[Federal Register Volume 65, Number 36 (Wednesday, February 23, 2000)]
[Rules and Regulations]
[Pages 8859-8867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4237]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300968; FRL-6490-3]

RIN 2070-AB78


Furilazole; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the inert ingredient (herbicide safener)

[[Page 8860]]

3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine, which is also 
known as furilazole (CAS Reg. No.121776-33-8) in or on corn 
commodities, (grain, forage, and stover), at 0.01 ppm. Monsanto Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. The 
tolerances will expire and be revoked on February 25, 2002.

DATES: This regulation is effective February 23, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300968, 
must be received by EPA on or before April 24, 2000.

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 VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300968 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Indira Gairola, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703-308-6379; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be 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 Potentially
              Categories                NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                   111  Crop production
                                           112  Animal production
                                           311  Food manufacturing
                                         32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300968. 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, Crystal 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

    Time-limited tolerances for 3-dichloroacetyl-5-(2-furanyl)-2,2-
dimethyloxazolidine (furilazole) in or on corn commodities, (grain, 
fodder, and forage), at 0.01 ppm were previously established as 
requested by Monsanto Company under the Federal Food, Drug, and 
Cosmetic Act in a pesticide tolerance rule dated May 10, 1994 (59 FR 
24059) (FRL-4777-2). These tolerances expired on June 30, 1996.
    In the Federal Register of October 20, 1999, (64 FR 56502-56505) 
(FRL-6386-9), EPA issued a notice pursuant to section 408 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended 
by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of a pesticide petition (PP 1E4031) for tolerance 
by Monsanto Company, Suite 1100, 700 14th Street NW., 
Washington, DC 20005. This notice included a summary of the petition 
prepared by Monsanto, the petitioner. There were no comments received 
in response to the notice of filing.
    The petition requested that 40 CFR 180.471 be amended to establish 
again tolerances for residues of the inert ingredient (herbicide 
safener) (3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine), 
which is also known as furilazole in or on the following corn 
commodities: (fodder, forage and grain) at 0.01 parts per million 
(ppm). The tolerances will expire on February 25, 2002.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings. 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).

[[Page 8861]]

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of furilazole on corn 
commodities (grain, forage, and stover) at 0.01 ppm. EPA's assessment 
of the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    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. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by furilazole are 
discussed in this unit.
    1. Acute toxicity. Six acute toxicity studies were conducted and 
the results are summarized as follows:
    i. Oral. In the acute oral toxicity study for rats, the 
LD50 was equal to 521 mg/kg in males and was classified as 
Toxicity Category III.
    ii. Dermal. In the acute dermal toxicity study for rats, the 
LD50 was equal to >5,000 mg/kg and was classified as 
Toxicity Category IV.
    iii. Inhalation. In the acute inhalation, toxicity study for rats, 
the LC50 was equal to >2.3 mg/L and was classified as 
Toxicity Category IV.
    iv.Primary eye irritation. In a primary eye irritation study in 
rabbits, furilazole was found to be a mild irritant and is classified 
as Toxicity Category III.
    v. Primary skin irritation. In a primary skin irritation study in 
rabbits, furilazole was found to be a negligible irritant and is 
classified as Toxicity Category IV.
    vi. Dermal sensitization. In a dermal sensitization study 
furilazole was not a sensitizer.
    2. Subchronic and chronic toxicity. This section summarizes the 
results of subchronic, and chronic toxicity studies in animals.
    i. Subchronic toxicity. In a 3-month rat feeding study, the no 
observed adverse effect level (NOAEL) is 100 ppm (7 mg/kg/day for males 
and females) and the lowest observed adverse effect level (LOAEL) is 
500 ppm (34 mg/kg/day for males and 38 mg/kg/day for females) based on 
the increased absolute liver weight in males, increased liver-to-body 
weight ratio in males and females, and increased levels of gamma 
glutamyltransferase in females.
    In a 90-day dog study, the NOAEL is 5 mg/kg/day. The LOAEL for this 
study is 15 mg/kg/day based on bile duct inflammation in one female and 
decreased body weight gain in females.
    In a 21-day dermal toxicity study, the NOAEL for systemic effects 
in both sexes is  1,000 mg/kg, the limit dose. A LOAEL was 
not established.
    ii. Chronic toxicity. In a 2-year rat feeding chronic toxicity/
carcinogenicity study, the NOAEL for chronic toxicity is 5 ppm (0.26 
mg/kg/day) for males and 100 ppm (6.03 mg/kg/day) for females. The 
LOAEL is 100 ppm (5.05 mg/kg/day) for males based on significantly 
increased absolute and/or relative liver and kidney weights. The LOAEL 
is 1,000 ppm (61 mg/kg/day) for females based on significantly 
increased absolute and/or relative liver and kidney weight, kidney 
nephropathy, increased GGT, decreased body weight gain, and a moderate 
increase in non-neoplastic liver lesions (eosinophilic focus, cystic 
degeneration, and telangiectasis). Under the conditions of this study, 
furilazole appeared to be carcinogenic in both sexes.
    In an 18-month mouse dietary carcinogenicity study, the NOAEL for 
systemic toxicity is 40 ppm (5.9 mg/kg/day) for males and 400 ppm (92.0 
mg/kg/day) for females. The systemic toxicity LOAEL in males is 400 ppm 
(60.2 mg/kg/day) based on increased incidence of mortality and elevated 
alanine aminotransferase. The systemic toxicity LOAEL in females was 
1,250 ppm (289.5 mg/kg/day), based on increased liver weight, increased 
incidence of hepatocellular hypertrophy of the panlobular area, and 
chronic inflammation of the lungs. At the doses tested, there was a 
treatment-related increase in tumor incidence.
    3. Developmental toxicity. In a developmental toxicity study in 
rats, the maternal toxicity NOAEL is 10 mg/kg/day and the maternal 
toxicity LOAEL is 75 mg/kg/day based on increased liver weight. The 
developmental toxicity NOAEL is 10 mg/kg/day and the developmental 
LOAEL is 75 mg/kg/day based on increased number of resorptions.
    4. Reproductive toxicity. In a two-generation reproduction study in 
rats, the NOAEL for systemic toxicity is 150 ppm (8.97 mg/kg/day in 
males and 10.67 mg/kg/day in females). The LOAEL for systemic toxicity 
is 1,500 ppm (92.39 mg/kg/day in males and 106.42 mg/kg/day in females) 
based on decreased body weight gains in the adults and offspring of 
both generations and microscopic lesions of the liver in F0 
and F1 males and females and kidneys of F0 
females and F1 males and females. The NOAEL for reproductive 
toxicity is  1,500 ppm ( 92.39 mg/kg/day in males 
and  106.42 mg/kg/day, in females), the highest dose tested. 
The reproductive toxicity LOAEL was not determined.
    5. Mutagenicity. Furilazole induced a weak positive response for 
inducing reverse gene mutations at high precipitating doses in 
Salmonella typhimurium but was negative in cultured mammalian cells. 
Furilazole was also negative for the induction of micronuclei in the 
bone marrow cells of mice and negative for the induction of unscheduled 
DNA synthesis (UDS) in rat primary hepatocytes.

B. Toxicological Endpoints

    1. Acute dietary toxicity. For an acute dietary risk assessment, 
for females ages 13-50 years, the Agency selected a developmental 
toxicity NOAEL of 10 mg/kg/day from a developmental toxicity study in 
rats. The developmental toxicity LOAEL of 75 mg/kg/day for this 
developmental study was based on increased resorptions.
    For an acute dietary risk assessment for the general population 
including infants and children, the Agency selected a maternal toxicity 
NOAEL of 75 mg/kg/day from a developmental toxicity study in the rat. 
The maternal toxicity LOAEL of 175 mg/kg/day for this study was based 
on decreased maternal body weight.
    2.Dermal toxicity. For a short-term dermal risk assessment, the 
Agency selected a NOAEL of 10 mg/kg/day from a developmental toxicity 
study in rats. The LOAEL of 75 mg/kg/day for this study was based on 
increased resorptions. Since an oral NOAEL was selected for dermal risk 
assessment a dermal absorption factor (30%) was used.
    For an intermediate-term dermal risk assessment the Agency selected 
a NOAEL of 7 mg/kg/day from a 90-day feeding study in rats. The LOAEL 
of 34 mg/kg/day for males and 38 mg/kg/day for females for this study 
was based on increased absolute liver weights in males, increased 
liver-to-body weight ratio in males and females, and increased gamma 
glutamyltransferase in females. Since an oral NOAEL was selected for 
dermal risk assessment a dermal absorption factor (30%) was used.
    A long-term dermal exposure scenario is not required for this use 
since furilazole is applied once per year.

[[Page 8862]]

    3.Chronic dietary toxicity. For a chronic dietary risk assessment, 
the Agency selected a NOAEL of 0.26 mg/kg/day from the chronic 
toxicity/carcinogenicity study in rats. The LOAEL of 5.05 mg/kg/day was 
based on significantly increased absolute and/or relative liver and 
kidney weights in males.
    4. Carcinogenicity. EPA has classified furilazole as ``likely to be 
carcinogenic to humans'' by the oral route in accordance with the EPA 
Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996), 
based on multiple tumors seen at multiple sites in two species 
including both benign and malignant liver tumors in male and female rat 
and mice, rare tumors such as stomach and testicular tumors in male 
rats, and lung tumors in both sexes of mice. A Q1* was 
calculated to be 8.22  x  10-2 (mg/kg/day)-1 
based on male mouse bronchiolar-alveolar adenoma and/or carcinoma 
combined tumor rates.
    5. Inhalation toxicity. For a short-term inhalation risk assessment 
the Agency selected an oral NOAEL of 10 mg/kg/day from the 
developmental toxicity study in rats. The LOAEL of 75 mg/kg/day was 
based on increased resorptions.
    For the intermediate-term risk assessment, the Agency selected a 
NOAEL of 7 mg/kg/day from a 90 day feeding study in rats as the 
endpoint. The LOAEL of 34 mg/kg/day for males and 38 mg/kg/day for 
females for this study was based on increased absolute liver weights in 
males, increased liver-to-body weight ratio in males and females, and 
increased gamma glutamyltransferase in females.
    A long-term inhalation exposure scenario is not required for this 
use, since furilazole is applied once per year.
    6. Dermal penetration. A dermal absorption factor of 30% was 
extrapolated by the Agency from a developmental toxicity study and a 
21-day dermal toxicity study both in the rat, where effects on liver 
weights were seen by both routes of exposure. In the developmental 
toxicity study in the rat, increased liver weight was seen at the 
maternal toxicity LOAEL of 75 mg/kg/day. In the 21-day dermal toxicity 
study in the rat, adaptive effects on liver weights were seen at 250 
mg/kg/day and are indicative of absorption. The Agency determined a 
dermal absorption ratio of 75/250 or 30%.
    7. Safety (uncertainty) factors, including FQPA safety factor. The 
Agency will use the above NOAELs and LOAELs to assess the risks of 
using furilazole to the general population and certain subgroups of the 
general population. However, the Agency first modifies these values 
numerically, downward, by dividing the NOAEL by two or more safety 
factors. The standard safety (uncertainty) factors used are: a tenfold 
factor to account for intraspecies variability (the differences in how 
the test animals reacted to the test substance), and a tenfold factor 
to account for interspecies variation (the use of animal studies to 
predict human risk).
    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 post-natal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. As 
noted, the Agency has used an additional 10-fold safety factor for the 
acute dietary assessment for females 13-50 only.
    The basis for this conclusion is that in the rat development 
toxicity study, although the NOAELs and LOAELs for maternal and 
developmental toxicity were the same, there does appear to be an 
increased severity of developmental effects in comparison to maternal 
effects. Increased resorptions (or death of fetuses) seen at the LOAEL 
is a more severe effect than increased maternal liver weight seen at 
the same level. Additionally, the database is incomplete since there is 
a data gap for a developmental toxicity study in rabbits.
    i. Acute dietary toxicity (females 13-50). For an acute dietary 
risk assessment for females ages 13-50 years old the Agency divided the 
NOAEL of 10 mg/kg/day from a developmental toxicity study in the rat by 
an uncertainty factor of 1,000 (10x for interspecies difference, 10x 
for intraspecies variations, and 10x safety factor to address 
additional susceptibility in fetus and data gaps). The acute Population 
Adjusted Dose (aPAD) is 0.010 mg/kg/day.
    ii. Acute dietary toxicity (general population and infants and 
children). For an acute dietary risk assessment (general population and 
infants and children ) the Agency divided the NOAEL of 75 mg/kg/day 
from the developmental rat study by an uncertainty factor of 100 (10x 
for interspecies difference, 10x for intraspecies variations and 1x for 
FQPA safety factor). The aPAD is 0.75 mg /kg/day
    iii. Chronic toxicity. For a chronic dietary risk assessment the 
Agency divided the NOAEL of 0.26 mg/kg/day from a 2-year combined 
chronic toxicity/carcinogenicity study in the rat by an uncertainty 
factor of 300 (10x for interspecies differences, 10x for intraspecies 
variations and 3x for lack of chronic toxicity study in the dog and 1x 
for FQPA safety factor). The chronic Population Adjusted Dose (cPAD) is 
0.0009 mg/kg/day.

C. Exposures and Risks

    1. From food and feed uses. Time-limited tolerances were previously 
established (40 CFR 180.471) for the residues of furilazole, in or on 
corn commodities (grain, forage, and fodder) at 0.01 ppm. Risk 
assessments were conducted by EPA to assess dietary exposures from 
furilazole as follows:
    i. Acute exposure and risk. 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. An acute dietary risk assessment was 
performed for furilazole. The acute dietary analysis for furilazole is 
a conservative estimate of dietary exposure from food, or Tier 1 
assessment, with the use of tolerance level residues for all corn 
commodities at 0.01 ppm, and 100 percent crop treated (PCT) 
information. The Agency's level of concern is for acute dietary 
exposures greater than 100% aPAD. The acute dietary exposure analysis 
was performed for the U.S. population and 26 subgroups. Acute estimates 
of the per capita dietary exposures from food at the 95th 
percentile for the U.S. population and all subgroups are 1% aPAD which 
is less than the Agency's level of concern.
    ii. Chronic exposure and risk. A chronic dietary risk assessment 
was performed for furilazole. The chronic dietary analysis for 
furilazole is a refined estimate, or Tier 3 assessment, with the use of 
anticipated residues (ARs) (calculated from field trial data using half 
the level of quantitation) for all commodities and PCT information. 
EPA's level of concern is for chronic dietary exposures greater than 
100% cPAD. For the U.S. population and all subgroups, including infants 
and children, 1% of the cPAD is occupied by dietary (food) exposure. 
The results of this analysis indicate that the estimated chronic 
dietary risk associated with the use of furilazole on corn is below 
EPA's level of concern.
    iii. Carcinogenic exposure and risk. A cancer dietary risk 
assessment was performed. ARs and PCT were used to calculate the upper 
bound lifetime risk for dietary exposure to furilazole. EPA generally 
considers 1  x  10-6 as negligible risk (i.e, less than 1 in 
1 million) for cancer. The results of this analysis indicate that the 
cancer dietary risk of 7.2  x  10-8 associated with the use 
of furilazole on corn is below the Agency's level of concern.

[[Page 8863]]

    iv. Use of anticipated residues and percent crop treated 
information. Section 408(b)(2)(E) authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    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 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 percent crop 
treated (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: For the acute dietary 
risk assessment, the Agency assumed 100% crop treated i.e, that the 
entire crop was treated. For chronic (non-cancer and cancer) dietary 
analyses it was assumed that 25% of the corn was treated.
    For assessing chronic dietary risk, the Agency believes that the 
three conditions listed above have been met. With respect to Condition 
1, it was assumed that 25% of the corn was treated. The petitioner 
supplied the percent crop treated data to the Agency. The information 
was based on the amount of acetochlor since furilazole is used as a 
safener with acetochlor to treat corn. The Agency reviewed the estimate 
and found it to be reasonable. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be underestimated. 
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 furilazole may 
be applied in a particular area.
    2. From drinking water--
    i. Chemical specific information. Based on laboratory data, 
furilazole and its principal degradates show low to moderate 
persistence and high mobility. Furilazole is stable against simple 
hydrolysis. Photolysis and soil metabolism are its main routes of 
transformation. ``Half-lives' for parent in the laboratory vary from 8 
days to 95 days. Furilazole is likely to be highly mobile. 
Bioconcentration is not expected. Major degradates identified included 
N (dichloroacetyl) glycine, furilazole oxazolidine acid, and furilazole 
oxamic acid. These degradates could be produced in soil and natural 
waters.
    ii. Ground water. The Agency used its SCI-GROW (Screening 
Concentration in Ground Water) screening model and environmental fate 
data to determine the estimated environmental concentrations (EECs) of 
furilazole in ground water. SCI-GROW is an empirical model based upon 
actual ground water monitoring data collected for the registration of a 
number of pesticides that serve as benchmarks for the model. The 
current version of SCI-GROW appears to provide realistic estimates of 
pesticide concentrations in shallow, highly vulnerable ground water 
sites (i.e., sites with sandy soils and depth to ground water of 10 to 
20 feet). The SCI-GROW ground water screening concentration is 0.019 
ppb.
    iii. Surface water. The Agency used its PRZM (Pesticide Root Zone 
Model)/EXAMS (Exposure Analysis Modeling System) screening model and 
environmental fate data to determine the EECs of furilazole in surface 
water. PRZM/EXAMS simulates a 1 hectare by 2 meter deep edge-of-the-
field farm pond which receives pesticide runoff from a treated 10 
hectare field. PRZM/EXAMS can overestimate true pesticide 
concentrations in drinking water. It has certain limitations and is not 
the ideal tool for use in drinking water risk assessments. However, it 
can be used in screening calculations and does provide an upper bound 
on the concentration of pesticide that can be found in drinking water.
    Using the PRZM/EXAMS model and available environmental fate data, 
EPA calculated the following Tier 2 EECs for furilazole:
    Acute (Peak) EEC: 1.007 ppb
    Mean (chronic) EEC: 0.214 ppb
    A Drinking Water Level of Comparison (DWLOC) is a theoretical upper 
limit on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food, drinking water, and 
through residential uses. A DWLOC will vary depending on the toxic 
endpoint, drinking water consumption, body weights, and pesticide uses. 
Different populations will have different DWLOCs. EPA uses DWLOCs 
internally in the risk assessment process as a surrogate measure of 
potential dietary exposure associated with pesticide exposure through 
drinking water. In the absence of monitoring data for pesticides, it is 
used as a point of comparison against conservative model estimates of a 
pesticide's concentration in water. DWLOC values are not regulatory 
standards for drinking water.
    It is current Agency policy that the following subpopulations be 
addressed when calculating drinking water levels of comparison U.S. 
population (48 States), any other adult populations whose %PAD is 
greater than that of the U.S. population, and the Female and Infant/
Children subgroups (1 each) with the highest food exposure. The 
subgroups which are listed below are those which fall into these 
categories.
    iv. Acute exposure and risk. Based on the acute dietary exposure 
estimates from food, acute drinking water levels of comparison for 
furilazole were calculated to be 26,250 ppb for the U.S. population, 
26,250 ppb for Non-Hispanic Blacks, 7,500 ppb for non-nursing infants 
(1 year), and 300 ppb for Females (13-19 yrs/np/nn).
    v.Chronic (non-cancer) exposure and risk. Based on the chronic 
dietary exposure estimates from food, chronic drinking water levels of 
comparison for furilazole were calculated, and are summarized below:
    U.S. population (48 States): 31 ppb
    Females 13-50 years: 27 ppb
    Children (non nursing infants): 9 ppb
    vi. Carcinogenic exposure and risk. Based on the carcinogenic 
dietary

[[Page 8864]]

exposure estimates from food, a carcinogenic drinking water level of 
comparison for furilazole in water was calculated to be 0.36 ppb for 
the U.S. Population (48 States).
    vii. Drinking water risks. The modeled groundwater and surface 
water concentrations are less than the DWLOCs for furilazole in 
drinking water for acute, chronic (non-cancer) and cancer aggregate 
exposures. Thus, the Agency is able to screen out furilazole drinking 
water risks.
    3. From non-dietary exposure. There are no currently registered 
residential uses for furilazole. Therefore a non-dietary assessment was 
not performed.
    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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether furilazole (3-dichloroacetyl-5-(2-furanyl)-2,2-
dimethyloxazolidine) has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Furilazole is structurally related to chloroacetanilides 
such as alachlor and acetochlor. However at this time the Agency has 
not yet made a final decision concerning a possible common mechanism of 
toxicity for the chloroacetanilides. For the purposes of this tolerance 
action, therefore, EPA has not assumed that furilazole has a common 
mechanism of toxicity with other substances.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. For the U.S. population and all subgroups, including 
infants and children, < 1% of the aPAD is occupied by exposure through 
food, which is below EPA's level of concern of 100%. The estimated 
acute concentrations of furilazole in surface and ground water are less 
than EPA's levels of comparison for furilazole in drinking water. 
Therefore, EPA does not expect the aggregate risk to exceed 100% of the 
aPAD.
    2. Chronic (non-cancer) risk. Since there are no residential uses 
for furilazole, the chronic (non-cancer) aggregate exposure includes 
only food and water. For the U.S. population and all subgroups, 
including infants and children, < 1% of the cPAD is occupied by 
exposure through food which is below EPA's level of concern of 100%. 
The estimated average concentrations of furilazole in surface and 
ground water are less than EPA's levels of comparison for furilazole in 
drinking water. Therefore, EPA does not expect the aggregate risk to 
exceed 100% of the cPAD.
    3. Short-and intermediate-term risk. Short-and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. Since there are no residential uses or exposure 
scenarios, short, intermediate, and long-term aggregate risk 
assessments were not conducted.
    4. Aggregate cancer risk for U.S. population. For the U.S. 
population, the cancer dietary risk from food of 7.2  x  
10-8 from food exposure is below the Agency's level of 
concern for excess lifetime cancer risk. The estimated average 
concentrations of furilazole in surface and ground water are less than 
EPA's drinking water level of comparison for furilazole in drinking 
water. Therefore, EPA does not expect aggregate risk to exceed 1  x  
10-6 as negligible risk (i.e., less than 1 in 1 million).
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to furilazole residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of furilazole, EPA considered data from a 
developmental toxicity study in the rat and a 2-generation reproduction 
study in the rat. The developmental toxicity studies are designed to 
evaluate adverse effects on the developing organism resulting from 
maternal pesticide exposure during gestation. Reproduction studies 
provide information relating to effects from exposure to the pesticide 
on the reproductive capability of mating animals and data on systemic 
toxicity. The Agency is requiring a developmental toxicity study in the 
rabbit.
    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 unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans. EPA believes that reliable data 
support using the standard uncertainty factor (usually 100 for combined 
interspecies and intraspecies variability) and the additional 3-fold 
uncertainty factor, as described above, when EPA has a complete data 
base under existing guidelines and when the severity of the effect in 
infants or children or the potency or unusual toxic properties of a

[[Page 8865]]

compound do not raise concerns regarding the adequacy of the standard 
MOE/safety factor.
    ii. Conclusion. There is not a complete toxicity data base for 
furilazole. EPA concluded that the 10x safety factor should be retained 
and is applicable to females 13-15 years only. This decision was based 
on the following: (a) There is a data gap for a developmental toxicity 
study in rabbits; and (b) There is evidence of qualitative increased 
susceptibility in the developmental toxicity study in rats. Increased 
resorptions (or death of fetuses) seen at the LOAEL is a more severe 
effect than increased maternal liver weight seen at the same level.
    2. Acute risk. For infants and children, < 1% of the aPAD is 
occupied by dietary exposure through food which is below EPA's level of 
concern of 100%. The estimated acute concentrations of furilazole in 
surface and ground water are less than EPA's levels of comparison for 
furilazole in drinking water. Therefore, EPA does not expect the 
aggregate risk to exceed 100% of the aPAD.
    3. Chronic (non-cancer) risk. Using the exposure assumptions 
previously described, EPA has concluded that aggregate exposure to 
furilazole from food will utilize less than 1 percent of the cPAD for 
infants and children. EPA generally has no concern for exposures below 
100% of the cPAD because the cPAD represents the level at or below 
which daily aggregate dietary exposure over a lifetime will not pose 
appreciable risks to human health. The estimated average concentrations 
of furilazole in surface and ground water are less than EPA's levels of 
comparison for furilazole in drinking water. Therefore, EPA does not 
expect the aggregate risk to exceed 100% of the cPAD.
    4. Short- or intermediate-term risk. Since there are no residential 
uses or exposure scenarios, short, intermediate, and long-term 
aggregate risk assessments were not conducted.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to furilazole residues.

IV. Other Considerations

A. Endocrine Disruptor Effects

    FQPA requires EPA to develop a screening program to determine 
whether certain substances (including all pesticides and inerts or 
inactive ingredients) ``may have an effect in humans that is similar to 
an effect produced by a naturally occurring estrogen, or such other 
endocrine effect...'' EPA has been working with interested stakeholders 
to develop a screening and testing program as well as a priority 
setting scheme. As the Agency proceeds with implementation of this 
program, further testing of products containing furilazole (3-
dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine) for endocrine 
effects may be required.

B. Metabolism in Plants and Animals

    The nature of the residue in corn was found to be understood based 
on submitted greenhouse and field metabolism studies. It was concluded 
that there is possible incorporation into natural plant components. The 
only residue of concern is parent furilazole.

C. Analytical Enforcement Methodology

    An adequate enforcement method (capillary gas chromatography using 
electron capture detection) is available to enforce the tolerance 
expression. The method may be requested from: Calvin Furlow, PRRIB, 
IRSD (7502C), Office of Pesticide Programs, Environmental Protection 
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 
20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

D. Magnitude of Residues

    Field trials on field corn were conducted and the data submitted. 
The submitted data support the time-limited tolerance level of 0.01 ppm 
for corn (grain stover, forage).

E. International Residue Limits

    There are no CODEX, Canadian or Mexican limits for residues of 
furilazole in corn raw agricultural commodities.

F. Rotational Crop Restrictions

    EPA has determined that a plantback interval of 30 days for 
furilazole is supported by the data.

V. Conclusion

    Therefore, time-limited tolerances are established for residues of 
the inert ingredient herbicide safener 3-dichloroacetyl-5-(2-furanyl)-
2,2-dimethyloxazolidine), which is also known as furilazole in or on 
corn commodities, (grain, forage, and stover), at 0.01 ppm. The 
tolerances will expire and be revoked on February 25, 2002. The 
following residue chemistry data gaps have been identified for 
furilazole: (1) Animal metabolism studies (OPPTS GLN 860.1300), (2) 
radiovalidation and specificity studies for the analytical enforcement 
method for plants, (3) an additional 10 field trials (OPPTS GLN 
860.1500). The following toxicology data gaps have been identified for 
furilazole (1) Chronic Toxicity (dog) (OPPTS GLN 870.4100), (2) 
Developmental Toxicity (rabbit) (OPPTS GLN 870.3700), (3) General 
Metabolism (870.7485) and (4) in vitro cytogenetic assay (OPPTS GLN 
870.6375). These datagaps must be addressed to establish permanent 
tolerances. These tolerances are being established on a time-limited 
basis due to an incomplete database.

VI. 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-300968 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 April 24, 
2000.
    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

[[Page 8866]]

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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 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, Ariel Rios Bldg., 
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 VI.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 docket control number OPP-300968, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 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 file 
format 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by 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 petition under FFDCA section 408(d), 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).

VIII. 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).

[[Page 8867]]

List of Subjects in 40 CFR Part 180

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

    Dated: February 15, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.471 is revised to read as follows:


Sec. 180.471  Furilazole; tolerances for residues.

    (a) General. Tolerances to expire February 25, 2002 are established 
for residues of furilazole; 3-dichloroacetyl-5-(2-furanyl)-2,2-
dimethyloxazolidine) (CAS Reg. No.121776-33-8) when used as an inert 
ingredient (safener) in pesticide formulations in or on the following 
raw agricultural commodities:

------------------------------------------------------------------------
                                      Parts per   Revocations/Expiration
              Commodity                million             Date
------------------------------------------------------------------------
Corn, field, forage................         0.01  February 25, 2002
Corn, field, grain.................         0.01  February 25, 2002
Corn, field, stover................         0.01  February 25, 2002
Corn, pop, grain...................         0.01  February 25, 2002
Corn, pop, stover..................         0.01  February 25, 2002
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 00-4237 Filed 2-22-00; 8:45 am]
BILLING CODE 6560-50-F