[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Notices]
[Pages 65204-65206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31248]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-841; FRL 6039-7]


Notice of Filing of Pesticide Petition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition (PP) 8G5008 for an exemption from the requirement of a 
temporary tolerance for residues of the biopesticide, 2,6-
diisopropylnapthalene (2,6-DIPN) when used to inhibit sprouting in 
potatoes held in storage.

DATES: Comments, identified by the docket control number (PF-841), must 
be received on or before December 28, 1998.

ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticide 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.


[[Page 65205]]


FOR FURTHER INFORMATION CONTACT: By mail: Rita Kumar, PM 90, 
Biopesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number and e-mail: Rm. 
902W5, CM#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703) 308-
8291; 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 this 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 support granting 
of the petition. This petition was submitted to support an application 
for an experimental use permit (EUP) to treat potatoes in closed 
storage facilities, to evaluate the control of sprouting. A notice of 
receipt for this EUP is being published elsewhere in this issue of the 
Federal Register. 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-841) (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. Comments 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 number (PF-841) 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, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: November 4, 1998.

Janet L. Andersen,

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

Summary of the Petition

    Petitioners summary of the pesticide petition is printed below as 
required by section 408(d)(3) of the FFDCA. The summary of the petition 
was prepared by the petitioners and represent the views of the 
petitioners. EPA is publishing the petition summary verbatim with minor 
non-substantive editorial changes. The petiton 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.

Platte Chemical Company

 PP 8G5008

    EPA has received a pesticide petition (PP) 8G5008 from Platte 
Chemical Company, 419, 18th Street, Greeley, CO 80632, proposing 
pursuant to section 408(d) of the (FFDCA), 21 U.S.C. 346a(d), to amend 
40 CFR part 180 by establishing an exemption from the requirement of a 
temporary tolerance for residues of 2,6-DIPN in or on the raw 
agriculture commodity potatoes.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Platte Chemical Company has submitted the following summary of 
information, data and arguments in support of their pesticide petition. 
This summary was prepared by Platte Chemical Company 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. Proposed Use Practices

     The proposed experimental program will be conducted in potato 
storage facilities located in Idaho, Maine, Minnesota, North Dakota, 
Oregon, Washington, and Wisconsin. Stored potatoes will be treated in 
one or two facilities in each state. The proposed experimental program 
would utilize 1,500 pounds of active ingredient on approximately 90 
million pounds of stored potatoes during 1998 and 1999. The active 
ingredient, 2,6-DIPN, is a plant growth regulator that will be applied 
as an aerosol at a rate of one pound active ingredient per 60,120 
pounds of potatoes, to achieve an initial residue of 16.6 parts per 
million (ppm). A maximum of 3 applications may be made while the 
potatoes are held in storage.

B. Product Identity/Chemistry

    1. Identity of the biopesticide. EPA has classified DIPN as a 
biochemical pesticide. The formulated end product, Amplify Sprout 
Inhibitor, contains 100% DIPN as the active ingredient which is an 
odorless liquid.

C. Residue Chemistry

    Platte conducted studies to determine 2,6-DIPN residues in whole 
potatoes and peels at various times, up to 180 days, following 1 to 3 
treatments at the maximum application rate. A gas chromatography method 
was used to measure residues of 2,6-DIPN. Potatoes were treated using a 
small chamber system that reproduced a commercial environment, 
including temperatures and humidity. The 2,6-DIPN was applied to the 
chambers using a fogging device that reproduced a commercial operation, 
but on a small scale. When treated up to 3 times during storage at a 
rate of 1.2 pounds active ingredient per 60,120 pounds of potatoes and 
sampled 0 days after treatment (DAT) to 180 DAT, residues in the peel 
ranged from 0.15 ppm to 4.05 ppm. Residues for whole potatoes ranged 
from 0.03 ppm to 2.43 ppm.
    The 2,6-DIPN residues for potato peel were as follows: Potatoes 
treated 1 time at 1.2 pounds active ingredient per 60,120 pounds of 
potato had residues of 2.82 ppm, 3.39 ppm, and 4.05 ppm at 0 DAT; 1.01 
ppm, 2.59 ppm, and 2.77 ppm at 30 DAT; 0.33 ppm, 0.46 ppm, and 0.76 ppm 
at 90 DAT; and 0.15 ppm, 0.24 ppm, and 0.24 ppm at 180 DAT.
    Potatoes were treated 3 times at 1.2 pounds active ingredient per 
60,120 pounds of potato per treatment at 0 day and at 60 days, and 120 
days after the first treatment.
    The 2,6-DIPN residues in peels were 2.18 ppm, 2.55 ppm, and 3.52 
ppm at 0 DAT; 1.30 ppm, 1.82 ppm, and 2.59 ppm at 30 DAT; 2.43 ppm, 
2.71 ppm, and 4.51 ppm at 60 DAT; 0.86 ppm, 1.32 ppm, and 1.83 ppm at 
90 DAT; 2.41 ppm, 3.79 ppm, and 3.49 ppm at 120 DAT; and 0.74 ppm, 0.86 
ppm, and 0.91 ppm at 180 DAT.
    The 2,6-DIPN residues for whole potatoes were as follows: Potatoes 
treated 1 time at 1.2 pounds active

[[Page 65206]]

ingredient per 60,120 pounds of potato had residues of 0.82 ppm, 1.18 
ppm, and 1.27 ppm at 0 DAT; 0.22 ppm, 0.28 ppm, and 0.41 ppm at 30 DAT; 
0.10 ppm, 0.11 ppm, and 0.04 ppm at 90 DAT; and 0.03 ppm, 0.03 ppm, and 
0.05 ppm at 180 DAT.
    Potatoes treated 3 times at day 0, 60, and 120, as described above, 
had 2,6-DIPN residues of 0.83 ppm, 1.28 ppm, and 1.39 ppm at 0 DAT; 
0.25 ppm, 0.30 ppm, 0.37 ppm at 30 DAT; 0.80 ppm, 1.07 ppm, and 2.43 
ppm at 60 DAT; 0.28 ppm, 0.42 ppm, and 0.62 ppm at 90 DAT; 1.16 ppm, 
1.79 ppm, and 1.86 ppm at 120 DAT; and 0.13 ppm, 0.17 ppm, and 0.24 ppm 
at 180 DAT.
    Magnitude of residue at the time of harvest and method used to 
determine the residue. A statement of why an analytical method for 
detecting and measuring the levels of the pesticide residue are not 
needed. Since the petitioner has requested a tolerance exemption, an 
analytical method to detect residues is not required.

D. Toxicology Profile

    1. Acute toxicity. Technical 2,6-DIPN exhibits low acute toxicity. 
It is a toxicity category IV biopesticide. The rat oral LD50 
is greater than 5,000 milligram/kilogram (mg/kg), the rabbit dermal 
LD50 is greater than 5,000 mg/kg, and the rat inhalation 
LC50 is greater than 2.60 milligram/Liter (mg/L) at the 
maximum attainable condition. In addition, 2,6-DIPN is not a skin 
sensitizer in guinea pigs, shows no dermal irritation at 72 hours in 
rabbits, and shows minimal ocular irritation in rabbits. The end use 
formulation is the same as the technical formulation; it contains no 
intentionally added inert ingredients.
    2. Genotoxicity. Short-term assays for genotoxicity consisting of a 
bacterial reverse mutation assay (Ames test), an in vivo/in vitro 
unscheduled DNA synthesis in rat primary hepatocyte cultures at 2 time 
points, and an in vivo mouse micronucleus assay have been conducted for 
2,6-DIPN. These studies show a lack of genotoxicity for 2,6-DIPN.
    3. Other tests. No additional mammalian toxicology testing has been 
conducted. Platte requested a waiver from the requirement to submit 
further mammalian toxicology studies on the basis of the favorable 
toxicological profile for 2,6-DIPN, the low residues observed in 
treated potatoes, the specific plant growth regulator mode of action, 
and the confined nature of the proposed use. No data were found in the 
literature that would indicate 2,6-DIPN has any adverse effect on 
mammals. No incidents of hypersensitivity or any other adverse effects 
have been observed in individuals handling the material over the past 6 
years.

E. Aggregate Exposure

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information about exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from groundwater or surface water and exposure 
through pesticide use in gardens, lawns, or buildings (residential and 
other indoor uses).
    1. Dietary exposure from food and drinking water. Any dietary 
exposure resulting from applications made under an experimental use 
permit (EUP) would be through potato consumption and animal products in 
which animals are fed potato feed stocks. Residues in treated potatoes 
have been shown to be low. Residues would be expected to continue to 
decline after potatoes are removed from storage and before consumption. 
Cooking and/or processing would be expected to further lower the 
residue level in consumed potatoes or potato products. Since 2,6-DIPN 
would only be used in commercial storage warehouses, there is little if 
any potential for drinking water exposure. There are no other 
established U.S. tolerances or exemptions from tolerances for 2,6-DIPN 
food or feed crops in the United States. The Agency has classified 2,6-
DIPN as a biochemical pesticide.
    2. Non-dietary exposure. The EUP would only cover use for direct 
application to potatoes when stored in commercial warehouses. There are 
currently no other registered uses of 2,6-DIPN. Non-dietary exposure to 
2,6-DIPN via lawn care, topical treatments, etc., will not occur. Thus, 
the potential for non-occupational exposure to the general population 
is virtually non-existent.

F. Cumulative Exposure

     EPA also is required to consider the potential for cumulative 
effects of 2,6-DIPN and other substances that have a common mechanism 
of toxicity. Consideration of a common mode of toxicity is not 
appropriate, given that there is no indication of mammalian toxicity of 
2,6-DIPN and no information that indicates toxic effects, if any, would 
be cumulative with any other compounds. Since, 2,6-DIPN does not 
exhibit a toxic mode of action in the target plant, it is appropriate 
to consider only the potential risks of 2,6-DIPN in this exposure 
assessment.

G. Endocrine Effects

     Platte has no information to suggest that 2,6-DIPN will adversely 
affect the immune or endocrine systems. The Agency is not requiring 
information on endocrine effects of this biochemical pesticide at this 
time.

H. Safety Determinations

    1. U.S. population in general and infants and children. Since there 
are no anticipated residues in drinking water or from other non-
occupational sources, and no reliable information exists on cumulative 
effects due to a common mechanism of toxicity, the aggregate exposure 
to 2,6-DIPN is adequately represented by the dietary route. The lack of 
toxicity of 2,6-DIPN has been demonstrated by the results of acute 
toxicity testing in mammals in which 2,6-DIPN caused no adverse effects 
when dosed orally, dermally, and via inhalation at the limit dose for 
each study. Anticipated residues in consumed potatoes are low. 
Moreover, 2,6-DIPN exhibits close similarity to other plant-based, 
naturally occurring methyl and isopropyl naphthalenes. Thus, the 
dietary exposure to 2,6-DIPN should pose negligible risks to human 
health. Based on the lack of toxicity and low exposure, there is a 
reasonable certainty that no harm to infants, children, or adults will 
result from aggregate exposure to 2,6-DIPN residues. Exempting 2,6-DIPN 
from the requirement of a tolerance should pose no significant risk to 
humans or the environment.

I. Analytical Method

     An analytical method for residues is not applicable, as this 
proposes an exemption from the requirement of a tolerance.

J. Existing Tolerances

     No codex maximum residue levels are established for residues of 
2,6-DIPN in or on any food or feed crop.

[FR Doc. 98-31248 Filed 11-24-98; 8:45 am]
BILLING CODE 6560-50-F