Pesticide Tolerances:

Federal Register: November 17, 2010 (Volume 75, Number 221)

Rules and Regulations

Page 70143-70149

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr17no10-19

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

EPA-HQ-OPP-2009-0812; FRL-8851-7

Acequinocyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of acequinocyl in or on bean, edible podded; hop, dried cones; okra and vegetable, fruiting, group 8. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and

Cosmetic Act (FFDCA).

DATES: This regulation is effective November 17, 2010. Objections and requests for hearings must be received on or before January 18, 2011, 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: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0812. 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.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division

(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   A . Does this action apply to me?

   You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer.

   Potentially affected entities may include, but are not limited to those engaged in the following activities:

   Crop production (NAICS code 111).

   Animal production (NAICS code 112).

   Food manufacturing (NAICS code 311).

   Pesticide manufacturing (NAICS code 32532).

   This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System

   (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult

   Page 70144

   the person listed under FOR FURTHER INFORMATION CONTACT.

   2. 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.gpoaccess.gov/ecfr.

   3. 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-2009-0812 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

      January 18, 2011. 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-2009-0812, by one of the following methods:

      Federal eRulemaking Portal: http://www.regulations.gov.

      Follow the on-line instructions for submitting comments.

      Mail: Office of Pesticide Programs (OPP) Regulatory Public

      Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania

      Ave., NW., Washington, DC 20460-0001.

      Delivery: OPP Regulatory Public Docket (7502P),

      Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South

      Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

      Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

2. Summary of Petitioned-for Tolerance

   In the Federal Register of January 6, 2010 (75 FR 868) (FRL-8801- 5), 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 9E7598) by IR-4 Project Headquarters, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.599 be amended by establishing tolerances for residues of the insecticide acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric equivalent of acequinocyl and by establishing a tolerance for the residues of acequinocyl, including its metabolites and degradates in or on vegetable, fruiting, group 8 at 0.7 parts per million (ppm); okra at 0.7 ppm; bean, edible podded at 0.25 ppm and hop, dried cone at 3.5 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Arysta LifeScience North America

   LLC, 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 revised the proposed tolerance for hop dried cones from 3.5 ppm to 4.0 ppm as available data submitted support the higher tolerance. The reason(s) for these changes are explained in Unit IV.D.

3. 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 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 acequinocyl including exposure resulting from the tolerances established by this action.

   EPA's assessment of exposures and risks associated with acequinocyl follows.

   1. Toxicological Profile

      EPA has evaluated the available toxicity data and considered their 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.

      Acequinocyl exhibits low acute toxicity in oral, dermal and inhalation routes of exposure, as well as, primary eye and primary skin irritation studies. It is not a dermal sensitizer.

      In rat studies including a subchronic oral toxicity study, a 28-day dermal toxicity study, and a chronic feeding/oncogenicity study, acequinocyl increased prothrombin and activated partial thromboplastin.

      Internal hemorrhages were observed in both a rat and rabbit developmental toxicity study, a mouse subchronic/chronic toxicity study, and in a 2-generation reproduction rat study. In a combined chronic toxicity/oncogenicity study in rats, enlarged eyeballs were observed. Hepatotoxicity in the mouse was evidenced by histopathology and increased liver enzymes.

      In both rat and rabbit developmental toxicity studies, acequinocyl increased the number of resorptions. Developmental effects (i.e., resorptions) occurred at a dose that was higher than or the same as the dose that caused maternal toxicity. In the 2-generation reproduction toxicity study in the rat, there was no evidence of reproductive toxicity, though there were notable toxic effects observed in offspring that were not observed in adults including swollen body parts, protruding eyes, clinical signs, delays in pupil development and increased mortality occurring mainly after weaning.

      There was no evidence of carcinogenic potential in either the rat or mouse carcinogenicity study, indicating that acequinocyl is ``not likely'' to be carcinogenic to humans. There was no concern for mutagenic activity as indicated by several

      Page 70145

      mutagenicity studies. Acequinocyl is classified as ``Not likely to be

      Carcinogenic to Humans.''

      Specific information on the studies received and the nature of the adverse effects caused by acequinocyl 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, ``Acequinocyl; Human-Health Risk

      Assessment for Proposed Section 3 Uses on Fruiting Vegetables, Hops,

      Okra, and Edible-Podded Beans'' dated August 26, 2010, at pp. 32-35 in docket ID number EPA-HQ-OPP-2009-0812-0004.

   2. 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 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 acequinocyl used for human risk assessment is shown in Table 1 of this unit.

      Table 1--Summary of Toxicological Doses and Endpoints for Acequinocyl for Use in Human Health Risk Assessment

      Point of departure and

      Exposure/Scenario

      uncertainty/safety

      RfD, PAD, LOC for risk

      Study and toxicological factors

      assessment

      effects

      Acute dietary...................... N/A................... N/A................... An endpoint attributable to

      (General population including

      a single dose was not infants and children).

      identified in the database.

      Chronic dietary.................... NOAEL = 2.7 mg/kg/day. Chronic RfD = 0.027 mg/ Carcinogenicity study in

      (All populations).................. UFA = 10x............. kg/day.

      mice (18 month); LOAEL =

      UFH = 10x............. cPAD = 0.027 mg/kg/day 7.0 mg/kg/day based on the

      FQPA SF = 1x..........

      clinical chemistry and microscopic nonneoplastic lesions (brown pigmented cells and perivascular inflammatory cells in liver).

      Short-term......................... Dermal NOAEL = 200 mg/ LOC (occupational/

      28-day dermal study in

      (1 to 30 days) and intermediate-

      kg/day.

      residential) for MOE rats; term (1-6 months) dermal.

      = DB) is not needed to account for lack of this study.

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      Although a 28-day inhalation study is not available, EPA has determined that the additional FQPA SF is not needed. Residential inhalation risk was estimated by calculating exposure using the

      Agency's Residential SOPs. For chemicals with low vapor pressure (7.5 x 10-5mmHg or below for outdoor uses at 20-30 [deg]C), these standard assumptions are expected to overestimate the exposure via the inhalation route. Acequinocyl is such a compound (1.69 x 10-11mmHg at 25 [deg]C) and exposure through the inhalation route is expected to be minimal. Therefore, the risk estimate is conservative and is considered protective and the additional FQPA SF is not needed. Since all calculated inhalation MOEs for residential handlers are significantly greater than the Agency's LOC (MOE >100), even retaining the FQPA SF would not affect EPA's conclusion on safety.

      There is potential evidence of neurotoxicity or neuropathology in the 2-generation reproduction study as well as the rat subchronic oral toxicity study, however these toxicities are not considered to be primary effects since they occur in the presence of more severe systemic effects in both studies. Therefore, although an acute and subchronic neurotoxicity studies are now required as a part of new data requirements in the 40 CFR part 158 for conventional pesticide registration, the agency does not believe that conducting these studies will result in a lower point of departure (POD) than that currently used for overall risk assessment. ii. There is no evidence that acequinocyl results in increased susceptibility in in utero rat or rabbit fetuses in the prenatal developmental studies or in young rats in the 2-generation reproduction study. In the 2-generation rat reproduction study, more severe effects were observed in the offspring, however these effects were observed at the same doses as parental effects, and a clear NOAEL was established which is being used in endpoint selection. 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 water and surface water modeling used to assess exposure to acequinocyl in drinking water. The residential use (ornamentals) is not expected to result in post- application exposure to infants and children. These assessments will not underestimate the exposure and risks posed by acequinocyl.

   5. Aggregate Risks and Determination of Safety

      EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, acequinocyl is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to acequinocyl from food and water will utilize 45% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. Based on the use pattern, chronic residential exposure to residues of acequinocyl is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

      Acequinocyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to acequinocyl.

      Using the exposure assumptions described in this unit for short- term exposures, EPA has concluded that the combined short-term food, drinking water, and dermal and inhalation residential exposures result in aggregate MOE of 2,700 for adults 50+ years old, the highest exposed population. Because EPA's level of concern for chemical name is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Acequinocyl is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no 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 intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for acequinocyl. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity, acequinocyl is not expected to pose a cancer risk to humans. 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, or to infants and children from aggregate exposure to acequinocyl residues.

4. Other Considerations

   1. Analytical Enforcement Methodology

      Adequate enforcement methodologies are available for enforcing tolerances for acequinocyl residues of concern in/on the proposed/ registered plant commodities. Methods include two high-performance liquid chromatography methods with tandem mass-spectroscopy detection

      (HPLC/MS/MS).

      The methods may be requested from: Chief, Analytical Chemistry

      Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

   2. International Residue Limits

      In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and

      Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the U.S. is a party. EPA may establish a tolerance that is different from a Codex

      MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

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      The Codex has not established MRLs for acequinocyl.

   3. Revisions to Petitioned-for Tolerances

      The Agency revised the 3.5 ppm proposed tolerance on hop, dried cones to 4.0 ppm. The Agency's tolerance spreadsheet as specified by the Guidance for Setting Tolerances Based on Field Trial Data SOP

      (August 2009 version) was used to determine appropriate tolerance levels.

      EPA has revised the tolerance expression for acequinocyl to clarify 1. That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of acequinocyl not specifically mentioned; and 2. That compliance with the specific compounds mentioned in the tolerance expression.

5. Conclusion

   Therefore, tolerances are established for residues of acequinocyl including its metabolites and degradates in or on bean, edible podded at 0.25 ppm, hop, dried cones at 4.0 ppm, okra at 0.70 ppm, and vegetable, fruiting, group 8 at 0.70 ppm. Compliance with the tolerance levels specified is to be determined by measuring only the sum of acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric equivalent of acequinocyl, in or on the commodity.

6. Statutory and Executive Order Reviews

   This final rule establishes tolerances under section 408(d) of

   FFDCA 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning

   Regulations That Significantly Affect Energy Supply, Distribution, or

   Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled

   Protection of Children from Environmental Health Risks and Safety Risks

   (62 FR 19885, April 23, 1997). 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., 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).

   Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, 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.

   This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled

   Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates

   Reform Act of 1995 (UMRA) (Pub. L. 104-4).

   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).

7. Congressional Review Act

   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 Representatives, and the Comptroller General of the

   United States prior to publication of this final rule in the Federal

   Register. This final rule is not a ``major rule'' as defined by 5

   U.S.C. 804(2).

   List of Subjects in 40 CFR Part 180

   Environmental protection, Administrative practice and procedure,

   Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

   Dated: November 4, 2010.

   Lois Rossi,

   Director, Registration Division, Office of Pesticide Programs. 0

   Therefore, 40 CFR chapter I is amended as follows:

   PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows:

   Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. Section 180.599 is amended by revising paragraph (a) introductory text and alphabetically adding the following commodities to the table in paragraph (a) to read as follows:

   Sec. 180.599 Acequinocyl; tolerance for residues.

   (

   1. General. Tolerances are established for residues of acequinocyl, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric equivalent of acequinocyl, in or on the commodity.

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   Commodity

   Parts per million

   * * * * *

   Bean, edible podded..................................

   0.25

   * * * * *

   Hop, dried cones.....................................

   4.0

   * * * * *

   Okra.................................................

   0.70

   * * * * *

   Vegetable, fruiting, group 8.........................

   0.70

   * * * * *

   FR Doc. 2010-28973 Filed 11-16-10; 8:45 am

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