[Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
[Notices]
[Pages 6777-6780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3517]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-710; FRL-5588-9]
Appropriate Technology Limited; Pesticide Tolerance Petition
Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of filing.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of a regulation for an exemption
from the requirement of a tolerance for residues of extract from
Quercus falcata (red oak), Rhus aromatic (sumac), Rhizophora mangle
(mangrove), and Opuntia lindheimeri (prickly pear cactus) in or on all
raw agricultural commodities. The summary was prepared by Appropriate
Technology Limited.
[[Page 6778]]
DATES: Comments, identified by the docket number [PF-710], must be
received on or before, April 14, 1997.
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 Highway, Arlington, VA 22202. Comments and data may
also be submitted electronically be 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 docket number [PF-710].
Electronic comments on this notice may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions
can be found below this document.
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. 1132 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: Teung F. Chin c/o (PM 90),
Biopesticides and Pollution Prevention Division, Office of Pesticide
Programs, U.S. Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number and e-mail
address: 5th floor, CS#1, 2800 Crystal Drive, Arlington, VA 22202,
Telephone No. 703-308-1259, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP
8F3635) from Appropriate Technology Limited, 3601 Garden Brook, Dallas,
TX 75234 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 by
establishing an exemption from the requirement of a tolerance the
residues of Plant Extract 620. Pursuant to section 408(d)(2)(A)(i) of
the FFDCA, as amended, Appropriate Technology Limited has submitted the
following summary of information, data and arguments in support of
their pesticide petition. This summary was prepared by Appropriate
Technology Limited 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 to clarify that the
conclusions and arguments were the petitioner's and not necessarily
EPA's and to remove certain extraneous material, or the summary was not
clear that it reflected the conclusion of the petitioner and not
necessarily EPA.
I. Petition Summary
A. Product Identity/Chemistry
Appropriate Technology Limited states that Plant Extract 620 is an
aqueous extract derived from Quercus falcata (red oak), Rhus aromatic
(sumac), Rhizophora mangle (mangrove), and Opuntia lindheimeri (prickly
pear cactus). The resulting botanical extracts are used in the
preparation of end-use formulations. Agrispon and
Sincocin are water-based products containing trace minerals
and Plant Extract 620. Agrispon is a plant growth regulator
that may be applied to turf and agricultural products to stimulate root
growth and increase a plant's ability to withstand pests and
environmental stresses. Sincocin is used to control plant
parasitic nematodes by reducing the feeding vigor of nematodes.
Studies submitted by Appropriate Technology Limited show that the
identified active constituents known to be present in the subject plant
extracts are present naturally in many plants and would, therefore, be
indistinguishable from existing natural background levels. This
petition proposes an exemption for the requirement of a tolerance;
therefore, Appropriate Technology Limited does not believe an
analytical method is necessary to protect the human health and
environment.
B. Proposed Use Practices
Plant extract from Quercus falcata, Rhus aromatic, Rhizophora
mangle, and Opuntia lindheimeri is the sole active ingredient in the
end-use products Agrispon and Sincocin. Both products are mixed with
enough water to evenly cover the desired area at the recommended rate
of application. The maximum recommended application rate for any use
pattern would not exceed 60 grams of plant extract/acre/application;
the maximum application rate for food crops would not exceed 18 grams
of plant extract/acre/application.
Agrispon is diluted with water to evenly cover the
desired area at an application rate of 13 fluid ounces/acre (oz/acre)
for annuals, and greenhouses. The recommended timing and frequency of
applications depends on the plant growth cycle length. A single
application is recommended for plants with a growth cycle of 60 days or
less. A second application, 45 to 60 days after the first, is
recommended for plants with a growing cycle of 60 to 120 days. For long
season plants, or those having a growing cycle longer than 120 days,
Agrispon may be applied every 45 to 60 days during the period
when the plant is growing vigorously. Agrispon is applied to
the soil surface under trees at a rate of 13 fluid oz/acre, with an
additional 6 fluid oz/acre applied to the tree canopy. For evergreens,
applications are recommended every 60 days. Deciduous trees should
first be treated at bud break or leaf flush in the spring. Subsequent
applications are recommended every 60 days until dormancy occurs.
Sincocin is applied to food crops and orchards at a rate
of 26 fluid ounces/acre. For both food crops and orchards, the first
application should be made during initial root flush with subsequent
applications every 60 days during active growth. The application rate
for turf and ornamentals is 2.75 gallons (87 fluid ounces)/acre. Golf
greens and tee boxes should be treated every day for root pathogens or
every 30 days for nematode control. Golf fairways should be treated
every 30 days. Ornamentals should first be treated at root flush, with
subsequent applications every 30 to 60 days during active growth.
C. Toxicological Profile
Plant Extract 620 is derived from Quercus falcata (red oak), Rhus
aromatic (sumac), Rhizophora mangle (mangrove), and Opuntia lindheimeri
(prickly pear cactus). Plant Extract 620 will not itself be offered for
sale, but is used by the manufacturer in formulating the end-use
products Agrispon and Sincocin . Agrispon
and Sincocin are the only products to which consumers and the
public could be exposed. The following table summarizes the
toxicological data Appropriate Technology Limited has submitted in
support of the exemption from the requirement of a tolerance:
[[Page 6779]]
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Study Product Result Toxicity Category
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Acute Oral........................... Plant Extract 620 LD50 >5,000 mg/kg IV
Acute Dermal......................... Plant Extract 620 LD50 >5,000 mg/kg IV
Acute Inhalation..................... Sincocin LD50 >2.04 mg/l IV
Eye Irritation....................... Plant Extract 620 unwashed eyes: severely I
irritating
................................... washed eyes: moderately III
irritating
................................... Agrispon unwashed eyes: IV
minimally irritating
................................... Sincocin unwashed eyes: IV
minimally irritating
Dermal Irritation.................... Plant Extract 620 moderately irritating III
Ames Mutagenicity.................... Agrispon not mutagenic n/a
................................... Sincocin not mutagenic n/a
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Appropriate Technology Limited states that Agrispon and
Sincocin, the products that will be available for
distribution, are toxicity categories III and IV for all routes and
responses. Based on the results of the acute toxicology and
mutagenicity data summarized above, the Agency has determined that all
toxicology data requirements have been satisfied. Subchronic, chronic,
immune, endocrine, and non-dietary cumulative exposure data
requirements have been waived. Appropriate Technology Limited believes
the submitted data are sufficient to demonstrate that there are no
foreseeable human health hazards likely to arise from the use of either
Agrispon or Sincocin.
D. Aggregate Exposure
Occupational exposure will be mitigated through the use of proper
personal protective equipment. Appropriate Technology Limited believes
the lack of mammalian toxicity and low active ingredient concentration
of the end-use products illustrate that health risks resulting from
inhalation and dermal exposure of applicators and other handlers is
negligible.
Appropriate Technology Limited states that dietary exposure will be
extremely small due to the low application rate of 18 grams/acre or
less, washing off of foliage and fruit by rainfall or during food
processing and handling, and likely by degradation of the plant
extracts by soil microflora. Furthermore, the oral toxicity of Plant
Extract 620 is so low that Appropriate Technology Limited asserts that
any foreseeable residues would be of little consequence.
Appropriate Technology Limited states that exposure to drinking
water will be minimal. Neither Agrispon or Sincocin
will be applied directly to water. The active ingredient concentration
of any potential spray drift will be extremely minimal due to the low
active ingredient concentration. The active ingredient concentration of
both products is 0.56% and the products are diluted with water prior to
application, further reducing the concentration. Additionally, the
subject plant extracts are of natural origin and therefore subject to
degradation by soil microorganisms. Finally, if residues of Plant
Extract 620 do occur in drinking water, Appropriate Technology Limited
believes that toxicity data demonstrate that there is no foreseeable
human health hazard.
E. Cumulative Effects
Appropriate Technology Limited believes that none of the active
constituents are known or suspected to have any cumulative effect. The
water solubility of the constituents in this aqueous extract are likely
to be easily excreted resulting in no tissue accumulations.
Furthermore, there is no indication of mammalian toxicity.
F. Safety Determination
Appropriate Technology Limited believes the toxicology data are
sufficient to demonstrate that there are no foreseeable human health
hazards likely to arise from the use of plant extracts derived from
Quercus falcata, Rhus aromatic, Rhizophora mangle, and Opuntia
lindheimeri. Furthermore, the identified active ingredients known to be
present in these plant extracts are present naturally in many plants.
G. Existing Tolerances
No tolerances or tolerance exemptions have previously been granted
for extracts from Quercus falcata, Rhus aromatic, Rhizophora mangle,
and Opuntia lindheimeri.
II. Public Record
Interested persons are invited to submit comments on this notice of
filing. Comments must bear a notation indicating the document control
number, [PF-710].
A record has been established for this notice under docket number
[PF-710] 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 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 rulemaking, 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 rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking 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.
[[Page 6780]]
Dated: February 6, 1997.
Janet L. Anderson,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 97-3517 Filed 2-12-97; 8:45 am]
BILLING CODE 6560-50-F