[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: opp-docket@epamail.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 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:
welch.connie@epamail.epa.gov.
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
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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:
opp-docket@epamail.epa.gov.
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
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(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
