Fenbuconazole; Pesticide Tolerances, 55293-55300 [06-7957]
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55293
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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: September 12, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.579 is amended by
adding text and a table to paragraph (b)
to read as follows:
I
§ 180.579 Fenamidone; tolerances for
residues.
*
*
*
*
*
(b) Section 18 emergency exemptions.
A time-limited tolerance is established
for residues of the fungicide
fenamidone, (4H-imidazol-4-one, 3,5dihydro-5-methyl-2-(methylthio)-5phenyl-3-(phenylamino), (S)-) in
connection with use of the pesticide
under a section 18 emergency
exemption granted by EPA. The
tolerance will expire and is revoked on
the date specified in the following table:
Commodity
Parts per million
Carrot ...........................................................................................................................................................
[FR Doc. 06–7956 Filed 9–21–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0053; FRL–8093–9]
Fenbuconazole; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
fenbuconazole, a–(2–(4–chlorophenyl)–
ethyl)–a–phenyl–3–(1H–1,2,4–triazole)–
1–propanenitrile, and its metabolites
RH–9129, cis–5–(4–chlorophenyl)–
dihydro–3–phenyl–3–(1H–1,2,4–
triazole–1–ylmethyl)–2–3H–furanone,
and RH–9130, trans–5–(4–
chlorophenyl)–dihydro–3–phenyl–3–
(1H–1,2,4–triazole–1–ylmethyl)–2–3H–
furanone, in or on almond; almond,
hulls; apple; apple wet pomace; banana;
beet, sugar, dried pulp; beet, sugar,
molasses; beet, sugar, roots; beet, sugar,
tops; bushberry subgroup 13B; cattle,
meat byproducts; citrus, dried pulp;
citrus, oil; cranberry; fruit, citrus, group
10; fruit, stone, group 12; goat, meat
byproducts; grain, aspirated fractions;
grape; horse, meat byproducts; peanut;
pecan; sheep, meat byproducts; wheat,
forage; wheat, grain; wheat, hay; and
wheat, straw. EPA is also deleting
several existing tolerances that are no
longer needed as a result of this action.
Dow AgroSciences requested these
tolerances under the Federal Food,
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Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
DATES: This regulation is effective
September 22, 2006. Objections and
requests for hearings must be received
on or before November 21, 2006, 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–2005–0053. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Tony Kish, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
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0.20
Expiration/revocation date
12/31/2009
(703) 308–9443; e–mail address:
kish.tony@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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.
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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the 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–2005–0053 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 November 21, 2006.
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–2005–0053, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on–
line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
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arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of July 20,
2005, 70 FR 41718 (FRL–7702–7), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 0E6208, PP
1E6252, PP 1F3989, PP 1F3995, PP
2F4127, PP 2F4135, PP 2F4154, PP
3F4914, PP 4F6879, PP 7F4887, PP
9E5041, and PP 9F6024) by Dow
AgroSciences LLC, 9330 Zionsville
Road, Indianapolis, Indiana 46268–
1054. The petition requested that 40
CFR 180.480 be amended by
establishing tolerances for combined
residues of the fungicide fenbuconazole,
a–(2–(4–chlorophenyl)–ethyl)–a–
phenyl–3–(1H–1,2,4–triazole)–1–
propanenitrile, and its metabolites cis–
5–(4–chlorophenyl)–dihydro–3–
phenyl–3–(1H–1,2,4–triazole–1–
ylmethyl)–2–3H–furanone and trans–5–
(4–chlorophenyl)–dihydro–3–phenyl–
3–(1H–1,2,4–triazole–1–ylmethyl)–2–
3H–furanone, in or on almond at 0.05
parts per million (ppm) (PP 3F4194);
almond, hulls at 3.0 ppm (PP 3F4194);
apple at 0.4 ppm (PP 2F4135); apple,
wet pomace at 1.0 ppm (PP 2F4135);
banana at 0.3 ppm (PP 2F4154);
blueberry at 0.3 ppm (PP 9E5041);
cranberry at 1.0 ppm (PP 1E6252); fruit,
citrus, group 10 at 1.0 ppm (PPs 7F4900
and 4F6879); fruit, stone, group 12
(except plum, prune) at 2.0 ppm (PP
1F3989); grape at 1.0 ppm (PP 0E6208);
pecan at 0.1 ppm (PP 1F3995); plum at
2.0 ppm (PP 1F3989); plum, prune,
dried at 7.0 ppm (PP 1F3989); sugar
beet, dried pulp at 1.0 ppm (PP 7F4887);
sugar beet, molasses at 0.4 ppm (PP
7F4887); sugar beet, roots at 0.2 ppm
(PP 7F4887); sugar beet, tops at 9.0 ppm
(PP 7F4887); wheat, grain at 0.05 ppm
(PP 2F4127); and wheat, straw (PP
2F4127) at 10.0 ppm; establishing
tolerances for combined residues of the
fungicide fenbuconazole, a–(2–(4–
chlorophenyl)–ethyl)–a–phenyl–3–(1H–
1,2,4–triazole)–1–propanenitrile, and its
metabolite a–(2–(4–chloro–3–(D–
glucopyranosyloxy)–phenyl)ethyl)–a–
phenyl–1H–1,2,4–triazole–1–
propanenitrile, in or on peanut at 0.1
ppm (PP 9F6024) and peanut, hay at 20
ppm (PP 9F6024); by establishing
tolerances for combined residues of the
fungicide fenbuconazole, a–(2–(4–
chlorophenyl)–ethyl)–a–phenyl–3–(1H–
1,2,4–triazole)–1–propanenitrile, and its
metabolites cis–5–(4–chlorophenyl)–
dihydro–3–phenyl–3–(1H–1,2,4–
triazole–1–ylmethyl)–2–3H–furanone,
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trans–5–(4–chlorophenyl)–dihydro–3–
phenyl–3–(1H–1,2,4–triazole–1–
ylmethyl)–2–3H–furanone, and 4–
chloro–a–hydroxymethyl–a–phenyl–
benzenebutanenitrile in or on fat of
cattle, goats, hogs, horses, and sheep at
0.05 ppm (PP 2F4127), and liver of
cattle, goats, hogs, horses, and sheep at
0.3 ppm (PP 2F4127). That notice
included a summary of the petition
prepared by Dow AgroSciences LLC, the
registrant. There were no comments
received in response to the notice of
filing.
EPA is also deleting several
established time–limited tolerances in
§ 180.480(b) that are no longer needed.
These revisions are as follows:
i. Delete the cattle, goat, horse, and
sheep meat byproducts tolerances, each
for 0.01 ppm and expiring on December
31, 2008. These tolerances are replaced
by permanent tolerances of 0.05 ppm for
cattle, goat, horse, and sheep meat
byproducts, respectively.
ii. Delete the grapefruit tolerance of
0.5 ppm that expires on December 31,
2008. It is replaced by a permanent
tolerance of 1.0 ppm for fruit, citrus,
group 10.
iii. Delete the grapefruit, dried pulp
tolerance of 4.0 ppm that expires on
December 31, 2008. It is replaced by a
permanent tolerance of 5.0 ppm for
citrus, dried pulp.
iv. Delete the grapefruit, oil tolerance
of 35 ppm that expires on December 31,
2008. It is replaced by a permanent
tolerance of 40.0 ppm for citrus, oil.
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....’’
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 the
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FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA–PEST/1997/
November/Day–26/p30948.htm, https://
www.epa.gov/oppfead1/trac/science,
https://www.epa.gov/pesticides/
factsheets/riskassess.htm, and https://
www.epa.gov/pesticides/trac/science/
aggregate.pdf.
III. Aggregate Risk Assessment and
Determination of Safety
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 and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for tolerances for combined
residues of fenbuconazole, a–(2–(4–
chlorophenyl)–ethyl)–a–phenyl–3–(1H–
1,2,4–triazole)–1–propanenitrile), and
its metabolites RH–9129, cis–5–(4–
chlorophenyl)–dihydro–3–phenyl–3–
(1H–1,2,4–triazole–1–ylmethyl)–2–3H–
furanone, and RH–9130, trans–5–(4–
chlorophenyl)–dihydro–3–phenyl–3–
(1H–1,2,4–triazole–1–ylmethyl)–2–3H–
furanone, in or on almond at 0.05 ppm;
almond, hulls at 1.0 ppm; apple at 0.4
ppm; apple, wet pomace at 1.0 ppm;
banana at 0.3 ppm; beet, sugar, dried
pulp at 1.0 ppm; beet, sugar, molasses
at 0.4 ppm; beet, sugar, roots at 0.3 ppm;
beet, sugar, tops at 9.0 ppm; bushberry
subgroup 13B at 0.3 ppm; cattle, meat
byproducts at 0.05 ppm; citrus, dried
pulp at 5.0 ppm; citrus, oil at 40.0 ppm;
cranberry at 0.5 ppm; goat, meat
byproducts at 0.05 ppm; fruit, citrus,
group 10 at 1.0 ppm; fruit, stone, group
12 at 1.0 ppm; grain, aspirated fractions
at 6.0 ppm; grape at 1.0 ppm; horse,
meat byproducts at 0.05 ppm; peanut at
0.1 ppm; pecan at 0.05 ppm; sheep,
meat byproducts at 0.05 ppm; wheat,
forage at 4.0 ppm; wheat, grain at 0.1
ppm; wheat, hay at 8.0 ppm; and wheat,
straw at 8.0 ppm. EPA’s assessment of
exposures and risks associated with
establishing the tolerances follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
fenbuconazole as well as the no–
observed–adverse–effect–level (NOAEL)
and the lowest–observed–adverse–
effect–level (LOAEL) from the toxicity
studies can be found at https://
www.regulations.gov, Docket
Identification (ID) Number EPA–HQ–
OPP–2005–0053.
55295
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, 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 level
of concern (LOC). 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.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for fenbuconazole used for
human risk assessment is shown below
in Table 1 of this document.
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN RISK
ASSESSMENT
Dose Used in Risk Assessment;
Interspecies and Intraspecies and
any Traditional UF
Special FQPA Safety Factor
(SF); Level of Concern for Risk
Assessment
Study; Endpoint and Toxicological Effects
Acute Dietary (Females 13-49
years of age)
NOAEL = 30 mg/kg/day;
UF = 100; Acute RfD1 = 0.3 mg/kg/
day
Special FQPA SF = 1;
aPAD = acute RfD1 ÷ Special
FQPA SF = 0.3 mg/kg/day
Rat developmental study;
Developmental LOAEL = 75 mg/
kg/day based on increased resorptions and decreased live
fetuses per dam
Acute Dietary (General population including infants and
children)
No NOAEL was identified; UF is not
applicable; no Acute RfD1 was
calculated.
Special FQPA SF is not applicable; no aPAD2 was calculated.
No study was selected because
no appropriate dose and endpoint could be identified for
this population group
Chronic Dietary (All populations)
NOAEL= 3 mg/kg/day; UF = 100;
Chronic RfD1 = 0.03 mg/kg/day.
Special FQPA SF = 1; cPAD3 =
chronic RfD1 ÷ Special FQPA
SF = 0.03 mg/kg/day.
Rat combined chronic toxicity/
carcinogenicity study;
LOAEL = 30.6 mg/kg/day for
males and 43.1 mg/kg/day for
females based on decreased
body weight gain, increased
thyroid
weight,
and
histopathological lesions in the
liver and thyroid gland
Incidental Oral (all durations)
No NOAEL was identified; UF is not
applicable; no RfD1 was calculated.
Special FQPA SF is not applicable; no LOC was determined.
No study was selected because
no registered uses would result in residential exposure
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Exposure Scenario
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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENBUCONAZOLE FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Dose Used in Risk Assessment;
Interspecies and Intraspecies and
any Traditional UF
Special FQPA Safety Factor
(SF); Level of Concern for Risk
Assessment
Study; Endpoint and Toxicological Effects
Long-Term Dermal (several
months to lifetime)
Oral study NOAEL= 3 mg/kg/day
(dermal absorption rate = 4.25%).
Residential LOC for MOE4 = not
applicable;.
Occupational LOC for MOE =
100
Rat combined chronic toxicity/
carcinogenicity study;
LOAEL = 30.6 mg/kg/day for
males and 43.1 mg/kg/day for
females based on decreased
body weight gain, increased
thyroid
weight,
and
histopathological lesions in the
liver and thyroid gland
Inhalation (all durations)
Oral study NOAEL= 3 mg/kg/day;
Absorption factor = 100%).
Residential LOC for MOE4 = not
applicable;.
Occupational LOC for MOE =
100
Rat combined chronic toxicity/
carcinogenicity study;
LOAEL = 30.6 mg/kg/day for
males and 43.1 mg/kg/day for
females based on decreased
body weight gain, increased
thyroid
weight,
and
histopathological lesions in the
liver and thyroid gland
Cancer (oral, dermal, inhalation)
Classification: Under the 1986 cancer classification scheme, fenbuconazole was classified as a Group C Possible Human Carcinogen with a low dose extrapolation model applied to the animal data for the quantification of human risk (Q1*). This was based on increased incidence of hepatocellular adenomas and carcinomas in male and female mice and of thyroid follicular adenomas and combined adenomas/carcinomas
in male rats. Based on mechanistic data, quantification of risk was derived using combined hepatocellular
adenomas/carcinomas in female mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-1, is 3.59 x
10-3 in human equivalents.
Exposure Scenario
1RfD means ‘‘Reference Dose’’; 2aPAD means ‘‘acute Population Adjusted Dose’’; 3cPAD means ‘‘chronic Population Adjusted Dose; 4MOE
means ‘‘Margin of Exposure’’
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have previously
been established (40 CFR 180.480) for
the combined residues of fenbuconazole
and its metabolites RH-9129 and RH9130, in or on a variety of raw
agricultural commodities. These raw
agricultural commodities include fat,
meat, and meat byproducts of cattle,
goat, hog, horse, and sheep. Risk
assessments were conducted by EPA to
assess dietary exposures from
fenbuconazole in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide if
a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure.
The Dietary Exposure Evaluation
Model (DEEMTM) 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 following assumptions
were made for the acute exposure
assessments: The acute dietary (food
plus water) assessment was very
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conservative — a screening level, Tier 1
assessment. It was based on tolerancelevel residues and assumed that 100%
of each crop was treated with
fenbuconazole. For water exposure the
assessment used the estimated
maximum peak concentration of
fenbuconazole in surface water that was
calculated from the requested use
pattern for cherries, a worst-case
estimate. The only population subgroup
that is relevant for this acute assessment
is females (13-49 years old).
ii. Chronic (non-cancer) exposure. In
conducting this chronic dietary risk
assessment the Dietary Exposure
Evaluation Model (DEEMTM) 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
following assumptions were made for
the chronic exposure assessments: The
chronic (non-cancer) dietary assessment
included contributions from both food
and water. This analysis is more refined
than the acute dietary assessment in that
it uses average residues from field trials.
Due to the manner in which these data
were submitted and reviewed, multiple
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averages were calculated for many of the
crops. For these crops the highest
average was used in the analysis. The
non-cancer chronic dietary analysis
assumed 100% crop treated and the
annual average estimated surface water
concentration from the cherry use.
iii. Cancer. The cancer dietary
assessment used the same food residue
inputs as those of the non-cancer
assessment—average residues from field
trials and 100% crop treated for all
crops. The water component of this
assessment used the estimated 30–year
average surface water concentration
from the cherry use.
iv. Anticipated residue information.
Section 408(b)(2)(E) of the FFDCA
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,
pursuant to section 408(f)(1), 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. For the present
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action, EPA will issue such data call-ins
for information relating to anticipated
residues as are required by FFDCA
section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such
data call-ins will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
Anticipated residue data were used in
the chronic (non-cancer) and cancer
dietary risk analyses but not in the acute
dietary risk analysis. The anticipated
residues used were the highest perstudy-volume average residue from the
field trial studies for each crop that were
submitted by the registrant.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
fenbuconazole in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
fenbuconazole. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and SCIGROW models, the estimated
environmental concentrations (EECs) of
fenbuconazole for acute exposures are
estimated to be 20.3 parts per billion
(ppb) for surface water and 0.031 ppb
for ground water. The EECs for chronic
(non-cancer) and for cancer exposures
are estimated to be 16.5 ppb for surface
water and 0.031 ppb for ground water.
3. From non-dietary exposure. Where
the term ‘‘residential exposure’’ is used
in this document, it refers to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets). However,
fenbuconazole is not registered for any
use that will result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the 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.’’
Fenbuconazole 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
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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 https://www.epa.gov/
pesticides/cumulative.
Fenbuconazole is a triazole-derived
pesticide. This class of compounds can
form the common metabolite 1,2,4triazole and two triazole conjugates
(triazole alanine and triazole acetic
acid). To support existing tolerances
and to establish new tolerances for
triazole-derivative pesticides, including
fenbuconazole, U.S. EPA conducted a
human health risk assessment for
exposure to 1,2,4-triazole, triazole
alanine, and triazole acetic acid
resulting from the use of all current and
pending uses of any triazole-derived
fungicide. The risk assessment is a
highly conservative, screening-level
evaluation in terms of hazards
associated with common metabolites
(e.g., use of a maximum combination of
uncertainty factors) and potential
dietary and non-dietary exposures (i.e.,
high end estimates of both dietary and
non-dietary exposures). In addition, the
Agency retained the additional 10X
FQPA safety factor for the protection of
infants and children. The assessment
includes evaluations of risks for various
subgroups, including those comprised
of infants and children. The Agency’s
complete risk assessment is found in the
propiconazole reregistration docket at
https://www.regulations.gov, Docket
Identification (ID) Number EPA–HQ–
OPP–2005–0497.
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D. 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 prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data 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. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
The data provided no indication of
increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure to
fenbuconazole. In the prenatal
developmental study in rats and rabbits
and the 2-generation study in rats,
effects in the offspring were observed
only at or above those treatment levels
which resulted in maternal toxicity.
The degree of concern for infants and
children exposed to fenbuconazole in
utero and/or postnatally is low; there
are no residual uncertainties. The
toxicology database for fenbuconazole is
complete and adequate for risk
assessment purposes. Acceptable
developmental studies in rats and
rabbits and the 2-generation
reproduction study in rats did not show
evidence of increased susceptibility in
offspring exposed to fenbuconazole in
utero and/or postnatally. A NOAEL for
acute effects has been selected for the
subpopulation females (13-49 years old)
based on developmental effects
(increased resorptions and decreased
live fetuses per dam) seen at the LOAEL
in the developmental rat study. By
regulating on the effect of concern for
this subpopulation, the risk assessment
is protective of potential effects to
infants and children. No acute effects of
fenbuconazole were identified in any of
the other studies.
3. Conclusion. There is a complete
toxicity data base for fenbuconazole and
exposure data are complete or are
estimated based on data that reasonably
account for potential exposures. The
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FQPA safety factor was therefore
removed (i.e., reduced to 1x) in
assessing the risk posed by
fenbuconazole, based on the following
considerations:
i. There are no toxicology data gaps
for the assessment of the effects of
fenbuconazole; a developmental
neurotoxicity study is not required.
ii. There is no indication of
quantitative or qualitative susceptibility
of rats or rabbits to in utero and/or
postnatal exposure to fenbuconazole.
iii. The dietary exposure assessment
is based on models and input
parameters designed to be protective of
human health.
iv. At this time, there are no registered
residential uses for fenbuconazole, so
this type of exposure to infants and
children is not expected.
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E. Aggregate Risks and Determination of
Safety
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute exposure to
fenbuconazole from dietary (food plus
water) consumption was calculated only
for the population subgroup females
(13-49 years old). It will occupy 3% of
the aPAD for this subgroup based on a
95th percentile acute dietary exposure of
0.009014 mg/kg/day. The surface water
concentration that was used in this
analysis was 20.3 ppb. Because of the
toxicology of fenbuconazole, an acute
risk analysis is not relevant for the
general U.S. population or any other
population subgroup.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has calculated
that chronic dietary exposure to
fenbuconazole from food plus water will
utilize 2% of the cPAD for the general
U.S. population, 7% of the cPAD for all
infants (less than 1 year old), and 6% of
the cPAD for children (1-2 years old).
There are no residential uses for
fenbuconazole that result in chronic
residential exposure to fenbuconazole.
The surface water concentration of
fenbuconazole that was used for the
general U.S. population and each
population subgroup in this analysis
was 16.5 ppb. EPA does not expect the
aggregate exposure to exceed 100% of
the cPAD for the general U.S.
population or any subgroup of it, as
shown below, in Table 2 of this
document.
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TABLE 2.—AGGREGATE RISK ASSESS- characterization of changes in risk
MENT FOR CHRONIC (NON-CANCER) which might result from potential risk
mitigation. This rounding procedure
EXPOSURE TO FENBUCONAZOLE
Population/
Subgroup
Exposure
(mg/kg/day)
General U.S.
Population
0.000666
2
All Infants (>1
Year Old)
0.002016
7
Children (1-2
Years Old)
0.001795
6
Children (3-5
Years Old)
0.001408
5
Children (6-12
Years Old)
0.000783
3
Youth (13-19
Years Old)
0.000419
1
Adults (20-49
Years Old)
0.000525
2
Adults (50+
Years Old)
0.000612
2
Females (1349 Years
Old)
0.000539
2
% cPAD
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate
exposures take into account residential
exposure plus chronic exposure to food
and water (considered to be a
background exposure level).
Fenbuconazole is not registered for use
on any site(s) that would result in
residential exposure. Therefore, the
aggregate risks are the sums of the risks
from food and water, which do not
exceed the Agency’s level of concern.
4. Aggregate cancer risk for U.S.
population. Dietary exposure (food plus
water) is the only source of exposure to
fenbuconazole that is expected to be
chronic (cancer exposure is considered
to be life-time exposure). The chronic
(cancer) aggregate exposure and risk
estimates are based on those for the
general U.S. population group. In this
case the risk is based on a cancer
potency (Q1*) value of 3.59 x 10-3 and
a dietary exposure to fenbuconazole of
0.000666 mg/kg/day. The dietary
exposure is the same as that used for the
chronic (non-cancer) assessment. The
estimated cancer risk that resulted from
this assessment is 2.4 x 10-6. In general,
the precision which can be assumed for
cancer risk estimates is best described
by rounding to the nearest integral order
of magnitude on the log scale, e.g., 3.16
x 10-7 to 3.16 x 10-6, expressed as 10-6.
Risks are generally reported to two
significant figures in Agency risk
assessments to allow better
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indicates that risks should generally not
be assumed to exceed the benchmark
level of concern of 1 x 10-6 until the
calculated risks exceed approximately 3
x 10-6. Therefore, the Agency considers
this risk estimate to be negligible
because it falls within the range of 1 in
1 million. In addition, the cancer risk
estimate for fenbuconazole is overstated due to very conservative exposure
assumptions. The exposure estimate
used in the cancer risk assessment
assumes that 100 percent of crops
covered by tolerances are treated and
that all crops contain residues at the
highest per-study-volume average
residue found in crop field trials using
maximum, or greater than maximum,
permitted application amounts.
5. Determination of safety. Based on
these risk assessments, EPA therefore
concludes that there is a reasonable
certainty that no harm will result to the
general population, infants, or children
from aggregate exposure to
fenbuconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography with nitrogenphosphorus detection) is available to
enforce the tolerance expression. The
method may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
B. International Residue Limits
Codex MRL’s are established on
bananas and pecans at 0.05 ppm, wheat
grain at 0.1 ppm, peach at 0.5 ppm,
cherries at 1.0 ppm, and wheat straw at
3.0 ppm. Although the residue
definitions differ (i.e., Codex does not
include the metabolites), the U.S.
tolerances for pecans and wheat grain
match the Codex limits numerically.
The U.S. stone fruit crop group
tolerance of 1.0 ppm is consistent with
the highest Codex MRL on an individual
member (cherries) of that crop group. In
the cases of bananas and wheat straw,
the levels of total residues in the U.S.
tolerance expression (which includes
fenbuconazole metabolites) are higher
than the Codex MRL (which excludes
these metabolites). Therefore, EPA has
not harmonized these values.
V. Conclusion
Therefore, tolerances are established
for combined residues of fenbuconazole,
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rwilkins on PROD1PC63 with RULES_1
a-(2-(4-chlorophenyl)-ethyl)-a-phenyl-3(1H-1,2,4-triazole)-1-propanenitrile and
its metabolites cis-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-triazole-1ylmethyl)-2-3H-furanone and trans-5-(4chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3Hfuranone, expressed as fenbuconazole,
in or on almond at 0.05 ppm; almond,
hulls at 1.0 ppm; apple at 0.4 ppm;
apple, wet pomace at 1.0 ppm; banana
at 0.3 ppm; beet, sugar, dried pulp at 1.0
ppm; beet, sugar, molasses at 0.4 ppm;
beet, sugar, roots at 0.3 ppm; beet, sugar,
tops at 9.0 ppm; bushberry subgroup
13B at 0.3 ppm; cattle, meat byproducts
at 0.05 ppm; citrus, dried pulp at 5.0
ppm; citrus, oil at 40.0 ppm; cranberry
at 0.5 ppm; fruit, citrus, group 10 at 1.0
ppm; fruit, stone, group 12 at 1.0 ppm;
goat, meat byproducts at 0.05 ppm;
grain, aspirated fractions at 6.0 ppm;
grape at 1.0 ppm; horse, meat
byproducts at 0.05 ppm; peanut at 0.1
ppm; pecan at 0.05 ppm; sheep, meat
byproducts at 0.05 ppm; wheat, forage at
4.0 ppm; wheat, grain at 0.1 ppm;
wheat, hay at 8.0 ppm; and wheat, straw
at 8.0 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 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
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Jkt 208001
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 petition
under section 408(d) of FFDCA, such as
the tolerances 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
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55299
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.
VII. 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: September 13, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.480 is amended in
paragraph (a)(1) by revising the table
and in paragraph (b), in the table, by
removing the commodities cattle, meat
byproducts; goat, meat byproducts;
grapefruit; grapefruit, dried pulp;
grapefruit, oil; horse, meat by products;
and sheep, meat byproducts.
The amendment reads as follows:
I
§ 180.480
residues.
Fenbuconazole; tolerances for
(a) General. (1) * * *
Commodity
Almond ............................
Almond, hulls ..................
Apple ...............................
Apple, wet pomace .........
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0.05
1.0
0.4
1.0
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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations
Commodity
Parts per million
Banana ...........................
Beet, sugar, dried pulp ...
Beet, sugar, molasses ....
Beet, sugar, roots ...........
Beet, sugar, tops ............
Bushberry subgroup 13B
Cattle, meat byproducts
Citrus, dried pulp ............
Citrus, oil .........................
Cranberry ........................
Fruit, citrus, group 10 .....
Fruit, stone, group 12 .....
Goat, meat byproducts ...
Grain, aspirated fractions
Grape1 ............................
Horse, meat byproducts
Peanut ............................
Pecan ..............................
Sheep, meat byproducts
Wheat, forage .................
Wheat, grain ...................
Wheat, hay .....................
Wheat, straw ...................
0.3
1.0
0.4
0.3
9.0
0.3
0.05
5.0
40.0
0.5
1.0
1.0
0.05
6.0
1.0
0.05
0.1
0.05
0.05
4.0
0.1
8.0
8.0
1There are no United States registrations for
grape as of August 2006.
*
*
*
*
*
[FR Doc. 06–7957 Filed 9–21–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
[EPA–HQ–OPP–2006–0347; FRL–8092–1]
Propiconazole; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
rwilkins on PROD1PC63 with RULES_1
AGENCY:
SUMMARY: This regulation establishes or
revises tolerances for combined residues
of propiconazole and its metabolites
containing the dichlorobenzoic acid
(DCBA) moiety expressed as parent
compound in or on various
commodities; and inadvertent residues
in or on alfalfa, forage and alfalfa, hay.
Syngenta Crop Protection, Inc. and
Interregional Research Project No. 4 (IR4), requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective
September 22, 2006. Objections and
requests for hearings must be received
on or before November 21, 2006, 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–2006–0347. All documents in the
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Jkt 208001
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Mary Waller, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9354; e-mail address:
waller.mary@epa.gov.
SUPPLEMENTARY 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 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the 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–2006–0347 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 November 21, 2006.
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–2006–0347, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
E:\FR\FM\22SER1.SGM
22SER1
]]>Agencies
[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55293-55300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7957]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0053; FRL-8093-9]
Fenbuconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-
(1H-1,2,4-triazole)-1-propanenitrile, and its metabolites RH-9129, cis-
5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on almond; almond,
hulls; apple; apple wet pomace; banana; beet, sugar, dried pulp; beet,
sugar, molasses; beet, sugar, roots; beet, sugar, tops; bushberry
subgroup 13B; cattle, meat byproducts; citrus, dried pulp; citrus, oil;
cranberry; fruit, citrus, group 10; fruit, stone, group 12; goat, meat
byproducts; grain, aspirated fractions; grape; horse, meat byproducts;
peanut; pecan; sheep, meat byproducts; wheat, forage; wheat, grain;
wheat, hay; and wheat, straw. EPA is also deleting several existing
tolerances that are no longer needed as a result of this action. Dow
AgroSciences requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
of 1996 (FQPA).
DATES: This regulation is effective September 22, 2006. Objections and
requests for hearings must be received on or before November 21, 2006,
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-2005-0053. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9443; e-mail address: kish.tony@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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.
[[Page 55294]]
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the 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-2005-0053 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 November 21, 2006.
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-2005-0053, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of July 20, 2005, 70 FR 41718 (FRL-7702-7),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of pesticide petitions (PP 0E6208, PP
1E6252, PP 1F3989, PP 1F3995, PP 2F4127, PP 2F4135, PP 2F4154, PP
3F4914, PP 4F6879, PP 7F4887, PP 9E5041, and PP 9F6024) by Dow
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, Indiana 46268-
1054. The petition requested that 40 CFR 180.480 be amended by
establishing tolerances for combined residues of the fungicide
fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile, and its metabolites cis-5-(4-
chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-
furanone and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone, in or on almond at 0.05 parts per
million (ppm) (PP 3F4194); almond, hulls at 3.0 ppm (PP 3F4194); apple
at 0.4 ppm (PP 2F4135); apple, wet pomace at 1.0 ppm (PP 2F4135);
banana at 0.3 ppm (PP 2F4154); blueberry at 0.3 ppm (PP 9E5041);
cranberry at 1.0 ppm (PP 1E6252); fruit, citrus, group 10 at 1.0 ppm
(PPs 7F4900 and 4F6879); fruit, stone, group 12 (except plum, prune) at
2.0 ppm (PP 1F3989); grape at 1.0 ppm (PP 0E6208); pecan at 0.1 ppm (PP
1F3995); plum at 2.0 ppm (PP 1F3989); plum, prune, dried at 7.0 ppm (PP
1F3989); sugar beet, dried pulp at 1.0 ppm (PP 7F4887); sugar beet,
molasses at 0.4 ppm (PP 7F4887); sugar beet, roots at 0.2 ppm (PP
7F4887); sugar beet, tops at 9.0 ppm (PP 7F4887); wheat, grain at 0.05
ppm (PP 2F4127); and wheat, straw (PP 2F4127) at 10.0 ppm; establishing
tolerances for combined residues of the fungicide fenbuconazole,
[alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-1,2,4-
triazole)-1-propanenitrile, and its metabolite [alpha]-(2-(4-chloro-3-
(D-glucopyranosyloxy)-phenyl)ethyl)-[alpha]-phenyl-1H-1,2,4-triazole-1-
propanenitrile, in or on peanut at 0.1 ppm (PP 9F6024) and peanut, hay
at 20 ppm (PP 9F6024); by establishing tolerances for combined residues
of the fungicide fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-
[alpha]-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile, and its
metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone, trans-5-(4-chlorophenyl)-dihydro-3-
phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, and 4-chloro-
[alpha]-hydroxymethyl-[alpha]-phenyl-benzenebutanenitrile in or on fat
of cattle, goats, hogs, horses, and sheep at 0.05 ppm (PP 2F4127), and
liver of cattle, goats, hogs, horses, and sheep at 0.3 ppm (PP 2F4127).
That notice included a summary of the petition prepared by Dow
AgroSciences LLC, the registrant. There were no comments received in
response to the notice of filing.
EPA is also deleting several established time-limited tolerances in
Sec. 180.480(b) that are no longer needed. These revisions are as
follows:
i. Delete the cattle, goat, horse, and sheep meat byproducts
tolerances, each for 0.01 ppm and expiring on December 31, 2008. These
tolerances are replaced by permanent tolerances of 0.05 ppm for cattle,
goat, horse, and sheep meat byproducts, respectively.
ii. Delete the grapefruit tolerance of 0.5 ppm that expires on
December 31, 2008. It is replaced by a permanent tolerance of 1.0 ppm
for fruit, citrus, group 10.
iii. Delete the grapefruit, dried pulp tolerance of 4.0 ppm that
expires on December 31, 2008. It is replaced by a permanent tolerance
of 5.0 ppm for citrus, dried pulp.
iv. Delete the grapefruit, oil tolerance of 35 ppm that expires on
December 31, 2008. It is replaced by a permanent tolerance of 40.0 ppm
for citrus, oil.
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....''
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 the
[[Page 55295]]
FFDCA and a complete description of the risk assessment process, see
https://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm,
https://www.epa.gov/oppfead1/trac/science, https://www.epa.gov/
pesticides/factsheets/riskassess.htm, and https://www.epa.gov/
pesticides/trac/science/aggregate.pdf.
III. Aggregate Risk Assessment and Determination of Safety
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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for combined residues of
fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile), and its metabolites RH-9129, cis-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on almond at 0.05
ppm; almond, hulls at 1.0 ppm; apple at 0.4 ppm; apple, wet pomace at
1.0 ppm; banana at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet,
sugar, molasses at 0.4 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar,
tops at 9.0 ppm; bushberry subgroup 13B at 0.3 ppm; cattle, meat
byproducts at 0.05 ppm; citrus, dried pulp at 5.0 ppm; citrus, oil at
40.0 ppm; cranberry at 0.5 ppm; goat, meat byproducts at 0.05 ppm;
fruit, citrus, group 10 at 1.0 ppm; fruit, stone, group 12 at 1.0 ppm;
grain, aspirated fractions at 6.0 ppm; grape at 1.0 ppm; horse, meat
byproducts at 0.05 ppm; peanut at 0.1 ppm; pecan at 0.05 ppm; sheep,
meat byproducts at 0.05 ppm; wheat, forage at 4.0 ppm; wheat, grain at
0.1 ppm; wheat, hay at 8.0 ppm; and wheat, straw at 8.0 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by fenbuconazole as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-
0053.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, 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 level of
concern (LOC). 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.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for fenbuconazole used for
human risk assessment is shown below in Table 1 of this document.
Table 1.--Summary of Toxicological Dose and Endpoints for Fenbuconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment; Special FQPA Safety
Exposure Scenario Interspecies and Factor (SF); Level of Study; Endpoint and
Intraspecies and any Concern for Risk Toxicological Effects
Traditional UF Assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of NOAEL = 30 mg/kg/day; Special FQPA SF = 1; Rat developmental
age) UF = 100; Acute RfD\1\ aPAD = acute RfD\1\ / study;
= 0.3 mg/kg/day. Special FQPA SF = 0.3 Developmental LOAEL =
mg/kg/day. 75 mg/kg/day based on
increased resorptions
and decreased live
fetuses per dam
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population No NOAEL was Special FQPA SF is not No study was selected
including infants and children) identified; UF is not applicable; no aPAD\2\ because no appropriate
applicable; no Acute was calculated. dose and endpoint
RfD\1\ was calculated. could be identified
for this population
group
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 3 mg/kg/day; UF Special FQPA SF = 1; Rat combined chronic
= 100; Chronic RfD\1\ cPAD\3\ = chronic toxicity/
= 0.03 mg/kg/day. RfD\1\ / Special FQPA carcinogenicity study;
SF = 0.03 mg/kg/day. LOAEL = 30.6 mg/kg/day
for males and 43.1 mg/
kg/day for females
based on decreased
body weight gain,
increased thyroid
weight, and
histopathological
lesions in the liver
and thyroid gland
----------------------------------------------------------------------------------------------------------------
Incidental Oral (all durations) No NOAEL was Special FQPA SF is not No study was selected
identified; UF is not applicable; no LOC was because no registered
applicable; no RfD\1\ determined. uses would result in
was calculated. residential exposure
----------------------------------------------------------------------------------------------------------------
[[Page 55296]]
Long-Term Dermal (several months to Oral study NOAEL= 3 mg/ Residential LOC for Rat combined chronic
lifetime) kg/day (dermal MOE\4\ = not toxicity/
absorption rate = applicable;. carcinogenicity study;
4.25%). Occupational LOC for LOAEL = 30.6 mg/kg/day
MOE = 100. for males and 43.1 mg/
kg/day for females
based on decreased
body weight gain,
increased thyroid
weight, and
histopathological
lesions in the liver
and thyroid gland
----------------------------------------------------------------------------------------------------------------
Inhalation (all durations) Oral study NOAEL= 3 mg/ Residential LOC for Rat combined chronic
kg/day; Absorption MOE\4\ = not toxicity/
factor = 100%). applicable;. carcinogenicity study;
Occupational LOC for LOAEL = 30.6 mg/kg/day
MOE = 100. for males and 43.1 mg/
kg/day for females
based on decreased
body weight gain,
increased thyroid
weight, and
histopathological
lesions in the liver
and thyroid gland
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: Under the 1986 cancer classification scheme,
fenbuconazole was classified as a Group C - Possible Human Carcinogen
with a low dose extrapolation model applied to the animal data for the
quantification of human risk (Q1*). This was based on increased
incidence of hepatocellular adenomas and carcinomas in male and female
mice and of thyroid follicular adenomas and combined adenomas/carcinomas
in male rats. Based on mechanistic data, quantification of risk was
derived using combined hepatocellular adenomas/carcinomas in female
mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-\1\, is
3.59 x 10-\3\ in human equivalents.
----------------------------------------------------------------------------------------------------------------
\1\RfD means ``Reference Dose''; \2\aPAD means ``acute Population Adjusted Dose''; \3\cPAD means ``chronic
Population Adjusted Dose; \4\MOE means ``Margin of Exposure''
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have
previously been established (40 CFR 180.480) for the combined residues
of fenbuconazole and its metabolites RH-9129 and RH-9130, in or on a
variety of raw agricultural commodities. These raw agricultural
commodities include fat, meat, and meat byproducts of cattle, goat,
hog, horse, and sheep. Risk assessments were conducted by EPA to assess
dietary exposures from fenbuconazole in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
The Dietary Exposure Evaluation Model (DEEM\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 following assumptions were made for the acute exposure
assessments: The acute dietary (food plus water) assessment was very
conservative -- a screening level, Tier 1 assessment. It was based on
tolerance-level residues and assumed that 100% of each crop was treated
with fenbuconazole. For water exposure the assessment used the
estimated maximum peak concentration of fenbuconazole in surface water
that was calculated from the requested use pattern for cherries, a
worst-case estimate. The only population subgroup that is relevant for
this acute assessment is females (13-49 years old).
ii. Chronic (non-cancer) exposure. In conducting this chronic
dietary risk assessment the Dietary Exposure Evaluation Model
(DEEM\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 following
assumptions were made for the chronic exposure assessments: The chronic
(non-cancer) dietary assessment included contributions from both food
and water. This analysis is more refined than the acute dietary
assessment in that it uses average residues from field trials. Due to
the manner in which these data were submitted and reviewed, multiple
averages were calculated for many of the crops. For these crops the
highest average was used in the analysis. The non-cancer chronic
dietary analysis assumed 100% crop treated and the annual average
estimated surface water concentration from the cherry use.
iii. Cancer. The cancer dietary assessment used the same food
residue inputs as those of the non-cancer assessment--average residues
from field trials and 100% crop treated for all crops. The water
component of this assessment used the estimated 30-year average surface
water concentration from the cherry use.
iv. Anticipated residue information. Section 408(b)(2)(E) of the
FFDCA 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, pursuant to section 408(f)(1),
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. For the present
[[Page 55297]]
action, EPA will issue such data call-ins for information relating to
anticipated residues as are required by FFDCA section 408(b)(2)(E) and
authorized under FFDCA section 408(f)(1). Such data call-ins will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances. Anticipated residue data were used in the
chronic (non-cancer) and cancer dietary risk analyses but not in the
acute dietary risk analysis. The anticipated residues used were the
highest per-study-volume average residue from the field trial studies
for each crop that were submitted by the registrant.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenbuconazole in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fenbuconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the PRZM/EXAMS and SCI-GROW models, the estimated
environmental concentrations (EECs) of fenbuconazole for acute
exposures are estimated to be 20.3 parts per billion (ppb) for surface
water and 0.031 ppb for ground water. The EECs for chronic (non-cancer)
and for cancer exposures are estimated to be 16.5 ppb for surface water
and 0.031 ppb for ground water.
3. From non-dietary exposure. Where the term ``residential
exposure'' is used in this document, it refers 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).
However, fenbuconazole is not registered for any use that will result
in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
Fenbuconazole 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 https://www.epa.gov/pesticides/
cumulative.
Fenbuconazole 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 fenbuconazole, U.S. EPA
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic acid resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment is found in the propiconazole
reregistration docket at https://www.regulations.gov, Docket
Identification (ID) Number EPA-HQ-OPP-2005-0497.
D. 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 prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The data provided no
indication of increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to fenbuconazole. In the prenatal
developmental study in rats and rabbits and the 2-generation study in
rats, effects in the offspring were observed only at or above those
treatment levels which resulted in maternal toxicity.
The degree of concern for infants and children exposed to
fenbuconazole in utero and/or postnatally is low; there are no residual
uncertainties. The toxicology database for fenbuconazole is complete
and adequate for risk assessment purposes. Acceptable developmental
studies in rats and rabbits and the 2-generation reproduction study in
rats did not show evidence of increased susceptibility in offspring
exposed to fenbuconazole in utero and/or postnatally. A NOAEL for acute
effects has been selected for the subpopulation females (13-49 years
old) based on developmental effects (increased resorptions and
decreased live fetuses per dam) seen at the LOAEL in the developmental
rat study. By regulating on the effect of concern for this
subpopulation, the risk assessment is protective of potential effects
to infants and children. No acute effects of fenbuconazole were
identified in any of the other studies.
3. Conclusion. There is a complete toxicity data base for
fenbuconazole and exposure data are complete or are estimated based on
data that reasonably account for potential exposures. The
[[Page 55298]]
FQPA safety factor was therefore removed (i.e., reduced to 1x) in
assessing the risk posed by fenbuconazole, based on the following
considerations:
i. There are no toxicology data gaps for the assessment of the
effects of fenbuconazole; a developmental neurotoxicity study is not
required.
ii. There is no indication of quantitative or qualitative
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to fenbuconazole.
iii. The dietary exposure assessment is based on models and input
parameters designed to be protective of human health.
iv. At this time, there are no registered residential uses for
fenbuconazole, so this type of exposure to infants and children is not
expected.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute exposure to fenbuconazole from
dietary (food plus water) consumption was calculated only for the
population subgroup females (13-49 years old). It will occupy 3% of the
aPAD for this subgroup based on a 95\th\ percentile acute dietary
exposure of 0.009014 mg/kg/day. The surface water concentration that
was used in this analysis was 20.3 ppb. Because of the toxicology of
fenbuconazole, an acute risk analysis is not relevant for the general
U.S. population or any other population subgroup.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has calculated that chronic dietary
exposure to fenbuconazole from food plus water will utilize 2% of the
cPAD for the general U.S. population, 7% of the cPAD for all infants
(less than 1 year old), and 6% of the cPAD for children (1-2 years
old). There are no residential uses for fenbuconazole that result in
chronic residential exposure to fenbuconazole. The surface water
concentration of fenbuconazole that was used for the general U.S.
population and each population subgroup in this analysis was 16.5 ppb.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD
for the general U.S. population or any subgroup of it, as shown below,
in Table 2 of this document.
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
Fenbuconazole
------------------------------------------------------------------------
Exposure
Population/Subgroup (mg/kg/day) % cPAD
------------------------------------------------------------------------
General U.S. Population 0.000666 2
------------------------------------------------------------------------
All Infants (>1 Year Old) 0.002016 7
------------------------------------------------------------------------
Children (1-2 Years Old) 0.001795 6
------------------------------------------------------------------------
Children (3-5 Years Old) 0.001408 5
------------------------------------------------------------------------
Children (6-12 Years Old) 0.000783 3
------------------------------------------------------------------------
Youth (13-19 Years Old) 0.000419 1
------------------------------------------------------------------------
Adults (20-49 Years Old) 0.000525 2
------------------------------------------------------------------------
Adults (50+ Years Old) 0.000612 2
------------------------------------------------------------------------
Females (13-49 Years Old) 0.000539 2
------------------------------------------------------------------------
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Fenbuconazole is not registered for use on any site(s) that
would result in residential exposure. Therefore, the aggregate risks
are the sums of the risks from food and water, which do not exceed the
Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Dietary exposure
(food plus water) is the only source of exposure to fenbuconazole that
is expected to be chronic (cancer exposure is considered to be life-
time exposure). The chronic (cancer) aggregate exposure and risk
estimates are based on those for the general U.S. population group. In
this case the risk is based on a cancer potency (Q1*) value
of 3.59 x 10-\3\ and a dietary exposure to fenbuconazole of
0.000666 mg/kg/day. The dietary exposure is the same as that used for
the chronic (non-cancer) assessment. The estimated cancer risk that
resulted from this assessment is 2.4 x 10-\6\. In general,
the precision which can be assumed for cancer risk estimates is best
described by rounding to the nearest integral order of magnitude on the
log scale, e.g., 3.16 x 10-\7\ to 3.16 x 10-\6\,
expressed as 10-\6\. Risks are generally reported to two
significant figures in Agency risk assessments to allow better
characterization of changes in risk which might result from potential
risk mitigation. This rounding procedure indicates that risks should
generally not be assumed to exceed the benchmark level of concern of 1
x 10-\6\ until the calculated risks exceed approximately 3 x
10-\6\. Therefore, the Agency considers this risk estimate
to be negligible because it falls within the range of 1 in 1 million.
In addition, the cancer risk estimate for fenbuconazole is over-stated
due to very conservative exposure assumptions. The exposure estimate
used in the cancer risk assessment assumes that 100 percent of crops
covered by tolerances are treated and that all crops contain residues
at the highest per-study-volume average residue found in crop field
trials using maximum, or greater than maximum, permitted application
amounts.
5. Determination of safety. Based on these risk assessments, EPA
therefore concludes that there is a reasonable certainty that no harm
will result to the general population, infants, or children from
aggregate exposure to fenbuconazole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with nitrogen-
phosphorus detection) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
Codex MRL's are established on bananas and pecans at 0.05 ppm,
wheat grain at 0.1 ppm, peach at 0.5 ppm, cherries at 1.0 ppm, and
wheat straw at 3.0 ppm. Although the residue definitions differ (i.e.,
Codex does not include the metabolites), the U.S. tolerances for pecans
and wheat grain match the Codex limits numerically. The U.S. stone
fruit crop group tolerance of 1.0 ppm is consistent with the highest
Codex MRL on an individual member (cherries) of that crop group. In the
cases of bananas and wheat straw, the levels of total residues in the
U.S. tolerance expression (which includes fenbuconazole metabolites)
are higher than the Codex MRL (which excludes these metabolites).
Therefore, EPA has not harmonized these values.
V. Conclusion
Therefore, tolerances are established for combined residues of
fenbuconazole,
[[Page 55299]]
[alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-1,2,4-
triazole)-1-propanenitrile and its metabolites cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone and
trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-
ylmethyl)-2-3H-furanone, expressed as fenbuconazole, in or on almond at
0.05 ppm; almond, hulls at 1.0 ppm; apple at 0.4 ppm; apple, wet pomace
at 1.0 ppm; banana at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm;
beet, sugar, molasses at 0.4 ppm; beet, sugar, roots at 0.3 ppm; beet,
sugar, tops at 9.0 ppm; bushberry subgroup 13B at 0.3 ppm; cattle, meat
byproducts at 0.05 ppm; citrus, dried pulp at 5.0 ppm; citrus, oil at
40.0 ppm; cranberry at 0.5 ppm; fruit, citrus, group 10 at 1.0 ppm;
fruit, stone, group 12 at 1.0 ppm; goat, meat byproducts at 0.05 ppm;
grain, aspirated fractions at 6.0 ppm; grape at 1.0 ppm; horse, meat
byproducts at 0.05 ppm; peanut at 0.1 ppm; pecan at 0.05 ppm; sheep,
meat byproducts at 0.05 ppm; wheat, forage at 4.0 ppm; wheat, grain at
0.1 ppm; wheat, hay at 8.0 ppm; and wheat, straw at 8.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 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
petition under section 408(d) of FFDCA, such as the tolerances 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.
VII. 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: September 13, 2006.
Lois Rossi,
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 180.480 is amended in paragraph (a)(1) by revising the table
and in paragraph (b), in the table, by removing the commodities cattle,
meat byproducts; goat, meat byproducts; grapefruit; grapefruit, dried
pulp; grapefruit, oil; horse, meat by products; and sheep, meat
byproducts.
The amendment reads as follows:
Sec. 180.480 Fenbuconazole; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Almond............................................... 0.05
Almond, hulls........................................ 1.0
Apple................................................ 0.4
Apple, wet pomace.................................... 1.0
[[Page 55300]]
Banana............................................... 0.3
Beet, sugar, dried pulp.............................. 1.0
Beet, sugar, molasses................................ 0.4
Beet, sugar, roots................................... 0.3
Beet, sugar, tops.................................... 9.0
Bushberry subgroup 13B............................... 0.3
Cattle, meat byproducts.............................. 0.05
Citrus, dried pulp................................... 5.0
Citrus, oil.......................................... 40.0
Cranberry............................................ 0.5
Fruit, citrus, group 10.............................. 1.0
Fruit, stone, group 12............................... 1.0
Goat, meat byproducts................................ 0.05
Grain, aspirated fractions........................... 6.0
Grape\1\............................................. 1.0
Horse, meat byproducts............................... 0.05
Peanut............................................... 0.1
Pecan................................................ 0.05
Sheep, meat byproducts............................... 0.05
Wheat, forage........................................ 4.0
Wheat, grain......................................... 0.1
Wheat, hay........................................... 8.0
Wheat, straw......................................... 8.0
------------------------------------------------------------------------
\1\There are no United States registrations for grape as of August 2006.
* * * * *
[FR Doc. 06-7957 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S
