[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]]
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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.
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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
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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.
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Guideline No. Study Product Results Toxicity Category
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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
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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
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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
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``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