[Federal Register: August 10, 2005 (Volume 70, Number 153)]
[Proposed Rules]
[Page 46444-46448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au05-18]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0216; FRL-7729-3]
40 CFR Chapter 1
Fenpyroximate; 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 identification (ID) number OPP-
2005-0216, must be received on or before September 9, 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: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2005-0216. 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 http//http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's
[[Page 46445]]
electronic public docket and comment system, EPA Dockets. You may use
EPA Dockets at http://www.epa.gov/edocket/ to submit or review 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 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
specific 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 allow 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-2005-0216. 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-2005-0216. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2005-0216.
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-2005-0216. 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
[[Page 46446]]
docket and EPA's electronic public docket. If you submit the copy that
does not contain CBI on disk or CD ROM, mark the outside of the disk or
CD ROM clearly that it does not contain CBI. Information not marked as
CBI will be included in the public docket and EPA's electronic public
docket without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the person listed under FOR
FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action Is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: July 29, 2005.
Lois Rossi,
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 Interregional Research Project Number 4 (IR-4), and
represents the view of the petitioner. The petition summary announces
the availability of a description of the analytical methods available
to EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
Interregional Research Project Number 4 (IR-4)
PP 5E6943
EPA has received a pesticide petition (5E6943) from Interregional
Research Project Number 4 (IR-4), 681 U.S. Highway 1 S. North
Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.566, by establishing tolerances for residues of
fenpyroximate in or on the raw agricultural commodities nut, tree,
group 14 at 0.1 parts per million (ppm); pistachio at 0.1 ppm; almond,
hulls at 1.8 ppm; fruit, citrus, group 10 at 0.4 ppm; fruit, citrus,
dried pulp at 2.5 ppm; citrus, oil at 15 ppm; hop at 4.5 ppm;
peppermint, tops at 3.0 ppm; and spearmint, tops at 3.0 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. This notice includes a
summary of the petition that was prepared by Nichino America, Inc.,
4550 New Linden Hill Road, Suite 501, Wilmington, Delaware 19808.
A. Residue Chemistry
1. Plant metabolism. Fenpyroximate and the Z-isomer are the
residues of concern for tolerance setting purposes in crops. The
metabolism of fenpyroximate and its Z-isomer has been studied, and is
adequately understood.
2. Analytical method. An enforcement method has been developed
which involves extraction of fenpyroximate from crops with acetone,
filtration, partitioning and cleanup, and analysis by gas
chromatography using a nitrogen/phosphorous detector. This method
allows detection of residues at or above the proposed tolerances. The
method has undergone independent laboratory validation as required by
PR Notices 88-5 and 96-1.
3. Magnitude of residues. The magnitude of residues for
fenpyroximate, and the Z-isomer are adequately understood for the
requested tolerances.
B. Toxicological Profile
An extensive battery of toxicology studies has been conducted with
fenpyroximate. EPA has evaluated the available toxicity data and
considered its validity, completeness, and reliability as well as the
relationship of the results of the studies to human risk. An assessment
of toxic effects caused by fenpyroximate, including the toxicological
endpoints of concern, is discussed in Unit III.A. and Unit III.B. of
the fenpyroximate final rule published in the June 10, 2004 issue of
the Federal Register (69 FR 32457) (FRL-7362-9).
1. Animal metabolism. The qualitative nature of the residues of
fenpyroximate, Z-isomer, and acid metabolite in animals is adequately
understood.
2. Metabolite toxicology. No toxicologically significant
metabolites were detected in plant or animal metabolism studies for
citrus, hops, mint, and tree nuts.
3. Endocrine disruption. Chronic, lifespan, and multi-generational
bioassays in mammals and acute and subchronic studies on aquatic
organisms and wildlife did not reveal any endocrine effects for
fenpyroximate. Any endocrine related effects would have been detected
in this comprehensive series of required tests. The probability of any
such effect due to agricultural uses of fenpyroximate is negligible.
C. Aggregate Exposure
1. Dietary exposure. Tolerances have been established (40 CFR
180.566) for the combined residues of fenpyroximate and its
metabolites, in or on a variety of raw agricultural commodities. Acute
and chronic dietary risk analyses were conducted to estimate the
potential fenpyroximate and Z-isomer residues in or on the following
crops: Citrus orange, citrus lemon, citrus grapefruit, citrus oil, mint
oil, hops, almond, pecans, and pistachio, using modeling based on USDA
survey data.
i. Food. The acute dietary exposure was based on the following
assumptions: Residues at tolerance levels, 100% crop treated, and
default
[[Page 46447]]
processing factors for all proposed commodities (Tier 1, 95th
percentile consumption). The chronic dietary exposure was based on the
following assumptions: Residues at tolerance levels, 100% crop treated,
using dietary exposure modeling, based on USDA survey data.
ii. Drinking water. The Agency does not have comprehensive
monitoring data; therefore, drinking water concentration estimates are
made by reliance on simulation or modeling taking into account data on
the physical characteristics of fenpyroximate. The Agency uses the Food
Quality Protection Act (FQPA) Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) to produce estimates of pesticide concentrations in an index
reservoir to predict surface water concentrations. The Screen
Concentrations in Groundwater (SCI-GROW) model is used to predict
pesticide concentrations in shallow ground water.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a reference dose (%RfD) or
population adjusted dose (%PAD). Instead, drinking water levels of
comparison (DWLOCs) are calculated and used as a point of comparison
against the model estimates of a pesticide's concentration in water.
DWLOCs are theoretical upper limits on a pesticide's concentration in
drinking water in light of total aggregate exposure to a pesticide in
food, and from residential uses.
The residue of concern in drinking water was determined to be
fenpyroximate. There are no established maximum contaminant levels or
health advisory levels for residues of fenpyroximate in drinking water.
Laboratory and field data have demonstrated that fenpyroximate is
immobile in soil and will not leach into ground water. Other data show
that fenpyroximate is virtually insoluble in water. As a result, EPA
concluded that residues reaching surface waters from field runoff will
quickly absorb to sediment particles and be partitioned from the water
column.
Estimates of the contribution of the petitioned crops to water
concentrations were derived. The acute and chronic EEC's in surface
water calculated by PRZM/EXAMS, Version 3.12, were 1.5 parts per
billion (ppb), and 0.13 ppb respectively. In ground water, using Tier I
SCI-GROW (Version 2.3), the estimated EEC was 0.006 ppb.
2. Non-dietary exposure. The term, residential exposure, is used in
this document to refer to non-occupational, non-dietary exposure (e.g.,
for lawn and garden pest control, indoor pest control, termiticides,
and flea and tick control on pets). Fenpyroximate is not registered for
use on any sites that would result in residential exposure.
D. Cumulative Effects
A determination has not been made that fenpyroximate has a common
mechanism of toxicity with other substances. Fenpyroximate does not
appear to produce a common toxic metabolite with other substances. A
cumulative risk assessment was not performed for this analysis. Section
408(b)(2)(D)(v) of FFDCA requires that when considering whether to
establish, modify, or revoke a tolerance the Agency considers,
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
fenpyroximate and any other substances. Fenpyroximate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, EPA has not assumed that
fenpyroximate has a common mechanism of toxicity with other substances.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs (OPP) concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/
.
E. Safety Determination
1. U.S. population--i. Acute risk. The acute dietary acute
Population Adjusted Dose (aPAD) was set at 0.05 milligrams/kilogram/day
(mg/kg/day) for females ages 13-49 years old based on a developmental
toxicity study in rats that had an oral no observed adverse effect
level (NOAEL) of 5.0 mg/kg/day. The resulting food exposure estimate
for this population subgroup was less than 1% of the aPAD. The
petitioned crops in addition to the registered crop uses accounted for
less than 6% of the aPAD.
The addition of these new uses results in a DWLOC of approximately
1,400 ppb. Surface water concentration estimates increase from 1.5 ppb
to 1.6 ppb with the added crops. The aggregate exposure will not exceed
100% of the aPAD.
ii. Chronic risk. The chronic dietary chronic Population Adjusted
Dose (cPAD) was determined to be 0.01 mg/kg/day for the general
population based on an oral NOAEL of 0.97 mg/kg/day in the 2-year rat
chronic/carcinogenicity study. The Agency determined that exposure from
currently registered crops utilize 8% of the cPAD. The additional new
uses will result in a utilization of 10% of the cPAD. Using the
exposure assumptions previously described, EPA has concluded that
exposure to fenpyroximate from food, including the additional new uses,
will utilize 10% of the cPAD for the U.S. population, 21% of the cPAD
for all infants (< 1 year old), and 33% of the cPAD for children (1-2
years old).
In addition, there is potential for chronic dietary exposure to
fenpyroximate in drinking water. The DWLOC for the general population,
infants (< 1 year old) and children (1-6 years old) were 320 ppb, 82
ppb, and 71 ppb, respectively. Average yearly drinking water
concentration in surface water was estimated at 0.13 ppb, and 0.006 ppb
in ground water for both registered and petitioned uses. After
calculating the DWLOCs and comparing them to the EECs for surface and
ground water, the aggregate exposure will not exceed 100% of the cPAD.
2. Infants and children. The Agency confirmed the endpoint
selection for fenpyroximate and evaluated the potential for increased
susceptibility of infants and children from exposure to fenpyroximate
(July 2003). Based on toxicological considerations, the special FQPA
safety factor was set at 1X when assessing acute and chronic dietary
exposures.
3. Aggregate cancer risk for U.S. population. Fenpyroximate is
classified as not likely to be carcinogenic to humans; therefore, an
aggregate cancer risk assessment was not performed.
4. Determination of safety. Based on these risk assessments, EPA
concluded that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to fenpyroximate residues.
[[Page 46448]]
F. International Tolerances
Codex MRLs have been established for residues of fenpyroximate and
Z-isomer on hops in Germany at 10 ppm.
[FR Doc. 05-15738 Filed 8-9-05; 8:45 am]
BILLING CODE 6560-50-M