United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-016
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.3100:

Earthworm Subchronic Toxicity Test

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  NOTICE
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  This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).  To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number.  Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in their title.
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  	The OCSPP harmonized test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice.  At places in this guidance, the Agency uses the word "should."  In this guidance, the use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis.
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  	For additional information about these test guidelines and to access these guidelines electronically, please go to http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.
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OCSPP 850.3100: Earthworm subchronic toxicity test.
(a) Scope --
      (1) Applicability.  This guideline is intended to be used to help develop data to submit to EPA under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).
      (2) Background.  The source materials used in developing this harmonized OCSPP test guideline include the OPPT guideline under 40 CFR 795.150 Earthworm Toxicity Test (proposed in the Federal Register of June 25, 1991 (56 FR 29155)) and ASTM E 1676, Standard Guide for Conducting Laboratory Soil Toxicity or Bioaccumulation Tests with the Lumbricid Earthworm Eisenia fetida.  This guideline was formerly Public Draft OCSPP 850.6200 (April, 1996).
(b) Purpose.  This guideline is intended for use in developing data on the toxicity of chemical substances and mixtures ("test chemicals" or "test substances") subject to environmental effects test regulations.  This guideline sets forth the procedures for a toxicity test using earthworms which are maintained in direct contact with an artificial (formulated) soil, allowing earthworms to ingest contaminated soil ad libitum.  The Environmental Protection Agency will use data from this test in assessing the hazard of a chemical to earthworms in the soil environment.
(c) Definitions.  The definitions in OCSPP 850.3000 apply to this guideline.  In addition, the more specific definitions in this paragraph also apply to this guideline:
	Artificial (formulated) soil means a defined dry weight mixture of 70 percent (70%) of number 70 mesh silica sand, 20% kaolin clay, 10% sphagnum peat moss, and calcium carbonate (to adjust the pH).  These ingredients are weighed and mixed in the stated proportions and moistened to 35 - 45% (by weight) with reagent water.
	Behavioral symptoms are indicators of toxicity to earthworms such that a distinct difference in position in the test container can be identified, e.g., below surface or on the surface; writhing on the surface; stiffened and shortened on the surface or elongated and pulsing; or inactive below surface in a ball.
	Clitellum means a glandular portion of the anterior epidermis, appearing as saddle-shaped or annular, usually differentiated externally by color.  It is the most visible feature of an adult earthworm and secretes the cocoon into which eggs and sperm are deposited.
	Mature or adult worms mean a condition of the worm exhibiting a clitellum in the anterior of the body.
	Mortality means the lack of movement by the test organism in response to a definite tactile stimulus to the anterior end.  Also, because earthworms tend to disintegrate rapidly after death, the absence of organisms in the enclosed soil test container is considered to mean death has occurred.
	Pathological symptoms mean toxic effects, such as surface lesions and mid-segmental swellings or general ulcerated areas on the surface of the earthworm.
	Test mixture means the test substance/artificial soil mixture(s) which the earthworms are exposed to during the test.
(d) General considerations--
      (1) Summary of the test.  This toxicity test is conducted by placing acclimated earthworms in test chambers containing artificial (formulated) soil which has been spiked with the test substance.  Earthworms are allowed to ingest this test mixture soil ad libitum.  Mortality and other effects are examined on a weekly basis for 28 days.  The results are expressed as the 28-d LC50 (median lethal concentration).  Sublethal effects may also be determined, and expressed as EC50, (experimentally derived concentration of a test substance in a test matrix (e.g., growth medium, soil sediment, feed) that would be expected to cause a defined adverse effect in 50% of a group test organisms under specified exposure conditions), NOEC (no observed effect concentration), LOEC (lowest observed effect concentration), and MATC (maximum acceptable toxicant concentration) values.
	(2) General test guidance.  The general guidance in OCSPP 850.3000 applies to this guideline except as specifically noted herein.
	(3) Range-finding test.  A range-finding test is usually conducted to establish the appropriate test concentrations to be used in the definitive test.  The earthworms should be exposed (for at least 28 days) to a series of widely spaced concentrations of the test substance (e.g., 0.1, 1.0, 10, 100, 1,000 milligrams per kilogram (mg/kg) dry weight artificial soil).  Treatment replication is not needed and nominal concentrations of the chemical are acceptable.  The number of test organisms used and details of observations do not have to be the same as definitive testing.  However, the range-finding test will be more useful the greater the similarity between the range-finding test and the definitive test.  Results of range-finding tests should be reported along with the results of the definitive test, if range-finding tests are conducted.
	(4) Definitive test.  The goal of the definitive test is to determine the concentration-response curve for mortality and the LC50 (95% confidence limits and standard error) at 28 days, as well as the slope of the concentration-response curve, its associated standard error and 95% confidence interval.  Where sufficient data warrant, these values are also calculated for the 7, 14, and 21-day concentration response-curves for mortality.  An additional desired endpoint is the weight loss EC50 (95% confidence interval) and the LOEC, NOEC and MATC values at each sampling time.  For this determination, a minimum of five concentrations of the test chemical, plus appropriate controls, are tested.  Analytical confirmation of test concentrations is performed as described in OCSPP 850.3000.  A summary of test conditions is provided in Table 1 and validity elements for an acceptable definitive test are listed in Table 2 of this guideline.
	(5) Limit test.  In some situations, it is only necessary to ascertain that the 28-d LC50 is above a certain limit, and at the limit there is also no observable adverse growth effect.  In a limit test, at least 20 earthworms are exposed to a single "limit concentration," with the same number of organisms in appropriate control(s).  The multiple-concentration definitive test may be waived if the following conditions are met.  First, if one or fewer mortalities occur at the limit concentration (i.e. the LC50 > limit concentration), and second, the limit treatment responses are not significantly reduced (or inhibited) as compared to the control response (i.e., NOEC > limit concentration).  For most chemicals, 1,000 mg test substance (based upon 100% active ingredient for pesticides) per kg dry weight of artificial soil is considered appropriate as the limit concentration.  Except for the number of treatment groups and number of test organisms, an acceptable limit test follows the same test procedures and is the same duration as the definitive test (see Table 1 of this guideline).
(e) Test standards--
      (1) Test substance.  The substance to be tested should be technical grade unless the test is designed to test a specific formulation, mixture, or end-use product.  For pesticides, if more than one active ingredient constitutes a technical product, the technical grade of each active ingredient should be tested separately, in addition to the combination, if applicable.  OCSPP 850.3000 lists the type of information that should be known about the test substance before testing, and discusses methods for preparation of test substances.
	(2) Test duration.  The test duration is 28 days.
	(3) Test organism--
            (i) Species.  The test species is the earthworm Eisenia fetida andrei (Bouche).  Some taxonomists consider these to be two separate species, Eisenia fetida (Savigny 1826) and Eisenia andrei (Andre 1963); see the references under paragraph (j)(1), (j)(5) and (j)(11) of this guideline for additional information about the taxonomy of the Eisenia fetida complex.  These organisms naturally inhabit high organic environments such as compost and manure piles.  They are easily bred in the laboratory and have been used commonly in laboratory experiments.  The species identity of the test organism should be verified using appropriate taxonomic keys as described by Fender (paragraph (j)(4) of this guideline), or an equivalent method.
            (ii) Source.
                  (A) Earthworms used in toxicity tests should be purchased from a commercial source that can verify the species.  Once verified, cultures should be maintained at the test facility.  Information about culturing procedures can be found in the reference in paragraph (j)(1) of this guideline.  Records should be kept regarding the source of the initial stock and culturing techniques.  All organisms used for a particular test should have originated from the same population (culture).
                  (B) All newly acquired earthworms should be quarantined and observed for at least 14 days prior to use in a test.
            (iii) Age and size.  Adult earthworms are used to start the test.  The weight of the individual adult earthworms should be between 300 mg and 600 mg each.  All organisms used in a test should be as uniform as possible in the state of maturity and weight.
            (iv) Acclimation.  It is recommended that earthworms be cultured at the test temperature.  In any event, earthworms should be held for a minimum of 7 days in uncontaminated soil at the test temperature prior to testing.  Any changes in soil temperature should not exceed 3 degrees Celsius ([o]C) per day or 1 [o]C per hour.
            (v) Health status.  Earthworms should not be used if they have been under stress from too much moisture or a lack of moisture as described by Reinecke and Venter (see paragraph (j)(13) of this guideline); excessive or inadequate food or temperature as described by Tomlin and Miller (paragraph (j)(17) of this guideline); pH variation as described by Satchell and Dottie (paragraph (j)(14) of this guideline); or crowding.  Any of these conditions will produce earthworms that may not be healthy.
            (vi) Care and handling.  Adult earthworms should be handled with care.  Sufficient numbers of earthworms should be harvested and sorted to insure that healthy individuals are used for the test.  For a satisfactory test, any animals that appear to be injured are discarded and not used in the test.  Additionally, any organisms that touch dry surfaces or are dropped or injured during handling are discarded.
            (vii) Diet and feeding--
                  (A) Culture Period.  Substrate food for culturing Eisenia fetida andrei should be commercial alfalfa (Medicago sativa) pellets, saturated with reagent water at a ratio of approximately 1 gram (g) of dry pellets per 2 milliliters (mL) water and aged for two weeks in a covered container.  Worms are fed once or twice per week and the bedding turned by hand to inspect the general condition of the culture.
			(B) Test Period.  The earthworms are not fed during the test period.
      (4) Administration of test substance.  The test is started by introducing adult earthworms, which have been acclimated to the test conditions, into test chambers which contain artificial (formulated) soil (see paragraph (e)(7)(vii) of this guideline) to which the test substance has been added.  Earthworms should be introduced into test soils on the surface of the test medium so as to evaluate burrowing behavior.  The jar capped and secured without making an airtight seal.
            (i) Preparation of treated soil.
                  (A) Appropriate portions of artificial soil are mixed thoroughly with appropriate amounts of test substance (see paragraph (e)(4)(i)(B) of this guideline).  Hand mixing or mechanical mixing may be used.  Test concentrations should be prepared on day -1 and allowed to equilibrate overnight before adding test organisms.
                  (B) Test substances may be added directly to the artificial soil on a dry weight basis, but are typically dissolved in reagent water (preferably) or a vehicle to form a stock solution.  Aliquots of the stock solution, or dilutions thereof, are then added to the artificial soil.  If a solvent is used, the opened chambers are placed in a hood for 24 hours to evaporate the solvent prior to adding the earthworms.
            (ii) Test concentrations.  For the definitive test, a minimum of five concentrations of the test chemical, plus appropriate controls, are tested.  Test concentrations should be chosen in a geometric series in which the ratio is between 1.5 and 2.0 (e.g., 2, 4, 8, 16, 32, and 64 mg/kg).  All test concentrations should be based on milligram of test chemical (100% active ingredient for pesticides) per kilogram of artificial soil (air-dry weight).
	(5) Controls.
            (i) Every test should include a negative control consisting of the same artificial (formulated) soil, conditions, procedures, and earthworms from the same group as used with the test substance, except that none of the test substance is added.  In addition if a vehicle is used, a vehicle control is tested, using the same vehicle batch as used to make the stock solution and at the highest concentration used to prepare test concentrations.  See OCSPP 850.3000 for additional information on preparation of test substances using a vehicle.
            (ii) A test is not acceptable if average survival of either the negative or solvent control earthworms was less than 80% at the end of the test or the total mean weight of the earthworms in either the negative or solvent control containers declined significantly during the test (i.e., by 30%).
	(6) Number of test organisms and replicates--
            (i) Definitive test.  In the definitive test, there is a minimum of three replicates for each treatment concentration and control group, with a minimum of 10 earthworms per replicate.  The earthworms are selected from the culture randomly into groups of 10.  These groups are then randomly assigned to the test chambers and then weighed to verify they do not differ more than +- 10% among the replicates.  Each test chamber contains 200 g (dry weight) of artificial soil.  Each test chamber should contain an equal amount of test soil and an equal number of earthworms.  For a satisfactory test, replicate test chambers are to be physically separated, since the test chamber is the experimental unit.  In addition, test chambers within the testing area are positioned in a random manner or in a way in which appropriate statistical analyses can be used to determine the variation due to placement.
            (ii) Limit test.  In a limit test, at least 20 earthworms are exposed to a single "limit concentration," with the same number of organisms in appropriate control(s).
            (iii) Loading.  The number of earthworms placed in a test chamber should not be so great as to affect the results of the test.
      (7) Facilities, apparatus and supplies.  Normal laboratory equipment and supplies, and items especially listed in (e)(7)(i) through (e)(7)(vii).
            (i) Facilities.
                  (A) Facilities should be well ventilated and free of fumes and disturbances that may affect the test organisms.
                  (B) Ventilation hood for evaporating solvent from test soil when a solvent is used.
            (ii) Instruments and general equipment.
            (A) Suitable balances to measure soil mixtures.
                  (B) A properly calibrated balance with sufficient accuracy should be used to weigh the worms.
            (iii) Culturing. Polyethylene containers (e.g., rectangular dish pans measuring 32.5 by 27.5 by 12.5 centimeters) for culturing earthworms.
            (iv) Environmental control equipment.
            	(A) Apparatus for providing continuous lighting.
                  (B) A mechanism (e.g., environmental chamber) for controlling and maintaining the artificial soil temperature and relative humidity during the culturing, holding, acclimation, and test periods.  Relative humidity should be maintained above 85%.  An open pan of water can be used for this purpose to prevent moisture loss from the containers.
            (v) Test containers and exposure system.
                  (A) Chambers for exposing test earthworms to the test substance.  Glass canning jars, 1-pint capacity, or their equivalent, should be used for testing.  The lids should be reversed (i.e., turned upside down), loosely capped and secured without making an airtight seal to reduce evaporation and permit air exchange.
                  (B) Construction materials and equipment that contact test mixtures should not contain substances that can be leached or dissolved into artificial soil in quantities that can affect the test results.  Construction materials and equipment that contact test mixtures should be chosen to minimize sorption of test substances.
            (vi) Cleaning.  The test chambers should be cleaned before each test following standard laboratory procedures.  Hard glass jars are preferable and should be heated in an ashing oven between tests.  For a satisfactory test, if soft glass is used it should be used only once and then be discarded.  Refer to OCSPP 850.3000 for additional information.
            (vii) Artificial soil.
                  (A) For each test substance concentration and control tested, enough artificial soil is prepared by recipe to yield 270 g of artificial soil (wet weight) per replicate.  The constituents identified in this paragraph are mixed together on a dry weight basis: 10% Canadian sphagnum peat moss (that portion passing through a 2.36 millimeter (mm) screen); 20% kaolin clay (97% kaolinite with a particle size under 40 micrometers (um)); and 70% silica sand (grade 70, 97.1% particle size of 0.053 to 0.3 mm).
                  (B) After these materials are mixed together, an amount of calcium carbonate (99% purity) is added to the mixture to adjust the soil pH to 6.5 +- 0.5.  The amount of calcium carbonate used will depend on the pH of the peat moss used.
                  (C) An appropriate amount of reagent water (e.g., 70 g per 200 g of dry soil) is added to the artificial soil and mixed with the artificial soil to raise the artificial soil moisture level to 35% by weight.
      (8) Environmental conditions.  Environmental parameters during the test should be maintained as follows:
            (i) Temperature.  The test soil temperature should be 22 [o]C and it should be constant within +- 2 [o]C during the test, as described by Edwards (paragraph (j)(3) of this guideline), or using an equivalent method.
            (ii) Lighting and photoperiod.  Replicates should be illuminated continuously with incandescent or fluorescent lights as described by Edwards (paragraph (j)(3) of this guideline), or using an equivalent method.  Light intensity should be about 5.7 micromoles per square meter per second (umol/m[2]/s) (for cool-white lights, this is equivalent to approximately 420 lux) measured at the artificial soil surface.
      (9) Observations.  Earthworms in the test chambers are observed periodically during the test; the dead worms are removed and the findings recorded.  Soil temperature and pH, and the concentration of test substance in the treated soil are measured at specified intervals.  Data collected during the test are used to develop concentration-response curves and LC50 values for the test substance.
            (i) Measurement of test substance.  Analytical confirmation of test concentrations in artificial soil is to be performed using validated analytical methods, as described in OCSPP 850.3000.  A 10-g sample should be removed from each replicate prior to addition of earthworms to measure pH and test substance concentrations.  The homogeneity of the test substance in treated soil should be determined.
                  (A) For stable test substances, monitor test concentrations at the beginning and at the end of the test.  However, for volatile, unstable substances, those subject to ready degradation, or where there is uncertainty in the analytical measurements, it may be necessary to measure test concentrations more often during the test, e.g. every seven days.
                  (B) In addition to analyzing samples of artificial soil, at least one reagent blank, containing all reagents used, should also be analyzed.
                  (C) The measured concentration of the test substance in artificial soil in any chamber during the test should not vary more than 50% from the measured concentration prior to initiation of the test; concentration measurements should be as described by Neuhauser et al. (paragraphs (j)(9) and (j)(10) of this guideline), or an equivalent method.
                  (D) The mean measured concentration of test substance in artificial soil (dry weight) should be used to plot all concentration-response curves and to calculate all LC50, EC50, LOEC, and NOEC values.
            (ii) Environmental conditions--
                  (A) Temperature.  Temperature should be measured and reported at the beginning of the test and on days 7, 14, 21, and 28 in all test chambers.  The temperature should be measured at least hourly in one test container.
                  (B) Light intensity.  Light intensity should be measured at least once during the test at the surface of the container and checked weekly in the test chambers.
                  (C) Total organic carbon (TOC) concentration.  The TOC concentration in soil at test initiation should be determined as measured by the method of Plumb (paragraph (j)(12) of this guideline), or an equivalent method.
                  (D) Soil pH.  The pH should be measured at test initiation and 7 day intervals (days 7, 14, 21, 28) thereafter in each test chamber.
            (iii) Organisms--
                  (A) Mortality, behavior, and other adverse effects.  At test initiation burrowing behavior of earthworms placed on the surface of the test medium is recorded for each test chamber.  Each test and control chamber should be checked for dead or affected earthworms and observations recorded 7, 14, 21, and 28 days after the beginning of the test or within 1 hour of the designated times in all test chambers.  Missing earthworms should be considered to have died.  Mortality is assessed by emptying the test medium on a glass or other inert surface, sorting earthworms from the test mixture and testing their reaction to a gentle mechanical stimulus.  Any adverse effects (e.g., behavioral or pathological symptoms) are noted and should be reported.  The medium is returned to each container.
                  (B) Weight loss.  Total biomass of test organisms per test chamber is measured at the beginning and end of the test.  The worms should be washed and purged before weighing.  To accomplish this, the bedding is rinsed from the worms with reagent water; the worms are placed in petri dishes with wet filter paper, and allowed to purge the gut contents for 24 hours.  Before weighing worms, excess surface water may be removed by placing the worms between layers of an absorbent towel.  However, it is very important not to dry the surface of the worms which might stress the worms unduly.
(f) Treatment of results --
      (1) Descriptive summary statistics --
            (i) Environmental conditions.  The soil characteristics and TOC content should be described.  Temperature and light intensity results should be summarized in tabular form, showing the range, mean and standard deviation during the test.  The pH in each test chamber should be summarized in tabular form, showing the range, mean, and standard deviation.
            (ii) Test substance soil concentration.  Soil concentrations should be summarized in tabular form by treatment and sample time, showing mean concentrations and standard deviations.  The treatment mean soil concentration should be calculated.
            (iii) Mortality.  Death is the primary effect used in this test guideline to evaluate the toxicity of the test substance.  The number of initial earthworms at each treatment and control and the number of dead earthworms should be summarized in tabular form by observation time (e.g. day 7, 14, 21, and 28) treatment, and replicate.
            (iv) Sublethal effects and growth.  The sublethal effects and growth (i.e., fresh weight) data should be used to determine concentration-response curves, calculate EC50 values, and determine LOEC, NOEC, and MATC values.  Number of earthworms with abnormal appearance or behavior symptoms should be summarized in tabular form by symptom, time of observation, treatment, and replicate.  Mean total biomass at the beginning and end of the test for each treatment replicate should be summarized in tabular form and the mean and standard deviation in weight loss or gain calculated by treatment.
	(2) Percent --
            (i) Mortality.  Calculate the percent mortality at each treatment level and control by observation time.
            (ii) Appearance and behavior.  Calculate the percent effected at each treatment level and control by symptom, and observation time.

      (3) Limit test --
            (i) LC50 value.  At test termination (28 days), if one or fewer earthworms are dead at the limit concentration, the LC50 is considered to be greater than the limit concentration.  This is because the Binomial Theorem predicts that when 20 earthworms are tested, the probability of seeing <1 dead earthworm if the true 28-d LC50 is at or below the limit concentration is <0.001.  Conversely the probability of seeing 2 or more dead earthworms if the true 28-d LC50 is at or below the limit dose is >0.999.  Therefore, if <1 mortality occurs among the 20 earthworms tested, the 28-d LC50 is reported as greater than the limit concentration (i.e., 28-d LC50 >1,000 mg/kg dry wt in soil).
            (ii) Proportion of mortality ().  The Binomial Theorem also can provide both an estimate of the true proportion of mortality () in the population as well as confidence bounds on that estimate (see Table A4 of the reference in paragraph (j)(2)).  For small sample sizes the interval may be large.  For no mortalities in 20 earthworms (= 0), the upper 99% confidence bound on the estimate of  is 0.24 (95% upper confidence bound is 0.17), this means that the estimate of the true proportion of mortality may actually be as high as 0.24 when no earthworms die out of 20 tested (or as high as 0.17 for the 95% confidence estimate).  For one mortality in 20 earthworms (= 0.05), the upper 99% confidence bound on the estimate of  is 0.32 (95% upper confidence bound is 0.29).  For assessing risks, the confidence in the proportion impacted is considered in determining acute effects at environmental exposure doses.
            (iii) NOEC.  To ascertain that there is no observable adverse growth effect at the limit treatment (i.e., NOEC > limit dose), the limit treatment response is compared to the control treatment response using a one-sided two-sample parametric or nonparametric test for a reduction in growth from the control (see OCSPP 850.3000).  The minimum significant difference detectable by the test or a similar estimate of the sensitivity of the test should be determined and reported.
            (iv) Multiple-concentration definitive testing.
                  (A) At test termination, if two or more mortalities occur among the 20 earthworms tested or growth was significantly reduced from the control, a definitive dose-response test should be conducted.
                  (B) Multiple-concentration definitive testing may be waived if at test termination (28 days), one or fewer earthworms are dead at the limit concentration, and at the limit treatment there is also no observable adverse growth effect.
      (4) Multiple-concentration definitive test--
            (i) Concentration-response curve, slope and LC50.  Statistical procedures are employed to calculate the 28-d LC50 (standard error and 95% confidence interval) based upon mortality.  If a concentration-response model (e.g., probit) was fit to the data to determine the LC50, the model parameters (e.g., slope) and their uncertainty estimates (e.g., standard error) should be recorded.
            (ii) Concentration-response curve, slope and EC50.  Statistical procedures are employed to calculate the 28-d EC50 (standard error and 95% confidence interval) based upon biomass weight loss.  If a concentration-response model was fit to the data to determine the EC50, the model parameters (e.g., slope) and their uncertainty estimates (e.g., standard error) should be recorded.
            (iii) NOEL.  Appropriate statistical methods (e.g., one-way analysis of variance and multiple comparison tests) should be used to test for significant differences between treatment means and determine LOEC, NOEC and MATC for mortality, biomass weight loss, and other sublethal effects.
            (iv) Statistical methods.  Statistical procedures for modeling quantal and continuous data are available and should be used.  Additional discussion about measurement endpoints and statistical procedures is found in OCSPP 850.3000.
(g) Tabular summary of test conditions.  Table 1 lists the important conditions that should prevail during the definitive test.  Except for the number of test organisms per concentration, number of replicate chambers, and test concentrations, Table 1 also lists the important conditions that should prevail during a limit test.  Meeting these test conditions will greatly increase the likelihood that the completed test will be acceptable or valid.

	Table 1. -- Summary of Test Conditions for Earthworm Subchronic Toxicity Test
Test type
Spiked formulated soil
Test duration
28 days
Temperature
22 °C (constant during test within +- 2 °C)
Light quality
Incandescent or fluorescent lights
Light intensity
5.7 μmol/m[2]/s (approximately 420 lux)
Photoperiod
Continuous light
Test chamber size
Glass canning jars, 1 pint, or equivalent
Substrate
Artificial (formulated) soil
Substrate amount per replicate
270 g wet weight (200 g dry weight)
Age/size of test organisms per replicate
Adult earthworms, 300 - 600 mg
Number of test organisms per concentration
30 (minimum)
Number of organisms per test chamber
10
Number of replicate chambers per concentration
3 (minimum)
Loading
300 - 600 mg per 270 g of soil
Feeding regime
No feeding during test
Test concentrations
Minimum of 5 test concentrations chosen in a geometric series plus a control, and a vehicle control if a vehicle is used
Measures of Effect or Measurement Endpoints
LC50 based upon mortality at 28 days at a minimum; EC50, NOEC, LOEC and MATC based upon sublethal effects (weight change)

(h) Test validity elements.  This test would be considered to be unacceptable or invalid if one or more of the conditions in Table 2 occurred.  This list should not be misconstrued as limiting the reason(s) that a test could be found unacceptable or invalid.  However, except for the conditions listed in Table 2 and in OCSPP 850.3000, it is unlikely a study will be rejected when there are slight variations from guideline environmental conditions and study design unless the control organisms are significantly affected, the precision of the test is reduced, the power of a test to detect differences is reduced, and/or significant biases are introduced in defining the magnitude of effect on measurement endpoints as compared to guideline conditions.  Before departing significantly from this guideline, the investigator should contact the Agency to discuss the reason for the departure and the effect the change(s) will have on test acceptability.  In the test report, all departures from the guideline should be identified, reasons for these changes given, and any resulting effects on test endpoints noted and discussed.
	Table 2. -- Test Validity Elements for Earthworm Subchronic Toxicity Test
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1. All test chambers were not identical.

2. Treatments were not randomly assigned to individual test chamber locations or individual test organisms were not impartially or randomly assigned to test chambers.

3. The negative and vehicle control [when a vehicle was used] were not included in the test.

4. Average survival of either the negative or solvent control earthworms was less than 80% at the end of the test.

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5. The total mean weight of the earthworms in the control containers declined significantly during the test (i.e., by 30%).

(i) Reporting--
      (1) Background information.  Background information to be supplied in the report consists at a minimum of those background information items listed in paragraph (j)(1) of OCSPP 850.3000.
      (2) Guideline deviations.  Provide a statement of the guideline or protocol followed.  Include a description of any deviations from the test guideline or any occurrences which may have influenced the results of the test.
     	(3) Test substance.
            (i) Identification of the test substance:  common name, IUPAC and CAS names, CAS number, structural formula, source, lot or batch number, chemical state or form of the test substance, and its purity (i.e. for pesticides, the identity and concentration of active ingredient(s)).  If radiolabeled substance was used provide the radio purity and location(s) of the label.
      	(ii) Storage conditions of the test chemical or test substance and stability of the test chemical or test substance under storage conditions if stored prior to use.
      	(iii) Methods used for preparation of artificial soil, its age (i.e., prepared 1 day or 7 days prior to use), and storage conditions if stored prior to use.  If artificial soil is not used describe the source, collection method, handling and preparation of soil used in the test, its composition (percent sand, silt, and clay), and textural classification.
      	(iv) Source and amount of hydration water added to test soil and the moisture content for the test mixture at test initiation.
      	(v) Methods of preparation of the test substance and the treatment concentrations used in the range-finding and definitive test, or limit test: description of test chemical introduction into the test medium (e.g., as a powder, stock solution), the mass and volume of soil and test substance used for each treatment, how test substance was mixed into the soil, number of treatments and nominal test substance concentration in soil in each treatment at the beginning of the test.
      	(vi) If a vehicle (e.g., solvent) is used to prepare stock or test substance provide: the name and source of the vehicle, the nominal concentration(s) of the test substance in the vehicle, in stock solutions, or mixtures, and the vehicle concentrations used in the treatments.
      	(vii) Description of stock solution preparation.
	(4) Test organisms.
      (i) Scientific and common names and method of verification, and source.
			(ii) Culture method and conditions, and feeding history.
            (iii) Health status of culture used for collection of test earthworms (e.g., any prophylactic or preventative treatments, quarantine period).
			(iv) Collection method and date of collection.
			(v) Acclimation period.
			(vi) Age and weight (by treatment and replicate) in tabular form at test initiation.
      (5) Test system and conditions.  Description of the test system and conditions used in the definitive or limit test, any preliminary range-finding tests, and any positive control tests.
            (i) Description of the test chambers: type, size, volume, material, and conditioning method.
			(ii) Statement verifying that earthworms were not fed during the test.
			(iii) Volume and weight of soil used in each test container.
            (iv) Time between introduction and mixing of the test substance with the soil and introduction of the earthworms.
			(v) Number of worms per test container.
			(vi) Number of test containers per concentration.
            (vii) Methods used for test container and treatment randomization as well as methods for impartial assignment of earthworms to test containers.
			(viii) Method of introducing earthworms to test containers.
			(ix) Test duration.
            (x) Methods and frequency of environmental monitoring performed during the definitive or limit study for lighting, soil temperature and soil pH.
            (xi) Method, type and frequency of observations made on earthworms during the test.
            (xii) For the definitive or limit test, all analytical procedures and preservation methods should be described.  The accuracy of the method, method detection limit, and limit of quantification should be given.
	(6) Results.
            (i) Environmental monitoring data results (lighting, soil temperature and pH) in tabular form (provide raw data for measurements not made on a continuous basis), and descriptive statistics (mean, standard deviation, minimum, maximum).
      	(ii) For preliminary range-finding test(s), if conducted, the number of dead and intoxicated earthworms at each concentration level and in the control(s).
      	(iii) For the definitive and limit test, test substance concentration in the soil at test initiation (day 0), during (if needed, at day 7, 14, 21) and test conclusion (day 28), in tabular form and descriptive statistics (time weighted average, standard deviation, minimum, maximum).
      	(iv) The total organic carbon (TOC) content of the soil mixture.
      	(v) For the definitive and limit test, the number of dead earthworms at each observation period at each treatment level and control(s) (provide the raw data).
      	(vi) For the definitive and limit test, the burrowing behavior of earthworms observed at test initiation: description of behavior, duration, severity, and number affected at each treatment level and control(s) (provide the raw data).
      	(vii) For the definitive and limit test, a description of all observations made on the test earthworms that are suggestive or predictive of toxicity and all concomitant gross toxicological manifestations include time of onset, duration, severity, and number affected at each treatment level and control(s) (provide the raw data).
      	(viii) For the definitive and limit test, the weight, in tabular form, at each test concentration (including controls), in each test chamber at test initiation and termination.
      	(ix) For the definitive test, the LC50 value, and its standard error and 95% confidence interval should be reported for 7, 14, 21, and 28-day periods.  The slope of the concentration-response curve, its standard error, and 95% confidence interval should also be reported.
      	(x) For the definitive test, the EC50 for weight with its standard error and 95% confidence interval, and the LOEC, NOEC, and MATC for day 28.
      	(xi) Description of statistical method used, including software package, for determining LC50 EC50, LOEC, NOEC, and MATC values and the concentration-response model parameters and the basis for the choice of method.  Provide results of any goodness-of-fit tests and determination of minimum significant differences.
(j) References.  For additional background information on this test guideline, the references in this paragraph should be consulted:
	(1) American Society for Testing and Materials.  ASTM E 1676-04, Standard guide for conducting laboratory soil toxicity or bioaccumulation tests with the lumbricid earthworm Eisenia fetida and the enchytraeid potworm Enchytraeus albidus. Current edition approved April 1, 2004. In Annual Book of ASTM Standards, Vol. 11.06, West Conshohocken, PA.
	(2)  Conover, W.  1980.  Practical Nonparametric Statistics, 2[nd] Edition.  John Wiley & Sons, Inc., New York, NY.  493 pp.
	(3) Edwards, C.A., 1984. Report of the second stage in development of a standardized laboratory method for assessing the toxicity of chemical substances to earthworms. The Artificial Soil Test. DG X1/AL/82/43, Revision 4.
	(4) Fender, W.M., 1985. Earthworms of the Western United States. Part 1. Lumbricidae, Megadrilogica 4: 93-129.
	(5) Jaenicke, J., 1982.  "Eisenia foetida" is two biological species. Megadrilogica 4:6-8.
	(6) Greene, J.C., Bartels, C.L., Warren-Hicks, W.J., Parkhurst, B.R., Linder, G.L., Peterson, S.A., and Miller, W.E., 1989.  Protocols for Short-Term Toxicity Screening of Hazardous Waste Sites, EPA/600/3-88/029, U.S. Environmental Protection Agency, Environmental Research Laboratory, Corvallis, OR.
	(7) Hartenstein, R. et al., 1979.  Reproductive potential of the earthworm Eisenia foetida.  Oecologia 43:329-340.
	(8) Meier, J.R., Chang, L.W., Jacobs, S., Torsella, J., Meckes, M.C. and Smith, M.K., 1997.  Use of plant and earthworm bioassays to evaluate remediation of soil from a site contaminated with polychlorinated biphenyls.  Environmental Toxicology and Chemistry 16(5): 928-938.
	(9) Neuhauser, E.F. et al., 1986. Contact and artificial soil tests using earthworms to evaluate the impact of wastes in soils, In: Hazardous and Industrial Soil Waste Testing: Fourth Symposium, ASTM STP 886. J.K. Petros, Jr. and R.A. Conway, eds., American Society for Testing and Materials. Philadelphia, PA  pp. 192-203.
	(10) Neuhauser, E.F. et al., 1985.  The toxicity of selected organic chemicals to the earthworm Eisenia fetida. Journal of Environmental Quality 14: 383-388.
	(11) Oien, N. and J. Stenerson, 1984.  Esterases of earthworm - III. Electrophoresis reveals that Eisenia foetida (Savigny) is two species.  Comparative Biochemistry and Physiology 78c (2):277-282.
	(12) Plumb, R.H., Jr., 1981.  Procedures for handling and chemical analysis of sediment and water samples.  Technical Report EPA/CE-81-1, prepared by Great Lakes Laboratory, State University College at Buffalo, Buffalo, NY., for the U.S. Environmental Protection Agency/Corps of Engineers Technical Committee on Criteria for Dredged and Fill Material. U.S. Army Engineer Waterways Experiment Station, CE, Vicksburg, MS.
	(13) Reinecke, A.J. and Venter, J.M., 1987.  Moisture preferences, growth and reproduction of the compost worm Eisenia fetida (Oligochaeta).  Biology and Fertility of Soils 3: 135-141.
	(14) Satchell, J.E. and Dottie, D.J., 1984. Factors affecting the longevity of earthworms stored in peat. Journal of Applied Ecology 21: 285-291.
	(15) Stafford, E.A. and Edwards, C.A., 1985. Comparison of heavy metal uptake by Eisenia faetida with that of other common earthworms. Final Technical Report. Entomology Department, Rothamsted Experiment Station, Harpenden, Herts. ALS 2JQ, U.K. U.S. Army Contract DAJA 45-84-0027.
	(16) Spurgeon, D.J. and Hopkin, S.P., 1995. Extrapolation of the laboratory-based OECD earthworm toxicity test to metal-contaminated field sites. Ecotoxicology 4:190-205.
	(17) Tomlin, A.D. and Miller, J.J., 1980. Development and fecundity of the manure worm, Eisenia faetida (Annelida:Lumbricidae), under laboratory conditions.  In: D.L. Dindal (ed.), Soil Biology as Related to Land Use Practices. Proc. 7th Internat. Soil Zool. Coll. of ISSS. EPA, Washington, DC., pp. 673-678.
	(18) vanGestel, C.A.M., and van Dis, W.A., 1988. The influence of soil characteristics on the earthworm Eisenia fetida andrei (Oligochaeta). Biology and Fertility of Soils 6:262-265.


[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67682-67683]
[FR Doc No: 2022-24443]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings in Existing Proceedings

    Docket Numbers: RP23-53-001.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Tariff Amendment: 11.3.22 Negotiated Rate--Shell
Energy North America (U.S.), L.P. R-2170-22 to be effective 11/1/2022.
    Filed Date: 11/3/22.
    Accession Number: 20221103-5059.
    Comment Date: 5 p.m. ET 11/10/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.

Filings Instituting Proceedings

    Docket Numbers: PR23-5-000.
    Applicants: Black Hills/Kansas Gas Utility Company, LLC.
    Description: Sec.  284.123 Rate Filing: BHKG Revised SOC and
Statement of Rates to be effective 11/1/2022.
    Filed Date: 11/3/22.
    Accession Number: 20221103-5038.
    Comment Date: 5 p.m. ET 11/25/22.

    Docket Numbers: RP23-163-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 11-2-2022 to be effective 11/2/2022.
    Filed Date: 11/2/22.
    Accession Number: 20221102-5097.
    Comment Date: 5 p.m. ET 11/14/22.

    Docket Numbers: RP23-164-000.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Compliance filing: Annual Operational Flow Order
Report 2022 to be effective N/A.
    Filed Date: 11/3/22.
    Accession Number: 20221103-5000.
    Comment Date: 5 p.m. ET 11/15/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at:
    http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: November 3, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-24443 Filed 11-8-22; 8:45 am]
BILLING CODE 6717-01-P


PAPERWORK REDUCTION ACT SUBMISSION 1. Agency/ Subagency originating request EPA/ OSWER/ OSW 2. OMB control number b.

None a. 2050 0154 3. Type of information collection ( check one) a.

New collection b. Revision of a currently approved collection c. X Extension of a currently approved collection d.

Reinstatement, without change, of a previously approved collection for which approval has expired e.

Reinstatement, with change, of a previously approved collection for which approval has expired f.

Existing collection in use without an OMB control number 4. Type of review requested ( check one) a.  Regular b.

Emergency c.

Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities?

Yes X No 6. Requested Expiration Date a.  Three years from the approval date b.

Other 7. Title Criteria for Classification of Solid Waste Disposal Facilities and Practices  40 CFR Part 257 Subpart B 8. Agency form number( s) ( If applicable) ICR # 1745.04 9. Keywords RCRA; Non Municipal, Non Hazardous Waste Disposal Facilities: Construction and Demolition Waste Disposal Facilities 10. Abstract In order to effectively implement and enforce the 40 CFR Part 257 Subpart B Criteria on a State level, owners/ operators of construction and demolition waste landfills that receive conditionally exempt small quantity generator ( CESQG) hazardous waste will have to comply with the recordkeeping and reporting requirements of 40 CFR Part 257 Subpart B.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a.

Individuals or households d.

Farms b. P Business or other for profit e. X Federal Government c.

Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a.

Voluntary b.

Required to obtain or retain benefits c. X Mandatory Primary obligation to respond: c. Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 145 b. Total annual responses 145 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 9,675 d. Current OMB inventory 11,105 e. Difference  1,430 f. Explanation of difference 1. Program Change 0 2. Adjustment  1,430 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 442 b. Total annual costs ( O& M) $ 496 c. Total annualized cost requested $ 938 d. Current OMB inventory $ 0 e. Difference $ 938 f. Explanation of difference 1. Program change 0 2. Adjustment $ 938 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a.

Application for benefits e.

Program planning or management b.

Program evaluation f.

Research c.

General purpose statistics g. X Regulatory or compliance d.

Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Paul Cassidy Phone: 703 308 7281 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Thea McManus, Director Municipal and Industiral Solid Waste Division Office of Solid Waste Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

10/ 95


P-20-0154 Sanitized Support Documents Index:
 P-20-0154 Sanitized Determination Document (linked)
 P-20-0154 Sanitized CHEM Report (attached)
 P-20-0154 Sanitized ECO Report (attached)
 P-20-0154 Sanitized ENG Report (attached)
 P-20-0154 Sanitized EXP Report (attached)
 P-20-0154 Sanitized Fate Report (attached)
 P-20-0154 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Pages 85299-85302]
[FR Doc No: 2016-28312]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79356; File No. SR-NSCC-2016-007]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing of Proposed Rule Change To Accommodate
Shorter Standard Settlement Cycle and Make Other Changes

November 18, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 7, 2016, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the clearing agency.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of amendments to NSCC's Rules &
Procedures (``Rules'') \3\ in order to ensure that the Rules are
consistent with the anticipated industry-wide move to a shorter
standard settlement cycle for certain securities \4\ from the third
business day after the trade date (``T+3'') to the second business day
after the trade date (``T+2''), as described below. The proposed rule
change would not become effective until NSCC has submitted a subsequent
proposed rule change under Rule 19b-4.\5\ Therefore, NSCC would not
implement this version of the Rules until an effective date is
established by the subsequent proposed rule change.\6\
---------------------------------------------------------------------------

    \3\ Capitalized terms not defined herein are defined in the
Rules, available at http://dtcc.com/~/media/Files/Downloads/legal/
rules/nscc_rules.pdf.
    \4\ The financial services industry, in coordination with its
regulators, is planning to shorten the standard settlement cycle for
equities, corporate and municipal bonds, unit investment trusts and
financial instruments comprised of the foregoing products traded on
the secondary market from T+3 to T+2 (the ``Shortened Settlement
Cycle''). See Securities Exchange Act Release No. 78962 (September
28, 2016), 81 FR 69240 (October 5, 2016) (S7-22-16) (Amendment to
Securities Transaction Settlement Cycle).
    \5\ 17 CFR 240.19b-4.
    \6\ NSCC will post a version of the relevant sections of the
Rules reflecting the changes as they would appear upon the
effectiveness of the subsequent proposed rule change mentioned above
and will include a note on the cover page of the Rules to advise
Members of these changes.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
(i) Background
    The standard settlement cycle has not changed since 1993, when the
Commission adopted the current version of Rule 15c6-1(a) under the
Securities Exchange Act of 1934, as amended (the ``Act''), which
(subject to certain exceptions) prohibits any broker-dealer from
entering into a contract for the purchase or sale of a security that
provides for payment and delivery later than three business days after
the trade date, unless otherwise expressly agreed to by the parties at
the time of the transaction.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 240.15c6-1.
---------------------------------------------------------------------------

    In an effort to reduce counterparty risk, decrease clearing capital
requirements, reduce liquidity demands and harmonize the settlement
cycle globally, the financial services industry has been working on
shortening the standard settlement cycle from T+3 to T+2. In connection
therewith, the Commission has proposed a rule change to shorten the
standard settlement cycle from T+3 to T+2.\8\
---------------------------------------------------------------------------

    \8\ Supra note 4.
---------------------------------------------------------------------------

    A number of provisions in the Rules currently define ``regular
way'' settlement as occurring on T+3 and, as such, would need to be
amended in connection with shortening the standard settlement cycle to
T+2. Further, certain timeframes or cutoff times in the Rules key off
the current settlement date of T+3, either expressly or indirectly. In
such cases, these timeframes and cutoff times would also need to be
amended in connection with the Shortened Settlement Cycle. Therefore,
to facilitate the anticipated industry-wide move to the Shortened
Settlement Cycle, NSCC proposes to make certain amendments to the
Rules.
(ii) Proposed Changes to the Rules
    The primary purpose of the proposed rule change is to modify the
Rules to accommodate the anticipated industry-wide move to a two-day
settlement cycle.\9\ While the core functions of NSCC will continue to
operate in the same way in the Shortened Settlement Cycle, NSCC has
determined that the move to T+2 would necessitate certain amendments to
the Rules because currently the Rules are designed to accommodate a T+3
settlement cycle. In particular, NSCC has identified and is proposing
to change (i) rules that have timeframes and/or cutoff times that are
tied to the standard settlement cycle and (ii) rules affected by
process changes relating to the Shortened Settlement Cycle. In
addition, NSCC is proposing to make a number of technical changes and
corrections to the Rules.
---------------------------------------------------------------------------

    \9\ Id.
---------------------------------------------------------------------------

A. Rules Tied to the Standard Settlement Cycle

    Certain provisions in the Rules are tied to the standard settlement
cycle because they reference timeframes and/or cutoff times that are
based on the timing of settlement. These are provisions that (i)
directly track the timeframe and/or Settlement Date of the standard
settlement cycle, (ii) address non-standard settlement cycles or (iii)
provide for timeframes and/or cutoff times that are connected to or are
affected by the timing of the standard settlement cycle, and they would
need to be changed in order to accommodate the Shortened Settlement
Cycle. As an example, the Rules contain a number of provisions that
refer to ``three days'' or ``T+3'' as the timeframe and Settlement Date
of the standard settlement cycle. These provisions would need to be
updated to reflect ``two days'' or ``T+2'' to be in conformance with
the Shortened Settlement Cycle. Similarly, a number of provisions in
the Rules refer to timeframes and Settlement Dates that are intended to
be shorter or earlier, as applicable, than the timeframe and/or
Settlement Date of the standard

settlement cycle. These provisions would also need to be changed in
order to accommodate the Shortened Settlement Cycle. Likewise, the
length and timing of certain cutoff times are based on either a
standard settlement cycle or a non-standard settlement cycle.
Therefore, when the timeframe and Settlement Date of the standard
settlement cycle and non-standard settlement cycle are changed, these
cutoff times would also need to be revised accordingly.
    NSCC is proposing changes to the following Rules because they
contain provisions that are tied to the standard settlement cycle and
would need to be changed to facilitate the move to Shortened Settlement
Cycle:
1. Rule 4A (Supplemental Liquidity Deposits)
    In Section 2, delete references to the ``third Settlement Day'' and
replace them with references to the ``second Settlement Day'' in the
definition of ``Options Expiration Activity Period.''
2. Procedure II (Trade Comparison and Recording Service)
    In Section C.1.(p), with regards to trade input and comparison of
debt securities transactions submitted for non-standard settlement,
delete the reference to ``T+2 and T+1 settlement'' and replace it with
``T+1 settlement.''
    In Section D.2.(A)(1)(b), with regards to municipal and corporate
debt securities, delete the reference to ``two days'' and replace it
with ``one day.''
    In Section F.2, with regards to the Settlement Date for the Index
Receipts, delete the reference to ``T+1, T+2 or T+3'' and replace it
with ``T+1 or T+2.''
    In Section G, with regards to the eligibility of trades to be
settled in the normal settlement cycle and the cutoff time for updating
the totals reported for such trades, delete references to ``T+3'' and
replace them with ``T+2.''
3. Procedure III (Trade Recording Service (Interface With Qualified
Clearing Agencies))
    In Section B, with regards to the Settlement Date for the exercise
or assignment of options at OCC, delete the reference to ``three days''
and replace it with ``two days.''
4. Procedure V (Balance Order Accounting Operation)
    In Section C, (i) with regards to the timing for the netting of
trades in Balance Order Securities, delete references to ``T and T+1''
and replace them with ``T'' and (ii) with regards to the listing of the
Clearance Cash Adjustment amount for all Balance Orders on the
Consolidated Trade Summary, delete the reference to the Consolidated
Trade Summary being available on T+2.
5. Procedure VII (CNS Accounting Operation)
    In Section B, (i) with regards to the timing of the comparison or
recording of trades in CNS Securities for inclusion on the Consolidated
Trade Summary, delete the words ``T+1 up to'' and (ii) with regards to
the timing of as-of trades in CNS Securities that are reported on the
Consolidated Trade Summary, delete references to ``T+2'' and ``T+3''
and replace them with ``T+1'' and ``T+2,'' respectively.
    In Section G.3, with regards to the time period for determining the
rate of the split for adjustments to Current Market Price in the case
of stock splits, delete the reference to ``last two days'' and replace
it with ``one day.''
    In Section H.4(b), (i) with regards to timing related to securities
subject to voluntary reorganizations, delete references to protect
periods of ``two days'', ``three days'' and ``greater than three days''
and replace them with ``one day'', ``two days'' and ``greater than two
days'', respectively and delete references to ``E+2'', ``E+3'' and
``E+4'' and replace them with ``E+1'', ``E+2'' and ``E+3,''
respectively, (ii) in the table listing the time frames for the
processing of securities subject to voluntary reorganizations with a
protect period, delete the reference to ``two days or less'' and
replace it with ``one day or less'' as well as delete the entries for
the 2 day protect period and (iii) with regards to the timing for the
recording of ID Net Service eligible transactions on the Miscellaneous
Activity Report, delete the words ``on the night of T+2.''
    In Section K, with regards to the timing for advising a Member
about its potential liability with respect to a short position or a
short Settling Trade position in a security to which an exercise
privilege attaches, delete the reference to ``T+2'' and replace it with
``T+1.''
6. Procedure XIII (Definitions)
    In the definition for ``T,'' delete the reference to ``T+3'' and
replace it with ``T+2.''
7. Procedure XVI (ID Net Service)
    In Procedure XVI, with regards to the timing for processing by NSCC
of ID Net Service transactions, delete references to ``the evening of
T+2'' and ``the night of T+2'' and replace them with ``the evening
prior to Settlement Date'' and ``the night prior to Settlement Date,''
respectively.
8. Addendum A (Fee Structure)
    In Section E.1, with regards to the fee for Index Creation and
Redemption instructions submitted for regular way settlement, delete
the explanatory parenthetical ``(T+3)'' and replace it with ``(T+2).''
9. Addendum K (Interpretation of the Board of Directors Application of
Clearing Fund
    In Section I.2, with regards to the endpoint of NSCC's guaranty for
balance order transactions, delete the reference to ``T+3'' and replace
it with ``T+2.''

B. Rules Covering Processes Affected by a Shortened Settlement Cycle

    NSCC conducted an in-depth review of its internal operational
processes to identify those processes that would require changes in
order to accommodate the Shortened Settlement Cycle. In connection with
that review, NSCC has identified the following provisions in the Rules
that would need to be updated in connection with such process changes:
1. Procedure V (Balance Order Accounting Operation)
    In Section B, with regards to trades that are to be processed on a
trade-for-trade basis, clarify that such processing occurs for trades
that are compared or otherwise entered into the Balance Order
Accounting Operation on SD-1, ``after the cutoff time established by
the Corporation.'' This is because under the Shortened Settlement
Cycle, trades that are compared or otherwise entered into the Balance
Order Accounting Operation on SD-1 would be processed as multilaterally
netted balance orders when reported on the Consolidated Trade Summary
issued at approximately 12:00 p.m. ET on SD-1. Trades compared and
reported thereafter would continue to be processed on a trade-for-trade
basis.
    Similarly, in Section B, with regards to trades that are to be
processed on a trade-for-trade basis, clarify that such process occurs
for securities that are subject to a voluntary corporate reorganization
which have a trade date on or before the expiration of the voluntary
corporate reorganization and which are compared or received ``on SD-1,
after the cutoff time established by the Corporation'' and not ``after
SD-1.'' This shift in cutoff time is because ``as of'' regular way
trades compared and received prior to 11:30 a.m. on SD-1 would be
processed as multilaterally netted balance orders when reported on the
Consolidated Trade Summary issued at approximately 12:00 p.m. ET on SD-
1. ``As of'' regular way trades compared

and reported thereafter would continue to be processed on a trade-for-
trade basis.
2. Procedure VII (CNS Accounting Operation)
    In Section D.1, with regards to the timing of the distribution of
Projection Reports, delete the reference to ``[e]ach morning'' and
replace it with ``[t]wice a day'' because currently NSCC distributes
the Projection Report only once a day; however, after the
implementation of the Shortened Settlement Cycle, NSCC would be
distributing the Projection Reports twice a day to enable Members to
view their updated positions on a more timely basis.

C. Other Technical Changes and Corrections

    During its review of the Rules in connection with the Shortened
Settlement Cycle, NSCC has identified the following technical changes
and/or corrections that it proposes to make to the Rules in order to
ensure that the Rules remain consistent and accurate.
    1. In Rule 3, Section 1(c), add a footnote that identifies the term
``CUSIP'' as a registered trademark of the American Bankers
Association.
    2. In Procedure II, Section G, correct a grammatical error.
    3. In Procedure VII, Sections B and D, correct grammatical errors.
    4. In Procedure X, Section B, delete the reference to the timeframe
for the delivery of Liability Notices to the contra party by Members
holding the receive balance orders for warrants, rights, convertible
securities or certain other securities so the Members would remain
solely subject to the schedules of the relevant exchanges.
    5. In Procedure XIII, delete the incorrect reference to
``Settlement Day'' and replace it with ``Settlement Date'' in the
definition for ``T'' to clarify that T+2 would normally be the
Settlement Date after the implementation of the Shortened Settlement
Cycle.
    6. In Procedure XVI, correct a grammatical error.
Implementation Timeframe
    The proposed rule change would not become effective until NSCC has
submitted a subsequent proposed rule change under Rule 19b-4.\10\
Therefore, NSCC would not implement this version of the Rules until an
effective date is established by the subsequent proposed rule change.
NSCC anticipates that the implementation date would correspond with the
industry's transition to a T+2 settlement cycle, which is currently
anticipated to be in September 2017.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4.
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2. Statutory Basis
    NSCC believes the proposed rule change is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to NSCC.
    In particular, Section 17A(b)(3)(F) of the Act requires, in part,
that NSCC's Rules be designed to promote the prompt and accurate
clearance and settlement of securities transactions and to protect
investors and the public interest.\11\ NSCC believes that the proposed
changes are consistent with the requirements of Section 17A(b)(3)(F)
because by changing the timeframes and/or cutoff times that are based
on timing of settlement to accommodate the Shortened Settlement Cycle,
the proposal would ensure that securities transactions would be
promptly and accurately cleared and settled within the industry
standard settlement cycle. Similarly, the related process changes
proposed are designed to update NSCC's operations in order to
facilitate the move to the Shortened Settlement Cycle and, by
extension, facilitate the prompt and accurate clearance and settlement
of securities transactions submitted to NSCC for clearing and
settlement. Therefore, NSCC believes the proposed rule change promotes
the prompt and accurate clearance and settlement of securities
transactions, consistent with Section 17A(b)(3)(F) of the Act.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
    \12\ Id.
---------------------------------------------------------------------------

    In addition, the proposed changes to (i) update the Rules to remove
references to the settlement timeframes or Settlement Dates that would
be rendered incorrect by the Shortened Settlement Cycle and (ii) make
other technical changes and corrections as described in detail above
would provide additional clarity to Members of their rights and
obligations under the Rules and ensure technical accuracy of the Rules.
Therefore, NSCC believes these proposed changes would protect investors
and the public interest, consistent with the requirements of Section
17A(b)(3)(F) of the Act.\13\
---------------------------------------------------------------------------

    \13\ Id.
---------------------------------------------------------------------------

    For the reasons noted above, NSCC believes that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to NSCC.
(B) Clearing Agency's Statement on Burden on Competition
    NSCC does not believe that the proposed rule changes would impose
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.\14\ While the anticipated
industry-wide move to the Shortened Settlement Cycle would likely have
an impact on competition because the cost of required system changes
for individual firms to shift from a T+3 to T+2 settlement may have a
disproportionate impact on those firms with relatively smaller revenue
bases, NSCC does not believe that the proposed rule changes themselves
would have a significant impact on competition because they are
operational in nature and consist of changes to processing timeframes
and cutoff times for NSCC's services. Moreover, NSCC believes that the
proposed rule changes are necessary because they are required to
facilitate and accommodate the anticipated move to the Shortened
Settlement Cycle and are appropriate in that they have been
specifically tailored to be in conformance with the requirements of the
Shortened Settlement Cycle. Therefore, NSCC does not believe that the
proposed rule changes would impose any burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received from Members, Participants, or Others
    NSCC has not received any written comments relating to this
proposal. NSCC will notify the Commission of any written comments
received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self- regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NSCC-2016-007 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2016-007. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of NSCC and on
DTCC's Web site (http://dtcc.com/legal/sec-rule-filings.aspx). All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NSCC-2016-007 and should be
submitted on or before December 16, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-28312 Filed 11-23-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 250 (Wednesday, December 30, 2020)]
[Notices]
[Page 86591]
[FR Doc No: 2020-28810]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90785]

Acknowledgement of Receipt of Notice of Registration as a
National Securities Exchange Pursuant to Section 6(g) of the Securities
Exchange Act of 1934 by the Minneapolis Grain Exchange, LLC

December 22, 2020.
    Section 6(g) of the Securities Exchange Act of 1934 (``Exchange
Act'') \1\ provides that an exchange that lists or trades security
futures products may register as a national securities exchange solely
for the purposes of trading security futures products by filing a
written notice with the Securities and Exchange Commission
(``Commission'') if: (1) The exchange is a board of trade, as that term
is defined by the Commodity Exchange Act (``CEA''),\2\ that has been
designated a contract market by the Commodity Futures Trading
Commission (``CFTC'') and such designation is not suspended by order of
the CFTC; and (2) such exchange does not serve as a market place for
transactions in securities other than security futures products or
futures on exempted securities or groups or indexes of securities or
options thereon that have been authorized under Section 2(a)(1)(C) of
the CEA.\3\ Rule 6a-4 under the Exchange Act \4\ requires that such an
exchange submit written notice of registration to the Commission on
Form 1-N.\5\ Under Exchange Act Section 6(g)(2)(B), an exchange's
registration as a national securities exchange becomes effective
contemporaneously with the submission of the written notice on Form 1-
N.\6\
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    \1\ 15 U.S.C. 78f(g).
    \2\ 7 U.S.C. 1a(2).
    \3\ 7 U.S.C. 2(a)(1)(C).
    \4\ 17 CFR 240.6a-4.
    \5\ Under Rule 202.3(b)(3) of the Commission's Informal and
Other Procedures, upon receipt of a Form 1-N, the Division of Market
Regulation (now the Division of Trading and Markets) examines the
notice to determine whether all necessary information has been
supplied and whether all other required documents have been
furnished in proper form. 17 CFR 202.3(b)(3).
    \6\ 15 U.S.C. 78f(g)(2)(B).
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    On December 11, 2020, the Minneapolis Grain Exchange, LLC
(``MGEX'') filed a Form 1-N with the Commission.\7\ Pursuant to Section
6(g)(3) of the Exchange Act,\8\ the Commission hereby acknowledges
receipt of the Form 1-N submitted by MGEX. Copies of the Form 1-N,
including all exhibits, are available in the Commission's Public
Reference Room.
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    \7\ This Form 1-N is being filed by MGEX in connection with a
Commission exemptive order issued under Section 36 of the Exchange
Act. See Securities Exchange Act Release No. 90510 (November 20,
2020), 85 FR 77297 (December 1, 2020) (``Exemptive Order''). The
Exemptive Order relates to listing and trading contracts for sale
for future delivery on the SPIKES Index on MGEX consistent with the
terms and conditions set forth in the order.
    \8\ 15 U.S.C. 78f(g)(3).
---------------------------------------------------------------------------

    For questions regarding this Release, please contact David
Dimitrious, Senior Special Counsel, at<PHONE_NUMBER>, Michou Nguyen,
Special Counsel, at<PHONE_NUMBER>, or Eli Kozminsky, Attorney-Adviser,
at<PHONE_NUMBER>; Division of Trading and Markets, Securities and
Exchange Commission, 100 F Street NE, Washington, DC 20549.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(75).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2020-28810 Filed 12-29-20; 8:45 am]
BILLING CODE 8011-01-P