[Federal Register: March 12, 2003 (Volume 68, Number 48)]
[Notices]
[Page 11843-11846]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr03-91]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0055; FRL-7295-3]
Ultramarine Sodium Alumino Sulpho Silicate; Notice of Filing 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-2003-0055, must be
received on or before April 11, 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: Treva C. Alston, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8373; e-mail address:
alston.treva@epa.gov.
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 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
[[Page 11844]]
the person listed under FOR FURTHER INFORMATIONCONTACT.
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-2003-0055. 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
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-2003-0055. 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 opp-docket@epa.gov,
Attention: Docket ID number OPP-2003-0055. 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,
[[Page 11845]]
DC 20460-0001, Attention: Docket ID number OPP-2003-0055.
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-2003-0055. 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: February 28,2003.
Peter Caulkins,
Acting 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.
EPA has not fully evaluated the merits of the pesticide petition. 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. The summary of
the petition announces the availability of a description of the
analytical methods available to EPA for the detection and measurement
of the pesticide chemical residues or an explanation of why no such
method is needed.
Holliday Pigments Limited
PP 3E6549
EPA has received a pesticide petition (3E6549) from Holliday
Pigments Limited, Morley Street, Hull, East Yorkshire, England HU8 8DN
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 ultramarine (sodium alumino sulpho
silicate) when used as an inert ingredient as a dye in seed coatings.
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. Ultramarine is a synthetic form of the
naturally occurring semi-precious mineral Lapis Lazuli, which has been
mined, processed and used for decorative purposes for thousands of
years. It is a zeolitic mineral and is totally insoluble in water. As
such, it is not metabolized by plants. It is stable in neutral and
alkaline soils. Under acidic conditions it decomposes to give hydrogen
sulphide, which is evolved as a gas together with an insoluble, inert
clay-like residue, which will not be metabolized by plants.
2. Analytical method. Since this petition is for an exemption from
the requirement of a tolerance, an analytical method is not required.
3. Magnitude of residues. The proposed use for ultramarine is as a
seed coating to impart color for identification. It will not be
metabolized and will remain in the soil. There will therefore, be no
residues on the crop produced.
B. Toxicological Profile
The last of the following tests described was completed in 1981.
Holliday Pigments no longer carries out tests of any of their products
on animals nor do they subscribe to any form of animal testing.
1. Acute toxicity--i. Skin irritation. Albino rabbits were used for
a study of irritation producted by ultramarine contact with abraded and
intact skin. No irritation was found and no reactions were observed
throughout the study.
ii. Skin sensitization. Skin sensitization in the guinea pig was
studied using the maximization test of Magnusson and Kligman. No
visible reaction was exhibited by any animal in the test or control
group throughout the trials. The report concluded that there was no
evidence that ultramarine acts as a sensitizer in the guinea pig.
2. Genotoxicity. Bacterial toxicity and mutagenicity were studied
using two
[[Page 11846]]
strains each of Salmonella typhimurium and Escherichia coli. These
tests showed ultramarine to be non-toxic and non-mutagenic to the four
strains.
3. Reproductive and developmental toxicity. Female rats were fed
with diets containing up to 100,000 ppm ultramarine before and during
pregnancy. There were no maternal deaths and the test report concluded
that ultramarine had no teratogenic activity at levels from 100 to
100,000 ppm in the diet.
4. Subchronic toxicity--i. Fifteen--Day test. Ultramarine was
administered to male mice and female rats at increasing dose levels up
to the maximum that could be given in a single dose. No deaths were
observed in either species over a period of 15 days. The
LD50 is greater than 10,000 mg/kg (rats).
ii. Ninety-Day test. In feeding trials on rats and mice, after 90
days at levels of 100,000 part per million (ppm) in the diet the effect
of ultramarine was very much like that of inert clay with
(LD50) greater than 10,000 milligrams/kilograms (mg/kg).
5. Chronic toxicity. There are no reported studies on chronic
toxicity but ultramarine has a history of well over 100 years of safe
manufacture and use with no reports of ill effects of any kind. In the
early years of industrial production the work force was subjected to
conditions which would be totally unacceptable today. Large amounts of
fine ultramarine dust were inhaled and ingested without any reported
ill effects. In addition ultramarine was used as a whitening agent for
sugar in many parts of the world, again with no reported ill effects.
In Europe, the use of ultramarine in lipsticks has been permitted for
over 50 years. Its use at levels up to 0.5% for coloring cattle salt
licks where it is clearly ingested by the cattle, has been permitted
for many years. Ultramarine is also permitted world-wide for use in
toys and children's paints including powder and finger paints.
C. Aggregate Exposure
1. Dietary exposure. In the proposed use of ultramarine as a seed
coating it will not come into contact with the grown and harvested
crop. As ultramarine is insoluble, it will not be metabolized by the
plants grown from the treated seed. There is therefore no risk of
dietary exposure.
i. Food. For the reasons stated above there is no risk that food
produced from the treated seed will contain any ultramarine.
ii. Drinking water. As ultramarine and any of its decomposition
products are insoluble in water there is no danger of any leaching into
water courses used for production of drinking water.
2. Non-dietary exposure. The only anticipated human exposure to
ultramarine used for seed coating will be during the coating process
and any handling of the coated seed. Good practice should ensure
minimal contact and in any case there is no evidence of adverse health
effects from exposure to ultramarine during over 100 years of
production and use.
D. Cumulative Effects
As ultramarine and its decomposition products are totally insoluble
and not metabolized by plants or animals there is no risk of any
cumulative effect. Also, in the proposed end use there is no risk of
long term exposure to humans.
E. Safety Determination
1. U.S. population. The use of ultramarine as a seed coating does
not pose a safety concern for the U.S. population due to its non-
toxicity and the absence of exposure.
2. Infants and children. Infants and children will not be exposed
to ultramarine from its use in seed coating applications. In any case,
ultramarine is permitted in the United States and world-wide for use in
children's toys, modeling clay, and finger paints.
F. International Tolerances
There is no listed threshold limit value or maximum exposure limit
for ultramarine. Normal practice is to consider it as a nuisance dust
with threshold limit value (TLV) 10 mg/m3. The pigment is
not listed as a dangerous substance in the European Community or any
similar national or international classification; neither is it
classified as hazardous for disposal.
[FR Doc. 03-5751 Filed 3-11-03; 8:45 am]
BILLING CODE 6560-50-S