[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49599-49607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16807]


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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.

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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:<a href="/cdn-cgi/l/email-protection#84f7ede6ebe8e0aae5eaeac4e1f4e5aae3ebf2"><span class="__cf_email__" data-cfemail="23504a414c4f470d424d4d634653420d444c55">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111)
    <bullet> Animal production (NAICS 112)
    <bullet> Food manufacturing (NAICS 311)
    <bullet> 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 <greek-i>2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or 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 http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select`` ``search,'' and then key in docket ID 
number OPP-2005-0206. 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 <a href="/cdn-cgi/l/email-protection#117e61613c757e727a7465517461703f767e67"><span class="__cf_email__" data-cfemail="771807075a1318141c12033712071659101801">[email protected]</span></a>, 
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 
<greek-i>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<greek-i> 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 95<SUP>th</SUP> 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 <greek-i>3 (3 x 10<SUP>-5</SUP> mg/kg/day) is 
greater that scenario <greek-i>2 (1.2 x 10<SUP>-6</SUP> 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 
<greek-i>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<SUP>-3</SUP> mg/kg bw/day and 1.78 x 10<SUP>-6</SUP> mg/kg bw/day, 
respectively. The non-dietary, oral (hand to mouth) was estimated to be 
no greater than 3.0 x 10<SUP>-5</SUP> mg/kg bw/day. The post-
application dermal exposure for toddlers was estimated to be 1.0 x 
10<SUP>-3</SUP> 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<SUP></SUP>. The average daily dose for dermal and inhalation 
exposure were 6.0 x 10<SUP>-4</SUP> mg/kg bw/day and 1.3 x 
10<SUP>-6</SUP> 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<SUP>-3</SUP> 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<SUP>-6</SUP> 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


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