Document ID: EPA-HQ-OPP-2005-0206-0003
Agency: epa
Document Type: Rule
Title: Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Fipronil
Posted Date: 2007-08-22T04:00Z

[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Rules and Regulations]               
[Page 46906-46914]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au07-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0206; FRL-8142-6]

 
Fipronil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of fipronil and its two metabolites and one photodegradate in or on 
potato and potato, wet peel, and indirect or inadvertent residues of 
fipronil and its two metabolites and one photodegradate in or on wheat, 
forage; wheat, grain;

[[Page 46907]]

wheat, hay; and wheat, straw. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In 
addition, this establishes time-limited tolerances for combined 
residues of fipronil in or on turnip and rutabaga. This action is in 
response to EPA's granting of emergency exemptions under section 18 of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on turnip and rutabaga. This 
regulation establishes maximum permissible levels for combined residues 
of fipronil in these food commodities. The tolerances for rutabaga and 
turnip expire and are revoked on December 31, 2010.

DATES: This regulation is effective August 22, 2007. Objections and 
requests for hearings must be received on or before October 22, 2007, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0206. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division 
(7505P), 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 are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2005-0206 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before October 22, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2005-0206, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerances

    In the Federal Register of August 24, 2005 (70 FR 49599) (FRL-7726-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5F6948) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.517 be amended by 
establishing tolerances for combined residues of the insecticide 
fipronil, 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-
((1,R,S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 
2 metabolites, MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-

[[Page 46908]]

[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile), and 
photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in or on vegetable, tuberous , corm, subgroup 1C at 0.04 
parts per million (ppm) and potato, wet peel at 0.4 ppm and indirect or 
inadvertent residues of the insecticide fipronil, 5-amino-1-(2,6-
dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-
trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2 
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-
carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in or on wheat, forage at 0.04 ppm, wheat, grain at 0.04 
ppm, wheat, hay at 0.04 ppm, and wheat, straw at 0.04 ppm. That notice 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, which is available to the public in the docket, http://www.regulations.gov.
 One comment was received on the notice of filing. 

EPA's response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance for vegetable tuberous corm crop subgroup 1C to 
limit it to potato. The reason for these changes is explained in Unit 
V.
    EPA is also establishing time-limited tolerances for combined 
residues of the insecticide fipronil, in or on turnip and rutabaga at 
1.0 ppm. These tolerances expire and are revoked on December 31, 2010. 
The tolerances are being established in response to EPA's authorization 
to the Oregon Department of Agriculture, for the emergency use of 
fipronil to control the cabbage maggot, a highly damaging pest to root 
crops, in these crops, under a FIFRA section 18 specific exemption. The 
request was based upon three factors:
    1. A recent severe increase in cabbage maggot populations.
    2. The apparent increasing resistance of the maggot to the 
organophosphate registered alternative.
    3. Phytotoxicity of the organophosphate alternative to the emerging 
seedlings.
    The Applicant stated that significant economic losses would occur 
without the requested use of fipronil under an emergency exemption. 
After having reviewed the submission, EPA concurs that emergency 
conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fipronil in or on rutabaga 
and turnip. In doing so, EPA considered the safety standard in section 
408(b)(2) of FFDCA, and EPA decided that the necessary tolerances under 
section 408(l)(6) of FFDCA would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing these tolerances without notice and opportunity for public 
comment as provided in section 408(l)(6) of the FFDCA. Although the 
tolerances expire and are revoked on December 31, 2010, under section 
408(l)(5) of FFDCA, residues of the pesticide not in excess of the 
amounts specified in the tolerances remaining in or on rutabaga and 
turnip after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed levels that were authorized by these tolerances at the time 
of that application. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because the rutabaga and turnip tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
fipronil meets EPA's registration requirements for use on rutabaga and 
turnip or whether permanent tolerances for these uses would be 
appropriate. Under these circumstances, EPA does not believe that these 
tolerances serve as a basis for registration of fipronil by a State for 
special local needs under FIFRA section 24(c). Nor do these tolerances 
serve as the basis for any State other than Oregon to use this 
pesticide on these crops under section 18 of FIFRA without following 
all provisions of EPA's regulations implementing FIFRA section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemptions for fipronil, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerances 
for combined residues of fipronil and its metabolites and its degradate 
on potato at 0.03 ppm and potato, wet peel at 0.10 ppm and indirect or 
inadvertent residues of fipronil and its metabolites and its degradate 
on wheat, forage at 0.02 ppm, wheat, grain at 0.005 ppm, wheat, hay at 
0.03 ppm, and wheat, straw at 0.03 ppm, and the tolerances to support 
authorization of an emergency exemption on turnip at 1.0 ppm and 
rutabaga at 1.0 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by fipronil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
 The referenced document, ``Fipronil:

[[Page 46909]]

Third Reevaluation--Report of the Hazard Identification Assessment 
Review Committee, December 6, 2000,'' is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2005-0206 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable uncertainty/safety factors. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the margin of exposure (MOE) called for by the 
product of all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for fipronil used for 
human risk assessment is shown in Table 1 of this unit.

       Table 1.--Summary of Toxicological Dose and Endpoints for Fipronil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL= 2.5 milligrams/   FQPA SF = 1              Acute neurotoxicity--
(All populations including infants      kilograms (mg/kg)       aPAD = acute RfD/FQPA     rat
 and children).                        UF = 100...............   SF = 0.025 mg/kg.       LOAEL = 7.0 mg/kg based
                                       acute RfD = 0.025 mg/kg                            on: Decreased hind leg
                                                                                          splay in males at 7
                                                                                          hours
Chronic dietary                        NOAEL= 0.019 mg/kg/day   FQPA SF = 1              Chronic/carcinogenicity
(All populations)....................  UF = 100...............  cPAD = chr RfD/FQPA SF    study --rat
                                       chronic RfD = 0.0002 mg/  = 0.0002 mg/kg/day.     LOAEL = 0.059 mg/kg/day
                                        kg/day.                                           based on: Increased
                                                                                          incidence of seizures
                                                                                          and death, alterations
                                                                                          in clinical chemistry
                                                                                          (protein), increased
                                                                                          thyroid stimulating
                                                                                          hormone (TSH), and
                                                                                          decreased T4
Short-term oral (1-7 days)             Oral study maternal      LOC for MOE = 300        Developmental toxicity
(Residential)........................   LOAEL < 0.1 mg/kg/day    (Residential, includes    study--rabbit
                                        UF of 3 for no NOAEL,    the FQPA SF).           maternal LOAEL = 0.1 mg/
                                        100 for interspecies                              kg/day based on:
                                        extrapolation and                                 Maternal toxicity of
                                        intraspecies variation                            decreased body weight
                                                                                          gain, decreased food
                                                                                          consumption, and
                                                                                          decreased food
                                                                                          efficiency
Intermediate-term oral (1 week--       Oral study LOAEL < 0.1    LOC for MOE = 300        Developmental toxicity
 several months)                        mg/kg/day UF of 3 for   (Residential, includes    study--rabbit
(Residential)........................   no NOAEL, 100 for        the FQPA SF).           LOAEL = 0.1 mg/kg/day
                                        interspecies                                      based on: Maternal
                                        extrapolation and                                 toxicity of decreased
                                        intraspecies variation                            body weight gain,
                                                                                          decreased food
                                                                                          consumption, and
                                                                                          decreased food
                                                                                          efficiency
Short-termdermal (1-7 days)            Dermal study NOAEL= 5    LOC for MOE = 100        21-Day dermal toxicity
(Residential)........................   mg/kg/day                (Occupational)           study--rabbit
                                                                LOC for MOE = 100        LOAEL = 10.0 mg/kg/day
                                                                 (Residential, includes   based on: Decreased
                                                                 FQPA SF).                body weight gain, and
                                                                                          food consumption in
                                                                                          both sexes
Intermediate-term dermal (1 week--     Dermal study NOAEL = 5   LOC for MOE = 100        21-Day dermal toxicity
 several months)                        mg/kg/day                (Occupational)           study-- rabbit
(Residential)........................                           LOC for MOE = 100        LOAEL = 10.0 mg/kg/day
                                                                 (Residential, includes   based on: Decreased
                                                                 FQPA SF).                body weight gain, and
                                                                                          food consumption in
                                                                                          both sexes
Long-term dermal (several months--     Oral study NOAEL =       acceptable MOE = 100     Chronic/carcinogenicity
 lifetime)                              0.019 mg/kg/day(dermal   (Occupational)           study --rat
(Residential)........................   absorption rate = 1%)   acceptable MOE = 100     LOAEL = 0.059 mg/kg/day
                                                                 (Residential, includes   based on: Increased
                                                                 FQPA SF).                incidence of seizures
                                                                                          and death, alterations
                                                                                          in clinical chemistry
                                                                                          (protein), increased
                                                                                          TSH, and decreased T4
Short-term inhalation (1-7 days)       Oral study NOAEL = 0.05  LOC for MOE = 100        Developmental
(Residential)........................   mg/kg/day(inhalation     (Occupational)           neurotoxicity-- rat
                                        absorption rate =       LOC for MOE = 100        LOAEL = 0.90 mg/kg/day
                                        100%)                    (Residential, includes   based on: Decrease in
                                                                 FQPA SF).                group mean pup weights
                                                                                          during lactation, and
                                                                                          significant increase
                                                                                          in time of preputial
                                                                                          separation in males
                                                                                          (dietary)
Intermediate-term inhalation (1 week-- Oral study NOAEL = 0.05  LOC for MOE = 100        Developmental
 several months)                        mg/kg/day (inhalation    (Occupational) LOC for   neurotoxicity-- rat
(Residential)........................   absorption rate =        MOE = 100               LOAEL = 0.90 mg/kg/day
                                        100%)                    (Residential, includes   based on: Decrease in
                                                                 FQPA SF)                 group mean pup weights
                                                                                          during lactation, and
                                                                                          significant increase
                                                                                          in time of preputial
                                                                                          separation in males
                                                                                          (dietary)

[[Page 46910]]

Long-term inhalation (several months-- O ral study NOAEL=       acceptable MOE = 100     Chronic/carcinogenicity
 lifetime)                              0.019 mg/kg/day          (Occupational)           rat study
(Residential)........................   (inhalation absorption  acceptable MOE = 100     LOAEL = 0.059 mg/kg/day
                                        rate = 100%)             (Residential, includes   based on: Increased
                                                                 FQPA SF).                incidence of seizures
                                                                                          and death, alterations
                                                                                          in clinical chemistry
                                                                                          (protein), increased
                                                                                          TSH, and decreased T4
Cancer                                 Group C--possible human  Use chronic RfD to       Increases in thyroid
(Oral, dermal, inhalation)...........   carcinogen               estimate human risk      follicular cell tumors
                                                                                          with fipronil (male/
                                                                                          female)
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA Safety Factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose,
  LOC = level of concern, MOE = margin of exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fipronil, EPA considered exposure under the petitioned-for 
tolerances, as well as the turnip and rutabaga tolerances to support 
the authorized section 18s, and all existing fipronil tolerances in (40 
CFR 180.517). EPA assessed dietary exposures from fipronil in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a one-day or single exposure. In estimating acute 
dietary exposure, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed all foods for which there are tolerances 
were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide CSFII. As to residue levels in food, EPA relied 
upon anticipated residues and percent crop treated information for some 
commodities A partially refined analysis was performed using 
anticipated residues from field trial data for existing uses for which 
data were available. Anticipated residues were also used for potato 
commodities. Processing factors were used for existing uses. Percent 
crop treated was not used.
    iii. Cancer. Fipronil has been classified as a Group C--Possible 
Human Carcinogen, based on increases in thyroid follicular cell tumors 
in both sexes of the rat, which were statistically significant by both 
pair-wise and trend analyses. There is no apparent concern for 
mutagenicity (no mutagenic activity). The RfD methodology should be 
used to estimate human risk for the following reasons: The thyroid 
tumors appear to be related to a disruption in the thyroid-pituitary 
status, and fipronil is not likely to be carcinogenic to humans at 
doses that do not alter rat thyroid hormone homeostasis. In addition, 
the cRfD is based on the NOAEL from the combined chronic/
carcinogenicity study in rats. The NOAEL is based on increased 
incidence of seizures and death, alterations in clinical chemistry 
(protein) and thyroid toxicity (increase in TSH), decrease in thyroxine 
(T4)). Therefore, the cRfD is considered to be protective of both 
cancer and non-cancer effects of fipronil.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to FFDCA section 408(f)(1) require that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water.The Agency lacks sufficient 
monitoring data to complete a comprehensive dietary exposure analysis 
and risk assessment for fipronil in drinking water. Because the Agency 
does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
fipronil. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
fipronil for acute exposures are estimated to be 2.654 parts per 
billion (ppb) for surface water and 0.021 ppb for ground water. The 
EECs for chronic exposures are estimated to be 0.3179 ppb for surface 
water and 0.021 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 2.654 ppb was used to 
access the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.3179 ppb was used to 
access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fipronil is currently registered for the following residential non-
dietary sites: For use on cats and dogs for flea control and on turf to 
control fire ants. These products may be applied by homeowners. EPA 
assessed residential exposure using the following assumptions: The 
probability of applying fipronil to dogs and cats to control fleas and 
ticks and applying fipronil to control turf pests on the same day is 
considered to be negligible for the following reasons: Use on turf 
application is limited to application one per year. For the pet care 
products, fipronil is applied as a Ready-to-Use (RTU) pump spray to the 
fur of the animal or as a RTU, pour-on, spot

[[Page 46911]]

treatment made on the back of the animal between the shoulder blades. 
Repeated applications if necessary may be made once every one to three 
months during flea or tick season. Therefore, since these applications 
are infrequent, for aggregate risk assessment, exposure from pet and 
turf treatments were not combined. Based on the existing and proposed 
uses, the pet uses result in the highest estimated handler exposure. 
Since more exposure is expected from the pet care spray product, 
exposure to the spray product represents the worst case for all 
residential scenarios. For post-application risk, the use on pets is 
used to estimate exposure to toddlers. Adult post-application exposure 
is considered negligible.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fipronil and any other 
substances and fipronil does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of these tolerance 
actions, therefore, EPA has not assumed that fipronil has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional uncertainty/safety 
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA concluded that there is 
no indication of increased susceptibility of rats or rabbits to in 
utero and/or postnatal exposure to fipronil. In the prenatal 
developmental toxicity studies in rats and rabbits and in the 2-
generation reproduction study in rats, developmental toxicity occurred 
at the same or greater doses than those that caused maternal toxicity. 
In particular, the toxicity endpoint used for the short term oral 
exposure scenario was based on maternal effects seen in the 
developmental toxicity study. However, because no maternal NOAEL was 
established, an additional 3X safety factor was added to the maternal 
LOAEL. The developmental or offspring NOAEL was 10x greater than the 
maternal LOAEL. In addition, the combined chronic/carcinogenicity study 
in rats is based on increased incidence of seizures and deaths, 
alterations in clinical chemistry (protein) and an increase in TSH and 
a decrease in T4 at the LOAEL of 0.059 mg/kg/day. No effects on body 
weights and body weigh gains were observed at the LOAEL in the chronic 
toxicity study. For this reason EPA believes that the additional 3X 
safety factor is protective of infants and children.
    However, the developmental neurotoxicity study identified a 
developmental NOAEL (0.05 mg/kg/day) which is less than the maternal 
NOAEL of 0.9 mg/kg/day, indicating an apparent susceptibility issue. 
EPA determined that the evidence regarding appearance of susceptibility 
was not convincing for several reasons. First, the findings at 0.9 mg/
kg/day in the developmental neurotoxicity study (decrease in offspring 
body weight and delayed time to preputial separation) were equivocal. 
EPA, using a conservative approach, established the LOAEL for offspring 
developmental toxicity at 0.9 mg/kg/day with the understanding that 
these effects, although statistically significant, were marginal and 
appeared to define a threshold response level. This conservative 
approach resulted in the NOAEL for offspring developmental toxicity 
(0.05 mg/kg/day) being lower than the NOAEL for maternal toxicity (0.9 
mg/kg/day) giving an appearance of increased susceptibility. Second, 
the findings in the developmental neurotoxicity study were not 
supported by the overall weight-of-the-evidence from the fipronil 
database. Evaluation of the database indicated that:
     The offspring body weight findings in the developmental 
neurotoxicity study are not supported by the results of the 2-
generation reproduction study in rats at similar treatment levels.
     Increased susceptibility to the offspring was not 
demonstrated following prenatal and/or postnatal dosing in the prenatal 
developmental toxicity study nor the 2-generation reproduction study in 
rats.
     No increased susceptibility was seen in the prenatal 
developmental toxicity study in rats following in utero exposure to the 
photodegradate, MB46513.
More specific information may be found in the referenced document, 
``Fipronil: Third Reevaluation--Report of the Hazard Identification 
Assessment Review Committee, December 6, 2000,'' available in the 
docket established by this action, as noted in this unit.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for fipronil is complete for food use.
    ii. The weight of the evidence does not indicate that there is 
increased sensitivity in young animals. In any event, there is a clear 
NOAEL identified in the one study where there was an appearance of 
sensitivity in the young. The degree of concern for prenatal and/or 
postnatal toxicity is low.
    iii. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% crop treated (CT) and anticipated residues were used as 
described in this unit. They are based in reliable data and will not 
underestimate the exposure and risk. Conservative ground and surface 
water modeling estimates were used. Similarly conservative Residential 
Standard Operating Procedures (SOPs) were used to assess post-
application exposure to children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by fipronil.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the (``aPAD'') and (``cPAD''). 
The aPAD and cPAD are calculated by dividing the level of concern (LOC) 
by all applicable uncertainty/safety factors. For linear

[[Page 46912]]

cancer risks, EPA calculates the probability of additional cancer cases 
given aggregate exposure. Short-term, intermediate-term, and long-term 
risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable 
uncertainty/safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fipronil will occupy 25% of the aPAD for the population group 
(children 1-2 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to fipronil 
from food and water will utilize 96% of the cPAD for the population 
group (children (1-2 years old). Based the use pattern, chronic 
residential exposure to residues of fipronil is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Fipronil is currently registered for use that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for fipronil.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs as follows: The short-
term aggregate risk assessment takes into account average exposure 
estimates from dietary consumption of fipronil (food and drinking 
water) and non-occupational exposures (pet uses). Postapplication 
exposure from the use on pets is considered short-term. Therefore, a 
short-term aggregate risk assessment was conducted, using children with 
combined dermal and oral exposures from pet uses as a worst case. Table 
3 of this unit summarizes the results. Since the LOC is different for 
oral and dermal exposures, 300 and 100, respectively, the Aggregate 
Risk Index (ARI) method was used to determine short-term aggregate 
risk. The aggregate ARI from food, water, and non-occupational 
exposures is 1.5. Therefore, short-term aggregate risk estimates do not 
exceed the Agency's level of concern (i.e. ARIs greater than or equal 
to 1). Adult post-application risk is considered negligible and so an 
aggregate risk assessment for adults is not considered necessary.

                                                             Table 3.--Aggregate Short-Term
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Food + Water                  Oral                     Dermal
                    Population                    ------------------------------------------------------------------------------   ARI \3\Aggregate \4\
                                                     LOC \1\      MOE \2\        LOC          MOE          LOC          MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                   300          532          300        3,300          100        5,000                      1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ LOC=Level of Concern
\2\ MOE= NOAEL (or LOAEL)/exposure
\3\ ARI=MOE Calculated/MOELOC
\4\ARI=Aggregate= 1/((1/ARIfood)+(1/ARIoral)+(1/ARIdermal)).

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fipronil is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for fipronil.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water, and 
residential exposures aggregated result in aggregate MOEs as follows: 
Intermediate-term risk to children is not expected to be higher than 
short-term risk due to the lack of inhalation exposure and a soil 
ingestion MOE of 1 million.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to fipronil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method EC-95-303) is available to 
enforce the tolerance expression. The method may be requested from: 
Chief, Analytical Chemistry Branch, Environmental Science Center, 701 
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) established for fipronil + metabolites MB46136 and MB45950 + 
photodegradate MB46513 on the commodities included in this request.

C. Response to Comments

    One comment was received from a private citizen who opposes the 
approval of any pesticide that leaves a residue on food. The comment 
contained no specific information pertaining to fipronil but was 
limited to general claims such as EPA was providing inadequate 
protection for Americans. The Agency has received the same comment from 
this commenter on numerous previous occasions and rejects it for the 
reasons previously stated in the Federal Registers of January 7, 2005 
(70 FR 1349) (FRL-7691-4), June 30, 2005 (70 FR 37686) (FRL-7718-3), 
and October 29, 2004 (69 FR 63096) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
fipronil (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-
[(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile) and its two 
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-
carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in or on potato at 0.03 ppm, potato, wet peel at 0.1 ppm 
and indirect or inadvertent residues of fipronil and its metabolites 
and its degradate on wheat, forage at 0.02 ppm, wheat, grain at 0.005 
ppm, wheat, hay at 0.03 ppm, and wheat, straw at 0.03 ppm. Time-limited 
tolerances are also

[[Page 46913]]

established for combined residues of fipronil and its metabolites and 
degradate on turnip at 1.0 ppm and rutabaga at 1.0 ppm.
    The registrant petitioned for tolerances on vegetable, tuberous 
corm, subgroup 1C. In evaluating this petition, the Agency determined 
that planting methods associated with the different members of crop 
subgroup vegetable, tuberous corm, subgroup 1C result in different 
amounts of fipronil and its metabolites and degradate being loaded into 
the environment. Further, because of the planting depth of potatoes, 
the environmental loading of fipronil and its metabolites and degradate 
is expected to be lower for potatoes than other members of vegetable 
tuberous corm crop group 1C and is expected to be below levels of 
concern. For this reason, the Agency is establishing tolerances only 
for potato and the rotational crop wheat at this time. The Agency is 
working to resolve these issues as they relate to other members of 
vegetable tuberous corm crop group 1C.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, or are established under 
section 408(l)(6) of FFDCA, such as the tolerances in this final rule, 
do not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 3, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180. 517 is amended by alphabetically adding commodities to 
the table in paragraph (a) and by adding text to paragraphs (b) and (d) 
to read as follows:

Sec.  180.517  Fipronil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Potato.........................................                     0.03
Potato, wet peel...............................                     0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for combined residues of the insecticide, fipronil, 5-
amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-
trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2 
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-
carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-
carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-
4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in connection with use of the pesticide under Section 18 
emergency exemptions granted by EPA. The tolerances expire and are 
revoked on the dates specified in the table for this paragraph.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Rutabaga......................................          1.0     12/31/10
Turnip........................................          1.0     12/31/10
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for combined indirect or inadvertent residues of the insecticide 
fipronil and its metabolites and photodegradate in or on food 
commodities when present therein as a result of the application of 
fipronil to growing crops listed in paragraphs (a) and (b) of this 
section and other nonfood crops to read as follows:

[[Page 46914]]

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Wheat, forage..................................                     0.02
Wheat, grain...................................                    0.005
Wheat, hay.....................................                     0.03
Wheat, straw...................................                     0.03
------------------------------------------------------------------------

[FR Doc. E7-16621 Filed 8-21-07; 8:45 am]

BILLING CODE 6560-50-S