[Federal Register Volume 63, Number 130 (Wednesday, July 8, 1998)]
[Notices]
[Pages 36901-36903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18076]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-808; FRL-5791-6]


Notice of Filing of a Pesticide Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-808, must 
be received on or before August 7, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under ``SUPPLEMENTARY 
INFORMATION.'' No confidential business information should be submitted 
through e-mail.
    Information submitted as a comment 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. 119 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: Richard W. King, Regulatory 
Action Leader, Biopesticides and Pollution Prevention Division, 
(7511C), Office of Pesticide Programs,

[[Page 36902]]

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone number: Rm. 14, 9th floor, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA. 22202, (703) 308-8052; e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that the petition 
contains data or information regarding the elements set forth in 
section 408(d)(2); 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.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-808] (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 official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can 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. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-808] and appropriate petition number. 
Electronic comments on this notice may be filed online at many Federal 
Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: June 29, 1998.

Kathleen D. Knox,

Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

Asahi Chemical Manufacturing Company

PP 7F4835

    EPA has received a pesticide petition (PP 7F4835) from Asahi 
Manufacturing Company, Ltd., c/o Chemical Consultants International, 
Inc., 7270 West 98th Terrace, Suite 100, Overland Park, KS, 66212, 
proposing pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish 
an amendment/expansion of an existing tolerance exemption for the 
biochemical pesticide Sodium o-Nitrophenolate, Sodium p-Nitrophenolate, 
and Sodium 5-Nitroguaiacolate in or on all crops.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Asahi 
Manufacturing Company, Ltd. has submitted the following summary of 
information, data and arguments in support of their pesticide petition. 
This summary was prepared by Asahi Manufacturing Company, Ltd. and EPA 
has not fully evaluated the merits of the petition. The summary may 
have been edited by EPA if the terminology used was unclear, the 
summary contained extraneous material, or the summary was not clear 
that it reflected the conclusion of the petitioner and not necessarily 
EPA.

A. ATONIK and Proposed Use Practices

    ATONIK is registered for use as a plant growth stimulator 
on cotton, rice and soybeans. Application should be made with the 
addition of a non-ionic surfactant.
    1. Cotton. ATONIK may be applied twice during the growing 
season in 40 to 60 gallons of water per acre. ATONIK may be 
applied at 8 fluid ounces per acre at first bloom with a second 
application at 14 fluid ounces during early boll development.
    2. Rice. ATONIK may be applied twice during the growing 
season in 40 to 60 gallons of water. ATONIK may be applied at 
6 to 8 fluid ounces per acre at the beginning of panicle initiation 
with a second application of 6 to 8 fluid ounces at post anthesis.
    3. Soybeans. ATONIK may be applied twice during the 
growing season in 40 to 60 gallons of water. ATONIK may be 
applied at 6 to 8 fluid ounces per acre 5 days after first bloom with a 
second application of 6 to 8 fluid ounces 3 to 4 weeks after first 
bloom.

B. Product Identity/Chemistry

    ATONIK is comprised of three active ingredients. These 
three active ingredients have each been exempted from the requirements 
of tolerance for cotton, rice and soybeans. The three active 
ingredients and the percentage of each in ATONIK are:
    i. Sodium o-Nitrophenolate 0.20%
    ii. Sodium p-Nitrophenolate 0.30%
    iii. Sodium 5-Nitroguaiacolate 0.10%
    The Chemical properties of each of the three ingredients in 
ATONIK and of ATONIK itself are presented in 
section A of the submission. The three active ingredients have all been 
shown to be taken up into plants and immediately metabolized. 
Therefore, no measurable residues have been found or will be expected.

C. Mammalian Toxicological Profile

    Acute toxicology studies place ATONIK in Category IV. 
Acute toxicology studies place Sodium o-Nitrophenolate in Category II 
based upon the results of the primary eye study, Sodium p-
Nitrophenolate is in Category II based upon the results of the acute 
oral and the primary eye studies and Sodium 5-Nitroguaiacolate is in 
Category I based upon the results of the primary eye study. 
ATONIK was found to be a mild sensitizer in the guinea pig.
    A subchronic oral feeding study was performed on the end-use 
product ATONIK using dietary dose levels of 0, 5,000, 15,000 
and 50,000 parts per million (ppm), which was equivalent to 515, 1,590, 
and 5,056 milligrams/kilograms (mg/kg/day) for male rats and 531, 
1,723, and 6,553 mg/kg/day for female rats. The lowest observed effect 
level (LOEL) was 1,589 mg/kg/day for male rats and 1,723 mg/kg/day for 
female rats based upon decreased weight gains, changes in hematology 
parameters, relative organ weights of the liver and kidney, and pigment 
accumulation in kidney and spleen.

[[Page 36903]]

    A developmental toxicity study in rats was conducted on 
ATONIK. Administration was by gavage at dose levels of 0, 
100, 300, and 600 mg/kg/day. Significantly decreased body weight gain 
and food consumption was observed at 600 mg/kg/day in the female rats. 
One death was noted and attributed to the test chemical. The maternal 
no observed effect level (NOEL) and LOEL were determined to be 300 and 
600 mg/kg/day, respectively. No developmental toxicity was observed. 
The NOEL for developmental toxicity was determined to be 600 mg/kg/day.
    The Ames Test, Mouse Micronucleus Assay and the Mouse Lymphoma 
Assay were each performed with each of the three active ingredients in 
ATONIK. All results were negative.
    The toxicity studies are sufficient to demonstrate that there are 
no foreseeable human or domestic animal health hazards possible from 
use of these active ingredients as plant regulators in the 
concentrations present in ATONIK.

D. Aggregate Exposure

    The end-use product, ATONIK, contains the three active 
ingredients in very low concentrations. At the application rates 
employed, the level of active ingredient which may be present in any of 
the food or feed items would be far below the levels which demonstrated 
any effects in the subchronic oral feeding study, the developmental 
toxicity study or the mutagenicity studies. It can be shown that in 
order to reach a dose rate comparable to the LOEL of 1,600 mg/kg/day 
obtained in the subchronic oral feeding study, a person weighing 50 kg 
would have to consume all of the produce from 4 acres of crop every 
day.
     Further, due to the rapid uptake and metabolism of the three 
active ingredients in the plants, it is most unlikely that any of the 
residue would be available for potential exposure.
    Similarly, exposure of the residues to humans from consumption of 
water would be equally unlikely. There is no allowed use of the product 
containing the three active ingredients on lawns, rights-of-way, golf 
courses, or other areas where human exposure may result. Therefore, 
exposure from these areas would be non-existent.

E. Cumulative Exposure

    Exposure through other pesticides and substances with the same mode 
of toxicity is not likely. What little toxicity that is observed is 
only observed at extremely high concentrations of these active 
ingredients.

F. Safety Determination

    The three active ingredients in the end-use product, 
ATONIK, are all biochemicals. The low toxicity of each of 
these alone and in combination, as discussed above, demonstates that 
these chemicals, at the rates established, will not pose any known risk 
to human health, either as children or as adults. These three active 
ingredients are already exempted from the requirements of a tolerance 
for use on cotton, rice and soybeans.

G. Effects on the Immune and Endocrine Systems

    The Agency has no information to suggest that ATONIK will 
have an effect on the immune and endorine systems. The Agency is not 
requiring information on the endocrine effects of this biological 
pesticide at this time. Congress has allowed 3 years after August 3, 
1996, for the Agency to implement a screening program with respect to 
endocrine effects.

H. Existing Tolerances

    Exemptions from the requirements of a tolerance have already been 
established for residues of the biochemical plant regulators Sodium o-
Nitrophenolate, Sodium p-Nitrophenolate, and Sodium 5-Nitroguaiacolate 
in or on the raw agricultural commodities cottonseed, cotton gin by 
products, rice, rice straw, soybeans, and soybean forage and hay.

I. International Tolerances

    No known international tolerances have been granted for this 
pesticide. Therefore, based on the completeness and reliability of the 
toxicity data from the published literature and conservative exposure 
assessment, Asahi Manufacturing Company, Ltd., concludes that there is 
a reasonable certainty that no harm will result from aggregate exposure 
to residues of the ATONIK including all anticipated dietary 
exposure and all non-occupational exposures.

[FR Doc. 98-18076 Filed 7-7-98; 8:45 am]
BILLING CODE 6560-50-F