1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM PC Code: 109901 DPBarcode: 328531 SUBJECT: Response to Bayer Public Comments Regarding the Environmental Fate And Effects Division Triadimefon Risk Assessment FROM: Fred Jenkins, MS Jonathan Angier, PhD Environmental Risk Branch II Environmental Fate and Effects Division ( 7507C)

TO: John Pates Jr. Special Registration and Review Division ( 7505 C)

THRU: Tom Bailey, PhD Branch Chief Environmental Risk Branch II / EFED ( 7507C)

DATE: June 1, 2006 In response to the phase 3 Bayer public comments submitted about the revised EFED ecological risk assessment ( dated January, 9 2006), EFED has prepared the attached responses to comments. 2 Tier 2 Drinking Water Assessment for Triadimefon and its Major Degradate Triadimenol ( Aug. 31, 2005), page 4 and Triadimefon  Preliminary Human Health Risk Assessment ( Revised), February 9, 2006, Section 5.7.1, page 49 51 of 102.

Surface Water Modeling EPA: " A default Percent Cropped Area ( PCA) factor of 0.87 ( 87% percent has been applied to all the scenarios except turf, for which 100% of area is considered ( no adjustment)."

Bayer Response: The high drinking water concentrations from turf uses of triadimefon are a direct result of the assumption that 100% of a surface drinking water system ( SDWS) watershed is covered with golf courses, and consequently 100% of a SDWS watershed is treated with the compound. This assumption is extremely conservative. Studies conducted by Bayer CropScience to calculate the percent of golf course areas within 56 SDWS watersheds in Florida, North Carolina, and South Carolina ( MRID 465637 01; Bayer Report 04RAOAY001) showed that golf course areas represented between 0% and 5.8 % of SDWS watershed ( i. e. maximum PCA of 5.8%). Moreover, Bayer is in the process of determining the PCA factors of recreational grasses for the 1606 SDWS watersheds which were used by the USGS for WARP modeling. To date, Bayer has received data from USGS on 947 of the SDWS watersheds, and the results indicate PCA factors ranged from 0% to 7.7%. Therefore, a turf PCA factor of 7.7% is more appropriate for the evaluation of drinking water exposure and risk.

The 7.7% PCA can be used to recalculate the drinking water expected concentrations as follows ( EPA derived values for Florida turf with 3 applications, times 0.077): ° Acute: 7.76 ppb ° Chronic 1 in 10 year: 1.92 ppb ° Chronic 30 year mean: 1.00 ppb Considering that triadimefon has agricultural uses, which could contribute to the load within a watershed, Bayer has evaluated a combination of sales data for the turf uses, and Doanes use data for the agricultural uses. This comparison indicates that agricultural uses are minimal, representing less than 5% of the total triadimefon used. To confirm these data, Bayer, in conjunction with USGS, is calculating the seasonal use rates for the 1606 SDWS based on 2005 sales data ( all uses). The results are expected to show a significantly lower use than the conservative estimate of 100% of the watershed.

Thus, the PCA factor should be considered in the drinking water risk assessments, to 3 provide a more realistic measure of the potential exposure of triadimefon and triadimenol. The additional information regarding PCA factors for the remaining watersheds, and the use data per watershed will be provided to the agency as soon as it is available.

Agency Response We have performed multiple alternate model runs with varying amounts of Triadimefon applied, varying numbers of applications, and various PCAs and other adjustment factors ( e. g., Golf Course Adjustment Factors   GCAFs). When appropriate GCAFs are applied, EEC numbers drop considerably. The 100% cropped area with no further adjustments only applies to non golf course turf uses. While assuming 100% cropped area may indeed be overly conservative, we currently do not have sufficient quality data to confidently make any other assumption; a Scientific Advisory Panel ( SAP) on this subject has basically said as much. At present, the lowest PCAs applied to any crop are still substantially higher ( 20%) than that proposed by Bayer for turf usage ( 7.7%). We would have to see some very compelling and extensive evidence to support this assertion.

Tier 2 Drinking Water Assessment for Triadimefon and its Major Degradate Triadimenol ( Aug. 31, 2005), page 5, and Triadimefon  Preliminary Human Health Risk Assessment ( Revised), February 9, 2006, Section 5.7.1, page 51 of 102.

Ground Water Monitoring EPA: " The most recent studies show maximum concentrations of approximately 25 ppb for turf application in New Jersey ( MRID 45544202) and 1.67 ppb for turf application in California ( MRID 455I44202, 45688801 & 46097201)."

Bayer Response: The referenced concentrations are total residues ( triadimefon plus all degradates), and this should be clarified. The maximum concentrations of triadimefon plus triadimenol in the New Jersey ground water monitoring study was 6.58 ppb ( 0.21 ppb triadimefon, 6.37 ppb triadimenol), and it should also be noted that these residues dissipated quickly in the groundwater, and therefore greatly overestimate chronic concentrations. The maximum concentrations of triadimefon plus triadimenol in the California groundwater monitoring study was 0.52 ppb ( 0.16 ppb triadimefon, 0.36 ppb triadimenol), and showed no indication of persistence in the groundwater. Use of these values provides a proper comparison to the SCIGROW results, which represent concentrations of triadimefon plus triadimenol.

Agency Response The sentence just prior to this in the document specifies that these are total residues   it should not be necessary to repeat this in every sentence. The values cited in the Drinking Water Assessment ( DWA) were taken from Agency approved studies and represent ` high end' monitoring data. The most recent Bayleton Prospective Groundwater 4 Monitoring Study for Fresno, CA ( Bayer Study Number BL212402) yielded maximum triadimefon + triadimenol residues at 0.52 ppb; nevertheless, the relationship between the monitoring data concentrations and concentrations predicted by SciGrow remains similar. In any event, it is the surface water concentrations that are of greater concern.

I. EXECUTIVE SUMMARY Bayer Response: The executive summary of the Environmental Fate and Effects Chapter should be revised to take into consideration the many mitigating factors that can be used in a refined assessment for triadimefon and that are included in the following response.

Page 10: Uncertainties and Data Gaps EPA: EPA notes that one of the greatest uncertainties in the risk assessment concerns the major degradate of triadimefon, triadimenol. Bayer Response: Some of the uncertainty associated with triadimenol and the terrestrial risk assessment can be addressed by examining the wheat metabolism study ( Bayer Report number 80293). The wheat metabolism study examined the time course of the parent and metabolite over a 4 week period. The peak parent was observed in day 0 for both trials. The peak triadimenol occurred on day 14. The calculated half lives for the parent and total residue range from 6.3 to 8.3 days and 12.8 and 24.8 days, respectively. Therefore the screening level risk assessment takes into account the potential exposure to the metabolite in a highly conservative manner. Furthermore, residue decline trial for wheat ( Bayer report number 100111) demonstrated a significantly shorter total residue half life ( 3.5 days), which may be a more appropriate half life to use in the terrestrial risk assessment.

Agency Response:

The soil half life study submitted to the Agency ( MRID 4224104) indicates that triadimefon is very persistent ( 240 day half life) in the terrestrial environment ( specifically in soils). Bayer asserts that a half life value of 1.5 to 3.5 days in wheat is most appropriate to use as a terrestrial exposure value. However, this value does not account for the significant disparity with the results of the soil half life study. Given the large disparity and uncertainty between the Bayer asserted wheat residue half life of 1.5 to 3.5 days and the soil half life of 240 days, the Agency calculated the risk quotients based on the Agency default foliar half life value of 35 days. 5 III. Analysis A. Expanded Use Characterization Page 29: Table 6 EPA: EPA notes that the current label for triadimefon use on golf course turf does not state a maximum number of applications per season or a maximum total seasonal applications rate. EPA states that 2 applications of the profession care lawn and turf label allows 2 applications of 1.36 lb ai/ A.

Bayer Response: BCS concurs that the golf course turf label does not currently state that a maximum number of applications or total seasonal application rate. However, BCS is prepared to add to the label a maximum number of applications of 3 for the golf course use pattern, and a maximum total seasonal application of 8.1 lb ai/ A. For curative control of southern blight, the profession care lawn and turf label allows 3 applications of 1.36 lb ai/ A, with a 30 day interval.

Agency Response The current label for triadimefon use on golf course turf did not specify a maximum number of applications per season or a maximum total seasonal applications rate. Thus, EFED'S revised ecological risk assessment ( dated 1/ 19/ 06) evaluated a range of different scenarios for turf application rates. These scenarios of application rates ranged from 1 to 26 applications of either 1.36, 1.31, or 2.7 lbs. a. i./ acre with intervals of either 7, 14, 28, 30, or 60 days. There are bird and mammal Agency level of concern ( LOC) exceedances throughout the entire range of application rates. In particular, there are bird and mammal LOC exceedances which would result from Bayer's proposals to add to the label which include: 1) a maximum number of applications of 3 for the golf course use pattern for a maximum total seasonal application of 8.1 lbs. a. i./ acre ( equivalent to 3 applications of 2.7 lbs. a. i./ acre) and 2) a professional care lawn and turf maximum use rate that allows 3 applications of 1.36 lbs. a. i./ acre, with a 30 day interval for curative control of southern blight. Tables 1 3 illustrate these use rates and their resulting LOC exceedances for birds and mammals.

Tables 1 3 also include risk quotient calculations with a range of interval times ( 7, 14, 30, and 60 days for interval times) between applications for the Bayer proposed maximum seasonal application amount of 8.1 lbs. a. i./ acre ( equivalent to 3 applications of 2.7 lbs. a. i./ acre). The Agency took this measure because Bayer did not specify an interval time between applications for this application rate. 6 There would be no LOC exceedances for fish, aquatic invertebrate, and aquatic plants for Bayer's newly proposed turf maximum application rates of either: 1) 3 applications for the golf course use pattern for a maximum total seasonal application of 8.1 lbs. a. i./ acre or 2) a professional care lawn and turf maximum use rate that allows 3 applications of 1.36 lbs. a. i. / A, with a 30 day interval for curative control of southern blight.

Table 1. Avian dietary based acute and chronic risk quotients for selected uses of nongranular triadimefon ( based on LC50 of 8392 mg/ kg diet and NOAEC of 20 mg/ kg diet) based on upperbound Kenega values. Use ( Application Rate) Food Item Upper Bound EEC ( mg/ kg) Acute dietary Based RQ ( EEC/ LC50) Chronic Dietary based RQ ( EEC/ NOAEC) Short Grass 1703.21 0.20 85.16 Tall Grass 780.64 0.09 39.03 Broadleaf plants/ sm Insects 958.06 0.11 47.9 Turf ( 2.7 lbs. a. i./ A, 3 applications, 7 day interval)

Fruits/ pods/ seeds/ lg insects 106.45 0.01 5.32 Short Grass 1511.27 0.18 75.56 Tall Grass 692.67 0.08 34.63 Broadleaf plants/ sm Insects 850.09 0.10 42.50 Turf ( 2.7 lbs. a. i./ A, 3 applications, 14 day interval)

Fruits/ pods/ seeds/ lg insects 94.45 Below LOC 4.72 Short Grass 1203.21 0.14 60.16 Tall Grass 551.47 Below LOC 27.57 Broadleaf plants/ sm Insects 676.80 Below LOC 33.84 Turf ( 2.7 lbs. a. i./ A, 3 applications, 30 days interval)

Fruits/ pods/ seeds/ lg insects 75.20 Below LOC 3.76 Short Grass 905.66 0.11 45.28 Tall Grass 415.10 Below LOC 20.75 Broadleaf plants/ sm Insects 509.44 Below LOC 25.47 Turf ( 2.7 lbs. a. i./ A, 3 applications, 60 days interval)

Fruits/ pods/ seeds/ lg insects 56.60 Below LOC 2.83 Short Grass 606.06 Below LOC 30.30 Tall Grass 277.78 Below LOC 13.89 Broadleaf plants/ sm Insects 340.91 Below LOC 17.05 Turf ( 1.36 lbs. a. i./ A, 3 applications 30 day interval)

Fruits/ pods/ seeds/ lg insects 37.88 Below LOC 1.89 7 Table 2. Mammalian dose based acute risk quotients for selected uses of non granular triadimefon ( based on triadimenol LD50 OF 689 mg/ kg in rats) based on upper bound Kenega values Mammalian Dose based Acute Risk Quotients Use ( Application Rate) Body Weight Adjusted LD50 Short Grass Tall Grass Broadleaf Fruits/ pods/ large insects Seeds 15 1514 1.07 0.49 0.60 Below LOC Below LOC 35 1225 0.92 0.42 0.52 Below LOC Below LOC Turf ( 2.7 lbs. a. i./ A, 3 applications, 7 day interval) 1000 530 0.49 0.23 0.28 Below LOC Below LOC 15 1514 0.95 0.44 0.54 Below LOC Below LOC 35 1225 0.81 0.37 0.46 Below LOC Below LOC Turf ( 2.7 lbs. a. i./ A, 3 applications, 14 day interval) 1000 530 0.44 0.20 0.25 Below LOC Below LOC 15 1514 0.76 0.35 0.43 Below LOC Below LOC 35 1225 0.65 0.30 0.36 Below LOC Below LOC Turf ( 2.7 lbs. a. i./ A, 3 applications, 30 days interval) 1000 530 0.35 0.16 0.20 Below LOC Below LOC 15 1514 0.57 0.26 0.32 Below LOC Below LOC 35 1225 0.49 0.22 0.27 Below LOC Below LOC Turf ( 2.7 lbs. a. i./ A, 3 applications, 60 days interval) 1000 530 Below LOC Below LOC 15 1514 0.38 0.17 0.21 35 1225 0.33 0.15 0.18 Turf ( 1.36 lbs. a. i./ A, 3 applications 30 day interval) 1000 530 0.17 Below LOC Below LOC Below LOC Below LOC 8 Table 3. Mammalian dietary based chronic risk quotients for selected uses of non granular triadimefon ( based on triadimefon rat NOEAL of 50 mg/ kg diet) based on upper bound Kenega values Risk Quotients for each mammalian food item Use ( Application Rate)

Short Grass Tall Grass Broadleaf Fruits/ pods/ large insects/ Seeds Turf ( 2.7 lbs. a. i./ A, 3 applications, 7 day intervals) 34.06 15.61 19.16 2.13 Turf ( 2.7 lbs. a. i./ A, 3 applications, 14 day intervals) 30.23 13.85 17.00 1.89 Turf ( 2.7 lbs. a. i./ A, 3 applications, 30 days intervals) 24.06 11.03 13.54 1.50 Turf ( 2.7 lbs. a. i./ A, 3 applications, 60 days intervals) 18.11 8.30 10.19 1.13 Turf ( 1.36 lbs. a. i./ A, 3 applications 30 day interval) 12.12 5.56 6.82 0.76 9 B. Exposure Characterization Page 37. Table 12 and associated EEC's in subsequent tables and text EPA: EPA used various turf exposure scenarios to calculate the aquatic EEC's. These scenarios are summarized in Table 12.

Bayer Response: As noted earlier, BCS agrees with the Agency that the golf course labels did not adequately specify the number of applications or the total seasonal maximum application rates. However, BCS is prepared to amend the label to specify a maximum of 3 applications per season for a total seasonal application of 8.1 lb ai/ A. In order to adequately characterize the potential risk for aquatic organisms, the proposed use pattern should be modeled with PRZM/ EXAMS. A similar statement can be made for the exposure scenarios for terrestrial vertebrates ( pages 42   Table 14).

Agency Response:

There would be no LOC exceedances for fish, aquatic invertebrate, and aquatic plants for Bayer's newly proposed turf maximum application rates of either: 1) 3 applications for the golf course use pattern for a maximum total seasonal application of 8.1 lbs. a. i./ acre or 2) a professional care lawn and turf maximum use rate that allows 3 applications of 1.36 lbs. a. i./ acre, with a 30 day interval for curative control of southern blight.

Pages 38   39 EPA: EPA calculated the potential environmental exposure for terrestrial organisms. Bayer Response: Wheat residue trials were conducted for triadimefon ( Bayer report number 100111) which demonstrate a rapid decline of the parent and total residues for triadimefon on wheat forage. Four trials were conducted; the forage residue data for 3 of the trials provide a half life of 1.0 to 2.3 days for the parent, and a half life of 1.5 to 3.5 days of the total residue, which would include the triadimenol metabolite. The data from the fourth decline trial were not useful. If a half life of 1 to 3.5 days were used in the calculation of the terrestrial EECs, the exposure would be reduced by as much as 53%. Given that these trials included an examination for triadimenol residues, some of the uncertainty associated with potential exposure to the metabolite is addressed. The half life for the total residue was not significantly greater than the half life for the parent material alone. EPA should consider using these residue trials in a refinement of the terrestrial risk assessment. 10 Agency Response:

The soil half life study submitted to the Agency ( MRID 4224104) indicates that triadimefon is very persistent ( 240 day half life) in the terrestrial environment ( specifically in soils). Bayer asserts that a half life value of 1.5 to 3.5 days in wheat is most appropriate to use as a terrestrial exposure value. However, this value does not account for the significant disparity with the results of the soil half life study. Given the large disparity and uncertainty between the Bayer asserted wheat residue half life of 1.5 to 3.5 days and the soil half life of 240 days, the Agency calculated the risk quotients based on the Agency default foliar half life value of 35 days.

C. Ecological Effects Characterization Page 51. Chronic toxicity to Birds Page 9 of 15 EPA: In the bobwhite quail study ( MRID 110431), the NOAEC was determined to be 20 ppm ai based on an increase in cracked eggs and decreases in the number of fertile eggs, viable embryos, hatchlings, and 14 day survivors. The primary effect of triadimefon on avian reproduction seems to be the number of fertile eggs and viable 14 day old survivors. Both of these endpoints demonstrated an 83% decrease at the highest dose of 500 ppm. 7The LOAEC was100 ppm ai. The other bobwhite quail study ( MRID 42342301) was classified as supplemental because of problems with the incubator causing cracked eggs in the control dose. A mallard duck study ( MRID 42342302) demonstrated a NOAEC at the highest concentration tested of 780 ppm ai. There were no effects of triadimefon exposure on mortality, behavior, or reproductive performance at this concentration. A second mallard duck study ( MRID 248117) was classified as supplemental because of poor reproductive success of the control ( poor hatchling survival rates in the controls).

Bayer Response: BCS disagrees with the selection of the NOAEC derived form the avian reproduction studies. The first bobwhite quail study was conducted in 1982, prior to the implementation of GLP. The second bobwhite quail study was conducted in 1992 under GLP. The first bobwhite quail study had an unexplained increase in the number of cracked eggs. However the number of cracked eggs was not related to the eggshell thickness, the primary indicator for egg quality. While there was an increase with increasing concentration, there was not dose response relationship. The percent cracked eggs per hen were 4.4, 7.7, 12.9 and 13.8 in the control, 20, 100 and 500 ppm groups, respectively. As noted in the report and in the US EPA rejection rate analysis, there are a number of reasons why eggs may crack ( egg handling by birds, egg handling by study personnel, and/ or cage related cracking), and without an indication of an effect on egg shell thickness, there is insufficient evidence to implicate triadimefon as the cause of 11 cracking ( particularly in these older studies. A study conducted by Toll et al. ( 1990) examined the number of cracked eggs in the control groups of 95 studies. Toll et al. reported eggs cracked in control groups averaged 7.4% and ranged from 0  24%. The numbers of cracked eggs observed in the triadimefon study were within the historical control data at the time the study was conducted. The only other significant difference noted in the report were the percent fertile eggs of the number of eggs laid. However the primary driver for this finding is the number of cracked eggs. When the percent fertile eggs of the number of eggs set ( which corrects for the number cracked) then there were no significant differences in the fertility of the eggs. While EPA contends that the primary effect in the study was on egg fertility and hatchling survival, neither of these endpoints was statistically different from the control when the percentages were based upon the number of eggs set. EPA also made the statement that these endpoints resulted in an 83% decrease in the high dose group. This statement is not accurate; the percent reduction compared to the control group was 12% for the fertile eggs of eggs set and 11% of 14 day survivor of hatchling ( neither being statistically different). Even if you were to erroneously compare the number of 14 day survivors between the control and highest treatment group, the reduction is 31% BUT this number does not account for the differences in the number of eggs laid or the differences observed in the number of eggs set due to cracked eggs. A second bobwhite quail study was conducted in 1992 under GLP conditions. Unfortunately in this second study a malfunction occurred with the incubator that caused the loss of three weeks of eggs, resulting in the study being classified as supplemental. In the review of the study EPA contends that there is too much uncertainty that the eggs produced at the beginning of the study ( when the malfunction occurred) are comparable to eggs produced later in the study, and hence the 2 triadimefon studies are not comparable. There is no evidence in avian reproduction studies that egg quality decreases under the duration of the normal bobwhite quail reproduction study. In the second bobwhite quail study with triadimefon, 9 weeks of data were available for analysis and over 500 eggs were produced in each of the control and treatment groups. The test levels in the second study were 50, 200 and 600 ppm. As noted in the report, there were no significant differences noted between the triadimefon treatment groups and the control in any of the reproductive or growth parameters. While the report concluded that no statistical differences in the number of eggs cracked, EPA in their review of the study noted a significant difference between the control and the 200 ppm treatment group. This difference ( whether it is statistically different or not) was not treatment related. The percent eggs cracked of eggs laid per hen were:

Mean Percent Standard Deviation Control 3.6 5.3 50 ppm 2.7 2.5 200 ppm 4.4 3.9 600 ppm 4.2 5.4 12 There was only a minor difference noted between the control group and the 200 ppm treatment group. There was no dose response relationship between the treatment groups and the number of eggs cracked. The standard deviations clearly indicate a wide overlap between the control and all of the treatment groups. The percent cracked eggs falls well within the historical control data of Toll et al. ( 1990) and is well below the acceptable limits of cracked eggs in the controls as noted in the rejection rate analysis. Additionally, in the study there were no statistical differences in egg shell thickness or egg shell strength, indicating egg quality was comparable between all groups. The NOAEC from this test is 600 ppm ( nominal concentration) or 587 ppm ( mean measured concentration). If the 2 studies are examined in total, there is a compelling argument that triadimefon has minimal effect on bobwhite quail reproduction or growth. While the first study may have had an unexplained difference in the number of cracked eggs, it is not at all clear that his was related to the exposure to triadimefon. Without any concurrence of an effect on egg shell thickness or egg shell strength, and nor could a second study repeat the finding, the number of cracked eggs observed in the first bobwhite quail study was nuisance variable, that is not relevant to the risk assessment. The risk assessment for triadimefon should consider 600 ppm ( nominal or 587 ppm measured) as the NOAEC for the compound.

Citations: Toll, P. A., J. B. Beavers, and D. W. Fletcher. 1990. Biological Significance of Cracked Eggs In Avian Reproduction Studies. Society Environmental Toxicology and Chemistry Eleventh Annual Meeting, Arlington, Virginia. November 11 15, 1990.

Agency Response In regards to risk quotient calculations, it is the Agency's policy that for screening level risk assessments the most sensitive acute and/ or chronic endpoint is selected from the available test data and is used in the risk assessment.

The Bobwhite Quail reproductive toxicity study, MRID 110431, was reviewed by the Agency. The Agency review determined that the study was acceptable and that it produced a NOEAC of 20 ppm for the number of: eggs cracked fertile eggs, viable 3 week embryos, hatchlings, and 14 day survivors. The study results illustrated a clear dose response for each of the affected entities ( Table 1). The 20 ppm NOAEC produced in this study was the most sensitive reproductive toxicity endpoint among all available avian reproductive studies. Thus, in accordance with Agency policy, EFED used the endpoint to calculate reproductive risk to Avian Species. 13 Table 1. Summary of Affected Reproductive Entities in the Bobwhite Quail Reproductive Toxicity Test MRID 110431 Results Reproductive Endpoint Significantly Affected Control 20 ppm 100 ppm 500 ppm Eggs Cracked 63 101 184 205 Fertile Eggs 1138 1042 937 941 Viable 3 Week Embryos 1060 972 897 877 Hatchlings 635 724 570 488 14 Day Survivors 595 613 472 411 Page 52. Chronic toxicity to mammals EPA: Similar to the acute data, mammalian chronic data obtained from the Agency's HED are substituted for wild mammalian testing. HED reproductive and developmental toxicity values are reported in Appendix C. These studies provide adequate toxicity data on chronic developmental and reproductive effects of triadimefon. Chronic triadimefon studies using laboratory rats show decreased pup weights and viability in the F1 and F2 generations and decreased litter size in the F2 generation ( MRID 00155075, 92188019, 9 2188320), with an offspring NOAEL of 50 ppm ai. Bayer Response: BCS has fully examined the available chronic toxicity data for rats, and strongly believes the NOAEC for ecological risk assessment is 300 ppm ai ( NOAEL = 15 mg/ kg/ day). Two rat reproduction studies are available. The first study with 3 treatment groups ( 50, 300 and 1800 ppm) and a control group was conducted for 3 generations in 1979 ( rated as acceptable/ nonguideline by the EPA reviewers). The second study with 2 treatment groups ( 50, and 1800 ppm) and a control group was conducted for 2 generations in 1984 ( also rated as acceptable/ nonguideline by the EPA reviewers). Both studies demonstrate that exposure to 1800 ppm triadimefon had significant effects on the growth and reproduction of rats. BCS agrees that the parental/ reproductive LOAEC was 1800 ppm ( 90 mg/ kg/ day). Since no parental/ reproductive effects were observed in the 300 ppm treatment group ( 1979 study), the parental/ reproductive NOAEC is 300 ppm ( 15 mg/ kg/ day), as concluded by the EPA reviewers. The EPA reviewers state that the offspring NOAEC is 50 ppm ( 2.5 mg/ kg/ day); however consideration must be given to the relevance and potential long term impact of an endpoint in determining the ecologically relevant NOAEC. BCS believes the 14 relevant NOAEC is 300 ppm. In the first study with the 3 triadimefon treatment groups, the only difference observed in the 300 ppm treatment group was related to body weight development during lactation. In 2 of the 6 litters produced ( the 2 Page 12 of 15 litters from the second mating of the F1 and F2 generations; i. e., F2b and F3b litters) had a slight decrease in body weight during the lactation period. However these slight differences may not be ecologically relevant given that the F2b generation were reared until maturity and mated. As the development of these animals progressed, there were no further effects noted on the growth or development and no effects were observed on the reproduction of these animals. Therefore any effect observed on body size during lactation was slight and transient. Additionally, the exposure that caused this effect occurred over a constant and very long exposure period, and the offspring produced in the second mating are based on aging parental animals, which may have an impact on the study. In conclusion, the ecologically relevant NOAEC that should be used for the ecological risk assessment is 300 ppm ( 15 mg/ kg/ day).

Agency Response In regards to risk quotient calculations, it is the Agency's policy that for screening level risk assessments the most sensitive acute and/ or chronic endpoint is selected from the available test data and is used in the risk assessment.

Therefore in accordance with Agency policy for calculating the triadimefon mammalian chronic toxicity risk quotient the Agency has selected the mammalian chronic toxicity NOEAL endpoint of 50 ppm produced in multigeneration rat study, MRID 00155075. The results of this study demonstrated a parental NOAEC of 50 ppm for decreases in litter size, number of pups produced, fertility, body weight, and decrease in ovary size. The results of this study also produced an offspring NOAEC of 50 ppm for decreases in pup weights, pup viability, and decreases in litter size. Based on the evidence produce in this study showing multiple adverse reproductive effects, EFED presumes that the adverse effects demonstrated in this study may represent biologically significant effects that may adversely impact the reproductive success of wild mammals exposed to triadimefon. This presumption is may especially be applicable to endangered mammalian species populations that may already be stressed.

The results of the study demonstrated more adversely affected factors and a more sensitive NOAEL value than the only other available multigeneration rat reproductive toxicity study, MRID 00032541. This study produced: 1) a parental NOAEL of 300 ppm based on decreased fertility, body weights, body weight gains, and litter size, and 2) an offspring NOAEL of 300 ppm based on decreases in pup body weight and pup weight gains. Consequently, because this study produced a less sensitive NOAEL than the previously mentioned rat multigenerational study ( MRID 00155075), the Agency did not use the less sensitive results of this study to calculate the chronic risk quotient calculations for mammals. 15 IV. RISK CHARACTERIZATION Pages 56   60 and Tables 20   22. EPA: EPA provides a concise summary of the RQs and LOC exceedences for the freshwater risk assessment. Bayer Response: BCS does not disagree with the presentation of the RQs and LOC exceedences presented. However as noted above, a useful scenario to present would be for the golf course turf with 3 applications at 2.7 lb ai/ A ( total seasonal application of 8.1 lb ai/ A). This is a reduction in 23 applications of the worst case scenario conducted by the reviewers. For the fish and invertebrate acute and chronic risk quotients ( Tables 20 and 21), the only LOC exceedences were for turf scenarios that had 13 or more applications. Given that the acute RQ for 13 applications of 2.7 lb ai/ A was 0.07 ( only a slightly above the endangered species LOC), when the exposure scenario is reduced by another 10 applications, there would no longer be any LOC exceedences. Similarly the chronic RQ for 13 applications of 2.7 lb ai/ A was 2.3; the reduction of the number of applications to 3 would result in a RQ well below the chronic LOC. For the risk quotients for aquatic non vascular plants, the only LOC exceedences were for turf scenarios with 13 or more applications. The RQ for the turf scenario with 13 applications of 2.7 lb ai/ A was 1.5. As mentioned above, when the number of applications is reduced to 3, the RQ will be well below the endangered species LOC.

Agency Response The Agency is in agreement that there would be no LOC exceedances for fish, aquatic invertebrate, and aquatic plants for Bayer's newly proposed turf maximum application rates of either: 1) 3 applications for the golf course use pattern for a maximum total seasonal application of 8.1 lbs. a. i./ acre or 2) a professional care lawn and turf maximum use rate that allows 3 applications of 1.36 lbs. a. i./ acre, with a 30 day interval for curative control of southern blight.

However, the Agency deems it not necessary to amend the current Agency ` s ecological risk assessment to reflect this particular application rate because the current Agency's ecological risk assessment already reflects a large range of various turf application rates ranging from a total seasonal application of 70 lbs. a. i./ acre ( 26 applications of 2.7 lbs. a. i./ acre) to a total seasonal application of 2.6 lbs. a. i./ acre ( 2 applications of 1.3 lbs. a. i./ acre). Within that range of application rates, the Agency LOC exceedances for 16 aquatic organisms begin at a maximum seasonal rate of 35 lbs. a. i./ acre ( 13 applications of 2.7 lbs a. i./ acre.).

1. Non target Terrestrial Animals Pages 60 66 Page 13 of 15 EPA: EPA present the risk assessment for birds and mammals using the endpoints described in Ecological Effects Characterization section. A discussion of the RQs and LOCs follow. Bayer Response: Similar to the discussion for the aquatic risk assessment, a golf course assessment for 3 applications of 2.7 lb ai/ A should be performed. This would result in a significant reduction in the acute and chronic RQs for both birds and mammals, compared to the 26 application scenario. As discussed above, the appropriate endpoint ( NOAEL) for the chronic avian risk assessment is 600 ppm ( 587 ppm measured), based on the hazard characterization using the complete set of data available for triadimefon. This would result in a 30 fold decrease in the RQs for the chronic avian risk assessment; a significant reduction in the potential risk. Similarly, the appropriate endpoint for the chronic mammalian risk assessment is 300 ppm ( 15 mg/ kg/ day). This would result in a 6 fold decrease in the RQs for the chronic mammalian risk assessment, a significant reduction in the potential risk.

The golf course turf use pattern represents the worst case scenario for birds and wild mammals. In assessing the potential risk under this scenario, there are many mitigating factors that reduce the exposure/ and/ or risk: ° The screening level assessment assumes a mammal or bird consumes 100% of diet from treated field ( or food items), a highly conservative assumption that is not realistic. For reasons explained below: It is highly unlikely that a bird and mammal will consume 100% of their diet on treated food items that maintain a constant concentration over a very long period of time with a golf course use pattern. ° Golf courses are highly managed areas. While watering in of the compound is not a requirement, frequent irrigation of the course occurs. This irrigation will decrease the potential exposure of triadimefon on the relevant avian and mammalian food items. ° As noted on the label, application of triadimefon should occur when the turf is established and growing. The rapid growth of the turf during the growing season will have a dilution effect on the residues of triadimefon in/ on the food items. Therefore the triadimefon exposure will decrease over time as the plant grows. ° Golf courses are also mowed frequently. As the plant is cut and new growth occurs, the potential exposure to triadimefon is significantly reduced over time ° Triadimefon is not applied to the entire golf course acres; it is primarily applied to tees, greens and fairways, which encompass approximately 28% of 17 the acres. Therefore triadimefon will generally not be applied to the primary Page 14 of 15 wildlife habitat and nor would 100% of the diet be receiving a direct overspray of the product. In conclusion, the screening level risk assessment for the golf course use pattern is highly conservative. The agronomic practices associated with golf courses, significantly reduces the potential risks for birds and mammals.

Agency Response In response to the Bayer's proposal to use Chronic NOEAL of 600 ppm for birds and 300 ppm for mammals, the Agency has determined ( as previously explained in above Agency responses) that in accordance with Agency policy the results of the study that produces the most sensitive chronic NOEAL endpoint must be used to calculate chronic risk quotients for birds and mammals. Thus, the Agency used the chronic toxicity NOAEL of 20 ppm for birds and 50 ppm for mammals ( MRIDs 110431 and 00155075).

The current label for triadimefon use on golf course turf did not specify a maximum number of applications per season or a maximum total seasonal applications rate. Thus, EFED'S revised ecological risk assessment ( dated 1/ 19/ 06) evaluated a range of different scenarios for turf application rates. These scenarios of application rates ranged from 1 to 26 applications of either 1.36, 1.31, or 2.7 lbs. a. i./ with intervals of either 7, 14, 28, 30, or 60 days. There are bird and mammal Agency level of concern ( LOC) exceedances throughout the entire range of application rates. In particular, there are bird and mammal LOC exceedances which would result from Bayer's proposals to add to the label which include: 1) a maximum number of applications of 3 for the golf course use pattern for a maximum total seasonal application of 8.1 lbs. a. i./ acre ( equivalent to 3 applications of 2.7 lbs. a. i./ acre) and 2) a professional care lawn and turf maximum use rate that allows 3 applications of 1.36 lbs. a. i./ A, with a 30 day interval for curative control of southern blight. Tables 1 3 illustrate these use rates and their resulting LOC exceedances for birds and mammals.

Tables 1 3 also include risk quotient calculations with a range of interval times ( 7, 14, 30, and 60 days for interval times) between applications for the Bayer proposed maximum seasonal application amount of 8.1 lbs. a. i./ acre ( equivalent to 3 applications of 2.7 lbs. a. i./ acre). The Agency took this measure because Bayer did not specify an interval time between applications for this application rate.

In response s to Bayer's comment about the assumption about terrestrial organism's diet and exposure on a golf course the Agency concludes the following. In accordance with Agency policy in all screening level assessments, the organisms are assumed to consume 100% of their diet as one food type, thereby eliminating the need at the screening level for evaluating mixtures of dietary items ( i. e. items off the golf course). 18 Risk Description Pages 72 and 74: Risk to Terrestrial Organisms and Plants  Spray Drift EPA: EPA used the AgDrift model to calculate the distance from the edge of the field required to bring spray drift below the LOC. Bayer Response: The use of AgDrift to calculate the distance to achieve drift below the LOC must be done with extreme caution, and may not be appropriate use of the tool. The spray deposition is to wildlife food items is not equivalent to the deposition that was measured to develop the model. The AgDrift model was developed under scenarios to bare ground, which is not the case for any of the scenarios modeled. For example, the golf course scenario is not bare ground, and it is well known that golf courses will have vegetation ( trees, shrubs, etc.) that will intercept drift. Therefore AgDrift will grossly overestimate the deposition distance. In addition, the droplet spectrum in a drift event will be different than the spectrum from a direct application event to a wildlife food item. These differences in spectrum will result in difference in coverage of the item upon which deposition as occurred. Deposition onto a food item will be less from a drift event; therefore the AgDrift model will overestimate the residues on the wildlife food item. Drift onto a plant will occur primarily on the surface of the plant, and may not occur at the base of the plant where, for example, a small mammal would forage. For the insectivorous animals, the insect food items will be immigrating and emigrating from any one area, and therefore to assume that 100% of the insects have equivalent residues is not appropriate. Additionally, drift onto many insects will be low given the potential for drift interception to occur by surrounding plants. In conclusion, the use of AgDrift to determine these differences may not provide a meaningful tool for interpreting risks to birds and mammals. 19 Agency Response For screening terrestrial risk assessments for listed species, a generic bird or mammal is assumed to occupy either the treated field, or adjacent areas receiving pesticide a rate commensurate with the treatment rate on the field. Spray drift model predictions suggest that this assumption leads to an overestimation of exposure to species that do not occupy the treated field. AgDrift estimated drift to areas removed from the fields ( below) indicates that off site drift is but a fraction of on field treatment rate.

Spray Droplet Size AgDrift Model Drift Point Estimate 0 to 990 from field ( Tier 1)

Very fine fine 50% to 4% Fine to medium 50% to 1% Medium to coarse 50% to 0.5% Coarse to very coarse 50% to 0.3%

For screening risk assessment purposes, the actual habitat requirements of any particular terrestrial species are not considered, and it is assumed that species occupy, exclusively and permanently, the treatment area being modeled. This assumption leads to a maximum level of exposure in the risk characterization. To the extent that a species does not reside exclusively and permanently in treated areas, exposure will be less, and presumably significantly less.

Page 82: Risk to Terrestrial Organisms and Plants EPA: EPA calculated the probability of an acute event at the highest application rate. Bayer Response: While it has been acknowledged that the golf course label has not specified and the number of applications, the presentation of 26 applications will grossly overestimate the potential toxicity of the compound, which has low acute toxicity. 20 Agency Response The current label for triadimefon use on golf course turf did not specify a maximum number of applications per season or a maximum total seasonal applications rate. Thus, EFED'S revised ecological risk assessment ( dated 1/ 19/ 06) evaluated a range of different scenarios for turf application rates. These scenarios of application rates ranged from 1 to 26 applications of either 1.36, 1.31, or 2.7 lbs. a. i./ with intervals of either 7, 14, 28, 30, or 60 days. There are bird and mammal Agency level of concern ( LOC) exceedances throughout the entire range of application rates. In particular, there are bird and mammal LOC exceedances which would result from Bayer's proposals to add to the label which include: 1) a maximum number of applications of 3 for the golf course use pattern for a maximum total seasonal application of 8.1 lbs. a. i./ acre ( equivalent to 3 applications of 2.7 lbs. a. i./ acre) and 2) a professional care lawn and turf maximum use rate that allows 3 applications of 1.36 lbs. a. i./ A, with a 30 day interval for curative control of southern blight. Tables 1 3 illustrate these use rates and their resulting LOC exceedances for birds and mammals.

Tables 1 3 also include risk quotient calculations with a range of interval times ( 7, 14, 30, and 60 days for interval times) between applications for the Bayer proposed maximum seasonal application amount of 8.1 lbs. a. i./ acre ( equivalent to 3 applications of 2.7 lbs. a. i./ acre). The Agency took this measure because Bayer did not specify an interval time between applications for this application rate.

APPENDIX 3   Triadimefon and Triadimenol Toxicity Data Page 176   Mammals, Acute and Chronic EPA: EPA provides the summary of the mammalian toxicity data. Bayer Response: As discussed earlier, EPA should present the results from both of the rat reproduction studies.

Agency Response In regards to risk quotient calculations, it is the Agency's policy that for screening level risk assessments the most sensitive acute and/ or chronic endpoint is selected from the available test data and is used in the risk assessment.

Therefore in accordance with Agency policy for calculating the triadimefon mammalian chronic toxicity risk quotient the Agency has selected the mammalian chronic toxicity NOEAL endpoint of 50 ppm produced in multigeneration rat study, MRID 00155075. The results of this study demonstrated a parental NOAEC of 50 ppm for decreases in litter size, number of pups produced, fertility, body weight, and decrease in ovary size. The results of this study also produced an offspring NOAEC of 50 ppm for decreases in pup weights, pup viability, and decreases in litter size. Based on the evidence produce in this study showing multiple adverse reproductive effects, EFED presumes that the adverse effects demonstrated in this study may represent biologically significant effects that may adversely impact the reproductive success of wild mammals exposed to 21 triadimefon. This presumption is may especially be applicable to endangered mammalian species populations that may already be stressed.

The results of the study demonstrated more adversely affected factors and a more sensitive NOAEL value than the only other available multigeneration rat reproductive toxicity study, MRID 00032541. This study produced: 1) a parental NOAEL of 300 ppm based on decreased fertility, body weights, body weight gains, and litter size, and 2) an offspring NOAEL of 300 ppm based on decreases in pup body weight and pup weight gains. Consequently, because this study produced a less sensitive NOAEL than the previously mentioned rat multigenerational study ( MRID 00155075), the Agency did not use the less sensitive results of this study to calculate the chronic risk quotient calculations for mammals.


[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Page 13888]
[FR Doc No: 2020-04879]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP20-631-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Petition for
Declaratory Order

    Take notice that on February 28, 2020, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure and Section 284.501 of the Commission's regulations,
Tennessee Gas Pipeline Company, L.L.C. (TGP) filed a petition seeking
authorization to charge market-based rates for a proposed firm storage
service to be offered using storage capacity and deliverability from a
firm storage contract TGP has entered into with Pine Prairie Energy
Center, LLC, all as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on March 13, 2020.

    Dated: March 4, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-04879 Filed 3-9-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Rules and Regulations]
[Pages 2056-2060]
[FR Doc No: 2019-00785]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 19

[FRL-9988-90-OAR-OECA]

Civil Monetary Penalty Inflation Adjustment Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is promulgating this
final rule to adjust the level of the maximum (or minimum) statutory
civil monetary penalty amounts under the statutes EPA administers. This
action is mandated by the Federal Civil Penalties Inflation Adjustment
Act of 1990, as amended through the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of 2015 (``the 2015 Act''). The 2015
Act prescribes a formula for annually adjusting the statutory maximum
(or minimum) amount of civil penalties to reflect inflation, maintain
the deterrent effect of statutory civil penalties, and promote
compliance with the law. The rule does not necessarily revise the
penalty amounts that EPA chooses to seek pursuant to its civil penalty
policies in a particular case. EPA's civil penalty policies, which
guide enforcement personnel on how to exercise EPA's statutory penalty
authorities, take into account a number of fact-specific
considerations, e.g., the seriousness of the violation, the violator's
good faith efforts to comply, any economic benefit gained by the
violator as a result of its noncompliance, and a violator's ability to
pay.

DATES: This final rule is effective February 6, 2019, and applicable
beginning January 15, 2019.

FOR FURTHER INFORMATION, CONTACT: David Smith-Watts, Office of Civil
Enforcement, Office of Enforcement and Compliance Assurance, Mail Code
2241A, Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20460, telephone number:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Since 1990, federal agencies have been required to issue
regulations adjusting for inflation the statutory civil penalties \1\
that can be imposed under the laws administered by that agency. The
Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by
the Debt Collection Improvement Act of 1996 (DCIA), required agencies
to review their statutory civil penalties every 4 years, and to adjust
the statutory civil penalty amounts for inflation if the increase met
the DCIA's adjustment methodology. In accordance with the DCIA, EPA
reviewed and, as appropriate, adjusted the civil penalty levels under
each of the statutes the agency implements in 1996 (61 FR 69360), 2004
(69 FR 7121), 2008 (73 FR 75340), and 2013 (78 FR 66643).
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    \1\ The Federal Civil Penalties Inflation Adjustment Act of
1990, Public Law 101-410, 28 U.S.C. 2461 note, defines ``civil
monetary penalty'' as ``any penalty, fine, or other sanction that--
(A)(i) is for a specific monetary amount as provided by Federal law;
or (ii) has a maximum amount provided for by Federal law; and (B) is
assessed or enforced by an agency pursuant to Federal law; and (C)
is assessed or enforced pursuant to an administrative proceeding or
a civil action in the Federal courts.''
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    The 2015 Act \2\ required each federal agency to adjust the level
of statutory civil penalties under the laws implemented by that agency
with an initial ``catch-up'' adjustment through an interim final
rulemaking. The 2015 Act also required federal agencies, beginning on
January 15, 2017, to make subsequent annual adjustments for inflation.
Section 4 of the 2015 Act requires each federal agency to publish these
annual adjustments by January 15 of each year. The purpose of the 2015
Act is to maintain the deterrent effect of civil penalties by
translating originally enacted statutory civil penalty amounts to
today's dollars and rounding statutory civil penalties to the nearest
dollar.
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    \2\ The Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (Section 701 of Pub. L. 114-74) was signed
into law on Nov. 2, 2015, and further amended the Federal Civil
Penalties Inflation Adjustment Act of 1990.
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    As required by the 2015 Act, EPA issued a catch-up rule on July 1,
2016, which was effective August 1, 2016 (81 FR 43091). EPA made its
first annual adjustment on January 12, 2017, which was effective on
January 15, 2017 (82 FR 3633). EPA made its second annual adjustment on
January 10, 2018, which was effective on January 15, 2018 (83 FR 1190).
Today's rule implements the third annual adjustment mandated by the
2015 Act.
    The 2015 Act describes the method for calculating the adjustments.
Each statutory maximum and minimum \3\ civil monetary penalty is
multiplied by the cost-of-living adjustment, which is

the percentage by which the Consumer Price Index for all Urban
Consumers (CPI-U) for the month of October 2018 exceeds the CPI-U for
the month of October 2017.\4\
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    \3\ Under Section 3(2)(A) of the 2015 Act, ``civil monetary
penalty'' means ``a specific monetary amount as provided by Federal
law''; or ``has a maximum amount provided for by Federal law.'' EPA-
administered statutes generally refer to statutory maximum
penalties, with the following exceptions: Section 311(b)(7)(D) of
the Clean Water Act, 33 U.S.C. 1321(b)(7)(D), refers to a minimum
penalty of ``not less than $100,000 . . .''; Section 104B(d)(1) of
the Marine Protection, Research, and Sanctuaries Act, 33 U.S.C.
1414b(d)(1), refers to an exact penalty of $600 ``[f]or each dry ton
(or equivalent) of sewage sludge or industrial waste dumped or
transported by the person in violation of this subsection in
calendar year 1992 . . .''; and Section 325(d)(1) of the Emergency
Planning and Community Right-to-Know Act, 42 U.S.C. 11045(d)(1),
refers to an exact civil penalty of $25,000 for each frivolous trade
secret claim.
    \4\ Current and historical CPI-U's can be found on the Bureau of
Labor Statistics' website here: https://www.bls.gov/cpi/tables/supplemental-files/historical-cpi-u-201810.pdf.
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    With this rule, the new statutory maximum and minimum penalty
levels listed in the seventh column of Table 2 of 40 CFR 19.4 will
apply to all civil penalties assessed on or after February 6, 2019, for
violations that occurred after November 2, 2015, the date the 2015 Act
was enacted. The former maximum and minimum statutory civil penalty
levels, which are in the sixth column of Table 2 to 40 CFR 19.4, will
now apply only to violations that occurred after November 2, 2015,
where the penalties were assessed on or after January 15, 2018 but
before February 6, 2019. The statutory penalty levels for violations
that occurred after November 2, 2015, where the penalties were assessed
on or after August 1, 2016 but before January 15, 2017, are codified in
the fourth column of Table 2 to 40 CFR 19.4. The statutory civil
penalty levels that apply to violations that occurred on or before
November 2, 2015, are codified at Table 1 to 40 CFR 19.4.
    The formula for determining the cost-of-living or inflation
adjustment to statutory civil penalties consists of the following
steps:
    Step 1: The cost-of-living adjustment multiplier for 2019 is the
percentage by which the CPI-U of October 2018 (252.885) exceeds the
CPI-U for the month of October 2017 (246.663), which is 1.02522.\5\
Multiply 1.02522 by the current penalty amount. This is the raw
adjusted penalty value.
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    \5\ Section 5(b) of the 2015 Act states ``. . . the term `cost-
of-living adjustment' means the percentage (if any) for each civil
monetary penalty by which-
    (A) the Consumer Price Index for the month of October preceding
the date of the adjustment, exceeds
    (B) the Consumer Price Index for the month of October 1 year
before the month of October referred to in subparagraph (A).''
    Because the CPI-U for October 2018 is 252.885 and the CPI-U for
October 2017 is 246.663, the cost-of-living multiplier is 1.02522
(252.885 divided by 246.663).
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    Step 2: Round the raw adjusted penalty value. Section 5 of the 2015
Act states that any adjustment shall be rounded to the nearest multiple
of $1. The result is the final penalty value for the year.
    II. The 2015 Act Requires Federal Agencies To Publish Annual
Penalty Inflation Adjustments Notwithstanding Section 553 of the
Administrative Procedures Act
    Pursuant to section 4 of the 2015 Act, each federal agency is
required to publish the next annual adjustments no later than January
15, 2019. However, due to the government shutdown from December 22,
2018, to January 25, 2019, EPA and the Office of Federal Register were
unable to publish the rule by the January 15, 2019 deadline.
    In accordance with section 553 of the Administrative Procedures Act
(APA), most rules are subject to notice and comment and are effective
no earlier than 30 days after publication in the Federal Register.
However, Section 4(b)(2) of the 2015 Act provides that each agency
shall make the annual inflation adjustments ``notwithstanding section
553'' of the APA. Consistent with the language of the 2015 Act, this
rule is not subject to notice and an opportunity for public comment and
will be effective on February 6, 2019.

III. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to OMB for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA. This rule merely increases the level of statutory civil
penalties that can be imposed in the context of a federal civil
administrative enforcement action or civil judicial case for violations
of EPA-administered statutes and their implementing regulations.

D. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
APA, 5 U.S.C. 553, or any other statute. Because the 2015 Act directs
Federal agencies to publish this rule notwithstanding section 553 of
the APA, this rule is not subject to notice and comment requirements or
the RFA.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action is required by the 2015 Act, without the
exercise of any policy discretion by EPA. This action also imposes no
enforceable duty on any state, local or tribal governments or the
private sector. Because the calculation of any increase is formula-
driven pursuant to the 2015 Act, EPA has no policy discretion to vary
the amount of the adjustment.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
a substantial direct effect 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. This rule merely reconciles the real value of
current statutory civil penalty levels to reflect and keep pace with
the levels originally set by Congress when the statutes were enacted.
The calculation of the increases is formula-driven and prescribed by
statute, and EPA has no discretion to vary the amount of the adjustment
to reflect any views or suggestions provided by commenters.
Accordingly, this rule will not have a substantial direct effect 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.
    Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

I. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    The rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. Rather, this action is
mandated by the 2015 Act, which prescribes a formula for adjusting
statutory civil penalties on an annual basis to reflect inflation.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and comment rulemaking procedures are
impracticable, unnecessary or contrary to the public interest (5 U.S.C.
808(2)). The 2015 Act directs Federal agencies to publish their annual
penalty inflation adjustments ``notwithstanding section 553 [of the
APA].'' EPA finds that the APA's notice and comment rulemaking
procedures are impracticable, unnecessary or contrary to the public
interest.

List of Subjects in 40 CFR Part 19

    Environmental protection, Administrative practice and procedure,
Penalties.

    Dated: December 21, 2018.
Andrew R. Wheeler,
Acting Administrator.
    For the reasons set out in the preamble, EPA amends title 40,
chapter I, part 19 of the Code of Federal Regulations as follows:

PART 19--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION

0
1. The authority citation for part 19 continues to read as follows:

    Authority:  Pub. L. 101-410, Oct. 5, 1990, 104 Stat. 890, as
amended by Pub. L. 104-134, title III, sec. 31001(s)(1), Apr. 26,
1996, 110 Stat. 1321-373; Pub. L. 105-362, title XIII, sec. 1301(a),
Nov. 10, 1998, 112 Stat. 3293; Pub. L. 114-74, title VII, sec.
701(b), Nov. 2, 2015, 129 Stat. 599.

0
2. Revise Sec.  19.2 to read as follows:

Sec.  19.2  Effective date.

    The statutory penalty levels in the last column of Table 1 to Sec.
19.4 apply to all violations which occurred after December 6, 2013
through November 2, 2015, and to violations occurring after November 2,
2015, where penalties were assessed before August 1, 2016. The
statutory civil penalty levels set forth in the fourth column of Table
2 of Sec.  19.4 apply to all violations which occurred after November
2, 2015, where the penalties were assessed on or after August 1, 2016
and before January 15, 2017. The statutory civil penalty levels set
forth in the fifth column of Table 2 of Sec.  19.4 apply to all
violations which occurred after November 2, 2015, where the penalties
were assessed on or after January 15, 2017 but before January 15, 2018.
The statutory civil penalty levels set forth in the sixth column of
Table 2 of Sec.  19.4 apply to all violations which occurred after
November 2, 2015, where the penalties were assessed on or after January
15, 2018 but before February 6, 2019. The statutory civil penalty
levels set forth in the seventh and last column of Table 2 of Sec.
19.4 apply to all violations which occur or occurred after November 2,
2015, where the penalties are assessed on or after February 6, 2019.

0
3. In Sec.  19.4, revise the introductory text and table 2 of section
19.4 to read as follows:

Sec.  19.4  Statutory civil penalties, as adjusted for inflation, and
tables.

    Table 1 to Sec.  19.4 sets out the statutory civil penalty
provisions of statutes administered by EPA, with the original statutory
civil penalty levels, as enacted, and the operative statutory civil
penalty levels, as adjusted for inflation, for violations that occurred
on or before November 2, 2015, and for violations that occurred after
November 2, 2015, where penalties were assessed before August 1, 2016.
Table 2 to Sec.  19.4 sets out the statutory civil penalty provisions
of statutes administered by EPA, with the third column displaying the
original statutory civil penalty levels, as enacted. The fourth column
of Table 2 displays the operative statutory civil penalty levels where
penalties were assessed on or after August 1, 2016 but before January
15, 2017, for violations that occurred after November 2, 2015. The
fifth column displays the operative statutory civil penalty levels
where penalties were assessed on or after January 15, 2017 but before
January 15, 2018, for violations that occurred after November 2, 2015.
The sixth column displays the operative statutory civil penalty levels
where penalties were assessed on or after January 15, 2018 but before
January 15, 2019, for violations that occurred after November 2, 2015.
The seventh and last column displays the operative statutory civil
penalty levels where penalties are assessed on or after January 15,
2019, for violations that occur or occurred after November 2, 2015.
* * * * *

                                          Table 2 of Section 19.4--Civil Monetary Penalty Inflation Adjustments
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Statutory civil     Statutory civil
                                                                            Statutory civil      penalties for       penalties for      Statutory civil
                                                                             penalties for      violations that     violations that      penalties for
                                                                            violations that     occurred after      occurred after      violations that
                                                        Statutory civil     occurred after     November 2, 2015,   November 2, 2015,    occurred after
       U.S. Code citation            Environmental       penalties, as     November 2, 2015,    where penalties     where penalties    November 2, 2015,
                                        statute             enacted         where penalties    were assessed on    were assessed on     where penalties
                                                                           were assessed on    or after January    or after January   are assessed on or
                                                                          or after August 1,     15, 2017 but        15, 2018 but      after January 15,
                                                                            2016 but before   before January 15,  before January 15,         2019
                                                                           January 15, 2017          2018                2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
7 U.S.C. 136l.(a)(1)............  Federal             $5,000............  $18,750...........  $19,057...........  $19,446...........  $19,936
                                   Insecticide,
                                   Fungicide, and
                                   Rodenticide Act
                                   (FIFRA).
7 U.S.C. 136l.(a)(2)\1\.........  FIFRA.............  $1,000/$500/$1,000  $2,750/$1,772/      $2,795/$1,801/      $2,852/$1,838/      $2,924/$1,884/
                                                                           $2,750.             $2,795.             $2,852.             $2,924
15 U.S.C. 2615(a)(1)............  Toxic Substances    $25,000...........  $37,500...........  $38,114...........  $38,892...........  $39,873
                                   Control Act
                                   (TSCA).
15 U.S.C. 2647(a)...............  TSCA..............  $5,000............  $10,781...........  $10,957...........  $11,181...........  $11,463
15 U.S.C. 2647(g)...............  TSCA..............  $5,000............  $8,908............  $9,054............  $9,239............  $9,472
31 U.S.C. 3802(a)(1)............  Program Fraud       $5,000............  $10,781...........  $10,957...........  $11,181...........  $11,463
                                   Civil Remedies
                                   Act (PFCRA).
31 U.S.C. 3802(a)(2)............  PFCRA.............  $5,000............  $10,781...........  $10,957...........  $11,181...........  $11,463

33 U.S.C. 1319(d)...............  Clean Water Act     $25,000...........  $51,570...........  $52,414...........  $53,484...........  $54,833
                                   (CWA).
33 U.S.C. 1319(g)(2)(A).........  CWA...............  $10,000/$25,000...  $20,628/$51,570...  $20,965/$52,414...  $21,393/$53,484...  $21,933/$54,833
33 U.S.C. 1319(g)(2)(B).........  CWA...............  $10,000/$125,000..  $20,628/$257,848..  $20,965/$262,066..  $21,393/$267,415..  $21,933/$274,159
33 U.S.C. 1321(b)(6)(B)(i)......  CWA...............  $10,000/$25,000...  $17,816/$44,539...  $18,107/$45,268...  $18,477/$46,192...  $18,943/$47,357
33 U.S.C. 1321(b)(6)(B)(ii).....  CWA...............  $10,000/$125,000..  $17,816/$222,695..  $18,107/$226,338..  $18,477/$230,958..  $18,943/$236,783
33 U.S.C. 1321(b)(7)(A).........  CWA...............  $25,000/$1,000....  $44,539/$1,782....  $45,268/$1,811....  $46,192/$1,848....  $47,357/$1,895
33 U.S.C. 1321(b)(7)(B).........  CWA...............  $25,000...........  $44,539...........  $45,268...........  $46,192...........  $47,357
33 U.S.C. 1321(b)(7)(C).........  CWA...............  $25,000...........  $44,539...........  $45,268...........  $46,192...........  $47,357
33 U.S.C. 1321(b)(7)(D).........  CWA...............  $100,000/$3,000...  $178,156/$5,345...  $181,071/$5,432...  $184,767/$5,543...  $189,427/$5,683
33 U.S.C. 1414b(d)(1)...........  Marine Protection,  $600..............  $1,187............  $1,206............  $1,231............  $1,262
                                   Research, and
                                   Sanctuaries Act
                                   (MPRSA).
33 U.S.C. 1415(a)...............  MPRSA.............  $50,000/$125,000..  $187,500/$247,336.  $190,568/$251,382.  $194,457/$256,513.  $199,361/$262,982
33 U.S.C. 1901 note (see          Certain Alaskan     $10,000/$25,000...  $13,669/$34,172...  $13,893/$34,731...  $14,177$35,440....  $14,535/$36,334
 1409(a)(2)(A)).                   Cruise Ship
                                   Operations
                                   (CACSO).
33 U.S.C. 1901 note (see          CACSO.............  $10,000/$125,000..  $13,669/$170,861..  $13,893/$173,656..  $14,177/$177,200..  $14,535/$181,669
 1409(a)(2)(B)).
33 U.S.C. 1901 note (see          CACSO.............  $25,000...........  $34,172...........  $34,731...........  $35,440...........  $36,334
 1409(b)(1)).
33 U.S.C. 1908(b)(1)............  Act To Prevent      $25,000...........  $70,117...........  $71,264...........  $72,718...........  $74,552
                                   Pollution From
                                   Ships (APPS).
33 U.S.C. 1908(b)(2)............  APPS..............  $5,000............  $14,023...........  $14,252...........  $14,543...........  $14,910
42 U.S.C. 300g-3(b).............  Safe Drinking       $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
                                   Water Act (SDWA).
42 U.S.C. 300g-3(g)(3)(A).......  SDWA..............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 300g-3(g)(3)(B).......  SDWA..............  $5,000/$25,000....  $10,781/$37,561...  $10,957/$38,175...  $11,181/$38,954...  $11,463/$39,936
42 U.S.C. 300g-3(g)(3)(C).......  SDWA..............  $25,000...........  $37,561...........  $38,175...........  $38,954...........  $39,936
42 U.S.C. 300h-2(b)(1)..........  SDWA..............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 300h-2(c)(1)..........  SDWA..............  $10,000/$125,000..  $21,563/$269,535..  $21,916/$273,945..  $22,363/$279,536..  $22,927/$286,586
42 U.S.C. 300h-2(c)(2)..........  SDWA..............  $5,000/$125,000...  $10,781/$269,535..  $10,957/$273,945..  $11,181/$279,536..  $11,463/$286,586
42 U.S.C. 300h-3(c).............  SDWA..............  $5,000/$10,000....  $18,750/$40,000...  $19,057/$40,654...  $19,446/$41,484...  $19,936/$42,530
42 U.S.C. 300i(b)...............  SDWA..............  $15,000...........  $22,537...........  $22,906...........  $23,374...........  $23,963
42 U.S.C. 300i-1(c).............  SDWA..............  $100,000/           $131,185/           $133,331/           $136,052/           $139,483/
                                                       $1,000,000.         $1,311,850.         $1,333,312.         $1,360,525.         $1,394,837
42 U.S.C. 300j(e)(2)............  SDWA..............  $2,500............  $9,375............  $9,528............  $9,722............  $9,967
42 U.S.C. 300j-4(c).............  SDWA..............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 300j-6(b)(2)..........  SDWA..............  $25,000...........  $37,561...........  $38,175...........  $38,954...........  $39,936
42 U.S.C. 300j-23(d)............  SDWA..............  $5,000/$50,000....  $9,893/$98,935....  $10,055/$100,554..  $10,260/$102,606..  $10,519/$105,194
42 U.S.C. 4852d(b)(5)...........  Residential Lead-   $10,000...........  $16,773...........  $17,047...........  $17,395...........  $17,834
                                   Based Paint
                                   Hazard Reduction
                                   Act of 1992.
42 U.S.C. 4910(a)(2)............  Noise Control Act   $10,000...........  $35,445...........  $36,025...........  $36,760...........  $37,687
                                   of 1972.
42 U.S.C. 6928(a)(3)............  Resource            $25,000...........  $93,750...........  $95,284...........  $97,229...........  $99,681
                                   Conservation and
                                   Recovery Act
                                   (RCRA).
42 U.S.C. 6928(c)...............  RCRA..............  $25,000...........  $56,467...........  $57,391...........  $58,562...........  $60,039
42 U.S.C. 6928(g)...............  RCRA..............  $25,000...........  $70,117...........  $71,264...........  $72,718...........  $74,552
42 U.S.C. 6928(h)(2)............  RCRA..............  $25,000...........  $56,467...........  $57,391...........  $58,562...........  $60,039
42 U.S.C. 6934(e)...............  RCRA..............  $5,000............  $14,023...........  $14,252...........  $14,543...........  $14,910
42 U.S.C. 6973(b)...............  RCRA..............  $5,000............  $14,023...........  $14,252...........  $14,543...........  $14,910
42 U.S.C. 6991e(a)(3)...........  RCRA..............  $25,000...........  $56,467...........  $57,391...........  $58,562...........  $60,039
42 U.S.C. 6991e(d)(1)...........  RCRA..............  $10,000...........  $22,587...........  $22,957...........  $23,426...........  $24,017
42 U.S.C. 6991e(d)(2)...........  RCRA..............  $10,000...........  $22,587...........  $22,957...........  $23,426...........  $24,017
42 U.S.C. 7413(b)...............  Clean Air Act       $25,000...........  $93,750...........  $95,284...........  $97,229...........  $99,681
                                   (CAA).
42 U.S.C. 7413(d)(1)............  CAA...............  $25,000/$200,000..  $44,539/$356,312..  $45,268/$362,141..  $46,192/$369,532..  $47,357/$378,852
42 U.S.C. 7413(d)(3)............  CAA...............  $5,000............  $8,908............  $9,054............  $9,239............  $9,472
42 U.S.C. 7524(a)...............  CAA...............  $25,000/$2,500....  $44,539/$4,454....  $45,268/$4,527....  $46,192/$4,619....  $47,357/$4,735
42 U.S.C. 7524(c)(1)............  CAA...............  $200,000..........  $356,312..........  $362,141..........  $369,532..........  $378,852
42 U.S.C. 7545(d)(1)............  CAA...............  $25,000...........  $44,539...........  $45,268...........  $46,192...........  $47,357
42 U.S.C. 9604(e)(5)(B).........  Comprehensive       $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
                                   Environmental
                                   Response,
                                   Compensation, and
                                   Liability Act
                                   (CERCLA).
42 U.S.C. 9606(b)(1)............  CERCLA............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 9609(a)(1)............  CERCLA............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 9609(b)...............  CERCLA............  $25,000/$75,000...  $53,907/$161,721..  $54,789/$164,367..  $55,907/$167,722..  $57,317/$171,952
42 U.S.C. 9609(c)...............  CERCLA............  $25,000/$75,000...  $53,907/$161,721..  $54,789/$164,367..  $55,907/$167,722..  $57,317/$171,952

42 U.S.C. 11045(a)..............  Emergency Planning  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
                                   and Community
                                   Right-To-Know Act
                                   (EPCRA).
42 U.S.C. 11045(b)(1)(A)........  EPCRA.............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 11045(b)(2)...........  EPCRA.............  $25,000/$75,000...  $53,907/$161,721..  $54,789/$164,367..  $55,907/$167,722..  $57,317/$171,952
42 U.S.C. 11045(b)(3)...........  EPCRA.............  $25,000/$75,000...  $53,907/$161,721..  $54,789/$164,367..  $55,907/$167,722..  $57,317/$171,952
42 U.S.C. 11045(c)(1)...........  EPCRA.............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 11045(c)(2)...........  EPCRA.............  $10,000...........  $21,563...........  $21,916...........  $22,363...........  $22,927
42 U.S.C.11045(d)(1)............  EPCRA.............  $25,000...........  $53,907...........  $54,789...........  $55,907...........  $57,317
42 U.S.C. 14304(a)(1)...........  Mercury-Containing  $10,000...........  $15,025...........  $15,271...........  $15,583...........  $15,976
                                   and Rechargeable
                                   Battery
                                   Management Act
                                   (Battery Act).
42 U.S.C. 14304(g)..............  Battery Act.......  $10,000...........  $15,025...........  $15,271...........  $15,583...........  $15,976
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Note that 7 U.S.C. 136l.(a)(2) contains three separate statutory maximum civil penalty provisions. The first mention of $1,000 and the $500
  statutory maximum civil penalty amount were originally enacted in 1978 (Pub. L. 95-396), and the second mention of $1,000 was enacted in 1972 (Pub. L.
  92-516).

[FR Doc. 2019-00785 Filed 2-5-19; 8:45 am]
 BILLING CODE 6560-50-P