[Federal Register Volume 62, Number 16 (Friday, January 24, 1997)]
[Notices]
[Pages 3696-3698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1765]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-691; FRL-5583-6]


Rhone-Poulenc Ag Company; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing.

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SUMMARY: This notice announces the filing of a pesticide petition 
proposing the extension of the time-limited tolerance for the 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] (CAS Number 36734-19-7, PC Code 
109801) in or on the raw agricultural commodity (RAC) cottonseed at 
0.10 parts per million (ppm). The notice includes a summary of the 
petition prepared by the petitioner, Rhone-Poulenc Ag Company.

DATES: Comments, identified by the docket number [PF-691], must be 
received on or before February 24, 1997.

ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring comments to Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PF-691]. Electronic comments on this notice of filing 
may be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found in Unit II. of this 
document.
    Information submitted as comments concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment 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. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Connie Welch, Product Manager 
(PM 21), Registration Division (7505W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Crystal Mall #2, 
Room 227, 1921 Jefferson Davis Highway, Arlington, VA, 703-305-6226, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP 
2F4111) from Rhone-Poulenc Ag Company (Rhone-Poulenc), P.O. Box 12014, 
T.W. Alexander Drive, Research Triangle Park, NC 27709 proposing 
pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act 
(FFDCA), 21 U.S.C. 346(d), to amend 40 CFR part 180 by extending the 
time-limited tolerance for 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 the RAC cottonseed at 0.10 ppm. The 
current time-limited tolerance was established under pesticide petition 
(PP) 2F4111 and expires on March 15, 1997. EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

[[Page 3697]]

    As required by section 408(d) of the FFDCA, as recently amended by 
the Food Quality Protection Act, Rhone-Poulenc included in the petition 
a summary of the petition and authorization for the summary to be 
published in the Federal Register in a notice of receipt of the 
petition. The summary represents the views of Rhone-Poulenc. EPA is in 
the process of evaluating the petition. As required by section 
408(d)(3) of the FFDCA, EPA is including the summary as a part of this 
notice of filing. EPA may have made minor edits to the summary for the 
purpose of clarity.

I. Petition Summary

    There is an extensive data base supporting the registration of 
iprodione. All the studies required under the reregistration process 
mandated by the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) 88 have been submitted. Most of these studies have been 
reviewed by the Agency and accepted.
    The time-limited tolerance for iprodione on cottonseed at 0.10 ppm 
is considered adequate to cover residues resulting from the use of 
iprodione on cotton. No residues were detected in cottonseed field 
trial studies. A processing study conducted at 12x the label rate 
showed no detectable residues. The nature of the residue in plants is 
adequately defined. Plant metabolism studies have been reviewed in 
connection with previous petitions for tolerances. The residues of 
concern are iprodione, its isomer RP30228, and its metabolite RP32490. 
The Phase IV Review concluded that additional plant metabolism studies 
are not needed.
    The nature of the residue in animals is adequately understood for 
the proposed use of iprodione on cotton. Dietary contribution for 
animals from cottonseed as a result of the proposed use will be very 
small and secondary residues in animal commodities (ruminant and 
poultry) are expected to be nondetectable (i.e. <0.01 ppm in milk and 
<0.05 ppm in other animal commodities). A restriction is included in 
the use directions for cotton prohibiting grazing and feeding of cotton 
forage to livestock. Furthermore, based on market share information, 
only approximately 3% of the cotton crop is expected to be treated with 
iprodione in 1997. The established tolerances for iprodione and its 
metabolites in meat, milk, poultry, and eggs are therefore adequate to 
cover secondary residues in animal commodities resulting from the use 
on cotton.
    An adequate analytical method, gas liquid chromatography using an 
electron-capture detector, is available in the Pesticide Analytical 
Manual, Vol. II, for enforcement purposes. In the Phase IV Review, EPA 
requested that a substitute for benzene be used in the method of 
analysis used in new crop field trials. In response to this request, 
Rhone-Poulenc developed a common moiety GC method with a 0.05 ppm limit 
of quantitation (LOQ). An independent laboratory validation for this 
method was submitted.
    Iprodione is an important product for growers of several minor 
crops. These include garlic, ginseng, chinese mustard, broccoli, 
caneberries (blackberries, loganberries, and raspberries), and 
bushberries (blueberries, currant, elderberries, gooseberries, and 
huckleberries).
    Iprodione is also an important tool for cotton growers in 
controlling Rhizoctonia solani, a seedling disease. The Cotton Disease 
Loss Estimate Committee of the National Cotton Council ranks seedling 
diseases as the most important cotton disease. Furthermore, based on 
the cotton use directions for iprodione products, the maximum amount of 
product applied would be 0.2 lb active ingredient/acre on a 40 inch row 
and 13,000 linear row ft. This is a five- to six-fold decrease in 
active ingredient concentration compared to that required for 
competitive soil applied cotton fungicides which control Rhizoctonia 
solani. This allows for reduction of total pesticide usage in cotton 
production and thus reduces pesticide exposure in the environment. 
Another benefit is that iprodione is efficacious against all five 
anastomosis groups of Rhizoctonia solani. Currently, there are no 
registered products which possess this characteristic.
    There are no Codex tolerances for iprodione on cottonseed.
    The following mammalian toxicity studies have been conducted to 
support the extension of the tolerance for iprodione on cotton.

A. Toxicological Profile

    Rhone-Poulenc's explanation of the toxicological profile of 
iprodione is being published elsewhere in today's issue of the Federal 
Register in another notice of filing [PF-689] for a tolerance for 
iprodione.

B. Aggregate Exposure

    Rhone-Poulenc's explanation concerning aggregate exposure to 
residues of iprodione is being published elsewhere in today's issue of 
the Federal Register in another notice of filing [PF-689] for a 
tolerance.

C. Safety Determination

    1. DRES--US population--infants--children (1-6 yrs old). According 
to EPA's Dietary Risk Evaluation System (DRES) chronic analysis, the 
percent RfD falls within a safe margin even when considering tolerance 
levels and 100% crop treated. For the overall U.S. population, dietary 
exposure to iprodione uses 0.353% of the RfD when using Anticipated 
Residue Contribution (ARC) or 54.22 % of the RfD when using tolerance 
levels. These figures remain the same when cotton is included in the 
analysis. Exposure to iprodione resulting from the use of the product 
on cotton is negligible considering that:
    i. Residues above the LOQ (0.05 ppm) were not observed in cotton 
field trial studies.
    ii. A processing study conducted at 12x the label rate showed no 
detectable residues.
    iii. Only 3% of the cotton crop is expected to be treated with 
iprodione.
    A DRES detailed acute exposure analysis was performed by EPA using 
conservative values. The resulting high end margin of exposure value of 
100 for the DRES subgroup of concern (females 13 + years) is above the 
acceptable level and demonstrates no acute dietary concern.
    For the reasons stated in Unit I.A.5. in a notice of filing for 
iprodione published elsewhere in this issue of the Federal Register, 
Rhone-Poulenc considers the use of a low dose quantitative risk 
assessment for iprodione to be inappropriate. As previously indicated 
Rhone-Poulenc recommends the use of a safety factor approach and a RfD 
of 0.0725--mg/kg/day. The use of the Q* (Q star) value of 0.0439 (mg/
kg/day)-1 previously calculated by EPA represents a very 
conservative estimate of the lifetime cancer risk from potential 
residues of iprodione.
    Nevertheless, an assessment of the lifetime cancer risk from 
iprodione residues in food using a Q* value of 0.0439 (mg/kg/day)-
1 has been conducted to specifically demonstrate that the use of 
iprodione on cotton does not measurably increase exposure above that 
estimated for current uses. The upper bound cancer risk attributed to 
the use of iprodione on cotton is calculated to be 1.8 x 10-8. 
This assessment also indicates the total cancer risk to be in the de 
minimus range of 10-6, even with a very conservative Q* value.
    Based on results of the analyses, Rhone-Poulenc concludes that the 
added use on cotton will not measurably increase the cancer risk

[[Page 3698]]

estimate for any population subgroup, and iprodione residues in 
currently registered foods would not be expected to result in 
significant levels of chronic toxicity to any segment of the U.S. 
population.
    2. Infants and children--adequate margin of safety. In assessing 
the potential for additional sensitivity of infants and children to 
residues of iprodione, the available teratology and reproductive 
toxicity studies and the potential for endocrine modulation by 
iprodione were considered.
    Developmental studies in two species indicate that iprodione has no 
teratogenic potential, even at maternally toxic dose levels. Maternal 
and developmental no observed effect levels and lowest observed effect 
levels were generally comparable indicating no increased susceptibility 
of developing organisms. Multigeneration rodent reproduction studies 
indicated that iprodione has no adverse effects on reproductive 
performance, fertility, fecundity or sex ratio. Effects on pup weight 
and viability were only noted in the presence of severe parental 
toxicity.
    The mechanism of endocrine modulation associated with iprodione 
(inhibition of testosterone biosynthesis) appears to be distinct from 
that of anti-androgens acting at the level of the androgen receptor and 
may help to explain the lack of adverse effects on reproductive 
function observed with iprodione.
    Therefore, based upon the completeness and reliability of the 
toxicity data and the conservative exposure assessment, Rhone-Poulenc 
believes that there is a reasonable certainty that no harm will result 
to infants and children from exposure to residues of iprodione and no 
additional uncertainty factor is warranted.
    3. Endocrine discussion and conclusion. As indicated in Unit I.A.5. 
in a notice of filing for iprodione published elsewhere in this issue 
of the Federal Register, the primary lesion at the level of the target 
organs (testes, ovaries adrenals) is likely to be related to an 
inhibition of steroid/androgen biosynthesis. The resulting endocrine 
toxic effect due to iprodione is fairly moderate compared to that 
produced by potent endocrine disruptors such as flutamide (and other 
structural analogs) and is insufficiently potent to produce effects on 
reproduction or development.
    The increased incidence in tumors in both rats and mice was only 
observed when animals were treated at or above the MTD. For all three 
tumor sites (testis, liver, ovary) tumors only develop on pre-existing 
non-neoplastic lesions (cell hypertrophy/vacuolation, hyperplasia) and 
a clear threshold level exist for both non-neoplastic lesions and 
tumors. Those thresholds are far in excess of those levels of iprodione 
that the general public would be exposed to.
    Conclusion. Rhone-Poulenc believes that iprodione would not be 
expected to induce any adverse effects related to endocrine disruption 
in members of the general population via the consumption of food crops 
containing residues of this compound.

II. Public Record

    EPA invites interested persons to submit comments on this notice of 
filing. Comments must bear a notation indicating the docket number, 
[PF-691].
    A record has been established for this notice of filing under 
docket number [PF-691] including comments and data submitted 
electronically as described below. 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 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice of filing, as well as the 
public version, as described above will be kept in paper form. 
Accordingly, EPA will transfer all comments 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 address in ``ADDRESSES'' at the beginning of this 
document.

List of Subjects

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

    Dated: January 15, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 97-1765 Filed 1-23-97; 8:45 am]
BILLING CODE 6560-50-F