83 FR 7111 - Quizalofop ethyl; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 34 (February 20, 2018)
Federal Register Volume 83, Issue 34 (February 20, 2018)
| Page Range | 7111-7115 | |
| FR Document | 2018-03412 |
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)] [Rules and Regulations] [Pages 7111-7115] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03412] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: 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 http://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 http://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: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://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, http://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 http://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 http://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 http://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 http://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
![Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations 7111
deviation, call or email LT Allan Storm, The Coast Guard will also inform the ENVIRONMENTAL PROTECTION
Sector Jacksonville, Waterways users of the waterways through our AGENCY
Management Division, U.S. Coast Local and Broadcast Notices to Mariners
Guard; telephone 904–714–7616, email of the change in operating schedule for 40 CFR Part 180
Allan.H.Storm@uscg.mil. the bridge so that vessel operators can [EPA–HQ–OPP–2011–0152; FRL–9972–24]
SUPPLEMENTARY INFORMATION: arrange their transits to minimize any
I. Background, Purpose and Legal Basis impact caused by the temporary Quizalofop ethyl; Pesticide Tolerances
deviation. AGENCY: Environmental Protection
Mathers Bridge across the Banana
River, mile 0.5, at Indian Harbour In accordance with 33 CFR 117.35(e), Agency (EPA).
Beach, FL is a swing bridge. It has a the drawbridge must return to its regular ACTION: Final rule.
vertical clearance of 7 feet at mean high operating schedule immediately at the
water in the closed position and a end of the effective period of this SUMMARY: This regulation establishes
horizontal clearance of 74 feet and 81 temporary deviation. This deviation tolerances for residues of quizalofop
feet. Presently, the bridge operates in from the operating regulations is ethyl in or on field corn forage, grain,
accordance with 33 CFR 117.263. authorized under 33 CFR 117.35. and stover. E.I. du Pont de Nemours and
On January 12, 2017, the Brevard Company requested these tolerances
County Public Works Department, the II. Public Participation and Request for under the Federal Food, Drug, and
bridge owner, requested the Coast Guard Comments Cosmetic Act (FFDCA).
consider allowing the bridge to not open DATES: This regulation is effective
We view public participation as February 20, 2018. Objections and
for vessels except every 30 minutes on
essential to effective rulemaking, and requests for hearings must be received
the hour and half hour. The county
requested this action in order to reduce will consider all comments and material on or before April 23, 2018, and must
traffic delays caused by the numerous received during the comment period. be filed in accordance with the
openings of the bridge. Your comment can help shape the instructions provided in 40 CFR part
On April 24, 2017, we published a outcome of this rulemaking. If you 178 (see also Unit I.C. of the
notice of proposed rulemaking (NPRM) submit a comment, please include the SUPPLEMENTARY INFORMATION).
entitled Drawbridge Operation docket number for this rulemaking, ADDRESSES: The docket for this action,
Regulation; Banana River, Indian indicate the specific section of this identified by docket identification (ID)
Harbour Beach, FL in the Federal document to which each comment number EPA–HQ–OPP–2011–0152, is
Register (82 FR 18877) and received applies, and provide a reason for each available at http://www.regulations.gov
minimul comments. The City of Indian suggestion or recommendation. or at the Office of Pesticide Programs
Harbour Beach, FL requested to have the We encourage you to submit Regulatory Public Docket (OPP Docket)
comment period re-opened as they in the Environmental Protection Agency
comments through the Federal
believed their constituency did not have Docket Center (EPA/DC), West William
awareness of the initial notice and eRulemaking Portal at http://
www.regulations.gov. If your material Jefferson Clinton Bldg., Rm. 3334, 1301
comment period. On October 23, 2017, Constitution Ave. NW, Washington, DC
we published a notice of proposed cannot be submitted using http://
20460–0001. The Public Reading Room
rulemaking; reopening comment period www.regulations.gov, contact the person
is open from 8:30 a.m. to 4:30 p.m.,
entitled Drawbridge Operation in the FOR FURTHER INFORMATION Monday through Friday, excluding legal
Regulation; Banana River, Indian CONTACT section of this document for
holidays. The telephone number for the
Harbour Beach, FL in the Federal alternate instructions. Public Reading Room is (202) 566–1744,
Register (82 FR 48939). We accept anonymous comments. All and the telephone number for the OPP
Due to the numerous comments comments received will be posted Docket is (703) 305–5805. Please review
received both for and against the without change to http:// the visitor instructions and additional
proposed rule, the Coast Guard is www.regulations.gov and will include information about the docket available
publishing this temporary deviation to at http://www.epa.gov/dockets.
any personal information you have
test the proposed schedule change to
provided. For more about privacy and FOR FURTHER INFORMATION CONTACT:
determine whether a permanent change
the docket, visit http:// Michael Goodis, Registration Division
is appropriate to better balance the
www.regulations.gov/privacynotice. (7505P), Office of Pesticide Programs,
needs of maritime and vehicle traffic.
Under this test deviation, in effect Documents mentioned in this notice Environmental Protection Agency, 1200
from 6 a.m. on February 5, 2018 to 6 Pennsylvania Ave. NW, Washington, DC
as being available in this docket and all
a.m. on August 4, 2018, the bridge shall 20460–0001; main telephone number:
public comments, will be in our online
open for vessels requesting passage on (703) 305–7090; email address:
docket at http://www.regulations.gov
the hour and half hour, from 6 a.m. to RDFRNotices@epa.gov.
and can be viewed by following that
10 p.m., Sunday through Thursday. On SUPPLEMENTARY INFORMATION:
website’s instructions. Additionally, if
Friday, Saturday and all Federal you go to the online docket and sign up I. General Information
holidays, 24 hours a day, the bridge for email alerts, you will be notified
shall open for vessels on the hour and A. Does this action apply to me?
when comments are posted or a final
half hour. At all other times, the bridge rule is published. You may be potentially affected by
shall open on signal if at least two hours this action if you are an agricultural
sradovich on DSK3GMQ082PROD with RULES
notice is given. Vessels able to pass Dated: February 6, 2018. producer, food manufacturer, or
through the bridge in the closed Barry L. Dragon, pesticide manufacturer. The following
position may do so at anytime. The Director, Bridge Branch, Seventh Coast Guard list of North American Industrial
bridge will be able to open for District. Classification System (NAICS) codes is
emergencies and there is no immediate [FR Doc. 2018–03347 Filed 2–16–18; 8:45 am] not intended to be exhaustive, but rather
alternate route for vessels to pass BILLING CODE 9110–04–P provides a guide to help readers
through the bridge in closed position. determine whether this document
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![7112 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations
applies to them. Potentially affected DC), (28221T), 1200 Pennsylvania Ave. 408(b)(2)(C) of FFDCA requires EPA to
entities may include: NW, Washington, DC 20460–0001. give special consideration to exposure
• Crop production (NAICS code 111). • Hand Delivery: To make special of infants and children to the pesticide
• Animal production (NAICS code arrangements for hand delivery or chemical residue in establishing a
112). delivery of boxed information, please tolerance and to ‘‘ensure that there is a
• Food manufacturing (NAICS code follow the instructions at http:// reasonable certainty that no harm will
311). www.epa.gov/dockets/where-send- result to infants and children from
• Pesticide manufacturing (NAICS comments-epa-dockets. aggregate exposure to the pesticide
code 32532). Additional instructions on chemical residue. . . .’’
commenting or visiting the docket, Consistent with FFDCA section
B. How can I get electronic access to along with more information about 408(b)(2)(D), and the factors specified in
other related information? dockets generally, is available at http:// FFDCA section 408(b)(2)(D), EPA has
You may access a frequently updated www.epa.gov/dockets. reviewed the available scientific data
electronic version of EPA’s tolerance II. Summary of Petitioned-For and other relevant information in
regulations at 40 CFR part 180 through Tolerances support of this action. EPA has
the Government Printing Office’s e-CFR sufficient data to assess the hazards of
In the Federal Register of March 29, and to make a determination on
site at http://www.ecfr.gov/cgi-bin/text- 2011 (76 FR 17374) (FRL–8867–4), EPA
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ aggregate exposure for quizalofop ethyl,
issued a document pursuant to FFDCA including exposure resulting from the
40tab_02.tpl. To access the OCSPP test section 408(d)(3), 21 U.S.C. 346a(d)(3),
guidelines referenced in this document tolerances established by this action.
announcing the filing of a pesticide EPA’s assessment of exposures and risks
electronically, please go to http:// petition (PP 1F7822) by E.I. du Pont de
www.epa.gov/test-guidelines-pesticides- associated with quizalofop ethyl
Nemours and Company, 1007 Market follows.
and-toxic-substances. Street, Wilmington, DE 19898. The
petition requested that 40 CFR 180.441 A. Toxicological Profile
C. How can I file an objection or hearing
request? be amended by establishing tolerances EPA has evaluated the available
for residues of the herbicide quizalofop- toxicity data and considered its validity,
Under FFDCA section 408(g), 21 P-ethyl, ethyl-2-[4-(6-chloroquinoxalin- completeness, and reliability as well as
U.S.C. 346a, any person may file an 2-yl-oxy)phenoxy]propanoate, in or on the relationship of the results of the
objection to any aspect of this regulation corn, forage at 0.01 parts per million studies to human risk. EPA has also
and may also request a hearing on those (ppm); corn, grain at 0.01 ppm; and considered available information
objections. You must file your objection corn, stover at 0.03 ppm. That document concerning the variability of the
or request a hearing on this regulation referenced a summary of the petition sensitivities of major identifiable
in accordance with the instructions prepared by E.I. du Pont de Nemours subgroups of consumers, including
provided in 40 CFR part 178. To ensure and Company, the registrant, which is infants and children.
proper receipt by EPA, you must available in the docket, http:// Quizalofop ethyl is a 50/50 racemic
identify docket ID number EPA–HQ– www.regulations.gov. A comment was mixture of R- and S-enantiomers.
OPP–2011–0152 in the subject line on received on the notice of filing. EPA’s Quizalofop-P-ethyl, the purified R-
the first page of your submission. All response to this comment is discussed enantiomer, is the pesticidally-active
objections and requests for a hearing in Unit IV.C. isomer. Since the toxicological profiles
must be in writing, and must be Based upon review of the data of quizalofop ethyl and quizalofop-P-
received by the Hearing Clerk on or supporting the petition, EPA is ethyl are similar, the available toxicity
before April 23, 2018. Addresses for establishing higher tolerance levels for studies are adequate to support both
mail and hand delivery of objections corn forage and corn grain than the compounds. For the purposes of this
and hearing requests are provided in 40 petition requested. In addition, the final rule, both quizalofop ethyl and
CFR 178.25(b). names of the commodities for which quizalofop-P-ethyl are collectively
In addition to filing an objection or tolerances are being established in this referred to as ‘‘quizalofop ethyl.’’
hearing request with the Hearing Clerk action differ slightly from what the Quizalofop ethyl has very low acute
as described in 40 CFR part 178, please petition requested. The reasons for these toxicity via the oral, dermal, and
submit a copy of the filing (excluding changes are explained in Unit IV.D. inhalation routes of exposure, is not an
any Confidential Business Information eye or skin irritant, and is not a skin
(CBI)) for inclusion in the public docket. III. Aggregate Risk Assessment and sensitizer. There were no adverse effects
Information not marked confidential Determination of Safety observed in the oral toxicity studies that
pursuant to 40 CFR part 2 may be Section 408(b)(2)(A)(i) of FFDCA could be attributable to a single-dose
disclosed publicly by EPA without prior allows EPA to establish a tolerance (the exposure.
notice. Submit the non-CBI copy of your legal limit for a pesticide chemical Repeated-dose toxicity studies
objection or hearing request, identified residue in or on a food) only if EPA indicate the liver as the target organ, as
by docket ID number EPA–HQ–OPP– determines that the tolerance is ‘‘safe.’’ evidenced by increased liver weights
2011–0152, by one of the following Section 408(b)(2)(A)(ii) of FFDCA and histopathological changes.
methods: defines ‘‘safe’’ to mean that ‘‘there is a Following oral administration,
• Federal eRulemaking Portal: http:// reasonable certainty that no harm will quizalofop ethyl is rapidly excreted via
www.regulations.gov. Follow the online result from aggregate exposure to the urine and feces. In the subchronic oral
sradovich on DSK3GMQ082PROD with RULES
instructions for submitting comments. pesticide chemical residue, including toxicity rat study, effects of decreased
Do not submit electronically any all anticipated dietary exposures and all body weight gains, increased liver
information you consider to be CBI or other exposures for which there is weight, and centrilobular liver cell
other information whose disclosure is reliable information.’’ This includes enlargement were observed. In the
restricted by statute. exposure through drinking water and in subchronic oral toxicity dog study, an
• Mail: OPP Docket, Environmental residential settings, but does not include increased incidence of testicular
Protection Agency Docket Center (EPA/ occupational exposure. Section atrophy was observed. In the combined
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![Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Rules and Regulations 7115
FFDCA. Upon review of the available Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371.
information, EPA concludes that these seq.) do not apply.
This action directly regulates growers, ■ 2. In § 180.441, add alphabetically the
tolerances would be safe.
food processors, food handlers, and food commodities ‘‘Corn, field, forage’’,
D. Revisions to Petitioned-for retailers, not States or tribes, nor does ‘‘Corn, field, grain’’, and ‘‘Corn, field,
Tolerances this action alter the relationships or stover’’ to the table in paragraph (a)(1)
EPA changed the proposed distribution of power and to read as follows:
commodity names to the correct responsibilities established by Congress § 180.441 Quizalofop ethyl; tolerances for
commodity definitions as follows: From in the preemption provisions of FFDCA residues.
‘‘corn, forage’’ to ‘‘corn, field, forage;’’ section 408(n)(4). As such, the Agency (a) * * * (1) * * *
‘‘corn, grain’’ to ‘‘corn, field, grain;’’ and has determined that this action will not
‘‘corn, stover’’ to ‘‘corn, field, stover.’’ have a substantial direct effect on States
Also, EPA is establishing higher or tribal governments, on the
tolerance levels for corn, field, forage relationship between the national Parts per
and corn, field, grain than what was government and the States or tribal Commodity million
requested based on results from use of governments, or on the distribution of
the Organisation for the Economic Co- power and responsibilities among the
operation and Development (OECD) various levels of government or between * * * * *
MRL calculation procedures. the Federal Government and Indian Corn, field, forage ....................... 0.02
Corn, field, grain ......................... 0.02
V. Conclusion tribes. Thus, the Agency has determined
Corn, field, stover ....................... 0.03
that Executive Order 13132, entitled
Therefore, tolerances are established ‘‘Federalism’’ (64 FR 43255, August 10, * * * * *
for residues of quizalofop ethyl, in or on 1999) and Executive Order 13175,
corn, field, forage at 0.02 ppm; corn, entitled ‘‘Consultation and Coordination * * * * *
field, grain at 0.02 ppm; and corn, field, with Indian Tribal Governments’’ (65 FR [FR Doc. 2018–03412 Filed 2–16–18; 8:45 am]
stover at 0.03 ppm. 67249, November 9, 2000) do not apply BILLING CODE 6560–50–P
VI. Statutory and Executive Order to this action. In addition, this action
Reviews does not impose any enforceable duty or
contain any unfunded mandate as
This action establishes tolerances DEPARTMENT OF COMMERCE
described under Title II of the Unfunded
under FFDCA section 408(d) in Mandates Reform Act (UMRA)(2 U.S.C.
response to a petition submitted to the National Oceanic and Atmospheric
1501 et seq.) Administration
Agency. The Office of Management and This action does not involve any
Budget (OMB) has exempted these types technical standards that would require
of actions from review under Executive 50 CFR Part 679
Agency consideration of voluntary
Order 12866, entitled ‘‘Regulatory consensus standards pursuant to section [Docket No. 160920866–7167–02]
Planning and Review’’ (58 FR 51735, 12(d) of the National Technology
October 4, 1993). Because this action RIN 0648–XF902
Transfer and Advancement Act
has been exempted from review under (NTTAA)(15 U.S.C. 272 note).
Executive Order 12866, this action is Fisheries of the Exclusive Economic
not subject to Executive Order 13211, VII. Congressional Review Act Zone Off Alaska; Pollock in Statistical
entitled ‘‘Actions Concerning Pursuant to the Congressional Review Area 630 in the Gulf of Alaska
Regulations That Significantly Affect Act (5 U.S.C. 801 et seq.), EPA will AGENCY: National Marine Fisheries
Energy Supply, Distribution, or Use’’ (66 submit a report containing this rule and Service (NMFS), National Oceanic and
FR 28355, May 22, 2001); Executive other required information to the U.S. Atmospheric Administration (NOAA),
Order 13045, entitled ‘‘Protection of Senate, the U.S. House of Commerce.
Children from Environmental Health Representatives, and the Comptroller ACTION: Temporary rule; closure.
Risks and Safety Risks’’ (62 FR 19885, General of the United States prior to
April 23, 1997); or Executive Order publication of the rule in the Federal SUMMARY: NMFS is prohibiting directed
13771, entitled ‘‘Reducing Regulations Register. This action is not a ‘‘major fishing for pollock in Statistical Area
and Controlling Regulatory Costs’’ (82 rule’’ as defined by 5 U.S.C. 804(2). 630 in the Gulf of Alaska (GOA). This
FR 9339, February 3, 2017). This action List of Subjects in 40 CFR Part 180 action is necessary to prevent exceeding
does not contain any information the A season allowance of the 2018 total
collections subject to OMB approval Environmental protection, allowable catch of pollock for Statistical
under the Paperwork Reduction Act Administrative practice and procedure, Area 630 in the GOA.
(PRA) (44 U.S.C. 3501 et seq.), nor does Agricultural commodities, Pesticides
DATES: Effective 1200 hours, Alaska
it require any special considerations and pests, Reporting and recordkeeping
local time (A.l.t.), February 14, 2018,
under Executive Order 12898, entitled requirements.
through 1200 hours, A.l.t., March 10,
‘‘Federal Actions to Address Dated: February 2, 2018. 2018.
Environmental Justice in Minority Donna S. Davis,
Populations and Low-Income FOR FURTHER INFORMATION CONTACT: Josh
Acting Director, Registration Division, Office
Populations’’ (59 FR 7629, February 16, of Pesticide Programs.
Keaton, 907–586–7228.
sradovich on DSK3GMQ082PROD with RULES
1994). SUPPLEMENTARY INFORMATION: NMFS
Therefore, 40 CFR chapter I is
Since tolerances and exemptions that manages the groundfish fishery in the
amended as follows:
are established on the basis of a petition GOA exclusive economic zone
under FFDCA section 408(d), such as PART 180—[AMENDED] according to the Fishery Management
the tolerance in this final rule, do not Plan for Groundfish of the Gulf of
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 Alaska (FMP) prepared by the North
the requirements of the Regulatory continues to read as follows: Pacific Fishery Management Council
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Document Created: 2018-02-17 02:29:29
Document Modified: 2018-02-17 02:29:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| 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). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 7111 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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