Novaluron; Pesticide Tolerances
Federal Register, Volume 80 Issue 140 (Wednesday, July 22, 2015)
Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)
Rules and Regulations
Pages 43329-43335
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-17676
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ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2014-0232; FRL-9929-57
Novaluron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of novaluron in or on multiple commodities and removes several existing tolerances which are identified and discussed later in this document. This regulation additionally revises existing tolerances in or on vegetable, cucurbit, group 9; and plum, prune, dried. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 22, 2015. Objections and requests for hearings must be received on or before September 21, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0232, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0232 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 21, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0232, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
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Summary of Petitioned-For Tolerance
In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8241) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide novaluron, (N-3-chloro-4-1,1,2-trifluoro-2- (trifluoromethoxy)ethoxyphenylaminocarbonyl-2,6-difluorobenzamide), in or on avocado at 0.60 parts per million (ppm); carrot at 0.05 ppm; bean at 0.60 ppm; vegetable, fruiting, group 8-10 at 1.0 ppm; fruit, pome, group 11-10 at 2.0 ppm; cherry subgroup 12-12A at 8.0 ppm; peach
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subgroup 12-12B at 1.9 ppm; and plum subgroup 12-12C at 1.9 ppm.
Upon approval of the petitioned-for tolerances listed above, the petition proposed to remove the following established tolerances for residues of novaluron from 40 CFR 180.598: Bean, succulent, snap at 0.60 ppm; bean, dry, seed at 0.30 ppm; cherry at 8.0 ppm; fruit, pome, group 11 at 2.0 ppm; fruit, stone, group 12, except cherry at 1.9 ppm; vegetable, fruiting, group 8 at 1.0 ppm; cocona at 1.0 ppm; African eggplant at 1.0 ppm; pea eggplant at 1.0 ppm; scarlet eggplant at 1.0 ppm; goji berry at 1.0 ppm; garden huckleberry at 1.0 ppm; martynia at 1.0 ppm; naranjilla at 1.0 ppm; okra at 1.0 ppm; roselle at 1.0 ppm; sunberry at 1.0 ppm; bush tomato at 1.0 ppm; currant tomato at 1.0 ppm; and tree tomato at 1.0 ppm. These tolerances were requested for removal because they will be superseded by establishment of the petitioned-for tolerances. That document referenced a summary of the petition prepared on behalf of IR-4 by Makhteshim-Agan of North America, Inc., the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has revised several proposed tolerances. EPA has also determined that the previously established tolerances in or on vegetable, cucurbit, group 9 and plum, prune, dried should be revised. Finally, EPA determined that establishing a tolerance on bean is not appropriate; rather, a tolerance should be established on bean, succulent and the previously established tolerance on bean, dry, seed should not be removed. The reasons for these changes are explained in Unit IV.D.
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Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .''
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA 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 for novaluron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with novaluron follows.
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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.
In subchronic and chronic toxicity studies, novaluron primarily produced hematotoxic effects such as methemoglobinemia, decreased hemoglobin, decreased hematocrit, decreased red blood cells (RBCs) (or erythrocytes) and increased reticulocyte counts that were associated with compensatory erythropoiesis. Increased spleen weights or hemosiderosis in the spleen were considered to be due to enhanced removal of damaged erythrocytes and not to a direct immunotoxic effect.
There was no maternal or developmental toxicity seen in the rat and rabbit developmental toxicity studies up to the limit doses. In the 2-
generation reproductive toxicity study in rats, both parental and offspring toxicity (increased spleen weights) were observed at the same dose. Reproductive toxicity, including decreases in epididymal sperm counts and increased age at preputial separation in the F1 generation, was observed at a higher dose than the increased spleen weights and were consistent with the primary effects in the database.
Clinical signs of neurotoxicity (piloerection, irregular breathing), changes in functional observational battery (FOB) parameters (increased head swaying, abnormal gait), and neuropathology (sciatic and tibial nerve degeneration) were seen in the rat acute neurotoxicity study at the limit dose. However, no signs of neurotoxicity or neuropathology were observed in the subchronic neurotoxicity study in rats at similar doses or in any other subchronic or chronic toxicity study in rats, mice, or dogs. In the submitted immunotoxicity study, the only sign of potential immunotoxicity for novaluron was a decreased anti-sheep red blood cell (anti-SRBC) response at twice the limit dose in female rats. There was no evidence of carcinogenic potential in either the rat or mouse carcinogenicity studies, and there was also no concern for genotoxicity or mutagenicity.
Specific information on the studies received and the nature of the adverse effects caused by novaluron as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``Novaluron: Human Health Risk Assessment for the Petition for the Establishment of Permanent Tolerances for Residues of Novaluron in/on Avocado; Carrot; Succulent Bean; Vegetable, Fruiting, Crop Group 8-10; Fruit, Pome, Crop Group 11-
10; Cherry Subgroup 12-12A; Peach Subgroup 12-12B; and Plum Subgroup 12-12C; and Revisions to the Label to Include Uses on Greenhouse-Grown Cucumber'' at pages 36-40 in docket ID number EPA-HQ-OPP-2014-0232.
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Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles
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EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for novaluron used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Novaluron for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (General An endpoint of concern attributable to a single dose was not identified, and
population, including infants an acute RfD was not established.
and children).
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Chronic dietary (All populations) NOAEL = 1.1 mg/kg/ Chronic RfD = 0.011 Combined chronic toxicity/
day. mg/kg/day. carcinogenicity feeding in rat.
UFA = 10x........... cPAD = 0.011 mg/kg/ LOAEL = 30.6 mg/kg/day based on
UFH = 10x........... day. erythrocyte damage resulting in a
FQPA SF = 1x........ compensatory regenerative anemia.
Incidental oral, all durations... NOAEL = 4.38 mg/kg/ LOC for MOE = 100.. 90-day feeding study in rat.
day. LOAEL = 8.64 mg/kg/day based on
UFA = 10x........... clinical chemistry (decreased
UFH = 10x........... hemoglobin, hematocrit, and RBC
FQPA SF = 1x........ counts) and histopathology
(increased hematopoiesis and
hemosiderosis in spleen and
liver).
Inhalation, all durations........ Inhalation (or oral) LOC for MOE = 100.. 90-day feeding study in rat.
study NOAEL = 4.38 LOAEL = 8.64 mg/kg/day based on
mg/kg/day clinical chemistry (decreased
(inhalation hemoglobin, hematocrit, and RBC
absorption rate = counts) and histopathology
100%). (increased hematopoiesis and
UFA = 10x........... hemosiderosis in spleen and
UFH = 10x........... liver).
FQPA SF = 1x........
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Cancer (Oral, dermal, inhalation) Classified as not likely to be carcinogenic to humans.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
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Exposure Assessment
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Dietary exposure from food and feed uses. In evaluating dietary exposure to novaluron, EPA considered exposure under the petitioned-for tolerances as well as all existing novaluron tolerances in 40 CFR 180.598. EPA assessed dietary exposures from novaluron in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure. No such effects were identified in the toxicological studies for novaluron; therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA under the National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA); 2003-2008. As to residue levels in food, EPA incorporated average field trial residues for the majority of commodities; anticipated residues (ARs) for meat, milk, hog, and poultry commodities; and average percent crop treated (PCT) data for apples, blueberries, cabbage, cauliflower, cotton, dry beans, pears, peppers, potatoes, strawberries, and tomatoes. Percent crop treated for new use (PCTn) data were incorporated for the recently registered grain sorghum and sweet corn uses. For the remaining food commodities, 100 PCT was assumed. The registered food-handling use was also incorporated into the dietary assessment. Empirical processing factors were utilized for apple juice (translated to pear and stone fruit juice), cottonseed oil, dried plums, and tomato paste and pureacutee. Dietary Exposure Evaluation Model (DEEM) (ver. 7.81) default processing factors were used for the remaining processed commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that novaluron does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) 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. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a valid basis to
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show what percentage of the food derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the average PCT for existing uses as follows:
Apple, 10%; blueberry, 1%; cabbage, 5%; cauliflower, 2.5%; cotton, 2.5%; dry beans, 1%; pear, 15%; pepper, 2.5%; potato, 2.5%; strawberry, 35%; and tomato, 2.5%.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency estimated the PCT for new uses as follows: Grain sorghum, 2%; and sweet corn, 36%.
EPA estimates PCTn for novaluron based on the PCT of the dominant pesticide (i.e., the one with the greatest PCT) on that site over the three most recent years of available data. Comparisons are only made among pesticides of the same pesticide types (i.e., the dominant insecticide on the use site is selected for comparison with a new insecticide). The PCTs included in the analysis may be for the same pesticide or for different pesticides since the same or different pesticides may dominate for each year. Typically, EPA uses USDA/NASS as the source for raw PCT data because it is publicly available and does not have to be calculated from available data sources. When a specific use site is not surveyed by USDA/NASS, EPA uses proprietary data and calculates the estimated PCT.
This estimated PCTn, based on the average PCT of the market leader, is appropriate for use in the chronic dietary risk assessment. This method of estimating a PCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial five years of actual use. The predominant factors that bear on whether the estimated PCTn could be exceeded are: The extent of pest pressure on the crops in question; the pest spectrum of the new pesticide in comparison with the market leaders as well as whether the market leaders are well-established for this use; and resistance concerns with the market leaders.
Novaluron specifically targets lepidopterous insects, which are not key pests of sorghum but are key pests of sweet corn. However, novaluron has a relatively narrow spectrum of pest activity when compared to the market leader insecticides. In addition, there are no resistance or pest pressure issues as indicated in Section 18 Emergency Exemption requests for use of novaluron on sorghum or sweet corn. All information currently available has been considered for novaluron use on sorghum and sweet corn, and it is the opinion of EPA that it is unlikely that actual PCT for novaluron will exceed the estimated PCT for new uses during the next five years.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, 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 reliable information on the regional consumption of food to which novaluron may be applied in a particular area.
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Dietary exposure from drinking water. The residues of concern in drinking water for risk assessment purposes are novaluron, the chlorophenyl urea degradate, and the chloroaniline degradates. The estimated drinking water concentrations (EDWCs) for each of these was calculated using a molecular weight conversion and then combined for each modeled scenario. The degradates are assumed to have equal toxicity to the parent. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for novaluron and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of novaluron and its degradates. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), the Screening Concentration in Ground Water (SCI-
GROW), and Pesticide Root Zone Model Ground Water (PRZM GW) models, the combined EDWCs of novaluron, chlorophenyl urea, and chloroaniline for chronic exposures are estimated to be 16.7 ppb for surface water and 77.8 ppb for groundwater.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 77.8 ppb was used to assess the contribution to drinking water.
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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).
Novaluron is currently registered for the following uses that could result in residential exposures: Indoor and outdoor crack and crevice or perimeter applications in residential areas and their immediate surroundings, including homes and apartment buildings; on modes of transportation; and as a spot-on use for pets. EPA assessed residential exposure using the following assumptions:
Adult handlers were assessed for potential short-term inhalation exposures from mixing, loading, and
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applying novaluron via manually-pressurized hand wand and from liquid applications of novaluron to turf. Adults were also assessed for potential short-term post-application inhalation exposures to novaluron from indoor uses. For children 1 to
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