[Federal Register Volume 66, Number 50 (Wednesday, March 14, 2001)]
[Rules and Regulations]
[Pages 14837-14846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6328]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301106; FRL-6766-9]
RIN 2070-AB78
Pymetrozine; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of pymetrozine in or on pecans. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on pecans. This regulation establishes a maximum
permissible level for residues of pymetrozine in this food commodity.
[[Page 14838]]
The tolerance will expire and is revoked on December 31, 2002.
DATES: This regulation is effective March 14, 2001. Objections and
requests for hearings, identified by docket control number OPP-301106,
must be received by EPA on or before May 14, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301106 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; and e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently
under development.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301106. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with section 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for residues of the
insecticide pymetrozine, 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-
4-[(3-pyridinylmethylene)amino], in or on pecans at 0.020 part per
million (ppm). This tolerance will expire and is revoked on December
31, 2002. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Pymetrozine on Pecans and FFDCA
Tolerances
The Applicant, the Georgia Department of Agriculture, states that
aphids have developed resistance to all labeled products (all
chlorinated hydrocarbons, organophosphates, carbamates, or synthetic
pyrethroids), except for imidacloprid and aldicarb,
[[Page 14839]]
which still provide some suppression of the yellow aphid complex
(comprised of the yellow pecan and the blackmargined aphid). Resistance
to the organophosphates has also developed in the black pecan aphid,
which until recently, had been controlled with this class of chemicals.
Unfortunately, the two materials which still retain some effectiveness
(imidacloprid and aldicarb) must be used at high rates, performance is
often inconsistent, and frequently they fail to provide adequate
control. Furthermore, the Applicant states that many growers cannot use
aldicarb at all due to its high toxicity.
Growers employ cultural control practices, such as the use of
legume ground cover crops to provide alternate hosts for aphids within
the orchards. This management of ground cover on orchard floors has
been very effective in maintaining lady beetle populations, which have
greatly enhanced natural aphid suppression, especially early in the
season. However, this practice alone does not provide adequate control,
particularly late in the season.
Pecan aphids reproduce parthenogenetically, with up to 32
generations per year, and develop populations which are resistant to
chemicals very rapidly. The Applicant states that resistance to a
chemical or a chemical class can develop after only three or four
applications, as has been seen with the synthetic pyrethroids. High,
uncontrolled populations of the yellow aphid complex, especially late
in the season, cause damage by removing large amounts of carbohydrates
from the trees, reducing the current crop, as well as the bloom the
following year. This may reduce yields by 50-75% over a 5-year period.
The black pecan aphid causes more serious and immediate damage, by
injecting a toxin during feeding which causes leaflet abortion. Heavy
infestations can defoliate entire orchards in 7-10 days, with
devastating effects lasting at least 2 years.
The Applicant states that pymetrozine is necessary to control
aphids and avoid significant economic losses in pecan production. The
available materials do not provide adequate control, and pymetrozine
has the added benefit of providing another mode of action to help
forestall complete resistance development. The Applicant also states
that without newer efficacious materials, the black pecan aphid will
ultimately threaten the long-term economic viability of commercial
pecan production.
EPA has authorized under FIFRA section 18 the use of pymetrozine on
pecans for control of yellow pecan aphids, Blackmargined aphids and
black pecan aphids in Georgia. After having reviewed the submission,
EPA concurs that emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of pymetrozine in or on
pecans. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2002, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on pecans after that date
will not be unlawful, provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this tolerance at the time of that application.
EPA will take action to revoke this tolerance earlier if any experience
with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether pymetrozine
meets EPA's registration requirements for use on pecans or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of pymetrozine by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Georgia to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
pymetrozine, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
pymetrozine and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of pymetrozine in or on pecans at 0.020 ppm. EPA's assessment
of the dietary exposures and risks associated with establishing the
tolerance follows.
A. 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 endpoint. 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 intraspecies differences. To estimate the acute dietary risk from
the exposure of pymetrozine for infants, children and the general
population, an UF of 300 is appropriate due to the use of a LOAEL to
estimate the toxicological endpoint.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factor is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100.
[[Page 14840]]
To estimate risk, a ratio of the NOAEL to exposures (margin of
exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary
method currently used by the Agency to quantify carcinogenic risk. The
Q* approach assumes that any amount of exposure will lead to
some degree of cancer risk. A Q* is calculated and used to
estimate risk which represents a probability of occurrence of
additional cancer cases (e.g., risk is expressed as 1 x
10-\6\ or one in a million). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated. A summary of the toxicological endpoints for pymetrozine
used for human risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Pymetrozine for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF*1 and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Asessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 10 mg/kg UF = FQPA SF = 3 Rabbit developmental
Females 13-50 years of age........... 100 aPAD = 0.033 mg/kg..... study
Acute RfD = 0.10 mg/kg. LOAEL = 75 mg/kg based
on increased incidence
of skeletal anomalies
----------------------------------------------------------------------------------------------------------------
Acute dietary LOAEL = 125 mg/kg FQPA SF = 3 Acute neurotoxicity
Infants, children.................... UF = 300............... aPAD = 0.14 mg/kg...... study
Acute RfD = 0.42 mg/kg. LOAEL =125 mg/kg based
on decreased body
temperature, decreased
motor activity and
fuctional
observational battery
(FOB) parameters
associated with
decreased activity
----------------------------------------------------------------------------------------------------------------
Acute dietary LOAEL = 125 mg/kg FQPA SF = 1 Acute neurotoxicity
General population................... UF = 300............... aPAD = 0.42 mg/kg...... study
Acute RfD = 0.42 mg/kg. LOAEL = 125 mg/kg based
on decreased body
temperature, decreased
motor activity and
fuctional
observational battery
(FOB) parameters
associated with
decreased activity
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL = 0.377 mg/kg/day FQPA SF = 3 Rat chronic feeding
Females 13-50 years of age, infants, UF = 100............... cPAD = 0.0013 mg/kg/day study
and children. Chronic RfD = 0.0038 mg/ LOAEL = 3.76 mg/kg/day
kg/day. based on liver
hypertrophy and
pathology supported by
the rat chronic
feeding and
multigeneration
reproduction studies
and dog subchronic and
chronic studies
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL = 0.377 mg/kg/day FQPA SF = 1 Rat chronic feeding
General population................... UF = 100............... cPAD = 0.0038 mg/kg/day study
Chronic RfD = 0.0038 mg/ LOAEL = 3.76 mg/kg/day
kg/day. based on liver
hypertrophy and
pathology supported by
the rat chronic
feeding and
multigeneration
reproduction studies
and dog subchronic and
chronic studies
----------------------------------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days) None None Rat dermal toxicity -
no effects at the
highest dose tested
(HDT)
----------------------------------------------------------------------------------------------------------------
Intermediate-term dermal (1 week to None None Rat dermal toxicity -
several months) NOAEL at the HDT
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to None None None
life-time)
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) Oral study NOAEL = 10 LOC for MOE = 100 Rabbit developmental
(residential)........................ mg/kg/day (residential) study
Inhalation absorption LOAEL = 75 mg/kg based
rate = 100%. on reduced body weight
gain, food
consumption, and feed
efficiency. Also
increased skeletal
anomalies in pups
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1 week Oral study NOAEL = LOC for MOE = 100 Rat chronic feeding
to several months) (residential) 0.377 mg/kg/day (residential) study
Inhalation absorption LOAEL = 3.76 mg/kg/day
rate = 100%. based on liver
hypertrophy and
pathology supported by
the rat chronic
feeding and
multigeneration
reproduction studies
and dog subchronic and
chronic studies
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (several months None None None
to life-time)
----------------------------------------------------------------------------------------------------------------
[[Page 14841]]
Cancer (oral, dermal, inhalation) Q1* = 0.0119 (mg/kg/ LOC = 1 x 10-6 ``Likely human
day)-1 carcinogen'' based on
combined (benign
hepatoma and/or
carcinomas) liver
tumors
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.556) for the residues of pymetrozine, in or on
tuberous and corm vegetables (crop group 1), cucurbit vegetables (crop
group 8) and fruiting vegetables (crop group 9). Risk assessments were
conducted by EPA to assess dietary exposures from pymetrozine in food
as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: it was assumed that 100% of the all
crops were treated resulting in tolerance level residues on all crops.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEMTM analysis evaluated the individual
food consumption as reported by respondents in the USDA 1989-1992 -
nationwide CSFII and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: it was assumed that 100% of the all crops were treated
resulting in tolerance level residues on all crops.
iii. Cancer. In conducting this cancer dietary risk assessment the
DEEMTM analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide CSFII and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the cancer exposure assessments: use of
average field trial residue values and percent crop treated (PCT) data
were used for truberous and corm vegetables, cucurbit vegetables, and
fruiting vegetables.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide chemicals that have been measured in food. If EPA relies on
such information, EPA must require that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. As
required by section 408(b)(2)(E), EPA will issue a Data Call-In for
information relating to anticipated residues to be submitted no later
than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used PCT information as follows: Tuberous and corm
vegetables, 20%; cucurbit vegetables, 16% except cucumbers (10%);
squash (8%); melons (25%); pumpkins (10%); zucchini (10%); and fruiting
vegetables, 11% except, tomatoes (12%); peppers (8%); eggplant (6%). It
was assumed that 100% of the pecan crop was treated.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an 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 pymetrozine
may be applied in a particular area.
a. Dietary exposure from drinking water. The Agency lacks
sufficient
[[Page 14842]]
monitoring exposure data to complete a comprehensive dietary exposure
analysis and risk assessment for pymetrozine 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
pymetrozine.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS
(a tier 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOC) 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 pymetrozine, they are further
discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models, the EECs of pymetrozine
for acute exposures are estimated to be 4.0 parts per billion (ppb) for
surface water and 0.02 ppb for ground water. The EECs for chronic
exposures are estimated to be 2.3 ppb for surface water and 0.02 ppb
for ground water.
b. 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). Currently,
pymetrozine is not registered for use on any sites that would result in
residential exposure.
c. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether pymetrozine has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
pymetrozine does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that pymetrozine has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
C. Safety Factor for Infants and Children
1. Safety factor for infants and children--i. In general. FFDCA
section 408 provides that EPA shall apply an additional tenfold margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
data base on toxicity and exposure unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii. Developmental toxicity studies. In the rat, developmental
toxicity was observed only at maternally toxic dose levels: maternal
NOAEL: 30 mg/kg/day, LOAEL: 100 mg/kg/day (reduced body weight gains
and food consumption); developmental NOAEL: 100 mg/kg/day, LOAEL: 300
mg/kg/day (increased incidence of skeletal anomalies). In the rabbit,
developmental toxicity was also observed only at maternally toxic dose
levels: (maternal NOAEL: 10 mg/kg/day, LOAEL: 75 mg/kg/day reduced body
weight gains and reduced food consumption and efficiency);
developmental NOAEL: 10 mg/kg/day, LOAEL: 75 mg/kg/day (increased
incidence of skeletal anomalies).
iii. Reproductive toxicity study. In the rat reproduction study,
systemic/developmental toxicity was observed in the pups at parentally
toxic dose levels (parental systemic NOAEL: 1.4 mg/kg/day for males,
1.6 mg/kg/day for females, LOAEL: 13.9 mg/kg/day for males, 16.0 mg/kg/
day for females (liver effects in the F0 and F1 males); offspring
systemic/developmental NOAEL: 13.9 mg/kg/day for males, 16.0 mg/kg/day
for females, LOAEL: 136.9 mg/kg/day for males, 151.6 mg/kg/day for
females (decreased pup weight and delay in eye opening in both F1 and
F2 litters). There was no reproductive toxicity at dose levels up to
136.9 mg/kg/day for males and 151.6 mg/kg/day for females.
iv. Prenatal and postnatal sensitivity. Based on the results of the
developmental and reproduction studies, there is no indication of
increased sensitivity in rats or rabbits to in utero and/or postnatal
exposure to pymetrozine.
v. Neurotoxicity. Acute and subchronic neurotoxicity studies are
available for pymetrozine. The acute neurotoxicity study did not
establish a NOAEL for effects on body temperature, FOB parameters or
motor activity. In the subchronic neurotoxicity study, stereotypy in
males and tiptoe gate or walking on toes in females were observed. The
frequency and magnitude of these effects were low. Before any
regulatory decision based on the conclusion that pymetrozine exerts a
direct effect on the nervous system, a confirmatory study that more
definitively establishes that pymetrozine causes stereotypy in males
(head moving and excessive sniffing) and tiptoe gait in females is
needed. The Agency has requested a developmental neurotoxicity study in
rats be conducted.
[[Page 14843]]
vi. Conclusion. Although there was no indication of increased
susceptibility in the existing prenatal and postnatal studies, the 10x
FQPA safety factor has been reduced to 3x because there is a data gap
for a developmental neurotoxicity study. The FQPA safety factor for
pymetrozine is applicable to females aged 13-50 years, infants,
children aged 1-6 years, and children aged 7-12 years for all exposure
scenarios.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to pymetrozine 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
pymetrozine on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
pymetrozine will occupy 2% of the aPAD for the U.S. population, 5% of
the aPAD for females 13 years and older, 1% of the aPAD for all infants
and 3% of the aPAD for children 1-6 years old, the children
subpopulation at greatest exposure. In addition, despite the potential
for acute dietary exposure to pymetrozine in drinking water, after
calculating DWLOCs and comparing them to conservative model EECs of
pymetrozine in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 2:
Table 2.-- Aggregate Risk Assessment for Acute Exposure to Pymetrozine
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.42 2 4.0 0.02 15,000
----------------------------------------------------------------------------------------------------------------
Females aged 13-50 years 0.033 5 4.0 0.02 940
----------------------------------------------------------------------------------------------------------------
All infants 0.14 1 4.0 0.02 1,400
----------------------------------------------------------------------------------------------------------------
Children aged 1-6 years 0.14 3 4.0 0.02 1,400
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pymetrozine from food will utilize 12% of the cPAD for the U.S.
population, 29% of the cPAD for females 13 years and older, 23% of the
cPAD for all infants, and 74% of the cPAD for children 1-6 years, the
children subpopulation with greatest exposure. There are no residential
uses for pymetrozine that result in chronic residential exposure to
pymetrozine. In addition, despite the potential for chronic dietary
exposure to pymetrozine in drinking water, after calculating DWLOCs and
comparing them to conservative model EECs of pymetrozine in surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pymetrozine
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.0038 12 2.3 0.02 120
----------------------------------------------------------------------------------------------------------------
Females aged 13-50 0.0013 29 2.3 0.02 30
----------------------------------------------------------------------------------------------------------------
All infants 0.0013 23 2.3 0.02 10
----------------------------------------------------------------------------------------------------------------
Children aged 1-6 years 0.0013 74 2.3 0.02 3
----------------------------------------------------------------------------------------------------------------
[[Page 14844]]
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). Pymetrozine 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 were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Pymetrozine 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 were previously addressed.
5. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in this unit for cancer exposure, EPA has
concluded that exposure to pymetrozine from food will result in a
estimated risk of 1.2 x 10-7 for the U.S. population. There
are no residential uses for pymetrozine that result in residential
exposure to pymetrozine. In addition, despite the potential for dietary
exposure to pymetrozine in drinking water, after calculating a DWLOC
and comparing it to conservative model EECs of pymetrozine in surface
and ground water, EPA does not expect the aggregate exposure to exceed
1 x 10-6, as shown in the following Table 4:
Table 4.-Aggregate Cancer Risk Assessment for Pymetrozine
----------------------------------------------------------------------------------------------------------------
Estimated
Q1*(mg/kg/ Cancer Risk Surface Ground Cancer Risk
Population Subgroup day)-1 (Food + Non- Water EEC Water EEC DWLOC (ppb)
dietary) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U.S. population 0.0119 1.2 107 2.3 0.02 3
----------------------------------------------------------------------------------------------------------------
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to pymetrozine residues.
V. Other Considerations
A. Analytical Enforcement Methodology
The Agency has evaluated and accepted Method AG-643 (HPLC/UV) as a
tolerance enforcement method for a number of plant commodities,
including cucurbit vegetables, fruiting vegetables, and tuberous and
corm vegetables. This method has a limit of quantitation (LOQ) of 0.02
ppm. In data submitted to support a pending petition to establish
tolerances of pymetrozine in cotton commodities (PP 8F4984), the
registrant has indicated that this method produces acceptable recovery
of pymetrozine from refined cottonseed oil. Based on this, the Agency
will assume that Method AG-643 is adequate for enforcement of
tolerances for residues of pymetrozine in pecan nutmeat for purposes of
this section 18 only.
The method may be requested from: Calvin Furlow, PIRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number:
(703) 305-5229; e-mail address: [email protected].
B. International Residue Limits
There are no Codex maximum residue levels (MRLs) established for
pymetrozine. There are provisional MRLs in Germany for hops (10 ppm)
and potatoes (0.02 ppm), and the European Union is currently evaluating
a proposed tolerance of 5 ppm on hops. There are no international
residue limits that affect this section 18 exemption.
C. Conditions
Maximum application rate per application is 0.125 lbs active
ingredient per acre. A maximum of 0.25 lbs active ingredient per acre
may be applied per year. A minimum of 7 days between applications is
required. A 14-day pre-harvest interval (PHI) is required. For the
proposed section 18 use on pecans there are no rotational crop issues
since pecans are not rotated to another crop.
VI. Conclusion
Therefore, the tolerance is established for residues of
pymetrozine, 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-
pyridinylmethylene)amino], in or on pecans at 0.020 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301106 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 May 14,
2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You
[[Page 14845]]
may also deliver your request to the Office of the Hearing Clerk in Rm.
C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office
of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Office
of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301106, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under FFDCA
section 408. 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).
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 other
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 FIFRA section 18 exemption under FFDCA
section 408, such as the tolerance in this final rule, do not require
the issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
IX. 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
[[Page 14846]]
that before a rule may take effect, the agency promulgating the rule
must submit a rule report, which includes a copy of the rule, to each
House of the Congress and to the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 2, 2001.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.556 is amended by revising paragraph (b) to read as
follows:
Sec. 180.556 Pymetrozine; tolerance for residues.
* * * * *
(b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the insecticide pymetrozine, 1,2,4-triazin-
3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene)amino] in
connection with use of the pesticide under the section 18 exemption
granted by EPA. The time-limited tolerance will expire and is revoked
on the date specified in the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Pecan 0.020 December 31, 2002
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-6328 Filed 3-13-01; 8:45 am]
BILLING CODE 6560-50-S