[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Notices]
[Pages 39966-39967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19081]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-659; FRL-5378-9]


Rhone Poulenc Ag Company; Notice of Initial Filing of Pesticide 
Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces an initial filing of a pesticide 
petition and of a food/feed additive petition by Rhone Poulenc Ag 
Company of 2 T. W. Alexander Drive, in Research Triangle Park, NC for 
cyclanilide, a plant growth regulator used to aid in the harvest of 
cotton.
DATES:  Comments, identified by the docket number PF-659, must be 
received on or before August 30, 1996.
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 Hwy., Arlington, VA. Information submitted and any 
comment(s) concerning this notice may be claimed confidential by 
marking any part or all of that information as ``Confidential Business 
Information'' (CBI). Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
comment(s) 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 to the submitter. Information on 
the proposed test and any written comments will be available for public 
inspection in Rm. 1132 at the Virginia address given above, from 8 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays.
    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-659]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Electronic comments on this 
proposed 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: Cynthia Giles-Parker, Product 
Manager (PM) 22, Registration Division, (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 247, CM #2, 2801 
Jefferson Davis Highway, Arlington, VA 22202, 703-305-5540; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: PP 6F4643 and FAP 6H5744. Rhone Poulenc Ag 
Company, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709, 
proposes to amend 40 CFR parts 180 and 186 by establishing a tolerance 
regulation and a feed additive tolerance to permit (2,4-
dichlorophenylaminocarbonyl)-cyclopropanecarboxylic acid, and its 
metabolite 2,4-dichloroaniline in or on cottonseed at 0.75 part per 
million (ppm), milk at 0.03 ppm, liver of beef cattle, goat and sheep 
at 0.25 ppm, kidney of beef cattle, goat and sheep at 2.5 ppm, fat of 
beef cattle, goat and sheep at 0.07 ppm, meat byproducts of beef 
cattle, goat and sheep at 2.5 ppm, organ meats of beef cattle, goat and 
sheep at 2.5 ppm, lean (fat free) meat of beef cattle, goats and sheep 
at 0.03 ppm, horse meat at 0.03 ppm, and cotton gin trash at 25 ppm.
    Scientific data and related documents cited by Rhone-Poulenc Ag 
Company in support of the petition inlcude:
    1. A rat acute oral study with an LD50 of 315 mg/kg (male) and 
208 mg/kg (female).
    2. A rabbit acute dermal LD50 of
> 2,000 mg/kg.
    3. A rat acute inhalation LD50 of > 2.6 mg/L.
    4. A primary eye irritation in the rabbit which showed a severe, 
but reversible reaction.
    5. A primary dermal irritation study which showed slight 
irritation.
    6. A dermal sensitization study which showed no sensitization.
    7. An acute neurotoxicity study using dosage levels of 15, 50, 150 
mg/kg by gavage with a NOEL of 50 mg/kg and no neuropathological 
findings at any dose.
    8. A 28 day feeding study in the rat using dosage levels of 30, 
100, 300, 1,000 and 3,000 with a NOEL of 1,000 ppm.
    9. A 90 day feeding study in the rat with doses of 400, 800 and 
1,600 ppm with a NOEL of 400 ppm.
    10. A 21 day dermal toxicity in the rabbit study with a NOEL at > 
1,000 mg/kg/day.
    11. A 90 day subchronic oral toxicity study in the mouse with doses 
at 40, 200, 2,000 and 4,000 ppm and a NOEL of 200 ppm. At 2,000 and 
4,000 ppm forestomach irritation, focal hepatocellular necrosis, 
increased serum alkaline phosphatase, increased liver weight, transient 
increase in body tone and some mortalities were observed.
    12. A 90 day subchronic neurotoxicity study in the rat using dosage 
levels of 50, 450 and 1,200 ppm in the diet with a neurotoxicity NOEL 
of 1,200 ppm and an overall NOEL of 50 ppm with decreased body weight 
at 450 and 1,200 ppm. No histopathological effects on the peripheral or 
central nervous system were observed.
    13. A 24 month chronic feeding/oncogenicity study in the rat with 
doses at 50, 150, 450 and 1,000 ppm showing a NOEL of 150 ppm and no 
evidence of an oncogenic response.
    14. A 12 month feeding study in the dog with doses of 40, 160 and 
640 ppm with a NOEL of 160 ppm. At 640 ppm, decreased body weight and 
decreased weight gain occurred with increased serum alanine 
aminotransferase and aspartate aminotransferase.
    15. A mouse oncogenicity study using dosage levels at 0, 50, 250, 
1,000 ppm with a NOEL of 250 ppm and no evidence of oncogenicity.
    16. A teratogenicity study in the rat with doses at 3, 10 and 30 
mg/kg by gavage with a maternal NOEL of 10 mg/kg/day (decreased body 
weight) and fetal NOEL of > 30 mg/kg/day.
    17. A teratogenicity study in the rabbit with doses at 3, 10 and 30 
mg/kg by gavage with a maternal NOEL of 10 mg/kg/day (decreased body 
weight, wobbly gait) and fetal NOEL of > 30 mg/kg/day.
    18. A two-generation reproductive study in the rat with doses at 
30, 300 and 1,000 ppm with a NOEL of 1,000 ppm for reproductive 
parameters. Decreased body weight at 300 and 1,000 ppm was observed 
with minimal increased mineralization of kidney papilla of F1 adult 
offspring with no apparent physiological effect.

[[Page 39967]]

    19. A Modified Ames Test: Negative; HGPRT (CHO): Negative; Mouse 
Micronucleus: Negative.
    20. A chromosomal aberration in vitro (CHO): Positive (These 
results were not reproduced in the in vivo test.)
    21. Dermal penetration: with absorption of  4.24 percent 
after exposure to doses  5.16 mg/animal, (0.413 mg/cm2) 
for 10 hours.
    The residue chemistry data submitted in support of the cyclanilide 
tolerance include:
    22. A common moiety analytical method was submitted for enforcement 
purposes. This method hydrolyzes cyclanilide to 2,4-dichloroanaline 
with subsequent conversion to N-(2,4-dichlorophenyl)-2-
chloropropylamide.
    23. A description of the metabolism of cyclanilide in animal and 
plants. Metabolism in mature cotton plants is minimal. Esterification, 
cyclopropane ring cleavage, dechlorination and hydrolysis of the amide 
are the primary routes of metabolism in soil and rotational crops. 
Cyclanilide was rapidly excreted in rat, hen and goat studies. Very low 
residue levels were found in animal tissues at sacrifice. In the rat, 
cyclanilide was metabolized by conjugation or methylation. Cyclanilide 
did not undergo metabolism in the goat or hen.
    24. Proposed tolerances, based on analyses performed using the 
common moiety method. Proposed tolerances are: cottonseed 0.75 ppm, gin 
trash 25.0 ppm, dairy cattle milk 0.03 ppm, and for beef cattle, goat 
and sheep: liver 0.25 ppm, kidney 2.5 ppm, fat 0.07 ppm, meat 
byproducts, 2.5 ppm, organ meats 2.5 ppm, lean (fat/free) 0.03 ppm and 
horse 0.03 ppm.
    25. Dietary Exposure Margin of Safety Calculations. Levels of 
cyclanilide residues in cotton were: cotton seed meal < 0.05 ppm, crude 
cotton seed oil < 0.05 ppm, refined cotton seed oil < 0.05 ppm and 
cotton seed hulls 0.06 to 0.13 ppm. The proposed tolerance for 
cyclanlide is 0.75 ppm. The rat reproduction study defined the LOEL to 
be 30 ppm or 1.5 mg/kg/day (for a non reproductive end point). Assuming 
a 300X safety factor, the RfD would be 0.005 mg/kg/day. In a worse case 
scenario, assuming that cyclanilide is used on 100 percent of US cotton 
and assuming that residues on all treated cotton are at the proposed 
tolerance level of 0.75 ppm, the US population would be exposed to 6.2 
percent and children 1 to 6 years would be exposed to 19.9 percent of 
the RfD. Under more realistic conditions assuming 45 percent market 
share and anticipated residue levels, the US population would be 
exposed to 0.4 percent and children 1 to 6 years would be exposed to 
1.4 percent of the RfD. Both exposure scenarios demonstrate a margin of 
exposure well below 100 percent.
     A record has been established for this document under docket 
number [PF-659] (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 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 can be sent directly to EPA at:
    opp-D[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 document, 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.

    Authority: 7 U.S.C. 136a.
    Dated: July 16, 1996.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 96-19081; Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F