[Federal Register Volume 64, Number 105 (Wednesday, June 2, 1999)]
[Rules and Regulations]
[Pages 29589-29598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13948]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185 and 186

[OPP-300807; FRL 6064-5]
RIN 2070-AB78


Iprodione; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of iprodione, 3-(3,5-dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-
imidazolidinecarboxamide, its isomer, 3-(1-methylethyl)-N-(3,5-

[[Page 29590]]

dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide and its 
metabolite, 3-(3,5-dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide 
in or on cottonseed. Rhone-Poulenc Ag Company requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.

DATES: This regulation is effective June 2, 1999. Objections and 
requests for hearings must be received by EPA on or before August 2, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300807], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300807], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of objections and hearing requests 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII 
file format. All copies of objections and hearing requests in 
electronic form must be identified by the docket control number [OPP-
300807]. No Confidential Business Information (CBI) should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Product 
Manager (21), Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number, and e-mail address: Rm. 
249, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 
308-9354, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 1997 
(62 FR 3696) (FRL 5582-7), 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) (Pub. L. 104-
170) announcing the filing of a pesticide petition (PP) for tolerance 
by Rhone-Poulenc Ag Company, P.O. Box 12014, 2 T.W. Alexander Drive, 
Research Triangle Park, NC 27709. This notice included a summary of the 
petition prepared by Rhone-Poulenc Ag Company, the registrant. There 
were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.399 be amended by 
establishing a tolerance for combined residues of the fungicide 
iprodione, 3-(3,5-dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-
imidazolidinecarboxamide, its isomer, 3-(1-methylethyl)-N-(3,5-
dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide and its 
metabolite, 3-(3,5-dichlorophenyl)-2,4-dioxo-1-
imidazolidinecarboxamide], in or on cottonseed at 0.10 part per million 
(ppm).

I. Background and Statutory Findings

    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. 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).

II. 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 iprodione 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for a tolerance for combined residues of iprodione, 
3-(3,5-dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-
imidazolidinecarboxamide, its isomer, 3-(1-methylethyl)-N-(3,5-
dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide and its 
metabolite, 3-(3,5-dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide 
on cottonseed at 0.10 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 iprodione are 
discussed in this unit.
    1. Acute studies. Iprodione is not acutely toxic by oral, dermal, 
inhalation, or ocular routes of exposure. Acute oral, acute dermal and 
primary eye irritation studies were in toxicity category III. Acute 
inhalation and primary skin irritation studies were in toxicity 
category IV. Iprodione is not a dermal sensitizer.
    2. Subchronic toxicity testing--a. In a dermal toxicity study, 
rabbits were administered iprodione on the skin at dose levels of 0, 
100, 500, and 1,000 mg/kg/day for 21 days. There were no deaths or 
clinical signs of toxicity and no adverse effects were observed on body 
weight, food consumption, the skin, liver or kidneys. The NOAEL was 
1,000 mg/kg/day, the highest dose tested.
    b. In a 90-day subchronic feeding study, rats were administered 
iprodione in the diet at doses of 0, 1,000, 2,000, 3,000 and 5,000 ppm 
(0, 78, 151, 252 and 355 mg/kg/day for males and 0, 89, 189, 266 and 
408 mg/kg/day for females). The NOAEL in this study was 1,000 ppm (78 
mg/kg/day for males and

[[Page 29591]]

89 mg/kg/day for females). The LOAEL was 2,000 ppm (151 mg/kg/day for 
males and 189 mg/kg/day for females), based on decreased body weight 
gain, decreased food consumption and food utilization, organ weight 
effects, and microscopic lesions in the sex organs.
    3. Chronic toxicity studies--a. In a chronic feeding study, dogs 
were administered iprodione in the diet at dose levels of 0, 100 ppm 
(4.1 mg/kg/day for males and 4.3 mg/kg/day for females), 600 ppm (24.9 
mg/kg/day for males and 28.3 mg/kg/day for females) and 3,600 ppm 
(145.3 mg/kg/day for males and 152.5 mg/kg/day for females) for one 
year. The NOAEL was 100 ppm (4.1 mg/kg/day for males and 4.3 mg/kg/day 
for females, and the LOAEL was 600 ppm (24.9 mg/kg/day for males and 
28.3 mg/kg/day for females) based on decreased prostate weight and an 
increased incidence of erythrocytes with Heinz bodies.
    b. A second chronic feeding study designed to compliment the above 
study was conducted using dose levels of 0, 200 ppm (7.8 mg/kg/day for 
males and 9.1 mg/kg/day for females), 300 ppm (12.4 mg/kg/day for males 
and 13.1 mg/kg/day for females), 400 ppm (17.5 mg/kg/day for males and 
18.4 mg/kg/day for females) and 600 ppm (24.6 mg/kg/day for males and 
26.4 mg/kg/day for females) for 12 months. The NOAEL for systemic 
toxicity is 400 ppm (17.5 mg/kg/day for males and 18.4 mg/kg/day for 
females). The LOAEL is 600 ppm (24.6 mg/kg/day for males and 26.4 mg/
kg/day for females) based on decreased red blood cell values. When both 
chronic dog studies are considered together, the NOAEL is 400 ppm (18 
mg/kg/day).
    4. Carcinogenicity--a. In a combined chronic toxicity/
carcinogenicity study in rats, iprodione was administered in the diet 
of rats at dose levels of 0, 150, 300 and 1,600 ppm (6.1, 12.4, and 69 
mg/kg/day for males and 8.4, 16.5, and 95 mg/kg/day for females, 
respectively) for 24 months. The NOAEL for non-neoplastic changes in 
this study was 150 ppm (6.1 mg/kg/day for males and 8.4 mg/kg/day for 
females). The LOAEL was 300 ppm (12.4 mg/kg/day for males and 16.5 mg/
kg/day for females) based on increases in generalized enlargement of 
the cells of the zona glomerulosa in males and females, in fine 
vacuolation of the zona fasciculata and in generalized fine vacuolation 
of the zona reticularis in males in the adrenal cortex, an increased 
incidence of interstitial cell hyperplasia, reduced spermatozoa in the 
epididymides, reduced secretion of the seminal vesicles, increased 
hemosiderosis in the spleen in females, and increased liver weight.
    b. In a carcinogenicity study, iprodione was administered in the 
diet to mice for 99 weeks at dose levels of 0, 160, 800, and 4,000 ppm 
(0, 23, 115, and 604 mg/kg/day for males and 0, 27, 138, and 793 mg/kg/
day for females, respectively). The NOAEL for this study was 160 ppm 
(23 mg/kg/day for males and 27 mg/kg/day for females). The LOAEL was 
800 ppm (115 mg/kg/day for males and 138 mg/kg/day for females) based 
on the increased incidence of centrilobular hepatocyte enlargement in 
females and the increased incidence of generalized vacuolation/
hypertrophy of the interstitial cells in the testes of males.
     5. Developmental toxicity--a. In a developmental toxicity study, 
pregnant rats were administered iprodione at dose levels of 0, 40, 90, 
and 200 mg/kg/day by gavage from day 6 through 15 of gestation. There 
were no significant differences observed in the mean number of viable 
fetuses, implantations, corpora lutea, resorptions, and pre- and post-
implantation losses were comparable among the groups. There was no 
evidence of maternal toxicity at any dose level. The developmental 
NOAEL was 90 mg/kg/day and the developmental toxicity LOAEL was 200 mg/
kg/day, based on delayed fetal development (slightly reduced fetal body 
weight and increased incidences of space between the body wall and 
organs in the fetuses).
     b. In a special prenatal developmental toxicity study, pregnant 
rats received iprodione by gavage at dose levels of 0, 20, 120 or 250 
mg/kg/day during gestation days 6 through 19. For maternal toxicity, 
the NOAEL was 20 mg/kg/day and the LOAEL was 120 mg/kg/day based on 
decreased body-weight gain and decreased food efficiency. For 
developmental toxicity, the NOAEL was 20 mg/kg/day and the LOAEL was 
120 mg/kg/day, based on decreased anogenital distance in the male pups.
     c. In a prenatal developmental toxicity study on rabbits, dosed by 
gavage with iprodione at 0, 20, 60 or 200 mg/kg/day during gestation 
days 6 through 18, the NOAEL for maternal toxicity was 20 mg/kg/day and 
the LOAEL was 60 mg/kg/day based on decreased body weight gain. For 
developmental toxicity, the NOAEL was 60 mg/kg/day and the LOAEL was 
200 mg/kg/day based upon increased skeletal variations.
     6. Reproductive toxicity. In a 2-generation reproduction study, 
male and female rats received diets containing iprodione at 0, 300, 
1,000, or 3,000/2,000 ppm (0, 18.5, 61.4, or 154.8 mg/kg/day for males 
and 22.49, 76.2, or 201.2 mg/kg/day for females). For parental systemic 
toxicity, the NOAEL was 300 ppm (21 mg/kg/day) and the LOAEL was 1,000 
ppm (69 mg/kg/day), based on decreased body weight, body weight gain, 
and food consumption in both sexes and generations. For offspring 
toxicity, the NOAEL was 1,000 ppm (69 mg/kg/day) and the LOAEL was 
3,000/2,000 ppm (178 mg/kg/day), based on decreased pup viability (as 
evidenced by an increased number of still born pups and decreased 
survival during postnatal days 0-4), decreased pup body weight 
throughout lactation, and an increased incidence in clinical signs 
(smallness, reduced mobility, unkempt appearance, hunching and or 
tremors) in pups during the lactation period.
     7. Mutagenicity. Several mutagenicity studies were conducted. 
Iprodione was negative for induction of reverse gene mutations at the 
histidine locus in Salmonella typhimurium strains, both in the presence 
and absence of S9 activation. Iprodione did not induce mutation with or 
without metabolic activation in the in vitro forward gene mutation 
(CHO/HGPRT) assay at adequate dose levels. Iprodione was negative in an 
in vitro chromosomal aberration assay in Chinese hamster ovary (CHO) 
cells both in the presence and absence of metabolic activation. In an 
in vivo mouse micronucleus assay, iprodione was administered by oral 
gavage once at dose levels of 750, 1,500, and 3,000 mg/kg. Bone marrow 
cells were collected for micronucleated polychromatic erythrocytes 
(MPEs). One male and eight females died at the high dose. Dose-related 
cytotoxic effects on the target tissue were also seen at 48 hours post 
dose. The positive control induced the expected high yield of MPEs in 
both sexes. There was no evidence of a clastogenic or aneugenic effect 
at any dose or harvest time. Iprodione was negative in a sister 
chromatid exchange assay in Chinese hamster ovary cells both with and 
without metabolic activation. Iprodione was tested against 19 strain of 
Bacillus subtilis both with and without metabolic activation. Iprodione 
was positive both with and without metabolic activation.
     8. Metabolism. A general metabolic pathway for iprodione in the 
rat indicates that biotransformation results in hydroxylation of the 
aromatic ring, degradation of the isopropylcarbamoyl chain, and 
rearrangement followed by cleavage of the hydantoin moiety. 
Additionally, structural isomers of iprodione resulting from molecular 
rearrangement, as well as intermediates in the pathway, were detected.

[[Page 29592]]

     9. Neurotoxicity Neurotoxicity studies are not required since 
iprodione is not an organophosphate nor structurally related to 
compounds that are known to induce neurotoxicity.
     10. Other toxicological considerations. In a dermal penetration 
study, rats were exposed dermally to a single dose of iprodione at dose 
levels of 0.4, 4.0, and 40 mg/rat for 0.5, 1, 2, 4, 10, and 24 hours. 
Skin residues increased with the duration of exposure to 5-10% of the 
applied dose, although there was no apparent dose response. The portion 
of the test material absorbed increased with the duration of exposure 
to 7.41%, 3.16% and 0.19% of the applied dose at 0.4, 4.0 and 40 mg/
rat, respectively. Absorption appears to be saturated at the two 
highest dose levels. Following a 10-hour exposure period, about 5% 
iprodione is absorbed.

B. Toxicological Endpoints

    1. Acute toxicity. The Agency determined that the developmental 
NOAEL of 20 mg/kg/day based on decreased anogenital distance (AGD) in 
male fetuses at 120 mg/kg/day (LOAEL) should be used for acute dietary 
risk assessment). This NOAEL is from a special rat developmental study 
which was designed to determine the impact of iprodione on sexual 
differentiation. This endpoint applies only for females 13 years or 
older because the endpoint (decreased AGD) is an in utero effect 
occurring during prenatal exposure. An appropriate endpoint 
attributable to a single dose was not identified for the general 
population including infants and children. The target acute dietary 
margin of exposure (MOE) for iprodione is 300, based on uncertainty 
factors of 10x for interspecies variability, 10x for intraspecies 
variability, and 3x for added protection of infants and children. The 
acute RfD is 0.06 mg/kg/day based on the 20 mg/kg/day NOAEL and an 
uncertainty factor of 300.
     2. Short- and intermediate-term toxicity. The Agency determined 
that short- and intermediate-term dermal risk assessments are not 
required since no dermal or systemic toxicity was seen. It was 
concluded that there is no potential hazard by the dermal route because 
of lack of systemic toxicity at the limit-dose (1,000 mg/kg/day) and 
the demonstration of low (5%) absorption by the dermal route. For 
short-term inhalation exposure, the developmental NOAEL of 20 mg/kg/day 
from the special rat developmental toxicity study was selected. This 
NOAEL is based on decreased AGD in male fetuses at 120 mg/kg/day. For 
intermediate-term inhalation exposure, the NOAEL of 6.1 mg/kg/day from 
the rat combined chronic toxicity/carcinogenicity study was selected. 
This NOAEL is based on histopathological lesions in the male 
reproductive system and effects on the adrenal glands in males at 12.4 
mg/kg/day and in females at 16.5 mg/kg/day (LOAEL). The inhalation unit 
exposures (in ug ai/lb/day) should be converted to an equivalent oral 
dose (mg/kg/day) using a 100% absorption rate (default value). The 
converted oral doses should then be compared to the NOAELs identified 
above.
    3.  Chronic toxicity. EPA has established the RfD for iprodione at 
0.02 milligrams/kilogram/day (mg/kg/day). This Reference Dose (RfD) is 
based on a NOAEL of 6.1 mg/kg/day from the rat combined chronic 
toxicity/carcinogenicity study in which histopathological lesions 
occurred in the male reproductive system and there were effects on the 
adrenal glands in males at 12.4 mg/kg/day and in females at 16.5 mg/kg/
day (LOAEL). The NOAEL was adjusted with an uncertainty factor of 300 
(10x for interspecies extrapolation, 10x for intraspecies extrapolation 
and 3x for added protection for infants and children).
    4. Carcinogenicity. In accordance with the EPA Proposed Guidelines 
for Carcinogenic Risk Assessment (April 10, 1996), iprodione was 
classified as a ``likely'' human carcinogen based on the combined 
hepatocellular adenomas/carcinomas in mice and testicular tumors in 
male rats with a linear low-dose extrapolation approach and a 3/4s 
interspecies scaling factor for human risk characterization. For the 
combined hepatocellular adenomas/carcinomas, the Q1*s are 
8.7 x 10-3 mg/kg/day for the male mouse and 5.07 x 
10-3 mg/kg/day for the female mouse. The Leydig cell tumor 
Q1* is 4.3 x 10-2 mg/kg/day which was determined 
to be appropriate for estimating carcinogenic risk.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.399) for the combined residues of iprodione, 3-(3,5-
dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-imidazolidinecarboxamide, 
its isomer, 3-(1-methylethyl)-N-(3,5-dichlorophenyl)-2,4-dioxo-1-
imidazolidinecarboxamide and its metabolite, 3-(3,5-dichlorophenyl)-
2,4-dioxo-1-imidazolidinecarboxamide, in or on a variety of raw 
agricultural commodities. Commodities include various vegetable crops, 
field crops, stone fruits, small fruit and berry crops and commodities 
of animal origin (meat, milk, poultry and eggs). Risk assessments were 
conducted by EPA to assess dietary exposures from iprodione as follows:
    Dietary exposures for iprodione were reevaluated as part of the 
reregistration process. The risk assessment in the Reregistration 
Eligibility Decision (RED) document is being used to establish the 
tolerance for iprodione on cottonseed. The resulting estimates included 
refinements using both anticipated residues and percent crop treated 
for many crops but not for cottonseed. The requirements indicated below 
regarding anticipated residues and percent crop treated apply to both 
iprodione and its 3,5- dichloroaniline metabolite.
     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 (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: 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; that the exposure estimate does not underestimate exposure for 
any significant subpopulation group; and 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 of crop treated as required by the section 408(b)(2)(f), EPA 
may require registrants to submit data on PCT.
    The Agency used PCT information as follows: PCT was used for 
various crops in reevaluating dietary exposures for iprodione as part 
of the reregistration process. For cottonseed, it was considered that 
100% of the crop would be treated with iprodione.

[[Page 29593]]

    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(f) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. The PCT 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. Typically, a range of 
estimates are supplied and the upper end of this range is assumed for 
the exposure assessment. By using this upper end estimate of the PCT, 
the Agency is reasonably certain that the percentage of the food 
treated is not likely to be underestimated. The 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 iprodione may be applied in a particular area.
    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. The acute dietary risk for iprodione was 
reevaluated as part of the reregistration process. The target margin of 
exposure (MOE) for dietary risk for iprodione is 300. MOEs above 300 
are not considered to be of concern. Prior to the reevaluation, dietary 
MOEs were 111 for existing tolerances and 66.6 for existing and 
proposed tolerances. Following reevaluation, which included risk 
mitigation measures imposed in the Reregistration Eligibility Decision 
(RED) document, the acute dietary MOE was calculated to be 351 for the 
population subgroup of concern (females 13 years old or older).
    ii. Chronic exposure and risk. The total dietary exposure for 
iprodione, expressed as percent of the RfD for the chronic (non-
carcinogenic) risk was calculated based on the theoretical maximum 
residue contribution (TMRC) and the RfD of 0.02 mg/kg/day to be less 
than 1% for all populations from the registered uses. The additional 
use on cotton would not increase the chronic (non-carcinogenic) risk to 
an unacceptable level. The upper bound carcinogenic risk from food uses 
of iprodione for the general U.S. population was calculated using the 
equation: upper bound cancer risk equals dietary exposure (anticipated 
residue contribution) multiplied by the Q1*. Based on a Q1* 
of 0.0439 (mg/kg/day)-1 the upper bound cancer risk for all 
commodities with proposed and established tolerances was calculated to 
be 3.9 x 10-6. This risk estimate is above the range the 
Agency generally considers negligible for excess life-time cancer risk. 
During the reregistration process, the upper bound cancer risk was 
reevaluated, taking into consideration the risk mitigation measures 
imposed in the RED. The reevaluated dietary cancer risk for iprodione 
with mitigation measures in place is estimated to be approximately 1.8 
x 10-6 and is within the range the Agency generally 
considers negligible for excess life-time cancer risk. The upper bound 
cancer risk attributed to the use of iprodione on cotton was calculated 
to be 1.8 x 10-8.
    2. From drinking water. In the absence of reliable, available 
monitoring data, EPA uses models to estimate concentrations of 
pesticides in ground and surface water. For iprodione, modeling was 
used to estimate surface water concentrations because of very limited 
surface water monitoring data. However, EPA does not use these model 
estimates to quantify risk. Currently, EPA uses drinking water levels 
of comparison (DWLOCs) as a surrogate to capture risk associated with 
exposure to pesticides in drinking water. A DWLOC is the concentration 
of a pesticide in drinking water that would be acceptable as an upper 
limit in light of total aggregate exposure to that pesticide from food, 
water, and residential uses (if any). A DWLOC will vary depending on 
the residue level in foods, the toxicity endpoint and with drinking 
water consumption patterns and body weights for specific 
subpopulations. The calculated DWLOC is compared with the model 
estimate from PRZM 2.3/EXAMS 2.94 model estimates. If the estimates are 
below the DWLOC, the risks are not considered to be of concern. EPA 
believes the PRZM 2.3/EXAMS 2.94 model estimates to be overestimations 
of concentrations of iprodione expected in drinking water. Iprodione is 
strongly absorbed to sediment and is expected to be removed through 
treatment. Given low concentrations estimated in surface water (1-3 
ppb), expected absorption to sediments, and the likelihood of removal 
through treatment, the Agency does not believe iprodione will be 
present in drinking water.
    i. Acute exposure and risk. The acute DWLOC for iprodione was 
calculated for the population subgroup females 13 years old or older to 
be 324 g/L. Conservative model estimates of maximum 
concentrations in surface water associated with use of iprodione range 
from 10-15 ppb (g/L). The estimated concentrations in surface 
water are much lower than EPA's DWLOC of 324 g/L for the 
population of females 13 years old or older. Therefore, acute drinking 
water exposures and risks are not of concern.
    ii. Chronic exposure and risk. The chronic DWLOC was calculated for 
adult males, adult females and children. The DWLOCs were 693 
g/L for adult males, 594 g/L for adult females and 
197 g/L for children. Conservative model estimates of a long-
term average concentration of iprodione in surface water range up to a 
few parts per billion (1-3 g/L) The estimated concentrations 
in surface water are much lower than EPA's calculated DWLOCs for the 
above subpopulations for chronic exposure and risk assessments. 
Therefore, chronic drinking water exposures and risks are not of 
concern.
    iii. Carcinogenic exposure and risk. Because cancer risk estimates 
(without risk mitigation) for exposure to iprodione residues through 
food and residential uses each exceeded EPA's level of concern 
individually, combined exposures through these routes resulted in an 
aggregate risk that further exceeded the level of concern. Any 
additional exposure through drinking water would result in aggregate 
risks that further exceed the level of concern. In effect, the drinking 
water level of comparison (DWLOC) is zero. So, effectively, with risk 
reduction measures is place, exposures from food, residential uses and 
through drinking water would be below the level of concern.
    3. From non-dietary exposure. Iprodione is currently registered for 
use on the following residential non-food sites: ornamental plants 
including shade trees, evergreens and shrubs, and turfgrass. As one of 
the risk mitigation measures included in the RED, the registrant has 
agreed to cancel all residential uses for iprodione. Therefore, there 
will be no exposure or risk from residential uses.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the

[[Page 29594]]

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.
     Although at present the Agency is still considering how to apply 
the information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides for 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).
     Iprodione is structurally related to vinclozolin and procymidone, 
which belong to the imide class of fungicides. Each of these three 
pesticides can metabolize to 3,5-dichloroaniline (3,5-DCA). FQPA 
requires EPA to estimate cumulative risk from consumption of food and 
water containing 3,5-DCA derived from iprodione, vinclozolin, and 
procymidone.
     The Agency has determined that it is not necessary to include 
exposure to DCA derived from vinclozolin and procymidone in a 
cumulative exposure assessment for iprodione per se. Based on available 
metabolism data (discussed below), the contribution of DCA from 
vinclozolin and procymidone to the total chronic iprodione dietary 
exposure is less than an order of magnitude. Therefore, inclusion of 
DCA from vinclozolin and procymidone in the iprodione chronic exposure 
assessment would not have a significant impact on the risk estimates. A 
similar negligible contribution is expected for acute dietary exposure. 
Iprodione residues are measured as DCA by the analytical method, thus, 
any DCA formed from iprodione is already accounted for in the iprodione 
exposure assessment.
     3,5-DCA is not a registered pesticide; therefore, there are no 
FIFRA toxicology data for this compound so EPA has used the 
Q1* for p-chloroaniline (PCA) to assess the carcinogenic 
risk for other structurally related chloroanilines. The EPA policy on 
chloroanilines specifies that chloroaniline metabolites should be 
considered to be toxicologically equivalent to PCA unless there is 
sufficient evidence that the metabolite is not carcinogenic. No other 
toxicological endpoints have been identified for DCA. A Q1* 
of 6.38 x 10-2 (mg/kg/day)-1 in human equivalents 
has been calculated for p-chloroaniline. This is based on the spleen 
sarcoma rate in male rats from an NTP bioassay, linearized low dose 
multistage model, and the 3/4s interspecies scaling factor.
    i.  3,5-DCA residues in food and wine--a. For iprodione, metabolism 
data submitted to fulfill reregistration data requirements indicated 
that 3,5-DCA represented 1% of the total radioactive residue (TRR) in 
eggs, smaller proportions in other livestock commodities, and was not 
detected in primary or rotational crops. The total estimated exposure 
to iprodione-derived 3,5-DCA in food is 0.00000009219 mg/kg/day.
     b. For vinclozolin, metabolism data indicated that DCA represented 
9.6% TRR in peaches, smaller proportions in strawberries and was not 
detected in lettuce or grapes. Therefore, EPA assumed that 10% 
vinclozolin residues would be appropriate for use in an assessment for 
3,5-DCA. Wine was included in the analysis because the metabolism 
studies for procymidone showed that the 3,5-DCA metabolite is formed in 
wine even though it is not detected in grapes. The total estimated 
exposure to vinclozolin-derived 3,5-DCA in food is 0.000143224 mg/kg/
day.
     c. Procymidone is not registered for use in the U.S. so only 
imported wine was considered under the procymidone tolerance for wine 
grapes. The 3,5-DCA metabolite was not detected in grapes, but occurs 
during fermentation. Residues in wine were 0.3 ppm for parent 
procymidone and 0.06 ppm for 3,5-DCA. The estimated exposure to 
procymidone-derived 3,5 DCA in wine is 0.0000058 mg/kg/day using 
tolerance levels and 100% of crop treated.
     ii.  3,5-DCA residues in water--a. EPA estimated the concentration 
of iprodione in surface water as a result of an application to peaches 
for a chronic exposure to be 1.5 parts per billion (ppb). This 
assessment was refined by assuming that only some of the iprodione will 
convert to 3,5-DCA. A soil photolysis study indicated that a value of 
30% would be reasonable to account for the iprodione that is actually 
converted. The concentration of 3,5-DCA was estimated to be 0.45 ppb in 
surface water.
     b. A tier 1 estimated environmental concentration (EEC) was 
calculated for 3,5-DCA from degradation of vinclozolin when applied to 
peaches. EPA estimated the concentration of vinclozolin in surface 
water for a chronic exposure to be 2.6 ppb. The maximum of the parent 
vinclozolin that would be expected to convert to 3,5-DCA based on a 
field dissipation study is 20%. The concentration of 3,5-DCA in surface 
water was estimated to be 0.52 ppb.
     c. There are no U.S. registrations for procymidone; therefore, an 
evaluation of exposure to procymidone-derived 3,5-DCA in water is not 
appropriate.
     iii.  Cumulative risk from all sources of 3,5-DCA. The cumulative 
carcinogenic risk estimate for consumption of food and wine containing 
residues of 3,5-DCA as a result of use of iprodione, vinclozolin and 
procymidone is 9.5 x 10-7. This can be considered to be a 
conservative estimate. Metabolism studies for iprodione and vinclozolin 
were used to estimate the amount of 3,5-DCA present in various 
commodities by using total radioactive residues to convert iprodione or 
vinclozolin exposures to 3,5-DCA exposures. There is another 
uncertainty in the risk estimate in that a surrogate Q1* is 
being used for 3,5-DCA. However, due to the structural similarities of 
3,5-DCA and PCA, EPA believes that for 3,5-DCA, the use of the PCA 
Q1* represents an upper-bound estimate. This risk estimate 
is within the range the Agency generally considers negligible for 
excess life-time cancer risk. Because drinking water data on DCA 
residues in water are not available, EPA compared the conservative 
screening-level model estimates of iprodione concentrations in surface 
water to drinking water levels of comparison (DWLOCs) for DCA. The 
estimated concentrations of 3,5-DCA from iprodione applications in 
water was 0.22 ppb and is less than the DWLOC calculated for the cancer 
risk assessment. From applications of vinclozolin, the model estimated 
the concentration of DCA in water at 0.37 ppb. This is above the DWLOC 
calculated for the cancer risk assessment. However, the Agency 
recognizes that the model estimates are very conservative (upper bound 
estimates with a high degree of uncertainty) and are not likely to be 
representative of what might be expected in drinking water. When model 
estimates for water exceed DWLOCs, EPA makes an attempt to gather 
monitoring data (required for surface water). These data are used to 
confirm or deny the model estimate. The RED for iprodione requires that 
registrants develop and submit surface water monitoring data to confirm 
or deny the model estimates. The risks indicated for 3,5-DCA are not 
added to

[[Page 29595]]

those for the parent compounds since the risk estimates for the parent 
already include the 3,5-DCA component.

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

    1. Acute risk. The aggregate acute dietary risk estimate includes 
exposure to iprodione residues in foods and water. Iprodione uses are 
not expected to impact ground water. Upper bound estimates of iprodione 
in surface waters from conservative screening models indicate 
concentrations of a few parts per billion. For the acute dietary 
exposure and risk assessment, the toxic endpoint selected for risk 
assessment was the NOAEL of 20 mg/kg/day based on decreased anogenital 
distance (AGD) in male offspring observed in the developmental study in 
rats, in which the LOAEL was 120 mg/kg/day. The FQPA safety factor is 
applied for acute dietary risk assessment for only females 13+ because 
the endpoint (decreased AGD) is an in utero effect occurring during 
prenatal exposures. The MOE for this subgroup was calculated to be 351.
    2. Chronic risk. The chronic aggregate risk assessment for 
iprodione includes risk estimates associated with exposure through 
food, water, and registered residential uses. Using anticipated 
residues and percent crop-treated data for commodities with published 
tolerances results in an exposure to iprodione through food that will 
utilize 1% of the RfD for the U.S. population. The major identifiable 
subgroup with the highest aggregate exposure is non-nursing infants 
less than 1 year old, (discussed below) which represents up to 1.6% of 
the chronic FQPA RfD. Exposure to all other groups is less than or 
equal to 1% of the chronic FQPA RfD. EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human beings. Chronic aggregate risk from 
iprodione in food and drinking water associated with registered uses of 
iprodione is not of concern. Estimated average concentrations of 
iprodione in ground water were not available for comparison against 
DWLOC values; however, based on iprodione's physical/chemical 
characteristics and available, but limited monitoring data, iprodione 
is not expected to impact ground water. No chronic exposure scenarios 
for residential uses of iprodione were identified; therefore, no 
chronic exposure from residential uses was included in the aggregate 
risk estimate.
    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.
    4.  Short-term aggregate risk. Aggregate risk estimates associated 
with short-term risk include exposures to average residues of iprodione 
in the diet (food and water) and inhalation exposure (1 to 7 days in 
duration) through the residential application of iprodione. The 
resulting risk, calculated without any risk mitigation, represented 
3.6% of the acute FQPA RfD for the U.S. population representing the 
most exposed population of adult males and females. It was assumed that 
children and infants do not apply pesticides. The Agency believes that 
iprodione's impact on drinking water will not affect the aggregate 
short-term risk significantly. Therefore, the Agency concluded with 
reasonable certainty that residues of iprodione in drinking water (when 
considered along with exposure from food and residential uses) would 
not result in an unacceptable short-term aggregate human health risk 
estimate. Since residential uses will be canceled, short-term risk 
would be even lower.
     5. Intermediate-term aggregate risk. Aggregate risk estimates 
associated with intermediate-term risk include exposures to average 
residues of iprodione in the diet (food and water) and inhalation 
exposure (7 days to several months in duration) through the residential 
application of iprodione. The resulting risk, calculated without 
mitigation measures, was 9.5% of the chronic FQPA RfD for the U.S. 
population representing the most exposed population of adult males and 
females. It was assumed that children and infants do not apply 
pesticides. The Agency believes that iprodione's impact on drinking 
water will not affect the aggregate intermediate-term risk 
significantly. Therefore, The Agency concluded with reasonable 
certainty that residues of iprodione in drinking water (when considered 
along with exposure from food and residential uses) would not result in 
an unacceptable intermediate-term aggregate human health risk estimate. 
Since residential uses of iprodione will be canceled, intermediate-term 
risk would be even lower. Assuming that the conditions imposed by the 
RED are met by the registrant, the Agency concludes that aggregate 
risks for the general population resulting from iprodione uses are not 
of concern.
    6. Aggregate cancer risk for U.S. population. Without risk 
mitigation measures in place, combined exposure and the risk estimates 
for each of the residential exposure scenarios plus dietary exposure to 
iprodione residues results in cancer risk estimates that are all 
greater than 10-6. The first step in reducing the cancer 
aggregate risk is to make ineligible for reregistration all those 
residential uses which are greater than 10-6. Therefore, the 
Agency has decided, based on the current risk assessment, that 
residential use of iprodione on vegetable/small fruit gardens is 
ineligible for reregistration; use of iprodione on residential turf and 
lawns will be reclassified as restricted-use (professional application 
only); and, residential use of iprodione on ornamentals using a garden 
hose end-sprayer is ineligible for reregistration. The registrant has 
agreed to cancel these uses. With these mitigation measures in place 
cancer risks from residential uses of iprodione are expected to be 
negligible.
    For dietary cancer risk, with no risk mitigation measures in place, 
the upper bound dietary cancer risk estimate (3.9 x 10-6) 
exceeds EPA's level of concern. With risk mitigation measures in place, 
the upper bound dietary cancer risk estimate is approximately 1.8 x 
10-6 and is within the range the Agency generally considers 
negligible for excess life-time cancer risk. This risk estimate is 
based the new use patterns which include the risk mitigation measures 
in the RED, which is based on a refined estimate of dietary exposure 
using the most recent percent crop-treated data (1995) and anticipated 
residue data from monitoring programs (USDA's PDP) and field trials. 
Residues of iprodione, including its metabolites, are not expected to 
exceed the Agency's drinking water level of comparison as indicated 
above.
    7. 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 iprodione 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 iprodione, EPA considered data from 
developmental toxicity studies in the rat and rabbit 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 gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the

[[Page 29596]]

reproductive capability of mating animals and data on systemic 
toxicity.
    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 pre-and post-natal toxicity and the 
completeness of the database 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 inter- 
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor 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 compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Conclusion. Based on developmental and reproductive data for 
iprodione, EPA determined that an additional 10x safety factor for the 
protection of infants and children (as required by FQPA) should be 
reduced to 3x. The rationale for reducing the 10x factor to 3x is as 
follows: No enhanced susceptibility was seen in rat and rabbit 
developmental and 2-generation reproduction study in rats.
    a. The critical endpoint for acute dietary risk assessment 
(decreased AGD) was seen at a high dose (120 mg/kg/day) and there were 
only marginal differences in the degree of decreased AGD between the 
doses 20 mg/kg/day, 120 mg/kg/day and 250 mg/kg/day , thus indicating 
the ``true'' NOAEL could be higher than the one established at 20 mg/
kg/day.
    b. The proposed mode of action of iprodione is disruption of 
testosterone biosynthesis with a corresponding increase in plasma 
luteinizing hormone to dose levels which induce benign Leydig cell 
tumors. The dose response for this type of hormonally-mediated effect 
would be expected to be non-linear.
    c. The use of realistic dietary exposure data (refined using 
monitoring data and percent crop treated).
    d. The endpoints selected for both the acute (AGD) and the chronic 
(histopathology of the male reproductive system) risk assessments are 
based on developmental/reproductive effects and therefore, these 
effects are already adequately considered in the risk evaluation. These 
factors favor removal of the safety factor but, although the data base 
for iprodione is complete, the Agency still has questions about any 
effects that iprodione may have on the developing reproductive system. 
The Agency is requiring an additional pre/post exposure study to assess 
the effects of iprodione on the male reproductive system. A safety 
factor of 3x is being retained pending completion of this additional 
study. There is a complete toxicity database for [iprodione] and 
exposure data is complete or is estimated based on data that reasonably 
accounts for potential exposures.
    2. Acute risk. The acute dietary risk for iprodione was calculated 
and the MOE was determined to be 351. Using the 3x safety factor for 
protection of infants and children, MOEs above 300 are not considered 
to be of concern. For drinking water, the estimated concentrations in 
surface water are much lower than the DWLOC of 324 g/L for the 
population subgroup females 13 years old or older, so no acute risk 
concerns are posed by drinking water. There will be no residential 
exposure.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to iprodione from food 
will utilize 1.6% of the RfD for non-nursing infants less than 1 year 
old and less than 1% for all other population subgroups. EPA generally 
has no concern for exposures below 100% of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. Since 
the potential for exposure to iprodione in drinking water is low and 
there will be no risk from non-dietary, non-occupational exposure, EPA 
does not expect the aggregate exposure to exceed 100% of the RfD.
    4. Short- or intermediate-term risk. EPA has concluded that there 
are no short- or intermediate-term risk factors associated with infants 
and children. Residential handler exposure scenarios for short- and 
intermediate-term inhalation exposures are not applicable to children.
    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 iprodione residues.

III. Other Considerations

A. Metabolism In Plants and Animals

    1. Plants. The metabolism of iprodione in plants is well 
understood. EPA concluded that the residues of concern in plants are 
the parent, its isomer 3-(1-methylethyl)-N-(3,5-dichlorophenyl)-2,4--
dioxo-1-imidazolidinecarboxamide, and its metabolite 3-(3,5-
dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide.
    2. Animals. In rats, radio-labeled iprodione was absorbed readily 
from the gastrointestinal tract, metabolized and excreted by rats of 
both sexes. Peak blood levels were observed at 4 and 2 hours, 
respectively, in the low-dose males and females and at 6 hours in the 
high dose rats of both sexes. The elimination from the blood was slower 
in males than in females. Although radioactivity was found in most 
tissues monitored, the levels were <0.05% of the total amount 
administered. The primary route of elimination following single and 
repeat low-dose exposure was the urine, and the feces was the primary 
route following high-dose exposure. Dealkylation and cleavage of the 
hydantoin ring were the two primary steps in the metabolism of 
iprodione. Hydroxylation of the phenyl ring and oxidation of the alkyl 
chain also occurred. The nature of residues in animals is adequately 
understood for the use on cotton since the dietary contribution for 
animals from cottonseed as a result of the use on cotton will be small 
and the secondary residues in animal commodities would be expected to 
be nondetectable. The residues of concern in animal commodities are the 
parent, its isomer 3-(1-methylethyl)-N-(3,5-dichlorophenyl)-2,4-dioxo-
1-imidazolidinecarboxamide and its metabolites 3-(3,5-dichlorophenyl)-
2,4-dioxo-1-imidazolidinecarboxamide and N-(3,5-dichloro-4-
hydroxyphenyl)-ureidocarboxamide.

B. Analytical Enforcement Methodology

     An adequate analytical method, gas-liquid chromatography using an 
electron-capture detector, is available in the Pesticide Analytical 
Manual, Vol. II, for enforcement purposes.

C. Magnitude of Residues

    The combined residues of iprodione, its isomer and its metabolite 
resulting from the use of iprodione on cotton will not exceed the 
tolerance level of 0.10 ppm.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican tolerances for iprodione 
on cottonseed. Therefore, no compatibility questions exist for 
cottonseed with respect to Codex.

[[Page 29597]]

E. Rotational Crop Restrictions

    The following crops may be rotated after harvest: beans, broccoli, 
carrots, Chinese mustard, cotton, dry bulb onions, garlic, lettuce, 
peanuts, potatoes and rice.

IV. Conclusion

    Therefore, the tolerance is established for combined residues of 
iprodione, 3-(3,5-dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-
imidazolidinecarboxamide, its isomer, 3-(1-methylethyl)-N-(3,5-
dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide and its 
metabolite, 3-(3,5-dichlorophenyl)-2,4-dioxo-1-
imidazolidinecarboxamide, in cottonseed at 0.10 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408 and (l)(6) as was provided in the old section 408 and 
in section 409. However, the period for filing objections is 60 days, 
rather than 30 days. EPA currently has procedural regulations which 
govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by August 2, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
regulation. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). 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 tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is 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 in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). 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.

VI. Public Record and Electronic Submissions

     EPA has established a record for this regulation under docket 
control number [OPP-300807] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].


     E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
     The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or 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 in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, 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 
(R.A.) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a

[[Page 29598]]

generic matter, that there is no adverse economic impact. The factual 
basis for the Agency's generic certification for tolerance actions 
published on May 4, 1981 (46 FR 24950), and was provided to the Chief 
Counsel for Advocacy of the Small Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

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 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 the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 180, 185 and 186

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

    Dated: April 16, 1999.

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 180.399 is amended as follows:
    a. By revising the phrase ``raw agricultural commodities'' or ``raw 
agricultural commodity'' to read ``food commodities'' or ``food 
commodity'', respectively, wherever it appears.
    b. By adding a paragraph heading to paragraph (a), and 
redesignating the text following the heading as paragraph (a)(1).
    c. By adding alphabetically to the table in paragraph (a)(1) the 
entries: Cottonseed at 0.10 ppm; Ginseng, dried 4.0 ppm; Raisins 300 
ppm; Rice bran 30.0 ppm and Rice hulls 50.0 ppm.
    d. By redesignating paragraph (b) as paragraph (a)(2).
    e. By adding a paragraph heading to paragraph (c).
    f. By adding and reserving with a paragraph heading, new paragraph 
(b), and by removing and reserving paragraph (d) with a paragraph 
heading to read as follows:
    The additions read as follows:


Sec. 180.399  Iprodione; tolerances for residues.

    (a)  General. (1) *  *  *
*      *      *      *      *
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. *  *  *
    (d) Indirect or inadvertent residues. [Reserved]

PART 185 -- [AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 21 U.S.C. 348.


Sec. 185.3750 [Removed]

    b. Section 185.3750 is removed.

PART 186 -- [AMENDED]

    3. In part 186:
    a. The authority citiation for part 186 continues to read as 
follows:
    Authority 21 U.S.C. 342, 348, and 371.


Sec. 186.3750 [Removed]

    b. Section 186.3750 is removed.

[FR Doc. 99-13948 Filed 6-1-99; 8:45 am]
BILLING CODE 6560-50-F