[Federal Register Volume 66, Number 148 (Wednesday, August 1, 2001)]
[Rules and Regulations]
[Pages 39640-39648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19173]


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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: 
[email protected].

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
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                                                                 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: 
[email protected].

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 [email protected], 
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: [email protected]. 
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