copper octanoate Pesticide Tolerance Petition Filing 1/97
CHEMICAL PROFILES/FUNGICIDE & NEMATICIDE/copper octanoate
ENVIRONMENTAL PROTECTION AGENCY
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
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-
email@example.com. 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: firstname.lastname@example.org.
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
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
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
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
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
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: email@example.com
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,
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]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]