Quizalofop ethyl; Pesticide Tolerances, 7111-7115 [2018-03412]

Download as PDF Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES deviation, call or email LT Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone 904–714–7616, email Allan.H.Storm@uscg.mil. SUPPLEMENTARY INFORMATION: I. Background, Purpose and Legal Basis Mathers Bridge across the Banana River, mile 0.5, at Indian Harbour Beach, FL is a swing bridge. It has a vertical clearance of 7 feet at mean high water in the closed position and a horizontal clearance of 74 feet and 81 feet. Presently, the bridge operates in accordance with 33 CFR 117.263. On January 12, 2017, the Brevard County Public Works Department, the bridge owner, requested the Coast Guard consider allowing the bridge to not open for vessels except every 30 minutes on the hour and half hour. The county requested this action in order to reduce traffic delays caused by the numerous openings of the bridge. On April 24, 2017, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation; Banana River, Indian Harbour Beach, FL in the Federal Register (82 FR 18877) and received minimul comments. The City of Indian Harbour Beach, FL requested to have the comment period re-opened as they believed their constituency did not have awareness of the initial notice and comment period. On October 23, 2017, we published a notice of proposed rulemaking; reopening comment period entitled Drawbridge Operation Regulation; Banana River, Indian Harbour Beach, FL in the Federal Register (82 FR 48939). Due to the numerous comments received both for and against the proposed rule, the Coast Guard is publishing this temporary deviation to test the proposed schedule change to determine whether a permanent change is appropriate to better balance the needs of maritime and vehicle traffic. Under this test deviation, in effect from 6 a.m. on February 5, 2018 to 6 a.m. on August 4, 2018, the bridge shall open for vessels requesting passage on the hour and half hour, from 6 a.m. to 10 p.m., Sunday through Thursday. On Friday, Saturday and all Federal holidays, 24 hours a day, the bridge shall open for vessels on the hour and half hour. At all other times, the bridge shall open on signal if at least two hours notice is given. Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass through the bridge in closed position. VerDate Sep<11>2014 15:46 Feb 16, 2018 Jkt 244001 The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation. In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35. II. Public Participation and Request for Comments We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. We encourage you to submit comments through the Federal eRulemaking Portal at https:// www.regulations.gov. If your material cannot be submitted using https:// www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. We accept anonymous comments. All comments received will be posted without change to https:// www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit https:// www.regulations.gov/privacynotice. Documents mentioned in this notice as being available in this docket and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website’s instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published. Dated: February 6, 2018. Barry L. Dragon, Director, Bridge Branch, Seventh Coast Guard District. [FR Doc. 2018–03347 Filed 2–16–18; 8:45 am] BILLING CODE 9110–04–P PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 7111 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2011–0152; FRL–9972–24] Quizalofop ethyl; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of quizalofop ethyl in or on field corn forage, grain, and stover. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 20, 2018. Objections and requests for hearings must be received on or before April 23, 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–2011–0152, is available at https://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 https://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: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. 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. 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 E:\FR\FM\20FER1.SGM 20FER1 7112 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations 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). B. 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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https:// www.epa.gov/test-guidelines-pesticidesand-toxic-substances. sradovich on DSK3GMQ082PROD with RULES C. 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–2011–0152 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 April 23, 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– 2011–0152, by one of the following methods: • Federal eRulemaking Portal: https:// 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/ VerDate Sep<11>2014 15:46 Feb 16, 2018 Jkt 244001 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 https:// www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerances In the Federal Register of March 29, 2011 (76 FR 17374) (FRL–8867–4), 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 1F7822) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR 180.441 be amended by establishing tolerances for residues of the herbicide quizalofopP-ethyl, ethyl-2-[4-(6-chloroquinoxalin2-yl-oxy)phenoxy]propanoate, in or on corn, forage at 0.01 parts per million (ppm); corn, grain at 0.01 ppm; and corn, stover at 0.03 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, https:// www.regulations.gov. A comment was received on the notice of filing. EPA’s response to this comment is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA is establishing higher tolerance levels for corn forage and corn grain than the petition requested. In addition, the names of the commodities for which tolerances are being established in this action differ slightly from what the petition requested. The reasons for these changes are explained in Unit IV.D. III. 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 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 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 quizalofop ethyl, including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with quizalofop ethyl follows. A. 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. Quizalofop ethyl is a 50/50 racemic mixture of R- and S-enantiomers. Quizalofop-P-ethyl, the purified Renantiomer, is the pesticidally-active isomer. Since the toxicological profiles of quizalofop ethyl and quizalofop-Pethyl are similar, the available toxicity studies are adequate to support both compounds. For the purposes of this final rule, both quizalofop ethyl and quizalofop-P-ethyl are collectively referred to as ‘‘quizalofop ethyl.’’ Quizalofop ethyl has very low acute toxicity via the oral, dermal, and inhalation routes of exposure, is not an eye or skin irritant, and is not a skin sensitizer. There were no adverse effects observed in the oral toxicity studies that could be attributable to a single-dose exposure. Repeated-dose toxicity studies indicate the liver as the target organ, as evidenced by increased liver weights and histopathological changes. Following oral administration, quizalofop ethyl is rapidly excreted via urine and feces. In the subchronic oral toxicity rat study, effects of decreased body weight gains, increased liver weight, and centrilobular liver cell enlargement were observed. In the subchronic oral toxicity dog study, an increased incidence of testicular atrophy was observed. In the combined E:\FR\FM\20FER1.SGM 20FER1 sradovich on DSK3GMQ082PROD with RULES Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations chronic toxicity/carcinogenicity study in rats, an increased incidence of centrilobular liver cell enlargement was observed in both sexes and mild anemia in males. No dermal toxicity effects were observed in the subchronic dermal toxicity rabbit study at up to the limit dose. Subchronic inhalation toxicity is assumed to be equivalent to oral toxicity. In the chronic oral toxicity dog study, no toxicity effects were observed at the highest dose tested. In the rat and rabbit developmental toxicity studies, maternal effects including decreased body weight gains and food consumption were observed; no developmental effects were observed up to the highest dose tested. In the twogeneration reproduction toxicity study in rats, maternal effects including decreased body weight and decreased body weight gains were observed at the same dose level that resulted in prenatal and postnatal effects (decreased percentage of pups born alive and decreased pup weights); no evidence of adverse effects on the functional development of pups was observed. Although tumors were observed in male and female mice after exposure to quizalofop ethyl, the overall evidence for carcinogenicity is weak, as discussed in supporting documents. Additionally, the point of departure used for establishing the chronic reference dose for quizalofop ethyl is significantly lower (30X) than the dose that induced tumors in male and female mice. EPA has determined that quantification of cancer risk using a non-linear approach would adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to quizalofop ethyl. Based on the results of acceptable toxicity studies, quizalofop ethyl does not show evidence of neurotoxicity or neuropathology. Quizalofop ethyl showed no evidence of immunotoxicity. Specific information on the studies received and the nature of the adverse effects caused by quizalofop ethyl as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at https:// www.regulations.gov in document Quizalofop-P-ethyl. Human Health Risk assessment in Support of the Proposed New Use on Rice in docket ID number EPA–HQ–OPP–2015–0412. B. 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 VerDate Sep<11>2014 15:46 Feb 16, 2018 Jkt 244001 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 https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoints for quizalofop ethyl used for human risk assessment is discussed in Unit II.B. of the final rule published in the Federal Register of December 1, 2016 (81 FR 86581) (FRL–9950–89). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to quizalofop ethyl, EPA considered exposure under the petitioned-for tolerances as well as all existing quizalofop ethyl tolerances in 40 CFR 180.441. EPA assessed dietary exposures from quizalofop ethyl 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 one-day or single exposure. No such effects were identified in the toxicological studies for quizalofop ethyl; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA incorporated tolerancelevel residues, 100 percent crop treated PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 7113 (PCT) for all commodities, and default processing factors for all processed commodities except sunflower oil. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that the chronic reference dose will be protective of any potential carcinogenicity; therefore, a separate 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 quizalofop ethyl. Tolerance-level residues and/or 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for quizalofop ethyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of quizalofop ethyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/ pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. Based on the Modified Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of quizalofop ethyl for chronic exposures for non-cancer assessments are estimated to be 127 parts per billion (ppb) for surface water and 89 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 value of 127 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 nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Quizalofop ethyl 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 E:\FR\FM\20FER1.SGM 20FER1 7114 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES substances that have a common mechanism of toxicity.’’ EPA has not found quizalofop ethyl to share a common mechanism of toxicity with any other substances, and quizalofop ethyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that quizalofop ethyl does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 10X, 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. As summarized in Unit III.A., results from the rat and rabbit developmental toxicity and the two-generation rat reproduction toxicity studies indicated no qualitative or quantitative evidence of increased susceptibility in developing fetuses or in the offspring following prenatal and/or postnatal exposure to quizalofop ethyl. 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 1X. That decision is based on the following findings: i. The toxicity database for quizalofop ethyl is complete. ii. There is no indication that quizalofop ethyl 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 qualitative or quantitative evidence that quizalofop ethyl results in increased susceptibility in in utero rats or rabbits in the prenatal VerDate Sep<11>2014 15:46 Feb 16, 2018 Jkt 244001 developmental studies or in young rats in the 2-generation reproduction study. iv. 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 quizalofop ethyl in drinking water. These assessments will not underestimate the exposure and risks posed by quizalofop ethyl. E. 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. Since there are no residential uses for quizalofop ethyl, the aggregate risk assessment only includes exposure estimates from dietary consumption of food and drinking water. 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-dose exposure was identified and no acute dietary endpoint was selected. Therefore, quizalofop ethyl 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 quizalofop ethyl from food and water will utilize 97% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no residential uses, quizalofop ethyl is not expected to pose short- or intermediateterm risk. 4. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has concluded that regulating on the chronic reference dose will be protective of potential carcinogenicity. Based on the results of the chronic risk assessment, EPA concludes that PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 quizalofop ethyl is not expected to pose a cancer risk to humans. 5. 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 quizalofop ethyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodologies (Morse Meth-147, a high performance liquid chromatography (HPLC) method using fluorescence detection for plant commodities including corn; and AMR– 515–86, AMR–623–86, AMR–627–86, AMR–845–87, and AMR–846–87, HPLC methods using ultraviolet detection for livestock commodities) are available to enforce the tolerance expression. 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; email address: residuemethods@ epa.gov. B. 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. The Codex has not established a MRL for quizalofop ethyl. C. Response to Comments EPA received one comment in response to the Notice of Filing that stated, in part, ‘‘. . . only zero residue.’’ (The remainder of the comment related to the other petitions that were discussed in that Notice.) Although this commenter is encouraging EPA to deny this petition, the commenter provides no information for EPA to take into consideration in making the safety finding under the E:\FR\FM\20FER1.SGM 20FER1 7115 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations FFDCA. Upon review of the available information, EPA concludes that these tolerances would be safe. D. Revisions to Petitioned-for Tolerances EPA changed the proposed commodity names to the correct commodity definitions as follows: From ‘‘corn, forage’’ to ‘‘corn, field, forage;’’ ‘‘corn, grain’’ to ‘‘corn, field, grain;’’ and ‘‘corn, stover’’ to ‘‘corn, field, stover.’’ Also, EPA is establishing higher tolerance levels for corn, field, forage and corn, field, grain than what was requested based on results from use of the Organisation for the Economic Cooperation and Development (OECD) MRL calculation procedures. sradovich on DSK3GMQ082PROD with RULES V. Conclusion Therefore, tolerances are established for residues of quizalofop ethyl, in or on corn, field, forage at 0.02 ppm; corn, field, grain at 0.02 ppm; and corn, field, stover at 0.03 ppm. VI. 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); Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997); or 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 VerDate Sep<11>2014 15:46 Feb 16, 2018 Jkt 244001 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 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). VII. 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: February 2, 2018. Donna S. Davis, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.441, add alphabetically the commodities ‘‘Corn, field, forage’’, ‘‘Corn, field, grain’’, and ‘‘Corn, field, stover’’ to the table in paragraph (a)(1) to read as follows: ■ § 180.441 Quizalofop ethyl; tolerances for residues. (a) * * * (1) * * * Parts per million Commodity * * * * Corn, field, forage ....................... Corn, field, grain ......................... Corn, field, stover ....................... * * * * * * * * 0.02 0.02 0.03 * * * [FR Doc. 2018–03412 Filed 2–16–18; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 160920866–7167–02] RIN 0648–XF902 Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 630 in the Gulf of Alaska National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. AGENCY: NMFS is prohibiting directed fishing for pollock in Statistical Area 630 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 total allowable catch of pollock for Statistical Area 630 in the GOA. DATES: Effective 1200 hours, Alaska local time (A.l.t.), February 14, 2018, through 1200 hours, A.l.t., March 10, 2018. SUMMARY: FOR FURTHER INFORMATION CONTACT: Josh Keaton, 907–586–7228. NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council SUPPLEMENTARY INFORMATION: E:\FR\FM\20FER1.SGM 20FER1

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[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Rules and Regulations]
[Pages 7111-7115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03412]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0152; FRL-9972-24]


Quizalofop ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
quizalofop ethyl in or on field corn forage, grain, and stover. E.I. du 
Pont de Nemours and Company requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 20, 2018. Objections and 
requests for hearings must be received on or before April 23, 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-2011-0152, is available at https://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 https://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:

I. 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. 
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

[[Page 7112]]

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).

B. 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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

C. 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-2011-0152 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 
April 23, 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-2011-0152, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of March 29, 2011 (76 FR 17374) (FRL-8867-
4), 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 
1F7822) by E.I. du Pont de Nemours and Company, 1007 Market Street, 
Wilmington, DE 19898. The petition requested that 40 CFR 180.441 be 
amended by establishing tolerances for residues of the herbicide 
quizalofop-P-ethyl, ethyl-2-[4-(6-chloroquinoxalin-2-yl-
oxy)phenoxy]propanoate, in or on corn, forage at 0.01 parts per million 
(ppm); corn, grain at 0.01 ppm; and corn, stover at 0.03 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, https://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing higher tolerance levels for corn forage and corn grain 
than the petition requested. In addition, the names of the commodities 
for which tolerances are being established in this action differ 
slightly from what the petition requested. The reasons for these 
changes are explained in Unit IV.D.

III. 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 quizalofop ethyl, including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with quizalofop 
ethyl follows.

A. 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.
    Quizalofop ethyl is a 50/50 racemic mixture of R- and S-
enantiomers. Quizalofop-P-ethyl, the purified R-enantiomer, is the 
pesticidally-active isomer. Since the toxicological profiles of 
quizalofop ethyl and quizalofop-P-ethyl are similar, the available 
toxicity studies are adequate to support both compounds. For the 
purposes of this final rule, both quizalofop ethyl and quizalofop-P-
ethyl are collectively referred to as ``quizalofop ethyl.''
    Quizalofop ethyl has very low acute toxicity via the oral, dermal, 
and inhalation routes of exposure, is not an eye or skin irritant, and 
is not a skin sensitizer. There were no adverse effects observed in the 
oral toxicity studies that could be attributable to a single-dose 
exposure.
    Repeated-dose toxicity studies indicate the liver as the target 
organ, as evidenced by increased liver weights and histopathological 
changes. Following oral administration, quizalofop ethyl is rapidly 
excreted via urine and feces. In the subchronic oral toxicity rat 
study, effects of decreased body weight gains, increased liver weight, 
and centrilobular liver cell enlargement were observed. In the 
subchronic oral toxicity dog study, an increased incidence of 
testicular atrophy was observed. In the combined

[[Page 7113]]

chronic toxicity/carcinogenicity study in rats, an increased incidence 
of centrilobular liver cell enlargement was observed in both sexes and 
mild anemia in males.
    No dermal toxicity effects were observed in the subchronic dermal 
toxicity rabbit study at up to the limit dose. Subchronic inhalation 
toxicity is assumed to be equivalent to oral toxicity. In the chronic 
oral toxicity dog study, no toxicity effects were observed at the 
highest dose tested.
    In the rat and rabbit developmental toxicity studies, maternal 
effects including decreased body weight gains and food consumption were 
observed; no developmental effects were observed up to the highest dose 
tested. In the two-generation reproduction toxicity study in rats, 
maternal effects including decreased body weight and decreased body 
weight gains were observed at the same dose level that resulted in 
prenatal and postnatal effects (decreased percentage of pups born alive 
and decreased pup weights); no evidence of adverse effects on the 
functional development of pups was observed.
    Although tumors were observed in male and female mice after 
exposure to quizalofop ethyl, the overall evidence for carcinogenicity 
is weak, as discussed in supporting documents. Additionally, the point 
of departure used for establishing the chronic reference dose for 
quizalofop ethyl is significantly lower (30X) than the dose that 
induced tumors in male and female mice. EPA has determined that 
quantification of cancer risk using a non-linear approach would 
adequately account for all chronic toxicity, including carcinogenicity, 
which could result from exposure to quizalofop ethyl.
    Based on the results of acceptable toxicity studies, quizalofop 
ethyl does not show evidence of neurotoxicity or neuropathology. 
Quizalofop ethyl showed no evidence of immunotoxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by quizalofop ethyl 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 https://www.regulations.gov in document Quizalofop-P-ethyl. Human Health Risk 
assessment in Support of the Proposed New Use on Rice in docket ID 
number EPA-HQ-OPP-2015-0412.

B. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for quizalofop ethyl used 
for human risk assessment is discussed in Unit II.B. of the final rule 
published in the Federal Register of December 1, 2016 (81 FR 86581) 
(FRL-9950-89).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to quizalofop ethyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing quizalofop ethyl 
tolerances in 40 CFR 180.441. EPA assessed dietary exposures from 
quizalofop ethyl 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 one-day or single exposure. No such effects were 
identified in the toxicological studies for quizalofop ethyl; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated 
tolerance-level residues, 100 percent crop treated (PCT) for all 
commodities, and default processing factors for all processed 
commodities except sunflower oil.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that the chronic reference dose will be protective of any 
potential carcinogenicity; therefore, a separate 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 quizalofop ethyl. Tolerance-level residues and/
or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for quizalofop ethyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of quizalofop ethyl. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Modified Tier 1 Rice Model and Pesticide Root Zone 
Model Ground Water (PRZM GW), the estimated drinking water 
concentrations (EDWCs) of quizalofop ethyl for chronic exposures for 
non-cancer assessments are estimated to be 127 parts per billion (ppb) 
for surface water and 89 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 value of 127 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). Quizalofop ethyl 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

[[Page 7114]]

substances that have a common mechanism of toxicity.''
    EPA has not found quizalofop ethyl to share a common mechanism of 
toxicity with any other substances, and quizalofop ethyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
quizalofop ethyl does not have a common mechanism of toxicity with 
other substances. For information regarding EPA's efforts to determine 
which chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 10X, 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. As summarized in Unit 
III.A., results from the rat and rabbit developmental toxicity and the 
two-generation rat reproduction toxicity studies indicated no 
qualitative or quantitative evidence of increased susceptibility in 
developing fetuses or in the offspring following prenatal and/or 
postnatal exposure to quizalofop ethyl.
    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 1X. That decision is based on the following 
findings:
    i. The toxicity database for quizalofop ethyl is complete.
    ii. There is no indication that quizalofop ethyl 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 qualitative or quantitative evidence that 
quizalofop ethyl results in increased susceptibility in in utero rats 
or rabbits in the prenatal developmental studies or in young rats in 
the 2-generation reproduction study.
    iv. 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 quizalofop ethyl in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
quizalofop ethyl.

E. 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. Since there are no residential uses for quizalofop 
ethyl, the aggregate risk assessment only includes exposure estimates 
from dietary consumption of food and drinking water.
    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-dose exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
quizalofop ethyl 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 
quizalofop ethyl from food and water will utilize 97% of the cPAD for 
all infants less than 1 year old, the population group receiving the 
greatest exposure.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because there are no 
residential uses, quizalofop ethyl is not expected to pose short- or 
intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has concluded that regulating on the chronic reference dose 
will be protective of potential carcinogenicity. Based on the results 
of the chronic risk assessment, EPA concludes that quizalofop ethyl is 
not expected to pose a cancer risk to humans.
    5. 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 quizalofop ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (Morse Meth-147, a high 
performance liquid chromatography (HPLC) method using fluorescence 
detection for plant commodities including corn; and AMR-515-86, AMR-
623-86, AMR-627-86, AMR-845-87, and AMR-846-87, HPLC methods using 
ultraviolet detection for livestock commodities) are available to 
enforce the tolerance expression.
    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; email address: 
[email protected].

B. 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. The Codex has not 
established a MRL for quizalofop ethyl.

C. Response to Comments

    EPA received one comment in response to the Notice of Filing that 
stated, in part, ``. . . only zero residue.'' (The remainder of the 
comment related to the other petitions that were discussed in that 
Notice.) Although this commenter is encouraging EPA to deny this 
petition, the commenter provides no information for EPA to take into 
consideration in making the safety finding under the

[[Page 7115]]

FFDCA. Upon review of the available information, EPA concludes that 
these tolerances would be safe.

D. Revisions to Petitioned-for Tolerances

    EPA changed the proposed commodity names to the correct commodity 
definitions as follows: From ``corn, forage'' to ``corn, field, 
forage;'' ``corn, grain'' to ``corn, field, grain;'' and ``corn, 
stover'' to ``corn, field, stover.'' Also, EPA is establishing higher 
tolerance levels for corn, field, forage and corn, field, grain than 
what was requested based on results from use of the Organisation for 
the Economic Co-operation and Development (OECD) MRL calculation 
procedures.

V. Conclusion

    Therefore, tolerances are established for residues of quizalofop 
ethyl, in or on corn, field, forage at 0.02 ppm; corn, field, grain at 
0.02 ppm; and corn, field, stover at 0.03 ppm.

VI. 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or 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 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).

VII. 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: February 2, 2018.
Donna S. Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.441, add alphabetically the commodities ``Corn, field, 
forage'', ``Corn, field, grain'', and ``Corn, field, stover'' to the 
table in paragraph (a)(1) to read as follows:


Sec.  180.441  Quizalofop ethyl; tolerances for residues.

    (a) * * * (1) * * *

 
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Corn, field, forage.........................................        0.02
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        0.03
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-03412 Filed 2-16-18; 8:45 am]
BILLING CODE 6560-50-P


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