[Federal Register: June 2, 2004 (Volume 69, Number 106)]
[Notices]
[Page 31106-31110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn04-52]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0139; FRL-7359-3]
Aminopyralid; 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 a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket ID number OPP-2004-0139, must be
received on or before July 2, 2004.
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: Joanne Miller, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6224; e-mail address: Joanne Miller@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
agricultual producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 110)
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-2004-0139. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA
Dockets. Information claimed as CBI and other information whose
disclosure is restricted by statute, which is not included in the
official public docket, will not be available for public viewing in
EPA's electronic public docket. EPA's policy is that copyrighted
material will not be placed in EPA's electronic public docket but will
be available only in printed, paper form in the official public docket.
To the extent feasible, publicly available docket materials will be
made available in EPA's electronic public docket. When a document is
selected from the index list in EPA Dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although, not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.
EPA intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on paper,
will be made available for public
[[Page 31107]]
viewing in EPA's electronic public docket as EPA receives them and
without change, unless the comment contains copyrighted material, CBI,
or other information whose disclosure is restricted by statute. When
EPA identifies a comment containing copyrighted material, EPA will
provide a reference to that material in the version of the comment that
is placed in EPA's electronic public docket. The entire printed
comment, including the copyrighted material, will be available in the
public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also, include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2004-0139. 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-2004-0139. 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-2004-0139.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2004-0139. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included, in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical
[[Page 31108]]
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: May 14, 2004.
Betty Shackleford,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by Dow AgroScience, LLC 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.
Dow AgroSciences, LLC
PP 7F4851
EPA has received a pesticide petition PP 7F4851 from Dow
AgroSciences, LLC 9330 Zionsville Road, Indianapolis, IN 46268
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d),
to amend 40 CFR part 180, by establishing a tolerance for residues of
combined residues of aminopyralid (XDE-750: 4-amino-3,6-
dichloropyridine-2-carboxylic acid) and its glucose conjugate,
expressed as total parent in or on the raw agricultural commodity grass
forage at 25 parts per million (ppm), grass hay at 65 ppm, wheat forage
at 2 ppm, wheat hay at 4 ppm, wheat grain at 0.05 ppm, wheat straw at
0.5 ppm, wheat bran at 0.1 ppm, wheat middlings at 0.02 ppm, wheat
shorts at 0.05 ppm, wheat flour at 0.01 ppm, wheat germ at 0.02 ppm,
wheat aspirated grain fractions at 0.5 ppm. Tolerances of the parent,
aminopyralid (free) are also proposed for milk at 0.02 ppm, cream at
0.02 ppm, edible animal tissues except kidney at 0.05 ppm and kidney at
1.0 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 support granting of the
petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant metabolism. The nature of the residue in plants (grass and
wheat) and in animals is adequately understood for the purpose of this
tolerance. Based on the findings from these metabolism studies, the
residues of concern in grass and wheat are the combined residues of
aminopyralid and its glucose conjugates, expressed as the total parent.
In animal commodities, the residue of concern is only the parent,
aminopyralid (free).
2. Analytical method. Adequate analytical methods for enforcement
purposes are available to monitor residues of aminopyralid in grass and
wheat commodities, milk, meat and meat by-products. The analytical
method uses liquid chromatography and positive ion electrospray tandem
spectrometry (LC/MS/MS) with limits of quantitation (LOQ) of 0.01 ppm.
The methods had been successfully validated independently by outside
laboratories. Aminopyralid had also been tested through the Food and
Drug Administration (FDA), Multi-residue Methodology, Protocols C, D,
and E.
3. Magnitude of residues. Geographically representative field
trials were conducted on grass pasture and wheat according to use
patterns to support the proposed tolerances in these commodities. In
addition, wheat processing and cow feeding studies were conducted to
determine transfer of residues into wheat processed products, milk,
meat and meat by-products. The proposed tolerances in grass and wheat
commodities and in milk, meat and meat by-products are adequate to
cover the highest residues from the maximum label use of aminopyralid
in grass pasture and wheat.
B. Toxicological Profile
1. Acute toxicity. Aminopyralid has low acute toxicity. The rat
oral lethal dose (LD)50 is >5,000 milligrams/kilogram (mg/
kg) and the rat inhalation LC50 is >5.5 milligrams per liter
(mg/L). In addition, aminopyralid is not a dermal sensitizer in guinea
pigs, has no dermal irritation in rabbits, and shows ocular irritation
in rabbits.
2. Genotoxicty. Short-term assays for genotoxicity consisting of a
bacterial reverse mutation assay (Ames test), an in vitro assay for
cytogenetic damage using the Chinese hamster ovary cells, an in vitro
chromosomal aberration assay using rat lymphocytes, and an in vitro
cytogenetic assay in the mouse bone marrow (micronucleus test) have
been conducted with aminopyralid. Taken together, these studies show a
lack of genotoxicity.
3. Reproductive and developmental toxicity. Developmental studies
in rats and rabbits were conducted with aminopyralid. Studies with
aminopyralid showed maternal no observed effect levels (NOELs) of 1,000
milligrams/kilogram/day (mg/kg/day) (rat) and 250 mg/kg/day (rabbit)
and fetal NOELs of 1,000 mg/kg/day (rat) and 500 mg/kg/day (rabbit).
These studies show that aminopyralid is not teratogenic nor will it
interfere with in utero development. A multi-generation reproduction
study conducted with aminopyralid in Sprague-Dawley rats showed a NOEL
for reproductive effects of 1,000 mg/kg/day for males and 1,000 females
(highest dose tested). The NOEL for neonatal effects was also 1,000 mg/
kg/day.
4. Subchronic toxicity. Aminopyralid showed a NOEL of 100 mg/kg/day
in a 28-day rat dermal study. 90-day feeding studies with aminopyralid
showed NOELs of 100 mg/kg/day in Fischer 344 rats, 257 mg/kg/day in
Beagle dogs, and 1,000 mg/kg/day in CD-1 mice.
5. Chronic toxicity. Based on chronic testing with aminopyralid in
the mouse, dog, and rat, a reference dose (RfD) of 0.5 mg/kg/day is
proposed. The RfD has incorporated a 100-fold safety factor to the NOEL
found in the rat chronic test. NOELs found in the chronic dietary
studies are as follows: 96 mg/kg/day (male and female dogs), 250 mg/kg/
day in female mice and 1,000 mg/kg/day in male mice, and 50 mg/kg/day
in male Fischer 344 rats and 500 mg/kg/day in female Fischer 344 rats.
6. Animal metabolism. Aminopyralid has been evaluated in a rat
metabolism study. In summary, this study shows that aminopyralid is
efficiently cleared through the urine and feces with an average of 74-
93% of the administered radioactivity excreted during the first 24-
hours post-dose administration. Aminopyralid is rapidly absorbed and
urinary and fecal elimination totaled 41-59 and 33-43% of the
administered dose, respectively. Analysis of excreted material indicate
no evidence of metabolism. Repeated administration of aminopyralid was
not associated with accumulation in tissues.
7. Metabolite toxicology. No mammalian metabolites of aminopyralid
[[Page 31109]]
have been identified in the rat metabolism study. Nature of residue
studies in wheat and grass (three species) revealed the presence of
unchanged parent aminopyralid and glucose conjugates of aminopyralid.
8. Endocrine disruption. There is no evidence to suggest that
aminopyralid has an effect on any endocrine system.
C. Aggregate Exposure
1. Dietary exposure--i. Food. In conducting the potential dietary
exposure and risk assessments, Dow AgroSciences used the Dietary
Exposure Evaluation Model (DEEM), Version 7.87, Exponent) software that
evaluated the individual food consumption as reported by respondents in
the United States Department of Agriculture 1994-1998 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). The dietary
exposure assessment was performed using a conservative approach (Tier
I) wherein the estimated theoretical maximum residue contribution
(TMRC) was based on the assumptions that 100% of the crops were treated
with aminopyralid and the residues were present at the proposed
tolerance levels.
The chronic population adjusted dose (cPAD) used was 0.50 mg/kg/
day based on a NOEL of 50 mg/kg/day from a 2-year combined chronic
feeding/carcinogenicity rat study and an uncertainty factor of 100 (10
for intraspecies variation x 10 for interspecies variation). No
additional FQPA safety factor is required. For the U.S. general
population, the theoretical maximum residue contribution (TMRC) was
estimated to be 0.000237 milligrams/kilogram (mg/kg/day) that utilized
less than 0.1% of the chronic population adjusted dose (cPAD). The
population subgroup with the highest potential exposure is children 1-2
years old with a TMRC of 0.000933 mg/kg/day that represents only 0.2%
of the cPAD. The percent of the cPAD is significantly below the
acceptable 100%, therefore, demonstrates no chronic dietary concern.
No appropriate toxicological endpoint attributable to a single
exposure was identified in the available toxicological studies on
aminopyralid. Thus, the risk from acute exposure is considered
negligible and no acute risk assessment was performed.
ii. Drinking water. No monitoring exposure data are available to
complete a comprehensive dietary exposure analysis and risk assessment
for aminopyralid in drinking water.
Guidance from EPA has indicated that Tier 1 screening level
models, such as generic expected environmental concentration (GENEEC)
and 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: 2 Liter/70 kilogram (2L/70 kg) adult male, 2L/60
kg adult female and 1L/10 kg child.
The concentration of aminopyralid in surface water using GENEEC is
4.4 [mu]g/L. For ground water, the estimated concentration by SCI-GROW
is 1.6 [mu]g/L. As shown below the EECs in surface water and ground
water are substantially below the DWLOC. Therefore, exposure to
aminopyralid in drinking water would not result in unacceptable levels
of aggregate human health risk.
2. Non-dietary exposure. Aminopyralid is not currently registered
for use on any sites that would result in residential exposure.
Therefore, considerations of aggregate exposure to aminopyralid will
not include non-dietary or residential exposures.
--------------------------------------------------------------------------------------------------------------------------------------------------------
cPAD/milligrams/ EEC [mu]g/Liter ([mu]g/L)
Population Group kilogram body weight/ Dietary Exposurea DWLOCb -------------------------------------
day (mg/kg bwt/day) Surface water Ground water
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population (total) 0.50 0.000237 17492 4.4 1.6
----------------------------------------------------
All infants (< 1 year old) 0.50 0.000270 4997 4.4 1.6
----------------------------------------------------
Children (1-2 years old) 0.50 0.000933 4991 4.4 1.6
----------------------------------------------------
Females (13-49 years old) 0.50 0.000145 14996 4.4 1.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
a From DEEM Analysis.
b DWLOC = (cPAD - Dietary Exposure) x Body weight, kg/Drinking water consumption, L x 1,000.
D. Cumulative Effects
At this time, no data are available to determine whether
aminopyralid has a common mechanism of toxicity with other substances.
Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, aminopyralid does not
appear to produce a common toxic metabolite generated by other
substances. For purposes of this tolerance action, therefore, it is
assumed that aminopyralid does not have a mechanism of toxicity common
with other substances.
E. Safety Determination
1. U.S. population. Using the above conservative exposure
assumptions, aggregate exposure to aminopyralid from the proposed
tolerances in wheat and animal commodities will utilize less than 0.1%
of the cPAD for the general U.S. population. The population subgroup
with the highest exposure of 0.2% of the cPAD is children 1-2 years
old. Generally, EPA has no concern for exposures below 100% of the cPAD
because the cPAD represents the level at or below which daily aggregate
dietary exposures over a lifetime will not pose appreciable risks to
human health. No endpoint of concern was identified to quantitate
acute-dietary risk to the general population, therefore, acute risk
exposure is considered to be negligible. Additionally, the potential
contribution of aminopyralid residues in drinking water to aggregate
exposure is expected to be minimal. Calculated DWLOCs for assessing
aggregate dietary risk ranged from 4991 [mu]g/L children 1-2 years old
to 1,7492 [mu]g/L; U.S. population which are more than 4,000-10,000
greater than the potential environmental water concentration.
Therefore, based on these risk assessments, Dow AgroSciences concludes,
that there is reasonable
[[Page 31110]]
certainty that no harm will result to the U.S. population from
aggregate exposure to aminopyralid residues.
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 aminopyralid relative to prenatal
and postnatal effects for children is complete. Overall, aminopyralid
had no effect on reproduction or embryo-fetal development at any dosage
tested. No quantitative or qualitative susceptibility was seen
following prenatal and postnatal exposures. In a 2-generation
reproductive toxicity study in rats, no effects on reproductive
performance or neonatal development were observed. Dow AgroSciences
concluded that there is no indication of increased sensitivity of
infants and children relative to adults and that no additional Food
Quality Protection Act (FQPA) safety factor is required. Using the
above conservative assumptions, aggregate exposure to aminopyralid will
utilize only 0.1% of the cPAD for all infants < 1 year old, 0.2% of the
cPAD for children 1-2 years old and 0.1% of the cPAD for children 6-12
years old. Even when considering the potential exposure to drinking
water, the aggregate exposure is not expected to exceed 100% of the
cPAD. Therefore, based on the completeness and reliability of the
toxicity data and the conservative exposure assessment, Dow
AgroSciences concludes, with reasonable certainty that no harm will
result to infants and children from the aggregate exposure to
aminopyralid residues.
F. International Tolerances
No Codex maximum residue levels are established for residues of
aminopyralid on any food or feed crop. Therefore, no compatibility
problems exist for the proposed tolerances.
[FR Doc. 04-12020 Filed 6-1-04; 8:45 am]
BILLING CODE 6560-50-S