[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.
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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
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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