Source: https://www.federalregister.gov/documents/2010/09/01/2010-21686/spiromesifen-pesticide-tolerances
Timestamp: 2017-08-17 22:40:28
Document Index: 749105989

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 2', 'in fine', '§ 180']

A Rule by the Environmental Protection Agency on 09/01/2010
This regulation is effective September 1, 2010. Objections and requests for hearings must be received on or before November 1, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
53581-53586 (6 pages)
EPA-HQ-OPP-2009-0682
FRL-8841-9
https://www.federalregister.gov/d/2010-21686 https://www.federalregister.gov/d/2010-21686
This regulation establishes tolerances for residues of spiromesifen in or on leaf petioles subgroup 4B, dry pea seed, spearmint tops, and peppermint tops. The Interregional Research Project Number 4 (IR-4) and Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0682. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
Andrew Ertman, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
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.gpoaccess.gov/​ecfr.
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 Start Printed Page 53582identify docket ID number EPA-HQ-OPP-2009-0682 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 November 1, 2010. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0682, by one of the following methods:
In the Federal Register of March 24, 2010 (75 FR 14156) (FRL-8815-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 0E7684 by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540 and PP 9F7602 by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The petitions requested that 40 CFR 180.607 be amended by establishing tolerances for residues of the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate, and its enol metabolite, 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as parent compound equivalents, in or on pea, dry, seed at 0.15 parts per million (ppm); spearmint, tops at 25 ppm; and peppermint, tops at 25 ppm (PP 0E7684) and vegetable, leafy petiole, crop subgroup 4B at 6.0 ppm (PP 9F7602). The notice referenced summaries of the petitions prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has recommended for tolerances levels different from those proposed in the petitions for dry pea seed, spearmint tops, and peppermint tops. The reason for these changes are explained in Unit IV.D.
Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for spiromesifen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with spiromesifen follows.
Spiromesifen shows low acute toxicity via the oral, dermal and inhalation routes of exposure. It was neither an eye nor dermal irritant, but showed moderate potential as a contact sensitizer. In short- and long-term animal toxicity tests, the critical effects observed were loss of body weight, adrenal effects (discoloration, decrease in fine vesiculation, and the presence of cytoplasmic eosinophilia in zona fasciculata cells), thyroid effects (increased thyroid stimulating hormone, increased thyroxine binding capacity, decreased T3 and T4 levels, colloidal alteration and thyroid follicular cell hypertrophy), liver effects (increased alkaline phosphatase, ALT and decreased cholesterol, triglycerides), and spleen effects (atrophy, decreased spleen cell count, and increased macrophages). Spiromesifen shows no significant developmental or reproductive effects, is not likely to be carcinogenic based on bioassays in rats and mice, and lacks in vivo and in vitro mutagenic effects. Spiromesifen is not considered a neurotoxic chemical based on the chemical's mode of action and the available data from multiple studies, including acute and subchronic neurotoxicity studies.
Specific information on the studies received and the nature of the adverse effects caused by spiromesifen 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 the document titled “Spiromesifen: Human-Health Risk Assessment for Proposed Section 3 Uses on Leaf Petioles Subgroup 4B; Pea, Dry, Seed; Spearmint, Tops; and Peppermint, Tops” on pages 22 to 26 in docket ID number EPA-HQ-OPP-2009-0682.
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 Start Printed Page 53583are 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 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 spiromesifen used for human risk assessment is shown in the Table of this unit.
Table —Summary of Toxicological Doses and Endpoints for Spiromesifen for Use in Human Health Risk Assessment
Acute dietary (general population and all population subgroups An endpoint of concern attributable to a single dose was not identified. An aRfD was not established.
Chronic dietary (All populations) NOAEL= 2.2 mg/kg/day UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.022 mg/kg/day cPAD = 0.022 mg/kg/day 2-generation reproduction study in rats. The parental systemic LOAEL: 13.2 mg/kgbw/day based on significantly decreased spleen weight (absolute and relative in parental females and F1 males) and significantly decreased growing ovarian follicles in females.
Cancer (Oral, dermal, inhalation) Spiromesifen has been classified as “not likely to be carcinogenic to humans.”
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Cummulative Survey of Food Intake by Individuals. As to residue levels in food, EPA assumed tolerance-level residues for all commodities except for the leafy-greens and leafy Brassica greens subgroups (4A and 5B). The tolerance values for leafy vegetables and spearmint and peppermint tops and oil were adjusted upward to account for the metabolite BSN 2060-4-hydroxymethyl (free and conjugated), which is a residue of concern in leafy vegetables for risk assessment purposes only. EPA used data from the lettuce metabolism studies to create a tolerance-equivalent value for the parent spiromesifen and the BSN 2060-4-hydroxymethyl metabolite to estimate residues in leafy crops. Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors and 100 percent crop treated were assumed for all commodities.
iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for spiromesifen. As discussed above, for the leafy-greens and leafy Brassica greens subgroups (4A and 5B) and spearmint and peppermint tops and oil, the residue values were adjusted upward to account for the metabolite BSN 2060-4-hydroxymethyl (free and conjugated).
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for spiromesifen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of spiromesifen. 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) and Screening Concentration in Ground Water (SCI-GROW) models the estimated drinking water concentrations (EDWCs) of spiromesifen for chronic exposures for non-cancer assessments are estimated to Start Printed Page 53584be 188 ppb for surface water and 86 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 188 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Spiromesifen is not registered for any specific use patterns that would result in residential exposure.
b. There is no concern for neurotoxicity resulting from exposure to spiromesifen. Neurotoxic effects such as reduced motility, spastic gait, increased reactivity, tremors, clonic-tonic convulsions, reduced activity, labored breathing, vocalization, avoidance reaction, piloerection, limp, cyanosis, squatted posture, and salivation were observed in two studies (5-day inhalation and subchronic oral rat) at high doses (134 and 536 milligrams/kilogram/day (mg/kg/day), respectively). These effects were neither reflected in neurohistopathology nor in other studies. Because these effects were not observed in the acute and subchronic neurotoxicity studies, they were not considered reproducible. Thus, based on the chemical's mode of action and the available data from multiple studies, the chemical is not considered neurotoxic.
iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to spiromesifen in drinking water. These assessments will not underestimate the exposure and risks posed by spiromesifen.
2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to spiromesifen from food and water will utilize 78% of the cPAD for all infants <1 year old, the population group receiving the greatest exposure. There are no residential uses for spiromesifen.
3. Short- and intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
A short-term and intermediate-term adverse effect was identified; however, spiromesifen is not registered for any use patterns that would result in short-term or intermediate-term residential exposure. Short-term and intermediate-term risk is assessed based on short-term and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short-term or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term and intermediate-term risk), no further assessment of short-term or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term and intermediate-term risk for spiromesifen.
4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two Start Printed Page 53585adequate rodent carcinogenicity studies, spiromesifen is not expected to pose a cancer risk to humans.
No Codex or Canadian MRLs have been established for spiromesifen in/on leaf petioles subgroup 4B; pea, dry, seed; spearmint, tops; and peppermint, tops.
Pea, dry, seed: The Agency is modifying the tolerance from the proposed level of 0.15 to 0.20. The adjusted field trial data for dry peas were evaluated using the Agency's maximum-likelihood estimation (MLE) spreadsheet and then the Agency's maximum-residue limit (MRL) tolerance spreadsheet as described in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine the appropriate tolerance level. The tolerance spreadsheet recommended a tolerance of 0.20 ppm for total residues of spiromesifen in/on dry peas.
Spearmint, tops and peppermint, tops: The Agency is modifying the tolerances from the proposed level of 25 ppm to 45 ppm. The adjusted field trial data for mint were evaluated using the Agency's MRL tolerance spreadsheet as described in the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP to determine the appropriate tolerance level. The tolerance spreadsheet recommended a tolerance of 45 ppm for total residues of spiromesifen for both spearmint and peppermint tops.
1. That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of spiromesifen not specifically mentioned; and
Therefore, tolerances are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate], its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), calculated as the stoichiometric equivalent of spiromesifen, in or on pea, dry, seed at 0.20 ppm; spearmint, tops at 45 ppm; peppermint, tops at 45 ppm; and leaf petiole subgroup 4B at 6.0 ppm.
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 Start Printed Page 53586Representatives, 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).
2. Section 180.607 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) and revising paragraphs (a)(1) introductory text, (a)(2) introductory text, (b) introductory text, and (d) introductory text to read as follows:
§ 180.607
(a) General. (1) Tolerances are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the stoichiometric equivalent of spiromesifen, in or on the following primary crop commodities:
Leaf petiole subgroup 4B 6.0
Pea, dry, seed 0.20
Peppermint, tops 45
Spearmint, tops 45
(2) Tolerances are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and its metabolites containing the 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one and 4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one moieties, calculated as the stoichiometric equivalent of spiromesifen, in the following livestock commodities:
(b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the stoichiometric equivalent of spiromesifen, in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the table.
(d) Indirect or inadvertent residues. Tolerances are established for the inadvertent or indirect residues of the insecticide/miticide spiromesifen, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate], 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, and its metabolites containing the 4-hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one moiety, calculated as the stoichiometric equivalent of spiromesifen, in the following rotational crop commodities:
[FR Doc. 2010-21686 Filed 8-31-10; 8:45 am]