[Federal Register Volume 68, Number 127 (Wednesday, July 2, 2003)]
[Notices]
[Pages 39554-39557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16738]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0226; FRL-7315-2]


Copper Hydroxide; Notice of Filing of a Pesticide Petition to 
Establish a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2003-0226, must be 
received on or before August 1, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6304; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 39555]]

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0226. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0226. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2003-0226. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0226.

[[Page 39556]]

    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2003-0226. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: June 23, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The summary may have been edited by EPA if the terminology used was 
unclear, the summary contained extraneous material, or the summary 
unintentionally made the reader conclude that the findings reflected 
EPA's position and not the position of the petitioner.

Syngenta Crop Protection

PP 2E6471

    EPA has received a pesticide petition (PP 2E6471) from Syngenta 
Crop Protection, P.O. Box 18300, Greensboro, North Carolina, 27419-8300 
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 to establish an exemption from the requirement 
of a tolerance for copper (II) hydroxide in or on raw agricultural 
commodities. EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of the 
petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. Copper hydroxide is exempt from the 
requirement of a tolerance (40 CFR 180.1021(b)) for use as a broad-
spectrum foliar fungicide on growing crops. It is used at application 
rates greater than an order of magnitude higher than the proposed use 
as a formulation inert. As such, the metabolism and magnitude of the 
residue is well understood at application rates much higher than in the 
current petition.
    2. Analytical method. Copper ions are released from copper 
hydroxide by solubilization in the presence of moisture. A method for 
copper is listed in the January 2002 Pesticide Analytical Volume II.
    3. Magnitude of residues. Copper hydroxide is exempt from the 
requirement of a tolerance (CFR 180.1021(b)) for use as a broad-
spectrum foliar fungicide on growing crops. It is used as a fungicide 
at application rates greater than an order of magnitude higher than the 
proposed use as a formulation inert. As such, the metabolism and 
magnitude of the residue is well understood at application rates much 
higher than in the current petition. Copper is naturally found at 
significant levels in many different types of foods.

B. Toxicological Profile

    Copper hydroxide is a versatile and safe material which is used 
almost everywhere where copper is needed in chemistry. Copper hydroxide 
is used directly in the planting and ceramics industry, and in 
agriculture as a fungicide and bactericide. It is widely used as a 
manufacturing intermediate in numerous applications, for example to 
make copper compounds, for the production of pigments containing 
copper, in the manufacture of copper fibers, in galvanizing, 
metallurgy, pyrotechnics, and electronics, to name just a few 
applications. Copper ions are released from copper hydroxide by 
solubilization in the presence of moisture. Copper is ubiquitous in 
nature and is a necessary nutritional element for both animals 
(including humans), and plants. Copper is found naturally in the food 
we eat, in soils, in the water we drink, in the air we breathe and in 
our bodies. It is one of 26 elements found essential to life. The 
copper ion is present in the adult human body at levels of 70-150 
milligrams (mg).

[[Page 39557]]

    Due to its being used in small percentages in the proposed 
formulations, oral ingestion of quantifiable amounts of copper will not 
result from use of copper hydroxide as an inert. Copper compounds are 
irritating to the gastric mucosa. Ingestion of large amounts of copper 
results in prompt emesis. This protective reflex reduces the amount of 
copper ion available for absorption into the human body. Additionally, 
at high levels humans are also sensitive to the taste of copper. 
Because of this organoleptic property, oral ingestion would also serve 
to limit high doses. Only a small percentage of ingested copper is 
absorbed, and most of the absorbed copper is excreted. The copper ion 
occurs naturally in many foods and the metabolism of copper is well 
understood. There are several factors unique to copper which indicate 
that additional studies are not needed to regulate copper hydroxide as 
an inert in pesticide formulations. One of the foremost of these is the 
fact that copper is a required nutritional element for both plants and 
animals. It appears that more evidence is available to define the 
adverse effects of a deficiency in the diet than to show the toxic 
effects of an excess intake. In fact, no account has been found in the 
literature reviewed which describes a toxic effect to normal humans 
from ingestion of common foodstuffs containing copper. Because copper 
toxicity to man through the diet has been shown in normal persons, 
little is known about the minimum levels of dietary copper necessary to 
cause evidence of adverse effects. This situation is likely due, to an 
effective homoeostatic mechanism that is involved in the dietary intake 
of copper and that protects man from excess body copper. This complex 
mechanism integrates absorption, retention, and excretion to stabilize 
the copper body burden. Given that copper is ubiquitous and is 
routinely consumed as part of the daily diet, it is unlikely that with 
current exposure patterns there would be any long-term adverse effects. 
The hydroxide ion is also ubiquitous in plants, animals including 
humans, and the environment. The use of copper hydroxide as an inert 
will not result in any increased burden on the environment or living 
organisms.

C. Aggregate Exposure

    1. Dietary exposure. Twelve Food and Drug Administration (FDA) 
total diet studies, conducted from mid 1982-1984, examined dietary 
intake of copper for age groups 14-16, 25-30, and 60-65 years. The 
copper intake ranged from 0.77 (14-16 year old females) to 1.24 mg/day 
(25-30 year old males). Use of copper hydroxide as an inert at rates at 
an order of magnitude lower than current pesticide rates will not 
result in any quantifiable increase in exposure to copper from dietary 
sources.
    i. Food. The main source of copper for infants, children, and 
adults, regardless of age, is the diet. Copper is typically present in 
mineral rich foods like vegetables (potato, legumes (beans and peas)), 
nuts (peanuts and pecans), grains (wheat and rye), fruits (peach and 
raisins), and chocolate in levels ranging from 0.3 to 3.9 parts per 
million (ppm). A single day's diet may contain 10 mg or more of copper. 
The daily recommended allowance of copper for adults nutritional needs 
is 2 mg.
    ii. Drinking water. Copper is a natural element found in the 
earth's crust. As a result, most of the world's surface water and 
ground water that is used for drinking purposes contains copper. 
Naturally occurring copper in drinking water is safe for human 
consumption, even in rare instances where it is at levels high enough 
to impart a metallic taste to the water. The Agency has set a maximum 
contaminant level for copper at 1.3 ppm. Use of copper hydroxide as an 
inert at rates at an order of magnitude lower than current pesticide 
rates will not result in any quantifiable increase in exposure to 
copper from drinking water.
    2. Non-dietary exposure. Copper is a naturally occurring element 
present in the earth's crust, and it is therefore naturally occurring 
in soil, water and air. Soils would be considered copper deficient if 
they contain less than 2 ppm available copper in the context of plant 
health. Air concentrations of copper are relatively low. A study based 
on several thousand samples assembled by EPA's Environmental Monitoring 
Systems Laboratory showed copper levels ranging from 0.003 to 7.32 
micrograms per cubic meter. Use of copper hydroxide as an inert at 
rates at an order of magnitude lower than current pesticide rates will 
not result in quantifiable increase in exposure to copper from non-
dietary sources.

D. Cumulative Effects

    Exposure to copper occurs over a lifetime from numerous sources and 
does not result in any known toxicity. Use of copper hydroxide as an 
inert will not result in quantifiable increase in cumulative exposure 
to copper.

E. Safety Determination

    1. U.S. population. Copper is an essential trace element for which 
the National Academy of Sciences has issued a recommended daily 
allowance of up to 3 mg/day for adults. Accordingly, there is 
reasonable certainty that no harm will result from aggregate exposure 
of the U.S. population to copper. The use of copper hydroxide as an 
inert in pesticide formulations will not result in any measurable 
increase in exposure to copper.
    2. Infants and children. Copper is also a component of the diet of 
infants and children and also an essential element of their diet. The 
use of copper hydroxide as an inert in pesticide formulations will not 
result in any measurable increase in exposure of infants and children 
to copper.

F. International Tolerances

    There does not appear to be any international tolerances for copper 
or copper hydroxide, and no CODEX maximum residue levels has been 
established for any food crops at this time.
[FR Doc. 03-16738 Filed 7-1-03; 8:45 am]
BILLING CODE 6560-50-S