Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of sulfometuron-methyl in or on sugarcane, cane. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective March 27, 2019. Objections and requests for hearings must be received on or before May 28, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0194, 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.
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: RDFRNotices@epa.gov.
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:
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.
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-2017-0194 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 May 28, 2019. 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-2017-0194, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/?dockets.
In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-9965-43), 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 6E8529) by E. I. du Pont de Nemours and Company, 974 Centre Road, Wilmington, Delaware 19805, now Corteva Agriscience after E.I. du Pont de Nemours and Company merged with Dow AgroScience. The petition requested that 40 CFR 180 be amended by establishing tolerances for residues of the herbicide sulfometuron-methyl, in or on sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by E. I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received in response to the notice of filing, and the Agency's response can be found in Unit IV.C.
based upon review of the data supporting the petition, EPA has determined a tolerance of 0.1 sugarcane, cane is appropriate, but that tolerances on sugarcane, sugar, refined and sugarcane, molasses is not needed. The reasons for these changes are further explained in Unit IV.D.
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 Start Printed Page 11417all 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 sulfometuron-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with sulfometuron-methyl follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The primary toxic effect in the toxicological database is changes in hematological parameters and body weight decrements. There is no evidence that sulfometuron-methyl is a developmental toxicant based on a prenatal developmental study in rats and increased susceptibility was not commonly observed in the database for other registered sulfonylurea herbicides (SUs). There is no evidence of neurotoxicity or immunotoxicity in the toxicology databased for sulfometuron-methyl. Sulfometuron-methyl is classified as “not likely to be carcinogenic to humans” based on lack of treatment-related increases in tumor incidence compared to controls in the mouse carcinogenicity study and negative findings in the genotoxicity toxicity studies. Sulfometuron-methyl has low acute toxicity via oral, dermal, and inhalation routes of exposure. It shows minimal eye irritation and is not a dermal irritant or sensitizer. Specific information on the studies received and the nature of the adverse effects caused by sulfometuron-methyl 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 “Sulfometuron-Methyl. Human Health Risk Assessment for a Tolerance without a U.S. Registration for Residues in/on imported Sugarcane” at pages 18-20 in docket ID number EPA-HQ-OPP-2017-0194.
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 NOAEL and 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 used for human risk assessment is shown in Table 1 of this unit.
Table 1—Summary of Toxicological Doses and Endpoints for Sulfometuron-methyl for Use in Human Health Risk Assessment
|
Exposure/scenario |
Point of departure and uncertainty/safety factors |
RfD, PAD, LOC for risk assessment |
Study and toxicological effects |
|
Acute dietary (All populations) |
A dose and endpoint of concern attributable to a single dose was not observed at doses relevant for human health risk assessment. |
||
|
Chronic dietary (All populations) |
NOAEL = 27.5 mg/kg/day UFA = 10× UFH = 10× FQPA SF = 1× |
Chronic RfD = 0.275 mg/kg/day cPAD = 0.275 mg/kg/day |
Chronic Oral Toxicity Study (dog) LOAEL = 148.5 mg/kg/day based on decreases in body-weight gain in males, hemolytic anemia, and a slight increase in alkaline phosphates in both sexes. |
|
Cancer (Oral, dermal, inhalation) |
Sulfometuron-methyl is classified as “not likely to be carcinogenic to humans” based on lack of treatment-related increases in tumor incidence compared to controls in the mouse carcinogenicity study and negative findings in the mutagenicity/genetic toxicity studies. |
||
|
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (c = chronic). RfD = reference dose. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). |
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1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sulfometuron-methyl, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from sulfometuron-methyl 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 Start Printed Page 11418identified in the toxicological studies for sulfometuron-methyl; 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 United States Department of Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100% crop treated (CT) and used tolerance-level residues for the sugarcane commodities. The 2018 default processing factors were used (in this case, the factors were 1 for sugarcane commodities).
iii. Cancer. based on the data summarized in Unit III.A., EPA has concluded that sulfometuron-methyl 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 and/or PCT information in the dietary assessment for sulfometuron-methyl. Tolerance level residues and/or 100% CT were assumed for sugarcane.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sulfometuron-methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sulfometuron-methyl. 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.
Instead of generating chemical-specific estimated drinking water concentrations (EDWCs) for sulfometuron-methyl, EPA used model inputs (rate, soil mobility, persistence) from all the sulfonylurea herbicides (sulfometuron-methyl is a sulfonylurea herbicide) to determine coarse-screen estimates that should exceed upper-bound, chemical-specific EDWCs for any SU. The resulting coarse-screen EDWCs generated with the Pesticide Root Zone Model Ground Water (PRZM GW) were higher than the surface water estimates and were used as conservative estimates of potential residues from sulfometuron-methyl in drinking 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 0.492 ppm 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). Sulfometuron-methyl is not registered for any specific use patterns that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
In 2016, EPA's Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: framework for Screening Analysis https://www.epa.gov/?pesticide-science-and-assessing-pesticide-risks/?pesticide-cumulative-risk-assessment-framework. EPA has utilized this framework for sulfometuron-methyl and determined that although sulfometuron-methyl shares some chemical and/or toxicological characteristics (e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data are required to determine that no common mechanism of toxicity exists for sulfometuron-methyl and other pesticides, and no further cumulative evaluation is necessary for sulfometuron-methyl.
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10×) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10×, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence that sulfometuron-methyl is a developmental toxicant based on a prenatal developmental study in rats and increased susceptibility was not commonly observed in the database for other registered SUs.
3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1×. That decision is based on the following findings:
i. The toxicity database for sulfometuron-methyl is complete.
ii. There is no indication that sulfometuron-methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that sulfometuron-methyl results in increased susceptibility in rabbits in a prenatal developmental study. EPA has concluded based on a weight-of-evidence approach that the rat developmental and reproduction toxicity studies are not required for sulfometuron-methyl at this time for the following reasons: (1) Increased susceptibility was not commonly observed in the SU database; and (2) the chronic oral dog study, which is the study used to establish points of departure for sulfometuron-methyl, provides similar or lower NOAEL/LOAEL values than the rat developmental and rat reproduction toxicity studies across the SU database.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sulfometuron-methyl in drinking water. These assessments will not underestimate the exposure and risks posed by sulfometuron-methyl.
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 Start Printed Page 11419exposure 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, sulfometuron-methyl 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 sulfometuron-methyl from food and water will utilize 9.7% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for sulfometuron-methyl; therefore, the chronic aggregate risk assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern.
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). Because there are no uses for sulfometuron-methyl that result in residential exposures, the short-term aggregate assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern as described above.
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). Because there are no uses for sulfometuron-methyl that result in residential exposures, the intermediate-term aggregate assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern as described above.
5. Aggregate cancer risk for U.S. population. based on the lack of evidence of carcinogenicity in the rodent mouse carcinogenicity study and negative findings in the mutagenicity/genetic toxicity studies, sulfometuron-methyl 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 sulfometuron-methyl residues.
Adequate enforcement methodology (high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.
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. The Codex has not established a MRL for sulfometuron-methyl.
One comment was submitted insisting that no residues of sulfometuron-methyl be permitted in food, although no additional information was provided that would support a conclusion that the tolerances requested for sulfometuron-methyl are not safe. Although some individuals do not want pesticides to be used on food, the FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action, and the commenter provided no information to support a determination that the tolerance is not safe.
The petitioner requested a tolerance for residues of 0.01 ppm in/on sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses. The residue data support a tolerance on sugarcane, cane of 0.1 ppm. This value is also harmonized with the MRL established in the major exporting country, Brazil. A value of 0.01 ppm may create a perceived trade irritant if the U.S. tolerance is lower than the MRL in the major exporting country. Tolerances for residues in/on sugarcane, sugar, refined and sugarcane, molasses are not needed, since residues are not expected to concentrate in the processed commodities.
Therefore, a tolerance is established for residues of sulfometuron-methyl, in or on sugarcane, cane at 0.1 ppm.
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 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 Start Printed Page 11420or 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 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).
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).
Dated: March 18, 2019.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1.The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2.Add § 180.704 to subpart C to read as follows:
(a) General. (1) Tolerances are established for residues of the herbicide sulfometuron-methyl, including its metabolites and degradates, in or on the commodity in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only sulfometuron-methyl, (methyl 2-[[[[(4,6-dimethyl-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]benzoate), in or on the following raw agricultural commodities:
|
Commodity |
Parts per million |
|
Sugarcane, cane 1 |
0.1 |
|
1 There are no U.S. Registrations on Sugarcane as of September 24, 2018. |
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2019-05877 Filed 3-26-19; 8:45 am]