Diflubenzuron; Pesticide Tolerances for Emergency Exemptions, 72352-72357 [E8-28308]

Download as PDF 72352 Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations Original amendment submission date * November 19, 2007. Date of final publication * November 28, 2008. Citation/description * * * * * Revegetation Success Guidelines; Normal Husbandry Practices; Kansas Regulations: K.A.R. 47–4– 14a(c)(2), (d)(2)(A), (d)(3)(A); K.A.R. 47–5–5a(a)(4), (a)(5), (a)(9), and (a)(11) through (a)(13). [FR Doc. E8–28337 Filed 11–26–08; 8:45 am] § 200.19 BILLING CODE 4310–05–P 2. On page 64508, in the second column, in § 200.19, in amendment 5, instruction B is corrected to read: ‘‘Removing paragraph (d) and redesignating paragraphs (b) and (c) as paragraphs (c) and (d), respectively.’’. Electronic Access to This Document: You can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF) on the Internet at the following site: https://www.ed.gov/news/ fedregister. To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1– 888–293–6498; or in the Washington, DC, area at (202) 512–1530. DEPARTMENT OF EDUCATION 34 CFR Part 200 RIN 1810–AB01 [Docket ID ED–2008–OESE–0003] Title I—Improving the Academic Achievement of the Disadvantaged Office of Elementary and Secondary Education, Department of Education. ACTION: Final rule; correction. dwashington3 on PROD1PC60 with RULES AGENCY: SUMMARY: The Department of Education is correcting a final regulation that was published in the Federal Register on October 29, 2008 (73 FR 64436). The final regulations clarified and strengthened the Title I regulations in the areas of assessment, accountability, public school choice, and supplemental educational services. DATES: Effective November 28, 2008. FOR FURTHER INFORMATION CONTACT: Zollie Stevenson, Jr., Director, Student Achievement and School Accountability Programs, Office of Elementary and Secondary Education, U.S. Department of Education, 400 Maryland Avenue, SW., Room 3W230, Washington, DC 20202–6132. Telephone: (202) 260– 1824. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1– 800–877–8339. Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or computer diskette) on request to the contact person listed under this section. SUPPLEMENTARY INFORMATION: In FR Doc. E8–25270 appearing on page 64436 in the Federal Register on October 29, 2008, the following corrections are made: § 200.7 [Corrected] 1. On page 64508, in the first column, in § 200.7, in amendment 3, instruction D is removed. VerDate Aug<31>2005 14:57 Nov 26, 2008 Jkt 217001 [Corrected] Note: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available on GPO Access at: https://www.gpoaccess.gov/nara/ index.html Dated: November 24, 2008. Kerri L. Briggs, Assistant Secretary for Elementary and Secondary Education. [FR Doc. E8–28266 Filed 11–26–08; 8:45 am] BILLING CODE 4000–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2008–0714; FRL–8388–9] Diflubenzuron; Pesticide Tolerances for Emergency Exemptions Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes time-limited tolerances for combined residues of diflubenzuron and its metabolites p-chlorophenylurea and pchloroaniline in or on alfalfa, forage and alfalfa, hay. This action is in response to EPA’s granting of an emergency exemption under section 18 of the PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on alfalfa and mixed grass/alfalfa fields. This regulation establishes a maximum permissible level for residues of diflubenzuron and its metabolites p-chlorophenylurea and p-chloroaniline, in these food commodities. The time-limited tolerances expire and are revoked on December 31, 2011. This regulation is effective November 28, 2008. Objections and requests for hearings must be received on or before January 27, 2009, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION. DATES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0714. All documents in the docket are listed in the docket index available in https://www.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 https://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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9364; e-mail address: pemberton.libby@epa.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations 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: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides 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 questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. dwashington3 on PROD1PC60 with RULES B. How Can I Access Electronic Copies of this Document? In addition to accessing electronically available documents at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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–2008–0714 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 on or before January 27, 2009. VerDate Aug<31>2005 14:57 Nov 26, 2008 Jkt 217001 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 your copies, identified by docket ID number EPA–HQ–OPP–2008–0714, by one of the following methods: • Federal eRulemaking Portal: https:// 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 Facility’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. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing timelimited tolerances for combined residues of the insecticide diflubenzuron and its metabolites pchlorophenylurea and p-chloroaniline, in or on alfalfa, forage and alfalfa, hay at 6 parts per million (ppm). These timelimited tolerances expire and are revoked on December 31, 2011. EPA will publish a document in the Federal Register to remove the revoked tolerances from the CFR. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related timelimited tolerances to set binding precedents for the application of section 408 of FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 72353 exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ‘‘emergency conditions exist which require such exemption.’’ EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Diflubenzuron on Alfalfa and FFDCA Tolerances The United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA/APHIS) requested the use diflubenzuron to control Mormon crickets and grasshoppers on alfalfa grown for hay to protect pollinators of Spalding’s catchfly, a threatened plant species endemic to the proposed treatment area in Montana. The alfalfa fields are interspersed within the rangeland spray blocks. EPA evaluated this request and found that USDA/APHIS had identified an emergency situation. Thus, EPA concurred on the request. In a separate action, the Oregon Department of Agricultural (ODA) declared a crisis emergency exemption for use of diflubenzuron to control the same pests on alfalfa grown for hay, and mixed grass/alfalfa hay on June 30, 2008. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by combined residues of diflubenzuron in or on alfalfa, forage and alfalfa, hay. In doing so, EPA considered the safety E:\FR\FM\28NOR1.SGM 28NOR1 dwashington3 on PROD1PC60 with RULES 72354 Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. EPA has previously evaluated the use of diflubenzuron on alfalfa and established time-limited tolerances initially for a similar use in Federal Register: September 20, 2002 (67 FR 59177), OPP–2002–0253; FRL–7273–7 in association with earlier emergency exemption request. This notice reestablishes those time-limited tolerances. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2011, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on alfalfa, forage and alfalfa, hay after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether it meets FIFRA’s registration requirements for use on alfalfa, forage and alfalfa, hay or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of diflubenzuron by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than USDA/ODA to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for diflubenzuron, contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. VerDate Aug<31>2005 14:57 Nov 26, 2008 Jkt 217001 IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for combined residues of diflubenzuron on alfalfa, forage and alfalfa, hay at 6 ppm. EPA’s assessment of exposures and risk associated with establishing timelimited tolerances follows. A. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD 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 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 and chronic dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). 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 greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for diflubenzuron used for human risk assessment is discussed in Unit III. B. of the final rule published in the Federal Register of September 19, 2002 (67 FR 59006) (FRL–7200–4). B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to diflubenzuron, EPA considered exposure under the timelimited tolerances established by this action as well as all existing diflubenzuron tolerances in (40 CFR 180.377). EPA assessed dietary exposures from diflubenzuron in food as follows: i. Acute exposure. No such effects were identified in the toxicological studies for diflubenzuron, therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994–1996 and 1998 CSFII. As to residue levels in food, EPA used the established/recommended tolerances for all food commodities, 100 percent crop treated (PCT) information for all proposed and existing uses, and Dietary Exposure Evaluation Model (DEEMTM) Version 7.81 default processing factors for some processed commodities. iii. Cancer. The Agency has classified diflubenzuron as ‘‘Group E,’’ evidence of non-carcinogenicity for humans, based on lack of evidence of carcinogenicity in rats and mice. There are also two metabolites of E:\FR\FM\28NOR1.SGM 28NOR1 dwashington3 on PROD1PC60 with RULES Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in male rats and hepatocellular adenomas/ carcinomas in male mice in a National Toxicology Program (NTP) study. Therefore, EPA classified PCA as a ‘‘Group B2’’ probable human carcinogen. The Agency determined for those commodities that contained PCA and CPU, the Q1* of PCA should be used to calculate the cancer risk from the sum of these two metabolites. Based on the submitted metabolism studies, there are two possible sources for dietary exposure to PCA and CPU: residues in mushrooms and residues in milk and liver. Because human exposure to PCA and CPU will not be affected by the proposed new uses, and EPA has previously concluded that exposure to these compounds is safe, therefore, the cancer dietary risk from PCA and CPU will not be addressed in this document. For a detailed discussion on the exposure and risks to PCA and CPU, please refer to the September, 2002 Federal Register document titled Diflubenzuron; Pesticide Tolerances (September 19, 2002, FR 67 59006); https://www.epa.gov/fedrgstr/EPA-PEST/ 2002/September/Day-19/p23818.htm. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for diflubenzuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of diflubenzuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://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 (SCIGROW) models, the estimated drinking water concentrations (EDWCs) of diflubenzuron and the major degradate CPU for chronic exposures are estimated to be 2.76 ppb for surface water and 0.208 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model DEEMTM-Food Commodity Intake Database (FCID), Version 2.03). For chronic dietary risk assessment, the annual average concentration of 2.76 ppb was used to represent the drinking water contribution to chronic dietary exposure for diflubenzuron. 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, VerDate Aug<31>2005 14:57 Nov 26, 2008 Jkt 217001 indoor pest control, termiticides, and flea and tick control on pets). Although there are no registered homeowner uses, there are registered uses for professional applications to outdoor residential and recreational areas to control mosquitoes, moths, and other insects. However, the potential for post-application residential exposure is expected to be limited, due to the low dermal absorption rate (0.5%) of diflubenzuron, and since it is only applied to the tree canopy, minimal non-occupational exposure is expected. 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.’’ EPA has not found diflubenzuron to share a common mechanism of toxicity with any other substances, and diflubenzuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that diflubenzuron does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at https:// www.epa.gov/pesticides/cumulative. C. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Based on the developmental and PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 72355 reproductive toxicity studies, there is no indication of increased susceptibility of rats or rabbits to in utero or postnatal exposure. 3. Conclusion. There is a complete toxicity database for diflubenzuron and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for diflubenzuron is complete. ii. There is no indication that diflubenzuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that diflubenzuron results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2–generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to diflubenzuron in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by diflubenzuron. There are currently no registered or proposed residential (non-occupational) uses of diflubenzuron for homeowners. Although there are no registered homeowner uses, there is potential for professional applications to outdoor residential and recreational areas. However, the potential for postapplication residential exposures are expected to be limited. Due to the low dermal absorption rate (0.5%) of diflubenzuron, and since it is only applied to the tree canopy to control gypsy moths and mosquitoes, minimal bystander contact is expected. D. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of E:\FR\FM\28NOR1.SGM 28NOR1 dwashington3 on PROD1PC60 with RULES 72356 Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified, therefore, no acute dietary endpoint was selected. Therefore, diflubenzuron is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to diflubenzuron from food and water will utilize 12% of the cPAD for the U.S. population, 12% of the cPAD for (all infants less than 1 year old) and 38% of the cPAD for children 1-2 years old. There are no residential uses for diflubenzuron that result in chronic residential exposure. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Diflubenzuron is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to diflubenzuron through food and water. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). Diflubenzuron is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to diflubenzuron through food and water, which has already been addressed. 5. Aggregate cancer risk for U.S. population. Based on the available evidence, which included adequate carcinogenicity studies in rats and mice, and battery of negative mutagenicity studies, diflubenzuron has been classified as ‘‘Group E,’’ evidence of non-carcinogenicity for humans, by the Agency. As noted in Unit IV.B.1.iii. of this document, the Agency has concluded that human exposure to PCA and CPU (metabolites of diflubenzuron) will not be affected by the proposed VerDate Aug<31>2005 14:57 Nov 26, 2008 Jkt 217001 new uses. EPA has previously found aggregate exposure to these compounds to be safe. (September 19, 2002, 67 FR 59006); at https://www.epa.gov/fedrgstr/ EPA-PEST/2002/September/Day-19/ p23818.htm. 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 diflubenzuron residues. V. Other Considerations A. Analytical Enforcement Methodology There are adequate enforcement methods, published in the Pesticide Analytical Manual (PAM, Vol. II), for determining diflubenzuron residues of concern. In addition, a new analytical methodology for plant commodities was successfully validated by an independent laboratory as well as by Agency chemists at the Analytical Chemistry Branch (ACB)/Biological and Economics Analysis Division (BEAD) in conjunction with an approved rice petition (PP 8F4925). The new methods were forwarded to the Food and Drug Administration (FDA) for publication in PAM Vol. II as Roman Numeral Methods. These methods can separately determine residues of diflubenzuron by gas chromatography/electron-capture detection (GC/ECD), CPU by GC/ECD, and PCA by GC/mass spectrometry (MS). B. International Residue Limits There are no Codex maximum residue limits established for diflubenzuron on alfalfa forage and hay. VI. Conclusion Therefore, time-limited tolerances are established for combined residues of the insecticide diflubenzuron, (N-[[(4chlorophenyl)amino]carbonyl]-2,6difluorobenzamide and its metabolites 4-chlorophenylurea and 4-chloroaniline, in or on alfalfa, forage and alfalfa, hay at 6 ppm. These tolerances expire and are revoked on December 31, 2011. VII. Statutory and Executive Order Reviews This final rule establishes tolerances under sections 408(e) and 408(l)(6) of FFDCA 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 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 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 in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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 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) (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). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 73, No. 230 / Friday, November 28, 2008 / Rules and Regulations 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: November 7, 2008. Deborah McCall, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: ■ PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.377(b), amend the table under the heading ‘‘Expiration/ Revocation Date’’ by replacing the phrase ‘‘6/30/07’’ to read ‘‘12/31/11’’ for the entries ‘‘Alfalfa, forage’’ and ‘‘Alfalfa, hay.’’ ■ [FR Doc. E8–28308 Filed 11–26–08; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA–2007–29083; Docket No. NHTSA–2007–28707] Federal Motor Vehicle Safety Standards: Tires; Correction, Occupant Crash Protection; Correction National Highway Traffic Safety Administration (NHTSA), Department of Transportation. ACTION: Final rule; correcting amendments. dwashington3 on PROD1PC60 with RULES AGENCY: SUMMARY: This document corrects Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New pneumatic radial tires for light vehicles, which specifies tire dimensions, test VerDate Aug<31>2005 14:57 Nov 26, 2008 Jkt 217001 requirements, and labeling requirements and which defines tire load ratings for certain types of light vehicle tires. The corrections relate to a definition for snow tires and tire marking requirements, which were inadvertently removed. This document also corrects FMVSS No. 208, Occupant Crash Protection, with respect to specifying a test tolerance for a procedure used to test air bag suppression systems and low risk deployment systems. DATES: Effective December 29, 2008. FOR FURTHER INFORMATION CONTACT: Ms. Rebecca Yoon, Office of the Chief Counsel, by telephone at (202) 366– 2992, by fax at (202) 366–3820, or by mail at the following address: National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590. SUPPLEMENTARY INFORMATION: FMVSS No. 139 FMVSS No. 139 specifies tire dimensions, test requirements, and labeling requirements, and defines tire load ratings for new pneumatic radial tires for use on certain motor vehicles that have a gross vehicle weight rating (GVWR) of 10,000 pounds or less. The tire labeling requirements, S5.5(a) through (h) of the standard, were originally added to FMVSS No. 139 in November 2002 to maintain consistent labeling requirements for all tires for use on light vehicles.1 S5.5(i), concerning the ‘‘Alpine Symbol’’ for snow tires, was added to FMVSS No. 139 in January 2006 to allow manufacturers to certify snow tires to special requirements for snow tires, and to help consumers identify those tires.2 However, the January 2006 amendments adding S5.5(i) inadvertently did not reference this subparagraph (i) in the introductory paragraph of S5.5. To correct that oversight, the agency issued an August 2007 final rule intending to amend only the introductory paragraph of S5.5 to specify that the subparagraphs included (a) through (i).3 However, the rule inadvertently removed the nine subparagraphs (a) through (i) of S5.5. This document corrects the CFR by adding the inadvertently removed paragraphs of FMVSS No. 139. Additionally, in the August 2007 final rule, the agency added a definition for ‘‘light truck (LT) tires’’ but inadvertently removed the definition of ‘‘snow tire’’ from the list of definitions in S3. The 1 67 FR 69600 (Nov. 18, 2002). FR 877 (Jan. 6, 2006). 3 72 FR 49207, 49209–10 (Aug. 28, 2007). 2 71 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 72357 ‘‘snow tire’’ definition is needed in the standard to make clearer how the standard applies to snow tires. This document corrects the CFR by adding the inadvertently removed snow tire definition. We are also correcting FMVSS No. 139 to address another labeling requirement that had been inadvertently omitted from the standard when labeling requirements were moved from FMVSS No. 119 to FMVSS No. 139. This was the requirement that light truck tires load range C, D, and E be labeled with the tire load range designation on both sides of the tire. The agency did not intend to change (delete) the requirement then in FMVSS No. 119 that the tire load range designation be labeled on the tires.4 Today’s document reinstates the labeling requirement. FMVSS No. 208 FMVSS No. 208 requires passenger vehicles to be equipped with seat belts and frontal air bags for the protection of vehicle occupants in crashes. On July 24, 2007, NHTSA issued a final rule that established test procedures for installing child restraint systems (CRSs) to a child restraint anchorage system in a front passenger seating position in vehicles certified to meet advanced air bag requirements through the use of a suppression system or low risk deployment system.5 As part of the procedure for installing child restraints with a rigid ratchet mechanism built into the CRS, the agency stated in the preamble that a force of 475 ±25 Newtons (N) will be applied to the CRS (72 FR at 40256, columns 1 and 2). However, S20.2.1.6.2(g) and S22.2.1.6.2(h) of the regulatory text inadvertently did not specify the tolerance of ±25 N. The lack of a specified tolerance may prove to be misleading and needs to be clarified. This document corrects the CFR by adding the ±25 N tolerance to those sections of the standard. List of Subjects in 49 CFR Part 571 Motor vehicles, Motor vehicle safety; Reporting and recordkeeping requirements; Tires. ■ Accordingly, 49 CFR part 571 is corrected by making the following correcting amendments: 4 Notice of proposed rulemaking (NPRM), 66 FR 65536, December 19, 2001. The only change to FMVSS No. 119 labeling requirements discussed in the preamble of the NPRM related to locating the type of ply, cord, and tube on one sidewall only, rather than both sides. 66 FR at 65564. Current tires are labeled with the C, D, and E tire load range designation on both sides of the tire. 5 72 FR 40252. E:\FR\FM\28NOR1.SGM 28NOR1

Agencies

[Federal Register Volume 73, Number 230 (Friday, November 28, 2008)]
[Rules and Regulations]
[Pages 72352-72357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28308]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0714; FRL-8388-9]


Diflubenzuron; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of diflubenzuron and its metabolites p-
chlorophenylurea and p-chloroaniline in or on alfalfa, forage and 
alfalfa, hay. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on alfalfa and mixed grass/alfalfa fields. This regulation establishes 
a maximum permissible level for residues of diflubenzuron and its 
metabolites p-chlorophenylurea and p-chloroaniline, in these food 
commodities. The time-limited tolerances expire and are revoked on 
December 31, 2011.

DATES: This regulation is effective November 28, 2008. Objections and 
requests for hearings must be received on or before January 27, 2009, 
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-2008-0714. All documents in the 
docket are listed in the docket index available in https://
www.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 https://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: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; e-mail address: pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 72353]]

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
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 
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 electronically available documents at 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at https://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
The EPA procedural regulations which govern the submission of 
objections and requests for hearings appear in 40 CFR part 178. 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-
2008-0714 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 on or before January 27, 2009.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0714, by one of the following methods:
     Federal eRulemaking Portal: https://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 Facility'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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for combined residues of the insecticide 
diflubenzuron and its metabolites p-chlorophenylurea and p-
chloroaniline, in or on alfalfa, forage and alfalfa, hay at 6 parts per 
million (ppm). These time-limited tolerances expire and are revoked on 
December 31, 2011. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Diflubenzuron on Alfalfa and FFDCA 
Tolerances

    The United States Department of Agriculture, Animal and Plant 
Health Inspection Service (USDA/APHIS) requested the use diflubenzuron 
to control Mormon crickets and grasshoppers on alfalfa grown for hay to 
protect pollinators of Spalding's catchfly, a threatened plant species 
endemic to the proposed treatment area in Montana. The alfalfa fields 
are interspersed within the rangeland spray blocks. EPA evaluated this 
request and found that USDA/APHIS had identified an emergency 
situation. Thus, EPA concurred on the request.
    In a separate action, the Oregon Department of Agricultural (ODA) 
declared a crisis emergency exemption for use of diflubenzuron to 
control the same pests on alfalfa grown for hay, and mixed grass/
alfalfa hay on June 30, 2008.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by combined residues of 
diflubenzuron in or on alfalfa, forage and alfalfa, hay. In doing so, 
EPA considered the safety

[[Page 72354]]

standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of FFDCA would be 
consistent with the safety standard and with FIFRA section 18. EPA has 
previously evaluated the use of diflubenzuron on alfalfa and 
established time-limited tolerances initially for a similar use in 
Federal Register: September 20, 2002 (67 FR 59177), OPP-2002-0253; FRL-
7273-7 in association with earlier emergency exemption request. This 
notice re-establishes those time-limited tolerances. Consistent with 
the need to move quickly on the emergency exemption in order to address 
an urgent non-routine situation and to ensure that the resulting food 
is safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of 
FFDCA. Although these time-limited tolerances expire and are revoked on 
December 31, 2011, under section 408(l)(5) of FFDCA, residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on alfalfa, forage and alfalfa, hay after that date 
will not be unlawful, provided the pesticide was applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by these time-limited tolerances at the time of 
that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether it 
meets FIFRA's registration requirements for use on alfalfa, forage and 
alfalfa, hay or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
diflubenzuron by a State for special local needs under FIFRA section 
24(c). Nor does this tolerance serve as the basis for persons in any 
State other than USDA/ODA to use this pesticide on these crops under 
FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for diflubenzuron, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with the factors specified in section 408(b)(2)(D) of 
FFDCA, EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of this emergency exemption request and 
the time-limited tolerances for combined residues of diflubenzuron on 
alfalfa, forage and alfalfa, hay at 6 ppm. EPA's assessment of 
exposures and risk associated with establishing time-limited tolerances 
follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
     A summary of the toxicological endpoints for diflubenzuron used 
for human risk assessment is discussed in Unit III. B. of the final 
rule published in the Federal Register of September 19, 2002 (67 FR 
59006) (FRL-7200-4).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to diflubenzuron, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
diflubenzuron tolerances in (40 CFR 180.377). EPA assessed dietary 
exposures from diflubenzuron in food as follows:
    i. Acute exposure. No such effects were identified in the 
toxicological studies for diflubenzuron, therefore, a quantitative 
acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used the established/
recommended tolerances for all food commodities, 100 percent crop 
treated (PCT) information for all proposed and existing uses, and 
Dietary Exposure Evaluation Model (DEEM\TM\) Version 7.81 default 
processing factors for some processed commodities.
    iii. Cancer. The Agency has classified diflubenzuron as ``Group 
E,'' evidence of non-carcinogenicity for humans, based on lack of 
evidence of carcinogenicity in rats and mice. There are also two 
metabolites of

[[Page 72355]]

diflubenzuron; PCA and CPU. PCA tested positive for splenic tumors in 
male rats and hepatocellular adenomas/carcinomas in male mice in a 
National Toxicology Program (NTP) study. Therefore, EPA classified PCA 
as a ``Group B2'' probable human carcinogen. The Agency determined for 
those commodities that contained PCA and CPU, the Q1* of PCA should be 
used to calculate the cancer risk from the sum of these two 
metabolites. Based on the submitted metabolism studies, there are two 
possible sources for dietary exposure to PCA and CPU: residues in 
mushrooms and residues in milk and liver. Because human exposure to PCA 
and CPU will not be affected by the proposed new uses, and EPA has 
previously concluded that exposure to these compounds is safe, 
therefore, the cancer dietary risk from PCA and CPU will not be 
addressed in this document. For a detailed discussion on the exposure 
and risks to PCA and CPU, please refer to the September, 2002 Federal 
Register document titled Diflubenzuron; Pesticide Tolerances (September 
19, 2002, FR 67 59006); https://www.epa.gov/fedrgstr/EPA-PEST/2002/
September/Day-19/p23818.htm.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for diflubenzuron in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of diflubenzuron. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://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 
diflubenzuron and the major degradate CPU for chronic exposures are 
estimated to be 2.76 ppb for surface water and 0.208 ppb for ground 
water. Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model DEEM\TM\-Food Commodity Intake 
Database (FCID), Version 2.03). For chronic dietary risk assessment, 
the annual average concentration of 2.76 ppb was used to represent the 
drinking water contribution to chronic dietary exposure for 
diflubenzuron.
    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).
    Although there are no registered homeowner uses, there are 
registered uses for professional applications to outdoor residential 
and recreational areas to control mosquitoes, moths, and other insects. 
However, the potential for post-application residential exposure is 
expected to be limited, due to the low dermal absorption rate (0.5%) of 
diflubenzuron, and since it is only applied to the tree canopy, minimal 
non-occupational exposure is expected.
    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.''
    EPA has not found diflubenzuron to share a common mechanism of 
toxicity with any other substances, and diflubenzuron does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
diflubenzuron does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Based on the developmental 
and reproductive toxicity studies, there is no indication of increased 
susceptibility of rats or rabbits to in utero or postnatal exposure.
    3. Conclusion. There is a complete toxicity database for 
diflubenzuron and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA has 
determined that reliable data show that the safety of infants and 
children would be adequately protected if the FQPA SF were reduced to 
1X. That decision is based on the following findings:
    i. The toxicity database for diflubenzuron is complete.
    ii. There is no indication that diflubenzuron is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that diflubenzuron results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to diflubenzuron in 
drinking water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by diflubenzuron. There are currently no 
registered or proposed residential (non-occupational) uses of 
diflubenzuron for homeowners. Although there are no registered 
homeowner uses, there is potential for professional applications to 
outdoor residential and recreational areas. However, the potential for 
post-application residential exposures are expected to be limited. Due 
to the low dermal absorption rate (0.5%) of diflubenzuron, and since it 
is only applied to the tree canopy to control gypsy moths and 
mosquitoes, minimal bystander contact is expected.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of

[[Page 72356]]

additional cancer cases given the estimated aggregate exposure. Short-, 
intermediate-, and chronic-term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the POD to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified, therefore, no acute dietary endpoint was selected. 
Therefore, diflubenzuron is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
diflubenzuron from food and water will utilize 12% of the cPAD for the 
U.S. population, 12% of the cPAD for (all infants less than 1 year old) 
and 38% of the cPAD for children 1-2 years old. There are no 
residential uses for diflubenzuron that result in chronic residential 
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Diflubenzuron is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term aggregate 
risk is the sum of the risk from exposure to diflubenzuron through food 
and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Diflubenzuron is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to diflubenzuron through food and water, which has already been 
addressed.
    5. Aggregate cancer risk for U.S. population. Based on the 
available evidence, which included adequate carcinogenicity studies in 
rats and mice, and battery of negative mutagenicity studies, 
diflubenzuron has been classified as ``Group E,'' evidence of non-
carcinogenicity for humans, by the Agency. As noted in Unit IV.B.1.iii. 
of this document, the Agency has concluded that human exposure to PCA 
and CPU (metabolites of diflubenzuron) will not be affected by the 
proposed new uses. EPA has previously found aggregate exposure to these 
compounds to be safe. (September 19, 2002, 67 FR 59006); at https://
www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-19/p23818.htm.
    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 diflubenzuron residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate enforcement methods, published in the Pesticide 
Analytical Manual (PAM, Vol. II), for determining diflubenzuron 
residues of concern. In addition, a new analytical methodology for 
plant commodities was successfully validated by an independent 
laboratory as well as by Agency chemists at the Analytical Chemistry 
Branch (ACB)/Biological and Economics Analysis Division (BEAD) in 
conjunction with an approved rice petition (PP 8F4925). The new methods 
were forwarded to the Food and Drug Administration (FDA) for 
publication in PAM Vol. II as Roman Numeral Methods. These methods can 
separately determine residues of diflubenzuron by gas chromatography/
electron-capture detection (GC/ECD), CPU by GC/ECD, and PCA by GC/mass 
spectrometry (MS).

B. International Residue Limits

    There are no Codex maximum residue limits established for 
diflubenzuron on alfalfa forage and hay.

VI. Conclusion

    Therefore, time-limited tolerances are established for combined 
residues of the insecticide diflubenzuron, (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6-difluorobenzamide and its metabolites 
4-chlorophenylurea and 4-chloroaniline, in or on alfalfa, forage and 
alfalfa, hay at 6 ppm. These tolerances expire and are revoked on 
December 31, 2011.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) of FFDCA 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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 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) (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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides

[[Page 72357]]

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: November 7, 2008.
Deborah McCall,
Acting 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. In Sec.  180.377(b), amend the table under the heading ``Expiration/
Revocation Date'' by replacing the phrase ``6/30/07'' to read ``12/31/
11'' for the entries ``Alfalfa, forage'' and ``Alfalfa, hay.''

[FR Doc. E8-28308 Filed 11-26-08; 8:45 am]
BILLING CODE 6560-50-S