[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Rules and Regulations]
[Pages 76190-76197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21493]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0655; FRL-8095-4]


Metconazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the fungicide metconazole, 5-[(4-chlorophenyl)methyl]-2,2-
dimethyl-1-(1H -1,2,4-triazole-1-yl-methyl)cyclopentanol in or on 
aspirated grain fractions; egg; meat, fat and meat by-products of 
cattle, goat, hog, horse, poultry and sheep; milk; soybean, hulls; 
soybean, meal; soybean, refined oil; and soybean, seed. This action is 
associated with EPA's granting of an emergency exemption under section 
18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on soybeans. This regulation 
establishes a maximum permissible level for residues of metconazole in 
these food commodities. These tolerances will expire and be revoked on 
December 31, 2010.

DATES: This regulation is effective December 20, 2006. Objections and 
requests for hearings must be received on or before February 20, 2007, 
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-2006-0655. All documents in the 
docket are listed on the regulations.gov website. 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 either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Room S-4400, 
One Potomac Yard (South Bldg.), 2777 South Crystal Dr. Arlington, VA 
22202-3553. The hours of operation of this Docket Facility are from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0327; fax: (703) 308-8041; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     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 provides 
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 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, as amended by the Food Quality 
Protection Act of 1996 (FQPA), any person may file an objection to any 
aspect of this regulation and may also request a hearing on those 
objections. The EPA procedural regulations which govern the submission 
of objections and requests for hearings appear in 40 CFR part 178. 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-
2006-0655 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 on or before February 20, 2007.
    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

[[Page 76191]]

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 your 
copies, identified by docket ID number EPA-HQ-OPP-2006-0655, 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, Room S-4400, One Potomac Yard (South 
Bldg.), 2777 South Crystal Dr., Arlington, VA 22202-3553. 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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing time-limited tolerances for residues of 
the fungicide metconazole in or on aspirated grain fractions at 1.00 
parts per million (ppm); egg at 0.02 ppm; meat, fat and meat by-
products of cattle, goat, hog, horse, poultry and sheep at 0.02 ppm; 
milk at 0.02 ppm; soybean, hulls at 1.20 ppm; soybean, meal at 0.25 
ppm; soybean, refined oil at 1.20 ppm; and soybean, seed at 0.10 ppm. 
These tolerances will expire and be revoked on December 31, 2010. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerances from the Code of Federal Regulations (CFR).
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of the section 408 safety standard to other tolerances and 
exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance 
or an exemption from the requirement of a tolerance on its own 
initiative, i.e., without having received any petition from an outside 
party.
    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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the FQPA. EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Metconazole on Soybeans and FFDCA 
Tolerances

    Australasian soybean rust (SBR) is a plant disease caused by two 
fungal species, Phakopsora pachyrhizi and P. meibomiae, and is spread 
primarily by windborne spores that can be transported over long 
distances. SBR models suggest that most of the soybean acreage in the 
United States could be compromised by an SBR epidemic. In accordance 
with the 2002 Agricultural Bioterrorism Protection Act, SBR was 
identified by the United States Department of Agriculture (USDA) as a 
select biological agent with the potential to pose a severe threat to 
the soybean industry and livestock production, in general. As such, 
USDA has invested in extensive readiness and outreach activities among 
soybean producers. The States of Minnesota and South Dakota petitioned 
EPA to allow under FIFRA section 18 the use of metconazole on soybeans 
for control of SBR in Minnesota and South Dakota. After having reviewed 
the submission, EPA concurs that emergency conditions exist for these 
States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of metconazole in or on 
aspirated grain fractions; egg; meat, fat and meat by-products of 
cattle, goat, hog, horse, poultry and sheep; milk; soybean, hulls; 
soybean, meal; soybean, refined oil; and soybean, seed. In doing so, 
EPA considered the safety standard in section 408(b)(2) of FFDCA, and 
EPA decided that the necessary tolerance 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 tolerances will 
expire and be revoked on December 31, 2010, under section 408(l)(5) of 
FFDCA, residues of the pesticide not in excess of the amounts specified 
in the tolerance remaining in or on aspirated grain fractions; egg; 
meat, fat and meat by-products of cattle, goat, hog, horse, poultry and 
sheep; milk; soybean, hulls; soybean, meal; soybean, refined oil; and 
soybean, seed after that date will not be unlawful, provided the 
pesticide is applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by these tolerances 
at the time of that application. EPA will take action to revoke these 
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 tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether metconazole 
meets EPA's registration requirements for use in soybeans or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of metconazole by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for growers in any State other than those in which State lead 
agencies have obtained an exemption to use this pesticide on this crop 
under section 18 of FIFRA without following all provisions of EPA's 
regulations implementing FIFRA section 18 as identified in 40 CFR part 
166. For additional information regarding the

[[Page 76192]]

emergency exemption for metconazole, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with section 408(b)(2)(D) of FFDCA, 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 
metconazole and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of FFDCA, for time-limited tolerances 
for residues of metconazole in or on aspirated grain fractions at 1.00 
ppm; egg at 0.02 ppm; meat, fat and meat by-products of cattle, goat, 
hog, horse, poultry and sheep at 0.02 ppm; milk at 0.02 ppm; soybean, 
hulls at 1.20 ppm; soybean, meal at 0.25 ppm; soybean, refined oil at 
1.20 ppm; and soybean, seed at 0.10 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing these 
tolerances follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect 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. An UF of 100 
is routinely used, 10x to account for interspecies differences and 10x 
for intraspecies differences.
    For dietary risk assessment (other than cancer), the Agency uses 
the UF to calculate an acute or chronic reference dose (aRfD or cRfD) 
where the RfD is equal to the NOAEL divided by the appropriate UF (RfD 
= NOAEL/UF). Where an additional safety factor is retained due to 
concerns unique to the FQPA, this additional factor is applied to the 
RfD by dividing the RfD by such additional factor. The acute or chronic 
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10x to account for interspecies differences and 10x for 
intraspecies differences), the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for metconazole used for human risk assessment is shown in 
Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Metconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF and Level of
          Exposure/Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (U.S. general            Not applicable           None                     An endpoint of concern
 population including infants and                                                         (effect) attributable
 children)                                                                                to a single exposure
                                                                                          (dose) for the U.S.
                                                                                          general population was
                                                                                          not identified in the
                                                                                          oral toxicity studies
                                                                                          reviewed.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of  NOAEL = 12.0 milligram/  FQPA SF = 1x             Developmental toxicity--
 age)                                   kilogram/day (mg/kg/    aPAD = acute RfD / FQPA   rat; LOAEL = 30.0 mg/
                                        day)                     SF = 0.12 mg/kg/day.     kg/day based on
                                       UF = 100x..............                            increases in skeletal
                                       Acute RfD = 0.12 mg/kg/                            variations.
                                        day.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 4.3 mg/kg/day     FQPA SF = 1x             Chronic oral toxicity -
                                       UF = 100x..............  cPAD = chronic RfD /      rat; LOAEL = 13.1 mg/
                                       Chronic RfD = 0.04 mg/    FQPA SF = 0.04 mg/kg/    kg/day based on
                                        kg/day.                  day.                     increased liver
                                                                                          weights and associated
                                                                                          hepatocellular lipid
                                                                                          vacuolation and
                                                                                          centrilobular
                                                                                          hypertrophy observed
                                                                                          in males. Similar
                                                                                          effects were observed
                                                                                          in females at 54 mg/kg/
                                                                                          day, plus increased
                                                                                          spleen weight.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1 to 30    NOAEL = 9.1 mg/kg/day    LOC for MOE = 100        28-day oral toxicity -
 days)                                  UF = 100x                                         rat; LOAEL = 90.5 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight
                                                                                          gain in males,
                                                                                          increased liver and
                                                                                          kidney weight and
                                                                                          hepatocellular
                                                                                          hypertrophy and
                                                                                          vacuolation in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------

[[Page 76193]]

 
Intermediate-Term Incidental Oral(1    NOAEL = 6.4 mg/kg/day    LOC for MOE = 100        90-day oral toxicity--
 to 6 months)                           UF =100 x                                         rat; LOAEL = 19.2 mg/
                                                                                          kg/day based on
                                                                                          hepatic vacuolation in
                                                                                          males and increased
                                                                                          spleen weight in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 30 days)       NOAEL = 9.1 mg/kg/day    LOC for MOE = 100        28-day oral toxicity--
                                       UF = 100x (dermal                                  rat; LOAEL = 90.5 mg/
                                        absorption rate = 5%).                            kg/day based on
                                                                                          decreased body weight
                                                                                          gain in males,
                                                                                          increased liver and
                                                                                          kidney weight and
                                                                                          hepatocellular
                                                                                          hypertrophy and
                                                                                          vacuolation in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal(1 to 6        NOAEL = 6.4 mg/kg/day    LOC for MOE = 100        90-day oral toxicity--
 months)                               UF = 100x (dermal                                  rat; LOAEL = 19.2 mg/
                                        absorption rate = 5%).                            kg/day based on
                                                                                          hepatic vacuolation in
                                                                                          males and increased
                                                                                          spleen weight in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (>6 months)           NOAEL= 4.3 mg/kg/day     LOC for MOE = 100        Chronic oral toxicity--
                                       UF = 100x (dermal                                  rat; LOAEL = 13.1 mg/
                                        absorption rate = 5%).                            kg/day based on
                                                                                          increased liver
                                                                                          weights and associated
                                                                                          hepatocellular lipid
                                                                                          vacuolation and
                                                                                          centrilobular
                                                                                          hypertrophy observed
                                                                                          in males. Similar
                                                                                          effects were observed
                                                                                          in females at 54 mg/kg/
                                                                                          day, plus increased
                                                                                          spleen weight.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   NOAEL= 9.1 mg/kg/day     LOC for MOE = 100        28-day oral toxicity--
                                       UF = 100x (inhalation-                             rat; LOAEL = 90.5 mg/
                                        absorption rate = 100%                            kg/day based on
                                        oral equivalent).                                 decreased body weight
                                                                                          gain in males,
                                                                                          increased liver and
                                                                                          kidney weight and
                                                                                          hepatocellular
                                                                                          hypertrophy and
                                                                                          vacuolation in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 to 6   NOAEL= 6.4 mg/kg/day     LOC for MOE = 100        90-day oral toxicity--
 months)                               UF = 100x (inhalation-                             rat; LOAEL = 19.2 mg/
                                        absorption rate = 100%                            kg/day based on
                                        oral equivalent).                                 hepatic vacuolation in
                                                                                          males and increased
                                                                                          spleen weight in
                                                                                          females.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (>6 months)       NOAEL= 4.3 mg/kg/day     LOC for MOE = 100        Chronic oral toxicity--
                                       UF = 100x (inhalation-                             rat; LOAEL = 13.1 mg/
                                        absorption rate = 100%                            kg/day based on
                                        oral equivalent).                                 increased liver
                                                                                          weights and associated
                                                                                          hepatocellular lipid
                                                                                          vacuolation and
                                                                                          centrilobular
                                                                                          hypertrophy observed
                                                                                          in males. Similar
                                                                                          effects were observed
                                                                                          in females at 54 mg/kg/
                                                                                          day, plus increased
                                                                                          spleen weight.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)        Metconazole has been classified as ``not likely to be carcinogenic in
                                             humans.'' As a result, a quantified carcinogenic assessment (Q*
                                                       approach) is not required for metconazole.
----------------------------------------------------------------------------------------------------------------

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Metconazole is not 
currently registered for any use in the United States. An import 
tolerance has been established for metconazole on bananas. Risk 
assessments were conducted by EPA to assess dietary exposures from 
metconazole in food as follows:
    i. Acute exposure. Acute dietary 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 one day 
or single exposure. The Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity.
    The acute dietary exposure analysis for metconazole was conducted 
for the proposed food use and drinking water. Except for drinking 
water, the acute analysis is based on Tier 1 assumptions of the 
proposed/recommended tolerance-level residues and 100% crop treated 
(CT). A Tier 2 drinking water assessment for the proposed use in 
soybeans was performed using the Pesticide Root Zone Model/Exposure 
Analysis Modeling System (PRZM/EXAMS) model with index reservoir (IR) 
scenarios and percent cropped area (PCA) adjustment factors. Estimated 
concentrations of metconazole in drinking water (from use in soybeans) 
were incorporated directly into the acute dietary risk assessment.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment, the DEEM-FCID\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1994-1996 and 1998 
nationwide CSFII and accumulated exposure to the chemical for each 
commodity.
    The chronic dietary exposure analysis for metconazole was conducted 
for the proposed food use and drinking water. Except for drinking 
water, the chronic analysis is based on Tier 1 assumptions of the 
proposed/recommended tolerance-level residues and 100% CT. A Tier 2 
drinking water assessment for the proposed use in soybeans was 
performed using PRZM/EXAMS model with IR scenarios and PCA adjustment

[[Page 76194]]

factors. As with the acute analysis, estimated concentrations of 
metconazole in drinking water (from use in soybeans) were incorporated 
directly into the chronic dietary risk assessment.
    As a result, all acute and chronic dietary risk estimates were less 
than the Agency's LOC for the U.S. general population and all 
population subgroups (i.e., they are all less than 100% of the aPAD and 
cPAD).
    iii. Cancer. Metconazole has been classified as ``not likely to be 
carcinogenic in humans'' based on convincing evidence that carcinogenic 
effects are not likely below a defined dose range. As a result, a 
quantified carcinogenic assessment (Q* approach) is not required for 
metconazole.
    2. Dietary exposure from drinking water. The Agency used the PRZM/
EXAMS to calculate estimated drinking water concentrations (EDWCs) for 
the use of metconazole in soybeans, using the IR scenarios and PCA 
adjustment factors. Thus, the estimated exposure concentrations for 
water are based on the proposed highest use rate. Ground water 
concentrations were estimated with the Screening Concentration in 
Ground Water (SCI-GROW) model.
    A Tier 2 drinking water assessment was conducted for the proposed 
use of metconazole in soybeans using the proposed maximum application 
rate of 0.07 lbs. a.i./acre with 2 applications per year and a 10- to 
21-day RTI. The preharvest interval (PHI) will be 30 days. Based on 
PRZM/EXAMS, the EDWCs for metconazole in surface water are 1.57 parts 
per billion (ppb) and 0.48 ppb for acute and chronic (non-cancer) 
exposures, respectively. For chronic/cancer assessments, the 30-year 
annual average from PRZM/EXAMS is 0.34 ppb. The EDWC for both acute and 
chronic exposures is estimated as 0.04 ppb for ground water using the 
SCI-GROW model.
    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 not registered for use on any sites that would 
result in residential exposure.
    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 (EPA, 2002). 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.
    Metconazole is a triazole-derived pesticide. This class of 
compounds 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 triazole-derived fungicide. The risk assessment is 
a highly conservative, screening-level evaluation in terms of hazards 
associated with the common metabolites (e.g., use of 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 population 
subgroups, including those comprised of infants and children. The 
Agency's complete risk assessment is found in the propiconazole 
reregistration docket at http://www.regulations.gov, Docket ID number 
EPA-HQ-OPP-2005-0497-0013.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for pre- and/or post-natal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Developmental toxicity studies. Developmental studies in rats 
and rabbits show some evidence of developmental effects (skeletal 
variations, post-implantation loss, reduction in fetal body weight), 
but only at dose levels that are maternally toxic. In the developmental 
toxicity study in rats, skeletal variations (predominantly lumbar ribs) 
occurred in the presence of maternal toxicity (decreased body weight 
gains). In the pre-natal developmental toxicity study in rabbits, 
developmental effects (increased post-implantation loss and reduced 
fetal body weights) were observed at the same dose that caused maternal 
toxicity (decreased body weight gains, reduced food consumption and 
alterations in hematology parameters). In the 2-generation reproduction 
study in rats with cis metconazole, offspring toxicity (reduced fetal 
body weights in F1 and F2 offspring) were 
observed only at the highest tested dose which also resulted in 
evidence of parental toxicity (reduced parental body weight gains and 
increased ovarian weight). The chemical is non-genotoxic and not likely 
to be carcinogenic below a defined dose range based on bioassays in the 
rat and the mouse combined with a lack of in vitro or in vivo 
mutagenicity. Metconazole did not demonstrate the potential for 
neurotoxicity in the four species (mouse, rat, dog and rabbit) tested. 
NOAELs/LOAELs are well characterized and are used as endpoints for 
appropriate risk assessments.
    There are adequate data in the metconazole toxicology database to 
characterize the potential for pre- and/or post-natal risks to infants 
and children: a 2-generation reproduction study in rats (cis-only 
isomer; one with

[[Page 76195]]

the cis/trans mixture has been completed and will be submitted in the 
near future); a developmental study in rats; and several developmental 
studies with rabbits. The effects seen in these studies do not suggest 
that pups are more susceptible: pup effects were only seen in the 
presence of maternal toxicity and, in general, were of comparable or 
less severity to the effects observed in adults. Thus, there are no 
residual uncertainties for pre- and/or post-natal exposure to 
metconazole and the Agency has determined that the special FQPA safety 
factor can be reduced to 1x.
    3. Reproductive toxicity study. In the submitted 2-generation 
reproduction study in rats with cis metconazole, offspring toxicity 
(reduced fetal body weights in F1 and F2 offspring) was observed only 
at the highest tested dose, which also resulted in evidence of parental 
toxicity (reduced parental body weight gains and increased ovarian 
weight). As discussed in Unit IV.C.2., there are no residual 
uncertainties for pre- and/or post-natal exposure to metconazole.
    4. Pre-natal and post-natal sensitivity. Please refer to the 
explanation provided in Unit IV.C.2. for a detailed discussion 
regarding ``pre- and/or post-natal sensitivity.''
    5. Conclusion. The Agency evaluated the quality of the hazard and 
exposure database for metconazole to characterize its potential for 
pre- and/or post-natal risks to infants and children. The effects 
observed in the developmental and reproductive studies do not suggest 
that pups are more susceptible; pup effects were only seen in the 
presence of maternal toxicity and, in general, were of comparable or 
less severity to the effects observed in adults. Thus, based on the 
hazard and exposure data, the special FQPA SF is reduced to 1x as there 
are low concerns and no residual uncertainties with regard to pre- and/
or post-natal toxicity.

D. Aggregate Risks and Determination of Safety

    EPA conducted human health risk assessments for acute, chronic and 
cancer dietary exposures (food + drinking water only) for the proposed 
use. Because there are no uses of metconazole that are expected to 
result in residential exposures, this aggregate risk assessment takes 
into consideration dietary (food + drinking water) exposure only; 
therefore, the acute and chronic aggregate estimates would be the same 
as the dietary exposure results.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit, the acute dietary exposure from food and water to metconazole 
will occupy 1% of the aPAD for females 13-49 years old, the population 
subgroup of concern. Given the proposed use, the Agency has no risk 
concern for exposure to metconazole through food and/or drinking water. 
EPA does not expect the aggregate exposure to exceed 100% of the aPAD.
    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 2% of the cPAD for the 
U.S. general population and 5% of the cPAD for children 1-2 years old. 
There are no residential uses for metconazole that will result in 
chronic residential exposure to metconazole. Given the proposed use, 
the Agency has no risk concern for exposure to metconazole through food 
and/or drinking water. EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD.
    3. Short- and intermediate-term risk. Short-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and drinking water (considered to be a background exposure level). 
Intermediate-term aggregate exposure takes into account non-dietary, 
non-occupational exposure plus chronic exposure to food and drinking 
water (considered to be a background exposure level). Since metconazole 
is not registered for use on any sites that would result in residential 
exposure, short- and intermediate-term aggregate risk assessments are 
not needed.
    4. Aggregate cancer risk for U.S. population. Metconazole is ``not 
likely to be carcinogenic in humans'' based on convincing evidence that 
carcinogenic effects are not likely below a defined dose range. A non-
genotoxic mode of action for mouse liver tumors was established. No 
quantification is required.
    5. Determination of safety. Based on all these considerations, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the U.S. general population and to infants and children from 
aggregate exposure to metconazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (example--gas chromatography) 
is available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    No CODEX, Canadian or Mexican maximum residue limits (MRLs) or 
tolerances have been established for metconazole in or on soybeans. 
Further, no provisional MRL has been established in Japan for imported 
soybeans. Therefore, international harmonization is not an issue at 
this time.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
metconazole in or on aspirated grain fractions at 1.00 ppm; egg at 0.02 
ppm; meat, fat and meat by-products of cattle, goat, hog, horse, 
poultry and sheep at 0.02 ppm; milk at 0.02 ppm; soybean, hulls at 1.20 
ppm; soybean, meal at 0.25 ppm; soybean, refined oil at 1.20 ppm; and 
soybean, seed at 0.10 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of FFDCA. 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 due to its lack of significance, 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). 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., or 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). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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

[[Page 76196]]

(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: December 5, 2006.
Donald R. Stubbs,
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 adding text and table to paragraph (b) 
to read as follows:


Sec.  180.617  Metconazole; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide metconazole, 5-[(4-
chlorophenyl)methyl]-2,2-dimethyl-1-(1H -1,2,4-triazole-1-yl-
methyl)cyclopentanol in or on aspirated grain fractions; egg; meat, fat 
and meat by-products of cattle, goat, hog, horse, poultry and sheep; 
milk; soybean, hulls; soybean, meal; soybean, refined oil; and soybean, 
seed in connection with the use of the pesticide under section 18 
emergency exemptions granted by EPA. The tolerances will expire and be 
revoked on the date specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Aspirated grain fractions.........               1.00           12/31/10
Cattle, fat.......................               0.02           12/31/10
Cattle, meat......................               0.02           12/31/10
Cattle, meat byproducts...........               0.02           12/31/10
Egg...............................               0.02           12/31/10
Goat, fat.........................               0.02           12/31/10
Goat, meat........................               0.02           12/31/10
Goat, meat byproducts.............               0.02           12/31/10
Hog, fat..........................               0.02           12/31/10
Hog, meat.........................               0.02           12/31/10
Hog, meat byproducts..............               0.02           12/31/10
Horse, fat........................               0.02           12/31/10
Horse, meat.......................               0.02           12/31/10
Horse, meat byproducts............               0.02           12/31/10
Milk..............................               0.02           12/31/10
Poultry, fat......................               0.02           12/31/10
Poultry, meat.....................               0.02           12/31/10
Poulty, meat byproducts...........               0.02           12/31/10
Sheep, fat........................               0.02           12/31/10
Sheep, meat.......................               0.02           12/31/10
Sheep, meat byproducts............               0.02           12/31/10

[[Page 76197]]

 
Soybean, hulls....................               1.20           12/31/10
Soybean, meal.....................               0.25           12/31/10
Soybean, refined oil..............               1.20           12/31/10
Soybean, seed.....................               0.10           12/31/10
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-21493 Filed 12-19-06; 8:45 am]
BILLING CODE 6560-50-S