[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:
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Office location/
Product Manager telephone number Address
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Cynthia Giles-Parker.......... Rm. 247, CM #2, 703- 1921 Jefferson
305-7740, e-mail: Davis Hwy,
giles- Arlington, VA
parker.cynthia@epamai
l.epa.gov.
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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:
[email protected]
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 LD50 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 g/m3.
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