[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Rules and Regulations]
[Pages 18906-18915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7461]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0307; FRL-8864-1]


Mancozeb; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mancozeb in or on almonds, cabbage, lettuce, peppers, and broccoli. Dow 
AgroSciences LLC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 6, 2011. Objections and 
requests for hearings must be received on or before June 6, 2011, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0307. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: <a href="/cdn-cgi/l/email-protection#0d687f79606c63236c63697f687a4d687d6c236a627b"><span class="__cf_email__" data-cfemail="8eebfcfae3efe0a0efe0eafcebf9ceebfeefa0e9e1f8">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2005-0307 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
June 6, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2005-0307, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 30, 2005 (70 FR 71836) (FRL-
7747-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
3E6536 for mandarin oranges/mandarins; PP 4F4324 for almond nuts and 
almond hulls; PP 4F4333 for broccoli, cabbage, lettuce, and peppers) by 
Dow AgroSceinces LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The 
petitions requested that 40 CFR 180.176 be amended by establishing 
tolerances for residues of the fungicide mancozeb, zinc manganese 
ethylenebis dithiocarbamate, in or on mandarin

[[Page 18907]]

oranges/mandarins at 5.0 parts per million (ppm) (PP 3E6536), almond 
nuts at 0.1 ppm and almond hulls at 10.0 ppm (PP 4F4324); and broccoli 
at 13.0 ppm, cabbage at 10.0 ppm, lettuce at 10.0 ppm, and peppers at 
7.0 ppm (PP 4F4333). That notice referenced a summary of the petition 
prepared by Dow AgroSciences LLC, the registrant, which is available in 
the docket, http://www.regulations.gov. One comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
setting the tolerances at levels different than originally requested in 
the petitions, with the exception of almond. The reason for these 
changes is explained in Unit IV.D. The request for mandarin oranges has 
been withdrawn.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for mancozeb including 
exposure resulting from the tolerances established by this action.
    Mancozeb is a member of the ethylene bisdithiocarbamate (EBDC) 
group of fungicides that also includes the related active ingredients 
maneb and metiram. Mancozeb, maneb and metiram, are all metabolized to 
ethylenethiourea (ETU) in the body and all degrade to ETU in the 
environment. Therefore, EPA has considered the aggregate or combined 
risks from food, water and non-occupational exposure resulting from 
mancozeb alone and ETU from all sources (i.e., the other EBDC 
fungicides) for this action.
    In response to the petitions submitted to establish tolerances for 
residues of mancozeb on almond, cabbage, leaf lettuce, peppers, and 
broccoli, EPA completed two risk assessments in 2007:
    <bullet> A mancozeb risk assessment which considered all existing 
and proposed uses for mancozeb, and
    <bullet> An ETU risk assessment that considered exposure to ETU 
from all sources (mancozeb, metiram, and maneb) for all existing and 
proposed uses.
    Although the 2007 mancozeb review showed risks that were 
acceptable, the 2007 ETU review demonstrated unacceptable cancer risks, 
therefore preventing the Agency from acting on the petitions for 
almond, cabbage, leaf lettuce, peppers, and broccoli. The Agency worked 
to refine the cancer risk assessment for ETU. A refined cancer risk 
assessment for ETU from all sources has been completed and the Agency 
is now prepared to act on the proposed tolerances for almond, cabbage, 
leaf lettuce, peppers, and broccoli. Because the 2010 ETU review dealt 
strictly with refining the cancer risk, the Agency will be relying on 
three risk assessments to support this tolerance document. These 
assessments are as follows:
    <bullet> A 2007 risk assessment for mancozeb for acute, short-term, 
intermediate-term, chronic, and cancer risk (refer to risk assessment 
in the Docket EPA-HQ-OPP-2005-0307 titled ``Mancozeb: Human Health Risk 
Assessment to Support Proposed New Uses on Broccoli, Cabbage, Lettuce, 
Peppers and Almonds''),
    <bullet> A 2007 risk assessment for ETU for acute, short-term, 
intermediate-term and chronic risk (refer to risk assessment in the 
Docket EPA-HQ-OPP-2005-0307 titled ``Ethylenethiourea (ETU) from EBDCs: 
Health Effects Division (HED) Human Health Risk Assessment of the 
Common Metabolite/Degradate ETU''),
    <bullet> A 2010 addendum to the 2007 ETU assessment for cancer risk 
(refer to risk assessment in the Docket EPA-HQ-OPP-2005-0307 titled 
``Addendum to the Aggregate Human Health Risk Assessment of the Common 
Metabolite/Degradate Ethylene Thiourea (ETU) to Support New Tolerances 
on Imported Grapes and Bananas for Metiram and for New Tolerances for 
Mancozeb on Almonds, Broccoli, Cabbage, Lettuce, and Peppers.'').
    In the Federal Register of April 16, 2010, (75 FR 19967) (FRL-8822-
2) the voluntary cancellation of the last product containing maneb 
registered for use in the United States was announced by the Agency. 
Therefore, it is important to note that since all products for maneb 
have been cancelled and there are limited existing stocks for maneb 
still in the channels of trade, the risk assessments for ETU likely 
overestimates the exposures to this common metabolite. EPA's assessment 
of exposures and risks associated with mancozeb and ETU follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. In addition to evaluating mancozeb, EPA also evaluated the 
risks of ETU, a contaminant, metabolite and degradation product of 
mancozeb and the other EBDC group of fungicides, which includes the 
related active ingredients metiram and maneb.
    1. Mancozeb. Mancozeb is not acutely toxic via the oral, dermal or 
inhalation routes of exposure. Further, mancozeb is not a skin irritant 
nor is it a skin sensitizer, although it does cause mild eye 
irritation. The findings in multiple studies demonstrate that the 
thyroid is a target organ for mancozeb. Thyroid toxicity was manifested 
as alternations in thyroid hormones, increased thyroid weight, and 
microscopic thyroid lesions (mainly thyroid follicular cell 
hyperplasia). These effects are due to the ETU metabolite. In a 
subchronic study in the rat, neuropathology was seen (injury to 
peripheral nerves) microscopically with associated clinical signs 
(abnormal gait and limited use of rear legs) and loss of muscle mass. 
An acute neurotoxicity study with mancozeb has been completed and 
reviewed since the 2007 risk assessment; neuropathology was not 
observed, and minimal effects upon motor activity were observed at high 
doses. The Agency conducted a preliminary dietary assessment using a 
point-of-departure from this study and found no risk concerns. Other 
toxicity included increases in bilateral retinopathy in the chronic rat 
study. Elevated cholesterol and a mild, regenerative, anemia occurred 
in subchronic and chronic dog studies.
    Mancozeb is rapidly absorbed and eliminated in the urine. In oral 
rat metabolism studies with radiolabelled

[[Page 18908]]

mancozeb and other EBDCs, an average 7.5% in vivo metabolic conversion 
of EBDC to ETU occurred, on a weight-to-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.
    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 T<INF>4</INF>, increases or decreases in T<INF>3</INF>, 
compensatory increases in levels of TSH, increased thyroid weight, and 
microscopic thyroid changes, chiefly hyperplasia. Overt liver toxicity 
was observed in one chronic dog study. ETU is classified as a probable 
human carcinogen based on liver tumors in female mice.
    Developmental defects in the rat developmental study were similar 
to those seen with mancozeb, and included hydrocephaly and related 
lesions, skeletal system defects, and other gross defects. These 
defects showed increased susceptibility to fetuses because they 
occurred at a dose which only caused decreased maternal food 
consumption and body weight gain.
    Specific information on the studies received and the nature of the 
adverse effects caused by mancozeb as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Mancozeb: Human Health 
Risk Assessment to Support Proposed New Uses on Broccoli, Cabbage, 
Lettuce, Peppers and Almonds'' on pages 13-15 in docket ID number EPA-
HQ-OPP-2005-0307.
    Additionally, specific information on the studies received and the 
nature of the toxic effects caused by ETU as well as the NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document titled ``Ethylenethiourea (ETU) from 
EBDCs: Health Effects Division (HED) Human Health Risk Assessment of 
the Common Metabolite/Degradate ETU'' on pages 16-17 in docket ID 
number EPA-HQ-OPP-2005-0307.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for mancozeb and ETU used 
for human risk assessment is discussed in Unit IV.B. of the final rule 
published in the Federal Register of August 18, 2010 (75 FR 50902) 
(FRL-8841-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mancozeb, EPA considered exposure under the petitioned-for 
tolerances as well as all existing mancozeb tolerances in 40 CFR 
180.176. In evaluating dietary exposure to ETU, EPA considered exposure 
under the petitioned-for tolerances discussed in this document as well 
as all existing uses of the EBDC group of fungicides (maneb, metiram, 
mancozeb) including the uses for which there are maneb tolerances even 
though all maneb registrations have been canceled. EPA assessed dietary 
exposures from mancozeb and ETU in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for mancozeb and ETU. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII).
    a. Mancozeb. The following assumptions were made for the acute 
exposure assessments: The Agency conducted a highly refined, 
probabilistic acute dietary assessment incorporating maximum percent 
crop treated information for new and existing uses, field trial or 
monitoring data, and processing and cooking factors.
    b. ETU. The following assumptions were made for the acute exposure 
assessments: The Agency conducted a highly refined, probabilistic acute 
dietary assessment incorporating maximum percent crop treated 
information for new and existing EBDC uses, field trial or monitoring 
data for existing EBDC uses, and processing and cooking factors. It was 
assumed that commodities would not be treated with more than one EBDC 
in a season, as there are label restrictions regarding treatment with 
multiple EBDCs. Percent crop treated was estimated by summing the 
percent crop treated for the individual EBDCs. For residue values, EPA 
used either market basket survey data or field trial data. For a few 
commodities, mancozeb-derived ETU from mancozeb field trial data were 
used for both mancozeb and maneb because maneb field trial data were 
not available and application rates were sufficiently similar to 
estimate maneb-derived ETU values.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII.

[[Page 18909]]

    a. Mancozeb. The chronic dietary exposure and risk assessment for 
mancozeb (non-cancer and cancer) incorporated average values based 
either on field trial data or monitoring data and average percent crop 
treated data for new and existing uses, as well as processing and 
cooking factors.
    b. ETU. Chronic anticipated residues were calculated from field 
trial data on EBDCs or monitoring data for ETU. Averages of the field 
trial and market basket survey residues were used. EPA also used PCT 
data.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use 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 non-linear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Mancozeb degrades and/or metabolizes to ETU which causes 
thyroid tumors; therefore, EPA has historically attributed mancozeb's 
carcinogenicity to the formation of ETU, which is classified as a 
probable human carcinogen. The Agency has used the cancer potency 
factor (Q<INF>1</INF><SUP>*</SUP>) of 0.0601 (mg/kg/day) <SUP>-1</SUP> 
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 Q<INF>1</INF>* 
for ETU. The same approach has been taken for the other EBDCs. EPA's 
estimated exposure to mancozeb-derived ETU and ETU from other EBDCs 
included ETU residues found in food as well as ETU formed by metabolic 
conversion on parent mancozeb in the body (conversion rate of 0.075). 
EPA relied on the same estimates used for the chronic exposure 
assessment in assessing cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    In the 2007 acute risk assessment for mancozeb, the Agency 
estimated the PCT for existing uses as follows:
    Apple, 41%; asparagus, 34%; barley, 0.9%, beet, sugar, 2.9%; 
cantaloupe, 10%; carrot, 13%; casaba, 10%; corn, field, 1%; corn, 
sweet, 22%; cottonseed, oil, 0.8%; cucumber, 32%; grape, 14%; honeydew 
melon, 13%; oat, 1%; onion, dry bulb, 77%; peanut, 2.3%; pear, 51%; 
potato, 50%; pumpkin, 10%; rice, 1%; rye grain, 1%; squash, summer, 
86%; squash, winter, 10%; tomato, 80%; watermelon, 30%; wheat, grain, 
2.3%.
    In the 2007 chronic risk assessment for mancozeb, the Agency 
estimated the PCT for existing uses as follows:
    Apple, 26%; asparagus, 16%; barley, 0.2%, beet, sugar, 1.3%; 
carrot, 9%; casaba, 8%; corn, field, 1%; corn, sweet, 12%; cottonseed, 
oil, 0.2%; cucumber, 18%; grape, 9%; honeydew melon, 8%; oat, 1%; 
onion, dry bulb, 38%; peanut, 0.9%; pear, 32%; potato, 36%; pumpkin, 
8%; rice, 1%; rye grain, 1%; squash, summer, 41%; squash, winter, 8%; 
tomato, 49%; watermelon, 28%; wheat, grain, 0.9%.
    In the 2007 acute risk assessment for ETU the Agency estimated the 
PCT for existing uses as follows:
    Apple, 65%; asparagus, 30%; barley, 2%; bean, dried, 2.5%; beets, 
sugar, 15%; Brussels sprouts, 32%; cantaloupe, 12.5%; carrot, 2.5%; 
casaba, 12.5%; cauliflower, 15%; celery, 12%; chickpea, 2.5%; Chinese 
waxgourd, 15%; chive, 20%; collards, 10%; corn, field, 2.5%; corn, 
sweet, 17.5%; cottonseed, oil, 3.5%; cranberry, 31%; cucumber, 40%; 
eggplant, 65%; fennel, Florence, 12%; fig, 1%; garlic, 25%; grape, 
81.5%; grape, wine, 81.5%; guar, seed, 1%; honeydew melon, 12.5%; kale, 
5%; leek, 25%; mustard greens, 5%; oat, 2%; onion, dry bulb, 85%; 
peanut, 3.5%; pear, 55%; potato, 85%; pumpkin, 15%; rice, 2.5%; rye 
grain, 2%; squash, summer, 35%; squash, winter, 0%; tomato, fresh, 80%; 
tomato, processed, 25%; turnip tops, 86%; walnut, 37.5%; watermelon, 
55%; wheat, grain, 3.5%.
    In the 2007 chronic risk assessment for ETU the Agency estimated 
the PCT for existing uses as follows:
    Apple, 42%; asparagus, 21%; barley, 2%; bean, dried, 1%; beets, 
sugar, 6%; Brussels sprouts, 21%; cantaloupe, 6%; carrot, 8%; casaba, 
6%; cauliflower, 5%; celery, 12%; chickpea, 1%; Chinese waxgourd, 5%; 
chive, 10%; collards, 10%; corn, field, 1%; corn, sweet, 11%; 
cottonseed, oil, 2%; cranberry, 31%; cucumber, 20%; eggplant, 45%; 
fennel, Florence, 12%; fig, 1%; garlic, 25%; grape, 60%; grape, wine, 
60%; guar, seed, 1%; honeydew melon, 6%; kale, 6%; kohlrabi, 1%; leek, 
10%; mustard greens, 5%; oat, 2%; onion, dry bulb, 60%; peanut, 2%; 
pear, 40%; potato, 63%; pumpkin, 6%; rice, 1%; rye grain, 2%; squash, 
summer, 25%; squash, winter, 25%; tomato, fresh, 54%; tomato, 
processed, 54%; walnut, 31%; watermelon, 10%; wheat, grain, 2%.
    For the 2010 ETU cancer risk assessment the Agency estimated the 
PCT for existing uses as follows:
    Apple, 51%; asparagus, 15%; barley, 1%; bean, dried, 1%; beets, 
sugar, 3.5%; Brussels sprouts, 15%; cantaloupe, 7.5%, carrot, 5%; 
cauliflower, 10%; chickpea, 1%; collards, 31%; corn, field, 1%; corn, 
sweet, 6%; cottonseed, oil, 11%; cranberry, 45%; cucumber, 30%; 
eggplant, 30%; fig, 5%; flaxseed, 11%; garlic, 25%; grape, 6%; grape, 
wine, 26%; guar, seed, 1%; kale, 73%; leek, 15%; mustard greens, 22%; 
oat, 11%; onion, dry bulb, 75%; peanut, 2%; pear, 35%; potato, 67.5%; 
pumpkin, 20.5%; rice, 1%; rye grain, 11%; safflower, oil, 11%; squash, 
summer, 57%; squash, winter, 26%; tomato, fresh, 30%; tomato, 
processed, 30%; turnip tops, 36%; walnut, 36%; watermelon, 45%; wheat, 
grain, 11%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (USDA/NASS), proprietary market 
surveys, and the National Pesticide Use Database for the chemical/crop 
combination for the most

[[Page 18910]]

recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk 
analysis. The average PCT figure for each existing use is derived by 
combining available public and private market survey data for that use, 
averaging across all observations, and rounding to the nearest 5%, 
except for those situations in which the average PCT is less than 1. In 
those cases, 1% is used as the average PCT and 2.5% is used as the 
maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. 
The maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    In the 2007 acute risk assessment for mancozeb, the Agency 
estimated the PCT for new uses as follows:
    Almond, 35%; broccoli, 9%; cabbage, 47%; cabbage, Chinese, 47%; 
head lettuce 66%; leaf lettuce 61%; pepper, bell, 48%; pepper, non-
bell, 48%.
    In the 2007 chronic risk assessment for mancozeb, the Agency 
estimated the PCT for new uses as follows:
    Almond, 35%; broccoli, 7%; cabbage, 42%; cabbage, Chinese, 42%; 
head lettuce 58%; leaf lettuce 59%; pepper, bell, 43%; pepper, non-
bell, 43%.
    For the 2007 ETU acute assessment, the Agency estimated the PCT for 
new uses as follows:
    Almond, 50%; broccoli, 22%; cabbage, 82%; cabbage, Chinese, 82%; 
pepper, bell, 88%; pepper, non-bell, 88%.
    For the 2007 ETU chronic assessment, the Agency estimated the PCT 
for new uses as follows:
    Almond, 45%; broccoli, 17%; cabbage, 57%; cabbage, Chinese, 57%; 
pepper, bell, 73%; pepper, non-bell, 73%.
    For the 2010 ETU cancer assessment, the Agency estimated the PCT 
for new uses as follows:
    Almond, 28%; broccoli, 15%; cabbage, 62%; cabbage, Chinese, 62%; 
pepper, bell, 74%; pepper, non-bell, 74%.
    EPA estimates the percent crop treated for new uses (PCTn) of a 
pesticide represent the upper bound of use expected during the 
pesticide's initial 5 years of registration. The PCTn recommended for 
use in the chronic dietary assessment is calculated as the average PCT 
of the pesticide or pesticides that are the market leader or leaders, 
(i.e., the pesticides with the greatest PCT) on that site over the 
three most recent years of available survey data. The PCTn recommended 
for use in the acute dietary assessment is the maximum observed PCT 
over the same period. Comparisons are only made among pesticides of the 
same pesticide types (e.g., the market leader for fungicides on the use 
site is selected for comparison with a new fungicide). The market 
leader included in the estimation may not be the same for each year 
since different pesticides may dominate at different times.
    Typically, EPA uses USDA/NASS as the source data because it is 
publicly available and directly reports values for PCT. When a specific 
use site is not reported by USDA/NASS, EPA uses proprietary data and 
calculates the PCT given reported data on acres treated and acres 
grown. If no data are available, EPA may extrapolate PCTn from other 
crops, if the production area and pest spectrum are substantially 
similar.
    EPA refines PCTn estimates based on approaches other than the 
market leader approach if the previous PCTn estimates based on the 
market leader indicate that the chemical exposure potentially poses a 
risk of concern. EPA considers the pest or pest spectrum targeted by 
the chemical for the new uses and identifies other pesticides already 
registered on that crop that target the same pest or pest spectrum. The 
PCTn is calculated based on the data from the three most recently 
available pesticide usage surveys. If multiple chemicals are identified 
that target the same pest spectrum, then the one with the highest PCT 
is selected from each year/crop combination. Consideration is also 
given to the potential for the development of resistance for each 
chemical using data available from the Resistance Action Committees.
    EPA has considered all available relevant information and concludes 
that it is unlikely that the PCTn values will be exceeded during the 
next 5 years.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which mancozeb may be applied in a particular area.
    2. Dietary exposure from drinking water--i. Mancozeb. The Agency 
has determined that mancozeb is very short-lived 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 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 
chronic exposure is estimated to be ppb for ground water 0.21.
    Estimates of drinking water concentrations were directly entered 
into the dietary exposure model. For acute dietary risk assessment, the 
water concentration value of 25.2 ppb was used to assess the 
contribution to drinking water. For chronic dietary risk assessment of 
ETU, the water concentration of value 0.21 ppb was used to assess the 
contribution to drinking water. For cancer dietary risk assessment of 
ETU, the water concentration of value 0.21 ppb was used to assess the 
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-

[[Page 18911]]

occupational, non-dietary exposure (e.g., for lawn and garden pest 
control, indoor pest control, termiticides, and flea and tick control 
on pets).
    i. Mancozeb. Mancozeb is currently registered for use on the 
following residential sites: Home gardens, golf courses, and sod farms 
(potential exposure to mancozeb is from residues remaining on 
transplanted turf). The Agency has determined that it is appropriate to 
aggregate chronic exposure through food with short- and intermediate-
term residential exposures to mancozeb. Since residues of mancozeb are 
not expected in drinking water, only mancozeb food residues are 
considered.
    The two scenarios that were evaluated for mancozeb are the ``short/
intermediate-term home garden aggregate (adult)'' which considers 
residential handler exposures (inhalation) to adult applicators 
combined with average food exposures and the ``short/intermediate-term 
treated turf aggregate (toddler)'' which considers residential 
incidental oral exposures to toddlers combined with average food 
exposures. The only postapplication scenario for adults in contact with 
treated turf (golf courses) is via the dermal route of exposure. Since 
no dermal endpoints were selected for mancozeb, a quantitative risk 
assessment for this scenario is not required.
    ii. ETU. ETU non-dietary exposure is expected as a result of the 
registered uses of mancozeb and the other EBDCs on home gardens, golf 
courses and sod farms. For ETU, aggregate exposure sources include 
food, drinking water, home gardening activities and golfing. The Agency 
has determined that it is appropriate to aggregate chronic exposure 
through food with short- and intermediate-term residential exposures to 
mancozeb.
    The three scenarios that were evaluated for ETU are as follows: The 
first is the ``short/intermediate-term home garden aggregate'' which 
combines handler exposures (inhalation and dermal) and postapplication 
garden exposures (dermal) plus average daily food and drinking water 
exposure for adults and postapplication garden exposures (dermal) plus 
average daily food and drinking water exposure for youth. The second is 
the ``short-term treated turf aggregate (toddlers)'' which combines 
treated turf post application exposures (incidental oral and dermal) 
plus average daily food and drinking water exposure for toddlers. And 
the last is the ``short/intermediate-term treated turf aggregate'' 
which considers short-term residential exposures (dermal) plus average 
daily food and drinking water exposure for adults such as golfing on 
treated turf. This assessment is protective of adult and youth golfers. 
Although exposure to children golfing could be almost twice that of the 
adult golfer because of increased surface area/body weight (SA/BW) 
ratios, younger golfers are not expected to use the golf course for the 
same length of time as adolescents and adults. The shorter duration on 
the golf course for younger golfers offsets the higher SA/BW; 
therefore, risks from short-term post-application exposures to young 
golfers are likely to be similar to risks for adult golfers.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    As previously mentioned, the risk estimates summarized in this 
document are those that result only from the use of mancozeb, and ETU 
derived from mancozeb and the other EBDC chemicals, which are all 
dithiocarbamates. For the purposes of this action, EPA has concluded 
that mancozeb does not share a common mechanism of toxicity with other 
substances. The Agency reached this conclusion after a thorough 
internal review and external peer review of the data on a potential 
common mechanism of toxicity.
    EPA concluded that the available evidence does not support grouping 
the dithiocarbamates based on a common toxic effect (neuropathology) 
occurring by a common mechanism of toxicity (related to metabolism to 
carbon disulfide). After a thorough internal and external peer review 
of the existing data bearing on a common mechanism of toxicity, EPA 
concluded that the available evidence shows that neuropathology can not 
be linked with carbon disulfide formation. For more information, please 
see the December 19, 2001 memo, ``The Determination of Whether 
Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity'' on 
the internet at http://www.epa.gov/oppsrrd1/cumulative/dithiocarb.pdf.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity--i. Mancozeb. In the rat 
developmental study, developmental effects were observed in the 
presence of severe maternal effects, including maternal mortality and 
clinical signs. In the rabbit developmental study, developmental 
effects (spontaneous abortions) were observed at the same dose (80 mg/
kg/day) at which maternal effects included mortality and clinical 
signs. In the rat reproduction study, no effects were observed in 
offspring, while thyroid effects and body weight gain decrements 
occurred in adults.
    ii. ETU. There was evidence of increased susceptibility of fetuses 
to ETU in the rat developmental studies because hydrocephaly occurred 
at doses below that causing maternal toxicity. Acceptable reproductive 
and rabbit developmental toxicity studies were not available for ETU. 
As a result, the Agency evaluated the level of concern for the effects 
observed when considered in the context of all available toxicity data. 
In addition, the Agency evaluated the database to determine if there 
were residual uncertainties after establishing toxicity endpoints and 
traditional uncertainty factors to be used in the ETU risk assessment.
    3. Conclusion--i. Mancozeb. In the 2007 assessment, EPA retained 
the presumptive 10X FQPA safety factor for the protection of children 
due to the absence of a required developmental neurotoxicity study. 
That study has recently been received. Neurotoxicity was not observed 
in the study, and the young animals did not show susceptibility, as 
compared to the adults, for the slight toxicity that was observed 
(reduced body weight gain). Additionally, since the completion of the 
2007 assessment, EPA has imposed a new data requirement for 
immunotoxicity data and such data has

[[Page 18912]]

not been submitted for mancozeb. The absence of an immunotoxicity study 
does not raise significant uncertainty. In the absence of that study, 
the available toxicity data for mancozeb have been thoroughly examined 
for any information which suggests a potential for immunotoxicity. The 
analysis did not reveal such information and the Agency does not 
believe that conducting the immunotoxicity study will result in a point 
of departure (POD) less than the currently selected PODs for risk 
assessment.
    Because EPA is relying on the 2007 assessment in evaluating acute 
and chronic risks, EPA is retaining the children's safety factor 
determination in that assessment (retain the additional 10X factor). 
EPA expects that once that determination is revisited, the children's 
safety factor will be lowered or removed entirely due to the submission 
of the DNT study and the fact that immunotoxicity is not a concern with 
mancozeb. These changed circumstances certainly do not support an 
additional safety factor higher than 10X. Further, as discussed below, 
EPA believes that the 2007 risk assessment does not underestimate 
exposure to mancozeb. Accordingly, EPA concludes that the 2007 
determination on the children's safety factor protects the safety of 
infants and children.
    ii. ETU. The toxicity database for ETU is not complete. EPA lacks 
the following studies: A DNT study; a developmental study in rabbits; a 
2-generation reproduction study; and a comparative thyroid study in 
adults and offspring. Given these multiple data gaps for studies that 
directly assess the risk to the young, EPA does not have reliable data 
to remove or modify the presumptive 10X FQPA safety factor.
    No further safety factor to protect is needed for the following 
reasons. First, the Agency determined that the degree of concern for 
the susceptibility seen in ETU developmental studies was low. The 
reasons for this conclusion are:
    <bullet> The teratogenic effects of ETU have been well-
characterized in numerous studies in the published literature, as well 
as in a guideline study submitted by the registrant. In addition, since 
metabolism studies have shown that approximately 7.5% of mancozeb 
converts to ETU in mammalian systems, the extensive toxicity database 
with mancozeb on developmental effects provide extensive information 
about pre- and post-natal toxicity of ETU;
    <bullet> 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.
    <bullet> The developmental endpoint with the lowest NOAEL was 
selected for deriving the acute RfD.
    <bullet> The target organ (thyroid) was selected for deriving the 
chronic RfD as well as endpoints for non-dietary exposures (incidental 
oral, dermal, and inhalation). Since the ETU doses selected for overall 
risk assessments will address the concern for developmental and thyroid 
toxicity, there are no residual uncertainties with regard to prenatal 
and/or postnatal toxicity.
    Second, the information on ETU gleaned from the extensive mancozeb 
database on effects other than development effects also reduces, to a 
degree, the uncertainty arising from the significant datagaps for ETU.
    Third, EPA has concluded that the exposure assessment, although 
refined, is unlikely to under-estimate potential exposures especially 
considering exposure to maneb was included even though all maneb 
products have been canceled. In making this judgment, EPA has taken 
into account that it is relying on three separate reviews in this 
Notice:
    <bullet> A 2007 risk assessment for mancozeb for acute, short-term, 
intermediate-term, chronic, and cancer risk,
    <bullet> A 2007 risk assessment for ETU for acute, short-term, 
intermediate-term and chronic risk, and
    <bullet> A 2010 addendum to the 2007 ETU assessment for cancer 
risk--and that the percent crop treated estimates differ slightly 
between reviews.
    In comparing the percent crop treated information from 2007 and 
2010, there are some increases in usage for some crops, and there are 
decreases in usage for other crops. These differences appear to largely 
offset each other. Further, most of the increases are attributable to 
estimated increases in maneb usage but, as noted, maneb was canceled in 
2010 and it is unlikely that existing stocks are sufficient to sustain 
prior usage levels much less any increased usage. An EPA sensitivity 
analysis of the main contributors to ETU exposure showed no significant 
increase in exposure from the changed percent crop treated estimated. 
The percent crop treated values used in these risk assessments are 
detailed in the memo titled ``Mancozeb. Discussion on Percent Crop 
Treated Values Used in Aggregate and Chronic Assessments'' in docket 
number EPA-HQ-OPP-2005-0307.
    In any event, there are two other aspects of the exposure 
assessment that are likely to significantly overstate exposure to 
mancozeb and ETU. First, exposure estimates for some crops, including 
bananas, a high-consumption food, include the assumption that 
everything consumed in the United States has been treated. Second, the 
residue data used in the assessment for the proposed commodities and 
many other crops are based on crop field trials. Monitoring studies 
conducted for several crops have shown that residues on foods close to 
the point of consumption are much lower than the residues found in crop 
field trials.
    For all of these reasons, EPA concludes that it has not 
underestimated exposure to mancozeb and ETU.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk (Mancozeb). The mancozeb acute aggregate assessment 
considers acute exposure to mancozeb only and not ETU. Further, this 
assessment is based on residues of mancozeb in food only since residues 
of mancozeb are not expected in drinking water. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
dietary exposure from food and water to mancozeb will occupy 6.9% of 
the aPAD for females 13-49 years of age, the only population group of 
concern.
    2. Acute risk (ETU). Using the exposure assumptions discussed in 
this unit for acute exposure, the acute dietary exposure from food and 
water to ETU will occupy 87% of the aPAD for females 13-49 years of 
age, the only population group of concern.
    3. Chronic risk (Mancozeb). There are no long-term residential 
exposure scenarios for mancozeb and there is not likely to be residues 
of mancozeb in drinking water. Therefore, the long-term or chronic 
(non-cancer) aggregate risk for mancozeb includes contribution from 
food alone. Using the exposure assumptions described in this unit for 
chronic exposure, EPA has concluded that chronic exposure to mancozeb 
from food will utilize 3.3% of the cPAD for children 1-2 years of age, 
the population group receiving the greatest exposure.
    4. Chronic Risk (ETU). The aggregate chronic risks were calculated 
using food

[[Page 18913]]

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 
intermediate-term aggregate exposure takes into account short- and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Mancozeb is currently registered for uses that could result in 
short- and intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food with short- and intermediate-term residential exposures to 
mancozeb. The two scenarios that were evaluated for mancozeb are the 
following:
    i. Short/intermediate-term home garden aggregate (adult). The 
aggregate short/intermediate-term home garden MOEs for adults are 
110,000. Because for mancozeb EPA is concerned only with MOEs that are 
below 1,000, this MOE does not raise a risk concern.
    ii. Short-term treated turf aggregate (toddler). The mancozeb 
short-term aggregate risk (MOE) for toddlers exposed to treated turf is 
1,100. Because for mancozeb EPA is concerned only with MOEs that are 
below 1,000, this MOE does not raise a risk concern.
    6. Short- and intermediate-term risk (ETU). Short- and 
intermediate-term aggregate exposure takes into account short-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Mancozeb is currently registered for uses that could result in 
short- and intermediate-term residential exposure to ETU. The 2007 
assessment also included products containing maneb which were expected 
to result in short- and intermediate-term exposure. As previously 
discussed, these products have since been cancelled. The Agency 
determined that it was appropriate to aggregate chronic exposure 
through food with short- and intermediate-term residential exposures to 
ETU. The three scenarios that were evaluated for ETU are the following.
    i. ETU short/intermediate-term home garden aggregate. The ETU 
short/intermediate-term home garden aggregate MOEs for adults is 13,000 
and 17,000 for youth, respectively. Because for ETU EPA is concerned 
only with MOEs that are below 1,000, this MOE does not raise a risk 
concern.
    ii. ETU short-term treated turf aggregate (toddlers). The ETU 
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. The ETU 
short-term treated turf aggregate MOE for golfers is 6,100. Because for 
ETU EPA is concerned only with MOEs that are below 1,000, this MOE does 
not raise a risk concern.
    7. Aggregate cancer risk for U.S. population (mancozeb and ETU). As 
noted earlier in this document, mancozeb degrades and/or metabolizes to 
ETU which causes the same types of thyroid tumors as those seen when 
animals are dosed with mancozeb; therefore, EPA has historically 
attributed mancozeb's carcinogenicity to the formation of ETU, which is 
classified as a probable human carcinogen (B2).
    The cancer risks were aggregated using the food and drinking water 
doses for the general population and the food, water and recreational 
doses for golfers, home gardeners and athletes. The average daily dose 
was used for food and water exposures and the lifetime average daily 
dose was used for the recreational exposures. The aggregate doses were 
multiplied times the potency factor for ETU, 0.0601 (mg/kg/
day)<SUP>-1</SUP> to determine the cancer risks. The risk is estimated 
to be 3 x 10<SUP>-6</SUP>.
    EPA generally considers cancer risks (expressed as the probability 
of an increased cancer case) in the range of 1 in 1 million (or 1 x 
10<SUP>-6</SUP>) 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 x 10<SUP>-7</SUP> and 3 x 
10<SUP>-6</SUP> are expressed as risks in the range of 10<SUP>-6</SUP>. 
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<SUP>-6</SUP> until the calculated risk exceeds approximately 3 x 
10<SUP>-6</SUP>. This is particularly the case where some conservatism 
is maintained in the exposure assessment. Although the ETU exposure 
risk assessment is refined, it retains significant conservatism in 
that, for leafy greens, field trial data and not market basket data on 
similar crops is used in estimating exposure. The leafy greens have 
tended to be among the top contributors to the aggregate risk (along 
with water and leaf lettuce). For other commodities, market basket data 
has shown reductions in residues one to two orders of magnitude lower 
than field trial data. Moreover, the only remaining EBDC registration 
for leafy greens (maneb) was canceled in 2010 but the exposure 
assessment does not take this into account. Additional conservatism is 
included in the exposure assessment by the assumption of 100 percent 
crop treated for many commodities. Accordingly, EPA has concluded the 
aggregate cancer risk for all existing mancozeb and other EBDC uses and 
the uses associated with the tolerances established in this action fall 
within the range of 1 x 10<SUP>-6</SUP> and are thus negligible.
    8. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to mancozeb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate methods are available for the enforcement of tolerances 
for the plant commodities which are the subject of this request. The 
Pesticide Analytical Method (PAM) Vol. II lists Methods I, II, III, IV, 
and A for the determination of dithiocarbamate residues in/on plant 
commodities. The Keppel colorimetric method (Method III) is the 
preferred method for tolerance enforcement. The Keppel method 
determines EBDCs as a group by degradation to CS<INF>2</INF>. 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; e-mail address: 
<a href="/cdn-cgi/l/email-protection#2f5d4a5c464b5a4a424a5b47404b5c6f4a5f4e01484059"><span class="__cf_email__" data-cfemail="bfcddaccd6dbcadad2dacbd7d0dbccffdacfde91d8d0c9">[email protected]</span></a>.

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

[[Page 18914]]

standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are no established or proposed Codex MRLs for residues of 
mancozeb; however, Codex limits for mancozeb and similar fungicides are 
grouped under dithiocarbamates measured as carbon disulfide. There are 
Codex MRLs for almonds; almond hulls; cabbages, head; lettuce, head; 
cos lettuce; peppers, sweet. Tolerances for the EBDC pesticides are 
expressed in terms of carbon disulfide (CS<INF>2</INF>), which is the 
same as the Codex tolerance expression. The level of 0.1 ppm for 
almonds is also the same as the Codex MRL for almonds. However, for the 
reasons indicated below, the tolerance levels being established for the 
other subject crops cannot be harmonized with the associated Codex 
MRLs.
    <bullet> Based on the calculations in the Agency's tolerance 
spreadsheet, in accordance with the Agency's ``Guidance for Setting 
Pesticide Tolerances Based on Field Trial Data,'' the appropriate 
tolerance level for cabbage is 9.0 ppm. The tolerance level cannot be 
harmonized with Codex; the highest residue level in the crop field 
trials (6.0 ppm in CS<INF>2</INF> equivalents) is greater than the 
Codex MRL for cabbage (5 ppm).
    <bullet> The available data indicate that the appropriate tolerance 
level for head lettuce is 3.5 ppm. The tolerance level cannot be 
harmonized with Codex; the highest residue level in the crop field 
trials (2.2 ppm in CS<INF>2</INF> equivalents) is considerably less 
than the Codex MRL of 10 ppm for head lettuce.
    <bullet> The available data indicate that the appropriate tolerance 
level for leaf lettuce is 18 ppm. The tolerance level cannot be 
harmonized with Codex; the highest residue level in the crop field 
trials (14 ppm in CS<INF>2</INF> equivalents) is greater than the Codex 
MRL for Cos lettuce (10 ppm).
    <bullet> The appropriate tolerance level for pepper is 12 ppm. The 
tolerance level cannot be harmonized with Codex as the Codex MRL has 
been established for sweet pepper only.
    <bullet> The appropriate tolerance level for almond hulls is 4 ppm. 
This value cannot be harmonized with Codex as it is significantly below 
the Codex MRL of 20 ppm.

C. Response to Comments

    The company Cerexagri, Inc. submitted a comment on the initial 
notice of filing in 2006. Cerexagri proposed that EPA reject the 
petitions for reasons primarily dealing with information included in 
the risk assessment provided by Dow AgroSciences in the petitions. The 
Agency conducts its own risk assessments and does not rely on those 
provided by registrants. For example, Cerexagri did not agree with Dow 
AgroSciences proposal to assume that ``mancozeb uses will simply 
replace a share of the existing maneb market''. Nor did Cerexagri agree 
with Dow AgroSciences use of market basket data to extrapolate expected 
residues on the proposed commodities. The EPA did not base PCT 
estimates for new commodities based on the assumption that one EBDC 
will replace another but instead used its standard market leader 
approach to determine appropriate PCT numbers. Further, the EPA relied 
on the results of the crop field trial data to estimate exposure to the 
proposed commodities and many other crops. Results of the Market Basket 
Survey were only used for commodities/chemicals associated with the 
survey. Therefore, the objections voiced by Cerexagri are not relevant 
to the conclusions reached by the Agency regarding these petitions.
    Finally, Cerexagri requested that the EPA first engage in a public 
process that would seek the participation of the grower community, 
research community and other interested parties before determining 
which new uses of EBDC fungicides should be approved because approval 
of the uses requested in this petition may preclude the approval of 
other uses. EPA, however, has followed all procedural requirements in 
the FFDCA section. Moreover, in the time since this petition was 
submitted, no further uses of EBDCs have been requested.

D. Revisions to Petitioned-For Tolerances

    All of the tolerance levels being established in this document, 
with the exception of almond, are different than the levels requested 
in the original tolerance petitions. EPA revised the tolerance levels 
based on analysis of the residue field trial data using the Agency's 
Tolerance Spreadsheet in accordance with the Agency's ``Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data.''

V. Conclusion

    Therefore, tolerances are established for residues of mancozeb, 
zinc manganese ethylenebis dithiocarbamate in or on almond at 0.1 ppm; 
almond, hulls at 4 ppm; broccoli at 7 ppm; cabbage at 9 ppm; lettuce, 
head at 3.5 ppm; lettuce, leaf at 18 ppm; and pepper at 12 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined

[[Page 18915]]

that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000) do not apply to this final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 21, 2011.
Lois Rossi,
 Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Section 180.176 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.176  Mancozeb; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................          0.1
Almond, hulls..............................................          4
 
                                * * * * *
Broccoli...................................................          7
Cabbage....................................................          9
 
                                * * * * *
Lettuce, head..............................................          3.5
Lettuce, leaf..............................................         18
 
                                * * * * *
Pepper.....................................................         12
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-7461 Filed 4-5-11; 8:45 am]
BILLING CODE 6560-50-P


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