[Federal Register Volume 67, Number 167 (Wednesday, August 28, 2002)]
[Rules and Regulations]
[Pages 55137-55150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21678]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0140; FRL-7192-1]


Thiophanate-methyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
thiophanate-methyl and its metabolite (methyl 2-benzimidazoyl carbamate 
(MBC)) in or on grapes, pears, potatoes, canola and pistachios. 
Cerexagri, Inc. and the Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective August 28, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0140, 
must be received on or before October 28, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket ID number OPP-2002-0140 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 308-9354; 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
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0140. 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

[[Page 55138]]

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 August 8, 1997 (62 FR 42788) (FRL-5237-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 5F4550) by Cerexagri, Inc., 2000 Market 
Street, Philadelphia, PA 19103. This notice included a summary of the 
petition prepared by Cerexagri, Inc., the registrant. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.371 be amended by 
establishing tolerances for residues of the fungicide thiophanate-
methyl in or on grapes at 5.0 part per million (ppm), and in or on 
pears at 7.0 ppm.
    In the Federal Register of March 28, 2002 (67 FR 14944) (FRL-6829-
1), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 2E6355, 2E6367, and 2E6368) by the 
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 
1 South, North Brunswick, NJ, 08902-3390. This notice included 
a summary of the petition prepared by IR-4. There were no comments 
received in response to the notice of filing.
    The petitions requested that 40 CFR 180.371 be amended by 
establishing tolerances for combined residues of the fungicide 
thiophanate-methyl, (dimethyl [(1,2-phenylene)- 
bis(iminocarbonothioyl)] bis(carbamate), its oxygen analogue dimethyl-
4,4-o-phenylenebis(allophonate), and its benzimidazole-containing 
metabolites (calculated as thiophanate-methyl), in or on potatoes at 
0.05 ppm (PP 2E6367), on pistachios at 0.2 ppm (PP 2E6355), and on 
canola at 0.1 ppm (PP 2E6368).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    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 residues of thiophanate-methyl and its 
metabolite MBC, expressed as thiophanate-methyl on grapes at 5.0 ppm, 
on pears at 3.0 ppm, on pistachios at 0.1 ppm, on potatoes at 0.1 ppm, 
and on canola 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 thiophanate-methyl 
are discussed in Table 1 below. In addition, the nature of the toxic 
effects caused by carbendazim or MBC are discussed in Table 2 below. 
MBC which is also a pesticide is the primary metabolite and the 
metabolite of concern for thiophanate-methyl. The tables also include 
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 of Thiophanate-Methyl
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity in     NOAEL = 15.7 milligrams/kilograms/day (mg/
                                          rodents                     kg/day)
                                                                     LOAEL = 155.0 mg/kg/day, based on anemia,
                                                                      increased serum cholesterol and calcium
                                                                      (males), increased liver and thyroid
                                                                      weights, increased kidney (males) weight
                                                                      and increased incidence of thyroid
                                                                      hyperplasia/hypertrophy, liver swelling
                                                                      and lipofuscin deposition, and
                                                                      glomerulonephrosis (males) were observed
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 50 mg/kg/day
                                          dogs                       LOAEL = 200 mg/kg/day, based on thin/
                                                                      dehydrated appearance, tarry stools,
                                                                      decreased body weight/weight gain,
                                                                      decreased food consumption, slight anemia,
                                                                      increased serum cholesterol, decreased
                                                                      serum T3/T4 (females), increased liver and
                                                                      thyroid weights, thyroid follicular cell
                                                                      hypertrophy and hyperplasia, hypoplasia/
                                                                      atrophy of the prostate, thymic involution/
                                                                      atrophy (males) and depletion of spleen
                                                                      lymphoid cells
----------------------------------------------------------------------------------------------------------------

[[Page 55139]]

 
870.3200                                 21-Day dermal toxicity in   Systemic toxicity NOAEL = 100 mg/kg/day
                                          rabbits                    Systemic toxicity LOAEL = 300 mg/kg/day,
                                                                      based on decreased food consumption in
                                                                      females
                                                                     Slight dermal irritation was observed at
                                                                      all dose levels
----------------------------------------------------------------------------------------------------------------
870.3465                                 14-Day inhalation toxicity  NOAEL = 0.00514 mg/Liter (L)
                                          in rodents                 LOAEL = 0.0151 mg/L, based on increased
                                                                      incidence of alveolar macrophages,
                                                                      pneumonocyte hyperplasia of the lung and
                                                                      nonsuppurative alveolitis
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity in   Maternal NOAEL = 300 mg/kg/day
                                          rodents                    Maternal LOAEL = 1,000 mg/kg/day based on
                                                                      decreased body weight gain
                                                                     Developmental NOAEL []
                                                                      1,000 mg/kg/day
                                                                     LOAEL > 1,000 mg/kg/day
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity in   Maternal NOAEL = 18 mg/kg/day
                                          rodents                    Maternal LOAEL = 85 mg/kg/day based on
                                                                      decreased food consumption
                                                                     Developmental NOAEL []
                                                                      163 mg/kg/day (HDT)
                                                                     Developmental LOAEL none established
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity in   Maternal NOAEL = 6 mg/kg/day
                                          rabbits                    Maternal LOAEL = 20 mg/kg/day, based on
                                                                      transiently decreased body weight gain,
                                                                      increased abortion/total litter loss
                                                                     Developmental NOAEL [] 20
                                                                      mg/kg/day
                                                                     Developmental LOAEL - none established
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity in   Maternal NOAEL = 10 mg/kg/day
                                          rabbits                    Maternal LOAEL = 20 mg/kg/day, based on
                                                                      decreased body weight gain and food
                                                                      consumption
                                                                     Developmental NOAEL = 20 mg/kg/day
                                                                     Developmental LOAEL = 40 mg/kg/day, based
                                                                      on increased supernumerary ribs and
                                                                      decreased fetal weight
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental systemic NOAEL < 13.7 mg/kg/day
                                          effects                    Parental systemic LOAEL = 13.7 mg/kg/day
                                                                      based on hepatocellular hypertrophy and
                                                                      thyroid hypertrophy/hyperplasia
                                                                     Reproductive NOAEL []
                                                                      138.9 mg/kg/day
                                                                     Reproductive LOAEL > 138.9 mg/kg/day
                                                                     Offspring NOAEL = 13.7 mg/kg/day
                                                                     Offspring LOAEL = 43.3 mg/kg/day based on
                                                                      slightly reduced body weights of the F2b
                                                                      offspring during lactation
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental systemic/reproductive NOAEL
                                          effects                     [] 32 mg/kg/day
                                                                     Parental/systemic/reproductive LOAEL > 32
                                                                      mg/kg/day
                                                                     Offspring NOAEL = 8 mg/kg/day
                                                                     Offspring LOAEL = 32 mg/kg/day based on
                                                                      slightly decreased mean litter weights
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = 8 mg/kg/day
                                                                     LOAEL = 40 mg/kg/day based on decreased
                                                                      body weight/weight gain, markedly
                                                                      increased serum TSH (1 male) and decreased
                                                                      T4 (males), increased serum cholesterol
                                                                      (males), increased abs/rel thyroid weights
                                                                      (both sexes) and thyroid follicular cell
                                                                      hypertrophy (females)
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = 23.7 mg/kg/day
                                                                     LOAEL = 123.3 mg/kg/day based on
                                                                      hepatocellular hypertrophy in females
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity in         NOAEL = 5.75 mg/kg/day
                                          rodents                    LOAEL = 24.3 mg/kg/day based on decreased
                                                                      body weight and body weight gain in both
                                                                      sexes and increased incidence of thyroid
                                                                      and testicular microscopic effects in
                                                                      males
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity/           NOAEL = 8.8 mg/kg/day
870.4200...............................   Carcinogenicity in         LOAEL = 54.4 mg/kg/day based on decreased
                                          rodents                     body weight/weight gain (males; marginal
                                                                      in females), decreased food efficiency
                                                                      (males; marginal in females), sporadic
                                                                      effects on circulating T3/T4 and TSH,
                                                                      increased serum cholesterol and
                                                                      creatinine, decreased serum cholinesterase
                                                                      in females, increased liver, thyroid and
                                                                      kidney weights, liver hypertrophy and
                                                                      lipofuscin accumulation, thyroid
                                                                      hypertrophy and hyperplasia and lipofuscin
                                                                      accumulation in the kidney
----------------------------------------------------------------------------------------------------------------


[[Page 55140]]


                            Table 2.--Subchronic, Chronic, and Other Toxicity of MBC
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 11.3 mg/kg/day (F), 14.4 mg/kg/day
                                          dogs                        (M)
                                                                     LOAEL = 35 mg/kg/day (F), 40.7 mg/kg/day
                                                                      (M) based on histopathology changes in
                                                                      liver 1/4 males and 1/4 females) and
                                                                      testes (1/89/21/13/23/81/163/8
                                                                      males) and increased alkaline phosphatase,
                                                                      cholesterol and serum glutamate pyruvate
                                                                      transaminase (SGPT). Liver effects
                                                                      included hepatic cirrhosis (hepatic cell
                                                                      necrosis, tubular collapse, and increased
                                                                      fibrous connective tissue around triads)
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity in   Maternal NOAEL = 20 mg/kg/day
                                          rodents                    Maternal LOAEL = 90 mg/kg/day based on
                                                                      increased absolute liver weight
                                                                     Developmental NOAEL = 10 mg/kg/day
                                                                     Developmental LOAEL = 20 mg/kg/day based on
                                                                      decreased fetal body weight and increases
                                                                      in skeletal variations and a threshold for
                                                                      malformations
----------------------------------------------------------------------------------------------------------------
870.3700                                 Developmental toxicity in   Maternal NOAEL = 20 mg/kg/day
                                          nonrodents                 Maternal LOAEL = 125 mg/kg/day based on
                                                                      abortions and decreased body weight
                                                                     Developmental NOAEL = 10 mg/kg/day
                                                                     Developmental LOAEL = 20 mg/kg/day based on
                                                                      decreased implantations and litter size,
                                                                      and increased resorptions. Malformations
                                                                      (fused ribs, and malformed cervical
                                                                      vertebrae) were noted at 125 mg/kg/day)
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Reproductive NOAEL = 25 mg/kg/day
                                          effects                    Reproductive LOAEL = 250 mg/kg/day based on
                                                                      toxic signs of decrased pup weight noted
                                                                      at weaning
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity in dogs    NOAEL = 2.5 mg/kg/day
                                                                     LOAEL = 12.5 mg/kg/day based on swollen,
                                                                      vacuolated hepatic cells, hepatic
                                                                      cirrhosis and chronic hepatitis and
                                                                      biochemical alterations indicative of
                                                                      liver damage (i.e., increased cholesterol,
                                                                      total protein, serum glutamate pyruvate
                                                                      transaminase (SGPT) and alkaline
                                                                      phosphatase levels, and decreased A/G
                                                                      ratio)
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity in dogs    NOAEL = 6.43 mg/kg/day (200 ppm)
                                                                     LOAEL = 16.54 mg/kg/day (500 ppm) based on
                                                                      possible transient increase in cholesterol
                                                                      (males and females) consistent
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity/           NOAEL = 25 mg/kg/day
870.4200...............................   Carcinogenicity in         LOAEL = 250 mg/kg/day based on
                                          rodents                     statistically significant decreases in red
                                                                      blood cell parameters (hematocrit,
                                                                      hemoglobin an red blood cells) in females
                                                                      and histological lesions in the liver
                                                                      (cholangiohepatitis and pericholangitis)
                                                                      in males and females. No evidence of
                                                                      carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity in rodents  NOAEL (non-cancer systemic) = 75 mg/kg/day
                                                                     LOAEL (non-cancer systemic) = 225 mg/kg/day
                                                                      based on liver toxicity (hepatocellular
                                                                      necrosis and swelling), body weight
                                                                      decrease and lymphoid depletion. In both
                                                                      sexes, there was an increased incidence of
                                                                      liver tumors In males, hepatocellular
                                                                      carcinomas were noted at 225 mg/kg/day,
                                                                      while females exhibited carcinomas and
                                                                      adenomas at all dose levels
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity in mice     NOAEL (non-cancer systemic) = 34.4-41.9 mg/
                                                                      kg/day
                                                                     LOAEL (non-cancer systemic) = 522-648 mg/kg/
                                                                      day based on increases the incidences of
                                                                      hepatic cell hypertrophy, clear cell foci
                                                                      and hepatocellular necrosis. No increased
                                                                      incidence of carcinogenicity was noted
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity in mice     NOAEL = 45 mg/kg/day
                                                                     LOAEL = 750 mg/kg/day based on hepatic
                                                                      alterations which included increased
                                                                      relative liver weights in both sexes,
                                                                      increased number of foci of cellular
                                                                      alterations in the liver in females,
                                                                      neoplastic nodules in females and
                                                                      hepatoblastomas in males
----------------------------------------------------------------------------------------------------------------
NA                                       Single dose (gavage) rat    NOAEL: none observed
                                          study                      LOAEL: 50 mg/kg/day based on premature
                                                                      release of immature germ cells 2 days post
                                                                      exposure, and atrophy of a few
                                                                      seminiferous tubules and significant
                                                                      decrease in seminiferous tubule diameter
                                                                      70 days post exposure
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which 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 LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    The Agency used a toxic equivalency factor (TEF) approach to sum 
exposure

[[Page 55141]]

and risk estimates from TM and MBC plus other metabolites of concern as 
MBC equivalents. A TEF approach was used because both TM and MBC share 
common toxicological effects (i.e., developmental and liver effects, 
and liver tumors), and because individuals may be exposed to both 
compounds simultaneously on food commodities, in drinking water and on 
treated lawns. Using the TEF approach, all thiophanate-methyl dietary 
exposure estimates were adjusted upwards to account for differences in 
acute population adjusted doses (aPADs) and chronic population adjusted 
doses (cPADs) between thiophanate-methyl and MBC.
    The Population Adjusted Dose (PAD) is the adjusted Reference Dose 
(RfD) reflecting the retention or reduction of the FQPA safety factor 
for all populations. The PAD is the RfD which is derived from an 
exposure level at which there are no statistically or biologically 
significant increases in the frequency or severity of adverse effects 
between the exposed population and its appropriate control, along with 
the application of uncertainty factors. The percent of the PAD is 
calculated as the ratio of the exposure value to the PAD (exposure/PAD 
x 100 = % PAD). A non-cancer TEF is derived based on a ratio of the MBC 
PAD to the TM PAD.
    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 
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 thiophanate-methyl used for human risk assessment is 
shown in the following Table 3. Table 4 summarizes the toxicological 
endpoints for MBC.

  Table 3.--Summary of Toxicological Dose and Endpoints for Thiophanate-methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and/or Level
          Exposure Scenario               Dose Used in Risk       of Concern for Risk    Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary, females 13-50 years     NOAEL = 20 mg/kg/day     FQPA SF = 3              1997 Rabbit
                                       UF = 100...............  aPAD = acute RfD.......   developmental study
                                       Acute RfD = 0.2 mg/kg/   FQPA SF = 0.067 mg/kg/   LOAEL = 40 mg/kg/day
                                        day.                     day.                     based on supernumerary
                                                                                          ribs in fetuses of
                                                                                          exposed dams and
                                                                                          decreased fetal weight
----------------------------------------------------------------------------------------------------------------
Acute dietary,                         NOAEL = 40 mg/kg/day     FQPA SF = 3              Chronic oral toxicity
General population...................  UF = 100...............  aPAD = acute RfD.......   dog study
                                       Acute RfD = 0.4 mg/kg/   FQPA SF = 0.13 mg/kg/    LOAEL = 200 mg/kg/day
                                        day.                     day.                     based on tremors 2-4
                                                                                          hours post-dosing in 7
                                                                                          of 8 dogs
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 8 mg/kg/day      FQPA SF = 3              Chronic oral toxicity
                                       UF = 100...............  cPAD = chronic RfD.....   dog study
                                       Chronic RfD = 0.08 mg/   FQPA SF = 0.027 mg/kg/   LOAEL = 40 mg/kg/day
                                        kg/day.                  day.                     based on thyroid
                                                                                          effects and decreased
                                                                                          body weight
----------------------------------------------------------------------------------------------------------------
Short- and intermediate-term -         Oral NOAEL = 10 mg/kg/   LOC for MOE = 300 for    1997 Rabbit
Incidental ingestion.................   day                      all residential          developmental study
                                                                 populations             LOAEL = 20 mg/kg/day
                                                                                          based on decreased
                                                                                          maternal body weight
                                                                                          and food consumption
----------------------------------------------------------------------------------------------------------------
Short- and intermediate term - dermal  Dermal NOAEL = 100       LOC for MOE = 300 for    21-day rabbit dermal
                                                                 all residential          toxicity study
                                                                 populations             LOAEL = 300 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight (28%) and
                                                                                          food consumption (15%)
----------------------------------------------------------------------------------------------------------------
Short- and intermediate term -         Oral NOAEL = 10 mg/kg/   LOC for MOE = 300 for    1997 Rabbit
 inhalation**                           day                      all residential          developmental study
                                       (inhalation absorption    populations             LOAEL = 20 mg/kg/day
                                        rate = 100% relative                              based on decreased
                                        to oral absorption).                              maternal body weight
                                                                                          and food consumption
----------------------------------------------------------------------------------------------------------------

[[Page 55142]]

 
Long-term dermal and inhalation**      NOAEL = 8 mg/kg/day      LOC for MOE = 300 for    Chronic oral toxicity
                                        (dermal absorption       all residential          dog study
                                        rate = 7% relative to    populations             LOAEL = 40 mg/kg/day
                                        oral absorption;                                  based on thyroid
                                       inhalation absorption                              effects and decreased
                                        rate = 100% relative                              body weight
                                        to oral absorption).
----------------------------------------------------------------------------------------------------------------
Cancer**                               Q1* = 1.16 x 10-2 (mg/    Q1* = 1.16 x 10-2 (mg/  78-Week mouse study
                                        kg/day)-1 (dermal        kg/day)-1                based on male mouse
                                        absorption rate = 7%                              liver adenoma and/or
                                        relative to oral                                  carcinoma and/or
                                        absorption;                                       hepatoblastoma
                                       inhalation absorption                              combined tumor rates
                                        rate = 100% relative
                                        to oral absorption).
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.
**Since an oral value was selected, 7% dermal absorption factor and 100% inhalation absorption factor
  (equivalent to oral absorption) should be used for route-to-route extrapolation.


         Table 4.--Summary of Toxicological Dose and Endpoints for MBC for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and/or Level
          Exposure Scenario               Dose Used in Risk       of Concern for Risk    Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary, females 13-50 years     NOAEL = 10 mg/kg/day     FQPA SF = 10             Rat developmental study
                                       UF = 100...............  aPAD = acute RfD.......   with MBC
                                       Acute RfD = 0.1 mg/kg/   FQPA SF = 0.01 mg/kg/    LOAEL = 20 mg/kg/day
                                        day.                     day.                     based on decreased
                                                                                          fetal body weight and
                                                                                          increases in skeletal
                                                                                          variations and a
                                                                                          threshold for
                                                                                          malformations in
                                                                                          fetuses of exposed
                                                                                          dams
----------------------------------------------------------------------------------------------------------------
Acute dietary,                         LOAEL = 50 mg/kg/day     FQPA SF = 10 for         Single dose rat study
General population, including infants  UF = 300 acute RfD =      infants and children    LOAEL = 50 mg/kg/day
 and children.                          0.17 mg/kg/day.         FQPA SF = 1 general       based on adverse
                                                                 population.              testicular effects
                                                                aPAD = acute RfD.......   including sloughing
                                                                FQPA SF = 0.017 mg/kg/    (premature release) of
                                                                 day (infants and         immature germ cells 2
                                                                 children) = 0.17         days post exposure,
                                                                 (general population).    atrophy of a few
                                                                                          seminiferous tubules
                                                                                          in one testicle,
                                                                                          significant decrease
                                                                                          in seminiferous tubule
                                                                                          diameter, and slight
                                                                                          abnormal growth of the
                                                                                          efferent ductules at
                                                                                          70 days post exposure
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 2.5 mg/kg/day    FQPA SF = 10 for         2-year dog study with
                                       UF = 100...............   children and females     MBC
                                       Chronic RfD = 0.025 mg/   13-50 yrs               LOAEL = 12.5 mg/kg/day
                                        kg/day.                 FQPA SF = 1 general       based on
                                                                 population.              histopathological
                                                                cPAD = chronic RfD /      lesions of the liver
                                                                 FQPA SF.                 characterized as
                                                                = 0.0025 mg/kg/day        swollen, vacuolated
                                                                 (children and females)   hepatic cells, hepatic
                                                                 = 0.025 (general pop.).  cirrhosis and chronic
                                                                                          hepatitis in both
                                                                                          sexes
----------------------------------------------------------------------------------------------------------------
Short-term incidental ingestion        Oral NOAEL = 10 mg/kg/   LOC for MOE = 1,000 for  1997 Rabbit
                                        day                      all residential          developmental study
                                                                 populations              with thiophanate-
                                                                                          methyl
                                                                                         LOAEL = 20 mg/kg/day
                                                                                          based on decreased
                                                                                          maternal body weight
                                                                                          and food consumption
----------------------------------------------------------------------------------------------------------------
Intermediate - term                    Oral NOAEL = 11 mg/kg/   LOC for MOE = 1,000 for  90-day dog feeding
Incidental ingestion.................   day                      all residential          study with MBC
                                       (rounded to 10 mg/kg/     populations             LOAEL = 35 mg/kg/day
                                        day).                                             based on adverse liver
                                                                                          effects.
----------------------------------------------------------------------------------------------------------------
Short- and intermediate term dermal**  Oral NOAEL = 10 mg/kg/   LOC for MOE = 1,000 for  Rat developmental study
                                        day (dermal absorption   children and females     with MBC
                                        rate = 3.5% relative     (residential)           LOAEL = 20 mg/kg/day
                                        to oral absorption)                               based on decreased
                                                                                          fetal body weight and
                                                                                          increases in skeletal
                                                                                          variations and a
                                                                                          threshold for
                                                                                          malformations in
                                                                                          fetuses of exposed
                                                                                          dams
----------------------------------------------------------------------------------------------------------------

[[Page 55143]]

 
Long-term dermal**                     Oral NOAEL = 2.5 mg/kg/  LOC for MOE = 1,000 for  2-year dog study with
                                        day (dermal absorption   children and females     MBC
                                        rate = 3.5% relative     (residential)           LOAEL = 12.5 mg/kg/day
                                        to oral absorption)                               based on
                                                                                          histopathological
                                                                                          lesions of the liver
                                                                                          characterized as
                                                                                          swollen, vacuolated
                                                                                          hepatic cells, hepatic
                                                                                          cirrhosis and chronic
                                                                                          hepatitis in both
                                                                                          sexes of dogs
----------------------------------------------------------------------------------------------------------------
Short-, intermediate- and long term    Inhalation NOAEL = 0.96  LOC for MOE = 1,000 for  90-day rat inhalation
 inhalation                             (10 mg/m3)               children and females     study with benomyl
                                                                 (residential)           LOAEL = 4.8 mg/kg/day
                                                                                          (50 mg/m3) based on
                                                                                          Olfactory degeneration
                                                                                          in the nasal cavity
----------------------------------------------------------------------------------------------------------------
Cancer**                               Q1* = 2.39 x 10-3 (mg/    Q1* = 2.39 x 10-3 (mg/  2-Year mouse study with
                                        kg/day)-1 (dermal        kg/day)-1                MBC based on
                                        absorption rate = 3.5%                            hepatocellular
                                        relative to oral                                  (adenoma and/or
                                        absorption;                                       carcinoma) tumors in
                                       inhalation absorption                              female CD-1 mice
                                        rate = 100% relative
                                        to oral absorption).
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.
**Since an oral value was selected, 7% dermal absorption factor and 100% inhalation absorption factor
  (equivalent to oral absorption) should be used for route-to-route extrapolation.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.371) for the residues of thiophanate methyl 
(dimethyl [(1,2- phenylene)-bis(iminocarbonothioyl)] bis[carbamate]), 
its oxygen analogue dimethyl-4,4-o-phenylene bis (allophonate), and its 
benzimidazole-containing metabolites (calculated as thiophanate-methyl) 
in or on the following crops and commodities: Almonds, apples, 
apricots, beans, celery, cherries, cucumbers, melons, nectarines, 
onions, pecans, peaches, peanuts, plums, potatoes (seed pieces), 
prunes, pumpkins, soybeans, squash, strawberries, sugar beets, wheat, 
eggs, and the meat, meat-by-products, fat and liver of cattle, goats, 
hogs, horses, and sheep. Emergency exemptions have been established for 
the use of thiophanate-methyl on citrus and blueberries. The Agency is 
modifying the tolerance expression so that the residues to be regulated 
in plant and animal commodities for purposes of tolerance enforcement 
will consist of the residues of thiophanate-methyl and its metabolite 
(methyl 2-benzimidazolyl carbamate (MBC)), expressed as thiophanate-
methyl.
    Exposure from the use of benomyl, another pesticide which degrades 
under environmental conditions to MBC was not included in this 
assessment because the only basic registrant of benomyl requested 
voluntary cancellation of all benomyl-containing products in April 
2001. Product cancellations were effective in early 2001 with sales and 
distribution of benomyl containing products ending by December 31, 
2001. However, the Agency conducted a dietary assessment using USDA 
Pesticide Data Program (PDP) monitoring data for benomyl, measured as 
MBC to estimate residues of thiophanate-methyl because MBC is a common 
metabolite of both benomyl and thiophanate-methyl. PDP data were 
available for apples, bananas, beans, cucurbits, peaches and 
strawberries. The PDP analytical method employs a hydrolysis step that 
converts any benomyl present to MBC. MBC is then quantitated and 
corrected for molecular weight, and results are measured as the sum of 
benomyl and MBC. Therefore, using MBC data to estimate thiophanate-
methyl residues may be a conservative approach in that it may 
overestimate thiophanate-methyl residues. Risk assessments were 
conducted by EPA to assess dietary exposures from thiophanate-methyl 
and MBC in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM[reg]) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: Maximum percent crop treated (PCT) estimates and 
anticipated residue estimates were used. The estimate of acute dietary 
exposure to thiophanate-methyl for the most highly exposed population 
subgroup of concern, (infants <1 year) is 25% of the aPAD at the 99.9th 
percentile and the estimate for the general U.S. population is 10% of 
the aPAD at the 99.9th percentile. The estimate of acute dietary 
exposure to MBC + other metabolites from thiophanate-methyl for the 
most highly exposed population subgroup of concern, (infants <1 year) 
is 89% of the aPAD at the 99.9th percentile and the estimate for the 
general U.S. population is 4% of the aPAD at the 99.9th percentile.
    In addition, acute dietary risk estimates for thiophanate-methyl 
and MBC and other metabolites of concern were added together for 
females (13-50 years) to account for the total acute dietary risk 
estimate for developmental effects. Addition of acute dietary risk 
estimates is appropriate since both chemicals have aPADs that are based 
on developmental effects for females, and because individuals may 
consume both residues simultaneously on a given food commodity. The 
estimate of total acute dietary exposure to thiophanate-methyl and MBC 
for the only population subgroup of concern, (females 13-50 years) is 
51% of the aPAD.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM[reg] analysis evaluated the

[[Page 55144]]

individual food consumption as reported by respondents in the USDA 
1989-1992 nationwide CSFII and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: Average residues from field trial data and 
average PCT estimates were used. The chronic dietary exposure estimates 
for thiophanate-methyl are as follows: children (1-6 years) is 2.3% of 
the cPAD; infants (<1 year) is 1.6% of the cPAD; children (7-12 years) 
is 1.3% of the cPAD; general U.S. population is 0.8% of the cPAD; 
females (13-50 years) and males (13-19 years) is 0.6% of the cPAD. The 
chronic dietary exposure estimates for MBC and other metabolites from 
thiophanate-methyl are as follows: children (1-6 years) is 26% of the 
cPAD; children (7-12 years) is 16% of the cPAD; infants (<1 year) is 
12% of the cPAD; females (13-50) is 8% of the cPAD; general U.S. 
population and males (13-19 years) is 1% of the cPAD. The total chronic 
dietary exposure estimates for thiophanate-methyl and MBC are as 
follows: Children (1-6 years) is 28% of the cPAD; children (7-12 years) 
is 17% of the cPAD; infants (<1 year) is 13% of the cPAD; females (13-
50 years) is 8.5% of the cPAD; general U.S. population is 1.7% of the 
cPAD; and males (13-19 years) is 1.6% of the cPAD.
    iii. Cancer. Cancer risk estimates included existing uses, new 
uses, and 1 year of citrus use under an emergency exemption amortized 
over 70 years. The lifetime cancer risk estimate from thiophanate-
methyl using benomyl/MBC PDP data is 7.6 x 10-7. The 
lifetime cancer risk estimate from MBC and other metabolites from 
thiophanate-methyl is 9.3 x 10-8. The total lifetime 
thiophanate-methyl and MBC dietary cancer risk estimate is 8.5 x 
10-7. It is appropriate to add the cancer risk estimates 
from TM and MBC because both chemicals cause mouse liver tumors, and 
because both chemicals may be found concurrently on food items treated 
with thiophanate-methyl.
    iv. Anticipated residue and PCT 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 these tolerances.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information for almonds, apples, apricots, 
beans (succulent or dried), green beans, bananas, blueberries, canola, 
celery, cherries, citrus, cucurbits (cantaloupe, cucumbers, melons, 
pumpkins, squash, watermelons), garlic, grapes, nectarines, onions 
(bulb and green), peaches, peanuts, pears, pecans, pistachios, plums/
prunes, potatoes, soybeans, strawberries, sugar beets, and wheat. In 
addition, when PCT estimates indicated no thiophanate-methyl use, a 
default minimum assumption of 1% crop treated was applied. Where 
residues were nondetectable, one-half the limit of quantitation was 
assumed for treated commodities.
    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 underestimated. 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 thiophanate-
methyl may be applied in a particular area.
    2. Dietary exposure from drinking water. Available environmental 
fate data suggest that thiophanate-methyl rapidly degrades to MBC 
following application to ornamentals, turf and agricultural crops. MBC 
has a low potential to leach to ground water in measurable quantities 
from most typical uses based on its high soil organic carbon partition 
coefficient (Koc) of 2,100 L/kg. Available data indicate that the 
primary metabolite of thiophanate-methyl, MBC, is less mobile and 
significantly more persistent in many soils, especially under anaerobic 
conditions. The MBC aerobic soil half-life is 320 days, while the 
aerobic and anaerobic aquatic metabolism half lives are 61 and 743 
days, respectively. The Agency concludes that MBC will probably not 
reach ground water to any significant concentration due to its high 
Koc.
    The Agency currently lacks sufficient monitoring data to complete a 
quantitative drinking water exposure analysis and risk assessment for 
thiophanate-methyl and MBC. Therefore, the Agency is presently relying 
on water-quality models to estimate environmental concentrations (EECs) 
of pesticides in ground and surface water in order to estimate drinking 
water exposures to thiophanate-methyl and MBC. None of these models 
include consideration of

[[Page 55145]]

the impact processing (mixing, dilution, or treatment) of raw water for 
distribution as drinking water would likely have on the removal of 
pesticides from the source water. The primary use of these models by 
the Agency at this stage is to provide a coarse screen for sorting out 
pesticides for which it is highly unlikely that drinking water 
concentrations would ever exceed human health levels of concern.
    EPA does not use these model estimates to quantify risk. Currently, 
EPA uses a drinking water level of comparison (DWLOC) as a surrogate to 
capture risk associated with exposure to pesticides in drinking water. 
A DWLOC represents the concentration of a pesticide in drinking water 
that would be acceptable as an upper limit in light of total aggregate 
exposure to that pesticide from food, water, and residential uses (if 
any). A DWLOC will vary depending on the residue level in foods, the 
toxicity endpoint and the drinking water consumption patterns and body 
weights for specific population subgroups. The calculated DWLOC is 
compared to the model estimate (EEC), and if the model estimates are 
below the DWLOC, the risks are not considered to be of concern.
    For estimating ground water concentrations of thiophanate-methyl 
and MBC, EPA used the Screening Concentration in Ground Water (SCI-
GROW) model. The SCI-GROW is based on scaled ground water concentration 
from ground water monitoring studies, and environmental fate properties 
(aerobic soil half-lives and organic carbon partitioning coefficients-
Koc's). SCI-GROW provides a screening concentration which is an 
estimate of likely ground water concentrations if the pesticide were 
used at the maximum allowed label rate in areas with ground water 
vulnerable to contamination. In most cases, a majority of the pesticide 
use area will have ground water that is less vulnerable to 
contamination than the areas used to derive the SCI-GROW estimate. 
Using SCI-GROW, the acute and chronic ground water EEC for thiophanate-
methyl ranged from 0.033 part per billion (ppb) to 0.006 ppb, and the 
acute and chronic EEC for MBC ranged from 0.51 ppb to 3.0 ppb.
    For estimating surface water concentrations of thiophanate-methyl 
and MBC, EPA used a Tier II model, Pesticide Root Zone Model/Exposure 
Analysis Modeling System (PRZM/EXAMS). PRZM (3.12)/EXAMS (2.97.5) 
modeling uses an index reservoir and a percent crop area (PCA) 
adjustment to estimate concentrations in surface water used as a source 
of drinking water. The index reservoir represents a watershed that is 
more vulnerable than most watersheds used as drinking water sources. 
The index reservoir is used as a standard watershed that is combined 
with local soils, weather, and cropping practices to represent a 
vulnerable watershed for each crop that could support a drinking water 
supply. If a community derives its drinking water from a large river, 
the estimated exposure would likely be higher than the actual exposure. 
Conversely, a community that derives its drinking water from smaller 
bodies of water with minimal outflow would likely get higher drinking 
water exposure than estimated using the index reservoir. Areas with a 
more humid climate that use a similar reservoir and cropping patterns 
would likely get more pesticides in their drinking water than predicted 
levels.
    A single steady flow was used to represent the flow through the 
reservoir. Discharge from the reservoir also removes chemicals so this 
assumption will underestimate removal of the pesticide from the 
reservoir during wet periods and overestimate removal during dry 
periods. This assumption can both underestimate or overestimate the 
concentration of pesticide in the reservoir depending upon the annual 
precipitation pattern at the site. The index reservoir scenario uses 
the characteristic of a single soil to represent all soils in the 
basin. Soils can vary substantially across even small areas, thus, this 
variation is not reflected in these simulations.
    The index reservoir scenario does not consider tile drainage. Areas 
that are prone to substantial runoff are often tiled drained. This 
assumption may underestimate exposure, particularly on a chronic basis. 
However, the watershed used to model the EECs for thiophanate-methyl 
and MBC had no documented tile drainage. Additionally, PRZM/EXAMS is 
unable to easily model spring and fall turnover which would result in 
complete mixing of a chemical through the water column during these 
events. Because of this inability, the watershed used was simulated 
without stratification. However, there is data that suggests that the 
watershed used does stratify in the deepest parts of the lake at least 
in some years, thereby adding to the conservativeness of the estimate.
    The EEC's for thiophanate-methyl and MBC were estimated based on 
the new maximum agricultural application rate which was the proposed 
new use on pears (2.8 pound active ingredient/Acre/season (lb./a.i./
acre)). The previous existing maximum label rate was reduced by half as 
a result of risk mitigation. The EEC's using the new maximum rate are 
as follows: The acute or peak (1 in 10 years) EEC for thiophanate-
methyl is 8.2 ppb and 23.5 ppb for MBC; the non-cancer chronic (1 in 10 
years) EEC for thiophanate-methyl is 0.70 ppb and 14.0 ppb for MBC; and 
the cancer chronic (mean 36-year annual concentration) EEC is 0.5 ppb 
for thiophanate-methyl and 11.5 ppb for MBC.
    As a result of risk mitigation, the maximum nonagricultural 
application rate (tees and greens of golf courses - 8.16 lb. a.i./acre) 
was also substantially reduced. Using the mitigated rate (tees and 
greens of golf courses - 8.16 lb. a.i./acre), the EEC's for 
thiophanate-methyl and MBC are as follows: The acute EEC for 
thiophanate-methyl is 22.7 ppb and 25 ppb for MBC; the non-cancer 
chronic EEC for thiophanate-methyl is 0.92 ppb and 8.8 ppb for MBC; and 
the cancer chronic EEC is 0.41 ppb and is 6.0 ppb for MBC.
    Since the chronic and cancer endpoints are based on the same 
adverse effect, the thiophanate-methyl and MBC EECs are added together. 
The total thiophanate-methyl plus MBC chronic EEC is 9.72 ppb and the 
cancer EEC is 6.39 ppb.
    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). Thiophanate-methyl is 
currently registered for use on the following residential non-dietary 
sites: Lawns and home orchards. MBC is registered for use as an in-can 
paint preservative which can be used in residential settings and as a 
fungicide applied as a tree injection. The risk assessment was 
conducted using the following residential exposure assumptions: 
Potential residential or nonoccupational post-application exposure to 
adults and children may occur as a result of residential application or 
professional lawn care operator application of thiophanate-methyl 
products to home lawns and golf courses.
    As a result of risk mitigation, application rates for 
nonagricultural uses have been reduced, the use of thiophanate-methyl 
by residents will be limited to granular products for broadcast turf 
treatment and liquid treatments for ornamentals, and application using 
a belly grinder or by hand will be removed from pesticide labels. In 
addition, the Agency has negotiated a reduction in the rate of MBC used 
as an in-can paint preservative. The following exposure

[[Page 55146]]

and risk estimates are based on the mitigated rates and label revisions 
negotiated by the Agency.
    i. Chronic exposure and risk. The Agency estimated cancer risks 
based on the number of years a person typically works in a home garden 
(50 years) and lifetime (70 years) which are also the population 
defaults used by the Agency. Therefore, cancer risks are based on 50 
applications in a lifetime. A cancer risk assessment is considered 
appropriate because thiophanate-methyl has been assessed as a 
carcinogen using a model for carcinogenesis that assumes any exposure 
at any point in time may result in carcinogenic effects. These 
estimated risk do not exceed the Agency's level of concern.
    Lifetime cancer risk estimates for applying thiophanate-methyl 
products once per year for 50 years (i.e., 50 times in a lifetime) 
range from 4.7 x 10-9 to 2.8 x 10-8 for 
ornamental treatment using a backpack sprayer and a ready to use hose-
end sprayer, respectively. Cancer risk estimates for the other 
application methods are between these ranges.
    Lifetime cancer risk estimates for post-application exposure to 
thiophanate-methyl ranged from 1.3 x 10-7 to 1.3 x 
10-9 for adults. Cancer risk estimates were not calculated 
for children as the exposure scenario was not applicable.
    ii. Short- and intermediate-term exposure and risk. All residential 
exposures are considered to be short-term (1-30 days) for residential 
handlers during the application of thiophanate-methyl products to turf 
and ornamentals. Intermediate- and long-term exposures of residential 
applicators were not anticipated based on the use pattern of 
thiophanate-methyl and information from the registrant. Considering 
toxicological criteria and potential for exposure, the Agency conducted 
dermal and inhalation exposure assessments. The Agency only assessed 
exposure to thiophanate-methyl because MBC risk from treated turf are 
considered to be negligible relative to thiophanate-methyl risks (i.e., 
at least 10 fold lower) based on chemical-specific turf transferable 
residue data.
    Residential application of thiophanate-methyl products to lawns and 
ornamentals at the new maximum rate resulted in short-term risk 
estimates that are below the Agency's level of concern (i.e., total MOE 
<300). The inhalation MOE ranged from 140,000 to 620,000. The dermal 
MOE ranged from 1,900 to 37,000. Total dermal and inhalation MOEs range 
from 1,900 to 35,000.
    Short-term risk estimates for residential/recreational post-
application dermal exposure to adults resulted in estimates below the 
Agency's level of concern. The dermal MOE for adults ranged from 1,700 
to 49,000. Short-term risk estimates for children (1-6 years) are as 
follows: MOE of 73,000 for incidental soil ingestion; MOE of 1,000 for 
contact with treated turf; MOE of 990 for object to mouth exposure; MOE 
of 250 for hand to mouth exposure; and MOE of 31 for incidental 
granular ingestion. The MOEs below 300 exceed the Agency's level of 
concern. However, the Agency believes that the exposure is 
significantly lower than that estimated in this assessment because the 
scenarios used to determine risk estimates are conservative and are 
considered as a screening level for risk. Both the adult and toddler 
transfer coefficients are upper percentile exposure duration values. 
Where study data were used, the risk estimates were better refined, and 
hence, less conservative. The dermal exposure estimates related to lawn 
skin contact which were based on study data were more refined than the 
estimates of incidental ingestion of thiophanate-methyl residues which 
were based on standard defaults from Agency standard operating 
procedures for residential exposure assessments. The registrant is 
undertaking a study to refine the oral exposures. If these data do not 
confirm that the Agency's estimates were overestimates, the registrant 
has agreed to cancel the use on turf in residential areas.
    Inhalation exposures are thought to be negligible in outdoor post-
application scenarios relative to dermal and oral exposures because of 
the low vapor pressure of thiophanate-methyl (1.3 x 10-5 
milimeter mercury (mmHg)) and MBC (1 x 10-7 mmHg) and 
because the uses (and primary exposures) are outdoors allowing for 
significant dilution. As such, inhalation exposures were not considered 
in the post-application exposure assessment.
    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 
considers ``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 thiophanate-methyl and MBC have 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, 
thiophanate-methyl and MBC do not appear to produce a toxic metabolite 
produced by other substances. For the purposes of these tolerances 
action, EPA has not assumed that thiophanate-methyl and MBC have 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. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity of thiophanate-methyl. In 
assessing the potential for additional sensitivity of infants and 
children to residues of thiophanate-methyl and MBC, EPA considered data 
from developmental toxicity studies in the rat and rabbit and a 2-
generation reproduction study in the rat. The Agency determined that 
the FQPA safety factor should be retained at 3X for assessing the risk 
posed by thiophanate-methyl for the following reasons:
    (i). The toxicity data base is incomplete (acute and subchronic 
neurotoxicity studies are required due to evidence of neurotoxicity) 
and the requirement for a developmental neurotoxicity study has been 
reserved.
    (ii). The Agency evaluated the new 1997 prenatal developmental 
toxicity study in rabbits and classified this study as acceptable for 
assessment of susceptibility.
    (iii). The Agency determined that the prenatal developmental 
toxicity study in the rat was acceptable for assessment of 
susceptibility.
    (iv). The Agency concluded that the available data provided no 
indication of increased susceptibility for in utero exposure in the 
developmental studies

[[Page 55147]]

in rats and rabbits or following prenatal/postnatal exposure in the 
multi-generation reproduction studies in rats.
    (v). The dietary (food and drinking water) and non-dietary exposure 
assessments will not underestimate the potential exposures for infants 
and children from the use of thiophanate-methyl.
    3. Prenatal and postnatal sensitivity of MBC. The Agency determined 
that the FQPA Safety factor should be retained at 10X for assessing the 
risk posed by MBC for the following reasons:
    (i). Evidence of increased susceptibility following in utero 
exposure to MBC in the prenatal developmental toxicity in rats and 
rabbits.
    (ii). The need for developmental neurotoxicity study in rats for 
carbendazim.
    4. Conclusion. Based on the developmental and reproductive data on 
thiophanate-methyl and MBC, EPA determined that an additional 3X safety 
factor for thiophanate-methyl and that an additional 10X safety factor 
for MBC for the protection of infants and children (as required by 
FQPA) should be retained.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by EPA are used to calculate DWLOCs: 2L/70 kg (adult 
male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body 
weights and drinking water consumption values vary on an individual 
basis. This variation will be taken into account in more refined 
screening-level and quantitative drinking water exposure assessments. 
Different populations will have different DWLOCs. Generally, a DWLOC is 
calculated for each type of risk assessment used: Acute, short-term, 
intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. The thiophanate-methyl acute dietary risk estimate 
uses 10% of the aPAD for the general U.S. population and 25% of the 
aPAD for the most highly exposed population subgroup of concern, 
infants, (<1 year). For MBC, the acute dietary risk estimate uses 4% of 
the aPAD for the general U.S. population and 89% of the aPAD for the 
population subgroup of concern, infants, (<1 year). The total 
thiophanate-methyl plus MBC acute dietary risk estimate for the only 
population subgroup of concern, females (13-50 years) uses 51% of the 
aPAD. The DWLOC based on simultaneous dietary exposure to both MBC and 
thiophanate-methyl which was converted to MBC equivalents resulted in 
the following DWLOCs: Infants (<1 year) 18 ppb; children (1-6 years) 57 
ppb; females (13-50 years) 150 - 170 ppb; and general U.S. population 
5,700 ppb. The lowest DWLOC for the population subgroup, infants (<1 
year) does not exceed the EEC for ground water (0.033 ppb); however, 
the DWLOC does exceed the EEC for surface water (25 ppb). Although the 
EEC is exceeded, the DWLOC is greatly inflated as 50% of the aPAD 
percentage is consumed by citrus which is a 1-year registration only. 
When citrus is removed from the DWLOC estimation, the DWLOC becomes 94 
ppb which is well above the EEC of 25 ppb. The DWLOC is significantly 
lowered by the addition of citrus because field trial data was used 
which results in an overly conservative estimation.
    Another indication that the addition of citrus based on field trial 
data results in an over estimation is the fact that benomyl PDP data 
available for citrus indicated that there were zero hits out of 689 
Florida samples of orange juice. These data were not used to refine the 
DWLOC estimation as the benomyl application rate is somewhat lower than 
the thiophanate-methyl rate approved in this year's emergency exemption 
for thiophanate-methyl. However, the Agency believes that while most 
growers used the benomyl rate as the emeregency exemption was approved 
later in the use season and thus fewer applications than were 
authorized were actually used. Furthermore, if the higher rate were 
used, the impact would be lessened by the fact that juice is a blended 
commodity. Therefore, although the DWLOC is exceeded, the acute dietary 
risk from food and water does not exceed the Agency's level of concern.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
thiophanate-methyl and MBC will utilize the following percentages of 
the RfD for the U.S. population: Thiophanate-methyl - 0.7%; MBC - 1.0% 
and total thiophanate-methyl plus MBC - 1.7%. The major identifiable 
subgroup with the highest aggregate exposure is children (1-6 years), 
and EPA has concluded that aggregate dietary exposure to thiophanate-
methyl and MBC wil utilize the following percentages of the RfD: 
thiophate-methyl - 2.3%; MBC - 26% and total thiophanate-methyl plus 
MBC - 28%. EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. The aggregate chronic DWLOCs are as follows: 858 
ppb for the general U.S. population; 69 ppb for females (13-50 years); 
22 ppb for infants (<1 year); and 18 ppb for children (1-6 years). The 
aggregate surface water EEC for thiophanate-methyl is 0.7 ppb; 14 ppb 
for MBC and 14.7 ppb for thiophanate-methyl plus MBC. Therefore, the 
chronic aggregate risk to not exceed the Agency's level of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Thiophanate-methyl and 
MBC are currently registered for use that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for thiophanate-methyl and MBC.
    All residential exposures are considered to be short-term. The 
MOE's (converted to MBC equivalents) for

[[Page 55148]]

aggregate short-term exposure to thiophanate-methyl are as follows: 
Oral exposure of children (1-6 years) is 670; dermal exposure of 
children (1-6 years) is 1,000; and dermal exposure of females (13-50 
years) is 1,315. The MOEs for aggregrate exposure to MBC from the use 
of MBC as an in-can paint preservative are 670 for dermal exposure and 
770 for exposure via inhalation. The MOEs (converted to MBC 
equivalents) for the total thiophanate-methyl and MBC aggregate 
exposure are as follows: 630 for oral and dermal exposure of children 
(1-6 years); 770 for exposure via inhalation for females (13-50 years); 
and 620 for oral and dermal exposure for females (13-50 years). 
Although the MOEs below 1,000 exceed the Agency's level of concern, 
when considering the conservative method of exposure estimation 
previously discussed, and the negotiated risk mitigation whereby the 
registrant has agreed to conduct hand-press studies to help refine this 
assessment, the risks do not exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. The total 
thiophanate-methyl and MBC dietary cancer risk is 8.5 x 10-7 
for existing and new uses. The cancer risk from non-occupational 
residential exposure is 3.7 x 10-7. The aggregate cancer 
risk is 1.2 x 10-6. This risk estimate includes cancer risk 
from both thiophanate-methyl and MBC on food including all pending uses 
and section 18 uses, thiophanate-methyl exposure from treating 
ornamentals, thiophanate-methyl exposure from performing post-
application lawn activities, and exposure from applying paint 
containing MBC. This is considered to be a high-end risk scenario since 
it is not expected that someone would treat ornamentals, perform high 
exposure post-application activities, and apply paint containing MBC 
every year for 70 years. Therefore, this estimate is considered to be a 
conservative estimate. Additionally, the cancer risk estimate based on 
the highest EEC (thiophanate-methyl plus MBC EEC) is 9.6 x 
10-7. This is also a very high-end risk estimate as it is 
based on the maximum rate being applied every season for 70 years. 
Thus, food plus water (assuming that the modeled surface water EEC is 
equivalent to concentrations in finished drinking water) plus non-
occupational residential cancer risk is 2.2 x 10-6 which is 
still within the range considered as negligible. In addition, the 
cancer risk estimates using benomyl/MBC PDP monitoring data to estimate 
thiophanate-methyl residues are below 1 x 10-6 for 
thiophanate-methyl existing uses, new uses, and the amortized section 
18 use on citrus. Therefore, the risks do not exceed the Agency's level 
of concern.
    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 thiophanate-methyl and MBC residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high pressure liquid 
chromatography/ultra violet (HPLC/UV) is available to enforce the 
tolerance expression. The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue 
limits (MRLs) for thiophanate-methyl residues in/on various plant and 
animal commodities. Codex MRLs for thiophanate-methyl are currently 
expressed as MBC. The Codex MRL residue definition and the U.S. 
tolerance definition are currently incompatible and will remain 
incompatible even after the U.S. tolerance definition is revised, as 
the revised tolerance definition will include both thiophanate-methyl 
and MBC.

C. Conditions

    A 30-day plant back interval is required for crops without labeled 
uses of thiophanate-methyl. Registrations for the use on canola will be 
restricted to use in Minnesota, Montana and North Dakota (East of 
Interstate 15).

V. Conclusion

    Therefore, the tolerances are established for residues of 
thiophanate-methyl and its metabolite (methyl 2-benzimidazoyl carbamate 
(MBC)), expressed as thiophanate-methyl in or on grapes at 5.0 ppm, on 
pears at 3.0 ppm, on pistachios at 0.1 ppm, on potatoes at 0.1 ppm, and 
on canola (restricted to use in Minnesota, Montana and North Dakota 
(East of Interstate 15)) 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 ID number OPP-2002-0140 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
28, 2002.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your written request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall  2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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

[[Page 55149]]

Office of the Hearing Clerk is (703) 603-0061.
    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 ID number OPP-2002-0140, 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). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from 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 ``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.

[[Page 55150]]

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: July 3, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.371 is amended as follows:
    i. By alphabetically adding entries for the commodities ``grape,'' 
``pear,'' and ``pistachio'' and revising the entry for ``potatoes, seed 
treatment'' to read ``potato'' to the table in paragraph (a) as set 
forth below.
    ii. By adding text and a table to paragraph (c):


Sec. 180.371  Thiophanate-methyl; tolerances for residues.

    (a) General. Thiophanate-methyl and its metabolite (methyl 2-
benzimidazoyl carbamate (MBC)), expressed as thiophanate-methyl

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                      *      *      *      *      *
Grape................................................                5.0
                      *      *      *      *      *
Pear.................................................                3.0
                      *      *      *      *      *
Pistachio............................................                0.1
                      *      *      *      *      *
Potato...............................................                0.1
                      *      *      *      *      *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec. 180.1(n), are established for 
the residues of thiophanate-methyl and its metabolite (methyl 2-
benzimidazolyl carbamate (MBC)), expressed as thiophanate-methyl in or 
on the following raw agricultural commodity:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Canola...............................................                0.1
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-21678 Filed 8-27-02; 8:45 am]
BILLING CODE 6560-50-S