[Federal Register: December 20, 2006 (Volume 71, Number 244)]
[Rules and Regulations]
[Page 76190-76197]
[DOCID:fr20de06-18]

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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<PHONE_NUMBER>.

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:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

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

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<PHONE_NUMBER>.

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

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.
----------------------------------------------------------------------------------------------------------------

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

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

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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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

(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

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


[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Rules and Regulations]
[Pages 34896-34897]
[FR Doc No: 2013-13753]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0332]

Safety Zone; Red, White, and Tahoe Blue Fireworks, Incline
Village, NV

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the Red,
White, and Tahoe Blue Fireworks display in the Captain of the Port, San
Francisco area of responsibility during the dates and times noted
below. This action is necessary to protect life and property of the
maritime public from the hazards associated with the fireworks display.
During the enforcement period, unauthorized persons or vessels are
prohibited from entering into, transiting through, or anchoring in the
safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in this notice will be enforced from 7 a.m. on
June 29, 2013 through 10:45 p.m. on July 4, 2013.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Junior Grade William Hawn, Sector San
Francisco Waterways Safety Division, U.S. Coast Guard; telephone 415-
399-7442, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a safety zone
in navigable waters around and under the fireworks barges within a
radius of 100 feet during the loading, transit, and arrival of the
fireworks barges to the display location and until the start of the
fireworks display. From 7 a.m. on June 29, 2013 until 8 p.m. on July 4,
2013 the fireworks barges will be loaded off of Incline Beach, near
Incline Village, NV at approximate position 39[deg]14'21'' N,
119[deg]56'51'' W (NAD 83). From 8 p.m. to 9 p.m. on July 4, 2013 the
loaded barges will transit from Incline Beach to the launch site off of
Incline Village, NV at approximate position 39[deg]14'14'' N,
119[deg]56'56'' W (NAD 83), where it will remain until the commencement
of the fireworks display. Upon the commencement of the 30 minute
fireworks display, scheduled to take place between 9 p.m. and 10 p.m.
on July 4, 2013, the safety zone will increase in size to encompass the
navigable waters around and under the fireworks barges within a radius
1,000 feet at approximate position 39[deg]14'14'' N, 119[deg]56'56'' W
(NAD 83). Pursuant to 33 CFR 165.1191, Table 1, Item number 22, this
safety zone will be in effect from 7 a.m. on June 29, 2013 until 10:45
p.m. on July 4, 2013.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San

Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: May 18, 2013.
Gregory G. Stump,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2013-13753 Filed 6-10-13; 8:45 am]
BILLING CODE 9110-04-P