Trifluralin; Pesticide Tolerance
Federal Register, Volume 78 Issue 147 (Wednesday, July 31, 2013)
Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)
Rules and Regulations
Pages 46267-46274
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-18420
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
EPA-HQ-OPP-2012-0304; FRL-9393-5
Trifluralin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of trifluralin in or on the oilseed crop group 20. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 31, 2013. Objections and requests for hearings must be received on or before September 30, 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-2012-0304, 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
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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: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-7090; email address: RDFRNotices@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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0304 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 September 30, 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-2012-0304, 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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Summary of Petitioned-For Tolerance
In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 2E8011) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The petition requested that 40 CFR 180.207 be amended by establishing tolerances for residues of the herbicide trifluralin, (alpha, alpha, alpha-trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine), in or on oilseed, crop group 20 at 0.05 parts per million (ppm). That document referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
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Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for trifluralin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with trifluralin follows.
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Toxicological Profile
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The kidney and the liver are the principal target organs for trifluralin in rats and dogs. In subchronic oral studies liver effects include increased liver weights and changes in clinical chemistry parameters. Kidney effects include decreased kidney weights, kidney and bladder tumors, increased blood urea nitrogen (BUN), increases in total protein, aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) in the urine. Also, protein electrophoresis of urine samples showed alpha1-globulin and alpha2-globulin. Kidney effects also included tubular hyaline casts, minimal cortical tubular
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epithelial regeneration, observed microscopically, and an increased incidence of progressive glomerulo-nephritis. In dogs exposed to trifluralin for 1 year, multifocal cortical tubular cytoplasmic pigment deposition was noted in the kidneys of both sexes. In the subchronic studies, blood effects such as lower hemoglobin levels and changes in clinical chemistry were reported in rats.
There was qualitative evidence of increased susceptibility in the rat developmental toxicity study, where fetal developmental effects (increased resorptions and wavy ribs) occurred in the presence of less severe maternal effects (decreases in body weight gain, clinical signs, and changes in organ weights). Also qualitatively, there is an indication of increased sensitivity in the 2-generation reproduction study in the rat in that offspring effects (decreased fetal, neonatal and litter viability) were observed at a dose level where there was less severe maternal toxicity (decreased body weight, body weight gain and food consumption).
In male rats, trifluralin was associated with increased incidence of thyroid follicular cell combined adenoma, papillary adenoma, cystadenoma, and carcinoma tumors. Based on the available data, trifluralin has been classified as a possible human carcinogen. Extensive testing showed, however, that trifluralin is neither mutagenic nor genotoxic, and does not inhibit the polymerization of microtubules in mammalian cells. It is also not a neurotoxicant and does not appear to be an immunotoxicant.
Specific information on the studies received and the nature of the adverse effects caused by trifluralin 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 the document titled ``Trifluralin: Human Health Risk Assessment for the Establishment of Tolerances on Oilseed Crop Group 20'' pages 43-55 in docket ID number EPA-HQ-OPP-2012-0304.
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Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for trifluralin used for human risk assessment is shown in the following Table.
Table 1--Summary of Toxicological Doses and Endpoints for Trifluralin 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 = 100 mg/kg/ Acute RfD = 1.0 mg/ Developmental Toxicity Study Rat.
years of age). day. kg/day. LOAEL = 500 mg/kg/day, based on
UFA = 10x........... aPAD = 1.0 mg/kg/ reduced ossification of the
UFH = 10x........... day. vertebrae and ribs; thickened,
FQPA SF = 1x........ wavy or bent ribs; and increased
total litter resorptions.
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Acute dietary (General population No endpoints identified from the available developmental toxicity studies
including infants and children). (rat and rabbit) were appropriate for an acute dietary assessment for
trifluralin in the general population, including infants and children.
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Chronic dietary (All populations) NOAEL= 2.4 mg/kg/day Chronic RfD = 0.024 Chronic (capsule) Toxicity--Dog.
UFA = 10x........... mg/kg/day. LOAEL = 40 mg/kg/day, based on
UFH = 10x........... cPAD = 0.024 mg/kg/ increased frequency of abnormal
FQPA SF = 1x........ day. stool, decreased body weights and
body weight gains, and decreased
erythrocytes and hemoglobin and
increased thrombocytes (males).
Incidental oral short-term (1 to NOAEL= 10 mg/kg/day. LOC for MOE = 100.. 2-generation Reproduction Study in
30 days). UFA = 10x........... Rats.
UFH = 10x........... LOAEL = 32.5 mg/kg/day, based on
FQPA SF = 1x........ decreased pup weights in both
generations and increased
relative to body liver weights in
the F2b females.
Inhalation short-term (1 to 30 Inhalation study LOC for MOE = 100.. 30-Day Inhalation Study--Rat.
days). NOAEL = 300 mg/kg/ LOAEL = 1000 mg/m\3\ (270 mg/kg/
day (inhalation day), based on increased
absorption rate = methemoglobin and bilirubin in
100%). females and the incidence of
UFA = 10x........... dyspnea and rufflerd fur in males
UFH = 10x........... and females.
FQPA SF = 1x........
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Cancer (Oral, dermal, inhalation) Classification: Possible Human Carcinogen Q1 \*\ = 2.96 x 10-3 (mg/kg/day)-1
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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 trifluralin, EPA considered exposure under the petitioned-
for tolerances as well as all existing trifluralin tolerances in 40 CFR 180.207. EPA assessed dietary exposures from trifluralin in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.
Such effects were identified for trifluralin. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA conducted an unrefined assessment using tolerance level residues, 100 percent crop treated (PCT), and default Dietary Exposure Evaluation Model (DEEM) processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, the chronic dietary exposure and risk estimates are somewhat refined and assumed tolerance level residues, PCT data for some existing uses, and DEEM default processing factors. Pesticide Data Program (PDP) monitoring data were used for carrot, orange, orange juice, pepper, potato, and tomato.
iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that trifluralin should be classified as a possible human carcinogen and a linear approach has been used to quantify cancer risk since no mode of action data are available.
The aggregate cancer risk assessment for the general U.S. population takes into account exposure estimates from dietary consumption of trifluralin from food, residential and drinking water sources. Exposures from residential uses are based on the lifetime average daily dose and assume an exposure period of 5 days per year and 50 years of exposure in a lifetime. Dietary exposure assumptions were quantified using the same estimates as discussed in Unit III.C.1.ii., Chronic exposure.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the average PCT for existing uses as follows:
Almonds: 1%; asparagus: 20%; barley: 1%; green bean: 25%; broccoli: 10%; cabbage: 40%; canola: 2.5%; cantaloupe: 25%; carrot: 40%; cauliflower: 10%; celery: 2.5%; corn: 1%; cotton: 30%; cucumber: 2.5%; dry bean/pea: 10%; garlic: 5%; grapefruit: 1%; grape: 2.5%; honeydew: 20%; lemon: 1%; onion: 2.5%; orange: 1%; peach: 1%; peanut: 5%; pecan: 1%; pepper: 25%; pistachio: 2.5%; potato: 2.5%; pumpkin: 5%; sorghum: 1%; soybean: 5%; squash: 5%; sugarbeet: 2.5%; sugarcane: 5%; sunflower: 10%; tomato: 60%; walnut: 1%; watermelon: 10%; and wheat: 1%.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
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maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which trifluralin may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for trifluralin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of trifluralin. 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 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of trifluralin and its major degradates TR-4 (alpha,alpha,alpha-
trifluoro-5-nitro-N4,N4-dipropyl-toluene-3,4-diamine), TR-6 (5-
trifluoromethyl-3-nitro-1,2-benzenediamine) and TR-15 (2-ethyl-7-nitro-
5-(trifluoromethyl) benzimidazole) (the residues of concern in drinking water) for acute exposures are estimated to be 23.83 parts per billion (ppb) for surface water and 0.0275 ppb for ground water. For chronic exposures for non-cancer assessments they are estimated to be 1.97 ppb for surface water and 0.0275 ppb for ground water. And for cancer assessments are estimated to be 1.59 ppb for surface water and 0.0275 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 23.83 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 1.97 ppb was used to assess the contribution to drinking water. And for cancer dietary risk assessment, the water concentration of value 1.59 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).
Trifluralin is currently registered for the following uses that could result in residential exposures including vegetable gardens, turf, and ornamentals. EPA assessed residential exposure using the following assumptions: EPA evaluated residential handler inhalation exposures, which are considered short-term in duration. The handler assessment did not consider dermal exposures because a dermal endpoint was not identified; in three dermal toxicity studies (21/28 days in rabbits; 21/28 days in rats; and 31-days in rats), trifluralin was tested up to the limit dose (1000 mg/kg/day) and caused no systemic toxicity. Handler exposure scenarios evaluated include the following:
Loading/applying granulars with a push-type spreader;
loading/applying granulars using a spoon, measuring scoop, shaker can, or via hand;
mixing/loading/applying liquids with a hose-end sprayer;
mixing/loading/applying liquids with low pressure handwand sprayer;
mixing/loading/applying liquids with backpack sprayer; and applying trifluralin impregnated fabric squares to soil.
In terms of cancer risk, the Agency considers all exposure to trifluralin, including the dermal and inhalation exposure expected for homeowners, to have an associated carcinogenic risk. Carcinogenic risk for homeowner applicators was assessed based on the application methods outlined above. An upper-end assumption was made that the users assessed will apply trifluralin each season, as labeled, with an assumed exposure period of 5 days per year for 50 years of their life. Specific methods (or scenarios) of application (spreader, sprayer, etc.) were assessed to demonstrate the full range of exposure due to method and area treated, although users are not expected to use one method for 50 years. Carcinogenic risk for homeowner applicators was assessed by combining dermal exposure (adjusted for an estimated 3% absorption based on ethalfluralin data) and inhalation exposure (100% absorption), calculating this exposure on a per day basis (``Lifetime Average Daily Dose'', in mg/kg/day), and then quantifying risk by multiplying the updated upper-bound carcinogenic potency factor (Q1*) of 2.96 x 10-3 (mg/kg/day)-1 by the combined exposure estimate.
There is the potential for post-application exposure for individuals exposed as a result of being in an environment (vegetable garden, golf course turf, turf) that has been previously treated with trifluralin. All residential exposures are considered to be short-term in duration (1-30 days). No acute dietary or short-term dermal points of departure have been selected for trifluralin; therefore; only incidental oral post-application non-cancer risk estimates for children 1 Dermal exposure to residues on lawns
Dermal exposure to golf course turf
Dermal exposure in home vegetable gardens.
There may be post-application residential exposure scenarios for trifluralin which could be combined for purposes of an aggregate exposure assessment. Combinations for residential exposure scenarios should have a reasonable probability of occurring on a single day and the pest that an individual is attempting to
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control must be considered. It is reasonable that an adult may treat their turf and garden on the same day.
The worst case residential exposure for use in the adult non-cancer aggregate assessment reflects residential handler inhalation exposure from applying granules by hand to pre-plant ornamentals.
The worst case residential exposure for use in the children 1-6. EPA generally considers cancer risks (expressed as the probability of an increased cancer case) in the range of 1 in 1 million (or 1 x 10-6) or less to be negligible.
6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to trifluralin residues.
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Other Considerations
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Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography (GC) with electron capture detection (ECD)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.
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International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for trifluralin for the crops addressed in this document.
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Revisions to Petitioned-For Tolerances
PA has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of trifluralin not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.
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Conclusion
Therefore, tolerances are established for residues of trifluralin, including its metabolites and degradates, in or on oilseed, crop group 20 at 0.05 ppm. Compliance with the tolerance level is to be determined by only trifluralin alpha,alpha,alpha-trifluoro-2,6-dinitro-N,N-
dipropyl-p-toluidine, in or on the oilseed, crop group 20.
Also, due to the establishment of the tolerance on oilseed, crop group 20, the existing tolerances for rapeseed, seed; flax, seed; mustard, seed; sunflower, seed; safflower, seed; and cotton undelinted seed are removed as unnecessary.
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Statutory and Executive Order Reviews
This final rule 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children From Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This final rule 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 final rule 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
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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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).
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Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: July 25, 2013.
Lois Rossi,
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. 180.207:
0
a. Revise the introductory text of paragraph (a).
0
b. Remove the commodities cotton undelinted seed; flax, seed; mustard, seed; rapeseed, seed; safflower, seed; and sunflower, seed in the table in paragraph (a).
0
c. Add alphabetically the following commodity to the table in paragraph (a).
The amendment read as follows:
Sec. 180.207 Trifluralin; tolerances for residues.
(a) General. Tolerances are established for residues of trifluralin, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by only trifluralin alpha,alpha,alpha-trifluoro-2,6-dinitro-N,N-dipropyl-
p-toluidine, in or on the commodity.
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Parts per
Commodity million
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* * * * *
Oilseed, crop group 20...................................... 0.05
* * * * *
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* * * * *
FR Doc. 2013-18420 Filed 7-30-13; 8:45 am
BILLING CODE 6560-50-P
