[Federal Register Volume 67, Number 235 (Friday, December 6, 2002)]
[Rules and Regulations]
[Pages 72585-72593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30839]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0237; FRL-7274-8]


Cyromazine; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This regulation establishes a tolerance for residues of 
cyromazine in or on bean, dry at 3.0 parts per million (ppm). The 
Interregional Research Project Number 4 (IR-4), requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act (FQPA) of 1996.

DATES:  This regulation is effective December 6, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0237, 
must be received on or before February 4, 2003.

ADDRESSES:  Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected]@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 72586]]

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:
    [sbull] Industry (NAICS 111, 112, 311, 32532), e.g., Crop 
production, Animal production, Food manufacturing, and 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 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0237. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., 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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of July 17, 2002 (67 FR 4697) (FRL-7185-6), 
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 0E6219) by IR-4. The notice included a summary 
of the petition prepared by Novartis Crop Protection Inc., Greensboro, 
NC 27419, the registrant. There were no comments received in response 
to the notice of filing.
    The petition requested that 40 CFR 180.414 be amended by 
establishing a tolerance for residues of the insecticide cyromazine, 
(N-cyclopropyl-1,3,5-triazine-2,4,6-triamine), in or on dry bean 
(except cowpea) at 3.0 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) of the 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 the 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 the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the 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 the FFDCA, for a tolerance for residues of cyromazine on 
dry bean at 0.3 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 their 
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 cyromazine 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.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
         Guideline No.              Study Type            Results
------------------------------------------------------------------------
870.3100                        90-Day oral        NOAEL = 3.0
                                 toxicity           (milligram/kilogram/
                                 rodents--rat       day (mg/kg/day)
                                                   LOAEL = 30 mg/kg/day
                                                    based on alteration
                                                    in the liver weight
                                                    changes in males
-------------------------------

[[Page 72587]]

 
870.3150                        90-Day oral        NOAEL = 7.5 mg/kg/day
                                 toxicity--dog     LOAEL = 25 mg/kg/day
                                                    based on alteration
                                                    in liver weight in
                                                    males
-------------------------------
870.3200                        21-Day dermal      NOAEL = > 2,010 mg/kg/
                                 toxicity           day
                                                   LOAEL = > 2,010 mg/kg/
                                                    day. No dermal
                                                    irritation was
                                                    noted. No treatment
                                                    related systemic
                                                    toxicity was noted.
-------------------------------
870.3700                        Developmental      Maternal NOAEL = 100
                                 toxicity in        mg/kg/day
                                 rodents--rat      LOAEL = 300 mg/kg/day
                                                    based on clinical
                                                    signs (red or clear
                                                    nasal discharge) and
                                                    decrease body
                                                    weights
                                                   Developmental NOAEL =
                                                    300 mg/kg/day
                                                   LOAEL = 600 mg/kg/day
                                                    highest dose tested
                                                    (HDT) based on
                                                    increased incidence
                                                    of minor skeletal
                                                    variations
-------------------------------
870.3700                        Developmental      Maternal NOAEL = 10
                                 toxicity in non-   mg/kg/day
                                 rodents--rabbit   LOAEL = 30 mg/kg/day
                                                    based on reduced
                                                    body weight
                                                   Developmental NOAEL =
                                                    > 60 mg/kg/day (HDT)
                                                   LOAEL was not
                                                    established
-------------------------------
870.3800                        2-Generation       Parental/Systemic
                                 reproduction--ra   NOAEL = 50 mg/kg/day
                                 t                 LOAEL = 150 mg/kg/day
                                                    based on based on
                                                    decreased body
                                                    weights that were
                                                    associated with
                                                    decreased food
                                                    efficiency
                                                   Reproductive NOAEL =
                                                    > 150 mg/kg/day
                                                   LOAEL = Not
                                                    determined. No
                                                    effects were noted
                                                    on reproductive
                                                    parameters at HDT
                                                   Offspring NOAEL = 50
                                                    mg/kg/day
                                                   LOAEL = 150 mg/kg/day
                                                    based on based on
                                                    decreased body
                                                    weights at birth and
                                                    through weaning
-------------------------------
870.4100                        Chronic oral       NOAEL = 7.5 mg/kg/day
                                 toxicity--dogs    LOAEL = 75.0 mg/kg/
                                                    day based on
                                                    alteration in the
                                                    hematological
                                                    parameters
                                                    (hemoglobin and
                                                    hermatocrit)
-------------------------------
870.4300                        Combined chronic/  NOAEL = 0.75 mg/kg/
                                 carcinogenicity-   day
                                 -rats             LOAEL = 7.5 mg/kg/day
                                                    based on based on
                                                    decreased body
                                                    weight
                                                   There is no evidence
                                                    of carcinogenicity.
-------------------------------
870.4200                        Carcinogenicity--  NOAEL = 7.5 mg/kg/day
                                 mice              LOAEL = 50.0 mg/kg/
                                                    day based on
                                                    decreased body
                                                    weight
                                                   There is no evidence
                                                    of carcinogenicity
-------------------------------
                                Mammalian          Negative for
                                 chromosomal        mutagenicity in
                                 aberration         Chinese hamster
                                                    study
-------------------------------
870.5100                        Mutagenic--point   Negative results for
                                 mutation           point mutations in
                                 Salmonella         TA1537, TA98, TA100,
                                 typhimurium        with and without
                                                    activation
-------------------------------
870.5450                        Mutagenic--domina  Negative mutagen
                                 nt lethal--mouse
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
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 (SF) 
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 SF.
    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

[[Page 72588]]

used by the Agency to quantify carcinogenic risk. The Q* approach 
assumes that any amount of exposure will lead to some degree of cancer 
risk. A Q* is calculated and used to estimate risk which represents a 
probability of occurrence of additional cancer cases (e.g., risk is 
expressed as 1 x 10-\6\ or one in a million). Under certain 
specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for cyromazine used for human risk assessment is shown in 
Table 2 of this unit:

      Table 2.--Summary of Toxicological Dose and Endpoints for Cyromazine 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                         Not Applicable (NA)      NA                       An appropriate end point
General population including infants                                                     attributable to a
 and children.                                                                           single dose (exposure)
                                                                                         was not observed in
                                                                                         oral toxicity studies.
-------------------------------------
Chronic dietary                       NOAEL = 7.5 mg/kg/day    FQPA SF = 1x             6-Month Feeding--dog
All populations.....................  UF = 100...............  cPAD = chronic RfD/FQPA  LOAEL = 75 mg/kg/day
                                      Chronic RfD = 0.075 mg/   SF = 0.075 mg/kg/day.    based on alterations in
                                       kg/day.                                           hematological
                                                                                         parameters [hematocrit,
                                                                                         and hemoglobin
                                                                                         (males)], body weight
                                                                                         and body weight gain
                                                                                         decreases and increase
                                                                                         in several organ
                                                                                         weights
-------------------------------------
Incidental oral                       NOAEL = 10               LOC for MOE = 100        Developmental toxicity--
Short-term (1 to 30 days)...........                           (Residential)..........   rabbit study.
(Residential).......................                                                    LOAEL = 30 mg/kg/day
                                                                                         based on decreases in
                                                                                         body weight gain and
                                                                                         food consumption.
-------------------------------------
Incidental Oral                       NOAEL = 7.5 mg/kg/day    LOC for MOE = 100        6-Month feeding--dog
Intermediate-term (1 to 6 months)...                           (Residential)..........  LOAEL = 75 mg/kg/day
(Residential).......................                                                     based on alterations in
                                                                                         hematological
                                                                                         parameters [hematocrit,
                                                                                         and body weight gain
                                                                                         decreases and increase
                                                                                         in several organ
                                                                                         weights].
-------------------------------------
Dermal (any time period)              NA                       NA                       Dermal risk assessments
(Residential).......................                                                     were not performed
                                                                                         since no hazard was
                                                                                         identified via dermal
                                                                                         exposure; there are no
                                                                                         concerns for pre-/post-
                                                                                         natal toxicity and
                                                                                         dermal exposure is not
                                                                                         expected since there
                                                                                         are no registered
                                                                                         residential uses.
-------------------------------------
Short-term inhalation (1 to 30 days)  Oral NOAEL= 10 mg/kg/    LOC for MOE = 100        Developmental toxicity--
(Residential).......................   day                     (Residential)..........   rabbit study
                                      (inhalation absorption                            LOAEL = 30 mg/kg/day
                                       rate = 100%).                                     based on decreases in
                                                                                         body weight gain and
                                                                                         food consumption
-------------------------------------
Intermediate-term inhalation (1 to 6  Oral study NOAEL = 7.5   LOC for MOE = 100        6-Month feeding--dog
 months)                               mg/kg/day               (Residential)..........   study
(Residential).......................  (inhalation absorption                            LOAEL = 75.0 mg/kg/day
                                       rate = 100%).                                     based on alterations in
                                                                                         hematological
                                                                                         parameters [hematocrit,
                                                                                         and hemoglobin
                                                                                         (males)], body weight
                                                                                         and body weight gain
                                                                                         decreases and increase
                                                                                         in several organ
                                                                                         weights.
-------------------------------------
Long-term inhalation (>6 months)      Oral study NOAEL= 7.5    LOC for MOE = 100        6-Month feeding--dog
(Residential).......................   mg/kg/day               (Residential)..........   study
                                      (inhalation absorption                            LOAEL = 75.0 mg/kg/day
                                       rate = 100%).                                     based on alterations in
                                                                                         hematological
                                                                                         parameters [hematocrit,
                                                                                         and hemoglobin
                                                                                         (males)], body weight
                                                                                         and body weight gain
                                                                                         decreases and increase
                                                                                         in several organ
                                                                                         weights.
-------------------------------------
Cancer                                NA                       NA                       Based on weight-of-the-
                                                                                         evidence, classified in
                                                                                         Category E ``no
                                                                                         evidence of
                                                                                         carcinogenicity in
                                                                                         humans''
----------------------------------------------------------------------------------------------------------------
* The reference to the Food Quality Protection Act Safety Factor (FQPA SF) refers to any additional SF 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 180.414) for the residues of cyromazine, in or on a 
variety of raw agricultural commodities. There are currently tolerances 
for cyromazine use on a number of food crops including cucurbits, leafy 
vegatables, onions, lima beans, pepper, potato, and tomato. Tolerances 
exist as well for livestock commodities. Cyromazine is generally used 
on terrestrial crops as a foliar spray throughout the growing season, 
although for onions it is used as a seed treatment and for poultry it 
is used as a feed-through to control flies breeding

[[Page 72589]]

in poultry waste. There are no existing or pending residential uses of 
cyromazine. Risk assessments were conducted by EPA to assess dietary 
exposures from cyromazine 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. An endpoint was not identified for acute dietary 
exposure and risk assessment because no effects were observed in oral 
toxicity studies including developmental toxicity studies in rats or 
rabbits that could be attributable to a single dose (exposure). 
Therefore, an acute dietary exposure assessment was not performed.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the United States Department of Agriculture (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 chronic exposure assessments: Chronic 
dietary exposure estimates are based on tolerance level residues for 
plant and poultry commodities and on anticipated residue estimates for 
ruminant commodities. Dietary exposure estimates are also factored by 
the estimated (weighted average) usage of cyromazine, or ``percent crop 
treated'' (PCT) data.
    iii. Cancer. Cyromazine is classified into Group E (non-carcinogen) 
based on carcinogenicity studies in rats and mice following long-term 
dietary administration. A quantified carinogenic risk estimate is not 
appropriate for cyromazine.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the 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 the 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 the 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 
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 the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows.
    Cantaloupe 0.3%; cucurbits 0.1%; lettuce 2.6%; leafy vegetables, 
other 9.4%; celery 14.2%; spinach 6.0%; onions 2.4%; pepper 5.3%; 
peppers, bell 9.0%; tomatoes 5.8%; tomatoes, fresh 22.2%; and 
watermelon 1.5%.
    The Agency believes that the three conditions listed in this unit 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which cyromazine 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 cyromazine 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 cyromazine.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow groundwater. For a screening-level assessment 
for surface water EPA will use FIRST (a tier 1 model) before using 
PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for 
pesticides. While both FIRST and PRZM/EXAMS incorporate an index 
reservoir environment, 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 
highly unlikely that drinking water concentrations would exceed human 
health levels of concern.

[[Page 72590]]

    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 cyromazine they are further 
discussed in the aggregate risk sections in Unit E.
    Based on the FIRST and SCI-GROW models the EECs of cyromazine for 
chronic exposures are estimated to be 16 parts per billion (ppb) for 
surface water and 5.0 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).
    Cyromazine is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Cyromazine is a member of the triazine class of chemicals. EPA 
evaluated available scientific evidence to determine whether a common 
mechanism of toxicity exists among certain triazine-containing 
pesticides. Based on the available weight-of-evidence, cyromazine can 
not be grouped with other triazines based on a common mechanism of 
toxicity. EPA determined that only atrazine, simazine, propazine, and 
their specified degradants could be grouped based a common mechanism of 
toxicity for disruption of the hypothalamic-pituitary-gonadal (HPG) 
axis. For purposes of this tolerance action, EPA has concluded that 
cyromazine does not have a common mechanism of toxicity with other 
triazine-containing compounds. If additional data become available to 
support its inclusion in a common mechanism group, these data will be 
considered. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional ten-fold margin of safety for infants and children 
in the case of threshold effects to account for pre-natal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Pre-natal and post-natal sensitivity. The developmental and 
reproductive toxicity data from a pre-natal developmental study in 
rats, a pre-natal developmental study in rabbits, and a 2-generation 
reproductive toxicity study in rats, did not indicate increased 
susceptibility of young rats on rabbits to un urero and/or post-natal 
exposure.
    3. Conclusion. There is a complete toxicity data base for 
cyromazine and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10x safety factor to protect infants and children should be 
reduced to 1x. The FQPA factor was reduced based on reliable data 
supporting the following weight-of-evidence considerations:
    i. There are no data deficiencies and hence there are no residual 
uncertainties for pre- and/or post-natal exposure, and no additional 
traditional SFs are needed with regard to the completeness of the 
cyromazine toxicity data base;
    ii. There is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with cyromazine;
    iii. There is no evidence of increased susceptibility of young rats 
in the reproduction study with cyromazine; and
    iv. There are also no residual uncertainties identified in the 
exposure data bases.

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. 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: 2 liter (L)/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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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, OPP 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. There were no toxicological effects attributable to 
a single exposure (dose) observed in the oral toxicity studies. A dose 
and an endpoint for an acute RfD was not selected. Therefore, acute 
risk from exposure to cyromazine is not expected.

[[Page 72591]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
cyromazine from food will utilize 2.0% of the cPAD for both males and 
females of the U.S. population, and 4.0% of the cPAD for children 1-6 
years old, subpopulation at greatest exposure. There are no residential 
uses for cyromazine that result in chronic residential exposure to 
cyromazine. Based the use pattern, chronic residential exposure to 
residues of cyromazine is not expected. In addition, there is potential 
for chronic dietary exposure to cyromazine 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 cPAD, as shown in Table 3 of this unit:

                                   Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Cyromazine
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           %cPAD (Food)               (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Males                                0.075                   2.0                     16                     5                      2,550
 
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
 
 
--------------------------------------------------------------------------------------------------------------------------------------------------------


    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).
    Cyromazine 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. Aggregate cancer risk for U.S. population. Cyromazine has been 
classified as a chemical showing ``no evidence of carcinogenicity in 
humans.'' The Agency concludes that pesticidal uses of cyromazine are 
not likely to pose a carcinogenic risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to cyromazine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Analytical methods, AG-408 and AG-417, as listed in the Food and 
Drug Administration's Pesticide Analytical Manual (PAM) II, are 
adequate for tolerance enforce purposes.

B. International Residue Limits

    There are currently no codex, Canadian or Mexican limits for 
residues of cyromazine on dry bean.

V. Conclusion

    Therefore, the tolerance is established for residues of cyromazine, 
(N-cyclopropyl-1,3,5-triazine-2,4,6-triamine), in or on dry bean 
(except cowpea) at 3.0 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the 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 the FFDCA, as was provided in the old sections 408 and 409 of the 
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-2002-0237 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 February 
4, 2003.
    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 Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office

[[Page 72592]]

of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2002-0237, 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 Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under section 408(d) of the 
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 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 the 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 the 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. 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

[[Page 72593]]

and pests, Reporting and recordkeeping requirements.


    Dated: November 15, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.414 is amended by alphabetically adding a commodity 
to the table in paragraph (a)(1) to read as follows:


Sec.  180.414  Cyromazine, tolerances for residues.

    (a) * * *
    (1) * * *


------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry, except cowpea...................................          3.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-30839 Filed 12-5-02; 8:45 am]
BILLING CODE 6560-50-S