[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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. 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: welch.connie@epamail.epa.gov.
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/="">-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:
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 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
