[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