[Federal Register: December 6, 2002 (Volume 67, Number 235)]
[Rules and Regulations]
[Page 72585-72593]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de02-13]
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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.
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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: jackson.sidney@epa.gov@epa.govjackson.sidney@epa.gov@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
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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