Paraquat Dichloride; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 37397-37403 [05-12445]
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iii. Aggregate exposure (diet + water).
The estimated chronic aggregate
exposure of imazethapyr from potential
residues in food and water are
summarized in Table 3 as follows.
Imazethapyr is not registered for
residential use and therefore residential
exposure was not considered.
TABLE 3. — ESTIMATED CHRONIC AGGREGATE EXPOSURE FROM THE USE OF IMAZETHAPYR
Aggregate Exposure2
(mg/kg/day)
Chronic Food Exposure (mg/kg/day)
Chronic Drinking Water
Exposure1 (mg/kg/day)
U.S. Population
0.000476
0.003600
0.004076
0.16
Infants (< 1 year old)
0.000693
0.012600
0.013293
0.53
Children (1-6 years
old)
0.000937
0.012600
0.013537
0.54
Females (13-49
years old)
0.000379
0.004000
0.004379
0.18
Adults (20-49 years
old)
0.000424
0.003600
0.004024
0.16
Population Subgroup
1
2
Aggregate %cPAD
Aggregate Exposure = Food Exposure + Drinking Water Exposure
Drinking Water Exposure (mg/kg/day) = [Drinking Water Concentration (µg/L) * Water Consumed (L/day)/ Body weight (kg)]/1,000
The assessment results indicate the
aggregate exposure of imazethapyr from
potential residues in food and drinking
water will not exceed the U.S. EPA’s
level of concern (100% of PAD). The
percent chronic PAD was <1% for all
subpopulations. Additional refinements
such as the use of anticipated residues
and predicted percent crop treated
would further reduce the estimated
chronic dietary exposure and %cPAD.
Overall, considering a ‘‘worst-case’’
scenario, we can conclude with
reasonable certainty that no harm will
occur from chronic aggregate exposure
of imazethapyr residues from the
current crops, including the higher
proposed tolerance values.
2. Non-dietary exposure . Imazethapyr
products are not currently registered for
requested to be registered for residential
use; therefore the estimate of residential
exposure is not relevant to this tolerance
petition.
D. Cumulative Effects
Imazethapyr is a member of the
imidazolinone class of herbicides. Other
compounds of this class are registered
for use in the United States However,
the herbicidal activity of the
imidazolinones is due to the inhibition
of acetohydroxyacid synthase (AHAS),
an enzyme only found in plants. AHAS
is part of the biosynthetic pathway
leading to the formation of branched
chain amino acids. Animals lack AHAS
and this biosynthetic pathway. This lack
of AHAS contributes to the low toxicity
of the imidazolinone compounds in
animals. We are aware of no information
to indicate or suggest that imazethapyr
has any toxic effects on mammals that
would be cumulative with those of any
other chemical. Therefore, for the
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purposes of this tolerance petition no
assumption has been made with regard
to cumulative exposure with other
compounds having a common mode of
action.
E. Safety Determination
1. U.S. population. Using the
conservative exposure assumptions
described above and based on the
completeness and the reliability of the
toxicity data, BASF has estimated the
aggregate exposure to imazethapyr will
utilize less than 1% of the cPAD for the
U.S. population and all subpopulations,
respectively.
2. Infants and children. All
subpopulations based on age were
considered. Infants and children
remained below 1% of the aggregate
cPAD for food and water. BASF,
considering a worst-case situation,
concludes with reasonable certainty that
no harm will result to infants or
children from aggregate exposure to
imazethapyr residues.
No additional FQPA safety factor(s)
are considered to be appropriate for
imazethapyr. There is a complete
toxicity database for imazethapyr and
the exposure data are complete or are
estimated based on data that reasonably
accounts for potential exposures. Based
on the toxicology data and conclusions,
a FQPA safety factor of 1X appears to be
appropriate for imazethapyr.
F. International Tolerances
There are no Codex maximum residue
levels established or proposed for
residues of imazethapyr on rice.
[FR Doc. 05–12444 Filed 6–28–05; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0033; FRL–7718–8]
Paraquat Dichloride; Notice of Filing a
Pesticide Petition to Establish a
Tolerance for a Certain Pesticide
Chemical in or on Food
Environmental Potection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
initial filing of a pesticide petition
proposing the establishment of
regulations for residues of a certain
pesticide chemical in or on various food
commodities.
DATES: Comments, identified by docket
identification (ID) number OPP–2005–
0033, must be received on or before July
29, 2005.
ADDRESSES: Comments may be
submitted electronically, by mail, or
through hand delivery/courier. Follow
the detailed instructions as provided in
Unit I of the SUPPLEMENTARY
INFORMATION.
Jim
Tompkins, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone
number:(703) 305–5697; e-mail address:
tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
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pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS
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–
0033. 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
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the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
Certain types of information will not
be placed in the EPA Dockets.
Information claimed as CBI and other
information whose disclosure is
restricted by statute, which is not
included in the official public docket,
will not be available for public viewing
in EPA’s electronic public docket. EPA’s
policy is that copyrighted material will
not be placed in EPA’s electronic public
docket but will be available only in
printed, paper form in the official public
docket. To the extent feasible, publicly
available docket materials will be made
available in EPA’s electronic public
docket. When a document is selected
from the index list in EPA Dockets, the
system will identify whether the
document is available for viewing in
EPA’s electronic public docket.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B. EPA
intends to work toward providing
electronic access to all of the publicly
available docket materials through
EPA’s electronic public docket.
For public commenters, it is
important to note that EPA’s policy is
that public comments, whether
submitted electronically or in paper,
will be made available for public
viewing in EPA’s electronic public
docket as EPA receives them and
without change, unless the comment
contains copyrighted material, CBI, or
other information whose disclosure is
restricted by statute. When EPA
identifies a comment containing
copyrighted material, EPA will provide
a reference to that material in the
version of the comment that is placed in
EPA’s electronic public docket. The
entire printed comment, including the
copyrighted material, will be available
in the public docket.
Public comments submitted on
computer disks that are mailed or
delivered to the docket will be
transferred to EPA’s electronic public
docket. Public comments that are
mailed or delivered to the docket will be
scanned and placed in EPA’s electronic
public docket. Where practical, physical
objects will be photographed, and the
photograph will be placed in EPA’s
electronic public docket along with a
brief description written by the docket
staff.
C. How and To Whom Do I Submit
Comments?
You may submit comments
electronically, by mail, or through hand
delivery/courier. To ensure proper
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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
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–2005–0033. 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–
2005–0033. 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
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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–2005–0033.
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–2005–0033. 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.
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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 a potential burden
or costs, explain how you arrived at the
estimate that you provide.
5. Provide specific examples to
illustrate your concerns.
6. Make sure to submit your
comments by the deadline in this
notice.
7. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition
as follows proposing the establishment
and/or amendment of regulations for
residues of a certain pesticide chemical
in or on various food commodities
under section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a. EPA has determined that
this petition contains data or
information regarding the elements set
forth in FFDCA section 408(d)(2);
however, EPA has not fully evaluated
the sufficiency of the submitted data at
this time or whether the data support
granting of the petition. Additional data
may be needed before EPA rules on the
petition.
List of Subjects
Environmental protection,
Agricultural commodities, Feed
additives, Food additives, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 10, 2005.
Betty Shackleford,
Acting Director, Registration Division, Office
of Pesticide Programs.
Summary of Petition
The petitioner summary of the
pesticide petition is printed below as
required by FFDCA section 408(d)(3).
The summary of the petition was
prepared by the petitioner and
represents the view of the petitioner.
The petition summary announces the
availability of a description of the
analytical methods available to EPA for
the detection and measurement of the
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37399
pesticide chemical residues or an
explanation of why no such method is
needed.
Syngenta Crop Protection, Inc.
PP 2F6433 , 3E 6763, 1E 6332, 1E 6319,
1E 6223
EPA has received pesticide petitions
(2F6433, 3E6763, 1E6332, 1E6319, and
1E6223) from Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC
27419–8300 and Interregional Research
Project#4 (IR4), 681 US Highway #1
South, New 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 by establishing
a tolerance for residues of paraquat
dichloride in or on the raw agricultural
commodities: cotton, seed at 5.0 parts
per million (ppm); cotton gin
byproducts at 82.0 ppm; soybean, seed
at 0.70 ppm; soybean, forage at 0.40
ppm; soybean, hay at 6.0 ppm; soybean,
aspirated grain fractions at 60.0 ppm;
wheat, grain at 1.5 ppm; wheat, forage
at 0.40 ppm; wheat, hay at 3.0 ppm;
wheat, straw at 40.0 ppm; wheat,
aspirated grain fractions at 65.0 ppm;
barley, hay at 3.0 ppm; vegetable,
brassica leafy, group at 0.05 ppm; fruit,
pome, group at 0.05 ppm; fruit, stone,
group at 0.05 ppm; berry group at 0.05
ppm; animal feed, nongrass, group at 5.0
ppm; vegetable, legume, edible-podded,
subgroup at 0.05 ppm; pea and bean,
succulent, shelled, subgroup at 0.05
ppm; pea and bean, dried, shelled,
except soybean, subgroup at 0.3 ppm;
grape at 0.05 ppm; cranberry at 0.05
ppm; barley, straw at 1.0 ppm; beet,
sugar, tops at 0.05 ppm; sorghum, forage
at 0.1 ppm; hops, cone, dry at 0.5 ppm;
cattle, kidney at 0.3 ppm; goat, kidney
at 0.3 ppm; hog, kidney at 0.3 ppm;
horse, kidney at 0.3 ppm; sheep, kidney
at 0.3 ppm; vegetable, fruiting, group at
0.05 ppm; vegetable, cucurbit, group at
0.05 ppm; nut, tree, group at 0.05 ppm;
ginger at 0.1 ppm, okra at 0.05 ppm,
tanier at 0.05 ppm, and onion (dry bulb)
at 0.1 ppm.. EPA has determined that
the petition contains data or information
regarding the elements set forth in
section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated
the sufficiency of the submitted data at
this time or whether the data supports
granting of the petition. Additional data
may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant metabolism. The qualitative
nature of the residue in plants is
adequately understood based on studies
depicting the metabolism of paraquat
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dichloride in carrots and lettuce
following preemergence treatments and
in potatoes and soybeans following
desiccant treatment. The residue of
concern in plants is the parent, paraquat
dichloride; the current tolerance
expression for plant commodities, as
defined in 40 CFR 180.205(a) and (b).
2. Analytical method. An adequate
analytical method (spectrometric
method) has been accepted and
published in The Pesticide Analytical
Manual (PAM Vol. II) for the
enforcement of tolerances in plant
commodities.
3. Magnitude of residues—i. Cotton.
As required under reregistration,
residue studies (MRID No. 44432402)
were conducted to determine the levels
of paraquat cation on ginned cotton seed
and cotton byproducts. Twelve residue
field trials were conducted during 1995
in the United States. This data reflects
a use pattern of a total of 3 lbs ai/A per
season as preemergence; followed by
two post-directed applications with
shielded/hooded sprayers; followed by
three broadcast defoliation/desiccation
applications. Paraquat dichloride
residues in cotton seed ranged from
<0.05 to 4.6 mg/kg. These data support
a cotton seed tolerance of 5.0 ppm and
a gin byproducts tolerance of 82.0 ppm
with a 3 day PHI.
ii. Wheat. As required under
reregistration, residue studies (MRID
No. 44965703) were conducted to
determine levels of paraquat cation in or
on wheat grain, forage, hay, straw, and
aspirated grain fractions. Twenty-two
residue trials were conducted on wheat
(nine on spring wheat and thirteen on
winter wheat) during 1997 and 1998.
This data reflects a use pattern
(preemergence/broadcast, prior to
heading/spot spray and three days
before grain and straw harvest/broadcast
for a total of 1.75 lbs. ai/A. The range
of paraquat dichloride residues was:
wheat grain (0.06 to 1.1 ppm), wheat
forage (<0.050 to 0.29 ppm), wheat hay
(<0.050 to 2.8 ppm), wheat straw (4.0 to
40 ppm), and aspirated grain fractions
(40 to 61 ppm). These data support a
revised tolerance for grain of 1.5 ppm,
forage of 0.4 ppm, hay of 3.0 ppm, straw
of 40 ppm, and aspirated grain fractions
of 65 ppm.
iii. Soybean. As required under
reregistration, residue studies (MRID
No. 44965702) were conducted to
determine levels of paraquat cation on
soybean seed, forage, hay, and aspirated
grain fractions (MRID No. 44965701).
Twenty-two field residue studies were
conducted on soybeans during 1997 and
1998. The aspirated grain fractions
study was conducted during 1995 at
12X the label rate two days prior to
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harvest. The 1997–1998 data reflects a
use pattern (preemergence, directed
spray, spot spray, and three days before
harvest for a total seasonal rate of 2.9
lbs. ai/A. The range of paraquat
dichloride residues was: soybean seed
(<0.05 to 0.69 ppm), soybean hay (<0.05
to 5.65 ppm), soybean forage (<0.05to
0.38 ppm), and aspirated grain fractions
(57 ppm based on calculations
presented in MRID No. 44965701).
These data support a revised tolerance
for soybean seed at 0.7 ppm, hay at 6.0
ppm, forage at 0.4 ppm and aspirated
grain fractions at 60 ppm.
iv. Ginger. As required under
reregistration, residue studies, residue
studies were conducted to determine
levels of paraquat cation on ginger. Data
was collected from three field studies in
Hawaii. All samples from these studies
showed residues less than 0.1 ppm.
v. Okra. As required under
reregistration, residue studies were
conducted to determine levels of
paraquat cation on okra. Trials were
conducted in South Carolina, Tennessee
and Texas. No quatifiable residues were
found in any of the samples.
vi. Onion (dry bulb). There is an
established tolerance for pre-plant and
preemergence applications of paraquat
dichloride. Several states appealed to
IR4 to request a tolerance for postdirected applications in onion (dry
bulb). Field trials were conducted in
New York, Texas, Ohio, Washington,
California and Colorado. No quatifiable
residues were observed in any of the
samples.
vii. Tanier. As required under
reregistration, residue studies were
conducted to determine levels of
paraquat cation on tanier. There is an
existing tolerance for tanier for Puerto
Rico only. Data was collected from one
field trial in Florida. No quantifiable
residues were observed in any of the
samples.
The 1997 Paraquat Dichloride
Reregistration Eligibility Decision (RED)
indicates that crop group tolerances will
be established and indicates the
tolerance levels (0.05 ppm) for
vegetable, brassica leafy, group; fruit,
pome group; fruit, stone, group; and
berry group. These are based on existing
tolerances. New grape (0.05 ppm) and
cranberry (0.05 ppm) tolerances are
proposed as they were part of the small
fruit group which is being changed to
berry group. The request for animal
feed, nongrass, group tolerance is also
based on statements in the RED to group
alfalfa, clover, and birdsfoot trefoil
existing tolerances (these are based on
broadcast preemergence uses). The RED
indicates that tolerances should be
raised for forage (75 ppm) and hay (210
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ppm). These tolerances are not being
proposed as they appear to be based on
harvest aid uses in clover and birdsfoot
trefoil which are not relevant as only the
broadcast preemergence uses are desired
in these crops. The field residue data for
preemergence broadcast uses in alfalfa,
clover and birdsfoot trefoil supports the
existing tolerance of 5 ppm. The only
harvest aid use for crops in this group
is for use on alfalfa grown for seed
which has a grazing and feeding
prohibition.
Proposed tolerance for barley, straw
(1.0 ppm) is a new tolerance indicated
in the RED assessment. Proposed
individual (miscellaneous) tolerance
changes based on the RED assessment
include beet, sugar, tops (0.05 ppm);
sorghum, forage (0.1ppm); and hops,
cone, dry (0.5 ppm). The proposed
increased tolerances for kidney are to
harmonize U. S. tolerances with Codex
Maximum Residue Levels (MRL’s) as
discussed in the RED. Proposed
tolerances for vegetable, fruiting, group;
vegetable, cucurbit, group, and nut, tree,
group update the crop group
nomenclature only. They are based on
existing crop group tolerances. The
proposed tolerances for Crop Subgroups
6A, 6B, and 6C (Peas and Beans) are not
discussed in the RED and result from a
new tolerance (peas, dry) granted in
Sept. 1991. The use pattern for Group
6C is for a harvest aid application while
6A and 6B are for preplant/
preemergence application.
Tolerances discussed in the RED
which are not being requested include:
grape, juice (the processing factor is 1.0
so the tolerance is the same as grape),
raisin (processing factor is 1.0),
pineapple, process residue (the
processing factor is 0.6), sugarcane
molasses (processing factor is 0.1 for
refined molasses) and corn, field, flour
(processing factor is 1.0, discussed in
the Sept. 1991 FR Notice).
Animal feed, grass, group will not be
requested. Syngenta Crop Protection,
Inc. is voluntarily removing animal
feed, grass (pasture and range) uses from
the label except for grasses grown for
seed and ‘‘juniper leaf moisture
reduction or desiccation prior to
prescribed burning of pastures’’ which
have a feeding/grazing prohibition.
B. Toxicological Profile
1. Acute toxicity. Acute toxicity
studies conducted with the 45.6%
paraquat dichloride technical
concentrate give the following results:
oral LD50 in the rat of 344 mg/kg (males)
and 283 mg/kg (females) (Category II);
dermal LD50 in the rat of >2,000 mg/kg
for males and females (Category III); the
primary eye irritation study showed
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corneal involvement with clearing in 17
days (Category II) ; and dermal irritation
of slight erythema and edema at 72
hours (Category IV). Paraquat dichloride
is not a dermal sensitizer. Acute
inhalation studies conducted to EPA
guideline with aerosolized sprays result
in LC50 of 0.6 to 1.4 µg paraquat cation/
L (Category I). However, since paraquat
dichloride has no measurable vapor
pressure, and hydraulic spray droplets
are too large to be respired, inhalation
exposure is not a concern in practice.
2. Genotoxicity. Paraquat dichloride
was not mutagenic in the Ames test
using Salmonella typhimurium strains
TA1535, TA1538, TA98, and TA100; the
chromosomal aberrations in the bone
marrow test system; or in the dominant
lethal mutagenicity study with CD–1
mice. Additionally, paraquat dichloride
was negative for unscheduled DNA
synthesis in rat hepatocyctes in vitro
and in vivo. Paraquat dichloride was
weakly positive in the mouse lymphoma
cell assay only in the presence of
metabolic activation. Paraquat
dichloride was weakly positive in
mammalian cells (lymphocytes) and
positive in the sister chromatid
exchange (SCE) assay in Chinese
hamster lung fibroblasts. Paraquat
dichloride is nonmutagenic.
3.Reproductive and developmental
toxicity. A three-generation
reproduction study in rats fed diets
containing 0, 25, 75, and 150 ppm (0,
1.25, 3.75, or 7.5 mg of paraquat cation/
kg/day, respectively) showed no effect
on body weight gain, food consumption
and utilization, fertility and length of
gestation of the F0, F1, and F2 parents
at any dose. The no observed effect level
(NOEL) and lowest observed effect level
(LOEL) for systemic toxicity are 25 ppm
(1.25 mg/kg/day) and 75 ppm (3.75 mg/
kg/day), respectively, expressed as
paraquat cation, based on high mortality
due to lung damage (alveolar
histiocytes). The NOEL for reproductive
toxicity is less than or equal to 150 ppm
[7.5 mg/kg/day; highest dose tested
(HDT)] expressed as paraquat cation, as
there were no reproductive effects.
Two developmental toxicity studies
were conducted in rats given gavage
doses of 0, 1, 5, and 10 mg/kg/day and
0, 1, 3, and 8 mg/kg/day, respectively,
expressed as paraquat cation. In the first
study, the NOEL for maternal toxicity
was 1 mg/kg/day based on clinical signs
of toxicity and decreased body weight
gain at 5 mg/kg/day (the LOEL). The
NOEL for developmental toxicity was
set at 5 mg/kg/day based on delayed
ossification of the forelimb and
hindlimb digits. In the second study, the
maternal and developmental NOEL is 8
mg/kg/day (HDT) as there were no
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effects observed at any dose level even
though the animals were examined
more carefully in the manus and pes
assessment. Based on both studies the
overall NOEL for maternal and
developmental toxicity is at least 3 mg/
kg/day.
The developmental toxicity studies
were conducted in mice given gavage
doses of 0, 1, 5, and 10 mg/kg/day and
0, 7.5, 15, or 25 mg/kg/day paraquat ion,
respectively. In the first study the NOEL
and LOEL for maternal toxicity are 5
mg/kg/day and 10 mg/kg/day,
respectively, based on reductions in
body weight gain and death (rangefinding study). The NOEL and LOEL for
developmental toxicity are 5 mg/kg/day
and 10 ma/kg/day, respectively, based
on an increased number of litters and
fetuses with partial ossification of the
4thsternebrae at 10 mg/kg/day (HDT).
Both the maternal and developmental
NOELs are at 15 mg/kg/day in the
second study. The maternal LOEL of 25
mg paraquat cation/kg/day is based on
death, decreases in body weight and
body weight gain, and mean fetal
weights, retarded ossification and other
skeletal effects. The developmental/
maternal NOEL should be based on the
second study and is 15 mg/kg/day.
Paraquat dichloride is not a
developmental toxin.
4. Subchronic toxicity.A 90 day
feeding study in dogs fed doses of 0, 7,
20, 60, or 120 ppm with a NOEL of 20
ppm (equivalent to 0.56 mg paraquat
cation/kg/d for males and 0.71 mg
paraquat cation/kg/d for females) based
on lung effects such as alveolitis and
alveolar collaps seen at the LOEL of 60
ppm.
A 21 day dermal toxicity study in
which rabbits were exposed dermally to
doses of 0, 1.5, 3.4, 7.8, or 17.9 mg/kg/
day resulted in a NOEL of 1.15 mg
paraquat cation/kg.day and a LOEL of
2.6 mg paraquat cation/kg/day based on
dermal irritation.
A 21 day inhalation toxicity study in
rats that were exposed to respirable
aerosols of paraquat at doses of 0, 0.01,
0.1, 0.5, and 1.0 q/L with a NOEL of
0.01 ug paraquat cation/L and a LOEL
of 0.10 µg paraqut cation/L based on
histopathological changes to the
epithelium of the larynx and nasal
discharge.
5.Chronic toxicity. In a 12–month
feeding study, dogs were fed dose levels
of 0, 15, 30, or 50 ppm, expressed as
paraquat cation. These levels
corresponded to 0, 0.45, 0.93, or 1.51 mg
of paraquat cation/kg/day, respectively,
in male dogs or 0, 0.48, 1.00, or 1.58 mg
of paraquat cation/kg/day, respectively
for female dogs. There was a doserelated increase in the severity and
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extent of chronic pneumonitis in the
mid-dose and high-dose male and
female dogs. This effect was also noted
in the low-dose male group, but was
minimal when compared with the male
controls. The systemic NOEL is 15 ppm
(0.45 mg/kg/day for males and 0.48 mg/
kg/day for females, expressed as
paraquat cation). The systemic LOEL is
30 ppm (0.93 mg/kg/day for males and
1.00 mg/kg/day for females, expressed
as paraquat cation).
In a 2–year chronic feeding/
carcinogenicity study, rats were fed
doses of paraquat dichloride at 0, 25, 75,
or 150 ppm which corresponds to 0,
1.25, 3.75, or 7.5 mg of paraquat cation/
kg/day. Paraquat dichloride enhanced
the development of ocular lesions in all
of the treated groups. The predominant
lesions detected opthamoscopically
were lenticular opacities and cataracts.
At test week 103, dose-related
statistically significant (P<0.001)
increases in the incidence of ocular
lesions were observed only in the middose and high-dose male and female
groups. Based on these findings, the
NOEL (approximate) and the LOEL for
systemic toxicity, for both sexes, are 25
ppm (1.25 mg/kg/day) and 75 ppm (3.75
mg/kg/day), respectively. In this study,
there was uncertain evidence of
carcinogenicity (squamous cell
carcinomas in the head region; ears,
nasal cavity, oral cavity, and skin) in
males at 7.5 mg/kg/day (HDT) with a
systemic NOEL of 1.25 mg/kg/day.
Upon submission of additional data to
EPA, the incidence of pulmonary
adenomas and carcinomas was well
within historical ranges and it was
determined that paraquat dichloride
was not carcinogenic in the lungs and
head region of the rat.
In another 2–year chronic feeding/
carcinogenicity study, rats were dosed
at 0, 6, 30, 100 or 300 ppm, expressed
as paraquat dichloride (nominal
concentrations), equivalent to 0, 0.25,
1.26, 4.15, or 12.25 mg/kg/day,
respectively (males) and 0, 0.30, 1.5,
5.12, or 15.29 mg/kg/day respectively
(females), expressed as paraquat
dichloride. The incidence of ocular
changes was low and not caused by
paraquat dichloride in this study. The
systemic NOEL is 100 ppm of paraquat
dichloride (4.15 and 5.12 mg/kg/day, for
males and females, respectively); or 3.0
mg/kg/day (males) and 3.7 mg/kg/day
(females), expressed as paraquat cation.
The systemic LOEL is 300 ppm of
paraquat dichloride (12.25 and 15.29
mg/kg/day, for males and females,
respectively); or 9.0 mg/kg/day (males)
and 11.2 mg/kg/day (females), expressed
as paraquat cation. There were no
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Federal Register / Vol. 70, No. 124 / Wednesday, June 29, 2005 / Notices
evidence of carcinogenicity in this study
even at the highest dose tested.
In a two year chronic feeding/
oncogenicity study, SPF Swiss derived
mice were fed paraquat dichloride at
dose levels of 0, 12.5, 37.5, or 100/125
ppm, expressed as cation. Because no
toxic signs appeared after 35 weeks of
dosing, the 100 ppm level was increased
to 125 ppm at week 36. There were no
carcinogenic effects observed in this
study. The systemic NOEL for both
sexes is 12.5 ppm (1.87 mg/kg/day) and
the systemic LOEL is 37.5 ppm (5.6 mg/
kg/day), each expressed as paraquat
cation based on renal tubular
degeneration in males and weight loss
and decreased food intake in females.
Paraquat dichloride is classified
Category E of carcinogenicity (no
evidence of carcinogenicity in animal
studies).
6. Animal metabolism. The qualitative
nature of the residue in animals is
adequately understood based on the
combined studies conducted with
ruminants (goats and cows), swine, and
poultry. The residue of concern in eggs,
milk, and poultry and livestock tissue is
the parent, paraquat dichloride.
7. Metabolite toxicology. The nature of
the residues in plants and animals is
adequately understood. The residue of
concern in eggs, milk, poultry, livestock,
and in crops is the parent, paraquat
dichloride.
8. Endocrine disruption. There is no
evidence of endocrine effects in the
database supporting registration of
paraquat dichloride.
C. Aggregate Exposure
1. Dietary exposure. Syngenta Crop
Protection, Inc. has estimated aggregate
exposure based on all proposed and
established tolerances.
2. Food. For the purposes of assessing
the potential dietary exposure under the
proposed tolerances, Syngenta Crop
Protection has estimated aggregate
exposure from all crops for which
tolerances are established or proposed
(i.e., pesticide petition PP#2F6433).
i. Acute exposure. The paraquat
dichloride acute dietary exposure
assessment utilized the Dietary
Exposure Evaluation Model (DEEMTM,
version 7.76) and the USDA’s
Continuing Survey of Food Intake by
Individuals (CSFII) with the 1994–96
consumption database and the
Supplemental CSFII Children’s Survey
(1998) consumption database. The acute
reference dose (aRfD) for paraquat
dichloride is 0.0042 mg/kg-bw/day for
females 13–50 years of age and 0.0125
mg/kg-bw/day for children and the U.S.
population. The aRfD is based on a
reproduction study in rats with a no
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observable adverse effect level (NOAEL)
of 1.25 mg/kg-bw/day and an
uncertainty factor of 100X. An
additional FQPA safety factor of 3X was
applied for females between the ages of
13 and 50 years due to a data gap for
a prenatal developmental study
conducted in a non-rodent species. The
paraquat dichloride Tier II acute dietary
exposure assessment was based upon
established and proposed tolerances for
paraquat dichloride. The maximum
percent crop treated (%CT) values that
were described in the most recent EPA
exposure assessment for paraquat
dichloride (published in the Federal
Register) of September 21, 2001 (66 FR
48593)(FRL-6799-2) were used for all
currently registered crops. One-hundred
percent crop treated was assumed for all
proposed crops. It should be noted that
the most recent EPA acute exposure
assessment for paraquat dichloride was
based on a probabilistic Monte Carlo
analysis using tolerance residue values.
The current Syngenta acute assessment
was performed deterministically using
tolerance residue values. For the
purpose of aggregate risk assessment,
the exposure values were expressed in
terms of margin of exposure (MOE)
which was calculated by dividing the no
observable adverse effect level (NOAEL)
by the exposure for each population
subgroup. In addition, exposure was
expressed as a percent of the acute
reference dose (%aRfD). Acute exposure
to the U.S. population resulted in a
MOE of 377 (26.47% of the aRfD of
0.0125 mg/kg-bw/day). The most
exposed sub-population was females
(13–19 years, not pregnant or nursing)
with a MOE of 712 (41.78% of the aRfD
of 0.0042 mg/kg-bw/day). Since the
benchmark MOE for females (13–50
years of age) was 300 and since EPA
generally has no concern for exposures
below 100% of the RfD, Syngenta
believes that there is a reasonable
certainty that no harm will result from
dietary (food) exposure to residues
arising from the current and proposed
uses of paraquat dichloride.
ii. Chronic exposure. The paraquat
dichloride chronic dietary exposure
assessment utilized the Dietary
Exposure Evaluation Model (DEEMTM,
version 7.76) and the USDA’s
Continuing Survey of Food Intake by
Individuals (CSFII) with the 1994–96
consumption database and the
Supplemental CSFII Children’s Survey
(1998) consumption database. The
chronic reference dose (cRfD) for
paraquat dichloride is 0.0045 mg/kg-bw/
day and is based on a one-year feeding
study in dogs with a NOAEL of 0.45 mg/
kg-bw/day and an uncertainly factor of
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100X. No additional FQPA safety factor
was applied. The paraquat dichloride
Tier II chronic dietary exposure
assessment was based upon established
and proposed tolerances for paraquat
dichloride. The average percent crop
treated (%CT) values that were
described in the most recent EPA
exposure assessment for paraquat
dichloride published in the Federal
Register of September 21, 2001, were
used for all currently registered crops.
For the proposed crops, it was assumed
that 100 percent of these crops were
treated. For the purpose of aggregate risk
assessment, the exposure values were
expressed in terms of MOE and as a
percent of the reference dose (%RfD).
Chronic exposure to the U.S. population
resulted in a MOE of 1,475 (6.8% of the
cRfD of 0.0045 mg/kg-bw/day). The
most exposed sub-population was
children (1–6 years old) with a MOE of
507 (19.7% of the cRfD). Since the
benchmark MOE for this assessment
was 100 and since EPA generally has no
concern for exposures below 100% of
the RfD, Syngenta believes that there is
a reasonable certainty that no harm will
result from dietary (food) exposure to
residues arising from the current and
proposed uses of paraquat dichloride.
1. Drinking water. To estimate total
aggregate exposure to a pesticide from
food, drinking water and residential
uses, the Agency calculates the drinking
water level of comparison (DWLOCs)
which are used as a point of comparison
against the model estimates of a
pesticide’s concentration in water
(EECs). When EECs for surface water
and ground water are less than the
calculated DWLOCs, EPA concludes
with reasonable certainty that exposures
to the pesticide in drinking water would
not result in unacceptable levels of
aggregate human health risk. The
calculated DWLOC for acute exposure to
paraquat dichloride in surface and
ground water was 74 ppb for the most
exposed sub-population (females 13–19
years, not pregnant or nursing). The
calculated DWLOC for chronic exposure
to paraquat dichloride in surface and
ground water was 36 ppb for the most
exposed sub-population (children 1–6
years). Based on the comparison to the
EECs for surface and ground water, the
estimated environmental concentrations
of paraquat dichloride in surface and
ground water are below the DWLOC
based upon food exposures; therefore,
the EPA should not have a drinking
water concern for paraquat dichloride.
2. Non-dietary exposure. Paraquat
dichloride is not registered for use on
any sites that would result in residential
exposure.
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Federal Register / Vol. 70, No. 124 / Wednesday, June 29, 2005 / Notices
D. Cumulative Effects
Cumulative exposure to substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) requires that,
when considering whether to establish,
modify, or revoke a tolerance, the
Agency consider ‘‘available
information’’ concerning the cumulative
effects of a particular pesticide’s
residues and ‘‘other substances that
have a common mechanism of toxicity.’’
The EPA does not have, at this time,
available data to determine whether
paraquat dichloride has a common
mechanism of toxicity with other
substances or how to include this
pesticide in a cumulative risk
assessment. For the purposes of this
tolerance action, the EPA has not
assumed that paraquat dichloride has a
common mechanism of toxicity with
other substances.
E. Safety Determination
1. U.S. population—i. Acute risk. The
acute dietary exposure analysis (food
only) showed that exposure from all
established and proposed paraquat
dichloride tolerances would be 26.5% of
the aRfD for the general U.S. population.
ii. Chronic risk. The chronic dietary
exposure analysis (food only) showed
that exposure from all established and
proposed paraquat dichloride tolerances
would be 6.8% of the cRfD for the
general U.S. population.
2. Females 13–50 years of age— Acute
risk. The acute dietary exposure
analysis (food only) showed that
exposure from all established and
proposed paraquat dichloride tolerances
would be 41.8% of the aRfD for the most
exposed sub-population (females 13–19,
not pregnant or nursing).
3. Infants and children—i. Acute risk.
The acute dietary exposure analysis
(food only) showed that exposure from
all established and proposed paraquat
dichloride tolerances would be 38.3% of
the aRfD for the next most exposed subpopulation (children 1–6 years).
ii. Chronic risk. The chronic dietary
exposure analysis (food only) showed
that exposure from established and
proposed paraquat dichloride tolerances
would be 19.7% of the cRfD for the most
exposed sub-population (children 1–6
years). The next most exposed subpopulation was non-nursing infants
with an exposure of 12.7% of the cRfD.
There is no indication of quantitative or
qualitative increased susceptibility of
rats or mice to in utero and/or prenatal/
postnatal exposure to paraquat
dichloride. The EPA has determined
that a developmental neurotoxicity
study is not required. Infants and
children are not expected to show any
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particular sensitivity to paraquat
dichloride.
Syngenta has considered the potential
aggregate exposure from food and water
and concluded that aggregate exposure
is not expected to exceed 100% of the
acute or chronic reference dose and that
there is a reasonable certainty that no
harm will result to infants and children
from the aggregate exposure to paraquat
dichloride.
F. International Tolerances
Compatibility between U.S. tolerances
and Codex Maximum Residue Levels
(MRLs) exist for eggs, milk, ruminant
tissues, passion fruit, sunflower seed
and vegetables including beans
(succulent), brassica (cole) leafy
vegetables group, carrots, cassava, corn
(sweet), cucurbits, fruiting vegetables,
lettuce, onions (dry bulb and green),
peas (succulent), pigeon peas, turnips
(roots and tops), and yams.
Incompatibilities of U.S. tolerances and
Codex MRLs on the following raw plant
commodities remain because of
differences in agricultural practices:
Cottonseed, dry hops, dry peas/beans,
maize, olives, potatoes, rice, sorghum,
soybeans and wheat. No questions of
compatibility exists with respect to
commodities where no Codex MRLs
have been established but United States
tolerances exist or where Codex MRLs
have been established but U.S.
tolerances do not exist.
[FR Doc. 05–12445 Filed 6–28–05; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collection(s) Being Submitted for
Review to the Office of Management
and Budget
June 16, 2005.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
Act (PRA) of 1995, Public Law 104–13.
An agency may not conduct or sponsor
a collection of information unless it
displays a currently valid control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
Paperwork Reduction Act (PRA) that
does not display a valid control number.
Comments are requested concerning (a)
whether the proposed collection of
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information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
(b) the accuracy of the Commission’s
burden estimate; (c) ways to enhance
the quality, utility, and clarity of the
information collected; and (d) ways to
minimize the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology.
DATES: Written Paperwork Reduction
Act (PRA) comments should be
submitted on or before July 29, 2005. If
you anticipate that you will be
submitting PRA comments, but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contact listed below as soon
as possible.
ADDRESSES: Direct all Paperwork
Reduction Act (PRA) comments to
Leslie F. Smith, Federal
Communications Commission, Room 1–
A804, 445 12th Street, SW., DC 20554
or via the Internet to
Leslie.Smith@fcc.gov, and/or to Kristy L.
LaLonde, Office of Management and
Budget (OMB), Room 10236 NEOB,
Washington, DC 20503, (202) 395–3087
or via the Internet at
Kristy_L._LaLonde@omb.eop.gov. If you
would like to obtain or view a copy of
this new information collection, you
may do so by visiting the FCC PRA Web
page at: https://www.fcc.gov/omd/pra.
FOR FURTHER INFORMATION CONTACT: For
additional information or copies of the
information collection(s), contact Leslie
F. Smith at (202) 418–0217 or via the
Internet at Leslie.Smith@fcc.gov.
SUPPLEMENTARY INFORMATION: The
Commission has requested approval of
these information collections under the
emergency processing provisions of the
PRA by July 1, 2005.
OMB Control Number: 3060–XXXX.
Title: Federal Communications
Commission Proposes Collection of
Location Information, Provision of
Notice and Reporting on Interconnected
voice over Internet Protocol (VoIP) E911
Compliance.
Type of Review: Emergency.
Form Number: N/A.
Respondents: Business or other forprofit entities; Not-for-profit
institutions; State, Local or Tribal
Governments; and Individuals or
households.
Number of Respondents: 100.
Estimated Time per Response: 0.09
hours–16 hours.
Frequency of Response:
Recordkeeping; on occasion, annual,
E:\FR\FM\29JNN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 124 (Wednesday, June 29, 2005)]
[Notices]
[Pages 37397-37403]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12445]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0033; FRL-7718-8]
Paraquat Dichloride; Notice of Filing a Pesticide Petition to
Establish a Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Potection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2005-0033, must be received on or before July 29, 2005.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:(703) 305-5697; e-mail address: tompkins.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or
[[Page 37398]]
pesticide manufacturer. Potentially affected entities may include, but
are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 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-2005-0033. 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. EPA intends to work toward
providing electronic access to all of the publicly available docket
materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at 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-2005-0033. 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-2005-0033. 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
[[Page 37399]]
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-2005-0033.
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-2005-0033. 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 a potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: June 10, 2005.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
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.
Syngenta Crop Protection, Inc.
PP 2F6433 , 3E 6763, 1E 6332, 1E 6319, 1E 6223
EPA has received pesticide petitions (2F6433, 3E6763, 1E6332,
1E6319, and 1E6223) from Syngenta Crop Protection, Inc., P.O. Box
18300, Greensboro, NC 27419-8300 and Interregional Research
Project4 (IR4), 681 US Highway 1 South, New
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 by establishing a tolerance for residues of
paraquat dichloride in or on the raw agricultural commodities: cotton,
seed at 5.0 parts per million (ppm); cotton gin byproducts at 82.0 ppm;
soybean, seed at 0.70 ppm; soybean, forage at 0.40 ppm; soybean, hay at
6.0 ppm; soybean, aspirated grain fractions at 60.0 ppm; wheat, grain
at 1.5 ppm; wheat, forage at 0.40 ppm; wheat, hay at 3.0 ppm; wheat,
straw at 40.0 ppm; wheat, aspirated grain fractions at 65.0 ppm;
barley, hay at 3.0 ppm; vegetable, brassica leafy, group at 0.05 ppm;
fruit, pome, group at 0.05 ppm; fruit, stone, group at 0.05 ppm; berry
group at 0.05 ppm; animal feed, nongrass, group at 5.0 ppm; vegetable,
legume, edible-podded, subgroup at 0.05 ppm; pea and bean, succulent,
shelled, subgroup at 0.05 ppm; pea and bean, dried, shelled, except
soybean, subgroup at 0.3 ppm; grape at 0.05 ppm; cranberry at 0.05 ppm;
barley, straw at 1.0 ppm; beet, sugar, tops at 0.05 ppm; sorghum,
forage at 0.1 ppm; hops, cone, dry at 0.5 ppm; cattle, kidney at 0.3
ppm; goat, kidney at 0.3 ppm; hog, kidney at 0.3 ppm; horse, kidney at
0.3 ppm; sheep, kidney at 0.3 ppm; vegetable, fruiting, group at 0.05
ppm; vegetable, cucurbit, group at 0.05 ppm; nut, tree, group at 0.05
ppm; ginger at 0.1 ppm, okra at 0.05 ppm, tanier at 0.05 ppm, and onion
(dry bulb) at 0.1 ppm.. EPA has determined that the petition contains
data or information regarding the elements set forth in section
408(d)(2) of the FFDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The qualitative nature of the residue in
plants is adequately understood based on studies depicting the
metabolism of paraquat
[[Page 37400]]
dichloride in carrots and lettuce following preemergence treatments and
in potatoes and soybeans following desiccant treatment. The residue of
concern in plants is the parent, paraquat dichloride; the current
tolerance expression for plant commodities, as defined in 40 CFR
180.205(a) and (b).
2. Analytical method. An adequate analytical method (spectrometric
method) has been accepted and published in The Pesticide Analytical
Manual (PAM Vol. II) for the enforcement of tolerances in plant
commodities.
3. Magnitude of residues--i. Cotton. As required under
reregistration, residue studies (MRID No. 44432402) were conducted to
determine the levels of paraquat cation on ginned cotton seed and
cotton byproducts. Twelve residue field trials were conducted during
1995 in the United States. This data reflects a use pattern of a total
of 3 lbs ai/A per season as preemergence; followed by two post-directed
applications with shielded/hooded sprayers; followed by three broadcast
defoliation/desiccation applications. Paraquat dichloride residues in
cotton seed ranged from <0.05 to 4.6 mg/kg. These data support a cotton
seed tolerance of 5.0 ppm and a gin byproducts tolerance of 82.0 ppm
with a 3 day PHI.
ii. Wheat. As required under reregistration, residue studies (MRID
No. 44965703) were conducted to determine levels of paraquat cation in
or on wheat grain, forage, hay, straw, and aspirated grain fractions.
Twenty-two residue trials were conducted on wheat (nine on spring wheat
and thirteen on winter wheat) during 1997 and 1998. This data reflects
a use pattern (preemergence/broadcast, prior to heading/spot spray and
three days before grain and straw harvest/broadcast for a total of 1.75
lbs. ai/A. The range of paraquat dichloride residues was: wheat grain
(0.06 to 1.1 ppm), wheat forage (<0.050 to 0.29 ppm), wheat hay (<0.050
to 2.8 ppm), wheat straw (4.0 to 40 ppm), and aspirated grain fractions
(40 to 61 ppm). These data support a revised tolerance for grain of 1.5
ppm, forage of 0.4 ppm, hay of 3.0 ppm, straw of 40 ppm, and aspirated
grain fractions of 65 ppm.
iii. Soybean. As required under reregistration, residue studies
(MRID No. 44965702) were conducted to determine levels of paraquat
cation on soybean seed, forage, hay, and aspirated grain fractions
(MRID No. 44965701). Twenty-two field residue studies were conducted on
soybeans during 1997 and 1998. The aspirated grain fractions study was
conducted during 1995 at 12X the label rate two days prior to harvest.
The 1997-1998 data reflects a use pattern (preemergence, directed
spray, spot spray, and three days before harvest for a total seasonal
rate of 2.9 lbs. ai/A. The range of paraquat dichloride residues was:
soybean seed (<0.05 to 0.69 ppm), soybean hay (<0.05 to 5.65 ppm),
soybean forage (<0.05to 0.38 ppm), and aspirated grain fractions (57
ppm based on calculations presented in MRID No. 44965701). These data
support a revised tolerance for soybean seed at 0.7 ppm, hay at 6.0
ppm, forage at 0.4 ppm and aspirated grain fractions at 60 ppm.
iv. Ginger. As required under reregistration, residue studies,
residue studies were conducted to determine levels of paraquat cation
on ginger. Data was collected from three field studies in Hawaii. All
samples from these studies showed residues less than 0.1 ppm.
v. Okra. As required under reregistration, residue studies were
conducted to determine levels of paraquat cation on okra. Trials were
conducted in South Carolina, Tennessee and Texas. No quatifiable
residues were found in any of the samples.
vi. Onion (dry bulb). There is an established tolerance for pre-
plant and preemergence applications of paraquat dichloride. Several
states appealed to IR4 to request a tolerance for post-directed
applications in onion (dry bulb). Field trials were conducted in New
York, Texas, Ohio, Washington, California and Colorado. No quatifiable
residues were observed in any of the samples.
vii. Tanier. As required under reregistration, residue studies were
conducted to determine levels of paraquat cation on tanier. There is an
existing tolerance for tanier for Puerto Rico only. Data was collected
from one field trial in Florida. No quantifiable residues were observed
in any of the samples.
The 1997 Paraquat Dichloride Reregistration Eligibility Decision
(RED) indicates that crop group tolerances will be established and
indicates the tolerance levels (0.05 ppm) for vegetable, brassica
leafy, group; fruit, pome group; fruit, stone, group; and berry group.
These are based on existing tolerances. New grape (0.05 ppm) and
cranberry (0.05 ppm) tolerances are proposed as they were part of the
small fruit group which is being changed to berry group. The request
for animal feed, nongrass, group tolerance is also based on statements
in the RED to group alfalfa, clover, and birdsfoot trefoil existing
tolerances (these are based on broadcast preemergence uses). The RED
indicates that tolerances should be raised for forage (75 ppm) and hay
(210 ppm). These tolerances are not being proposed as they appear to be
based on harvest aid uses in clover and birdsfoot trefoil which are not
relevant as only the broadcast preemergence uses are desired in these
crops. The field residue data for preemergence broadcast uses in
alfalfa, clover and birdsfoot trefoil supports the existing tolerance
of 5 ppm. The only harvest aid use for crops in this group is for use
on alfalfa grown for seed which has a grazing and feeding prohibition.
Proposed tolerance for barley, straw (1.0 ppm) is a new tolerance
indicated in the RED assessment. Proposed individual (miscellaneous)
tolerance changes based on the RED assessment include beet, sugar, tops
(0.05 ppm); sorghum, forage (0.1ppm); and hops, cone, dry (0.5 ppm).
The proposed increased tolerances for kidney are to harmonize U. S.
tolerances with Codex Maximum Residue Levels (MRL's) as discussed in
the RED. Proposed tolerances for vegetable, fruiting, group; vegetable,
cucurbit, group, and nut, tree, group update the crop group
nomenclature only. They are based on existing crop group tolerances.
The proposed tolerances for Crop Subgroups 6A, 6B, and 6C (Peas and
Beans) are not discussed in the RED and result from a new tolerance
(peas, dry) granted in Sept. 1991. The use pattern for Group 6C is for
a harvest aid application while 6A and 6B are for preplant/preemergence
application.
Tolerances discussed in the RED which are not being requested
include: grape, juice (the processing factor is 1.0 so the tolerance is
the same as grape), raisin (processing factor is 1.0), pineapple,
process residue (the processing factor is 0.6), sugarcane molasses
(processing factor is 0.1 for refined molasses) and corn, field, flour
(processing factor is 1.0, discussed in the Sept. 1991 FR Notice).
Animal feed, grass, group will not be requested. Syngenta Crop
Protection, Inc. is voluntarily removing animal feed, grass (pasture
and range) uses from the label except for grasses grown for seed and
``juniper leaf moisture reduction or desiccation prior to prescribed
burning of pastures'' which have a feeding/grazing prohibition.
B. Toxicological Profile
1. Acute toxicity. Acute toxicity studies conducted with the 45.6%
paraquat dichloride technical concentrate give the following results:
oral LD50 in the rat of 344 mg/kg (males) and 283 mg/kg
(females) (Category II); dermal LD50 in the rat of >2,000
mg/kg for males and females (Category III); the primary eye irritation
study showed
[[Page 37401]]
corneal involvement with clearing in 17 days (Category II) ; and dermal
irritation of slight erythema and edema at 72 hours (Category IV).
Paraquat dichloride is not a dermal sensitizer. Acute inhalation
studies conducted to EPA guideline with aerosolized sprays result in
LC50 of 0.6 to 1.4 [mu]g paraquat cation/L (Category I).
However, since paraquat dichloride has no measurable vapor pressure,
and hydraulic spray droplets are too large to be respired, inhalation
exposure is not a concern in practice.
2. Genotoxicity. Paraquat dichloride was not mutagenic in the Ames
test using Salmonella typhimurium strains TA1535, TA1538, TA98, and
TA100; the chromosomal aberrations in the bone marrow test system; or
in the dominant lethal mutagenicity study with CD-1 mice. Additionally,
paraquat dichloride was negative for unscheduled DNA synthesis in rat
hepatocyctes in vitro and in vivo. Paraquat dichloride was weakly
positive in the mouse lymphoma cell assay only in the presence of
metabolic activation. Paraquat dichloride was weakly positive in
mammalian cells (lymphocytes) and positive in the sister chromatid
exchange (SCE) assay in Chinese hamster lung fibroblasts. Paraquat
dichloride is nonmutagenic.
3.Reproductive and developmental toxicity. A three-generation
reproduction study in rats fed diets containing 0, 25, 75, and 150 ppm
(0, 1.25, 3.75, or 7.5 mg of paraquat cation/kg/day, respectively)
showed no effect on body weight gain, food consumption and utilization,
fertility and length of gestation of the F0, F1, and F2 parents at any
dose. The no observed effect level (NOEL) and lowest observed effect
level (LOEL) for systemic toxicity are 25 ppm (1.25 mg/kg/day) and 75
ppm (3.75 mg/kg/day), respectively, expressed as paraquat cation, based
on high mortality due to lung damage (alveolar histiocytes). The NOEL
for reproductive toxicity is less than or equal to 150 ppm [7.5 mg/kg/
day; highest dose tested (HDT)] expressed as paraquat cation, as there
were no reproductive effects.
Two developmental toxicity studies were conducted in rats given
gavage doses of 0, 1, 5, and 10 mg/kg/day and 0, 1, 3, and 8 mg/kg/day,
respectively, expressed as paraquat cation. In the first study, the
NOEL for maternal toxicity was 1 mg/kg/day based on clinical signs of
toxicity and decreased body weight gain at 5 mg/kg/day (the LOEL). The
NOEL for developmental toxicity was set at 5 mg/kg/day based on delayed
ossification of the forelimb and hindlimb digits. In the second study,
the maternal and developmental NOEL is 8 mg/kg/day (HDT) as there were
no effects observed at any dose level even though the animals were
examined more carefully in the manus and pes assessment. Based on both
studies the overall NOEL for maternal and developmental toxicity is at
least 3 mg/kg/day.
The developmental toxicity studies were conducted in mice given
gavage doses of 0, 1, 5, and 10 mg/kg/day and 0, 7.5, 15, or 25 mg/kg/
day paraquat ion, respectively. In the first study the NOEL and LOEL
for maternal toxicity are 5 mg/kg/day and 10 mg/kg/day, respectively,
based on reductions in body weight gain and death (range-finding
study). The NOEL and LOEL for developmental toxicity are 5 mg/kg/day
and 10 ma/kg/day, respectively, based on an increased number of litters
and fetuses with partial ossification of the 4thsternebrae
at 10 mg/kg/day (HDT). Both the maternal and developmental NOELs are at
15 mg/kg/day in the second study. The maternal LOEL of 25 mg paraquat
cation/kg/day is based on death, decreases in body weight and body
weight gain, and mean fetal weights, retarded ossification and other
skeletal effects. The developmental/maternal NOEL should be based on
the second study and is 15 mg/kg/day. Paraquat dichloride is not a
developmental toxin.
4. Subchronic toxicity.A 90 day feeding study in dogs fed doses of
0, 7, 20, 60, or 120 ppm with a NOEL of 20 ppm (equivalent to 0.56 mg
paraquat cation/kg/d for males and 0.71 mg paraquat cation/kg/d for
females) based on lung effects such as alveolitis and alveolar collaps
seen at the LOEL of 60 ppm.
A 21 day dermal toxicity study in which rabbits were exposed
dermally to doses of 0, 1.5, 3.4, 7.8, or 17.9 mg/kg/day resulted in a
NOEL of 1.15 mg paraquat cation/kg.day and a LOEL of 2.6 mg paraquat
cation/kg/day based on dermal irritation.
A 21 day inhalation toxicity study in rats that were exposed to
respirable aerosols of paraquat at doses of 0, 0.01, 0.1, 0.5, and 1.0
q/L with a NOEL of 0.01 ug paraquat cation/L and a LOEL of 0.10 [mu]g
paraqut cation/L based on histopathological changes to the epithelium
of the larynx and nasal discharge.
5.Chronic toxicity. In a 12-month feeding study, dogs were fed dose
levels of 0, 15, 30, or 50 ppm, expressed as paraquat cation. These
levels corresponded to 0, 0.45, 0.93, or 1.51 mg of paraquat cation/kg/
day, respectively, in male dogs or 0, 0.48, 1.00, or 1.58 mg of
paraquat cation/kg/day, respectively for female dogs. There was a dose-
related increase in the severity and extent of chronic pneumonitis in
the mid-dose and high-dose male and female dogs. This effect was also
noted in the low-dose male group, but was minimal when compared with
the male controls. The systemic NOEL is 15 ppm (0.45 mg/kg/day for
males and 0.48 mg/kg/day for females, expressed as paraquat cation).
The systemic LOEL is 30 ppm (0.93 mg/kg/day for males and 1.00 mg/kg/
day for females, expressed as paraquat cation).
In a 2-year chronic feeding/carcinogenicity study, rats were fed
doses of paraquat dichloride at 0, 25, 75, or 150 ppm which corresponds
to 0, 1.25, 3.75, or 7.5 mg of paraquat cation/kg/day. Paraquat
dichloride enhanced the development of ocular lesions in all of the
treated groups. The predominant lesions detected opthamoscopically were
lenticular opacities and cataracts. At test week 103, dose-related
statistically significant (P<0.001) increases in the incidence of
ocular lesions were observed only in the mid-dose and high-dose male
and female groups. Based on these findings, the NOEL (approximate) and
the LOEL for systemic toxicity, for both sexes, are 25 ppm (1.25 mg/kg/
day) and 75 ppm (3.75 mg/kg/day), respectively. In this study, there
was uncertain evidence of carcinogenicity (squamous cell carcinomas in
the head region; ears, nasal cavity, oral cavity, and skin) in males at
7.5 mg/kg/day (HDT) with a systemic NOEL of 1.25 mg/kg/day. Upon
submission of additional data to EPA, the incidence of pulmonary
adenomas and carcinomas was well within historical ranges and it was
determined that paraquat dichloride was not carcinogenic in the lungs
and head region of the rat.
In another 2-year chronic feeding/carcinogenicity study, rats were
dosed at 0, 6, 30, 100 or 300 ppm, expressed as paraquat dichloride
(nominal concentrations), equivalent to 0, 0.25, 1.26, 4.15, or 12.25
mg/kg/day, respectively (males) and 0, 0.30, 1.5, 5.12, or 15.29 mg/kg/
day respectively (females), expressed as paraquat dichloride. The
incidence of ocular changes was low and not caused by paraquat
dichloride in this study. The systemic NOEL is 100 ppm of paraquat
dichloride (4.15 and 5.12 mg/kg/day, for males and females,
respectively); or 3.0 mg/kg/day (males) and 3.7 mg/kg/day (females),
expressed as paraquat cation. The systemic LOEL is 300 ppm of paraquat
dichloride (12.25 and 15.29 mg/kg/day, for males and females,
respectively); or 9.0 mg/kg/day (males) and 11.2 mg/kg/day (females),
expressed as paraquat cation. There were no
[[Page 37402]]
evidence of carcinogenicity in this study even at the highest dose
tested.
In a two year chronic feeding/oncogenicity study, SPF Swiss derived
mice were fed paraquat dichloride at dose levels of 0, 12.5, 37.5, or
100/125 ppm, expressed as cation. Because no toxic signs appeared after
35 weeks of dosing, the 100 ppm level was increased to 125 ppm at week
36. There were no carcinogenic effects observed in this study. The
systemic NOEL for both sexes is 12.5 ppm (1.87 mg/kg/day) and the
systemic LOEL is 37.5 ppm (5.6 mg/kg/day), each expressed as paraquat
cation based on renal tubular degeneration in males and weight loss and
decreased food intake in females. Paraquat dichloride is classified
Category E of carcinogenicity (no evidence of carcinogenicity in animal
studies).
6. Animal metabolism. The qualitative nature of the residue in
animals is adequately understood based on the combined studies
conducted with ruminants (goats and cows), swine, and poultry. The
residue of concern in eggs, milk, and poultry and livestock tissue is
the parent, paraquat dichloride.
7. Metabolite toxicology. The nature of the residues in plants and
animals is adequately understood. The residue of concern in eggs, milk,
poultry, livestock, and in crops is the parent, paraquat dichloride.
8. Endocrine disruption. There is no evidence of endocrine effects
in the database supporting registration of paraquat dichloride.
C. Aggregate Exposure
1. Dietary exposure. Syngenta Crop Protection, Inc. has estimated
aggregate exposure based on all proposed and established tolerances.
2. Food. For the purposes of assessing the potential dietary
exposure under the proposed tolerances, Syngenta Crop Protection has
estimated aggregate exposure from all crops for which tolerances are
established or proposed (i.e., pesticide petition PP2F6433).
i. Acute exposure. The paraquat dichloride acute dietary exposure
assessment utilized the Dietary Exposure Evaluation Model
(DEEMTM, version 7.76) and the USDA's Continuing Survey of
Food Intake by Individuals (CSFII) with the 1994-96 consumption
database and the Supplemental CSFII Children's Survey (1998)
consumption database. The acute reference dose (aRfD) for paraquat
dichloride is 0.0042 mg/kg-bw/day for females 13-50 years of age and
0.0125 mg/kg-bw/day for children and the U.S. population. The aRfD is
based on a reproduction study in rats with a no observable adverse
effect level (NOAEL) of 1.25 mg/kg-bw/day and an uncertainty factor of
100X. An additional FQPA safety factor of 3X was applied for females
between the ages of 13 and 50 years due to a data gap for a prenatal
developmental study conducted in a non-rodent species. The paraquat
dichloride Tier II acute dietary exposure assessment was based upon
established and proposed tolerances for paraquat dichloride. The
maximum percent crop treated (%CT) values that were described in the
most recent EPA exposure assessment for paraquat dichloride (published
in the Federal Register) of September 21, 2001 (66 FR 48593)(FRL-6799-
2) were used for all currently registered crops. One-hundred percent
crop treated was assumed for all proposed crops. It should be noted
that the most recent EPA acute exposure assessment for paraquat
dichloride was based on a probabilistic Monte Carlo analysis using
tolerance residue values. The current Syngenta acute assessment was
performed deterministically using tolerance residue values. For the
purpose of aggregate risk assessment, the exposure values were
expressed in terms of margin of exposure (MOE) which was calculated by
dividing the no observable adverse effect level (NOAEL) by the exposure
for each population subgroup. In addition, exposure was expressed as a
percent of the acute reference dose (%aRfD). Acute exposure to the U.S.
population resulted in a MOE of 377 (26.47% of the aRfD of 0.0125 mg/
kg-bw/day). The most exposed sub-population was females (13-19 years,
not pregnant or nursing) with a MOE of 712 (41.78% of the aRfD of
0.0042 mg/kg-bw/day). Since the benchmark MOE for females (13-50 years
of age) was 300 and since EPA generally has no concern for exposures
below 100% of the RfD, Syngenta believes that there is a reasonable
certainty that no harm will result from dietary (food) exposure to
residues arising from the current and proposed uses of paraquat
dichloride.
ii. Chronic exposure. The paraquat dichloride chronic dietary
exposure assessment utilized the Dietary Exposure Evaluation Model
(DEEMTM, version 7.76) and the USDA's Continuing Survey of
Food Intake by Individuals (CSFII) with the 1994-96 consumption
database and the Supplemental CSFII Children's Survey (1998)
consumption database. The chronic reference dose (cRfD) for paraquat
dichloride is 0.0045 mg/kg-bw/day and is based on a one-year feeding
study in dogs with a NOAEL of 0.45 mg/kg-bw/day and an uncertainly
factor of 100X. No additional FQPA safety factor was applied. The
paraquat dichloride Tier II chronic dietary exposure assessment was
based upon established and proposed tolerances for paraquat dichloride.
The average percent crop treated (%CT) values that were described in
the most recent EPA exposure assessment for paraquat dichloride
published in the Federal Register of September 21, 2001, were used for
all currently registered crops. For the proposed crops, it was assumed
that 100 percent of these crops were treated. For the purpose of
aggregate risk assessment, the exposure values were expressed in terms
of MOE and as a percent of the reference dose (%RfD). Chronic exposure
to the U.S. population resulted in a MOE of 1,475 (6.8% of the cRfD of
0.0045 mg/kg-bw/day). The most exposed sub-population was children (1-6
years old) with a MOE of 507 (19.7% of the cRfD). Since the benchmark
MOE for this assessment was 100 and since EPA generally has no concern
for exposures below 100% of the RfD, Syngenta believes that there is a
reasonable certainty that no harm will result from dietary (food)
exposure to residues arising from the current and proposed uses of
paraquat dichloride.
1. Drinking water. To estimate total aggregate exposure to a
pesticide from food, drinking water and residential uses, the Agency
calculates the drinking water level of comparison (DWLOCs) which are
used as a point of comparison against the model estimates of a
pesticide's concentration in water (EECs). When EECs for surface water
and ground water are less than the calculated DWLOCs, EPA concludes
with reasonable certainty that exposures to the pesticide in drinking
water would not result in unacceptable levels of aggregate human health
risk. The calculated DWLOC for acute exposure to paraquat dichloride in
surface and ground water was 74 ppb for the most exposed sub-population
(females 13-19 years, not pregnant or nursing). The calculated DWLOC
for chronic exposure to paraquat dichloride in surface and ground water
was 36 ppb for the most exposed sub-population (children 1-6 years).
Based on the comparison to the EECs for surface and ground water, the
estimated environmental concentrations of paraquat dichloride in
surface and ground water are below the DWLOC based upon food exposures;
therefore, the EPA should not have a drinking water concern for
paraquat dichloride.
2. Non-dietary exposure. Paraquat dichloride is not registered for
use on any sites that would result in residential exposure.
[[Page 37403]]
D. Cumulative Effects
Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The EPA does not have, at this time,
available data to determine whether paraquat dichloride has a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment. For the purposes of this
tolerance action, the EPA has not assumed that paraquat dichloride has
a common mechanism of toxicity with other substances.
E. Safety Determination
1. U.S. population--i. Acute risk. The acute dietary exposure
analysis (food only) showed that exposure from all established and
proposed paraquat dichloride tolerances would be 26.5% of the aRfD for
the general U.S. population.
ii. Chronic risk. The chronic dietary exposure analysis (food only)
showed that exposure from all established and proposed paraquat
dichloride tolerances would be 6.8% of the cRfD for the general U.S.
population.
2. Females 13-50 years of age-- Acute risk. The acute dietary
exposure analysis (food only) showed that exposure from all established
and proposed paraquat dichloride tolerances would be 41.8% of the aRfD
for the most exposed sub-population (females 13-19, not pregnant or
nursing).
3. Infants and children--i. Acute risk. The acute dietary exposure
analysis (food only) showed that exposure from all established and
proposed paraquat dichloride tolerances would be 38.3% of the aRfD for
the next most exposed sub-population (children 1-6 years).
ii. Chronic risk. The chronic dietary exposure analysis (food only)
showed that exposure from established and proposed paraquat dichloride
tolerances would be 19.7% of the cRfD for the most exposed sub-
population (children 1-6 years). The next most exposed sub-population
was non-nursing infants with an exposure of 12.7% of the cRfD. There is
no indication of quantitative or qualitative increased susceptibility
of rats or mice to in utero and/or prenatal/postnatal exposure to
paraquat dichloride. The EPA has determined that a developmental
neurotoxicity study is not required. Infants and children are not
expected to show any particular sensitivity to paraquat dichloride.
Syngenta has considered the potential aggregate exposure from food
and water and concluded that aggregate exposure is not expected to
exceed 100% of the acute or chronic reference dose and that there is a
reasonable certainty that no harm will result to infants and children
from the aggregate exposure to paraquat dichloride.
F. International Tolerances
Compatibility between U.S. tolerances and Codex Maximum Residue
Levels (MRLs) exist for eggs, milk, ruminant tissues, passion fruit,
sunflower seed and vegetables including beans (succulent), brassica
(cole) leafy vegetables group, carrots, cassava, corn (sweet),
cucurbits, fruiting vegetables, lettuce, onions (dry bulb and green),
peas (succulent), pigeon peas, turnips (roots and tops), and yams.
Incompatibilities of U.S. tolerances and Codex MRLs on the following
raw plant commodities remain because of differences in agricultural
practices: Cottonseed, dry hops, dry peas/beans, maize, olives,
potatoes, rice, sorghum, soybeans and wheat. No questions of
compatibility exists with respect to commodities where no Codex MRLs
have been established but United States tolerances exist or where Codex
MRLs have been established but U.S. tolerances do not exist.
[FR Doc. 05-12445 Filed 6-28-05; 8:45 am]
BILLING CODE 6560-50-S
