[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]
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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.
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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