[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Rules and Regulations]
[Pages 23882-23891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10333]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2005-0308; FRL-8869-1]


Metiram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of metiram 
in or on bananas and wine grapes. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 29, 2011. Objections and 
requests for hearings must be received on or before June 28, 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-2005-0308. 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.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-OPP-2005-0308 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 28, 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-2005-0308, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register issue of November 30, 2005 (70 FR 71829) 
(FRL-7747-2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E6006) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 
27709. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide metiram: A 
mixture of 5.2 parts by weight of ammoniates of 
ethylenebis(dithiocarbamato) zinc with 1 part by weight 
ethylenebis(dithiocarbamic acid) bimolecular and trimolecular cyclic 
anhydrosulfides and disulfides, calculated as zinc 
ethylenebisdithiocarbamate in or on

[[Page 23883]]

imported bananas (whole fruit) at 5.0 parts per million (ppm) and 
grapes at 7.0 ppm. That notice referenced a summary of the petition 
prepared by BASF Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. BASF subsequently revised their 
petition by requesting that the tolerances be set for banana at 3.0 ppm 
and for grape wine at 5.0 ppm.
    In the Federal Register issue of September 16, 2009, (74 FR 47507) 
(FRL-8431-4) in a document titled ``Mancozeb, Maneb, Metiram, and 
Thiram; Proposed Tolerance Actions,'' EPA proposed:
    1. Revising the existing tolerances for apple and potato.
    2. Adding a tolerance for apple, pomace, wet.
    3. Revising the tolerance expression in Sec.  180.217. The reasons 
for these changes are explained in Unit V.D.
    EPA did not receive comments on the Federal Register notice of 
November 30, 2005, but comments were received on the Federal Register 
proposed rule of September 16, 2009. EPA's response to these comments 
is discussed 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 metiram, including exposure 
resulting from the tolerances established by this action.
    Metiram is a member of the ethylene bisdithiocarbamate (EBDC) group 
of fungicides that also includes the related active ingredients 
mancozeb and maneb. 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 
metiram 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 metiram on bananas and grapes, EPA completed two risk 
assessments in 2007: A metiram risk assessment which considered all 
existing and proposed uses for metiram and an ETU risk assessment that 
considered exposure to ETU from all sources (mancozeb, maneb, and 
metiram) for all existing and proposed uses.
    Although the 2007 metiram review showed risks that were acceptable, 
the 2007 ETU review demonstrated unacceptable cancer risks, therefore 
preventing the Agency from acting on the petition for bananas and 
grapes. 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 bananas and wine grapes. Because the 2010 ETU review 
dealt strictly with refining the cancer risk, the Agency will be 
relying on three risk assessments to support this tolerance document. 
These assessments are as follows:
     A 2007 risk assessment for metiram for acute, chronic, and 
cancer risk (refer to the risk assessment in docket ID number EPA-HQ-
OPP-2005-0308 titled ``Metiram: Human Health Risk Assessment for 
PP9E6006. Petition for the Establishment of Import Tolerances 
on Grapes and Bananas'').
     A 2007 risk assessment for ETU for acute, short-term, 
intermediate-term, and chronic risk (refer to the risk assessment in 
docket ID number EPA-HQ-OPP-2005-0308 titled ``Ethylenethiourea (ETU) 
from EBDCs: Health Effects Division (HED) Human Health Risk Assessment 
of the Common Metabolite/Degradate ETU'').
     A 2010 addendum to the 2007 ETU assessment for cancer risk 
(refer to the risk assessment in docket ID number EPA-HQ-OPP-2005-0308 
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 issue 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 metiram 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 metiram, EPA also evaluated the 
risks of ETU, a contaminant, metabolite, and degradation product of 
metiram and the other EBDC group of fungicides, which includes the 
related active ingredients mancozeb and maneb.
    1. Metiram. Metiram is not acutely toxic via the oral, dermal, or 
inhalation routes of exposure, nor is it a skin or eye irritant. It is, 
however, a strong-to-severe skin sensitizer. The thyroid is a target 
organ for metiram. Thyroid effects observed in subchronic studies in 
rats include increased thyroid weights, increased thyroid stimulating 
hormone (TSH), and decreased T4 (serum thyroxin) values. 
Metiram degrades and/or is metabolized to ETU. In oral rat metabolism 
studies with radiolabelled metiram 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 metiram does not bio-accumulate.
    The nervous system is a target for metiram. Neurotoxic signs and 
neuropathology have been observed in subchronic studies in rats 
following oral dosing with metiram. Signs of neurotoxicity occurred 
after 2 weeks of dosing, including reduced forelimb grip strength, hind 
limb paralysis, muscle wasting, and ataxia. Neuropathology findings 
indicated decreased areas of myelinated axons in the sciatic, sural, 
and tibial nerves.

[[Page 23884]]

    Metiram has been tested in a series of in vitro and in vivo 
genotoxicity assays. Metiram did not cause bacterial gene mutation, but 
there was evidence of mammalian gene mutation in two studies. The 
genotoxic effect was not considered to be related to the metabolism of 
metiram to ETU.
    Metiram degrades and/or metabolizes to ETU which causes thyroid 
tumors; therefore, EPA has historically attributed metiram's potential 
for 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 (milligram/kilogram/day (mg/kg/day)\-
1\) for ETU (based on liver tumors in female mice) for risk assessment.
    Developmental toxicity was observed for metiram in the rat 
(increased incidence of post-implantation loss, decreased litter size, 
and decreased litter weight) at a dose level where minimal maternal 
toxicity (decreased body-weight gains) was observed. However, there is 
low concern for the qualitative susceptibility observed in the rat 
study since the dose response was well characterized; there was a clear 
NOAEL (no observed adverse effect level)/LOAEL (lowest observed adverse 
effect level) for maternal and developmental toxicity; and the doses 
selected for risk assessment were based on neurotoxicity and address 
concerns for developmental toxicity and thyroid toxicity, which 
occurred at higher doses. Additionally, in a rabbit developmental 
study, in which the maternal animals were adequately assessed, maternal 
toxicity observed included abortions and decreased body-weight gains.
    2. ETU. The thyroid is a target organ for ETU; thyroid toxicity in 
subchronic and chronic rat, mouse, and dog studies included decreased 
levels of T4, increases or decreases in T3, 
compensatory increases in levels of TSH, increased thyroid weight, and 
microscopic thyroid changes, chiefly hyperplasia. Overt liver toxicity 
was observed in one chronic dog study. ETU is classified as a probable 
human carcinogen based on liver tumors in female mice.
    Developmental defects in the rat developmental study were similar 
to those seen with metiram, 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 (BW) gain.
    Specific information on the studies received and the nature of the 
adverse effects caused by metiram as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at http://www.regulations.gov in 
the document titled ``Metiram: Human Health Risk Assessment for 
PP9E6006. Petition for the Establishment of Import Tolerances 
on Grapes and Bananas'' on pages 18-21 in docket ID number EPA-HQ-OPP-
2005-0308.
    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 the 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-2005-0308.

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 (LOC) 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 the NOAEL and the LOAEL are identified. 
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 metiram used for human 
risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Metiram for Use in Human Health Risk Assessment
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                                        POD and  uncertainty/   RfD, PAD,  LOC for risk         Study and
          Exposure/scenario                safety  factors             assessment         toxicological  effects
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Acute dietary (General population      There was no appropriate endpoint attributable to a single dose in the
 including infants and children).       available toxicity studies.
                                      --------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  NOAEL = 10 mg/kg/day...  Acute RfD = 0.01 mg/kg/  Developmental Toxicity
 age).                                 UFA = 10x..............   day.                     (Rabbit).
                                       UFH = 10x..............  aPAD = 0.01 mg/kg/day..  LOAEL = 40 mg/kg/day,
                                       FQPA SF = 10x UFDB.....                            based on abortions.
Chronic dietary (All populations)....  NOAEL = 0.4 mg/kg/day..  Chronic RfD = 0.0004 mg/ Subchronic Oral
                                       UFA = 10x..............   kg/day.                  Toxicity (Rat,
                                       UFH = 10x..............  cPAD = 0.0004 mg/kg/day   bridging study).
                                       FQPA SF = 10x UFDB.....                           LOAEL = 6.7 mg/kg/day
                                                                                          based on decreased
                                                                                          forelimb grip
                                                                                          strength.
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[[Page 23885]]

 
Cancer (Oral, dermal, inhalation)....  Q1* = 6.01x10\-2\ (mg/kg/day)\-1\
                                       Metiram is classified as Group B2 carcinogen (probable human carcinogen);
                                        use low-dose extrapolation for human risk assessment, based on ETU.
                                        Quantitative cancer risk assessments for metiram and other EBDCs are
                                        based on exposure to the ETU degradate.
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EBDC = ethylene bisdithiocarbamate. ETU = ethylenethiourea. FQPA SF = Food Quality Protection Act Safety Factor.
  LOC = level of concern. LOAEL = lowest observed adverse effect level. Mg/kg/day = milligram/kilogram/day.
  NOAEL = no observed adverse effect level. PAD = population adjusted dose (a = acute, c = chronic). POD = point
  of departure. Q1* = cancer potency factor. RfD = reference dose. 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).

    A summary of the toxicological endpoints for ETU used for human 
risk assessment is discussed in Unit IV.B. of the final rule published 
in the Federal Register issue 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 metiram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing metiram tolerances in 40 CFR 
180.217. In evaluating dietary exposure to ETU, EPA considered exposure 
under the petitioned-for tolerances discussed in this document as well 
as all existing and proposed uses of the EBDC group of fungicides 
(mancozeb, maneb, and metiram,) including the uses for which there are 
maneb tolerances even though all maneb registrations have been 
cancelled. EPA assessed dietary exposures from metiram 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 metiram and ETU. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and the 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII).
    a. Metiram. The following assumptions were made for the acute 
exposure assessments: The Agency conducted a refined probabilistic 
assessment using a distribution of either field trial or monitoring 
data for commodities considered to be either non-blended or partially 
blended. Average field trial or monitoring residues were used for 
blended commodities. Maximum percent crop treated (PCT) and relevant 
processing factors were also included in the assessment. The PCT 
information is not available for the proposed import tolerances; 
however, percent imported factors were incorporated for wine grapes. It 
was assumed 100% of imported wine grapes would contain residues of 
metiram. EPA assumed 100% of bananas are imported and would contain 
residues of metiram.
    b. ETU. The following assumptions were made for the acute exposure 
assessments: The Agency conducted a highly refined, probabilistic acute 
dietary assessment incorporating maximum PCT 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 PCT of 
total EBDCs could not exceed 100%; and if commodities were treated with 
more than one EBDC in a season, the combination of EBDC applications 
leading to the highest total exposure potential was assumed to occur.
    The PCT was estimated by summing the PCT 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.
    a. Metiram. To estimate chronic dietary exposure and risk to 
metiram per se, a refined assessment was conducted using average field 
trial or average monitoring residues. In addition, average PCT and 
relevant processing factors were included. The PCT information is not 
available for the proposed import tolerances; however, percent imported 
factors were incorporated for bananas and wine grapes. It was assumed 
100% of imported wine grapes would contain residues of metiram. EPA 
assumed 100% of bananas are imported and would contain residues of 
metiram.
    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 nonlinear approach is used and a cancer RfD is calculated 
based on an earlier non-cancer key event. If carcinogenic mode of 
action data are not available, or if the mode of action data determines 
a mutagenic mode of action, a default linear cancer slope factor 
approach is utilized.
    Metiram degrades and/or metabolizes to ETU which causes thyroid 
tumors; therefore, EPA has historically attributed metiram's potential 
for carcinogenicity to the formation of ETU, which is classified as a 
probable human carcinogen. The Agency has used the 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 metiram 
has been calculated by estimating exposure to metiram-derived ETU and 
using the Q1* for ETU. The same approach has been taken for 
the other EBDCs. EPA's estimated exposure to metiram-derived ETU and 
ETU from other EBDCs included ETU residues found in food as well as ETU 
formed by metabolic conversion on parent metiram in the body 
(conversion rate of 0.075).

[[Page 23886]]

    EPA relied on the same estimates used for the chronic exposure 
assessment in assessing cancer risk.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a. The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b. The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c. Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    In the 2007 acute risk assessment for metiram, the Agency estimated 
the PCT for existing uses as follows: Apple, 25% and potatoes, 10%.
    In the 2007 chronic risk assessment for metiram the Agency 
estimated the PCT for existing uses as follows: Apple, 15% and 
potatoes, 10%.
    In the 2007 acute risk assessment for ETU the Agency estimated the 
PCT for existing uses as follows: Apple, 65%; asparagus, 30%; barley, 
2%; beans, 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%; 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%; and wheat, grain, 3.5%.
    For the 2007 chronic risk assessment for ETU the Agency estimated 
the PCT for existing uses as follows: Apple, 42%; asparagus, 21%; 
barley, 2%; beans, 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%; guar, seed, 1%; honeydew melon, 6%; kale, 5%; 
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%; and wheat, 
grain, 31%.
    For the 2010 ETU cancer risk assessment the Agency estimated the 
PCT for existing uses as follows: Apple, 51%; asparagus, 15%; barley, 
1%; beans, 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%; 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%; and 
wheat, grain, 11%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (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%.
    Percent crop treated information is not available for the proposed 
import tolerances; however, percent imported factors were incorporated 
for wine grapes.
    In the 2007 acute risk assessment for metiram, the Agency estimated 
the percent imported factors for new uses as follows: Wine grape, 20%.
    In the 2007 chronic risk assessment for metiram, the Agency 
estimated the percent imported factors for new uses as follows: Wine 
grape, 20%.
    In the 2007 acute risk assessment for ETU the Agency estimated the 
percent imported for existing uses as follows: Wine grape, 81.5%.
    For the 2007 chronic risk assessment for ETU the Agency estimated 
the percent imported for existing uses as follows: Wine grape, 60%.
    For the 2010 ETU cancer risk assessment the Agency estimated the 
percent imported for existing uses as follows: Wine grape, 26%.
    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 3 
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

[[Page 23887]]

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 pose a 
risk of concern. EPA considers the pest or pest spectrum targeted by 
the chemical for the new uses and identifies other pesticides already 
registered on that crop that target the same pest or pest spectrum. The 
PCTn is calculated based on the data from the three most recently 
available pesticide usage surveys. If multiple chemicals are identified 
that target the same pest spectrum, then the one with the 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 metiram may be applied in a particular area.
    2. Dietary exposure from drinking water--i. Metiram. The Agency has 
determined that metiram 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 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 non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    i. Metiram. Metiram is not registered for any specific use patterns 
that would result in residential exposure.
    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 ETU.
    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 post application 
garden exposures (dermal) plus average daily food and drinking water 
exposure for adults and post application garden exposures (dermal) plus 
average daily food and drinking water exposure for youth. The 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. The 
third 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 (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 metiram, and ETU 
derived from metiram and the other EBDC chemicals, which are all 
dithiocarbamates. For the purposes of this action, EPA has concluded 
that metiram 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

[[Page 23888]]

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 (CS2)). 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 CS2 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 Food Quality 
Protection Act Safety Factor (FQPA 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. Metiram. Developmental 
toxicity was observed in the rat (increased incidence of post-
implantation loss, decreased litter size, and decreased litter weight) 
at a dose level where minimal maternal toxicity (decreased BW gains) 
was observed. However, there is low concern for the qualitative 
susceptibility observed in the rat study since the dose response was 
well characterized; there was a clear NOAEL/LOAEL for maternal and 
developmental toxicity; and the doses selected for risk assessment were 
based on neurotoxicity and address concerns for developmental toxicity 
and thyroid toxicity, which occurred at higher doses. In a rabbit 
developmental study, in which the maternal animals were adequately 
assessed, maternal toxicity observed included abortions and decreased 
BW gains. No qualitative or quantitative sensitivity was identified in 
the young in this study for the developmental effects assessed. 
Although many developmental effects were assessed, a new study was 
required because the study did not assess soft tissue and internal 
structures of the head. In a recently submitted developmental rabbit 
study with ETU, developmental effects in the brain were not observed at 
dose levels below those currently used for quantifying metiram risks, 
reducing concerns for these effects (see further description of study 
in this unit).
    ii. ETU. There was evidence of increased susceptibility of fetuses 
to ETU in the rat developmental studies because hydrocephaly occurred 
at doses below those causing maternal toxicity. Recently the Agency 
reviewed a new developmental study in rabbits. Effects seen in the pups 
(decreased BW, domed heads, and hydrocephaly) were observed in the 
presence of maternal toxicity. The incidence of domed heads and 
hydrocephaly is within the range of historical controls. In addition, 
these effects are observed at levels higher than the effects observed 
in the rat study. An acceptable reproductive 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--i. Metiram. Although there are no residual 
uncertainties for pre- and/or postnatal toxicity, the FQPA SF of 10X 
was retained due to database uncertainties for metiram. There are data 
gaps for a developmental neurotoxicity study (DNT), a developmental 
toxicity study in the rabbit and a 2-generation reproduction study in 
the rat. EPA determined that the FQPA SF must be retained to account 
for the lack of these studies, since the available data do not provide 
a basis to support reduction or removal of the factor.
    No additional FQPA SF is needed beyond the 10X database uncertainty 
factor that was applied to account for the data gaps for a 
developmental neurotoxicity study, a developmental toxicity study in 
the rabbit, and a 2-generation reproduction study in the rat with 
metiram. The reasons for this conclusion are:
    a. There are data gaps for studies that are critical for assessing 
effects on infants and children, but the Agency does have developmental 
toxicity (rat and rabbit) and reproduction data on metiram that 
provides some characterization of developmental and reproductive 
hazard. Although there was incomplete assessment of the fetal rabbit 
and there was incomplete measurement of some reproductive parameters in 
the reproduction study, the submitted studies provide a partial 
assessment of the effects of concern and sufficient information on 
pertinent toxic effects for EPA to conclude that a 10x database 
uncertainty factor is adequately protective.
    b. Pre- and/or postnatal susceptibility has been adequately 
characterized in one species (rat).
    c. The exposure assessment, although refined, is unlikely to 
underestimate potential exposures.
    d. Although there is a data gap for a developmental neurotoxicity 
study, since the available metiram database includes NOAELs for 
neurotoxicity and neuropathology (decreased grip strength at lower 
doses, demyelination at high doses) in adult animals upon which risk 
assessments are based, this information helps to characterize the dose 
range at which effects can be expected in the developmental 
neurotoxicity study and thus informs dose selection for that study. 
Selected doses would be in the range of the dose levels from the prior 
studies at the NOAEL and LOAEL levels (0.4 and 6.7 mg/kg/day, 
respectively). Significant toxic effects occurring at doses more than 
10-fold below these levels are unlikely.
    ii. ETU. The toxicity database for ETU is not complete. EPA lacks 
the following studies: A DNT study, a 2-generation reproduction study, 
and a comparative thyroid study in adults and offspring. The Agency has 
recently received and evaluated a developmental toxicity study in 
rabbits. Given the remaining data gaps are for studies that directly 
assess the risk to the young, EPA does not have reliable data to remove 
or modify the presumptive 10X FQPA SF.
    No additional safety factor beyond 10X is needed to account for the 
missing toxicity data for ETU for the following reasons:
    a. The teratogenic effects of ETU have been well characterized in 
numerous studies in the published literature, as well as in a guideline 
study submitted by the registrant. In addition, since metabolism 
studies have shown that approximately 7.5% of the EBDCs (mancozeb, 
maneb, and metiram,) convert to ETU in mammalian systems, the extensive 
toxicity database on the EBDCs on developmental effects provide 
information about the pre- and postnatal toxicity of ETU as well as the 
parent compound;
    b. There are clear NOAELs for developmental effects seen in the ETU 
developmental studies, and the dose-

[[Page 23889]]

response relationships, although steep, are well characterized.
    c. The developmental endpoint with the lowest NOAEL was selected 
for deriving the acute PAD (aPAD).
    d. Thyroid toxicity was selected for deriving the chronic PAD 
(cPAD) as well as endpoints for non-dietary exposures (incidental oral, 
dermal, and inhalation). Since the available ETU database includes 
NOAELs for thyroid toxicity in adult animals upon which risk 
assessments are based, this information helps to characterize the dose 
range at which effects can be expected in the developmental 
neurotoxicity study and thus would inform dose selection for the 
comparative thyroid study; selected doses would be in the range of 
these dose levels (NOAEL of 0.2 mg/kg/day and LOAEL of 2 mg/kg/day). 
Significant toxic effects occurring at doses more than 10-fold below 
these levels are unlikely.
    e. Information on ETU gleaned from the extensive EBDC database on 
effects other than development effects also reduces, to a degree, the 
uncertainty arising from the significant data gaps for ETU.
    f. EPA has concluded that the exposure assessment, although 
refined, is unlikely to underestimate 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 
document:
     A 2007 risk assessment for mancozeb for acute, short-term, 
intermediate-term, chronic, and cancer risk.
     A 2007 risk assessment for ETU for acute, short-term, 
intermediate-term, and chronic risk.
     A 2010 addendum to the 2007 ETU assessment for cancer 
risk--and that the PCT estimates differ slightly between reviews.

In comparing the PCT 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 PCT estimated. The PCT 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 ID number EPA-HQ-OPP-2005-0308.
    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 
aPAD and 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--i. Metiram. The metiram acute aggregate assessment 
considers acute exposure to metiram only and not ETU. Further, this 
assessment is based on residues of metiram in food only since residues 
of metiram are not expected in drinking water. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
dietary exposure from food to metiram will occupy 22% of the aPAD for 
females 13-49 years of age, the only population group of concern.
    ii. 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.
    2. Chronic risk--i. Metiram. There are no long-term residential 
exposure scenarios for metiram and there is not likely to be residues 
of metiram in drinking water. Therefore, the long-term or chronic (non-
cancer) aggregate risk for metiram includes contribution from food 
alone. Using the exposure assumptions described in this unit for 
chronic exposure, EPA has concluded that chronic exposure to metiram 
from food will utilize 70% of the cPAD for children 1-2 years of age, 
the population group receiving the greatest exposure.
    ii. ETU. The aggregate chronic risks were calculated using food and 
water exposure only because golfing and toddler transplanted turf 
exposure scenarios were considered to occur only on a short term basis. 
Using the exposure assumptions described in this unit for chronic 
exposure, EPA has concluded that chronic exposure to ETU from food and 
water will utilize 50% of the cPAD for children (1 to 2 years old), the 
population group receiving the greatest exposure.
    3. Short- and Intermediate-term risk--i. Metiram. 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).
    A short- and/or intermediate-term adverse effect was identified; 
however, metiram is not registered for any use patterns that would 
result in short- and/or intermediate-term residential exposure. Short- 
and intermediate-term risk is assessed based on short- and/or 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or 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 short-term risk), no further assessment of short- 
and/or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short- and intermediate-
term risk for metiram.
    ii. 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).
    Although there are no residential uses for metiram, the previous 
ETU aggregate assessment included residential exposures to other EBDCs. 
Mancozeb is currently registered for uses that could result in short- 
and intermediate-term residential exposure to ETU. The 2007 ETU 
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

[[Page 23890]]

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:
    a. ETU Short/Intermediate-Term Home Garden Aggregate. The ETU 
short/intermediate-term home garden aggregate MOEs are 13,000 and 
17,000 for adults and youth, respectively. For ETU EPA is concerned 
only with MOEs that are below 1,000, these MOEs do not raise a risk 
concern.
    b. ETU Short-Term Treated Turf Aggregate (Toddlers). The ETU short-
term treated turf aggregate MOE for toddlers is 1,100. For ETU EPA is 
concerned only with MOEs that are below 1,000; therefore, this MOE does 
not raise a risk concern.
    c. ETU Short/Intermediate-Term Treated Turf Aggregate. The ETU 
short-term treated turf aggregate MOE for golfers is 6,100. For ETU EPA 
is concerned only with MOEs that are below 1,000; therefore, this MOE 
does not raise a risk concern.
    4. Aggregate cancer risk for U.S. population--Metiram and ETU. As 
noted earlier in this document, EPA has historically attributed 
metiram's potential for 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 
exposures for the general population and the food, water and 
recreational exposures for golfers, home gardeners and athletes. The 
average daily dose was used for food and water exposures and the 
lifetime average daily dose was used for the recreational exposures. 
The aggregate doses were multiplied times the potency factor for ETU, 
0.0601 (mg/kg/day)-1 to determine the cancer risks. The risk 
is estimated to be 3 x 10-6.
    EPA generally considers cancer risks (expressed as the probability 
of an increased cancer case) in the range of 1 in 1 million (or 1 x 
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 x 10-7 and 3 x 
10-6 are expressed as risks in the range of 10-6. 
Considering the precision with which cancer hazard can be estimated, 
the conservativeness of low-dose linear extrapolation, and the rounding 
procedure described in this unit, cancer risk should generally not be 
assumed to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. This is particularly the case where some conservatism 
is maintained in the exposure assessment. Although the ETU exposure 
risk assessment is refined, it retains significant conservatism in 
that, for leafy greens, field trial data and not monitoring 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 PCT 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 10-6 and are thus negligible.
    5. 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 metiram and/or ETU residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The available analytical methodology is considered adequate for 
tolerance enforcement. The Pesticide Analytical Manual (PAM) Vol. II 
lists Methods I, II, III, IV, and A for the determination of 
dithiocarbamate residues in or on plant commodities. The Keppel 
Colorimetric Method (PAM Method III) is the preferred method for 
tolerance enforcement. The Keppel Colorimetric Method determines EBDCs 
as a group by degradation to CS2. For determination of ETU 
residues, the Agency recommends the gas chromatography (GC) Method of 
Onley (Association of Analytical Communities (AOAC) 14th Edition 
29.119:554).
    The methods 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: 
[email protected].

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 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 are no established or proposed CODEX MRLs for residues of 
metiram per se; however, CODEX limits for dimethyldithiocarbamates 
fungicides are grouped under dithiocarbamates. There are CODEX MRLs for 
banana and grapes.
    Tolerances for the EBDC pesticides are expressed in terms of 
CS2, which is the same as the CODEX tolerance expression. 
The level of 5 ppm for wine grapes is the same as the CODEX MRL, 
although the CODEX MRL is for simply ``grapes.'' The recommended 
tolerance for banana (3 ppm) cannot be harmonized with CODEX because 
residues in field trials exceeded the CODEX MRL of 2 ppm.

C. Response to Comments

    As discussed in Unit II., EPA proposed tolerance actions for 
metiram in the Federal Register issue of September 16, 2009. EPA did 
receive comments on the proposed rule; however, none of these comments 
are related to the uses in this action.

D. Revisions to Petitioned-For Tolerances

    EPA has revised the tolerance expression to clarify that:
    1. As provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of metiram not specifically mentioned.
    2. Compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression. The change in the tolerance expression has 
resulted in the existing tolerances for apple and potato needing to be 
modified. These tolerances are being modified by this document. In 
addition, as a follow-up to recommendations made in the Metiram RED 
document, a tolerance is being added for apple, pomace, wet at 2 ppm. 
All of these revisions were proposed in the Federal Register issue of 
September 16, 2009.

[[Page 23891]]

V. Conclusion

    Therefore, tolerances are established for residues of metiram (a 
mixture of 5.2 parts by weight of ammoniates of [ethylenebis 
(dithiocarbamato)] zinc with 1 part by weight ethylenebis 
[dithiocarbamic acid] bimolecular and trimolecular cyclic 
anhydrosulfides and disulfides), including its metabolites and 
degradates, in or on banana at 3 ppm and grape, wine at 5 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).
    Pursuant to the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this 
action will not have significant negative economic impact on a 
substantial number of small entities. Establishing a pesticide 
tolerance or an exemption from the requirement of a pesticide tolerance 
is, in effect, the removal of a regulatory restriction on pesticide 
residues in food and thus such an action will not have any negative 
economic impact on any entities, including small entities.
    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) (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: April 20, 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 180.217 is amended by revising the section heading and 
paragraph (a) to read as follows:


Sec.  180.217  Metiram; tolerances for residues.

    (a) General. Tolerances are established for residues of a metiram 
(a mixture of 5.2 parts by weight of ammoniates of [ethylenebis 
(dithiocarbamato)] zinc with 1 part by weight ethylenebis 
[dithiocarbamic acid] bimolecular and trimolecular cyclic 
anhydrosulfides and disulfides), including its metabolites and 
degradates, in or on the commodities in the following table. Compliance 
with the tolerance levels specified in this paragraph is to be 
determined by measuring only those metiram residues convertible to and 
expressed in terms of the degradate carbon disulfide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple........................................................        0.5
Apple, pomace, wet...........................................          2
Banana \1\...................................................          3
Grape, wine \1\..............................................          5
Potato.......................................................        0.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations on bananas and grape, wine as of
  April 29, 2011.

* * * * *
[FR Doc. 2011-10333 Filed 4-28-11; 8:45 am]
BILLING CODE 6560-50-P