Sulfentrazone; Pesticide Tolerances
Federal Register, Volume 83 Issue 72 (Friday, April 13, 2018)
Federal Register Volume 83, Number 72 (Friday, April 13, 2018)
Rules and Regulations
Pages 15977-15982
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-07740
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ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2017-0072; FRL-9975-77
Sulfentrazone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of sulfentrazone in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 13, 2018. Objections and requests for hearings must be received on or before June 12, 2018, 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-2017-0072, 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: Michael Goodis, 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: email protected.
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-2017-0072 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 June 12, 2018. 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-2017-0072, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), 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 6E8532) by IR-4, Rutgers, The State University of New Jersey, 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 herbicide sulfentrazone in or on Chia, dry seed at 0.15 parts per million (ppm); Teff, forage at 0.50 ppm; Teff, grain at 0.15 ppm; Teff, hay at 0.30 ppm; Teff, straw at 1.5 ppm; Stalk and stem vegetable subgroup 22A at 0.15 ppm; Vegetable, brassica, head and stem, group 5-16 at 0.20 ppm; Brassica, leafy greens, subgroup 4-16B at 0.60 ppm; and Nut, tree, group 14-12 at 0.15 ppm. The petition also requested to remove the tolerances for Asparagus at 0.15 ppm; Brassica, head and stem, subgroup 5A at 0.20 ppm; Brassica, leafy greens, subgroup 5B at 0.40 ppm; Nut, tree, group 14 at 0.15 ppm;
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Pistachio at 0.15 ppm; and Turnip, tops at 0.60 ppm. That document referenced a summary of the petition prepared by FMC, 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.
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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 sulfentrazone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with sulfentrazone 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.
Subchronic and chronic toxicity studies in rats, mice, and dogs identified the hematopoietic system as the target of sulfentrazone. Sulfentrazone inhibits the enzyme protoporphyrinogen oxidase (PPO) in target plants, and the results of subchronic and chronic toxicity studies in mammalian systems are consistent with PPO inhibition. Disruption of heme biosynthesis was indicated by signs of anemia, and decreases in hematocrit (Hct), hemoglobin (HGB), and mean corpuscular volume (MCV) in mice, rats, and dogs at comparable dose levels from short- through long-term exposures without a significant increase in severity.
Sulfentrazone caused developmental effects when administered via the oral (rats and rabbits) and dermal (rat only) routes of exposure. Developmental effects in rats and rabbits consisted of reductions in the number of implantations in rats, and increases in early resorptions and reduction in live fetuses per litter in rats and rabbits. Surviving rat fetuses exhibited reduced/delayed skeletal ossifications, and decreased fetal body weights. Developmental effects in rats were seen in the absence of maternal toxicity. In contrast with the rat studies, developmental effects in rabbits were observed at a maternally toxic dose, where clinical signs of toxicity included hematuria (red blood cells in urine), abortions, and decreased body-weight gains. In the 2-
generation reproductive toxicity study in rats, developmental effects included an increased duration of gestation, reduced prenatal viability (fetal and litter), reduced litter size, and an increased number of stillborn pups. Pup body-weight deficits, along with reduced pup and litter postnatal survival, were also observed. All of the offspring effects were reported in the presence of mild maternal toxicity (decreased body weight and body-weight gain, particularly in F1 females).
No systemic toxicity was seen via the dermal route up to the limit dose in a 28-day dermal toxicity study in adult non-pregnant rabbits. In a dermal developmental study in rats, there was an increased quantitative fetal susceptibility. While no maternal effects were observed up to the highest dose tested, fetal effects were observed at this dose, and consisted of decreased body weights, increased incidences of fetal variations, hypoplastic or wavy ribs, incompletely ossified lumbar vertebral arches, incompletely ossified ischia or pubis, and a reduced number of thoracic vertebral and rib ossification sites.
In the 26-day inhalation toxicity study, effects that were considered treatment related and adverse occurred only at the highest concentration tested. Systemic effects at this concentration consisted of significant reductions in red blood cell (RBC) parameters in both sexes. Portal-of-entry effects in this study consisted of an increased incidence of minimal nasal respiratory epithelial hyperplasia in both sexes as well as minimal laryngeal epithelial attenuation in all test material exposure groups. The effects on hematological parameters were reversible after 28 days of recovery, while the nasal injury persisted.
In an acute neurotoxicity (ACN) study in rats, effects consisted of an increased incidence of clinical signs of toxicity (staggered gait, splayed hind limbs, and abdominal gripping), changes in functional-
observation battery (FOB) parameters, and decreased motor activity at a high dose level. Complete recovery was observed by day 14, and there was no evidence of neuropathology. In a rat subchronic neurotoxicity (SCN) study, clinical signs of toxicity, increased motor activity, and/
or decreased body weights, body-weight gain, and food consumption were also observed with no evidence of neuropathology. A published, non-
guideline developmental toxicity study in the rat did not conclusively demonstrate developmental neurotoxicity and contained several shortcomings that limit its use for regulatory purposes, including the lack of a no-observed-adverse-effect-level (NOAEL) (DeCastro VL, Destefani CR, Diniz C, Poli P., 2007, Evaluation of neurodevelopmental effects on rats exposed prenatally to sulfentrazone. Neurotoxicology 28(6):1249-59). The reported effects involving measures of physical and reflex development are likely secondary effects reflective of the poor general state of the offspring as reported in the rat two-generation reproductive toxicity study at similar dose levels but with a well-
defined NOAEL.
In the 28-day rat immunotoxicity study, there were no effects on the immune system and systemic effects consisted of reduced body weight, and increased absolute and relative spleen weights at the highest dose tested. Carcinogenicity studies in rats and mice showed no evidence of increased incidence of tumor formation due to treatment with sulfentrazone, and the EPA has classified sulfentrazone as not likely to be carcinogenic to humans. The available mutagenicity studies indicate that sulfentrazone is weakly clastogenic in the in vitro mouse lymphoma assay in the absence of S9 activation. There is no evidence that sulfentrazone is mutagenic in bacterial cells or clastogenic in male or female mice in vivo.
Specific information on the studies received and the nature of the adverse effects caused by sulfentrazone as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the
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toxicity studies can be found at http://www.regulations.gov in the document titled Sulfentrazone--Human Health Risk Assessment for a Section 3 Registration Request to Add New Uses on Chia and Teff; an Amended Use on Mint; and Crop Group Conversions for Tree Nut Group 14-
12, Stalk and Stem Vegetable Subgroup 22A; Vegetable, Brassica, Head and Stem, Group 5-16; and Brassica, Leafy Greens, Subgroup 4-16B on pages 26-31 in docket ID number EPA-HQ-OPP-2017-0072.
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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 EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for sulfentrazone used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of September 12, 2014 (79 FR 54620) (FRL-9915-47).
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Exposure Assessment
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Dietary exposure from food and feed uses. In evaluating dietary exposure to sulfentrazone, EPA considered exposure under the petitioned-for tolerances as well as all existing sulfentrazone tolerances in 40 CFR 180.498. EPA assessed dietary exposures from sulfentrazone in food as follows:
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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. Such effects were identified for sulfentrazone and EPA performed separate acute risk assessments for females 13 to 49 years old and for the general population, including infants and children, based on different endpoints and acute population-adjusted doses (aPADs). In estimating acute dietary exposures, EPA used the Dietary Exposure Evaluation Model, Food Consumption Intake Database (DEEM-FCID, ver. 3.16), which incorporates consumption data from United States Department of Agriculture (USD
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National Health and Nutrition Examination Survey, What We Eat in America, NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crop treated (PCT), and DEEM (ver. 7.81) default processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used DEEM-FCID, ver. 3.16, which incorporated consumption data from the USDA's NHANES/WWEIA; 2003-2008. As to residue levels in food, EPA assumed tolerance-level residues, 100 PCT, and DEEM (ver. 7.81) default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that sulfentrazone 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 percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for sulfentrazone. Tolerance-level residues and 100 PCT were assumed for all food commodities.
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Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sulfentrazone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sulfentrazone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of sulfentrazone for acute exposures are estimated to be 37.3 parts per billion (ppb) for surface water and 134 ppb for ground water; and for chronic exposures for non-cancer assessments are estimated to be 5.3 ppb for surface water and 98 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 134 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 98 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).
Sulfentrazone is currently registered for the following uses that could result in residential exposures: Residential home lawns/turf and recreational turf, such as golf courses. EPA assessed residential exposures using the following assumptions: Adults were assessed for potential short-term dermal and inhalation handler exposures from applying sulfentrazone to residential turf/home lawns and for short-
term post-application dermal exposure from contact with treated residential and recreational turf.
Children, ages 11 email protected.
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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 United Nations 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 United States 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.
No Codex MRLs have been established for sulfentrazone on the crops cited in this document.
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Response to Comments
Two comments were received in response to the notice of filing. One was against the establishment of any tolerances for sulfentrazone and the other stated ``deny this application to change the tolerance on this product.''
Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that these sulfentrazone tolerances are safe. The commenters have provided no information supporting a contrary conclusion.
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Conclusion
Therefore, tolerances are established for residues of sulfentrazone in or on Brassica, leafy greens, subgroup 4-16B at 0.60 ppm; chia, seed at 0.15 ppm; nut, tree, group 14-12 at 0.15 ppm; stalk and stem vegetable subgroup 22A at 0.15 ppm; teff, forage at 0.50 ppm; teff, grain at 0.15 ppm; teff, hay at 0.30 ppm; teff, straw at 1.5 ppm; and vegetable, Brassica, head and stem, group 5-16 at 0.20 ppm. In addition, the following existing tolerances are removed as unnecessary since they are superseded by the new tolerances: asparagus; Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; nut, tree, group 14; pistachio; and turnip, tops.
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Statutory and Executive Order Reviews
This action establishes tolerances 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 action has been exempted from review under Executive Order 12866, this action 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), nor is it considered a regulatory action under Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action 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 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.
This action 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 FFDCA section 408(n)(4). 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
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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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
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Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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: April 3, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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In Sec. 180.498, in the table in paragraph (a)(2):
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i. Remove the entries ``Asparagus''; ``Brassica, head and stem, subgroup 5A''; and ``Brassica, leafy greens, subgroup 5B''.
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ii. Add alphabetically the entries ``Brassica, leafy greens, subgroup 4-16B'' and ``Chia, seed''.
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iii. Remove the entry ``Nut, tree, group 14''.
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iv. Add alphabetically the entry ``Nut, tree, group 14-12''.
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v. Remove the entry ``Pistachio''.
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vi. Add alphabetically the entries ``Stalk and stem vegetable subgroup 22A''; ``Teff, forage''; ``Teff, grain''; ``Teff, hay''; and ``Teff, straw''.
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vii. Remove the entry ``Turnip, tops''.
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viii. Add alphabetically the entry ``Vegetable, Brassica, head and stem, group 5-16''.
The additions read as follows:
Sec. 180.498 Sulfentrazone; tolerances for residues.
(a) * * *
(2) * * *
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Parts
Commodity per
million
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* * * * *
Brassica, leafy greens, subgroup 4-16B......................... 0.60
Chia, seed..................................................... 0.15
* * * * *
Nut, tree, group 14-12......................................... 0.15
* * * * *
Stalk and stem vegetable subgroup 22A.......................... 0.15
* * * * *
Teff, forage................................................... 0.50
Teff, grain.................................................... 0.15
Teff, hay...................................................... 0.30
Teff, straw.................................................... 1.5
* * * * *
Vegetable, Brassica, head and stem, group 5-16................. 0.20
* * * * *
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FR Doc. 2018-07740 Filed 4-12-18; 8:45 am
BILLING CODE 6560-50-P
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