[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