[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]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-737; FRL-5719-7]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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