Document ID: EPA-HQ-OPP-2007-0514-0005
Agency: epa
Document Type: Rule
Title: Metconazole; Pesticide Tolerances
Posted Date: 2009-05-07T04:00Z

[Federal Register: May 7, 2009 (Volume 74, Number 87)]
[Rules and Regulations]               
[Page 21260-21267]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my09-9]                         

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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: keigwin.tracy@epa.gov. 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: pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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: residuemethods@epa.gov.

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