; potatoes: 65%; pumpkins: 

15%; rice: 2.5%; spinach: 2.5%; squash: 

30%; sugar beets: 2.5%; sweet corn: 

15%; tomatoes: 50%; watermelons: 

50%; and wheat: 2.5%. A percent 

import value of 99% was used for 

banana. 

For mancozeb and ETU derived from 

mancozeb, the following average PCT 

estimates were used in the chronic and 

cancer dietary risk assessments for the 

following crops: Apples: 40%; 

asparagus: 15%; barley: 1%; 

cantaloupes: 5%; carrots: 1%; celery: 

1%; cherries: 1%; corn: 1%; cranberries: 

20%; cucumbers: 25%; grapes: 10%; 

oats: 1%; onions: 60%; peanuts: 2.5%; 

pears: 40%; potatoes: 55%; pumpkins: 

10%; rice: 1%; spinach: 1%; squash: 

20%; sugar beets: 1%; sweet corn: 5%; 

tomatoes: 25%; watermelons: 40%; and 

wheat: 1%. A percent import value of 

99% was used for banana. 

As a further refinement, the 

commodity having the highest PCT 

results with livestock feed uses had 

these values applied to meat and milk 

(potato; 65% CT maximum for acute 

and 55% CT average for chronic). 

For ETU derived from metiram, the 

following maximum PCT estimates were 

used in the acute dietary risk 

assessment: apples: 15%; potatoes: 10%. 

A 31% imported commodity in 

domestic consumption was used for 

wine grapes. 

For ETU derived from metiram, the 

following average PCT estimates were 

used in the chronic and cancer dietary 

risk assessment: Apples: 10%; potatoes: 

5%. A 31% imported commodity in 

domestic consumption was used for 

wine grapes. 

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%. 

Also, for the acute risk assessment for 

mancozeb and ETU derived from 

mancozeb, the Agency estimated PCT 

for the following uses for mancozeb, 

which were recently approved in 2011: 

Almond, 25%; broccoli, 6%; cabbage, 

47%; cabbage, Chinese, 47%; head 

lettuce 75%; leaf lettuce 66%; pepper, 

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

the chronic risk assessment for 

mancozeb and ETU derived from 

mancozeb, the Agency estimated PCT as 

follows: Almond, 18%; broccoli, 5%; 

cabbage, 42%; cabbage, Chinese, 42%; 

head lettuce 67%; leaf lettuce 62%; 

pepper, bell, 44%; pepper, non-bell, 

44%. Since metiram is not registered for 

use on these crops, all potential ETU 

exposure on these crops will result from 

use of mancozeb. 

EPA developed these refined PCT 

values based on a detailed chemicalspecific analysis. EPA has considered 

all available relevant information and 

concludes that it is unlikely that the 

PCT values for these uses will be 

exceeded during the next 5 years. 

Further discussion of how these PCT 

values were derived can be found at 

www.regulations.gov in the document 

titled ‘‘Percent Crop Treated for new 

Uses (PCTn) of Mancozeb on Almonds, 

Broccoli, Cabbage, Pepper, Pumpkin, 

and Winder Squash, PC Code: 014504; 

DP Barcode: 360397; Lettuce, both head 

and Other; PC Code: 014504; DP 

Barcode: 364745, NON PRIA, Parent DP: 

635267; and Percent Crop Treated with 

Maneb for Collards, Mustard Greens, 

Turnip Greens, and Kale’’ in docket ID 

number EPA–HQ–OPP–2012–0628. 

For mancozeb and ETU derived from 

mancozeb, a maximum PCT projected 

estimate of 50% for walnuts and a 

maximum percent import consumption 

value of 35% for tangerines were used 

in the acute dietary risk assessment. An 

average PCT estimate of 40% for 

walnuts as well as an average percent 

imported commodity in domestic 

consumption value of 29% for 

tangerines were used in the chronic and 

cancer dietary risk assessments. 

The walnut information is an 

amalgamation of the USDA/NASS and 

private pesticide market research data. 

The PCT values for walnuts are derived 

from survey data reported in 2006, 2010, 

and 2011. Only the state of California is 

represented in the survey data as 99% 

of the walnuts grown in the United 

States are grown in that state. The 

percent of imported fresh mandarin 

oranges in domestic consumption was 

calculated with data for the reporting 

period of 2008–2013 obtained from the 

Foreign Agricultural Service (FAS) 

USDA/Office of Global Analysis (FAS, 

2013). 

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 water 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 water 

and ground water values represent 


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upper-bound 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 acute and 

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). 

1. Mancozeb. Mancozeb is currently 

registered for use on the following 

residential sites: Home gardens, golf 

courses, and sod farms (where treated 

sod could be transplanted to a 

residential setting). The Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

with short-term residential exposures to 

mancozeb. 

The exposure scenario that was 

evaluated for mancozeb was the 

residential handler home garden use 

which considers residential handler 

exposures (inhalation) to adult 

applicators combined with average food 

exposures. Dermal exposure was not 

evaluated because no effects were 

observed in a mancozeb 28-day dermal 

toxicity study. 

For post-application, dermal exposure 

to home gardeners (adults and youth) 

harvesting vegetables from treated 

gardens and golfers (adults and youth) 

contacting mancozeb-treated turf after 

application is possible. However, as no 

dermal hazard was identified for 

mancozeb, a quantitative dermal postapplication assessment (non-cancer/ 

short-term and cancer) for the dermal 

exposure to home gardeners and golfers 

(adults and youth) was only performed 

for its metabolite, ETU. 

The previous mancozeb risk 

assessment had evaluated the short/ 

intermediate-term exposure of toddlers 

to treated turf from the sod farm use. In 

the most recent risk assessment, the 

Agency considered post-application 

exposure resulting from this scenario to 

be negligible for the following reasons: 

(1) Mancozeb has a post-harvest interval 

(PHI) of 5 days for sod; (2) it is unlikely 

that sod treated with mancozeb would 

be installed more than once per year; (3) 

transplanted sod requires constant and 

significant watering which will result in 

decreased mancozeb residues on the 

transplanted sod; and (4) it is unlikely 

that adults or children will spend any 

significant amount of time on recently 

transplanted sod until it is rooted which 

typically occurs around 2 weeks after 

transplanting. Therefore, dermal and 

incidental oral post-application 

scenarios were not quantitatively 

assessed for the sod farm use of 

mancozeb. There are no postapplication exposure risks of concern 

anticipated from the use of mancozeb on 

sod farms. 

ii. ETU. ETU non-dietary exposure is 

expected as a result of the registered 

uses of mancozeb, which is currently 

registered for use on the following 

residential sites: home gardens, golf 

courses, and sod farms (where treated 

sod could be transplanted to a 

residential setting). There are no uses of 

metiram that will result in exposure in 

residential settings. The Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

with short-term residential exposures to 

ETU. 

The scenario that was evaluated for 

ETU was the residential home garden 

use, which considered handler garden 

exposures (inhalation and 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 females 13–49 years old and youths. 

The previous risk assessment also 

considered treated turf (sod farm) postapplication exposures to toddlers 

(incidental oral and dermal). This more 

recent risk assessment did not evaluate 

the sod farm use for the reasons 

outlined above in the mancozeb nondietary exposure section. 

The previous risk assessment also 

calculated risks for adult and youth 

golfers from golfing on treated turf. The 

more recent assessment concluded that 

for residential post-application, the 

gardening scenarios represent the most 

conservative exposure estimates and are 

used in the aggregate assessment. The 

gardening scenarios result in higher 

estimated exposure than the golfing 

scenarios and are therefore protective of 

any golfer risk. 

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 metiram, the other 

registered EBDC chemical, both of 

which are 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 cannot 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 


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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. There 

was evidence of sensitivity in the 

developmental neurotoxicity study with 

mancozeb with decreased pup body 

weight occurring in the absence of 

maternal toxicity; risk assessment 

endpoints are protective for these pup 

effects. 

ii. ETU. There is evidence of 

increased susceptibility of fetuses to 

ETU. Fetal malformations occurred 

mainly in rats, although hydrocephaly 

and domed head were observed in a 

rabbit developmental study with ETU. 

The malformations in rats occurred 

throughout the body. Hydrocephaly 

occurred in the absence of maternal 

toxicity after treatment with a single 

dose of ETU. There was a steep doseresponse for the malformations in rats. 

An acceptable reproductive toxicity 

study was 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 for mancozeb. EPA is 

retaining the 10X FQPA safety factor for 

women of childbearing age and for 

children less than 6 years old but has 

determined that reliable data show the 

safety of children greater than 6 years of 

age would be adequately protected if the 

FQPA safety factor were reduced to 1X. 

That decision is based on the following 

findings: 

i. The toxicology database for 

mancozeb is complete, except that it 

lacks adequate data on the developing 

thyroid. Brain development is very 

sensitive to perturbations in thyroid 

hormones and it is possible that the 

developmental thyroid study (being 

conducted with ETU) could result in 

lower NOAELs for women of 

childbearing age (i.e., fetuses) and for 

children less than 6 years old. Results 

from the developmental thyroid study 

will not affect endpoints for children 

over 6 years of age (for whom the 

thyroid system is more developed) or 

adults as thyroid data for those 

populations are already available. 

Therefore, the FQPA safety factor is 

reduced to 1X for these populations. 

ii. There was some evidence of 

neurotoxicity for mancozeb as seen in 

the acute and subchronic neurotoxicity 

studies; however, no neurotoxicity 

occurred in the DNT. Additionally, 

there are clear NOAELs identified for 

the effects observed in the toxicity 

studies. The doses and endpoints 

selected for risk assessment are 

protective of all neurotoxicological 

effects observed in the database. 

iii. As noted above in Unit III.D.2., 

there was some evidence of increased 

susceptibility of rat pups to mancozeb 

exposure. Aside from the uncertainty 

resulting from the lack of adequate 

thyroid data (for which EPA is retaining 

the 10X FQPA safety factor), there are 

clear NOAELs for the offspring effects, 

and regulatory doses were selected to be 

protective of these effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute, chronic, and cancer dietary 

exposure assessments were refined and 

used PCT estimates and monitoring 

residue values for several commodities, 

including some major contributors to 

the dietary risk such as milk and corn 

commodities. Monitoring or modeling 

data were used to derive estimated 

drinking water concentrations. The 

drinking water concentrations that were 

derived from monitoring data reflect the 

highest value found in a community 

well monitoring program. The drinking 

water concentrations from modeling 

used conservative, health-protective, 

high-end estimates and are unlikely to 

be exceeded. The residential exposure 

assessment used residential SOPs, 

which are based on conservative highend assumptions such as maximum 

application rates and day 0 exposures. 

Given the overall conservative nature of 

the exposure assumptions, the aggregate 

(food, water, and residential) exposure 

and risk estimates presented in this 

assessment are not expected to 

underestimate actual exposure and risk 

expected based on the current and 

proposed use patterns. 

4. Conclusion for ETU. EPA is 

retaining the 10X FQPA safety factor for 

women of childbearing age and for 

children less than 6 years old but has 

determined that reliable data show the 

safety of children 6 years of age or older 

would be adequately protected if the 

FQPA safety factor were reduced to 1X. 

That decision is based on the following 

findings: 

i. The toxicology database for ETU is 

missing a developmental thyroid study, 

a reproduction study, and a 

developmental neurotoxicity (DNT) 

study. These data gaps are being 

addressed by an ongoing extended onegeneration reproductive toxicity study. 

Because the developing brain is very 

sensitive to perturbations in thyroid 

hormones, it is possible that these 

studies could result in lower NOAELs 

for women of childbearing age (i.e., 

fetuses) and for children less than 6 

years old; however, results from the 

developmental thyroid study will not 

affect points of departure for children 

greater than 6 years of age, who have a 

thyroid system similar to adults, adult 

females greater than 49 years of age 

(assumed to be beyond typical childbearing age), or adult males since 

thyroid data for those populations are 

already available. Additionally, 

endpoints from the other segments of 

the extended one-generation study will 

not affect these latter populations, and 

the FQPA safety factor is being reduced 

to 1X for these populations. 

ii. Although the ETU studies were 

inadequate in evaluating signs of 

neurotoxicity, there was no evidence of 

neurotoxicity seen in any study in the 

database. In any event, the Agency has 

determined that the selected endpoints 

would be protective of potential 

neurotoxicity. The basis for this is that 

the principal toxic effects occur in the 

thyroid; thyroid effects provide the most 

sensitive endpoint, which the Agency is 

regulating on. Although the extended 1- 

gen study being performed on ETU is 

evaluating the potential for effects on 

the developing brain, the Agency does 

not believe that a 10X FQPA safety 

factor is necessary to protect children 6 

years old or older because: (1) The 

weight-of-evidence of the available data 

indicates that thyroid effects are the 

most sensitive effect of this chemical; 

(2) the Agency is regulating on the more 

sensitive thyroid effect; and (3) the 

Agency is retaining a 10X FQPA safety 

factor for the population most likely 

affected by the thyroid effects. 

iii. As noted in Unit III.D.2., there is 

evidence of increased quantitative and 

qualitative susceptibility following 

increased in utero exposure to ETU. The 

developmental study with the lowest 

NOAEL was selected for the acute 

endpoint for women of childbearing age 

and is therefore protective of the 

developmental malformations. The only 

remaining developmental uncertainties 

are related to effects on the developing 

fetus caused by perturbations in the 


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still-not-completely-developed thyroid 

in children younger than 6 years old. 

Brain development being very sensitive 

to perturbations in thyroid hormones, it 

is possible that the extended 1- 

generation reproductive toxicity test, in 

which developmental thyroid effects 

will be evaluated, will result in lower 

NOAELs for these populations than are 

presently being used to assess risk; 

therefore, the Agency is retaining the 

10X FQPA safety factor for females 13– 

49 years of age and for children less 

than 6 years of age. 

iv. There are no residual uncertainties 

identified in the EBDC’s (mancozeb or 

metiram) exposure databases for ETU 

assessment. The acute, chronic, and 

cancer dietary exposure assessments 

were refined and used PCT estimates 

and monitoring residue values for 

several commodities including some 

major contributors to the dietary risk 

such as milk and corn commodities. 

Monitoring or modeling data were used 

to derive estimated drinking water 

concentrations. The drinking water 

concentrations that were derived from 

monitoring data reflect the highest value 

found in a community well monitoring 

program. The drinking water 

concentrations from modeling used 

conservative, health-protective, highend estimates and are unlikely to be 

exceeded. The residential exposure 

assessment used residential SOPs, 

which are based on conservative highend assumptions such as maximum 

application rates and day 0 exposures. 

Given the overall conservative nature of 

the exposure assumptions, the aggregate 

(food, water, and residential) exposure 

and risk estimates presented in this 

assessment are not expected to 

underestimate actual exposure and risk 

expected based on the current and 

proposed use patterns. 

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 to mancozeb will occupy 

9.9% of the aPAD for children 1–2 years 

old, the population subgroup receiving 

the greatest exposure. 

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 (from mancozeb and metiram) will 

occupy 60% 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 2.3% of the cPAD for 

children 1–2 years of age, the 

population group receiving the greatest 

exposure. 

4. Chronic risk (ETU). There are no 

long-term residential exposure scenarios 

for ETU; the aggregate chronic risks 

were calculated using food and water 

exposure only. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to ETU (from 

mancozeb and metiram) 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-term risk (mancozeb). Shortterm 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-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

with short-term residential exposures to 

mancozeb. The scenario that was 

evaluated for mancozeb was the 

residential handler home garden use. 

The aggregate short-term home garden 

MOEs for adult males and females 

greater than 49 years old is 99,000 and 

the MOE for adult females 13–49 years 

old is 94,000. Because for mancozeb 

EPA is concerned only with MOEs that 

are below 30 (adult males and females 

greater than 49 years old) and 300 (adult 

females 13–49 years old), these MOEs 

do not raise a risk concern. 

6. Short-term risk (ETU). Short-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-term 

residential exposure to ETU. There are 

no residential uses for metiram. The 

Agency determined that it was 

appropriate to aggregate chronic 

exposure through food with short-term 

residential exposures to ETU. The ETU 

short-term handler home garden 

aggregate MOE for adult females 13–49 

years old is 27,000 and for adult males 

(and females older than 49 years old) is 

42,000. The ETU short-term postapplication home garden aggregate MOE 

for adult females 13–49 years old is 

2,600 and for youths 11–16 years old is 

3,100. Because for ETU EPA is 

concerned only with MOEs that are 

below 1,000 (adult females 13–49 years 

old) and 100 (adult males, females >49 

years old and youth 11–16 years old), 

these MOEs do not raise a risk concern. 

7. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, mancozeb is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

mancozeb. 

8. Aggregate cancer risk for U.S. 

population. 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. 

The cancer aggregate risk estimates 

(home garden handler and postapplication scenarios) for the U.S. 


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44454 Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations 

population are 2 × 10¥6 and 3 × 10¥6, 

respectively. 

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 

mancozeb risk assessment is highly 

refined, the Agency believes there is 

some conservatism for the following 

reasons: (1) The linear low-dose 

extrapolation approach is conservative 

because it does not take into account 

certain human biological processes such 

as reversibility and repair; (2) the 

residential SOPs are based on 

conservative high-end assumptions such 

as maximum application rates and day 

0 exposures; and (3) some food 

exposures are estimated based on 

tolerance-level residues. 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 × 10¥6 and are thus 

negligible. 

9. 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. 

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 

United Nations 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 is no Codex MRL established 

for mancozeb on walnuts. 

There is a MRL of 10 ppm established 

by Codex for the use of EBDC 

compounds on mandarins which is 

consistent with the 10 ppm tolerance on 

tangerine being established by this 

document. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the evaluation of the residue 

data, the Agency is modified the 

tolerance for walnuts from the proposed 

level of 0.75 ppm to 0.70 ppm. EPA 

revised the tolerance levels based on 

analysis of the residue field trial data 

using the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of mancozeb, in or on 

walnut at 0.70 ppm and tangerine at 10 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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 


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Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Rules and Regulations 44455 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: July 16, 2013. 

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 § 180.176, add alphabetically the 

following commodities and the footnote 

to the table in paragraph (a) to read as 

follows: 

§ 180.176 Mancozeb; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Tangerine1 .................................. 10 

* * * * * 

Walnut ......................................... 0.70 

* * * * * 

1There are no U.S. registrations for use of 

mancozeb on tangerine. 

* * * * * 

[FR Doc. 2013–17869 Filed 7–23–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1990–0010; FRL 9836–9] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Deletion 

of the Sola Optical U.S.A., Inc. 

Superfund Site 

AGENCY: Environmental Protection 

Agency. 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 9 is publishing a 

direct final Notice of Deletion of the 

Sola Optical U.S.A., Inc. Superfund Site 

(Site), located in Petaluma, California, 

from the National Priorities List (NPL). 

The NPL, promulgated pursuant to 

section 105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, is an 

appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the State of 

California, through the California 

Regional Water Quality Control Board— 

San Francisco Bay Region, because EPA 

has determined that all appropriate 

response actions under CERCLA have 

been completed. However, this deletion 

does not preclude future actions under 

Superfund. 

DATES: This direct final deletion is 

effective September 23, 2013, unless 

EPA receives adverse comments by 

August 23, 2013. If adverse comments 

are received, EPA will publish a timely 

withdrawal of the direct final deletion 

in the Federal Register informing the 

public that the deletion will not take 

effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1990–0010, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

on-line instructions for submitting 

comments. 

• Email: rodriguez.dante@epa.gov. 

• Fax: (415)947–3528. 

• Mail: Dante Rodriguez, U.S. EPA 

Region 9, mail code SFD–8–2, 75 

Hawthorne Street, San Francisco, CA 

94105. 

• Hand delivery: U.S. EPA Region 9, 

75 Hawthorne Street, mail code SFD–8– 

2, San Francisco, CA 94105. 

Such deliveries are only accepted 

during the Docket’s normal hours of 

operation, and special arrangements 

should be made for deliveries of boxed 

information. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1900– 

0010. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through http:// 

www.regulations.gov, your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket 

All documents in the docket are listed 

in the http://www.regulations.gov index. 

Although listed in the index, some 

information is not publicly available, 

e.g., CBI or other information whose 

disclosure is restricted by statue. Certain 

other material, such as copyrighted 

material, will be publicly available only 

in the hard copy. Publicly available 

docket materials are available either 

electronically in http:// 

www.regulations.gov or in hard copy at: 

Superfund Records Center, 95 

Hawthorne St., Room 403, Mail Stop 

SFD–7C, San Francisco, CA 94105, 

(415) 536–2000, Mon–Fri: 8:00 a.m. to 

5:00 p.m.; 

or the Site Repository at 

Petaluma Public Library, 100 

Fairgrounds Drive, Petaluma, CA 

94952, (707) 763–9801, Mon, Thurs, 

Fri, Sat: 10:00 a.m. to 6:00 p.m., Tues, 

Wed: 10:00 a.m. to 9:00 p.m. 


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