Spinosad; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 41730-41735 [05-13977]
Download as PDF
<![CDATA[
41730
Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices
transformed by monoamine oxidases,
through a variety of pathways. These
include: deamination, methylation , Ndealkylation, N-oxidation, Nacetylation, cyclization, Nhydroxylation, and nitrosation.
7. Metabolite toxicology. Secondary
amines are prone to react with nitrite,
depending on the pH of the media, to
form nitrosamines, some of which are
potent animal carcinogens. Some
studies have suggested the possibility of
in vivo formation of carcinogenic
nitrosamines within the acidic
environment of the stomach following
ingestion of secondary amines. The
major human intake of nitrates (≈50 mg/
day) comes from vegetables, water
supplies, or additives in the meat and
fish curing process (Ellen et al. 1990.
Food Additives Contaminants 7(2) :207–
221). Nitrates are converted to nitrites in
the upper part of the gastrointestinal
tract by nitroreductase bacteria normally
present in the lower bowel.
Amines or amine precursors are
present in vegetables, wine, spirits, beer,
tea, fish, food flavoring agents, and
some drugs. As indicated above, at least
10 mg of amine nitrogen is excreted per
day; the intake of amines or their
precursors is therefore probably in the
100 mg/day range. Thus there exists the
required elements for the in vivo
formation of carcinogenic nitrosamines
from amine ingestion. Despite this
theoretical possibility, epidemiologic
studies have not provided evidence for
a causal association between nitrite
exposure and human cancer. Nor has a
causal link been shown between Nnitroso compounds preformed in the
diet or endogenously synthesized and
the incidence of human cancer
(Gangilli., S.D., 1999, ‘‘Nitrate, nitrite
and N-nitroso compounds’’, In
Ballintine, B., Marrs, T., and Turner, P.,
General and Applied Toxicology,
Stockton Press, New York, p. 2111,
2143). It has been demonstrated in
animals that nitrosation of diethylamine
and dimethyamine in vivo is a very slow
process. When these substances were
fed to rats together with nitrite for over
two years no tumors typical of treatment
of rats with nitrosodiethylamine were
observed Druckery et al, 1963 Cited by
Benya et al., Patty’s, 4th Ed. Vol II, Part
B , page 1097). In any event, the
addition to the diet of nanogram levels
of amines from the proposed used of
amine based surfactants is insignificant
compared to normal endogenous levels
and to those naturally occurring in food.
8. Endocrine disruption. There is no
evidence to suggest that the alkyl
amines have an effect on any endocrine
system. In developmental and twogeneration reproduction toxicity tests
VerDate jul<14>2003
14:24 Jul 19, 2005
Jkt 205001
systemic toxicity was noted but no
developmental or reproductive effects
were found.
compound is covered by the
assessments in this submission.
C. Aggregate Exposure
1. U.S. population. As a general rule
in any pesticide assessments, exposures
of children are the highest of any
subpopulation. This pattern was found
to hold true for the alkoxylated
surfactants and lead to simplifications
in the assessment procedure. When
exposures to children were found to be
acceptable, e.g., acute and chronic Tier
2 estimated dietary exposures to
children yielded large MOEs, separate
estimates for other subpopulations were
not deemed necessary. In the risk
assessment we ultimately have adopted
the dietary exposures for children for all
subpopulations. Exposures for females
13–49 were calculated in certain
instances and found to be comparable to
each other and less than for children.
Hence, exposure estimates for the latter
were not formally completed. Rather the
exposure numbers for females were
assumed for the full U.S. population.
2. Infants and children. Except when
using acute Tier 1 dietary exposure
estimates and the most conservative
toxicity endpoint, 3 mg/kg-bw/day, all
MOEs were found to be comfortably
greater than 100. Given the worst-case
conservatism built into all the analyses,
the results support a conclusion that
Tomah3’s alkoxylated surfactants may
be used safely in pesticide formulations
without concerns for dietary and nonoccupational exposures.
1. Dietary exposure. Exposure through
both food and drinking water were
estimated using data and methods more
commonly applied to pesticide active
ingredients. The methods for estimating
dietary exposure are discussed above
under residues. Drinking water
exposures were estimated using EPA’s
combined Pesticide Root Zone Model/
Exposure Assessment Modeling System
(PRZM/EXAMS) and the 1 ha pond
scenario.
i. Food. Both Tier 1 and Tier 2, acute
and chronic dietary assessments were
constructed in several different ways
and in general margin of exposures
(MOEs) >100 were found. Tier 1 acute
assessments did yield MOEs <100, but
the Tier 2 analysis gave an MOE = 1,500
for the lowest Tier 1 scenario.
ii. Drinking water. Using the average
peak value from PRZM/EXAMS
modeling for acute exposure, the
average 60–day concentration for
chronic exposure and the standard
estimates of water consumption, acute
and chronic margins of exposure for
drinking water all MOEs were greater
than 460. In using the model, maximum
application rates and number of
applications were assumed and the
alkoxylated surfactants were assumed
not to degrade in water or the
environment. The modeling provides an
extreme worst-case estimate of exposure
in that the peak values simulated
accumulation (i.e., no degradation) of
the surfactants in water during a 30
years period of application.
2. Non-dietary exposure. For nondietary exposure and risk analysis
outdoor lawn care with broadcast
application via hose-end sprayer was
selected as the worst case. Dermal
absorption was assumed to be 10%.
Applicators were assumed to have
dermal and inhalation exposures, while
re-entry exposures were dermal and
oral, the oral via hand-to-mouth
activities by children. MOE’s >100 were
estimated by Tier 1 analyses, indicating
reasonable certainty of no harm for the
worst-case bounding scenario evaluated.
D. Cumulative Effects
Other alkoxylated amine compounds
may be used in pesticide formulations.
However, the assessment of this class of
compounds assumes 100% of the
pesticide products applied to crops will
use one member of this class of
alkoxylated amines. Therefore, the
cumulative risk for this class of
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
E. Safety Determination
[FR Doc. 05–13978 Filed 7–19–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0180; FRL–7721–6]
Spinosad; Notice of Filing a Pesticide
Petition to Establish a Tolerance for a
Certain Pesticide Chemical in or on
Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
initial filing of pesticide petitions
proposing the establishment of
regulations for residues of a certain
pesticide chemical in or on various food
commodities.
DATES: Comments, identified by docket
identification (ID) number OPP–2005–
0180, must be received on or before
August 19, 2005.
ADDRESSES: Comments may be
submitted electronically, by mail, or
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• 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.
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 ID number OPP–2005–
0180. 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,
VerDate jul<14>2003
14:24 Jul 19, 2005
Jkt 205001
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.
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.1. 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 on 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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
41731
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 email 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
E:\FR\FM\20JYN1.SGM
20JYN1
41732
Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices
at https://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–2005–0180. 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–
2005–0180. 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–2005–0180.
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, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID
number OPP–2005–0180. 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
VerDate jul<14>2003
14:24 Jul 19, 2005
Jkt 205001
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 pesticide petitions
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
these petitions contain 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
these petitions.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 30, 2005.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Summary of Petition
The petitioner’s summary of the
pesticide petitions is printed below as
required by FFDCA section 408(d)(3).
The summary of the petitions was
prepared by the Interregional Research
Project Number 4, and represents the
view of the petitioner. The petition
summary 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.
Interregional Research Project Number
4
PP 3E6699, PP 3E6780, PP 3E6782, PP
3E6802, PP 3E6804, PP 4E6811
EPA has received pesticide petitions
(PP 3E6699, PP 3E6780, PP 3E6782, PP
3E6802, PP 3E6804, and PP 4E6811)
from Interregional Research Project
Number 4 (IR–4), 681 U.S. Highway #1
South, North Brunswick, NJ 08902–3390
proposing, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.495 by
establishing tolerances for residues of
spinosad in or on the following raw
agricultural commodities:
PP 3E6699 proposes to establish
tolerances for banana and plantain at
0.25 parts per million (ppm).
PP 3E6780 proposes to establish
tolerances for food commodities at 0.02
ppm.
PP 3E6782 proposes to establish
tolerances for spearmint, tops at 5.0
ppm and peppermint, tops at 5.0 ppm.
PP 3E6802 proposes to establish
tolerances for animal feed, nongrass,
group 18, forage at 20 ppm; animal feed,
nongrass, group 18 hay at 25 ppm; and
peanut, hay at 25 ppm.
PP 3E6804 proposes to establish
tolerances for vegetable, bulb, except
green onion, group 3 at 0.1 ppm and
onion, green at 2.0 ppm.
PP 4E6811 proposes to establish
tolerances for:
• Grass, forage, fodder and hay, group 17,
forage at 1.5 ppm.
• Grass, forage, fodder and hay, group 17,
hay at 5 ppm.
• Corn, field, stover; corn, pop, stover; and
corn, sweet, stover at 5.0 ppm.
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices
• Corn, field, forage; corn, sweet, forage;
and corn, pop, forage at 1.5 ppm.
• Teosinte, forage at 1.5 ppm.
• Millet, pearl, forage; and millet, proso,
forage at 1.5 ppm.
• Millet, pearl, hay; millet, proso, hay;
millet proso, straw at 5.0 ppm.
• Sorghum, forage, forage and sorghum,
grain, forage at 1.5 ppm.
• Sorghum, forage, hay; and sorghum,
grain, stover at 5.0 ppm.
• Wheat, forage at 1.5 ppm.
• Wheat, hay and wheat, straw at 5.0 ppm.
• Barley, straw and barley, hay at 5.0 ppm.
• Rye, forage at 1.5 ppm.
• Rye, straw at 5 ppm.
• Oat, forage at 1.5 ppm.
• Oat, hay and oat, straw at 5.0 ppm.
• Triticale, forage at 1.5 ppm.
• Triticale, hay and 5.0 ppm.
These petitions were prepared by
Dow AgroSciences LLC, Indianapolis
IN, 46268. EPA has determined that the
petitions contain data or information
regarding the elements set forth in
section 408(d)(2) of FFDCA; however,
EPA has not fully evaluated the
sufficiency of the submitted data at this
time or whether the data support
granting of the petitions. Additional
data may be needed before EPA rules on
the petitions.
A. Residue Chemistry
1. Plant metabolism. The nature of the
residue of spinosad in plants is
adequately understood for the purpose
of these tolerances. A rotational crop
study showed no carryover of
measurable spinosad related residues in
representative test crops.
2. Analytical method. There is a
practical method (immunoassay) for
detecting and measuring levels of
spinosad in or on food with a limit of
detection 0.005 ppm that allows
monitoring of food with residues at or
above the level set for these tolerances.
The method had undergone successful
EPA laboratory validation.
3. Magnitude of residues. Five field
trials were conducted for bananas and
showed residues of 0.02–0.20 ppm.
Three field trials were conducted for
mint and showed residues in mint tops
of 0.25–3.25 ppm. No residue was found
in mint oil. Three field trials were
conducted for onions (representative for
bulb vegetable, group 3). Residues were
1 ppm in onion, dry (bulb) and 2 ppm
in green onion. A magnitude of residue
study was conducted at 7 sites on grass.
Residues were 1.4–6.9 ppm for forage
and 0.57–4.2 ppm in hay. Residue data
generated from this study were used in
support of the proposed tolerances for
group 17 (grass forage, fodder and hay)
and group 16 (forage, fodder and straw
of cereal grains). A magnitude of residue
study was conducted at 5 sites each for
alfalfa and clover. Residues were 1.8–20
VerDate jul<14>2003
14:24 Jul 19, 2005
Jkt 205001
ppm in alfalfa forage and 1.6–5.3 ppm
in clover forage. In hay, residues were
0.7–24.8 ppm for alfalfa and 1.3–9.5
ppm for clover. Residue data generated
from this study were used in support of
the proposed tolerances for peanut hay
and group 18 (non-grass animal feeds,
forage, fodder, straw and hay).
B. Toxicological Profile
1. Acute toxicity. Spinosad has low
acute toxicity. The rat oral LD50 is 3,738
milligrams/kilogram (mg/kg) for males
and >5,000 mg/kg for females, whereas
the mouse oral LD50 is >5,000 mg/kg.
The rabbit dermal LD50 is >5,000 mg/kg
and the rat inhalation LC50 is >5.18 mg/
Liter (L) air. In addition, spinosad is not
a skin sensitizer in guinea pigs and does
not produce significant dermal or ocular
irritation in rabbits. End use
formulations of spinosad that are waterbased suspension concentrates have
similar low acute toxicity profiles.
2. Genotoxicty. Short-term assays for
genotoxicity consisting of a bacterial
reverse mutation assay (Ames test), and
in vitro assay for cytogenetic damage
using the Chinese hamster ovary cells,
an in vitro mammalian gene mutation
assay using lymphoma cells, an in vitro
assay for DNA damage and repair in rat
hepatocytes, and an in vivo cytogenetic
assay in the mouse bone marrow
(micronucleus test) have been
conducted with spinosad. These studies
show a lack of genotoxicity.
3. Reproductive and developmental
toxicity. Spinosad caused decreased
body weights in maternal rats given 200
mg/kg/day by gavage in a teratology
study (highest dose tested). This was not
accompanied by either embryotoxicity,
fetal toxicity, or teratogenicity. The noobserved-adverse-effect levels (NOAELs)
for maternal and fetal toxicity in rats
were 50 and 200 mg/kg/day,
respectively. A teratology study in
rabbits showed that spinosad caused
decreased body weight gain and a few
abortions in maternal rabbits given 50
mg/kg/day (highest dose tested).
Maternal toxicity was not accompanied
by either embryotoxicity, fetal toxicity,
or teratogenicity. The NOAELs for
maternal and fetal effects in rabbits were
10 and 50 mg/kg/day, respectively. In a
two-generation reproduction study in
rats, parental toxicity was observed in
both males and females given 100 mg/
kg/day (highest dose tested). Perinatal
effects (decreased litter size and pup
weight) at 100 mg/kg/day were
attributed to maternal toxicity. The
NOAEL for maternal and pup effects
was 10 mg/kg/day.
4. Subchronic toxicity. Spinosad was
evaluated in 13–week dietary studies
and showed NOAELs of 4.9 mg/kg/day
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
41733
in dogs, 6 mg/kg/day in mice, and 8.6
mg/kg/day in rats. No dermal irritation
or systemic toxicity occurred in a 21–
day repeated dose dermal toxicity study
in rabbits given 1,000 mg/kg/day.
5. Chronic toxicity. Based on chronic
testing with spinosad in the dog and the
rat, the EPA has set a reference dose
(RfD) of 0.027 mg/kg/day for spinosad.
The RfD has incorporated a 100-fold
safety factor to the NOAELs found in the
chronic dog study to account for
interspecies and intra-species variation.
The NOAELs in the chronic dog study
were 2.68 and 2.72 mg/kg/day
respectively, for male and female dogs.
The NOAELs (systemic) shown in the
rat chronic/carcinogenicity/
neurotoxicity study were 9.5 and 12.0
mg/kg/day, respectively for male and
female rats. Using the Guidelines for
Carcinogen Risk Assessment published
September 24, 1986 (51 FR 33992), it is
proposed that spinosad be classified as
Group E for carcinogenicity (no
evidence of carcinogenicity) based on
the results of carcinogenicity studies in
two species. There was no evidence of
carcinogenicity in an 18–month mouse
feeding study and a 24–month rat
feeding study at any dosages. The
NOAELs in the mouse oncogenicity
study were 11.4 and 13.8 mg/kg/day,
respectively for male and female mice.
A maximum tolerated dose was
achieved at the top dosage level in both
of these studies based on excessive
mortality. Thus, the doses tested are
adequate for identifying a cancer risk.
Accordingly, a cancer risk assessment
was not performed. Spinosad did not
cause neurotoxicity in rats in acute,
subchronic, or chronic toxicity studies.
6. Animal metabolism. There were no
major differences in the bioavailability,
routes or rates of excretion or
metabolism if spinosyn A and spinosyn
D following oral administration in rates.
Urine and fecal excretions were almost
completed in 48–hours post-dosing. In
addition, the routes and rates of
excretion were not affected by repeated
administration.
7. Metabolite toxicology. The residue
of concern for tolerance setting purposes
is the parent material (spinosyn A and
spinosyn D). Thus, there is no need to
address metabolite toxicity.
8. Endocrine disruption. There is no
evidence to suggest that spinosad has an
effect on any endocrine system.
C. Aggregate Exposure
1. Dietary exposure—i. Food. An
acute dietary exposure was not
performed because the Agency did not
identify an acute dietary endpoint that
was applicable to females (13+ years) or
to the general U.S. population,
E:\FR\FM\20JYN1.SGM
20JYN1
41734
Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices
including infants and children. EPA has
recently assessed the chronic dietary
exposure to spinosad on existing crop
uses and time-limited use on onions
(Federal Register of August 6, 2003, (68
FR 46491) (FRL–7317–3). In conducting
the chronic dietary assessment, EPA
used the Dietary Exposure Evaluation
Model-Trade Mark (DEEMTM) software
with the food commodity intake
database which incorporates food
consumption data as reported by
respondents in the U.S. Department of
Agriculture (USDA) 1989–1992
nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). The
chronic dietary analysis represents a
moderately refined estimate of dietary
exposure using percent crop treated
(PCT) estimates, anticipated residues for
meat and milk, and default processing
factors. EPA has concluded that
exposure to spinosad from food will
utilize 30% of the chronic population
adjusted dose (cPAD) for the general
U.S. population, 24% of the cPAD for
females 13–49 years old, and 69% of the
cPAD for children 1–2 years old, the
sub-population at greatest exposure.
When the calculated, anticipated
residues from the new crop uses
proposed in this notice are included in
the risk assessment dietary exposure
evaluation model food commodity
intake data base (DEEM-FCID), the
estimated exposure is increased by
approximately 5% for the U.S.
population, 4% for females 13–49 years
old, and 19% for children 1–2 years old.
Adverse effects are not expected for
exposures utilizing less than 100% of
the RfD, therefore, chronic dietary
exposure and risk for the general U.S.
population and children are well within
the acceptable levels.
ii. Drinking water. Since the Agency
lacks sufficient monitoring data to
complete a comprehensive exposure
and risk for spinosad in drinking water,
drinking water concentration estimates
are made on simulation taking into
account data on the physical
characteristics of spinosad.
Guidance from EPA has indicated that
Tier 1 screening level models, such as
the generic expected environmental
concentration (GENEEC) and the
screening concentration in ground water
(SCI-GROW), maybe used to estimate
upper-bound pesticide residues in
surface water and ground water when
assessing potential exposure through
drinking water. Estimated
environmental concentrations (EEC) of
cPAD milligrams/
kilogram/day (mg/
kg/day)
Population Subgroup
pesticide in surface water or ground
water are then compared to a drinking
water level of comparison (DWLOC).
DWLOC is not a regulatory standard for
drinking water but a theoretical upper
limit on a pesticide’s concentration in
drinking water in light of total aggregate
exposure to a pesticide in food and from
residential uses. DWLOC determines
how much of the acceptable exposure
(PAD) is available for exposure through
drinking water. In calculating DWLOC,
default values for body weights and
water consumption were used: 2L/70 kg
adult male, 2L/60 kg adult female, and
1L/10 kg child.
In a recent assessment, published in
the August 6, 2003 Federal Register,
EPA used the first index reservoir
screening tool (FIRST) and SCI-GROW
models to estimate the EECs of spinosad
in surface water and ground water. The
EECs for chronic exposures are
estimated to be 2.3 parts per billion
(ppb) in surface water and 0.037 ppb in
ground water.
As shown in the table in this unit, the
EECs in surface water and ground water
are substantially below the chronic
DWLOC, therefore, aggregate chronic
exposure is not expected to exceed
100% of the cPAD.
Surface Water
parts per billion
(ppb)
%cPAD
Ground Water ppb
DWLOC ppb
U.S. population
0.027
35
2.3
0.037
615
Children 1–2 years old
0.027
88
2.3
0.037
35
Females 13–49 years old
0.027
28
2.3
0.037
615
2. Non-dietary exposure. Spinosad is
also currently registered for outdoor use
on turf and ornamentals at low rates of
application 0.04–0.54 lb active
ingredient/Acre (a.i./A) that could result
in short-term residential exposure.
Intermediate-term residential exposure
is considered negligible because
residues on turf after 30 days were
insignificant. Since dermal postapplication exposure is not of concern
(no identified toxicological end-point),
only hand-to-mouth, object-to-mouth,
and incidental ingestion of soil
exposures for turf and ornamental uses
were considered for exposure. The
Agency has developed exposure
formulas and estimated doses to
theoretically assess residential
incidental oral exposure. The resulting
incidental oral ingestion margin of
exposures (MOEs) from the residential
use of spinosad calculated by the
Agency are all below EPA’s level of
concern. The combined incidental oral
VerDate jul<14>2003
14:24 Jul 19, 2005
Jkt 205001
MOE is 640, as published in the August
6, 2003 Federal Register.
D. Cumulative Effects
The potential for cumulative effects of
spinosad and other substances that have
a common mechanism of toxicity is also
considered. In terms of insect control,
spinosad causes excitation of the insect
nervous system, leading to involuntary
muscle contractions, prostration with
tremors, and finally paralysis. These
effects are consistent with the activation
of nicotinic acetylcholine receptors by a
mechanism that is clearly novel and
unique among known insecticidal
compounds. Spinosad also has effects
on the gamma aminobatopic acid
(GABA) receptor function that may
contribute further to its insecticidal
activity. Based on results found in tests
with various mammalian species,
spinosad appears to have a mechanism
of toxicity like that of many amphiphilic
cationic compounds. There is no
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
reliable information to indicate that
toxic effects produced by spinosad
would be cumulative with those of any
other pesticide chemical. Thus, it is
appropriate to consider only the
potential risks of spinosad in an
aggregate exposure assessment.
Spinosad is classified in a mechanismof-action group of its own for the
purpose of resistance management in
insects and for rotation with other crop
protection products.
E. Safety Determination
1. U.S. population. Chronic dietary
exposures for the general U.S.
population and females (13–49 years
old) to residues of spinosad from the
new uses proposed in this notice were
estimated to increase the recent EPA
risk estimate (see the August 6, 2003
Federal Register by approximately 5%
of the cPAD. After calculating the
chronic DWLOCs and comparing them
to the EECs for surface water and
E:\FR\FM\20JYN1.SGM
20JYN1
Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices
ground water, the aggregate exposure is
not expected to exceed 100% of the
cPAD. Additionally, all MOEs for shortterm risk are below the level of concern.
Thus, based on the completeness and
reliability of the toxicity data and the
moderately refined exposure
assessment, it is concluded that there is
a reasonable certainty that no harm will
result to the U.S. population from shortterm or chronic aggregate exposures to
spinosad residues from current and
proposed uses.
2. Infants and children. FFDCA
section 408 provides that EPA may
apply an additional safety factor for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base. Based on
the current toxicological data
requirements, the data base for spinosad
relative to prenatal and postnatal effects
for children is complete. Furthermore,
the NOAELs in the dog chronic feeding
study which were used to calculate the
RfD of 0.027 mg/kg/day are already
lower than the NOAELs from the
developmental studies in rats and
rabbits by a factor of more than 10–fold.
In the reproductive study in rats, the
pup effects shown at the highest dose
tested were attributed to the maternal
toxicity. Also, no neurotoxic signs have
been observed in any of the standard
required studies conducted. Therefore,
it is concluded that there is no
indication of increased sensitivity of
infants and children relative to adults
and that an additional Food Quality
Protection Act (FQPA) safety factor is
not required.
Chronic dietary exposure to residues
of spinosad from the new uses proposed
in this notice was estimated to increase
the EPA risk estimate by approximately
19% for children 1–2 years old, the
population subgroup predicted to be
most highly exposed. After calculating
the chronic DWLOCs and comparing
them to the EECs for surface water and
ground water, the aggregate exposure is
not expected to exceed 100% of the
cPAD.
Thus, based on the completeness and
reliability of the toxicity data and the
moderately refined exposure
assessment, it is concluded that there is
a reasonable certainty that no harm will
result to infants and children from
short-term and chronic aggregate
exposures to spinosad residues from
current and proposed uses.
several fruits and vegetables, as well as
animal commodities.
F. International Tolerances
In 2003, Codex Alimentarius
Commission adopted 29 new maximum
residue levels (MRLs) for spinosad and
included cotton, almonds, corn, and
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. 05–13862 Filed 7–19–05; 8:45 am]
VerDate jul<14>2003
18:38 Jul 19, 2005
Jkt 205001
[FR Doc. 05–13977 Filed 7–19–05; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
Public Information Collections
Approved by Office of Management
and Budget
July 5, 2005.
SUMMARY: The Federal Communications
Commission (FCC) has received Office
of Management and Budget (OMB)
approval for the following public
information collections pursuant to the
Paperwork Reduction Act of 1995,
Public Law 104–13. An agency may not
conduct or sponsor and a person is not
required to respond to a collection of
information unless it displays a
currently valid control number.
FOR FURTHER INFORMATION CONTACT:
Dana Jackson, Federal Communications
Commission, 445 12th Street, SW.,
Washington DC 20554, (202) 418–2247
or via the Internet at
Dana.Jackson@fcc.gov.
SUPPLEMENTARY INFORMATION:
OMB Control No.: 3060–0717.
OMB Approval date: 6/28/2005.
Expiration Date: 6/30/2008.
Title: Billed Party Preference for
InterLATA 0+ Calls, CC Docket No. 92–
77, 47 CFR 64.703(a), 64.709, and
64.710.
Form No.: N/A.
Estimated Annual Burden: 54,375,330
responses; 30 seconds to 50 hours
average per response; 477,185 hours.
Total Annual Cost: $216,150.
Needs and Uses: Pursuant to 47 CFR
64.703(a), Operator Service Providers
(OSPs) are required to disclose, audibly
and distinctly to the consumer, at no
charge and before connecting any
interstate call, how to obtain rate
quotations, including any applicable
surcharges. 47 CFR 64.709 codifies the
requirements for OSP’s to file
informational tariffs with the
Commission. 47 CFR 64.710, among
other things, requires providers of
interstate operator services to inmates at
correctional institutions to identify
themselves, audibly and distinctly, to
the party to be billed.
BILLING CODE 6712–01–P
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
41735
FEDERAL COMMUNICATIONS
COMMISSION
Public Information Collection
Approved By the Office of
Management and Budget
July 11, 2005.
SUMMARY: The Federal Communications
Commissions (FCC) has received Office
of Management and Budget (OMB)
approval for the following public
information collection pursuant to the
Paperwork Reduction Act of 1995
(PRA), Public Law 104–13, 109 Stat 163
(1995). An agency may not conduct or
sponsor a collection of information
unless it displays a currently valid
control number. Notwithstanding any
other provisions of law, no person shall
be subject to any penalty for failing to
comply with a collection of information
subject to the PRA that does not display
a valid control number.
FOR FURTHER INFORMATION CONTACT: For
additional information or questions
concerning the OMB control number
and expiration date should be directed
to Evan Baranoff, Kenneth Lewis or
Eloise Gore, Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC 20554, (202) 418–2120
or via the Internet to
Evan.Baranoff@fcc.gov,
Kenneth.Lewis@fcc.gov or
Eloise.Gore@fcc.gov.
OMB Control Number: 3060–0311.
OMB Approval Date: 5/25/05.
OMB Expiration Date: 5/31/08.
Title: 47 CFR 76.54, Significantly
Viewed Signals; Method to be followed
for Special Showings.
Form Number: Not applicable.
Respondents: Business or other forprofit entities.
Number of Respondents: 500.
Estimated Time Per Response: 1–15
hours.
Total Annual Burden: 20,610 hours.
Total Annual Costs: $200,000.
Needs and Uses: 47 CFR 76.54(b)
provides for cable operators and
broadcast stations seeking cable carriage
of ‘‘significantly viewed’’ signals to use
the Section 76.7 petition process to
demonstrate ‘‘significantly viewed’’
status on a community basis by
independent professional audience
surveys. The proposed rule changes, if
adopted, would require satellite carriers
or broadcast stations seeking satellite
carriage of ‘‘significantly viewed’’
signals to use the same petition process
now in place for cable operators, as
required by 47 CFR sections 76.5, 76.7
and 76.54 of the FCC’s rules.
47 CFR 76.54(c) is used to notify
interested parties, including licensees or
permittees of television broadcast
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 70, Number 138 (Wednesday, July 20, 2005)]
[Notices]
[Pages 41730-41735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13977]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0180; FRL-7721-6]
Spinosad; 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.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2005-0180, must be received on or before August 19, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
[[Page 41731]]
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
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.
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 ID number OPP-2005-0180. 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.
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.1.
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 on 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
[[Page 41732]]
at https://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-2005-0180. 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-2005-0180. 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-2005-0180.
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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2005-0180. 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 pesticide petitions 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 these petitions contain 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 these petitions.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: June 30, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petitions is printed
below as required by FFDCA section 408(d)(3). The summary of the
petitions was prepared by the Interregional Research Project Number 4,
and represents the view of the petitioner. The petition summary
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.
Interregional Research Project Number 4
PP 3E6699, PP 3E6780, PP 3E6782, PP 3E6802, PP 3E6804, PP 4E6811
EPA has received pesticide petitions (PP 3E6699, PP 3E6780, PP
3E6782, PP 3E6802, PP 3E6804, and PP 4E6811) from Interregional
Research Project Number 4 (IR-4), 681 U.S. Highway 1 South,
North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.495 by establishing tolerances for residues of
spinosad in or on the following raw agricultural commodities:
PP 3E6699 proposes to establish tolerances for banana and plantain
at 0.25 parts per million (ppm).
PP 3E6780 proposes to establish tolerances for food commodities at
0.02 ppm.
PP 3E6782 proposes to establish tolerances for spearmint, tops at
5.0 ppm and peppermint, tops at 5.0 ppm.
PP 3E6802 proposes to establish tolerances for animal feed,
nongrass, group 18, forage at 20 ppm; animal feed, nongrass, group 18
hay at 25 ppm; and peanut, hay at 25 ppm.
PP 3E6804 proposes to establish tolerances for vegetable, bulb,
except green onion, group 3 at 0.1 ppm and onion, green at 2.0 ppm.
PP 4E6811 proposes to establish tolerances for:
Grass, forage, fodder and hay, group 17, forage at 1.5
ppm.
Grass, forage, fodder and hay, group 17, hay at 5 ppm.
Corn, field, stover; corn, pop, stover; and corn,
sweet, stover at 5.0 ppm.
[[Page 41733]]
Corn, field, forage; corn, sweet, forage; and corn,
pop, forage at 1.5 ppm.
Teosinte, forage at 1.5 ppm.
Millet, pearl, forage; and millet, proso, forage at 1.5
ppm.
Millet, pearl, hay; millet, proso, hay; millet proso,
straw at 5.0 ppm.
Sorghum, forage, forage and sorghum, grain, forage at
1.5 ppm.
Sorghum, forage, hay; and sorghum, grain, stover at 5.0
ppm.
Wheat, forage at 1.5 ppm.
Wheat, hay and wheat, straw at 5.0 ppm.
Barley, straw and barley, hay at 5.0 ppm.
Rye, forage at 1.5 ppm.
Rye, straw at 5 ppm.
Oat, forage at 1.5 ppm.
Oat, hay and oat, straw at 5.0 ppm.
Triticale, forage at 1.5 ppm.
Triticale, hay and 5.0 ppm.
These petitions were prepared by Dow AgroSciences LLC,
Indianapolis IN, 46268. EPA has determined that the petitions contain
data or information regarding the elements set forth in section
408(d)(2) of FFDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
support granting of the petitions. Additional data may be needed before
EPA rules on the petitions.
A. Residue Chemistry
1. Plant metabolism. The nature of the residue of spinosad in
plants is adequately understood for the purpose of these tolerances. A
rotational crop study showed no carryover of measurable spinosad
related residues in representative test crops.
2. Analytical method. There is a practical method (immunoassay) for
detecting and measuring levels of spinosad in or on food with a limit
of detection 0.005 ppm that allows monitoring of food with residues at
or above the level set for these tolerances. The method had undergone
successful EPA laboratory validation.
3. Magnitude of residues. Five field trials were conducted for
bananas and showed residues of 0.02-0.20 ppm. Three field trials were
conducted for mint and showed residues in mint tops of 0.25-3.25 ppm.
No residue was found in mint oil. Three field trials were conducted for
onions (representative for bulb vegetable, group 3). Residues were 1
ppm in onion, dry (bulb) and 2 ppm in green onion. A magnitude of
residue study was conducted at 7 sites on grass. Residues were 1.4-6.9
ppm for forage and 0.57-4.2 ppm in hay. Residue data generated from
this study were used in support of the proposed tolerances for group 17
(grass forage, fodder and hay) and group 16 (forage, fodder and straw
of cereal grains). A magnitude of residue study was conducted at 5
sites each for alfalfa and clover. Residues were 1.8-20 ppm in alfalfa
forage and 1.6-5.3 ppm in clover forage. In hay, residues were 0.7-24.8
ppm for alfalfa and 1.3-9.5 ppm for clover. Residue data generated from
this study were used in support of the proposed tolerances for peanut
hay and group 18 (non-grass animal feeds, forage, fodder, straw and
hay).
B. Toxicological Profile
1. Acute toxicity. Spinosad has low acute toxicity. The rat oral
LD50 is 3,738 milligrams/kilogram (mg/kg) for males and
>5,000 mg/kg for females, whereas the mouse oral LD50 is
>5,000 mg/kg. The rabbit dermal LD50 is >5,000 mg/kg and the
rat inhalation LC50 is >5.18 mg/Liter (L) air. In addition,
spinosad is not a skin sensitizer in guinea pigs and does not produce
significant dermal or ocular irritation in rabbits. End use
formulations of spinosad that are water-based suspension concentrates
have similar low acute toxicity profiles.
2. Genotoxicty. Short-term assays for genotoxicity consisting of a
bacterial reverse mutation assay (Ames test), and in vitro assay for
cytogenetic damage using the Chinese hamster ovary cells, an in vitro
mammalian gene mutation assay using lymphoma cells, an in vitro assay
for DNA damage and repair in rat hepatocytes, and an in vivo
cytogenetic assay in the mouse bone marrow (micronucleus test) have
been conducted with spinosad. These studies show a lack of
genotoxicity.
3. Reproductive and developmental toxicity. Spinosad caused
decreased body weights in maternal rats given 200 mg/kg/day by gavage
in a teratology study (highest dose tested). This was not accompanied
by either embryotoxicity, fetal toxicity, or teratogenicity. The no-
observed-adverse-effect levels (NOAELs) for maternal and fetal toxicity
in rats were 50 and 200 mg/kg/day, respectively. A teratology study in
rabbits showed that spinosad caused decreased body weight gain and a
few abortions in maternal rabbits given 50 mg/kg/day (highest dose
tested). Maternal toxicity was not accompanied by either
embryotoxicity, fetal toxicity, or teratogenicity. The NOAELs for
maternal and fetal effects in rabbits were 10 and 50 mg/kg/day,
respectively. In a two-generation reproduction study in rats, parental
toxicity was observed in both males and females given 100 mg/kg/day
(highest dose tested). Perinatal effects (decreased litter size and pup
weight) at 100 mg/kg/day were attributed to maternal toxicity. The
NOAEL for maternal and pup effects was 10 mg/kg/day.
4. Subchronic toxicity. Spinosad was evaluated in 13-week dietary
studies and showed NOAELs of 4.9 mg/kg/day in dogs, 6 mg/kg/day in
mice, and 8.6 mg/kg/day in rats. No dermal irritation or systemic
toxicity occurred in a 21-day repeated dose dermal toxicity study in
rabbits given 1,000 mg/kg/day.
5. Chronic toxicity. Based on chronic testing with spinosad in the
dog and the rat, the EPA has set a reference dose (RfD) of 0.027 mg/kg/
day for spinosad. The RfD has incorporated a 100-fold safety factor to
the NOAELs found in the chronic dog study to account for interspecies
and intra-species variation. The NOAELs in the chronic dog study were
2.68 and 2.72 mg/kg/day respectively, for male and female dogs. The
NOAELs (systemic) shown in the rat chronic/carcinogenicity/
neurotoxicity study were 9.5 and 12.0 mg/kg/day, respectively for male
and female rats. Using the Guidelines for Carcinogen Risk Assessment
published September 24, 1986 (51 FR 33992), it is proposed that
spinosad be classified as Group E for carcinogenicity (no evidence of
carcinogenicity) based on the results of carcinogenicity studies in two
species. There was no evidence of carcinogenicity in an 18-month mouse
feeding study and a 24-month rat feeding study at any dosages. The
NOAELs in the mouse oncogenicity study were 11.4 and 13.8 mg/kg/day,
respectively for male and female mice. A maximum tolerated dose was
achieved at the top dosage level in both of these studies based on
excessive mortality. Thus, the doses tested are adequate for
identifying a cancer risk. Accordingly, a cancer risk assessment was
not performed. Spinosad did not cause neurotoxicity in rats in acute,
subchronic, or chronic toxicity studies.
6. Animal metabolism. There were no major differences in the
bioavailability, routes or rates of excretion or metabolism if spinosyn
A and spinosyn D following oral administration in rates. Urine and
fecal excretions were almost completed in 48-hours post-dosing. In
addition, the routes and rates of excretion were not affected by
repeated administration.
7. Metabolite toxicology. The residue of concern for tolerance
setting purposes is the parent material (spinosyn A and spinosyn D).
Thus, there is no need to address metabolite toxicity.
8. Endocrine disruption. There is no evidence to suggest that
spinosad has an effect on any endocrine system.
C. Aggregate Exposure
1. Dietary exposure--i. Food. An acute dietary exposure was not
performed because the Agency did not identify an acute dietary endpoint
that was applicable to females (13+ years) or to the general U.S.
population,
[[Page 41734]]
including infants and children. EPA has recently assessed the chronic
dietary exposure to spinosad on existing crop uses and time-limited use
on onions (Federal Register of August 6, 2003, (68 FR 46491) (FRL-7317-
3). In conducting the chronic dietary assessment, EPA used the Dietary
Exposure Evaluation Model-Trade Mark (DEEMTM) software with
the food commodity intake database which incorporates food consumption
data as reported by respondents in the U.S. Department of Agriculture
(USDA) 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). The chronic dietary analysis represents a
moderately refined estimate of dietary exposure using percent crop
treated (PCT) estimates, anticipated residues for meat and milk, and
default processing factors. EPA has concluded that exposure to spinosad
from food will utilize 30% of the chronic population adjusted dose
(cPAD) for the general U.S. population, 24% of the cPAD for females 13-
49 years old, and 69% of the cPAD for children 1-2 years old, the sub-
population at greatest exposure. When the calculated, anticipated
residues from the new crop uses proposed in this notice are included in
the risk assessment dietary exposure evaluation model food commodity
intake data base (DEEM-FCID), the estimated exposure is increased by
approximately 5% for the U.S. population, 4% for females 13-49 years
old, and 19% for children 1-2 years old. Adverse effects are not
expected for exposures utilizing less than 100% of the RfD, therefore,
chronic dietary exposure and risk for the general U.S. population and
children are well within the acceptable levels.
ii. Drinking water. Since the Agency lacks sufficient monitoring
data to complete a comprehensive exposure and risk for spinosad in
drinking water, drinking water concentration estimates are made on
simulation taking into account data on the physical characteristics of
spinosad.
Guidance from EPA has indicated that Tier 1 screening level
models, such as the generic expected environmental concentration
(GENEEC) and the screening concentration in ground water (SCI-GROW),
maybe used to estimate upper-bound pesticide residues in surface water
and ground water when assessing potential exposure through drinking
water. Estimated environmental concentrations (EEC) of pesticide in
surface water or ground water are then compared to a drinking water
level of comparison (DWLOC). DWLOC is not a regulatory standard for
drinking water but a theoretical upper limit on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and from residential uses. DWLOC determines how
much of the acceptable exposure (PAD) is available for exposure through
drinking water. In calculating DWLOC, default values for body weights
and water consumption were used: 2L/70 kg adult male, 2L/60 kg adult
female, and 1L/10 kg child.
In a recent assessment, published in the August 6, 2003 Federal
Register, EPA used the first index reservoir screening tool (FIRST) and
SCI-GROW models to estimate the EECs of spinosad in surface water and
ground water. The EECs for chronic exposures are estimated to be 2.3
parts per billion (ppb) in surface water and 0.037 ppb in ground water.
As shown in the table in this unit, the EECs in surface water and
ground water are substantially below the chronic DWLOC, therefore,
aggregate chronic exposure is not expected to exceed 100% of the cPAD.
--------------------------------------------------------------------------------------------------------------------------------------------------------
cPAD milligrams/ Surface Water
Population Subgroup kilogram/day (mg/ %cPAD parts per billion Ground Water ppb DWLOC ppb
kg/day) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.027 35 2.3 0.037 615
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 years old 0.027 88 2.3 0.037 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.027 28 2.3 0.037 615
--------------------------------------------------------------------------------------------------------------------------------------------------------
2. Non-dietary exposure. Spinosad is also currently registered for
outdoor use on turf and ornamentals at low rates of application 0.04-
0.54 lb active ingredient/Acre (a.i./A) that could result in short-term
residential exposure. Intermediate-term residential exposure is
considered negligible because residues on turf after 30 days were
insignificant. Since dermal post-application exposure is not of concern
(no identified toxicological end-point), only hand-to-mouth, object-to-
mouth, and incidental ingestion of soil exposures for turf and
ornamental uses were considered for exposure. The Agency has developed
exposure formulas and estimated doses to theoretically assess
residential incidental oral exposure. The resulting incidental oral
ingestion margin of exposures (MOEs) from the residential use of
spinosad calculated by the Agency are all below EPA's level of concern.
The combined incidental oral MOE is 640, as published in the August 6,
2003 Federal Register.
D. Cumulative Effects
The potential for cumulative effects of spinosad and other
substances that have a common mechanism of toxicity is also considered.
In terms of insect control, spinosad causes excitation of the insect
nervous system, leading to involuntary muscle contractions, prostration
with tremors, and finally paralysis. These effects are consistent with
the activation of nicotinic acetylcholine receptors by a mechanism that
is clearly novel and unique among known insecticidal compounds.
Spinosad also has effects on the gamma aminobatopic acid (GABA)
receptor function that may contribute further to its insecticidal
activity. Based on results found in tests with various mammalian
species, spinosad appears to have a mechanism of toxicity like that of
many amphiphilic cationic compounds. There is no reliable information
to indicate that toxic effects produced by spinosad would be cumulative
with those of any other pesticide chemical. Thus, it is appropriate to
consider only the potential risks of spinosad in an aggregate exposure
assessment. Spinosad is classified in a mechanism-of-action group of
its own for the purpose of resistance management in insects and for
rotation with other crop protection products.
E. Safety Determination
1. U.S. population. Chronic dietary exposures for the general U.S.
population and females (13-49 years old) to residues of spinosad from
the new uses proposed in this notice were estimated to increase the
recent EPA risk estimate (see the August 6, 2003 Federal Register by
approximately 5% of the cPAD. After calculating the chronic DWLOCs and
comparing them to the EECs for surface water and
[[Page 41735]]
ground water, the aggregate exposure is not expected to exceed 100% of
the cPAD. Additionally, all MOEs for short-term risk are below the
level of concern. Thus, based on the completeness and reliability of
the toxicity data and the moderately refined exposure assessment, it is
concluded that there is a reasonable certainty that no harm will result
to the U.S. population from short-term or chronic aggregate exposures
to spinosad residues from current and proposed uses.
2. Infants and children. FFDCA section 408 provides that EPA may
apply an additional safety factor for infants and children in the case
of threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base. Based on the current toxicological
data requirements, the data base for spinosad relative to prenatal and
postnatal effects for children is complete. Furthermore, the NOAELs in
the dog chronic feeding study which were used to calculate the RfD of
0.027 mg/kg/day are already lower than the NOAELs from the
developmental studies in rats and rabbits by a factor of more than 10-
fold. In the reproductive study in rats, the pup effects shown at the
highest dose tested were attributed to the maternal toxicity. Also, no
neurotoxic signs have been observed in any of the standard required
studies conducted. Therefore, it is concluded that there is no
indication of increased sensitivity of infants and children relative to
adults and that an additional Food Quality Protection Act (FQPA) safety
factor is not required.
Chronic dietary exposure to residues of spinosad from the new uses
proposed in this notice was estimated to increase the EPA risk estimate
by approximately 19% for children 1-2 years old, the population
subgroup predicted to be most highly exposed. After calculating the
chronic DWLOCs and comparing them to the EECs for surface water and
ground water, the aggregate exposure is not expected to exceed 100% of
the cPAD.
Thus, based on the completeness and reliability of the toxicity
data and the moderately refined exposure assessment, it is concluded
that there is a reasonable certainty that no harm will result to
infants and children from short-term and chronic aggregate exposures to
spinosad residues from current and proposed uses.
F. International Tolerances
In 2003, Codex Alimentarius Commission adopted 29 new maximum
residue levels (MRLs) for spinosad and included cotton, almonds, corn,
and several fruits and vegetables, as well as animal commodities.
[FR Doc. 05-13977 Filed 7-19-05; 8:45 am]
BILLING CODE 6560-50-S
