[Federal Register Volume 62, Number 10 (Wednesday, January 15, 1997)]
[Notices]
[Pages 2154-2156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-985]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-687; FRL-5580-4]


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 for a tolerance for residues of copper octanoate 
when used in accordance with good agricultural practice as an active 
ingredient in pesticide formulations applied to growing crops. This 
notice includes a summary of the petition that was prepared by the 
petitioner, W. Neudorff GmbH KG (``Neudorff'').

DATES: Comments, identified by the docket number [PF-687], must be 
received on or before February 14, 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 be sending electronic mail (e-
mail) to: [email protected]. Electronic comments must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Comments and data will also be accepted on 
disks in WordPerfect in 5.1 file format or ASCII file format. All 
comments and data in electronic form must be identified by docket 
number [PF-687]. Electronic comments on this notice may be filed online 
at many Federal Depository Libraries. Additional information on 
electronic submissions can be found below this document.
    Information submitted as a comments 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: Philip V. Errico, Acting Product 
Manager (22), Rm. 229, CM#2, 1921 Jefferson Davis Highway, Arlington, 
VA. 22202, 703-305-5540, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP 
6F4734) from W. Neudorff GmbH KG (``Neudorff''), c/o Walter G. Talarek, 
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. 
section 346a(d), to amend 40 CFR Part 180 by establishing an exemption 
from the requirement for a tolerance for residues of the fungicide 
copper octanoate when used in accordance with good agricultural as an 
active ingredient in pesticide formulations applied to growing crops.
    As required by section 408(d) of the FFDCA, as recently amended by 
the Food Quality Protection Act, Neudorff 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 Neudorff. EPA 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 
has made minor edits to the summary for the purpose of clarity.

I. Petition Summary

A. Residue Chemistry

    1. Magnitude of the residue anticipated at the time of harvest and 
method used to determine the residue. No residues are expected at the 
time of harvest on crops treated with copper octanoate, because 
rainwater readily washes copper octanoate off plants, and this chemical 
is biodegraded by water hydrolysis into its copper ion and fatty acid 
components, and then the fatty acids are further degraded by two carbon 
units at a time until they eventually degrade to water and CO2. In 
addition, the physio-chemical properties of soils naturally modify 
copper ion availability, and when soils are adjusted/limed to the pH 
required for normal crop production, the effect is to reduce copper 
availability to the crop. Furthermore, toxic copper levels in plants 
induce an imbalance with iron which causes plant dwarfing, stunted 
roots and decreased growth and yields, which effects appear before 
significant copper buildup occurs, and consequently acts as a warning 
which prevents excess application of copper compounds to food/feed 
crops. Last, even if residues were to remain on plants, the copper ion 
is a trace element, or micronutrient, essential for the growth and well 
being of higher plants and animals, including man. Therefore, the 
amount of this chemical proposed for application to plants is highly 
unlikely to cause harm to plants or animals or to leave excess residues 
on the plants.
    2. Statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. Neudorff 
has not proposed a new analytical method, because copper levels harmful 
to plants and animals are highly unlikely to occur when its copper 
octanoate product is applied according to label instructions. However, 
should EPA require such a method, because copper octanoate is a copper 
salt of a fatty acid, Neudorff would propose the use of the same 
analytical method submitted by registrants of products containing other 
copper salts of fatty acids.

[[Page 2155]]

B. Toxicological Profile

    1. Acute toxicity. Result of studies conducted on a concentrate 
product containing copper octanoate and for which Neudorff has applied 
for registration indicate that this chemical has low acute toxicities.
    2. Genotoxicity, reproductive and developmental toxicity, 
subchronic toxicity, and chronic toxicity. There is adequate 
information available from literature sources to characterize the 
toxicity of the copper ion. The available literature shows that copper 
is ubiquitous in nature and is a necessary nutritional element for both 
animals and plants. It is one of 26 elements found essential to life. 
The copper ion is present in the adult human body at levels of 80-150 
mg. Oral ingestion of excessive amounts of the copper ion from 
pesticidal uses is unlikely; copper compounds are irritating to the 
gastric mucosa and emesis usually occurs promptly, thereby reducing the 
amount of copper ion available for absorption into the human body. 
Moreover, copper is a trace element essential for the growth and well 
being of man. However, man is protected from excess copper ion in the 
body by an effective homeostatic mechanism which integrates absorption, 
retention and excretion to stabilize the copper ion burden in the body. 
Only a small percentage of copper ingested is absorbed, and most of the 
absorbed copper is excreted. In view of the facts that the copper ion 
occurs naturally in most foods and the metabolism of copper is well 
understood, there is no reason to expect that long-term exposure to 
copper ion in the diet is likely to pose the risks of chronic or sub-
chronic adverse effects.

C. Aggregate Exposure

    1. Dietary exposure. a. Food. There is no known evidence of sub-
chronic or chronic adverse health effects from dietary exposure to the 
copper ion, except in the case of massive intake disrupting the natural 
homeostatic mechanism controlling body level of copper.
    b. Drinking water. As a copper salt of a fatty acid, copper 
octanoate can be washed off growing plants by rain and during 
processing of crops by water. However, as stated previously, copper 
octanoate is biodegraded first by water hydrolysis into the copper ion 
and fatty acid components, and then the fatty acids are further 
degraded by two carbon units at a time until they eventually degrade to 
water and CO2. But, even if the chemical were to wash off plants 
and the copper ion were to get into a public drinking water source, EPA 
has promulgated Safe Drinking Water Act standards for copper which 
would be protective of pubic health.
    2. Non-dietary exposure. The only non-dietary exposure expected is 
that to applicators. However, the protective measures prescribed by the 
product's label are expected to be adequate to minimize exposure and 
protect applicators of the chemical.

D. Cumulative Effects

    No cumulative adverse effects are expected from long-term exposure 
to this chemical.

E. Safety Determination

    1. U.S. population. The metabolism of copper in man and growing 
plants is well understood and documented in the available literature. 
The use of copper octanoate as a pesticide would have essentially the 
same results in terms of contribution of copper ion to growing crops as 
the use of copper sulfate and the Group II copper compounds that have 
already been granted exemptions from tolerance by EPA. Further, there 
is adequate information to show that there is no toxicological concern 
raised by the contribution of the copper ion to growing crops which is 
likely to result from application of pesticides containing copper, and 
consequently no tolerances should be required for the use of copper 
octanoate.
    2. Infants and children. Because the fetus and newborn have 
elevated copper levels (Sternlieb, 1980), and since homeostatic 
mechanisms are not fully developed at birth (Underwood, 1977), the 
newborn represents a risk group that may not be able to cope with 
excess copper exposure. However, the fetus does not have a ``abnormal 
burden'' of copper; it needs a store of copper from which it will start 
fulfilling its requirements as a newborn (USEPA, 1987). Data show that 
in small children ingestion of approximately 10 mg C/10 kg 
child/day from contaminated milk can cause severe liver disorders 
(Tanner et al, 1983). EPA theorizes that ``given that 1 mg/kg bw is an 
upper limit of exposure, it is conceivable that, for instance, 20 
percent of this level (2 mg/child/day) could result in less severe, 
though still significant, liver damage. This intake is well within the 
normal adult recommended nutritional level, indicting that children may 
be more susceptible systematically to copper than adults. The main 
action my be the intestinal mucosa, especially in infants with 
preexisting GI tract disturbances.'' (USEPA, 1987).

F. Existing Tolerances

    1. Existing tolerances or tolerance exemptions. EPA has not 
established a tolerance or an exemption from the requirement for a 
tolerance for this chemical. However, EPA has promulgated a tolerance 
exemption for a group of similar copper-based chemicals, i. e., 
Bordeaux mixture, copper acetate, basic copper carbonate (malachite), 
copper hydroxide, copper-lime mixtures, copper linoleate, copper oleate 
copper oxychloride, copper sulfate basic, copper sulfate monohydrate, 
copper sulfate pentahydrate, copper-zinc chromate, cupric oxide, and 
cuprous oxide (two of these chemicals are copper salts of fatty acids), 
when they are applied to growing crops in accordance with good 
agricultural practice. See 40 CFR 180.1001(b)(1). In addition, EPA has 
promulgated a tolerance exemption for copper residues in meat, milk, 
poultry, eggs, fish, and irrigated crops when they result from the use 
of certain copper compounds, i. e., copper sulfate, basic copper 
carbonate, copper triethanolamine, copper monoethanolamine, and cuprous 
oxide, at certain sites. See 40 CFR 180.1021. The common basis for 
EPA's tolerance exemptions for the compounds in these two classes of 
copper compounds appears to be the fact that the copper ion is the 
entity responsible for their fungicidal action, and there is adequate 
data on the copper ion upon which EPA can make judgments about its 
potential for causing unreasonable adverse effects on the environment.
    2. International tolerances. No maximum residue level has been 
established for this substance by the Codex Alimentarius Commission.

II. Administrative Matters

    Interested persons are invited to submit comments on the this 
notice of filing. Comments must bear a notation indicating the document 
control number, [PF-687]. All written comments filed in response to 
this petition will be available in the Public Response and Program 
Resources Branch, at the address given above from 8:30 a.m. to 4 p.m., 
Monday through Friday, except legal holidays.
    A record has been established for this notice under docket number 
[PF-687] 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

[[Page 2156]]

holidays. The public record is located in Rm. 1132 of the Public 
Response and Program resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.

List of Subjects

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

    Dated: January 7, 1997.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 97-985 Filed 1-14-97; 8:45 am]
BILLING CODE 6560-50-F