[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: docket@epamail.epa.gov. 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: kumar.rita@epamail.epa.gov.
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:
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 5.1/6.1 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
