[Federal Register Volume 74, Number 87 (Thursday, May 7, 2009)]
[Rules and Regulations]
[Pages 21260-21267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10500]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0514; FRL-8408-6]
Metconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the residues of
metconazole, including its metabolites and degradates, in or on corn,
field, forage; corn, field, grain; corn, field, stover; corn, pop,
grain; corn, pop, stover; corn, sweet, forage; corn, sweet, kernel plus
cob with husks removed; corn, sweet, stover; cotton, undelinted seed;
and cotton, gin byproducts. BASF Corporation requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation
also establishes tolerances for residues of metconazole, including its
metabolites and degradates, in or on canola seed, and eggs. Valent
U.S.A. Corporation requested the tolerance for canola seed under the
FFDCA. EPA required an additional tolerance for eggs based on findings
in the studies submitted by the registrant.
In addition, this action establishes time-limited tolerances for
the residues of metconazole, including its metabolites and degradates,
in or on sugarcane, cane at 1.6 ppm and sugarcane, molasses at 3.2 ppm,
in response to the approval of crisis exemptions declared by the states
of Florida and Louisiana under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing the quarantine use
of the fungicide on sugarcane to control the fungal pathogen, Puccinia
kuehnii. This regulation establishes a maximum permissible level of
residues in this food commodity. The time-limited tolerances expire and
are revoked on December 31, 2011.
DATES: This regulation is effective May 7, 2009. Objections and
requests for hearings must be received on or before July 6, 2009, 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 these actions under docket
identification (ID) number EPA-HQ-OPP-2007-0514 (for BASF Corporation
requested tolerances) and EPA-HQ-OPP-2008-0718 (for Valent U.S.A.
Corporation requested tolerances). 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: For further information regarding the
tolerances requested by BASF Corporation or Valent U.S.A. Corporation,
please contact Tracy Keigwin, Registration Division (7505P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6605;
e-mail address: [email protected]. For further information
regarding the time-limited tolerance for the use of metconazole on
sugarcane, please contact Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs,
[[Page 21261]]
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-9364; 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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR site
at http://www.gpoaccess.gov/ecfr.
To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2007-0514 (for BASF Corporation requested
tolerances) and EPA-HQ-OPP-2008-0718 (for Valent U.S.A. Corporation
requested tolerances) in the subject line on the first page of your
submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before July 6, 2009.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0514 (for BASF Corporation requested tolerances) and
EPA-HQ-OPP-2008-0718 (for Valent U.S.A. Corporation requested
tolerances), 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. Petition for Tolerance
In the Federal Register of November 5, 2008 (73 FR 65849) (FRL-
8385-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7221) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR
180.617 be amended by establishing tolerances for residues of the
fungicide metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-
1,2,4-triazol-1-ylmethyl)cyclopentanol), measured as the sum of cis-
and trans- isomers in or on the food commodities corn, field, aspirated
grain fractions at 0.05 parts per million (ppm); corn, field, forage at
3.5 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 4.5
ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 4.5 ppm; corn,
sweet, forage at 3.5 ppm; corn, sweet, kernel plus cob with husks
removed at 0.01 ppm; corn, sweet, stover at 4.5 ppm; cotton, undelinted
seed at 0.25 ppm; and cotton, gin byproducts at 8.0 ppm. That notice
referenced a summary of the petition prepared by BASF Corporation, the
registrant, which is available to the public in the docket, http://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Additionally, in the Federal Register of November 5, 2008 (73 FR
65849), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7292) by Valent U.S.A. Company, 1600 Riviera Ave., Suite 200, Walnut
Creek, CA 94596-8025. The petition requested that 40 CFR 180.617 be
amended by establishing a tolerance for residues of the fungicide
metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, measured as the sum of cis- and
trans-isomers in or on the food commodity canola seed at 0.04 ppm. That
notice referenced a summary of the petition prepared by Valent U.S.A.
Corporation, the registrant, which is available to the public in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
Based upon review of the data supporting the petition, EPA has
modified the proposed tolerance levels as follows: Corn, field, forage
and corn, sweet, forage decreased to 3.0 ppm. Additionally, no specific
tolerance for corn, field, aspirated grain fractions is needed since
residues from this commodity are covered under the 7.0 ppm tolerance
for ``grain, aspirated grain fractions'' already established under
Sec. 180.617. Finally, a tolerance is required for metconazole
residues in egg at 0.04 ppm. EPA has also modified the tolerance
expression to clarify the scope of the tolerance and how compliance
with the tolerance levels is to be determined.
The reason for these changes is explained in Unit IV.D.
At this time, EPA is also establishing time-limited tolerances for
the residues of metconazole, including its
[[Page 21262]]
metabolites and degradates, in or on sugarcane, cane at 1.6 ppm and
sugarcane, molasses at 3.2 ppm. These tolerances expire and are revoked
on December 31, 2011. The Agency is establishing these time-limited
tolerances in response to a crisis exemption request under FIFRA
section 18 on behalf of the Florida Department of Agriculture &
Consumer Services and the Louisiana Department of Agriculture &
Forestry for emergency use of metconazole as a quarantine use on
sugarcane to control fungal growth of Puccinia kuehnii.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of metconazole
in or on sugarcane, cane and sugarcane, molasses. In doing so, EPA
considered the safety standard in section 408(b)(2) of FFDCA, and EPA
decided that the necessary tolerances under section 408(l)(6) of FFDCA
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in
section 408(l)(6) of FFDCA. Although these time-limited tolerances
expire and are revoked on December 31, 2011, under section 408(l)(5) of
FFDCA, residues of the pesticide not in excess of the amounts specified
in the tolerances remaining in or on sugarcane, cane and sugarcane,
molasses after that date will not be unlawful, provided the pesticide
was applied in a manner that was lawful under FIFRA, and the residues
do not exceed a level that was authorized by these time-limited
tolerances at the time of that application. EPA will take action to
revoke these time-limited tolerances earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
metconazole meets FIFRA's registration requirements for use in or on
sugarcane, cane and sugarcane, molasses or whether permanent tolerances
for this use would be appropriate. Under these circumstances, EPA does
not believe that these time-limited tolerances serve as a basis for
registration of metconazole by a State for Special Local Needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for
persons in any State other than Florida and Louisiana to use this
pesticide on these crops under FIFRA section 18 absent the issuance of
an emergency exemption applicable within that State. For additional
information regarding the emergency exemption for metconazole, contact
the Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.
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 the residues of metconazole,
including its metabolites and degradates, in or on corn, field, forage;
corn, field, grain; corn, field, stover; corn, pop, grain; corn, pop,
stover; corn, sweet, forage; corn, sweet, kernel plus cob with husks
removed; corn, sweet, stover; cotton, undelinted seed; cotton, gin
byproducts; canola seed, and eggs. Additionally, EPA has sufficient
data to assess the hazards of and to make a determination on aggregate
exposure expected as a result of the additional emergency exemption
request and the time-limited tolerances for the residues of metconazole
including its metabolites and degradates, in or on sugarcane, cane at
1.6 ppm and sugarcane, molasses at 3.2 ppm. EPA's assessment of
exposures and risks associated with establishing the permanent and
time-limited tolerances 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.
Acute oral and dermal toxicities to metconazole are moderate, while
acute inhalation toxicity is low. Metconazole is a moderate eye
irritant and a mild skin irritant. It is not a skin sensitizer. The
liver is the primary target organ in the mouse, rat and dog following
oral exposure to metconazole via subchronic or chronic exposure
durations. Developmental studies in rats and rabbits show some evidence
of developmental effects, but only at dose levels that are maternally
toxic. Metconazole did not demonstrate the potential for neurotoxicity
in the four species (mouse, rat, dog and rabbit) tested. Metconazole is
considered nongenotoxic and liver tumors seen in a chronic mouse study
appear to have been formed via a mitogenic mode of action and
therefore, metconazole is classified as ``not likely to be carcinogenic
to humans'' at levels that do not cause mitogenesis.
Specific information on the studies received and the nature of the
adverse effects caused by metconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov under docket ID number EPA-HQ-OPP-2006-0855.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the
[[Page 21263]]
human population as well as other unknowns. Safety is assessed for
acute and chronic dietary risks by comparing aggregate food and water
exposure to the pesticide to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). The aPAD and cPAD are
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
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
greater than that 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 metconazole used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of April 28, 2008 (73 FR 22823) (FRL-
8360-5).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to metconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing metconazole tolerances in 40 CFR
180.617. EPA assessed dietary exposures from metconazole and its
metabolites, 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.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). An acute dietary (food and drinking water)
analysis for metconazole was conducted using tolerance level residues
(for parent compound) and 100 percent crop treated (%CT) for all
existing and proposed uses. For commodities that include metabolites as
residues of concern in the risk assessment (i.e., cereal grains and
livestock commodities), maximum residue values for the metabolites from
field trials were added to the metconazole tolerance levels. Default
concentration factors were used for processed commodities that do not
have tolerances.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the same assumptions as stated in Unit C.1.i. for
acute exposure.
iii. Cancer. Metconazole is classified as ``not likely to be
carcinogenic to humans'' at levels that do not cause mitogenesis. The
cPAD would be protective of mitogenesis/carcinogenesis and the chronic
exposure assessment is appropriate for evaluating cancer risk.
iv. Anticipated residue 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.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for metconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of metconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
metconazole for acute exposures are estimated to be 45 parts per
billion (ppb) for surface water and 0.38 ppb for ground water. The EECs
for chronic exposures for non-cancer assessments are estimated to be 31
ppb for surface water and 0.38 ppb for ground water. The EECs for
chronic exposures for cancer assessments are estimated to be 22 ppb for
surface water and 0.38 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 45 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 31 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).
Metconazole is currently registered for the following residential
non-dietary sites: Turf and ornamentals. Adult residential handlers may
be exposed to metconazole as a result of applying metconazole to turf
and ornamentals. Because dermal toxicity endpoints for the appropriate
duration of exposure were not identified, only residential handler
inhalation short-term exposures were assessed. Additionally, adults and
adolescents may experience short-term and intermediate-term dermal
post-application exposure from golfing and other activities on treated
turf. Toddlers may experience short-term and intermediate-term dermal
and incidental oral exposure from activities on treated turf. However,
because dermal toxicity endpoints for the appropriate durations of
exposure were not identified, and because inhalation exposure is
considered to be insignificant for post-application exposures, only
toddler incidental oral post-application exposures were assessed.
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.''
Metconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
[[Page 21264]]
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative.
Triazole-derived pesticides can form the common metabolite, 1,2,4-
triazole and three triazole conjugates (triazole alanine, triazole
acetic acid, and triazolylpyruvic acid). To support existing tolerances
and to establish new tolerances for triazole-derivative pesticides,
including metconazole, EPA conducted a human health risk assessment for
exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid
resulting from the use of all current and pending uses of any triazole-
derived fungicide as of September 1, 2005. The risk assessment is a
highly conservative, screening-level evaluation in terms of hazards
associated with common metabolites (e.g., use of a maximum combination
of uncertainty factors) and potential dietary and non-dietary exposures
(i.e., high end estimates of both dietary and non-dietary exposures).
In addition, the Agency retained the additional 10X FQPA safety factor
(SF) for the protection of infants and children. The assessment
included evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's September 1, 2005 risk
assessment can be found in the propiconazole reregistration docket at
http://www.regulations.gov, Docket Identification Number EPA-HQ-OPP-
2005-0497. In October and December of 2008, EPA updated the dietary and
aggregate risk assessments for exposure to 1,2,4-triazole, triazole
alanine, triazole acetic acid, and triazolylpyruvic acid resulting from
the use of all current and pending uses of any triazole-derived
fungicide to support existing tolerances and to establish new
tolerances for new uses of metconazole (canola, corn, cotton, and
sugarcane; PPs 7F7221, 7F7292, 08FL03), propiconazole (beets,
parsley, and pineapple; PP 7F7300), prothioconazole (wheat and
barley; PP 7F7279), and tetraconazole (grapes; PP
7E7273). These updated dietary and aggregate assessments are below the
Agency's LOC. These updated triazole risk assessments can be found in
the dockets associated with this Rule at http://www.regulations.gov
(Docket IDs EPA-HQ-OPP-2007-0514 and EPA-HQ-OPP-2008-0718).
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. Acceptable developmental
toxicity studies are available in the rat and rabbit as well as a 2-
generation reproductive toxicity study in the rat. There is no evidence
of susceptibility following in utero exposure in the rabbit. In the rat
there is qualitative evidence of susceptibility, however the concern is
low since the developmental effects are characterized as variations
(not malformations), occur in the presence of maternal toxicity, the
NOAELs are well defined, and the dose/endpoint is used for acute
dietary risk assessment for the sensitive population. There is no
evidence of increased susceptibility in the offspring based on the
result of the 2-generation reproduction study.
3. Immunotoxicity. An immunotoxicity study is one of the new 40 CFR
Part 158 toxicological data requirements. The Agency has evaluated the
available metconazole toxicity database and has determined there is no
evidence of immunotoxicity. Splenic effects were observed in the
subchronic and chronic rat (19.2 and 56.2 milligrams/kilogram/day (mg/
kg/day), respectively), subchronic and cancer mouse (50.5 and 56.2 mg/
kg/day, respectively) and subchronic and chronic dog (22.5 and 114 mg/
kg/day, respectively). However, the observed splenic effects including
increased spleen weight and spleen congestion are likely a secondary
effect of increased erythropoiesis due to a reduction in erythroctyes.
The Agency does not believe that conducting an immunotoxicity study
(OPPTS 870.7800) will result in a NOAEL lower than 4.3 mg/kg/day, which
is presently used as the chronic Reference dose (cRfD) point of
departure. An additional uncertainty factor for database uncertainties
(UFDB) does not need to be applied.
4. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for metconazole is complete except for
immunotoxicity testing. EPA began requiring functional immunotoxicity
testing of all food and non-food use pesticides on December 26, 2007.
Since this requirement went into effect after the tolerance petition
was submitted, these studies are not yet available for metconazole. The
Agency has evaluated the available metconazole toxicity database and
has determined there is no evidence of immunotoxicity. Due to the lack
of evidence of immunotoxicity for metconazole, EPA does not believe
that conducting immunotoxicity testing will result in a NOAEL less than
the NOAEL of 4.3 mg/kg/day, which is already established as the cRfD
point of departure for metconazole. An additional factor
(UFDB) for database uncertainties is not needed to account
for potential immunotoxicity.
ii. There was no evidence of neurotoxicity observed in the
toxicology database and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
neurotoxicity.
iii. There is no evidence of susceptibility following in utero
exposure in the rabbit or in young rats in the 2-generation
reproduction study. In the rat there is qualitative evidence of
susceptibility, however the concern is low since the developmental
effects are characterized as variations (not malformations), occur in
the presence of maternal toxicity, the NOAELs are well defined, and the
dose/endpoint is used for acute dietary risk assessment for the
sensitive population.
iv. There are no residual uncertainties identified in the exposure
databases. Dietary exposure assessments were conducted using tolerance
level residues and assumed 100% crop treated for all crops. Therefore,
the acute and chronic dietary, food only, exposure
[[Page 21265]]
is considered an upper bound conservative estimate. Acute and chronic
exposure estimates in this analysis are unlikely to underestimate
actual exposure. The drinking water component of the dietary assessment
utilizes water concentration values generated by model and associated
modeling parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded. While there is potential for post application
residential exposure, the Agency used the current conservative
approaches for residential assessment. The Agency believes that the
calculated risks represent conservative estimates of exposure because
maximum application rates are used to define residue levels upon which
the calculations are based.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to the residues of metconazole, including its metabolites and
degradates, will occupy 3.7% of the aPAD for the population group
(females 13-49 years old) receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to the
residues of metconazole, including its metabolites and degradates, from
food and water will utilize 5.6% of the cPAD for the U.S. population
and 12% of the cPAD for the most highly exposed population group
(children 1-2 years old).
3. Short-term risk. Short-term risk takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Metconazole is currently registered for
uses that could result in short-term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic food,
water, and short-term exposures for the residues of metconazole,
including its metabolites and degradates.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that short-term aggregate MOE from
dietary exposure (food + drinking water) and non-occupational/
residential handler exposure (inhalation) for adults is 1,900. The
short-term aggregate MOE from dietary exposure (food + drinking water)
and non-occupational/residential exposure (incidental oral) for
children 1-2 years old is 430. These MOEs are not of concern to the
Agency since they are greater than the LOC of 100.
4. Intermediate-term risk. Intermediate-term risk takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Metconazole is
currently registered for uses that could result in intermediate-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food, water, and intermediate-term
exposures for the residues of metconazole, including its metabolites
and degradates.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that intermediate-term
aggregate MOEs from dietary exposure (food + drinking water) and non-
occupational/residential handler exposure (inhalation) for adults is
1,400. The intermediate-term aggregate MOE from dietary exposure (food
+ drinking water) and non-occupational/residential exposure (incidental
oral) for children 1-2 years old is 480. These MOEs are not of concern
to the Agency since they are greater than the LOC of 100.
5. Aggregate cancer risk for U.S. population. Metconazole is
classified as ``not likely to be carcinogenic to humans'' at levels
that do not cause mitogenesis. As explained above, the cPAD is
protective of mitogenesis and because the chronic risk assessment for
metconazole shows exposure to be below the cPAD, there is no cancer
concern.
6. 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 metconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) and liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS) Method) is available to
enforce the tolerance expression. 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
There are currently no Codex, Canadian, or Mexican MRLs established
for metconazole.
C. Response to Comments
EPA received a total of three comments with regard to either EPA-
HQ-OPP-2007-0514 or EPA-HQ-OPP-2008-0718. One of the comments appeared
to have been filed in error as it discussed the security requirements
for aircraft exceeding 12,500 lbs. The remaining two comments expressed
concern regarding the potential for residues of metconazole to remain
in the human body and the potential for adverse effects from pesticide
application. EPA responds that before a chemical is registered for a
particular use pattern a registrant is required to submit extensive
data regarding the nature of the chemical and the potential for adverse
effects on either the human or ecological population. This data is
evaluated using the most conservative and stringent methods of safety,
including the addition of extra SFs established for the protection of
infants and children in order to ensure the well-being of the general
U.S. population and various population subgroups.
D. Revisions to Petitioned-For Tolerances
Based upon review of the data supporting the petition for tolerance
for corn commodities, EPA has modified the proposed tolerance levels
for corn commodites as follows: Corn, field, forage decreased from 3.5
ppm to 3.0 ppm and corn, sweet, forage decreased from 3.5 ppm to 3.0
ppm. EPA revised these tolerance levels based on analysis of the
residue field trial data using the Agency's Tolerance Spreadsheet in
accordance with the Agency's Guidance for Setting Pesticide Tolerances
Based on Field Trial Data Standard Operating Procedure (SOP).
Additionally, no specific tolerance for corn, field, aspirated grain
fractions is required
[[Page 21266]]
since residues from this commodity are covered under the established
7.0 ppm tolerance for ``grain, aspirated grain fractions.'' EPA is
establishing a tolerance for metconazole residues in egg at 0.04 ppm
because quantifiable residues of cis-metconazole were found in eggs in
the animal feed study involving hens. Finally, EPA is modifying the
tolerance expression for metconazole, as it applies to the newly-
established tolerances, to clarify the scope of the tolerance and how
compliance with the tolerance levels is to be determined. The revised
tolerance expression makes clear that the tolerance covers metconazole,
including all of its metabolites and degradates, although compliance
with the residue levels specified in the tolerance is to be determined
by measuring only metconazole (5-[4(-chlorophenyl)-methyl]-2, 2-
dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol) as the sum of
its cis- and trans-isomers. The new tolerances will be included in a
new paragraph with the revised tolerance expression. This revised
expression is meant to capture more precisely EPA's intent with regard
to the tolerance expression for the exisiting tolerances. EPA plans to
update the tolerance expression for the existing tolerances in its next
metconazole tolerance action.
V. Conclusion
Therefore, tolerances are established for the residues of
metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, including its metabolites and
degradates, in or on canola seed at 0.04 ppm; corn, field, forage at
3.0 ppm; corn, field, grain at 0.02 ppm; corn, field, stover at 4.5
ppm; corn, pop, grain at 0.02 ppm; corn, pop, stover at 4.5 ppm; corn,
sweet, forage at 3.0 ppm; corn, sweet, kernel plus cob with husks
removed at 0.01 ppm; corn, sweet, stover at 4.5 ppm; cotton, undelinted
seed at 0.25 ppm; cotton, gin byproducts at 8.0 ppm; egg at 0.04 ppm;
and time-limited tolerances for sugarcane, cane at 1.6 ppm and
sugarcane, molasses at 3.2 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this rule. In addition, This
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
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 24, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
0
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. 617 is amended by:
i. Redesignating paragraph (a) as paragraph (a)(1);
ii. Adding paragraph (a)(2); and
iii. Revising paragraph (b) to read as follows:
Sec. 180.617 Metconazole; tolerances for residues.
(a) General. (1) * * *.
(2). Tolerances are established for the residues of the fungicide
metconazole, including its metabolites and degradates, in or on
commodities in the following table. Compliance with the tolerance
levels specified in the table is to be determined by measuring only
metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol) as the sum of its cis- and trans-
isomers in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Canola seed.......................................... 0.04
Corn, field, forage.................................. 3.0
Corn, field, grain................................... 0.02
Corn, field, stover.................................. 4.5
Corn, pop, grain..................................... 0.02
Corn, pop, stover.................................... 4.5
[[Page 21267]]
Corn, sweet, forage.................................. 3.0
Corn, sweet, kernel plus cob with husks removed...... 0.01
Corn, sweet, stover.................................. 4.5
Cotton, undelinted seed.............................. 0.25
Cotton, gin byproducts............................... 8.0
Egg.................................................. 0.04
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of the fungicide metconazole, including
its metabolites and degradates, in or on the commodities listed in the
following table in connection with the use of the pesticide under
section 18 emergency exemptions granted by EPA. The tolerances expire
and are revoked on the dates specified in the following table.
Compliance with the tolerance levels specified below is to be
determined by measuring only metconazole (5-[(4-chlorophenyl)-methyl]-
2,2-dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol) as the sum
of its cis- and trans-isomers in or on the following commodities:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Sugarcane, cane................... 1.6 12/31/11
Sugarcane, molasses............... 3.2 12/31/11
------------------------------------------------------------------------
* * * * *
[FR Doc. E9-10500 Filed 5-6-09; 8:45 am]
BILLING CODE 6560-50-S