[Federal Register Volume 61, Number 87 (Friday, May 3, 1996)]
[Rules and Regulations]
[Pages 19845-19847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10921]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 2F4111/R2226; FRL-5360-3]
RIN 2070-AB78


Pesticide Tolerance for Iprodione

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes a time-limited tolerance for the 
combined residues of the fungicide iprodione in or on the raw 
agricultural commodity cottonseed. The regulation to establish a 
maximum permissible level for residues of iprodione was requested in a 
petition submitted by Rhone-Poulenc Ag Company.

 EFFECTIVE DATE: This regulation becomes effective March 18, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 2F4111/R2226], may 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 should be 
identified by the document control number and submitted 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 copy of 
objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA 22202.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also 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 in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number [PP 
2F4111/R2226]. 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. Additional information on electronic submissions can be 
found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Connie B. Welch, Product 
Manager (PM) 21, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 227, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA 22202 (703) 305-6900; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Rhone-Poulenc Ag Co., P.O. Box 12014,2 T.W. 
Alexander Drive, Research Triangle Park, NC 27709, has 
submittedpesticide petition (PP) 2F4111 to EPA requesting that the 
Administrator,pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act(FFDCA), 21 U.S.C. 346a(d), establish a 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], in or on the raw agricultural 
commodity cottonseed at 0.10 parts per million (ppm).
    Through an oversight, an announcement of receipt of this petition 
by the Agency was not published in the Federal Register as required by 
regulation in 40 CFR 177.88. In lieu of the 30-day comment period prior 
to establishing the tolerance requested, this tolerance is being 
established with the provision that any comments received within 30 
days after publication in the Federal Register which contain objections 
will be reviewed and if the objections are substantial, the tolerance 
will be withdrawn, if justified. The publication of this notice is 
deemed to be in the public interest and is justified by the fact that 
the resulting changes in the use pattern for iprodione, which resulted 
from an agreement between Rhone-Poulenc Ag Co. and the Agency, will 
significantly lower the overall use of iprodione and consequently 
reduce the risk to the public posed by its current uses.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. The toxicological data considered in 
support of the tolerance include:
    1. A three-generation rat reproduction study using dosage levels of 
0, 250, 500 and 2,000 ppm with a no-observed-effect level (NOEL) of 500 
ppm (25 milligrams/kilogram(mg/kg) body weight (bwt)/day), a 
reproductive lowest effect level (LEL) of 2,000 ppm (100 mg/kg/day), 
and a systemic NOEL equal to or greater than 2,000 ppm (100 mg/kg/day).
    2. A rabbit developmental toxicity study in which the following 
doses were administered by gavage; 0, 20, 60, and 200 mg/kg bwt, 
resulting in a developmental toxicity NOEL equal to or greater than 60 
mg/kg bwt, and an LEL of 200 mg/kg bwt.
    3. A rat developmental toxicity study in which the following doses 
were administered by gavage: 0, 40, 90, and

[[Page 19846]]

200 mg/kg bwt, with a developmental toxicity NOEL equal to or greater 
than 90 mg/kg bwt, and an LEL of 200 mg/kg bwt.
    4. A 24-month feeding/oncogenicity study in rats using dosage 
levels of 125, 250 and 1,000 ppm (6.25, 12.5 and 50 mg/kg/day) which 
showed no treatment-related tumors were reported but testicular 
intersticial cell tumors were observed.
    5. A repeated 24-month rat feeding study at dose levels of 0, 150, 
300 and 1,600 ppm which showed non-neoplastic changes such as 
intersticial cell hyperplasia in the testes of males and tubular 
hyperplasia in the ovaries and increased sciatic nerve fiber 
degeneration in females. The NOEL for non-neoplastic changes was 150 
ppm (6.1 mg/kg/day for males and 8.4 mg/kg/day for females) and an LEL 
of 300 ppm (12.4 mg/kg/day for males and 16.5 mg/kg/day for females).
    6. An 18-month oncogenicity study in mice using dosage levels of 
200, 500 and 1,250 ppm (28.6, 71.4 and 178.6 mg/kg/day, which showed no 
carcinogenicity.
    7. A repeated mouse feeding study of 99 weeks at dose levels of 0, 
160, 800, and 4,000 ppm in which there was a significantly increased 
incidence of single and multiple areas of enlarged eosinophilic 
hepatocytes and focal fat-containing hepatocytes in both males and 
females. In males there was an increased incidence of generalized 
vacuolation/hypertrophy of the interstitial cells of the testes in the 
mid- and high-dose mice. There was a dose-related increase in female 
mice displaying luteinization of the interstitial cell of the ovary, 
but statistical significance was not attained at any dose level. The 
NOEL for non-neoplastic changes was 160 ppm (23 mg/kg/day for males and 
27 mg/kg/day for females) and the LEL was 800 ppm (115 mg/kg/day for 
males and 138 mg/kg/day for females).
    8. A 1-year dog feeding study using dosage levels of 100, 600 and 
3,600 ppm (4.2, 15, and 90 mg/kg/day) with a NOEL of 100 ppm (4.2 mg/
kg/day) and an LEL of 600 ppm (15 mg/kg/day) based on decreased 
prostate weight and an increased number of erythrocytes with Heinz 
bodies in males.
    9. Another 1-year dog feeding study at dosage levels of 200, 300, 
400 and 600 ppm in which the NOEL was set at 400 ppm (17.5 mg/kg for 
males and 18.4 mg/kg for females and an LEL set at 600 ppm (24.6 mg/kg 
for males and 26.4 mg/kg for females) based on depressed red blood cell 
parameters.
    10. A 90-day feeding study in dogs using dosage levels of 800, 
2,400 and 7,200 ppm (20, 60, and 180 mg/kg/day) with a NOEL of 2,400 
ppm (60 mg/kg/day) and an LEL of 7,200 ppm (180 mg/kg/day) based on 
liver hypertrophy and increased SAP.
    11. Iprodione was tested in several mutagenicity studies. The 
chemical was negative in the Ames assay; CHO/HGPRT mammalian cell 
forward mutation assay, with and without metabolic activation; in vitro 
chromosome aberration assay in CHO cells; in vitro sister chromatid 
exchange assay in CHO cells; and dominant lethal test in mice. 
Iprodione was positive in the Bacillus subtilis assay for DNA damage 
without metabolic activation.
    The Reference Dose (RfD) of 0.06 mg/kg/day based on a NOEL of 6.1 
mg/kg/day and an uncertainty factor of 100 was used in the chronic risk 
analysis for iprodione. Using percent crop treated data and the 
Anticipated Residue Contribution (ARC), the Theoretical Maximum Residue 
Contribution (TMRC) for the overall U.S. population is 0.015134 mg/kg/
day and utilizes 25% of the RfD. For the most highly exposed subgroup, 
non-nursing infants, the TMRC is 0.045389 mg/kg/day and utilizes 76% of 
the RfD. The calculated percentage of the RfD is within a safe margin 
and the chronic dietary risk posed from iprodione is not of concern.
    In analyzing for the acute dietary risk tolerance level, residues 
were used to calculate the exposure of the highest exposed individual 
for the females (13 years old or older) which was compared to the 
developmental NOEL of 60 mg/kg/day from the rabbit study to determine 
the Margin of Exposure (MOE). The MOE was calculated to be 333. The 
Agency is not generally concerned with acute risk unless the MOE is 
below 100 when the NOEL is taken from an animal study.
    The Health Effects Division (HED) Cancer Peer Review Committee 
determined that iprodione should be classified as a group B2 carcinogen 
(probable human carcinogen). Calculations of Q1* from the rat 
study used in the risk analysis was based upon interstitial cell benign 
tumor rates and was calculated to be 0.0439 (mg/kg/day)-1. In the 
dietary cancer risk assessment, the upper bound cancer risk was 
calculated for all registered commodities when using anticipated 
residues to be 6.0  x  10-6. This upper bound cancer risk estimate 
exceeds the Agency's generally accepted level of concern for dietary 
risk, even when anticipated residues are used and adjustments for 
percent crop treated are made. In an agreement between the Agency and 
Rhone-Poulenc Ag Co., various changes in the use pattern of iprodione 
will be made to reduce the residues of iprodione in or on several 
crops. Although data are not available to quantitatively determine the 
amount of reduction, the overall quantity of iprodione used will be 
reduced enough to significantly affect the amount of residues. This 
reduction is expected to lower the upper bound cancer risk estimate to 
an acceptable level.
    The upper bound cancer risk attributed to the use of iprodione on 
cotton was calculated to be 1.8  x  10-8. Therefore, the added use 
would be unlikely to significantly affect the overall cancer risk 
estimate. The tolerance being established for cottonseed is time-
limited and the time limitation is being imposed on the condition that 
sufficient data are submitted within the time period to demonstrate 
that the risk has been reduced to an acceptable level through the 
changes in the use pattern of iprodione containing products.
    An adequate analytical method, gas liquid chromatography using an 
electron-capture detector, is available in the Pesticide Analytical 
Manual, Vol. II, for enforcement purposes.
    There are presently no actions pending against the continued 
registration of this chemical. The pesticide is considered useful for 
the purpose for which the tolerance is sought.
    Based on the information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR part 180 
will protect the public health. Therefore, the tolerance is established 
as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the 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 above (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 rulemaking. 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). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the

[[Page 19847]]

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 issue(s) in the manner sought by the 
requestor would be adequate to justify the action requested (40 CFR 
178.32).
    EPA has established a record for this rulemaking under docket 
number [PP 2F4111/R2226] (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 a.m. to 
4:30 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 may 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 rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to all the requirements of the Executive Order 
(i.e., Regulatory Impact Analysis, review by the Office of Management 
and Budget (OMB)). Under section 3(f), the order defines 
``significant'' as those actions likely to lead to a rule (1) having an 
annual effect on the economy of $100 million or more, or adversely and 
materially affecting a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local or tribal governments or communities (also known as 
``economically significant''); (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement, 
grants, user fees, or loan programs; or (4) raising novel legal or 
policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

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

Dated: March 18, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.399, is amended by adding paragraph (d) to read as 
follows:


Sec. 180.399  Iprodione; tolerances for residues.

* * * * *
    (d)(1) A time-limited tolerance, to expire March 15, 1997, is 
established permitting 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] in or on the following raw agricultural 
commodity:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Cottonseed.................................................         0.10
------------------------------------------------------------------------

    (2) Residues in this commodity not in excess of the established 
tolerance resulting from the use described in this paragraph remaining 
after expiration of the time-limited tolerance will not be considered 
to be actionable if the fungicide is applied during the term of and in 
accordance with the provisions of the above regulation.

[FR Doc. 96-10921 Filed 5-2-96; 8:45 am]
BILLING CODE 6560-50-F