[Federal Register Volume 66, Number 216 (Wednesday, November 7, 2001)]
[Rules and Regulations]
[Pages 56233-56245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27602]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301188; FRL-6807-1]
RIN 2070-AB78


Chlorothalonil; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation re-establishes a time-limited tolerance for 
combined residues of chlorothalonil and its metabolite, 4-hydroxy-
2,5,6- trichloroisophthalonitrile in or on ginseng. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on ginseng. This regulation re-establishes a 
maximum permissible level for residues of chlorothalonil and its 
metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile (SDS-3701) in 
this food commodity. The tolerance will expire and is revoked on 
December 31, 2003.

DATES: This regulation is effective November 7, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301188, 
must be received by EPA on or before January 7, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301188 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Dan Rosenblatt, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number:(703) 308-9375; and e-mail address: 
[email protected].

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 categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 56234]]

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180._00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301188. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is re-establishing a tolerance for combined residues of 
the fungicide chlorothalonil and its metabolite, 4-hydroxy-2,5,6- 
trichloroisophthalonitrile, in or on ginseng at 0.10 part per million 
(ppm). This tolerance will expire and is revoked on December 31, 2003. 
EPA will publish a document in the Federal Register to remove the 
revoked tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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) 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) 
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. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Chlorothalonil on Ginseng and FFDCA 
Tolerances

    Ginseng is a valuable root crop that is used as a health supplement 
in a variety of foods such as teas, wine, herbal medicines and gum. 
Ginseng is grown over multiple growing seasons, so disease control is 
necessary to ensure that the harvested roots and seeds are not damaged 
by intensifying disease pressure over successive seasons. Roots are not 
harvested until the plants are four years old. Growers are concerned 
about the damage that the fungal disease Alternaria panax causes to 
ginseng gardens. The fungus can produce leaf and stem blight which 
defoliates and diminishes the overall vigor of effected ginseng. These 
blights can result in high or complete yield loss of the harvested 
ginseng root.
    Growers have typically relied upon mancozeb treatments to protect 
gardens against Alternaria panax. However, during the 2001 growing 
season, Wisconsin experienced significant precipitation and also hot 
humid conditions. This weather cycle further heightened the probability 
of significant disease pressure. At the same time, the rain events 
negated the effectiveness of the traditional control means, mancozeb. 
If applied prior to rain events, mancozeb will wash off of the ginseng 
plants. The Applicant identified a weather-stick formulation of 
chlorothalonil that has the characteristic of adhering strongly to the 
ginseng plants. Thus, on June 15, 2001, the Wisconsin Department of 
Agriculture, Trade, and Consumer Protection availed itself of its 
authority to declare a crisis situation under section 18, thereby 
permitting growers to immediately use a weather-stick formulation of 
chlorothalonil on ginseng.
    EPA acknowledges that there are not sufficient registered 
alternatives and concurred on the crisis declaration by the State to 
control leaf and stem blight in ginseng.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of chlorothalonil in or on 
ginseng. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) 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 this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6). Although this tolerance will 
expire and is revoked on December 31, 2003, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on ginseng 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

[[Page 56235]]

exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether chlorothalonil 
meets EPA's registration requirements for use on ginseng or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of chlorothalonil by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Wisconsin to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
chlorothalonil, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
    Consistent with 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 
chlorothalonil and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
combined residues of chlorothalonil and its metabolite, 4-hydroxy-
2,5,6-trichloroisophthalonitrile in or on ginseng at 0.10 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    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 endpoint. 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. An UF of 100 
is routinely used, 10x to account for interspecies differences and 10x 
for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10x to account for interspecies differences and 10x for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for chlorothalonil used for human risk assessment is shown in 
the following Table 1.

    Table 1.--Summary of Toxicological Dose and Endpoints for Chlorothalonil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       LOAEL = 175 mg/kg/day    FQPA SF = 1X             Subchronic Dietary -
 including infants and children        UF = 300 Acute RfD       aPAD = acute RfD/FQPA     Rats
                                        =0.58 mg/kg/day.         SF= 0.58 mg/kg/day.     LOAEL = 175 mg/kg/day
                                                                                          based on increased
                                                                                          cell proliferation
                                                                                          correlated with
                                                                                          histopathological
                                                                                          lesions of
                                                                                          degeneration of the
                                                                                          proximal convoluted
                                                                                          tubules and epithelial
                                                                                          hyperplasia.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL = 2 mg/kg/day      FQPA SF = 1X             Chronic Toxicity/
                                       UF = 100...............  cPAD =.................   Carcinogenicity Study
                                       Chronic RfD = 0.02 mg/   chronic RfD/FQPA SF=       Rats
                                        kg/day.                  0.02 mg/kg/day.         LOAEL = 4 mg/kg/day
                                                                                          based on increased
                                                                                          kidney weights and
                                                                                          hyperplasia of the
                                                                                          proximal convoluted
                                                                                          tubules in the kidneys
                                                                                          as well asulcers and
                                                                                          forestomach
                                                                                          hyperplasia.
----------------------------------------------------------------------------------------------------------------

[[Page 56236]]

 
Short-term dermal (1 to 7 days)        dermal (or oral) study   LOC for MOE = 100        21-Day Dermal Toxicity
(Residential)........................   NOAEL= 600 mg/kg/day    (Residential)..........   Study - Rats
                                       (dermal absorption rate                           LOAEL = 600 mg/kg/day
                                        = 0.15%).                                         based on no treatment-
                                                                                          related systemic
                                                                                          toxicity in the
                                                                                          highest dose tested.
----------------------------------------------------------------------------------------------------------------
Intermediate-termdermal (1 week to     dermal (or oral) study   LOC for MOE = 100        21-Day Dermal Toxicity
 several months)                        NOAEL = 600 mg/kg/day   (Residential)..........   Study - Rats
(Residential)........................   (dermal absorption                               LOAEL = 600 mg/kg/day
                                        rate = 0.15%                                      based on no treatment-
                                                                                          related systemic
                                                                                          toxicity in the
                                                                                          highest dose tested.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal,inhalation)       Q* = 7.66 x 10-3 (mg/kg/                          Chronic toxicity/
                                        day)-1                                            carcinogenicity study
                                                                                          in rats. Findings
                                                                                          based on evidence of
                                                                                          increased incidence of
                                                                                          renal adenomas,
                                                                                          carcinomas and
                                                                                          adenomas/carcinomas
                                                                                          combined in rats and
                                                                                          mice following chronic
                                                                                          dosing at 15 and 175
                                                                                          milligram/kilograms/
                                                                                          day (mg/kg/day), as
                                                                                          well as increased
                                                                                          incidence of
                                                                                          forestomach carcinomas
                                                                                          in CD-1 mice and
                                                                                          papillomas and/or
                                                                                          carcinomas combined in
                                                                                          Fisher 344 rats. A 3/4
                                                                                          scaling factor was
                                                                                          applied to the Q*.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NOAEL = 1.5 mg/kg/day    LOC for MOE = 9,500      Cell proliferation
                                                                                          study in rats;
                                                                                         LOAEL = 15 mg/kg/day
                                                                                          based on toxic
                                                                                          response of the kidney
                                                                                          and forestomach.
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

    1. Mechanistic data. In a cell proliferation study, 28 male Fischer 
344 rats received technical chlorothalonil (97.9%) in the diet at 175 
mg/kg/day for up to 91 days. Mean labeling index was statistically 
increased in the kidneys of male rats treated with 175 mg/kg/day 
chlorothalonil at all scheduled sacrifice times. From Day 7 to Day 28, 
the increase in labeling index was relatively stable (approximately 10-
fold over control), with a decrease to approximately 3.5-fold over 
control on Day 91. Increased cell proliferation correlated with 
histopathological lesions of degeneration of the proximal convoluted 
tubules and epithelial hyperplasia. The results of this study 
demonstrate a sustained cell proliferative response as a result of 
dietary administration of technical chlorothalonil at a dose of 175 mg/
kg/day.
    In another study, 96 male SPR rats were divided into test groups of 
6 animals per group. Rats received technical chlorothalonil (98.98% 
a.i.) in the diet at dose levels of 0, 1.5, 15, or 175 mg/kg/day for 
either 7, 14, 21, or 28 days (total of 24 rats per time point). 
Histological examination of kidney and stomach tissue was performed for 
each group after the appropriate exposure. In addition, kidneys were 
subjected to PCNA staining and stomachs to BrdU staining, and the 
labeling index and labeling count of cell nuclei were performed. 
Duodenum was used as a negative control for PCNA and BrdU staining. 
Increased absolute and relative weight of the kidneys was observed at 
175 mg/kg/day at all time points, and, in one animal, at 15 mg/kg/day 
on Day 28. Increased incidence of vacuolization of the epithelium of 
the proximal convoluted tubules was observed at all time points at 175 
mg/kg/day on Days 7, 14, and 21 at 15 mg/kg/day. PCNA immunostaining of 
the proximal convoluted tubule epithelial cells showed increased 
labeling of cells at the 175 mg/kg/day dose level at all time points, 
and increased labeling at 15 mg/kg/day on Days 7, 14 and 21. BrdU 
labeling of the rat forestomach showed marked labeling at 175 mg/kg/day 
at all time points, and increased labeling on Day 28 at 15 mg/kg/day. 
The results of this study demonstrate a toxic response of the kidney 
and forestomach to repeated dietary administration of chlorothalonil at 
doses of 15 and 175 mg/kg/day.
    2. Summary of toxicological dose and levels of concern for SDS-3701 
for use in human risk assessment. There is no evidence of 
carcinogenicity for the SDS-3701 metabolite in either rats or mice. For 
the acute and chronic non-cancer exposure assessments, residues of SDS-
3701 were combined with residues of chlorothalonil and the sum compared 
to chlorothalonil levels of concern (the LOAEL for acute dietary risk 
and the RfD for chronic non-dietary risk).
    3. Summary of toxicological dose and levels of concern for HCB for 
use in human risk assessment. A summary of the toxicological endpoints 
for HCB used for human risk assessment is shown in the following Table 
2.

         Table 2.--Summary of Toxicological Dose and Endpoints for HCB for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL = 0.08 mg/kg/day   Chronic RfD = 0.0008 mg/ 130-week study in rats.
                                       UF = 100...............   kg/day                   Effects observed were
                                                                                          hepatic centrilobular
                                                                                          basophilic
                                                                                          chromogenesis.
----------------------------------------------------------------------------------------------------------------

[[Page 56237]]

 
Cancer (oral, dermal, inhalation)      Q* = 1.02 (mg/kg/day)-1                           Carcinogenicity study
                                                                                          in rodents. Based on
                                                                                          increased tumor
                                                                                          incidences in hamsters
                                                                                          and rats. A 3/4
                                                                                          scaling factor was
                                                                                          applied to the Q*.
----------------------------------------------------------------------------------------------------------------

B. 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. Because it is a low consumption specialty crop, ginseng is 
not uniquely identified in the dietary exposure system the Agency uses 
to estimate food consumption behaviors in the U.S. Thus, there is not 
likely to be a measurable difference in the exposures and risks from 
chlorothalonil when ginseng is added into the exposure scenario. Also, 
there are not likely to be implications for livestock as ginseng is not 
a feed item. However, in connection with another registration action 
involving chlorothalonil, EPA recently completed a comprehensive risk 
assessment for chlorothalonil. These risk assessments were conducted by 
EPA to assess dietary exposures from chlorothalonil and its metabolite 
in food as follows:
    i. Acute exposure. Acute dietary 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. The Dietary Exposure Evaluation Model 
(DEEMTM) analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1977-1978-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 acute exposure assessments: Each analysis assumes uniform 
distribution of chlorothalonil in the commodity supply. Acute dietary 
exposure was estimated based on the theoretical maximum residue 
contribution (TMRC) or anticipated residues for combined residues of 
chlorothalonil and SDS-3701. Percent crop treated and anticipated 
residue refinements were used.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Risk Evaluation System (DRES) was used. The 
following assumptions were made for the chronic exposure assessments: 
Tolerance level residues and percent of crop treated information were 
used in the analysis for chlorothalonil and SDS-3701. Anticipated 
residues were used in the chronic dietary exposure analysis from food 
for HCB.
    iii. Cancer. In this analysis, dietary exposure from chlorothalonil 
was estimated based on anticipated residues (excluding meat and milk, 
eggs and poultry). Meat and milk, eggs and poultry were not included in 
this analysis since chlorothalonil residues are not expected in these 
commodities. SDS-3701 was not included in this analysis since it is not 
carcinogenic. The dietary exposure from food from HCB was estimated 
based on anticipated residues (includes meat and milk, eggs, and 
poultry). Since HCB is a contaminant in several other pesticides, an 
aggregate exposure assessment for HCB was conducted with food uses of 
chlorothalonil, pentachlorobenzene, picloram, and dacthal. HCB is 
present in five other food-use pesticides but at low levels which do 
not significantly add to the aggregate dietary exposure. 
Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has 
concluded that the carcinogenic potential of PCB is comparable to HCB. 
In estimating dietary carcinogenic risk from HCB in these four 
pesticides, the Q* for PCB is assumed to be equal to that for HCB. The 
assumption was made that the impurities would occur on food commodities 
at the same ratio to the active ingredient as was present in the 
formulation applied to these crops. It is also assumed that the 
impurity would dissipate from the food commodity at an equal or greater 
rate than the active ingredient. The Agency believes these are 
reasonable assumptions because there are data from studies with 
chlorothalonil, picloram, and dacthal which support this approach.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) 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 relies on such information, EPA must 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. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) 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 percent crop 
treated (PCT) as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as shown in 
the following Table 3.

[[Page 56238]]



                                         Table 3.--Estimation of Percentage of Crops Treated With Chlorothalonil
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Anticipated Residues (ppm)
           Commodity             Processing Factors ------------------------------------------------------------              % Crop Treated
                                                            Chlorothalonil                      HCB
--------------------------------------------------------------------------------------------------------------------------------------------------------
Apricots                         None                                      0.0078                    3.9 x 10-6                                       35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Banana pulp                      None                                      0.0005                    0.3 x 10-6                                       10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beans, dry                       None                                      0.0087                    4.4 x 10-6                                        2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beans, snap                      0.05 for all                              0.0133                    6.7 x 10-6                                       40
                                  cooked canned or
                                  frozen beans
--------------------------------------------------------------------------------------------------------------------------------------------------------
Broccoli                         None                                      0.0015                    0.8 x 10-6                                       15
--------------------------------------------------------------------------------------------------------------------------------------------------------
Brussels sprouts                 None                                      0.0135                    6.8 x 10-6                                       42
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cabbage                          0.2 for all food                          0.0137                    6.9 x 10-6                                       50
                                  forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cabbage, Chinese                 0.2 for all food                          0.0116                    5.8 x 10-6                                      100
                                  forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle fat                       None                                           0                   1.65 x 10-4                                     None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle meat                      None                                           0                   1.24 x 10-5                                     None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle liver                     None                                           0                      8 x 10-6                                     None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle kidney                    None                                           0                      8 x 10-6                                     None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cocoa                            0.1 for all food                            0.05                    2.5 x 10-6                                      100
                                  forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cantaloupe                       None                                      0.0191                    9.6 x 10-6                                       30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carrots                          0.005 for all                             0.0036                    1.8 x 10-6                                       35
                                  cooked or
                                  processed food
                                  forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cauliflower                      None                                      0.0115                    5.8 x 10-6                                       20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Celery                           None                                      0.0874                   43.7 x 10-6                                       85
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cherries                         0.05 for all                               0.002                      1 x 10-6                                       40
                                  processed food
                                  forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cranberries                      None                                      0.4125                    206 x 10-6                                       60
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coffee                           0.1 for all food                            0.20                      1 x 10-4                                      100
                                  forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corn, sweet                      None                                      0.0002                    0.1 x 10-6                                        5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cucumber                         0.2 for cold-                             0.0062                    3.1 x 10-6                                       35
                                  canned pickles;
                                  0.04 for hot-
                                  canned pickles
--------------------------------------------------------------------------------------------------------------------------------------------------------
Garlic                           None                                      0.0005                    0.3 x 10-6                                       10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Honeydew                         None                                      0.0033                    1.7 x 10-6                                       20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nectarines                       None                                     0.00175                    0.9 x 10-6                                       35
--------------------------------------------------------------------------------------------------------------------------------------------------------
Onions, bulb                     None                                      0.0033                    1.7 x 10-6                                       65
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 56239]]

 
Onions, green and leeks          None                                      0.0262                   13.1 x 10-6                                       65
--------------------------------------------------------------------------------------------------------------------------------------------------------
Papayas                          None                                       0.005                    2.5 x 10-6                                      100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Parsnips                         None                                      0.0052                    2.6 x 10-6                                       10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Passion fruit                    None                                           3                    1.5 x 10-3                                      100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Peaches                          0.02 for all                              0.0018                    0.9 x 10-6                                       35
                                  cooked or canned
                                  food forms
--------------------------------------------------------------------------------------------------------------------------------------------------------
Peanuts                          0.5 for peanut oil                        0.0045                    2.3 x 10-6                                       90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Plums                            0.33 for dried                            0.0005                    0.3 x 10-6                                       10
                                  prunes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potatoes                         None                                      0.0030                    1.5 x 10-6                                       30
--------------------------------------------------------------------------------------------------------------------------------------------------------
Poultry fat                      None                                           0                    2.2 x 10-6                                     None
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pumpkins                         0.002 for raw                             0.0065                    3.3 x 10-6                                       30
                                  pumpkin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Soybeans                         0.5 for soybean                          0.00005                    2.5 x 10-8                                        1
                                  oil
--------------------------------------------------------------------------------------------------------------------------------------------------------
Squash                           None for summer                           0.0058                    2.9 x 10-6                                       15
                                  squash; 0.002 for
                                  raw winter
                                  squash; 0.001 for
                                  cooked winter
                                  squash
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tomatoes                         0.25 for juice;                           0.0716                   35.8 x 10-6                                       70
                                  0.02 for paste,
                                  puree and catsup
--------------------------------------------------------------------------------------------------------------------------------------------------------
Watermelons                      None                                      0.0228                   11.4 x 10-6                                       55
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. 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

[[Page 56240]]

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--i.  Ground water exposure 
- chlorothalonil and SDS-3701. Exposure to chlorothalonil in drinking 
water is derived from the monitoring data. The metabolites (SDS-46851, 
SDS-47525, SDS-3701, and SDS-19221) were measured at a combined 
concentration of approximately 16 parts per billion (ppb) in Suffolk 
County, Long Island in 1981. Chlorothalonil itself has been detected in 
the Sates of California, Florida, Massachusetts, and Maine at levels 
typically below 1 ppb. These observations are predictable based on 
laboratory mobility studies and evidence of metabolite persistence. It 
is expected that the levels of chlorothalonil metabolites detected in 
the ground water in New York are relatively high compared to the 
country as a whole, because (a) they were the highest values reported 
in the data base, (b) potatoes are a major crop on Long Island, and (c) 
Long Island ground water is generally shallow and vulnerable. The Long 
Island values were used to represent a high-end potential exposure. In 
the absence of data demonstrating otherwise, this assessment is based 
on the conservative assumption that the detected metabolites of 
chlorothalonil have the same toxicity as the parent. As indicated 
above, this assessment relies on other conservative factors.
    ii. Surface water exposure chlorothalonil and SDS-3701. 
Chlorothalonil can contaminate surface water at application via spray 
drift or after application through runoff and erosion. The intermediate 
soil/water partitioning of chlorothalonil indicates that its 
concentration is suspended and bottom sediment will be substantially 
greater than its concentration in water. The major degradate of 
chlorothalonil in the soil under aerobic conditions is SDS-3701. SDS-
3701 appears to be more persistent and mobile than chlorothalonil, 
based on ground water detections. Substantial amounts of SDS-3701 could 
be available for runoff for longer periods than chlorothalonil, and 
SDS-3701 may be more persistent in water/sediment systems than 
chlorothalonil. The apparent greater mobility of SDS-3701 suggests that 
it exhibits lower soil/water partitioning than chlorothalonil. 
Therefore, the ratio of SDS-3701 runoff loss via dissolution in runoff 
to runoff loss via adsorption to eroding soil for SDS-3701 may be 
greater than for chlorothalonil. In addition, the ratios of 
concentrations dissolved in the water column to concentrations adsorbed 
to suspended and bottom sediment may be higher for SDS-3701 than for 
chlorothalonil. The Agency has be unable to calculate drinking water 
risk for SDS-3701 in surface water because no monitoring data were 
available.
    The South Florida Water Management District (SFWMD) summarized 
chlorothalonil detections in samples collected every 2 to 3 months from 
surface water sites within the SFWMD from November 1988 through 
November 1993. Approximately 810 samples (30 sampling intervals x 27 
sites sampled/interval) were collected during that time. Chlorothalonil 
was detected in 25 samples at concentrations ranging from 0.003 ppb to 
0.35 ppb. Six of the samples had concentrations greater than 0.01 ppb.
    iii. Ground and surface water exposure HCB and PCB. HCB and 
pentachlorobenzene are present in ground water and surface water from 
sources other than current usage of contaminated pesticides, including 
manufacturer of solvents and tires, incineration of wastes, and coal 
combustion. HCB and PCB are persistent and relatively immobile in the 
environment; the major route of dissipation is through sorption to 
soil, sediment, and suspended particulates in water. HCB and PCB 
contamination of ground water sources is relatively unlikely due to the 
high binding potential of both compounds. Detections of HCB in ground 
water generally have ranged between 0.0002 to 0.100 ppb. Based on 
monitoring data and fate properties, it seems unlikely that long-term 
HBC and PCB concentration in surface water would exceed 10 parts per 
trillion (ppt) (0.01 ppb).
    Surface water detection shows much more variability than 
concentrations in ground water and have been measured at up to 750 ppb. 
These values appear to include sorbed HCB. The HCB concentration which 
actually appear to be dissolved in the water are generally less than 
0.001 ppb. Great Lakes region concentrations generally ranged from 
0.00002 to 0.0001 ppb. When concentrations exceeded this range, they 
appeared to be related to industrial areas or areas of historic 
contamination (more than 20 years ago). Concentrations of PCB in 
surface water have ranged between 0.00002 and 0.0001 ppb. 
Concentrations of HCB and PCB in drinking water can be greatly reduced 
through treatment with activated granular charcoal.
    Higher concentrations of HCB and PCB have been reported in surface 
and ground water, but tend to be related to hazardous waste, landfill 
sites, and suspended sediment. The U.S. Department of Health and Human 
Services in 1996 estimated that the average exposure in the United 
States from drinking HCB contaminated water is 0.00085 g/kg/
year (-0.000082 ppb). Since potential exposures are generally so low, 
and because pesticides are just one source of HCB and PCB in drinking 
water, the Agency concluded that there are insufficient data to 
quantify risk and that drinking water risk estimates from HCB in 
pesticides do not exceed the Agency's level of concern.
    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: Home vegetable gardens, ornamentals, 
paint, stain, and wood preservatives. The risk assessment was conducted 
using the following exposure assumptions: The Agency completed an 
exposure assessment for uses of chlorothalonil as an additive contained 
40.4% active ingredient for use in caulks, sealants, polymer lattices, 
grouts, joint compounds, and paper coatings. All relevant occupational 
and residential exposures were considered. Data were not available to 
estimate application and post application exposure and risk for primary 
and secondary homeowner exposure. Primary homeowner exposure occurs in 
individuals who use or install chlorothalonil-containing material; 
secondary residential exposure occurs when other individuals live and 
work in places where chlorothalonil-containing materials have been 
used. For these exposures, no risk assessment could be conducted, but 
the Agency believes that secondary and homeowner exposures to these 
products by themselves are generally lower than primary occupational 
application exposures.
    Since other residential risks could not be quantified, risk 
concerns and uncertainties about exposure resulted in the following 
agreements with the registrants. To mitigate potential residential 
exposure concerns and uncertainties about the packaging and 
concentration of chlorothalonil additives for paint, the registrants 
have agreed that chlorothalonil mildewicidal additives must be labeled 
to prohibit sale over-the-counter in retail outlets. The registrants 
have committed to

[[Page 56241]]

working with the Agency to develop measures for the protection of 
employees of paint sales outlets who mix mildewicidal additives into 
paint for sale. To mitigate potential residential exposure concerns and 
uncertainties about the in-container preservative use of 
chlorothalonil, particularly because the chlorothalonil content of 
products in which the preservative is used may not be known to the 
purchaser, and because such preservatives may be used in paints 
intended for use by children, the registrants have agreed that the in-
container preservative use of chlorothalonil is prohibited.
    The contact rate for activities with ornamentals (5,800 
cm2/hr) is based on a study by Brouwer et al., in which 
chlorothalonil was applied to carnation sprays and carnations grown for 
cut flowers. Rates for dermal contact with treated turf by adults 
(1,000 cm2/hr)and toddlers (8,700 cm2/hr) are 
based on EPA estimates for low exposure activities. Contact rates for 
hand-to-mouth transfer by toddlers (1.56 events/hour), ingestion of 
treated grass by toddlers (25 cm2/day, and ingestion of soil 
from treated areas by children (100 mg/day) are default values which 
originate with high-end exposure scenarios. For the cancer risk 
estimates, the Agency assumed that activities with ornamentals occur 4 
days per year for 50 years, and that an application is made once a 
year, for adults in dermal contact with treated turf, that contact 
occurred 40 days per year for 50 years, and that three applications 
were made each year. The Agency also assumed that reentry occurred on 
the day of treatment.
    For residential post-application exposures related to the use of 
chlorothalonil on turf and ornamentals, short- and intermediate-term 
MOEs ranged from 14 to 26,000. Only the MOEs for toddlers exposed to 
treated turf were at a risk level of concern at which the EPA typically 
takes regulatory action. To address this risk, the registrants have 
agreed to delete the home lawn use from their manufacturing-use and 
end-use products registered solely for this use. When considering the 
elimination of the home lawn use of chlorothalonil, EPA had determined 
that residential post-application exposures to toddlers exposed to 
treated turf do not exceed EPA's level of concern.
    A summary of the residential post-application scenarios and cancer 
risks from chlorothalonil is shown in the following table 4.

         Table 4.--Surrogate Residential Post-application Scenarios and Cancer Risks from Chlorothalonil
----------------------------------------------------------------------------------------------------------------
                                     Application Rate    DFR  (g/    LADD*  (mg/kg/      Cancer Risk
 Exposure Activity/Crop or Target      (lb ai/acre)             cm2)               day)          (Based on Q*)
----------------------------------------------------------------------------------------------------------------
Ornamentals (Transplanting/        0.183                              0.41             2.5E-6             2.0E-9
 Pruning/Bundling Flowers)
----------------------------------------------------------------------------------------------------------------
                                   8.7                                  20             1.3E-5             9.6E-8
----------------------------------------------------------------------------------------------------------------
                                   15.7                                 35             2.3E-5             1.8E-7
----------------------------------------------------------------------------------------------------------------
Vegetables (Harvesting)            0.183                              0.41             4.6E-7             3.5E-9
----------------------------------------------------------------------------------------------------------------
                                   0.74                                1.7             1.9E-6             1.4E-8
----------------------------------------------------------------------------------------------------------------
                                   8.7                                  20             2.2E-5             1.7E-7
----------------------------------------------------------------------------------------------------------------
Adult Dermal Contact with Turf     8.7                                  20             3.3E-5             2.5E-7
----------------------------------------------------------------------------------------------------------------
                                   11.8                                 26             4.4E-5             3.4E-7
----------------------------------------------------------------------------------------------------------------
                                   15.7                                 35             5.5E-5             4.2E-7
----------------------------------------------------------------------------------------------------------------
* Lifetime average daily dose.

    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether chlorothalonil has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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. 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 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 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 margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The developmental and 
reproductive data for chlorothalonil indicate that there is no evidence 
of increased sensitivity to chlorothalonil from prenatal and postnatal 
exposures. In the rat developmental toxicity study, the developmental 
NOAEL and LOAEL were based on an increase in total resoprtions per dam 
with a related increase in post-implantation loss. These observations 
occurred at a dose (400 mg/kg/day) which produced increased mortality 
and reduced body weight gain in maternal animals. No developmental 
toxicity was observed in

[[Page 56242]]

the rabbit developmental toxicity study, and no maternal toxicity was 
observed at the highest dose tested (20 mg/kg/day).
    iii. Conclusion. There is a complete toxicity data base for 
chlorothalonil and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
removed. The FQPA factor is removed because no reproductive effects 
were observed in any study and developmental effects occurred only in 
the presence of significant maternal toxicity. HCB was not considered 
in this evaluation of the special sensitivity of infants and children. 
HCB will be considered at a future date when the Agency is better 
equipped to understand the implications of FQPA for HCB, which is a 
common contaminant of at lest nine other pesticides and which also 
enters the environment from non-pesticidal sources.

D. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the estimated MOEs from exposure to 
chlorothalonil and SDS-3701 residues from food and water do not exceed 
the Agency's LOC. A summary of the aggregate risk assessment for acute 
exposure to chlorothalonil is shown in the following Table 5.

              Table 5.--Aggregate Risk Assessment for Acute Exposure to Chlorothalonil and SDS-3701
----------------------------------------------------------------------------------------------------------------
      Population Subgroup                     LOC for MOE                                  MOE
----------------------------------------------------------------------------------------------------------------
Food - U.S. Population                                              300                                    1,166
----------------------------------------------------------------------------------------------------------------
Food - Infants <1 year old                                          300                                      875
----------------------------------------------------------------------------------------------------------------
Food - Children (1-6 years)                                         300                                      875
----------------------------------------------------------------------------------------------------------------
Food - Females (13+ years)                                          300                                    1,750
----------------------------------------------------------------------------------------------------------------
Food - Males (13+ years)                                            300                                    1,750
----------------------------------------------------------------------------------------------------------------
Drinking water (ground water) -                                     300                                  110,000
  Children
----------------------------------------------------------------------------------------------------------------
Drinking water (ground water) -                                     300                                  380,000
  Adults
 
Drinking water (surface water)                                      300                               50,000,000
 - Children
----------------------------------------------------------------------------------------------------------------
Drinking water (surface water)                                      300                              175,000,000
 - Adults
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
chlorothalonil and SDS-3701 from food will utilize 34% of the cPAD for 
the U.S. population and 68% of the cPAD for children. Based on the use 
pattern, chronic residential exposure to residues of chlorothalonil is 
not expected. EPA does not have chronic non-cancer concerns for HCB in 
chlorothalonil. EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). The estimated MOEs from residential uses ranged from 310 for 
adults transplanting, pruning or bundling flowers to 110,000 for 
infants ingesting paint chips. Though residential exposure could occur 
with the use of chlorothalonil, the potential short- and intermediate-
term exposure were not aggregated with chronic food and water exposures 
because the toxic effects are different. Therefore, based on the best 
available data and current policies, potential risks do not exceed the 
Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. HCB and 
pentachlorobenzene are present in ground water and surface water from 
sources other than current usage of contaminated pesticides, including 
manufacturing of solvents and tires, incineration of wastes, and coal 
combustion. Both are persistent and relatively immobile in the 
environment; the major route of dissipation is through sorption to 
soil, sediment, and suspended particulates in water.
    HCB and PCB contamination of ground water sources is relatively 
unlikely due to the high binding potential of both compounds. 
Detections of HCB in ground water generally have ranged between 0.0002 
to 0.100 g/L. PCB levels in ground water at a hazardous waste 
site ranged from 0.001 to 62 g/L.
    Based on monitoring data and fate properties, it seems unlikely 
that long-term HCB and PCB concentrations in surface water would exceed 
10 ppt (0.01 g/L). As discussed previously, surface water 
detections show much more variability than concentrations in ground 
water but concentrations which actually appear to be dissolved in the 
water are generally less than 0.001 g/L.
    The upper bound carcinogenic risk from food uses of HCB for the 
general U.S. population was calculated using the following equation: 
HCB Upper Bound Cancer Risk = Dietary Exposure (ARC) x Q*, where the Q* 
of 1.02 mg/kg/day)-\1\, the upper bound cancer risk was calculated to 
be 2.4 x 10-\7\, contributed through all the published, pending and new 
uses for chlorothalonil.
    The upper bound risk for HCB in chlorothalonil is in the range the 
Agency generally considers negligible for excess lifetime cancer risk. 
The exposure assessment for carcinogenic risk from HCB in 
chlorothalonil includes many a assumptions and uncertainties which 
impact the Agency's confidence in the calculated risk.
    HCB is also a contaminant in several other pesticides, and an 
aggregate risk assessment for HCB from chlorothalonil and these other 
sources has been conducted. The exposure assessment for aggregate risk 
is subject to the same kinds of uncertainties and assumptions as the 
risk assessment for HCB in chlorothalonil. For some of the individual 
pesticide contributors, these

[[Page 56243]]

limitations impact the assessment to an even greater extent.
    Four pesticides that are used on food/feed crops have been assessed 
for cancer risk due to contamination with HCB -- chlorothalonil, 
dacthal, picloram, and pentachlornitrobenzene (PCNB). 
Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has 
concluded that the carcinogenic potential of PCB is comparable to HCB, 
based on the similarities of the chemical structures and toxicities of 
HCB and PCB. In estimated dietary risk from HCB in these four 
pesticides, the Q* for PCB is assumed to be equal to that for HCB.
    HCB is also present in pentachlorophenol, but pentachlorophenol is 
not a food use pesticide and so that contaminant in pentachlorophenol 
does not contribute to aggregate dietary risk (the contribution to 
drinking water risk is discussed below). HCB and/or PCB is present in 
five other food-use pesticides, but at low levels which do not 
significantly add to the aggregate dietary exposure.
    The estimated aggregate dietary cancer risk from HCB from all known 
pesticide sources is 1.34 x 10-\6\. An additional 0.46 x 10-\6\ may be 
attributed to PCB for a total of 1.8 x 10-\6\.
    A summary of the cancer risks for chlorothalonil, HCB, and PCB are 
shown in the following Table 6.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Upperbound Cancer Risk                          Upper Bound  Cancer
              Chemical                         Q*                     (Food)          Cancer MOE for food       Risk  (Water)       Cancer MOE for Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chlorothalonil                       0.00766                 1.2 x 10-\6\            9,500                  8 x 10-\9\             <1.5 million
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCB from Chlorothalonil              2.4 x 10-\7\            Not applicable          5 x 10-\9\             Not applicable
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCB and PCB - all pesticide sources                          1.8 x 10-\6\            Not applicable         Does not exceed        Not applicable
                                                                                                             Agency's level of
                                                                                                             concern
--------------------------------------------------------------------------------------------------------------------------------------------------------

    EPA has estimated cancer risk using both the Q* and MOE approaches. 
Under the MOE approach, cancer risk is estimated at MOE = 9,500. At 
this time, EPA is not able to conclusively determine that 
chlorothalonil is a non-linear carcinogen nor to apply approved policy 
determinations on non-linear carcinogens to chlorothalonil, and so 
cannot determine whether the MOE of 9,500 represents an excess lifetime 
risk. Under the Q* approach, cancer risk is estimated at 1.2 x 10-\6\. 
This figure is at a level which the EPA considers negligible for excess 
lifetime cancer risk estimates.
    Cancer risk for HCB is estimated at 2.4 x 10-\7\, and EPA does not 
have cancer risk concerns for chlorothalonil alone. Although subject to 
considerable uncertainty, cancer risk from HCB from chlorothalonil and 
other pesticides, combined with cancer risk from the related 
contaminate PCB present in other pesticides, is estimated at 1.8 x 10-
\6\. a level at which the EPA typically takes regulatory action. To 
address this risk, the registrants of chlorothalonil have agreed that 
the level of HCB in all chlorothalonil products must be reduced to no 
greater than 0.004% (40 ppm). This is the lowest level that has been 
shown to be technologically feasible for chlorothalonil. All 
registrations are conditional on achieving this level, and failure to 
achieve this level will result in a suspension of manufacture or import 
of the subject products. In addition, registrants of chlorothalonil 
products will maintain approximately historic levels of production and 
import of chlorothalonil manufacturing use product to assure that 
chlorothalonil with higher levels of HCB will not be stockpiled and 
formulated. When this decrease in the amount of HCB is considered, EPA 
has determined that the cancer risk estimates do not exceed the level 
for regulatory action.
    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, and to infants and children from aggregate 
exposure to combined residues of chlorothalonil and SDS-3701 or from 
residues of the contaminant HCB.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using gas chromotography is 
available to enforce the established tolerance expressions. The 
Pesticide Analytical Manual (PAM) vol. II lists Method I, a gas 
chromatography method with electron capture detection (ECD), for 
enforcement of tolerances for plant commodities. An acceptable 
enforcement method for residues of SDS-3701, a modification of the 
method for chlorothalonil, is also available.

B. International Residue Limits

    There are no Canadian, Mexican, or Codex tolerances for 
chlorothalonil on ginseng.

VI. Conclusion

    Therefore, the tolerance is re-established for combined residues of 
chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile, in or on ginseng at 0.10 ppm.

VII. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301188 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 on or before January 
7, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in

[[Page 56244]]

the regulation that you object to, and the grounds for the objections 
(40 CFR 178.25). If a hearing is requested, the objections must include 
a statement of the factual issues(s) on which a hearing is requested, 
the requestor's contentions on such issues, and a summary of any 
evidence relied upon by the objector (40 CFR 178.27). Information 
submitted in connection with an objection or hearing request may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the information 
that does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301188, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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. 3501et 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 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 FIFRA 
section 18 exemption under FFDCA section 408, 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, entitled Federalism 
(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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled

[[Page 56245]]

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.

IX. Submission to Congress and the Comptroller General

    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: October 20, 2001.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.275 is amended by revising the entry for the 
commodity in the table in paragraph (b) to read as follows:


Sec. 180.275  Chlorothalonil; tolerances for residues.

* * * * *

    (b)*  *  *  

------------------------------------------------------------------------
                                                  Expiration/Revocation
          Commodity           Parts per million            Date
------------------------------------------------------------------------
Ginseng.....................               0.10                 12/31/03
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-27602 Filed 11-6-01; 8:45 am]
BILLING CODE 6560-50-S