PMEP Home Page --> Pesticide Active Ingredient Information --> Fungicides and Nematicides --> Acetic acid to Etridiazole --> copper octanoate --> copper octanoate Pesticide Tolerance Petition Filing 1/97

copper octanoate Pesticide Tolerance Petition Filing 1/97

CHEMICAL PROFILES/FUNGICIDE & NEMATICIDE/copper octanoate 
--------------------------------------------------------------------------
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.
--------------------------------------------------------------------------

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: opp-
docket@epamail.epa.gov. 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: errico.philip@epamail.epa.gov. 

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.

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<greek-m>/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 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: opp-docket@epamail.epa.gov

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]
[Federal Register: January 15, 1997 (Volume 62, Number 10)] [Notices]
[Page 2149-2154]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]