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Plant Extract 620 - Pesticide Tolerance Petition 2/97

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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.

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:
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 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:

chin.teung@epamail.epa.gov. 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/Register and Sincocin/Register are water-based products
containing trace minerals and Plant Extract 620. Agrispon/Register 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/Register 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/Register 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/Register may be applied every 45 to 60 days during the period
when the plant is growing vigorously. Agrispon/Register 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/Register 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/Register and
Sincocin/Register . Agrispon/Register and Sincocin/Register 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:

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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      LD505,000 mg/kg   IV
Acute Inhalation.........Sincocin/Register      LD502.04 mg/l  IV
Eye Irritation...........Plant Extract 620      unwashed eyes: severely I
                                                irritating
                                                washed eyes: moderately III
                                                irritating
                         Agrispon/Register      unwashed eyes: IV
                                                minimally irritating
                         Sincocin/Register      unwashed eyes: IV
                                                minimally irritating
Dermal Irritation........Plant Extract 620      moderately irritating III
Ames Mutagenicity........Agrispon/Register      not mutagenic n/a
.........................Sincocin/Register      not mutagenic n/a
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Appropriate Technology Limited states that Agrispon/Register and
Sincocin/Register, 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/Register or Sincocin/Register.

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/Register or Sincocin/Register 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=Docket@epamail.epa.gov

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.

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]