[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: <a href="/cdn-cgi/l/email-protection#e9869999c48d868a828c9da98c998884888085c78c9988c78e869f"><span class="__cf_email__" data-cfemail="d4bba4a4f9b0bbb7bfb1a094b1a4b5b9b5bdb8fab1a4b5fab3bba2">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#53303b3a3d7d2736263d34133623323e323a3f7d3623327d343c25"><span class="__cf_email__" data-cfemail="9af9f2f3f4b4eeffeff4fddaffeafbf7fbf3f6b4ffeafbb4fdf5ec">[email protected]</span></a>.
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:

[[Page 6779]]



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                Study                          Product                   Result              Toxicity Category  
----------------------------------------------------------------------------------------------------------------
Acute Oral...........................  Plant Extract 620        LD<INF>50 >5,000 mg/kg        IV                     
Acute Dermal.........................  Plant Extract 620        LD<INF>50 >5,000 mg/kg        IV                     
Acute Inhalation.....................  Sincocin<Register>       LD<INF>50 >2.04 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                    
----------------------------------------------------------------------------------------------------------------

    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=D<a href="/cdn-cgi/l/email-protection#8fe0ece4eafbcfeaffeee2eee6e3a1eaffeea1e8e0f9"><span class="__cf_email__" data-cfemail="f699959d9382b69386979b979f9ad8938697d8919980">[email protected]</span></a>

    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


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