Document ID: EPA-HQ-OPP-2007-0275-0003
Agency: epa
Document Type: Rule
Title: Chlorantraniliprole; Pesticide Tolerance
Posted Date: 2008-05-07T04:00Z

[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Rules and Regulations]               
[Page 25518-25524]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my08-11]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0275; FRL-8357-3]

 
Chlorantraniliprole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
chlorantraniliprole in or on apple, wet pomace; brassica, head and 
stem, subgroup 5A; brassica, leafy greens, subgroup 5B; cotton, gin 
byproduct; cotton, hulls; cotton undelinted seed; fruit, pome, group 
11; fruit, stone, group 12; grape; grape, raisin; potato; vegetable, 
cucurbit, group 9; vegetable, fruiting, group 8; vegetable, leafy, 
except brassica, group 4; milk; meat; meat byproduct; fat. E.I. DuPont 
de Nemours and Company requested this tolerance under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). This regulation also removes existing 
time-limited tolerances for residues of chlorantraniliprole in or on 
apple; apple, wet pomace; celery; cucumber; lettuce, head; lettuce, 
leaf; pear; pepper; spinach; squash; tomato and watermelon and modifies 
40 CFR 180.628 by removing the third column (Expiration/Revocation 
Date) from the table in paragraph (a), since it is no longer 
applicable. In addition, this action establishes a time-limited 
tolerance for residues of chlorantraniliprole in or on rice in response 
to the approval of a specific exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing the use 
the insecticide on rice to control rice water weevil, Lissorhoptrus 
oryzophilus. This regulation establishes a maximum permissible level of 
residues of chlorantraniliprole in this food commodity. The time-
limited tolerance expires and is revoked on December 31, 2011.

DATES: This regulation is effective May 7, 2008. Objections and 
requests for hearings must be received on or before July 7, 2008, 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-2007-0275. 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: Kable Bo Davis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0415; e-mail address: davis.kable @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:

[[Page 25519]]

     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-2007-0275 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 July 7, 2008.
    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-2007-0275, 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 Tolerance

    In the Federal Register of April 30, 2007 (72 FR 21263) (FRL-8124-
5), 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 
7F7181) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, 
1090 Elkton Road, Newark, DE 19711. The petition requested that 40 CFR 
180.628 be amended by exempting the requirement of tolerances for 
residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-
methyl-6-[(methylamino) carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-
pyrazole-5-carboxamide, in or on commodities. That notice referenced a 
summary of the petition prepared by E.I. DuPont de Nemours and Company, 
the registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, the Agency 
concluded that the request for exemption of tolerances for 
chlorantraniliprole is not appropriate. The appropriate tolerance 
levels for chlorantraniliprole residues in or on pending crops should 
be established as follows: Apple, wet pomace at 0.60 ppm, brassica, 
head and stem, subgroup 5A at 4.0 ppm, brassica, leafy greens, subgroup 
5B at 11 ppm, cotton, gin byproduct at 30 ppm, cotton, hulls at 0.40 
ppm, cotton, undelinted seed at 0.30 ppm, fruit, pome, group 11 at 0.30 
ppm, fruit, stone, group 12 at 1.0 ppm, grape at 1.2 ppm, grape, raisin 
at 2.5 ppm, potato at 0.01 ppm, vegetable, cucurbit, group 9 at 0.25 
ppm, vegetable, fruiting, group 8 at 0.70 ppm, vegetable, leafy, except 
brassica, group 4 at 13 ppm, milk at 0.01 ppm, meat at 0.01 ppm, meat 
byproducts at 0.01 ppm and fat at 0.01 ppm.
    EPA is also establishing a time-limited tolerance for residues of 
the insecticide chlorantraniliprole in or on rice, grain at 0.10 ppm 
and rice, straw at 0.25 ppm. This tolerance expires and is revoked on 
December 31, 2011. The Agency is establishing this time-limited 
tolerance in response to two specific exemption requests under FIFRA 
section 18 on behalf of the Louisiana Department of Agriculture and 
Forestry and the Texas Department of Agriculture for emergency use of 
chlorantraniliprole on rice seed to control rice water weevil, 
Lissorhoptrus oryzophilus.
    According to Louisiana, the current emergency situation with 
respect to rice water weevil management has arisen primarily from the 
continuing, and probably increasing, practice of cultivating crawfish 
in ponds in close proximity to rice fields in southern Louisiana and 
the phase-out of pyrethroid seed treatments as an alternative for 
control. All of the alternative insecticides, the liquid and fertilizer 
impregnated pyrethroid formulations, currently registered and available 
for use against weevil in Louisiana are toxic to crawfish and have a 
very short treatment window which frequently precludes their timely use 
due to unfavorable weather and insufficient availability of aerial 
applicators. Another constraint is that these insecticides only offer 
protection for 4 to 7 days, while adult weevil movement into flooded 
rice fields may occur over a several week period. Additionally, drift 
of foliar applied liquid insecticide alternatives to adjacent crawfish 
ponds have resulted in numerous crawfish kills. The Applicant claims 
that rice water weevil populations have historically plagued the state 
and that registered insecticides for this use and/or cultural practices 
are inadequate.
    According to Texas, the current emergency situation with respect to 
rice water weevil management has arisen primarily from the continuing, 
and probably increasing, practice of cultivating fish (catfish and 
hybrid stripped bass) and crawfish for

[[Page 25520]]

commercial production in ponds in close proximity to rice fields and 
the loss of a registered seed treatment as an alternative for control. 
A great majority of the fish and crawfish ponds are close enough to 
rice fields to be affected by the management practices used in rice. 
All insecticides currently registered for use against weevil in Texas 
are toxic to fish and crawfish, and also are subject to the same timing 
and logistical challenges noted by Louisiana. The Applicant claims that 
the registered insecticides for this use and/or cultural practices are 
inadequate to control rice water weevil.
    As part of its assessment of the emergency exemption request, EPA 
assessed the potential risks presented by the residues of 
chlorantraniliprole in or on rice. In doing so, EPA considered the 
safety standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary time-limited tolerance 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 the urgent non-routine situation and to ensure that 
the resulting food is safe and lawful, EPA is issuing this time-limited 
tolerance without notice and opportunity for public comment as provided 
in section 408(l)(6) of FFDCA. Although, this time-limited tolerance 
expires and is revoked on December 31, 2011, under section 408(l)(5) of 
FFDCA, residues of the pesticide not in excess of the amount specified 
in the tolerance remaining in or on rice 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 a level that was authorized 
by this time-limited tolerance at the time of application. EPA will 
take action to revoke this time-limited tolerance earlier if any 
experience with, scientific data, or other relevant information on this 
pesticide indicates that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
chlorantraniliprole meets EPA's registration requirements for use on 
rice or whether a permanent tolerance for this use would be 
appropriate. Under this circumstance, EPA does not believe that the 
time-limited tolerance serves as a basis for registration of 
chlorantraniliprole by a State for special local needs under FIFRA 
section 24(c). Nor does the time-limited tolerance serve as the basis 
for any State other than Louisiana and Texas to use this pesticide on 
this crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR 
part 166.

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 section 408(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 tolerance 
for residues of chlorantraniliprole on apple, wet pomace at 0.60 ppm, 
brassica, head and stem, subgroup 5A at 4.0 ppm, brassica, leafy 
greens, subgroup 5B at 11 ppm, cotton, gin byproduct at 30 ppm, cotton, 
hulls at 0.40 ppm, cotton, undelinted seed at 0.30 ppm, fruit, pome, 
group 11 at 0.30 ppm, fruit, stone, group 12 at 1.0 ppm, grape at 1.2 
ppm, grape, raisin at 2.5 ppm, potato at 0.01 ppm, vegetable, cucurbit, 
group 9 at 0.25 ppm, vegetable, fruiting, group 8 at 0.70 ppm, 
vegetable, leafy, except brassica, group 4 at 13 ppm, milk at 0.01 ppm, 
meat at 0.01 ppm, meat byproducts at 0.01 ppm and fat at 0.01 ppm as 
well as the time-limited tolerance for residues of chlorantraniliprole 
on rice, grain at 0.10 pp and rice, straw at 0.25 ppm. EPA's assessment 
of exposures and risks associated with establishing the tolerance 
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.
    Chlorantraniliprole has no significant acute toxicity via the oral, 
dermal, and inhalation routes of exposure. The LD50 for oral 
and dermal acute exposure is <=5,000 mg/kg/day and the LC50 
for acute inhalation exposure is <=5.1 mg/L. This substance is not an 
eye or skin irritant and does not cause skin sensitization. In short-
term studies, the most consistent effects are those associated with non 
adverse pharmacological response to the xenobiotic, induction of liver 
enzymes and subsequent increase in liver weights. Chlorantraniliprole 
is not genotoxic, neurotoxic, immunotoxic, carcinogenic, or 
teratogenic. Furthermore, it is not uniquely toxic to the conceptus as 
there were no maternal or fetal effects in studies conducted in rats 
and rabbits. Based on the results of a 28-day dermal study in rats, as 
well as the dermal LD50 study, chlorantraniliprole has 
relatively low dermal toxicity.
    Overall, chlorantraniliprole exhibits minimal mammalian toxicity 
after long-term exposure. The only consistent observation in the 
mammalian toxicology studies is an increased degree of 
microvesiculation of the adrenal cortex after dermal or dietary 
administration of chlorantraniliprole. Based on the lack of adverse 
effect on the function of the adrenal gland, this observation was 
considered treatment related, but not ``adverse.''
    In addition to the adrenal effects, liver effects (e.g., increased 
liver weight and induction of Cytochrome P450 enzymes) were reported in 
the 90-day oral subchronic studies across species and only at the 
highest dose tested (HDT) (<1,000 mg/kg/day). While in the subchronic 
studies, these effects were considered adaptive, the liver effects were 
more pronounced in the 18-month chronic mouse study at the HDT. 
Increased eosinophilic foci (preneoplastic foci) were noted in male 
mice at 935 mg/kg/day and liver hypertrophy and weight increase were 
evident at the next lower dose (158 mg/kg/day), but progression to 
tumors was not apparent for these effects. Therefore, the eosinophilic 
foci appear to be an adverse effect only seen in the HDT and was graded 
minimal in severity.

[[Page 25521]]

    Specific information on the studies received and the nature of the 
adverse effects caused by chlorantraniliprole 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 is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2007-0275 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 (UFs) 
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 UFs. Short-, intermediate-, 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 
UFs 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 chlorantraniliprole 
used for human risk assessment can be found at http://
www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45): Human 
Health Risk Assessment for Proposed Uses on Pome fruit, Stone fruit, 
Leafy vegetables, Brassica leafy vegetables, Cucurbit vegetables, 
Fruiting vegetables, Cotton, Grapes, Potatoes, Rice, Turf and 
Ornamentals at pages 22-24 in docket ID number EPA-HQ-OPP-2007-0275.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to chlorantraniliprole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing chlorantraniliprole 
tolerances in (40 CFR 180.628). EPA assessed dietary exposures from 
chlorantraniliprole 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 1-day or single exposure. No such effects were 
identified in the toxicological studies for chlorantraniliprole; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues.
    iii. Cancer. Because chlorantraniliprole has been classified as a 
``not likely human carcinogen'', a quantitative exposure assessment 
relative to cancer risk is not required.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for chlorantraniliprole 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 chlorantraniliprole. 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 
chlorantraniliprole for acute exposures are estimated to be 26.862 
parts per billion (ppb) for surface water and 1.06 ppb for ground 
water. The EECs for chronic exposures are estimated to be 3.650 ppb for 
surface water and 1.06 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. Because no acute hazard, 
attributable to a single dose, was identified; acute dietary risk was 
not assessed. For chronic dietary risk assessment, the water 
concentration value 3.650 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).
    Chlorantraniliprole is proposed for use on the following 
residential non-dietary sites: Turfgrass and ornamental plants. 
Although residential exposure could occur, due to the lack of toxicity 
identified for short- and intermediate-term durations via the relevant 
routes of exposure, no risk is expected from these exposures.
    Additional information on residential exposure assumptions can be 
found at www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0275, pages 36 
through 37).
    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 chlorantraniliprole and 
any other substances and chlorantraniliprole does not appear to produce 
a toxic metabolite produced by other substances. For the purposes of 
this tolerance action, therefore, EPA has not assumed that 
chlorantraniliprole 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

[[Page 25522]]

additional tenfold (``10X'') 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 UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There were no effects on 
fetal growth or post-natal development up to the limit dose of 1,000 
mg/kg/day in rats or rabbits in the developmental or 2-generation 
reproduction studies. Additionally, there were no treatment related 
effects on the numbers of litters, fetuses (live or dead), resorptions, 
sex ratio, or post-implantation loss and no effects on fetal body 
weights, skeletal ossification, and external, visceral, or skeletal 
malformations or variations.
    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 toxicology database for chlorantraniliprole is complete for 
the purposes of this risk assessment and the characterization of 
potential pre- and postnatal risks to infants and children.
    ii. No susceptibility was identified in the toxicological database, 
and there are no residual uncertainties re: pre-and/or postnatal 
exposure.
    iii. There are no treatment-related neurotoxic findings in the 
acute and subchronic oral neurotoxicity studies in rats.
    iv. The exposure assessment is protective: The dietary food 
exposure assessment utilizes tolerance level residues and 100% crop 
treated information for all commodities; the drinking water assessment 
utilizes values generated by models and associated modeling parameters 
which are designed to provide conservative, health protective, high-end 
estimates of water concentrations. By using these screening-level 
exposure assessments, the chronic dietary (food and drinking water) 
risk is not underestimated.
    v. Although residential exposure is expected over the short- and 
possibly intermediate-term (via the dermal and/or incidental oral 
route), there is no hazard expected via these routes/durations, and 
therefore no risk for these scenarios.

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 LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, 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 UFs is 
not exceeded.
    1. Acute risk. No acute risk is expected because no acute hazard, 
attributable to a single dose, was identified.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
chlorantraniliprole from food and water will utilize <1% of the cPAD 
for the population group children 1-2 years (the highest exposed 
subpopulation). Based on the use pattern, chronic residential exposure 
to residues of chlorantraniliprole is not expected.
    3. Short-term/intermediate risk. Short-term aggregate and 
intermediate-term exposure takes into account residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level).
    There is potential for short- and intermediate-term postapplication 
dermal (adults and children) and incidental oral (children only) 
exposure to chlorantrantiliprole. However, due to the lack of toxicity 
via dermal route, as well as the lack of toxicity over the acute, 
short- and intermediate-term via the oral route - no risk is expected 
from these exposures. Inhalation exposure is not expected due to the 
low vapor pressure of chlorantraniliprole (so applied/deposited 
residues are not expected to volatilize into the air).
    4. Aggregate cancer risk for U.S. population. Chlorantraniliprole 
has been classified as a ``not likely human carcinogen.'' It is not 
expected to pose a cancer risk to humans.
    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 chlorantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography/mass 
spectrometry (LC/MS/MS) is available to enforce the tolerance 
expression. The methods 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 international residue limits that affect the Agency's 
recommendations at this time. There are no Canadian, CODEX or Mexican 
maximum residue limits (MRLs) for chlorantraniliprole.
    Secondary reasons that contribute to harmonization difficulties 
include use pattern differences (for one crop, application rates and 
formulations may be different in different countries due to different 
pest pressures/conditions).

C. Response to Comments

    There were no comments received in response to the notice of 
filing.

V. Conclusion

    Therefore, the tolerance is established for residues of 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino) 
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide, 
in or on apple, wet pomace at 0.60 ppm, brassica, head and stem, 
subgroup 5A at 4.0 ppm, brassica, leafy greens, subgroup 5B at 11 ppm, 
cotton, gin byproduct at 30 ppm, cotton, hulls at 0.40 ppm, cotton, 
undelinted seed at 0.30 ppm, fruit, pome, group 11 at 0.30 ppm, fruit, 
stone, group 12 at 1.0 ppm, grape at 1.2 ppm, grape, raisin at 2.5 ppm, 
potato at 0.01 ppm, vegetable, cucurbit, group 9 at 0.25 ppm, 
vegetable, fruiting, group 8 at 0.70 ppm, vegetable, leafy, except 
brassica, group 4 at 13 ppm, milk at 0.01 ppm, meat at 0.01 ppm, meat 
byproducts at 0.01 ppm and fat at 0.01 ppm. In addition, this 
regulation establishes a time-limited tolerance for residues of 
chlorantraniliprole in or on rice, grain at 0.10 ppm and rice, straw at 
0.25 ppm.

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,

[[Page 25523]]

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, such as the tolerance 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: April 24, 2008.
Debra Edwards,
Director, 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 180.628 is amended by revising the table in paragraph (a) 
and by adding text to paragraph (b) to read as follows:

Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple, wet pomace....................................               0.60
Brassica, head and stem, subgroup 5A.................                4.0
Brassica, leafy greens, subgroup 5B..................                 11
Cattle, fat..........................................               0.01
Cattle, meat.........................................               0.01
Cattle, meat byproducts..............................               0.01
Cotton, gin byproduct................................                 30
Cotton, hulls........................................               0.40
Cotton, undelinted seed..............................               0.30
Fruit, pome, group 11................................               0.30
Fruit, stone, group 12...............................                1.0
Goat, fat............................................               0.01
Goat, meat...........................................               0.01
Goat, meat byproduct.................................               0.01
Grape................................................                1.2
Grape, raisin........................................                2.5
Horse, fat...........................................               0.01
Horse, meat..........................................               0.01
Horse, meat byproduct................................               0.01
Milk.................................................               0.01
Potato...............................................               0.01
Sheep, fat...........................................               0.01
Sheep, meat..........................................               0.01
Sheep, meat byproduct................................               0.01
Vegetable, cucurbit, group 9.........................               0.25
Vegetable, fruiting, group 8.........................               0.70
Vegetable, leafy, except brassica, group 4...........                 13
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for the residues of the insecticide chlorantraniliprole, 3-
bromo-N-[4-chloro-2-methyl-6-[(methylamino) carbonyl]phenyl]-1-(3-
chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide, in connection with use 
of the pesticide under a section 18 emergency exemption granted by EPA. 
This tolerance will expire and is revoked on the date specified in the 
following table.

------------------------------------------------------------------------
                                Parts per
          Commodity              million     Expiration/Revocation Date
------------------------------------------------------------------------
Rice, grain..................         0.10                      12/31/11
Rice, straw..................         0.25                      12/31/11
------------------------------------------------------------------------

[[Page 25524]]

* * * * *
[FR Doc. E8-9950 Filed 5-6-08; 8:45 am]

BILLING CODE 6560-50-S