[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58424-58434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25048]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301058; FRL-6746-2]
RIN 2070-AB78


Halosulfuron-methyl; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This regulation establishes a tolerance for residues of 
halosulfuron-methyl in or on the squash/cucumber subgroup. The 
Interregional Research Project 4 (IR-4) requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996.

DATES:  This regulation is effective September 29, 2000. Objections and 
requests for hearings,identified by docket control number OPP-301058, 
must be received by EPA on or before November 28, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the  SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301058 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: Sidney Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 305-7610; and e-mail address: 
<a href="/cdn-cgi/l/email-protection#bfd5dedcd4ccd0d191ccd6dbd1dac6ffdacfde91d8d0c9"><span class="__cf_email__" data-cfemail="f892999b938b9796d68b919c969d81b89d8899d69f978e">[email protected]</span></a>.

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

[[Page 58425]]

 
                                  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/. To access the OPPTS Harmonized 
Guidelines referenced in the 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 control number OPP-301058. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 23, 2000 (65 FR 51314) (FRL-6738-
9), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide petition (0E6085) for tolerance by IR-4, 681 
U.S. Highway 1 South, North Brunswick, New Jersey 08902-3390. This 
notice included a summary of the petition prepared by Monsanto Company, 
the registrant. There were no comments received in response to the 
notice of filing.
    The petition requested that 40 CFR 180.479 be amended by 
establishing a tolerance for residues of the herbicide halosulfuron-
methyl, methyl 5-(4,6-dimethoxy-2-pyrimidinyl)amino 
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, and 
its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-
carboxylic acid, in or on the squash/cucumber subgroup at 0.5 parts per 
million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.''. Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is 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 November 26, 1997 (62 FR 62961) (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 a tolerance for residues of halosulfuron-methyl on 
squash/cucumber subgroup at 0.5 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by halosulfuron-methyl 
are discussed in the following Table 1 as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies reviewed. Acute toxicological 
studies placed the technical-grade halosulfuron-methyl in Toxicity 
Category III for acute dermal toxicity and in Category IV for all other 
types of acute toxicity.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study type            Results
------------------------------------------------------------------------
870.3100                          90-day oral         NOAEL = 116 males/
                                   toxicity rodents    147 females
                                                       milligrams/
                                                       kilograms/day (mg/
                                                       kg/day)

[[Page 58426]]

 
                                                      LOAEL = 497 males/
                                                       640 females mg/kg/
                                                       day based on
                                                       decreased body
                                                       weight gain,
                                                       decreased
                                                       absolute weights
                                                       of adrenal,
                                                       liver, thymus,
                                                       heart, and
                                                       kidneys,
                                                       decreased
                                                       cholesterol,
                                                       bilirubin, total
                                                       protein, albumin,
                                                       and calcium;
                                                       increases in MCH,
                                                       ALT, and
                                                       creatinine; and
                                                       vacuolated livers
                                                       and pigmented
                                                       kidney tubules.
------------------------------------------------------------------------
870.3200                          21/28-day dermal    NOAEL = 100
                                   toxicity (rats)     (males), 1,000
                                                       (females) mg/kg/
                                                       day
                                                      LOAEL = 1,000/
                                                       >1,000 mg/kg/day
                                                       male/female (M/F)
                                                       based on dose-
                                                       related decrease
                                                       in total body
                                                       weight gain in
                                                       males.
------------------------------------------------------------------------
870.3700a                         Prenatal            Maternal NOAEL =
                                   developmental in    250 mg/kg/day
                                   rodents (rat)
                                                      Maternal LOAEL =
                                                       750 mg/kg/day
                                                       (increased
                                                       incidence of
                                                       clinical
                                                       observations; and
                                                       reduced body
                                                       weight gains,
                                                       food consumption,
                                                       and food
                                                       efficiency)
                                                      Developmental
                                                       NOAEL= 250 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 750 mg/kg/
                                                       day (decreased
                                                       mean litter size,
                                                       increased number
                                                       of resorptions,
                                                       decreased mean
                                                       fetal body
                                                       weight, increases
                                                       in fetal and
                                                       litter incidences
                                                       of dilation of
                                                       the lateral
                                                       ventricles and
                                                       other anomalies
                                                       in the
                                                       development of
                                                       the fetal nervous
                                                       system, and
                                                       skeletal
                                                       variations such
                                                       as anomalies or
                                                       delays in
                                                       ossification in
                                                       the thoracic
                                                       vertebrae,
                                                       sternebrae, and
                                                       ribs)
------------------------------------------------------------------------
870.3700b                         Prenatal            Maternal NOAEL =
                                   developmental in    50 mg/kg/day
                                   nonrodents
                                   (rabbit)
                                                      Maternal LOAEL =
                                                       150 mg/kg/day
                                                       (decreased body
                                                       weight gain, food
                                                       consumption, and
                                                       food efficiency)
                                                      Developmental
                                                       NOAEL= 50 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 150 mg/kg/
                                                       day (decreased
                                                       mean litter size,
                                                       increased number
                                                       of resorptions
                                                       and increased
                                                       post implantation
                                                       loss)
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 50.5 /
                                                       58.7 mg/kg/day M/
                                                       F
                                                      Parental/Systemic
                                                       LOAEL = 223.2 /
                                                       261.4 mg/kg/day M/
                                                       F - reductions in
                                                       body weight, body
                                                       weight gains, and
                                                       food consumption
                                                       during the
                                                       premating period
                                                       in both sexes)
                                                      Offspring NOAEL >
                                                       261.4 mg/kg/day
                                                       highest dose
                                                       tested (HDT).
------------------------------------------------------------------------
870.4100b                         Chronic toxicity    NOAEL (systemic) =
                                   dogs                10 mg/kg/day
                                                      LOAEL (systemic) =
                                                       40 mg/kg/day
                                                       (decreased body
                                                       weight gains and
                                                       changes in
                                                       hematological and
                                                       blood chemistry
                                                       parameters in
                                                       females)
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL (systemic) =
                                   mice                410 / 1214.6 mg/
                                                       kg/day M/F
                                                      LOAEL (systemic) =
                                                       971.9 / 1214.6 mg/
                                                       kg/day M/F -
                                                       decreased mean
                                                       body weight in
                                                       males, increased
                                                       incidence of
                                                       microconcentratio
                                                       n/mineralization
                                                       in the testis and
                                                       epididymides) No
                                                       evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.4300                          Combined toxicity/  NOAEL (systemic) =
                                   carcinogenicity     108.3 / 56.4 mg/
                                   rats                kg/day M/F
                                                      LOAEL (systemic) =
                                                       225.2 / 138.6 mg/
                                                       kg/day M/F -
                                                       marginal
                                                       decreases in body
                                                       weight gains) No
                                                       evidence of
                                                       carcinogenicity

[[Page 58427]]

 
870.7485                          Metabolism and      Radiolabelled
                                   pharmacokinetics    technical was
                                                       administered to 5
                                                       rats/sex/group as
                                                       a single low-dose
                                                       (5 mg/kg), single
                                                       high-dose (250 mg/
                                                       kg), or repeated
                                                       low-dose (5 mg/kg/
                                                       day x 14 days).
                                                       Absorption was
                                                       rapid, incomplete
                                                       sic, and similar
                                                       in both sexes.
                                                       Elimination was
                                                       via urine and
                                                       feces within 72
                                                       hours, and
                                                       appeared to be
                                                       independent of
                                                       dose and sex.
                                                       Desmethyl
                                                       halosulfuron-
                                                       methyl and its 5-
                                                       hydroxy
                                                       derivative were
                                                       the major urinary
                                                       and fecal
                                                       metabolites.
------------------------------------------------------------------------
                                  Genotoxicity        Bacterial/
                                                       mammalian
                                                       microsomal
                                                       mutagenicity
                                                       assays were
                                                       performed and
                                                       halosulfuron-
                                                       methyl was found
                                                       not to be
                                                       mutagenic. Two
                                                       mutagenicity
                                                       studies were
                                                       performed to test
                                                       gene mutation and
                                                       found to produce
                                                       no chromosomal
                                                       aberrations or
                                                       gene mutations in
                                                       cultured Chinese
                                                       hamster ovary
                                                       cells. An in vivo
                                                       mouse
                                                       micronucleus
                                                       assay did not
                                                       cause a
                                                       significant
                                                       increase in the
                                                       frequency of
                                                       micronucleated
                                                       polychromatic
                                                       erythrocytes in
                                                       bone marrow
                                                       cells. A
                                                       mutagenicity
                                                       study was
                                                       performed on rats
                                                       and found not to
                                                       induce
                                                       unscheduled DNA
                                                       synthesis in
                                                       primary rat
                                                       hepatocytes.
------------------------------------------------------------------------
                                  Endocrine           No specific tests
                                   disruption          have been
                                                       conducted with
                                                       halosulfuron-
                                                       methyl to
                                                       determine whether
                                                       the chemical may
                                                       have an effect in
                                                       humans that is
                                                       similar to an
                                                       effect produced
                                                       by a naturally
                                                       occurring
                                                       estrogen or other
                                                       endocrine
                                                       effects. However,
                                                       there were no
                                                       significant
                                                       findings in other
                                                       relevant toxicity
                                                       tests, i.e.,
                                                       teratology and
                                                       multi- generation
                                                       reproduction
                                                       studies, which
                                                       would suggest
                                                       that halosulfuron-
                                                       methyl produces
                                                       effects
                                                       characteristic of
                                                       the disruption of
                                                       the estrogenic
                                                       hormone.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which verved (the NOAEL) from the toxicology study 
identified as appropriate for use in risk assessment is used to 
estimate the toxicological level of concern (LOC). However, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment if no NOAEL was achieved in the 
toxicology study selected. An uncertainty factor (UF) is applied to 
reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the 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<SUP>-6</SUP> 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 (MOE<INF>cancer</INF> = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for halosulfuron-methyl used for human risk assessment is 
shown in the following Table 2:

[[Page 58428]]



 Table 2.--Summary of Toxicological Doses and Endpoints for halosulfuron-methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and level of
          Exposure scenario               Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   NOAEL = 50 mg/kg/day,    FQPA SF = 1X, aPAD =     Developmental rabbit
 age, infants and children.             UF = 100 acute RfD =     acute RfD FQPA SF =      LOAEL = 150 mg/kg/day
                                        0.5 mg/kg/day            0.5 mg/kg/day            based on decreased
                                                                                          mean litter size and
                                                                                          increases in
                                                                                          resorptions and post-
                                                                                          implantation loss.
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL = 10 mg/kg/day UF  FQPA SF = 1X, cPAD =     Chronic toxicity - dog
                                        = 100, Chronic RfD =     chronic RfD FQPA SF =    LOAEL = 40 mg/kg/day
                                        0.1 mg/kg/day            0.1 mg/kg/day            based on decrease in
                                                                                          bodyweight gain and
                                                                                          alterations in
                                                                                          hematology and
                                                                                          clinical chemistry
                                                                                          parameters.
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        oral NOAEL = 50 mg/kg/   LOC for MOE = 100        Developmental - rabbit
 (Residential)                          day, (dermal             (Residential)            LOAEL = 150 mg/kg/day
                                        absorption rate = 75%)                            based on decreased
                                                                                          mean litter size and
                                                                                          increases in
                                                                                          resorptions, and post-
                                                                                          implantation loss.
----------------------------------------------------------------------------------------------------------------
Interme diate-term dermal (1 week to   oral NOAEL = 10 mg/kg/   LOC for MOE = 100        Chronic toxicity dog
 several months) (Residential)          day, (dermal             Residential              LOAEL = 40 mg/kg/day
                                        absorption rate = 75%                             based on decrease in
                                                                                          bodyweight gain and
                                                                                          alterations in
                                                                                          hematology and
                                                                                          clinical chemistry
                                                                                          parameters.
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    oral NOAEL= 10 mg/kg/    LOC for MOE = 100        Chronic toxicity - dog
 lifetime) (Residential)                day (dermal absorption   (Residential)            LOAEL = 40 mg/kg/day
                                        rate = 75%                                        based on decreased
                                                                                          body weight gain and
                                                                                          alterations in
                                                                                          hematology and
                                                                                          clinical chemistry
                                                                                          parameters.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.479) for the residues of halosulfuron-methyl, 
in or on various raw agricultural commodities (RACs) with tolerances 
ranging from 0.05 to 0.8 ppm. Halosulfuron-methyl is currently 
registered on a variety of use sites, including agricultural crops and 
residential lawns. Tolerances have been established for plant and 
animal RACs including field corn at 0.05 ppm, grain sorghum (milo) at 
0.05 ppm, sweet corn (kernel + cobs with husks removed) at 0.05 ppm, 
pop corn grain at 0.05 ppm, sugarcane cane at 0.05 ppm, tree nuts 
nutmeat at 0.05 ppm, pistachio nuts nutmeat at 0.05 ppm, cotton 
undelinted seed at 0.05 ppm, and rice grain at 0.05 ppm; and secondary 
tolerances in meat and meat by-products at 0.1 ppm (cattle, goats, 
hogs, horses, and sheep). Tolerances are established for indirect or 
inadvertent residues of halosulfuron-methyl ranging from 0.1 to 0.5 ppm 
in or on certain soybean and wheat RACs when present therein as a 
result of the application of halosulfuron-methyl to growing crops. 
Indirect or inadvertent tolerances including soybean forage at 0.5 ppm, 
soybean hay at 0.5 ppm, soybean seed at 0.5 ppm, wheat forage at 0.1, 
wheat grain at 0.1, and wheat straw at 0.2 have also been established 
for RACs. Tolerances for the fruiting vegetable crop group 8 have been 
proposed by Gowan Company at 0.05 ppm. An additional tolerance is 
herein being requested for the crop group 9B, squash/cucumber subgroup 
of the cucurbit vegetable group, at 0.5 ppm. Risk assessments were 
conducted by EPA to assess dietary exposures from halosulfuron-methyl 
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 one day 
or single exposure. The acute dietary endpoint for halosulfuron-methyl 
was based on developmental effects (decreased mean litter size, 
increased resorptions, and increased postimplantation loss). The 
endpoint applies only to subgroups consisting of females (aged 13-50 
years), infants and children. The 10X FQPA factor was removed, 
therefore, the acute RfD of 0.5 mg/kg/day is equal to the aPAD. The 
Dietary Exposure Evaluation Model (DEEM<Register>) 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: 
acute dietary exposure analysis was performed assuming tolerance level 
residues and 100% crop treated for all commodities for which 
halosulfuron-methyl is registered as well as for crops in the cucumber/
squash subgroup (9B), which are being evaluated in this action. 
Further, standard processing factors were used for all processed 
commodities. The results of the DEEM analysis indicate that exposure 
for all applicable subgroups is less than 1% of the aPAD at the 
95<SUP>th</SUP> percentile.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEM<Register> 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

[[Page 58429]]

the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: chronic dietary analysis was 
performed assuming tolerance level residues and 100% crop treated for 
all commodities for which halosulfuron-methyl is registered as well as 
for crops in the cucumber/squash subgroup (9B), which are being 
evaluated in this action. The results of the DEEM analysis indicate 
that exposure for all applicable subgroups is less than 1% of the cPAD.
    The chronic dietary endpoint for halosulfuron-methyl is based on 
decreased body weight gains, changes in hematological and blood 
chemistry parameters. Since the 10X FQPA factor was removed, the 
chronic RfD of 0.1 mg/kg/day is equal to the cPAD.
    iii. Cancer. Halosulfuron-methyl is classified as a ``not likely'' 
human carcinogen based on a lack of evidence of carcinogenicity in male 
and female mice and rats. A cancer risk assessment is not required.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for halosulfuron-methyl 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 halosulfuron-methyl.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/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 coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever 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) from these models to quantify 
drinking water exposure and risk as a %RfD or %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 halosulfuron-methyl they are 
further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of halosulfuron-methyl in surface 
water and ground water for acute exposures are estimated to be 4.73 
parts per billion (ppb) for surface water and 0.097 ppb for ground 
water. The EECs for chronic exposures are estimated to be 1.4 ppb for 
surface water and 0.097 ppb for ground water.
    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).
    Halosulfuron-methyl is currently registered for use on the 
following residential non-dietary site: residential lawns. The risk 
assessment was conducted using the following residential exposure 
assumptions: Adults may be dermally exposed after treatments to lawns, 
and children may be exposed through dermal, hand-to-mouth and 
incidental oral sources.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether halosulfuron-methyl has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
halosulfuron-methyl 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 halosulfuron-methyl has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances 
November 26, 1997 (62 FR 62961).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children-- In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The available data provided 
no indication of increased susceptibility of rats or rabbits to in 
utero and/or postnatal exposure to halosulfuron-methyl.
    3. Conclusion. A postnatal developmental neurotoxicity study in 
rats is required for confirmatory purposes because of evidence of fetal 
nervous system alterations in rats at 750 mg/kg/day. This requirement 
is a condition of registration.
    Notwithstanding the above study requirement, there is an otherwise 
complete toxicity data base for halosulfuron-methyl and exposure data 
are complete or are estimated based on data that reasonably accounts 
for potential exposures. EPA determined that the 10X FQPA Safety Factor 
to protect infants and children should be removed because:
    i. There was no indication of increased susceptibility of rats or 
rabbits to in utero and/or postnatal exposure to halosulfuron-methyl. 
In the prenatal developmental toxicity studies in rats

[[Page 58430]]

and rabbits and the two-generation reproduction study in rats, effects 
in the offspring were observed only at or above treatment levels which 
resulted in evidence of parental toxicity.
    ii. The committee determined that the requirement of a 
developmental neurotoxicity study in rats did not warrant an 
application of additional safety factors because:
    a. The alterations observed in the fetal nervous system occurred in 
only one species (in rats and not in rabbits)
    b. The fetal effects which will be investigated in the required 
developmental neurotoxicity study were seen only at a dose of 750 mg/
kg/day which is close to the limit-dose (LTD) (1,000 mg/kg/day).
    c. There was no evidence of clinical signs of neurotoxicity, brain 
weight changes, or neuropathology in the subchronic or chronic studies 
in rats.
    d. The developmental neurotoxicity study is required only as 
confirmatory data to understand what the effect is at a high exposure 
(dose) level.
    e. Exposure assessments do not indicate a concern for potential 
risk to infants and children based on the results of the field trial 
studies and the very low application rate ( 0.06 lbs. active ingredient 
(a.i) per acre). Detectable residues are not expected in foods.

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 the USEPA Office of Water 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
halosulfuron-methyl will occupy < 1.0 percent of the aPAD for the U.S. 
population, < 1.0 percent of the aPAD for females 13 years and older, < 
1.0 percent of the aPAD for infant subpopulation and < 1.0 percent of 
the aPAD for children population. In addition, there is potential for 
acute dietary exposure to halosulfuron-methyl 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 following Table 3:

                  Table 3.--Aggregate Risk Assessment for Acute Exposure to halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
                                                                          Surface       Ground
             Population Subgroup               aPAD (mg/      %aPAD      water EEC    water EEC     Acute DWLOC
                                                  kg)         (Food)       (ppb)        (ppb)          (ppb)
----------------------------------------------------------------------------------------------------------------
(All Infants)                                        0.50         <1.0         4.73        0.097           5,000
 Female (13-50 years)                                0.50         <1.0         4.73        0.097          15,000
Children (1-6 years)                                 0.50         <1.0         4.73        0.097           5,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
halosulfuron-methyl from food will utilize <1.0% of the cPAD for the 
U.S. population, for infant subpopulations at greatest exposure and for 
children subpopulation at greatest exposure]. Based the use pattern, 
chronic residential exposure to halosulfuron-methyl is not expected. In 
addition, there is potential for chronic dietary exposure to 
halosulfuron-methyl in drinking water. After calculating the DWLOCs and 
comparing them to the EECs for surface 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 halosulfuron-methyl
----------------------------------------------------------------------------------------------------------------
                                                                          Surface       Ground
             Population subgroup              cPAD mg/kg/     %cPAD      water EEC    water EEC    Chronic DWLOC
                                                  day         (Food)       (ppb)        (ppb)          (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                      0.10         <1.0          1.4        0.097           3,500

[[Page 58431]]

 
(All Infants                                         0.10         <1.0          1.4        0.097             990
Children (1-6 years)                                 0.10         <1.0          1.4        0.097           1,000
Females (13-50 years)                                0.10         <1.0          1.4        0.097           2,300
Males (13-19 years)                                  0.10         <1.0          1.4        0.097           3,500
----------------------------------------------------------------------------------------------------------------

    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). Halosulfuron-methyl is 
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 halosulfuron-methyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 310 and 2,200 for all infants 
and females (13 to 50 years), respectively. Note that there is no oral 
residential exposure for adults. These aggregate MOEs do not exceed the 
Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, short-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of halosulfuron-methyl in 
ground and surface water. After calculating DWLOCs and comparing them 
to the EECs for surface and ground water, EPA does not expect short-
term aggregate exposure to exceed the Agency's level of concern, as 
shown in the following Table 5:

                                   Table 5.--Aggregate Risk Assessment for Short-Term Exposure to halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Aggregate MOE (Food +    Aggregate level of      Surface water EEC       Ground water EEC       Short-term DWLOC
        Population subgroup               Residential)            concern (LOC)              (ppb)                  (ppb)                  (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(All Infants)                        310                     100                     1.4                    0.097                  4,900
Females (13-50 years)                2,200                   100                     1.4                    0.097                  10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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). Halosulfuron-
methyl is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for halosulfuron-methyl.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food and 
residential exposures aggregated result in aggregate MOEs of 1,000, 
1,700, and 2,000 for all infants, females (13 to 50 years) and males 
(13 to 19), respectively. It should be noted that there is no oral 
residential exposure for adults. These aggregate MOEs do not exceed the 
Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, intermediate-term DWLOCs were calculated 
and compared to the EECs for chronic exposure of halosulfuron-methyl in 
ground and surface water. After calculating DWLOCs and comparing them 
to the EECs for surface and ground water, EPA does not expect 
intermediate-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 6:

                                Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to halosulfuron-methyl
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Aggregate MOE (Food +     Aggregate level of     Surface water EEC      Ground water EEC       Intermediate-term
        Population subgroup            Residential)(oral)         concern (LOC)              (ppb)                  (ppb)               DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(All Infants)                       1,000                     100                    1.4                    0.097                 920
Females (13-50 years                1,700                     100                    1.4                    0.097                 2,800
Males (13-19 years)                 2,000                     100                    1.4                    0.097                 3,300
--------------------------------------------------------------------------------------------------------------------------------------------------------

    5. Aggregate cancer risk for U.S. population. Halosulfuron-methyl 
is classified as a ``not likely'' human carcinogen based on a lack of 
evidence of carcinogenicity in male and female mice and rats.

[[Page 58432]]

    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 halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The analytical method for cucumber and squash is based on 
``Analytical Method for the Determination of MON 12000 and 3-
Chlorosulfonamide Acid Producing residues in Field Corn'', Monsanto 
Doc. No. RES-026-92. This method has been submitted to FDA for 
publication in the Pesticide Analytical Manual (PAM) II. The analytical 
method involves sample extraction, acid hydrolysis under reflux to 
convert halosulfuron-methyl to 3-chlorosulfonamide acid (CSA), and 
derivatization to convert the CSA to chlorosufonamide ester (CSE). 
Detection is by GC/ECD (gas chromatography using electron capture 
detection). Quantitation is expressed in terms of halosulfuron-methyl 
equivalents. Chromatograms, calibration curves and calculations were 
included in this submission. The Agency concludes that the GC/ECD 
method is adequate for enforcement of tolerances and data collection on 
residues of halosulfuron-methyl in or on squash/cucumber subgroup. 
Information regarding availability of the method may be requested from: 
Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
<a href="/cdn-cgi/l/email-protection#e08695928c8f97ce83818c96898ea0859081ce878f96"><span class="__cf_email__" data-cfemail="076172756b68702964666b716e694762776629606871">[email protected]</span></a>.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRL) for halosulfuron-methyl in or on squash/cucumber subgroup. 
Therefore, international harmonization is not an issue for this 
tolerance.

C. Conditions

    The Agency requires a satisfactory postnatal developmental 
neurotoxicity study in rats for confirmatory purposes because of 
evidence of fetal nervous system alterations in rats at 750 mg/kg/day. 
The study requirement is a condition of this registration.

V. Conclusion

    Therefore, the tolerance is established for residues of 
halosulfuron-methyl, methyl 5-(4,6-dimethoxy-2-pyrimidinyl)amino 
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, and 
its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-
carboxylic acid, in or on the squash/cucumber subgroup at 0.5 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301058 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 November 
28, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(I) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at <a href="/cdn-cgi/l/email-protection#f783989a879c9e9984d99d9e9ab7928796d9909881"><span class="__cf_email__" data-cfemail="94e0fbf9e4fffdfae7bafefdf9d4f1e4f5baf3fbe2">[email protected]</span></a>, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301058, 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: <a href="/cdn-cgi/l/email-protection#a2cdd2d28fc6cdc1c9c7d6e2c7d2c38cc5cdd4"><span class="__cf_email__" data-cfemail="38574848155c575b535d4c785d4859165f574e">[email protected]</span></a>. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption.

[[Page 58433]]

Copies of electronic objections and hearing requests will also be 
accepted on disks in WordPerfect 6.1/8.0 file format 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 October 4, 1993 (58 FR 51735). 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 prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments May 19, 1998 (63 FR 27655); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations February 16, 1994 (59 FR 7629); or require OMB review or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks April 23, 
1997 (62 FR 19885). 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 August 10, 1999 (64 FR 
43255). 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).

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: September 21, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.479 is amended by alphabetically adding an entry to 
the table in paragraph (a)(2) for ``squash/cucumber subgroup'' to read 
as follows:


Sec. 180.479  Halosulfuron-methyl, tolerances for residues.

* * * * *
    (a)* * * 

 
----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                   *        *        *        *      *
 Squash/cucumber subgroup                                                                                    0.5
                                   *        *        *        *      *
----------------------------------------------------------------------------------------------------------------


[[Page 58434]]

* * * * *
[FR Doc. 00-25048 Filed 9-28-00; 8:45 am]
BILLING CODE 6560--50--S


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