Rules and Regulations. Final rule

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BILLING CODE 3710-08-M ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0654; FRL-8093-4] Cyproconazole; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for residues of cyproconazole ((2RS,3RS)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H -1,2,4- triazole-1-yl)butan-2-ol) in or on soybean seed. This action is associated with 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 soybeans.

This regulation establishes a maximum permissible level for residues of cyproconazole in this food commodity. The tolerance will expire and be revoked on December 31, 2009. DATES: This regulation is effective December 8, 2006. Objections and requests for hearings must be received on or before February 6, 2007, 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-2006-0654. All documents in the docket are listed on the regulations.gov website. 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 available in hard copy, at the Office of Pesticide Programs

(OPP)Regulatory Public Docket in Room S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive Arlington, VA 22202-3553. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)306-0327; fax:

(703)308-8041; e-mail address: *rodia.carmen@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: • 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 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 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 the FFDCA, as amended by the FQPA, 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-2006-0654 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 February 6, 2007. 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-2006-0654, 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 Avenue, NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Room S-4400, One Potomac Yard (South Building), 2777 South Crystal Drive, Arlington, VA 22202-3553. 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 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 the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and 346a(l)(6), is establishing a tolerance for residues of the fungicide cyproconazole, in or on soybean seed at 0.10 parts per million (ppm). This tolerance will expire and be revoked on December 31, 2009. EPA will publish a document in the **Federal Register** to remove the revoked tolerance from the Code of Federal Regulations (CFR). Section 408(l)(6) of the 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 tolerances to set binding precedents for the application of the section 408 safety standard to other tolerances and exemptions. Section 408(e) of the 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 the 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 the 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 the 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 the 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 Cyproconazole on Soybeans and FFDCA Tolerances Australasian soybean rust

(SBR)is a plant disease caused by two fungal species, *Phakopsora pachyrhizi* and *P. meibomiae* , and is spread primarily by windborne spores that can be transported over long distances. SBR models suggest that most of the soybean acreage in the U.S. could be compromised by an SBR epidemic. In accordance with the 2002 Agricultural Bioterrorism Protection Act, SBR was identified by USDA as a select biological agent with the potential to pose a severe threat to the soybean industry and livestock production, in general. As such, USDA has invested in extensive readiness and outreach activities among soybean producers. The states of Minnesota and South Dakota petitioned EPA to allow under FIFRA section 18, the use of cyproconazole on soybeans for control of Australasian soybean rust in Minnesota and South Dakota. After having reviewed the submission, EPA concurs that emergency conditions exist for these States. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of cyproconazole in or on soybeans. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance expires and is revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on soybean seed after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether cyproconazole meets EPA's registration requirements for use on soybeans or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of cyproconazole by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for growers in any State other than those in which State lead agencies have obtained an exemption to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for cyproconazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . Consistent with section 408(b)(2)(D) of the 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 cyproconazole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for residues of cyproconazole in or on soybean seed at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows. A. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect 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. An UF of 100 is routinely used, 10x to account for interspecies differences and 10x for intra species differences. For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10x to account for interspecies differences and 10x for intraspecies differences), the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure

(MOE)= NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE <sup>cancer</sup> = point of departure/exposures) is calculated. A summary of the toxicological endpoints for cyproconazole used for human risk assessment is shown in the following Table: **Summary of Toxicological Dose and Endpoints for Cyproconazole for Use in Human Risk Assessment** Exposure/Scenario Dose Used in Risk Assessment, UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary (U.S. general population including infants and children) Not applicable None An endpoint of concern (effect) attributable to a single exposure

(dose)for the U.S. General Population was not identified in the oral toxicity studies reviewed. Acute Dietary (Females 13-49 years of age) LOAEL = 2.0 mg/kg/day UF = 300 Acute RfD = 2.0 mg/kg/day/300 = 0.01 mg/kg/day FQPA SF = 1x aPAD = acute RfD ÷ FQPA SF = 0.01 mg/kg/day Developmental toxicity - Chinchilla rabbits; LOAEL = 2.0 mg/kg/day based on hydrocephalus internus observed in one fetus at each treatment level. Chronic Dietary (All populations) NOAEL = 1.0 mg/kg/day UF = 100 Chronic RfD = 1.0 mg/kg/day/100 = 0.01 mg/kg/day FQPA SF = 1x cPAD = chronic RfD÷FQPA SF = 0.01 mg/kg/day Chronic oral toxicity - dog; LOAEL = 3.2 mg/kg/day based on liver effects (P450 induction in females and histopathology, laminar eosinophilic intrahepatocytic bodies in males). Short-Term Incidental Oral (1 to 30 days) Intermediate-Term Incidental Oral (1 to 6 months) NOAEL = 1.5 mg/kg/day Residential LOC for MOE = 100 Occupational LOC for MOE = 100 90-day oral toxicity - rat; LOAEL = 27.3 mg/kg/day based on decreased body weight gain in males and increased liver weight in females. Short-Term Dermal (1 to 30 days) Intermediate-Term Dermal (1 to 6 months) NOAEL = 2.0 mg/kg/day (dermal absorption rate = 11%) Residential LOC for MOE = 300 Occupational LOC for MOE = 300 Developmental toxicity - Chinchilla rabbits; LOAEL = 2.0 mg/kg/day based on hydrocephalus internus observed in one fetus at each treatment level. Long-Term Dermal (>6 months) NOAEL = 1.0 mg/kg/day (dermal absorption rate = 11%) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Chronic oral toxicity - dog; LOAEL = 3.2 mg/kg/day based on liver effects (P450 induction in females and histopathology, laminar eosinophilic intrahepatocytic bodies in males). Short-Term Inhalation (1 to 30 days) Intermediate-Term Inhalation (1 to 6 months) NOAEL = 2.0 mg/kg/day (inhalation-absorption rate = 100% oral equivalent) Residential LOC for MOE = 300 Occupational LOC for MOE = 300 Developmental toxicity - Chinchilla rabbits; LOAEL = 2.0 mg/kg/day based on hydrocephalus internus observed in one fetus at each treatment level. Long-Term Inhalation (>6 months) NOAEL = 1.0 mg/kg/day (inhalation-absorption rate = 100% oral equivalent) Residential LOC for MOE = 100 Occupational LOC for MOE = 100 Chronic oral toxicity - dog; LOAEL = 3.2 mg/kg/day based on liver effects (P450 induction in females and histopathology, laminar eosinophilic intrahepatocytic bodies in males). Cancer (oral, dermal, inhalation) Cyproconazole has been classified as a Group B2, probable human carcinogen; Q1* is 1.58 x 10 -1 (mg/kg/day) -1 in human equivalents, based on male mouse liver adenoma and/or carcinoma combined tumor rates. * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA. UF = uncertainty factor; FQPA SF = Special FQPA safety factor; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose; MOE = margin of exposure; and LOC = level of concern. B. Exposure Assessment 1. *Dietary exposure from food and feed uses.* A tolerance has been established (40 CFR 180.485) for residues of cyproconazole in or on the imported agricultural commodity coffee, bean, green. There are no U.S. registrations for cyproconazole on raw agricultural commodities at this time. Risk assessments were conducted by EPA to assess dietary exposures from cyproconazole in food as follows: i. *Acute exposure* . Acute dietary risk assessments are performed for a food use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The acute dietary exposure analysis for cyproconazole is based on Tier 1 assumptions of tolerance-level residues and 100% crop treated (CT). ii. *Chronic exposure* . In conducting the chronic dietary risk assessment, the DEEM-FCID TM analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The chronic dietary exposure analysis for cyproconazole is refined in that it incorporates estimates of anticipated residues

(AR)for all commodities, 10% CT for soybeans and empirical processing factors (a Tier 3 analysis). iii. *Cancer* . The Q1* for cyproconazole is 1.58 x 10 -1 milligrams/kilograms/day (mg/kg/day) in human equivalents, based on liver tumor data in male mice. The 10% CT (i.e., 7.4 million acres) resulted in an acceptable calculated dietary cancer risk of 1.1 x 10 -6 , which is equivalent to the Agency's LOC (generally 1 x 10 -6 ). iv. *Anticipated residue and percent crop treated

(PCT)information* . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must, pursuant to section 408(f)(1), require that data be provided 5 years after the tolerance is established, modified or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information for cyproconazole as follows: As stated in Unit IV.B.1. acute and chronic dietary exposure and risk analyses were conducted to determine the exposure and risk estimates resulting from the use of cyproconazole in soybeans to control Australasian soybean rust. The acute analysis is based on Tier 1 assumptions of tolerance-level residues and 100% CT. The chronic analysis is refined in that it incorporates estimates of AR for all commodities, 10% CT for soybeans and empirical processing factors (a Tier 3 analysis). The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA finds that the PCT information described in Unit IV.B.1. and in the preceding paragraph for cyproconazole used on soybeans is reliable and has a valid basis. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which cyproconazole may be applied in a particular area. 2.—i. *Dietary exposure from drinking water* . The Agency used the Pesticide Root Zone Model and Exposure Analysis Modeling System (PRZM/EXAMS) to calculate estimated drinking water concentrations (EDWCs) for the use of cyproconazole in soybeans, using the standard Mississippi soybean scenario. Thus, the estimated exposure concentrations for water are based on the proposed highest use rate. The Agency used the Generic Expected Environmental Concentration model to calculate estimated environmental concentrations

(EECs)for the use of cyproconazole in turf. Ground water concentrations were estimated with the Screening Concentration in Groundwater (SCI-GROW) model. ii. *Ground water and surface water EDWCs* . A Tier 2 drinking water assessment was conducted for the proposed use of cyproconazole in soybeans using the proposed maximum application rate of 0.026 lbs. a.i./acre with 2 applications per year and a 7-day Retreatment interval (RTI). The Preharvest interval

(PHI)will be 30 days. The linked PRZM and EXAMS models predicted a peak EDWC of 0.79 parts per billion

(ppb)for aerial applications. The PRZM/EXAMS model predicted chronic EDWCs of 0.21 ppb (1-in-10 Year Annual Average) for aerial applications and 0.12 ppb (30-year Annual Average) for ground applications. The SCI-GROW model estimated the concentration of cyproconazole in shallow ground water sources to be 0.027 ppb. 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). Cyproconazole 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 the 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.” Cyproconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects form substances found to have a common mechanism of toxicity see EPA's website at *http://www.epa.gov/pesticides/cumulative.* Cyproconazole is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, including cyproconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with the common metabolites (e.g., use of maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e, high end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10x FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various population subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at *http://www.regulations.gov* , Docket ID number EPA-HQ-OPP-2005-0497-0013. C. Safety Factor for Infants and Children 1. *In general* . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and/or postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. *Developmental toxicity studies* . There is no evidence of increased susceptibility in either the developmental study in rats or in the 2-generation reproduction study in rats. The concern is low for the increased susceptibility in the New Zealand rabbit study since clear NOAELs/LOAELs were established for maternal and developmental toxicities. Similarly, the concern is low for the increased susceptibility in the Chinchilla rabbit study since the incidences of hydrocephaly were low, there was no dose response, the hydrocephaly was not seen at the same doses in the New Zealand White strain of rabbit and this endpoint of concern is used with a 3x FQPA safety factor for risk assessment. A 3x safety factor (as opposed to a 10x) for the lack of a NOAEL in this critical study is adequate because the magnitude of the response was low (low incidences without dose response) and the effect of concern was seen in an unusual strain (Chinchilla) of rabbits and not in the New Zealand strain commonly used in developmental toxicity studies. The Agency evaluated the quality of the hazard and exposure data for cyproconazole and determined that the FQPA safety factor can be reduced to 1x. Therefore, there is no residual uncertainty for prenatal and/or postnatal exposure to cyproconazole. 3. *Reproductive toxicity study* . There was no evidence of reproductive toxicity in the 2-generation reproduction study in rats. In this study, cyproconazole was administered to rats at dose levels of 0, 0.4, 1.7 and 10.6 mg/kg/day. The parental systemic NOAEL is 1.7 mg/kg/day and LOAEL of 10.6 mg/kg/day, based on liver effects. The reproductive toxicity NOAEL is 10.6 mg/kg/day. Although gestation length was slightly increased and litter size decreased, these changes were not considered to be treatment-related. 4. *Prenatal and postnatal sensitivity* . Please refer to the explanation provided above in Unit IV.C.2. for a detailed discussion regarding “prenatal and/or postnatal sensitivity.” 5. *Conclusion* . The Agency evaluated the quality of the hazard and exposure data and determined that, based on the hazard and exposure data, the special FQPA SF is reduced to 1x. In terms of hazard, there are low concerns and no residual uncertainties with regard to prenatal and/or postnatal toxicity. D. Aggregate Risks and Determination of Safety EPA conducted human health risk assessments for acute, chronic and cancer dietary exposures (food + drinking water only) for existing and proposed uses. Because there are no uses of cyproconazole that are expected to result in residential exposures, this aggregate risk assessment takes into consideration dietary food + drinking water exposure only; therefore, the acute and chronic aggregate estimates would be the same as the dietary exposure results. 1. *Acute risk* . Using the exposure assumptions discussed in this unit, the acute dietary exposure from food to cyproconazole will occupy 1.3% of the aPAD for females 13-49 years old. Given existing and proposed uses, the Agency has no risk concern for exposure to cyproconazole through food and/or drinking water. EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to cyproconazole from food will utilize 1% of the cPAD for all infants less than a year old. There are no residential uses for cyproconazole that will result in chronic residential exposure to cyproconazole. Given existing and proposed uses, the Agency has no risk concern for exposure to cyproconazole through food and/or drinking water. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Cyproconazole 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 drinking water, which were previously addressed. 4. *Intermediate-term risk.* Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Cyproconazole 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 drinking water, which were previously addressed. 5. *Aggregate cancer risk for U.S. population* . When relying on the exposure assumptions described in this notice, EPA calculated an acceptable cancer risk of 1.1 x 10 -6 , which is equivalent to the Agency's LOC (generally 1.0 x 10 -6 ). 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. general population and to infants and children from aggregate exposure to cyproconazole residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (example—gas chromatography) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits No CODEX, Canadian or Mexican MRLs or tolerances have been established for cyproconazole on soybeans. Therefore, international harmonization is not an issue at this time. C. Conditions EPA has concluded that the toxicological, residue chemistry, dietary exposure and occupational/residential exposure assessments are adequate to support a time-limited tolerance of 0.10 ppm for residues of cyproconazole per se in/on soybean, seed. VI. Conclusion Therefore, the tolerance is established for residues of cyproconazole per se, in or on soybean, seed at 0.10 ppm. VII. Statutory and Executive Order Reviews This final rule establishes a time-limited tolerance under section 408 of the FFDCA. 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, 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). 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* ., or 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). 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); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 24, 2006. Donald R. Stubbs, 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. Section 180.485 is amended by adding text and table to paragraph

(b)to read as follows: § 180.485 Cyproconazole; tolerances for residues.

(b)*Section 18 emergency exemptions* . A time-limited tolerance is established for residues of the fungicide cyproconazole per se ((2RS,3RS)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H -1,2,4- triazole-1-yl)butan-2-ol) in or on soybean seed in connection with the use of the pesticide under section 18 emergency exemptions granted by EPA. The tolerance will expire and be revoked on the date specified in the following table. Commodity Parts per million Expiration/revocation date Soybean, seed 0.10 12/31/09 [FR Doc. E6-20897 Filed 12-7-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 799 [EPA-HQ-OPPT-2005-0033; FRL-8103-2] RIN 2070-AD16 Revocation of TSCA Section 4 Testing Requirements for Coke-Oven Light Oil

(Coal)AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is amending the test rule entitled Testing of Certain High Production Volume Chemicals promulgated under section 4 of the Toxic Substances Control Act (TSCA). This amendment removes coke-oven light oil

(coal)(CAS No. 65996-78-3) from the list of chemicals subject to the test rule. EPA is basing its decision on information it received after publication of the test rule. Also, upon the effective date of the revocation of the TSCA section 4 testing requirements for coke-oven light oil (coal), persons who export or intend to export coke-oven light oil

(coal)are no longer subject to the TSCA section 12(b) export notification requirements to the extent that they were triggered by the testing requirements being revoked by this action. DATES: This direct final rule is effective on February 6, 2007 without further notice, unless EPA receives adverse comment in writing, or a request to present comments orally, by January 8, 2007. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPPT-2005-0033, by one of the following methods: *Federal eRulemaking Portal* : *http://www.regulation.gov* . Follow the on-line instructions for submitting comments. *Mail* : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. *Hand Delivery* : OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2005-0033. The DCO is open from 8:00 a.m. to 4:00 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is

(202)564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPPT-2005-0033. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/docket.htm* . *Docket* : All documents in the docket are listed in the regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy form. Publicly available docket materials are available electronically at *http://www.regulations.gov* , or, if only available in hard copy, at the OPPT Docket, EPA Docket Center (EPA/DC). The EPA/DC suffered structural damage due to flooding in June 2006. Although the EPA/DC is continuing operations, there will be temporary changes to the EPA/DC during the clean-up. The EPA/DC Public Reading Room, which was temporarily closed due to flooding, has been relocated in the EPA Headquarters Library, Infoterra Room (Room Number 3334) in EPA West, located at 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is

(202)566-1744, and the telephone number for the OPPT Docket is

(202)566-0280. EPA visitors are required to show photographic identification and sign the EPA visitor log. Visitors to the EPA/DC Public Reading Room will be provided with an EPA/DC badge that must be visible at all times while in the EPA Building and returned to the guard upon departure. In addition, security personnel will escort visitors to and from the new EPA/DC Public Reading Room location. Up-to-date information about the EPA/DC is on the EPA website at *http://www.epa.gov/epahome/dockets.htm* . FOR FURTHER INFORMATION CONTACT: *For general information contact* : Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)554-1404; e-mail address: *TSCA-Hotline@epa.gov.* *For technical information contact* : Catherine Roman, Chemical Control Division

(CCD)(7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(202)564-4780; e-mail address: *roman.catherine@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to those persons who manufacture (defined by statute to include import) or process coke-oven light oil (coal). Also, persons that export or intend to export coke-oven light oil

(coal)may have an interest in this action. Upon the effective date of the revocation of the TSCA section 4 testing requirements for coke-oven light oil (coal), persons who export or intend to export coke-oven light oil

(coal)are no longer subject to the TSCA section 12(b) export notification requirements to the extent that they were triggered by the testing requirements being revoked by this action. Because other persons may also be interested, the Agency has not attempted to describe all the specific persons that may be affected by this action. If you have any questions regarding the applicability of this action to a particular person, consult the technical person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Requesting an opportunity to present oral comments to the Agency* . When you submit a request for an opportunity to present oral comments, this request must be in writing. If a written request is received on or before January 8, 2007, EPA will hold a public meeting on this direct final rule in Washington, DC. Submit this written request to the Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. If a written request is received, EPA will announce the scheduling of the public meeting in a subsequent **Federal Register** document. If a public meeting is announced, and if you are interested in attending or presenting oral and/or written comments and data at the public meeting, you should follow the instructions provided in the subsequent **Federal Register** document announcing the public meeting. 3. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. What Action is the Agency Taking? Pursuant to TSCA section 4, EPA published a test rule on March 16, 2006 (Ref. 1) (HPV test rule) requiring that manufacturers (including importers) and processors of 17 high production volume

(HPV)chemicals conduct acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, genetic toxicity (gene mutations and chromosomal aberrations), ecotoxicity (in fish, Daphnia, and algae), and environmental fate (including 5 tests for physical chemical properties and biodegradation) testing. EPA found that each of the 17 chemicals included in the final HPV test rule is produced in substantial quantities (TSCA section 4(a)(1)(B)(i)) and that there is or may be substantial human exposure (TSCA section 4(a)(1)(B)(i)(II)) to each of them. Moreover, EPA determined that there are insufficient data to reasonably determine or predict the effects on health or the environment of the manufacture, distribution in commerce, processing, use, or disposal of the chemicals, or any combination of these activities (TSCA section 4(a)(1)(B)(ii)). EPA concluded that the testing program described in the HPV test rule is necessary and appropriate for developing such data (TSCA section 4(a)(1)(B)(iii)). Data developed under the HPV test rule will provide critical, basic information about the environmental fate and potential hazards of the chemicals included in the HPV test rule which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks at the screening level and take appropriate risk management or other actions, as necessary. To support the TSCA section 4(a)(1)(B)(i)(II) substantial human exposure finding for the 17 chemicals in the HPV test rule, EPA relied upon worker exposure data available from the National Occupational Exposure Survey

(NOES)(Ref. 2). EPA used a threshold of 1,000 workers to make such a finding for each chemical included in the HPV test rule, consistent with the policy discussed in the **Federal Register** notice entitled *TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria for Evaluating Substantial Production, Substantial Release, and Substantial or Significant Human Exposure* (58 FR 28736, May 14, 1993). In the case of coke-oven light oil (coal), the substantial human exposure finding was supported by NOES data which indicated that 2,559 roofers were exposed to this chemical (Ref. 3). Because 2,559 workers far exceeds EPA's general threshold of 1,000 workers, EPA was confident there was support for the substantial human exposure finding for coke-oven light oil

(coal)(Ref. 4). Shortly after publication of the HPV test rule in the **Federal Register** (Ref. 1), EPA was contacted by the American Coke and Coal Chemicals Institute (ACCCI) on behalf of the Coke Oven Environmental Task Force (COETF). ACCCI did not believe there was substantial worker exposure to coke-oven light oil

(coal)and, according to ACCCI, the chemical should not have been included in the HPV test rule. ACCCI had commented on the proposed HPV test rule, and had included a detailed analysis supporting its contention that only 103 workers were potentially exposed to coke-oven light oil

(coal)in COETF member facilities, the two processing facilities, and the transportation companies that linked them. EPA did not reject ACCCI's argument concerning the extent of worker exposure in the manufacturing facilities, processing facilities, and transportation companies in its Response to Comments document prepared for the HPV test rule (Ref. 4). However, ACCCI's contention that there is no use of coke-oven light oil

(coal)in the industry sector providing roofing services and that there also would have been no use of coke-oven light oil

(coal)in that industry sector during the 1980's (Ref. 5) was at odds with the NOES data on roofer exposure. Therefore, EPA finalized its proposed finding for substantial human (worker) exposure to coke-oven light oil

(coal)in the HPV test rule. Since EPA was contacted by ACCCI after the publication of the HPV test rule, new information has come to EPA's attention. EPA asked NIOSH to investigate the underlying data obtained by NIOSH for NOES which led to the conclusion that 2,559 roofers were potentially exposed to coke-oven light oil (coal). NIOSH responded that during the data collection years for NOES, 1981 to 1983, roofers were observed being exposed to coke-oven light oil

(coal)due to its presence in a coal-tar pitch product for which a Material Safety Data Sheet

(MSDS)had been provided to NIOSH by the product manufacturer. EPA subsequently searched for more recent information on the composition of this product and determined that the product was apparently reformulated in the 1990's and that since its reformulation, it no longer contains coke-oven light oil (coal). The name of this product is Noah's Pitch and it is manufactured by the Jim Walter Company of the Celotex Corp. (Ref. 6). Although the NOES data were an accurate representation of potential worker exposure to coke-oven light oil

(coal)in the 1980's, subsequent review of this matter has led EPA to believe that roofers are no longer exposed to coke-oven light oil

(coal)through contact. ACCCI (Ref. 7) and the two coke-oven light oil

(coal)processing facilities have provided letters (Refs. 8-10) assuring EPA that they do not manufacture or sell coke-oven light oil

(coal)for uses in roofing products (or other uses involving substantial worker exposure). Based upon this new information indicating a lack of potential substantial worker exposure, the Agency is revoking the requirements for coke-oven light oil

(coal)from the HPV test rule. B. What is the Agency's Authority for Taking this Action? The HPV test rule requiring testing of coke-oven light oil

(coal)(Ref. 1) was promulgated under TSCA section 4 (15 U.S.C. 2603), which mandates that EPA require that manufacturers and/or processors of chemicals and mixtures conduct testing if certain findings are made by EPA (see TSCA section 4(a)). One of the findings that EPA made in promulgating the HPV test rule was that there was substantial human (worker) exposure to each of the 17 chemicals in the HPV test rule (see TSCA section 4(a)(1)(B)(i)(II); see also Ref. 1). Information provided to EPA since finalization of the HPV test rule indicates that, at the time EPA finalized the rule, worker exposure to coke-oven light oil

(coal)did not constitute “substantial human exposure” under TSCA section 4(a)(1)(B), and thus EPA does not have a basis for making the TSCA section 4(a)(1)(B)(i)(II) exposure finding. III. Direct Final Rule EPA is revoking the testing required by the HPV test rule (Ref. 1) for coke-oven light oil

(coal)(CAS No. 65996-78-3). The testing is being revoked because new information does not support that, at the time EPA made its TSCA section 4(a) findings with respect to the chemical, a substantial number of workers were or might be exposed to this chemical. Therefore, EPA, in this amendment, is revoking the testing requirements for coke-oven light oil

(coal)(CAS No. 65996-78-3) by removing it from the list of chemicals in Table 2 in 40 CFR 799.5085(j) for which testing is required (Ref. 1). EPA is publishing this amendment without prior proposal because the Agency views this as a non-controversial amendment and anticipates no adverse comment as this action revokes testing for which new information has been provided to EPA which indicates that, at the time EPA finalized the HPV test rule, potential worker exposure to coke-oven light oil

(coal)did not constitute “substantial human exposure” under TSCA section 4(a)(1)(B). Despite the revocation of the testing requirements, much of the data may be made available for coke-oven light oil

(coal)because COETF, acting on behalf of ACCCI and the American Iron and Steel Institute (AISI), has informed EPA that it is prepared to assist EPA in assembling a summary of existing data on coke-oven light oil (coal), after the test rule requirements for coke-oven light oil

(coal)are revoked. This amendment is effective February 6, 2007 without further notice, unless EPA receives adverse comment or a written request for an opportunity to present oral comments by January 8, 2007. If EPA receives timely adverse comment or a request for an opportunity to present oral comments on the amendment in this direct final rule, the Agency will publish a timely withdrawal in the **Federal Register** indicating the amendment is being withdrawn due to adverse comment. If the Agency does not receive adverse comment or a request for an opportunity to present oral comments on the amendment in this direct final rule, the amendment is effective February 6, 2007. If the amendment in this direct final rule is withdrawn due to adverse comment or a request for an opportunity to present oral comments, EPA will publish a notice of proposed rulemaking in a future edition of the **Federal Register** . The Agency will address the comment or request for an opportunity to present oral comments on the amendment as part of that proposed rulemaking. IV. Economic Analysis In the economic analysis conducted for the HPV test rule, the Agency estimated the total cost to industry of the testing to be $4.03 million for all 17 chemicals, with an average of $237,000 per chemical (Ref. 11). This total included an additional 25% in administrative costs. This amendment reduces the total testing cost by an estimated $313,000 or approximately 8%, by eliminating the testing for coke-oven light oil (coal). In addition, the 25% administrative cost is eliminated for those tests as they relate to coke-oven light oil (coal). The new total cost of the testing is estimated to be $3.7 million (i.e., $4.03 million-$313,000). The average compliance cost per chemical without coke-oven light oil

(coal)is now $232,000 (Ref. 12). V. Export Notification Upon the effective date of the revocation of the TSCA section 4 test rule for coke-oven light oil (coal), persons who export or intend to export coke-oven light oil

(coal)are no longer subject to the TSCA section 12(b) export notification requirements to the extent that they were triggered by the testing requirements being revoked by this action. For all of the other chemicals listed as subject to the requirements of the HPV test rule (Ref. 1), the TSCA section 12(b) export notification requirements remain in effect. VI. References 1. EPA. Testing of Certain High Production Volume Chemicals; Final Rule. **Federal Register** (71 FR 13707, March 16, 2006) (FRL-7335-2). Available on line at: *http://www.epa.gov/fedrgstr* . 2. NIOSH. National Occupational Exposure Survey (NOES). Available on line at: *http://cdc.gov/noes.* 3. NIOSH. NOES. Estimated number of employees potentially exposed to light oil by occupation within 2-digit Standard Industrial Classification (SIC). 1981-1983. 4. EPA. Response to Public Comments. Prepared by Chemical Information and Testing Branch (CITB), OPPT. May 31, 2005. 5. ACCCI. Comments on EPA's Proposed Test Rule for Testing of Certain High Production Volume Chemicals submitted to the TSCA Public Docket Office, EPA. April 25, 2001. 6. EPA. Contact report of phone conversation between Greg Schweer, Chief, CITB, Chemical Control Division

(CCD)and Randy Johnson, NIOSH. April 25, 2006. 7. ACCCI. Letter from Bruce A. Steiner to Charles Auer, OPPT, EPA. Coke-Oven Light Oil. June 16, 2006. 8. Marathon Petroleum Company LLC. Letter from Harold Rinehart to Charles Auer, OPPT, EPA. June 1, 2006. 9. Marathon Petroleum. E-mail from Harold E. Rinehart to Charles Auer, EPA. Coke-Oven Light Oil Clarification. August 29, 2006. 10. Citgo Petroleum Corporation. Letter from Glenn C. Rabinak to Charles Auer, EPA. July 10, 2006. 11. EPA. Economic Analysis for the Final Section 4 Test Rule for High Production Volume Chemicals. Prepared by Lynne Blake-Hedges, EETD, OPPT. October 28, 2005. 12. EPA. E-mail from Lynne Blake-Hedges to Catherine Roman. Dropping coke-oven light oil

(coal)from HPV rule and revised economic analysis conclusions. June 15, 2006. VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This direct final rule implements changes to 40 CFR 799.5085 resulting in eliminating a burden and reducing cost. Because this direct final rule does not impose any new requirements, it is not subject to review by the Office of Management and Budget

(OMB)under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act This direct 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* . C. Regulatory Flexibility Act Because this direct final rule eliminates reporting requirements, the Agency certifies pursuant to section 605(b) of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .), that this revocation of certain requirements under TSCA section 4 will not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act This action 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). E. Executive Order 13132: Federalism This direct final rule has no Federalism implications, because it will not have substantial direct effects on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments This direct final rule has no tribal implications because it will not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, nor on the distribution of power and responsibilities between the Federal Government and Indian tribes as specified in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks This action is not subject to Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined under Executive Order 12866, and it does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This direct 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), because this action is not expected to affect energy supply, distribution, or use. I. National Technology Transfer Advancement Act Because this action does not involve any technical standards, 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), does not apply to this action. VIII. 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, which includes a copy of the rule, to each House of the Congress and 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 the rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 799 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: December 4, 2006. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. Therefore, 40 CFR chapter I is amended as follows: PART 799—AMENDED 1. The authority citation for part 799 continues to read as follows: Authority: 15 U.S.C. 2603, 2611, 2625. § 799.5085 [Amended] 2. By removing the entry “CAS No. 65996-78-3, Light oil (coal), coke-oven, in Table 2 of paragraph

(j)in § 799.5085. [FR Doc. E6-20908 Filed 12-7-06; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 411, 414, 415, and 424 CMS-1321-CN RIN 0938-AN84 Medicare Program; Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, and Changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B; Corrections AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Correction. SUMMARY: This correction document corrects a limited number of technical and typographical errors in the final rule with comment period that appeared in the December 1, 2006 **Federal Register** (71 FR 69624). The final rule with comment period addressed Medicare Part B payment policy, including the physician fee schedule

(PFS)that is applicable for calendar year

(CY)2007, finalized the CY 2006 interim relative value units (RVUs), and established interim RVUs for new and revised procedure codes for CY 2007. EFFECTIVE DATE: This correction notice is effective January 1, 2007. FOR FURTHER INFORMATION CONTACT: Diane Milstead,

(410)786-3355. SUPPLEMENTARY INFORMATION: I. Background In FR Doc. 06-9086 (71 FR 69624), the final rule with comment period entitled “Medicare Program; Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, and Changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B; Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for Ambulance Services; Ambulance Inflation Factor Update for CY 2007” (hereinafter referred to as the CY 2007 final rule with comment period), there were technical and typographical errors that are identified and corrected in this correction notice. The provisions of this correction notice are effective January 1, 2007. II. Summary of Errors A. Preamble In the preamble of the CY 2007 final rule with comment period, there were a number of technical errors and omissions. On page 69634, in step 8 of the Practice Expense

(PE)methodology calculation, we erroneously stated in the parenthetical note that unadjusted work RVUs are used to calculate the service level allocators for indirect practice expenses

(PEs)in this final rule. On pages 69636 and 69637, in Table 1, “Calculation of PE RVUs under Methodology For Selected Codes”, we found numerous errors that include amounts and row headings. On page 69640, under the discussion titled, “(4) Indirect PE RVUs Methodology” in the last sentence of the first response concerning the use of budget-neutralized work RVUs, we erroneously stated that we did not use the budget-neutralized work RVUs to calculate indirect PE. On page 69646, clarifying language was inadvertently omitted from the response. On page 69654, in Table 6, “Practice Expense Equipment Item Additions for CY 2007”, one of the equipment items is misspelled. On page 69692, the word “a” was inadvertently omitted from a response. On page 69694, the word “receiving” was erroneously omitted from a response. On pages 69741 through 69743, in Table 15, “AMA RUC and HCPAC recommendations and CMS' Decisions for New and Revised 2007 CPT Codes,” the title of the last column “2006 work RVUs” is incorrect. On page 69744, in Table 16, “AMA RUC Anesthesia Recommendations and CMS Decisions for New and Revised CPT codes”, the RUC-recommended base value for CPT code 00626 is incorrect. On page 69744, under section E. “Discussion of Codes for Which There Were No RUC recommendations or For Which the RUC Recommendations Were Not Accepted”, we inadvertently omitted the discussion related to CPT code 15830. On page 69747, we incorrectly stated that pricing information for an item was not provided. On page 69760, in section B “Anesthesia Fee Schedule Conversion Factor,” the discussion concerning the adjustment factor in Table 32 did not address all the included adjustments. In addition, Table 32 did not reflect the additional adjustment. On page 69768, in Table 35, a footnote was inadvertently omitted. On page 69770, in Table 36, a footnote was inadvertently omitted. These corrections are reflected in section III.A. of this correction notice. B. Addenda The following errors in Addenda B and C are revised under this correction notice. These addenda will not appear in the Code of Federal Regulations. In Addendum B, pages 69796 through 70011, we are making the following corrections:

(1)An indicator “+” denoting that the published RVUs are not used was omitted from the following Physicians' Current Procedural Terminology

(CPT)or alphanumeric Healthcare Procedure Coding System (HCPCS) codes: • *11000:* 11975, 11977; • *15000:* 15850; • *37000:* 37216; • *38000:* 38204, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215; • *43000:* 43842; • *58000:* 58300; • *61000:* 61630, 61635, 61640, 61641, 61642; • *72000:* 72159, 72159-TC, 72159-26; • *73000:* 73225, 73225-TC, 73225-26; • *76000:* 76390, 76390-TC, 76390-26; • *78000:* 78350, 78350-TC, 78350-26, 78351, 78890, 78890-TC, 78890-26, 78891, 78891-TC, 78891-26; • *90000:* 90875, 90876, 90885, 90887, 90918, 90919, 90920, 90921, 90922, 90923, 90924, 90925; • *92000:* 92015, 92310, 92314, 92340, 92341, 92342, 92352, 92353, 92354, 92355, 92358, 92370, 92371, 92551; • *93000:* 93668, 93740, 93740-TC, 93740-26, 93770, 93770-TC, 93770-26; • *94000:* 94005, 94150, 94150-TC, 94150-26; • *96000:* 96040, 96155, 96902; • *97000:* 97010, 97014, 97810, 97811, 97813, 97814; • *98000:* 98943, 98960, 98961, 98962; • *99000:* 99091, 99173, 99339, 99340, 99358, 99359, 99360, 99363, 99364, 99374, 99375, 99377, 99378, 99379, 99380, 99381, 99382, 99383, 99384, 99385, 99386, 99387, 99391, 99392, 99393, 99394, 99395, 99396, 99397, 99401, 99402, 99403, 99404, 99411, 99412, 99420; • *G codes:* G0122, G0122-TC, G0122-26, G0252-26, G0337.

(2)Incorrect RVUs were listed for the following CPT codes: 38207, 38210, 38211, 38212, 38213, 38214, and 38215.

(3)Incorrect practice expense RVUs were listed for the following CPT and HCPCS codes: 73223, 73323-TC, 76775, 76775-TC, 76775-26, 95060, 95065, G0389, G0389-TC, G0389-26, G0392, and G0393.

(4)Incorrect status indicators and RVUs were listed for CPT codes 93235, 93624, and 93624-TC. In Addendum C, page 70015, an indicator “+” denoting that the published RVUs are not used was omitted from the following Physicians' Current Procedural Terminology

(CPT)or alphanumeric Healthcare Procedure Coding System (HCPCS) codes: • *90000:* 94005, 96040, 99363, and 99364. These corrections are reflected in section III.B. of this correction notice. III. Correction of Errors A. Correction of Errors in the Preamble 1. On page 69634, in the 2nd column, in the 8th full paragraph, lines 11 through 13, in step 8 of the PE methodology calculation, the sentence “In this final rule, unadjusted work RVUs are used” is removed. 2. On pages 69636 through 69637, in Table 1: Calculation of PE RVUs under Methodology for Selected Codes, the table is corrected to read as follows: BILLING CODE 4120-01-P ER08DE06.002 ER08DE06.003 BILLING CODE 4120-01-C 3. On page 69640, in the 2nd column, the 1st full paragraph, the response beginning with the phrase “As discussed in section III.D.3. of this final rule with comment period * * *” and ending with the phrase “* * * budget-neutralized work RVUs to calculate indirect PE” is corrected to read as follows: “As discussed elsewhere in this rule, we do not believe it would be appropriate to allow the increases in work RVUs for certain services as a result of the 5-Year Review to reduce aggregate payments for PEs and professional liability under the Medicare PFS. Our final policy to use the budget-neutralized work RVUs in the calculation of indirect PEs appropriately maintains the current relationships between the work, PE, and professional liability (malpractice insurance expense) components of the PFS. We also believe it is important to apply the revised, budget-neutralized work RVUs consistently within the PFS framework. It would not be consistent to apply one set of work RVUs for work payments, but a different set for purposes of calculating indirect PEs. Therefore, we will base the calculation of both the work payments and the indirect PEs on the revised, budget-neutralized work RVUs adopted as part of this final rule, and maintain the overall current relationships between work, PE, and professional liability. The PE RVUs in Addendum B and throughout the rest of this rule reflect this policy.” 4. On page 69646, in the 2nd column, the 4th full paragraph, the response “We will implement these changes for CY 2007” is corrected to read as follows: “We are implementing these changes for CY 2007. Because we are implementing the bottom-up methodology, which utilizes the direct inputs to determine the PE RVUs for CY 2007, a separate payment for the contrast media used in various imaging procedures will be available. In addition to the CPT code representing the imaging procedure, providers are instructed to use the appropriate HCPCS Q-code, Q9942 through Q9964, to separately bill for the contrast medium utilized in performing the service.” 5. On page 69654, in Table 6, Practice Expense Equipment Item Additions for CY 2007, column 2, line 16, the word “Acerine” is corrected to read “Aerocrine.” 6. On page 69692, in the 3rd column, 1st paragraph, line 10, the phrase “verified in large trial” is corrected to read as “verified in a large trial.” 7. On page 69694, in the 3rd column, 3rd paragraph, lines 8 through 9, the phrase “may also be FDA-approved” is corrected to read “may also be receiving FDA-approved.” 8. On pages 69741 through 69743, in Table 15, “AMA RUC and HCPAC recommendations and CMS” Decisions for New and Revised 2007 CPT Codes”, last column, the column heading, “2006 work RVU” is corrected to read “2007 work RVU”. 9. On page 69744, in Table 16: AMA RUC Anesthesia Recommendations and CMS Decisions for New and Revised CPT Codes, column 3 (RUC-recommendation), line 2 (CPT code 00626), the value “13.00” is corrected to read “15.00.” 10. On page 69744, in the 1st column, after the 2nd full paragraph following the table, after the sentence “This summary refers only to work RVUs” and before the sentence beginning “For CPT code 22857 * * * ” the following paragraph is added to read as follows: “For CPT code 15830, *Excision, excessive skin and subcutaneous tissue (includes lipectomy); abdomen, infraumbilical panniculectomy* , the RUC recommended 15.60 work RVUs. We reviewed the summary of recommendations for an add-on procedure to CPT code 15830, CPT code 15847, *Excision, excessive skin and subcutaneous tissue (includes lipectomy); abdomen (eg, abdominoplasty) (includes umbilical transposition and fascial pilcation (List separately in addition to code for primary procedure)* , in which the RUC and the specialty society recommended that this code be carrier-priced to reduce the potential for abuse. In order to reduce the potential for abuse, we believe that, payment for CPT code 15830 should be similarly restricted and medical necessity should be established prior to payment. Therefore, we have assigned a status indicator of “R” (Restricted) to this code.” 11. On page 69747, in the 3rd column, 1st paragraph, lines 2 through 5, the sentence “We were not able to include a price for the pedigree software equipment as it was not provided with the PE inputs” is corrected to read as “We included a price of $950 for the pedigree software desktop version as the typical equipment used in a physician office.” 12. On page 69760, a. In the 3rd column, 1st full paragraph, lines 10 through 12, the sentence “The adjustment factor in Table 32 includes the combined effect of the PE adjustment and the BN adjustment” is corrected to read “The adjustment factor in Table 32 includes the combined effect of the PE adjustment, the BN adjustment and the adjustment to anesthesia work to account for the increase in the work of the E/M codes.” b. In the 3rd column, Table 32 is corrected as follows: Table 32 2006 Anesthesia Conversion Factor $17.7663 2007 Update −5.0 percent (0.94953) 2007 Combined Adjustment PE and BN 0.9110 2007 Anesthesia Conversion Factor $15.3682 13. On page 69768, Table 35 is corrected by adding a footnote to read as follows: “**Components may not sum due to rounding error.” 14. On page 69770, Table 36 is corrected by adding a footnote to read as follows: “Note: When applying the 0.8994 work adjuster to the work relative values printed in Addendum B, you must round the product to two decimal places.” B. Addenda 1. On pages 69796 through 70011, in Addendum B: Relative Value Units

(RVUs)And Related Information the following entries are corrected to read as follows: Addendum B.—Relative Value Units

(RVUs)and Related Information—Corrections CPT 1 /HCPCS 2 Mod Status Description Physician work RVUs 3 Fully implemented non-facility PE RVUs Year 2007 transitional non-facility PE RVUs Fully implemented facility PE RVUs Year 2007 transitional facility PE RVUs Malpractice RVUs Fully implemented non-facility total Year 2007 transitional non-facility total Fully implemented facility total Year 2007 transitional facility total Global 11975 N Insert contraceptive cap 1.48+ 1.52 1.45 0.34 0.51 0.17 3.17 3.10 1.99 2.16 XXX 11977 N Removal/reinsert contra cap 3.30+ 1.97 2.20 0.76 1.14 0.37 5.64 5.87 4.43 4.81 XXX 15850 B Removal of sutures 0.78+ 1.19 1.47 0.18 0.27 0.05 2.02 2.30 1.01 1.10 XXX 37216 N Transcath stent, cca w/o eps 18.85+ NA NA 5.75 8.05 1.04 NA NA 25.64 27.94 090 38204 B Bl donor search management 2.00+ 0.91 0.91 0.91 0.91 0.06 2.97 2.97 2.97 2.97 XXX 38207 I Cryopreserve stem cells 0.89+ 0.41 0.41 0.41 0.41 0.01 1.31 1.31 1.31 1.31 XXX 38208 I Thaw preserved stem cells 0.56+ 0.25 0.25 0.25 0.25 0.02 0.83 0.83 0.83 0.83 XXX 38209 I Wash harvest stem cells 0.24+ 0.11 0.11 0.11 0.11 0.01 0.36 0.36 0.36 0.36 XXX 38210 I T-cell depletion of harvest 1.57+ 0.72 0.72 0.72 0.72 0.03 2.32 2.32 2.32 2.32 XXX 38211 I Tumor cell deplete of harvst 1.42+ 0.65 0.65 0.65 0.65 0.02 2.09 2.09 2.09 2.09 XXX 38212 I Rbc depletion of harvest 0.94+ 0.43 0.43 0.43 0.43 0.02 1.39 1.39 1.39 1.39 XXX 38213 I Platelet deplete of harvest 0.24+ 0.11 0.11 0.11 0.11 0.01 0.36 0.36 0.36 0.36 XXX 38214 I Volume deplete of harvest 0.81+ 0.37 0.37 0.37 0.37 0.01 1.19 1.19 1.19 1.19 XXX 38215 I Harvest stem cell concentrte 0.94+ 0.43 0.43 0.43 0.43 0.02 1.39 1.39 1.39 1.39 XXX 43842 N V-band gastroplasty 20.90+ NA NA 6.75 7.53 2.45 NA NA 30.10 30.88 090 58300 N Insert intrauterine device 1.01+ 0.62 1.22 0.23 0.34 0.12 1.75 2.35 1.36 1.47 XXX 61630 N Intracranial angioplasty 22.07+ NA NA 6.44 10.98 2.02 NA NA 30.53 35.07 090 61635 N Intracran angioplsty w/stent 24.28+ NA NA 6.95 11.89 2.21 NA NA 33.44 38.38 090 61640 N Dilate ic vasospasm, init 12.32+ NA NA 2.85 2.85 0.71 NA NA 15.88 15.88 000 61641 N Dilate ic vasospasm add-on 4.33+ NA NA 1.00 1.00 0.25 NA NA 5.58 5.58 ZZZ 61642 N Dilate ic vasospasm add-on 8.66+ NA NA 2.00 2.00 0.50 NA NA 11.16 11.16 ZZZ 72159 N Mr angio spine w/o&w/dye 1.80+ 14.49 13.31 NA NA 0.74 17.03 15.85 NA NA XXX 72159 TC N Mr angio spine w/o&w/dye 0.00+ 14.07 12.69 NA NA 0.64 14.71 13.33 NA NA XXX 72159 26 N Mr angio spine w/o&w/dye 1.80+ 0.42 0.62 0.42 0.62 0.10 2.32 2.52 2.32 2.52 XXX 73223 A Mri joint upr extr w/o&w/dye 2.15 16.74 23.38 NA NA 0.94 19.83 26.47 NA NA XXX 73223 26 A Mri joint upr extr w/o&w/dye 2.15 0.61 0.69 0.61 0.69 0.10 2.86 2.94 2.86 2.94 XXX 73225 N Mr angio upr extr w/o&w/dye 1.73+ 14.47 12.38 NA NA 0.69 16.89 14.80 NA NA XXX 73225 TC N Mr angio upr extr w/o&w/dye 0.00+ 14.07 11.78 NA NA 0.59 14.66 12.37 NA NA XXX 73225 26 N Mr angio upr extr w/o&w/dye 1.73+ 0.40 0.60 0.40 0.60 0.10 2.23 2.43 2.23 2.43 XXX 76390 N Mr spectroscopy 1.40+ 9.31 10.94 NA NA 0.66 11.37 13.00 NA NA XXX 76390 TC N Mr spectroscopy 0.00+ 8.99 10.51 NA NA 0.59 9.58 11.10 NA NA XXX 76390 26 N Mr spectroscopy 1.40+ 0.32 0.43 0.32 0.43 0.07 1.79 1.90 1.79 1.90 XXX 76775 A Us exam abdo back wall, lim 0.58 2.23 1.77 NA NA 0.11 2.92 2.46 NA NA XXX 76775 TC A Us exam abdo back wall, lim 0.00 2.06 1.58 NA NA 0.08 2.14 1.66 NA NA XXX 76775 26 A Us exam abdo back wall, lim 0.58 0.17 0.19 0.17 0.19 0.03 0.78 0.80 0.78 0.80 XXX 78350 N Bone mineral, single photon 0.22+ 0.00 0.82 NA NA 0.06 0.28 1.10 NA NA XXX 78350 TC N Bone mineral, single photon 0.00+ 0.00 0.75 NA NA 0.05 0.05 0.80 NA NA XXX 78350 26 N Bone mineral, single photon 0.22+ 0.00 0.07 0.00 0.07 0.01 0.23 0.30 0.23 0.30 XXX 78351 N Bone mineral, dual photon 0.30+ NA NA 0.07 0.11 0.01 NA NA 0.38 0.42 XXX 78890 B Nuclear medicine data proc 0.05+ 0.38 1.10 NA NA 0.07 0.50 1.22 NA NA XXX 78890 TC B Nuclear medicine data proc 0.00+ 0.37 1.08 NA NA 0.06 0.43 1.14 NA NA XXX 78890 26 B Nuclear medicine data proc 0.05+ 0.01 0.02 0.01 0.02 0.01 0.07 0.08 0.07 0.08 XXX 78891 B Nuclear med data proc 0.10+ 0.86 2.22 NA NA 0.14 1.10 2.46 NA NA XXX 78891 TC B Nuclear med data proc 0.00+ 0.84 2.18 NA NA 0.13 0.97 2.31 NA NA XXX 78891 26 B Nuclear med data proc 0.10+ 0.02 0.04 0.02 0.04 0.01 0.13 0.15 0.13 0.15 XXX 90875 N Psychophysiological therapy 1.20+ 0.52 0.81 0.28 0.42 0.04 1.76 2.05 1.52 1.66 XXX 90876 N Psychophysiological therapy 1.90+ 0.67 1.04 0.44 0.66 0.05 2.62 2.99 2.39 2.61 XXX 90885 B Psy evaluation of records 0.97+ 0.22 0.33 0.22 0.33 0.02 1.21 1.32 1.21 1.32 XXX 90887 B Consultation with family 1.48+ 0.61 0.77 0.34 0.51 0.04 2.13 2.29 1.86 2.03 XXX 90918 I ESRD related services, month 11.16+ 4.68 5.75 3.74 5.52 0.36 16.20 17.27 15.26 17.04 XXX 90919 I ESRD related services, month 8.53+ 3.02 3.76 2.55 3.64 0.29 11.84 12.58 11.37 12.46 XXX 90920 I ESRD related services, month 7.26+ 2.73 3.50 2.27 3.38 0.23 10.22 10.99 9.76 10.87 XXX 90921 I ESRD related services, month 4.46+ 1.70 2.26 1.61 2.23 0.14 6.30 6.86 6.21 6.83 XXX 90922 I ESRD related services, day 0.37+ 0.16 0.20 0.12 0.19 0.01 0.54 0.58 0.50 0.57 XXX 90923 I Esrd related services, day 0.28+ 0.10 0.12 0.08 0.12 0.01 0.39 0.41 0.37 0.41 XXX 90924 I Esrd related services, day 0.24+ 0.09 0.11 0.08 0.11 0.01 0.34 0.36 0.33 0.36 XXX 90925 I Esrd related services, day 0.15+ 0.05 0.07 0.05 0.07 0.01 0.21 0.23 0.21 0.23 XXX 92015 N Refraction 0.38+ 0.10 1.14 0.09 0.14 0.01 0.49 1.53 0.48 0.53 XXX 92310 N Contact lens fitting 1.17+ 1.05 1.10 0.27 0.41 0.04 2.26 2.31 1.48 1.62 XXX 92314 N Prescription of contact lens 0.69+ 1.13 0.99 0.16 0.24 0.01 1.83 1.69 0.86 0.94 XXX 92340 N Fitting of spectacles 0.37+ 0.44 0.64 0.08 0.13 0.01 0.82 1.02 0.46 0.51 XXX 92341 N Fitting of spectacles 0.47+ 0.46 0.67 0.11 0.16 0.01 0.94 1.15 0.59 0.64 XXX 92342 N Fitting of spectacles 0.53+ 0.48 0.69 0.12 0.19 0.01 1.02 1.23 0.66 0.73 XXX 92352 B Special spectacles fitting 0.37+ 0.56 0.65 0.08 0.13 0.01 0.94 1.03 0.46 0.51 XXX 92353 B Special spectacles fitting 0.50+ 0.59 0.70 0.12 0.17 0.02 1.11 1.22 0.64 0.69 XXX 92354 B Special spectacles fitting 0.00+ 0.28 6.72 NA NA 0.10 0.38 6.82 NA NA XXX 92355 B Special spectacles fitting 0.00+ 0.44 3.36 NA NA 0.01 0.45 3.37 NA NA XXX 92358 B Eye prosthesis service 0.00+ 0.23 0.79 NA NA 0.05 0.28 0.84 NA NA XXX 92370 N Repair & adjust spectacles 0.32+ 0.39 0.51 0.07 0.12 0.02 0.73 0.85 0.41 0.46 XXX 92371 B Repair & adjust spectacles 0.00+ 0.24 0.53 NA NA 0.02 0.26 0.55 NA NA XXX 92551 N Pure tone hearing test, air 0.00+ 0.25 0.25 NA NA 0.01 0.26 0.26 NA NA XXX 93235 C ECG monitor/report, 24 hrs 0.00 0.00 0.00 NA NA 0.00 0.00 0.00 NA NA XXX 93624 C Electrophysiologic evaluation 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 000 93624 TC C Electrophysiologic evaluation 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 000 93668 N Peripheral vascular rehab 0.00+ 0.40 0.40 NA NA 0.01 0.41 0.41 NA NA XXX 93740 B Temperature gradient studies 0.16+ 0.04 0.15 NA NA 0.02 0.22 0.33 NA NA XXX 93740 TC B Temperature gradient studies 0.00+ 0.00 0.11 NA NA 0.01 0.01 0.12 NA NA XXX 93740 26 B Temperature gradient studies 0.16+ 0.04 0.04 0.04 0.04 0.01 0.21 0.21 0.21 0.21 XXX 93770 B Measure venous pressure 0.16+ 0.04 0.07 NA NA 0.02 0.22 0.25 NA NA XXX 93770 TC B Measure venous pressure 0.00+ 0.00 0.02 NA NA 0.01 0.01 0.03 NA NA XXX 93770 26 B Measure venous pressure 0.16+ 0.04 0.05 0.04 0.05 0.01 0.21 0.22 0.21 0.22 XXX 94005 B Home vent mgmt supervision 1.50+ 0.69 0.69 NA NA 0.06 2.25 2.25 NA NA XXX 94150 B Vital capacity test 0.07+ 0.48 0.48 NA NA 0.02 0.57 0.57 NA NA XXX 94150 TC B Vital capacity test 0.00+ 0.46 0.45 NA NA 0.01 0.47 0.46 NA NA XXX 94150 26 B Vital capacity test 0.07+ 0.02 0.03 0.02 0.03 0.01 0.10 0.11 0.10 0.11 XXX 95060 A Eye allergy tests 0.00 0.72 0.44 0.72 0.44 0.02 0.74 0.46 0.74 0.46 XXX 95065 A Nose allergy test 0.00 0.65 0.31 0.65 0.31 0.01 0.66 0.32 0.66 0.32 XXX 96040 B Genetic counseling, 30 min 0.00+ 0.97 0.97 NA NA 0.01 0.98 0.98 NA NA XXX 96155 N Interv hlth/behav fam no pt 0.44+ 0.10 0.16 0.10 0.15 0.02 0.56 0.62 0.56 0.61 XXX 96902 B Trichogram 0.41+ 0.11 0.16 0.10 0.15 0.01 0.53 0.58 0.52 0.57 XXX 97010 B Hot or cold packs therapy 0.06+ 0.07 0.06 NA NA 0.01 0.14 0.13 NA NA XXX 97014 I Electric stimulation therapy 0.18+ 0.18 0.19 NA NA 0.01 0.37 0.38 NA NA XXX 97810 N Acupunct w/o stimul 15 min 0.60+ 0.26 0.35 0.14 0.21 0.03 0.89 0.98 0.77 0.84 XXX 97811 N Acupunct w/o stimul addl 15m 0.50+ 0.15 0.23 0.12 0.17 0.03 0.68 0.76 0.65 0.70 ZZZ 97813 N Acupunct w/stimul 15 min 0.65+ 0.27 0.37 0.15 0.23 0.03 0.95 1.05 0.83 0.91 XXX 97814 N Acupunct w/stimul addl 15m 0.55+ 0.19 0.27 0.13 0.19 0.03 0.77 0.85 0.71 0.77 ZZZ 98943 N Chiropractic manipulation 0.40+ 0.17 0.22 0.09 0.14 0.01 0.58 0.63 0.50 0.55 XXX 98960 B Self-mgmt educ & train, 1 pt 0.00+ 0.48 0.48 0.00 0.00 0.01 0.49 0.49 0.01 0.01 XXX 98961 B Self-mgmt educ/train, 2-4 pt 0.00+ 0.23 0.23 0.00 0.00 0.01 0.24 0.24 0.01 0.01 XXX 98962 B Self-mgmt educ/train, 5-8 pt 0.00+ 0.17 0.17 0.00 0.00 0.01 0.18 0.18 0.01 0.01 XXX 99091 B Collect/review data from pt 1.10+ 0.25 0.25 NA NA 0.04 1.39 1.39 NA NA XXX 99173 N Visual acuity screen 0.00+ 0.06 0.06 NA NA 0.01 0.07 0.07 NA NA XXX 99339 B Domicil/r-home care supervis 1.25+ 0.58 0.58 NA NA 0.06 1.89 1.89 NA NA XXX 99340 B Domicil/r-home care supervis 1.80+ 0.76 0.76 NA NA 0.07 2.63 2.63 NA NA XXX 99358 B Prolonged serv, w/o contact 2.10+ 0.51 0.51 0.51 0.51 0.09 2.70 2.70 2.70 2.70 ZZZ 99359 B Prolonged serv, w/o contact 1.00+ 0.26 0.26 0.26 0.26 0.04 1.30 1.30 1.30 1.30 ZZZ 99360 X Physician standby services 1.20+ 0.00 0.00 0.00 0.00 0.05 1.25 1.25 1.25 1.25 XXX 99363 B Anticoag mgmt, init 1.65+ 1.29 1.29 0.38 0.38 0.07 3.01 3.01 2.10 2.10 XXX 99364 B Anticoag mgmt, subseq 0.63+ 0.38 0.38 0.15 0.15 0.04 1.05 1.05 0.82 0.82 XXX 99374 B Home health care supervision 1.10+ 0.54 0.66 0.25 0.38 0.05 1.69 1.81 1.40 1.53 XXX 99375 I Home health care supervision 1.73+ 0.75 1.35 0.40 1.26 0.07 2.55 3.15 2.20 3.06 XXX 99377 B Hospice care supervision 1.10+ 0.54 0.66 0.25 0.38 0.05 1.69 1.81 1.40 1.53 XXX 99378 I Hospice care supervision 1.73+ 0.75 1.64 0.40 1.56 0.07 2.55 3.44 2.20 3.36 XXX 99379 B Nursing fac care supervision 1.10+ 0.54 0.66 0.25 0.38 0.04 1.68 1.80 1.39 1.52 XXX 99380 B Nursing fac care supervision 1.73+ 0.75 0.93 0.40 0.60 0.06 2.54 2.72 2.19 2.39 XXX 99381 N Init pm e/m, new pat, inf 1.19+ 0.99 1.37 0.27 0.41 0.05 2.23 2.61 1.51 1.65 XXX 99382 N Init pm e/m, new pat 1-4 yrs 1.36+ 1.03 1.41 0.31 0.47 0.05 2.44 2.82 1.72 1.88 XXX 99383 N Prev visit, new, age 5-11 1.36+ 1.02 1.37 0.31 0.47 0.05 2.43 2.78 1.72 1.88 XXX 99384 N Prev visit, new, age 12-17 1.53+ 1.06 1.43 0.35 0.53 0.06 2.65 3.02 1.94 2.12 XXX 99385 N Prev visit, new, age 18-39 1.53+ 1.06 1.43 0.35 0.53 0.06 2.65 3.02 1.94 2.12 XXX 99386 N Prev visit, new, age 40-64 1.88+ 1.14 1.59 0.43 0.65 0.07 3.09 3.54 2.38 2.60 XXX 99387 N Init pm e/m, new pat 65+ yrs 2.06+ 1.27 1.72 0.48 0.71 0.07 3.40 3.85 2.61 2.84 XXX 99391 N Per pm reeval, est pat, inf 1.02+ 0.86 0.98 0.24 0.35 0.04 1.92 2.04 1.30 1.41 XXX 99392 N Prev visit, est, age 1-4 1.19+ 0.89 1.04 0.27 0.41 0.05 2.13 2.28 1.51 1.65 XXX 99393 N Prev visit, est, age 5-11 1.19+ 0.89 1.02 0.27 0.41 0.05 2.13 2.26 1.51 1.65 XXX 99394 N Prev visit, est, age 12-17 1.36+ 0.93 1.08 0.31 0.47 0.05 2.34 2.49 1.72 1.88 XXX 99395 N Prev visit, est, age 18-39 1.36+ 0.93 1.10 0.31 0.47 0.05 2.34 2.51 1.72 1.88 XXX 99396 N Prev visit, est, age 40-64 1.53+ 0.97 1.18 0.35 0.53 0.06 2.56 2.77 1.94 2.12 XXX 99397 N Per pm reeval est pat 65+ yr 1.71+ 1.11 1.30 0.40 0.60 0.06 2.88 3.07 2.17 2.37 XXX 99401 N Preventive counseling, indiv 0.48+ 0.36 0.56 0.11 0.17 0.01 0.85 1.05 0.60 0.66 XXX 99402 N Preventive counseling, indiv 0.98+ 0.47 0.77 0.23 0.34 0.02 1.47 1.77 1.23 1.34 XXX 99403 N Preventive counseling, indiv 1.46+ 0.58 0.96 0.34 0.51 0.04 2.08 2.46 1.84 2.01 XXX 99404 N Preventive counseling, indiv 1.95+ 0.70 1.17 0.45 0.68 0.05 2.70 3.17 2.45 2.68 XXX 99411 N Preventive counseling, group 0.15+ 0.22 0.19 0.03 0.05 0.01 0.38 0.35 0.19 0.21 XXX 99412 N Preventive counseling, group 0.25+ 0.24 0.25 0.06 0.09 0.01 0.50 0.51 0.32 0.35 XXX 99420 N Health risk assessment test 0.00+ 0.22 0.22 NA NA 0.01 0.23 0.23 NA NA XXX G0122 N Colon ca scrn; barium enema 0.99+ 5.58 3.32 NA NA 0.18 6.75 4.49 NA NA XXX G0122 TC N Colon ca scrn; barium enema 0.00+ 5.35 2.98 NA NA 0.13 5.48 3.11 NA NA XXX G0122 26 N Colon ca scrn; barium enema 0.99+ 0.23 0.34 0.23 0.34 0.05 1.27 1.38 1.27 1.38 XXX G0252 26 N PET imaging initial dx 1.50+ 0.00 0.60 0.00 0.60 0.04 1.54 2.14 1.54 2.14 XXX G0337 X Hospice evaluation preelecti 1.34+ 0.31 0.46 0.31 0.46 0.09 1.74 1.89 1.74 1.89 XXX G0389 A Ultrasound exam AAA screen 0.58 2.23 1.77 NA NA 0.11 2.92 2.46 NA NA XXX G0389 TC A Ultrasound exam AAA screen 0.00 2.06 1.58 NA NA 0.08 2.14 1.66 NA NA XXX G0389 26 A Ultrasound exam AAA screen 0.58 0.17 0.19 0.17 0.19 0.03 0.78 0.80 0.78 0.80 XXX G0392 A AV fistula or graft arterial 9.48 47.48 53.95 3.25 3.48 0.62 57.58 64.05 13.35 13.58 000 G0393 A AV fistula or graft venous 6.03 35.61 42.45 1.97 2.26 0.34 41.98 48.82 8.34 8.63 000 1 CPT codes and descriptions only are copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Apply. 2 Copyright 2006 American Dental Association. All rights reserved. 3 + Indicates RVUs are not used for Medicare payment. 2. On page 70015, in Addendum C: Codes with Interim RVUs the following entries are corrected to read as follows: Addendum C.— Codes With Interim RVUs—Corrections CPT 1 /HCPCS 2 Mod Status Description Physician work RVUs 3 Fully implemented non-facility PE RVUs Year 2007 transitional non-facility PE RVUs Fully implemented facility PE RVUs Year 2007 transitional facility PE RVUs Malpractice RVUs Fully implemented non-facility total Year 2007 transitional non-facility total Fully implemented facility total Year 2007 transitional facility total Global 94005 B Home vent mgmt supervision 1.50+ 0.69 0.69 NA NA 0.06 2.25 2.25 NA NA XXX 96040 B Genetic counseling, 30 min 0.00+ 0.97 0.97 NA NA 0.01 0.98 0.98 NA NA XXX 99363 B Anticoag mgmt, init 1.65+ 1.29 1.29 0.38 0.38 0.07 3.01 3.01 2.10 2.10 XXX 99364 B Anticoag mgmt, subseq 0.63+ 0.38 0.38 0.15 0.15 0.04 1.05 1.05 0.82 0.82 XXX 1 CPT codes and descriptions only are copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Apply. 2 Copyright 2006 American Dental Association. All rights reserved. 3 + Indicates RVUs are not used for Medicare payment. IV. Waiver of Proposed Rulemaking and Delay in Effective Date We ordinarily publish a notice of proposed rulemaking in the **Federal Register** to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act

(APA)(5 U.S.C. 553(b)). However, we can waive the notice and comment procedures if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the rule. Section 553(d) for the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication. This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued. This correction notice addresses technical errors and omissions made in FR Doc. 06-9086, entitled “Medicare Program; Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, and changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B; Revisions to the Payment Policies of Ambulance Services Under the Fee Schedule for Ambulance Services; Ambulance Inflation Factor Update for CY 2007,” which appeared in the December 1, 2006 **Federal Register** (71 FR 69624), and is effective January 1, 2007. The provisions of this final rule with comment period have been previously subjected to notice and comment procedures. These corrections are consistent with the discussion and text of the final rule with comment period, and do not make substantive changes to the CY 2007 published rule. As such, this correction notice is intended to ensure the CY 2007 final rule with comment period accurately reflects the policies adopted in that rule. Therefore, we find that undertaking further notice and comment procedures to incorporate these corrections into the final rule with comment is unnecessary and contrary to the public interest. For the same reasons, we are also waiving the 30-day delay in effective date for this correction notice. We believe that it is in the public interest to ensure that the CY 2007 final rule with comment period accurately states our policies relating to the PFS and other Part B payment policies. Therefore, delaying the effective date of these corrections beyond the January 1, 2007 effective date of the final rule with comment period would be contrary to the public interest. In so doing, we find good cause to waive the 30-day delay in the effective date. (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 30, 2006. Ann C. Agnew, Executive Secretary to the Department. [FR Doc. 06-9550 Filed 12-4-06; 9:46 am]

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