Terbacil; Pesticide Tolerance, 30811-30818 [E6-8275]
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Inert Ingredients
Limits
Uses
*
*
*
*
*
Sorbic acid (CAS Reg. No. 110–44–1) ............................................................. ........................................
*
*
*
*
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3. In § 180.920, the table is amended
by removing the entries for: Potassium
carbonate and vanillin and adding the
I
following two entries to the table to read
as follows:
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
Inert Ingredients
*
[Amended]
4. In § 180.930, the table is amended
by removing the entries for: Carnauba
wax (CAS Reg. No. 8015–86–9); glycerol
(glycerin); isopropyl alcohol; and
sodium benzoate.
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§ 180.940
[Amended]
5. Section 180.940 is amended as
follows:
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*
*
Limits
a. By removing from the table in
paragraph (a) the entries for 2-propanol
(isopropanol) and sodium bicarbonate.
b. By removing from the table in
paragraph (b) the entry for 2-propanol
(isopropanol).
c. By removing from the table in
paragraph (c) the entries for 2-propanol
(isopropanol) and sodium bicarbonate.
Buffering agent
Buffering agent
6. In § 180.950, the table in paragraph
(e) is amended by adding alphabetically
the following 12 entries to read as
follows:
I
§ 180.950 Tolerance exemptions for
minimal risk active and inert ingredients.
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*
*
(e) * * *
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Chemical Name
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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[EPA–HQ–OPP–2005–0215; FRL–8057–9]
Terbacil; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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SUMMARY: This regulation establishes a
tolerance for combined residues of
terbacil in or on watermelon. The
Interregional Research Project Number 4
(IR-4), on behalf of the registrant,
DuPont Crop Protection, requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of
1996 (FQPA). EPA is also deleting an
existing time-limited terbacil tolerance
that is no longer needed as a result of
this action.
This regulation is effective May
31, 2006. Objections and requests for
DATES:
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CAS Reg. No.
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Ascorbic acid (vitamin C) .....................................................................................................................................................
Beeswax ..............................................................................................................................................................................
Benzoic acid, sodium salt ....................................................................................................................................................
*
*
*
*
*
Carbonic acid, monopotassium salt ....................................................................................................................................
Carbonic acid, monosodium salt (sodium bicarbonate) ......................................................................................................
Carnauba wax ......................................................................................................................................................................
*
*
*
*
*
D-Glucitol (sorbitol) ..............................................................................................................................................................
Glycerol (glycerin) (1,2,3-propanetriol) ................................................................................................................................
*
*
*
*
*
2-Propanol (isopropyl alcohol) .............................................................................................................................................
*
*
*
*
*
Soap (The water soluble sodium or potassium salts of fatty acids produced by either the saponification of fats and
oils, or the neutralization of fatty acid). ............................................................................................................................
Sorbic acid, potassium salt ..................................................................................................................................................
*
*
*
*
*
Vanillin .................................................................................................................................................................................
*
*
*
*
*
[FR Doc. E6–8249 Filed 5–30–06; 8:45 am]
*
Uses
*
*
*
*
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Carbonic acid, dipotassium salt (CAS Reg. No. 584–08–7) ............................. ........................................
Carbonic acid, dipotassium salt, trihydrate (CAS Reg. No. 18662–52–7) ........ ........................................
*
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*
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§ 180.930
Preservative for formulations
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50–81–7
8012–89–3
532–32–1
298–14–6
144–55–8
8015–86–9
50–70–4
56–81–5
67–63–0
None
24634–61–5
121–33–5
hearings must be received on or before
July 31, 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).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0215. 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
ADDRESSES:
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Federal Register / Vol. 71, No. 104 / Wednesday, May 31, 2006 / Rules and Regulations
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 telephone
number for the Docket Facility is (703)
305–5805.
FOR FURTHER INFORMATION CONTACT:
Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7610; e-mail address:
jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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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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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. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gov/
opptsfrs/home/guidelin.htm.
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–2005–0215 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 July 31, 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–2005–0215, 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
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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
telephone number for the Docket
Facility is (703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of September
7, 2005 (70 FR 53180) (FRL–7731–1),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 3E6640) by IR-4,
on behalf of DuPont Crop Protection,
P.O. Box 30, Newark, Delaware 19714–
0030. The petition requested that 40
CFR 180.209 be amended by
establishing a tolerance for combined
residues of the herbicide terbacil, (3tert-butyl-5-chloro-6-methyluracil) and
its metabolites [3-tert-butyl-5-chloro-6hydroxymethyluracil], [6-chloro-2,3dihydro-7-hydroxymethyl 3,3-dimethyl5H-oxazolo(3,2-a) pyrimidin-5-one], and
[6-chloro-2,3-dihydro-3,3,7-trimethyl5H-oxazolo(3,2-a) pyrimidin-5-one], in
or on watermelon at 1.0 parts per
million (ppm). That notice included a
summary of the petition prepared by
DuPont Crop Protection, the registrant.
There were no comments received in
response to the notice of filing.
EPA is also deleting an established
tolerance in section 40 CFR 180.209(b)
that is no longer needed, as a result of
this action. The tolerance deletion
under section 40 CFR 180.209(b) is a
time-limited tolerance established under
section 18 emergency exemptions that is
superceded by the establishment of a
general tolerance for terbacil section 40
CFR 180.209(a). The revision to 40 CFR
180.209 is as follow:
Delete the time-limiting tolerance for
watermelon at 0.4 ppm under 40 CFR
180.209(b). Tolerance for watermelon at
1.0 ppm is established by this action
under 40 CFR 180.209(a).
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
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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
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
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A. Toxicological Profile
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 a tolerance for combined
residues of terbacil on watermelon at 1.0
ppm. EPA’s assessment of exposures
and risks associated with establishing
the tolerance follows.
EPA has evaluated the available
toxicity data and considered their
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
terbacil as well as the no observed
adverse effect level (NOAEL) and the
lowest observed adverse effect level
(LOAEL) from available toxicity studies
as summarized in Table 1 below:
TABLE 1: TOXICITY PROFILE FOR TERBACIL — SUBCHRONIC, CHRONIC AND OTHER TOXICITY
Study Type
Assessment Results
870.3100
90–Day oral toxicity rat
Dosage at 0, 8, 20, and 200 milligrams/kilogram/
day (mg/kg/day)
NOAEL = 500 ppm (20 mg/kg/day)
LOAEL = 5,000 ppm (200 mg/kg/day), based on
focal necrosis and triaditis in females (F),
vacuolization in males (M) and increased relative liver weight and hypertrophy of
hepatocytes in both sexes.
870.3200
21–Day dermal rabbit
Dosage at 0 and 5,000 mg/kg/day
NOAEL = 5,000 mg/kg/day
LOAEL was not established. There were no clinical signs of toxicity, gross or histopathologic
changes.
870.4100
Chronic oral 2–year dog
Dosage at 0, 1.0, 5.0, 50, and 200 mg/kg/day
NOAEL = 250 ppm (equivalent to 5.0 mg/kg/
day)
LOAEL = 2500 ppm (equivalent to 50 mg/kg/
day), based on increased relative thyroid
weights and thymic involution in both sexes.
870.4200
Carcinogenicity mouse
Dosage for M/F: 0/0, 6.5/8.0, 162/199, and 746/
895 mg/kg/day
NOAEL = 162 mg/kg/day
LOAEL = 746 mg/kg/day, based on increased
liver weights, hyperplastic nodules, necrosis,
and vacuolation in the liver in males.
There was no oncogenic potential at the doses
tested.
870.3700
Developmental toxicity rat
Dosage at 0, 24, 104 and 392 mg/kg/day
Maternal NOAEL was not established
Maternal LOAEL = 24 mg/kg/day based on decreased body weight gain.
Developmental NOAEL = 24 mg/kg/day
Developmental LOAEL = 104 mg/kg/day, based
on decreased number of live fetuses/litter.
870.3700
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Guideline No.
Developmental Toxicity rabbit
Dosage at 0, 30, 200, and 600 mg/kg/day
Maternal NOAEL = 200 mg/kg/day
Maternal LOAEL = 600 mg/kg/day, based on
mortality, clinical findings (anorexia, discharge), decreased body weight and body
weight gain.
Developmental NOAEL = 200 mg/kg/day
Developmental LOAEL = 600 mg/kg/day, based
on decreased body weight, increased incidence of skeletal malformations (fused ribs)
and increase frequency of skeletal variations.
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TABLE 1: TOXICITY PROFILE FOR TERBACIL — SUBCHRONIC, CHRONIC AND OTHER TOXICITY—Continued
Guideline No.
Study Type
Assessment Results
3–generation reproduction - rat
Dosage at 0, 2.0, and 10 mg/kg/day
Parental NOAEL = 50 ppm (equivalent to2.0 mg/
kg/day)
Parental LOAEL = 250 ppm (equivalent to 10
mg/kg/day) based on decreased body weight,
Reproductive NOAEL = 250 ppm (equivalent to
10 mg/kg/day)
Reproductive LOAEL was not established Offspring NOAEL = 250 ppm (equivalent to 10
mg/kg/day)
Offspring LOAEL was not established
870.4300
Combined Chronic Toxicity/Carcinogenicity rat
Dosage M/F: 0/0, 0.9/1.4, 58/83, 308/484 mg/kg/
day
NOAEL (M/F)= 58/1.4 mg/kg/day
LOAEL (M/F)= 308/83 mg/kg/day, based on decreased body weight and body weight gain
and increased absolute and relative liver
weights in males and females. There was no
oncogenic potential at the doses tested.
870.4300
Combined Chronic Toxicity/ Carcinogenicity rat
Dosage at 0, 2.0, 10 and 100/400 mg/kg/day)
Systemic NOAEL = 250 ppm (equivalent to 10
mg/kg/day)
Systemic LOAEL = 2,500/10,000 ppm (equivalent to 100/400 mg/kg/day) based on increased
mean
relative
liver
weights,
hepatocyte centrilobular hypertrophy in males
and females and vacuolation in females.
There was no oncogenic potential at the
doses tested.
870.5300
Mutagenic- (HGPRT)
Dosage at 0, 2, 3, 5 and 6 mM (-S9); 0, 1, 2,
2.5, 2.75, 3.25 and 3.50 mM (+S9)
Did not induce mutation in chinese hamster
ovary cells with or without metabolic activation.
870.5375
In vitro chromosome aberration assay CHO cells
Dosage at 0, 20, 100 and 500 mg/kg
Negative for clastogenic activity in the rat bone
marrow cytogenetic assay.
870.5500
Unscheduled DNA synthesis assay rat primary
hepatocyte
Dosage at 0, 0.010, 0.033, 0.10, 0.33, 1.0, 2.5,
5.0, 7.5, and 10 mM
Did not induce unscheduled DNA synthesis in
primary rat hepatocytes.
870.5100
Mutagenicity study (bacteriophage assay)
Did not show the suspected (5-bromo-uracil metabolite) mutagenic action.
870.7485
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870.3800
Metabolism study rat
Doseage at single doses of 6.5 or 500 mg/kg
Approximately 57–82% of the administered dose
was absorbed in 24 hours. Ninety one to
103% of radioactivity was recovered within 5
days; with 70 to 86% in urine and 14–28% in
feces. The major metabolites were glucuronide, sulfate and sulfate/N-acetylcysteine
conjugates. The primary metabolic pathway is
hydroxylation of the 6-methyl group to form
the alcohol which is conjugated to form the
glucuronide (35% of the dose) and the sulfate
derivatives (11%). Terbacil is also metabolized
to the 5-hydroxy intermediate, which is further
conjugated to form a sulfate derivative (17%).
There was no evidence suggestive of bioaccumulation.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which 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 LOAEL
is sometimes used for risk assessment if
no NOAEL was achieved in the
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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
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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
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characterization at https://www.epa.gov/
pesticide/health/human.htm.
A summary of the toxicological
endpoints for terbacil used for human
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risk assessment is presented in the
following Table 2:
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TERBACIL FOR USE IN HUMAN RISK ASSESSMENT
Exposure/Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
Level of Concern for Risk
Assessment
Study and Toxicological Effects
Acute Dietary
(General Population and Females 13–50 years of age)
NA
NA
An endpoint of concern attributable to a single
dose for the general population or female
13+ was not identified
Chronic dietary (All populations)
NOAEL= 1.4 mg/kg/day
UF = 100X
Chronic RfD = cRfD= 0.014
mg/kg/day
Special FQPA SF = 1X
cPAD = cRfD divided by
Special FQPA SF
= 0.014 mg/kg/day
Combined Chronic Toxicity/carcinogenicity rat
LOAEL = 83 mg/kg/day based on decreased
body weight and body weight gain in females
Short (1–30 days) and Intermediate (1–6 months) Term
Incidental oral
Oral NOAEL = 2.0 mg/kg/day
(inhalation absorption rate
= 100% oral equivalent)
LOC for margin of exposure (MOEs) <100 (occupational and residential)
3–Generation reproduction - rat
LOAEL = 10 mg/kg/day based on decreased
body weight
Dermal (any time period)
NA
NA
Quantification of dermal risk is not required;
the lack of dermal or systemic toxicity at
5,000 mg/kg (5X the limit dose) in a 21 day
dermal toxicity study in rats which indicates
poor dermal absorption.
Short- (1 to 30 days) and
Intermediate- (1 to 6 months)
term inhalation
NOAEL= 2.0 mg/kg/day (inhalation absorption rate =
100% oral equivalent)
LOC for MOEs <100 (residential)
3–Generation reproduction - rat
LOAEL = 10 mg/kg/day, based on decreased
body weight
Long-term inhalation (> 6
months)
Oral NOAEL= 1.4 mg/kg/day
(inhalation absorption rate
= 100% oral equivalent)
LOC for MOE <100 (residential and occupational)
Combined Chronic Toxicity/Carcinogeni-city rat
LOAEL = 83 mg/kg/day based on decreased
body weight and body weight gain in females
Cancer (oral, dermal, inhalation)
NA
NA
Classification: Not likely to be carcinogenic to
humans
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.209) for the
combined residues of terbacil, in or on
a variety of raw agricultural
commodities. Tolerances are currently
established for the combined residues of
terbacil, (3-tert-butyl-5-chloro-6methyluracil) and its metabolites [3-tertbutyl-5-chloro-6-hydroxymethyluracil],
[6-chloro-2,3-dihydro-7-hydroxymethyl
3,3-dimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], and [6-chloro-2,3dihydro-3,3,7-trimethyl-5H-oxazolo(3,2a) pyrimidin-5-one], calculated as
terbacil, in/on alfalfa, apple, asparagus,
blueberry, caneberry, peach,
peppermint, spearmint, strawberry, and
sugarcane ranging from 0.1–2.0 ppm. A
time-limited tolerance at 0.4 ppm in/on
watermelon is currently established
under section 18 exemption of the
FIFRA and scheduled to expire June 30,
2007. Tolerances in/on livestock are not
currently established. There are no feed
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commodities associated with
watermelon.
Risk assessments were conducted by
EPA to assess dietary exposures from
terbacil in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
An appropriate endpoint attributable
to a single dose for the general
population or females 13 years and
older was not identified in the
toxicological studies for terbacil;
therefore, a quantitative acute dietary
exposure assessment is not needed.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM ver. 2.3), which
incorporates food consumption data as
reported by respondents in the U.S.
Department of Agriculture (USDA)
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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 dietary
analysis incorporated tolerance level
residues, 100% crop treated, and
DEEMTM (ver 7.81) default processing
factors for all registered/proposed crops.
The chronic analysis also assumed the
Screening Concentration in Ground
Water (SCI-GROW) modeled water
estimates for all water sources (direct
and indirect). The ground water
estimate was generated using the
highest registered/proposed application
rate. Although rotational crop tolerances
are not currently established, the
Agency concluded that the dietary
analysis should incorporate residue
estimates for rotated crops. Of the
registered/proposed crops, alfalfa, mint,
strawberry, sugar cane, and watermelon
are crops which are rotated. Based on
the field rotational crop data (residues <
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= 0.19 ppm, 0.3–2.1 x the maximum
application rate, 30–day plant-back
intervals (PBIs)), the registered proposed
PBIs, and the application rates, residues
in/on crops rotated into alfalfa, mint,
and sugar cane fields which were
treated with terbacil are possible. Based
on the field rotational crop data, the
dietary analysis assumed a residue of
1.0 ppm for cereal grains and soybean
(these crops are commonly rotated into
alfalfa, mint, and sugarcane fields)
Based on the tolerances for the primary
crops (0.1–2.0 ppm) and the field
rotational crop data, EPA anticipates
that the 1.0 ppm residue for rotated
crops is conservative.
The Agency notes that the assessment
assumes, based on cultural practices,
that only cereal grains and soybean are
rotated into alfalfa, sugar cane, and mint
fields while the registered application
scenario for these crops permits the
rotation of any crop. When the residue
estimates used to generate the dietary
exposure estimates are taken in total
((SCI-GROW) drinking water estimates,
tolerance level residue, 100% crop
treated for all registered/proposed crops,
conservative residue estimates for cereal
grain and soybean rotation crops), EPA
concludes that chronic dietary exposure
to terbacil is likely to be less than the
estimates provided in this document.
iii. Cancer. Terbacil is classified as
not likely to be carcinogenic to humans
based on the lack of evidence of
carcinogenicity in a carcinogenicity
study in mice and two combined
chronic toxicity/carcinogenicity studies
in rats. Therefore, a cancer exposure
assessment was not performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for terbacil
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 terbacil. 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 Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and SCI-GROW
models, the estimated environmental
concentrations (EECs) of terbacil for
acute exposures are estimated to be 123
parts per billion (ppb) for surface water
and 111 ppb for ground water. The EECs
for chronic exposures are estimated to
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be 25.4 ppb for surface water and 111
ppb for ground water.
The drinking water estimates are
based upon the crop with the highest
application rate (sugarcane). The use of
terbacil on sugarcane has the highest
single application rate at 3.0 pounds
active ingredient/acre (lb ai/A), this
application rate was used in the PRZM/
EXAMS and SCI-GROW models to
estimate the concentrations of this
chemical in surface water and ground
water, respectively.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model
(DEEMTM - FCID). For chronic dietary
risk assessment, the annual average
concentration of 111 ppb was used to
access the contribution to drinking
water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Terbacil is not registered for use on
any sites that would result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
terbacil and any other substances and
terbacil does not appear to produce a
toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has not
assumed that terbacil has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s website at https://www.epa.gov/
pesticides/cumulative.
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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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. 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.
There is no indication of increased
susceptibility of rat and rabbit fetuses to
in utero and/or postnatal exposure to
terbacil.
3. Conclusion. There is a complete
toxicity database for terbacil and
exposure data are complete or are
estimated based on data that reasonably
account for potential exposures. Based
on analyses of available exposure data,
as outlined in Unit III.C.1.ii., the Agency
believes that exposure to terbacil from
existing and potential sources has been
adequately assessed and is likely to be
less than the estimates provided. EPA
concludes that the FQPA SF can be
reduced to 1x for the following reasons:
(i) There is no evidence of increased
susceptibility in rat and rabbit fetuses to
in utero exposure to terbacil; (ii) there
is no evidence of increased
susceptibility to terbacil following
prenatal exposure in a 3-generation
reproduction study in rats; (iii) there are
no residual toxicological uncertainties
or concerns for increased susceptibility;
(iv) there are well established NOAELs
and LOAELs in the developmental and
reproduction studies; (v) the
environmental fate database is adequate
to access the nature and magnitude of
the residue in drinking water; (vi) the
dietary exposure analysis assumed
tolerance-level residues and 100% crop
treated.
E. Aggregate Risks and Determination of
Safety
The Agency currently has two ways to
estimate total aggregate exposure to a
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pesticide from food, drinking water, and
residential uses. First, a screening
assessment can be used, in which the
Agency calculates drinking water levels
of comparison (DWLOCs) which are
used as a point of comparison against
estimated drinking water concentrations
(EDWCs). The DWLOC values are not
regulatory standards for drinking water,
but are theoretical upper limits on a
pesticide’s concentration in drinking
water in light of total aggregate exposure
to a pesticide in food and residential
uses. More information on the use of
DWLOCs in dietary aggregate risk
assessments can be found at https://
www.epa.gov/oppfead1/trac/science/
screeningsop.pdf.
More recently the Agency has used
another approach to estimate aggregate
exposure through food, residential and
drinking water pathways. In this
approach, modeled surface water and
ground water EDWCs are directly
incorporated into the dietary exposure
analysis, along with food. This provides
a more realistic estimate of exposure
because actual body weights and water
consumption from the CSFII are used.
The combined food and water exposures
are then added to estimated exposure
from residential sources to calculate
aggregate risks. The resulting exposure
and risk estimates are still considered to
be high end, due to the assumptions
used in developing drinking water
modeling inputs.
1. Acute risk. An endpoint of concern
attributable to a single exposure was not
identified in the hazard database and
therefore no acute risk is expected from
exposure to terbacil.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to terbacil from food and
water will utilize 40% of the cPAD for
the U.S. population, 99% of the cPAD
for all infants <1 year old
(subpopulations at greatest exposure),
and 94% of the cPAD for children 1–2
years old. There are no residential uses
for terbacil that result in chronic
residential exposure to terbacil. Based
on the use pattern, chronic residential
exposure to residues of terbacil is not
expected since there are no registered
residential use. The Agency believes
that exposure to terbacil from existing
and potential sources has been
adequately assessed and that chronic
exposure to terbacil is likely to be less
than the estimates provided in this
document as discussed in Unit III.C.1.ii.
3. Short-term and Intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
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to be a background exposure level).
Terbacil is not registered for use on any
sites that would result in residential
exposure. Therefore, the aggregate risk
is the sum of the risk from food and
water, which do not exceed the
Agency’s level of concern.
4. Aggregate cancer risk for U.S.
population. Terbacil has been classified
as ‘‘not likely to be carcinogenic to
humans’’ based on the results of a
carcinogenicity study in mice and the
combined chronic toxicity and
carcinogenicity study in rats. Therefore,
terbacil is not expected to pose a cancer
risk to humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to terbacil
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
There is a practical analytical method
gas chromatography/electron capture
detection (GC/ELCD) for detecting and
measuring levels of terbacil in or on
food with residues at or above the level
set by the terbacil tolerance(Method II of
PAM Vol. II). EPA has provided
information on this method to the Food
and Drug Administration (FDA). The
method is available to anyone who is
interested and 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
There are no Codex, Canadian, or
Mexican maximum residue limits in or
on watermelon.
C. Conditions of Registration
Data gaps exist as follow and are
required to be satisfactorily filled as
conditions of registration for this use.
1. Petition Method Validation (PMV)
of the plant method(s).
2. FDA multiresidue testing of terbacil
and its metabolites through protocol D.
3. Additional watermelon field trial,
conducted with application after crop
emergence, in Region 3 (n=1), 5 (n=1),
and 6 (n=1).
V. Conclusion
Therefore, tolerance is established for
combined residues of the herbicide,
terbacil (3-tert-butyl-5-chloro-6methyluracil) and its metabolites [3-tertbutyl-5-chloro-6-hydroxymethyluracil],
[6-chloro-2,3-dihydro-7-hydroxymethyl
3,3-dimethyl-5H-oxazolo(3,2-a)
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30817
pyrimidin-5-one], and [6-chloro-2,3dihydro-3,3,7-trimethyl-5H-oxazolo(3,2a) pyrimidin-5-one], calculated as
terbacil, in or on watermelon at 1.0
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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 tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
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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
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14:53 May 30, 2006
Jkt 208001
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.
May 16, 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 180.209 is revised to read
as follows:
I
§ 180.209 Terbacil; tolerances for
residues.
(a) General. Tolerances are
established for combined residues of the
herbicide terbacil, (3-tert-butyl-5-chloro6-methyluracil) and its metabolites [3tert-butyl-5-chloro-6hydroxymethyluracil], [6-chloro-2,3dihydro-7-hydroxymethyl 3,3-dimethyl5H-oxazolo(3,2-a) pyrimidin-5-one], and
[6-chloro-2,3-dihydro-3,3,7-trimethyl5H-oxazolo(3,2-a) pyrimidin-5-one],
calculated as terbacil, in or on the
following raw agricultural commodities:
Commodity
Parts per million
Alfalfa, forage .................
Alfalfa, hay ......................
Apple ...............................
Asparagus .......................
Blueberry ........................
Canebserry .....................
Peach ..............................
Peppermint, tops ............
Spearmint, tops ..............
Strawberry ......................
Sugarcane, cane ............
Watermelon ....................
1.0
2.0
0.3
0.4
0.2
0.2
0.2
2.0
2.0
0.1
0.4
1.0
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E6–8275 Filed 5–30–06; 8:45 am]
BILLING CODE 6560–50–S
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FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CG Docket No. 03–123; FCC 06–57]
Telecommunications Relay Services
and Speech-to-Speech Services for
Individuals With Hearing and Speech
Disabilities
Federal Communications
Commission.
ACTION: Clarification.
AGENCY:
SUMMARY: In this document, the
Commission addresses a petition
(Petition) requesting clarification that a
Video Relay Service (VRS) provider may
not receive compensation from the
Interstate telecommunications relay
service (TRS) Fund (Fund) if it blocks
calls to competing VRS providers from
equipment it gives to consumers.
DATES: Effective July 31, 2006.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Thomas Chandler, Consumer &
Governmental Affairs Bureau, Disability
Rights Office at (202) 418–1475 (voice),
(202) 418–0597 (TTY), or e-mail at
Thomas.Chandler@fcc.gov.
SUPPLEMENTARY INFORMATION: This
document does not contain new or
modified information collection
requirements subject to the PRA of
1995, Public Law 104–13. In addition, it
does not contain any new or modified
‘‘information collection burden for
small business concerns with fewer than
25 employees,’’ pursuant to the Small
Business Paperwork Relief Act of 2002,
Public Law 107–198, see 44 U.S.C. 3506
(c)(4). This is a summary of the
Commission’s document FCC 06–57,
Telecommunications Relay Services and
Speech-to-Speech Services for
Individuals with Hearing and Speech
Disabilities, Declaratory Ruling, CG
Docket No. 03–123, adopted May 3,
2006, released May 9, 2006 addressing
issues raised in the California Coalition
of Agencies Serving the Deaf and Hard
of Hearing (CCASDHH or Petitioner)
Petition for Declaratory Ruling: Petition
for Declaratory Ruling on
Interoperability, CC Docket No. 98–67,
CG Docket No. 03–123, filed February
15, 2005.
The full text of document FCC 06–57
and copies of any subsequently filed
documents in this matter will be
available for public inspection and
copying during regular business hours
at the FCC Reference Information
Center, Portals II, 445 12th Street, SW.,
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]]>Agencies
[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Rules and Regulations]
[Pages 30811-30818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8275]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0215; FRL-8057-9]
Terbacil; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for combined residues
of terbacil in or on watermelon. The Interregional Research Project
Number 4 (IR-4), on behalf of the registrant, DuPont Crop Protection,
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
EPA is also deleting an existing time-limited terbacil tolerance that
is no longer needed as a result of this action.
DATES: This regulation is effective May 31, 2006. Objections and
requests for hearings must be received on or before July 31, 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-2005-0215. 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
[[Page 30812]]
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 telephone number for the Docket Facility is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: jackson.sidney@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.
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. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gov/opptsfrs/home/guidelin.htm.
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-2005-0215 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 July 31, 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-2005-0215, 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
telephone number for the Docket Facility is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 7, 2005 (70 FR 53180) (FRL-
7731-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E6640) by IR-4, on behalf of DuPont Crop Protection, P.O. Box 30,
Newark, Delaware 19714-0030. The petition requested that 40 CFR 180.209
be amended by establishing a tolerance for combined residues of the
herbicide terbacil, (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], in or on watermelon at 1.0 parts per million (ppm).
That notice included a summary of the petition prepared by DuPont Crop
Protection, the registrant. There were no comments received in response
to the notice of filing.
EPA is also deleting an established tolerance in section 40 CFR
180.209(b) that is no longer needed, as a result of this action. The
tolerance deletion under section 40 CFR 180.209(b) is a time-limited
tolerance established under section 18 emergency exemptions that is
superceded by the establishment of a general tolerance for terbacil
section 40 CFR 180.209(a). The revision to 40 CFR 180.209 is as follow:
Delete the time-limiting tolerance for watermelon at 0.4 ppm under
40 CFR 180.209(b). Tolerance for watermelon at 1.0 ppm is established
by this action under 40 CFR 180.209(a).
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
[[Page 30813]]
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 FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
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 a tolerance for combined residues of terbacil
on watermelon at 1.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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 terbacil as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from available toxicity studies as summarized in Table 1
below:
Table 1: Toxicity Profile for Terbacil -- Subchronic, Chronic and Other
Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Assessment Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 500 ppm
toxicity rat (20 mg/kg/day)
Dosage at 0, 8, LOAEL = 5,000 ppm
20, and 200 (200 mg/kg/day),
milligrams/ based on focal
kilogram/day (mg/ necrosis and
kg/day). triaditis in
females (F),
vacuolization in
males (M) and
increased
relative liver
weight and
hypertrophy of
hepatocytes in
both sexes.
------------------------------------------------------------------------
870.3200 21-Day dermal NOAEL = 5,000 mg/
rabbit kg/day
Dosage at 0 and LOAEL was not
5,000 mg/kg/day. established.
There were no
clinical signs of
toxicity, gross
or
histopathologic
changes.
------------------------------------------------------------------------
870.4100 Chronic oral 2- NOAEL = 250 ppm
year dog (equivalent to
Dosage at 0, 1.0, 5.0 mg/kg/day)
5.0, 50, and 200 LOAEL = 2500 ppm
mg/kg/day. (equivalent to 50
mg/kg/day), based
on increased
relative thyroid
weights and
thymic involution
in both sexes.
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = 162 mg/kg/
mouse day
Dosage for M/F: 0/ LOAEL = 746 mg/kg/
0, 6.5/8.0, 162/ day, based on
199, and 746/895 increased liver
mg/kg/day. weights,
hyperplastic
nodules,
necrosis, and
vacuolation in
the liver in
males.
There was no
oncogenic
potential at the
doses tested.
------------------------------------------------------------------------
870.3700 Developmental Maternal NOAEL was
toxicity rat not established
Dosage at 0, 24, Maternal LOAEL =
104 and 392 mg/kg/ 24 mg/kg/day
day. based on
decreased body
weight gain.
Developmental
NOAEL = 24 mg/kg/
day
Developmental
LOAEL = 104 mg/kg/
day, based on
decreased number
of live fetuses/
litter.
------------------------------------------------------------------------
870.3700 Developmental Maternal NOAEL =
Toxicity rabbit 200 mg/kg/day
Dosage at 0, 30, Maternal LOAEL =
200, and 600 mg/ 600 mg/kg/day,
kg/day. based on
mortality,
clinical findings
(anorexia,
discharge),
decreased body
weight and body
weight gain.
Developmental
NOAEL = 200 mg/kg/
day
Developmental
LOAEL = 600 mg/kg/
day, based on
decreased body
weight, increased
incidence of
skeletal
malformations
(fused ribs) and
increase
frequency of
skeletal
variations.
------------------------------------------------------------------------
[[Page 30814]]
870.3800 3-generation Parental NOAEL =
reproduction - 50 ppm
rat (equivalent to2.0
Dosage at 0, 2.0, mg/kg/day)
and 10 mg/kg/day. Parental LOAEL =
250 ppm
(equivalent to 10
mg/kg/day) based
on decreased body
weight,
Reproductive NOAEL
= 250 ppm
(equivalent to 10
mg/kg/day)
Reproductive LOAEL
was not
established
Offspring NOAEL =
250 ppm
(equivalent to 10
mg/kg/day)
Offspring LOAEL
was not
established
------------------------------------------------------------------------
870.4300 Combined Chronic NOAEL (M/F)= 58/
Toxicity/ 1.4 mg/kg/day
Carcinogenicity LOAEL (M/F)= 308/
rat 83 mg/kg/day,
Dosage M/F: 0/0, based on
0.9/1.4, 58/83, decreased body
308/484 mg/kg/day. weight and body
weight gain and
increased
absolute and
relative liver
weights in males
and females.
There was no
oncogenic
potential at the
doses tested.
------------------------------------------------------------------------
870.4300 Combined Chronic Systemic NOAEL =
Toxicity/ 250 ppm
Carcinogenicity (equivalent to 10
rat mg/kg/day)
Dosage at 0, 2.0, Systemic LOAEL =
10 and 100/400 mg/ 2,500/10,000 ppm
kg/day). (equivalent to
100/400 mg/kg/
day) based on
increased mean
relative liver
weights,
hepatocyte
centrilobular
hypertrophy in
males and females
and vacuolation
in females. There
was no oncogenic
potential at the
doses tested.
------------------------------------------------------------------------
870.5300 Mutagenic- (HGPRT) Did not induce
Dosage at 0, 2, 3, mutation in
5 and 6 mM (-S9); chinese hamster
0, 1, 2, 2.5, ovary cells with
2.75, 3.25 and or without
3.50 mM (+S9). metabolic
activation.
------------------------------------------------------------------------
870.5375 In vitro Negative for
chromosome clastogenic
aberration assay activity in the
CHO cells rat bone marrow
Dosage at 0, 20, cytogenetic
100 and 500 mg/kg. assay.
------------------------------------------------------------------------
870.5500 Unscheduled DNA Did not induce
synthesis assay unscheduled DNA
rat primary synthesis in
hepatocyte primary rat
Dosage at 0, hepatocytes.
0.010, 0.033,
0.10, 0.33, 1.0,
2.5, 5.0, 7.5,
and 10 mM.
------------------------------------------------------------------------
870.5100 Mutagenicity Did not show the
study suspected (5-
(bacteriophage bromo-uracil
assay) metabolite)
mutagenic action.
------------------------------------------------------------------------
870.7485 Metabolism study Approximately 57-
rat 82% of the
Doseage at single administered dose
doses of 6.5 or was absorbed in
500 mg/kg. 24 hours. Ninety
one to 103% of
radioactivity was
recovered within
5 days; with 70
to 86% in urine
and 14-28% in
feces. The major
metabolites were
glucuronide,
sulfate and
sulfate/N-
acetylcysteine
conjugates. The
primary metabolic
pathway is
hydroxylation of
the 6-methyl
group to form the
alcohol which is
conjugated to
form the
glucuronide (35%
of the dose) and
the sulfate
derivatives
(11%). Terbacil
is also
metabolized to
the 5-hydroxy
intermediate,
which is further
conjugated to
form a sulfate
derivative (17%).
There was no
evidence
suggestive of
bioaccumulation.
------------------------------------------------------------------------
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which 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 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
[[Page 30815]]
characterization at https://www.epa.gov/pesticide/health/human.htm.
A summary of the toxicological endpoints for terbacil used for
human risk assessment is presented in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for terbacil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary NA NA An endpoint of concern
(General Population and Females 13-50 attributable to a
years of age). single dose for the
general population or
female 13+ was not
identified
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 1.4 mg/kg/day Special FQPA SF = 1X Combined Chronic
UF = 100X.............. cPAD = cRfD divided by. Toxicity/
Chronic RfD = cRfD= Special FQPA SF........ carcinogenicity - rat
0.014 mg/kg/day. = 0.014 mg/kg/day..... LOAEL = 83 mg/kg/day
based on decreased
body weight and body
weight gain in females
----------------------------------------------------------------------------------------------------------------
Short (1-30 days) and Intermediate (1- Oral NOAEL = 2.0 mg/kg/ LOC for margin of 3-Generation
6 months) Term Incidental oral day (inhalation exposure (MOEs) <100 reproduction - rat
absorption rate = 100% (occupational and LOAEL = 10 mg/kg/day
oral equivalent) residential) based on decreased
body weight
----------------------------------------------------------------------------------------------------------------
Dermal (any time period) NA NA Quantification of
dermal risk is not
required; the lack of
dermal or systemic
toxicity at 5,000 mg/
kg (5X the limit dose)
in a 21 day dermal
toxicity study in rats
which indicates poor
dermal absorption.
----------------------------------------------------------------------------------------------------------------
Short- (1 to 30 days) and NOAEL= 2.0 mg/kg/day LOC for MOEs <100 3-Generation
Intermediate- (1 to 6 months) term (inhalation absorption (residential) reproduction - rat
inhalation rate = 100% oral LOAEL = 10 mg/kg/day,
equivalent) based on decreased
body weight
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (> 6 months) Oral NOAEL= 1.4 mg/kg/ LOC for MOE <100 Combined Chronic
day (inhalation (residential and Toxicity/Carcinogeni-
absorption rate = 100% occupational) city - rat
oral equivalent) LOAEL = 83 mg/kg/day
based on decreased
body weight and body
weight gain in females
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) NA NA Classification: Not
likely to be
carcinogenic to humans
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.209) for the combined residues of terbacil, in
or on a variety of raw agricultural commodities. Tolerances are
currently established for the combined residues of terbacil, (3-tert-
butyl-5-chloro-6-methyluracil) and its metabolites [3-tert-butyl-5-
chloro-6-hydroxymethyluracil], [6-chloro-2,3-dihydro-7-hydroxymethyl
3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-one], and [6-chloro-2,3-
dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a) pyrimidin-5-one], calculated
as terbacil, in/on alfalfa, apple, asparagus, blueberry, caneberry,
peach, peppermint, spearmint, strawberry, and sugarcane ranging from
0.1-2.0 ppm. A time-limited tolerance at 0.4 ppm in/on watermelon is
currently established under section 18 exemption of the FIFRA and
scheduled to expire June 30, 2007. Tolerances in/on livestock are not
currently established. There are no feed commodities associated with
watermelon.
Risk assessments were conducted by EPA to assess dietary exposures
from terbacil in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
An appropriate endpoint attributable to a single dose for the
general population or females 13 years and older was not identified in
the toxicological studies for terbacil; therefore, a quantitative acute
dietary exposure assessment is not needed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\ ver. 2.3), which
incorporates food consumption data as reported by respondents in the
U.S. Department of Agriculture (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
dietary analysis incorporated tolerance level residues, 100% crop
treated, and DEEM\TM\ (ver 7.81) default processing factors for all
registered/proposed crops. The chronic analysis also assumed the
Screening Concentration in Ground Water (SCI-GROW) modeled water
estimates for all water sources (direct and indirect). The ground water
estimate was generated using the highest registered/proposed
application rate. Although rotational crop tolerances are not currently
established, the Agency concluded that the dietary analysis should
incorporate residue estimates for rotated crops. Of the registered/
proposed crops, alfalfa, mint, strawberry, sugar cane, and watermelon
are crops which are rotated. Based on the field rotational crop data
(residues <
[[Page 30816]]
= 0.19 ppm, 0.3-2.1 x the maximum application rate, 30-day plant-back
intervals (PBIs)), the registered proposed PBIs, and the application
rates, residues in/on crops rotated into alfalfa, mint, and sugar cane
fields which were treated with terbacil are possible. Based on the
field rotational crop data, the dietary analysis assumed a residue of
1.0 ppm for cereal grains and soybean (these crops are commonly rotated
into alfalfa, mint, and sugarcane fields) Based on the tolerances for
the primary crops (0.1-2.0 ppm) and the field rotational crop data, EPA
anticipates that the 1.0 ppm residue for rotated crops is conservative.
The Agency notes that the assessment assumes, based on cultural
practices, that only cereal grains and soybean are rotated into
alfalfa, sugar cane, and mint fields while the registered application
scenario for these crops permits the rotation of any crop. When the
residue estimates used to generate the dietary exposure estimates are
taken in total ((SCI-GROW) drinking water estimates, tolerance level
residue, 100% crop treated for all registered/proposed crops,
conservative residue estimates for cereal grain and soybean rotation
crops), EPA concludes that chronic dietary exposure to terbacil is
likely to be less than the estimates provided in this document.
iii. Cancer. Terbacil is classified as not likely to be
carcinogenic to humans based on the lack of evidence of carcinogenicity
in a carcinogenicity study in mice and two combined chronic toxicity/
carcinogenicity studies in rats. Therefore, a cancer exposure
assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for terbacil 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 terbacil. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and SCI-GROW models, the estimated environmental
concentrations (EECs) of terbacil for acute exposures are estimated to
be 123 parts per billion (ppb) for surface water and 111 ppb for ground
water. The EECs for chronic exposures are estimated to be 25.4 ppb for
surface water and 111 ppb for ground water.
The drinking water estimates are based upon the crop with the
highest application rate (sugarcane). The use of terbacil on sugarcane
has the highest single application rate at 3.0 pounds active
ingredient/acre (lb ai/A), this application rate was used in the PRZM/
EXAMS and SCI-GROW models to estimate the concentrations of this
chemical in surface water and ground water, respectively.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM\TM\ - FCID). For chronic
dietary risk assessment, the annual average concentration of 111 ppb
was used to access the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Terbacil is not registered for use on any sites that would result
in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to terbacil and any other
substances and terbacil does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that terbacil has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at https://www.epa.gov/pesticides/cumulative.
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 database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. 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. There is no indication of
increased susceptibility of rat and rabbit fetuses to in utero and/or
postnatal exposure to terbacil.
3. Conclusion. There is a complete toxicity database for terbacil
and exposure data are complete or are estimated based on data that
reasonably account for potential exposures. Based on analyses of
available exposure data, as outlined in Unit III.C.1.ii., the Agency
believes that exposure to terbacil from existing and potential sources
has been adequately assessed and is likely to be less than the
estimates provided. EPA concludes that the FQPA SF can be reduced to 1x
for the following reasons: (i) There is no evidence of increased
susceptibility in rat and rabbit fetuses to in utero exposure to
terbacil; (ii) there is no evidence of increased susceptibility to
terbacil following prenatal exposure in a 3-generation reproduction
study in rats; (iii) there are no residual toxicological uncertainties
or concerns for increased susceptibility; (iv) there are well
established NOAELs and LOAELs in the developmental and reproduction
studies; (v) the environmental fate database is adequate to access the
nature and magnitude of the residue in drinking water; (vi) the dietary
exposure analysis assumed tolerance-level residues and 100% crop
treated.
E. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a
[[Page 30817]]
pesticide from food, drinking water, and residential uses. First, a
screening assessment can be used, in which the Agency calculates
drinking water levels of comparison (DWLOCs) which are used as a point
of comparison against estimated drinking water concentrations (EDWCs).
The DWLOC values are not regulatory standards for drinking water, but
are theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food and
residential uses. More information on the use of DWLOCs in dietary
aggregate risk assessments can be found at https://www.epa.gov/oppfead1/
trac/science/screeningsop.pdf.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water
EDWCs are directly incorporated into the dietary exposure analysis,
along with food. This provides a more realistic estimate of exposure
because actual body weights and water consumption from the CSFII are
used. The combined food and water exposures are then added to estimated
exposure from residential sources to calculate aggregate risks. The
resulting exposure and risk estimates are still considered to be high
end, due to the assumptions used in developing drinking water modeling
inputs.
1. Acute risk. An endpoint of concern attributable to a single
exposure was not identified in the hazard database and therefore no
acute risk is expected from exposure to terbacil.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to terbacil
from food and water will utilize 40% of the cPAD for the U.S.
population, 99% of the cPAD for all infants <1 year old (subpopulations
at greatest exposure), and 94% of the cPAD for children 1-2 years old.
There are no residential uses for terbacil that result in chronic
residential exposure to terbacil. Based on the use pattern, chronic
residential exposure to residues of terbacil is not expected since
there are no registered residential use. The Agency believes that
exposure to terbacil from existing and potential sources has been
adequately assessed and that chronic exposure to terbacil is likely to
be less than the estimates provided in this document as discussed in
Unit III.C.1.ii.
3. Short-term and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Terbacil is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's level of concern.
4. Aggregate cancer risk for U.S. population. Terbacil has been
classified as ``not likely to be carcinogenic to humans'' based on the
results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in rats. Therefore, terbacil is not
expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to terbacil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
There is a practical analytical method gas chromatography/electron
capture detection (GC/ELCD) for detecting and measuring levels of
terbacil in or on food with residues at or above the level set by the
terbacil tolerance(Method II of PAM Vol. II). EPA has provided
information on this method to the Food and Drug Administration (FDA).
The method is available to anyone who is interested and may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd. Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits in
or on watermelon.
C. Conditions of Registration
Data gaps exist as follow and are required to be satisfactorily
filled as conditions of registration for this use.
1. Petition Method Validation (PMV) of the plant method(s).
2. FDA multiresidue testing of terbacil and its metabolites through
protocol D.
3. Additional watermelon field trial, conducted with application
after crop emergence, in Region 3 (n=1), 5 (n=1), and 6 (n=1).
V. Conclusion
Therefore, tolerance is established for combined residues of the
herbicide, terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], calculated as terbacil, in or on watermelon at 1.0
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10,
[[Page 30818]]
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.
May 16, 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 180.209 is revised to read as follows:
Sec. 180.209 Terbacil; tolerances for residues.
(a) General. Tolerances are established for combined residues of
the herbicide terbacil, (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], calculated as terbacil, in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Alfalfa, forage...................................... 1.0
Alfalfa, hay......................................... 2.0
Apple................................................ 0.3
Asparagus............................................ 0.4
Blueberry............................................ 0.2
Canebserry........................................... 0.2
Peach................................................ 0.2
Peppermint, tops..................................... 2.0
Spearmint, tops...................................... 2.0
Strawberry........................................... 0.1
Sugarcane, cane...................................... 0.4
Watermelon........................................... 1.0
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-8275 Filed 5-30-06; 8:45 am]
BILLING CODE 6560-50-S
