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cucurbitacins Pesticide Petition Filing 8/99


[Federal Register: September 1, 1999 (Volume 64, Number 169)]
[Notices]               
[Page 47788-47791]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se99-95]                         

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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:


------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production

                                  112                 Animal production

                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    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:


------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
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).
------------------------------------------------------------------------


    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-<greek-a>-elaterin] and E [25-(acetyloxy-2,16,20-trihydroxy-9-
methyl- 19-nor-9<greek-b>, 10<greek-a>-lanosta-1,5,23-triene-
3,11,22,trione; <greek-a>-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 
(LD<INF>50</INF>) in mice of the various cucurbitacins ranges from 5 to 
650 mg/kg body weight. Cucurbitacin I is the most toxic. The 
LD<INF>50</INF> 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, 
LD<INF>50</INF>=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 LD<INF>50</INF> 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