54386 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations 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 in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: September 4, 2003. James Jones, Director, 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), 346( a) and 371.

 2. Section 180.591 is added to read as follows:

§ 180.591 Trifloxysulfuron; tolerances for residues ( a) General. Tolerances are established for residues of the herbicide trifloxysulfuron, N[[( 4,6 dimethoxy 2 pyrimidinyl) amino] carbonyl] 3( 2,2,2 trifluoroethoxy) 2 pyridinesulfonamide in or on the following raw agricultural commodities.

Commodity Parts per million Almond ..................................................................................................................... 0.02 Almond, hulls ........................................................................................................... 0.01 Fruit, citrus, Group 10 .............................................................................................. 0.03 Cotton, undelinted seed ........................................................................................... 0.05 Cotton, gin byproducts ............................................................................................. 1.0 Sugarcane ................................................................................................................ 0.01 Tomato ..................................................................................................................... 0.01 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved] [ FR Doc. 03   23428 Filed 9   16   03; 8: 45am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0306; FRL   7327   5]

Thiamethoxam; Pesticide Tolerances AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of thiamethoxam and its metabolite in or on imported coffee, pecan, stone fruit, succulent bean, and sunflower. Syngenta Crop Protection, Inc. and the Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996.

DATES: This regulation is effective September 17, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0306, must be received on or before November 17, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Dani Daniel, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5409; e mail address: daniel. dani@ 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 VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54387 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 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 Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0306. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html/, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of April 2, 2003 ( 68 FR 16040) ( FRL   7298   7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Pub. L. 104   170), announcing the filing of pesticide petitions ( 3E06524, 2E06505, 2E06508, 1E06349, and 0F6142) by IR 4, 681 U. S. Highway # 1 South, North Bunswick, NJ 08902   3390 and Syngenta Crop Protection, Inc., P. O. Box 18300, Greensboro, NC 27419   8300. That notice included a summary on the petitions prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notices of filing. The petitions requested that 40 CFR 180.565 be amended by establishing tolerances for the combined residues of the insecticide thiamethoxam, 3[( 2 chloro 5 thiazolyl) methyl] tetrahydro 5 methyl N nitro 4H 1,3,5 oxadiazin 4 imine and its metabolite ( N( 2 chlorothiazol 5 ylmethyl) N' methyl N' nitroguanidine in or on imported coffee at 0.05 parts per million ( ppm) ( 1E6349), pecan at 0.02 ppm ( 0F6142), stone fruit group 12 at 0.5 ppm ( 2E6505), succulent bean at 0.02 ppm ( 2E6508), and sunflower at 0.02 ppm ( 3E6524). 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....'' 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 the final rule on Bifenthrin Pesticide Tolerances November 26, 1997 ( 62 FR 62961) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety 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 and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for tolerances for the combined residues of thiamethoxam and its metabolite on imported coffee at 0.05 ppm, pecan at 0.02 ppm, stone fruit group 12 at 0.5 ppm, succulent bean at 0.02 ppm, and sunflower at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by thiamethoxam as well as the no observed adverse effect level ( NOAEL) and the lowest observed adverse effect level ( LOAEL) from the toxicity studies reviewed are discussed in Unit III. A. of the Federal Register of November 1, 2002 ( 67 FR 66561) ( FRL   7279   6).

B. Toxicological Endpoints The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the 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 intraspecies differences.

VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54388 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( aRfD or cRfD) 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 safty factor. For non dietary risk assessments ( other than cancer) the UF is used to determine the 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 ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for thiamethoxam used for human risk assessment is shown in the following Table 1:

TABLE 1.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR THIAMETHOXAM 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 ( general population including infants and children) NOAEL = 100 mg/ kg/ day UF = 100 Acute RfD = 1 mg/ kg/ day FQPA SF = 10 aPAD = acute RfD FQPA SF = 0.1 mg/ kg/ day Acute mammalian neurotoxicity study in the rat LOAEL = 500 mg/ kg/ day based on treatmentrelated neurobehavioral effects observed in the FOB and LMA testing ( drooped palpebral closure, decreased rectal temperature and locomotor activity, increased forelimb grip strength)

Chronic dietary ( all populations NOAEL = 0.6 mg/ kg/ day UF = 100 Chronic RfD = 0.006 mg/ kg/ day FQPA SF = 10 cPAD = chronic RfD FQPA SF = 0.0006 mg/ kg/ day 2 Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males Oral non dietary ( all durations NOAEL = 0.6 mg/ kg/ day LOC for MOE = 1,000 ( Residential) 2 Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males Dermal ( all durations) ( Residential) Oral study NOAEL = 0.6 mg/ kg/ day ( dermal absorption rate = 27%) LOC for MOE = 1,000 ( Residential) LOC for MOE = 100 ( Occupational) 2 Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males Inhalation ( all durations) ( Residential) Oral study NOAEL = 0.6 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 1,000 ( Residential) LOC for MOE = 100 ( Occupational) 2 Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males Cancer ( oral, dermal, inhalation Likely carcinogen for humans based on increased incidence of hepatocellular adenomas and carcinomas in male and female mice. Quantification of risk based on most potent unit risk: Male mouse liver adenoma and/ or carcinoma combined tumor rate. The upper bound estimate of unit risk, Q1* ( mg/ kg/ day) 1 is 3.77 x 10 2 in human equivalents * The reference to the FQPA safty factor refers to any additional safty factor retained due to concerns unique to the FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.565) for the combined residues of thiamethoxam and its metabolite, in or on a variety of raw agricultural commodities. Tolerances for thiamethoxam are established on barley, canola, cotton, sorghum, wheat, tuberous and corm vegetables crop subgroup, fruiting vegetables crop group, tomato paste, cucurbit vegetables crop group, pome fruits crop group, field corn forage, field corn stover, sweet corn stover, field corn grain, popcorn grain, and sweet corn ( kernal and cob with husk removed) milk and the meat and meat by products of cattle, goats, horses, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from thiamethoxam in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a food

VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54389 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The Dietary Exposure Evaluation Model ( DEEMTM) with the Food Commodity Intake Database ( FCID) analysis evaluated the individual food consumption as reported by respondents in the U. S. Department of Agriculture ( USDA) 1994   1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The residues of concern for the acute analysis are thiamethoxam and its metabolite. The assessment assumed that 100% of the registered and proposed crops were treated and that all treated crops and livestock had residues of concern at the tolerance level. The general U. S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC ( i. e., the aPADs are all below 100%). The most highly exposed subgroup is children 1 to 2 years of age, which utilizes 3% of the aPAD. ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEMTM with the FCID 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 following assumptions were made for the chronic exposure assessments: The residues of concern for the chronic analysis are thiamethoxam and its metabolite. The chronic analysis was based on average field trial residue values as well as percent crop estimates. The general U. S. population and all population subgroups have exposure and risk estimates which are below EPA's LOC ( i. e., the cPADs are all below 100%). The most highly exposed subgroup is children 1 to 2 years of age, which utilizes 17% of the cPAD. iii. Cancer. The residue of concern for the cancer analysis is thiamethoxam, per se. The residues of its metabolite were removed from the cancer analysis because the metabolite was found to be `` not likely to be carcinogenic to humans'' when it was evaluated as an active ingredient. The cancer analysis was based on average field trial residue values as well as percent crop treated ( PCT) estimates. The estimated cancer risk from dietary exposure to thiamethoxam is 9.04 x 10 ¥ 7. iv. Anticipated residue and 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 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. As required by section 408( b)( 2)( E) of the FFDCA, EPA will issue a Data Call In for information relating to anticipated residues 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 in the following Table 2:

TABLE 2.   THIAMETHOXAM USES AND ESTIMATES OF CROP TREATED Commodity Percent Crop Treated1 Apples 5 Casabas 44 Cherries ( sweet) 37 Cherries ( tart) 88 Coffee 100 Crabapples 53 Crenshaws 44 Cucumbers 5 Field corn 6 Fruiting vegetables ( except cucurbits  crop group 8) 15 Lima beans ( fresh) 37 Lima beans ( processed) 52 Loquats 53 Melons 13 Peaches 45 VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54390 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations TABLE 2.   THIAMETHOXAM USES AND ESTIMATES OF CROP TREATED   Continued Commodity Percent Crop Treated1 Pears 9 Pecans 38 Plums 60 Prunes 43 Pumpkins 44 Quinces 53 Snap beans ( fresh) 26 Snap beans ( processed) 38 Squash 44 Sunflower 25 Tuberous and corm vegetables  crop subgroup 1C 9 The Agency believes that the three conditions listed in this Unit have been met. With respect to condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns ( both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. 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 thiamethoxam may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for thiamethoxam in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of thiamethoxam. The Agency uses the Generic Estimated Environmental Concentration ( GENEEC) or the Pesticide Root Zone Model/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and SCI GROW, which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC ( a Tier 1 model) before using PRZM/ EXAMS ( a Tier 2 model) for a screeninglevel assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to thiamethoxam, they are further discussed in the aggregate risk sections in Unit III. E. Based on the PRZM/ EXAMS and SCIGROW models, the estimated environmental concentrations ( EECs) of thiamethoxam for acute exposures are estimated to be 7.1 parts per billion ( ppb) for surface water and 1.94 ppb for VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54391 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations ground water. The EECs for chronic non cancer exposures are estimated to be 0.43 ppb for surface water and 1.94 ppb for ground water. The EECs for cancer exposures are estimated to be 0.13 ppb for surface water and 1.94 ppb for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Thiamethoxam 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.'' EPA does not have, at this time, available data to determine whether thiamethoxam has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to thiamethoxam and any other substances and thiamethoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that thiamethoxam has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

D. 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 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. Prenatal and postnatal sensitivity. The developmental toxicity studies indicated no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetus to in utero exposure based on the fact that the developmental NOAELs are either higher than or equal to the maternal NOAELs. However, the reproductive studies indicate effects in males rats in the form of increased incidence and severity of testicular tubular atrophy. These data are considered to be evidence of increased quantitative susceptibility for male pups when compared to the parents. 3. Conclusion. There is a complete toxicity data base for thiamethoxam and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be retained. The 10X safety factor is retained based on the following factors: Effects on endocrine organs observed across species; the significant decrease in alanine amino transferase levels in the companion animal studies in the dog studies; the mode of action of this chemical in insects ( interferes with the nicotinic acetyl choline receptors of the insect's nervous system); the transient clinical signs of neurotoxicity in several studies across species; and the suggestive evidence of increased quantitative susceptibility in the rat reproduction study.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA's Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to thiamethoxam will occupy 3% of the aPAD for the U. S. population, 2% of the aPAD for females 13 years and older, 9% of the aPAD for all infants ( less than 1 year old), and 10% of the aPAD for children 1 to 2 years old. In addition, there is potential for acute dietary exposure to thiamethoxam in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54392 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations TABLE 3.   AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO THIAMETHOXAM Population Subgroup aPAD ( mg/ kg) % aPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Acute DWLOC ( ppb)

General U. S. population 0.1 3 7.1 1.94 2,400 All infants (< 1 year old) 0.1 9 7.1 1.94 910 Children ( 1  2 years old) 0.1 10 7.1 1.94 900 Females ( 13  49 years old) 0.1 2 7.1 1.94 2,900 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to thiamethoxam from food will utilize 6% of the cPAD for the U. S. population, 14% of the cPAD for all infants ( less than 1 year old), and 17% of the cPAD for children 1 to 2 years old. There are no residential uses for thiamethoxam that result in chronic residential exposure to thiamethoxam. In addition, there is potential for chronic dietary exposure to thiamethoxam in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4:

TABLE 4.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO THIAMETHOXAM Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. population 0.0006 6 0.43 1.94 20 All infants (< 1 year old) 0.0006 14 0.43 1.94 5.1 Children ( 1  2 years old) 0.0006 17 0.43 1.94 5.0 3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Thiamethoxam is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Thiamethoxam is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. Aggregate cancer risk for U. S. population. The dietary cancer risk from residues in food is 9.04 x 10 7. A cancer DWLOC is calculated only for the general U. S. population. For risk management purposes, EPA considers a cancer risk to be greater than negligible when it exceeds the range of 1 in 1 million. EPA has generally treated cancer risks up to 3 in 1 million as within the range of 1 in 1 million. The DWLOC for cancer aggregate risk ( no residential uses) is calculated using the following equations: DWLOC cancer ( µ g/ L) = chronic water exposure milligrams/ kilogram/ day ( mg/ kg/ day) x ( body weight/ kg) / consumption ( L) x 10 3 mg/ µ g Chronic water exposure ( mg/ kg/ day) = negligible risk / Q*  ( chronic food exposure)( mg/ kg/ day) Assuming that the negligible risk value could be as high as 3 x 10 6, the chronic water exposure value is estimated to be: 3 x 10 6 / 3.77 x 10 2  0.000024 = 0.000056 mg/ kg/ day The DWLOC cancer = 0.000056 mg/ kg/ day x 70 kg / 2L x 10 3 mg/ µ g = 1.95 µ g/ L The surface water EEC is 0.13 µ g/ L and the ground water EEC is 1.94 µ g/ L. Since the ground water value is greater than the surface water value, it will be used for comparison purposes and will protect for any concerns for surface water concentrations. Since the cancer DWLOC is not exceeded by the ground water EEC, the cancer risk is below EPA's level of concern. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to thiamethoxam residues.

IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology ( solvent extraction, liquid liquid partitioning and solid phase extraction cleanup, and high performance liquid chromatography using ultra violet detection ( HPLC/ UV) analysis) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755   5350; telephone number: ( 410) 305   2905; e mail address: residuemethods@ epa. gov.

B. International Residue Limits There are no international residue limits for thiamethoxam.

V. Conclusion Therefore, the tolerances are established for combined residues of thiamethoxam, 3[( 2 chloro 5 thiazolyl) methyl] tetrahydro 5 methyl Nnitro 4H 1,3,5 oxadiazin 4 imine and its metabolite ( N( 2 chloro thiazol 5 ylmethyl) N' methyl N' nitroguanidine in or on imported coffee at 0.05 ppm, pecan at 0.02 ppm, stone fruit VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54393 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations group 12 at 0.5 ppm, succulent bean at 0.02 ppm, and sunflower at 0.02.

VI. Objections and Hearing Requests 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. EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0306 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 November 17, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0306, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve 1 or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this 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 VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1 54394 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Rules and Regulations ( 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 petition under section 408( d) 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 in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: September 10, 2003. Debra Edwards, 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), 346( a) and 371.

 2. Section 180.565 is amended by alphabetically adding the following commodities to the table in paragraph ( a) to read as follows:

§ 180.565 Thiamethoxam; tolerances for residues.

( a) * * *

Commodity Parts per million * * * * * * * Bean, succulent ..................................................................................................................... 0.02 * * * * * * * Coffee1 ................................................................................................................................... 0.05 * * * * * * * Fruit, stone, group 12 ............................................................................................................ 0.5 * * * * * * * Pecans ................................................................................................................................... 0.02 * * * * * * * Sunflower ............................................................................................................................... 0.02 1There are no U. S. registrations as of September 17, 2003.

* * * * * [ FR Doc. 03   23852 Filed 9   15   03; 1: 28 pm]

BILLING CODE 6560   50   S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [ DA 03   2830; MM Docket No. 01   244, RM   10234; MM Docket No. 01   245, RM   10235]

Digital Television Broadcast Service; Tyler and Lufkin, TX AGENCY: Federal Communications Commission. ACTION: Final rule.

SUMMARY: The Commission, by this document, denies a petition for reconsideration filed by International Broadcasting Network of the Report and Order, which substituted DTV channel 10 for DTV channel 38 at Tyler, Texas, and DTV channel 11 for DTV channel 43 at Lufkin, Texas. See 67 FR 63852, October 16, 2002. With this action, this proceeding is terminated.

VerDate jul< 14> 2003 16: 05 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17SER1. SGM 17SER1


[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78077-78081]
[FR Doc No: 2023-25007]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98873; File No. SR-PEARL-2023-60]

Self-Regulatory Organizations; MIAX PEARL, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the MIAX
Pearl Equities Fee Schedule

November 7, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 31, 2023, MIAX PEARL, LLC (``MIAX Pearl'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') a
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the fee schedule (the
``Fee Schedule'') applicable to MIAX Pearl Equities, an equities
trading facility of the Exchange.
    The text of the proposed rule change is available on the Exchange's
website at https://www.miaxglobal.com/markets/us-options/pearl-options/rule-filings, at MIAX Pearl's principal office, and at the Commission's
Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Section 1)e) of the Fee Schedule to
amend the Midpoint Peg Order Adding Liquidity at Midpoint Volume Tiers
table to offer a new enhanced rebate for executions of Midpoint Peg
Orders \3\ in securities priced at or above $1.00 per share that
execute at the midpoint of the Protected NBBO \4\ and add liquidity to
the Exchange in all Tapes. In response to the competitive environment,
the Exchange offers tiered pricing, which provides Equity Members \5\
with opportunities to qualify for higher rebates or lower fees when
certain volume criteria and thresholds are met. Tiered pricing provides
an incremental incentive for Equity Members to strive for higher tier
levels, which provides increasingly higher benefits or discounts for
satisfying increasingly more stringent criteria.
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    \3\ A Midpoint Peg Order is a non-displayed Limit Order that is
assigned a working price pegged to the midpoint of the PBBO. A
Midpoint Peg Order receives a new timestamp each time its working
price changes in response to changes in the midpoint of the PBBO.
See Exchange Rule 2614(a)(3).
    \4\ With respect to the trading of equity securities, the term
``the term ``Protected NBB'' or ``PBB'' shall mean the national best
bid that is a Protected Quotation, the term ``Protected NBO'' or
``PBO'' shall mean the national best offer that is a Protected
Quotation, and the term ``Protected NBBO'' or ``PBBO'' shall mean
the national best bid and offer that is a Protected Quotation. See
Exchange Rule 1901.
    \5\ The term ``Equity Member'' is a Member authorized by the
Exchange to transact business on MIAX Pearl Equities. See Exchange
Rule 1901.

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Midpoint Peg Orders
    The Exchange currently provides a standard rebate of ($0.00205) \6\
per share for executions of Midpoint Peg Orders in securities priced at
or above $1.00 per share that execute at the midpoint of the Protected
NBBO and add liquidity to the Exchange in all Tapes.\7\
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    \6\ Rebates are indicated by parentheses. See the General Notes
section of the Fee Schedule.
    \7\ See Fee Schedule, Sections (1)(a) and (1)(b), Liquidity
Indicator Code ``Ap'' (adds liquidity and executes at the midpoint,
non-displayed Midpoint Peg Order (all Tapes)). The Exchange notes
that the standard rebate is not changing under this proposal.
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    The Exchange also provides enhanced rebates through a tiered
pricing structure for executions of Midpoint Peg Orders in securities
priced at or above $1.00 per share that execute at the midpoint of the
Protected NBBO and add liquidity to the Exchange in all Tapes based on
an Equity Member achieving certain ``Midpoint ADAV'' thresholds
(defined below) (the ``Midpoint Volume Tiers Program'').\8\ Pursuant to
the Midpoint Volume Tiers Program, Midpoint ADAV means the average
daily added volume (``ADAV'') for the current month consisting of
Midpoint Peg Orders in securities priced at or above $1.00 per share
that execute at the midpoint of the Protected NBBO and add liquidity to
the Exchange.\9\ Pursuant to Tier 1 of the Midpoint Volume Tiers
Program, Equity Members may qualify for an enhanced rebate of ($0.0025)
per share for executions of Midpoint Peg Orders in securities priced at
or above $1.00 per share that execute at the midpoint of the Protected
NBBO and add liquidity to the Exchange by achieving a Midpoint ADAV
equal to or greater than 500,000 shares. Pursuant to Tier 2 of the
Midpoint Volume Tiers Program, Equity Members may qualify for an
enhanced rebate of ($0.0027) per share for executions of Midpoint Peg
Orders in securities priced at or above $1.00 per share that execute at
the midpoint of the Protected NBBO and add liquidity to the Exchange by
achieving a Midpoint ADAV equal to or greater than 1,000,000 shares.
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    \8\ See Fee schedule, Section (1)(e).
    \9\ ``ADAV'' means average daily added volume calculated as the
number of shares added per day and ``ADV'' means average daily
volume calculated as the number of shares added or removed,
combined, per day. ADAV and ADV are calculated on a monthly basis.
The Exchange excludes from its calculation of ADAV and ADV shares
added or removed on any day that the Exchange's system experiences a
disruption that lasts for more than 60 minutes during regular
trading hours (``Exchange System Disruption''), on any day with a
scheduled early market close, and on the ``Russell Reconstitution
Day'' (typically the last Friday in June). Routed shares are not
included in the ADAV or ADV calculation. With prior notice to the
Exchange, an Equity Member may aggregate ADAV or ADV with other
Equity Members that control, are controlled by, or are under common
control with such Equity Member (as evidenced on such Equity
Member's Form BD). See the Definitions section of the Fee Schedule.
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Proposal
    The Exchange now proposes to amend the Midpoint Volume Tiers
Program to add a new Tier 3 and associated increased rebate. In
particular, the Exchange proposes that pursuant to Tier 3 of the
Midpoint Volume Tiers Program, Equity Members may now qualify for an
enhanced rebate of ($0.0029) per share for executions of Midpoint Peg
Orders in securities priced at or above $1.00 per share that execute at
the midpoint of the Protected NBBO and add liquidity to the Exchange by
achieving a Midpoint ADAV equal to or greater than 1,500,000 shares.
    The purpose of the proposed enhanced Tier 3 rebate for executions
of Midpoint Peg Orders in securities priced at or above $1.00 per share
that execute at the midpoint of the Protected NBBO and add liquidity to
the Exchange is to encourage Equity Members that provide liquidity
through non-displayed orders to strive for a higher Midpoint ADAV on
the Exchange in order to qualify for the higher rebate, which should
encourage increased order flow (particularly in the form of liquidity
adding non-displayed Midpoint Peg Orders that execute at the midpoint
of the Protected NBBO) to the Exchange, thereby contributing to a
deeper and more liquid market to the benefit of all market
participants.
    The Exchange believes that providing a higher enhanced rebate for
executions of Midpoint Peg Orders in securities priced at or above
$1.00 per share that execute at the midpoint of the Protected NBBO and
add liquidity to the Exchange is a reasonable means to incentivize
additional liquidity at the midpoint of the Protected NBBO, which in
turn should increase the attractiveness of the Exchange as a
destination venue as Equity Members seeking price improvement would be
more motivated to direct their orders to the Exchange because they
would have a heightened expectation of the availability of liquidity at
the midpoint of the Protected NBBO.
    The Exchange notes that competing exchanges provide similar pricing
structures and the proposed enhanced rebate is comparable to and higher
than the rebate provided by at least two competing exchanges for
executions of non-displayed orders in securities priced at or above
$1.00 per share that are pegged to the midpoint of national best bid
and offer.\10\
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    \10\ See MEMX Equities Fee Schedule, available at https://info.memxtrading.com/equities-trading-resources/us-equities-fee-schedule/ (providing enhanced rebates ranging from ($0.0018) up to
($0.0028) per share for members that achieve non-displayed ADAV
ranging from 1,000,000 shares to 8,000,000 shares, which includes
midpoint peg order executions); see also Nasdaq PSX Pricing
Schedule, available at https://www.nasdaqtrader.com/Trader.aspx?id=PSX_Pricing (providing a standard rebate of $0.0018
per share for all firms that add non-displayed liquidity via an
order with midpoint pegging and a rebate of $0.0025 per share for
firms that add non-displayed liquidity via an order with midpoint
pegging of at least 1 million shares ADV).
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Implementation
    The Exchange proposes to implement the changes to the Fee Schedule
pursuant to this proposal on November 1, 2023.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \11\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \12\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among its Equity Members and issuers and other
persons using its facilities. The Exchange also believes that the
proposed rule change is consistent with the objectives of Section
6(b)(5) \13\ requirements that the rules of an exchange be designed to
prevent fraudulent and manipulative acts and practices, and to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest, and, particularly, is not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange operates in a highly fragmented and competitive market
in which market participants can readily direct their order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 registered equities exchanges, and there are
a number of alternative trading systems and other off-exchange venues,
to which market participants may direct their order flow. Based on
publicly

available information, as of October 26, 2023, no single registered
equities exchange currently has more than approximately 15-16% of the
total market share of executed volume of equities trading for the month
of October 2023.\14\ Thus, in such a low-concentrated and highly
competitive market, no single equities exchange possesses significant
pricing power in the execution of order flow, and the Exchange
currently represents approximately 2.36% of the overall market
share.\15\ The Commission and the courts have repeatedly expressed
their preference for competition over regulatory intervention in
determining prices, products, and services in the securities markets.
In Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and also recognized that
current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \16\
---------------------------------------------------------------------------

    \14\ See the ``Market Share'' section of the Exchange's website,
available at https://www.miaxglobal.com/ (last visited October 26,
2023).
    \15\ Id.
    \16\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37499 (June 29, 2005).
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
shift order flow or discontinue to reduce use of certain categories of
products, in response to new or different pricing structures being
introduced into the market. Accordingly, competitive forces constrain
the Exchange's transaction fees and rebates, and market participants
can readily trade on competing venues if they deem pricing levels at
those other venues to be more favorable. The Exchange believes the
proposal reflects a reasonable and competitive pricing structure
designed to incentivize market participants to direct their order flow
to the Exchange, which the Exchange believes would enhance liquidity
and market quality to the benefit of all Members and market
participants.
    The Exchange believes that the proposed change to add a new
enhanced rebate to the Midpoint Volume Tiers Program is reasonable
because it will provide Equity Members with an additional incentive to
achieve higher volume thresholds on the Exchange. The Exchange notes
that volume-based incentives for midpoint peg order executions have
been adopted by competing exchanges,\17\ and the Exchange believes its
proposal is reasonable, equitable, and not unfairly discriminatory
because it is open to all Equity Members on an equal basis and provides
an additional benefit that is reasonably related to the value to of the
Exchange's market quality associated with higher levels of market
activity, such as higher levels of liquidity provision and the
introduction of higher volumes of orders into the price and volume
discovery processes. The Exchange believes that the proposal is
reasonable because it is designed to incentivize market participants to
direct additional order flow to the Exchange, which should enhance the
Exchange's market quality and provide price improvement through the use
of orders that are designed to execute at the midpoint of the Protected
NBBO through the provision of enhanced rebates for executions of
Midpoint Peg Orders in securities priced at or above $1.00 per share
that execute at the midpoint of the Protected NBBO and add liquidity to
the Exchange in all Tapes.\18\ The Exchange believes its proposal will
promote price improvement and increased liquidity on the Exchange which
will benefit all market participants.
---------------------------------------------------------------------------

    \17\ See supra note 10.
    \18\ The Exchange notes that Equity Members that do not qualify
for one of the Midpoint Volume Tiers will continue to receive the
standard rebate of ($0.00205) per share for executions of Midpoint
Peg Orders in securities priced at or above $1.00 per share that
execute at the midpoint of the Protected NBBO and add liquidity to
the Exchange in all Tapes.
---------------------------------------------------------------------------

    The Exchange believes the proposed enhanced Tier 3 rebate is
equitable and not unfairly discriminatory because all Equity Members
will continue to be eligible to qualify for the enhanced rebates
provided in the Midpoint Volume Tiers Program, including the new
enhanced Tier 3 rebate, and have the opportunity to receive the
corresponding enhanced rebate if such criteria is achieved (as
described above, based on Midpoint ADAV).
    The Exchange further believes that the proposed criteria for the
Tier 3 rebate in the Midpoint Volume Tiers Program (Midpoint ADAV equal
to or greater than 1,500,000 shares) is reasonable because the proposed
criteria is incrementally more difficult to achieve than that of the
Tier 2 rebate; thus, proposed Tier 3 offers an appropriately higher
rebate commensurate with the corresponding higher Midpoint ADAV
requirement. Therefore, the Exchange believes the proposed changes to
the Midpoint Volume Tiers Program is consistent with an equitable
allocation of fees and rebates, as the more stringent criteria
correlates with the corresponding tier's higher rebate. Additionally,
the Exchange believes that the proposed rebate is reasonable as such
rebate is comparable to, and higher than, the rebates for executions of
liquidity-adding non-displayed orders provided by at least two other
exchanges under similar volume-based tiers.\19\
---------------------------------------------------------------------------

    \19\ See supra note 10.
---------------------------------------------------------------------------

    For the reasons discussed above, the Exchange submits that the
proposal satisfies the requirements of Sections 6(b)(4) and 6(b)(5) of
the Act in that it provides for the equitable allocation of reasonable
dues, fees and other charges among its Equity Members and other persons
using its facilities and is not designed to unfairly discriminate
between customers, issuers, brokers, or dealers. As described more
fully below in the Exchange's statement regarding the burden on
competition, the Exchange believes that its transaction pricing is
subject to significant competitive forces, and that the proposed fees
and rebates described herein are appropriate to address such forces.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed changes will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act. The Exchange believes the proposed change
will encourage Equity Members to maintain or increase their order flow
to the Exchange, thereby contributing to a deeper and more liquid
market to the benefit of all market participants and enhancing the
attractiveness of the Exchange as a trading venue. As a result, the
Exchange believes the proposal would enhance its competitiveness as a
market that attracts actionable orders, thereby making it a more
desirable destination venue for its customers. For these reasons, the
Exchange believes that the proposal furthers the Commission's goal in
adopting Regulation NMS of fostering competition among orders, which
promotes ``more efficient pricing of individual stocks for all types of
orders, large and small.'' \20\
---------------------------------------------------------------------------

    \20\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 47396 (June 29, 2005).
---------------------------------------------------------------------------

Intramarket Competition
    The Exchange believes that the proposal would incentivize Equity
Members to maintain or increase their order flow, thereby contributing
to a

deeper and more liquid market to the benefit of all market participants
and enhance the attractiveness of the Exchange as a trading venue, and
to provide price improvement through the use of orders that are
designed to execute at the midpoint of the Protected NBBO, which the
Exchange believes, in turn, would continue to encourage participants to
direct order flow to the Exchange. Greater liquidity benefits all
Equity Members by providing more trading opportunities and encourages
Equity Members to send orders to the Exchange, thereby contributing to
robust levels of liquidity, which benefits all market participants. The
opportunity to qualify for enhanced, incremental rebates under the
Midpoint Volume Tiers Program is available to all Equity Members that
meet the associated Midpoint ADAV requirements in any month. The
Exchange believes the requirements in the Midpoint Volume Tiers Program
are reasonably related to the enhanced market quality that the Midpoint
Volume Tiers Program is designed to promote. Similarly, the proposed
enhanced Tier 3 rebate for executions of Midpoint Peg Orders in
securities priced at or above $1.00 per share that execute at the
midpoint of the Protected NBBO and add liquidity to the Exchange would
apply equally to all Equity Members. As such, the Exchange believes the
proposed changes would not impose any burden on intramarket competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.
Intermarket Competition
    The Exchange believes its proposal will benefit competition, and
the Exchange notes that it operates in a highly competitive market.
Equity Members have numerous alternative venues they may participate on
and direct their order flow to, including fifteen other equities
exchanges and numerous alternative trading systems and other off-
exchange venues. As noted above, for the month of October 2023, no
single registered equities exchange currently has more than 15-16% of
the total market share of executed volume of equities trading.\21\
Thus, in such a low-concentrated and highly competitive market, no
single equities exchange possesses significant pricing power in the
execution of order flow. Moreover, the Exchange believes that the ever-
shifting market share among the exchanges from month to month
demonstrates that market participants can shift order flow in response
to new or different pricing structures being introduced to the market.
Accordingly, competitive forces constrain the Exchange's transaction
fees and rebates generally, and market participants can readily choose
to send their orders to other exchanges and off-exchange venues if they
deem fee levels at those other venues to be more favorable.
---------------------------------------------------------------------------

    \21\ See supra note 14.
---------------------------------------------------------------------------

    As described above, the proposal is designed to enhance market
quality on the Exchange and to encourage more Equity Members to
maintain or increase their order flow, thereby contributing to a deeper
and more liquid market to the benefit of all market participants and
enhancing the attractiveness of the Exchange as a trading venue, and to
encourage Equity Members to provide price improvement through the use
of orders that are designed to execute at the midpoint of the Protected
NBBO. In turn, the Exchange believes that the proposed enhanced Tier 3
rebate for executions of Midpoint Peg Orders in securities priced at or
above $1.00 per share that execute at the midpoint of the Protected
NBBO and add liquidity to the Exchange would encourage the submission
of additional order flow to the Exchange, particularly in the form of
Midpoint Peg Orders executed at the midpoint of Protected NBBO, thereby
promoting market depth, enhanced execution opportunities, price
improvement, and price discovery to the benefit of all Equity Members
and market participants.
    As described above the Exchange's proposal is a competitive
proposal designed to encourage additional order flow to the Exchange
through a combination of volume based incentives, which have been
widely adopted by exchanges, and standard pricing that is comparable
to, and/or competitive with, pricing for similar executions in place at
other exchanges.\22\
---------------------------------------------------------------------------

    \22\ See supra note 10.
---------------------------------------------------------------------------

    Accordingly, the Exchange believes its proposal would not burden,
but rather promote, intermarket competition by enabling it to better
compete with other exchanges that offer similar standard pricing for
Added Midpoint Volume to market participants that achieves certain
volume criteria and thresholds.
    Additionally, the Commission has repeatedly expressed its
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. Specifically,
in Regulation NMS, the Commission highlighted the importance of market
forces in determining prices and SRO revenues and, also, recognized
that current regulation of the market system ``has been remarkably
successful in promoting market competition in its broader forms that
are most important to investors and listed companies.'' \23\ The fact
that this market is competitive has also long been recognized by the
courts. In NetCoalition v. Securities and Exchange Commission, the D.C.
circuit stated: ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their routing agents, have a wide range of choices of where to
route orders for execution'; [and] `no exchange can afford to take its
market share percentages for granted' because `no exchange possess a
monopoly, regulatory or otherwise, in the execution of order flow from
broker dealers' . . .''.\24\ Accordingly, the Exchange does not believe
its proposed pricing changes impose any burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \23\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \24\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSE-2006-21)).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\25\ and Rule 19b-4(f)(2) \26\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \26\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-PEARL-2023-60 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to file number SR-PEARL-2023-60. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-PEARL-2023-60 and should be
submitted on or before December 5, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Christina Z. Milnor,
Assistant Secretary.
[FR Doc. 2023-25007 Filed 11-13-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 93 (Monday, May 14, 2012)]
[Rules and Regulations]
[Pages 28264-28266]
[FR Doc No: 2012-11184]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0556; FRL-9669-5 ]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Ohio; Determination of Clean Data for the 2006 24-Hour
Fine Particulate Standard for the Steubenville-Weirton Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is making a final determination regarding the two-state
Steubenville-Weirton, Ohio-West Virginia nonattainment area (hereafter
referred to as the ``Steubenville-Weirton Area'' or ``Area'') for the
2006 24-hour fine particulate matter (PM2.5) National
Ambient Air Quality Standard (NAAQS). EPA is determining that the
Steubenville-Weirton Area has attained the 24-hour 2006
PM2.5 NAAQS. This determination is based upon complete,
quality assured, and certified ambient air monitoring data showing that
this area has monitored attainment of the 24-hour 2006 PM2.5
NAAQS based on the 2008-2010 data. EPA's determination suspends the
obligation of Ohio and West Virginia to submit, with respect to this
area, attainment demonstrations, associated reasonably available
control measures (RACM), reasonable further progress plans, contingency
measures, and other planning State Implementation Plans (SIPs) related
to attainment of the 2006 PM2.5 standard for so long as the
Area continues to meet the 24-hour 2006 PM2.5 NAAQS.

DATES: Effective Date: This final rule is effective on June 13, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2011-0556. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., 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 electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: In Region III, Asrah Khadr, Office of
Air Program Planning, Environmental Protection Agency, Region III, 1650
Arch Street, Philadelphia, PA 19103-2023. The telephone number is (215)
814-2071. Ms. Khadr can also be reached via electronic mail at
<EMAIL_ADDRESS>In Region V, Carolyn Persoon, Air Planning and
Maintenance Section, Air Programs Branch (AR-18J), Environmental
Protection Agency, Region V, 77 West Jackson Boulevard, Chicago,
Illinois 60604-3507. Ms. Persoon's telephone number is<PHONE_NUMBER>.
Ms. Persoon can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?
II. What is the effect of this action?
III. Summary of Public Comment and EPA Response
IV. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is making a final determination that the Steubenville-Weirton
Area has attained the 24-hour 2006 PM2.5 NAAQS. This
determination is based upon complete, quality assured, and certified
ambient air monitoring data showing that this area has monitored
attainment of the 2006 PM2.5 NAAQS based on data for 2008-
2010.
    On October 4, 2011 (76 FR 61291), EPA proposed its determination of
attainment for the Steubenville-Weirton Area. A discussion of the
rationale behind this determination and the effect of the determination
were included in the notice of proposed rulemaking (NPR). One adverse
comment was submitted in response to EPA's October 4, 2011 NPR (76 FR
61291). A summary of the comment and EPA's response is provided in
section III of this document.

II. What is the effect of this action?

    Under the provisions of EPA's PM2.5 implementation rule
(40 CFR 51.1004(c)), the requirements for the States of Ohio and West
Virginia to submit, for the Steubenville-Weirton Area, an attainment
demonstration and associated RACM (including reasonably available
control technology (RACT)), a reasonable further progress plan,
contingency measures, and any other planning SIPs related to attainment
of the 2006 PM2.5 NAAQS are suspended for so long as the
Area continues to meet the 24-hour 2006 PM2.5 NAAQS. If EPA
subsequently determines that this Area violates the 24-hour 2006
PM2.5 NAAQS, the basis for the suspension of the specific
requirements, set forth at 40 CFR 51.1004(c), would no longer exist and
this area would thereafter have to address the pertinent requirements.
    This action, does not constitute a redesignation of the
Steubenville-Weirton Area to attainment of the 24-hour 2006
PM2.5 NAAQS under section 107(d)(3) of the Clean Air Act
(CAA). Further, this action does not involve approving maintenance
plans for the Area as required under section 175A of the CAA, nor does
it find that the Area has met all other requirements for redesignation.
Even after a determination of attainment by EPA, the designation status
of the Steubenville-Weirton Area remains nonattainment for the 24-hour
2006 PM2.5 NAAQS until such time as EPA determines that the
Area meets the CAA requirements for redesignation to attainment and
takes action to redesignate the Steubenville-Weirton Area.

III. Summary of Public Comment and EPA Response

    Comment: An Ohio resident expressed concern for the air quality in
the Steubenville-Weirton Area. The resident perceives the air quality
to be poor and thus questioned how this Area will be free from
requirements to create plans for air quality improvement. The resident
also proposed that areas with air quality problems should be subject to
more stringent standards.
    Response: Since 2006, the States of Ohio and West Virginia, as well
as the Federal government, have implemented various measures that have
resulted in cleaner air in the Steubenville-Weirton Area, including,
the nitrogen oxides (NOX) SIP Call which addressed
pollutants that can result in acid rain; mobile source engine standards
leading to a decrease in NOX and direct PM2.5;
fuel standards decreasing sulfur dioxide (SO2); as well as
rules affecting SO2 and

NOX from power plants. These and other measures have
resulted in a decrease in monitored PM2.5 concentrations in
the Steubenville-Weirton Area. Questions regarding the stringency of
existing air standards are not relevant to this determination. The sole
concern of this determination is whether the Area has attained the 2006
PM2.5 24-hour standard. Since 2008, based on complete,
quality assured and certified data, this Area has monitored attainment
of that standard, set by EPA to protect human health and the
environment. The Area continues to attain the standard. At this time,
therefore, no additional attainment planning or measures related to
attainment of the 2006 PM2.5 24-hour standard are needed. In
the future, should EPA determine that a violation of the standard
occurs, the States of Ohio and West Virginia will then be required to
submit an attainment demonstration, associated RACM, a reasonable
further progress plan, contingency measures, and other planning SIPs
related to attainment of the standard.

IV. Statutory and Executive Order Reviews

A. General Requirements

    This action merely makes an attainment determination based on air
quality data and does not impose any additional requirements. For that
reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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 action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 13, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This clean data determination for the 24-hour 2006
PM2.5 NAAQS for the Steubenville-Weirton Area may not be
challenged later in proceedings to enforce its requirements. (See
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter, Sulfur oxides, Nitrogen oxides,
Reporting and recordkeeping requirements.

    Dated: February 15, 2012.
W.C. Early,
Acting, Regional Administrator, Region III.

    Dated: April 18, 2012.
Susan Hedman,
Regional Administrator, Region V.
    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart KK--Ohio

0
2. In Sec.  52.1880, paragraph (r) is added to read as follows:

Sec.  52.1880  Control strategy: Particulate matter.

* * * * *
    (r) Determination of Attainment. EPA has determined, as of May 14,
2012, that based on 2008 to 2010 ambient air quality data, the
Steubenville-Weirton nonattainment area has attained the 24-hour 2006
PM2.5 NAAQS. This determination, in accordance with 40 CFR
52.1004(c), suspends the requirements for this area to submit an
attainment demonstration, associated reasonably available control
measures, a reasonable further progress plan, contingency measures, and
other planning SIPs related to attainment of the standard for as long
as this area continues to meet the 24-hour 2006 PM2.5 NAAQS.

Subpart XX--West Virginia

0
3. In Sec.  52.2526, paragraph (g) is added to read as follows:

Sec.  52.2526  Control strategy: Particulate matter.

* * * * *
    (g) Determination of Attainment. EPA has determined, as of May 14,
2012, that based on 2008 to 2010 ambient air quality data, the
Steubenville-Weirton nonattainment area has attained the 24-hour 2006
PM2.5 NAAQS. This determination, in accordance with 40 CFR
52.1004(c), suspends the requirements for this area to submit an
attainment demonstration, associated reasonably available control
measures, a reasonable further progress plan, contingency measures, and
other planning SIPs related to attainment of the standard for as long
as this area

continues to meet the 24-hour 2006 PM2.5 NAAQS.

[FR Doc. 2012-11184 Filed 5-11-12; 8:45 am]
BILLING CODE 6560-50-P