[Federal Register Volume 64, Number 105 (Wednesday, June 2, 1999)]
[Rules and Regulations]
[Pages 29581-29589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13947]
[[Page 29581]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
OPP-300863; FRL-6081-5
RIN 2070-AB78
Difenoconazole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for the fungicide
difenoconazole (((2S,4R)/(2R,4S)/(2R,4R)/(2S,4S)) 1-(2-(4-(4-
chlorophenoxy)-2-chlorophenyl)-4-methyl-1,3-dioxolan-2-yl)methyl-1H-
1,2,4-triazole) in or on the raw agricultural commodities bananas at
0.2 parts per million (ppm); wheat forage at 0.1 ppm; wheat grain at
0.1 ppm; wheat straw at 0.1 ppm; eggs at 0.05 ppm; milk at 0.01 ppm;
fat of cattle, goats, hogs, horses, poultry, and sheep at 0.05 ppm;
meat of cattle, goats, hogs, horses, poultry, and sheep at 0.05 ppm;
and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep
at 0.05 ppm. Novartis Crop Protection, Inc. requested this tolerance
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996.
DATES: This regulation is effective June 2, 1999. Objections and
requests for hearings must be received by EPA on or before August 2,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300863], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300863], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall 2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1/6.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300863]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 249, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-7740, giles-
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of July 25, 1997 (62
FR 40075) (FRL-5726-4), EPA issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-
170) announcing the filing of a pesticide petition (PP 5E4526) to
establish an import tolerance on bananas by Novartis Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419-8300. The notice included a
summary of the petition prepared by Novartis Crop Protection, Inc., the
registrant. There were no comments received in response to the notice
of filing. In the Federal Register of December 2, 1998 (63 FR 66535)
(FRL-6043-2), EPA issued a notice pursuant to section 408 of the FFDCA,
21 U.S.C. 346a as amended by the FQPA of 1996 (Pub. L. 104-170)
announcing the filing of a pesticide petition (PP 2F4107) to establish
a tolerance on wheat and related animal commodities by Novartis Crop
Protection, Inc. that included a summary of the petition prepared by
the same company. There were also no comments received in response to
this second notice of filing.
The petitions requested that 40 CFR 180.475 be amended by
establishing tolerances for the fungicide, difenoconazole, in or on the
raw agricultural commodities bananas at 0.2 ppm; wheat forage at 0.1
ppm; wheat grain at 0.1 ppm; wheat straw at 0.1 ppm; eggs at 0.05 ppm;
milk at 0.01 ppm; fat of cattle, goats, hogs, horses, poultry, and
sheep at 0.05 ppm; meat of cattle, goats, hogs, horses, poultry, and
sheep at 0.05 ppm; and meat byproducts of cattle, goats, hogs, horses,
poultry, and sheep at 0.05 ppm.
I. Background and Statutory Findings
Section 408(b)(2)(A)(i) of the 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) 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)
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....''
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 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
difenoconazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for tolerances in/on the raw
agricultural commodities wheat forage at 0.1 ppm; wheat grain at 0.1
ppm; wheat straw at 0.1 ppm; eggs at 0.05 ppm; milk at 0.01 ppm; fat of
cattle, goats, hogs, horses, poultry, and sheep at 0.05 ppm; meat of
cattle, goats, hogs, horses, poultry, and sheep at 0.05 ppm; and meat
byproducts of cattle, goats, hogs, horses, poultry, and sheep at 0.05
ppm, and an import tolerance for the fungicide difenoconazole in or on
the raw agricultural commodity bananas at 0.2 ppm. EPA's assessment of
the dietary exposures and risks associated with establishing the
tolerance follows.
[[Page 29582]]
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by difenoconazole are
discussed in this unit.
B. Toxicological Endpoints
1. Acute toxicity. Difenoconazole possesses low acute toxicity by
the oral, dermal and inhalation routes of exposure. It is considered to
be a mild eye and slight skin irritant and is not a dermal sensitizer.
The acute oral LD50 in rats is 1,453 milligrams per kilogram
(mg/kg). The acute dermal LD50 is estimated to be greater
than 2,010 mg/kg. The acute inhalation LC50 in rats is
greater than 3,300 mg/m3. The primary eye irritation
category is III and the primary skin irritation category is IV.
2. Short- and intermediate-term toxicity. Subchronic studies of the
effects of difenoconazole in mice and rats manifested decreased body
weights, decreased body weight gains, and effects on the liver at 200
ppm and higher. Microscopic examination of the eyes of dogs at 3,000
ppm revealed unilateral and bilateral lenticular cataracts in both
sexes of animals. In a 13-week feeding study in mice, nearly all mice
fed 7,500 or 15,000 ppm died during the first week of the study; there
was a significantly decreased body weight gain, hepatocellular
enlargement and vacuolation in animals receiving 2,500 ppm
difenoconazole in the diet; and hepatocyte enlargement in animals
receiving 200 ppm. The lowest observable adverse effect level (LOAEL)
was considered to be 200 ppm based on decreased body weight gains and
liver histopathology and the no observable adverse effect level (NOAEL)
was 20 ppm (equivalent to 2.0 mg/kg in males and 4.4 mg/kg in females).
In a 13-week feeding study in rats, the LOAEL was 200 ppm (10 mg/kg/
day) in females, based on a decrease in body weights (concurrent with a
negative trend for food consumption), and 750 ppm (37.5 mg/kg/day) for
males, based on increases in absolute liver weights; the NOAEL was 20
ppm (equivalent to 1 mg/kg/day). A 21-day dermal toxicity study using
rabbits produced a LOAEL of 100 mg/kg/day based on statistically
significant decrements in body weight, body weight gain, and food
consumption, and a NOAEL of 10 mg/kg/day. A feeding study in dogs for
26 weeks produced a LOAEL of 3,000 ppm based on unilateral or bilateral
cataracts in all three female and one of three male dogs. The NOAEL was
concluded to be 1,000 ppm (31.3 to 34.0 mg/kg/day).
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for difenoconazole at 0.01 mg/kg/day. This RfD is based on the NOAEL of
0.96 mg/kg/day (20 ppm) for males in a 104-week chronic toxicity/
carcinogenicity study in rats and using an uncertainty factor of 100
(10x for interspecies extrapolation and 10x for intraspecies
variability. The NOAEL for females (at the 20 ppm dietary exposure) was
1.27 mg/kg/day. The LOAEL in this study was 500 ppm (24.12 mg/kg/day
for males and 32.79 mg/kg/day for females), based on cumulative
decreases in body weight gains and hepatocellular hypertrophy. In the
dog, the LOAEL was 500 ppm, based on decreased body weight gains (and
decreased food intake) and the NOAEL was 100 ppm (3.4 to 3.7 mg/kg/day)
in a 52-week chronic dietary toxicity study.
The results of the 2-generation reproductive and developmental
toxicity studies do not demonstrate increased sensitivity of infants
and children to difenoconazole. In a developmental toxicity study in
rats, the maternal NOAEL was determined to be 20 mg/kg/day and the
maternal LOAEL was 100 mg/kg/day based on decreased body weight gains
and decreased food consumption. In the same study, the developmental
NOAEL was 100 mg/kg/day and the developmental LOAEL was 200 mg/kg/day
based on the incidence of bifid or unilateral ossification of the
thoracic vertebrae, which was significantly increased on a fetal basis,
and significant increases in the average number of ossified hyoid and
decreases in the number of sternal centers of ossification (per fetus
per litter). The average number of ribs was also significantly
increased with accompanying increases in the number of thoracic
vertebrae and decreases in the number of lumbar vertebrae in this
group. In a developmental toxicity study in rabbits, the LOAEL is 75
mg/kg/day for maternal toxicity based on decreases in body weight gain
and food consumption, and the NOAEL is 25 mg/kg/day for maternal
toxicity; for developmental toxicity, the LOAEL is 75 mg/kg/day based
on increases in post-implantation loss and resorptions per doe, and
decreases in fetal body weight, and the NOAEL is 25 mg/kg/day. In a 2-
generation reproduction study in rats, for parental toxicity, the LOAEL
of 250 ppm (12.5 mg/kg/day) is based on the decrease in maternal body
weight gain and the NOAEL is 25 ppm (1.25 mg/kg/day; for reproductive
toxicity the LOAEL of 250 ppm (12.5 mg/kg/day) is based on decreased
pup weights at day 21 and the NOAEL is 25 ppm (1.25 mg/kg/day).
Neurotoxicity studies are not applicable because difenoconazole is
not a cholinesterase inhibitor and there is no evidence in the
available data base that difenoconazole possesses neurotoxic
properties. It is not structurally related to known neurotoxic
compounds.
Difenoconazole was not mutagenic with or without metabolic
activation in two microbial/mammalian microsome plate incorporation
assays. In an in vivo micronucleus assay, no increases in
micronucleated polychromatic erythrocyte counts were seen in the bone
marrow cells of mice given difenoconazole. This chemical was negative
in an in vitro unscheduled DNA synthesis (UDS) assay with primary rat
hepatocytes.
4. Carcinogenicity. Chronic feeding studies in mice showed
decreased body weight gains in male and female mice at termination.
Treatment related non- neoplastic lesions were confined to the liver
and were supported by the clinical chemistry data at a level of 300 ppm
(46.29 and 57.79 mg/kg/day for males and females, respectively). Liver
tumors were observed in mice at 300 ppm and higher; however, based on
the excessive toxicity observed at the two highest doses of 2,500 and
4,500 ppm (females terminated after 2 weeks due to excessive toxicity
resulting in moribundity and death), the absence of tumors at the two
lower doses of 10 and 30 ppm, and the absence of genotoxic effects, in
1994 the Agency determined that the appropriate cancer classification
for difenoconazole is C (possible human carcinogen) and advocated the
use of the margin of exposure (MOE) approach to determining exposure/
risk. However, at this time the Agency has not defined the level of
concern for cancer using the MOE approach. Therefore, a quantitative
risk analysis was conducted using the Q1* approach. The
Q1* was determined to be 1.57 x 10-1 (mg/kg/
day)-1. This value incorporates the 3/4 scaling factor and
is based on the male mouse liver adenomas and/or carcinomas combined.
Metabolism studies in rats indicated that peak absorption occurred
between 24 and 48 hours post-dosing. Elimination in the feces ranged
between 78 and 94% and in the urine between 8 and 21%. Difenoconazole
did not accumulate to any appreciable extent since tissues contained
less than 1.0%
[[Page 29583]]
of the radioactivity after 7 days post-exposure. From the proposed
metabolic pathway of difenoconazole in rats, the compound undergoes
successive oxidation and conjugation reactions. One of the metabolites,
CGA-205375, accounts for 6-24% of the applied dose and is found only in
the urine and feces of high dose (300 mg/kg) rats. The presence of this
intermediate in the excreta of only high dose rats suggests that its
rate of further biotransformation has reached saturation at the high
dose. Additionally, excretion of radioactivity in the bile, feces, and
urine of rats orally dosed with 14C-difenoconazole is
consistent with saturation of the gastrointestinal absorption of the
chemical at 300 mg/kg. The distribution, metabolism, and excretion of
difenoconazole are not sex-dependent.
C. Exposures and Risks
1. From food and feed uses. Time-limited tolerances previously
existed in (40 CFR 180.475) for the residues of difenoconazole in or on
the following raw agricultural commodities: eggs at 0.05 ppm; fat of
cattle, goats, hogs, horses, poultry, and sheep at 0.05 ppm; meat of
cattle, goats, hogs, horses, poultry, and sheep at 0.05 ppm; meat
byproducts of cattle, goats, hogs, horses, poultry, and sheep at 0.05
ppm; milk at 0.01 ppm; wheat forage at 0.1 ppm; wheat grain at 0.1 ppm;
and wheat straw at 0.1 ppm. The time limits were conditional on
submission by the company of several studies. However, even though
Novartis Crop Protection, Inc. submitted the studies before the
expiration date of these tolerances, the tolerances expired on December
31, 1998, because the Agency was unable to complete review of the
studies by that date. These tolerances are reestablished and made
permanent by this rule. In addition to the above tolerances, import
tolerances also exist for the residues of difenoconazole on barley
grain at 0.1 ppm; eggs at 0.05 ppm; fat of cattle, goats, hogs, horses,
poultry, and sheep at 0.05 ppm; meat of cattle, goats, hogs, horses,
poultry, and sheep at 0.05 ppm; meat byproducts of cattle, goats, hogs,
horses, poultry, and sheep at 0.05 ppm; milk at 0.01 ppm; rye grain at
0.1 ppm; and wheat grain at 0.1 ppm. These import tolerances are
unaffected by this rule. Risk assessments were conducted by EPA to
assess food exposures from difenoconazole as follows:
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance. Anticipated residue data used in the current dietary risk
analysis were calculated from field trial data. The anticipated
residues used were 0.01 for bananas; 0.000019 for eggs; 0.0000043 for
egg whites; 0.000046 ppm for egg yolk; 0.000041 ppm for fat of cattle,
goats, hogs, horses, and sheep; 0.00012 ppm for kidney of cattle,
goats, hogs, horses, and sheep; 0.000014 ppm for meat of cattle, goats,
hogs, horses, and sheep; 0.00044 ppm for meat byproducts (except
kidney) of cattle, goats, hogs, horses, and sheep; 0.000013 ppm for
milk; 0.01 ppm for plantains; 0.0000030 ppm for poultry fat; 0.000034
ppm for poultry kidney; 0.000006 ppm for poultry meat; 0.000023 ppm for
poultry meat byproducts (except kidney); 0.005 ppm for sweet corn; and
0.005 ppm for wheat grain.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by the section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows: 3% crop treated for
sweet corn, 9% crop treated for wheat, and 10.5% imported for barley.
The percent imported data are used in the same way PCT data are used.
This refinement is used because difenoconazole is not registered for
use in the United States. The percentage means that 10.5% of the barley
used (potentially or actually) for human consumption in the United
States is imported; it is even more conservative because it also
assumes that all such imported barley has difenoconazole residues.
The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) concerning the Agency's responsibilities in assessing
chronic dietary risk findings, have been met. The PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. Typically, a range of estimates is supplied and
the upper end of this range is assumed for the exposure assessment. By
using this upper end estimate of the PCT, the Agency is reasonably
certain that the percentage of the food treated is not likely to be
underestimated. The regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which difenoconazole
may be applied in a particular area.
i. Acute exposure and risk. Acute risk assessments are performed
for a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. An acute risk assessment is required for
difenoconazole. The acute NOAEL of 25 mg/kg/day is based on the
developmental toxicity study in rabbits, in which the endpoint effects
at the LOAELs were post-implantation loss and resorptions per doe and a
significant decrease in fetal weight at 75 mg/kg/day during days 7 and
19. The uncertainty factor used was 100, resulting in an acute RfD of
0.25 mg/kg/day. The Agency's detailed acute analysis estimated the
distribution of single-day exposures for females older than 13 years. A
dose and endpoint were not selected for the general U.S. population and
infants and children because there were no effects observed in oral
toxicology studies including maternal toxicity in the developmental
toxicity studies in rats or rabbits that are attributable to a single
exposure. The
[[Page 29584]]
Dietary Exposure Evaluation Model (DEEM) analysis evaluated the data in
the USDA 1989-91 Continuing Surveys for Food Intake by Individuals
(CSFII). The acute analysis used tolerance level residues and 100% crop
treated. The FQPA Safety Factor was reduced to 1x. Therefore, the acute
Population Adjusted Dose (PAD) and the acute RfD are the same. For
acute risk the Agency's level of concern is for estimated exposure
greater than 100% of the RfD. Total exposures from the proposed new and
preexisting food and feed uses of difenoconazole, at the 95th
percentile of exposure are: (a) Females (13+/pregnant/not nursing),
0.000913 mg/kg/day (<1% of the RfD); (b) females (13+/nursing),
0.001079 mg/kg/day (<1% of the RfD); (c) females (13-19 years/not
pregnant or nursing), 0.000941 mg/kg/day (<1% of the RfD); (d) females
(20+ years/not pregnant or nursing), 0.000804 mg/kg/day (<1% of the
RfD); and (e) females (13-50 years), 0.000869 mg/kg/day (<1% of the
RfD). The acute risk from food exposure does not exceed the Agency's
level of concern.
ii. Chronic exposure and risk. A chronic risk assessment was
required for difenoconazole. The RfD used for the chronic analysis is
0.01 mg/kg based on the NOAEL of 0.96 mg/kg/day for male rats in the
104-week combined chronic and carcinogenicity study in rats, in which
the effects at the LOAEL were reduced body weight gains and
hepatocellular hypertrophy. The chronic Dietary Exposure Evaluation
Model (DEEM) exposure analysis used mean consumption (3-day average).
Anticipated residues and PCT or percent imported data were used for
selected commodities. The DEEM analysis evaluated the individual food
consumption as reported by respondents in the 1989-91 CSFII and
accumulated exposure to the chemical for each commodity. The FQPA
Safety Factor was reduced to 1x. Therefore, the chronic PAD and the RfD
are the same. The Agency's level of concern for chronic risk is
exceeded if the exposure utilizes more than 100% of the RfD. Food
exposures for the U.S. population and the most highly exposed subgroups
are: (a) U.S. Population (48 states), 0.000005 mg/kg/day; (b) non-
Hispanic (other than black or white), 0.000006 mg/kg/day; (c) all
infants (<1 year old), 0.000016 mg/kg/day; (d) nursing infants (<1 year
old), 0.000007 mg/kg/day; (e) non-nursing infants (<1 year old),
0.000019 mg/kg/day; (f) children (1-6 years old), 0.000011 mg/kg/day;
(g) children (7-12 years old), 0.000005 mg/kg/day; (h) females (13+/
nursing), 0.000006 mg/kg/day; and (i) seniors (55+), 0.000006 mg/kg/
day. The subgroups presented are all children subgroups and the food
exposures for the subgroups whose food exposures are higher than that
of the U.S. population. The chronic risk from residues in food does not
exceed the Agency's level of concern.
iii. Cancer exposure and risk. The Agency previously classified
difenoconazole as a possible human carcinogen. This chemical would now
be classified as a likely human carcinogen in accordance with the
Agency's ``Proposed Guidelines for Carcinogenic Risk Assessment''
(April 10, 1996). Initially a non-linear, MOE approach was used for
human risk characterization and extrapolation of risk using the 78-week
mouse carcinogenicity study, in which the LOAEL effects related to
tumor development (non-neoplastic hepatic lesions) were hepatocellular
hypertrophy, necrosis, fatty changes, and bile stasis. Using the NOAEL
of 4.7 mg/kg/day, the cancer MOE was determined to be 8,400 for the
U.S. population. However, at this time the Agency has not defined the
acceptable level of concern for cancer risk using the MOE approach.
Therefore, the linear Q1* approach was used for calculating
cancer risk. A Q1* of 0.157 (mg/kg/day)-1 was
determined, based on the male mouse liver adenoma and/or carcinoma
combined tumor rates in the 78-week carcinogenicity study in mice. The
exposure analysis estimating potential cancer risks for difenoconazole
was performed using anticipated residues and PCT or percent imported
refinements for selected commodities to determine Estimated Lifetime
Cancer Risk for the general population. The DEEM analysis evaluated the
individual food consumption as reported by respondents in the USDA
1989-91 nationwide CSFII and accumulated exposure to the chemical for
each commodity. The DEEM analysis used mean consumption values and
assumes a 70-year lifetime exposure. The exposure calculated for the
U.S. population (48 states) was 0.000005 mg/kg/day, providing a
lifetime cancer risk estimate of 8.4 x 10-7 from residues in
food. The cancer risk does not exceed the Agency's level of concern.
2. From drinking water. A Drinking Water Level of Comparison
(DWLOC) is a theoretical upper limit on a pesticide's concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, drinking water, and through residential uses. A DWLOC will vary,
depending on the toxic endpoint, with drinking water consumption and
body weights. Different populations will have different DWLOCs. The
Agency uses DWLOCs internally in the risk assessment process as a
surrogate measure of potential exposure through drinking water. In the
absence of monitoring data for pesticides, it is used as a point of
comparison against conservative model estimates of a pesticide's
concentration in water. DWLOC values are not regulatory standards for
drinking water but they do have an indirect regulatory impact through
aggregate exposure and risk assessments.
In calculating DWLOCs, the default assumptions for drinking water
consumption are 2 liters consumed per day by adults and 1 liter
consumed per day by children. The default assumptions for body weights
are 70 kg for adult males, 60 kg for adult females, and 10 kg for
children. Difenoconazole is used solely as a fungicidal seed treatment
and is not expected to pose a major threat to ground and surface
waters.
i. Acute exposure and risk. Model-derived estimates of the maximum
concentrations of difenoconazole for acute exposure in ground and
surface water are 0.125 parts per billion (ppb) and 0.00084 ppb,
respectively, generated by the Screening Concentration in Ground Water
(SCI-GROW) and Generic Expected Environmental Concentration (GENEEC)
models, respectively. The SCI-GROW and GENEEC model estimated maximum
concentrations were compared directly to the DWLOC for acute exposure.
The Agency has calculated the DWLOC for acute exposure to
difenoconazole in surface and ground water for females (13+ years old,
nursing) to be 7,500 ppb. To calculate the DWLOC for acute exposure
relative to an acute toxicity endpoint, the acute food exposure (from
the DEEM analysis) was subtracted from the acute RfD to obtain the
acceptable acute exposure to difenoconazole in drinking water. The
DWLOC was then calculated using the default body weights and drinking
water consumption figures. The maximum estimated concentrations of
difenoconazole in surface water are less than the Agency's DWLOCs for
difenoconazole in drinking water as a contribution to acute aggregate
exposure.
ii. Chronic exposure and risk. The SCI-GROW model was used to
estimate a maximum concentration of difenoconazole in ground water of
0.00084 ppb and the GENEEC model concentration was divided by three and
used to estimate an average concentration of difenoconazole in surface
water of 0.016 ppb. For chronic
[[Page 29585]]
(non-cancer) exposure to difenoconazole in surface and ground water,
the DWLOCs are 350 ppb for the U.S. population, 300 ppb for the
subgroup females (13+ years old/nursing), and 100 ppb for the subgroup
non-nursing infants (<1 year old). To calculate the DWLOC for chronic
(non-cancer) exposure relative to a chronic toxicity endpoint, the
chronic food exposure (from the DEEM analysis) was subtracted from the
RfD to obtain the acceptable chronic (non-cancer) exposure to
difenoconazole in drinking water. The maximum estimated concentration
of difenoconazole in surface water is less than the Agency's DWLOCs for
difenoconazole in drinking water as a contribution to chronic (non-
cancer) exposure.
iii. Cancer exposure and risk. Estimates generated by models of the
maximum concentration of difenoconazole for chronic exposure in ground
water is 0.00084 ppb (from the SCI-GROW model) and for the estimated
average concentration in surface water is 0.016 ppb (from the GENEEC
model). For chronic (cancer) exposure to difenoconazole in surface and
ground water, the DWLOC is 0.048 ppb for the U.S. population. To
calculate the DWLOC for chronic exposures relative to a carcinogenic
toxicity endpoint, the chronic (cancer) food exposure (from the DEEM
analysis) was subtracted from the ratio of the negligible cancer risk
to the Q1* to obtain the acceptable chronic (cancer)
exposure to difenoconazole in drinking water. DWLOCs were then
calculated using the default drinking water consumptions and body
weights. The average estimated concentration of difenoconazole in
surface water is less than the Agency's DWLOC for difenoconazole in
drinking water as a contribution to cancer aggregate exposure.
3. From non-dietary exposure. Difenoconazole is not currently
registered for use on residential non-food sites.
4. Cumulative exposure to substances with common mechanism of
toxicity. Difenoconazole is a member of the triazole class of
pesticides. Other members of this class include cyproconazole,
fenbuconazole, propiconazole, tebuconazole, and uniconazole. Section
408(b)(2)(D)(v) requires that, when considering whether to establish,
modify, or revoke a tolerance, the Agency considers ``available
information'' concerning the cumulative effects of a particular
pesticide's residues and ``other substances that have a common
mechanism of toxicity.'' While the Agency has some information in its
files that may be helpful in determining whether a pesticide shares a
common mechanism of toxicity with any other substances, EPA does not at
this time have the methodology to resolve the scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will enable it to develop and apply
policies for evaluating the cumulative effects of chemicals having a
common mechanism of toxicity. At present, however, the Agency does not
know how to apply the information in its files concerning common
mechanism issues to most risk assessments. There are pesticides as to
which the common mechanism issues can be resolved. These pesticides
include pesticides that are toxicologically dissimilar to existing
chemical substances (in which case the Agency can conclude that it is
unlikely that a pesticide shares a common mechanism of activity with
other substances) and pesticides that produce a common toxic metabolite
(in which case common mechanism will be assumed).
EPA does not have, at this time, available data to determine
whether difenoconazole has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
difenoconazole does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not assumed that difenoconazole has a comon
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide tolerances (62 FR 62961,
November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
There are no proposed or existing residential uses for
difenoconazole and occupational uses of difenoconazole will not result
in post-application residential exposure. Therefore, aggregate exposure
risk assessment has been limited to food and water only, using the
exposure estimates and risk characterizations described above.
1. Acute risk. From the acute food risk assessment, a high-end
exposure estimate was calculated for the subgroup females 13+ years
old. In this subgroup less than 1% of the RfD is occupied by food
exposure. The acute food exposure for females 13+ years old is below
the Agency's level of concern. An acute RfD is not established for the
general population including infants and children because there were no
effects observed in oral toxicity studies including maternal toxicity
in the developmental toxicity studies in rats and rabbits attributable
to a single exposure. The maximum estimated concentrations of
difenoconazole in surface and ground water are less than the Agency's
DWLOCs for difenoconazole as a contribution to acute aggregate
exposure. Therefore, the Agency concludes with reasonable certainty
that residues of difenoconazole in drinking water do not contribute
significantly to the aggregate acute human health risk at the present
time, considering the present uses and the uses proposed in this
action. EPA bases this determination on a comparison of estimated
concentrations of difenoconazole in surface waters and ground waters to
DWLOCs for difenoconazole. The estimated concentrations of
difenoconazole in surface and ground waters are derived from water
quality models that use conservative assumptions regarding pesticide
transport from the point of application to surface and ground water.
Because the Agency considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, DWLOC may vary as
those uses change. If new uses are added in the future, the Agency will
reassess the potential impacts of difenoconazole on drinking water as a
part of the aggregate acute risk assessment process.
2. Chronic risk. Chronic risk estimates associated with exposure to
difenoconazole in food and water do not exceed the Agency's level of
concern. The chronic DEEM food exposure analysis used mean consumption
(3-day average). Anticipated residues and PCT data for select
commodities were used to determine food exposure for the general
population and 28 subgroups. The Agency has concluded that the
percentage of the RfD that will be utilized by chronic food exposure to
residues of difenoconazole is less than 1% of the RfD for all groups
and subgroups. The estimated average concentrations of difenoconazole
in surface and ground water are less than the Agency's DWLOCs for
[[Page 29586]]
difenoconazole as a contribution to chronic dietary aggregate exposure.
Therefore, the Agency concludes with reasonable certainty that residues
of difenoconazole in drinking water do not contribute significantly to
the aggregate chronic human health risk at the present time considering
the present uses and the uses proposed in this action. The Agency bases
this determination on a comparison of estimated concentrations of
difenoconazole in surface and ground waters to DWLOCs for
difenoconazole. The estimates of difenoconazole in surface and ground
waters are derived from water quality models that use conservative
assumptions regarding pesticide transport from the point of application
to surface and ground water. Because the Agency considers the aggregate
risk resulting from multiple exposure pathways associated with a
pesticide's uses, DWLOCs may vary as those uses change. If new uses are
added in the future, OPP will reassess the potential impacts of
difenoconazole on drinking water as a part of the aggregate chronic
risk assessment process.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
Since no registered residential uses or exposure scenarios were
identified for short- and intermediate-term exposure scenarios, short-
and intermediate-term aggregate risks are deemed to be negligible.
4. Aggregate cancer risk for U.S. population. The DEEM cancer food
exposure analysis used anticipated residues and PCT information to
estimate the lifetime cancer risk for the general population. The food
exposure was calculated to be 0.000005 mg/kg/day and the lifetime
dietary risk was 8.4 x 10-7, since there are no uses
resulting in post-application exposure. The aggregate exposure for
cancer includes only food and water. Cancer risk estimates associated
with exposure to difenoconazole from food and water do not exceed the
Agency's level of concern.
The estimated average concentrations of difenoconazole in surface
and ground water are less than the Agency's DWLOCs for difenoconazole
as a contribution to cancer aggregate exposure. Therefore, the Agency
concludes with reasonable certainty that residues of difenoconazole in
drinking water do not contribute significantly to the aggregate chronic
human health risk at the present time considering the present use and
uses proposed in this action. The Agency bases this determination on a
comparison of estimated concentrations of difenoconazole in surface and
ground waters to DWLOCs for difenoconazole. The estimates of
difenoconazole in surface and ground waters are derived from water
quality models that use conservative assumptions regarding pesticide
transport from the point of application to surface and ground water.
Because the Agency considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, DWLOCs may vary
as those uses change. If new uses are added in the future, the Agency
will reassess the potential impacts of difenoconazole on drinking water
as a part of the aggregate cancer risk assessment process.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to difenoconazole residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of difenoconazole, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 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 postnatal toxicity and the
completeness of the data base 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. EPA believes that reliable data support using the standard
uncertainty factor (usually 100 for combined inter- and intra-species
variability) and not the additional tenfold MOE/uncertainty factor when
EPA has a complete data base under existing guidelines and when the
severity of the effect in infants or children or the potency or unusual
toxic properties of a compound do not raise concerns regarding the
adequacy of the standard MOE/safety factor.
ii. Pre- and postnatal sensitivity. The data provided no indication
of increased susceptibility of rats or rabbits to in utero or postnatal
exposure to difenoconazole.
iii. Conclusion. There is a complete toxicity data base for
difenoconazole and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures.
The FQPA 10x additional safety factor for infants and children was
reduced to 1x because: (a) The toxicology data base is complete, (b)
there is no indication of increased susceptibility of rat or rabbit
fetuses during in utero and/or postnatal exposure in the developmental
and reproductive toxicity data, (c) in the absence of complete
environmental fate data for difenoconazole and for protection of
infants and children, worst-case fate parameters will be used in the
models for ground and surface source drinking water exposure
assessments resulting in estimates that are upper-bound concentrations,
and (d) there are currently no registered residential uses for
difenoconazole and therefore, non-dietary exposure to infants and
children is not expected.
2. Acute risk. An acute RfD is not established for the general
population including infants and children because there were no effects
observed in oral toxicity studies including maternal toxicity in the
developmental toxicity studies in rats and rabbits attributable to a
single exposure. The Agency concludes that acute risks to infants and
children are negligible.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to difenoconazole from
food will utilize less than 1% of the RfD for infants and children. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. The estimated average concentrations of difenoconazole in
surface and ground water are less than the Agency's DWLOC for chronic
exposure among nursing infants (<1 year old) to difenoconazole. Despite
the potential for exposure to difenoconazole in drinking water and from
non-dietary, non-occupational exposure, EPA does not expect the
aggregate exposure to exceed 100% of the RfD.
4. Short- or intermediate-term risk. Since no registered
residential uses or exposure scenarios were identified for
[[Page 29587]]
short- and intermediate-term exposure scenarios among the general
population, short- and intermediate-term aggregate risk are negligible.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to difenoconazole
residues.
III. Other Considerations
A. Nature of the Residue In Plants and Animals
The nature of the residue in wheat is understood as a result of
acceptable metabolism studies being performed in wheat RACs. The major
terminal residues in wheat grain were the metabolites triazole and
triazole acetic acid, and in wheat straw and forage were triazole
alanine, triazole acetic acid, and CGA-205375. Parent difenoconazole
was not detected in the grain and comprised <8% of the total
recoverable residue (TRR) in forage and <0.4% of the TRR in straw. The
nature of the residue is also understood in tomatoes, potatoes, and
grapes, with the major terminal residues consisting of parent compound
and triazole alanine in tomatoes, triazole alanine and conjugation with
a number of naturally occurring substrates in potatoes, and metabolism
of parent by hydroxylation of the phenyl ring and/or oxidative cleavage
of the dioxolane ring, followed by cleavage of the carbon-carbon bridge
between the phenyl and triazole rings. Similar results were observed in
the wheat, tomato, and potato metabolism studies. Since the nature of
the residue is understood in different crops, no metabolism studies for
bananas were required. The Agency concluded that none of the
difenoconazole metabolites warrant inclusion in the tolerance
regulation or separate regulation or inclusion in the dietary risk
assessment or additional metabolism or toxicological studies. The
triazole metabolites (triazole, triazole alanine, triazole acetic acid)
have previously been determined not to be of toxicological concern.
CGA-205375 was determined not to be of concern due to the low potential
for residues associated with seed treatment. This conclusion can be
expanded to include triazole propanoic acid. Only the parent compound
difenoconazole will be used in the tolerance expression.
The nature of the residue in animals is considered understood, for
the purposes of the proposed uses, because the triazole metabolites
have previously been determined not to be of toxicological concern and
because CGA-205375 was determined not to be of concern due to the low
potential for residues associated with seed treatment. The additional
animal metabolite triazole propanoic acid was also determined not to be
of concern because of the low residue potential associated with seed
treatment.
B. Analytical Enforcement Methodology
The registrant proposed Method AG-575B as the analytical
enforcement method for banana and wheat. Detection is then achieved by
gas chromatography (GC) with a nitrogen/phosphorous detector. A
confirmatory method, AG-657, differing from the enforcement method in
the GC column and detector used, achieved good results in bananas
fortified with difenoconazole. The Agency concludes that method AG-575B
is adequate for enforcement purposes. The Agency has validated this
method.
The registrant proposed method AG-544A as the analytical
enforcement method for dairy and poultry tissue, eggs, and milk. The
Agency concludes that method AG-544A is adequate for enforcement
purposes. The Agency has validated this method.
Adequate enforcement methodology (e.g., gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 101FF, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.
C. Magnitude of Residues
1. Wheat. For wheat, 15 field trials were conducted in 13 states.
The wheat field trials were conducted at two application rates, 10.9
grams active ingredient (a.i.) per 100 lb. seed (1x) and 21.8 grams
a.i. per 100 lb. seed (2x). The residue levels of difenoconazole in
wheat grain (<0.01 ppm) and in wheat hay and straw (0.05 ppm) were less
than the limit of quantitation (LOQ). The LOQ for wheat grain is 0.01
ppm and 0.05 ppm in wheat straw, hay, and forage. Wheat forage had
levels ranging from <0.05 ppm to 0.077 ppm. The submitted data indicate
that residues of difenoconazole will not exceed the tolerance for wheat
RACs. The Agency has previously reviewed a processing study for spring
wheat which was seed-treated (2x) and also foliar treated (10x) 28 days
before harvest. No residues (<0.01 ppm) were detected in grain or any
processed fraction.
2. Bananas. Nine field trials were conducted in Columbia, Honduras,
and Ecuador. Field trials in each country were conducted at the single
maximum application rate 0.22 lb. a.i. per hectare. Difenoconazole was
applied 8 times for a total maximum application rate of 1.76 lb. a.i.
per hectare. At each site whole banana fruit were collected zero days
after the last application from the unbagged racemes (bunches). The
residue levels of difenoconazole in whole bananas ranged from <0.02 to
0.13 ppm. The residue levels in banana pulp were all less than the LOQ
(0.02 ppm). The residue levels in banana peel ranged from <0.02 to 0.25
ppm. An additional six field trials had been submitted and reviewed
previously. These field trials were conducted in Costa Rica, Ecuador,
Mexico, Guatemala, and Belize. Residue levels in these six field trials
ranged from 0.03 to 0.16 ppm in whole unbagged bananas and <0.02 to
0.03 ppm in unbagged banana pulp. The submitted data indicate that
residues of difenoconazole will not exceed the proposed tolerance level
of 0.2 ppm for bananas. There are no processed commodities associated
with bananas and therefore no tolerances for processed commodities are
required.
3. Meat, milk, poultry, and eggs. The registrant requested a waiver
for animal feeding studies based on the low potential for residues in
feed items and the exaggerated rates used in the animal feeding
studies. For now, the Agency is willing to accept the registrant's
proposal to allow the animal metabolism studies to also serve as
feeding studies. Feeding studies in cattle and poultry, as appropriate,
will be needed for any future tolerance requested on potential
livestock feed commodities which could lead to higher residues of
concern in meat, milk, and eggs.
D. International Residue Limits
There are pending Codex Maximum Residue Levels for this compound in
Mexico for oats, wheat, and barley.
E. Rotational Crop Restrictions
The nature of the residue is understood. The data indicate that the
phenyl/triazole bridge of difenoconazole is cleaved in the soil and
that triazole-specific metabolites are preferentially taken up by the
rotational crops. The maximum TRR observed with phenyl-labeled
difenoconazole was 0.009 ppm (wheat stalks) and with triazole-labeled
difenoconazole was 0.314 ppm in wheat grain. The registrant has
submitted the results of two confined crop rotation studies using
phenyl-labeled difenoconazole. In the raw agricultural commodities of
all rotational crops
[[Page 29588]]
planted 30-33 days after application of difenoconazole, the TRR was
<0.01 ppm. These results support the proposed 30 -day plantback
restrictions for all rotational crops.
IV. Conclusion
Therefore, tolerances are established for the fungicide
difenoconazole (((2S,4R)/(2R,4S)/(2R,4R)/(2S,4S) 1-(2-(4-(4-
chlorophenoxy)-2-chlorophenyl)-4-methyl-1,3-dioxolan-2-yl)methyl-1H-
1,2,4-triazole) in or on the raw agricultural commodities bananas at
0.2 ppm; eggs at 0.05 ppm; fat of cattle, goats, hogs, horses, poultry,
and sheep at 0.05 ppm; meat of cattle, goats, hogs, horses, poultry,
and sheep at 0.05 ppm; and meat byproducts of cattle, goats, hogs,
horses, poultry, and sheep at 0.05 ppm; milk at 0.01 ppm; wheat forage
at 0.1 ppm; wheat grain at 0.1 ppm; and wheat straw at 0.1 ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by August 2, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
regulation. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, [email protected]. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number OPP-300863 (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[email protected]
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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) (Pub. L. 104-4). Nor does
it require any special considerations as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or require OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4,
[[Page 29589]]
1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy
of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
VIII. Submission to Congress and the Comptroller General
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 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 the rule in the Federal Register. This 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: May 25, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a) and 371.
2. Section 180.475 is revised to read as follows:
Sec. 180.475 Difenoconazole; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide difenoconazole (((2S,4R)/(2R,4S)/(2R,4R)/(2S,4S)) (1-((2-(2-
chloro-4-(4-chlorophenoxy)phenyl)-4-methyl-1,3- dioxolan-2-yl)methyl)-
1H-1,2,4-triazole) in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.................................... 0.05
Cattle, meat................................... 0.05
Cattle, meat byproducts........................ 0.05
Eggs........................................... 0.05
Goats, fat..................................... 0.05
Goats, meat.................................... 0.05
Goats, meat byproducts......................... 0.05
Hogs, fat...................................... 0.05
Hogs, meat..................................... 0.05
Hogs, meat byproducts.......................... 0.05
Horses, fat.................................... 0.05
Horses, meat................................... 0.05
Horses, meat byproducts........................ 0.05
Milk........................................... 0.01
Poultry, fat................................... 0.05
Poultry, meat.................................. 0.05
Poultry, meat byproducts....................... 0.05
Sheep, fat..................................... 0.05
Sheep, meat.................................... 0.05
Sheep, meat byproducts......................... 0.05
Wheat, forage.................................. 0.1
Wheat, grain................................... 0.1
Wheat, straw................................... 0.1
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations.
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Commodity Parts per million
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Bananas\1\..................................... 0.2
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\1\There are no U.S. registrations.
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 99-13947 Filed 6-1-99; 8:45 am]
BILLING CODE 6560-50-F