i UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES PC Code: 006304, 006308, 006321 DP BARCODE: 315682 MEMORANDUM May 22, 2006 SUBJECT: Oxytetracycline: Tier I Drinking Water Exposure Assessment of Oxytetracycline Supporting the Reassessment Under FQPA of Pear and Peach & Nectarine Use Patterns and the Assessment of the New Use Pattern, Apple: Cover Memorandum TO: Lance Wormell, Chemical Review Manager RB2/ SRRD ( 7508C)

Stephen Schaible, Product Manager RSB/ RD ( 7505C)

FROM: Greg Orrick, Environmental Scientist Elizabeth Behl, Chief ERB4/ EFED ( 7507C)

THROUGH: R. David Jones, Ph. D., Senior Agronomist ERB4/ EFED ( 7507C)

The attached drinking water assessment for oxytetracycline on pear, peach & nectarine, and apple use patterns has been revised to address phase 3 comments received by the Agency. Oxytetracycline equivalents on agricultural end use product ( EUP) labels have been confirmed at 17%. Clarification of the molecular weight and structure of " oxytetracycline calcium complex" is recommended, however, as the term appears to represent oxytetracycline calcium salt in product chemistry studies ( e. g. MRID 43262301) and a complex of oxytetracycline and complexing agent in Confidential Statements of Formula.

The hydroxytetracycline monohydrochloride technical label ( EPA Reg. No. 74596 5; 80990 2) is labeled for " domestic outdoor use." However, this use was not addressed in this assessment because it is for a technical formulation.

Language clarification is recommended for crop use directions in EPA labels ( EPA Reg. No. 55146 89; 100 900; 80990 1). Maximum application rates per year, maximum numbers of ii applications per year, minimum application intervals, and application methods are often suggested rather than clearly listed as mandatory. For example, EPA Reg. No. 80990 1 offers a " recommended concentration or rate" for applications on pear, but doesn't give an annual limit. EPA Reg. No. 100 900 specifies a use rate on pear of up to 150 gal/ acre of 200 ppm solution, which is equivalent to 1.5 lbs product/ acre; but also directs not to apply more than 1 lb product/ acre. The latter instruction was followed for modeling, but the label should be rewritten so as not to contradict itself. EPA Reg. No. 80990 1, 100 900, and 55146 89 do not specify application methods for pears, although EPA Reg. No. 100 900 generally recommends application by air blast sprayer. In contrast, all labels with peach and nectarine use patterns specify pressure spray or air blast spray application.

All laboratory fate and degradation studies were waived for this chemical 12 years ago. Since then, the use of this chemical has expanded significantly. Availability of these basic environmental fate studies would greatly decrease the uncertainty associated with exposure assessments.

If the conservative EDWCs in this memo result in dietary risk exceedances, contact Greg Orrick ( 703 305 6140) of Environmental Risk Branch IV to request a refined Tier II drinking water exposure assessment. Page 1 of 14 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES PC Code: 006304, 006308, 006321 DP BARCODE: 315682 MEMORANDUM May 22, 2006 SUBJECT: Oxytetracycline: Tier I Drinking Water Exposure Assessment of Oxytetracycline Supporting the Reassessment Under FQPA of Pear and Peach & Nectarine Use Patterns and the Assessment of the New Use Pattern, Apple.

TO: Lance Wormell, Chemical Review Manager RB2/ SRRD ( 7508C)

Stephen Schaible, Product Manager RSB/ RD ( 7505C)

FROM: Greg Orrick, Environmental Scientist Elizabeth Behl, Chief ERB4/ EFED ( 7507C)

THROUGH: R. David Jones, Ph. D., Senior Agronomist ERB4/ EFED ( 7507C)

Executive Summary This assessment provides Tier I estimated drinking water concentrations ( EDWC) from the maximum use pattern of oxytetracycline, hydroxytetracycline monohydrochloride, and oxytetracycline calcium ( PC Codes 006304, 006308, 006321; hereafter collectively referred to as " oxytetracycline") in surface water and in groundwater in support of human health risk assessment ( Table 1). EDWC values were generated to compare the current oxytetracycline use patterns of pear and peach & nectarine, which are registered for three agricultural products, and the proposed oxytetracycline use on apples ( Table 5).

Table 1. Tier I EDWCs in surface water and groundwater for peaches and nectarines, which is the maximum use pattern for oxytetracycline. Maximum Use Pattern Surface Water Acute EDWC ( ppb) Surface Water Chronic EDWC ( ppb) Groundwater EDWC ( ppb) Peaches & Nectarines 89.4 4.6 0.033 Page 2 of 13 Model input parameters include conservative assumptions because all environmental fate studies for oxytetracycline were waived during the reregistration process. Label ambiguity contributes to uncertainty in EDWCs as well. Acute and chronic surface water EDWCs were calculated with the screening mechanistic model FIRST v1.0 ( Aug. 1, 2001). Groundwater EDWCs used for both acute and chronic risk assessment were generated with the screening regression model SCI GROW v2.3 ( Jul. 29, 2003).

Concentrations of oxytetracycline degradates are not estimated, as the Health Effects Division ( HED) has not found any degradates to be of toxic concern. 1 Monitoring data are not available to represent water quality impacts associated with the registered crop uses. Available monitoring data are described on page 11 to provide insight into the prevalence of oxytetracycline in the environment resulting from nonagricultural uses.

This assessment only considers potential drinking water exposure from oxytetracycline applied to selected crops in order to control fire blight and bacterial spot. Other uses of oxytetracycline, including pharmaceuticals, animal feeding operations, and aquaculture, are regulated by the FDA. The extent to which these nonagricultural uses may result in environmental and dietary exposure has not been assessed, nor has potential environmental risk from emergence of antimicrobial drug resistance in bacterial pathogens, development of cross resistance to other tetracycline compounds, or drug resistance transference from benign pathogens to harmful pathogens. Available monitoring data, which may include water quality impacts from some of these nonagricultural uses, is described.

Problem Formulation The purpose of this screening level drinking water risk assessment is to provide estimated drinking water concentrations ( EDWCs) of oxytetracycline in surface water and in groundwater in support of the human health chapters of the Tolerance Reregistration Eligibility Decision ( TRED) risk assessment and the registration for the new use on apple ( EPA Reg. No. 618 104). The EDWC values in Table 5 were generated for the current and proposed oxytetracycline use patterns of pear, peach & nectarine, and apple, which are registered for three agricultural formulated enduse products [ EPA Reg. No. 100 900 ( 618 104 proposed); 55146 89; and 80990 1 ( 74896 4)]. Other registered agricultural uses are tree injection and marine paint antifoulant additive uses; however, these uses are not calculated for in this assessment because they are not expected to lead to significant drinking water exposure. Other non pesticidal uses of oxytetracycline are also not considered in this assessment.

A screening level assessment is performed and available monitoring data is characterized for this Tier I drinking water exposure assessment. The Tier I models FIRST ( surface water) and SCI GROW ( ground water) are used to conservatively estimate concentrations in source surface and ground water that could potentially be used as drinking water. These screening models are designed not as explicit predictions of typical exposure, but as upper bound estimates of the exposure that could occur in the environment under conditions that are favorable to runoff ( FIRST) and leaching ( SCI GROW). The models simulate processes that could affect the transportation of compounds to water bodies via runoff, erosion, spray drift, or leaching in order to 1 Personal communication with William Donovan, OPP/ HED, on July 29, 2005. Page 3 of 13 indicate which chemicals exceed levels of concern, warranting a more refined assessment. The models estimate exposure based on a few chemical and use input parameters and on the conservative, upper end results of hundreds of runs on the PRZM and EXAMS models, which have limitations in their ability to represent some processes and factors, such as spray drift, certain runoff factors, within site variability, crop growth, soil water transport, and weather.

Oxytetracycline calcium complex is the active ingredient in two current registrations ( EPA Reg. No. 100 900 and 55146 89); hydroxytetracycline monohydrochloride is the active ingredient in the third current registration ( EPA Reg. No. 80990 1). Oxytetracycline base is not an active ingredient in any registered end products. All three oxytetracycline active ingredients are collectively referred to as " oxytetracycline" in this assessment because they all share the same biologically active oxytetracycline base, and are expected to behave similarly in the environment, displaying the same mechanisms of effect in each formulation. Note, however, that oxytetracycline calcium complex is not strictly a calcium salt, but a complex of oxytetracycline and calcium rich complexing agent. The percentage of the biologically active oxytetracycline base ( equivalent) for all end use formulations is 17%. Concentrations of oxytetracycline degradates are not estimated, as the Health Effects Division ( HED) has not found any degradates to be of toxic concern. 2 All requirements for fate data on oxytetracycline were waived during the reregistration process because oxytetracycline had a limited use pattern and because it was expected to pose low risk ( Office of Pesticide Programs, 1993). Product chemistry studies provide data on water solubility ( MRID 44219401, 46109401, 43262301, and 41602001). A peer reviewed study from the open literature on the soil to water partition coefficients ( Kd) of oxytetracycline in 30 soils of the eastern United States provides the information on mobility used in this assessment to model exposure ( Jones et al., 2005). However, all standard environmental degradation data required for risk assessment are unavailable Oxytetracycline has uses regulated by the FDA that may lead to environmental and irrigation reservoir exposure, such as concentrated animal feeding operations ( CAFO), concentrated aquatic animal production facilities ( CAAPF), aquaculture, and silviculture operations. These uses require an NPDES permit to discharge listed pollutants [ 40 CFR pt. 122 ( 2004)]; however, oxytetracycline is not currently a listed pollutant [ 40 CFR pt. 401.15 ( 2004)] under the Clean Water Act [ 33 U. S. C. Sec. 1251 et seq. ( 2003)]. Studies have shown that antibiotics mixed in aquaculture feed tend to accumulate in and persist in the sediment below, where wild fish and invertebrates can uptake them into their tissues to levels unacceptable for human consumption ( Milewski, 2001; Capone et al., 1996).

Fate and Transport Characterization Many data gaps exist for fate and transport characterization because no environmental fate ( Subdivision N) studies have been submitted for oxytetracycline. They were waived in the reregistration process ( USEPA, 1993) on the basis of limited use patterns at the time and low estimated risks. The following are fate and transport data from product chemistry studies and the 2 Personal communication with William Donovan, OPP/ HED, on July 29, 2005. Page 4 of 13 open literature. Data from open literature do not fulfill Subdivision N data requirements, but were used in this assessment in the absence of other data.

Solubility Product chemistry studies indicate that the water solubility of hydrochloride salt is 1g in 2 mL ( 500,000 mg L 1) and that oxytetracycline base and calcium salt are slightly soluble ( MRID 41602001, 46109401, 43262301, 44219401). They also report that the 0.1% solution pH of calcium salt is 7.5 to 10.0, which implies that the water solubility is somewhat near 10 g L 1 ( 10,000 mg L 1; MRID 44219401). Therefore, these compounds are soluble enough to dissolve in surface water and groundwater; however, their exact water solubilities are not well defined.

Mobility Soil to water partition coefficients ( Kd) for oxytetracycline in 30 eastern U. S. soils representing five soil orders and 28 soil series have been published in a peer reviewed study ( Jones et al., 2005). The study concluded that soil texture, cation exchange capacity, and iron oxide content appeared to most influence oxytetracycline sorption in soils with organic carbon content of 0 to 4%. Soil organic carbon content negatively correlated with compound sorption in those soils, but not with a single soil of 9% organic carbon. Kd values ranged from 486 L kg 1 to 12,047 L kg 1 ( pH 5.5). Data from this study were used to generate EDWCs for this assessment. Based on the range of Kd values presented in this literature review, oxytetracycline has relatively low mobility, and is expected to preferentially adsorb to soils with minimal expected transport in the dissolved phase in runoff or leachate.

Degradation The following studies from open literature may offer insight regarding the degradation of oxytetracycline. The USGS Kansas Water Science Center3 published a study on the chemical degradation of antibiotics in anaerobic swine lagoons, which found that oxytetracycline hydrolysis rates generally increase as pH deviates from 7 and as temperature increases in synthetic systems ( Loftin et al., 2004). A kinetics study of oxytetracycline found that high temperatures, light exposure, alkaline conditions, the presence of a substrate, and the presence of organic matter each led to decreased concentrations of the compound in deionized water as compared to contrasting conditions ( Doi and Stoskopf, 2000). An aerobic aquatic dissipation study performed in diffuse light found that oxytetracycline " might be considered as moderately persistent," displaying firstorder half lives of 31 to 175 days in natural surface water and sediment ( Ingerslev et al., 2001). These data are not acceptable according to 40 CFR Pt. 158 data requirements and cannot be used as inputs to model environmental exposure.

Models Used The Tier I screening model FIRST v1.0 ( Aug. 1, 2001) simulates the upper end exposure of the standard water body, the Index Reservoir, to pesticide residues in runoff and spray drift from an application within the standard watershed. Peak and annual mean EDWCs are generated 3 Online at: http:// ks. water. usgs. gov. Page 5 of 13 to estimate acute and chronic exposure. The Index Reservoir covers 5.2 hectares ( ha) with an average depth of 2.74 meters ( m) in a standard watershed of 172.8 ha. A more detailed description of the index reservoir watershed can be found in Jones et al., 1998. The FIRST model and users manual may be downloaded from the US Environmental Protection Agency Water Models webpage 4 The Tier I screening model SCI GROW v2.3 ( Jul. 29, 2003) simulates the exposure of shallow groundwater to pesticide residues from application to a field with highly permeable soil. A single 90 day running average EDWC is estimated through regression as a screen for both acute and chronic exposure. This estimated value is protective as a maximum acute exposure value because SCI GROW simulates exposure to shallow wells in unconfined aquifers with short well screens overlain by highly permeable soils that are conducive to leaching. Many drinking water wells have larger well screens and are not in unconfined aquifers overlain by highly permeable soils. The SCI GROW model and users manual may be downloaded from the EPA Water Models web page. 3 Both FIRST and SCI GROW were run to estimate screening level exposure of drinking water sources from oxytetracycline.

Use Characterization Oxytetracycline base [ 2 naphthacenecarboxamide, 4( dimethylamino) 1,4,4a, 5,5a, 6,11, 12a octahydro 3,5,6,10,12,12a hexahydroxy 6 methyl 1,11 dioxo, ( 4S, 4aR, 5S, 5aR, 6S, 12aS)], also known as terramycin ( CAS RN 79 57 2), its salts hydroxytetracycline monohydrochloride ( CAS RN 2058 46 0) and calcium oxytetracycline ( CAS RN 7179 50 2 and 15251 48 6) are three active ingredients that share the biologically active component of an antibiotic produced by the actinomycete Streptomyces rimosus. Oxytetracycline is a human and animal drug and is used as a pesticide to control bacteria, fungi, and mycoplasma like organisms.

The hydrochloride salt and calcium complex formulations of oxytetracycline are currently formulated as a wettable powder for agricultural uses, registered to control fire blight on pear and bacterial spot on peaches and nectarines ( EPA Reg. No. 55146 89; 100 900; and 80990 1 ( 74896 4)). The State of Washington has two special local need [ § 24( c)] registrations ( WA 010020 and WA 980014) to use the EPA Reg. No. 100 900 product on pears. Apple uses similar to EPA Reg. No. 100 900 are pending under EPA Reg. No. 618 104. Non agricultural registrations specify hydroxytetracycline monohydrochloride and oxytetracycline calcium complex as tree injections for coconut palm and pritchardia palm and hydroxytetracycline monohydrochloride as an antifoulant in marine paint for barnacle control.

Use pattern values from active and proposed labels with ground spray and aerial applications are listed in Table 2.

4 Online at: http:// www. epa. gov/ oppefed1/ models/ water/ index. htm. Page 6 of 13 Table 2. Labeled values for pear, peach & nectarine, and apple use patterns. Use Pattern EPA Reg. No. App. Rate1 ( lb a. i./ ac) Applications per Year Application Interval ( days) Application Method Apple 618 104 0.255 6 3 Air blast Peach & Nectarine 55146 89, 80990 1, 74896 11 0.638 9 7 Air blast Peach & Nectarine 100 900 0.255 8 7 Air blast Pear 100 900, 55146 89, 80990 1, 74896 11 0.170 10 4 Air blast Pear 100 900 WA 010020 0.170 6 4 Aerial Pear 100 900 WA 980014 0.085 10 4 Aerial 1. App. rate ( lb a. i./ ac) means application rate ( pounds of active ingredient per acre), which was calculated by multiplying the product oxytetracycline equivalent percentage by the maximum pounds of product applicable to an acre, as specified by the label.

Application rates in pounds of active ingredient per acre ( lb a. i./ ac) were calculated by multiplying oxytetracycline active ingredient equivalent percentages specified on the labels by the maximum pounds of product applicable to an acre ( e. g. ( 17% a. i.) x ( 3.75 lb / 500 gal) x ( 500 gal / 1 acre) = 0.638 lb a. i./ acre). The number of applications per year and the interval between them are found in rather ambiguous label directions, such as, " Applications are weekly," and " This may involve up to 8 to 10 applications" ( EPA Reg. No. 55146 89 and 80990 1). These instructions were interpreted as directions, not as suggestions. However, succinctly stated label directions would decrease the need for interpretation, and associated uncertainties.

EPA Reg. No. 100 900 specifies a use rate on pear of 200 ppm solution in up to 150 gal/ acre, which is equivalent to 1.5 lbs product/ acre; but also directs not to apply more than 1 lb product/ acre. The latter instruction was followed for modeling, but the label is confusing as written.

The recommended application method for use patterns under EPA Reg. No. 100 900 is airblast sprayer. Peach and nectarine uses on other labels are also specified for air blast spray or hand held spray. Pear uses on EPA Reg. No. 55146 89, 100 900, and 80990 1 have no application method specified; however, air blast spray was assumed to apply. The special local need labels for the State of Washington are the only labels that specifically allow aerial application.

Input Parameters This screening level assessment uses maximum application practices from each registered and proposed use to generate conservative EDWCs. Maximum application practices involve the maximum single application rate, the maximum number of applications per year, and the minimum interval between applications allowed by the label. All use patterns on the labels were modeled for surface water and groundwater in order to provide estimates of the range of concentrations associated with each crop and use pattern. The shaded values in Table 2 represent the maximum use pattern used to generate EDWCs in support of risk assessment, listed in Table 1. Page 7 of 13 FIRST Input parameters.

Input parameters, justifications, and source references for the FIRST model appear in Table 3 for oxytetracycline use on apple, peach and nectarine, and pear orchards.

Table 3. FIRST input parameters for oxytetracycline applied to pear, peach & nectarine, and apple. 1 Input Parameter Value Justification Source Percent cropped area 0.87 Default USEPA, 2002 Kd ( mL/ g) 771 Represents the lowest Kd for a non sand soil. Jones et al., 2005 Aerobic soil metabolism half life ( days) Stable Conservative assumption due to data gap. N/ A Wetted in? No Label directions Label Solubility in water ( ppm) 1000 Arbitrary value based on product chemistry study values for each compound. MRID 44219401 Aerobic aquatic metabolism half life ( days) Stable Conservative assumption due to data gap. N/ A Hydrolysis half life at pH 7 ( days) Stable Conservative assumption due to data gap. N/ A Aqueous photolysis half life ( days) Stable Conservative assumption due to data gap. N/ A 1. Use pattern parameters are listed in Table 2.

Because suitable environmental fate data were not available, degradation rate input parameters listed were assumed to be stable. This approach provides a highly conservative estimate of potential exposure.

The water solubilities of oxytetracycline salts and complexes are not well established. However, the water solubility value of the least soluble moiety is at least 10 g L 1, which is far above EDWCs. Solubility values serve as upper limits to EDWCs in the FIRST model. Therefore, an arbitrary water solubility value of 1000 mg L 1 was selected as a conservative and consistent upper EDWC limit for use in modeling oxytetracycline active ingredients.

The default percent cropped area ( PCA) used ( 0.87) is the maximum fraction of any HUC 8 basin in the United States that is agricultural land. It is a conservative estimate of actual cropped area fractions both because it is a maximum value and because a basin may contain more than one crop ( Effland et al., 1999).

The FIRST input ( and output) file for the use pattern of highest EDWCs is included in Attachment I of the Appendix.

SCI GROW Input parameters.

Input parameters, justifications, and source references for the SCI GROW model appear in Table 4 for oxytetracycline use on apple, peach and nectarine, and pear orchards. Page 8 of 13 Table 4. SCI GROW input parameters for oxytetracycline applied to pear, peach & nectarine, and apple. 1 Input Parameter Value Justification Source KOC ( L/ Kg) 9995 Assumption based on limit of model validity. N/ A Aerobic soil metabolism half life ( days) 1000 Conservative assumption due to data gap. N/ A 1. Use pattern parameters are listed in Table 2.

The lowest KOC value calculated for input into SCI GROW, based on Kd values from a literature review ( Jones et al., 2005), was 27,303 L kg 1, which is above 9,995 L kg 1, the limit of the scope of the model's regression data. The KOC is not a valid description of binding for oxytetracycline because of the negative correlation between organic carbon content and sorption; however, a Koc value is necessary to yield the model input. Due to these considerations, 9,995 L kg 1 was used as the KOC model input for oxytetracycline, which adds to the conservativeness of groundwater EDWCs in this assessment The aerobic soil metabolism half life of oxytetracycline was conservatively assumed to be stable in the absence of source data. The SCI GROW model does not accept a stable input value for the aerobic soil metabolism half life, however. Therefore, 1000 days was arbitrarily chosen as a half life value that is expected to exceed the true value in order to approach stability without escaping the scope of the regression data used to develop the model.

The SCI GROW input ( and output) file for the use pattern of highest EDWC is included in Attachment II of the Appendix.

Results EDWCs generated as described above are listed in Table 5. All use patterns on the labels were modeled for surface water and groundwater in order to provide estimates of the range of concentrations associated with each crop and use pattern. The maximum use pattern of oxytetracycline is on peaches and nectarines as directed by EPA Reg. No. 55146 89, 80990 1, and 74896 4, which yields maximum EDWCs recommended to represent drinking water exposure in this screening level assessment ( Table 1 and shaded in Table 5). EDWCs are highly conservative, due to conservative assumptions about the environmental fate of oxytetracycline.

Table 5. Tier I EDWCs in surface water and groundwater from use patterns for oxytetracycline. Use Pattern EPA Registration Number Surface Water Acute EDWC ( ppb) Surface Water Chronic EDWC ( ppb) Groundwater EDWC ( ppb)

Apple 618 104 23.9 1.3 0.009 Peaches & Nectarines 55146 89, 80990 1, 74896 4 89.4 4.6 0.033 Peaches & Nectarines 100 900 31.8 1.7 0.012 Pear 100 900, 55146 89, 80990 1, 74896 4 26.5 1.4 0.010 Pear 100 900 WA 010020 15.4 1.0 0.006 Pear 100 900 WA 980014 12.9 0.9 0.005 Page 9 of 13 The screening models are designed not as explicit predictors of typical exposure, but as upper bound estimators of the exposure that could occur in the environment under conditions which are highly favorable to runoff ( FIRST) and leaching ( SCI GROW). These models should simply indicate which chemicals exceed levels of concern, warranting more refined assessment. The models estimate exposure based on a few chemical and use input parameters and on the conservative, upper end results of hundreds of runs on the PRZM and EXAMS models, which have limitations in their ability to represent some processes and factors, such as spray drift, certain runoff factors, within site variability, crop growth, soil water transport, and weather.

Surface water acute EDWCs calculated by FIRST for control of fire blight on peach and nectarine range from 32 to 89 ppb due to the ranges of application rates and numbers of applications per year, as directed by the labels. The EDWC for EPA Reg. No. 55146 89, 80990 1, and 74896 4 ( 89.4 ppb) is a 181% increase over the EDWC for EPA Reg. No. 100 900 ( 31.8 ppb) due to the 150% increase in application rate and one additional application per year between the labels.

Monitoring A USGS monitoring study of 139 streams in 30 states was conducted from 1999 to 2000 to measure concentrations of 95 organic wastewater contaminants ( Kolpin et al., 2002). Sites selected for sampling in this reconnaissance study were in " areas considered susceptible to contamination from human, industrial, and agricultural wastewater ( i. e. downstream of intense urbanization and livestock production)." Sampling sites did not represent application of oxytetracycline to crops. Instead, their selection targeted streams that received wastewater from treatment facilities, septic systems, animal feeding operations, and land application of waste. However, results do provide some indication of the general prevalence of organic wastewater contaminants in the environment.

Oxytetracycline was analyzed using two methods. One method analyzed for oxytetracycline in 84 samples, yielding one detection at 0.34 µ g/ L ( detection frequency of 1.2%). The second method did not detect oxytetracycline in 115 samples. The minimum reporting level for both methods was 0.10 µ g/ L. The authors concluded that " the low frequency of detection for the tetracycline ( chlortetracycline, doxycycline, oxytetracycline, tetracycline) and quinolone ( ciprofloxacin, enrofloxacin, norfloxacin, sarafloxacin) antibiotics is not unexpected given their apparent affinity for sorption to sediment."

Further monitoring studies of oxytetracycline were not found in a brief literature search. Oxytetracycline and related tetracyclines are not analytes listed in the U. S. Geological Service ( USGS) National Water Quality Assessment ( NAWQA) database, 5 National Stream Quality Accounting Network ( NASQAN) database, 6 or the California Department of Pesticide Regulation ( DPR) Surface Water Database. 7 5 Online at: http:// infotrek. er. usgs. gov/ servlet/ page?_ pageid= 543&_ dad= portal30&_ schema= PORTAL30. 6 Online at: http:// water. usgs. gov/ nasqan. 7 Online at: http:// www. cdpr. ca. gov/ docs/ sw/ surfdata. htm. Page 10 of 13 States and federal agencies have no oxytetracycline monitoring data reporting requirements specified by statute, regulation, or guidance. Consequently, oxytetracycline is not listed in the EPA Safe Drinking Water Information System ( SDWIS) database, 8 nor is it found in EPA Unregulated Contaminants Monitoring Regulation ( UCMR) chemical monitoring databases. 9 Groundwater monitoring studies from 1971 to 1991 listed in the EPA Pesticides in Ground Water Database ( USEPA, 1992) did not include oxytetracycline as an analyte.

Drinking Water Treatment The Office of Pesticide Programs ( OPP) does not have direct data on the effects of drinking water treatment on oxytetracycline. Based on the soil to water partitioning data ( Jones et al., 2005), carbon filtering may reduce oxytetracycline concentrations, as other chemicals with high soil to water or octanol to water partition coefficients tend to be hydrophobic and are removed well with activated carbon filtering. Flocculation and sedimentation removal may be effective at reducing oxytetracycline concentrations as well. These processes use the affinity of the compound to organic matter to collect and remove it from water. However, the mobility study by Jones et al. ( 2005) referenced above found that oxytetracycline sorption to soils negatively correlated with soil organic carbon content in soils with 0 to 4% organic carbon. Consequently, the chemical complexity of oxytetracycline may render treatment processes such as carbon filtering, flocculation, and sedimentation ineffective.

Hydrolysis rates for oxytetracycline may increase as pH deviates from 7 ( Loftin et al., 2004). Therefore, softening may substantially reduce oxytetracycline concentrations ( via alkaline hydrolysis), as softening raises the pH of the water as high as 11.

The Office of Pesticide Programs currently does not have sufficient information to account for locations where activated carbon filtering, flocculation, sedimentation, or softening removal processes are utilized at public drinking water treatment facilities, and thus cannot systematically use this information to generate EDWCs. In the absence of direct data, and having insufficient ancillary data to consider hydrophobicity or hydrolysis, the effects of drinking water treatment were not taken into account in this assessment.

Uncertainties There are a number of factors inherent in exposure modeling that can affect the accuracy and precision of analysis including the quality of the input data, and the ability of the models to represent real scenarios. In this assessment, conservative assumptions were made in the absence of environmental fate data, and the resulting EDWCs are concomitantly inflated. These assumptions are consistent with Tier I exposure estimates. Additional data on rates of metabolism would greatly increase statistical confidence, and likely reduce the EDWCs. Clear label language regarding maximum application rates per year, maximum numbers of applications per year, minimum application intervals, and application methods would increase confidence in the EDWCs as well.

8 Online at: http:// www. epa. gov/ safewater/ data/ getdata. html. 9 Online at: http:// www. epa. gov/ safewater/ data/ ucmrgetdata. html. Page 11 of 13 Literature Citations Internal EPA Documents MRID 41602001. Dowd, N. E., J. D. DeFoe. 1990. Oxytetracycline Hydrochloride and Oxytetracycline Calcium Complex   Product Chemistry Data. Performed and submitted by Pfizer Inc.

MRID 44219401. McKay, Ph. D., B. M. 1997. Determination of Physical Chemical Characteristics of 4% w/ w Propylene Glycol Solution of the Calcium Salt of Oxytetracycline. Performed by Formulogics, Inc. Submitted by Tree Tech Microinjection System.

MRID 43262301. Johnson, Ph. D., N. A. 1994. Product Chemistry Data for the End Use Product Mycoshield ® Brand of Agricultural Terramysin ® . Performed by Merck Research Laboratories. Submitted by Merck & Co., Inc.

MRID 46109401. Irrig, H. 2003. Manufacturing Process Description and Supporting Data for Oxytetracycline Calcium Technical ( ASF793), Addendum to MRID: 41602001. Performed and submitted by Syngenta Crop Protection, Inc.

Open Literature Capone, D. G., D. P. Weston, V. Miller, C. Shoemaker. 1996. Antibacterial Residues in Marine Sediments and Invertebrates Following Chemotherapy in Aquaculture. Aquaculture 145( 1 4): 55 75.

Doi, A. M., M. K. Stoskopf. 2000. The Kinetics of Oxytetracycline Degradation in Deionized Water under Varying Temperature, pH, Light, Substrate, and Organic Matter. Journal of Aquatic Animal Health 12( 3): 246 253.

Effland, W. R., N. C. Thurman, I. Kennedy. 1999. Proposed Methods for Determining Watershed derived Percent Crop Areas and Considerations for Applying Crop Area Adjustments to Surface Water Screening Models. Presentation to the FIFRA Science Advisory Panel, May 27, 1999. Online at: http:// www. epa. gov/ scipoly/ sap/ 1999/ index. htm.

Ingerslev, F., L. Torang, M. Loke, B. Halling Sorensen, N. Nyholm. 2001. Primary Biodegradation of Veterinary Antibiotics in Aerobic and Anaerobic Surface Water Simulation Systems. Chemosphere 44: 865 872.

Jones, A. D., G. L. Bruland, S. G. Agrawal, D. Vasudevan. 2005. Factors Influencing the Sorption of Oxytetracycline to Soils. Environmental Toxicology and Chemistry 24( 4): 761 770. Page 12 of 13 Jones, R. D., S. Abel, W. R. Effland, R. Matzner, R. Parker. 1998. An Index Reservoir for Use in Assessing Drinking Water Exposure. Proposed Methods for Basin scale Estimation of Pesticide Concentrations in Flowing Water and Reservoirs for Tolerance Reassessment. Presentation to FIFRA Science Advisory Panel, June 29 30, 1998. Online at: http:// www. epa. gov/ scipoly/ sap/ 1998/ index. htm.

Kolpin, D., E. Furlong, M. Meyer, E. Thurman, S. Zaugg, L. Barber, H. Buxton. 2002. Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U. S. Streams, 1999 2000: A National Reconnaissance. Environmental Science & Technology 36( 6): 1202 1211.

Loftin, K., C. Adams, M. Meyer, R. Surampali. 2004. Hydrolysis of Selected Veterinary Antibiotics and Their Chemical Degradation in Anaerobic Swine Lagoons. The Ninth Symposium on the Chemistry & Fate of Modern Pesticides, Vail, Colorado. August 16 19, 2004. Abstract online at: http:// ks. water. usgs. gov/ Kansas/ pubs/ abstracts/ chemfate. kl. 2004. htm.

Milewski, I; Tlusty, M. F., D. A. Bengston, H. O. Halvorson, S. D. Oktay, J. B. Pearce, R. B. Rheault, Jr. ( eds.). 2001. Impacts of Salmon Aquaculture on the Coastal Environment: A Review. Marine Aquaculture and the Environment; A meeting for Stakeholders in the Northeast. 166  197 pp. Cape Cod Press, Falmouth, Massachusetts. 324 p.

USEPA. 1992. Pesticides in Ground Water Database: A Compilation of Monitoring Studies: 1971 1991: National Summary. U. S. Environmental Protection Agency. Washington DC.

USEPA. 1993. Reregistration Eligibility Document for Hydroxytetracycline Monohydrochloride and Calcium Oxytetracycline, List A, Case 0020. U. S. Environmental Protection Agency, Office of Pesticide Programs. March, 1993.

USEPA. 2002. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. U. S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division. Feb. 28, 2002. Online at: http:// www. epa. gov/ oppefed1/ models/ water/ input_ guidance2_ 28_ 02. htm. Page 13 of 13 Appendix Attachment I: FIRST Input/ Output File ( Mar. 24, 2006 09: 02)

RUN No. 3 FOR OTC ON P & N * INPUT VALUES *  RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE % CROPPED INCORP ONE( MULT) INTERVAL Koc ( PPM ) (% DRIFT) AREA ( IN)  .637( 5.737) 9 7 771.0 1000.0 ABLAST( 6.3) 87.0 .0 FIELD AND RESERVOIR HALFLIFE VALUES ( DAYS)  METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( RESERVOIR) ( RES. EFF) ( RESER.) ( RESER.)  .00 2 N/ A .00 .00 .00 .00 UNTREATED WATER CONC ( MICROGRAMS/ LITER ( PPB)) Ver 1.0 AUG 1, 2001  PEAK DAY ( ACUTE) ANNUAL AVERAGE ( CHRONIC) CONCENTRATION CONCENTRATION  89.347 4.536 Attachment II: SCI GROW Input/ Output File ( Mar. 24, 2006 09: 06)

SciGrow version 2.3 chemical: OTC time is 3/ 24/ 2006 9: 6: 59  Application Number of Total Use Koc Soil Aerobic rate ( lb/ acre) applications ( lb/ acre/ yr) ( ml/ g) metabolism ( days)  0.637 9.0 5.737 1.00E+ 04 1000.0  groundwater screening cond ( ppb) = 3.29E 02 ************************************************************************


[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Rules and Regulations]
[Pages 71258-71262]
[FR Doc No: 2022-24858]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2022-0103; FRL-9624-02-R8]

Air Plan Approval; Colorado; Reg 3 NSR and APEN Updates

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing
approval of regulatory amendments submitted by the State of Colorado on
May 13, 2020. The revisions make limited amendments to the State's New
Source Review (NSR) and Air Pollution Emission Notices (APEN). The EPA
is taking this action pursuant to the Clean Air Act (CAA).

DATES: This rule is effective on December 22, 2022.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2022-0103. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Kevin Leone, Air and Radiation
Division, EPA, Region 8, Mailcode 8ARD-IO, 1595 Wynkoop Street, Denver,
Colorado 80202-1129, telephone number<PHONE_NUMBER>, email address
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our March
23, 2022 proposed rulemaking (87 FR 16439). In that document we
proposed to approve revisions to Colorado's minor source NSR permitting
program. Specifically, EPA proposed to approve revisions to Regulation
Number 3 (Stationary Source Permitting and Air Pollution Emission
Notice Requirements), including Part A (General Provisions Applicable
to Reporting and Permitting), Part B (Construction Permits), and Part C
(Operating Permits).
    We invited comment on all aspects of our proposal and provided a
30-day comment period. The comment period ended on April 22, 2022. We
received comments on our proposed rulemaking. The comments and our
responses are listed below.

II. Response to Comments

    On April 22, 2022, the EPA received comments from The Center for
Biological Diversity, Henceforth referred to as ``commenter.''
    Comment: Commenter asserts, ``EPA must disapprove the Colorado
permitting program because it excludes emissions prior to operations
such as drilling, fracking, and completion which may cause or
contribute to violations of the NAAQS.'' In support of this assertion,
commenter offers three arguments. First, Commenter states that EPA has
not supported its approval of the State's revised definition of
``Commencement of Operation'' with modeling data to demonstrate that
the revised definition will not cause or contribute to NAAQS
violations. Commenter states that such modeling is required by EPA
regulations to be included in State Implementation Plan (SIP)
submittals. Second, Commenter states that available evidence indicates
that ``pre-production'' emissions from

oil and gas facilities endanger the National Ambient Air Quality
Standards (NAAQS). Commenter cites broadly to Colorado Air Mobile
Monitoring Lab (CAMML) data, asserting that it shows that ``activities
which EPA proposes to approve into the SIP can endanger the NAAQS in
violation of EPA's regulations for minor source permitting programs.''
Commenter also states that, ``Preproduction emissions from oil and gas
well pads are significant emitters of VOCs which contributes to
ozone.'' Finally, Commenter states that the revised definition of
Commencement of Operation ``excludes oil and gas pollution emitting
activities such as drilling wells, `fracking' wells, and completing
wells.'' Commenter argues, ``40 CFR 51.160(e) requires states to
justify the exclusion of any types of sources from review which is what
the definition of commencement of operations does. But no justification
has been provided here.''
    Response: This SIP revision is approving limited rule revisions by
Colorado that update the State's permitting regulations to reflect
consistency within the permitting program and with Colorado Statutes.
This comment raises issues that extend beyond those presented by the
two changes to Part A, Section I.B of Regulation 3, that EPA is
approving. This includes the addition of clarifying language to the
definition of ``Commencement of Operation'' at Section I.B.12 and a new
definition of the term ``Well Production Facility'' at Section I.B.47.
Prior to these changes, ``Commencement of Operation'' at any facility
was defined to occur when the facility ``first conduct[ed] the activity
that it was designed and permitted for.'' This part of the definition
has not been revised and remains applicable to all facilities. With the
two additions, however, ``Commencement of Operation'' at an oil and gas
well production facility has been clarified and is now defined to occur
on ``the date any permanent production equipment is in use and product
is consistently flowing to sales lines, gathering lines or storage
tanks from the first producing well at the stationary source, but no
later than end of well completion operations (including flowback).''
These additions, while limited in scope, provide improved clarity for
operators of oil and gas well production facilities and for the State
as to the timelines for certain actions required in the minor NSR
permit application process in Part B of Regulation 3. This includes
establishing a clear date for assessing compliance and impacts under
Section III.B and a firm deadline for submitting notices and
demonstrations under Section III.G. These regulatory changes are
essentially procedural in nature and do not alter Colorado's approach
to issuing construction permits for emissions from facilities that have
completed construction and begun operating.
    This comment does not address the revisions described above and,
instead, is based entirely on the part of the definition of
``Commencement of Operation'' that was not revised or addressed in the
proposal. As described above, the State has retained its original,
already approved definition and added language to clarify how that
definition applies to oil and gas well production facilities. The
limited revisions submitted for EPA's review in this instance do not
create a need for EPA to review the original definition language that
has not been amended.
    Commenter contends that EPA must use modeling data to support its
conclusion that the revised definition does not cause or contribute to
a violation of the NAAQS. However, Commenter bases this argument on an
assertion that the revised definition ``excludes oil and gas pollution
emitting activities such as drilling wells, `fracking' wells, and
completing wells.'' This comment conflates the revisions being approved
today with the original definition that is not being revised. This
comment seeks to have EPA and the State conduct air quality modeling
for already approved SIP elements.
    Because the two revisions being approved today serve only to
clarify timelines for making assessments and deadlines for making
submissions during the permit application process, the changes will
have no impact on emissions from facilities and no impact on the NAAQS.
The State has not revised the nature of the discussion of air quality
data under its regulations in a way that requires EPA to reevaluate
compliance with 40 CFR 51.160(f). Given the limited effect of the
revision here, there was no need for Colorado to submit air quality
modeling to support approval of these revisions.
    Commenter also argues that EPA must disapprove the revisions being
approved today because ``pre-production'' emissions from oil and gas
facilities endanger the NAAQS. Again, this is outside the scope of the
rulemaking because the Commenter does not tie this assertion to the
actual revisions to Part A, Section I.B, but instead points to the
existing part of the definition of ``Commencement of Operation'' that
is not being revised. Commenter provides links to the CAMML dataset,
but does not explain how this data relates to EPA's approval of the
revisions being approved today. Contrary to the Commenter's assertion,
the State is not required to consider air quality data concerning
already approved SIP elements when it revises other elements in a SIP
and did not do so here. And, because the revisions being approved today
are essentially procedural and only serve to establish timelines for
conducting assessments or deadlines for making submissions during the
permit application process, there is no air quality data available or
that can be generated to assess the effect of the State's revisions on
the NAAQS for this action. Moreover, the provisions of Regulation 3
contain requirements for Stationary Source Permitting and Air Pollution
Emission Notice Requirements. Drilling and fracking are not subject to
regulation under Regulation 3. Instead, completion (pre-production
flowback requirements) and production are regulated by Colorado's
Regulation 7, part D, which sources must be in compliance with
immediately, upon commencement of operation.
    Commenter also argues that the definition of ``Commencement of
Operation'' excludes certain types of oil and gas well development
activities and that the State must justify this exclusion. Commenter
again relies on the existing part of the definition of ``Commencement
of Operation'' that is not being modified or revised, rather than the
revisions to Part A, Section I.B that EPA is approving today. As
explained above, those additions serve to clarify certain timelines for
the minor NSR permit application process for oil and gas well
production facilities and have no impact on the State's determination
as to what facilities will be subject to review under the construction
permit program. Because these revisions provide clarity on procedures,
and do not by themselves exclude any types of sources from review, they
do not create a need in this rulemaking for EPA to review whether
unamended elements of the State's rule meet the requirements in 40 CFR
51.160(e).
    On the basis of the above arguments, Commenter states that EPA must
disapprove the entire Colorado minor NSR permitting program. This
assertion is incorrect. Under Section 110(l) of the CAA, ``The
Administrator shall not approve a revision to a plan if the revision
would interfere with any applicable requirement concerning attainment
and reasonable further progress (as defined in section 171), or any
other applicable requirement of this

chapter.'' This is captured in 40 CFR 51.105, which provides,
``Revisions of a plan, or any portion thereof, will not be considered
part of an applicable plan until such revisions have been approved by
the Administrator in accordance with this part.'' Even if the Commenter
had identified deficiencies with the actual revisions being approved
today, which they did not, the proper action for EPA would be to
disapprove the revisions we are acting on in this rulemaking, not the
entire Colorado minor NSR program. In this case, because the revisions
to Part A, Section I.B of Regulation 3 serve only to clarify the
timelines for certain actions required in the minor NSR permit
application process in Part B of Regulation 3, there is sufficient
basis to conclude that the revisions will not interfere with
attainment, reasonable further progress, or any other applicable
requirement of the CAA. EPA has made no changes to its proposed action
in response to this comment.
    Comment: Commenter states, ``EPA must disapprove Colorado's SIP
submittal because Colorado cannot prevent the construction of a source
authorized to pollute by a general permit even if the source will cause
or contribute to a violation of a NAAQS or interfer [sic] with
reasonable further progress.'' In support of this comment, Commenter
states that Part B, Section III.I.2.a authorizes a source to construct
and operate once they have obtained a valid general construction
permit. Commenter then argues that because Colorado's GP10 version 10
is considered valid upon receipt of a complete APEN registration for a
source, Section III.I.2.a allows a source to begin constructing and
operating before the Division takes any action on a general permit for
that source. Commenter explains that sources are not required to
demonstrate that they will not cause or contribute to a violation of
the NAAQS, that the Division does not require modeling for these
sources, that there is no public comment period during which the public
can submit modeling for these sources, and that when the Division does
require modeling for sources obtaining individual construction permits,
the Division uses significant impact levels (SILs) to allow sources to
avoid cumulative modeling. Commenter states that because EPA has
provided no evidence that allowing sources to construct and operate
pursuant to a general construction permit will not cumulatively or
individually cause or contribute to a NAAQS violation or interfere with
reasonable further progress, EPA cannot approve this SIP submittal.
    Commenter notes that Section 110(a)(2)(C) provides that a state
minor source program must ``include . . . regulation of the
modification and construction of any stationary source within the areas
covered by the plan as necessary to assure that [NAAQS] are achieved.''
Commenter asserts that ``EPA's minor source permitting regulations
require that the state minor source program must enable the permitting
agency to reject any permit application if it will interfere with
attainment,'' citing to 40 CFR 51.160(a)-(b). Commenter further asserts
that ``this requires the prevention of construction'' and that because
Colorado allows a source to construct and operate under a general
permit prior to Division review of the registration, EPA must
disapprove the SIP submittal.
    Finally, commenter asserts that Section III.I.2.a authorizes
sources to commence construction and operations by obtaining a valid
general construction permit without any opportunity for public notice
and comment with regard to that source. Commenter asserts that the
single public notice and comment period the State offers on a general
permit is insufficient, and that EPA and the Division must ensure that
all sources which obtain coverage under a general permit are subjected
to public notice and a public comment period.
    Response: Part B, Section III.I.2 of Regulation 3 provides that
``[a] source shall not perform'' the activities listed in Sections
III.I.2.a through III.I.2.e without first obtaining a valid
construction general permit. The State is revising Part B, Section
III.I.2.a by removing the words ``Commence construction'' and replacing
them with ``Construct, operate.'' Before the change, sources could not
commence construction or modify any facility without a valid permit.
After the change, sources cannot construct, operate or modify any
facility without a valid permit. The effect of the change is to make
the regulation textually consistent with Section 25-7-114.2 C.R.S.,
which provides that ``No person shall construct or substantially alter
any building, facility, structure, or installation . . . or commence
operations of any of the same . . . without first obtaining or having a
valid construction permit.''
    Because the Division implemented its construction permit program to
include operation with construction or modification, the change to the
wording within this provision has no effect on the scope or NAAQS
protection of the existing general permits program, or timing of when
permit coverage under the program is required. As such, the comment is
unrelated to the revised language that EPA is approving today and does
not demonstrate that EPA should not approve the submission addressed by
EPA in this rulemaking.
    In addition, EPA notes that the State's general permit regulation
includes provisions by which the State can prevent ``construction or
modification'' of a source under a permit, as required by 40 CFR
51.160(b). This includes denying a permit under Section III.I.4,
requiring a source to apply for and obtain an individual permit under
Section III.I.3.c.(i), or revoking or terminating a permit under
Section III.I.3.a.

III. Final Action

    The EPA is taking final action to approve the repealing and
addition of new and revised rules to Regulation 3 that were submitted
by the State of Colorado on May 13, 2020. Specifically, the EPA is
approving the following revisions: Regulation Number 3, Part A: I.
(Applicability)--I.B.12; I.B.47; Regulation Number 3, Part A: II (Air
Pollution Emission Notice (APEN) Requirements--II.A.1; II.A.2;
II.A.2(a); II.D.1.III; II.D.1.uuu; II.D.1.zzz; Regulation Number 3,
Part B: II. (General Requirements for Construction Permits)--II.A.1;
II.B; II.D.7;; Regulation Number 3, Part B: III. (Construction Permit
Review Procedures)--III.B.1; III.B.2; and III.G.1.a., III.I.2(a).

IV. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with requirements of
1 CFR 51.5, the EPA is finalizing the incorporation by reference of the
State of Colorado's revisions to regulations for its minor source NSR
permitting program into the SIP as described in section III of this
preamble. The EPA will continue to make these materials generally
available through www.regulations.gov and at the EPA Region 8 Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information). Therefore,
these materials have been approved by the EPA for inclusion in the
State implementation plan, have been incorporated by reference by the
EPA into that plan, are fully federally enforceable under sections 110
and 113 of the CAA as of the effective date of the final rulemaking of
the EPA's approval, and will be incorporated by reference in the next
update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).

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

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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, 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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by January 23, 2023. 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 action 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, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

    Dated: November 8, 2022.
K.C. Becker,
Regional Administrator, Region 8.

    For the reasons set forth in the preamble, 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart G--Colorado

0
2. In Sec.  52.320, in the table in paragraph (c):
0
a. Revise, under the center heading ``5 CCR 1001-05, Regulation Number
3, Part A, Concerning General Provisions Applicable to Reporting and
Permitting'' the entries: ``I. Applicability'' and ``II. Air Pollution
Emission Notice (APEN) Requirements''.
0
b. Revise, under the center heading ``5 CCR 1001-05, Regulation Number
3, Part B, Concerning Construction Permits the entries: ``II. General
Requirements for Construction Permits'' and ``III. Construction Permit
Review Procedures''.
    The revisions read as follows:

Sec.  52.320  Identification of plan.

* * * * *
    (c) * * *

----------------------------------------------------------------------------------------------------------------
                                          State       EPA effective   Final rule citation/
               Title                 effective date       date                date                 Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
5 CCR 1001-05, Regulation Number 3, Part A, Concerning General Provisions Applicable to Reporting and Permitting
----------------------------------------------------------------------------------------------------------------
I. Applicability...................       2/14/2020      12/22/2022  [insert Federal
                                                                      Register citation],
                                                                      11/22/2022.
II. Air Pollution Emission Notice         2/14/2020      12/22/2022  [insert Federal
 (APEN) Requirements.                                                 Register citation],
                                                                      11/22/2022.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                   5 CCR 1001-05, Regulation Number 3, Part B, Concerning Construction Permits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
II. General Requirements for              2/14/2020      12/22/2022  [insert Federal
 Construction Permits.                                                Register citation],
                                                                      11/22/2022.
III. Construction Permit Review           2/14/2020      12/22/2022  [insert Federal
 Procedures.                                                          Register citation],
                                                                      11/22/2022.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-24858 Filed 11-21-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Rules and Regulations]
[Page 75235]
[FR Doc No: C1-2020-13439]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2018-0747; FRL-10010-12-OAR]
RIN 2060-AU16

National Emission Standards for Hazardous Air Pollutants:
Miscellaneous Coating Manufacturing Residual Risk and Technology Review

Correction

    In rule document 2020-13439 beginning on page 49724 in the issue of
August 14, 2020, make the following correction:

Sec.  63.8000   [Corrected]

0
On page 49742, in the first column, in Sec.  63.8000(vi), in the 14th
line ``August 15, 2022'' should read ``August 15, 2018''.

[FR Doc. C1-2020-13439 Filed 11-24-20; 8:45 am]
BILLING CODE 1301-00-D


[Federal Register Volume 77, Number 249 (Friday, December 28, 2012)]
[Notices]
[Pages 76501-76503]
[FR Doc No: 2012-31305]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2012-0003; Internal Agency Docket No. FEMA-B-1282]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before March 28, 2013.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1282, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a

mutually acceptable resolution of an appeal. Additional information
regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.

------------------------------------------------------------------------
                                             Community Map Repository
               Community                             Address
------------------------------------------------------------------------
             Commonwealth of Puerto Rico, and Municipalities
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.rampp-team.com/pr_vi.htm
------------------------------------------------------------------------
Commonwealth of Puerto Rico............  Puerto Rico Planning Board,
                                          Centro Gubernamental, Roberto
                                          Sanchez Vilella, Torre Norte
                                          Piso 16 Oficina 1601, Avenida
                                          de Diego Esq. Parada 22,
                                          Santurce, PR 00940.
------------------------------------------------------------------------
            Highlands County, Florida, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.bakeraecom.com/index.php/florida/highlands/
------------------------------------------------------------------------
City of Avon Park......................  City Hall, 110 East Main
                                          Street, Avon Park, FL 33825.
City of Sebring........................  City Hall, 368 South Commerce
                                          Avenue, Sebring, FL 33870.
Town of Lake Placid....................  Town Hall, 311 West Interlake
                                          Boulevard, Lake Placid, FL
                                          33852,
Unincorporated Areas of Highlands        Highlands County Planning
 County.                                  Department, 501 South Commerce
                                          Avenue, Sebring, FL 33870.
------------------------------------------------------------------------
            Kendall County, Illinois, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionV/KendallIL RegionalWorkspaces/RegionV/KendallIL
------------------------------------------------------------------------
City of Joliet.........................  City Hall, 150 West Jefferson
                                          Street, Joliet, IL 60432.
City of Yorkville......................  City Hall, 800 Game Farm Road,
                                          Yorkville, IL 60560.
Unincorporated Areas of Kendall County.  Kendall County Planning,
                                          Building and Zoning Office,
                                          111 West Fox Street,
                                          Yorkville, IL 60560.
Village of Montgomery..................  Village Hall, 200 North River
                                          Street, Montgomery, IL 60538.
Village of Plattville..................  Kendall County Planning,
                                          Building, and Zoning Office,
                                          111 West Fox Road, Yorkville,
                                          IL 60560.
------------------------------------------------------------------------
               Jay County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.in.gov/dnr/water/6647.htm
------------------------------------------------------------------------
City of Portland.......................  Jay County Department of
                                          Building and Planning,
                                          Community Resource Center,
                                          Suite E, 118 South Meridian
                                          Street, Portland, IN 47371.
Town of Pennville......................  Town Hall, 110 North Washington
                                          Street, Pennville, IN 47369.
Town of Redkey.........................  Town Hall, 8927 West State Road
                                          67, Redkey, IN 47373.
Town of Salamonia......................  Jay County Department of
                                          Building and Planning,
                                          Community Resource Center,
                                          Suite E, 118 South Meridian
                                          Street, Portland, IN 47371.
Unincorporated Areas of Jay County.....  Jay County Department of
                                          Building and Planning,
                                          Community Resource Center,
                                          Suite E, 118 South Meridian
                                          Street, Portland, IN 47371.
------------------------------------------------------------------------
               Coos County, Oregon, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionX/coos_county_oregon/Preliminary%20Maps/Forms/AllItems.aspx
------------------------------------------------------------------------
City of Bandon.........................  Planning Department, 555
                                          Highway 101, Bandon, OR 97411.
City of Coos Bay.......................  Public Works and Development
                                          Department, 500 Central
                                          Avenue, Coos Bay, OR 97420.
City of Coquille.......................  City Hall, 851 North Central
                                          Boulevard, Coquille, OR 97423.
City of Lakeside.......................  City Hall, 915 North Lake Road,
                                          Lakeside, OR 97449.
City of Myrtle Point...................  City Hall, 424 5th Street,
                                          Myrtle Point, OR 97458.
City of North Bend.....................  City Hall, 835 California
                                          Street, North Bend, OR 97459.
City of Powers.........................  City Hall, 275 Fir Street,
                                          Powers, OR 97466.
Unincorporated Areas of Coos County....  Coos County Courthouse, 225
                                          North Adams Street, Coquille,
                                          OR 97423.
------------------------------------------------------------------------
              Kleberg County, Texas, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://riskmap6.com/Community.aspx?cid=386&sid=5
------------------------------------------------------------------------

City of Kingsville.....................  City Hall, 200 East Kleberg
                                          Avenue, Kingsville, TX 78363.
Unincorporated Areas of Kleberg County.  Kleberg County Courthouse,
                                          Floodplain Administrator's
                                          Office, 700 East Kleberg
                                          Avenue, Kleberg, TX 78363
------------------------------------------------------------------------
              Tarrant County, Texas, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://riskmap6.com/Community.aspx?cid=469&sid=5
------------------------------------------------------------------------
City of Arlington......................  City Hall, 101 West Abram
                                          Street, Arlington, TX 76010.
City of Fort Worth.....................  Department of Transportation
                                          and Public Works, 1000
                                          Throckmorton Street, Fort
                                          Worth, TX 76102.
City of Grand Prairie..................  City Development Center, 206
                                          West Church Street, Grand
                                          Prairie, TX 75050.
City of Haltom City....................  City Hall, 5024 Broadway
                                          Avenue, Haltom City, TX 76117.
City of Hurst..........................  City Hall, 1505 Precinct Line
                                          Road, Hurst, TX 76054.
City of North Richland Hills...........  City Hall, 7301 Northeast Loop
                                          820, North Richland Hills, TX
                                          76180.
City of Richland Hills.................  City Hall, 3200 Diana Drive,
                                          Richland Hills, TX 76118.
City of Saginaw........................  City Hall, 333 West McLeroy
                                          Boulevard, Saginaw, TX 76179.
Town of Edgecliff Village..............  Town Hall, 1605 Edgecliff Road,
                                          Edgecliff Village, TX 76134.
Unincorporated Areas of Tarrant County.  Tarrant County Administrative
                                          Building, Public Works
                                          Department, 100 East
                                          Weatherford Street, Fort
                                          Worth, TX 76196.
------------------------------------------------------------------------
         Grays Harbor County, Washington, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionX/GraysHarborMM/Preliminary%20Maps/Forms/AllItems.aspx
------------------------------------------------------------------------
Chehalis Reservation, Confederated       Chehalis Travel Center, 420
 Tribes of.                               Howanut Road, Oakville, WA
                                          98568.
City of Aberdeen.......................  City Hall, 200 East Market
                                          Street, Aberdeen, WA 98520.
City of Cosmopolis.....................  City Hall, 1300 1st Street,
                                          Cosmopolis, WA 98537.
City of Elma...........................  City Hall, 202 West Main
                                          Street, Elma, WA 98541.
City of Hoquiam........................  City Hall, 609 8th Street,
                                          Hoquiam, WA 98550.
City of McCleary.......................  City Hall, 100 South 3rd
                                          Street, McCleary, WA 98557.
City of Montesano......................  City Hall, 112 North Main
                                          Street, Montesano, WA 98563.
City of Oakville.......................  City Hall, 204 East Main
                                          Street, Oakville, WA 98568.
City of Ocean Shores...................  Planning and Permits Building,
                                          710 Point Brown Avenue
                                          Southeast, Ocean Shores, WA
                                          98569.
City of Westport.......................  City Hall, 740 North Montesano
                                          Street, Westport, WA 98595.
Unincorporated Areas of Grays Harbor     Grays Harbor County Division of
 County.                                  Emergency Management, 310 West
                                          Spruce Street, Suite 212,
                                          Montesano, WA 98563.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2012-31305 Filed 12-27-12; 8:45 am]
BILLING CODE 9110-12-P