[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: opp-docket@epa.gov. 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, waller.mary@epa.gov.
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,="">tompkins.jim@epa.gov. 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:
opp-docket@epa.gov.
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
