[Federal Register Volume 69, Number 165 (Thursday, August 26, 2004)]
[Rules and Regulations]
[Pages 52434-52444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19525]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0195; FRL-7371-2]


Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances as follows: For 
residues of pyrimethanil, 4,6-dimethyl-N-phenyl-2-pyrimidinamine, in or 
on almond; almond, hulls; apple, wet pomace; banana; citrus oil; fruit, 
citrus, group 10 (post-harvest); fruit, pome, group 11 (pre-harvest and 
post-harvest); fruit, stone (except cherry), group 12; grape; grape, 
raisin; onion, dry bulb; onion, green; pistachio; strawberry; tomato; 
and vegetable, tuberous and corm, subgroup 1C; for residues of 
pyrimethanil and its metabolite, 4-[4,6-dimethyl-2-
pyrimidinyl)amino]phenol in or on cattle, fat; cattle, kidney; cattle, 
meat; cattle meat-by-products (except kidney); goat, fat; goat, kidney; 
goat, meat; goat meat-by-products (except kidney); horse, fat; horse, 
kidney; horse, meat; horse, meat-by-products (except kidney); sheep, 
fat; sheep, kidney; sheep, meat; and sheep, meat-by-products (except 
kidney); and for residues of pyrimethanil and its metabolite 4,6-
dimethyl-2-(phenylamino)-5-pyrimidinol in milk. Bayer Crop Science and 
Janssen Pharmaceutica, Inc. 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 26, 2004. Objections and 
requests for hearings must be received on or before October 25, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0195. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Crystal Mall 2, 1801 S. Bell St., Arlington, 
VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The docket telephone number 
is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers;

[[Page 52435]]

greenhouse, nursery, and floriculture workers; ranchers; pesticide 
applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

 II. Background and Statutory Findings

    In the Federal Register of February 14, 2003 (68 FR 7548) (FRL-
7289-1), and March 5, 2003 (68 FR 10458) (FRL-7291-2), EPA issued 
notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 2F6480, 2F6439, and 
9E6054) by Janssen Pharmaceutica Inc., Plant and Material Protection 
Division, 1125 Trenton-Harbouton Road, Titusville, NJ 08560, and Bayer 
Crop Science, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. 
These notices included a summary of the petitions prepared by Janseen 
Pharmaceutica Inc., and Bayer Crop Science, the registrants. There were 
no comments received in response to these notices of filing.
    The petitions requested that 40 CFR 180.518 be amended by 
establishing tolerances for residues of the fungicide pyrimethanil, 
4,6-dimethyl-N-phenyl-2-pyrimidinamine, in or on citrus fruits 
(calamondin, citrus citron, citrus hybrids, grapefruit, kumquat, lemon, 
lime, mandarin, sour and sweet oranges, pummelo and satsuma mandarin) 
at 6 parts per million (ppm); pome fruit (apples, pears, oriental 
pears, crabapples, loquats, mayhaws, and quince) wet pomace at 12 ppm; 
and pome fruit (apples, pears, oriental pears, crabapples, loquats, 
mayhaws, and quince) at 3 ppm 2F6480; tree nut, nutmeat, group at 0.25 
ppm; tree nut, hulls, group at 12 ppm; fruit, pome, group at 0.20 ppm; 
apple, wet pomace at 0.75 ppm; fruit, stone, group at 3.0 ppm; grape at 
3.0 ppm; grape, dry pomace at 20 ppm,; grape, wet pomace at 7.0 ppm; 
grape, raisen waste at 50 ppm; grape, raisin at 5.0 ppm; vegetable, 
bulb, group at 2.0 ppm; vegetable, tuberous and corm, subgroup at 0.05 
ppm; strawberry at 3.0 ppm; tomato at 0.50 ppm; wheat, rotational at 
0.05 ppm; cattle, meat at 0.1 ppm; cattle, meat-by-products at 0.1 ppm; 
and milk at 0.03 ppm 2F6439;, and banana at 0.10 ppm 9E6054.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances as follows: (1) For residues of 
pyrimethanil on almond at 0.20 ppm; almond, hulls at 12 ppm; apple, wet 
pomace at 12 ppm; banana at 0.10 ppm; citrus oil at 150 ppm; fruit, 
citrus, group 10 (post-harvest) at 10 ppm; fruit, pome, group 11 (pre-
harvest and post-harvest) at 3.0 ppm; fruit, stone (except cherry), 
group 12 at 3.0 ppm; grape at 5.0 ppm; grape, raisin at 8.0 ppm; onion, 
dry bulb at 0.10 ppm; onion, green at 2.0 ppm; pistachio at 0.20 ppm; 
strawberry at 3.0 ppm; tomato at 0.50 ppm; and vegetable, tuberous and 
corm, subgroup 1C at 0.05 ppm; (2) for residues of pyrimethanil and its 
metabolite, 4-[4,6-dimethyl-2-pyrimidinyl)amino]phenol on cattle, fat 
at 0.01 ppm; cattle, kidney at 0.30 ppm; cattle, meat at 0.01 ppm; 
cattle, meat-by-products (except kidney) at 0.01 ppm; goat, fat at 0.01 
ppm; goat, kidney at 0.30 ppm; goat, meat at 0.01 ppm; goat, meat-by-
products (except kidney) at 0.01 ppm; horse, fat at 0.01 ppm; horse, 
kidney at 0.30 ppm; horse, meat at 0.01 ppm; horse, meat-by-products 
(except kidney) at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, kidney at 
0.30 ppm; sheep, meat at 0.01 ppm; and sheep, meat-by-products (except 
kidney) at 0.01 ppm; and (3) for residues of pyrimethanil and its 
metabolite, 4,[6-dimethyl-2-(phenyl]amino)-5-pyrimidinol in milk at 
0.03 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 pyrimethanil are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

[[Page 52436]]



                                Table 1.--Subchronic, Chronic, and Other Toxicity
----------------------------------------------------------------------------------------------------------------
             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity-       NOAEL = 54.5 milligrams/kilogram/day (mg/kg/
                                          rodents (rat)               day) male (M), 66.7 mg/kg/day female (F)
                                                                     LOAEL = 529.1 mg/kg/day M, 625.9 mg/kg/day
                                                                      F decreased body weights (20%), body
                                                                      weight gain (30%), food consumption, brown
                                                                      urine, increased urinary protein;
                                                                      decreased absolute heart, adrenal, spleen,
                                                                      thymus weights; increased relative liver
                                                                      kidney, gonad weights, liver, thyroid
                                                                      hypertrophy
----------------------------------------------------------------------------------------------------------------
870.3100                                 90-Day oral toxicity-       NOAEL = 139 mg/kg/day M, 203 mg/kg/day F
                                          rodents (mouse)            LOAEL = 1,864 mg/kg/day M, 2,545 mg/kg/day
                                                                      F based on decreased body-weight gain (7-
                                                                      12%); increased cholesterol, bilirubin F/
                                                                      M, dark thyroids, increased relative liver
                                                                      weights, kidney, thyroid, bladder
                                                                      histopathology
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity-       NOAEL = 80 mg/kg/day
                                          nonrodents                 LOAEL = 1,000/800 mg/kg/day based on
                                                                      decreased water consumption, vomiting,
                                                                      diarrhea, salivation, hypoactivity
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental-     Maternal
                                          rodents                    NOAEL = 85 mg/kg/day
                                                                     Maternal
                                                                     LOAEL = 1,000 mg/kg/day based on decreased
                                                                      body weight, and body weight gain
                                                                     Developmental
                                                                     NOAEL = 85 mg/kg/day
                                                                     Developmental
                                                                     LOAEL = 1,000 mg/kg/day based on decrease
                                                                      in mean litter weight and mean fetal
                                                                      weight
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental-     Maternal
                                          nonrodents                 NOAEL = 45 mg/kg/day
                                                                     Maternal
                                                                     LOAEL = 300 mg/kg/day based on deaths,
                                                                      decreased body weights, body weight gain,
                                                                      food consumption, production and size of
                                                                      fecal pellets
                                                                     Developmental
                                                                     NOAEL = 45 mg/kg/day
                                                                     Developmental
                                                                     LOAEL = 300 mg/kg/day based on death,
                                                                      decreased body weight, body weight gain,
                                                                      food consumption, production and size of
                                                                      fecal pellets; decreased fetal weight,
                                                                      increased fetal runts, retarded
                                                                      ossification, 13 thoracic vertebrae and
                                                                      pairs of ribs
----------------------------------------------------------------------------------------------------------------
870.3800                                 2-Generation reproduction   Parental/systemic
                                          and fertility effects      NOAEL = 23.1 mg/kg/day M, 27.4 mg/kg/day F
                                          (rats)                     Parental/systemic
                                                                     LOAEL = 294 mg/kg/day M, 343 mg/kg/day F
                                                                      based on decreased body weight (11-13%),
                                                                      and body weight gain (11-17%)
                                                                     Reproductive
                                                                     NOAEL = 294/343 mg/kg/day
                                                                     Reproductive
                                                                     Offspring
                                                                     NOAEL = 23.1 mg/kg/day M, 27.4 mg/kg/day F
                                                                     Offspring
                                                                     LOAEL = 294 mg/kg/day based on decreased
                                                                      pup body weights on PND 21
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity - dogs     NOAEL = 30 mg/kg/day
                                                                     LOAEL = 250 mg/kg/day based on decreased
                                                                      body weight, food and water consumption,
                                                                      food efficiency, increased neutrophils,
                                                                      decreased clotting time
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity mice        NOAEL = 210.9 mg/kg/day M, 253.8 mg/kg/day
                                                                      F
                                                                     No toxicologically significant effects were
                                                                      found
----------------------------------------------------------------------------------------------------------------
870.4300                                 Combined Chronic/           NOAEL = 17 mg/kg/day M, 22 mg/kg/day F
                                          carcinogenicity (rats)     LOAEL = 221 mg/kg/day M, 291 mg/kg/day F
                                                                      based on decreased body-weight gain (5-15%
                                                                      M, 15-45% F) 10-15% at 6 months; increased
                                                                      serum cholesterol, gamma glutamyl
                                                                      transferase, relative liver weights;
                                                                      liver, thyroid histopathology increased
                                                                      thyroid adenomas
----------------------------------------------------------------------------------------------------------------
870.5100                                 Gene mutation               There was no evidence of induced mutant
                                                                      colonies over background
----------------------------------------------------------------------------------------------------------------
870.5300                                 Cytogenetics                There was no clear evidence of biologically
                                                                      significant induction of mutant colonies
                                                                      over background
----------------------------------------------------------------------------------------------------------------
870.5375                                 Chromosome aberration       There was no evidence of chromosome
                                                                      aberrations induced over background
----------------------------------------------------------------------------------------------------------------

[[Page 52437]]

 
870.5395                                 Mammalian erythrocyte       There was no statistically significant
                                          micronucleus test in mice   increase in the frequency of
                                                                      micronucleated polychromatic erythrocytes
                                                                      in mouse bone marrow at any dose or
                                                                      harvest time
----------------------------------------------------------------------------------------------------------------
870.5550                                 Unscheduled DNA synthesis   Negative in inducing unscheduled DNA
                                          in mammalian culture        synthesis in rat hepatocytes as a result
                                                                      of in vivo gastric intubation
----------------------------------------------------------------------------------------------------------------
870.6200                                 Acute neurotoxicity         NOAEL = 100 mg/kg/day M, 100 mg/kg/day F
                                          screening battery (rat)    LOAEL = 1,000 mg/kg/day M, 1,000 mg/kg/day
                                                                      F based on decreased motor activity,
                                                                      ataxia, and decreased body temperature in
                                                                      both sexes, decreased hind limb grip
                                                                      strength in males, and increased dilated
                                                                      pupils in females on Day 1
----------------------------------------------------------------------------------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL = 44.3 mg/kg/day F
                                          screening battery (rat)    LOAEL = 429.9 mg/kg/day F, greater than
                                                                      391.9 mg/kg/day M based on decreased body
                                                                      weight (8%), body weight gain (21%), food
                                                                      consumpton (9-15%) F. No effects in males
----------------------------------------------------------------------------------------------------------------

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 lowest dose at which 
LOAEL of concern is identified 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.
    Three other types of safety or UFs may be used: ``Traditional UF'' 
the ``special FQPA safety factor; '' and the `` default FQPA safety 
factor.'' By the term ``traditional UF'' EPA is referring to those 
additional UFs used prior to FQPA passage to account for data base 
deficiencies. These traditional UFs have been incorporated by the FQPA 
into the additional safety factor for the protection of infants and 
children. The term ``special FQPA safety factor'' refers to those 
safety factors that are deemed necessary for the protection of infants 
and children primarily as a result of the FQPA. The ``default FQPA 
safety factor'' is the additional 10X safety factor that is mandated by 
the statute unless it is decided that there are reliable data to choose 
a different additional factor (potentially a traditional UF or a 
special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by an UF of 100 to account for 
interspecies and intraspecies differences and any traditional UFs 
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor 
or the default FQPA safety factor is used, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of 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). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5), one in a million (1 X 10-6), or one in ten 
million (1 X 10-7). 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 pyrimethanil used for 
human risk assessment is shown in the following Table 2.

     Table 2.--Summary of Toxicological Dose and Endpoints for Pyrimethanil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of  NOAEL = 45 mg/kg/day     Special FQPA SF = 1      Developmental toxicity
 age)                                  UF = 100...............  aPAD = aRfD / Special      rabbit
                                       Acute RfD = 0.45 mg/kg/   FQPA SF = 0.45 mg/kg/   LOAEL = 300 mg/kg/day
                                        day.                     day.                     based on increased in
                                                                                          fetuses with 13
                                                                                          thoracic vertebrae and
                                                                                          13 pairs of ribs
----------------------------------------------------------------------------------------------------------------

[[Page 52438]]

 
Acute dietary (general population      NOAEL = 100 mg/kg/day    Special FQPA SF = 1      Acute neurotoxicity -
 including infants and children)       UF = 100...............  aPAD = aRfD / Special     rat
                                       aRfD = 1 mg/kg/day.....   FQPA SF = 1 mg/kg/day.  LOAEL = 1,000 mg/kg/day
                                                                                          based on decreased
                                                                                          motor activity,
                                                                                          ataxia, decreased body
                                                                                          temperature, hind lim
                                                                                          grip strength, and
                                                                                          dilated pupils
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 17 mg/kg/day      Special FQPA SF = 1      Chronic toxicity - rat
                                       UF = 100...............  cPAD = chronic RfD /     LOAEL = 221 mg/kg/day
                                       Chronic RfD = 0.17 mg/    Special FQPA SF = 0.17   based on decreased
                                        kg/day.                  mg/kg/day.               body-weight gains,
                                                                                          increased serum
                                                                                          cholesterol and GGT,
                                                                                          increased relative
                                                                                          liver/body-weight
                                                                                          ratios, necropsy and
                                                                                          histopathological
                                                                                          findings in the liver
                                                                                          and thyroid
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                                                        Pyrimethanil was
                                                                                          classified as a Group
                                                                                          C carcinogen based on
                                                                                          thyroid follicular
                                                                                          cell tumors in both
                                                                                          sexes of the 2-year
                                                                                          rat study (NOAEL = 17
                                                                                          mg/kg/day). The
                                                                                          Agency's Cancer Peer
                                                                                          Review Committee
                                                                                          recommended a
                                                                                          threshold or Margin of
                                                                                          Exposure (MOE)
                                                                                          approach because the
                                                                                          thyroid tumors
                                                                                          associated with
                                                                                          administration of
                                                                                          pyrimethanil in
                                                                                          Sprague-Dawley rats
                                                                                          may be due to a
                                                                                          disruption in the
                                                                                          thyroid-pituitary
                                                                                          status.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.518) for the residues of pyrimethanil, in or on 
imported wine grapes. Risk assessments were conducted by EPA to assess 
dietary exposures from pyrimethanil plus the metabolites, 4-[4,6-
dimethyl-2-pyrimidinyl)amino]phenol and 4,6-dimethyl-2-(phenylamino)-5-
pyrimidinol, 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.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEMTM-FCID), which incorporates food 
consumption data as reported by respondents in the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII), and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments: The acute 
analysis assumed tolerance level residues, 100% crop treated, and 
DEEMTM (ver. 7.76) default processing factors for all 
proposed commodities. Percent crop treated (PCT) data and anticipated 
residues were not used.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM software with the FCID, which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide CSFII, and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: The chronic analyses assumed tolerance level 
residues for ruminant tissues and milk and was refined through the use 
of average crop field trial residues for all crops. Conservative 
projected PCT estimates were used.
    iii. Cancer. In conducting the cancer dietary risk assessment, EPA 
used the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCIDTM), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The cancer risk assessment used the MOE methodology (MOE equals NOAEL 
(17 mg/kg/day) divided by chronic exposure). The following assumptions 
were made for the cancer exposure assessment: The cancer analyses 
assumed tolerance level residues for ruminant tissues and milk and was 
refined through the use of average crop field trial residues for all 
crops. Conservative projected percent crop treated estimates were used.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide chemicals that have been measured in food. If EPA 
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) of FFDCA, EPA will issue a Data-Call-
In for information relating to anticipated residues to be submitted no 
later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if the Agency can make the following findings: Condition 1, 
that the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to

[[Page 52439]]

contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group, and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used projected PCT (PPCT) information for the following 
crops: almonds, apples (field use), grapes, onions, pear (field use), 
peach/stone fruit, potatoes, strawberries, tomatoes, post harvest pome 
fruit, and post-havest citrus. A 100% crop treated estimate was assumed 
for bananas, tuberous and corm vegetables (excluding potatoes), milk, 
meat and meat-by-products. These PPCT values are based on projected 
market share information. The registrants provided the Agency with 
their anticipated market share projections. The Agency estimated market 
share projections by comparing the efficacy spectrum of the registered 
alternatives to the efficacy spectrum of pyrimethanil. In conducting 
its risk assessment, the Agency utilized EPA-derived estimates. As to 
Condition 1, the Agency believes that this approach is conservative and 
will overestimate the potential risk. To further ensure the reliability 
of these data, as a condition of registration, the registrant will be 
required to provide annual reports on the market penetration and market 
share of pyrimethanil for each of the registered crops. 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 pyrimethanil 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pyrimethanil and its major 
metabolite, 2-amino-4,6-dimethylpyrimidine in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the physical characteristics of 
pyrimethanil and 2-amino-4,6-dimethylpyrimidine. Pyrimethanil is 
expected to have low mobility in the environment, and 2-amino-4,6,-
dimethylpyrimidine is expected to be moderately mobile and more 
persistent in the environment.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and SCI-GROW, which predicts pesticide concentrations in ground 
water. In general, EPA will use GENEEC (a Tier 1 model) before using 
PRZM/EXAMS (a Tier 2 model) for a screening-level assessment for 
surface water. The GENEEC model is a subset of the PRZM/EXAMS model 
that uses a specific high-end runoff scenario for pesticides. GENEEC 
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an 
index reservoir environment in place of the previous pond scenario. The 
PRZM/EXAMS model includes a percent crop area factor as an adjustment 
to account for the maximum percent crop coverage within a watershed or 
drainage basin.
    None of these models include consideration of 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 screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a percent 
referance dose (%RfD) or percent population adjusted dose (%PAD). 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in 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 from residential uses. 
Since DWLOCs address total aggregate exposure to pyrimethanil and 2-
amino-4,6-dimethylpyrimidine they are further discussed in the 
aggregate risk sections in Unit III.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
pyrimethanil and 2-amino-4,6-dimethylpyrimidine for acute exposures are 
estimated to be 37.8 parts per billion (ppb) for surface water and 4.8 
ppb for ground water. The EECs for chronic exposures are estimated to 
be 5.1 ppb for surface water and 4.8 ppb for ground water. All EECs 
were adjusted for regional percent cropped area and all EECs were 
developed using the strawberry use pattern which represents the worst 
case scenario (highest single and seasonal application rates).
    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).
    Pyrimethanil is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to pyrimethanil and any other 
substances and pyrimethanil does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that pyrimethanil has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the policy statements released by EPA's OPP concerning

[[Page 52440]]

common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety (MOS) for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different MOS will 
be safe for infants and children. MOS are incorporated into EPA risk 
assessments either directly through use of a MOE analysis or through 
using UFs (safety) in calculating a dose level that poses no 
appreciable risk to humans. In applying this provision, EPA either 
retains the default value of 10X when reliable data do not support the 
choice of a different factor, or, if reliable data are available, EPA 
uses a different additional safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA determined that there 
are no residual concerns for pyrimethanil for prenatal and postnatal 
toxicologically based on the following:
     There is no evidence of qualitative or quantitative 
increased susceptibility following prenatal or postnatal exposures.
     There are no concerns or residual uncertainties for 
prenatal and/or postnatal toxicity following exposure to pyrimethanil.
     Because a decrease in thyroid hormones may cause 
neurotoxicity in the young exposed prior to birth or early in life, the 
Agency considered the possible need for a comparative thyroid assay and 
reviewed the evidence for thyroid toxicity in the data base. The Agency 
concluded that a comparative thyroid assay in young and adult rats is 
not required.
     Based on the weight-of-evidence presented, the Agency 
concluded that a developmental neurotoxicity study is not required for 
pyrimethanil since there is no evidence of neuropathology and no 
neurotoxic signs up to 400 mg/kg/day in a subchronic neurotoxicity 
study in rats; the only evidence of neurotoxicity occurs after an acute 
dose level (1,000 mg/kg) much higher than those used to establish 
endpoints for risk assessment (100 mg/kg for acute exposures; 
approximately 20 mg/kg/day for repeated exposures), the 1,000 mg/kg/day 
dose is also higher than the doses tested or than those used in the 
reproduction study, which had a high dose of 343 mg/kg/day.
     The Agency noted, as seen in the CPRC report, that the 
effects on the thyroid-pituitary status were associated with the large 
increase in uridine diphosphate glucuronosyl transferases seen in the 
14-day dietary rat study. The effects seen in the thyroid and the 
liver, while treatment-related, are not severe in nature; in each of 
these studies there is a wide dose spread (approxiamately 10-fold 
difference between NOAELs and LOAELs) which provides a measure of 
protection for any potential effects reflecting increased sensitivity 
or susceptibility in offspring. Additionally, the endpoints selected 
for risk assessment will cover any concern for thyroid or liver effects 
seen at higher doses.
     The Agency has a complete database on rat thyroid tumors. 
The mode of action in thyroid tumors in rats is well understood.
    3. Conclusion. There is a complete toxicity data base for 
pyrimethanil and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The FQPA factor 
is removed because of the completeness of the data base and the lack of 
concern for prenatal and postnatal toxicity. EPA concluded that 
reliable data shows an additional safety factor of 10X is not needed 
for the protection of infants and children.

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 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 the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2 L/60 kg (adult female), and 1 
L/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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
pyrimethanil plus the metabolites, 4-[4,6-dimethyl-2-
pyrimidinyl)amino]phenol and 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol 
will occupy 10% of the aPAD for the U.S. population, 16% of the aPAD 
for females 13-49 years old, 15% of the aPAD for all infants less than 
1 year old, and 31% of the aPAD for children 1-2 years old. In 
addition, there is potential for acute dietary exposure to pyrimethanil 
and 2-amino-4, 6-dimethylpyrimidine in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the aPAD, as shown in the following Table 3.

[[Page 52441]]



 Table 3.--Aggregate Risk Assessment for Acute Exposure to Pyrimethanil plus the metabolites, 4-[4,6-dimethyl-2-
                     pyrimidinyl)amino]phenol and 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population                                    1           10         37.8          4.8       31,000
----------------------------------------------------------------------------------------------------------------
All infants less than (1 year old)                         1           15         37.8          4.8        8,500
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                   1           31         37.8          4.8        6,900
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                               0.45           16         37.8          4.8       33,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyrimethanil plus the metabolites, 4-[4,6-dimethyl-2-
pyrimidinyl)amino]phenol and 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol 
from food will utilize 1% of the cPAD for the U.S. population, 4.5% of 
the cPAD for all infants less than 1 year old, less than 1% of the cPAD 
for females 13-49 years old and 5.3% of the cPAD for children 1-2 years 
old. There are no residential uses for pyrimethanil that result in 
chronic residential exposure to pyrimethanil. Based on the use pattern, 
chronic residential exposure to residues of pyrimethanil is not 
expected. In addition, there is potential for chronic dietary exposure 
to pyrimethanil and 2-amino-4,6-dimethylpyrimidine in drinking water. 
After calculating DWLOCs and comparing them to the EECs for surface 
water and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the cPAD, as shown in the following Table 4.

 Table 4.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Pyrimethanil plus the metabolites, 4-
            [4,6-dimethyl-2- pyrimidinyl)amino]phenol and 4,6-dimethyl-2-(phenylamino)-5- pyrimidinol
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
           Population Subgroup             cPAD mg/kg/     %cPAD (Food)     Water EEC    Water EEC     Chronic
                                               day                            (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                   0.17                  1          5.1          4.8        5,900
----------------------------------------------------------------------------------------------------------------
All infants less than (1 year old)                0.17                4.5          5.1          4.8        1,600
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                         0.17        less than 1          5.1          4.8        5,100
----------------------------------------------------------------------------------------------------------------
Children (1-2 years)                              0.17                5.3          5.1          4.8        1,600
----------------------------------------------------------------------------------------------------------------

    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).
    Pyrimethanil is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pyrimethanil is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Pyrimethanil was 
classified as a Group C chemical (possible human carcinogen) and a non-
linear methodology MOE was applied for the estimation of human cancer 
risk. The chronic dietary food analyses resulted in MOEs for the U.S. 
population of greater than 9,000. The estimated cancer aggregate MOE 
for the U.S. population is 9,200.
    Generally, for threshold cancer effects where the mode of action is 
well understood, like thyroid carcinogens such as pyrimethanil, the 
general margin of exposure that indicates a reasonable certainty of no 
harm would be 100 (representing 2 factors of 10 for inter-species and 
intra-species extrapolation). The question of an acceptable MOE for 
threshold cancer effects is a relatively recent issue; however, given 
that the MOE here is 9,200, there is no question that this margin 
demonstrates that there is a reasonable certainty of no harm from 
cancer effects resulting from exposure to pyrimethanil.
    EPA has asked for an additional cancer study in the mouse because 
even at the highest dose tested there were no adverse effects. Given 
the dose levels used in the first mouse cancer study, EPA does not 
expect that even if the second study was positive it would result in a 
cancer risk estimate any higher than the current risk estimate. For 
example, the NOAEL and LOAEL from the 2 year combined chronic/
carcinogenicity study in rats are 17 mg/kg/day and 221mg/kg/day, 
respectively. The NOAEL (highest dose tested) from the first mouse 
cancer study was 210 mg/kg/day which is comparable to the LOAEL of 221 
mg/kg/day in rat.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to pyrimethanil plus the metabolites, 4-[4,6-dimethyl-2-
pyrimidinyl)amino]phenol and 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol 
residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography/mass 
spectrometry

[[Page 52442]]

(GS/MS) and high performance liquid chromatography/ultraviolet (HPLC-
UV)) are available to enforce the tolerance expression. The method may 
be requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected].

B. International Residue Limits

    There are no established or proposed CODEX or Mexican maximum 
residue limits (MRL). There is an established Canadian MRL for residues 
on grapes which is consistent with the recommended tolerance for grapes 
in this rule.

C. Conditions

    1. Plantback intervals will be required for all crops other than 
those with registered uses.
    2. Additional clarifying data will be required for Guideline 
860.1300 Nature of the Residue - Livestock and 860.1380 Storage 
Stability.
    3. A carcinogenicity study-mice (Guideline 870.4200(b) will be 
required because the high dose in the existing study was judged to be 
inadequate for assessing the carcinogenic potential of pyrimethanil.

V. Conclusion

    Therefore, tolerances are established (1) for residues of 
pyrimethanil on almond at 0.20 ppm; almond, hulls at 12 ppm; apple, wet 
pomace at 12 ppm; banana at 0.10 ppm; citrus oil at 150 ppm; fruit, 
citrus, group 10 (post-harvest) at 10 ppm; fruit, pome, group 11 (pre-
harvest and post-harvest) at 3.0 ppm; fruit, stone (except cherry), 
group 12 at 3.0 ppm; grape at 5.0 ppm; grape, raisin at 8.0 ppm; onion, 
dry bulb at 0.10 ppm; onion, green at 2.0 ppm; pistachio at 0.20 ppm; 
strawberry at 3.0 ppm; tomato at 0.50 ppm; and vegetable, tuberous and 
corm, subgroup 1C at 0.05 ppm; (2) for residues of pyrimethanil and its 
metabolite 4-[4,6-dimethyl-2-pyrimidinyl)amino]phenol on cattle, fat at 
0.01 ppm; cattle, kidney at 0.30 ppm; cattle, meat at 0.01 ppm; cattle, 
meat-by-products (except kidney) at 0.01 ppm; goat, fat at 0.01 ppm; 
goat, kidney at 0.30 ppm; goat, meat at 0.01 ppm; goat, meat-by-
products (except kidney) at 0.01 ppm; horse, fat at 0.01 ppm; horse, 
kidney at 0.30 ppm; horse, meat at 0.01 ppm; horse, meat-by-products 
(except kidney) at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, kidney at 
0.30 ppm; sheep, meat at 0.01 ppm; and sheep, meat-by-products (except 
kidney) at 0.01 ppm; and (3) for residues of pyrimethanil and its 
metabolite 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol in milk at 0.03 
ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA 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) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. 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-2004-0195 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 
25, 2004.
    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 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC. The Office of the Hearing Clerk is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Office of the Hearing Clerk is (202) 564-6255.
    2. 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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0195, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has

[[Page 52443]]

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 section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, 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 section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 13, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.518 is amended by adding text to paragraph (a), and by 
removing paragraph (e). Paragraph (a) reads as follows:


Sec.  180.518  Pyrimethanil; tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of the 
fungicide pyrimethanil 4,6-dimethyl-N-phenyl-2-pyrimidinamine in or on 
the following raw agricultural commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Almond..............................                                0.20
Almond, hulls.......................                                  12
Apple, wet pomace...................                                  12
Banana..............................                                0.10
Citrus oil..........................                                 150
Fruit, citrus, group 10 (post-                                        10
 harvest)...........................
Fruit, pome, group 11 (pre-harvest                                   3.0
 and post-harvest)..................
Fruit, stone (except cherry), group                                  3.0
 12.................................
Grape...............................                                 5.0
Grape, raisin.......................                                 8.0
Onion, dry bulb.....................                                0.10
Onion, green........................                                 2.0
Pistachio...........................                                0.20
Strawberry..........................                                 3.0

[[Page 52444]]

 
Tomato..............................                                0.50
Vegetable, tuberous and corm,                                       0.05
 subgroup 1C
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
fungicide pyrimethanil 4,6-dimethyl-N-phenyl-2-pyrimidinamine and its 
metabolite 4-[4,6-dimethyl-2-pyrimidinyl)amino]phenol in or on the 
following commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat.........................                                0.01
Cattle, kidney......................                                0.30
Cattle, meat........................                                0.01
Cattle, mbyp (except kidney)........                                0.01
Goat, fat...........................                                0.01
Goat, kidney........................                                0.30
Goat, meat..........................                                0.01
Goat, mbyp (except kidney)..........                                0.01
Horse, fat..........................                                0.01
Horse, kidney.......................                                0.30
Horse, meat.........................                                0.01
Horse, mbyp (except kidney).........                                0.01
Sheep, fat..........................                                0.01
Sheep, kidney.......................                                0.30
Sheep, meat.........................                                0.01
Sheep, mbyp (except kidney)                                         0.01
------------------------------------------------------------------------

    (3) Tolerances are established for the combined residues of the 
fungicide pyrimethanil 4,6-dimethyl-N-phenyl-2-pyrimidinamine and its 
metabolite 4,6-dimethyl-2-(phenylamino)-5-pyrimidinol in or on the 
following commodity:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
Milk................................                                0.03
------------------------------------------------------------------------

* * * * *
[FR Doc. 04-19525 Filed 8-25-04; 8:45 am]
BILLING CODE 6560-50-S