Document ID: EPA-HQ-OPP-2004-0257-0003
Agency: epa
Document Type: Rule
Title: Chlorthalonil; Pesticide Tolerance
Posted Date: 2007-07-27T04:00Z

[Federal Register: July 27, 2007 (Volume 72, Number 144)]
[Rules and Regulations]               
[Page 41224-41230]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy07-7]                         

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2004-0257; FRL-8127-9]

 
Chlorthalonil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for the combined 
residues of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on pea, edible podded. The Snowpea 
Commission of Guatemala requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective July 27, 2007. Objections and 
requests for hearings must be received on or before September 25, 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-2004-0257. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
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: Tony Kish, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-308-9443; e-mail address: kish.tony@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I 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 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2004-0257 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be

[[Page 41225]]

mailed or delivered to the Hearing Clerk on or before September 25, 
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 your copies, identified by docket ID 
number EPA-HQ-OPP-2004-0257, 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 Drive, 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. Background and Statutory Findings

    In the Federal Register of August 20, 2004 (69 FR 51672) (FRL-7674-
2), 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 
3E6795) by the Snowpea Commission of Guatemala, Guatemala City, 
Guatemala; GB Bioscience\TM\ Corporation of Greensboro, NC serves as 
the agent for the Snowpea Commission of Guatemala. The petition 
requested that 40 CFR 180.275 be amended by establishing a tolerance 
for combined residues of the fungicide chlorothalonil, and its 
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile, in or on pea, 
edible podded (to include snowpea, and sugar snap pea) at 5 parts per 
million (ppm). That notice included a summary of the petition prepared 
by GB BioscienceTM Corporation, the registrant. Comments 
were received on the notice of filing. EPA's response to these comments 
is discussed in Unit IV.C.
    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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see
     http://www.epa.gov/oppfead1/trac/science     http://www.epa.gov/pesticides/factsheets/riskassess.htm.

s/riskassess.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for the combined residues of 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile on pea, edible podded at 5 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. Specific information on the studies received and the nature 
of the toxic effects caused by chlorothalonil and its metabolite, 4-
hydroxy-2,5,6-trichloroisophthalonitrile, 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 Docket ID 

EPA-HQ-OPP-2004-0257.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at:
     http://www.epa.gov/pesticides/health/human.htm     http://www.epa.gov/pesticides/facsheets/riskassess.htm.

s/facsheets/riskassess.htm.

    The chronic dietary endpoint used in this rule 0.003 milligrams/
kilogram/day (mg/kg/day) is based on new toxicity data the Agency 
received, and is approximately 6.6 fold less than the endpoint of 0.02 
mg/kg/day used in the chlorothalonil risk assessment for the April 1999 
RED. The Agency has received and is reviewing additional information 
which could change this lower chronic dietary endpoint. A summary of 
the toxicological endpoints for chlorothalonil used for human risk 
assessment is shown in Table 1:

[[Page 41226]]

             Table 1.--Summary of Toxicological Dose and Endpoints for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= < 0.9 mg/kg/day    Special FQPA SF = 1X     Rat Chronic
                                       UF = 300...............  cPAD = chronic RfD/      LOAEL = 0.9 mg/kg/day
                                       Chronic RfD = 0.003 mg/   Special FQPA SF =        based on an increased
                                        kg/day.                  0.003 mg/kg/day.         incidence and severity
                                                                                          of epithelial
                                                                                          hyperplasia,
                                                                                          hyperkeratosis and
                                                                                          ulceration of the non-
                                                                                          glandular region of
                                                                                          the stomach in females
----------------------------------------------------------------------------------------------------------------
Short-Term Oral (1 to 7 days)          Oral study               LOC for Margin of        Rat Two-Generation
(Residential)........................  NOAEL= < 30.8 mg/kg/day.   Exposure (MOE) = 1,000  LOAEL = 30.8 mg/kg/day
                                                                (Residential)..........   based on thickening
                                                                                          and/or roughening of
                                                                                          the forestomach with
                                                                                          depressions in the
                                                                                          epithelial aspect, and
                                                                                          hyperplasia and
                                                                                          hyperkeratosis of the
                                                                                          non-glandular
                                                                                          epithelium of the
                                                                                          stomach
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 30 days)   Inhalation (or oral)     LOC for MOE = 1,000      Rat Reproduction Study
(Residential)........................   study                   (Residential)..........  LOAEL = 30.8 mg/kg/day
                                       NOAEL= 30.8 mg/kg/day                              based on thickening
                                        (inhalation absorption                            and/or roughening of
                                        rate = 100%.                                      the forestomach with
                                                                                          depressions in the
                                                                                          epithelial aspect, and
                                                                                          hyperplasia and
                                                                                          hyperkeratosis of the
                                                                                          non-glandular
                                                                                          epithelium of the
                                                                                          stomach
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1-6      Oral study               LOC for MOE = 1,000      Rat Reproduction Study
 months)                               NOAEL = 30.8 mg/kg/day   (Residential)..........  LOAEL = 30.8 mg/kg/day
(Residential)........................   inhalation absorption                             based on thickening
                                        rate = 100%.                                      and/or roughening of
                                                                                          the forestomach with
                                                                                          depressions in the
                                                                                          epithelial aspect, and
                                                                                          hyperplasia and
                                                                                          hyperkeratosis of the
                                                                                          non-glandular
                                                                                          epithelium of the
                                                                                          stomach
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Classification:
                                                                                          ``Likely'' to be a
                                                                                          human carcinogen by
                                                                                          all routes of
                                                                                          exposure. The Science
                                                                                          Advisory Panel
                                                                                          decision (6/30/98)
                                                                                          supports the use of an
                                                                                          MOE approach to
                                                                                          adequately quantify
                                                                                          cancer risk for
                                                                                          chlorothalonil
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.275) for the combined residues of 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on a variety of raw agricultural 
commodities. Tolerances currently exist on almond; apricot; asparagus; 
banana; bean, dry; bean, snap; blueberry; broccoli; Brussels sprouts; 
cabbage; carrot; cauliflower; celery; cherry, sweet; cherry, tart; 
cocoa bean; coffee bean, corn, sweet; cranberry; cucumber; mango; 
melon; mushroom; nectarine; onion, dry bulb; onion, green; papaya; 
parsnip; passionfruit; peach; peanut; pepper, nonbell; pistachio; plum; 
plum, prune; potato; pumpkin; soybean; squash, summer; squash, winter; 
tomato; and various animal commodities for cattle; goat; hog; horse; 
milk; and sheep. There is also a time-limited tolerance on ginseng and 
tolerances with regional registration on filbert and mint, hay. Risk 
assessments were conducted by EPA to assess dietary exposures from 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile 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 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile; therefore, a quantitative acute dietary 
exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCID\TM\), which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII), and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: A Tier 3, chronic dietary-exposure assessment was refined 
by making use of anticipated residues derived from monitoring data from 
the Pesticide Data Program (PDP) and Food and Drug Administration 
surveillance monitoring, percent crop treated estimates, and the 
processing factors used in the Reregistration Eligibility Decision for 
Chlorothalonil (Document number EPA 738-R-99-004, April 1999). Drinking 
water was incorporated directly into the dietary assessment using the 
estimated maximum allowable Estimated Drinking Water Concentration 
(EDWC) of 42 ppb.
    iii. Cancer. EPA has determined that a non-linear approach to 
cancer risk assessment is appropriate. Therefore the chronic RfD is 
considered to be protective for this effect.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of the 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 chemicals that have been 
measured in food. If EPA

[[Page 41227]]

relies on such information, EPA must pursuant to 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. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. For the present action, EPA will issue such 
Data Call-Ins (DCIs) for information relating to anticipated residues 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Such DCIs will be required to be submitted no 
later than 5 years from the date of issuance of this tolerance. Mean 
anticipated residues were estimated from PDP monitoring data for 
apricot; asparagus; banana and plantain; bean, green; bean/pea, dry; 
broccoli, Brussels sprouts; carrot; cauliflower; celery; cherry; corn, 
sweet; cucumber; melon; milk; mushroom; nectarine, parsnip; peach; 
pepper, non-bell; potato; plum; pumpkin; prune; squash; and tomato. 
Mean anticipated residues were estimated from FDA monitoring data for 
blueberry; cabbage; cranberry; mango; onion, dry bulb; papaya; peanut; 
and soybean. Empirical processing factors were used for bean, green, 
cooked, canned, or frozen; cabbage; carrot, processed or cooked; 
cherry, processed; cocoa; coffee; cucumber, pickled; peach, cooked and 
canned; peanut, oil; pea, edible podded, cooked and processed; prunes; 
pumpkin; soybean, oil; squash, winter, cooked; and tomato, processed. 
Default processing factors were used for all other food commodities.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows:
    Almond, 100%; apricot, 10%; asparagus; 15%; banana and plantain, 
100%; bean, green, 20%; bean/pea, dry, 1%; blueberry, 15%; broccoli, 
10%; Brussels sprouts, 68%; cabbage, 40%; carrot, 45%; cattle, 100%; 
cauliflower, 10%; celery, 65%; cherry, 35%; cocoa, 100%; coffee, 100%; 
corn, sweet, 100%; cranberry, 100%; cucumber, 45%; filbert, 100%; 
ginseng, 100%; goat, 100%; hog, 100%; horse, 100%; mango, 100%; melon, 
cantaloupe, 60%; melon, honeydew, 18%; melon, watermelon and other, 
84%; milk, 100%; mushroom, 100%; nectarine, 100%; onion, dry bulb, 50%; 
onion, green, 100%; papaya, 100%; parsnip, 100%; passionfruit, 100%; 
peach, 15%; peanut, 65%; pea, edible podded, 100%; pepper, non-bell, 
100%; pistachio, 100%; potato, 60%; plum and prune, 5%; pumpkin, 40%; 
sheep, 100%; soybean, 100%; squash, 35%; and tomato, 45%.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. The Agency is reasonably certain that the percentage of 
the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which chlorothalonil 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for chlorothalonil and its 
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile 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 physical 
characteristics of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile. 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.

    The modeling showed that chronic drinking water levels of 
chlorothalonil from the most intensive use (i.e., sodfarms) would, in 
combination with other exposures, raise a risk of concern. EPA believes 
that this modeling estimate significantly overstates exposure not only 
because its surface water model is generally conservative, but due to 
several factors unique to this risk assessment. First, the EDWC for 
chlorothalonil and its major metabolite was estimated using the 
mobility factor for chlorothalonil's major metabolite, which is 
considered more mobile than the parent. EPA does not have a method to 
calculate model input values for mobility of combined toxic residues; 
therefore, the most conservative value was used for the model. Second, 
EPA assumed use of maximum sodfarm application rates, application 
intervals, and agronomic practices which are not always employed. 
Third, EPA assumed that 100% of a watershed consists of sodfarm turf, 
compared with recent preliminary data showing that 50% or less is a 
more realistic number. Fourth, EPA assumed that all sodfarms in any 
given watershed area would be treated with chlorothalonil in the same 
season, and at the same time, which is unlikely to occur. Despite EPA's 
conclusion that the predicted EDWC overstates exposure, EPA conducted a 
sensitivity analysis to determine what sodfarm usage rate would lower 
predicted drinking water levels by a sufficient amount to eliminate any 
risk concerns. EPA's analysis showed that the maximum allowable EDWC to 
be 42 ppb, and that reducing the maximum application rate for sodfarms 
from 26 lbs of active ingredient/acre/year to 13 lbs active ingredient/
acre/year would result in acceptable EDWC of less than 42 ppb. This 
reduction in the maximum sodfarm application rate is being incorporated 
on all affected chlorothalonil product labels.
    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).
    Chlorothalonil is currently registered for use on the following 
residential non-dietary sites: Golf courses and additive for paints. 
The risk assessment was

[[Page 41228]]

conducted using the following residential exposure assumptions: There 
is potential for residential exposure from treated golf courses and 
from using treated paint. All other turf uses involving chlorothalonil 
exposure to toddlers and children have been canceled. EPA has 
determined that there is no hazard via the dermal route; therefore, 
quantification of a dermal risk assessment is not required. Inhalation 
post-application exposures for golf courses were not assessed since 
inhalation exposures are thought to be negligible in outdoor post-
application scenarios. Consequently, only inhalation and incidental 
oral exposures from the use of treated paint were assessed. The short- 
and intermediate-term inhalation and incidental oral MOEs are greater 
than the target MOE of 1000 and, therefore, do not exceed EPA's level 
of concern (LOC).
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 chlorothalonil and any 
other substances and chlorothalonil 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 chlorothalonil 
has a common mechanism of toxicity with other substances. In the 
chlorothalonil RED, chlorothalonil was grouped in the polychlorinated 
fungicide class of pesticides. Other members of this class include 
hexachlorobenzene (HCB), pentachlorophenol (PCP), and 
pentachloronitrobenzene (PCNB). This is considered a weak 
classification, with the only point of commonality is that they are 
polychlorinated compounds used as fungicides. Available data do not 
support a finding for a common mechanism of toxicity for chlorothalonil 
and the other pesticides in the polychlorinated fungicide class. 
Chlorothalonil produces renal (kidney) tubular adenomas and carcinomas 
and papillomas of the stomach in rats. Chlorothalonil also produces 
gastric lesions and kidney toxicity due to perturbation of 
mitochondrial respiration. The other pesticides in the class do not 
have the same toxic effects and do not have the same mode of action.For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on 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 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. 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 safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA has concluded that there 
is no increased susceptibility following prenatal or postnatal exposure 
to chlorothalonil in rats. There is equivocal evidence of increased 
susceptibility in rabbits; however, the degree of concern for prenatal 
susceptibility is low. There is a well-defined NOAEL in the rabbit 
developmental toxicity study protecting from these effects. In 
addition, developmental effects were observed in only one of the two 
developmental toxicity studies conducted in the same strain of rabbit 
at the same dose levels. Therefore, based on overall weight-of-
evidence, EPA concluded that there is no increased susceptibility 
following exposure to chlorothalonil or its 4-hydroxy-2,5,6-
trichloroisophthalonitrile metabolite.
    3. Conclusion. There is a complete toxicity data base for 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. The acute, subchronic, developmental, reproduction and 
chronic studies were sufficient to determine whether human hazard could 
exist within the context of dose, duration, timing, and route-of-
exposure. The uncertainty factor used in determining the chronic 
reference dose (cRfD) was 300 (10X for interspecies animal-to-human 
extrapolation; 10X for intraspecies human variations; and 3X for use of 
a LOAEL instead of a NOAEL). The uncertainty factor of 3X for use of 
the LOAEL instead of the NOAEL is considered appropriate because an 
increased incidence and severity of epithelial hyperplasia, 
hyperkeratosis and ulceration of the non-glandular region of the 
stomach in females were seen in few animals and were minimal in 
severity and observed in one sex only. The chlorothalonil FQPA safety 
factor was reduced to 3X for chronic risk assessment but retained at 
10X for residential assessments. The data from the chronic toxicity 
study in rats show that a 3X factor in the chronic risk assessment is 
protective of infants and children despite the lack of a NOAEL in that 
study. As to the residential risk assessment, there are insufficient 
reliable data to conclude that a reduction of the 10X FQPA safety 
factor is safe for infants and children given the lack of a NOAEL in 
the study upon which the residential risk assessment is based. Other 
than the lack of NOAELs in these two critical studies, other 
considerations raise no concern for the safety of infants and children. 
Specifically, (1) the hazard and exposure databases are complete; (2) 
there are low concerns for prenatal and/or postnatal toxicity; (3) 
there are no residual uncertainties with regard to prenatal and/or 
postnatal toxicity; and (4) there are no neurotoxic concerns.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No acute effects were identified in the 
toxicological studies for chlorothalonil and its metabolite, 4-hydroxy-
2,5,6-trichloroisophthalonitrile; therefore, a quantitative acute 
dietary exposure assessment is unnecessary. In the 1999 Chlorothalonil 
Registration Elibibility Document, the acute RfD was based on the 
results of a of 90-day study in rats in which gastric renal lesions 
were observed beginning at 7 days of continuous dosing. These type of 
lesions and in particular, the time frame at which they occurred (after 
7 days of continuous high-dose administrations), do not meet the 
criteria of a single-dose effect.

[[Page 41229]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile from food will utilize 3% of the cPAD for 
the U.S. population, 2% of the cPAD for all infants, and 8% of the cPAD 
for children 1-2 years old. There are no residential uses for 
chlorothalonil that result in chronic residential exposure to 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile. Based on approved use pattern, chronic 
residential exposure to residues of chlorothalonil are not expected. In 
addition, there is potential for chronic dietary exposure to 
chlorothalonil in drinking water. Analyses by the Agency indicate that 
42 ppb is the maximum residue concentration (parent plus metabolite) in 
drinking water which results in acceptable levels of chronic aggregrate 
risk. However, as explained prior in Unit III.C.2., this 42 ppb EDWC is 
considered conservative. EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD, as shown in Table 2:

             Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Chlorothalonil
----------------------------------------------------------------------------------------------------------------
                                                                %/cPAD/      Surface      Ground/
              Population/Subgroup                cPAD/mg/kg/   (Food plus   Water EEC/   Water EEC/    Chronic/
                                                     day         water)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.003           33     N/A (Not          N/A          N/A
                                                                           Applicable)
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                              0.003           99          N/A          N/A          N/A
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old                                 0.003           52          N/A          N/A          N/A
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old                                 0.003           30          N/A          N/A          N/A
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Chlorothalonil is currently registered for use that could result in 
short-term and intermediate-term residential exposure and the Agency 
has determined that it is appropriate to aggregate chronic food and 
water and short-term and intermediate-term exposures for chlorothalonil 
and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food, 
water, and residential exposures aggregated result in aggregate MOEs of 
8,600 for adults 20-49 years old. These aggregate MOEs do not exceed 
the Agency's level of concern for aggregate exposure to food, water, 
and residential uses. Dietary exposure was calculated assuming residues 
in water of 42 ppb.
    5. Aggregate cancer risk for U.S. population. EPA has determined 
that a non-linear approach to cancer risk assessment is appropriate and 
that the chronic RfD is considered to be protective for this effect.
    6. 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, and to infants and children from aggregate 
exposure to chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate residue analytical methods are available for purposes of 
registration. The Pesticide Analytical Manual (PAM) Vol. II lists 
Method I, a gas chromatography (GC) method with electron-capture 
detection (ECD), for the enforcement of tolerances for plant 
commodities.

B. International Residue Limits

    There are no conflicts between existing U.S. tolerances and MRLs 
established by the CODEX Alimentarius Commission.

C. Response to Comments

    One comment dated September 4, 2004, was received from B. Sachau. 
Ms. Sachau's comments regarding general exposure to pesticides 
contained no scientific data or evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to chlorothalonil, including all 
anticipated dietary exposures and other exposures for which there is 
reliable information. This comment, as well as her comments regarding 
animal testing, has been responded to by the Agency on several 
occasions. For example, January 7, 2005 (70 FR 1349) (FRL-7691-4) and 
October 29, 2004 (69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerance is established for the combined residues 
of chlorothalonil, and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on pea, edible podded (includes snow 
pea and sugar snap pea) at 5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 due to its lack of 
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from

[[Page 41230]]

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). 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). 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitledFederalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: July 13, 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 180.275 is amended by alphabetically adding the following 
commodity to the table in paragraph (a)(1) to read as follows:

Sec. 180.275   Chlorothalonil; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Pea, edible podded                                                     5
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E7-14567 Filed 7-26-07; 8:45 am]

BILLING CODE 6560-50-S