[Federal Register Volume 66, Number 196 (Wednesday, October 10, 2001)]
[Rules and Regulations]
[Pages 51587-51594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25021]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301179; FRL-6802-3]
RIN 2070-AB78


Sethoxydim; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of sethoxydim and its metabolites containing the 2-
cyclohexen-1-one moiety (calculated as the herbicide) in or on 
safflower, milk; and meat byproducts of cattle, goats, hogs, horses, 
and sheep. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) authorizing use of the pesticide on safflower. 
This regulation establishes maximum permissible levels for residues of 
sethoxydim in these food commodities. The tolerances will expire and 
are revoked on December 31, 2003.

DATES: This regulation is effective October 10, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301179, 
must be received by EPA on or before December 10, 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-301179 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9364; 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 homepage at http://www.epa.gov/. 
To access this document, on the homepage 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 theFederal 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_180/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-301179. 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(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for combined residues of the 
herbicide sethoxydim (2-[1-(ethoxyimino]butyl)-5-[2-(ethylthio)propyl]-
3-hydroxy-2-cyclohexen-1-one) and its metabolites containing the 2-
cyclohexen-1-one moiety, in or on safflower at 15.0 parts per million 
(ppm), in milk at 0.5 ppm; and in meat byproducts of cattle, goats, 
hogs, horses, and sheep at 1.0 ppm. These tolerances will expire and 
are revoked on December 31, 2003. EPA will publish a document in the 
Federal Register to remove the revoked tolerances 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

[[Page 51588]]

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 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 Sethoxydim on Safflower and FFDCA 
Tolerances

    The shift to no-till or direct seed systems has dramatically 
reduced the efficacy of herbicides labeled for use in safflower. As a 
result, wild oat has emerged as a larger management problem in 
safflower production. Cool, moist conditions, as in recent years, 
promotes maximum emergence. EPA has authorized under FIFRA section 18 
the use of sethoxydim on safflower for control of wild oats in Montana 
and North Dakota. After having reviewed the submissions, EPA concurs 
that emergency conditions exist for these States.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of sethoxydim in or 
on safflower. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerances 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 these tolerances without notice and opportunity for public 
comment as provided in section 408(l)(6). Although these tolerances 
will expire and are revoked on December 31, 2003, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerances remaining in or on safflower or milk or 
meat 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 these tolerances at the time 
of that application. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether sethoxydim 
meets EPA's registration requirements for use on safflower or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of sethoxydim by a State for special local needs 
under FIFRA section 24(c). Nor do these tolerances serve as the basis 
for any State other than Montana and North Dakota 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 sethoxydim, 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 
sethoxydim and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for time-limited tolerances for 
combined residues of sethoxydim (2-[1- (ethoxyimino]butyl)-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one) and its metabolites 
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide) 
in or on safflower at 15.0 ppm, in milk at 0.5 ppm; and in meat 
byproducts of cattle, goats, hogs, horses and sheep at 1.0 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerances 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 used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies 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.

[[Page 51589]]

 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 sethoxydim used for human risk assessment is shown in the 
following Table 1:

     Table 1.--Summary of Toxicological Doses and Endpoints for Sethoxydim for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF* and LOC for   Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-50 years of  NOAEL = 180 mg/kg/day    FQPA SF = 3x             Developmental - Rat
 age)                                  UF = 100 Acute RfD =     aPAD = acute RfD          (MRID 43092902)
                                        1.8 mg/kg/day.            FQPA SF = 0.6  LOAEL = 650 mg/kg based
                                                                 mg/kg/day.               on decreased fetal
                                                                                          weights, filamentous
                                                                                          tail, lack of tail,
                                                                                          and delayed
                                                                                          ossification.
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 180 mg/kg/day    FQPA SF = 1x             Developmental - Rat
 including infants and children)       UF = 100 Acute RfD =     aPAD = acute RfD          (MRID 43092902)
                                        1.8 mg/kg/day.            FQPA SF = 1.8  LOAEL = 650 mg/kg based
                                                                 mg/kg/day.               on irregular gait,
                                                                                          decreased activity,
                                                                                          excessive salivation
                                                                                          and ano-genital
                                                                                          staining.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL= 8.86 mg//kg/day   FQPA SF = 1x             1-Year feeding study -
                                       UF = 100 Chronic RfD =   cPAD = chronic RfD        Dog (MRID 00152669)
                                        0.09 mg/kg/day.           FQPA SF =      LOAEL = 17.5 mg/kg/day
                                                                 0.09 mg/kg/day.          based on equivocal
                                                                                          anemia in males.
----------------------------------------------------------------------------------------------------------------
Short-, intermediate-, and long-term   none                     No dermal or systemic    21-Day dermal toxicity
 dermal (Occupational/Residential)                               toxicity was seen at     study - Rabbit (MRID
                                                                 the limit dose (1,000    41987203)
                                                                 mg/kg/day). This risk
                                                                 assessment is not
                                                                 required.
----------------------------------------------------------------------------------------------------------------
Short-, intermediate-, and long-term   none                     Sethoxydim is placed in  Acute inhalation study
 inhalation (Occupational/                                       Toxicity Category IV.    (MRID 00045849)
 Residential)                                                                            LC50 = 6.03 mg/L in
                                                                                          males and 6.28 mg/L in
                                                                                          females. There are no
                                                                                          subacute, subchronic,
                                                                                          or chronic inhalation
                                                                                          studies.
----------------------------------------------------------------------------------------------------------------
*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 180.412) for the combined residues of sethoxydim, 
in or on a variety of raw agricultural commodities. Tolerances are 
already established in or on meat and milk but at levels lower than 
those discussed in this rule. Risk assessments were conducted by EPA to 
assess dietary exposures from sethoxydim 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 (DEEM) 
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: tolerance level residues and 100 percent crop 
treated (PCT).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM 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: tolerance 
level residues and 100 PCT for all crops except peanuts, potatoes, and 
tomatoes (for which an average crop treated value of 5% was used) and 
soybeans (for which the average crop treated value of 2% was used).
    iii. Cancer. Sethoxydim is not classified. Available studies show 
no evidence of carcinogenicity in rats or mice.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(F) 
states that the Agency may use data on the actual percent of food 
treated for assessing chronic dietary risk only if the Agency can make 
the following findings: Condition 1, that the data used are reliable 
and provide a valid basis to

[[Page 51590]]

show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information as follows. Assumptions were: 100 
PCT for all crops except peanuts, potatoes, and tomatoes (for which an 
average crop treated value of 5% was used) and soybeans (for which the 
average crop treated value of 2% was used).
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which sethoxydim may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for sethoxydim 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 sethoxydim.
    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 sethoxydim they are further 
discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of sethoxydim for 
acute exposures are estimated to be 42 parts per billion (ppb) for 
surface water and 33 ppb for ground water. The EECs for chronic 
exposures are estimated to be 27 ppb for surface water and 3 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).
    Sethoxydim is currently registered for use on the following 
residential non-dietary sites: ornamentals and flowering plants, 
recreational areas, and buildings/structures. These uses are not 
expected to result in chronic exposures but may result in short- and/or 
intermediate-term exposures. However, dermal and/or inhalation 
endpoints for short- and intermediate-term exposures were not 
identified. Therefore, these routes of exposure were not evaluated for 
risk.
    However, children's potential for oral exposure resulting from 
residential treatments will be considered as a contributor to short-
term aggregate risk. A short-term oral endpoint was not identified for 
sethoxydim. For short-term risk assessment (for incorporation of food, 
water, or oral hand-to-mouth type exposures into an aggregate risk 
assessment), the acute oral endpoint (acute RfD = 1.8 mg/kg/day, NOAEL 
= 180 mg/kg/day) will be used to incorporate the oral component into 
aggregate risk.
    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 sethoxydim has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides

[[Page 51591]]

for which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, sethoxydim 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 sethoxydim 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. 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 MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. There was no indication of 
increased susceptibility in the prenatal developmental toxicity study 
in rabbits following in utero exposure. In the 2-generation 
reproduction study in rats, effects in the offspring were observed only 
at or above treatment levels which resulted in evidence of appreciable 
parental toxicity. No increased susceptibility was demonstrated in the 
developmental toxicity studies; however developmental toxic effects, 
were observed at the highest dose tested (LOAEL).
    Acceptable developmental toxicity studies have been performed in 
rats and rabbits; an acceptable 2-generation reproduction study has 
also been performed in rats. A chronic feeding/carcinogenicity 
guideline study in rats has been submitted and is currently undergoing 
review. An initial examination of the study supports the current 
findings of no evidence of carcinogenicity. There is a complete 
toxicity data base for sethoxydim and exposure data is complete or is 
estimated based on data that reasonably accounts for potential 
exposures.
    The FQPA Safety Factor is to be retained in case of developmental 
toxicity in the absence of maternal toxicity. Since malformations were 
seen in the rat study at levels that produced minimal maternal 
toxicity. The Agency concluded that an FQPA factor is needed. However, 
it was determined that the 10X factor need not be retained, instead 
should be reduced to 3X based on the following weight of evidence 
considerations: (1) Developmental toxicity was seen in only one 
species, in the presence of maternal toxicity, and at a very high dose 
(650 mg/kg/day) that approached the Limit-Dose of 1,000 mg/kg/day; (2) 
no developmental toxicity was observed in the rabbit study at the 
highest dose tested (400 mg/kg/day); (3) there was no increased 
susceptibility seen in the two-generation reproduction study in rats at 
doses up to 150 mg/kg/day(highest dose tested); and 4) lack of concern 
for structure activity relationship (i.e. no significant developmental 
or reproductive toxicity was seen with the structural analog, 
clethodim.)
    Exposure assessments do not indicate a concern for potential risk 
to infants and children based on: (1) The dietary exposure assessments 
use field study data and assume 100% crop treated which results in an 
overestimate of dietary exposure; (2) limited monitoring data is used 
for ground and surface source drinking water exposure assessments, 
resulting in estimates considered to be reasonable upper-bound 
concentrations; (3) there is a potential for post-application hand-to-
mouth exposure to toddlers associated with lawn use, however, the use 
of conservative models and/or assumptions in the residential exposure 
assessment provide adequate protection of infants and children.
    The FQPA safety factor is applicable for acute dietary risk 
assessment for females 13+ because the endpoint occurs only during in 
urtero exposure and is not a postnatal effect. Since the effects occur 
during in utero exposure, it is not an appropriate endpoint for acute 
dietary risk assessment of infants and children. The FQPA safety factor 
is not applied for chronic risk assessment because the endpoint is an 
in urtero effect and can not result from postnatal exposure. The FQPA 
safety factor is not applicable to the post-application hand-to-mouth 
exposure associated with the lawn use since this exposure scenario 
would only be expected for toddlers and not for females 13+.
    3. Conclusion. There is a complete toxicity data base for 
sethoxydim and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures.

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 are used 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 sethoxydim 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 
are added in the future, EPA will reassess the potential impacts of 
sethoxydim 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 
sethoxydim will occupy 7% of the aPAD for the U.S. population, 14% of 
the aPAD for

[[Page 51592]]

females 13-50 years (not pregnant, not nursing), 10% of the aPAD for 
all infants (<1 year) and 14% of the aPAD for children 1-6 years old. 
In addition, despite the potential for acute dietary exposure to 
sethoxydim in drinking water, after calculating DWLOCs and comparing 
them to conservative model estimated environmental concentrations of 
sethoxydim 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 Sethoxydim
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD  (mg/     % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population (all seasons)                            1.8            7           42           33       59,000
----------------------------------------------------------------------------------------------------------------
Females (13+)                                            0.6           14           42           33       15,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 1.8           14           42           33       16,000
----------------------------------------------------------------------------------------------------------------
 Infants (< 1 year )                                     1.8           10           42           33       16,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
sethoxydim from food will utilize 22% of the cPAD for the U.S. 
population, 32% of the cPAD for all infants <1 year and 52% of the cPAD 
for children 1-6. Based on the use pattern, chronic residential 
exposure to residues of sethoxydim is not expected. In addition, 
despite the potential for chronic dietary exposure to sethoxydim in 
drinking water, after calculating DWLOCs and comparing them to 
conservative model estimated environmental concentrations of sethoxydim 
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 Sethoxydim
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD  mg/kg/    %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.09           22           27            3        2,500
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                  0.09           52           27            3          430
----------------------------------------------------------------------------------------------------------------
All Infants <1 year old                                 0.09           32           27            3          610
----------------------------------------------------------------------------------------------------------------

    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).
    Sethoxydim is currently registered for use(s) that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for sethoxydim.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 1,800 for children 1-6 years old 
(the subgroup of infants/children with the highest exposure). These 
aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to 
food and residential uses. In addition, short-term DWLOCs were 
calculated and compared to the EECs for chronic exposure of sethoxydim 
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 LOC, as 
shown in the following Table 4:

                    Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Sethoxydim
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate                  Surface       Ground
              Population Subgroup                MOE (Food +   Aggregate    Water EEC    Water EEC    Short-Term
                                                Residential)      LOC         (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                  1800          100           27            3       17,000
----------------------------------------------------------------------------------------------------------------

    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 
sethoxydim, no toxicological effects have been identified for 
intermediate-term toxicity. Therefore, 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. Sethoxydim has not 
ben classified. Available studies do not show evidence of 
carcinogenicity in rats or mice. Therefore, an aggregate cancer risk 
analysis was 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

[[Page 51593]]

population, and to infants and children from aggregate exposure to 
sethoxydim residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas-liquid chromatography (GLC) 
with flame photometric detection) is available (Method I, PAM II) to 
enforce the tolerance expression.

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican maximum residue limits 
(MRLs) or tolerances for sethoxydim on safflower. Thus, harmonization 
is not an issue for these section 18 requests.

VI. Conclusion

    Therefore, tolerances are established for combined residues of 
sethoxydim and its metabolites containing the 2-cyclohexen-1-one 
moiety, in or on safflower at 15.0 ppm, in milk at 0.5 ppm; and in meat 
byproducts of cattle, goats, hogs, horses, and sheep at 1.0 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. The 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-301179 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 December 
10, 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-301179, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania 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 time limited tolerances 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). 
Because this rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this rule is not subject to 
Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections

[[Page 51594]]

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 require OMB 
review or any Agency action under Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This action does not involve any 
technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and 
exemptions that are established on the basis of a 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).

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: September 21, 2001.
Richard P. Keigwin, Jr.,
Acting 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 180.412 is amended by alphabetically adding commodities 
to the table in paragraph (b) to read as follows:


Sec. 180.412  Sethoxydim; tolerances for residues.

* * * * *
    (b)   *  *  *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
                      *      *      *      *      *
Cattle, mbyp......................                1.0           12/31/03
Goats, mbyp.......................                1.0           12/31/03
Hogs, mbyp........................                1.0           12/31/03
                      *      *      *      *      *
Horses, mbyp......................                1.0           12/31/03
Milk..............................                0.5           12/31/03
Safflower.........................               15.0           12/31/03
Sheep, mbyp.......................                0.5           12/31/03
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-25021 Filed 10-9-01; 8:45 am]
BILLING CODE 6560-50-S