[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Rules and Regulations]
[Pages 4026-4032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1638]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0009; FRL-7695-3]


Quinoxyfen; 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 
residues of quinoxyfen in or on vegetable, cucurbit, subgroup 9A; 
pumpkin; and squash, winter. 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 melons, winter squash, and pumpkins. This regulation 
establishes a maximum permissible level for residues of quinoxyfen in 
these food commodities. These tolerances will expire and are revoked on 
December 31, 2007.

DATES: This regulation is effective January 28, 2005. Objections and 
requests for hearings must be received on or before March 29, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0009. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

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,

[[Page 4027]]

is establishing tolerances for residues of the fungicide quinoxyfen, 
5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or on vegetable, 
cucurbit, subgroup 9A; pumpkin; and squash, winter at 0.30 parts per 
million (ppm). These tolerances will expire and are revoked on December 
31, 2007. 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 of the FFDCA 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) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the 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 of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Quinoxyfen on Melons, Winter Squash, and 
Pumpkins and FFDCA Tolerances

    There are protectant fungicides registered that are effective in 
controlling powdery mildew on the upper leaf surfaces of melons, winter 
squash and pumpkins when the fungicide is in direct contact with the 
pathogen. However, these fungicides do not provide protection against 
the pathogen growing on the undersides of the leaves. During the 2003 
growing season, resistance of powdery mildew control from the systemic 
registered alternatives (strobilurins and myclobutanil) was confirmed. 
The registered strobilurins and myclobutanil proved to be ineffective 
in controlling powdery mildew in melons, winter squash and pumpkins. 
The Agency believes that under high disease pressure and disease 
favorable weather conditions 20-30 percent yield losses are likely 
without the use of quinoxyfen. EPA has authorized under FIFRA section 
18 the use of quinoxyfen on melons, winter squash, and pumpkins for 
control of powdery mildew in New York. After having reviewed the 
submission, EPA concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of quinoxyfen in or on 
cantaloupe, muskmelon, watermelon, watermelon juice, winter squash, 
pumpkin and pumpkin seed. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of the FFDCA 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) of the FFDCA. Although this tolerance will expire and 
is revoked on December 31, 2007, under section 408(l)(5) of the FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on melon subgroup 9A, pumpkin and winter 
squash 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 quinoxyfen 
meets EPA's registration requirements for use on melons, winter squash, 
and pumpkins or whether a permanent tolerance for these uses would be 
appropriate. Under these circumstances, EPA does not believe that these 
tolerances serve as a basis for registration of quinoxyfen 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 New York to use 
this pesticide on these crops under section 18 of FIFRA without 
following all provisions of EPA's regulations implementing FIFRA 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemption for quinoxyfen, 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 of the FFDCA 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) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
quinoxyfen and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for a time-limited 
tolerance for residues of quinoxyfen in or on vegetable, cucurbit, 
subgroup 9A; pumpkin; and squash, winter at 0.30 ppm. EPA's assessment 
of the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Endpoints

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. The toxicology database for 
quinoxyfen is complete. EPA has considered available information 
concerning the variability of the sensitivities of major identifiable

[[Page 4028]]

subgroups of consumers, including infants and children. The nature of 
the toxic effects caused by quinoxyfen are fully discussed in a Federal 
Register Notice published on September 29, 2003 (68 FR 55849) that 
established tolerances for residues of quinoxyfen on cherries, grapes 
and hops. Please refer to that document for a complete discussion of 
the no observed adverse effect level (NOAEL) and the lowest observed 
adverse effect level (LOAEL) from the toxicity studies reviewed.
    The dose, typically 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 (SF) 
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 SF.
    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 x10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In thisnon-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 Quinoxyfen used for human risk assessment is shown in the 
following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Quinoxyfen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                             FQPA SF* and Level of
         Exposure Scenario              Dose Used in Risk       Concern for Risk       Study and Toxicological
                                         Assessment, UF            Assessment                  Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years   Not applicable          Not applicable          There were no toxic effects
 of age) and Acute dietary (general                                                     attributable to a single
 population including infants and                                                    dose.Therefore, an endpoint
 children)                                                                                    of concern was not
                                                                                                   identified to
                                                                                    quantitateacute-dietary risk
                                                                                    to the general population or
                                                                                     to the subpopulationfemales
                                                                                                 13-50 years old
------------------------------------
Chronic Dietary (All populations)    NOAEL = 20 milligram/   FQPA SF = 1cPAD =        Combined chronic toxicity/
                                      kilogram/day (mg/kg/   chronic RfD/FQPA SF =  carcinogenicity study in rat
                                      day)UF = 100            0.20 mg/kg/day.        LOAEL = 80 mg/kg/day, based
                                     Chronic RfD = 0.20 mg/                           upon increases in severity
                                      kg/day.                                              ofchronic progressive
                                                                                     glomerulonephropathy in the
                                                                                               males and minimal
                                                                                     decreasesin body weight and
                                                                                         body weightgain in both
                                                                                                           sexes
------------------------------------
Cancer (oral, dermal, inhalation)    classified as not       Not applicable                       No evidence of
                                      likely to be                                   carcinogenicity in rats and
                                      carcinogenic to                                                       mice
                                      humans
----------------------------------------------------------------------------------------------------------------
\*\The reference to the FQPA SF refers to any additional SF 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 180.588) for the residues of quinoxyfen, in or on a 
variety of raw agricultural commodities including sweet and tart 
cherries, hops and grapes. Risk assessments were conducted by EPA to 
assess dietary exposures from quinoxyfen in food as follows:
    i. Acute exposure. Quantitative 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 one day or single exposure. There were no toxic effects 
attributable to a single dose. Therefore, an endpoint of concern was 
not identified to quantitate acute-dietary risk to the general 
population or to the subpopulation females 13-50 years old. As a 
result, no acute risk is expected from exposure to quinoxyfen and hence 
no quantitative acute dietary risk assessment was performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\ ) which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996

[[Page 4029]]

and 1998 nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII) and accumulated exposure to the chemical for each commodity. 
The following assumptions were made: An unrefined, Tier 1 chronic-
dietary exposure assessment using tolerance-level residues and assuming 
100% CT for all proposed commodities, and default DEEM Version 7.76 
processing factors for all commodities.
    iii. Cancer. Quinoxyfen has been classified as not likely to be 
carcinogenic to humans. Therefore, a quantitative exposure assessment 
was not conducted to assess cancer risk.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for quinoxyfen 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 quinoxyfen.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) 
to produce estimates of pesticide concentrations in an index reservoir. 
The Screening Concentrations in Groundwater (SCI-GROW) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will generally use 
FIRST (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The 
FIRST model is a subset of the PRZM/EXAMS model that uses a specific 
high-end runoff scenario for pesticides. While both FIRST and PRZM/
EXAMS incorporate an index reservoir environment, 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 quinoxyfen they are further 
discussed in the aggregate risk sections below.
    Based on the FIRST and SCI-GROW models the EECs of quinoxyfen for 
chronic exposures are estimated to be 0.8 parts per billion (ppb) for 
surface water and 0.006 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). Quinoxyfen is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism 
oftoxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether quinoxyfen 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, 
quinoxyfen 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 quinoxyfen 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. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines 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. Developmental toxicity studies. In a prenatal developmental 
study in rats the Maternal and Developmental NOAELs were 1,000 mg/kg/
day and no LOAELs were identified. In a prenatal developmental study in 
rabbits the Maternal NOAEL was 80 mg/kg/day and the LOAEL was 200 mg/
kg/day based on inanition, clinical signs, decreased body weights, body 
weight gains, and food consumption and on increased incidences of 
abortion. The Developmental NOAEL is 80 mg/kg/day and the LOAEL is 200 
mg/kg/day based on increased incidences of abortion.
    3. Reproductive toxicity study. In a reproduction toxicity study in 
rats the Parental/Systemic NOAEL was 100 mg/kg/day and no LOAEL was 
identified. The Reproductive NOAEL was 100 mg/kg/day and no LOAEL was 
identified. The Offspring NOAEL was 20 mg/kg/day and the LOAEL was 100 
mg/kg/day based on a minimal decrease in F1a pup weights.
    4. Prenatal and postnatal sensitivity. There is no quantitative or 
qualitative evidence of increased susceptibility of rat and rabbit 
fetuses to in utero exposure in developmental studies. There is 
evidence of increased quantitative susceptibility (minimal decrease in 
F1a pup weights) in the rat multi-generation reproduction 
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the pup effects are minimal at 
the LOAEL and only noted in the first-generation offspring; and, (3) 
the doses and endpoints selected for regulatory purposes would address 
the concerns of the pup effects noted in the rat reproduction study. 
Therefore, there are no residual uncertainties for prenatal/postnatal 
toxicity in this study.
    5. Conclusion. There is a complete toxicity data base for 
quinoxyfen and exposure data are complete or are estimated based on 
data that reasonably

[[Page 4030]]

accounts for potential exposures. There are no residual uncertainties 
for prenatal/postnatal toxicity. No additional safety factor is needed 
for database uncertainties. No clinical sign of neurotoxicity or 
neuropathology was seen in the data base. A developmental neurotoxicity 
study is not required. Therefore, EPA determined that the 10X SF to 
protect infants and children should be reduced 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 are used to calculate 
DWLOCs: 2 liter (L)/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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to quinoxyfen in drinking water (when considered along with 
other sources of exposure for which OPP has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. Because OPP 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, OPP will reassess the potential impacts of 
quinoxyfen on drinking water as a part of the aggregate risk assessment 
process.
    1. Acute risk. An endpoint of concern was not identified to 
quantitate acute-dietary risk to the general population or to the 
subpopulation females 13-50 years old. As a result, no acute risk is 
expected from exposure to quinoxyfen.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
quinoxyfen from food will utilize less than 1% of the cPAD for the U.S. 
population, 1% of the cPAD for all infants (<1 year old) and 2% of the 
cPAD for children (1-2 years old), the children subpopulation at 
greatest exposure. There are no residential uses for quinoxyfen that 
result in chronic residential exposure to quinoxyfen. In addition, 
there is potential for chronic dietary exposure to quinoxyfen in 
drinking water. After calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit:

               Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Quinoxyfen
----------------------------------------------------------------------------------------------------------------
                                                                              (Food)
                                                 cPAD mg/kg/                 Surface       Ground      Chronic
              Population Subgroup                    day         % cPAD     Water EEC    Water EEC   DWLOC (ppb)
                                                                              (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.20          <1%          0.8        0.006         7000
------------------------------------------------
All Infants (<1 year old)                               0.20           1%          0.8        0.006         2000
------------------------------------------------
Children (1-2 years old)                                0.20           2%          0.8        0.006         2000
----------------------------------------------------------------------------------------------------------------

    3. Short-term and Intermediate-term risks. Short- and intermediate-
term aggregate exposure take into account non-dietary, non-occupational 
plus chronic exposure to food and water (considered to be a background 
exposure level). Quinoxyfen is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which were previously 
addressed.
    4. Aggregate cancer risk for U.S. population. Quinoxyfen has been 
classified as not likely to be carcinogenic to humans. Therefore, 
quinoxyfen is expected to pose at most a negligible cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to quinoxyfen residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    IR-4 has proposed a gas chromatography (GC) method with mass-
selective detection (MSD) entitled Determination of DE-795 Residues in 
Grape Wine, Must, and Pomace ERC95.26 (and its supplement S1) for the 
enforcement of proposed tolerances for residues of quinoxyfen in/on 
grapes, cherries and hops. Method ERC 95.26 is classified as acceptable 
and conforms with the criteria of OPPTS GL 860.1340. The petitioner has 
submitted a study which investigated the behavior of quinoxyfen through 
MRMs outlined in FDA's Pesticide Analytical Manual (PAM), Volume I, 
Appendix II. The study summary reported that depending on spike levels, 
certain MRM Protocols (D, E, and F) yielded partial (incomplete) to 
complete recoveries of quinoxyfen in grapes (non-fatty matrix) and 
ground beef (fatty matrix).
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected]..

B. International Residue Limits

    There are no Mexican, Canadian or Codex Maximum Residue Limits 
(MRLs) established for quinoxyfen on sweet and tart cherries, grapes, 
or hops. Therefore, no compatibility problems exist for these 
tolerances.

[[Page 4031]]

VI. Conclusion

    Therefore, tolerances are established for quinoxyfen, 5,7-dichloro-
4-(4-fluorophenoxy)quinoline in or on vegetable, cucurbit, subgroup 9A; 
pumpkin; and squash, winter 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. 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. 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 ID number OPP-2005-0009 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 March 29, 
2005.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. 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 ADDRESSES. Mail 
your copies, identified by the docket ID number OPP-2005-0009, 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 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. 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. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States,

[[Page 4032]]

on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government.'' This final rule directly regulates growers, 
food processors, food handlers, and food retailers, not States. This 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 14, 2005.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.588 is amended by adding text to paragraph (b) to read 
as follows:


Sec.  180.588  Quinoxyfen; tolerances for residues.

    * * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide quinoxyfen, 5,7-dichloro-4-
(4-fluorophenoxy)quinoline in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. The time-limited 
tolerances will expire and are revoked on the date specified in the 
following table:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Pumpkin.......................................         0.30     12/31/07
Squash, winter................................         0.30     12/31/07
Vegetable, cucurbit, subgroup 9A..............         0.30     12/31/07
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-1638 Filed 1-27-05; 8:45 am]
BILLING CODE 6560-50-S