Fipronil; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 49599-49607 [05-16807]
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Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
II. Background
A. What Action is the Agency Taking?
EPA has reassessed the uses of
procymidone, and on July 7, 2005,
reached a tolerance reassessment
decision for this pesticide. Procymidone
is a fungicide used to treat wine grapes
outside of the United States. A tolerance
of 5 parts per million for wine grapes
has been established, with no U.S.
registrations, to permit the import of
wine produced from procymidone
treated grapes. Currently, procymidone
exposures to the U.S. general population
exist only through drinking imported
wine made from procymidone treated
grapes. Since there are no registered
uses of procymidone in the U.S., no
occupational, residential, or drinking
water exposures are expected. EPA has
not made a common mechanism of
toxicity finding and therefore, has not
assumed that procymidone has a
common mechanism of toxicity with
other substances for the purposes of this
tolerance action.
The Agency is now issuing for
comment the resulting Report on Food
Quality Protection Act (FQPA)
Tolerance Reassessment Progress and
Risk Management Decision for
procymidone, known as a TRED, as well
as related risk assessments and
technical support documents. EPA
developed the procymidone TRED
through a modified, streamlined version
of its public process for making
tolerance reassessment and
reregistration eligibility decisions.
Through these programs, the Agency is
ensuring that pesticides meet current
standards under the Federal Food, Drug,
and Cosmetic Act (FFDCA) and the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended
by FQPA. EPA must review tolerances
and tolerance exemptions that were in
effect when the FQPA was enacted, to
ensure that these existing pesticide
residue limits for food and feed
commodities meet the safety standard
established by the new law. Tolerances
are considered reassessed once the
safety finding has been made or a
revocation occurs. EPA has reviewed
and made the requisite safety finding for
the procymidone tolerance included in
this notice.
EPA is applying the principles of
public participation to all pesticides
undergoing reregistration and tolerance
reassessment. The Agency’s Pesticide
Tolerance Reassessment and
Reregistration; Public Participation
Process, published in the Federal
Register of May 14, 2004 (69 FR 26819)
(FRL–7357–9), explains that in
conducting these programs, the Agency
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is tailoring its public participation
process to be commensurate with the
level of risk, extent of use, complexity
of issues, and degree of public concern
associated with each pesticide. EPA can
expeditiously reach decisions for
pesticides like procymidone, which
pose no risk concerns and require no
risk mitigation. Once EPA assesses uses
and risks for such pesticides, the
Agency may go directly to a decision
and prepare a document summarizing
its findings, such as the procymidone
TRED.
The tolerance reassessment program
is being conducted under
Congressionally mandated time frames,
and EPA recognizes the need both to
make timely decisions and to involve
the public in finding ways to effectively
mitigate pesticide risks. Procymidone,
however, poses no risks that require
mitigation. The Agency therefore is
issuing the procymidone TRED, its risk
assessments, and related support
documents simultaneously for public
comment. The comment period is
intended to provide an opportunity for
public input and a mechanism for
initiating any necessary amendments to
the TRED. All comments should be
submitted using the methods in Unit I.
of the SUPPLEMENTARY INFORMATION, and
must be received by EPA on or before
the closing date. These comments will
become part of the Agency Docket for
procymidone. Comments received after
the close of the comment period will be
marked ‘‘late.’’ EPA is not required to
consider these late comments.
EPA will carefully consider all
comments received by the closing date
and will provide a Response to
Comments Memorandum in the Docket
and electronic EDOCKET. If any
comment significantly affects the
document, EPA also will publish an
amendment to the TRED in the Federal
Register. In the absence of substantive
comments requiring changes, the
decisions reflected in the TRED will be
implemented as presented.
B. What is the Agency’s Authority for
Taking this Action?
Section 408(q) of the FFDCA, 21
U.S.C. 346a(q), requires EPA to review
tolerances and exemptions for pesticide
residues in effect as of August 2, 1996,
to determine whether the tolerance or
exemption meets the requirements of
section 408(b)(2) or (c)(2) of FFDCA.
This review is to be completed by
August 3, 2006.
List of Subjects
Environmental protection, Pesticides
and pests.
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49599
Dated: August 15, 2005.
Debra Edwards,
Director, Special Review and Reregistration
Division, Office of Pesticide Programs.
[FR Doc. 05–16685 Filed 8–23–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0206; FRL–7726–3]
Fipronil; 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–
0206, must be received on or before
September 23, 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: Ann
Sibold, Registration Division (7505C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number: 703
305–6502; e-mail
address:sibold.ann@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 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
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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–
0206. 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
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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 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.
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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–2005–0206.
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–
2005–0206. 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.
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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–2005–0206.
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–2005–0206. 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.
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49601
5F6948 and 2E6490
346a(d), to amend 40 CFR 180.517 by
establishing a tolerance for residues of
mixture comprising fipronil, 5-amino-1[2,6-dichloro-4(trifluoromethyl)phenyl]-4-[(1R,S)(trifluoromethyl)sulfinyl]-1H-pyrazole3-carbonitrile and its metabolites 5amino-1-[2,6-dichloro-4(trifluoromethyl)phenyl]-4[(trifluoromethyl) sulfonyl]-1Hpyrazole-3-carbonitrile and 5-amino-1[2,6-dichloro-4(trifluoromethyl)phenyl]-4[(trifluoromethyl)thio]-1H-pyrazole-3carbonitrile and its photodegradate 5amino-1-[2,6-dichloro-4(trifluoromethyl)phenyl]-4-[(1R,S)(trifluoromethyl)]-1H-pyrazole-3carbonitrile in or on the raw agricultural
commodity corm vegetables (crop group
1-C at 0.04 parts per million (ppm), and
indirect and inadvertent residues on
wheat, grain at 0.005 and wheat, forage
at 0.02 ppm and wheat, hay and straw
at 0.03 ppm. EPA has received a
pesticide petition 2E6490 from The
Interregional Research Project No. 4 (IR4), Technology Centre of New Jersey,
Rutgers, the State University of New
Jersey, 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390 proposing,
pursuant to section 408(d) of the
FFDCA, 21 U.S.C. 346a(d), to amend 40
CFR 180.517 by establishing a tolerance
for residues of mixture comprising
fipronil, 5-amino-1-[2,6-dichloro-4(trifluoromethyl)phenyl]-4-[(1R,S)trifluoromethyl)sulfinyl]-1H-pyrazole-3carbonitrile) and its metabolites 5amino-1-[2,6-dichloro-4(trifluoromethyl)phenyl]-4[(trifluoromethyl) sulfonyl]-1Hpyrazole-3-carbonitrile and 5-amino-1[2,6-dichloro-4(trifluoromethyl)phenyl]-4[(trifluoromethyl)thio]-H-pyrazole-3carbonitrile and its photodegradate 5amino-1-[2,6-dichloro-4(trifluoromethyl)phenyl]-4-[(1R,S)(trifluoromethyl)]-1H-pyrazole-3carbonitrile in or on the raw agricultural
commodities onion (dry bulb), garlic,
shallot (dry bulb) at 0.02 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.
EPA has received a pesticide petition
(5F6948) from BASF Corporation, P.O.
Box 13528, Research Triangle Park, NC
27709 proposing, pursuant to section
408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C.
A. Residue Chemistry
1. Plant metabolism. The metabolism
of fipronil is adequately understood.
Adequate data on the nature of the
residues in both plant and animals,
including identification of major
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: August 15, 2005.
Donald R. Stubbs,
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.
BASF Corporation
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metabolites and degradates of fipronil,
are available. In plants and animal the
metabolism of fipronil proceeds via
oxidation of the sulfoxide to yield
sulfone and hydrolysis of nitrile to yield
the amide. Fipronil and its sulfone and
amide constitute greater than 75% of the
identified residues in all studies. A
limited amount of reduction of
sulfoxide to yield the sulfide occurs in
some cases. Further transformation of
primary metabolites affords minor
amounts of carboxylic acid, the amide
and the 4-protopyrazole.
2. Analytical method. Validated
analytical methods are available for
detecting and measuring levels of
fipronil and its metabolites in onion,
dry bulb, potato (corm vegetables) and
its processing fractions and wheat grain,
forage, hay, and straw. The Method
utilizes Capillary Gas Chromatography
equipped with a Ni electron capture
detector. The Limit of Quantitation
(LOQ) for all potato matrices is 0.003
ppm for all analytes. The LOQ for onion
is 0.005 for all analytes.
3. Magnitude of residues. Field trials
were carried out in order to determine
the magnitude of residue in potato.
Field trials were conducted in the
required regions. Field trials were
carried out using the maximum label
rate of 0.1 lbs active ingredient (a.i.) per
acre applied in furrow followed by four
sequential foliar applications at 0.05 lbs
a.i. per acre. The results demonstrate
that any residue present would originate
from the in-furrow not the foliar
applications. In addition a processing
study was conducted on potatoes.
Onion field trials were conducted in the
required regions. The application was
by seed treatment at 25 grams of active
ingredient/kilogram (g a.i./Kg) of seed.
Twelve field trials were conducted
where wheat was planted following
application to primary crops.
Applications rates were 0.13 lbs a.i. per
acre in-furrow for six corn trials and 0.2
lbs a.i. per acre foliar for six cotton
trials.
B. Toxicological Profile
1. Acute toxicity. For technical
fipronil:
Oral LD50
Rat
LD50 = 97 mg/kg b.w.
category II/(moderately toxic)
Dermal LD50
Rat
LD50 >2,000 mg/kg b.w.
(HDT)
category III (slightly toxic)
Dermal LD50
Rabbit
LD50 = 354 mg/kg b.w.
category II(moderately toxic)
Inhalation LC50
Rat
LC50 = 0.39 mg/L
category II(moderately toxic)
Eye Irritation
Rabbit
slight irritation
category III
Skin Irritation
Rabbit
slight irritation
category IV
Skin Sensitization (Maximization Test)
Guinea pig
Not sensitizing
Acute Neurotoxicity
Rat
NOAEL = 2.5 mg/kg/day (for
general toxicity)
2. Genotoxicity. Fipronil was negative
in both in vitro and in vivo assays
conducted to investigate gene
mutations, DNA damage, and
chromosomal aberrations.
3. Reproductive and developmental
toxicity. The developmental toxicity
NOELs in the rat and rabbit were 20 mg/
kg/day (HDT) and 1 mg/kg/day (HDT),
respectively. Maternal toxicity was
observed in the rat at the HDT as
evidenced by decreased body weight
gain and food efficiency. In the rabbit,
the maternal toxicity NOAEL was less
than 0.1 mg/kg/day, based on reduced
body weight gain and food efficiency at
all dose levels tested. In a twogeneration rat study, the NOEL for
parental (systemic) toxicity was 3 ppm
(0.26 mg/kg/day for both sexes
combined), based on increased weight
of the thyroid glands and liver in males
and females, decreased weight of the
pituitary gland in females, and an
increased incidence of follicular
epithelial hypertrophy in females at 30
ppm. The NOEL for reproductive
toxicity was 30 ppm (2.64 mg/kg/day for
both sexes combined), based on clinical
signs of toxicity in pups, decreased litter
size, decreased pup body weights,
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decreased mating, decreased fertility
index, reduced pre- and postnatal
survival, and delays in physical
development at 300 ppm (26.03 and
28.40 mg/kg/day for males and females,
respectively).
In a developmental neurotoxicity
study in the rat, the NOAEL for
maternal toxicity was 10 ppm (0.91 mg/
kg/day), based on decreased body
weights and body weight gain at 200
ppm (HDT; 15 mg/kg/day). Considerable
maternal toxicity at the HDT prevented
adequate neurotoxicity evaluation of
pups at this dose level. There was no
evidence of neurotoxicity at 10 ppm
(0.91 mg/kg/day), which was the
NOAEL for developmental
neurotoxicity. The NOAEL for general
developmental toxicity was 0.5 ppm
(0.05 mg/kg/day), based on systemic
effects consisting of decreases in pup
weights during lactation and increases
in time of preputial separation in males
at 10 ppm.
4. Subchronic toxicity. The NOAEL
for systemic toxicity in rat was 5 ppm
(0.35 mg/kg/day for both sexes
combined), based on alterations in
serum protein values and increased
weight of the liver and thyroid at 30
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ppm (1.93 and 2.28 mg/kg/day for males
and females, respectively). The NOAELs
in the dog were 2 and 0.5 mg/kg/day for
male and female, respectively, based on
clinical signs of toxicity in males at 10
mg/kg/day and clinical signs of toxicity
and decreased body weight gain in
females at 2 mg/kg/day. The NOAEL for
mice was 10 ppm (1.27 and 1.72 mg/kg/
day for males and females, respectively),
based on a possible decreased body
weight gain at 25 ppm (3.2 and 4.53 mg/
kg/day for males and females,
respectively). A repeated dose dermal
study in the rabbit had a systemic
NOAEL of 5 mg/kg/day, based on
decreased body weight gain and food
consumption at 10 mg/kg/day, and a
dermal irritation NOEL of 10.0 mg/kg/
day (HDT).
In a subchronic neurotoxicity study in
rats, the NOEL was 5 ppm (0.301 and
0.351 mg/kg/day for males and females,
respectively), based on results of the
functional observational battery (FOB)
at 150 ppm (8.89 and 10.8 mg/kg/day for
males and females, respectively).
5. Chronic toxicity. The NOAEL for
systemic toxicity in a 1–year feeding
study in the dog was 0.3 mg/kg/day in
females and 1 mg/kg/day in males,
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based on clinical signs of neurotoxicity
at 1 and 2 mg/kg/day in females and
males, respectively. The NOAEL for
systemic toxicity in mice was 0.5 ppm
(0.06 mg/kg/day) based on decreased
body weight gain, decreased food
conversion efficiency in males,
increased liver weights, and liver
histopathology at 10 ppm (1.3 mg/kg/
day). Fipronil was not carcinogenic
when administrated to mice at dose
levels up to 60 ppm. The NOAEL in a
2–year dietary study in the rat was 0.5
ppm (0.019 and 0.025 mg/kg/day for
males and females, respectively) based
on clinical signs of toxicity and
alterations in clinical chemistry and
thyroid parameters at 1.5 ppm (0.059
and 0.078 mg/kg/day for males and
females, respectively). The EPA’s Health
Effects Division Carcinogenicity Peer
Review Committee classified fipronil in
Group C - Possible Human Carcinogen,
based on thyroid tumors observed in
rats at 300 ppm (HDT). Mechanistic data
indicate that these tumors are related to
a disruption in the thyroid-pituitary
status and are specific to the rat. In
addition, there was no apparent concern
for mutagenic activity. Thus, it was
recommended that RfD methodology,
i.e. non-linear or threshold, be used for
the estimation of human risk.
6. Animal metabolism. The
metabolism of fipronil is adequately
understood. Adequate data on the
nature of residues in both plants and
animals, including identification of
major metabolites and degradates of
fipronil, are available. In plants and
animals the metabolism of fipronil
proceeds via oxidation of the sulfoxide
to yield sulfone and hydrolysis of nitrile
to yield the amide. Fipronil and its
sulfone and amide constitute greater
than 75% of the identified residues in
all studies. A limited amount of
reduction of sulfoxide to yield the
sulfide occurs in some cases. Further
transformation of the primary
metabolites affords minor amounts of
the carboxylic acid, the amide and the
4-protiopyrazole.
7. Metabolite toxicology. MB46513
photodegradate acute oral toxicity:
Oral LD50
Rat LD50 =
16 mg/kg
b.w.
category I
(highly
toxic)
Dermal LD50
Rabbit
LD50 >
2,000
mg/kg
b.w.
(HDT)
category
III
(slightly
toxic)
i. Acute neurotoxicity. The NOEL was
2 mg/kg, based on decreases in body
weight gain and food consumption in
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males and females during the week
following treatment, decreases in
locomotor activity, hind-limb splay and
rectal temperature 6–hour post dosing
in males and females, and decreases in
the proportion of males with an
immediate righting reflex on days 7 and
14, at 12 mg/kg/day.
In a rat developmental toxicity study,
the NOEL was 1 mg/kg/day, based on
the slight increase in fetal and litter
incidence of reduced ossification of
several bones at 2.5 mg/kg/day.
ii. Subchronic toxicity. The NOAEL in
the rat was 3 ppm (0.18 and 0.21 mg/
kg/day in males and females,
respectively), based on clinical signs of
toxicity in both sexes and decreased
body weight and body weight gain in
males at 10 ppm. The NOEL for the
mouse was 0.5 ppm (0.08 mg/kg/day),
based on the aggressive and irritable
behavior with increased motor activity
in males at 2 ppm. The NOEL for the
dog was 9.5 ppm (0.29 mg/kg/day),
based on behavioral changes in females
at 35 ppm (1.05 mg/kg/day).
The rat chronic/carcinogenicity study
was negative for carcinogenicity. The
LOAEL for females was 0.5 ppm (0.032
mg/kg/day), based on clinical signs of
toxicity. There was no NOEL
established. For males, the NOAEL was
2 ppm (0.098 mg/kg/day), based on
clinical signs of toxicity, and stomach
and lung histopathology at 10 ppm
(0.497 mg/kg/day). No thyroid effects
are observed in any of the rat, mouse or
dog studies with MB46513, supporting
the conclusion that there is no concern
for cancer due to exposure to MB46513.
8. Endocrine disruption. Data from the
reproduction/ developmental toxicity
and short- and long-term repeated dose
toxicity studies with fipronil in the rat,
rabbit, mouse, or dog, do not suggest
any endocrine disruption activity. This
information is based on the absence of
any treatment-related effects from the
histopathological examination of
reproductive organs as well as the
absence of possible effects on fertility,
reproductive performance, or any other
aspect of reproductive function, or on
growth and development of the
offspring. Evidence of offspring toxicity
was observed only in the presence of
significant parental toxicity. Fipronil
disrupts the thyroid-pituitary axis.
However, mechanistic studies have
demonstrated that fipronil decreases
thyroid hormone levels in long-term
studies via increased clearance, rather
than a direct effect on the thyroid.
Concerns related to long-term exposure
of fipronil are addressed in human risk
estimates, as the chronic RfD (0.0002
mg/kg/day) is based on endpoints that
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49603
include thyroid hormone related effects
in rats.
C. Aggregate Exposure
1. Dietary exposure. An assessment
was conducted to determine the acute
and chronic exposure of all population
sub-groups to residues of fipronil.
Tolerance values have previously been
established and are listed in 40 CFR
180.517.
This analysis included all crops with
established tolerance values and the
proposed new crops of white potato,
sweet potato, onion bulb, garlic, shallot
bulb and the inadvertent residue
tolerance on wheat grain. The dietary
exposure assessment for crops with
established tolerances was conducted by
the U.S. Environmental Protection
Agency in 2001 (PP# 7F04832. Fipronil
in/on Cotton. HED Risk Assessment.
Barcode D248827; PC Code 129121;
Case 288765 ; submission S547814).
Using these dietary exposure values is
conservative because the registration for
fipronil on cotton was withdrawn, and
the dietary exposure assessment
conducted by HED included all
currently registered uses and the
proposed cotton use. Using the HED
exposure values is conservative
(overestimates actual exposure) because
the cotton use and all requested
modifications to existing tolerances
were included in the dietary exposure
assessment.
The dietary exposure assessment for
white potato, sweet potato, onion bulb,
garlic, and shallot bulb were conducted
using tolerance level residues, default
processing factors, and 100% crop
treated factors. These assumptions are
conservative because it assumes all
commodities will be at tolerance level
and 100% of the crop has been treated
with fipronil. The dietary exposure
assessment for the inadvertent residues
in wheat grain was conducted using
tolerance level residues, default
processing factors, and a 7% crop
treatment factor. The U.S. EPA used a
7% crop treatment factor for corn in the
dietary exposure assessment. The
tolerance for wheat grain is from
inadvertent residues that would occur
when wheat is planted following a
fipronil treatment of corn. Therefore, the
7% crop treatment factor applies to
wheat inadvertent residues.
The dietary exposure assessments
were conducted using the Dietary
Exposure Evaluation Model software
with Food Commodity Intake Database
(DEEM-FCID).
i. Food—a. Acute dietary exposure
assessment. The acute population
adjusted dose (aPAD) used was 0.025
mg/kg bw/day. Using the exposure
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measured drinking water values will be
used in the drinking water assessment.
The ground water values model by the
EPA when the cotton use was examined
TABLE 2.—COMBINATION OF THE will also be used for comparison. Based
CHRONIC DEEM TM DIETARY ANAL- on the tier I screening model SCI-GROW
TABLE 1.—COMBINATION OF THE
YSIS FOR FIPRONIL CONDUCTED BY (screening concentration in ground
ACUTE DEEMTM DIETARY ANALTHE U.S. EPA FOR EXISTING USES water), the acute ground water value
YSIS AT 95TH PERCENTILE FOR
AND BASF FOR THE USE ON WHITE will not exceed 0.061 ppb (0.032 µg/L
for fipronil, 0.012 µg/L for MB46136,
FIPRONIL CONDUCTED BY THE US
AND SWEET POTATOES
0.016 µg/L for MB46513, and 0.001 µg/
EPA FOR EXISTING USES AND
L for MB45950). This value of 0.061 ppb
Exposure
BASF FOR THE USE ON WHITE AND
is also used for chronic ground water
Subgroups
(mg/kg bw/
% cPADa
SWEET POTATOES
day)
comparisons.
Exposure (mg/
In the drinking water monitoring
U.S. PopuSubgroups
% aPADa
kg bw/day)
study, water samples were collected
lation
0.0000546
27
from 12 municipal water treatment
U.S. PopuAll Infants (< 1
facilities. The water treatment facilities
lation
0.001495
6
year old)
0.0000685
34
were selected based on the source of
water and the previousdocumented use
All Infants
Children (1–6
(<1 year
of fipronil in the watershed area. Raw
years old)
0.0001114
56
old)
0.002502
10
and finished water samples were collect
at each water treatment site. The
Children (7–
Children
12 years
samples were collected on regular
(1–6
old)
0.0000738
37
intervals between April and August.
years
The water samples wereanalyzed for
old)
0.002859
11
Females (13–
firponil and metabolites: MB45950,
50 years
Children
MB46136, and MB46513. The LOQ for
old)
0.0000420
21
(7–12
the method was 10 parts per trillion
years
(ppt) and the LOD was 4 ppt. No
Males (13–19
old)
0.001814
7
residues were detected in any of the
years old)
0.0000619
31
finished water samples and no
Females
Males (20+
confirmed fipronil-related residues were
(13–50
years old)
0.0000494
25
found in any of the raw samples. This
years
study showed that the use of fipronil in
old)
0.0009342
4
Seniors (55+
corn production does not pose a risk to
years old)
0.0000425
21
Males (13–
surface drinking water.
a The cPAD = 0.0002 mg/kg bw/day.
19 years
a. Acute aggregate exposure and risk
old)
0.001332
5
ii. Drinking water. The drinking water (food and water). The acute dietary risk
values used for comparison to the
Males (20+
associated with the existing fipronil
years
DWLOC (Drinking Water Level of
uses and the proposed use of white and
old)
0.000962
4
Comparison) can be calculated from
sweet potatoes does not exceed a level
model estimates or actual monitoring
of concern. The estimated exposure at
Seniors
data. When modeling was conducted,
the 95th percentile uses ≤ 11% of the
(55+
the currently registered corn use
aPAD (Table 1). The surface water and
years
resulted in the highest predicted
ground water estimated concentrations
old)
0.0007642
3
estimated water concentrations. If
were used to compare to the DWLOC.
a The aPAD = 0.025 mg/kg bw/day.
monitoring data is available it can be
The estimated water concentrations are
used instead of model predictions. A
b. Chronic dietary exposure
less than the calculated DWLOC (Table
drinking water monitoring study for
assessment. The chronic population
3). Therefore, it can be concluded with
fipronil and relevant metabolites in
adjusted dose (cPAD) used was 0.0002
reasonable certainty that residues of
surface water from the corn growing
mg/kg bw/day. Using the exposure
fipronil and metabolites in drinking
regions has beenconducted (MRID
assumptions discussed above, the
water do not contribute significantly to
45526101). Therefore, these actual
maximum fipronil chronic dietary
the acute aggregate human health risk.
assumptions discussed above, the
maximum fipronil acute dietary
exposure from food is 11% aPAD. The
results of the acute dietary assessment
are presented in Table 1.
exposure from food is 56% cPAD. The
results of the chronic dietary assessment
are presented in Table 2.
TABLE 3.—ACUTE AGGREGATE EXPOSURE FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND ALL
EXISTING USES
aPAD mg/
kg/day
Population Subgroup
Dietary Exposure1,
mg/kg/day
Allowable
Drinking
Water Exposure2, mg/
kg/day
DWLOC,
ppb
Surface
Water3, ppb
Ground
Water EEC,
ppb
U.S. Population
0.025
0.001495
0.023505
823
0.04
0.061
All Infants (< 1 year old)
0.025
0.002502
0.022498
225
0.04
0.061
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TABLE 3.—ACUTE AGGREGATE EXPOSURE FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND ALL
EXISTING USES—Continued
aPAD mg/
kg/day
Population Subgroup
Dietary Exposure1,
mg/kg/day
Allowable
Drinking
Water Exposure2, mg/
kg/day
Surface
Water3, ppb
DWLOC,
ppb
Ground
Water EEC,
ppb
Children (1-6 years old)
0.025
0.002859
0.022141
221
0.04
0.061
Children (7-12 years old)
0.025
0.001814
0.023186
232
0.04
0.061
Females (13-50 years old)
0.025
0.0009342
0.024066
722
0.04
0.061
Males (13-19 years old)
0.025
0.001332
0.023668
828
0.04
0.061
Males (20+ years old)
0.025
0.000962
0.024038
841
0.04
0.061
Seniors (55+ years old)
0.025
0.0007642
0.024236
848
0.04
0.061
1
The dietary exposure values are from Table 1.
Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Acute Dietary Exposure (mg/kg/day).
The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 µg/L = 0.01 +
0.01 + 0.01 + 0.01).
2
3
b. Short- and intermediate-term
aggregate exposure and risk (food, water
and residential exposure). Short- and
intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure from food and
water. Aggregation of systemic oral,
dermal and inhalation exposure from
the residential use is not appropriate
due to differences in the toxicity
endpoints observed between oral
(neurotoxicity and alterations in clinical
chemistry and thyroid parameters),
dermal (decrease in body weight gain
and food consumption) and inhalation
(developmental effects including
decreases in pup weights during
lactation and increases in time of
preputial separation) routes. Also, there
is no significant post-application
exposure to adults. However, post-
application exposure to children is
included in the exposure assessment.
Post-application exposure of children
can occur from three scenarios: (1)
Incidental ingestion of fipronil pellets or
granules; (2) incidental ingestion of soil
(hand to mouth) from fipronil treated
residential areas; and (3) incidental
ingestion (hand to mouth) of fipronil
from treated pets. EPA’s OPP Health
Effects Division believes that exposure
from scenario 1 is episodic and is only
a one time occurrence and episodic
exposure is not aggregated with food
and water. Exposure from scenario #3 (3
x 10-5 mg/kg/day) is greater that
scenario #2 (1.2 x 10-6 mg/kg/day) and
therefore this exposure will be
aggregated with food and water
exposure.
The short- and intermediate-term
exposure risk assessment was only
determined for the most highly exposed
subpopulation which is children 1-6
years old (Table 4). The target MOE for
short- and intermediate- term exposure
risk assessment is 300 and therefore, the
maximum allowable exposure is
0.00033 mg/kg bw/day (LOAEL, 0.1/300
safety factor). The short- and
intermediate term MOE for children 16 years of age is 707 which is greater
than 300. Also, the calculated DWLOC
is greater than the predicted chronic
surface and ground water
concentrations. Therefore, taking into
account all registered uses and the
white and sweet potato uses, it can be
concluded with reasonable certainty
that residues of fipronil and metabolites
in drinking water will not result in
short- and intermediate-term aggregate
human health risks.
TABLE 4.—SHORT- AND INTERMEDIATE-TERM AGGREGATE EXPOSURE AND DWLOC CALCULATIONS FOR CHILDREN 1–6
YEARS OLD FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND ALL EXISTING USES
Chronic
Food Exposure2, mg/
kg/day
0.00033
Residential
Exposure3,
mg/kg/day
0.0001114
Max Exposure1, mg/kg/day
Short-and
IntermediateTerm Aggregate
MOE(food
and Residential)4
0.00003
707
Maximum
Water Exposure, mg/kg/
day5
DWLOC,
ppb
0.0001886
1.886
Surface
Water6,
ppb
0.04
Ground
Water
EEC, ppb
0.061
1
Maximum Exposure (mg/kg/day) = LOAEL / Targer MOE (0.1 / 300).
2 Chronic food exposure for children 1–6 years of age is from Table 2.
3 Residential exposure is for incidental ingestion (hand to mouth) of fipronil from treated pets.
4 Aggregater MOE = [LOAEL/(chronic food exposure + residential exposure)].
5 ;Maximum water exposure (mg/kg/day) = Target maximum exposure - (Food exposure and Residential exposure).
6 The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 µg/L = 0.01 +
0.01 + 0.01 + 0.01).
c. Chronic aggregate exposure and
risk (food and water). The chronic
dietary risk associated with the existing
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fipronil uses and the proposed use of
white and sweet potatoes does not
exceed a level of concern. The estimated
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exposures for all subpopulations are ≤
56% of the cPAD (Table 2). The surface
water and ground water estimated
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concentrations were used to compare to
the DWLOC. The estimated water
concentrations are less than the
calculated DWLOC (Table 5). Therefore,
it can be concluded with reasonable
certainty that residues of fipronil and
metabolites in drinking water do not
contribute significantly to the chronic
aggregate human health risk.
TABLE 5.—CHRONIC AGGREGATE EXPOSURE FOR THE USE OF FIPRONIL ON WHITE POTATOES, SWEET POTATOES, AND
ALL EXISTING USES
cPAD,/mg/
kg/day
Population Subgroup
Dietary Exposure 1,
mg/kg/day
Allowable
Drinking
Water Exposure 2, mg/
kg/day
DWLOC,
ppb
Surface
Water 3,
ppb
Ground
Water EEC,
ppb
U.S. Population
0.0002
0.0000546
0.0001454
5.09
0.04
0.061
All Infants (< 1 year old)
0.0002
0.0000685
0.0001315
1.32
0.04
0.061
Children (1–6 years old)
0.0002
0.0001114
0.0000886
0.89
0.04
0.061
Children (7–12 years old)
0.0002
0.0000738
0.0001262
1.26
0.04
0.061
Females (13–50 years old)
0.0002
0.0000420
0.0001580
4.74
0.04
0.061
Males (13–19 years old)
0.0002
0.0000619
0.0001381
4.83
0.04
0.061
Males (20+ years old)
0.0 002
0.0 000494
0.000 1506
5. 27
0.04
0.061
Seniors (55+ years old)
0.0002
0.0000425
0.0001575
5.51
0.04
0.061
1
The dietary exposure values are from Table 2.
Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Acute Dietary Exposure (mg/kg/day).
The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 µg/L = 0.01
+ 0.01 + 0.01 + 0.01)]
2
3
2. Non-dietary exposure. The
residential exposure for fipronil
products was assessed by the U.S. EPA
in the cotton risk evaluation in 2001.
i. Pet products. The residential
exposure for the Frontline pet
products was assessed. The residential
exposure for the Frontline pet
products was determined based on the
following submitted studies: (1) Dermal
and Inhalation Exposure of Commercial
Pet Groomers During the Application of
Frontline Spray Treatment (MRID
#44433302), (2) Dermal Exposure of
Commercial Pet Groomers During the
Application of Frontline and Top
Spot (MRID 44433303), and four
studies examining the dislodgeable
residues of fipronil following the spray
and spot treatment application to dogs
and cats (MRID 4443330–09). Based on
these studies, HED determined the
dermal and inhalation exposure for
residential applicators were 3.0 x 10-3
mg/kg bw/day and 1.78 x 10-6 mg/kg
bw/day, respectively. The non-dietary,
oral (hand to mouth) was estimated to
be no greater than 3.0 x 10-5 mg/kg bw/
day. The post-application dermal
exposure for toddlers was estimated to
be 1.0 x 10-3 mg/kg bw/day. The MOEs
for all exposure scenarios evaluated
were greater than 1500.
ii. Fire ant products. The applicator
exposure was determine using the
‘‘Draft Standard Operating Procedures
for Residential Exposure’’ (December 18,
1997). The greatest homeowner
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applicator exposure was calculated from
the application of the granular product
with a drop spreader. The average daily
dose for dermal and inhalation exposure
were 6.0 x 10-4 mg/kg bw/day and 1.3
x 10-6 mg/kg bw/day, respectively. The
MOEs for all exposure scenarios were ≥
8,000.
Post-application from the fire ant
granular products can occur from
dermal exposure and ingestion of
granules from treated soil and/or
ingestion of treated soil by children.
Based on a submitted dislodgeable foliar
residue study (MRID 44506901), HED
concluded that fipronil cannot be
dislodged from treated turf and postapplication exposure from turf will not
occur. HED calculated exposure to
children from the ingestion of granules
in the treated area to be 2.8 x 10-3 mg/
kg bw/day which resulted in a MOE of
890. The post-application exposure to
children from ingestion of treated soil
was calculated to be 1.2 x 10-6 mg/kg
bw/day which resulted in a MOE of
83,000.
HED concluded that there are no risk
concerns for fipronil from the
residential uses.
D. Cumulative Effects
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
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substances that have a common
mechanism of toxicity.
The EPA is currently developing
methodology to perform cumulative risk
assessments. At this time, there are no
available data to determine whether
fipronil has a common mechanism of
toxicity with other substances or how to
include this pesticide in a cumulative
risk assessment.
E. Safety Determination
1. U.S. population. Based on this risk
assessment, BASF concludes that there
is a reasonable certainty that no harm
will result to the general population
from the aggregate exposure to fipronil.
2. Infants and children. Based on this
risk assessment, BASF concludes that
there is a reasonable certainty that no
harm will result to infants or children
from the aggregate exposure to fipronil
residues.
F. International Tolerances
The following maximum residue
levels (MRLs) have been established by
the Codex Alimentarius Commission
(CODEX) for fipronil residues on the
following plant commodities: banana,
0.005 mg/kg; barley 0.002 mg/kg;
cabbage, head, 0.02 mg/kg; flowerhead
brassicas, 0.02 mg/kg; maize 0.01 mg/kg;
maize fodder 0.1 mg/kg; maize forage
0.1; oats, 0.002 mg/kg; potato 0.02 mg/
kg; rice 0.01 mg/kg; rice, straw and
fodder, dry, 0.2 mg/kg; rye 0.002 mg/kg;
sugar beet 0.2 mg/kg; sugar beet leaves
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or tops, 0.2 mg/kg; sunflower seed,
0.002 mg/kg; triticale, 0.002 mg/kg;
wheat 0.002 mg/kg.
The following maximum residue
levels (MRLs) have been established by
the Codex Alimentarius Commission
(CODEX) for fipronil residues on the
following animal commodities: cattle,
kidney 0.02 mg/kg; cattle liver 0.1 mg/
kg; cattle meat 0.05 mg/kg; eggs 0.02
mg/kg; poultry meat 0.01 mg/kg;
poultry, edible offal, 0.02 mg/kg.
[FR Doc. 05–16807 Filed 8–23–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0212; FRL–7728–3]
Emamectin; 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–
0212, must be received on or before
September 23, 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:
Thomas Harris, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9423; e-mail
address:harris.thomas@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)
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
• 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–
0212. 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.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
49607
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
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49599-49607]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16807]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0206; FRL-7726-3]
Fipronil; 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-
2005-0206, must be received on or before September 23, 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: Ann Sibold, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703 305-6502; e-mail address:sibold.ann@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 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
[[Page 49600]]
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-2005-0206. 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 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 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-2005-0206. 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-2005-0206. 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.
[[Page 49601]]
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-2005-0206.
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-2005-0206. 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 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: August 15, 2005.
Donald R. Stubbs,
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.
BASF Corporation
5F6948 and 2E6490
EPA has received a pesticide petition (5F6948) from BASF
Corporation, P.O. Box 13528, Research Triangle Park, NC 27709
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 180.517 by
establishing a tolerance for residues of mixture comprising fipronil,
5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(1R,S)-
(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile and its
metabolites 5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-
[(trifluoromethyl) sulfonyl]-1H-pyrazole-3-carbonitrile and 5-amino-1-
[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(trifluoromethyl)thio]-1H-
pyrazole-3-carbonitrile and its photodegradate 5-amino-1-[2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile in or on the raw agricultural commodity corm vegetables
(crop group 1-C at 0.04 parts per million (ppm), and indirect and
inadvertent residues on wheat, grain at 0.005 and wheat, forage at 0.02
ppm and wheat, hay and straw at 0.03 ppm. EPA has received a pesticide
petition 2E6490 from The Interregional Research Project No. 4 (IR-4),
Technology Centre of New Jersey, Rutgers, the State University of New
Jersey, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390
proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d),
to amend 40 CFR 180.517 by establishing a tolerance for residues of
mixture comprising fipronil, 5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(1R,S)-trifluoromethyl)sulfinyl]-1H-
pyrazole-3-carbonitrile) and its metabolites 5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(trifluoromethyl) sulfonyl]-1H-pyrazole-3-
carbonitrile and 5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-
[(trifluoromethyl)thio]-H-pyrazole-3-carbonitrile and its
photodegradate 5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-
[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-carbonitrile in or on the raw
agricultural commodities onion (dry bulb), garlic, shallot (dry bulb)
at 0.02 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 metabolism of fipronil is adequately
understood. Adequate data on the nature of the residues in both plant
and animals, including identification of major
[[Page 49602]]
metabolites and degradates of fipronil, are available. In plants and
animal the metabolism of fipronil proceeds via oxidation of the
sulfoxide to yield sulfone and hydrolysis of nitrile to yield the
amide. Fipronil and its sulfone and amide constitute greater than 75%
of the identified residues in all studies. A limited amount of
reduction of sulfoxide to yield the sulfide occurs in some cases.
Further transformation of primary metabolites affords minor amounts of
carboxylic acid, the amide and the 4-protopyrazole.
2. Analytical method. Validated analytical methods are available
for detecting and measuring levels of fipronil and its metabolites in
onion, dry bulb, potato (corm vegetables) and its processing fractions
and wheat grain, forage, hay, and straw. The Method utilizes Capillary
Gas Chromatography equipped with a Ni electron capture detector. The
Limit of Quantitation (LOQ) for all potato matrices is 0.003 ppm for
all analytes. The LOQ for onion is 0.005 for all analytes.
3. Magnitude of residues. Field trials were carried out in order to
determine the magnitude of residue in potato. Field trials were
conducted in the required regions. Field trials were carried out using
the maximum label rate of 0.1 lbs active ingredient (a.i.) per acre
applied in furrow followed by four sequential foliar applications at
0.05 lbs a.i. per acre. The results demonstrate that any residue
present would originate from the in-furrow not the foliar applications.
In addition a processing study was conducted on potatoes. Onion field
trials were conducted in the required regions. The application was by
seed treatment at 25 grams of active ingredient/kilogram (g a.i./Kg) of
seed. Twelve field trials were conducted where wheat was planted
following application to primary crops. Applications rates were 0.13
lbs a.i. per acre in-furrow for six corn trials and 0.2 lbs a.i. per
acre foliar for six cotton trials.
B. Toxicological Profile
1. Acute toxicity. For technical fipronil:
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Oral LD50 Rat LD50 = 97 mg/kg b.w. category II/(moderately
toxic)
--------------------------------------
Dermal LD50 Rat LD50 >2,000 mg/kg b.w. category III (slightly
(HDT) toxic)
--------------------------------------
Dermal LD50 Rabbit LD50 = 354 mg/kg b.w. category II(moderately
toxic)
--------------------------------------
Inhalation LC50 Rat LC50 = 0.39 mg/L category II(moderately
toxic)
--------------------------------------
Eye Irritation Rabbit slight irritation category III
--------------------------------------
Skin Irritation Rabbit slight irritation category IV
--------------------------------------
Skin Sensitization (Maximization Guinea pig Not sensitizing .......................
Test)
--------------------------------------
Acute Neurotoxicity Rat NOAEL = 2.5 mg/kg/day .......................
(for general toxicity)
----------------------------------------------------------------------------------------------------------------
2. Genotoxicity. Fipronil was negative in both in vitro and in vivo
assays conducted to investigate gene mutations, DNA damage, and
chromosomal aberrations.
3. Reproductive and developmental toxicity. The developmental
toxicity NOELs in the rat and rabbit were 20 mg/kg/day (HDT) and 1 mg/
kg/day (HDT), respectively. Maternal toxicity was observed in the rat
at the HDT as evidenced by decreased body weight gain and food
efficiency. In the rabbit, the maternal toxicity NOAEL was less than
0.1 mg/kg/day, based on reduced body weight gain and food efficiency at
all dose levels tested. In a two-generation rat study, the NOEL for
parental (systemic) toxicity was 3 ppm (0.26 mg/kg/day for both sexes
combined), based on increased weight of the thyroid glands and liver in
males and females, decreased weight of the pituitary gland in females,
and an increased incidence of follicular epithelial hypertrophy in
females at 30 ppm. The NOEL for reproductive toxicity was 30 ppm (2.64
mg/kg/day for both sexes combined), based on clinical signs of toxicity
in pups, decreased litter size, decreased pup body weights, decreased
mating, decreased fertility index, reduced pre- and postnatal survival,
and delays in physical development at 300 ppm (26.03 and 28.40 mg/kg/
day for males and females, respectively).
In a developmental neurotoxicity study in the rat, the NOAEL for
maternal toxicity was 10 ppm (0.91 mg/kg/day), based on decreased body
weights and body weight gain at 200 ppm (HDT; 15 mg/kg/day).
Considerable maternal toxicity at the HDT prevented adequate
neurotoxicity evaluation of pups at this dose level. There was no
evidence of neurotoxicity at 10 ppm (0.91 mg/kg/day), which was the
NOAEL for developmental neurotoxicity. The NOAEL for general
developmental toxicity was 0.5 ppm (0.05 mg/kg/day), based on systemic
effects consisting of decreases in pup weights during lactation and
increases in time of preputial separation in males at 10 ppm.
4. Subchronic toxicity. The NOAEL for systemic toxicity in rat was
5 ppm (0.35 mg/kg/day for both sexes combined), based on alterations in
serum protein values and increased weight of the liver and thyroid at
30 ppm (1.93 and 2.28 mg/kg/day for males and females, respectively).
The NOAELs in the dog were 2 and 0.5 mg/kg/day for male and female,
respectively, based on clinical signs of toxicity in males at 10 mg/kg/
day and clinical signs of toxicity and decreased body weight gain in
females at 2 mg/kg/day. The NOAEL for mice was 10 ppm (1.27 and 1.72
mg/kg/day for males and females, respectively), based on a possible
decreased body weight gain at 25 ppm (3.2 and 4.53 mg/kg/day for males
and females, respectively). A repeated dose dermal study in the rabbit
had a systemic NOAEL of 5 mg/kg/day, based on decreased body weight
gain and food consumption at 10 mg/kg/day, and a dermal irritation NOEL
of 10.0 mg/kg/day (HDT).
In a subchronic neurotoxicity study in rats, the NOEL was 5 ppm
(0.301 and 0.351 mg/kg/day for males and females, respectively), based
on results of the functional observational battery (FOB) at 150 ppm
(8.89 and 10.8 mg/kg/day for males and females, respectively).
5. Chronic toxicity. The NOAEL for systemic toxicity in a 1-year
feeding study in the dog was 0.3 mg/kg/day in females and 1 mg/kg/day
in males,
[[Page 49603]]
based on clinical signs of neurotoxicity at 1 and 2 mg/kg/day in
females and males, respectively. The NOAEL for systemic toxicity in
mice was 0.5 ppm (0.06 mg/kg/day) based on decreased body weight gain,
decreased food conversion efficiency in males, increased liver weights,
and liver histopathology at 10 ppm (1.3 mg/kg/day). Fipronil was not
carcinogenic when administrated to mice at dose levels up to 60 ppm.
The NOAEL in a 2-year dietary study in the rat was 0.5 ppm (0.019 and
0.025 mg/kg/day for males and females, respectively) based on clinical
signs of toxicity and alterations in clinical chemistry and thyroid
parameters at 1.5 ppm (0.059 and 0.078 mg/kg/day for males and females,
respectively). The EPA's Health Effects Division Carcinogenicity Peer
Review Committee classified fipronil in Group C - Possible Human
Carcinogen, based on thyroid tumors observed in rats at 300 ppm (HDT).
Mechanistic data indicate that these tumors are related to a disruption
in the thyroid-pituitary status and are specific to the rat. In
addition, there was no apparent concern for mutagenic activity. Thus,
it was recommended that RfD methodology, i.e. non-linear or threshold,
be used for the estimation of human risk.
6. Animal metabolism. The metabolism of fipronil is adequately
understood. Adequate data on the nature of residues in both plants and
animals, including identification of major metabolites and degradates
of fipronil, are available. In plants and animals the metabolism of
fipronil proceeds via oxidation of the sulfoxide to yield sulfone and
hydrolysis of nitrile to yield the amide. Fipronil and its sulfone and
amide constitute greater than 75% of the identified residues in all
studies. A limited amount of reduction of sulfoxide to yield the
sulfide occurs in some cases. Further transformation of the primary
metabolites affords minor amounts of the carboxylic acid, the amide and
the 4-protiopyrazole.
7. Metabolite toxicology. MB46513 photodegradate acute oral
toxicity:
------------------------------------------------------------------------
------------------------------------------------------------------------
Oral LD50 Rat LD50 = 16 mg/ category I (highly
kg b.w. toxic)
---------------------------------
Dermal LD50 Rabbit LD50 > category III
2,000 mg/kg b.w. (slightly toxic)
(HDT)
------------------------------------------------------------------------
i. Acute neurotoxicity. The NOEL was 2 mg/kg, based on decreases in
body weight gain and food consumption in males and females during the
week following treatment, decreases in locomotor activity, hind-limb
splay and rectal temperature 6-hour post dosing in males and females,
and decreases in the proportion of males with an immediate righting
reflex on days 7 and 14, at 12 mg/kg/day.
In a rat developmental toxicity study, the NOEL was 1 mg/kg/day,
based on the slight increase in fetal and litter incidence of reduced
ossification of several bones at 2.5 mg/kg/day.
ii. Subchronic toxicity. The NOAEL in the rat was 3 ppm (0.18 and
0.21 mg/kg/day in males and females, respectively), based on clinical
signs of toxicity in both sexes and decreased body weight and body
weight gain in males at 10 ppm. The NOEL for the mouse was 0.5 ppm
(0.08 mg/kg/day), based on the aggressive and irritable behavior with
increased motor activity in males at 2 ppm. The NOEL for the dog was
9.5 ppm (0.29 mg/kg/day), based on behavioral changes in females at 35
ppm (1.05 mg/kg/day).
The rat chronic/carcinogenicity study was negative for
carcinogenicity. The LOAEL for females was 0.5 ppm (0.032 mg/kg/day),
based on clinical signs of toxicity. There was no NOEL established. For
males, the NOAEL was 2 ppm (0.098 mg/kg/day), based on clinical signs
of toxicity, and stomach and lung histopathology at 10 ppm (0.497 mg/
kg/day). No thyroid effects are observed in any of the rat, mouse or
dog studies with MB46513, supporting the conclusion that there is no
concern for cancer due to exposure to MB46513.
8. Endocrine disruption. Data from the reproduction/ developmental
toxicity and short- and long-term repeated dose toxicity studies with
fipronil in the rat, rabbit, mouse, or dog, do not suggest any
endocrine disruption activity. This information is based on the absence
of any treatment-related effects from the histopathological examination
of reproductive organs as well as the absence of possible effects on
fertility, reproductive performance, or any other aspect of
reproductive function, or on growth and development of the offspring.
Evidence of offspring toxicity was observed only in the presence of
significant parental toxicity. Fipronil disrupts the thyroid-pituitary
axis. However, mechanistic studies have demonstrated that fipronil
decreases thyroid hormone levels in long-term studies via increased
clearance, rather than a direct effect on the thyroid. Concerns related
to long-term exposure of fipronil are addressed in human risk
estimates, as the chronic RfD (0.0002 mg/kg/day) is based on endpoints
that include thyroid hormone related effects in rats.
C. Aggregate Exposure
1. Dietary exposure. An assessment was conducted to determine the
acute and chronic exposure of all population sub-groups to residues of
fipronil. Tolerance values have previously been established and are
listed in 40 CFR 180.517.
This analysis included all crops with established tolerance values
and the proposed new crops of white potato, sweet potato, onion bulb,
garlic, shallot bulb and the inadvertent residue tolerance on wheat
grain. The dietary exposure assessment for crops with established
tolerances was conducted by the U.S. Environmental Protection Agency in
2001 (PP 7F04832. Fipronil in/on Cotton. HED Risk Assessment.
Barcode D248827; PC Code 129121; Case 288765 ; submission S547814).
Using these dietary exposure values is conservative because the
registration for fipronil on cotton was withdrawn, and the dietary
exposure assessment conducted by HED included all currently registered
uses and the proposed cotton use. Using the HED exposure values is
conservative (overestimates actual exposure) because the cotton use and
all requested modifications to existing tolerances were included in the
dietary exposure assessment.
The dietary exposure assessment for white potato, sweet potato,
onion bulb, garlic, and shallot bulb were conducted using tolerance
level residues, default processing factors, and 100% crop treated
factors. These assumptions are conservative because it assumes all
commodities will be at tolerance level and 100% of the crop has been
treated with fipronil. The dietary exposure assessment for the
inadvertent residues in wheat grain was conducted using tolerance level
residues, default processing factors, and a 7% crop treatment factor.
The U.S. EPA used a 7% crop treatment factor for corn in the dietary
exposure assessment. The tolerance for wheat grain is from inadvertent
residues that would occur when wheat is planted following a fipronil
treatment of corn. Therefore, the 7% crop treatment factor applies to
wheat inadvertent residues.
The dietary exposure assessments were conducted using the Dietary
Exposure Evaluation Model software with Food Commodity Intake Database
(DEEM-FCID).
i. Food--a. Acute dietary exposure assessment. The acute population
adjusted dose (aPAD) used was 0.025 mg/kg bw/day. Using the exposure
[[Page 49604]]
assumptions discussed above, the maximum fipronil acute dietary
exposure from food is 11% aPAD. The results of the acute dietary
assessment are presented in Table 1.
Table 1.--Combination of the Acute DEEMTM Dietary Analysis at 95th
Percentile for Fipronil Conducted by the US EPA for Existing Uses and
BASF for the Use on White and Sweet Potatoes
------------------------------------------------------------------------
Exposure (mg/
Subgroups kg bw/day) % aPAD\a\
------------------------------------------------------------------------
U.S. Population 0.001495 6
--------------------------------------------
All Infants (<1 year old) 0.002502 10
--------------------------------------------
Children (1-6 years old) 0.002859 11
--------------------------------------------
Children (7-12 years old) 0.001814 7
--------------------------------------------
Females (13-50 years old) 0.0009342 4
--------------------------------------------
Males (13-19 years old) 0.001332 5
--------------------------------------------
Males (20+ years old) 0.000962 4
--------------------------------------------
Seniors (55+ years old) 0.0007642 3
------------------------------------------------------------------------
\a\ The aPAD = 0.025 mg/kg bw/day.
b. Chronic dietary exposure assessment. The chronic population
adjusted dose (cPAD) used was 0.0002 mg/kg bw/day. Using the exposure
assumptions discussed above, the maximum fipronil chronic dietary
exposure from food is 56% cPAD. The results of the chronic dietary
assessment are presented in Table 2.
Table 2.--Combination of the Chronic DEEM TM Dietary Analysis for
Fipronil Conducted by the U.S. EPA for Existing Uses and BASF for the
Use on White and Sweet Potatoes
------------------------------------------------------------------------
Exposure
Subgroups (mg/kg bw/ % cPAD\a\
day)
------------------------------------------------------------------------
U.S. Population 0.0000546 27
-----------------------------------------------
All Infants (< 1 year old) 0.0000685 34
-----------------------------------------------
Children (1-6 years old) 0.0001114 56
-----------------------------------------------
Children (7-12 years old) 0.0000738 37
-----------------------------------------------
Females (13-50 years old) 0.0000420 21
-----------------------------------------------
Males (13-19 years old) 0.0000619 31
-----------------------------------------------
Males (20+ years old) 0.0000494 25
-----------------------------------------------
Seniors (55+ years old) 0.0000425 21
------------------------------------------------------------------------
\a\ The cPAD = 0.0002 mg/kg bw/day.
ii. Drinking water. The drinking water values used for comparison
to the DWLOC (Drinking Water Level of Comparison) can be calculated
from model estimates or actual monitoring data. When modeling was
conducted, the currently registered corn use resulted in the highest
predicted estimated water concentrations. If monitoring data is
available it can be used instead of model predictions. A drinking water
monitoring study for fipronil and relevant metabolites in surface water
from the corn growing regions has beenconducted (MRID 45526101).
Therefore, these actual measured drinking water values will be used in
the drinking water assessment. The ground water values model by the EPA
when the cotton use was examined will also be used for comparison.
Based on the tier I screening model SCI-GROW (screening concentration
in ground water), the acute ground water value will not exceed 0.061
ppb (0.032 [mu]g/L for fipronil, 0.012 [mu]g/L for MB46136, 0.016
[mu]g/L for MB46513, and 0.001 [mu]g/L for MB45950). This value of
0.061 ppb is also used for chronic ground water comparisons.
In the drinking water monitoring study, water samples were
collected from 12 municipal water treatment facilities. The water
treatment facilities were selected based on the source of water and the
previousdocumented use of fipronil in the watershed area. Raw and
finished water samples were collect at each water treatment site. The
samples were collected on regular intervals between April and August.
The water samples wereanalyzed for firponil and metabolites: MB45950,
MB46136, and MB46513. The LOQ for the method was 10 parts per trillion
(ppt) and the LOD was 4 ppt. No residues were detected in any of the
finished water samples and no confirmed fipronil-related residues were
found in any of the raw samples. This study showed that the use of
fipronil in corn production does not pose a risk to surface drinking
water.
a. Acute aggregate exposure and risk (food and water). The acute
dietary risk associated with the existing fipronil uses and the
proposed use of white and sweet potatoes does not exceed a level of
concern. The estimated exposure at the 95th percentile uses
<= 11% of the aPAD (Table 1). The surface water and ground water
estimated concentrations were used to compare to the DWLOC. The
estimated water concentrations are less than the calculated DWLOC
(Table 3). Therefore, it can be concluded with reasonable certainty
that residues of fipronil and metabolites in drinking water do not
contribute significantly to the acute aggregate human health risk.
Table 3.--Acute Aggregate Exposure for the Use of Fipronil on White Potatoes, Sweet Potatoes, and all Existing
Uses
----------------------------------------------------------------------------------------------------------------
Allowable
Dietary Drinking Surface Ground
Population Subgroup aPAD mg/kg/ Exposure\1\, Water DWLOC, ppb Water\3\, Water EEC,
day mg/kg/day Exposure\2\, ppb ppb
mg/kg/day
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.025 0.001495 0.023505 823 0.04 0.061
---------------------------------
All Infants (< 1 year old) 0.025 0.002502 0.022498 225 0.04 0.061
---------------------------------
[[Page 49605]]
Children (1-6 years old) 0.025 0.002859 0.022141 221 0.04 0.061
---------------------------------
Children (7-12 years old) 0.025 0.001814 0.023186 232 0.04 0.061
---------------------------------
Females (13-50 years old) 0.025 0.0009342 0.024066 722 0.04 0.061
---------------------------------
Males (13-19 years old) 0.025 0.001332 0.023668 828 0.04 0.061
---------------------------------
Males (20+ years old) 0.025 0.000962 0.024038 841 0.04 0.061
---------------------------------
Seniors (55+ years old) 0.025 0.0007642 0.024236 848 0.04 0.061
----------------------------------------------------------------------------------------------------------------
\1\ The dietary exposure values are from Table 1.
\2\ Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Acute Dietary Exposure (mg/kg/day).
\3\ The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and
MB46513 (0.04 [mu]g/L = 0.01 + 0.01 + 0.01 + 0.01).
b. Short- and intermediate-term aggregate exposure and risk (food,
water and residential exposure). Short- and intermediate-term aggregate
exposure takes into account residential exposure plus chronic exposure
from food and water. Aggregation of systemic oral, dermal and
inhalation exposure from the residential use is not appropriate due to
differences in the toxicity endpoints observed between oral
(neurotoxicity and alterations in clinical chemistry and thyroid
parameters), dermal (decrease in body weight gain and food consumption)
and inhalation (developmental effects including decreases in pup
weights during lactation and increases in time of preputial separation)
routes. Also, there is no significant post-application exposure to
adults. However, post-application exposure to children is included in
the exposure assessment.
Post-application exposure of children can occur from three
scenarios: (1) Incidental ingestion of fipronil pellets or granules;
(2) incidental ingestion of soil (hand to mouth) from fipronil treated
residential areas; and (3) incidental ingestion (hand to mouth) of
fipronil from treated pets. EPA's OPP Health Effects Division believes
that exposure from scenario 1 is episodic and is only a one time
occurrence and episodic exposure is not aggregated with food and water.
Exposure from scenario 3 (3 x 10-5 mg/kg/day) is
greater that scenario 2 (1.2 x 10-6 mg/kg/day) and
therefore this exposure will be aggregated with food and water
exposure.
The short- and intermediate-term exposure risk assessment was only
determined for the most highly exposed subpopulation which is children
1-6 years old (Table 4). The target MOE for short- and intermediate-
term exposure risk assessment is 300 and therefore, the maximum
allowable exposure is 0.00033 mg/kg bw/day (LOAEL, 0.1/300 safety
factor). The short- and intermediate term MOE for children 1-6 years of
age is 707 which is greater than 300. Also, the calculated DWLOC is
greater than the predicted chronic surface and ground water
concentrations. Therefore, taking into account all registered uses and
the white and sweet potato uses, it can be concluded with reasonable
certainty that residues of fipronil and metabolites in drinking water
will not result in short- and intermediate-term aggregate human health
risks.
Table 4.--Short- and Intermediate-Term Aggregate Exposure and DWLOC Calculations for Children 1-6 years old for the Use of Fipronil on White Potatoes,
Sweet Potatoes, and all Existing Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Short-and Maximum
Chronic Food Residential Intermediate- Water Surface Ground
Max Exposure\1\, mg/kg/day Exposure\2\, Exposure\3\, Term Aggregate Exposure, DWLOC, ppb Water\6\, Water
mg/kg/day mg/kg/day MOE (food and mg/kg/ ppb EEC, ppb
Residential)\4\ day\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.00033 0.0001114 0.00003 707 0.0001886 1.886 0.04 0.061
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Maximum Exposure (mg/kg/day) = LOAEL / Targer MOE (0.1 / 300).
\2\ Chronic food exposure for children 1-6 years of age is from Table 2.
\3\ Residential exposure is for incidental ingestion (hand to mouth) of fipronil from treated pets.
\4\ Aggregater MOE = [LOAEL/(chronic food exposure + residential exposure)].
\5\ ;Maximum water exposure (mg/kg/day) = Target maximum exposure - (Food exposure and Residential exposure).
\6\ The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and MB46513 (0.04 [mu]g/L = 0.01 + 0.01 +
0.01 + 0.01).
c. Chronic aggregate exposure and risk (food and water). The
chronic dietary risk associated with the existing fipronil uses and the
proposed use of white and sweet potatoes does not exceed a level of
concern. The estimated exposures for all subpopulations are <= 56% of
the cPAD (Table 2). The surface water and ground water estimated
[[Page 49606]]
concentrations were used to compare to the DWLOC. The estimated water
concentrations are less than the calculated DWLOC (Table 5). Therefore,
it can be concluded with reasonable certainty that residues of fipronil
and metabolites in drinking water do not contribute significantly to
the chronic aggregate human health risk.
Table 5.--Chronic Aggregate Exposure for the Use of Fipronil on White Potatoes, Sweet Potatoes, and all Existing
Uses
----------------------------------------------------------------------------------------------------------------
Allowable
Dietary Drinking
cPAD,/mg/kg/ Exposure Water Surface Ground
Population Subgroup day \1\, mg/kg/ Exposure DWLOC, ppb Water \3\, Water EEC,
day \2\, mg/kg/ ppb ppb
day
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.0002 0.0000546 0.0001454 5.09 0.04 0.061
-----------------------------------
All Infants (< 1 year old) 0.0002 0.0000685 0.0001315 1.32 0.04 0.061
-----------------------------------
Children (1-6 years old) 0.0002 0.0001114 0.0000886 0.89 0.04 0.061
-----------------------------------
Children (7-12 years old) 0.0002 0.0000738 0.0001262 1.26 0.04 0.061
-----------------------------------
Females (13-50 years old) 0.0002 0.0000420 0.0001580 4.74 0.04 0.061
-----------------------------------
Males (13-19 years old) 0.0002 0.0000619 0.0001381 4.83 0.04 0.061
-----------------------------------
Males (20+ years old) 0.0 002 0.0 000494 0.000 1506 5. 27 0.04 0.061
-----------------------------------
Seniors (55+ years old) 0.0002 0.0000425 0.0001575 5.51 0.04 0.061
----------------------------------------------------------------------------------------------------------------
\1\ The dietary exposure values are from Table 2.
\2\ Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Acute Dietary Exposure (mg/kg/day).
\3\ The surface water concentration is the sum of the LOQ for fipronil, and metabolites: MB45950, MB46136, and
MB46513 (0.04 [mu]g/L = 0.01 + 0.01 + 0.01 + 0.01)]
2. Non-dietary exposure. The residential exposure for fipronil
products was assessed by the U.S. EPA in the cotton risk evaluation in
2001.
i. Pet products. The residential exposure for the Frontline[reg]
pet products was assessed. The residential exposure for the
Frontline[reg] pet products was determined based on the following
submitted studies: (1) Dermal and Inhalation Exposure of Commercial Pet
Groomers During the Application of Frontline[reg] Spray Treatment (MRID
44433302), (2) Dermal Exposure of Commercial Pet Groomers
During the Application of Frontline[reg] and Top Spot[reg] (MRID
44433303), and four studies examining the dislodgeable residues of
fipronil following the spray and spot treatment application to dogs and
cats (MRID 4443330-09). Based on these studies, HED determined the
dermal and inhalation exposure for residential applicators were 3.0 x
10-3 mg/kg bw/day and 1.78 x 10-6 mg/kg bw/day,
respectively. The non-dietary, oral (hand to mouth) was estimated to be
no greater than 3.0 x 10-5 mg/kg bw/day. The post-
application dermal exposure for toddlers was estimated to be 1.0 x
10-3 mg/kg bw/day. The MOEs for all exposure scenarios
evaluated were greater than 1500.
ii. Fire ant products. The applicator exposure was determine using
the ``Draft Standard Operating Procedures for Residential Exposure''
(December 18, 1997). The greatest homeowner applicator exposure was
calculated from the application of the granular product with a drop
spreader. The average daily dose for dermal and inhalation
exposure were 6.0 x 10-4 mg/kg bw/day and 1.3 x
10-6 mg/kg bw/day, respectively. The MOEs for all exposure
scenarios were >= 8,000.
Post-application from the fire ant granular products can occur from
dermal exposure and ingestion of granules from treated soil and/or
ingestion of treated soil by children. Based on a submitted
dislodgeable foliar residue study (MRID 44506901), HED concluded that
fipronil cannot be dislodged from treated turf and post-application
exposure from turf will not occur. HED calculated exposure to children
from the ingestion of granules in the treated area to be 2.8 x
10-3 mg/kg bw/day which resulted in a MOE of 890. The post-
application exposure to children from ingestion of treated soil was
calculated to be 1.2 x 10-6 mg/kg bw/day which resulted in a
MOE of 83,000.
HED concluded that there are no risk concerns for fipronil from the
residential uses.
D. Cumulative Effects
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 is currently developing methodology to perform cumulative
risk assessments. At this time, there are no available data to
determine whether fipronil has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment.
E. Safety Determination
1. U.S. population. Based on this risk assessment, BASF concludes
that there is a reasonable certainty that no harm will result to the
general population from the aggregate exposure to fipronil.
2. Infants and children. Based on this risk assessment, BASF
concludes that there is a reasonable certainty that no harm will result
to infants or children from the aggregate exposure to fipronil
residues.
F. International Tolerances
The following maximum residue levels (MRLs) have been established
by the Codex Alimentarius Commission (CODEX) for fipronil residues on
the following plant commodities: banana, 0.005 mg/kg; barley 0.002 mg/
kg; cabbage, head, 0.02 mg/kg; flowerhead brassicas, 0.02 mg/kg; maize
0.01 mg/kg; maize fodder 0.1 mg/kg; maize forage 0.1; oats, 0.002 mg/
kg; potato 0.02 mg/kg; rice 0.01 mg/kg; rice, straw and fodder, dry,
0.2 mg/kg; rye 0.002 mg/kg; sugar beet 0.2 mg/kg; sugar beet leaves
[[Page 49607]]
or tops, 0.2 mg/kg; sunflower seed, 0.002 mg/kg; triticale, 0.002 mg/
kg; wheat 0.002 mg/kg.
The following maximum residue levels (MRLs) have been established
by the Codex Alimentarius Commission (CODEX) for fipronil residues on
the following animal commodities: cattle, kidney 0.02 mg/kg; cattle
liver 0.1 mg/kg; cattle meat 0.05 mg/kg; eggs 0.02 mg/kg; poultry meat
0.01 mg/kg; poultry, edible offal, 0.02 mg/kg.
[FR Doc. 05-16807 Filed 8-23-05; 8:45 am]
BILLING CODE 6560-50-S
