[Federal Register Volume 62, Number 88 (Wednesday, May 7, 1997)]
[Rules and Regulations]
[Pages 24839-24842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11900]



[[Page 24839]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300472; FRL-5600-1]
RIN 2070-AB78


Plant Extract Derived From Opuntia lindheimeri (Prickly Pear 
Cactus), Quercus falcata (Red Oak), Rhus Aromatica (Sumac), and 
Rhizophoria mangle (Mangrove): Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule establishes an exemption from the requirement of a 
tolerance for residues of the biochemical pesticide plant extract 
derived from Opuntia lindheimeri (prickly pear cactus), Quercus falcata 
(Red oak), Rhus aromatica (sumac), and Rhizophoria mangle (mangrove) in 
or on all raw agricultural commodities (RACs), when applied as a 
nematicide/plant regulator in accordance with good agricultural 
practices. This exemption was requested by Appropriate Technologies, 
Limited.

DATEs: This regulation becomes effective May 7, 1997. Objections and 
requests for hearings must be received by EPA on July 7, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [OPP-300472], may be submitted to: Hearing Clerk (1900), 
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, 
DC 20460. A copy of any objections and hearing requests filed with the 
Hearing Clerk should be identified by the docket control number and 
submitted 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 copy of objections and hearing requests to Rm. 1132, 
CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    An electronic copy of objections and hearing requests filed with 
the Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to: opp-docket-epamail.epa.gov. Copies of electronic 
objections and hearing requests must be submitted as an ASCII file 
avoiding the use of special characters and any form of encryption. 
Copies of electronic objections and hearing requests will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All copies of electronic objections and hearing requests must be 
identified by the docket number [OPP-300472]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Copies of 
electronic objections and hearing requests on this rule may be filed 
online at many Federal Depository Libraries. Additional information on 
electronic submissions can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product 
Manager (PM) [90], Biopesticides and Pollution Prevention Division 
(7501W), Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number and e-mail address: Rm. 5-
W57, CS-1, 2800 Crystal Drive, Arlington, VA 22202. (703) 308-8263; e-
mail: greenway.denise-epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 14, 
1994 [59 FR 47136], EPA issued a notice (FRL-4904-7) that ATL 
Enterprises, Inc., had submitted pesticide petition PP 8F3635 to EPA 
proposing to amend 40 CFR part 180 by establishing a regulation 
pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to exempt from the requirement of a 
tolerance the residues of the biochemical pesticide aqueous extract of 
roots, galls, and bark from four plant species. Incorrect taxonomic 
names were provided for two of the plant species. The published names 
were Opinta lindheimeri, Quercus falcata, Rhus aromatica, and 
Rhizophoria mangle for use in or on all raw agricultural commodities 
when applied as a plant regulator in soil and/or foliar applications in 
accordance with good agricultural practices. The petition was later 
revised by the petitioner and reannounced by EPA, in accordance with 
the requirements of the Food Quality Protection Act of 1996 in the 
Federal Register of February 13, 1997 (62 FR 6777)(FRL-5588-9). The 
notice announced that Appropriate Technology Limited was filing the 
petition to exempt from the requirement of a tolerance residues of 
extract from Opuntia lindheimeri (prickly pear cactus), Quercus falcata 
(red oak), Rhus aromatic (sumac), and Rhizophora mangle (mangrove) in 
or on all raw agricultural commodities when applied as a nematocide or 
as a plant regulator in soil and/or foliar applications in accordance 
with good agricultural practices. EPA received misspellings for two of 
the plant species for the February 13, 1997 notice. The correct 
spellings for all four are as follows: Opuntia lindheimeri (prickly 
pear cactus), Quercus falcata (red oak), Rhus aromatica (sumac), and 
Rhizophoria mangle (mangrove). The February 24, 1997 Federal Register 
(62 FR 8244)(FRL-5591-4) announced that the comment period would end on 
March 17, 1997. In response to the Notice of Filing, EPA received 
supporting comments from 14 companies/citizens in Egypt, Honduras, 
Australia, Saudi Arabia, Syria, Lebanon, Chile, the Philippines, 
Switzerland and the United States. No comments opposing the petition 
were received.
    The data submitted in the petition and all other relevant material 
have been evaluated. Following is a summary of EPA's findings regarding 
this petition as required by section 408(d) of the FFDCA, as recently 
amended by the Food Quality Protection Act.

I. Proposed Use Practices

    Biochemical pesticide extract powder, also known as Plant Extract 
620, derived from Opuntia lindheimeri (prickly pear cactus), Quercus 
falcata (red oak), Rhus aromatica (sumac), and Rhizophoria mangle 
(mangrove) will be diluted into two water-based products, Sincocin and 
Agrispon, both at a concentration of 0.56 percent Plant Extract 620. 
The maximum application rate for any use pattern would not exceed 14 
grams of plant extract/acre/application; the maximum application rate 
for food crops would not exceed 4 grams of plant extract/acre/
application. The maximum permissible amount applied per acre per year 
must not exceed 150.
    Agrispon is diluted with water and applied at a rate of 13 fluid 
ounces/acre (oz/acre) for annuals and greenhouses. Timing and frequency 
of applications depend on the plant growth cycle length; a single 
application for plants with a growth cycle of 60 days or less; a second 
application 45 to 60 days after the first for plants with a 60 to 120 
day growth cycle; every 45 to 60 days during vigorous growth stage for 
long season plants or those with longer than a 120 day growth cycle. 
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 made every 60 days. Deciduous 
trees are first treated at bud break or leaf flush in the spring with 
subsequent applications every 60 days until dormancy occurs.
    Sincocin is applied to food crops and orchards at a rate of 26 
fluid oz/acre. For both food crops and orchards, the first

[[Page 24840]]

application is 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 
fairways are treated every 30 days. Ornamentals are treated at root 
flush with subsequent applications every 30 to 60 days during active 
growth.

II. Toxicological Profile

    The toxicological data considered in support of the exemption from 
the requirement of a tolerance include: acute oral, acute dermal, acute 
inhalation, eye irritation, dermal irritation, and Ames mutagenicity 
tests. The following table summarizes the Agency's findings for the 
submitted toxicological data.

----------------------------------------------------------------------------------------------------------------
          Guideline No.                  Study              Product             Results        Toxicity Category
----------------------------------------------------------------------------------------------------------------
152-10..........................  Acute Oral (Rat)    Plant Extract 620   LD50 > 5050 mg/kg   IV                
                                                       (TGAI)                                                   
152-11..........................  Acute Dermal        Plant Extract 620   LD50 > 5050 mg/kg   IV                
                                   (Rabbit)                                                                     
152-12..........................   Acute inhalation   Sincocin (End-use   LC50 > 2.04 mg/L    IV                
                                   (Rat)               product)                                                 
152-13..........................  Primary eye         Plant Extract 620   Severe Irritation   I                 
                                   irritation                              in Non-Washed                        
                                                                           Eyes                                 
                                                                          Mild Irritation in  III               
                                                                           Washed Eyes at                       
                                                                           0.1 ml                               
                                                      Sincocin            Minimal             IV                
                                                                           irritation,                          
                                                                           reversible in 2                      
                                                                           days at 0.1 ml                       
                                                      Agrispon            No irritation at    IV                
                                                                           0.1 ml                               
152-14..........................  Primary dermal      Plant Extract 620   Moderate            III               
                                   irritation                              Irritation at 72                     
                                   (Rabbit)                                Hours                                
152-15..........................  Hypersensitivity                        Must be reported                      
                                                                           if/when it occurs                    
                                  Mutagenicity        Sincocin &          Negative                              
                                                       Agrispon                                                 
----------------------------------------------------------------------------------------------------------------

    The Agency granted a data waiver request for the acute inhalation 
toxicity test based on the aqueous end-use product, Sincocin, since 
Plant Extract 620, the technical grade active ingredient (TGAI) which 
is also the manufacturing use product, could not undergo inhalation 
testing by virtue of it being a powder. The end-use products, Agrispon 
and Sincocin, are Toxicity Category III for primary dermal irritation. 
The remaining acute toxicity tests were waived since the results from 
the TGAI were adequate to characterize the responses for the end-use 
products which are 0.56% dilutions of the TGAI. The results of the 
submitted acute toxicology and mutagenicity data, indicated that plant 
extract from Opuntia lindheimeri, Quercus falcata, Rhus aromatica, and 
Rhizophoria mangle are of a low acute toxicity such that test 
requirements for subchronic, chronic, immune, endocrine, dietary and 
non-dietary studies were not triggered. The Agency has determined that 
all toxicology data requirements have been satisfied. There were no 
toxic endpoints identified as a result of the submitted studies and 
therefore no reference dose or no observable effect level to be 
established.

III. Aggregate Exposure

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non 
dietary sources of exposure the Agency considers include drinking water 
or groundwater, and exposure through pesticide use in gardens, lawns, 
or buildings (residential and other indoor uses).
    1. Dietary Exposure-- a. Food. Dietary exposure from use of this 
plant extract is possible but the magnitude of the residues is expected 
to be minimal to negligible since the application rate is 4 grams per 
acre per application on food crops. The maximum total amount permitted 
for application for 1 year is 150 grams. Moreover, washing off of 
foliage and fruit by rainfall or during food processing and handling, 
and likely degradation of the plant extracts by soil microflora would 
further reduce the amount of dietary exposure.
    b. Drinking water. Oral exposure, at very low levels, may occur 
from ingestion residues of the plant extract in the drinking water. 
However a lack of mammalian toxicity for the plant extract has been 
demonstrated.
    2. Non-dietary, non-occupational exposure. The primary non-dietary 
sources of exposure the Agency looks at include exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses). Products containing the plant extract are not registered 
for use on residential lawns or indoor residences or buildings.

IV. Cumulative Effects

    The Agency has considered available information on the cumulative 
effects of such residues and other substances that have a common 
mechanism of toxicity. These considerations included the cumulative 
effects on infants and children of such residues and other substances 
with a common mechanism of toxicity. Because there is no indication of 
mammalian toxicity to this plant extract, there is no reason to expect 
any cumulative effects from this plant extract and other substances.

V. Endocrine Disruptors

    The Agency has no information to suggest that the plant extract, 
also known as Plant Extract 620, a composite of plant extract powder, 
will have an effect on the immune and endocrine systems. The Agency is 
not requiring information on the endocrine effects of this biochemical 
plant extract pesticide at this time; Congress has allowed 3 years 
after August 3, 1996, for the Agency to implement a screening program 
with respect to endocrine effects.

VI. Determination of Safety

    1. U.S. population. The results of acute toxicity tests and, 
mutagenicity tests demonstrate a low to minimal toxicity profile for 
the plant extract. Moreover, when Plant Extract 620 is incorporated 
into the end-use product formulation and following dilution of the 
product according to label instructions, the result is an extremely low 
amount of 2 to 14 grams of active ingredient applied per acre per 
application. A maximum limit of 150 grams per acre of the active 
ingredient per year will be in effect for this biochemical pesticide. 
The submitted data do not lead the Agency to suspect any acute or 
chronic dietary risks. The low toxicity, the low application rate, and 
the use patterns leads the Agency to conclude that residues from use of 
the biochemical pesticide extract from Opuntia lindheimeri (prickly 
pear cactus), Quercus falcata (Red oak), Rhus aromatica (sumac), and 
Rhizophoria mangle (mangrove) will not pose a

[[Page 24841]]

dietary risk of concern under reasonably foreseeable circumstances. 
Therefore, EPA concludes that there is a reasonable certainty of no 
harm from aggregate exposure under this exemption.
    2. Infants and children. The Agency has considered available 
information on the variability of the sensitivities of major 
identifiable subgroups of consumers including infants and children and 
the physiological differences between infants and children and adults 
and effects of in utero exposure to biochemical pesticides. As noted 
previously, the Agency has concluded that dietary exposure to the plant 
extract will be minimal due to the very low amounts, 4 grams per 
application, and the maximum of 150 grams permitted per acre per year. 
Natural degradation processes including soil microbial activity and 
rain fall plus food processing steps such as washing and cooking will 
further reduce the amounts available for exposure. Accidental ingestion 
of this product by children is possible but the end-use products have 
been classified as Toxicity Category IV, practically non-toxic with 
regards to oral toxicity. While the manufacturing product is Toxicity 
Category I, acutely toxic with regards to primary eye irritation, 
unwashed eyes, the end-use products will contain a hundredfold dilution 
of the plant extract which are further diluted upon spraying. 
Furthermore, the end-use products will not be used on lawns where 
children play.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (safety) for infants and children in the 
case of threshold effects to account for pre- and post-natal toxicity 
and the completeness of the database unless EPA determines that a 
different margin of exposure (safety) will be safe for infants and 
children. In this instance, EPA believes there is reliable data to 
support the conclusion that this plant extract is not toxic to mammals, 
including infants and children, and thus there are no threshold 
effects. As a result, the provision requiring an additional margin of 
exposure does not apply.

VII. Analytical Method

    The Agency has determined that an analytical method is unnecessary 
due to the low toxicity of the plant extract and due to the low 
application rate of up to 4 grams per acre on food crops and up to 14 
grams per acre for ornamentals and turf per application. The yearly 
maximum will be 150 grams of active ingredient per acre.

VIII. International Tolerances

    There are no CODEX tolerances nor international tolerances for the 
plant extract at this time.

IX. Conclusion

    There is a reasonable certainty that no harm will result from 
aggregate exposure of the U.S. population, including infants and 
children, to residues of plant extract from Opuntia lindheimeri 
(prickly pear cactus), Quercus falcata (red oak), Rhus aromatica 
(sumac), and Rhizophoria mangle (mangrove). This includes all 
anticipated dietary exposures and all other exposures for which there 
is reliable information. The Agency has arrived at this conclusion 
because, as discussed above, no toxicity to mammals has been observed 
for the plant extract. As a result, EPA establishes an exemption from 
tolerance requirements pursuant to FFDCA section 408(j)(3) for Opuntia 
lindheimeri, Quercus falcata, Rhus aromatica, and Rhizophoria mangle.

X. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance exemption regulation issued by 
EPA under new section 408(e) as was provided in the old section 408. 
However, the period for filing objections is 60 days, rather than 30 
days. EPA currently has procedural regulations which govern the 
submission of objections and hearing requests. These regulations will 
require some modification to reflect the new law. However, until those 
modifications can be made, EPA will continue to use those procedural 
regulations with appropriate adjustments to reflect the new law.
    Any person adversely affected by this regulation may, by July 7, 
1997, file written objections to the regulation and may also request a 
hearing on those objections. Objections and hearing requests must be 
filed with the Hearing Clerk, at the address given above (40 CFR 
178.20). A copy of the objections and/or hearing requests filed with 
the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). If a hearing is requested, the objections must 
include a statement of the factual issue(s) on which a hearing is 
requested, the requestor's contentions on such issues, and a summary of 
any evidence relied upon by the objector (40 CFR 178.27). A request for 
a hearing will be granted if the Administrator determines that the 
material submitted shows the following: There is genuine and 
substantial issue of fact; there is reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issue(s) in the manner sought by the 
requestor would be adequate to justify the action requested (40 CFR 
178.32). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as CBI. Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2. A copy 
of the information 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.

XI. Public Docket

    A record has been established for this rulemaking under the docket 
number [OPP-300472] (including any comments and data submitted 
electronically). 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 22202.
    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 any 
copies of objections and hearing requests 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

[[Page 24842]]

``ADDRESSES'' at the beginning of this document.

XII. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (FRA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that the RFA is 
inapplicable. Nonetheless, the Agency has previously assessed whether 
establishing tolerances or exemptions from tolerance, raising tolerance 
levels, or expanding exemptions from tolerance, adversely impact small 
entities and concluded, as a generic matter that there is no adverse 
impact (46 FR 24950, May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 24, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1179 is added to read as follows:


Sec. 180.1179   Plant extract derived from Opuntia lindheimeri, Quercus 
falcata, Rhus aromatica, and Rhizophoria mangle; exemption from the 
requirement of a tolerance.

    The biochemical pesticide plant extract derived from Opuntia 
lindheimeri, Quercus falcata, Rhus aromatica, and Rhizophoria mangle is 
exempted from the requirement of a tolerance in or on all raw 
agricultural commodities when applied as a nematicide/plant regulator 
in accordance with good agricultural practices.

[FR Doc. 97-11900 Filed 5-6-97; 8:45 am]
BILLING CODE 6560-50-F