[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)]
[Notices]
[Pages 34278-34281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16509]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[PF-737; FRL-5719-7]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing a pesticide petition
proposing the establishment of regulations for residues of certain
pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-737, must
be received on or before July 25, 1997.
ADDRESSES: By mail submit written comments to: Public Information and
[[Page 34279]]
Records Integrity Branch, Information Resources and Services Division,
(7506C), Office of Pesticides 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.
Comments and data may also be submitted electronically by following
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential
business information should be submitted through e-mail.
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: Rita Kumar, Product
Manager(PM)90, Biopesticides and Pollution Prevention Division, Office
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washinton, DC 20460. Office location, telephone number and e-mail
address: 5th Floor, CS1, 2800 Cystal Drive, Arlington, VA 703-308-8291,
e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various food
commodities under section 408 of the Federal Food, Drug, and Comestic
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions
contain data or information regarding the elements set forth in section
408(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-737] (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 official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment 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 the docket number (insert docket number) and appropriate
petition number. Electronic comments on this proposed rule may be filed
online at many Federal Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: June 17, 1997.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Summaries of Petitions
Petitioner summary of the pesticide petition is printed below as
required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summary announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
Micro Flo Company
PP 2E04064
The purpose of this submission is to summarize the information
provided by Micro Flo Company to the EPA in support of the proposed
change in beginning materials for the inert Cucurbitacin in the
manufacturing process of Slam/Adios (EPA Reg. No. 51036-185) and Adios
AG (EPA Reg. No. 51036-204). This amendment in the existing exmption is
submitted pursuant to section 408 of the FFDCA.
This change in beginning materials will require an amendment to the
existing tolerance exemption (40 CFR 180.1001(d)) for buffalo gourd
root powder and cucurbitacins.
40 CFR 180.1001(d) reads:
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
Buffalo Gourd Root Powder No more than 2.5 Gustatory
(Cucurbita Foetidissima root lbs/acre/season stimulant
powder). (3.4 gm/acre/
season of
Cucurbitacin)
------------------------------------------------------------------------
Cucurbitacins, found in plant of the Family Cucurbitaceae, act
specifically on Diabriticine beetles (corn rootworm and cucumber
beetles) as movement arrestants and compulsive feeding stimulants.
These have been used in pesticide products Slam/Adios and Adios AG,
which were developed to replace highly toxic corn rootworm and cucumber
beetle insecticides. When used along with cucurbitacin in the
formulation, a much smaller amount of the pesticide active ingredient
carbaryl is needed to achieve efficacy against these pests.
MicroFlo Company's current source of cucurbitacin is buffalo gourd
root powder. The Agency established an exemption from the requirement
of a tolerance for residues of buffalo gourd root powder (57 FR 40128,
September 2, 1992). Now MicroFlo Company proposes to add zucchini juice
as an alternative sources of cucurbitacin, since production of buffalo
gourd root powder is costly and unreliable.
Micro Flo Company believes that the submission and supporting data,
together with the Agency's earlier findings and determinations,
satisfies the Agency's requirement for the demonstrations, buffalo
gourd root powder (Cucurbita foetidissima root powder) and zucchini
juice (Cucurbita pepo juice).
Based upon the information presented, Micro Flo Company believes
that when used in accordance with good agricultural practice, the
ingredient zucchini juice is useful and a tolerance is not necessary to
protect the public health.
Therefore, Micro Flo Company proposes amending the existing
tolerance exemption by only adding zucchini juice to the ``Inert
Ingredients'' list, no change in ``Limits'' or ``Uses'' is proposed.
Proposed Amendment to 40 CFR 180.1001 (d):
[[Page 34280]]
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
Buffalo Gourd Root Powder No more than 2.5 Gustatory
(Cucurbita Foetidissima root lbs/acre/season stimulant
powder); or, Zucchini Juice (3.4 gm/acre/
(Cucurbita pepo juice). season of
Cucurbitacin)
------------------------------------------------------------------------
A. Proposed Use Practices
1. Recommended application method and rate (s), frequency of
application, and timing of application. The formulation containing
Zucchini Juice is to be applied according to good agricultural
practice, by air or ground application method, when Diabroticine beetle
populations reach the economic threshold and injury levels for the
specific crop.
No change in the frequency of applications is proposed. The maximum
number of applications will remain five (5) applications per crop
growing season. The total amount of cucurbitacin will not exceed 3.4
gm/acre/season.
B. Product Identity And Chemistry
1. Identity of the compound and corresponding residues. The
submitted product chemistry data for Zucchini Juice as an inert
ingredient satisfy the requirements regarding product identity (151-
10), beginning material and the manufacturing process (151-11),
discussion of formation of unintentional ingredients (151-12), analysis
of samples (151-13), certification of limits (151-15), analytical
method (151-16), and physical / chemical properties (151-17). No
additional data is required.
----------------------------------------------------------------------------------------------------------------
Name EPA Shaunessy Number Chemical identity Composition
----------------------------------------------------------------------------------------------------------------
Buffalo Gourd Root Powder (Cucurbita 128874 (Mar 90, Dry powder of plant Root powder percent
foetidissima root powder). Pesticide Data derived from the weight basis
Submitters List) cucurbit species
Cucurbita Foetidissima
Zucchini Juice Not Applicable........ Juice Of Plant derived Fruit Juice Percent
from the cucurbit weight basis
species Cucurbita pepo
----------------------------------------------------------------------------------------------------------------
The Product chemistries show similar nutritional profiles for each
cucurbit species; and both cucurbit species are used as a food source
for human consumption.
------------------------------------------------------------------------
Percent Weight
Component Percent Weight Zucchini Juice
Buffalo Gourd Root Powder
------------------------------------------------------------------------
Ash........................... 8.44 4.85
Protein....................... 15.4 3.78
Sugar......................... 1.87 0.91
Moisture...................... 10.0 66.7
Carbohydrate.................. 47.9 22.7
Fiber......................... 18.0 1.2
Fat........................... 0.25 0.77
------------------------------------------------------------------------
2. Magnitude of residue anticipated at the time of harvest and
method used to determine the residue. Based upon the proposed maximum
number of applications, no residues are anticipated at harvest for
Zucchini Juice (maximum 2.4375 pounds/acre/season); nor for
Cucurbitacins (maximum 3.319875 grams/acre/season). Methods used to
determine residues includes: high performance liquid chromatography
(HPLC), mass spectrometry (MS), nuclear magnetic resonance spectra
(NMRS), Rf values in normal phase thin layer chromatography (TLC),
specific color reactions, and diabroticine beetle quantified feeding
pattern bioassays.
3. A statement of why an analytical method for detecting and
measuring the levels of the residue are not needed. There are several
highly accurate, reliable and reproducible analytical methods available
for detecting and measuring the levels of the residue of zucchini juice
and cucurbitacins. Please see Section B-2 above.
C. Mammalian Toxicological Profile
1. Acute toxicity. The subject studies were found to be acceptable
and performed in accordance with the Subdivision M Guidelines.
Comparative toxicology data shows a more favorable toxicological
profile for the Zucchini Juice (Cucurbita pepo juice), as compared to
the Buffalo Gourd Root Powder (Cucurbita foetidissima root powder), as
a cucurbit source of cucurbitacins.
The acute mammalian toxicity studies indicate that the Zucchini
Juice is practically non-toxic to mammals. The acute oral, acute
dermal, acute inhalation, primary eye, and skin irritation are all
toxicity category IV. No acute systemic toxicity, irritation or dermal
sensitization was exhibited in the studies performed with the Zucchini
Juice.
2. Chronic toxicity. The proposed inert biochemical pesticide
ingredient Zucchini Juice and the associated component cucurbitacin do
not meet the conditions of 40 CFR 158.690 (b): based on the results of
Tier I toxicology studies, neither Tier II nor III toxicology data are
required.
Given the small amounts used and rapid degradation of Zucchini
Juice and associated cucurbitacins, no chronic effects are expected.
Neither the Zucchini Juice and associated cucurbitacins, nor
metabolites, are known to, or expected to have any effect on the immune
or endocrine systems. Zucchini Juice in general, and associated
cucurbitacins are not carcinogenic.
D. Aggregate Exposure
1. Dietary exposure-- a. Food. The petitioner presents the
following dietary risk data and assessment on potential crop residues
of Zucchini Juice. In accordance with 40 CFR 180.34, these data are
presented to establish, theoretically, the residues that would remain
under conditions most likely to result in high residues on the
commodity.
Assumptions, for the purpose of this maximum dietary risk - worst
case scenario, (case crop - corn; the example can be extended to other
crops) include that the Zucchini Juice and thus, the cucurbitacin, is
applied at the maximum label rate, the maximum number of times, the day
of harvest, and all of the material applied to the field is
concentrated in the grain; with no loss of Zucchini Juice nor
cucurbitacin due to any environmental, physical, chemical microbial or
milling / processing degradation. This will result in 2.4375 pounds of
Zucchini Juice and 0.0073125 pounds (3.319875 grams) of cucurbitacins
per acre.
The national average grain yield for corn is 120 - 130 bushels per
acre. At 56 pounds per bushel, for the purpose of the calculation, we
will use the lower yield value of 6,720 pounds per acre. The maximum
label rates allow for the application of 3.4 grams of cucurbitacin per
acre. Assuming all of the cucurbitacin is concentrated in the grain,
cucurbitacin levels would be 0.00051 grams cucurbitacin per pound of
grain corn.
It has been established that the cucurbitacins found in Zucchini
Juice are Cucurbitacin E and Cucurbitacin E Glycoside, at
concentrations of 0.2 - 0.3
[[Page 34281]]
percent. The acute oral LD50 values are: cucurbitacin E = 340 mg/kg:
cucurbitacin E Glycoside = 40 mg/kg. For the purpose of the
calculation, we will use the higher LD50 value of 40 mg/kg.
Assuming 50 kg human being as the average weight, the amount of
cucurbitacin required to reach the Acute Oral LD50 is 2,000
mg (40 mg/kg x 50 kg). One pound of grain corn contains 0.51
milligrams cucurbitacin. This is 1/3922 of the amount of cucurbitacin a
50 kg person would have to ingest to reach the acute oral
LD50 level. Therefore, to ingest 2,000 mg of cucurbitacin, a
50 kg person would need to consume 3,922 pounds of corn at one sitting.
Alternatively, to ingest 2,000 mg of cucurbitacin, a 50 kg person would
need to consume 11,013 ears of corn at one sitting, given an average
weight of grain in one ear of corn is 0.36 pounds.
b. Drinking water. Cucurbitacins are insoluble in water and
transfer of the zucchini juice to drink water is highly unlikely. No
leaching or groundwater contamination is expected to result from
registered uses according to good agricultural practice. No uses are
registered for application to bodies of water and none are being
sought.
2. Non-dietary exposure such as lawn care, topical insect
repellents, etc. Registered uses are limited to agricultural crop
production use.
E. Cumulative Exposure
Exposure through other pesticides and substances with the common
mode of toxicity as this compound. Consideration of a common mode of
toxicity is not appropriate given that the Zucchini Juice is
practically non-toxic to mammals and no information indicates that
toxic effects would be cumulative with any other compounds. Further, no
other pesticides or substances are registered with this mode of
toxicity.
F. Safety Determination
1. U.S. population. The fact that Zucchini Juice is practically
non-toxic to mammals: that to ingest the Acute Oral LD50
level of 2,000 mg of cucurbitacin, a 50 kg person would need to consume
3,922 pounds of corn at one sitting; that Aggregate Exposure and
Cumulative Exposure pose little, if any, risk at all; and previous
Agency actions granting a temporary exemption (55 FR 49700, November
30, 1990), and establishing a permanent exemption from the requirement
of a tolerance (57 FR 40128, September 2, 1992), support an amendment
to the existing tolerance exemption.
2. Infants and children. The use sites for the Zucchini Juice are
all agricultural for control of Diabroticine beetles. Therefore,
nondietary exposure to infants and children is not expected. The fact
that Zucchini Juice is practically non-toxic to mammals; that to ingest
the Acute Oral LD50 level 40 mg of cucurbitacin, a 1 kg
infant or child, would need to consume 78.44 pounds of corn at one
sitting; and that Aggregate Exposure and Cumulative Exposure pose
little, if any, risk at all; all provide reasonable certainty that no
harm will result to infants and children from exposure to residue of
Zucchini Juice.
G. Existing Tolerances
1. Existing tolerance or tolerance exemptions for this compound.
Prior EPA findings of significant relevance to this petition include a
temporary exemption from the requirements of a tolerance for residues
of the kairomone, Cucurbita foeidissima root powder in or on the raw
agricultural commodity field corn for control of adult corn rootworms
(55 FR 49700, November 30, 1990).
In addition, the Agency established a permanent exemption from the
requirement of a tolerance for residues of buffalo gourd root powder
when used as an inert ingredient (gustatory stimulant) in pesticide
formations applied to growing crops only (57 FR 40128, September 2,
1992).
40 CFR 180.1001 (d) reads:
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
Buffalo Gourd Root Powder No more than 2.5 Gustatory
(Cucurbita Foetidissima root lbs/acre/season stimulant
powder). (3.4 gm/acre/
season of
Cucurbitacin)
------------------------------------------------------------------------
2. International tolerances or tolerance exemptions. No
international tolerances of tolerance exemptions have been sought.
[FR Doc. 97-16509 Filed 6-24-97; 8:45 am]
BILLING CODE 6560-50-F