Mesotrione; Pesticide Tolerance, 1508-1512 [E8-181]

Download as PDF 1508 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations Dated: December 28, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. [EPA–HQ–OPP–2006–0093]; FRL–8344–3] the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–1243; e-mail address: montague.kathryn @epa.gov. SUPPLEMENTARY INFORMATION: Mesotrione; Pesticide Tolerance I. General Information Parts per million Commodity Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.475 is amended by revising paragraph (a) to read as follows: I § 180.475 Difenoconazole; tolerances for residues. (a) General. (1) Tolerances are established for residues of the fungicide difenoconazole, 1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on the following commodities: Goat, meat ................................ Goat, meat byproduct (except liver) ...................................... Hog, fat ..................................... Hog, liver .................................. Hog, meat ................................. Hog, meat byproduct (except liver) ...................................... Horse, fat .................................. Horse, liver ............................... Horse, meat .............................. Horse, meat byproduct (except liver) ...................................... Milk ........................................... Sheep, fat ................................. Sheep, liver ............................... Sheep, meat ............................. Sheep, meat byproduct (except liver) ...................................... * * * * 0.05 0.10 0.10 0.20 0.05 0.10 0.10 0.20 0.05 0.10 0.01 0.10 0.20 0.05 0.10 * [FR Doc. E8–15 Filed 1–8–08; 8:45 am] BILLING CODE 6560–50–S Parts per million Commodity Apple, wet pomace ................... Banana1 .................................... Barley, grain ............................. Barley, hay ................................ Barley, straw ............................. Beet, sugar ............................... Beet, sugar, dried pulp ............. Canola, seed ............................ Corn, sweet, forage .................. Corn, sweet, kernel plus cob with husks removed .............. Corn, sweet, stover .................. Cotton, gin byproducts ............. Cotton, undelinted seed ........... Fruit, pome group 11 ................ Grape1 ...................................... Papaya1 .................................... Potato, processed waste .......... Rye, grain1 ................................ Vegetable, fruiting, group 8 ...... Vegetable, tuberous and corm, subgroup 1C ......................... 1 4.5 0.2 0.1 0.05 0.05 0.01 1.9 0.01 0.01 0.01 0.01 0.05 0.05 1.0 0.10 0.30 0.04 0.1 0.60 0.01 There are no U.S. registrations. (2) Tolerances are established for residues of the fungicide difenoconazole, 1-[2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3dioxolan-2-ylmethyl]-1H-1,2,4-triazole, and its metabolite, CGA-205375, 1-[2chloro-4-(4-chloro-phenoxy)phenyl]-2[1,2,4]triazol-1-yl-ethanol, in or on the following commodities: pwalker on PROD1PC71 with NOTICES Commodity Parts per million Cattle, fat .................................. Cattle, liver ................................ Cattle, meat .............................. Cattle, meat byproduct (except liver) ...................................... Eggs .......................................... Goat, fat .................................... Goat, liver ................................. VerDate Aug<31>2005 20:06 Jan 08, 2008 0.10 0.20 0.05 0.10 0.10 0.10 0.20 Jkt 214001 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes tolerances for residues of mesotrione in or on berry, group 13; flax, seed; cranberry; lingonberry; millet, grain; millet, forage; millet, hay; and millet, straw. Syngenta Crop Protection requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective January 9, 2008. Objections and requests for hearings must be received on or before March 10, 2008, 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: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2006–0093. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 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. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any E:\FR\FM\09JAR1.SGM 09JAR1 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. pwalker on PROD1PC71 with NOTICES B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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–2006–0093 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before March 10, 2008. 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 that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA– HQ–OPP–2006–0093, by one of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Petition for Tolerance In the Federal Register of April 26, 2006 (71 FR 24695) (FRL–8063–7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7023) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC. The petition requested that 40 CFR 180.571 be amended by establishing tolerances for residues of the herbicide mesotrione, 2– [4- (methylsulfonyl)-2-nitrobenzoyl]-1,3cyclohexanedione, in or on flax, meal/ seed at 0.01 parts per million (ppm); millet, forage/grain at 0.01 parts per million (ppm); millet, hay/straw at 0.02 ppm; Berry group and cranberry at 0.01 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, to harmonize with the Food and Feed Commodity Vocabulary (http://www.epa.gov/ opphed01/foodfeed/index.htm) EPA has amended the commodity listing to read: Flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage at 0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry, group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02 ppm 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 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 1509 result to infants and children from aggregate exposure to the pesticide chemical residue....’’ These provisions were added to FFDCA by the Food Quality Protection Act (FQPA) of 1996. 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 the petitioned-for tolerance for residues of mesotrione on flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage at 0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02 ppm. EPA’s assessment of exposures and risks associated with establishing the tolerance 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. Specific information on the studies received and the nature of the adverse effects caused by mesotrione as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES, and is identified as ‘‘Mesotrione: Petition 6F7023 Human Health Risk Assessment for Proposed Section 3 New Uses on Berries, Cranberries, Millet, Flax, Grain Sorghum (Section 18)’’ in that docket. Additionally, mesotrione toxicological data are discussed in the final rule published in the Federal Register of June 21, 2001 (66 FR 33187) (FRL– 6787–7). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern (LOC) is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes E:\FR\FM\09JAR1.SGM 09JAR1 1510 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations used for risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/ November/Day–26/p30948.htm. A summary of the toxicological endpoints for mesotrione used for human risk assessment can be found at http://www.regulations.gov in document ‘‘Mesotrione: Petition 6F7023 Human Health Risk Assessment for Proposed Section 3 New Uses on Berries, Cranberries, Millet, Flax, Grain Sorghum (Section 18)’’ at page 16 in docket ID number EPA–HQ–OPP–2006– 0093. pwalker on PROD1PC71 with NOTICES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mesotrione, EPA considered exposure under the petitioned-for tolerances as well as all existing mesotrione tolerances in (40 CFR 180.571). EPA assessed dietary exposures from mesotrione in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1–day or single exposure. No such effects were identified in the toxicological studies for mesotrione; therefore, a quantitative acute dietary exposure assessment is unnecessary. VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculutre (USDA) 1994–1996, and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. iii. Cancer. Mesotrione was negative for carcinogenicity in feeding studies in rats and mice and was classified as ‘‘not likely’’ to be a human carcinogen. Therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for mesotrione in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of mesotrione. 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 First Index Reservoir Screening Tool (FIRST) for dry harvested cranberry and a modified Interim Rice Model for wet harvested cranberry and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of mesotrione for chronic exposures are estimated to be 4.7 parts per billion (ppb) for surface water and 0.18 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 of value 4.7 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Mesotrione is not registered for use on any sites 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 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ Mesotrione, pyrasulfotole, isoxaflutole and topramezone belong to a class of herbicides that inhibit the liver enzyme 4-hydroxyphenylpyruvate dioxygenase (HPPD), which is involved in the catabolism (metabolic breakdown) of tyrosine (an amino acid derived from proteins in the diet). Inhibition of HPPD can result in elevated tyrosine levels in the blood, a condition called tyrosinemia. HPPDinhibiting herbicides have been found to cause a number of toxicities in laboratory animal studies including ocular, developmental, liver and kidney effects. Of these toxicities, it is the ocular effect (corneal opacity) that is highly correlated with the elevated blood tyrosine levels. In fact, rats dosed with tyrosine alone show ocular opacities similar to those seen with HPPD inhibitors. Although the other toxicities may be associated with chemically-induced tyrosinemia, other mechanisms may also be involved. There are marked differences among species in the ocular toxicity associated with inhibition of HPPD. Ocular effects following treatment with HPPD inhibitor herbicides are seen in the rat but not in the mouse. Monkeys also seem to be recalcitrant to the ocular toxicity induced by HPPD inhibition. One explanation of this species-specific response in ocular opacity may be related to the species differences in the clearance of tyrosine. A metabolic pathway exists to remove tyrosine from the blood that involves a liver enzyme called tyrosine aminotransferase (TAT). In contrast to rats where ocular toxicity is observed following exposure to HPPD-inhibiting herbicides, mice and humans are unlikely to achieve the levels of plasma tyrosine necessary to produce ocular opacities because the activity of TAT in these species is much greater compared to rats. HPPD inhibitors (e.g., nitisinone) are used as an effective therapeutic agent to treat patients suffering from rare genetic diseases of tyrosine catabolism. Treatment starts in childhood but is often sustained throughout patient’s lifetime. The human experience indicates that a therapeutic dose (1 milligrams/kilogram/day (mg/kg/day) dose) of nitisinone has an excellent safety record in infants, children and adults and that serious adverse health outcomes have not been observed in a population followed for approximately a decade. Rarely, ocular effects are seen in patients with high plasma tyrosine E:\FR\FM\09JAR1.SGM 09JAR1 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations pwalker on PROD1PC71 with NOTICES levels; however, these effects are transient and can be readily reversed upon adherence to a restricted protein diet. This indicates that an HPPD inhibitor in and of itself cannot easily overwhelm the tyrosine-clearance mechanism in humans. Therefore, exposure to environmental residues of HPPD-inhibiting herbicides are unlikely to result in the high blood levels of tyrosine and ocular toxicity in humans due to an efficient metabolic process to handle excess tyrosine. The Agency continues to study the complex relationships between elevated tyrosine levels and biological effects in various species. Nonetheless, as a worst case scenario, EPA has assessed aggregate exposure to mesotrione based on ocular effects in rats. For similar reasons, a semi-quantitative screening cumulative assessment was conducted using the rat ocular effects and 100% crop treated information. The results of this screening analysis did not indicate a concern. In the future, assessments of HPPD-inhibiting herbicides will consider more appropriate models and cross species extrapolation methods. Therefore, EPA has not conducted cumulative risk assessment with other HPPD inhibitors. 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/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional (‘‘10X’’) tenfold 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. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There is quantitative evidence of increased susceptibility of the young in the oral prenatal developmental toxicity studies in rats, mice, and rabbits and in the multi-generation reproduction study in mice and lack of a developmental VerDate Aug<31>2005 15:44 Jan 08, 2008 Jkt 214001 neurotoxicity study in mice. Quantitative evidence of increased susceptibility was not demonstrated in the multi-generation reproduction study in rats. However, no NOAEL was established for parental or offspring systemic toxicity. There is evidence of a qualitative increase in susceptibility since the tyrosinemia observed in the young was much more severe than that observed in the adults. 3. Conclusion. There are 2 deficiencies in the mesotrione toxicity database. First, a Developmental Neurotoxicity Study has been required to assess the effects on the developing nervous/ocular system from exposed to mesotrione. Second, the mouse 2– generation reproduction study, on which the Reference Dose/ Population Adjusted Dose (RfD/PAD) is based failed to identify a NOAEL. In light of this data gap, the necessity of a reliance on a LOAEL to calculate the RfD/PAD, and the quantitative and qualitative evidence of increased susceptibility of the young discussed above, EPA is raising the 10X FQPA safety factor to the value of 30X. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediateterm, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. There were no effects observed in oral toxicity studies including developmental toxicity studies in rats and rabbits that could be attributable to a single dose (exposure). Therefore, mesotrione 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 exposure to mesotrione from food and water will utilize 51% of the cPAD for the population group (All Infants (<1 year old)). There are no residential uses for mesotrione that result in chronic residential exposure to mesotrione. 3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mesotrione is not registered for use on any sites that would result in residential PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 1511 exposure. Therefore, the aggregate risk is the sum of the risk from food and water. 4. Intermediate-term risk Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mesotrione is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency’s level of concern. 5. Aggregate cancer risk for U.S. population. Mesotrione is classified as a ‘‘not likely’’ to be carcinogenic in humans based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in the rat. Therefore, mesotrione is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to mesotrione residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (high-pressure liquid chromatography fluorescence detector (HPLC/FLD)) 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; e-mail address: residuemethods@epa.gov. B. International Residue Limits There are no CODEX, Canadian, or Mexican tolerances/Maximum Residue Levels for mesotrione residues for the proposed crops. V. Conclusion Therefore, the tolerance is established for residues of mesotrione, 2-[4(methylsulfonyl)-2-nitrobenzoyl]-1,3cyclohexanedione, in or on flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage at 0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and E:\FR\FM\09JAR1.SGM 09JAR1 pwalker on PROD1PC71 with NOTICES 1512 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations 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 rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This 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) (Public Law 104–4). 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 VerDate Aug<31>2005 20:06 Jan 08, 2008 Jkt 214001 Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 28, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.571 is amended by alphabetically adding the following commodities in the table in paragraph (a) to read as follows: I § 180.571 Mesotrione; tolerances for residues. (a) * * * Parts per million Berry, group 13 ............... * * * Cranberry ........................ Flax, seed ....................... Lingonberry ..................... Millet, grain ..................... Millet, forage ................... Millet, hay ....................... Millet, straw ..................... * * * * 0.01 * 0.02 0.01 0.01 0.01 0.01 0.02 0.02 * * [FR Doc. E8–181 Filed 1–8–08; 8:45 am] BILLING CODE 6560–50–S PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 40 CFR Part 180 [EPA–HQ–OPP–2005–0268; FRL–8345–8] The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Commodity ENVIRONMENTAL PROTECTION AGENCY Poly(hexamethylenebiguanide) hydrochloride (PHMB); Exemption from the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the insecticide, Poly(hexamethylenebiguanide) hydrochloride (PHMB) on all food when residues are the result of lawful application of a food contact surface sanitizer containing PHMB as a sanitizer solution in food handling establishments when applied as a sanitizer. Arch Chemicals Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of PHMB. DATES: This regulation is effective January 9, 2008. Objections and requests for hearings must be received on or before March 10, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2005–0268. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only ADDRESSES: E:\FR\FM\09JAR1.SGM 09JAR1

Agencies

[Federal Register Volume 73, Number 6 (Wednesday, January 9, 2008)]
[Rules and Regulations]
[Pages 1508-1512]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-181]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0093]; FRL-8344-3]


Mesotrione; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
mesotrione in or on berry, group 13; flax, seed; cranberry; 
lingonberry; millet, grain; millet, forage; millet, hay; and millet, 
straw. Syngenta Crop Protection requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 9, 2008. Objections and 
requests for hearings must be received on or before March 10, 2008, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0093. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kathryn V. Montague, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; e-mail address: 
montague.kathryn @epa.gov.

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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any

[[Page 1509]]

questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2006-0093 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before March 10, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0093, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 26, 2006 (71 FR 24695) (FRL-8063-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7023) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC. 
The petition requested that 40 CFR 180.571 be amended by establishing 
tolerances for residues of the herbicide mesotrione, 2-[4- 
(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on flax, 
meal/seed at 0.01 parts per million (ppm); millet, forage/grain at 0.01 
parts per million (ppm); millet, hay/straw at 0.02 ppm; Berry group and 
cranberry at 0.01 ppm. That notice referenced a summary of the petition 
prepared by Syngenta Crop Protection, the registrant, which is 
available to the public in the docket, http://www.regulations.gov. 
There were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, to harmonize 
with the Food and Feed Commodity Vocabulary (http://www.epa.gov/
opphed01/foodfeed/index.htm) EPA has amended the commodity listing to 
read: Flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage 
at 0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry, 
group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02 ppm

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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    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 the petitioned-for tolerance 
for residues of mesotrione on flax, seed at 0.01 ppm; millet, grain at 
0.01 ppm; millet, forage at 0.01 ppm; millet, hay at 0.02 ppm; millet, 
straw at 0.02 ppm; berry group 13 at 0.01 ppm, lingonberry at 0.01 ppm 
and cranberry at 0.02 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance 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. Specific information on the studies received and the nature 
of the adverse effects caused by mesotrione 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. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as ``Mesotrione: Petition 6F7023 Human Health Risk 
Assessment for Proposed Section 3 New Uses on Berries, Cranberries, 
Millet, Flax, Grain Sorghum (Section 18)'' in that docket. 
Additionally, mesotrione toxicological data are discussed in the final 
rule published in the Federal Register of June 21, 2001 (66 FR 33187) 
(FRL-6787-7).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes

[[Page 1510]]

used for risk assessment. Uncertainty/safety factors (UFs) are used in 
conjunction with the LOC to take into account uncertainties inherent in 
the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. Safety is assessed for acute and chronic risks by 
comparing aggregate exposure to the pesticide to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The 
aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. 
Short-term, intermediate-term, and long-term risks are evaluated by 
comparing aggregate exposure to the LOC to ensure that the margin of 
exposure (MOE) called for by the product of all applicable UFs is not 
exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for mesotrione used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Mesotrione: Petition 6F7023 Human Health Risk Assessment for 
Proposed Section 3 New Uses on Berries, Cranberries, Millet, Flax, 
Grain Sorghum (Section 18)'' at page 16 in docket ID number EPA-HQ-OPP-
2006-0093.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mesotrione, EPA considered exposure under the petitioned-
for tolerances as well as all existing mesotrione tolerances in (40 CFR 
180.571). EPA assessed dietary exposures from mesotrione in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
mesotrione; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculutre (USDA) 1994-1996, and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed all foods for which there are tolerances 
were treated and contain tolerance-level residues.
    iii. Cancer. Mesotrione was negative for carcinogenicity in feeding 
studies in rats and mice and was classified as ``not likely'' to be a 
human carcinogen. Therefore, a quantitative exposure assessment to 
evaluate cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for mesotrione in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
mesotrione. 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 First Index Reservoir Screening Tool (FIRST) for dry 
harvested cranberry and a modified Interim Rice Model for wet harvested 
cranberry and Screening Concentration in Ground Water (SCI-GROW) 
models, the estimated environmental concentrations (EECs) of mesotrione 
for chronic exposures are estimated to be 4.7 parts per billion (ppb) 
for surface water and 0.18 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 of value 4.7 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).
    Mesotrione is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Mesotrione, pyrasulfotole, isoxaflutole and topramezone belong to a 
class of herbicides that inhibit the liver enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD), which is involved in the 
catabolism (metabolic breakdown) of tyrosine (an amino acid derived 
from proteins in the diet). Inhibition of HPPD can result in elevated 
tyrosine levels in the blood, a condition called tyrosinemia. HPPD-
inhibiting herbicides have been found to cause a number of toxicities 
in laboratory animal studies including ocular, developmental, liver and 
kidney effects. Of these toxicities, it is the ocular effect (corneal 
opacity) that is highly correlated with the elevated blood tyrosine 
levels. In fact, rats dosed with tyrosine alone show ocular opacities 
similar to those seen with HPPD inhibitors. Although the other 
toxicities may be associated with chemically-induced tyrosinemia, other 
mechanisms may also be involved.
    There are marked differences among species in the ocular toxicity 
associated with inhibition of HPPD. Ocular effects following treatment 
with HPPD inhibitor herbicides are seen in the rat but not in the 
mouse. Monkeys also seem to be recalcitrant to the ocular toxicity 
induced by HPPD inhibition. One explanation of this species-specific 
response in ocular opacity may be related to the species differences in 
the clearance of tyrosine. A metabolic pathway exists to remove 
tyrosine from the blood that involves a liver enzyme called tyrosine 
aminotransferase (TAT). In contrast to rats where ocular toxicity is 
observed following exposure to HPPD-inhibiting herbicides, mice and 
humans are unlikely to achieve the levels of plasma tyrosine necessary 
to produce ocular opacities because the activity of TAT in these 
species is much greater compared to rats. HPPD inhibitors (e.g., 
nitisinone) are used as an effective therapeutic agent to treat 
patients suffering from rare genetic diseases of tyrosine catabolism. 
Treatment starts in childhood but is often sustained throughout 
patient's lifetime. The human experience indicates that a therapeutic 
dose (1 milligrams/kilogram/day (mg/kg/day) dose) of nitisinone has an 
excellent safety record in infants, children and adults and that 
serious adverse health outcomes have not been observed in a population 
followed for approximately a decade. Rarely, ocular effects are seen in 
patients with high plasma tyrosine

[[Page 1511]]

levels; however, these effects are transient and can be readily 
reversed upon adherence to a restricted protein diet. This indicates 
that an HPPD inhibitor in and of itself cannot easily overwhelm the 
tyrosine-clearance mechanism in humans.
    Therefore, exposure to environmental residues of HPPD-inhibiting 
herbicides are unlikely to result in the high blood levels of tyrosine 
and ocular toxicity in humans due to an efficient metabolic process to 
handle excess tyrosine. The Agency continues to study the complex 
relationships between elevated tyrosine levels and biological effects 
in various species. Nonetheless, as a worst case scenario, EPA has 
assessed aggregate exposure to mesotrione based on ocular effects in 
rats. For similar reasons, a semi-quantitative screening cumulative 
assessment was conducted using the rat ocular effects and 100% crop 
treated information. The results of this screening analysis did not 
indicate a concern. In the future, assessments of HPPD-inhibiting 
herbicides will consider more appropriate models and cross species 
extrapolation methods. Therefore, EPA has not conducted cumulative risk 
assessment with other HPPD inhibitors. 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/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is quantitative 
evidence of increased susceptibility of the young in the oral prenatal 
developmental toxicity studies in rats, mice, and rabbits and in the 
multi-generation reproduction study in mice and lack of a developmental 
neurotoxicity study in mice. Quantitative evidence of increased 
susceptibility was not demonstrated in the multi-generation 
reproduction study in rats. However, no NOAEL was established for 
parental or offspring systemic toxicity. There is evidence of a 
qualitative increase in susceptibility since the tyrosinemia observed 
in the young was much more severe than that observed in the adults.
    3. Conclusion. There are 2 deficiencies in the mesotrione toxicity 
database. First, a Developmental Neurotoxicity Study has been required 
to assess the effects on the developing nervous/ocular system from 
exposed to mesotrione. Second, the mouse 2-generation reproduction 
study, on which the Reference Dose/ Population Adjusted Dose (RfD/PAD) 
is based failed to identify a NOAEL. In light of this data gap, the 
necessity of a reliance on a LOAEL to calculate the RfD/PAD, and the 
quantitative and qualitative evidence of increased susceptibility of 
the young discussed above, EPA is raising the 10X FQPA safety factor to 
the value of 30X.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. There were no effects observed in oral toxicity 
studies including developmental toxicity studies in rats and rabbits 
that could be attributable to a single dose (exposure). Therefore, 
mesotrione 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 exposure to 
mesotrione from food and water will utilize 51% of the cPAD for the 
population group (All Infants (<1 year old)). There are no residential 
uses for mesotrione that result in chronic residential exposure to 
mesotrione.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Mesotrione is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water.
    4. Intermediate-term risk Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Mesotrione is not registered for use on any sites that would result 
in residential exposure. Therefore, the aggregate risk is the sum of 
the risk from food and water, which do not exceed the Agency's level of 
concern.
    5. Aggregate cancer risk for U.S. population. Mesotrione is 
classified as a ``not likely'' to be carcinogenic in humans based on 
the results of a carcinogenicity study in mice and the combined chronic 
toxicity and carcinogenicity study in the rat. Therefore, mesotrione is 
not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to mesotrione residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-pressure liquid 
chromatography fluorescence detector (HPLC/FLD)) 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; 
e-mail address: residuemethods@epa.gov.

B. International Residue Limits

     There are no CODEX, Canadian, or Mexican tolerances/Maximum 
Residue Levels for mesotrione residues for the proposed crops.

V. Conclusion

    Therefore, the tolerance is established for residues of mesotrione, 
2-[4- (methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on 
flax, seed at 0.01 ppm; millet, grain at 0.01 ppm; millet, forage at 
0.01 ppm; millet, hay at 0.02 ppm; millet, straw at 0.02 ppm; berry 
group 13 at 0.01 ppm, lingonberry at 0.01 ppm and cranberry at 0.02 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and

[[Page 1512]]

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 rule has been exempted from 
review under Executive Order 12866, this rule is not subject to 
Executive Order 13211, 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This 
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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: December 28, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.571 is amended by alphabetically adding the following 
commodities in the table in paragraph (a) to read as follows:


Sec.  180.571  Mesotrione; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Berry, group 13......................................               0.01
                                * * * * *
Cranberry............................................               0.02
Flax, seed...........................................               0.01
Lingonberry..........................................               0.01
Millet, grain........................................               0.01
Millet, forage.......................................               0.01
Millet, hay..........................................               0.02
Millet, straw........................................               0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-181 Filed 1-8-08; 8:45 am]
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