Bacillus Thuringiensis VIP3A Insect Control Protein and the Genetic Material Necessary for its Production; Notice of Filing a Pesticide Petition to Amend an Exemption from the Requirement of a Tolerance for a Certain Pesticide Chemical in or on Food; Correction, 12879-12880 [05-5212]
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Federal Register / Vol. 70, No. 50 / Wednesday, March 16, 2005 / Notices
using Monte Carlo modeling for
commodities that may be consumed in
a single serving. These assessments
show that the percent acute Population
Adjusted Dose (%aPAD) all fall below
the EPA’s level of concern (≥100%). The
95th percentile of exposure for the
overall U. S. population was estimated
to be 0.001177 mg/kg/day (%aRfD of
1.2); 99th percentile 0.003307 mg/kg/
day (%aRfD of 3.3); and 99.9th
percentile 0.012692 mg/kg/day (%aRfD
of 12.7). The 95th percentile of exposure
for all infants <1 year old was estimated
to be 0.002441 mg/kg/day (%aRfD of
2.4); 99th percentile 0.011178 mg/kg/
day (%aRfD of 11.2); and 99.9th
percentile 0.029462 mg/kg/day (%aRfD
of 29.5). The 95th percentile of exposure
for nursing infants <1 year old was
estimated to be 0.001247 mg/kg/day
(%aRfD of 1.3); 99th percentile 0.004540
mg/kg/day (%aRfD of 4.5); and 99.9th
percentile 0.011659 mg/kg/day (%aRfD
of 11.7). The 95th percentile of exposure
for non-nursing infants <1 year old (the
most highly exposed population
subgroup) was estimated to be 0.002786
mg/kg/day (%aRfD of 2.8); 99th
percentile 0.012899 mg/kg/day (%aRfD
of 12.9); and 99.9th percentile 0.033071
mg/kg/day (%aRfD of 33.1). The 95th
percentile of exposure for children 1 to
6 years old and children 7 to 12 years
old was estimated to be, respectively,
0.001942 mg/kg/day (%aRfD of 1.9) and
0.001244 mg/kg/day (%aRfD of 1.2);
99th percentile 0.005670 mg/kg/day
(%aRfD of 5.7) and 0.003082 (%aRfD of
3.1); and 99.9th percentile 0.018280 mg/
kg/day (%aRfD of 18.3) and 0.009335
(%aRfD of 9.3). The 95th percentile of
exposure for females (13+/nursing) was
estimated to be 0.001128 mg/kg/day
(%aRfD of 1.1); 99th percentile 0.003112
mg/kg/day (%aRfD of 3.1); and 99.9th
percentile 0.012903 mg/kg/day (%aRfD
of 12.9). Therefore, FMC concludes that
the acute dietary risk of zetacypermethrin, as estimated by the
dietary risk assessment, does not appear
to be of concern.
2. Infants and children— i. General.
In assessing the potential for additional
sensitivity of infants and children to
residues of zeta-cypermethrin, FMC
considered data from developmental
toxicity studies in the rat and rabbit,
and a two-generation reproductive study
in the rat. The data demonstrated no
indication of increased sensitivity of
rats to zeta-cypermethrin or rabbits to
cypermethrin in utero and/or postnatal
exposure to zeta-cypermethrin or
cypermethrin. The developmental
toxicity studies are designed to evaluate
adverse effects on the developing
organism resulting from pesticide
VerDate jul<14>2003
16:45 Mar 15, 2005
Jkt 205001
exposure during prenatal development
to one or both parents. Reproduction
studies provide information relating to
effects from exposure to the pesticide on
the reproductiveility of mating animals
and data on systemic toxicity. FFDCA
section 408 provides that EPA may
apply an additional margin of safety for
infants and children in the case of
thresholdeffects to account for pre- and
post-natal toxicity and the completeness
of the database.
ii. Developmental toxicity studies. In
the prenatal developmental toxicity
studies in rats and rabbits, there was no
evidence of developmental toxicity at
the highest doses tested (35.0 mg/kg/day
in rats and 700 mg/kg/day in rabbits).
Decreased body weight gain was
observed at the maternal LOEL in each
study; the maternal NOEL was
established at 12.5 mg/kg/day in rats
and 100 mg/kg/day in rabbits.
iii. Reproductive toxicity study. In the
two-generation reproduction study in
rats, offspring toxicity (body weight)
and parental toxicity (body weight,
organ weight, and clinical signs) was
observed at 27.0 mg/kg/day and greater.
The parental systemic NOEL as 7.0 mg/
kg/day and the parental systemic LOEL
was 27.0 mg/kg/day. There were no
developmental (pup) or reproductive
effects up to 45.0 mg/kg/day, highest
dose tested.
iv. Pre- and post-natal sensitivity— a.
Pre-natal. There was no evidence of
developmental toxicity in the studies at
the highest doses tested in the rat (70.0
mg/kg/day) or in the rabbit (700 mg/kg/
day). Therefore, there is no evidence of
a special dietary risk (either acute or
chronic) for infants and children which
wouldrequire an additional safety
factor.
b. Post-natal. Based on the absence of
pup toxicity up to dose levels which
produced toxicity in the parental
animals, there is no evidence of special
post-natal sensitivity to infants and
children in the rat reproduction study.
3. Conclusion
Based on the above, FMC concludes
that reliable data support use of the
standard 100-fold uncertainty factor,
and that an additional uncertainty factor
is not needed to protect the safety of
infants and children. As stated above,
aggregate exposure assessments utilized
significantly less than 1 percent of the
RfD for either the entire U. S.
population or any of the 26 population
subgroups including infants and
children. Therefore, it may be
concluded that there is reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to cypermethrin residues.
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12879
4. International Tolerances
There are no Canadian, or Mexican
residue limits for residues of
cypermethrin or zeta-cypermethrin in or
on all food/feed items (other than those
covered by a higher tolerance as a result
of use on growing crops) in food/feed
handling establishments.
[FR Doc. 05–5214 Filed 3–15–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0052; FRL–7703–3]
Bacillus Thuringiensis VIP3A Insect
Control Protein and the Genetic
Material Necessary for its Production;
Notice of Filing a Pesticide Petition to
Amend an Exemption from the
Requirement of a Tolerance for a
Certain Pesticide Chemical in or on
Food; Correction
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces a
correction to the Notice of Filing of a
pesticide petition proposing an
amendment to an existing exemption
from the requirement of a tolerance for
residues of a certain pesticide chemical
in or on various food commodities.
DATES: Comments, identified by docket
identification (ID) number OPP–2005–
0052, must be received on or before
April 15, 2005.
ADDRESSES: Comments may be
submitted electronically, by mail, or
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I.C. of the SUPPLEMENTARY
INFORMATION of the September 15, 2004,
Federal Register Notice.
FOR FURTHER INFORMATION CONTACT:
Sharlene Matten, Biopesticides and
Pollution Prevention Division (7511C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 605–0514; e-mail address:
matten.sharlene@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
The Agency included in the
September 15, 2004, Notice of Filing a
list of those who may be potentially
affected by the action. If you have any
questions regarding the applicability of
this action to a particular entity, consult
E:\FR\FM\16MRN1.SGM
16MRN1
12880
Federal Register / Vol. 70, No. 50 / Wednesday, March 16, 2005 / Notices
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Copies of this
Document and Other Related
Information?
In addition to using EDOCKET (http:/
/www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings
athttps://www.epa.gov/fedrgstr/.
II. Background
On July 26, 2004, Syngenta Seeds,
3054 Cornwallis Road, Research
Triangle Park, NC 27709–2257
submitted a petition (PP 3G6547) to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA), requesting that the temporary
tolerance exemption for Bacillus
thuringiensis VIP3A protein and the
genetic material necessary for its
production in cotton found at 40 CFR
180.1247 be amended to include all
VIP3A events. As it turns out, however,
this particular request was unnecessary
as the temporary tolerance exemption
found at 40 CFR 180.1247 already
includes all VIP3A events. In a
subsequent letter dated July 29, 2004,
Syngenta Seeds also petitioned the
Agency to amend the temporary
tolerance exemption found at 40 CFR
180.1247 by extending it from May 1,
2005 to May 1, 2006.
On September 15, 2004, EPA
published a Notice in the Federal
Register (69 FR 55605, FRL–7675–1)
announcing the filing of the Syngenta
Seeds petition. This Notice of Filing,
however, was incorrect in two respects.
First, it reiterated in summary fashion
Syngenta Seeds request that the
temporary tolerance exemption found at
40 CFR 180.1247 be amended to include
all VIP3A events. As noted above, this
was unnecessary since that temporary
tolerance exemption already includes
all VIP3A events. Second, the Notice
failed to include Syngenta Seeds’
petition to extend the approved time
frame for the temporary exemption.
III. What Does this Correction Do?
The purpose of this document,
therefore, is to clarify that pesticide
petition 3G6547 from Syngenta Seeds,
as summarized and presented in the
Agency’s September 15, 2004, Notice of
Filing, is solely a proposal to amend the
temporary tolerance exemption found at
40 CFR 180.1247 by extending it from
May 1, 2005 to May 1, 2006. To the
extent there is any language in that
Notice of Filing discussing or alluding
to Syngenta Seeds’ request to make that
VerDate jul<14>2003
16:45 Mar 15, 2005
Jkt 205001
temporary tolerance exemption nonevent specific, that language is to be
disregarded. All the other information
contained in that September 15, 2004,
Notice of Filing, however, is intended to
support Syngenta Seeds’ request to
extend the time frame of the subject
temporary tolerance exemption.
As noted elsewhere in this document,
EPA is providing an additional 30 days
for parties to comment on Syngenta
Seeds’ petition as corrected via this
document. Any comments received in
response to this document or the
original Notice of Filing dated
September 15, 2004, will be addressed
in any Final Rule issued by the Agency
concerning this matter.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 7, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. 05–5212 Filed 3–15–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0051; FRL–7702–8]
Issuance of an Experimental Use
Permit
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: EPA has granted an
experimental use permit (EUP) to the
following pesticide applicant. An EUP
permits use of a pesticide for
experimental or research purposes only
in accordance with the limitations in
the permit.
FOR FURTHER INFORMATION CONTACT:
Sharlene R. Matten, Biopesticides and
Pollution Prevention Division (7511C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 605–0514; e-mail address:
matten.sharlene@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. Although this action may be
of particular interest to those persons
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
who conduct or sponsor research on
pesticides, the Agency has not
attempted to describe all the specific
entities that may be affected by this
action. If you have any questions
regarding the information in this action,
consult the person listed under FOR
FURTHER INFORMATION CONTACT.
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–2005–0051. 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, 1801 S. Bell St.,
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
https://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 https://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.
II. EUP
EPA has issued the following EUP:
67979–EUP–5. Issuance. Syngenta
Seeds, 3054 Cornwallis Road, Research
Triangle Park, NC 27709–2257. This
EUP allows the use of 0.14 pounds of
the insecticide Vip3A insect control
protein as expressed in Events COT 202
and COT 203-derived cotton plants on
467 acres of cotton to evaluate the
control of various lepidopteran insect
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 70, Number 50 (Wednesday, March 16, 2005)]
[Notices]
[Pages 12879-12880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5212]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0052; FRL-7703-3]
Bacillus Thuringiensis VIP3A Insect Control Protein and the
Genetic Material Necessary for its Production; Notice of Filing a
Pesticide Petition to Amend an Exemption from the Requirement of a
Tolerance for a Certain Pesticide Chemical in or on Food; Correction
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a correction to the Notice of Filing of
a pesticide petition proposing an amendment to an existing exemption
from the requirement of a tolerance for residues of a certain pesticide
chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2005-0052, must be received on or before April 15, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION of the September
15, 2004, Federal Register Notice.
FOR FURTHER INFORMATION CONTACT: Sharlene Matten, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 605-0514; e-mail
address: matten.sharlene@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
The Agency included in the September 15, 2004, Notice of Filing a
list of those who may be potentially affected by the action. If you
have any questions regarding the applicability of this action to a
particular entity, consult
[[Page 12880]]
the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings athttps://www.epa.gov/
fedrgstr/.
II. Background
On July 26, 2004, Syngenta Seeds, 3054 Cornwallis Road, Research
Triangle Park, NC 27709-2257 submitted a petition (PP 3G6547) to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA), requesting that the
temporary tolerance exemption for Bacillus thuringiensis VIP3A protein
and the genetic material necessary for its production in cotton found
at 40 CFR 180.1247 be amended to include all VIP3A events. As it turns
out, however, this particular request was unnecessary as the temporary
tolerance exemption found at 40 CFR 180.1247 already includes all VIP3A
events. In a subsequent letter dated July 29, 2004, Syngenta Seeds also
petitioned the Agency to amend the temporary tolerance exemption found
at 40 CFR 180.1247 by extending it from May 1, 2005 to May 1, 2006.
On September 15, 2004, EPA published a Notice in the Federal
Register (69 FR 55605, FRL-7675-1) announcing the filing of the
Syngenta Seeds petition. This Notice of Filing, however, was incorrect
in two respects. First, it reiterated in summary fashion Syngenta Seeds
request that the temporary tolerance exemption found at 40 CFR 180.1247
be amended to include all VIP3A events. As noted above, this was
unnecessary since that temporary tolerance exemption already includes
all VIP3A events. Second, the Notice failed to include Syngenta Seeds'
petition to extend the approved time frame for the temporary exemption.
III. What Does this Correction Do?
The purpose of this document, therefore, is to clarify that
pesticide petition 3G6547 from Syngenta Seeds, as summarized and
presented in the Agency's September 15, 2004, Notice of Filing, is
solely a proposal to amend the temporary tolerance exemption found at
40 CFR 180.1247 by extending it from May 1, 2005 to May 1, 2006. To the
extent there is any language in that Notice of Filing discussing or
alluding to Syngenta Seeds' request to make that temporary tolerance
exemption non-event specific, that language is to be disregarded. All
the other information contained in that September 15, 2004, Notice of
Filing, however, is intended to support Syngenta Seeds' request to
extend the time frame of the subject temporary tolerance exemption.
As noted elsewhere in this document, EPA is providing an additional
30 days for parties to comment on Syngenta Seeds' petition as corrected
via this document. Any comments received in response to this document
or the original Notice of Filing dated September 15, 2004, will be
addressed in any Final Rule issued by the Agency concerning this
matter.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: March 7, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 05-5212 Filed 3-15-05; 8:45 am]
BILLING CODE 6560-50-S
