Use of Pharmacokinetic Data to Refine Carbaryl Risk Estimates from Oral and Dermal Exposure Presented To The FIFRA Scientific Advisory Panel By: U. S. EPA Office Of Pesticide Programs Health Effects Division Presented On: December 2, 2004 Office of Prevention, Pesticides & Toxic Substances U. S. Environmental Protection Agency Washington, D. C. 20460 Table of Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 1 of 16 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 2 of 16 2. Use of Pharmacokinetic Data to Refine Carbaryl Exposure Estimates from Oral and Dermal Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3 of 16 2.1 Summary of Carbaryl Metabolism . . . . . . . . . . . . . . . . . . . . . Page 3 of 16 2.2. Analysis of Bayer Mixed dose Pharmacokinetic Studies in Rats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 of 16 2.3 Calculating Plateau Brain Concentrations After Divided Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 6 of 16 2.4. Extrapolation of Results From Mixed dose Study to Biomonitoring Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 9 of 16 3. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 10 of 16 Supporting Tables & Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11 of 16 Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 16 of 16 List of Figures Figure 1. Chemical structure of carbaryl . . . . . . . . . . . . . . . . . . . . . . . . . . Page 2 of 16 Figure 2. Extrapolated Plateau Brain Concentration . . . . . . . . . . . . . . . . . Page 8 of 16 Figure 3. Results of Agency Exposure Assessments . . . . . . . . . . . . . . . Page 10 of 16 Figure 4. Average Total Radioactive Residue ( ppm) From Mixed Dose Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 14 of 16 List of Tables Table 1. Average Total Radioactive Residue ( ppm) . . . . . . . . . . . . . . . . Page 11 of 16 Table 2. Average Total Radioactive Residue ( ppm) . . . . . . . . . . . . . . . . Page 11 of 16 Table 3. Average Total Radioactive Residue ( ppm) . . . . . . . . . . . . . . . . Page 12 of 16 Table 4. Half life of Total Radioactive Residue . . . . . . . . . . . . . . . . . . . . Page 13 of 16 Table 5. Average Total Radioactive Residue ( ppm) From Mixed Dose Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 14 of 16 Table 6. Total Radioactive Residue ( TRR) and Metabolites Identified in Brain after Mixed Dose Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 15 of 16 Page 1 of 18 Preface The Food Quality Protection Act of 1996 requires EPA to reassess all previously approved pesticide tolerances by August, 2006. EPA issued the Interim Reregistration Eligibility Decision on June 30, 2003. That assessment is available at http:// www. epa. gov/ oppsrrd1/ REDs/ carbaryl_ ired. pdf. On October 27, 2004, EPA published a Federal Register Notice ( OPP 2003 0376). This Federal Register Notice indicated that Bayer CropScience, a registrant for technical carbaryl, had developed pharmacokinetic studies in rats to further evaluate the risk to children exposed to carbaryl following lawn treatment with liquid formulation. On December 2, 2004, the FIFRA Scientific Advisory Panel will hold a one day meeting to consider the pharmacokinetic studies and extrapolation approach proposed by Bayer CropScience. This approach may provide a more refined method to estimating risk by the use of internal doses to calculate peak target tissue concentrations associated with the use of carbaryl, instead of administered dose, as typically used by EPA. The purpose of the current document is to briefly summarize background information regarding the metabolic profile for carbaryl, the animal pharmacokinetic studies, and the proposed extrapolation approach. More detailed information can be found in the documents developed by Bayer CropScience which are provided to the panel as appendices. Page 2 of 18 1. Introduction Carbaryl is an N methylcarbamate insecticide with many agricultural and residential uses, which include uses on lawns, gardens, and ornamental plants. The primary mode of toxic action for carbaryl is inhibition of acetylcholinesterase through carbamylation of the enzyme active site. This inhibition leads to accumulation of acetylcholine and results in cholinergic toxicity due to continuous stimulation of cholinergic receptors. The binding of carbaryl to acetylcholinesterase is rapidly reversible. Figure 1. Chemical structure of carbaryl The exposure of key concern is for young children who play on turf treated with carbaryl which can lead to oral and dermal exposures because of mouthing behaviors and physical contact with treated turf.

The endpoint for short term incidental oral exposure was decreased cholinesterase activity ( erythrocyte, whole blood, plasma, brain) and functional observational changes in a developmental neurotoxicity study in rats; the no observedadverse effect level ( NOAEL) was 1 mg/ kg/ day and the lowest observed adverseeffect level was 10 mg/ kg/ day. For short term dermal exposure, the endpoint was decreased cholinesterase activity ( erythrocyte and brain) in a 4 week dermal toxicity study in rats; the NOAEL was 20 mg/ kg/ day and the LOAEL was 50 mg/ kg/ day. The NOAELs from these two studies provide the ' low' dose in the carbaryl pharmacokinetic studies summarized below.

The Agency typically assesses human risks to pesticides by comparing the noobserved adverse effect level ( NOAEL) in lab animals to human exposures and calculating a margin of exposure ( MOE): MOE = NOAEL/ Dose.

The Bayer approach compares internal peak or plateau doses in the target tissue, brain, rather than the total absorbed dose. Because of the pharmacokinetic and pharmacodynamic characteristics of carbaryl, peak tissue concentrations of carbaryl resulting from oral exposure do not overlap the peak concentrations from dermal exposure. Also, peak or plateau tissue concentrations resulting from repeated oral exposure that reflect childrens' behavior should be lower than peak concentrations from a single bolus administration used in the laboratory studies. Page 3 of 18 In the Bayer proposal, a margin of exposure would be calculated by comparing peak brain concentrations of carbaryl determined after dosing rats in two studies. In one study, rats received an oral dose equivalent to the oral NOAEL. In the other study, rats received concurrent dermal and oral exposure at doses similar to those expected in a residential setting. In the mixed dose study, rats received two oral bolus doses rather than twenty doses per hour assumed in children from residential exposure and the Bayer proposal included pharmacokinetic calculations extrapolating brain concentrations expected from twenty doses.

2. Use of Pharmacokinetic Data to Refine Carbaryl Exposure Estimates from Oral and Dermal Exposure This document cites 2 recent Bayer metabolism studies, which for convenience, shall be referred to as:

Bayer metabolism study: Metabolism of [ 14C] Carbaryl in Rats. Krolski, et al. Bayer CropScience. May 7, 2004. 230 pages. ( Appendix 2)

Bayer mixed dose study: Metabolism and Pharmacokinetics of [ 14C] Carbaryl in Rats Following Mixed Oral and Dermal Exposure. Krolski, et al. Bayer CropScience. May 7, 2004. 53 pages. ( Appendix 3)

2.1 Summary of Carbaryl Metabolism The Bayer proposal to calculate a margin of exposure using peak target tissue concentrations is based upon these pharmacokinetic and pharmacodynamic characteristics: 1) oral absorption of carbaryl is rapid and complete; 2) dermal absorption is prolonged in comparison to oral absorption; 3) duration of binding to acetylcholinesterase is brief; 4) plasma half life of carbaryl is short; and 5) metabolites are generally less toxic than parent carbaryl. Because of these characteristics, peak tissue concentrations of carbaryl resulting from oral exposure do not overlap peak concentrations from concurrent dermal exposure. Also, peak or plateau tissue concentrations resulting from repeated oral exposure should be lower than peak concentrations from a single bolus administration.

There are a number of studies characterizing rat and human metabolism of carbaryl. Although these studies were conducted for different time periods and used different analytical techniques, they showed that carbaryl metabolism is similar between rats and humans. Bayer's analysis focused on the alpha phase of kinetics, which is the first phase of the dose response curve, because this is the time period of concern for children on treated lawns.

Oral absorption of carbaryl is rapid and essentially complete. The near complete absorption of carbaryl by the oral route is shown by comparing tissue concentrations after oral and intravenous ( i. v.) exposure ( Bayer metabolism Page 4 of 18 study, Appendix 2). Tissue concentrations in the oral group of 1.08 mg/ kg were very comparable to those in an i. v. group of 0.80 mg/ kg at the same time periods ( Tables 1 and 2). The near complete absorption of carbaryl by the oral route is also shown by comparing excretion after administration by oral and i. v. routes. In a study in which rats received a single dose of 1 mg/ kg/ day by either oral or intravenous routes, both groups had 88 92% excretion of administered dose in urine and ~ 9% in feces ( Struble).

Oral absorption of carbaryl occurs rapidly. Peak radioactivity in brain, plasma, whole blood, and red blood cells was reached by the first sampling period 15 minutes after rats received an oral dose of 1.08 mg/ kg ( Table 2).

Dermal absorption is both a slower process and less complete than oral absorption. For dermal exposure, peak radioactivity in the same tissues was not reached until 4 hours after a dose of 17.25 mg/ kg. Peak tissue levels after a dermal dose of 17.25 mg/ kg were approximately an order of magnitude less than peak tissue levels after an oral dose 1.08 mg/ kg ( Tables 2 and 3 in Appendix). The dermal absorption values from a guideline study were 5% for 2 hr exposure, 13% for 10 hr exposure, and 25% for 24 hr exposure ( Cheng).

The duration of binding of carbaryl to cholinesterase is brief. Although the half life of cholinesterase inhibition in rats was reported as 3.0 hours in the Bayer proposal, more recent calculations show the half life is 1.7 hours ( Brooks and Broxup). The half life for cholinesterase inhibition in humans is 2.6 hours ( May).

The elimination half life of carbaryl is also short. The plasma half life in humans after oral ingestion of 1.0 mg/ kg carbaryl is 0.79 hours ( May). The plasma half life in rats for radioactivity in the alpha phase in the 2 recent Bayer metabolism studies varied somewhat depending on dose and route of exposure, but the plasma half life after oral ingestion of 1.0 mg/ kg carbaryl was 1.2 hours ( Table 4 in Appendix). The half life tended to decrease with decreasing dose.

Urine is the major route of excretion in rats and humans. Chromatograms of urine from rat and human studies were compared by one author ( Knaak, 1965 and 1968) and with the exception of one metabolite, had the same peaks. 1 Naphthol is a major urinary metabolite in both rats and humans, accounting for approximately 40% of administered dose in rats and humans ( Totis and Knaak, 1968).

Principal urinary metabolites identified in the guideline rat studies are free and conjugated naphthol and hydroxy carbaryl metabolites. Carbaryl metabolites are also excreted in bile and undergo extensive enterohepatic recirculation. Bile cannulated rats had 45% excretion in bile, 42% excretion in urine, and 1% in feces after oral administration of carbaryl ( Marshall). Page 5 of 18 A biomonitoring study was conducted by Bayer to quantify exposure after application of carbaryl to residential lawns and gardens. Twenty four hour composite urine samples were collected from each resident beginning 2 days prior to application and ending 3 days after application. A carbaryl metabolite ( 1 naphthol) was used to calculate absorbed dose estimates for carbaryl. Carbaryl absorbed dose estimates were calculated from 1 naphthol levels using factors determined in an analysis of rat and human pharmacokinetic data. Many individuals potentially experienced multiple exposures as they re entered lawns where carbaryl had been applied. The excretion profile indicated that it took approximately 96 hours for elimination and that approximately 50 percent was eliminated in the first 24 hours, which made calculation of absorbed dose estimates difficult because of the potential for multiple exposures ( Carbaryl Revised HED Risk Assessment, March 14, 2003).

The following metabolites were identified in tissues in the recent metabolism studies performed by Bayer. Carbaryl per se was identified in brain, fat, liver; 1 naphthol was identified in brain, fat, liver, blood, plasma, RBC; the sulfate conjugate of 1 naphthol was identified in plasma; N hydroxymethyl carbaryl was identified in brain. Low concentrations of carbaryl per se were found briefly in plasma after i. v. exposure, but carbaryl per se was not detected in plasma following oral or dermal exposure.

The Bayer proposal described carbaryl metabolism:

" When we look at the metabolic profile at " low" dosages, ( more comparable to those experienced by humans), the predominant pathway is hydrolysis of the carbamate linkage, although there is a small and insignificant amount of oxidative metabolism on the ring while the carbamate linkage is intact. When we look at the metabolic profile at " low" dosages, ( more comparable to those experienced by humans), the primary pathway is overwhelmingly hydrolytic. For example, at both the LOAEL and NOAEL in the rat ( 10 and 1 mg/ kg, respectively), the primary metabolite seen at peak plasma concentration of total radiocarbon is 1 naphthol. The other carbaryl metabolites retaining the carbamate linkage ( 3 and 4 hydroxy carbaryl) represent a total of less than 1 % of the TRR in any tissue ( Krolski et al., 2004a) and are also poorer cholinesterase inhibitors than carbaryl ( Kuhr, 1971). Additionally, hydroxylated metabolites exist almost exclusively as their secondary metabolites ( i. e., glucuronide and sulfate conjugates) that are much more water soluble and even less likely to interact with cholinesterase because of this water solubility and increased molecular bulk."

See Appendix 5, Proposed Metabolic Pathway in Rats ( Struble) Page 6 of 18 Page 7 of 18 2.2. Analysis of Bayer Mixed dose Pharmacokinetic Studies in Rats The Bayer pharmacokinetic proposal is based primarily upon a pharmacokinetic study in rats, referred to as the Bayer mixed dose study ( Metabolism and Pharmacokinetics of [ 14C] Carbaryl in Rats Following Mixed Oral and Dermal Exposure, Krolski, 2004, 53 pages  Appendix 3).

Doses in the Bayer mixed dose study were selected to mimic exposure estimated for children playing on lawns treated with carbaryl. Children's exposure can include dermal exposure and oral exposure from mouthing behaviors. In the mixed dose study, rats received concurrent dermal and oral exposure: rats were treated dermally for 2 hours with 0.871 mg/ kg and received two oral doses of 0.0841 mg/ kg at a 1 hour interval. Sacrifices were made 15 minutes, 30 minutes, 1 hour, 3 hours, and 5 hours following the second oral dose. Total radioactive residues were determined for whole blood, plasma, red blood cells, and brain. Metabolites were identified in plasma or brain when sufficient residue was present.

Total radioactive residue ( TRR) in all tissues had peaked at the first sampling period, 15 minutes after the second oral dose ( Table 5 and Figure 5 in Appendix). TRR in brain was 0.0206 ppm, of which 22% was carbaryl per se, 12% was 1 naphthol, and 12% was 1 naphthol sulfate ( Table 6). By 5 hours, TRR had declined to 0.0043 ppm, of which 15% was carbaryl per se, 6% was 1 naphthol, and 19% was 1 naphthol sulfate. There was a slight increase in radioactivity in whole blood at the 1 hour sampling period, possibly due to dermal absorption.

2.3 Calculating Plateau Brain Concentrations After Divided Doses Assumed oral exposure for a toddler is 20 exposures per hour for 2 hours, based on EPA's SOPs ( Agency's SOPs For Residential Exposure Assessment). However, the dosing regimen used in the mixed dose rat study was 2 oral doses given 1 hour apart. Because of carbaryl's short half life, the 2 oral bolus doses resulted in much higher peak brain concentrations than would be expected to occur from 40 divided doses. Bayer therefore calculated the plateau brain concentrations which would result from 40 divided doses over a 2 hour period.

Each individual dose would be 0.00375 mg/ kg ( 0.15/ 40). The brain concentration at this dose was extrapolated, rather than determined in an experiment. Bayer's explanation for this regimen was:

" A single oral dose at 0.00375 mg/ kg would yield brain concentrations several fold less than the lowest detection limit. Attempting to orally dose a rat 20 times per hour is extremely traumatic to the animal ( which would affect the results and not be allowed by the American Association for Accreditation of Laboratory Animal Care), and would have required Page 8 of 18 several people to dose four rats at this frequency resulting in additional experimental ( interperson) uncertainty." Page 9 of 18 Bayer extrapolated the carbaryl concentration in brain from a dose of 0.00375 mg/ kg using brain concentrations obtained following doses of 0.084 mg/ kg, 1 mg/ kg, and 10 mg/ kg in the two Bayer studies. The extrapolated plateau brain concentration following a single dose of 0.00375 mg/ kg was 0.000091 ppm ( pages 15 and 16, Bayer proposal).

The half life of carbaryl in brain from the mixed dose study was estimated to be 15 minutes because carbaryl concentration declined from 0.0045 ppm to 0.0023 ppm between the 15 minute and 30 minute sampling periods and 0.0023/ 0.0045 = 51% ( Table 6). The half life of total radioactive residues ( TRR) in brain from the mixed dose study was estimated to be 19 minutes because TRR declined from 0.0206 ppm to 0.0129 ppm between the 15 minute and 30 minute sampling periods ( Table 5). Bayer reported: " The 30 minute concentration is 62.7% of the 15 minute concentration. The ratio of 62.7% to 50% is 1.25, which adjusts the 15 minute period to 19 minutes or 0.33 hours" ( email, 10/ 12/ 04). Bayer reported that there was not a significant difference between 15 minute and 19 minute values, and the half life of 19 minutes was used to estimate the plateau value.

Bayer next estimated the plateau brain concentration resulting from 40 oral exposures of 0.00375 mg/ kg to be 0.0011 ppm using the following equation and explanation excerpted from page 19 of the Bayer proposal. Calculations are shown on the attached spread sheet ( Appendix4) ( MOE_ Derivation_ HtM_ EPAScenario_ 10Jun04. xls).

C p = ( C d_ event1 x F) + ( C d_ event2 thru n) x F)

where C p = carbaryl concentration ( mg/ mL or ppm) in the brain at plateau or peak;

C d_ event1 thru n = concentration ( mg/ mL or ppm) in the brain ( 0.000091 ppm) at each incremental time step ( min), where an oral dose of 0.00375 mg/ kg occurs at a frequency of 20 events per hour or once every 3 minutes ( 0.00375 mg/ kg = 0.15 mg/ kg/ day / 40 events per day);

F = fraction of brain level eliminated at each time step ( 0.025 per min based on 0.5 in 0.33 hrs [ the measured carbaryl half life ( hrs) in brain at 10 mg/ kg following oral dosing was 0.30 hours and the estimated carbaryl half life following first oral dose of 0.084 mg/ kg and concurrent dermal dose of 0.871 mg/ kg was 0.33 hours]). Page 10 of 18 Carbaryl Plateau Brain Level ( ppm) Following Discrete HtM Oral Doses of 0.00375 mg/ kg ( 9.1E 5 ppm in brain) Every 3 Min for 2 Hrs ( Carbaryl brain half life = 0.33 hrs)

0.00E+ 00 1.00E 04 2.00E 04 3.00E 04 4.00E 04 5.00E 04 6.00E 04 7.00E 04 8.00E 04 9.00E 04 1.00E 03 1.10E 03 1.20E 03 1.30E 03 0 10 20 30 40 50 60 70 80 90 100 110 120 Time ( min) Carbaryl Brain Level ( ppm) Figure 2 shows that the extrapolated plateau brain concentration is reached after approximately 90 minutes. After that time, repeated exposures do not result in appreciable increases in brain concentration of carbaryl.

Figure 2. Extrapolated Plateau Brain Concentration Adapted from Figure 3, page 19, Bayer proposal. Page 11 of 18 2.4. Extrapolation of Results From Mixed dose Study to Biomonitoring Study A second component of Bayer's proposal is to extrapolate peak internal doses from the mixed dose study in rats to absorbed doses in the biomonitoring study. In the biomonitoring study ( described above in Summary of carbaryl metabolism), total carbaryl absorbed dose was estimated after application of carbaryl in a residential setting. This absorbed dose in the biomonitoring study was estimated using urine concentrations of 1 naphthol in humans which were converted to absorbed carbaryl equivalents. The 1 naphthol to carbaryl conversion factor of 3.5 was determined from an analysis of human and rat pharmacokinetic data ( Carbaryl Revised HED Risk Assessment, March 14, 2003). The urine samples were 24 hour composite samples collected on the day of application and each day for 3 days after application. Following carbaryl human exposure, carbaryl is rapidly metabolized and 1 Naphthol is excreted over a 96 hour period. EPA's risk assessment estimated exposure using two different approaches:

Assuming total carbaryl dose values summed over a 96 hour period equals one daily dose

Assuming total carbaryl dose values summed for a 24 hour period equals one daily dose Bayer compared margins of exposure ( MOEs) calculated in the manner in which EPA traditionally assesses exposure to the method in Section 2.3, above. In the carbaryl risk assessment, EPA determined an MOE of 4 by dividing the NOAEL for incidental oral exposure ( 1 mg/ kg/ day from the rat developmental neurotoxicity study) to the expected toddler exposure ( 0.25 mg/ kg/ day) determined from EPA's SOPs For Residential Exposure Assessment.

Bayer reported an MOE of 70 by dividing the peak brain concentration ( 0.077 ppm) in rats dosed at the oral NOAEL by extrapolated plateau brain concentrations ( 0.0011 ppm) for repeated oral doses.

Because estimated plateau brain concentrations may more closely reflect concentrations at the target tissue, Bayer proposed extrapolating results from the rat mixed dose study to the biomonitoring study using an adjustment factor. Because 70 divided by 4 equals 17.5, or is approximately 20, Bayer proposed multiplying results in the biomonitoring study by this adjustment factor. Page 12 of 18 Carbaryl Residential Exposure for Children 3 5 from Households using Lawn Treatments ( Exposure Duration: days 0 3)

0.0001 0.001 0.01 0.1 1 10 100 0 10 20 30 40 50 60 70 80 90 100 Percentile of Population Exposure ( mg/ kg/ day) EPA Estimate from biomonitoring data Exp= 0.42 mg/ kg/ day Bayer Estimate from biomonitoring data Exp= 0.09 mg/ kg/ day EPA SOP Exp= 2 to 4 mg/ kg/ day 3. Summary Bayer has proposed, that because of carbaryl's pharmacokinetic and pharmacodynamic characteristics, peak or plateau concentrations of carbaryl in brain are a more accurate indicator of risk than is total absorbed dose. These characteristics include rapid oral absorption, prolonged dermal absorption, brief inhibition of acetylcholinesterase, and short half life in the body.

The Agency has completed three exposure assessments for carbaryl. One assessment is a deterministic assessment based upon the Standard Operating Procedures For Residential Exposure Assessment. The other two exposure assessments included a probabilistic model, CARES ( Cumulative And Aggregate Risk Evaluation System), which calculated distributions of exposures, and the biological monitoring study described above in Section 3.1. All three assessments gave similar results ( See Figure 3). The Agency has based its current regulatory position upon the results of the deterministic assessment and has used the biological monitoring data and the probabilistic assessment results to characterize exposure and risks associated with carbaryl lawn use.

The three exposure assessments described above all gave similar results, but only evaluated total exposure and did not consider peak exposure in the target tissue. At issue in this SAP meeting is whether an estimate of peak exposure in target tissue is appropriate to assess carbaryl exposure and if these results can modify results from traditional exposure assessments.

Figure 3. Results of Agency Exposure Assessments Page 13 of 18 Supporting Tables & Figures Following are tables and figures from the Bayer metabolism study and the Bayer mixeddose study.

Table 1. Average Total Radioactive Residue ( ppm). Intravenous dose = 0.80 mg/ kg/ day Time ( hr) Whole Blood Plasma RBC Brain 0.083 = 5min 1.2536 2.1310 1.0551 0.7360 0.167 = 10 min 1.1079 1.8310 0.9059 0.4137 0.333 = 20 min 0.9025 1.6940 0.6676 0.2299 0.5 0.7890 1.4345 0.4935 0.1431 1 0.5016 0.8508 0.2959 0.0562 2 0.3253 0.5798 0.1509 0.0251 4 0.1253 0.2080 0.0974 0.0130 8 0.064 0.1061 0.0488 0.0094 Table 2. Average Total Radioactive Residue ( ppm). Oral dose = 1.08 mg/ kg Time ( hr) Whole Blood Plasma RBC Brain 0.25 = 15 min 0.9004 1.4414 0.4427 0.1253 0.5 = 30 min 0.7270 1.1922 0.3191 0.0613 1 0.5741 0.810 0.1828 0.0339 2 0.4079 0.5406 0.1016 0.0282 4 0.2875 0.4046 0.1146 0.0202 6 0.1517 0.1921 0.0659 0.0145 12 0.0471 0.0559 0.0220 0.0052 24 0.0180 0.0140 0.0073 0.0030 Page 14 of 18 Table 3. Average Total Radioactive Residue ( ppm). Dermal dose = 17.25 mg/ kg Time ( hr) Whole Blood Plasma RBC Brain 0.25 = 15 min 0.0092 0.0090 0.0006 0.0051 0.5 = 30 min 0.0181 0.0287 0.0059 0.0068 1 0.0104 0.0119 0.0018 0.0020 2 0.0490 0.0968 0.0263 0.0089 4 0.0690 0.1467 0.0441 0.0111 6 0.0484 0.1020 0.0203 0.0052 12 0.0252 0.0441 0.0072 0.0046 24 0.0178 0.0239 0.0070 0.0034 Tables 1 3 above, were adapted from Tables 6, 2, and 4 respectively of Bayer metabolism study. Page 15 of 18 Table 4. Half life of Total Radioactive Residue Tissue ( Route) 10 mg/ kg 1 mg/ kg 0.084 mg/ kg Plasma ( Oral) 1.5 1.2 Plasma ( IV) 1.8 ( 0.40) a 1.2 Plasma ( Mixed) b 0.50 RBC ( Oral) 1.2 0.75 RBC ( IV) 1.0 0.6 RBC ( Mixed) b 0.80 Brain ( Oral) 0.8 ( 0.30) a 0.35 Brain ( IV) 0.6 ( 0.45) a 0.25 Brain ( Mixed) b 0.33 aHalf life of actual carbaryl residues in the alpha phase bIn " mixed dose study", samples taken following the second oral dose from a study where rats received two oral doses of 0.084 mg/ kg, one hour apart ( at time 0 and 1 hr), and a dermal dose of 0.871 mg/ kg at time 0, which remained on the rats skin for 2 hours.

NOTE: Bayer reported that:

" It was not possible to estimate half life for carbaryl itself in the alpha phase following oral dosing at 1 and 10 mg/ kg because it dissipated so rapidly, and levels beyond the peak could not be reliably quantified using the standard flow cell radiometric detector. However, at 0.084 mg/ kg oral dose a different detection method was employed ( fraction collector), and it was possible to estimate half life."

Adapted from Table 3, page 12 of Bayer proposal. Page 16 of 18 Table 5. Average Total Radioactive Residue ( ppm) From Mixed Dose Studya. Concurrent oral and dermal dosing. Samples taken after 2nd oral dose Time ( hr) Whole Blood Plasma RBC Brain 0.25 0.1633 0.2905 0.0664 0.0206 0.5 0.1075 0.2031 0.0570 0.0129 1 0.1237 0.1899 0.0382 0.0099 3 0.0511 0.0904 0.0161 0.0034 5 0.0359 0.0648 0.0127 0.0043 a In " mixed dose study", samples taken following the second oral dose from a study where rats received two oral doses of 0.084 mg/ kg, one hour apart ( at time 0 and 1 hr), and a dermal dose of 0.871 mg/ kg at time 0, which remained on the rats skin for 2 hours.

From Table 1, p 26 of mixed dose study Figure 4. Average Total Radioactive Residue ( ppm) From Mixed Dose Studya aIn " mixed dose study", samples taken following the second oral dose from a study where rats received two oral doses of 0.084 mg/ kg, one hour apart ( at time 0 and 1 hr), and a dermal dose of 0.871 mg/ kg at time 0, which remained on the rats skin for 2 hours.

From Figure 7, p 26 of mixed dose study Page 17 of 18 Table 6. Total Radioactive Residue ( TRR) and Metabolites Identified in Brain after Mixed Dose Study Time TRR ( ppm) 1 Naphthol Sulfate 1 Naphthol Carbaryl % TRR TRR ( ppm) % TRR TRR ( ppm) % TRR TRR ( ppm)

15 min 0.0206 12 0.0025 12 0.0025 22 0.0045 30 min 0.0129 18 0.0023 6 0.00077 18 0.0023 1 h 0.0099 23 0.0023 5 0.00050 15 0.0015 3 h 0.0034 28 0.00095 4 0.00014 13 0.00044 5 h 0.0043 19 0.00082 6 0.00026 15 0.00064 Adapted from Table 2, p 17of mixed dose study Page 18 of 18 Appendices Appendix 1 E file name: Bayer proposal. pdf Application of carbaryl pharmacokinetic data in the estimation of potential postapplication health risks associated with broadcast lawn care products. Ross, J; Driver, J; Lunchik, C. Bayer CropScience. September 8, 2004. 40 pages.

Appendix 2 E file name: Bayer metabolism study. pdf Metabolism of [ 14C] Carbaryl in Rats. Krolski, et al. Bayer CropScience. May 7, 2004. 230 pages.

Appendix 3 E file name: Bayer mixed dose study. pdf Metabolism and Pharmacokinetics of [ 14C] Carbaryl in Rats Following Mixed Oral and Dermal Exposure. Krolski, et al. Bayer CropScience. May 7, 2004. 53 pages.

Appendix 4 E file name: MOE_ Derivation_ HtM_ EPAScenario_ 10Jun04. xls Spreadsheet for calculation of plateau brain concentrations, Bayer CropScience.

Appendix 5 E file name: Proposed Path in Rats. pdf Proposed Path in Rats


[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Rules and Regulations]
[Pages 13213-13221]
[FR Doc No: 2013-04430]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 40

[Docket No. RM12-12-000; Order No. 775]

Regional Reliability Standard PRC-006-NPCC-1--Automatic
Underfrequency Load Shedding

AGENCY: Federal Energy Regulatory Commission.

ACTION: Final rule.

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SUMMARY: Under section 215 of the Federal Power Act (FPA), the Federal
Energy Regulatory Commission (Commission) approves regional Reliability
Standard PRC-006-NPCC-1 (Automatic Underfrequency Load Shedding),
submitted to the Commission for approval by the North American Electric
Reliability Corporation (NERC). Regional Reliability Standard PRC-006-
NPCC-1 applies to generator owners, planning coordinators, distribution
providers, and transmission owners in the Northeast Power Coordinating
Council

Region. Regional Reliability Standard PRC-006-NPCC-1 is designed to
ensure the development of an effective automatic underfrequency load
shedding (UFLS) program to preserve the security and integrity of the
Bulk-Power System during declining system frequency events, in
coordination with the NERC continent-wide UFLS Reliability Standard
PRC-006-1. The Commission approves the related violation risk factors,
violation severity levels, implementation plan, and effective dates
proposed by NERC.

DATES: Effective Date: This rule will become effective April 29, 2013.

FOR FURTHER INFORMATION CONTACT:
Enakpodia Agbedia (Technical Information), Office of Electric
Reliability, Division of Reliability Standards, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
Telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
Matthew Vlissides (Legal Information), Office of the General Counsel,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, Telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Before Commissioners: Jon Wellinghoff, Chairman; Philip D. Moeller,
John R. Norris, Cheryl A. LaFleur, and Tony T. Clark.

Final Rule

Issued February 21, 2013

    1. Under section 215 of the Federal Power Act (FPA),\1\ the
Commission approves regional Reliability Standard PRC-006-NPCC-1
(Automatic Underfrequency Load Shedding). The Commission also approves
the related violation risk factors (VRFs), violation severity levels
(VSLs), implementation plan, and effective dates proposed by the North
American Electric Reliability Corporation (NERC). NERC submitted
regional Reliability Standard PRC-006-NPCC-1 to the Commission for
approval. The regional Reliability Standard applies to generator
owners, planning coordinators, distribution providers, and transmission
owners in the Northeast Power Coordinating Council (NPCC) Region and is
designed to ensure the development of an effective automatic
underfrequency load shedding (UFLS) program to preserve the security
and integrity of the Bulk-Power System during declining system
frequency events, in coordination with NERC's continent-wide UFLS
Reliability Standard PRC-006-1.
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    \1\ 16 U.S.C. 824o (2006).
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I. Background

A. Mandatory Reliability Standards

    2. Section 215 of the FPA requires a Commission-certified Electric
Reliability Organization (ERO) to develop mandatory and enforceable
Reliability Standards that are subject to Commission review and
approval. Once approved, the Reliability Standards may be enforced by
NERC (the Commission-certified ERO), subject to Commission oversight,
or by the Commission independently.\2\
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    \2\ 16 U.S.C. 824o(e) (2006).
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    3. A Regional Entity may develop a Reliability Standard for
Commission approval to be effective in that region only.\3\ In Order
No. 672, the Commission stated that:
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    \3\ 16 U.S.C. 824o(e)(4). A Regional Entity is an entity
approved by the Commission to enforce Reliability Standards under
delegated authority from the ERO. See 16 U.S.C. 824o(a)(7) and
(e)(4).

As a general matter, we will accept the following two types of
regional differences, provided they are otherwise just, reasonable,
not unduly discriminatory or preferential and in the public
interest, as required under the statute: (1) a regional difference
that is more stringent than the continent-wide Reliability Standard,
including a regional difference that addresses matters that the
continent-wide Reliability Standard does not; and (2) a regional
Reliability Standard that is necessitated by a physical difference
in the Bulk-Power System.\4\
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    \4\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, at P 291 (2006), order on reh'g, Order No.
672-A, FERC Stats. & Regs. ] 31,212 (2006).

    4. On April 19, 2007, the Commission accepted delegation agreements
between NERC and each of the eight Regional Entities.\5\ In the order,
the Commission accepted NPCC as a Regional Entity.
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    \5\ North American Electric Reliability Corp., 119 FERC ] 61,060
(2007), order on reh'g, 120 FERC ] 61,260 (2007).
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    5. NERC's Commission-approved and currently-effective Reliability
Standard PRC-006-1 establishes continent-wide design and documentation
requirements for UFLS programs that arrest declining frequency and
assist recovery of frequency following system events leading to
frequency degradation.

B. NERC Petition

    6. On May 4, 2012, NERC petitioned the Commission to approve
regional Reliability Standard PRC-006-NPCC-1 and the related violation
risk factors, violation severity levels, effective dates, and
implementation plan.\6\ On August 3, 2012, NERC filed an errata
regarding the proposed implementation plan. NERC stated that regional
Reliability Standard PRC-006-NPCC-1 is based on the program
characteristics defined within NPCC Directory 12
Underfrequency Load Shedding Program Requirements (NPCC Directory
12), which contains the criteria that govern the NPCC
Automatic UFLS program that have been in place since June 26, 2009.\7\
According to NERC, regional Reliability Standard PRC-006-NPCC-1 will
achieve a coordinated, comprehensive UFLS region-wide consistent
program within the NPCC Region and provides the regional requirements
necessary to achieve and facilitate the broader program characteristics
contained in the requirements of the NERC Reliability Standard PRC-006-
1.\8\ NERC stated that the regional Reliability Standard adds
specificity not contained in NERC Reliability Standard PRC-006-1 and is
designed to work in conjunction with and augment Reliability Standard
PRC-006-1 by mitigating the consequences of an underfrequency event,
while accommodating differences in system transmission and distribution
topology among NPCC planning coordinators due to historical design
criteria, makeup of load demands, and generation resources.\9\ NERC
further stated that regional Reliability Standard PRC-006-NPCC-1
facilitates uniformity and compliance, and clearly delineates what the
applicable entities' requirements are within the NPCC Region to achieve
a robust, reliable and effective UFLS program.\10\
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    \6\ Regional Reliability Standard PRC-006-NPCC-1 is available on
the Commission's eLibrary document retrieval system in Docket No.
RM12-12-000 and on the NERC Web site, www.nerc.com.
    \7\ NERC Petition at 11.
    \8\ Id. at 29-30.
    \9\ Id.
    \10\ Id. at 30.
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    7. In the petition, NERC proposed violation risk factors and
violation severity levels for each requirement of the regional
Reliability Standard, an implementation plan, and effective dates. NERC
stated that these proposals were developed and reviewed for consistency
with NERC and Commission guidelines. NERC proposed two effective dates
for the regional Reliability Standard. NERC stated that Requirements R1
through R7 would become effective on the first day of the first
calendar quarter following applicable regulatory approval but no
earlier than January 1, 2016. For Requirements R8 through R23, NERC
stated that they will become effective the first day of the first
calendar quarter

two years following applicable regulatory approval.

C. Notice of Proposed Rulemaking

    8. On September 20, 2012, the Commission issued a Notice of
Proposed Rulemaking (NOPR) proposing to approve regional Reliability
Standard PRC-006-NPCC-1 as just, reasonable, not unduly discriminatory
or preferential, and in the public interest.\11\ The Commission
proposed to approve regional Reliability Standard PRC-006-NPCC-1
because it is designed to operate in conjunction with the NERC
continent-wide UFLS Reliability Standard PRC-006-1 by mitigating the
consequences of underfrequency events, while accommodating differences
in system transmission and distribution topology among NPCC planning
coordinators due to historical design criteria, makeup of load demands,
and generation resources. The NOPR determined that the regional
Reliability Standard includes requirements that are not found in the
corresponding NERC Reliability Standard PRC-006-1 and that are more
stringent than Reliability Standard PRC-006-1.
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    \11\ Regional Reliability Standard PRC-006-NPCC-1--Automatic
Underfrequency Load Shedding, Notice of Proposed Rulemaking, 77 FR
59,151 (September 26, 2012), FERC Stats. & Regs. ] 32,691 (2012).
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    9. While proposing to approve regional Reliability Standard PRC-
006-NPCC-1, the NOPR sought comment on two issues: (1) The technical
basis for the 57.8 Hz maximum tripping limit for existing nuclear units
established in Requirement R19; and (2) the time-frame for actions that
result in changes to the NPCC UFLS program.
    10. In response to the NOPR, initial comments were filed by NERC,
NPCC, New York Independent System Operator (NYISO), PSEG Companies
(PSEG),\12\ and Dominion Resources Services, Inc. (Dominion).\13\ NERC
and NPCC filed reply comments.
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    \12\ PSEG is comprised of PSEG Power LLC and PSEG Energy
Resources & Trade LLC.
    \13\ Dominion filed comments on behalf of Virginia Electric and
Power Company, Dominion Energy Kewaunee, Inc., Dominion Nuclear
Connecticut, Inc., Dominion Energy Brayton Point, LLC, Dominion
Energy Manchester Street, Inc., Elwood Energy, LLC, Kincaid
Generation, LLC, and Fairless Energy, LLC.
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II. Discussion

    11. Pursuant to FPA section 215(d)(2), we approve regional
Reliability Standard PRC-006-NPCC-1 as just, reasonable, not unduly
discriminatory or preferential, and in the public interest. Regional
Reliability Standard PRC-006-NPCC-1 is designed to operate in
conjunction with the NERC continent-wide UFLS Reliability Standard PRC-
006-1 by mitigating the consequences of underfrequency events, while
accommodating differences in system transmission and distribution
topology among NPCC planning coordinators. Regional Reliability
Standard PRC-006-NPCC-1 includes requirements that are not found in the
corresponding NERC Reliability Standard PRC-006-1 and that are more
stringent than Reliability Standard PRC-006-1 while accommodating
differences in system transmission and distribution topology among NPCC
planning coordinators due to historical design criteria, makeup of load
demands, and generation resources.
    12. We address below the following issues raised in the NOPR and/or
comments: (A) Requirement R19--nuclear generating plants; (B) Time-
frame for completion of actions; (C) Compensatory load shedding
requirements; and (D) violation risk factors and violations severity
levels.

A. PRC-006-NPCC-1, Requirement R19

    13. In the NOPR, the Commission sought comments on the technical
basis for the 57.8 Hz maximum tripping limit for existing nuclear units
established in Requirement R19. The NOPR observed that Requirement R19
provides that:

R19 Each Generator Owner of existing nuclear generating plants with
units that have underfrequency relay threshold settings above the
Eastern Interconnection generator tripping curve in Figure 1, based on
their licensing design basis, shall: [Violation Risk Factor: High]
[Time Horizon: Long Term Planning]
    19.1 Set the underfrequency protection to operate at as low a
frequency as possible in accordance with the plant design licensing
limitations but not greater than 57.8 Hz.
    19.2 Set the frequency trip setting upper tolerance to no greater
than + 0.1 Hz.
    19.3 Transmit the initial frequency trip setting and any changes to
the setting and the technical basis for the settings to the Planning
Coordinator.

    14. The NOPR stated that the NERC petition did not explain the
technical basis for establishing 57.8 Hz as the maximum frequency at
which existing nuclear units may trip pursuant to Requirement R19.1,
other than to state that the regional Reliability Standard was based on
the work of an NPCC working group.\14\ The NOPR stated that the NERC
petition and its attachments did not provide any information as to how
the 57.8 Hz limit was developed. The NOPR sought comment from NPCC,
NERC, and other interested entities explaining the technical basis for
the 57.8 Hz limit established in Requirement R19.1.
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    \14\ NERC Petition at 11.
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Comments
    15. NPCC states that its UFLS program is designed to arrest
frequency decline at or above 58.0 Hz while incorporating the
performance characteristics of regional generation. In determining the
57.8 Hz limit for existing nuclear units within the NPCC Region, NPCC
states that it ``considered the minimum program frequency of 58.0 Hz,
the existing maximum trip settings of the nuclear units (gathered
through surveys) within NPCC's footprint, system response, and credible
islands as determined by the NPCC Planning Coordinators.'' \15\ NPCC
states that a maximum frequency threshold trip setting of 57.8 Hz for
existing nuclear units provides a ``margin of 0.2 Hz above the highest
frequency at which [the nuclear units in NPCC's footprint] are expected
to be tripped by low coolant flow or under frequency protection and
yields acceptable system performance with minimum changes required to
the nuclear units.'' \16\ NPCC adds that it considered 0.2 Hz to be a
conservative margin and was developed in consideration of the typical
relay drift tolerance of  0.1 Hz,\17\ which ensures the
units do not trip above 58.0 Hz. NPCC states that if existing nuclear
units adhere to the 57.8 Hz maximum tripping limit requirement,
``islands with a 25% generation deficiency are able to survive,
maintain automatic UFLS program requirements, and the program will
achieve satisfactory system performance.'' \18\
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    \15\ NPCC Initial Comments at 4.
    \16\ Id. at 5.
    \17\ NPCC states that a relay setting of 57.8 Hz with a typical
relay drift tolerance of  0.1 Hz would result in actual
trip bandwidth of between 57.9 Hz and 57.7 Hz.
    \18\ Id.
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    16. NERC states that it supports the comments submitted by NPCC
regarding the technical basis for the 57.8 Hz limit. NERC also states
that the requirements in regional Reliability Standard PRC-006-NPCC-1
are consistent with the continent-wide UFLS Reliability Standard PRC-
006-1.\19\
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    \19\ NYISO supports approval of regional Reliability Standard
PRC-006-NPCC-1 without modification. NYISO Comments at 2.

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Commission Determination
    17. The Commission finds that NPCC has provided an adequate
technical basis for the 57.8 Hz maximum frequency threshold trip
setting for existing nuclear units, as set forth in Requirement R19. As
explained by NPCC, a maximum frequency threshold trip setting of 57.8
Hz for existing nuclear units provides a margin of 0.2 Hz above the
highest frequency at which the nuclear units in NPCC's footprint are
expected to trip by low coolant flow or underfrequency protection.
Adherence to the 57.8 Hz limit should also result in islands with a 25%
generation deficiency being able to survive and maintain automatic UFLS
program requirements.

B. Time-Frame for Completion of Actions

    18. In the NOPR, the Commission sought comments on the time-frames
for actions that result in changes to the NPCC UFLS program. The NOPR
observed that NERC's Reliability Standard PRC-006-1, Requirement R3,
requires the planning coordinator to set the schedule for distribution
providers and transmission owners to implement the UFLS program and
that regional Reliability Standard PRC-006-NPCC-1, Requirements R5,
R16.2, and R19.3, require distribution providers, transmission owners,
and generator owners to provide, inform, and transmit exceptions to the
UFLS program and justifications for the exceptions to the planning
coordinator. The NOPR stated that these Requirements in regional
Reliability Standard PRC-006-NPCC-1 do not specify a time-frame for the
completion of these actions. The NOPR indicated that Requirements R5,
R16.2, and R19.3 address actions that can result in changes to the UFLS
program and should occur before the UFLS program is implemented, thus
making it necessary for entities to provide the required information to
the planning coordinator within a specified period of time. The NOPR
further observed that other Requirements in regional Reliability
Standard PRC-006-NPCC-1 require actions of distribution providers,
transmission owners, and generator owners that should occur before the
UFLS program is implemented and that those actions include specific
time-frames for completion.\20\ The NOPR sought comment on whether
Requirements R5, R16.2, and R19.3 should also specify time-frames for
completion of the required actions and, if so, the appropriate time-
frames for each.
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    \20\ See, e.g., Requirements R11, R14, and R23 of proposed
regional Reliability Standard PRC-006-NPCC-1.
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Comments
    19. NPCC states that Requirement R5 addresses a limited set of non-
conforming circumstances and places the burden on entities to
demonstrate that such non-conforming circumstances do not degrade the
overall performance of the UFLS program. NPCC states that the absence
of time-frames for completion of the required actions in Requirement R5
means that responsible entities are required to notify the NPCC
planning coordinator ``upon identification of any non-conformance with
Requirement R5.'' \21\ NPCC states that this is the current practice
with respect to applicable entities. NPCC states that providing a time-
frame would ``result in delays of the transmittal of critical
information to the Planning Coordinator which could potentially impact
UFLS system performance.'' \22\
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    \21\ NPCC Initial Comments at 7.
    \22\ Id.
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    20. NPCC states that Requirement R16 addresses an existing class of
non-nuclear units that ``trip above the threshold curve for setting
underfrequency trip protection for generators and which already provide
compensatory load shedding in accordance with existing procedures.''
\23\ NPCC states that ``Planning Coordinators within NPCC have
information for the class of existing units for R16, with
underfrequency protection set to trip above the curve in Figure 1, [and
thus] assigning time-frames is of no benefit to the program.'' \24\
NPCC states, however, that Requirement R16.2 also requires changes to
underfrequency settings, along with the technical basis for those
settings from generators in this class of units, to be transmitted to
the planning coordinator. NPCC maintains that ``[i]t is the expectation
that in the absence of a time-frame,'' in Requirement R16.2 those
entities, ``immediately upon identification of such a change,'' would
notify the Planning Coordinator.\25\
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    \23\ Id.
    \24\ Id. at 7-8.
    \25\ Id. at 8.
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    21. NPCC states that Requirement R19.3, similar to the requirements
regarding non-nuclear units in Requirement R16.2, requires responsible
entities to provide planning coordinators with the current operating
parameters of an existing class of nuclear units that trip above the
threshold curve for setting underfrequency trip protection for
generators units. NPCC further states that like Requirement R16.2,
Requirement 19.3 requires responsible entities to transmit changes to
the underfrequency settings to the planning coordinator. NPCC maintains
that, in the absence of time-frames, responsible entities must notify
the planning coordinator ``immediately upon identification of such
change.'' \26\
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    \26\ Id.
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    22. NPCC also states that there is a limited number of existing
nuclear and non-nuclear units that trip above the curve in Figure 1.
NPCC notes that Requirement R15 requires that all new units conform to
the curve in Figure 1. According to NPCC, the number of units that must
comply with Requirement R16 and Requirement R19 is limited to the
existing set of units described above and thus the inclusions of time-
frames is unnecessary.
    23. NERC states that it supports the comments submitted by NPCC on
this issue.
Commission Determination
    24. The Commission finds that NPCC has provided adequate
justification for not including specific time-frames in Requirements
R5, R16.2, and R19.3. NPCC states that these Requirements apply to a
limited number of existing nuclear and non-nuclear units whose
performance characteristics are already incorporated in the regional
UFLS program, and that planning coordinators within NPCC have the
existing technical parameters necessary to incorporate existing unit
attributes and compensatory load shedding information into their
assessment. NPCC further states that the absence of specific time-
frames in these Requirements means that responsible entities must
immediately notify planning coordinators upon identification of any
non-conformance or changes to underfrequency settings pursuant to these
Requirements. The Commission determines that this satisfies the concern
raised in the NOPR.

C. Compensatory Load Shedding Requirements

    25. Reliability Standard PRC-006-NPCC-1, Requirements R3, R16 and
R18, address compensatory load shedding.\27\ In particular, Requirement
R16.3 requires generator owners of existing non-nuclear units that have
non-conforming underfrequency

protection set points to, among other things, ``[h]ave compensatory
load shedding, as provided by a Distribution Provider or Transmission
Owner that is adequate to compensate for the loss of their generator
due to early tripping.'' Requirement R18 requires that ``[e]ach
Generator Owner, Distribution Provider or Transmission Owner within the
Planning Coordinator area of ISO-NE or the New York ISO shall apply the
criteria described in Attachment B to determine the compensatory load
shedding that is required in Requirement R16.3 for generating units in
its respective NPCC area.'' Attachment B, Section 2.5, provides that
the ``amount of compensatory load shedding shall be equivalent (5%) to the average net generator megawatt output for the prior
two calendar years, as specified by the Planning Coordinator, plus
expected station loads to be transferred to the system upon loss of the
facility.''
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    \27\ Compensatory load shedding is automatic shedding of load
adequate to compensate for the loss of a generator due to the
generator tripping early (i.e., because the generator has
underfrequency protection set to trip above the curve in Figure 1).
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Comments
    26. Dominion states that there are technical difficulties
associated with Requirements R16.3 and R18. Dominion states that
shedding additional load equivalent to a non-conforming generator would
be extremely difficult to design and coordinate and that the design
would have to account for the real-time status and output of the
generator. Dominion also states that Requirements R16.3 and R18 are
unreasonable because they require non-conforming generators to procure
compensatory load shedding service for which Dominion has found no
willing provider. Dominion maintains that, as a result, the regional
Reliability Standard cannot be practically implemented and may have an
adverse impact on the Bulk-Power System. Dominion further states that
NPCC's assertion that generators in NPCC are already following these
procedures as part of NPCC Directory 12 is misleading because
only NPCC Full Members are required to follow the existing criteria.
Dominion maintains that the regional Reliability Standard will impact a
number of generators that are not NPCC Full Members. In addition,
Dominion observes that several entities raised concerns with the
compensatory load shedding provisions during the regional Reliability
Standard drafting process. Dominion also maintains that Order No.
763,\28\ in which the Commission approved the continent-wide NERC UFLS
Reliability Standard PRC-006-1, supports Dominion's position that it is
inappropriate for the regional Reliability Standard ``to require a non-
conforming generator to obtain compensating load shedding as it is
ultimately the planning coordinators responsibility to design the UFLS
system to account for such generator.'' \29\
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    \28\ Automatic Underfrequency Load Shedding and Load Shedding
Plans Reliability Standards, Order No. 763, 139 FERC ] 61,098,
clarified, 140 FERC ] 61,164 (2012).
    \29\ Dominion Comments at 8.
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    27. PSEG states that it is inappropriate for planning coordinators
to assign responsibility for compensatory load shedding, asserting that
it is inconsistent with Order No. 763. PSEG also contends that the
regional Reliability Standard contravenes the prohibition in FPA
section 215 against setting standards for ``adequacy or safety of
electric facilities or services'' because the regional Reliability
Standard requires generator owners with existing non-conforming units
to construct additional capacity or acquire off-setting UFLS at their
expense.\30\ PSEG also states that Requirement R16 imposes obligations
upon generator owners that are absent from the NERC Reliability
Functional Model.\31\ PSEG states that one of the tasks of a generator
owner is to ``[p]rovide verified generating facility performance
characteristics/data,'' but that there is no obligation for generators
to compensate other entities for performance that does not meet a
specific level. PSEG further states that distribution providers and
transmission owners in NPCC do not have tariffs in place that would
permit them to charge and/or provide generator owners with compensatory
load shedding.
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    \30\ 16 U.S.C. 824o(i)(2). PSEG also contends that the regional
Reliability Standard contravenes the definition of ``Reliability
Standard'' in FPA section 215, which excludes ``any requirement to
enlarge [Bulk-Power System] facilities or to construct new
transmission capacity or generation capacity.'' 16 U.S.C.
824o(a)(3).
    \31\ The NERC Reliability Functional Model provides the
framework for the development and applicability of NERC's
Reliability Standards. NERC, Reliability Functional Model, Version 5
at 7 (approved May 2010), available at http://www.nerc.com/files/Functional_Model_V5_Final_2009Dec1.pdf.
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    28. In reply to Dominion's and PSEG's comments, NPCC states that
the regional Reliability Standard drafting team considered comments
regarding the difficulty of designing and coordinating the shedding of
load equivalent to a non-conforming generator, but that the overarching
reliability objective of re-establishing a balance between load and
generation during possible islanding events made shedding additional
load necessary. NPCC states that it is impractical to expect an exact
match between compensatory load shedding and unit output but maintains
that compensatory load shedding based on an average megawatt output, as
provided in Attachment B, aligns the amount of compensatory load
shedding with the unit output most likely to be lost when the unit
trips prematurely. NPCC further states that requiring compensatory load
shedding based on a two year average net generator megawatt output is
an effective approach to integrating small non-conforming generators
into the design of a UFLS program. In addition, NPCC observes that that
Regional Criteria requiring non-conforming generation to secure
compensatory load shedding preexist the development of the regional
Reliability Standard and that it is a cost effective alternative for
generators. With respect to Order No. 763, NPCC states that the
regional Reliability Standard is consistent with the Commission's
determination that it is appropriate for planning coordinators to
consider generators that trip outside of the UFLS set points.
    29. NPCC maintains that the regional Reliability Standard
Requirements R1 and R3 are ``only intended to communicate the results
of locational assessments, and there is no obligation to obtain
compensatory load shedding based solely on this information nor does
the Planning Coordinator determine whether mitigation is necessary or
who will be responsible for providing mitigation.'' \32\ NPCC states
that compensatory load shedding is merely an option to bring non-
conforming generators into compliance. In response to comments
regarding the absence of tariffs that permit for compensatory load
shedding service, NPCC states that such concerns are tempered by the
fact that all new generators, going forward, must conform with the
underfrequency trip performance characteristics in the regional
Reliability Standard and that compensatory load shedding only
potentially impacts existing, non-conforming, non-nuclear units.
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    \32\ NPCC Reply Comments at 5.
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    30. NPCC further notes that the existing compensatory load shedding
requirements are presently contained in NPCC Directory 12 and
``have been successfully implemented within the region * * * and non-
conforming generators that are already interconnected either have
existing contracts to provide compensatory load shedding or have
mitigated the conditions that would trip the unit above the performance
curve in order to comply with the Regional Criteria.'' \33\

NPCC states that the regional Reliability Standard achieved an 83.5
percent overall approval ``with a majority of registered Generator
Owners in the region voting to approve the standard.'' \34\ With
respect to FPA section 215, NPCC maintains that compensatory load
shedding does not present a resource adequacy issue but, instead,
addresses a generating unit's ability to perform, with the generator
having the option of meeting the performance curve, mitigating the
operating condition, or obtaining compensatory load shedding. With
respect to the NERC Reliability Functional Model, NPCC states that the
absence of a task within the functional model does not preclude
assigning a new or existing task based on a new or revised Reliability
Standard. NPCC states that the functional model only defines the
functions that must be performed to ensure the reliability of the bulk
electric system and should not be used to restrict a reliability-
related activity or Reliability Standard requirements.
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    \33\ Id. at 6-7.
    \34\ Id. at 9.
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    31. In reply to Dominion's and PSEG's comments, NERC states it
never intended to suggest that it is inappropriate for planning
coordinators to determine whether mitigation is necessary and who will
provide mitigation with respect to generators that trip outside the
UFLS set points in UFLS programs. NERC states that ``[o]n the contrary,
the Planning Coordinator is one of the functional entities with
responsibility for maintaining the reliability of the Bulk-Power
System.'' \35\ NERC maintains that it has stated that it is
inappropriate for a Reliability Standard to supplant the planning
coordinator's role in establishing UFLS program requirements. However,
NERC states that regional Reliability Standard PRC-006-NPCC-1
``reflects the NPCC Planning Coordinators' collective assessment of how
to address this concern.'' \36\
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    \35\ NERC Reply Comments at 2.
    \36\ Id. at 3.
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    32. Further, NERC claims that the technical concerns raised in the
comments are overstated. NERC states that concerns ``regarding
potential overfrequency excursions due to overcompensating when a
generating unit with non-conforming trip setting is off-line would be
appropriate if compensatory loadshedding was applied to large
generating units or if the provision was open-ended with applicability
to future generating units not studied by the Planning Coordinator.''
\37\ NERC observes that the compensatory load shedding provisions in
the regional Reliability Standard, by contrast, are limited to a
``defined amount of generating capacity that is included in Planning
Coordinator assessments, [and] does not jeopardize reliability of the
Bulk-Power System.'' \38\
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    \37\ Id. at 4.
    \38\ Id.
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Commission Determination
    33. The Commission rejects the protests made by Dominion and PSEG
regarding the compensatory load shedding provisions of regional
Reliability Standard PRC-006-NPCC-1. Based on the record before us, we
are not persuaded that the compensatory load shedding option for
existing, non-conforming units in Requirement R16 presents a technical
barrier to implementation of the regional Reliability Standard. NPCC
states that generators already comply with the compensatory load
shedding requirements in NPCC Directory 12, which is not
disputed by Dominion and PSEG. While Dominion maintains that the
regional Reliability Standard will require more generators (i.e., non-
NPCC Full Members) to comply with the compensatory load shedding
requirement, the fact that there are generators who do so now refutes
the assertion that the requirement is technically or practically
infeasible.\39\ Moreover, we agree with NERC that the concerns
regarding overfrequency excursions due to overcompensating for loss of
off-line units might be valid if compensatory load shedding was applied
to large generating units or to new generating units, but that is not
the case here since compensatory load shedding only applies to
existing, non-conforming, non-nuclear units. We also observe that,
according to the implementation plan, compliance with Requirements
R16.3 and R18 will become effective the first day of the first calendar
quarter two years following applicable regulatory approval. Thus, the
implementation plan provides existing, non-conforming generators a
significant amount of time to prepare for compliance with the regional
Reliability Standard.
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    \39\ We also note NPCC's statement that the regional Reliability
Standard achieved an 83.5 percent overall approval ``with a majority
of registered Generator Owners in the region voting to approve the
standard.'' See NPCC Reply Comments at 9.
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    34. We agree with NPCC that the NERC Reliability Functional Model
does not preclude the assignment of a new or revised task in a
Reliability Standard, such as to generator owners. The NERC Reliability
Functional Model provides that:
The Model is a guideline for the development of standards and their
applicability. The Model it [sic] is not a Standard and does not have
compliance requirements. Standards developers are not required to
include all tasks envisioned in the model, nor are the developers
precluded from developing Reliability Standards that address functions
not described in the model. Where conflicts or inconsistency exist, the
Reliability Standards requirements take precedence over the Model.\40\
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    \40\ NERC Reliability Functional Model, Version 5 at 7.
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    35. We disagree with Dominion and PSEG that the regional
Reliability Standard is inconsistent with Order No. 763. In the context
of the rulemaking addressing the continent-wide UFLS Reliability
Standard PRC-006-1, Order No. 763 explained that it would be
inappropriate to include in Reliability Standard PRC-006-1 specific
requirements as to how to mitigate generators that tripped outside of
the UFLS program (e.g., by procuring load to shed).\41\ We agree with
NERC that, while it is inappropriate for a continent-wide Reliability
Standard to supplant the planning coordinator's role in establishing
UFLS program requirements, the regional Reliability Standard PRC-006-
NPCC-1 incorporates the NPCC's planning coordinators' views and
experience.\42\ Accordingly, we see no inconsistency between Order No.
763 and our determination in this Final Rule.
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    \41\ Order No. 763, 139 FERC ] 61,098 at P 58.
    \42\ We also note that the Commission granted clarification of
Order No. 763, regarding NERC's NOPR comments on compensatory load
shedding, and found that NERC stated that ``it is not appropriate
for the Reliability Standards to prescribe how a planning
coordinator determines whether mitigation is necessary or who is
responsible for providing mitigation.'' Automatic Underfrequency
Load Shedding and Load Shedding Plans Reliability Standards, Order
No. 763, 139 FERC ] 61,098, clarified, 140 FERC ] 61,164, at P 12
(2012).
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    36. Finally, we reject the claim that the compensatory load
shedding provisions in regional Reliability Standard PRC-006-NPCC-1
contravene FPA section 215. As discussed above, the compensatory load
shedding option for existing, non-conforming, non-nuclear units is one
option for such generators. Generator owners may instead choose to
bring their units into compliance rather than secure compensatory load
shedding. We do not find that the regional Reliability Standard
implicates the proscription in FPA section 215 against ordering the

``construction of additional generation or transmission capacity or to
set and enforce compliance with standards for adequacy or safety of
electric facilities or services.'' The regional Reliability Standard
does not require responsible entities to construct additional
generation capacity or address the adequacy of electric facilities
services. Instead, it merely requires generator owners, if they choose
to, to secure compensatory load shedding to balance the performance
characteristics of their existing, non-conforming units.
D. Violation Risk Factors, Violation Severity Levels, Implementation
Plan, and Effective Dates
    37. In the NOPR, the Commission proposed to approve NERC's proposed
violation risk factors and violation severity levels for regional
Reliability Standard PRC-006-NPCC-1 as consistent with the Commission's
established guidelines.\43\ In addition, the Commission proposed to
accept the implementation plan and effective dates proposed by NERC for
regional Reliability Standard PRC-006-NPCC-1.
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    \43\ See North American Electric Reliability Corp., 135 FERC ]
61,166 (2011).
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Comments
    38. No comments were received that specifically addressed the
violation risk factors, violation severity levels, implementation plan,
and effective dates proposed by NERC.\44\
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    \44\ Dominion's comments regarding the technical and practical
feasibility of implementing regional Reliability Standard PRC-006-
NPCC-1 were addressed in the previous section.
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Commission Determination
    39. The Commission approves the violation risk factors, violation
severity levels, implementation plan, and effective dates proposed by
NERC.

III. Information Collection Statement

    40. The Office of Management and Budget (OMB) regulations require
that OMB approve certain reporting and recordkeeping (collections of
information) imposed by an agency.\45\ Upon approval of a collection(s)
of information, OMB will assign an OMB control number and expiration
date. Respondents subject to the filing requirements of this rule will
not be penalized for failing to respond to these collections of
information unless the collections of information display a valid OMB
control number.
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    \45\ 5 CFR 1320.11.
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    41. The Commission is submitting these reporting and recordkeeping
requirements to OMB for its review and approval under section 3507(d)
of Paperwork Reduction Act of 1995. The Commission solicited comments
on the need for and the purpose of the information contained in
regional Reliability Standard PRC-006-NPCC-1 and the corresponding
burden to implement the regional Reliability Standard. The Commission
received comments on specific requirements in the regional Reliability
Standard, which we address in this Final Rule. However, the Commission
did not receive any comments on our reporting burden estimates. The
Final Rule approves regional Reliability Standard PRC-006-NPCC-1. As
noted previously, this is the first time NERC has requested Commission
approval of regional Reliability Standard PRC-006-NPCC-1. Regional
Reliability Standard PRC-006-NPCC-1 is designed to work with and
augment the NERC continent-wide UFLS Reliability Standard PRC-006-1 by
mitigating the consequences of underfrequency events, while
accommodating differences in system transmission and distribution
topology among NPCC planning coordinators due to historical design
criteria, makeup of load demands, and generation resources. Regional
Reliability Standard PRC-006-NPCC-1 is only applicable to generator
owners, planning coordinators, distribution providers, and transmission
owners in the NPCC Region. To properly account for the burden on
respondents, the Commission will treat the burden resulting from NERC-
approved Reliability Standard PRC-006-NPCC-1 as pertaining to entities
within the NPCC Region.
    42. Public Reporting Burden: Our estimate below regarding the
number of respondents is based on the NERC Compliance Registry as of
July 24, 2012. According to the NERC Compliance Registry, there are 2
planning coordinators and 135 generator owners within the United States
portion of the NPCC Region. The individual burden estimates are based
on the time needed for planning coordinators to incrementally gather
data, run studies, and analyze study results to design or update the
UFLS programs that are required in the regional Reliability Standard in
addition to the requirements of the NERC Reliability Standard PRC-006-
1.\46\ Additionally, generator owners must set each underfrequency trip
relay below the appropriate generator underfrequency trip protection
settings threshold curve in regional Reliability Standard PRC-006-NPCC-
1, Figure 1 and provide the generator underfrequency trip setting and
time delay to its planning coordinator within 45 days of the planning
coordinator's request. These burden estimates are consistent with
estimates for similar tasks in other Commission-approved Reliability
Standards. The following burden estimates relate to the requirements
for this Final Rule in Docket No. RM12-12-000 (For Planning
Coordinators) and are in addition to the burden estimates for the
continent-wide Reliability Standard PRC-006-1, which was approved in
Order No. 763 (approved by OMB Control No. 1902-0244 on 7/9/2012).
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    \46\ The burden estimates for Reliability Standard PRC-006-1 are
included in Order No. 763 and are not repeated here.
---------------------------------------------------------------------------

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    \47\ Reliability Standard PRC-006-NPCC-1 applies to planning
coordinators, transmission owners, distribution providers and
generator owners. However, the burden associated with the
transmission owners and distribution providers is not included
within this table because the Commission accounted for it under
Commission-approved Reliability Standards PRC-006-1, PRC-007-0 and
PRC-009-0.

----------------------------------------------------------------------------------------------------------------
                                                     Number of       Number of    Average burden
      PRC-006-NPCC-1 (FERC-725L) (Automatic         respondents    responses per     hours per     Total annual
        Underfrequency Load Shedding) 47             annually       respondent       response      burden hours
                                                             (1)             (2)             (3)     (1)x(2)x(3)
----------------------------------------------------------------------------------------------------------------
PCs*: Design and document Automatic UFLS Program               2               1               8              16
PCs: Update and Maintain UFLS Program Database..  ..............  ..............              16              32
GOs*: Provide Documentation and Data to the                  135               1              16            2160
 Planning Coordinator...........................
GOs: Record Retention...........................  ..............  ..............               4             540
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............            2748
----------------------------------------------------------------------------------------------------------------
* PC=planning coordinator; GO=generator owner.

    Total Annual Hours for Collection: (Compliance/Documentation) =
2,748 hours.
    Total Reporting Cost for planning coordinators: = 48 hours @ $120/
hour = $5,760.
    Total Reporting Cost for generator owners: = 2,160 hours @ $120/
hour = $259,200.
    Total Record Retention Cost for generator owners: 540 hours @ $28/
hour = $15,120.
    Total Annual Cost (Reporting + Record Retention) \48\: = $5,760 +
$259,200 + $15,120 = $280,080.
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    \48\ The Commission bases the hourly reporting cost on the cost
of an engineer to implement the requirements of the rule. The record
retention cost comes from Commission staff research on record
retention requirements.
---------------------------------------------------------------------------

    Title: Mandatory Reliability Standards for the NPCC Region.
    Action: Proposed Collection FERC-725L.
    OMB Control No.: 1902-0261.
    Respondents: Businesses or other for-profit institutions; not-for-
profit institutions.
    Frequency of Responses: On Occasion.
    Necessity of the Information: This Final Rule approves regional
Reliability Standard PRC-006-NPCC-1 pertaining to automatic
underfrequency load shedding. The regional Reliability Standard helps
ensure the development of an effective UFLS program that preserves the
security and integrity of the Bulk-Power System during declining system
frequency events in coordination with the continent-wide Reliability
Standard PRC-006-1 requirements.
    Internal Review: The Commission has reviewed the regional
Reliability Standard and made a determination that its action is
necessary to implement section 215 of the FPA. These requirements, if
accepted, should conform to the Commission's expectation for UFLS
programs as well as procedures within the NPCC Region.
    43. Interested persons may obtain information on the reporting
requirements by contacting the following: Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426 [Attention:
Ellen Brown, Office of the Executive Director, email:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>].
    For submitting comments concerning the collection(s) of information
and the associated burden estimate(s), please send your comments to the
Commission and to the Office of Management and Budget, Office of
Information and Regulatory Affairs, Washington, DC 20503 [Attention:
Desk Officer for the Federal Energy Regulatory Commission, phone: 202-
395-4638, fax:<PHONE_NUMBER>]. For security reasons, comments to OMB
should be submitted by email to<EMAIL_ADDRESS>Comments
submitted to OMB should include FERC-725L and Docket Number RM12-12-
000.

IV. Environmental Analysis

    44. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\49\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. Included in the exclusion are rules that are clarifying,
corrective, or procedural or that do not substantially change the
effect of the regulations being amended.\50\ The actions proposed here
fall within this categorical exclusion in the Commission's regulations.
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    \49\ Regulations Implementing National Environmental Policy Act
of 1969, Order No. 486, 52 FR 47897 (Dec. 17, 1987), FERC Stats. &
Regs., Regulations Preambles 1986-1990 ] 30,783 (1987).
    \50\ 18 CFR 380.4(a)(2)(ii).
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V. Regulatory Flexibility Act Certification

    45. The Regulatory Flexibility Act of 1980 (RFA) \51\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
The RFA mandates consideration of regulatory alternatives that
accomplish the stated objectives of a proposed rule and that minimize
any significant economic impact on a substantial number of small
entities. The Small Business Administration's (SBA) Office of Size
Standards develops the numerical definition of a small business.\52\
The SBA has established a size standard for electric utilities, stating
that a firm is small if, including its affiliates, it is primarily
engaged in the transmission, generation and/or distribution of electric
energy for sale and its total electric output for the preceding twelve
months did not exceed four million megawatt hours.\53\
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    \51\ 5 U.S.C. 601-612.
    \52\ 13 CFR 121.101.
    \53\ 13 CFR 121.201, Sector 22, Utilities & n.1.
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    46. Regional Reliability Standard PRC-006-NPCC-1 establishes a
coordinated, comprehensive UFLS region-wide consistent program with the
NPCC region to achieve and facilitate the broader program
characteristics contained in the requirements of the continent-wide
PRC-006-1.\54\ It will be applicable to planning coordinators,
generator owners, transmission owners and distribution providers.
Comparison of the NERC Compliance Registry with data submitted to the
Energy Information Administration on Form EIA-861 indicates that 5
small entities are registered as generator owners in the United States
portion of the NPCC Region.\55\ The Commission estimates that the small
generator owners to whom the proposed regional Reliability Standard
applies will incur compliance and record keeping costs of $10,160
($2,032 per generator owner). Accordingly, regional Reliability
Standard PRC-006-NPCC-1 should not impose a significant operating cost
increase or decrease on the affected small entities.
---------------------------------------------------------------------------

    \54\ NERC Petition at 29-30.
    \55\ The two planning coordinators in the United States portion
of the NPCC Region are not considered small entities.
---------------------------------------------------------------------------

    47. Further, NERC explains that the cost for smaller entities to
implement regional Reliability Standard PRC-006-NPCC-1 was considered
during the development process. NERC states that regional Reliability
Standard PRC-006-NPCC-1 provides an opportunity for smaller entities to
aggregate their load with other such entities in the same electrical
island. This allows each smaller entity's respective planning
coordinator to achieve the desired aggregate outcome within that island
according to program characteristics.\56\
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    \56\ NERC Petition at 25.
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    48. Based on this understanding, the Commission certifies that the
regional Reliability Standard will not have a significant economic
impact on a substantial number of small entities. Accordingly, no
regulatory flexibility analysis is required.

VI. Document Availability

    49. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5:00
p.m. Eastern time) at 888 First Street NE., Room 2A, Washington, DC
20426.
    50. From FERC's Home Page on the Internet, this information is
available on eLibrary. The full text of this document is available on
eLibrary in PDF and Microsoft Word format for viewing, printing, and/or
downloading. To access this document in eLibrary, type the docket
number excluding the last three

digits of this document in the docket number field.
    51. User assistance is available for eLibrary and the FERC's Web
site during normal business hours from FERC Online Support at 202-502-
6652 (toll free at 1-866-208-3676) or email at
<EMAIL_ADDRESS>or the Public Reference Room at 202-502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
<EMAIL_ADDRESS>
VII. Effective Date and Congressional Notification

    52. These regulations are effective April 29, 2013. The Commission
has determined, with the concurrence of the Administrator of the Office
of Information and Regulatory Affairs of OMB, that this rule is not a
``major rule'' as defined in section 351 of the Small Business
Regulatory Enforcement Fairness Act of 1996.

    By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-04430 Filed 2-26-13; 8:45 am]
BILLING CODE 6717-01-P