Fluridone; Pesticide Tolerances for Emergency Exemptions
Federal Register, Volume 77 Issue 216 (Wednesday, November 7, 2012)
Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)
Rules and Regulations
Pages 66715-66720
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2012-27066
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2012-0756; FRL-9366-8
Fluridone; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for residues of fluridone in or on cotton. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on cotton. This regulation establishes a maximum permissible level for residues of fluridone in or on cotton commodities. The time-limited tolerances expire on December 31, 2014.
DATES: This regulation is effective November 7, 2012. Objections and requests for hearings must be received on or before January 7, 2013, 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-2012-0756, 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), EPA West 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
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information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Debra Rate, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 306-0309; email address: rate.debra@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
emsp14Crop production (NAICS code 111).
emsp14Animal production (NAICS code 112).
emsp14Food manufacturing (NAICS code 311).
emsp14Pesticide manufacturing (NAICS code 32532).
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How Can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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How can I file an objection or hearing request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-
2012-0756 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 7, 2013. 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-2012-0756, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
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Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for residues of fluridone, 1-
methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, its metabolites and degradates, in or on cotton, undelinted seed at 0.1 parts per million (ppm). These time-limited tolerances expire on December 31, 2014.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.
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 * * *.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' EPA has established regulations governing such emergency exemptions in 40 CFR part 166.
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Emergency Exemption for Fluridone on Cotton and FFDCA Tolerances
This is the first section 18 request received for the use of fluridone on cotton. Since the introduction of glyphosate resistant cotton in 1997, twenty-one weed species have developed resistance to glyphosate. Glyphosate-resistant palmer amaranth is the most serious of these species across all the major agronomic crops in the southern U.S. Glyphosate-resistant palmer amaranth was confirmed in Arkansas in 2006. Since 2006, it has become the most severe weed problem that Arkansas cotton producers face. Greater than 95% of Arkansas cotton and 80% of soybean contain the glyphosate tolerant gene and thus glyphosate is the base herbicide for weed control. A significant economic loss is expected to occur on nearly 25% of acres grown or about 160,000 acres.
After having reviewed the Arkansas emergency exemption application, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of fluridone on cotton for control of glyphosate-resistant palmer amaranth in Arkansas.
As part of its evaluation of the emergency exemption application, EPA
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assessed the potential risks presented by residues of fluridone in or on cotton. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-
limited tolerances expire on December 31, 2014, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on cotton, undelinted seed after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether fluridone meets FIFRA's registration requirements for use on cotton or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of fluridone by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Arkansas to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for fluridone, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.
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Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.''
Consistent with 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 expected as a result of this emergency exemption request and the time-limited tolerances for residues of fluridone on cotton, undelinted seed at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.
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Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates non-threshold risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fluridone used for human risk assessment is shown in Table 1. of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fluridone for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (females 13-49 NOAEL = 125 mg/kg/ aRfD = 1.25 mg/kg/ Developmental toxicity--rabbit.
years of age). day. day. LOAEL = 300 mg/kg/day based on
UFA = 10x........... aPAD = 1.25 mg/kg/ increased incidences of
UFH = 10x........... day.. abortions.
FQPA SF = 1X........
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Chronic dietary (All populations) NOAEL = 15 mg/kg/day cRfD = 0.15 mg/kg/ 2 yr. cancer study in mice.
UFA = 10x........... day. LOAEL = 50 mg/kg/day based on
UFH = 10x........... cPAD = 0.15 mg/kg/ increased alkaline phosphatase
FQPA SF = 1X........ day.. activity and increased incidence
of heptocellular hyperplasia.
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Incidental oral short-term (1-30 NOAEL = 15 mg/kg/day LOC for MOE = 100.. 2 yr. cancer study in mice (same
days) and intermediate-term (1-6 UFA = 10x........... as above).
months) oral, dermal, and UFH = 10x...........
inhalation exposures.
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Cancer (oral, dermal, inhalation) Fluridone is classified as ``not likely'' to be a human carcinogen, based on
the lack of evidence of carcinogenicity in mice and rats. Quantitative
cancer risk assessment is not required.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
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Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluridone, EPA considered exposure under the time-limited tolerances established by this action as well as all existing fluridone tolerances in 40 CFR 180.420. EPA assessed dietary exposures from fluridone in food as follows:
i. Acute exposure. Such effects were identified for fluridone. In estimating acute dietary exposure for the subpopulation, females 13-49 years, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance level residues, DEEM (Ver. 7.81) default processing factors (as necessary) and 100 percent crop treated (PCT) for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance level residues, DEEM (Ver. 7.81) default processing factors (as necessary) and 100 PCT for all commodities.
iii. Cancer. Based on the data summarized in Unit IV.A., EPA has concluded that fluridone does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for fluridone. Tolerance level residues and 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 fluridone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluridone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the FQPA Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluridone for acute exposures are estimated to be 9.6 parts per billion (ppb) for surface water and 0.67 ppb for ground water. EDWCs of fluridone for chronic exposures for non-cancer assessments are estimated to be 2.5 ppb for surface water and 0.67 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 9.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.5 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, swimming in treated water, and flea and tick control on pets).
Fluridone is currently registered for one use that could result in residential handler and residential post-application exposures: Consumer use to control aquatic weeds in ponds. EPA assessed residential exposure using the following assumptions: Residents or consumers may experience short-term (1-30 days) skin contact or inhalation exposures. These exposures are assessed through residential handler scenarios. Post-application exposures of children and adults through contact with treated swimming ponds are also anticipated. These exposures are expected to be short- and intermediate-term (1-6 months) in duration through dermal, ingestion, aural, buccal/sublingual, and nasal/orbital exposure. All residential handler and post-application scenarios from the uses of fluridone have been assessed and no risks of concern have been identified (MOE
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