[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Notices]
[Pages 47788-47791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22328]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-889; FRL-6098-6]
Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by docket control number PF-889, must be
received on or before October 1, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number PF-889 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Vera Soltero, Minor Use,
Inerts and Emergency Response Branch, Registration Division (7505W),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460; telephone number: (703) 308-9359; and
e-mail address: Soltero.vera@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer.
[[Page 47789]]
Potentially affected categories and entities may include, but are not
limited to:
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Examples of
Categories NAICS potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number PF-889. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2 (CM #2), 1921 Jefferson Davis Highway, Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-889 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The PIRIB telephone
number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
E-mail to: opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 5.1/
6.1 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-889. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified in the ``FOR FURTHER INFORMATION
CONTACT'' section.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition 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 this petition contains 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.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
[[Page 47790]]
Dated: August 20, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represent the views of the
petitioner. EPA is publishing the petition summary verbatim without
editing it 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.
Agricultural Research Service (ARS), U.S. Dept. of Agriculture
PP 9E6047
EPA has received a pesticide petition (PP 9E6047) from Agricultural
Research Service (ARS), U.S. Dept. of Agriculture, Beltsville
Agricultural Reseach Center, Beltsville, MD 20705, proposing, pursuant
to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption
from the requirement of a tolerance for cucurbitacins in the powders
and juices of the wild and domestic members of the plant family
Cucurbitaceae. These powders and juices are the source materials for
cucurbitacins added as inert ingredients in field prepared tank mixes
of pesticides. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of
the FFDCA; 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.
As defined in 40 CFR 153.125, inert ingredients include, but are
not limited to the following types of ingredients (except when they
have a pesticidal efficacy of their own): solvents, surfactants,
thickners, wetting, spreading, and dispersing agents, carriers, or
emulsifiers. The proposed change in source materials requires an
amendment to the existing tolerance exemption (40 CFR 180.1001(d)) for
buffalo gourd root powder, zucchini juice and cucurbitacins. ARS
proposes the following amendment which changes only the inert
ingredient, not the limits or the uses:
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Inert Ingredients Limits Uses
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Cucurbitacins as components of No more than 2.5 Gustatory
powders or juices of wild or pounds (lbs)/acre/ stimulant
domestic species of the plant season (3.4 grams
family Cucurbitaceae. (gm)/acre/season
of cucurbitacin).
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Cucurbitacins are ubiquitous in wild and domestic members of the
plant family Cucurbitaceae, e.g., cucumbers, squash, melons, and
gourds. Many species in this family have been used as food by humans
for centuries and some have been valued for their medicinal properties.
The cucurbitacins occur in mixtures and are found in many tissues of
the plant including fruits and seeds. They act specifically on
Diabriticine beetles (corn rootworms and cucumber beetles) as movement
arresters and compulsive feeding stimulants. Cucurbitacins from the
buffalo gourd and zucchini squash are currently used in pesticide
products.
Cucurbitacins are oxygenated tetracyclic terpenes. At least 19
cucurbitacins, A-S, have been described from the family Cucurbitaceae.
Two or more alcoholic hydroxyl groups characterize the bitter
principles and cucurbitacins A-C and E also contain one acetoxy group.
Keto groups are characteristic of these cucurbitacins. Cucurbitacins B,
D, E, C, and I-L contain a diospenol grouping that can combine with
glucose to form naturally occurring enolglycocides. The cucurbitacins
occur in nature in mixtures. Cucurbitacin B [25-(acetyloxy)-2,16,20-
trihydroxy-9-methyl-19-norlanosta- 5,23-diene-3,11,22-trione;1,2-
dihydro--elaterin] and E [25-(acetyloxy-2,16,20-trihydroxy-9-
methyl- 19-nor-9, 10-lanosta-1,5,23-triene-
3,11,22,trione; -elaterin] are the most effective feeding
stimulants. Measurements from 11 species of Cucurbita fruit showed a
total level of cucurbitacins ranging from 3.20 miligrams/kilograms (mg/
kg) to 0.02 mg/kg.
When combined with an approved pesticide and applied according to
good agricultural practices, they provide pest control with a
significant reduction of the amount of toxic pesticide required. Based
upon the data provided and passed experience, ARS believes that the
limitations on application rate provide adequate safety and a tolerance
is not necessary to protect the public health.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA as amended, ARS
has submitted the following summary of information, data, and arguments
in support of their pesticide petition.
A. Residue Chemistry
Magnitude of residues. Based upon the limited amount of
cucurbitacin (3.4 gm/acre/season) that can be applied, the rate of
deterioration of the chemicals, and early season time of application,
no residue is expected on the crop at harvest time. A number of methods
including high performance liquid chromatography, mass spectrometry,
thin layer chromatography or insect feeding response, are available for
the detection of residues.
B. Toxicological Profile
1. Acute toxicity. Studies have shown that the acute oral toxicity
(LD50) in mice of the various cucurbitacins ranges from 5 to
650 mg/kg body weight. Cucurbitacin I is the most toxic. The
LD50 of cucurbitacin E-glycoside, one of the more effective
insect feeding stimulants, is 40 mg/kg body weight.
2. Chronic toxicity. Because of the low levels of cucurbitacins
required and their rapid degradation in the field, no chronic effects
are expected. Neither cucurbitacins nor their metabolites are known or
expected to have any effect on the immune or the endocrine systems.
Cucurbitacins are not known to be carcinogenic, in fact, some have been
shown to inhibit the growth of solid tumors in vivo.
C. Aggregate Exposure
1. Dietary exposure. Species of the Family Cucurbitaceae
``cucurbits'' have been commonly used as fruits and vegetables
throughout the world for centuries. They are valuable sources of
vitamins and minerals. Seeds of several species are used as sources of
flavorings in bakery goods or for oils and proteins. All of these
species contain some assortment of cucurbitacins in varying
concentrations. At the allowable rate of application the use of these
compounds as inert ingredients to control pests will add little to the
aggregate exposure. The use to control corn rootworm is given as an
example. Assuming that the maximum permitted level of 3.4 gm/acre/
season is applied, with no loss either in the field or during
processing, and that all the material is concentrated in the grain, the
following exposure would result. The average yield of corn in the
United States is 120-130 bushels per acre. At 56 pounds per bushel the
minimum yield is 6,720 pounds per acre
[[Page 47791]]
and the level of cucurbitacin would be 0.88951 gram per pound. A gram
of ``straightneck'' squash contains 0.00139 gram cucurbitacin per gram
of squash. Thus, consumption of a pound of treated corn would add less
cucurbitacin to the diet than a gram serving of squash. To have
consumed the sufficient amount of the most toxic cucurbitacin,
LD50=5 mg/kg body weight, a 50 kg human would have to eat
over 400 pounds of the treated corn.
i. Drinking water. Most cucurbitacins are insoluble in water and
transfer of these cucurbitacins to ground water is unlikely. The
glycosylated forms which are more water soluble are less toxic to
humans. No uses are registered for application to bodies of water and
none are anticipated.
2. Non-dietary exposure. Registered uses are limited to
agricultural crops.
D. Cumulative Effects
Exposure through other pesticides and substances with the common
mode of toxicity as this compound. 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 action.
E. Safety Determination
1. U.S. population. The fact that cucurbitacins are ubiquitous in
many plants regularly consumed by the general public, the maximum
projected additional exposure to these compounds is significantly less
than that from a normal serving of these plants, and the previously
granted temporary exemption for buffalo gourd root powder as a specific
source of cucurbitacins (55 FR 49700, November 30, 1990), and a
permanent exemption from the requirement of a tolerance (57 FR 40128,
September 2, 1992), later amended to include zucchini juice (63 FR
43085, August 12, 1998), (FRL-6017-5) support an amendment to the
existing tolerance exemption.
2. Infants and children. The use sites of the cucurbitacins are all
agricultural for the control of Diabrotine beetles. Therefore, non-
dietary exposure to infants and children is not expected. The limited
application rate and correspondingly low maximum residue requiring that
a 1 kg child would have to consume almost 10 pounds of corn in a single
meal to obtain a LD50 dose and that the aggregate exposure
and cumulative exposure pose little, if any, risk all; all provide
reasonable certainty that no harm will result to infants and children
from exposure to residue of the cucurbitacins.
F. International Tolerances
There are no international tolerances or tolerance exemptions for
cucurbitacins. However, prior EPA findings of significant relevance to
this petition include a temporary exemption from the requirements of a
tolerance for residues of the buffalo gourd (Cucurbita foetidissima)
root powder as source of cucurbitacins in or on the raw agricultural
commodity field corn for the 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
formulations applied to growing crops only (57 FR 40128, September 2,
1992).
In 1998 EPA amended the permanent exemption from the requirement of
a tolerance to add the residues of zucchini juice (Cucurbita pepo) to
the list of ``inert ingredients'' (63 FR 43085, August 12, 1998).
[FR Doc. 99-22328 Filed 8-31-99; 8:45 am]
BILLING CODE 6560-50-F
