[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Rules and Regulations]
[Pages 14330-14342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6087]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301088; FRL-6759-4]
RIN 2070-AB78


Chlorothalonil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of chlorothalonil and its metabolite, 4-hydroxy-2,5,6-
trichloroisophthalonitrile (SDS-3701) in or on almonds (nutmeats), 
almond hulls, asparagus, mangoes, non-bell peppers, and pistachios. In 
addition, tolerances for the metabolite SDS-3701 are established for 
milk and meat commodities. ISK Biosciences Corporation and the 
Interregional Research Project Number 4 (IR-4) requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.

DATES: This regulation is effective March 12, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301088, 
must be received by EPA on or before May 11, 2001.

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 VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301088 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: 703-305-7740; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be 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 potentially
             Categories                 NAICS       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.

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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301088. 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, Crystal 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

    In the Federal Register of February 13, 1997 (PP 5F4558) (62 FR 
6780) (FRL-5587-3), April 2, 1997 (PP 6F4676) (62 FR 15700) (FRL-5594-
9), July 11, 1997 (PP 6F4611) (62 FR 37246) (FRL-5723-1), and September 
17, 1997 (PP 2E4042, 2E4018 and 6E4672) (62 FR 48849) (FRL-5735-8), EPA 
issued notices pursuant to section 408 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality 
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the 
filing of pesticide petitions (PP) for tolerances by ISK Biosciences 
Corporation, 15966 Heisley Road, P.O. Box 8000, Mentor, OH 44061-8000 
and Interregional Research Project Number 4 (IR-4), New Jersey 
Agricultural Experimental Station, P.O. box 231, Rutgers University, 
New Brunswick, NJ 08903. These notices included a summary of the 
petition prepared by ISK Biosciences Corporation and IR-4, the 
registrants. The active ingredient has since been transferred to GB 
Biosciences Corporation, 1800 Concord Pike, P.O. Box 15458, Wilmington, 
DE 19850-5458. There were no comments received in response to the 
notices of filing.
    The petitions requested that 40 CFR 180.275 be amended by 
establishing tolerances for combined residues of the fungicide 
chlorothalonil, tetrachloroisophthalonitrile and its metabolite, 4-
hydroxy-2,5,6-trichloroisopthalonitrile (SDS-3701), in or on almonds 
(nutmeats) at 0.05 part per million (ppm), almond hulls at 1.0 ppm, 
asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm, 
and pistachios at 0.2 ppm, and for residues of the metabolite SDS-3701 
in or on the following milk and meat commodities: fat of cattle, hogs, 
goats, horses, and sheep at 0.1 ppm; kidney of cattle, hogs, goats, 
horses and sheep at 0.5 ppm; meat byproducts (mbyp) (except kidney) of 
cattle, goats, hogs, horses and sheep at 0.05 ppm and meat of cattle, 
goats, hogs, horses, and sheep at 0.03 ppm and milk at 0.1 ppm.
    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

[[Page 14331]]

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....''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for combined residues of chlorothalonil and 
its metabolite SDS-3701 in or on almonds (nutmeats) at 0.05 ppm, almond 
hulls at 1.0 ppm, asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell 
peppers at 5 ppm, and pistachios at 0.2 ppm, and for residues of the 
metabolite SDS-3701 in or on the following milk and meat commodities: 
fat of cattle, hogs, goats, horses, and sheep at 0.1 ppm; kidney of 
cattle, hogs, goats, horses and sheep at 0.5 ppm; meat byproducts 
(mbyp) (except kidney) of cattle, goats, hogs, horses and sheep at 0.05 
ppm and meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and 
milk at 0.1 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by chlorothalonil, 
SDS-3701, the major metabolite of chlorothalonil, and hexachlorobenzene 
(HCB), an impurity in chlorothalonil and other pesticide products, are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

Table 1.--Subchronic, Chronic and Other Toxicity; Chlorothalonil and SDS-
                                  3701
------------------------------------------------------------------------
            Study Type                             Results
------------------------------------------------------------------------
21-Day dermal toxicity in rats-     Dermal NOAEL = <60 mg/kg/day based
 chlorothalonil                      on dermal irritation and lesions;
                                     Systemic LOAEL = 600 mg/kg/day.
------------------------------------------------------------------------
Prenatal developmental in rodents - Maternal NOAEL = 100 mg/kg/day;
 chlorothalonil                      LOAEL = 400 mg/kg/day based on
                                     increased mortality and reduced
                                     body weight gain. Developmental
                                     LOAEL = 400 mg/kg/day based on an
                                     increase total resorptions and
                                     resorptions per dam with a related
                                     increase in post-implantation loss.
                                     No decrease in litter size was
                                     reported.
------------------------------------------------------------------------
Prenatal developmental in           Maternal NOAEL = 1 mg/kg/day; LOAEL
 nonrodents - SDS-3701               = 2.5 mg/kg/day based on increase
                                     in maternal death and abortion.
                                     Developmental NOAEL = 5 mg/kg/day,
                                     the highest dose tested. No
                                     developmental toxicity observed.
------------------------------------------------------------------------
Reproduction and fertility effects  Parental/Systemic NOAEL = <38 mg/kg/
 - chlorothalonil                    day; LOAEL = 38 mg/kg/day based on
                                     hyperplasia of renal and
                                     forestomach tissues. Offspring
                                     toxicity NOAEL = 115 mg/kg/day;
                                     LOAEL = 234 mg/kg/day based on
                                     lower neonatal body weights by day
                                     21.
------------------------------------------------------------------------
Carcinogenicity rats -              NOAEL = 2 mg/kg/day; LOAEL = 4 mg/kg/
 chlorothalonil                      day based on increased kidney
                                     weights as well as ulcers and
                                     forestomach hyperplasia. Renal
                                     tubular adenomas and carcinomas
                                     were seen in male Fisher 344 rats
                                     at 15 and 175 mg/kg/day and in
                                     females at 175 mg/kg/day. The
                                     incidence of forestomach papillomas
                                     and carcinomas was increased at 175
                                     mg/kg/day in males and at both 15
                                     and 175 mg/kg/day in females.
------------------------------------------------------------------------
Carcinogenicity rats -              NOAEL = <40 mg/kg/day; Chronic
 chlorothalonil                      hyperplasia of cortical tubules and
                                     pelvic/papillary epithelium,
                                     tubular cysts were found at all
                                     dose levels. Renal adenomas and
                                     carcinomas as well as stomach
                                     papillomas were also present at all
                                     dose levels. Female rat renal
                                     (adenomas and/or carcinomas) tumor
                                     rates were 0/60 in the control, 2/
                                     60 at 40 mg/kg/day, 7/61 at 80 mg/
                                     kg/day, and 19/59 at 175 mg/kg/day.
------------------------------------------------------------------------
Carcinogenicity mice -              NOAEL = <112.5 mg/kg/day; Bone
 chlorothalonil                      marrow and spleen red pulp
                                     hyperplasia, increased kidney
                                     weights with surface
                                     irregularities, pelvic dilation,
                                     cysts and nodules, and stomach /
                                     esophageal hyperplasia were found
                                     at all dose levels (equivalent to
                                     112.5, 225, or 450 mg/kg/day) in CD-
                                     1 mice.
------------------------------------------------------------------------
Carcinogenicity rats - SDS-3701     NOAEL = 3.0 mg/kg/day; LOAEL = 10 mg/
                                     kg/day based on reduced body
                                     weight. There was no evidence of
                                     carcinogenicity in either sex of
                                     Sprague-Dawley rats.
------------------------------------------------------------------------
Carcinogenicity mice - SDS-3701     LOAEL = <54 mg/kg/day based on
                                     increased liver-to-body weight
                                     ratios in males. There was no
                                     evidence of carcinogenicity in
                                     either sex of CD-1 mice.
------------------------------------------------------------------------

[[Page 14332]]

 
Gene Mutation                       In light of considerable body of
                                     evidence from acceptable whole
                                     animal testing, it is concluded
                                     that chlorothalonil is also not
                                     calstogenic or aneugenic in rats,
                                     mice or Chinese hamsters.
------------------------------------------------------------------------
Cytogenetics                        A weak positive response was seen
                                     under non-activated conditions in
                                     an in vivo cytogenetic CHO assay
                                     and in the subchronic phase of an
                                     in vivo bone marrow Chinese hamster
                                     cytogenetic assay.
------------------------------------------------------------------------
Metabolism and pharmacokinetics     Oral absorption was low
                                     (approximately 33% of the
                                     administered dose). Peak blood
                                     levels were considered low (less
                                     than 1% of the dose present in
                                     blood). Elimination was primarily
                                     by the gastrointestinal tract, with
                                     80 - 90% in feces and approximately
                                     15 - 20% was observed in bile.
------------------------------------------------------------------------
Dermal penetration                  An upper limit of 0.15% of
                                     chlorothalonil that contacts the
                                     skin during a workday is estimated
                                     to be absorbed. The dermal
                                     absorption rate is calculated using
                                     the lowest LOAEL from the
                                     subchronic oral dosing studies in
                                     rats, the oral absorption rate
                                     obtained from the rat metabolism
                                     study and the LOAEL from the 21-day
                                     dermal toxcity study.
------------------------------------------------------------------------
Cell proliferation study in male    LOAEL = 175 mg/kg/day based on
 Fisher 344 rats - chlorothalonil    increased cell proliferation
                                     correlated with histopathological
                                     lesions of degeneration of the
                                     proximal convoluted tubules and
                                     epithelial hyperplasia.
------------------------------------------------------------------------

B. 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 level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
ariations 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 intraspecies differences. In the 
case of acute dietary risk, effects were seen at the only dose tested 
in the subchronic dietary toxicity study in rats; therefore, no NOAEL 
was identified. Since the LOAEL was used for acute dietary risk 
assessment, an additional UF of 3X was added to the conventional UF of 
100X for a total UF of 300X.
    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 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  x  
10-\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 2:

    Table 2.--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 = 1 aPAD =       Subchronic dietary
 including infants and children         UF = 300 Acute RfD =     acute RfD/FQPA SF =      toxicity study in rats
                                        0.58 mg/kg/day           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.
----------------------------------------------------------------------------------------------------------------

[[Page 14333]]

 
Chronic Dietary general population     NOAEL= 2 mg/kg/day; UF   FQPA SF = 1 cPAD =       Chronic toxicity/
 including infants and children         = 100; Chronic RfD =     chronic RfD/FQPA SF =    carcinogenicity study
                                        0.02 mg/kg/day           0.02 mg/kg/day           in rats LOAEL = 4 mg/
                                                                                          kg/day based on
                                                                                          increased kidney
                                                                                          weights and
                                                                                          hyperplasia of the
                                                                                          proximal convoluted
                                                                                          tubules in the kidneys
                                                                                          as well as ulcers and
                                                                                          forestomach
                                                                                          hyperplasia.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)        dermal NOAEL = 600 mg/   LOC for MOE = 100        21-day dermal toxicity
 (Residential)                          kg/day (dermal           (Residential)            study in rats; LOAEL =
                                        absorption rate =                                 600 mg/kg/day based on
                                        0.15%)                                            No treatment-related
                                                                                          systemic toxicity in
                                                                                          the highest dose
                                                                                          tested.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to    dermal NOAEL = 600 mg/   LOC for MOE = 100        21-day dermal toxicity
 several months) (Residential)          kg/day (dermal           (Residential)            study in rats; LOAEL =
                                        absorption rate =                                 600 mg/kg/day based on
                                        0.15%                                             no treatment-related
                                                                                          systemic toxicity in
                                                                                          the highest dose
                                                                                          tested.
----------------------------------------------------------------------------------------------------------------
Short-, Intermediate, Long-Term        Oral NOAEL = 2 mg/kg/    LOC for MOE = 100        Chronic toxicity/
 Inhalation (Residential)               day (inhalation          (Residential)            carcinogenicity study
                                        absorption rate =                                 in rats; LOAEL = 4 mg/
                                        100%)                                             kg/day based on
                                                                                          increased kidney
                                                                                          weights and
                                                                                          hyperplasia of the
                                                                                          proximal convoluted
                                                                                          tubules in the kidneys
                                                                                          as well as ulcers and
                                                                                          forestomach
                                                                                          hyperplasia.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Q* = 7.66  x  10-3 (mg/                           Chronic toxicity/
                                        kg/day)-1                                         carcinogenicity study
                                                                                          in rats 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
                                                                                          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 SPF 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 
3:

[[Page 14334]]



         Table 3.--Summary of Toxicological Dose and Endpoints for HCB for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                           Dose Used in Risk      FQPA SF* and Endpoint          Study and
           Exposure Scenario                Assessment, UF        for Risk Assessment     Toxicological Effects
----------------------------------------------------------------------------------------------------------------
 Chronic Dietary all populations        NOAEL= 0.08 mg/kg/day    Chronic RfD = 0.0008     130-week feeding study
                                        UF = 100                 mg/kg/day                in rats. Effects
                                                                                          observed were hepatic
                                                                                          centrilobular
                                                                                          basophilic
                                                                                          chromogenesis.
----------------------------------------------------------------------------------------------------------------
 Cancer (oral, dermal, inhalation)      Q* = 1.02 (mg/kg/day)-                            Carcinogenicity study
                                        1                                                 in rodents. Based on
                                                                                          increased tumor
                                                                                          incidences in hamsters
                                                                                          and rats. A 3/4
                                                                                          scaling factor was
                                                                                          applied to the Q*.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.275) for the combined residues of 
chlorothalonil and its metabolite SDS-3701, in or on a variety of raw 
agricultural commodities. At levels ranging from 0.05 ppm in cocoa 
beans and bananas, edible pulp to 15 ppm in celery and papayas. Risk 
assessments were conducted by EPA to assess dietary exposures from 
chlorothalonil and its metabolite SDS-3701 in food as follows:
     Food uses evaluated in the dietary (food) risk assessments were 
the published uses of chlorothalonil in 40 CFR 180.275 and pending 
uses. U.S. Food and Drug Administration monitoring data (1988-1993), 
USDA Pesticide Data Program (PDP) (1992-1994 partial), and field trial 
data are types of anticipated residue data provided for chlorothalonil 
and HCB. Anticipated residues were used for pending tolerances for 
pistachios (0.068 ppm), mangoes (0.3 ppm), asparagus (0.03 ppm) and 
non-bell peppers (5 ppm). Percent of crop treated information was used 
for most crops with established tolerances. Residues of HCB in plant 
commodities were estimated to be present at 0.05% of the residues of 
chlorothalonil. This level is equivalent to the maximum level of HCB 
that is allowed in formulations of chlorothalonil. In meat products, 
anticipated residues were estimated based on HCB feeding studies.
    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 one day 
or single exposure. The following assumptions were made for the acute 
exposure assessments: The computerized modeling system (Dietary Risk 
Evaluation System (DRES) was used to estimate acute dietary exposure. 
The analysis evaluates individual food consumption as reported by 
respondents in the USDA 1977-1978 Nationwide Food Consumption Survey 
(NFCS) and accumulates exposure to chlorothalonil for each commodity. 
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.
    ii. Chronic exposure.In conducting this chronic dietary risk 
assessment the computerized modeling system (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

[[Page 14335]]

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 described 
in the following Table 4:

                     Table 4.--Estimation of Percentage of Crops Treated with Chlorothalonil
----------------------------------------------------------------------------------------------------------------
                                                                       Anticipated Residues (ppm)
               Commodity                     Processing factors     --------------------------------    % crop
                                                                     Chlorothalonil        HCB         treated
----------------------------------------------------------------------------------------------------------------
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 cooked,               0.0133   6.7  x  10-\6\           40
                                          canned or frozen beans
----------------------------------------------------------------------------------------------------------------
Broccoli                                 None                               0.0015       0.8 10-\6\           15
----------------------------------------------------------------------------------------------------------------
Brussels sprouts                         None                               0.0135    6.8  x 10-\6\           42
----------------------------------------------------------------------------------------------------------------
Cabbage                                  0.2 for all food forms             0.0137    6.9  x  1010-           50
                                                                                                \6\
----------------------------------------------------------------------------------------------------------------
Cabbage, Chinese                         0.2 for all food forms             0.0116   5.8  x  10-\6\          100
----------------------------------------------------------------------------------------------------------------
Cattle fat                               None                                    0     1.65  x  10-         None
                                                                                                \4\
----------------------------------------------------------------------------------------------------------------
Cattle meat                              None                                    0     1.24  x  10-         None
                                                                                                \5\
----------------------------------------------------------------------------------------------------------------
Cattle liver                             None                                    0     8  x  10-\6\         None
----------------------------------------------------------------------------------------------------------------
Cattle kidney                            None                                    0     8  x  10-\6\         None
----------------------------------------------------------------------------------------------------------------
Cocoa                                    0.1 for all food forms               0.05   2.5  x  10-\6\          100
----------------------------------------------------------------------------------------------------------------
Cantaloupe                               None                               0.0191   9.6  x  10-\6\           30
----------------------------------------------------------------------------------------------------------------
Carrots                                  0.005 for all cooked or            0.0036   1.8  x  10-\6\           35
                                          processed food forms
----------------------------------------------------------------------------------------------------------------
Cauliflower                              None                               0.0115   5.8  x  10-\6\           20
----------------------------------------------------------------------------------------------------------------
Celery                                   None                               0.0874     43.7  x  10-           85
                                                                                                \6\
----------------------------------------------------------------------------------------------------------------
Cherries                                 0.05 for all processed              0.002     1  x  10-\6\           40
                                          food forms
----------------------------------------------------------------------------------------------------------------
Cranberries                              None                               0.4125   206  x  10-\6\           60
----------------------------------------------------------------------------------------------------------------
Coffee                                   0.1 for all food forms               0.20     1  x  10-\4\          100
----------------------------------------------------------------------------------------------------------------
Corn, sweet                              None                               0.0002   0.1  x  10-\6\            5
----------------------------------------------------------------------------------------------------------------
Cucumbers                                0.2 for cold-canned                0.0062   3.1  x  10-\6\           35
                                          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
----------------------------------------------------------------------------------------------------------------
Onions, green and leeks                  None                               0.0262     13.1  x  10-           65
                                                                                                \6\
----------------------------------------------------------------------------------------------------------------
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 cooked or             0.0018   0.9  x  10-\6\           35
                                          canned food forms
----------------------------------------------------------------------------------------------------------------
Peanuts                                  0.5 for peanut oil                 0.0045   2.3  x  10-\6\           90
----------------------------------------------------------------------------------------------------------------

[[Page 14336]]

 
Plums                                    0.33 for dried prunes              0.0005   0.3  x  10-\6\           10
----------------------------------------------------------------------------------------------------------------
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 pumpkin              0.0065   3.3  x  10-\6\           30
----------------------------------------------------------------------------------------------------------------
Soybeans                                 0.5 for soybean oil               0.00005   2.5  x  10-\8\            1
----------------------------------------------------------------------------------------------------------------
Squash                                   None for summer squash;            0.0058   2.9  x  10-\6\           15
                                          0.002 for raw winter
                                          squash; 0.001 for cooked
                                          winter squash
----------------------------------------------------------------------------------------------------------------
Tomatoes                                 0.25 for juice; 0.02 for           0.0716     35.8  x  10-           70
                                          paste, puree and catsup                               \6\
----------------------------------------------------------------------------------------------------------------
Watermelon                               None                               0.0228     11.4  x  10-           55
                                                                                                \6\
----------------------------------------------------------------------------------------------------------------

    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 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 of 
chlorothalonil have been found in ground water in Long Island, New 
York, and have been attributed to potato use. These 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 States 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 database, (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--chlorothlonil 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 was 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 
27

[[Page 14337]]

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 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 
HCB and PCB concentrations in surface water would exceed 10 parts per 
trillion (ppt) (0.01 ppb).
     Surface water detections show much more variability than 
concentrations in ground water and have been measured at up to 750 ppb. 
These high values appear to include sorbed HCB. The HCB concentrations 
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 residential exposure assumptions: The Agency 
completed an exposure assessment for uses of chlorothalonil as an 
additive containing 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 occur 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 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 product labels and have requested voluntary cancellation of 
their 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 5:

[[Page 14338]]



         Table 5.--surrogate Residential Post-application Scenarios and Cancer Risks from Chlorothalonil
----------------------------------------------------------------------------------------------------------------
                                       Application Rate   DFR (g/                        Cancer Risk
  Exposure Activity/Crop or Target       (lb ai/acre)           cm2)        LADD* (mg/kg/day)    (based on Q*)
----------------------------------------------------------------------------------------------------------------
Ornamentals (Transplanting/Pruning/               0.183               0.41             2.6E-7             2.0E-9
 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).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. 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 
database 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.
    ii. Prenatal and postnatal sensitivity. The developmental and 
reproductive data for chlorothalonil indicate that there is no evidence 
of increased sensitivity to chlorothalonil from pre- or post-natal 
exposures. In the rat developmental toxicity study, the developmental 
NOAEL and LOAEL were based on an increase in total resorptions 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 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 database 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 least nine other pesticides and which also 
enters the environment from non-pesticidal sources.

E. 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 aggregrate risk assessment for acute 
exposure to chlorothalonil is shown in the following Table 6:

[[Page 14339]]



Table 6.--Aggregate Risk Assessment for Acute Exposure to Chlorothalonil
                              and SDS-3701
------------------------------------------------------------------------
           Population Subgroup            LOC for MOE         MOE
------------------------------------------------------------------------
Food - U.S. Population                            300               1166
------------------------------------------------------------------------
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               1750
------------------------------------------------------------------------
Drinking water (ground water) - Children          300            110,000
------------------------------------------------------------------------
Drinking water (ground water) - Adults            300            380,000
Drinking water (surface water) -                  300         50,000,000
 Children
------------------------------------------------------------------------
Drinking water (surface water) - Adults           300        175,000,000
------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to combined 
residues of chlorothalonil and SDS-3701 from food and water 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 62.1 g/L.
     Based on monitoring data and fate properties, its 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 follow equation:
    HCB Upper Bound Cancer Risk = Dietary Exposure (ARC)  x  
Q*

     Based on 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 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 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 estimating 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 the 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 pesticidal 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 7:

[[Page 14340]]



                                                 Table 7.--Cancer Risks For Chlorothalonil, HCB, and PCB
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Upperbound                            Upperbound
                            Chemical                                  Q*         cancer risk       Cancer MOE for      Cancer Risk       Cancer MOE for
                                                                                    (food)              Food             (Water)             Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Chlorothalonil                                                      0.00766       1.2 - 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 point in 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 manufacuring-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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available in PAM II for non-
bell peppers and almonds. Residue analytical methods are available for 
purposes of reregistration. The Pesticide Analytical Manual (PAM) Vol. 
II lists Method I, a gas chromatography method with electron capture 
detection (ECD), for the enforcement of tolerances for plant 
commodities. Residue data for plant commodities were collected using 
methods based on the enforcement method. An acceptable enforcement 
method for residues of SDS-3701 tolerances for peanuts, potatoes, and 
tomatoes which is a modification of the current enforcement method is 
available. This method underwent successful validation and is suitable 
for enforcement of tolerances for SDS-3710 in meat and milk.

B. International Residue Limits

    There are no Codex, Mexican or Canadian MRLs for almonds, almond 
hulls, asparagus, mango, and pistachio.

C. Conditions

    All data pertaining to rotational crops have been evaluated and 
deemed adequate. In response to Agency evaluations of confined 
rotational crop data, there is a 12-month rotational crop restriction 
on all pertinent product labels. Available data indicate that only 
residue that was detected in rotated crops was the soil metabolite 
(SDS-46851). Because of the low toxicity of this metabolite, an 
exemption for the requirement of a tolerance for residues of the soil 
metabolite 2-carbamyl-2,4,5-trichlorobenzoic acid (SDS-46851) as 
inadvertent residues in rotated crops has been established (40 CFR 
180.110).

V. Conclusion

    Therefore, tolerances are established for combined residues of 
chlorothalonil, chlorothalonil and its metabolite SDS-3701, in or on 
almonds (nutmeats) at 0.05 ppm, almond hulls at 1.0 ppm, asparagus at 
0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm, and pistachios 
at 0.2 ppm, and for residues of the metabolite, 4-hydroxy-2,5,6 
trichloroisopthalonitrile (SDS-3701), in or on the following milk and 
meat commodities: fat of cattle, hogs, goats, horses, and sheep at 0.1 
ppm,; kidney of cattle, hogs, goats, horses and sheep at 0.5 ppm; mbyp 
(except kidney) of cattle, goats, hogs, horses and sheep at 0.05 ppm, 
meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and milk at 
0.1 ppm.

VI. 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-301088 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be

[[Page 14341]]

mailed or delivered to the Hearing Clerk on or before May 11, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in 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 VI.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 docket control number OPP-301088, 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), 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 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

[[Page 14342]]

``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.

VIII. 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: January 24, 2001.
James Jones,
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), (346a) and 371.

    2. Section 180.275 is amended by revising paragraph (a) 
introductory text and redesignating it as paragraph (a)(1); by adding 
in alphabetical order entries for ``almonds (nutmeat)''; ``almond 
hulls''; ``mango''; ``peppers, non-bell''; and ``pistachio'' to the 
table in newly designated paragraph (a)(1), and by adding new paragraph 
(a) (2) to read as follows:


Sec. 180.275  Chlorothalonil; tolerances for residues.

     (a) General. (1) Tolerances are established for the fungicide 
chlorothalonil (tetrachloroisophthalonitrile) and its metabolite 4-
hydroxy-2,5,6-trichloroisophthalonitrile in or on the following food 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almonds (nutmeats).........................................         0.05
Almond hulls...............................................          1.0
Asparagus..................................................          0.1
                   *      *      *      *      *
Mango......................................................          1.0
                   *      *      *      *      *
Peppers, (non-bell\1\).....................................            5
                   *      *      *      *      *
Pistachio..................................................          0.2
                   *      *      *      *      *
------------------------------------------------------------------------
\1\There are no U.S. registrations as of January, 2001.

     (2) Tolerances are established for the metabolite 4-hydroxy-2,5,6-
trichloroisophthalonitrile in or on the following food commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................          0.1
Cattle, kidney.............................................          0.5
Cattle, mbyp (except kidney)...............................         0.05
Cattle, meat...............................................         0.03
Goat, fat..................................................          0.1
Goat, kidney...............................................          0.5
Goat, mbyp, (except kidney)................................         0.05
Goat, meat.................................................         0.03
Hog, fat...................................................          0.1
Hog, kidney................................................          0.5
Hog, mbyp (except kidney)..................................         0.05
Hog, meat..................................................         0.03
Horses, fat................................................          0.1
Horses, kidney.............................................          0.5
Horses, mbyp (except kidney)...............................         0.05
Horses, meat...............................................         0.03
Milk.......................................................          0.1
Sheep, fat.................................................          0.1
Sheep, kidney..............................................          0.5
Sheep, mbyp (except kidney)................................         0.05
Sheep, meat................................................         0.03
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-6087 Filed 3-9-01; 8:45 am]
BILLING CODE 6560-50-S