[Federal Register Volume 63, Number 113 (Friday, June 12, 1998)]
[Notices]
[Pages 32211-32212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15596]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-809; FRL-5792-7]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing to establish an exemption from the requirement of a 
tolerance for copper ammonium complex in or on all raw agricultural 
commodities.
DATES: Comments, identified by the docket control number PF-809, must 
be received on or before July 13, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment 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. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: The product manager listed in the 
table below:

------------------------------------------------------------------------
                                   Office location/                     
        Product Manager            telephone number          Address    
------------------------------------------------------------------------
Cynthia Giles-Parker..........  Rm. 247, CM #2, 703-    1921 Jefferson  
                                 305-7740, e-mail:       Davis Hwy,     
                                 giles-                  Arlington, VA  
                                 <a href="/cdn-cgi/l/email-protection#3c4c5d4e57594e125f45524854555d7c594c5d515d55365012594c5d125b534a">parker.cynthia@epamai
l.epa.gov</a>.                             
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as 
follows from Chemical Specialties, Inc., One Woodlawn Green, Suite 250, 
Charlotte, N.C. 28217, 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 to establish an exemption from the requirement of a tolerance 
for copper ammonium complex in or on all raw agricultural commodities 
when used in accordance with good agricultural practice as an active 
ingredient in pesticide formulations applied to growing crops. 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.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-809] (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 record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    <a href="/cdn-cgi/l/email-protection#d6b9a6a6fbb2b9b5bdb3a296b3a6b7bbb7bfbaf8b3a6b7f8b1b9a0"><span class="__cf_email__" data-cfemail="177867673a7378747c7263577267767a767e7b3972677639707861">[email protected]</span></a>

    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 5.1/6.1 file format or 
ASCII file format. All comments and data in electronic form must be 
identified by the docket control number [PF-809] and appropriate 
petition number. Electronic comments may be filed online at many 
Federal Depository Libraries.

List of Subjects

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

    Dated: June 2, 1998.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summary of the pesticide petition is printed below as 
required by section 408(d)(3) of the FFDCA. The summary of the petition 
was prepared by the petitioner and represents the views of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing them in any way.

Chemical Specialties, Inc.

PP 8F4959

     EPA has received a pesticide petition (PP 8F4959) from Chemical 
Specialties, Inc., One Woodlawn Green, Suite 250, Charlotte, N.C. 
28217, 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 to 
establish an exemption from the requirement of a tolerance for copper 
ammonium complex in or on all raw agricultural commodities when used in 
accordance with good agricultural

[[Page 32212]]

practice as an active ingredient in pesticide formulations applied to 
growing crops. 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 supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    1. Plant metabolism. No plant metabolism studies have been 
submitted in support of this tolerance exemption petition since copper 
ammonium complex forms, upon aqueous dilution, copper hydroxide. 
Accordingly, the actual plant residue is copper, which is an essential 
trace element critical for the propagation of plants.
    2. Analytical method. Since the petitioner has requested a 
tolerance exemption, a residue analytical method is not required.
    3. Magnitude of residues. No crop residue studies were conducted 
since copper is naturally found at significant levels ( > 1 ppm) in 
many different types of food. In addition, residue trials are not 
practical since it is very difficult to distinguish copper residues 
from naturally occurring copper versus copper residues from copper 
ammonium complex.

B. Toxicological Profile

     Acute toxicity. The acute oral LD<INF>50</INF> for a 31.4% 
solution of copper ammonium complex is approximately than 2,200 
milligrams/kilogram (mg/kg). Accordingly, copper ammonium complex is 
relatively non-toxic by the oral route.
    The petitioner has requested that the Agency waive all sub-chronic, 
chronic/oncogenicity, mutagenicity, developmental and reproductive 
toxicity study requirements for copper ammonium complex. The basis for 
this request is that the dietary residue is copper and the Agency has 
previously concluded (refer to the Toxicology Chapter for Group II 
Copper Compounds) that:
    1. Copper is essential for well-being in humans.
    2. Humans possess a natural efficient homeostatic mechanism for 
regulating copper body levels over a wide range of dietary intake.
    3. There is an overwhelming lack of evidence for any chronic 
effects induced by dietary ingestion of copper unless the intake is of 
such enormous magnitude that there is a disruption of the natural 
homeostatic mechanism for controlling body levels.

C. Aggregate Exposure

    1. Dietary exposure. Twelve 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). .
    2. Food. Copper is naturally found in several types of foods, such 
as fruits and vegetables, at levels ranging from 0.3-3.9 ppm.
    3. Drinking water. A 1987 EPA report noted that the average copper 
concentration in drinking water is approximately 130 ppb and a little 
over 1% of drinking water exceeds the Maximum Contaminant Level (MCL) 
of 1 ppm.
    4. Non-dietary exposure. Air concentrations of copper, based on 
several thousand samples assembled by EPA's Environmental Monitoring 
Systems Laboratory, ranges from 0.003-7.32 <greek-m>g/m<SUP>3</SUP>.
    Using the above exposure values, the petitioner estimates that the 
aggregate exposure to copper from food, drinking water and air ranges 
from < 1 to 3 mg/day. Consequently, the petitioner anticipates that the 
use of copper ammonium complex as a pre-harvest fungicide on 
established crops will, at most, make a negligible contribution to 
existing aggregate copper exposure.

D. Cumulative Effects

    No cumulative adverse effects are expected from long-term exposure 
to copper ammonium copper.

E. Safety Determination

    1. U.S. population. Several copper compounds, such as copper 
sulfate, are currently approved for use on food crops (40 CFR 
180.1001(b)(1). Since copper ammonium complex is a substitute for these 
copper compounds, and, under use-conditions, releases equivalent 
amounts of copper, approval of this petition will not increase dietary 
exposure to copper. Moreover, 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.
    2. Infants and children. Since copper is also an essential trace 
element for infants and children and the contribution to daily copper 
exposure from the use of copper ammonium complex is anticipated to be 
trivial, no adverse effects on infants or children are expected.

F. International Tolerances

    There are no approved CODEX maximum residue levels (MRLs) 
established for residues of copper ammonium complex.

[FR Doc. 98-15596 Filed 6-11-98; 8:45 am]
BILLING CODE 6560-50-F


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