[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Notices]
[Pages 17812-17814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9386]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-729; FRL-5597-6]


W. Neudorff GmbH KG; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of a regulation for an exemption 
from the requirement of a tolerance for residues of low erucic acid 
(less than 2%) rapeseed oil, i.e., canola oil, when used in accordance 
with good agricultural practice as an active ingredient in pesticide 
formulations applied to growing crops. The summary of the petition 
published in this notice was prepared by the petitioner.
DATES: Comments, identified by the docket number [PF-729], must be 
received on or before, May 12, 1997.

ADDRESSES: By mail, submit written comments 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 comments to Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION'' of this document. 
No Confidential Business Information (CBI) should be submitted through 
e-mail.
    Information submitted as comments concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). 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: Sheryl Reilly, Regulatory 
Action Leader (PM 90), Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 
M St., SW., Washington, DC 20460. Office location, telephone number, 
and e-mail address: 5th floor, CS 1-5W29, 2800 Crystal Drive, 
Arlington, VA, Telephone No. 703-308-8265, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP 
6F4747) from W. Neudorff GmbH KG (``Neudorff''), c/o Walter Telarek, 
1008 Riva Ridge Drive, Great Falls, VA 22066, proposing pursuant to 
section 408(d) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 
346a(d), to amend 40 CFR part 180 by establishing an exemption from the 
requirement of a tolerance for residues of the insecticide, canola oil, 
on growing crops. EPA has determined that the 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. As required by section 408(d) of the FFDCA, as recently 
amended by the Food Quality Protection Act, W. Neudorff GmbH KG 
included in the petition a summary of the petition and authorization 
for the summary to be published in the Federal Register in a notice of 
receipt of the petition. The summary represents the views of W. 
Neudorff GmbH KG; EPA, as mentioned above, is in the process of 
evaluating the petition. As required by section 408(d)(3) EPA is 
including the summary as a part of this notice of filing. EPA may have 
made minor edits to the summary for the purpose of clarity.
    EPA invites interested persons to submit comments on this notice of 
filing. Comments must bear a notification indicating the document 
control number [PF-729].
    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket number 
``PF-729'' (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 rulemaking record is located at the Virginia 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 PF-729; FRL-5597--6. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries.

List of Subjects

    Environmental Protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 28, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Below is a summary of the pesticide petition. The summary of the 
petition was prepared by the petitioner. 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.

[[Page 17813]]

W. Neudorff GmbH KG

PP 6F4747

A. Proposed Use Practices

    1. Recommended application method and rate(s), frequency of 
application, and timing of application. Spray tanks and sprinkler 
irrigation systems may be used. The rate of application is 3.84 to 7.68 
gallons of active ingredient per acre. The frequency and timing of 
application vary widely according to the crop being treated. For 
example: for fruit and nut trees, the product is applied during the 
dormant and pre-bloom stages and during the summer; for sugar beets, 
the product is applied as needed; and for cotton, the product is 
applied when insects appear, and thereafter, weekly as needed.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The active 
ingredient is low erucic acid (less than 2%) rapeseed oil, i.e., canola 
oil. Canola oil is the full refined edible oil obtained from certain 
varieties of plants, i.e., Brassica napus or B. campestris of the 
family Cruciferae. The organic substance is rapidly degraded in the 
environment to organic constituents by normal biological, physical and 
chemical processes that can be reasonably expected to exist where the 
pesticide is applied.
    2. Magnitude of residue anticipated at the time of harvest and 
method used to determine the residue. Neudorff has requested waivers 
for these data requirements. The waiver requests were based on canola 
oil's known low toxicity and risks, natural occurrence and abundance in 
the environment, widespread use as an edible fat and oil in foods, FDA 
generally recognized as safe (GRAS) status (21 CFR 184.1555(c)), non-
toxic mode of action, anticipated low volume use in pesticide products, 
and the data available in the open literature. Further, EPA has already 
promulgated an exemption from the requirement for a tolerance for 
canola oil when it is used as a surfactant or related adjuvant of a 
surfactant in pesticide formulations applied to growing crops (40 CFR 
180.1001(d)). In addition, EPA has expressly waived these data 
requirements for soybean oil, which is a vegetable oil whose fatty acid 
profile is very similar to that of canola oil.
    3. Statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. Neudorff 
has not proposed an analytical method, because canola oil levels 
harmful to plants and animals are highly unlikely to occur when it's 
formulated canola oil product is applied according to label 
instructions. Moreover, it is an organic compound known to be rapidly 
degraded in the environment to organic constituents by normal 
biological, physical and chemical processes that can be reasonably 
expected to exist where the pesticide is applied. Furthermore, the 
oils, or triglycerides, within canola oil already exist as normal 
constituents of the plants being treated. Last, there is no information 
indicating that this substance, its metabolites, and degradates either 
are absorbed by or cannot be metabolized by plants.

C. Mammalian Toxicological Profile

    1. Acute toxicity. Available literature indicates that this 
substance has low acute toxicities. In addition, FDA has promulgated a 
regulation granting GRAS status to this substance (21 CFR 184.1555(c)).
    2. Genotoxicity, reproductive and developmental toxicity, 
subchronic toxicity, and chronic toxicity. Canola oil is a food that is 
readily metabolized by humans. There is adequate information available 
from literature sources to characterize the toxicity of canola oil. 
These studies indicate that canola oil's nutritional and toxicological 
profile is similar to those of other vegetable oils (50 FR 3745, 3752, 
January 28, 1985). Moreover, the available literature indicates that 
the use of this substance as a component of food is safe (50 FR 3745, 
3753).

D. Aggregate Exposure

    1. Dietary exposure--a. Food. Canola oil is used as a fat and oil 
in food consumed by humans. FDA has promulgated a regulation listing 
canola oil as GRAS when used as a direct food additive (21 CFR 
184.1555(c)). Moreover, FDA has stated that the upper level of canola 
oil likely to be ingested by a U.S. consumer is safe (50 FR 3745).
    b. Drinking water. There is unlikely to be any exposure to this 
substance via drinking water. Even though the chemical can be washed 
off treated plants by rain and during processing of crops by water, it 
is an organic compound known to be rapidly degraded in the environment 
into organic constituents by normal biological, physical, and chemical 
processes.
    2. Non-dietary exposure. The only non-dietary exposure expected is 
to applicators. However, exposure to this chemical resulting from its 
application according to label directions is not expected to present 
any risk of adverse health effects.

E. Cumulative Exposure

    This substance has been designated by FDA as a GRAS food substance. 
It is a vegetable oil that has been used as a cooking oil and in 
margarine for many years. Because of these facts, and the fact that 
canola oil has a higher ratio of unsaturated fats to saturated fats 
than other vegetable oils, no cumulative adverse health effects are 
expected from long-term exposure to this chemical.
    1. Exposure through other pesticides and substances with the common 
mode of toxicity as this pesticide. Canola oil is an insect repellant 
which belongs to a class of structurally related compounds known as 
vegetable oils. This class includes corn, cottonseed, sesame and 
soybean oils. Of these, only soybean oil is a currently registered 
pesticide. Vegetable oils have a nontoxic mode of action; it has been 
theorized that they (a) alter the cuticle structure of the leaf 
surface, thus repelling the insects, or (b) act as irritants to 
insects. Consequently, the nontoxic mode of action for vegetable oils 
appears to be as functional blockades to the metabolic abilities or 
feeding abilities of insects. These compounds are approved for food 
uses in the United States and are recognized by the Food and Drug 
Administration as safe. Vegetable oils could be considered in an 
aggregate exposure assessment; however, there is no information showing 
that these compounds cause significant adverse effects to mammals or 
that the use of soybean oil and canola oil as insecticides will result 
in significant additional exposure. Moreover, Neudorff has no 
information indicating or suggesting that canola oil has toxic effects 
on animals that would be cumulative with those of any other compound.

F. Safety Determination

    1. U.S. population. Canola oil is a direct food additive that is 
considered GRAS by FDA (21 CFR 184.1555(c)). It is commonly used as a 
human food, i.e., as a fat or oil in food. Moreover, EPA has 
promulgated an exemption from the requirements for a tolerance for 
canola oil when it is used in accordance with good agricultural 
practice as a surfactant or related adjuvants of surfactants in 
pesticide formulations applied to growing crops (40 CFR 180.1001(d)). 
Canola oil is widely distributed in commerce and available to the 
general public throughout the United States for non-pesticidal uses. 
Canola oil has a non-toxic mode of action for the target pests. It is 
an organic compound known to be rapidly degraded in the environment to 
organic constituents by

[[Page 17814]]

normal biological, physical and chemical processes that can be 
reasonably expected to exist where the pesticide is applied. Use of 
canola oil as an active ingredient in the products sought to be 
registered is expected to be low, and is not likely to result in 
adverse human health effects, based upon available reports and 
information. Since people are exposed to this substance from food or 
other sources, the incremental exposure from its use in pesticide 
products is expected to be negligible.
    2. Infants and children. FDA's GRAS determination applies equally 
to adults and infants and children, with the exception of the 
chemical's use in infant formulas. This exception is due to FDA not 
evaluating the use, however. Moreover, the fatty acid profile for 
canola oil is similar to the fatty acid profiles for other vegetable 
oils. All vegetable oils are metabolized the same; and human metabolic 
pathways are well-established. In essence, vegetable oils are broken 
down in the digestive tract into useful components that are either 
burned as fuel or stored as fat for later use by the body. Furthermore, 
there is nothing about the chemistry of this substance or the 
anticipated levels of it that will be consumed by infants and children 
to indicate that their normal homeostatic mechanisms will not be 
protective.

G. Existing Tolerances

    1. Existing tolerances or tolerance exemptions. EPA has promulgated 
an exemption from the requirement for a tolerance for canola oil (low 
erucic acid rapeseed oil conforming to 21 CFR 184.1555(c)) when it is 
used in accordance with good agricultural practice as a surfactant or 
related adjuvants of surfactants in pesticide formulations applied to 
growing crops (40 CFR 180.1001(d)).
    2. International tolerances or tolerance exemptions. No maximum 
residue level has been established for this substance by the Codex 
Alimentarius Commission.

[FR Doc. 97-9386 Filed 4-10-97; 8:45 am]
BILLING CODE 6560-50-F