Document ID: EPA-HQ-OPP-2006-0855-0003
Agency: epa
Document Type: Rule
Title: Metconazole; Pesticide Tolerances
Posted Date: 2008-04-28T04:00Z

[Federal Register: April 28, 2008 (Volume 73, Number 82)]
[Rules and Regulations]               
[Page 22823-22828]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap08-11]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0855; FRL-8360-5]

 
Metconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
metconazole in or on wheat, barley, rye, oat, sugar beet, and soybeans. 
BASF Corporation requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). This regulation also establishes 
tolerances for residues of metconazole in or on stone fruit, tree nuts, 
and peanuts. Valent U.S.A. Corporation requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 28, 2008. Objections and 
requests for hearings must be received on or before June 27, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0855. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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: 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.

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 an electronic copy of this Federal 
Register document through the electronic docket 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 pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2006-0855 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 June 27, 2008.

[[Page 22824]]

    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-2006-0855, 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'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 February 13, 2008 (73 FR 8307) (FRL-
8351-5), 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 
6F7094) by BASF Corporation, 26 Davis Dr., 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 food commodities barley, grain at 2.0 parts per 
million (ppm); barley, hay at 7.0 ppm; barley straw at 7.0 ppm; beet, 
sugar, root at 0.1 ppm; beet, sugar, tops at 2.0 ppm; beet, sugar, 
pulp, dry at 1.9 ppm; beet, sugar, molasses at 0.2 ppm; beet, sugar, 
raw at 0.25 ppm; oat, grain at 1.0 ppm; oat, straw at 6.0 ppm; oat, hay 
at 17 ppm; rye, grain at 0.25 ppm; rye, straw at 14.0 ppm; soybean, 
forage at 3.0 ppm; soybean, hay at 6.0 ppm; soybean, seed at 0.10 ppm; 
soybean, aspirated grain fractions at 1.0 ppm; soybean, hulls at 0.2 
ppm; triticale at 0.25 ppm, wheat, grain at 0.15 ppm; wheat, hay at 
16.0 ppm; wheat, straw at 18.0 ppm; wheat, aspirated grain fractions at 
10.0 ppm; wheat, milled byproducts at 1.0 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. There were no comments received in response to the 
notice of filing.
    Additionally, in the Federal Register of February 13, 2008 (73 FR 
8307) (FRL-8351-5), 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 6F7095) 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 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 food commodities fruits, stone (crop group 12) 
at 0.2 ppm; nuts, tree (crop group 14) including pistachio at 0.02 ppm; 
almond hulls at 5.0 ppm; and peanut at 0.02 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. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the proposed tolerance levels as follows: Almond, hulls at 4.0 
ppm; barley, grain at 2.5 ppm; beet, sugar, dried pulp at 0.70 ppm; 
beet, sugar, molasses at 0.08 ppm; beet, sugar, roots at 0.07 ppm; 
grain, aspirated grain fractions at 7.0 ppm; nut, tree, group 14 at 
0.04 ppm; oat, grain at 1.0 ppm; peanut at 0.04 ppm; peanut, refined 
oil at 0.05 ppm; pistachio at 0.04 ppm; soybean, hulls at 0.08 ppm; 
soybean, seed at 0.05 ppm; wheat, milled byproducts at 0.20 ppm; and 
meat byproducts of cattle, goat, horse, and sheep at 0.04 ppm. 
Additionally, EPA is not establishing the tolerances requested for 
beet, sugar; sugar beet tops; and soybean meal. Finally, EPA has added 
tolerances for peanut, refined oil; for meat byproducts of cattle, 
goat, horse, and sheep. The reason for these changes is explained in 
Unit IV.D.

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 petitioned-for tolerances 
for residues of metconazole. EPA's assessment of exposures and risks 
associated with establishing the tolerance 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 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. The chronic

[[Page 22825]]

reference dose (RfD) would be protective of mitogenesis/carcinogenesis.
    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-2005-0016.

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 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 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 September 27, 2006 (71 FR 6383) 
(FRL-8085-2).

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 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). As to residue levels in food, EPA assumed all 
foods for which there are tolerances were treated and contain 
tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues.
    iii. Cancer. Metconazole is classified as ``not likely to be 
carcinogenic to humans'' at levels that do not cause mitogenesis. The 
chronic RfD would be protective of mitogenesis/carcinogenesis and the 
chronic exposure assessment is appropriate for evaluating cancer risk.
    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 45.48 parts per 
billion (ppb) for surface water and 0.384 ppb for ground water. The 
EECs for chronic exposures are estimated to be 31.25 ppb for surface 
water and 0.384 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 of value 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 
short-term inhalation 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

[[Page 22826]]

major biochemical events. In conazoles, however, a variable pattern of 
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 two triazole conjugates (triazole alanine and triazole 
acetic 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 for the 
protection of infants and children. The assessment includes 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 ID EPA-HQ-OPP-2005-0497). An addendum to 
the risk assessment, Dietary Exposure Assessments for the Common 
Triazole Metabolites 1,2,4-triazole, Triazolylalanine, Triazolylacetic 
Acid and Triazolylypyruvic Acid; Updated to Include New Uses of 
Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and Uniconazole 
can be found at http://www.regulations.gov in docket ID EPA-HQ-OPP-
2006-0855.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. 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. 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.
    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. Dietary exposure assessments were conducted using tolerance 
level residues and assumed 100% crop treated (CT). Therefore, the acute 
and chronic dietary, food only, exposure is considered an upper bound 
conservative estimate. Acute and chronic exposure estimates in this 
analysis are unlikely to underestimate actual exposure.
    v. 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.
    vi. 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 metconazole will occupy 3% 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 
metconazole from food and water will utilize 4% of the cPAD for the 
U.S. population and 9% of the cPAD for the most highly exposed 
population group (infants less than 1-year old).

[[Page 22827]]

    3. Short-term risk. Short-term risk takes into account residential 
exposure plus chronic exposure to food and water (considered to 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 
and water and short-term exposures for metconazole.
    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 and water and short-term 
exposures for metconazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that short-term aggregate MOEs from 
dietary exposure (food + drinking water) and non-occupational/
residential handler exposure (inhalation) for adults are 2,700; the 
children's residential combined short-term MOE from treated turf is 
810. The lowest MOE for residential handler short-term inhalation risks 
is 71,000. These MOEs are not of concern to the Agency, since they are 
greater than the level of concern MOE of 100.
    4. Intermediate-term risk. Intermediate-term risk takes into 
account residential exposure plus chronic exposure to food and water 
(considered to 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 and water and intermediate-term exposures for 
metconazole.
    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 are 
2,700; the children's residential combined short-term risk from treated 
turf are 1,000. These MOEs are not of concern to the Agency, since they 
are greater than the level of concern MOE 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 in Unit lll.E2, 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

    The following adequate enforcement methodologies are available to 
enforce the tolerance expression:
    1. A liquid chromatography/mass spectrometry method (LC/MS) (method 
D0508) along with multi-residue methods serving as a confirmatory 
method are adequate to enforce tolerances for residues in small grain, 
soybean, and sugarbeet agricultural and processed commodities.
    2. A gas chromatography/nitrogen-phosphorus detection method (GC/
NPD) (method RM-41C-1-1) is adequate to enforce tolerances for residues 
in stone fruit, tree nuts, and peanut commodities.
    3. A German multi-residue method (method DFG S19) is adequate for 
enforcing tolerances for residues in livestock commodities. 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

    There were no comments received in response to the notice of 
filing.

D. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerances should be revised as follows: 
Almond, hulls decreased from 5.00 ppm to 4.0 ppm; barley, grain 
increased from 2.0 ppm to 2.5 ppm; beet, sugar, dried pulp reduced from 
1.9 ppm to 0.70 ppm; beet, sugar, molasses reduced from 0.2 ppm to 0.08 
ppm; beet, sugar, roots reduced from 0.1 ppm to 0.07 ppm; nut, tree, 
group 14 increased from 0.02 to 0.04 ppm; oat, grain increased from 0.1 
ppm to 1.0 ppm; peanut increased from 0.02 ppm to 0.04 ppm; pistachio 
increased from 0.02 ppm to 0.04 ppm; soybean, hulls decreased from 0.2 
ppm to 0.08 ppm; soybean, seed reduced from 0.1 ppm to 0.05 ppm; and 
wheat, milled byproducts reduced from 1.0 ppm to 0.20 ppm. The wheat, 
aspirated grain fraction and soybean, aspirated grain fraction 
proposals at 10.0 ppm and 1.0 ppm, respectively, should be expressed as 
grain, aspirated grain fractions and revised to 7.0 ppm. EPA revised 
the tolerance levels based on analysis of the residue field trial data 
using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data Standard Operating Procedure (SOP). No tolerances are needed for 
beet sugar and soybean meal since metconazole does not increase in 
these commodities on processing. The tolerance on sugar beet root 
covers sugar. No tolerance is needed for sugar beet tops since this 
commodity is no longer a significant feed item. Separate tolerances are 
being established for meat byproducts of cattle, goat, horse, and sheep 
at 0.04 ppm based on a cattle feeding study in which dairy cattle were 
fed metconazole at levels corresponding to 1.3x, 3.9x, and 12x, 
respectively, the dietary burden for beef cattle and 0.54x, 1.7x, and 
5.2x, respectively, the dietary burden for dairy cattle. In liver, 
residues of cis and trans-metconazole were <0.02-0.021 ppm and <0.02 
ppm, respectively, in samples from the high-dose group and below the 
LOQ (both isomers) in samples from the low-dose and mid-dose groups. 
Maximum total metconazole residues (sum of cis and trans isomers) in 
liver were 0.041 ppm from the high-dose group. Because quantifiable 
residues of cis-metconazole were observed in liver (0.021 ppm) at the 
highest dosing level, tolerances are needed for meat byproducts at the 
limit of quantitation of the enforcement method (0.04 ppm).

V. Conclusion

    Therefore, the tolerances are established for residues of 
metconazole, 5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, in or on almond, hulls at 4.0 ppm; 
barley, grain at 2.5 ppm; barley, hay at 7.0 ppm; barley, straw at 7.0 
ppm; beet, sugar, dried pulp at 0.70 ppm; beet, sugar, molasses at 0.08 
ppm; beet, sugar, roots at 0.07 ppm; cattle, meat byproducts at 0.04 
ppm; fruit, stone, group 12 at 0.20 ppm; goat, meat byproducts at 0.04 
ppm; grain, aspirated grain fractions at 7.0 ppm; horse, meat 
byproducts at 0.04 ppm; nut, tree, group 14 at 0.04 ppm; oat, grain at 
1.0 ppm; oat, hay at 17 ppm; oat, straw at 6.0 ppm; peanut at 0.04 ppm; 
peanut, refined oil at 0.05 ppm; pistachio at 0.04 ppm; rye, grain at 
0.25 ppm; rye, straw at 14 ppm; sheep, meat byproducts at 0.04 ppm; 
soybean, forage at 3.0 ppm; soybean, hay at 6.0 ppm; soybean, hulls at 
0.08

[[Page 22828]]

ppm; soybean, seed at 0.05 ppm; wheat, grain at 0.15 ppm; wheat, hay at 
16 ppm; wheat, milled byproducts at 0.20 ppm; wheat, straw at 18 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 15, 2008.
Daniel Kenny,
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 alphabetically adding the following 
commodities to the table in paragraph (a) and by removing and reserving 
paragraph (b) with heading to read as follows:

180.617  Metconazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                4.0
                                * * * * *
Barley, grain........................................                2.5
Barley, hay..........................................                7.0
Barley, straw........................................                7.0
Beet, sugar, dried pulp..............................               0.70
Beet, sugar, molasses................................               0.08
Beet, sugar, roots...................................               0.07
Cattle, meat byproducts..............................               0.04
Fruit, stone, group 12...............................               0.20
Goat, meat byproducts................................               0.04
Grain, aspirated grain fractions.....................                7.0
Horse, meat byproducts...............................               0.04
Nut, tree, group 14..................................               0.04
Oat, grain...........................................                1.0
Oat, hay.............................................                 17
Oat, straw...........................................                6.0
Peanut...............................................               0.04
Peanut, refined oil..................................               0.05
Pistachio............................................               0.04
Rye, grain...........................................               0.25
Rye, straw...........................................                 14
Sheep, meat byproducts...............................               0.04
Soybean, forage......................................                3.0
Soybean, hay.........................................                6.0
Soybean, hulls.......................................               0.08
Soybean, seed........................................               0.05
Wheat, grain.........................................               0.15
Wheat, hay...........................................                 16
Wheat, milled byproducts.............................               0.20
Wheat, straw.........................................                 18
------------------------------------------------------------------------

    (b) Section 18 emergency exemption. [Reserved]
* * * * *
[FR Doc. E8-8971 Filed 4-25-08; 8:45 am]

BILLING CODE 6560-50-S