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Carfentrazone-ethyl. August 1,
2001, Pesticide Tolerances for Emergency Exemptions.
Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2001/August/Day-01/p19173.htm
[Federal Register: August 1, 2001 (Volume 66, Number 148)]
[Rules and Regulations]
[Page 39640-39648]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au01-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301150; FRL-6792-2]
RIN 2070-AB78
Carfentrazone-ethyl; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of carfentrazone-ethyl and its metabolite in or on
hop, dried cones. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
hops. This regulation establishes a maximum permissible level for
residues of carfentrazone-ethyl in this food commodity. The tolerance
will expire and is revoked on June 30, 2003.
DATES: This regulation is effective August 1, 2001. Objections and
requests for hearings, identified by docket control number OPP-301150
must be received by EPA on or before October 1, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301150 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; and e-mail address:
madden.barbara@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 categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml_00/Title_40/40cfr180_00 html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301150. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(1)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
herbicide carfentrazone-ethyl, ethyl-alpha-2-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-
fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-
[[Page 39641]]
5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid in or on
hop, dried cones at 0.30 part per million (ppm). This tolerance will
expire and is revoked on June 30, 2003. EPA will publish a document in
the Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue.''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Carfentrazone-ethyl on Hops and FFDCA
Tolerances
Powdery mildew (S. macularis) is a serious hop disease in many hop
growing areas throughout the world. During the early part of this
century, a commercial hop production industry in New York state was
devastated due to what is believed to have been an uncontroled outbreak
of powdery mildew. Before June of 1997, this disease had not been
observed in the Pacific Northwest. Though fungicides have been made
available to control powdery mildew in hops, the States indicate that
the role of carfentrazone-ethyl is to remove the main sources of
inoculum of powdery mildew. First, it desiccates the infected primary
shoots that first emerge in the spring. Second, it kills back the
tertiary shoots (suckers) that emerge after the secondary shoots are
trained to grow up to bear the crop. These tertiary shoots will harbor
secondary infection and be a source of spores to infect the crop; they
are too dense to be effectively sprayed with fungicides. Registered
alternative desiccants are inadequate for two reasons: limits on the
number of endothall applications preclude season-long control, and
paraquat causes injury to some varieties. Carfentrazone-ethyl would
allow season-long control. EPA has authorized under FIFRA section 18
the use of carfentrazone-ethyl on hops for control of sucker growth as
an indirect control for powdery mildew in Idaho, Oregon, and
Washington. After having reviewed the submissions, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of carfentrazone-ethyl in or
on hops. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on June 30, 2003, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on hop, dried cones after that date will not
be unlawful, provided the pesticide is applied in a manner that was
lawful under FIFRA, and the residues do not exceed a level that was
authorized by this tolerance at the time of that application. EPA will
take action to revoke this tolerance earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether carfentrazone-
ethyl meets EPA's registration requirements for use on hops or whether
a permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of carfentrazone-ethyl by a State for special
local needs under FIFRA section 24(c). Nor does this tolerance serve as
the basis for any State other than Idaho, Oregon, and Washington to use
this pesticide on this crop under section 18 of FIFRA without following
all provisions of EPA's regulations implementing section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for carfentrazone-ethyl, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
carfentrazone-ethyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of carfentrazone-ethyl and its metabolite in or on
hop, dries cones at 0.30 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed the (NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is
[[Page 39642]]
used to estimate the toxicological endpoint. However, the lowest dose
at which adverse effects of concern are identified (LOAEL) is sometimes
used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for intra
species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary
method currently used by the Agency to quantify carcinogenic risk. The
Q* approach assumes that any amount of exposure will lead to
some degree of cancer risk. A Q* is calculated and used to
estimate risk which represents a probability of occurrence of
additional cancer cases (e.g., risk is expressed as 1 x 10-6
or one in a million). Under certain specific circumstances, MOE
calculations will be used for the carcinogenic risk assessment. In this
non-linear approach, a ``point of departure'' is identified below which
carcinogenic effects are not expected. The point of departure is
typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for carfentrazone-ethyl used for
human risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Carfentrazone-ethyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population NOAEL = 500 mg/kg/day FQPA SF = 1 Acute neurotoxicity
including females 13-50 years of UF = 100............... aPAD = acute RfD....... study in rats
age, infants, and children Acute RfD = 5 mg/kg/day FQPA SF = 5 mg/kg/day.. LOAEL = 1,000 mg/kg/day
based on clinical
observations (i.e.,
salivation) and
decreased motor
activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL = 3 mg/kg/day FQPA SF = 1 2-Year chronic toxicity
UF = 100............... cPAD = chronic RfD..... study in rats
Chronic RfD = 0.03 mg/ FQPA SF = 0.03 mg/kg/ LOAEL = 12 mg/kg/day
kg/day. day. based on liver
histopathology
(increases in
microscopic red
fluorescence of the
liver, liver pigment)
and total mean urinary
porphyrin.
----------------------------------------------------------------------------------------------------------------
Short-term incidental oral exposures NOAEL = 500 mg/kg/day LOC for MOE = 100 Acute neurotoxicity
(1 to 7 days) (residential) study in rats
LOAEL = 1,000 mg/kg/day
based on clinical
observations (i.e.,
salivation) and
decreased motor
activity.
----------------------------------------------------------------------------------------------------------------
Intermediate-term incidental oral NOAEL = 50 mg/kg/day LOC for MOE = 100 Subchronic oral
exposures (1 week to several months) (residential) toxicity study in the
dog
LOAEL = 150 mg/kg/day
based on decreased
body weight gain and
increased porphyrin
levels.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days) and None None No systemic toxicity
intermediate-term dermal (1 week to was seen at the limit-
several months) (residential) dose (1,000 mg/kg/day)
in a 21-day dermal
toxicity study in
rats.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to None None None
lifetime) (residential)
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) Inhalation (or oral) LOC for MOE = 100 Acute neurotoxicity
(residential) study (residential) study in rats.
NOAEL= 500 mg/kg/day LOAEL = 1,000 mg/kg/day
(inhalation absorption based on clinical
rate = 100%). observations (i.e.,
salivation) and motor
activity changes.
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-week Inhalation (or oral) LOC for MOE = 100 Subchronic toxicity
to several months) (residential) study (residential) study in dogs
NOAEL = 50 mg/kg/day LOAEL = 150 mg/kg/day
(inhalation absorption based on decreased
rate = 100%). body weight gain and
increased porphyrin
levels.
----------------------------------------------------------------------------------------------------------------
[[Page 39643]]
Long-term inhalation (several months Inhalation (or oral) LOC for MOE = 100 Chronic toxicity study
to lifetime) (residential) study (residential) in rats
NOAEL = 3 mg/kg/day LOAEL = 12 mg/kg/day
(inhalation absorption based on liver
rate = 100%). histopathology and
increased urinary
porphyrin levels.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Carfentrazone-ethyl has None There was no evidence
been classified as of carcinogenicity in
``not likely'' to be a either a mouse
human carcinogen. carcinogenicity study
or a rat
carcinogenicity study.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.515) for the combined residues of
carfentrazone-ethyl and its metabolite, in or on a variety of raw
agricultural commodities including corn, cereal grains and sorghum.
Risk assessments were conducted by EPA to assess dietary exposures from
carfentrazone-ethyl in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 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: 100% crop treated, tolerance level
residues for all commodities and DEEMTM default processing
factors for all registered and proposed commodities.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEMTM analysis evaluated the individual
food consumption as reported by respondents in the USDA 1989-1992
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: 100% crop treated, tolerance level residues for all
commodities and DEEMTM default processing factors for all
registered and proposed commodities.
iii. Cancer. Carfentrazone-ethyl has been classified as ``not
likely'' to be a human carcinogen. Therefore, risk assessments to
estimate cancer risk were not conducted.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for carfentrazone-ethyl 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 carfentrazone-ethyl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to carfentrazone-ethyl, they
are further discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models, the estimated
environmental concentrations (EECs) of carfentrazone-ethyl for acute
exposures are estimated to be 21 parts per billion (ppb) for surface
water and 13.4 ppb for ground water. The EECs for chronic exposures are
estimated to be 6.6 ppb for surface water and 13.4 ppb for ground
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).
Carfentrazone-ethyl is not registered for use on any sites that
would result in residential exposure; however, there is a pending use
for carfentrazone-ethyl for use on ornamental lawns and turf, including
residential and institutional lawns. Therefore, the Agency assessed the
estimated exposure from non-dietary exposures. The Agency assessed the
non-dietary incidental ingestion via hand-to-mouth exposure by a
toddler as this scenario was anticipated to
[[Page 39644]]
represent the highest exposure potential in the residential setting.
Since dermal endpoints have not been selected, no residential post-
application dermal assessment was conducted.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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.''
EPA does not have, at this time, available data to determine
whether carfentrazone-ethyl has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
carfentrazone-ethyl 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 carfentrazone-ethyl 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 final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).
C. Safety Factor for Infants and Children
1. Safety factor for infants and children-- i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii. Developmental toxicity studies. In a developmental toxicity
study in rats, body weight, body weight gain, food consumption, gross
pathology, and cesarean section data were similar between control and
treated groups. The maternal LOAEL is 600 mg/kg/day (based on staining
of the abdominogenital area and of the cage pan liner); the maternal
NOAEL is 100 mg/kg/day. Evaluation of litter data and an assessment of
embryonic and fetal development, including litter size, post-
implantation loss, fetal weights, and sex ratio, did not reveal any
evidence of treatment-related toxicity. Examination of fetuses for
alterations of external, visceral, and skeletal development revealed
significantly increased litter incidences of wavy and thickened ribs in
the 1,250 mg/kg/day treatment group. The developmental LOAEL is 1,250
mg/kg/day (based upon a significant increase in the litter incidences
of wavy and thickened ribs); the developmental NOAEL is 600 mg/kg/day.
In a developmental toxicity study in rabbits, evidence of
treatment-related maternal toxicity consisted of unthriftiness and
emaciation in two doses at 300 mg/kg/day. The maternal LOAEL is 300 mg/
kg/day; the maternal NOAEL is greater than or equal to 150 mg/kg/day.
There was no evidence of treatment-related prenatal developmental
toxicity: the developmental LOAEL was not determined; the developmental
NOAEL is greater than or equal to 300 mg/kg/day.
iii. Reproductive toxicity study. In a 2-generation reproduction
study in rats, the parental systemic LOAEL is 4,000 ppm (equivalent to
343 mg/kg/day for males and 387 mg/kg/day for females) based on
decreased body weight gains, increased liver weights, liver and bile
duct histopathology, and reductions in the mean cell volume
(F0 and F1 males, F1 females), mean
cell hemoglobin (F0 and F1 males, F1
females), hematocrit (F1 males), and hemoglobin
(F1 males). The parental systemic NOAEL is 1,500 ppm
(equivalent to 127 mg/kg/day for males and 142 mg/kg/day for females).
The offspring LOAEL is 4,000 ppm (387 mg/kg/day) based on decreased pup
body weights in both sexes of the F2 generation. The
offspring NOAEL is 1,500 ppm (142 mg/kg/day).
iv. Prenatal and postnatal sensitivity. The toxicity data provided
no indication of increased susceptibility of rats or rabbits to in
utero and/or postnatal exposure to carfentrazone-ethyl. In the prenatal
developmental toxicity studies in rats and rabbits and the 2-generation
reproduction study in rats, effects in the offspring were observed only
at or above treatment levels which resulted in evidence of par ental
toxicity.
v. Conclusion. There are no data gaps for the assessment of the
effects of carfentrazone-ethyl following in utero and/or postnatal
exposure. There is a complete toxicity data base for carfentrazone-
ethyl and exposure data are complete or are estimated based on data
that reasonably accounts for potential exposures. The data provided no
indication of increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure to carfentrazone-ethyl. Based on the toxicity
profile for carfentrazone-ethyl, a developmental neurotoxicity study in
rats is not required. Therefore, the FQPA Safety Factor, for enhanced
sensitivity to infants and children was reduced from 10X to 1X.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs 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.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water to calculate DWLOCs: 2L/70
kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default
body weights and drinking water consumption values vary on an
individual basis. This variation will be taken into account in more
refined screening-level and quantitative drinking water exposure
assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to carfentrazone-ethyl in drinking water (when considered
along with other sources of exposure for which EPA has reliable data)
would not result in unacceptable levels of aggregate human health risk
at this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses
[[Page 39645]]
are added in the future, EPA will reassess the potential impacts of
carfentrazone-ethyl on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
carfentrazone-ethyl will occupy less than 0.1% of the aPAD for the U.S.
population and all population subgroups represented in
DEEMTM. In addition, despite the potential for acute dietary
exposure to carfentrazone-ethyl in drinking water, after calculating
DWLOCs and comparing them to conservative model EECs of carfentrazone-
ethyl in surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Acute Exposure to Carfentrazone-ethyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup aPAD (mg/kg) % aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 5 <0.1% 21 13.4 1.8 x 105
--------------------------------------------------------------------------------------------------------------------------------------------------------
All infants (<1-year old) 5 <0.1% 21 13.4 5 x 104
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 5 <0.1% 21 13.4 5 x 104
--------------------------------------------------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
carfentrazone-ethyl from food will utilize 1% of the cPAD for the U.S.
population, 3% of the cPAD for all infants less than 1-year old and 3%
of the cPAD for children 1-6 years old, the subpopulation with the
greatest exposure. Based on the use pattern, chronic residential
exposure to residues of carfentrazone-ethyl is not expected. In
addition, despite the potential for chronic dietary exposure to
carfentrazone-ethyl in drinking water, after calculating DWLOCs and
comparing them to conservative model estimated environmental
concentrations of carfentrazone-ethyl in surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Carfentrazone-ethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.03 1 6.6 13.4 1 x 103
----------------------------------------------------------------------------------------------------------------
All infants (1-year old) 0.03 3 6.6 13.4 1 x 103
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.03 3 6.6 13.4 1 x 103
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Carfentrazone-ethyl is
not registered for use on any sites that would result in residential
exposure; however, there is a pending use for carfentrazone-ethyl for
use on ornamental lawns and turf, including residential and
institutional lawns. Therefore, the Agency assessed the estimated
aggregate risk from non-dietary incidental ingestion via hand-to-mouth
exposure by a toddler. This scenario is expected to represent the
highest exposure potential in the residential setting. Since dermal
endpoints have not been selected, no residential post-application
dermal assessment was conducted. Therefore, the Agency has determined
that it is appropriate to aggregate chronic food and water and short-
term exposures for carfentrazone-ethyl.
Using the exposure assumptions described in this unit for non-
dietary exposures, EPA has concluded that food and residential
exposures aggregated result in aggregate MOEs of 3,600 for children and
4,100 for infants for incidental oral exposure. These aggregate MOEs do
not exceed the Agency's level of concern for aggregate exposure to food
and residential uses. In addition, short-term DWLOCs were calculated
and compared to the EECs for chronic exposure of carfentrazone-ethyl in
ground water and surface water. After calculating DWLOCs and comparing
them to the EECs for surface and ground water, EPA does not expect
short-term aggregate exposure to exceed the Agency's level of concern,
as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Carfentrazone-ethyl
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
All infants <(1-year old) 4,100 100 6.6 13.4 5 x 104
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 3,600 100 6.6 13.4 5 x 104
----------------------------------------------------------------------------------------------------------------
[[Page 39646]]
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Though residential exposure could occur with the use of
carfentrazone-ethyl, only endpoints have been identified for incidental
oral exposures. Intermediate-term incidental exposures (1 week to
several months) are not expected. Therefore, for intermediate-term
exposures, the aggregate risk is the sum of the risk from food and
water, which were previously addressed.
5. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl
has been classified as ``not likely'' to be a human carcinogen.
Therefore, risk assessments to estimate cancer risk were not conducted.
6. 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 carfentrazone-ethyl residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Calvin Furlow,
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican maximum
residue limits, for residues of carfentrazone-ethyl and its metabolite
in or on hops. Therefore harmonization is not issue.
C. Conditions
Carfentrazone-ethyl can be applied at 0.03 lbs per application per
acre with a seasonal maximum of 0.12 lbs carfentrazone-ethyl applied
per acre. Allow 14 days between treatments. A 7 day pre-harvest
interval (PHI) must be observed.
Corn (field, sweet, seed, popcorn, and silage), soybeans, grain
sorghum, rice, wheat, barley, oats, buckwheat, pearl millet, proso
millet, teosinte, and wild rice may be planted anytime following
application of carfentrazone-ethyl to hops. All other crops may be
planted 365 days after an application of carfentrazone-ethyl.
VI. Conclusion
Therefore, the tolerance is established for combined residues of
carfentrazone-ethyl, ethyl-alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl)-4-
fluorobenzenepropanoate) and carfentrazone-ethyl chloropropionic acid
(alpha,2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-
1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid in or on hop, dried
cones at 0.30 ppm.
VII. Objections and Hearing Requests
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. EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. Although the procedures in those regulations
require some modification to reflect the amendments made to the FFDCA
by the FQPA of 1996, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) provides essentially the same process for
persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d), as
was provided in the old FFDCA sections 408 and 409. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301150 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 October
1, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3.Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301150, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
[[Page 39647]]
Ave., NW., Washington, DC 20460. In person or by courier, bring a copy
to the location of the PIRIB described in Unit I.B.2. You may also send
an electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
This final rule does not contain any information collections subject to
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (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 other
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a FIFRA section 18 exemption under FFDCA
section 408, such as the tolerance in this final rule, do not require
the issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism implications
'' is defined in the Executive Order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.'' This
final rule directly regulates growers, food processors, food handlers
and food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
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.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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: July 13, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371
2. Section 180.515 is amended by alphabetically adding the
following commodity to the table in paragraph (b) to read as follows:
Sec. 180.515 Carfentrazone-ethyl; tolerances for residues.
* * * * *
(b) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hop, dried cones 0.30 6/30/03
[[Page 39648]]
* * * * * * *
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* * * * *
[FR Doc. 01-19173 Filed 7-31-01; 8:45 am]
BILLING CODE 6560-50-S