Environmental Protection Agency (EPA).
This regulation establishes tolerances for residues of pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] in or on cotton seed, undelinted at 0.3 parts per million (ppm); cotton gin byproducts at 2.0 ppm; fruiting vegetables at 0.2 ppm; cucurbit vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 0.6 ppm; head and stem Brassica vegetables at 0.5 ppm; leafy Brassica and turnip greens at 0.25 ppm; hops (dried) at 6.0 ppm; and pecans at 0.02 ppm. Syngenta Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
This regulation is effective December 27, 2001. Objections and requests for hearings, identified by docket control number OPP-301180, must be received by EPA on or before February 25, 2002.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301180 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
By mail: Daniel Peacock, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5407; and e-mail address: email@example.com.End Further Info End Preamble Start Supplemental Information
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
|Categories||NAICS||Examples of Potentially Affected Entities|
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_180/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-301180. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of July 19, 2001 (66 FR 37677-37681 (FRL-6793-9), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Start Printed Page 66787346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by, Syngenta Crop Protection of Greensboro, North Carolina 27419. This notice included a summary of the petition prepared by Syngenta, the registrant. There were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.556 be amended by 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 cotton seed, undelinted at 0.4 ppm; cotton gin byproducts at 3.0 ppm; fruiting vegetables at 0.2 ppm; cucurbit vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 6.0 ppm; head and stem Brassica vegetables at 2.0 ppm; leafy Brassica greens at 5.0 ppm; hops (dried) at 5.0 ppm; and pecans at 0.02 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of pymetrozine in or on cotton seed, undelinted at 0.3 ppm; cotton gin byproducts at 2.0 ppm; fruiting vegetables at 0.2 ppm; cucurbit vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 0.6 ppm; head and stem Brassica vegetables at 0.5 ppm; leafy Brassica and turnip greens at 0.25 ppm; hops (dried) at 6.0 ppm; and pecans at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by pymetrozine are discussed in this unit and in a previous Federal Register notice.
1. Acute toxicity. In general, technical pymetrozine has low acute toxicity, being classified as Toxicity Category III for acute dermal and primary eye irritation studies and Toxicity Category IV for acute oral, acute inhalation and primary dermal studies. It is a slight sensitizer.
2. Subchronic and chronic toxicity. EPA's September 29, 1999, Federal Register notice (64 FR 52438-52450) (FRL-6385-6) summarized the results of the subchronic and chronic toxicity, metabolism, and dermal penetration studies in animals.
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-6 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 was discussed in a previous Federal Register notice of September 29, 1999 (64 FR 52438-52450) (FRL-6385-6).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Prior to this Rule, the Agency had established tolerances for pymetrozine in or on corm and tuberous vegetables (Crop Subgroup 1-C) at 0.02 ppm, cucurbit vegetables (Crop Group 8) at 0.05 ppm, and fruiting vegetables (Crop Group 9) at 0.05 ppm (40 CFR 180.556). This Rule establishes new tolerances for residues of pymetrozine in or on a variety of raw agricultural commodities: cotton seed, undelinted at 0.3 ppm; cotton gin byproducts at 2.0 ppm; fruiting vegetables at 0.2 ppm; Start Printed Page 66788cucurbit vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 0.6 ppm; head and stem Brassica vegetables at 0.5 ppm; leafy Brassica and turnip greens at 0.25 ppm; hops (dried) at 6.0 ppm; and pecans at 0.02 ppm. 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 (DEEM® 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. 100% of the crop were treated, and the residue levels were assumed to be at the tolerance level.
Using these conservative assumptions, the acute dietary (food only) exposure to pymetrozine from all existing and proposed uses (tuberous and corm, fruiting, and cucurbit vegetables; cotton seed (undelinted); cotton gin byproducts; hops, dried; leafy vegetables (except Brassica); head and stem Brassica vegetables; leafy Brassica greens; turnip greens; and pecans will be below EPA's level of concern (100% of the acute Population-Adjusted Dose (aPAD)) and will not occupy more than 5.9% of the aPAD for any population subgroup, including those of infants and children. For the maximum-exposed subgroup, the 95th percentile of exposure (Females 13-50 years old) is predicted to be 5.9% of the aPAD. Due to pymetrozine's lower acute endpoint for females 13-50 years old (0.033 mg/kg) versus that of other population subgroups (0.14 mg/kg for infants and children), the percentage of the aPAD occupied for females 13-50 years old (5.9%) is higher than that estimated for children 1-6 years old. For an exposure analysis based on the assumptions that 100% of the crop is treated and residues are at the tolerance level, EPA considers exposure at the 95th percentile of exposure to be a reasonable estimate of high end of exposure. Even at the 99th percentile of exposure, the acute risk is well below EPA's level of concern.
ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) 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 chronic exposure assessments. The chronic analysis was a Tier 3 analysis. See Table 1 below. It was necessary to use both projected percent of crop treated (%CT) estimates and anticipated residues in the chronic analysis because when %CT alone was used, one population subgroup exceeded the Agency's level of concern.
The Tier 3 DEEM® chronic analysis indicates that exposure to pymetrozine from tuberous and corm, fruiting, and cucurbit vegetables; cotton seed (undelinted); cotton gin byproducts; hops, dried; leafy vegetables (except Brassica); head and stem Brassica vegetables; leafy Brassica greens; turnip greens; and pecans will occupy less than 3.4% of the cPAD for children ages 1-6 (the most highly exposed population subgroup). Chronic dietary risk to all other subgroups is less than that of children ages 1-6.
|Subgroup||cPAD (mg/kg/day)||Exposure (mg/kg/day)||% cPAD|
|U.S. Population (total)||0.0038||0.000034||<1|
|All Infants (1 year old)||0.0013||0.000018||1.4|
|Children 1-6 years old||0.0013||0.000045||3.4|
|Children 7-12 years old||0.0013||0.000040||3.1|
|Males 20+ years old||0.0038||0.000034||<1|
iii. Cancer. The Agency's level of concern for cancer exposure is 1 x 10-6. The lifetime risk of developing cancer from pymetrozine exposure is determined for the U.S. population (total) only. The estimated exposure to pymetrozine is 0.000034 mg/kg/day. Applying the Q11* of 0.0119 (mg/kg/day)-1 to the exposure value results in a cancer risk estimate of 4.0 x 10-7. Therefore, the lifetime risk to the U.S. population of developing cancer from dietary exposure to pymetrozine is below EPA's level of concern.
iv. Anticipated Residue and Percent Crop Treated 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 Start Printed Page 66789derived 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 percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The registrant provided projected percent crop treated data for pymetrozine, and the Agency revised them, as shown in the following Table 2.
|Squash (winter and summer)||8|
The Agency believes that the three conditions listed above have been met. With respect to Condition 1, for new and existing uses, the Agency received estimates from Syngenta based upon its analysis of the marketing data that compared all of the potential major pesticides for cost, efficacy, and demand. EPA received these figures and performed its own independent analysis. The Agency examined the registrant's data and assumptions for all these factors. Based on the information that the registrant has provided, together with in-house data and information from outside contacts if necessary, the Agency agreed with the company's estimate of projected PCT for many crops. For some crops, the Agency revised the company's estimates upward.
For existing uses, 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 values for the percentage of the food treated, as shown in Table 2 of this preamble, are reasonable and are 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.
2. Dietary exposure from drinking water. The Agency lacks sufficient 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 FIRST (FQPA Index Reservoir Screening Tool) or PRZM/EXAMS (Pesticide Root Zone/Exposure Analysis Modeling System) program to predict pesticide concentrations in surface water; and SCI-GROW (Screening Concentration In GROund Water version 1.0) program to predict pesticide concentrations in groundwater.
The 'FIRST' program is a tier I screening model recently developed by EPA. It is used as a coarse screen for estimation of pesticide concentrations based on index agricultural watershed-drinking water reservoir or index reservoir (IR) scenario and percent cropped area (CPA). The FIRST model produces both a peak value (acute) and an annual average (chronic) pesticide concentration, or Estimated Environmental Concentrations (EECs). If the FIRST EECs are within 10% of a DWLOC, EFED will move to the next tier and perform a PRZM/EXAMS assessment.
The PRZM/EXAMS is a tier II model that provides an upper-bound estimate of a pesticide's concentration in a 1 hectare pond resulting from surface water runoff from a 10 hectare field, and is used to refine EECs generate by the lower tier FIRST model. As with FIRST, PRZM/EXAMS incorporates an index reservoir environment and includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. However, this tier II model also uses NOAA climatological (rainfall) data for a 36-year period that allows for more realistic runoff events. PRZM/EXAMS produces maximum and annual concentrations for each of the 36 years for which there is rainfall data.
The Agency modeled six different scenarios, using the maximum application rate allowed for each crop: cotton, cucurbits, tomatoes, cabbage, pecans; and hops. The surface water concentrations for these crops were estimated using the Pesticide Root Zone Model (PRZM version 3.12) (Carsel et al., 1998) coupled with the Exposure Analysis Modeling System ( EXAMS version 2.97.5) (Burns, 1997) adjusted with the appropriate (or default) percent cropped area (PCA) factor. The PCA factor reflects the maximum percentage of a basin planted in the agricultural crop being considered in the risk Start Printed Page 66790assessment. EPA adapted a PCA factor of 0.20 for cotton. However, PCA factors are not available for cucurbits, tomatoes, cabbage, pecans, or hops, and a default value of 0.87 was used. This may result in an overestimation of the surface water concentrations for these crops compared to the cotton crop. The pecan scenario gives the highest estimated surface water concentrations, mainly due to a high level of rainfall in the areas where pecans are grown (sometimes as high as three times the level of other crops considered in this assessment) especially during the summer season. The peak (acute) EEC is 5.23 ppb and the average annual (chronic) EEC is 1.58 ppb.
PRZM is used to simulate pesticide transport as a result of runoff and erosion from an agricultural field. EXAMS estimates environmental fate and transport of pesticides in a receiving water body. For human health risk assessment, simulations were done using the Index Reservoir scenario with the consideration of a PCA factor. Weather and agricultural practices are simulated over 36 years so that the 10-year exceedance probability at the site can be estimated.
The SCI-GROW screening model was also developed by EPA, and is a regression model based upon actual groundwater monitoring data collected for the registration of a number of pesticides. The current version of SCI-GROW appears to provide a realistic estimate of pesticide concentrations in shallow, highly vulnerable ground water sites (i.e., sites with sandy soils and depth to ground water of 10 to 20 feet) for use in both chronic and acute ground water estimates.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to pymetrozine they are further discussed in the aggregate risk sections below.
Based on the FIRST, SCI-GROW, and PRZM/EXAMS models the EECs of pymetrozine for acute exposures are estimated to be 5.23 parts per billion (ppb) for surface water and < 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 1.58 ppb for surface water and < 0.02 ppb for ground water. See Tables 3 and 4 below.
|Scenario/Population Subgroup||aPAD mg/kg/day||Food Exposure, mg/kg/day||Maximum Water Exposure, mg/kg/day||SCI-GROW (groundwater) ppb||PRZM/EXAMS (surface water) ppb||DWLOC* μg/L|
|All Infants (<1 year old)||0.14||0.001404||0.13860||0.02||5.23||1,400|
|Children (1-6 yrs)||0.14||0.003517||0.13648||0.02||5.23||1,400|
|Children 7-12 years old||0.14||0.002615||0.13739||0.02||5.23||1,400|
|Males 20+ years old||0.42||0.001807||0.41819||0.02||5.23||15,000|
|* DWLOC = Maximum Water Exposure (mg/kg/day) 1000 μg/mg body weight (70 kg general population/males 13+, 60 kg females 13+, 10 kg infants and children) ÷ Water Consumption (2 L/day adults, 1 L/day infants and children). The acute EEC is 5.23 μg/L.|
|Scenario/Population Subgroup||cPAD mg/kg/day||Food Exposure, mg/kg/day||Maximum Water Exposure, mg/kg/day||SCI-GROW (groundwater) ppb||PRZM/EXAMS (surface water) ppb||DWLOC* μg/L|
|All Infants (<1 year old)||0.0013||0.000018||0.001282||0.02||1.58||13|
|Children (1-6 years old)||0.0013||0.000045||0.001255||0.02||1.58||13|
|Children 7-12 years||0.0013||0.000040||0.001260||0.02||1.58||13|
|Start Printed Page 66791|
|Males 20+ years old||0.0038||0.000034||0.003766||0.02||1.58||130|
|* DWLOC = Maximum Water Exposure (mg/kg/day) 1,000 μg/mg body weight (70 kg general population/males 13+, 60 kg females 13+, 10 kg infants and children) ÷ Water Consumption (2 L/day adults, 1 L/day infants and children). The chronic and cancer EEC is 1.58 μg/L.|
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Since the current proposed uses do not result in additional residential exposure, the Agency's earlier evaluation of approved residential uses, found in the Federal Register of August 9, 2000 (65 FR 48626-48634), will not be repeated here.
4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
Based on the information available to EPA, there are no other pesticides that have a common mechanism of toxicity with pymetrozine. 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).
D. Safety Factor for Infants and Children
1. In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.
2. Conclusion. There is a complete toxicity database for pymetrozine and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children could be reduced to 3. The FQPA factor is reduced after assessing the potential for additional sensitivity of infants and children to residues of pymetrozine in the following studies: developmental toxicity studies in rabbit and rat and two-generation reproduction study in the rat. There was no evidence of increased susceptibility in these studies. The FQPA safety factor was not reduced to one due to the need for a developmental neurotoxicity study.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.
1. Acute risk. The Tier 1 exposure estimates provided by the acute dietary analysis are based on the assumption that tolerance-level residues are present in/on all commodities on which pymetrozine will be used and that 100% of these commodities are treated. The exposure estimates are therefore conservative ones. As shown in Table 3 of this preamble the acute EECs for pymetrozine are below EPA's level of concern. That is, they are below the DWLOC values calculated for the various population subgroups. Thus, residues of pymetrozine in food and Start Printed Page 66792drinking water do not exceed the EPA's level of concern (100% of the aPAD) for acute aggregate exposure for any of the population subgroups. Based on its assumptions and underlying data, this risk assessment is considered confident, very conservative, and highly protective of human health.
2. Chronic risk. The Tier 3 exposure estimates provided by the chronic dietary analysis are based on anticipated residues and projected percent crop treated data. Anticipated residues (average field trial values) were calculated for the crops. The resulting exposure estimates are therefore refined ones. The chronic EECs for pymetrozine are below the Agency's level of concern. That is, as shown in Table 4 of this preamble, they are below the DWLOC values calculated for the various population subgroups. Thus, residues of pymetrozine in food and drinking water do not exceed the Agency's level of concern (100% of the cPAD) for chronic aggregate exposure for any of the population subgroups.
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). In aggregating short-term risk, the Agency considered background average dietary exposure and short-term, non-dietary oral exposure. Non-dietary oral exposure may occur with toddlers as hand-to-mouth transfer of residues from ornamental plants or incidental ingestion of treated ornamental plants and/or surrounding soil. The highest estimated exposure via these routes is 0.0046 mg/kg/day which results from hand-to-mouth transfer of residues. Combining this exposure with the chronic dietary exposure estimate of 0.000045 mg/kg/day results in an aggregate exposure of 0.0046 mg/kg/day. In the absence of a short-term oral endpoint, EPA has used the acute dietary endpoint for infants and children (125 mg/kg/day) to estimate aggregate short-term risk. Note that this endpoint is based on a LOAEL and therefore has a 300-fold uncertainty factor associated with it. Combining the exposure estimate with the toxicological endpoint gives an MOE of 27,000. For this scenario, the Agency would be concerned with an MOE of less than 900; thus, this exposure is below EPA's level of concern. Aggregated short-term exposure results in a DWLOC of 1,400 ppb. This value is in excess of the peak EEC of 5.23 ppb for pymetrozine. Therefore, the short-term aggregate risk is below the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). There are no intermediate-term residential exposure scenarios for pymetrozine based on the current uses. Therefore, aggregate intermediate-term risks do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. As with the chronic dietary exposure analysis, the cancer risk assessment is also based on a Tier 3 estimate of dietary exposure. The cancer aggregate risk consists of chronic dietary exposure as well as non-occupational exposure resulting from pruning and planting treated ornamental plants. The sum of the food and residential exposure is 0.000034 (food) + 0.0000012 (residential) = 3.5 x 10-5 mg/kg/day. Assuming a cancer risk limit of 1 x 10-6, the cancer dose of concern is 8.4 x 10-5 mg/kg/day (0.000001/Q1* = 0.000001/0.0119). As 3.5 x 10-5 mg/kg/day is less than 8.4 x 10-5 mg/kg/day, the aggregate food and residential exposure is below the level of concern. With respect to drinking water, the cancer DWLOC is calculated to be 1.7 ppb. The highest EEC for any of the crops in these petitions is 1.6 ppb (pecans). As a result, the aggregate cancer risk resulting from use of pymetrozine is below the Agency's level of concern.
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.
IV. Other Considerations
A. Analytical Enforcement Methodology
The Agency's Analytical Chemistry Laboratory has validated an enforcement methodology for pymetrozine (Syngenta Analytical Method AG-643A). It will be available to enforce the tolerance expression. The method may be requested from: Francis D. Griffith, Jr., Analytical Chemistry Branch, BEAD (7503C), 702 mapes Rd., Ft. George Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: firstname.lastname@example.org.
B. International Residue Limits
There are no established European (CODEX), Canadian, or Mexican Maximum Residue Limits (MRL's) for pymetrozine. There are provisional MRLs in Germany for hops, dried (10 ppm) and potatoes (0.02 ppm). The European Union is currently evaluating a proposed tolerance of 5 ppm on hops, dried. There are proposed tolerances in Canada for tuberous and corm vegetables at 0.02 ppm, fruiting vegetables at 0.2 ppm, head and stem Brassica vegetables at 2.0 ppm, leafy Brassica vegetables at 5.0 ppm, leafy vegetables at 6.0 ppm, pecans at 0.02 ppm, hops (dried) at 5.0 ppm, citrus at 0.2 ppm, and cucurbits at 0.1 ppm. At this time, international harmonization of residue levels is not an issue.
The Agency imposed the following conditions on pymetrozine at the time of the original Notices of Registration in the fall of 1999:
1. Storage stability (due December 2000).
2. Corrosion characteristics (due December 2000).
3. Acute estuarine/marine toxicity in shrimp (due October 2000)
4. Photodegradation on soil, 161-3, (due October 2000).
5. Developmental neurotoxicity Study, 870-6300 or 83-6, (due October 2001).
6. Avian reproduction (mallard), 71-4(b), (due October 2001).
7. Drinking water monitoring (originally due October 2002 but the requirement was no longer applicable after Cancer Q* was changed).
Therefore, the tolerances are established for residues of pymetrozine in or on cotton seed, undelinted at 0.3 ppm; cotton gin byproducts at 2.0 ppm; fruiting vegetables at 0.2 ppm; cucurbit vegetables at 0.1 ppm; leafy vegetables (except Brassica) at 0.6 ppm; head and stem Brassica vegetables at 0.5 ppm; leafy Brassica and turnip greens at 0.25 ppm, hops (dried) at 6.0 ppm; and pecans at 0.02 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the Start Printed Page 66793old 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-301180 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 25, 2002.
1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”
EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at email@example.com, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301180, 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: firstname.lastname@example.org. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any 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 petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (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 Start Printed Page 66794have 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.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).Start List of Subjects
List of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: December 17, 2001.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180— [AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 180.556 is amended by revising paragraph (a) to read as follows:End Amendment Part
(a) General. Tolerances are established 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 the following raw agricultural commodities. The tolerance level for each commodity is expressed in terms of the parent insecticide only, which serves as an indicator of the use of pymetrozine on these raw agricultural commodities.
|Commodity||Parts per million|
|Brassica, head and stem, subgroup (Crop Subgroup 5-A)||0.5|
|Brassica, leafy greens, subgroup (Crop Subgroup 5-B)||0.25|
|Cotton gin byproducts||2.0|
|Cotton, undelinted seed||0.3|
|Hops, dried cones||6.0|
|Vegetable, fruiting, group (Crop Group 8)||0.2|
|Vegetable, cucurbit, group (Crop Group 9)||0.1|
|Vegetable, leafy, execpt brassica, group (Crop Group 4)||0.6|
|Vegetable, tuberous and corm, subgroup (Crop Subgroup 1-C)||0.02|
[FR Doc. 01-31801 Filed 12-26-01; 8:45 am]
BILLING CODE 6560-50-S