United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-015
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.3200:

Soil Microbial Community 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 850.3200: Soil microbial community 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 material used in developing this harmonized OCSPP test guideline is the OPPT guideline under 40 CFR 797.3700 Soil Microbial Community Toxicity Test.  This guideline was formerly Public Draft OCSPP 850.5100 (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.  The guideline prescribes a test using natural soil samples to develop data on the toxicity of test substances to microbial populations indigenous to the soil.  The Environmental Protection Agency will use data from these tests to assess the hazard a test substance may present in the environment.
(c) Definitions.  The definitions in OCSPP 850.3000 apply to this guideline. The more specific definitions in this paragraph also apply:
	Ammonification is conversion of organic nitrogen compounds to ammonia (NH3) or to ammonium ion (NH4) compounds, performed by a variety of microorganisms in soil and water.
	Carbon dioxide (CO2) efflux is the evolution of CO2 gas from substrates mineralized by microbial action, indicative of respiration.
	kiloPascal (kPa) is a unit of pressure in the meter-kilogram-second system equivalent to one newton per square meter (i.e., 1 Pa x 1,000) used as a measure of water availability in soils.
	Mineralization is the complete or ultimate degradation by microorganisms of organic material to form inorganic end-products, e.g., carbon dioxide, water, chloride, ammonium, nitrates, or orthophosphate.
	Nitrification is the oxidation of ammonium salts to nitrites (NO2) and nitrates (NO3), performed by relatively specialized microorganisms.
	Surface soil is that layer of soil representing the top 15 centimeters (cm) of the area to be sampled, excluding the litter horizon.
(d) General considerations--
      (1) Summary of the test.  Surface soil is sieved and supplemented with ground, dry alfalfa.  The test substance, if soluble, is added as a solution to moisten the soil, or is added in a manner that best simulates its anticipated mode of entry in nature.  All soil samples are then incubated in darkness at approximately 22 degrees Celsius (°C).  On days 5 and 28 after introduction of the test substance, samples are analyzed for NH3 and NO3 content to establish ammonification and nitrification values, respectively, and for CO2 efflux as an indication of microbial respiration.
	(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 if definitive testing is necessary and, if so, the concentrations of test substance to be used in the definitive test.  If the maximum concentration of test substance to which the soil microbial community is likely to be exposed in nature can be predicted, soil samples should be treated with concentrations that are 0.1, 1, and 10 times the anticipated environmental exposure concentration.  Should reasonable predictions of anticipated environmental exposure concentrations not be possible, soil samples should be exposed to a series of widely spaced concentrations of the test substance (e.g., 1, 10, 100, 1,000, 10,000 micrograms (ug) test substance per gram (g) of soil).  The test should consist of exposing at least two samples of soil from the same source to each concentration of test substance and to each control.  Two samples are the minimum number used for measurement of test endpoints.  The details of the test do not have to be the same as for definitive testing.  Treatment replication is not needed and nominal concentrations of the chemical are acceptable.  However, the range-finding test will be more useful the greater the similarity between the range-finding test and the definitive test.  Report results of range-finding tests along with the results of the definitive test, if range-finding tests are conducted.
	(4) Definitive test.  The purpose of the definitive test is to evaluate the toxicity of the test substance to the community of microorganisms residing in a particular soil and to delineate the concentration-response curve and EC50 (with 95 percent (95%) confidence intervals) for each of three variables (CO2 evolution and NH3 and NO3 soil content) that indicate the capacity of the soil microbial community to decompose organic matter and release plant nutrients.  The slopes of the concentration-response curves, associated standard errors, and the 95% confidence intervals of the slopes should also be determined.  For this determination, a minimum of five concentrations of the test chemical, plus appropriate controls, are tested.  For each soil source tested, the concentration range should be selected to define, as closely as possible, the concentration-response curve between the EC10 and EC90 for each variable.  Analytical confirmation of the test concentrations is performed as described in OCSPP 850.3000.
(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.  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 after application of the test substance.
      (3) Test organism.  No particular species of test organisms are recommended for use in this test due to the emphasis placed on maintaining the natural state of the soil samples and their resident populations of microorganisms.  The test organisms are those that occur naturally in the soil; no other test organisms are introduced into the system.  Within a given test, all soil, including that of the controls is from the same source.
      (4) Administration of test substance.  Depending upon the properties of the test substance, it is added via a stock solution (aqueous or solvent vehicle) to the soil, adsorbed onto the soil, or directly mixed into the soil.
            (i) Preparation methods.
                  (A) Reagent water should be used in making stock solutions of a water-soluble test substance.  Sufficient quantities of each concentration should be available to minimize storage time and disposal volume.  A constant volume of the stock solution should be added at the beginning of the test to each soil sample designed to receive the test substance.  OCSPP 850.3000 contains additional information on the preparation of stock solutions.
                  (B) A test substance that is insoluble in water, but which can be suspended in an aqueous solution by a vehicle, should be added, with the vehicle, to those soil samples designated to receive the test substance.  The vehicle should be soluble in water, nontoxic to microbial life at the concentration applied, and used in a minimal amount to dissolve or suspend the test substance.  There are no preferred vehicles; however, acetone, gum arabic, ethanol, and others have been used extensively in testing herbicides, plant growth regulators, fungicides, and other chemical substances that affect plants.  Any such vehicle may be used for this test, providing it neither enhances nor inhibits the activities of the soil microbes.  Vehicle controls are included in the experimental design and tested simultaneously with the test substance, if a vehicle is used. OCSPP 850.3000 contains additional information on preparation of stock solutions using vehicles.
                  (C) A water-insoluble test substance for which no nontoxic, water-soluble vehicle is available should be dissolved in an appropriate volatile solvent.  The solution should be mixed with the ground alfalfa soil supplement, then placed in a rotary vacuum apparatus and evaporated, leaving a uniform coating of the test substance on the alfalfa.  A portion of the alfalfa is then weighed; the test substance extracted with the same organic solvent, and then the test substance is assayed before the alfalfa is mixed with the soil in the test containers.  Solvent controls (i.e., alfalfa treated only with solvent) should be included in the experimental design and tested simultaneously with the test substance.
                  (D) If the test substance is not readily soluble in water or in another commonly used vehicle, and is known to be applied or transported in nature directly to the soil as a previously prepared liquid or powder, it should be mixed, in its liquid or dry form, directly into the soil samples.  To ensure equal distribution of the test substance throughout each test sample, mix thoroughly.
            (ii) Test concentrations.  For this determination, a minimum of five treatment levels of the test chemical, plus appropriate controls, are tested.
            (iii) Soil.  To be appropriate for this guideline, a soil should possess a pH of 4 to 8, organic matter content between 1% and 8%, a cation exchange capacity (CEC) greater than 7 milliequivalents per 100 grams, and consist of less than 70% sand.  Soils to which fertilizer or pesticide(s) have been applied within the past 24 months should be avoided.  Soil collections should be restricted to the surface soil.  Large objects should be removed manually, and the remaining soil allowed to air-dry until sievable (approximately 12% water content), after which it is passed through a 2-millimeter (mm) mesh screen.  For each sample, an amount of soil equivalent to approximately 50 grams (g) oven-dry weight should be placed in an inert container.  At least one of these samples, considered to provide a baseline measurement, should be extracted immediately to determine NH3 and NO3 content (see paragraph (d)(4) of this guideline).  Alfalfa, dried and ground to pass through a 0.6-mm mesh screen should be added (0.3 g) to each remaining sample and the sample should be thoroughly mixed.  Water content of the soil should be adjusted to approximately 10 kPa by adding reagent (distilled, deionized or reverse osmosis) water containing the desired concentration of test substance (in vehicle, if necessary).  If insoluble in both water and commonly used vehicles, the test substance should be mixed into the soil as a solid and the appropriate amount of water added subsequently.  The test containers may be covered with 0.13 um (0.5 mil) polyethylene to minimize water loss, yet permit gas exchange, or left open and watered to their original weight every 7 days.  Regardless, the test substance should be applied only during the original watering.
	(5) Controls.
            (i) Every test includes a negative control, and a vehicle (solvent) control if a vehicle is used.  Controls consist of the same soil, soil supplements, test conditions, and procedures, except that no test substance is added.
            (ii) If an aqueous stock solution was used to prepare test concentrations, controls should receive an equal volume of reagent water without the test substance.  If a vehicle was used to dissolve or suspend the test substance, a vehicle control (i.e., solvent in water without the test substance) should also be included.  Should the test substance be a powder that is mixed directly into soil and subsequently moistened with distilled water; the control should receive an equal volume of such water only.
      (6) Number of replicates.  A total of 10 replicates of each test substance concentration, control, and vehicle control (if applicable) are used.  This provides two sets of five replicates, one set for the analyses conducted 5 days after test substance application and one set for the analyses conducted 28 days after test substance application.  The assignment of soil containers to test substance concentrations should be random.  In addition, placement of the containers in the incubation chamber should be randomized.
	(7) Facilities, apparatus and supplies --
            (i) Environmental chambers or incubators.  Environmental chambers or incubators should provide adequate space and controls necessary to incubate numerous soil samples in total darkness at a constant temperature for prolonged periods of time.  Chambers should be designed to prevent escape of internal air into the external environment other than through appropriate filtering material or media to prevent contamination of the external environment with the test substance.
            (ii) Test containers.  For each test, at least 60 to 70 soil containers (two series of five per concentration of test substance, two series of five for the control, and two series of five if a vehicle control is necessary) should be used.  In addition, soil to be extracted immediately as the control is most easily handled in an identical container.  All containers used in each experiment should be of equal size and volume, posses the same configuration, and should be made of the same inert material.  Wide mouth jars (for example, glass canning, 0.5 pint or 110-millilitre (mL) capacity) are adequate for this purpose.  Test containers may be covered with polyethylene film (0.13 micrometer (um); 0.5 mil) to prevent water loss.  Control containers should be handled identically to the test containers except that none of the test substance is added.
            (iii) Cleaning and sterilization.
                  (A) Soil containers and test solution storage containers should be cleaned before use.  All equipment should be washed to remove any residues remaining from manufacturing or prior use.  A dichromate solution should not be used for cleaning containers.
                  (B) If cleaning and rinsing of previously used soil containers has been thorough, the effects of any microorganisms remaining on the interior surface of the containers should be insignificant in the presence of the new test soil.  Sterilization should not be necessary, but is considered an acceptable option.
                  (C) Soil treated with the test substance and solvent control soil should be discarded at the end of the experiment.  Disposal should conform to applicable regulations.
      (8) Environmental conditions.  Environmental conditions should be maintained as follows:
            (i) Temperature.  The temperature should be 22 °C (or that temperature to which the microorganisms are most accustomed in nature) and it should be constant within +- 2°C during the test.
            (ii) Lighting and photoperiod.  Total darkness should be used during incubation to prevent photosynthesis by algae or the growth of moss.

      (9) Observations --
            (i) Measurement of test substance.  Analytical confirmation of the concentration of test substance in the stock solutions and/or in the soil should be performed as described in OCSPP 850.3000.  Validated analytical methods are used to measure the amount of test substance in a sample before beginning the test, as described in OCSPP 850.3000.
            (ii) Environmental conditions --
                  (A) Temperature.  Temperature in the incubation chamber should be monitored continuously.
                  (B) Stock solution pH.  The pH of the stock solutions should be measured before use.
		(iii) Measures of effect --
                  (A) Soil ammonia, nitrate and nitrogen content and carbon dioxide efflux.  Of the soil samples prepared for each test concentration or control, one set of five replicate samples should be assayed after 5 days of exposure to the test substance for NH3 and NO3 content, and then discarded.  A second set of 5 replicate samples should be analyzed the same day for CO2 evolution and then reincubated (dark, 22 °C).  On day 28 after exposure to the test substance, all remaining (reincubated) samples should be assayed first for CO2 efflux and then again for nitrogen content.
                  (B) Microorganisms.  On days 5 and 28 after introduction of the test substance, the effects of treatment should be assessed as the CO2 efflux rate and the NO3 and NH3 concentrations per gram of dry soil in treated samples, relative to untreated controls and, if applicable, vehicle controls, and to values in freshly sieved (pretreatment) soil.
                        (1) To measure CO2 efflux, each test container is closed with a two-hole stopper fitted with Teflon tubes and twistcock connectors for attachment to the measurement apparatus.  The apparatus (see Figure 1) should deliver a stream of humid, CO2-free air to the test system, and the effluent air should be dried, diluted, and delivered for infrared gas analysis (IRGA).  The period of incubation should be adjusted to match the CO2 efflux rate with the detection capability of the IRGA, and may vary from 1 to 77 hours.  In lieu of IRGA, CO2 may be trapped in a hydroxide solution and titrated, or measured by gas chromatography.  CO2 efflux rates are expressed in terms of micrograms per gram of dry soil per hour.
	Figure 1. -- Flow Diagram for the IRGA Method of Determining CO2 Evolution from Soil Samples

                        (2) Accumulation of inorganic nitrogen is measured by extracting each soil sample with 80 mL of 1 normal potassium chloride (N KCl) solution.  After adding KCl and shaking each container by hand to suspend the soil, sample containers should be placed on a rotary shaker at high speed for 1 hour, then shaken again by hand to resuspend the soil.  Samples should be filtered (Whatman 42 low-nitrate filter paper) and the extract (filtrate) should be analyzed for NO3 and NH3.  EPA or ASTM methods should be used for these analyses.  NO3 and NH4 concentrations are expressed in terms of micrograms per gram of dry soil.
(f) Treatment of results --
      (1) Data summary --
            (i) Environmental conditions.  Temperature data should be summarized in tabular form, showing the mean, standard deviation, and range of temperature during the test.
            (ii) Carbon dioxide efflux rates, and soil nitrate and ammonia content.  CO2 efflux rates and NO3 and NH3 concentrations in treated samples and from untreated controls, aqueous or solvent vehicle controls (if a vehicle is used), and from the freshly sieved, pretreatment soil should be summarized in tabular form by observation date.  Means and standard deviations should be plotted for each treated sample and each control.
      (2) NOEC.  The significance of differences between means may be established using analysis of variance and a multiple range test such as Dunnett's.  These hypothesis-testing procedures can be used to determine NOEC and LOEC values based upon the CO2 efflux, nitrification and ammonification.
      (3) Concentration-response curve, slope, and EC50.  The EC50 for each of CO2 efflux, nitrification and ammonification should be determined.  Appropriate statistical analyses should provide a goodness-of-fit determination for the concentration-response curves.  Standard error and 95% confidence intervals for the calculated EC50 values are to be included.  The slope of the concentration-response curve, its standard error, and 95% confidence interval should also be reported.
      (4) Statistical methods.  Statistical procedures for modeling continuous data are available and should be used.  Additional discussion about 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.  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 Soil Microbial Community Toxicity Test
Test type
Spiked natural soil
Test duration
28 days
Substrate
Soil, < 70% sand, pH of 4 - 8, organic content 1 - 8%, CEC > 7 meq/100 g; sieved to 2 mm
Temperature
22 °C (constant during test within +- 2 [o]C)
Lighting
Complete darkness at all times
Test container size
Sufficient to contain 50 g soil (e.g., 0.5 pint jars)
Number of replicate containers per test treatment
10 (minimum)
Test treatment levels
Minimum of 5 treatment levels plus appropriate controls
Test substance application method
Via aqueous stock solution, vehicle stock solution, adsorbed to the alfalfa supplement, or directly mixed into the soil.
Measures of effect (Measurement endpoints)
EC50 and NOEC/LOEC based upon CO2 efflux, ammonification and nitrification at day 5 and 28

(h) Test validity.  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 their effects on test endpoints noted and discussed.
	Table 2. -- Test validity elements for the soil microbial community toxicity test
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1. All test containers were not identical and did not contain the same amount of soil from the same source.

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2. Untreated (negative controls) and appropriate solvent controls were not included in a test.

(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 of preparation of the test substance in the range-finding and definitive test: description of test chemical introduction into the test medium (e.g., directly mixed, as an aqueous or solvent stock solution, or adsorbed onto the alfalfa supplement), the mass and volume of soil and test substance used for each treatment, how test substance was mixed into the soil.
      	(iv) For the definitive test, the number of treatments and nominal concentration at test initiation of the test substance per unit dry weight of test soil when the test substance is introduced as dissolved in water, solubilized with a vehicle, or coated on the alfalfa supplement and/or mixed directly into the soil.
      	(v) Description of stock solution preparation: 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 and controls, pH of test solutions applied to the soil samples.
      (4) Soil microorganisms.
            (i) Source of the test soil, the type of ecosystem from which it was removed, its chemical and physical characteristics (mechanical analysis), and any available geological information including soil type (classification).
            (ii) Collection method, storage, and handling of test soil prior to introduction of test substance.
		(iii) Source of alfalfa and amount added to soil.
      (5) Test system and conditions.  Description of the test system and conditions used in the definitive test and any preliminary range-finding tests.
            (i) Description of the test containers: type, size, volume, material, and conditioning method.
      	(ii) Description of incubation chamber: type and size.
      	(iii) Volume and weight of soil used in each test container.
      	(iv) Number of replicates per treatment level and control group(s).
      	(v) Frequency and methods of adding water to soil containers during the test period.
      	(vi) Description of experimental design and/or arrangement of equipment, including a diagram, if complex.
      	(vii) Methods used to determine the placement of soil containers in the incubation chamber and the assignment of test concentrations to containers to ensure randomization of exposure.
      	(viii) Test duration.
      	(ix) Methods and frequency of environmental monitoring performed during the definitive test for temperature and humidity.
      	(x) Method, type and frequency of observations made on soil microorganisms during the test.
      	(xi) For the definitive 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 (temperature and humidity) in tabular form (provide raw data for measurements not made on a continuous basis), and descriptive statistics (mean, standard deviation, minimum, maximum).
      	(ii) Micrograms of CO2 evolved per gram of dry soil per hour, and micrograms of each of NH3 and NO3 present per gram of dry soil, by soil source and treated and untreated samples at day 5 and 28 in tabular form (provide raw data).
      	(iii) For the definitive test, report the 5-day and 28-day EC50 values, with 95% confidence intervals for ammonification, nitrification, and CO2 evolution.  The slopes of the concentration-response curves, associated standard errors, and the 95% confidence intervals should be reported as well.
      	(iv) Description of statistical method(s) used, including software package, for determining EC50, LOEC and NOEC, 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.  The references in this paragraph should be consulted for additional background material on this test guideline.
      (1) Hammons, A.S. (Ed.), 1981. Methods for ecological toxicology. A critical review of laboratory multispecies tests. ORNL-5708. EPA-560/11-80-026, Office of Toxic Substances, U.S. EPA, Washington, DC and Oak Ridge National Laboratory, Oak Ridge, TN.


[Federal Register: August 12, 2009 (Volume 74, Number 154)]
[Notices]
[Page 40577-40578]
[DOCID:fr12au09-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2696-033]

Albany Engineering Corporation; and Town of Stuyvesant; Notice of
Application Tendered for Filing With the Commission and Soliciting
Additional Study Requests

DATES: August 5, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: P-2696-033.
    c. Date filed: July 31, 2009.
    d. Applicants: Albany Engineering Corporation and the Town of
Stuyvesant.
    e. Name of Project: Stuyvesant Falls Hydroelectric Project.
    f. Location: The existing project is located on Kinderhook Creek
(in the Hudson River drainage basin) in the town of Stuyvesant,
Columbia County, New York. The project does not occupy any Federal
lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Mr. James A. Besha, P.E., President, Albany
Engineering Corporation, 5 Washington Square, Albany, New York 12205;
(518) 456-7712.
    i. FERC Contact: Carolyn Templeton at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, State, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item (l) below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or

person believes that an additional scientific study should be conducted
in order to form an adequate factual basis for a complete analysis of
the application on its merit, the resource agency, Indian Tribe, or
person must file a request for a study with the Commission not later
than 60 days from the date of filing of the application, and serve a
copy of the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: September 29, 2009.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    Additional study requests and requests for cooperating agency
status may be filed electronically via the Internet in lieu of paper.
The Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov/docs-filing/ferconline.asp) under the ``efiling''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.''
    m. The application is not ready for environmental analysis at this
time.
    n. The Stuyvesant Falls Hydroelectric Project consists of the
following existing facilities: (1) A 13-foot-high, 240-foot-long,
masonry gravity dam with a Taintor gate and trash sluice near the south
abutment; (2) a 46-acre reservoir with a normal pool elevation of 174.3
feet USGS datum; (3) two 7.5-foot-diameter, 2,860-foot-long, riveted-
steel pipelines; (4) a 25-foot-diameter surge tank; (5) two 200-foot-
long steel penstocks; (6) a powerhouse containing a single 2.8-megawatt
generating unit; and (7) other appurtenances.
    The following generating equipment is proposed as part of the new
license: (1) A minimum flow turbine located in the powerhouse utilizing
a rated flow range of 10--65 cubic feet per second (cfs) and rated at
590 horsepower at 97 feet of head directly connected to a 440-kVA
generator; and (2) a minimum flow turbine utilizing a rated flow range
of 15 cfs and rated at 37 horsepower at 30 feet of head, directly
connected to a 35-kVA generator and located at the existing dam and
intake, and discharging directly to the current bypass reach
immediately below the dam via an equalizing weir.
    No new transmission lines are proposed for this project. The
following equipment would be procured and installed to replace
equipment previously removed from the project: (1) A new step up
transformer and 50-foot generator leads; and (2) a new 34.5-kilovolt
(kV) primary circuit breaker, adjacent to the proposed step up
transformer and 34.5-kV, 40-foot primary leads to an existing adjacent
Niagara Mohawk Power Corporation substation.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item (h) above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    p. With this notice, we are initiating consultation with the New
York State Historic Preservation Officer, as required by Sec.  106,
National Historic Preservation Act, and the regulations of the Advisory
Council on Historic Preservation, 36, CFR, at 800.4.
    q. Procedural schedule: The application will be processed according
to the following Hydro Licensing Schedule. Revisions to the schedule
will be made as appropriate.
    Issue deficiency letter; September 2009.
    Issue acceptance letter; January 2010.
    Issue Scoping Document 1 for comments; February 2010.
    Request additional information; March 2010.
    Issue Scoping Document 2; April 2010.
    Notice of application is ready for environmental analysis; April
2010.
    Notice of the availability of the draft EA; December 2010.
    Notice of the availability of the final EA; April 2011.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-19269 Filed 8-11-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 79 (Monday, April 25, 2011)]
[Rules and Regulations]
[Pages 22825-22827]
[FR Doc No: 2011-10026]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 98

[EPA-HQ-OAR-2009-0923; FRL-9299-1]

Mandatory Reporting of Greenhouse Gases: Petroleum and Natural
Gas Systems

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; Grant of reconsideration.

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SUMMARY: On November 30, 2010 EPA promulgated Subpart W: Petroleum and
Natural Gas Systems of the Greenhouse Gas Reporting Rule. As part of
the provisions outlined in this rule, the EPA stated that the Agency
would allow certain owners or operators to use best available
monitoring methods (BAMM) in lieu of specified parameters outlined for
calculating greenhouse gas emissions for the petroleum and natural gas
systems source category of the greenhouse gas reporting rule. EPA is
giving notice that the Agency has initiated the reconsideration process
in response to requests for reconsideration of certain provisions in
the regulations. First, EPA has been asked to reconsider the
requirement to submit requests to use best available monitoring methods
during the 2011 calendar year by April 30, 2011 and pursuant to its
authority under CAA section 307(d)(7)(B) consequently is extending the
deadline contained in those provisions until July 31, 2011. Second, EPA
has also been asked to reconsider the time period during which owners
and operators of certain specific sources could automatically use BAMM
without having to request approval by the Administrator. As a result of
this second request, pursuant to its authority under CAA section
307(d)(7)(B) EPA is also extending the date by which owners and
operators of certain specific sources would not be required to request
approval by the Administrator for the use of BAMM from June 30, 2011
until September 30, 2011.

DATES: This rule is effective on April 30, 2011.

FOR FURTHER INFORMATION CONTACT: Ms. Carole Cook, Climate Change
Division, Office of Atmospheric Programs (MC-6207J), Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460;
telephone number<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background Information

    The EPA published Subpart W: Petroleum and Natural Gas Systems of
the Greenhouse Gas Reporting Rule on November 30, 2011, 40 CFR Part 98,
Subpart W (75 FR 74458)(Subpart W). Included in the final rule were new
provisions allowing owners or operators the option of using best
available monitoring methods for specified parameters in 40 CFR 98.233.
Subpart W provides that owners or operators wishing to use BAMM during
2011 for emissions sources listed in 40 CFR 98.234(f)(4)or
98.234(f)(5)(iv) must submit BAMM applications by April 30, 2011. In
addition, subpart W provides that owners or operators with emissions
sources listed in 40 CFR 98.234(f)(2) or 40 CFR 98.234(f)(3) have the
option of using BAMM from January 1, 2011 to June 30, 2011 without
submitting a request to the Administrator for approval to use BAMM;
however to extend use of BAMM beyond June 30, 2011, those owners or
operators must submit a request to the Administrator by April 30, 2011.
    Following the publication of Subpart W in the Federal Register,
several industry groups sought reconsideration of several provisions in
the final rule, including the provisions requiring submittal of BAMM
requests for use or extension of BAMM in calendar year 2011 by April
30, 2011, and the time period for which owners or operators of sources
in 40 CFR 98.234(f)(2) or 40 CFR 98.234(f)(3) would not be required to
submit a BAMM request to the Administrator for approval, i.e., January
1 through June 30, 2011.
    By letter dated January 31, 2011, the American Petroleum Institute
(API) stated that ``[a]ggressive deadlines for BAMM are problematic for
reporters who are attempting to monitor GHG emissions for the first
time. In particular, the April 30, 2011 deadline for BAMM requests does
not provide reporters sufficient time to identify the sources for which
BAMM should be requested and gather the data that EPA requires be
submitted with a BAMM request.'' API, along with the Gas Processors
Association (GPA), Interstate Natural Gas Association of America
(INGAA), Chesapeake Energy Corporation (CEC)/American Exploration &
Production Council (AXPC), stated that they would not be able to
complete an initial assessment of their facilities to determine whether
they would need BAMM by the deadline of April 30, 2011. Further, a
subset of these petitioners further noted that the time period for
which owners and operators were granted the optional use of BAMM
without being required to submit a request to the Administrator for
approval was insufficient for them to make the necessary assessment of
their facilities to determine compliance with the rule.
    EPA believes that pursuant to CAA section 307(d)(7)(B) it is
appropriate to extend the deadlines in 40 CFR 98.234(f)(5)(iii)(A),
98.234(f)(5)(iv)(A), 98.234(f)(6)(i), and 98.234(f)(7)(i) by three
months, to allow owners and operators additional time to assess which
of their facilities would need to take advantage of the BAMM provisions
of Subpart W for calendar year 2011. EPA also believes that pursuant to
CAA section 307(d)(7)(B) it is appropriate to extend the deadlines, by
three months, by which owners and operators of emission sources listed
in 40 CFR 98.234(f)(2) or 40 CFR 98.234(f)(3), would have the option to
use BAMM without submitting a request for approval from the
Administrator to allow additional time to asses applicability of the
rule provisions to their facilities. EPA is taking no action at this
time on other issues raised by petitioners in their respective
Petitions for Reconsideration and reserves the right to further
consider those issues at a later time.
    Pursuant to Clean Air Act (CAA) section 307(d)(7)(B), EPA is
extending the deadlines in 40 CFR 98.234(f)(5)(iii)(A),
98.234(f)(5)(iv)(A), 98.234(f)(6)(i), and 98.234(f)(7)(i) for three
months, i.e., until July 31, 2011.
    Further, pursuant to CAA section 307(d)(7)(B) EPA is also extending
the deadlines contained in 40 CFR 98.234(f)(2), 40 CFR 98.234(f)(3), 40
CFR 98.234(f)(5)(i), 40 CFR 98.234(f)(5)(ii), 40 CFR 98.234(f)(6), 40
CFR 98.234(f)(6)(ii)(D), 40 CFR 98.234(f)(6)(iii), 40 CFR 98.234(f)(7),
and 40 CFR 98.234(f)(7)(iii) for three months, i.e., until September
30, 2011.
    Section 553 of the Administrative Procedure Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good

cause finds that notice and public procedure are impracticable,
unnecessary or contrary to the public interest, the agency may issue a
rule without providing notice and an opportunity for public comment.
EPA has determined that there is good cause for making today's rule
final without prior proposal and opportunity for comment. We are acting
pursuant to CAA section 307(d)(7)(B) to extend these deadlines in part
because both the affected universe of facilities subject to the rule
and the substantive requirements associated with the BAMM provisions in
the rule could change as a result of this reconsideration process. In
addition, we are extending these provisions to allow owners and
operators of affected facilities additional time to appropriately
assess their facilities to determine if it will be necessary for them
to apply for BAMM during calendar year 2011. Because we cannot predict
the resulting outcome of the reconsideration process with respect to
BAMM, we think a limited extension during the duration of the
administrative reconsideration process is appropriate so that owners
and operators of affected facilities would not incur additional costs
associated with applying for BAMM in advance of our final decision on
this issue. It would be impracticable to go through notice and comment
rulemaking to extend an imminent deadline and it is also unnecessary
because section 307(d)(7)(B) does not require notice and comment for a
three-month extension pending reconsideration. Thus, notice and public
procedure are impracticable and unnecessary. EPA finds that this
constitutes good cause under 5 U.S.C. 553(b)(B).

II. Statutory and Executive Order Reviews

A. General Requirements

    This action is not a ''significant regulatory action,'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and,
therefore, not subject to review under Executive Orders 12866 and 13563
(76 FR 3821, January 21, 2011). For this reason, this action is also
not subject to Executive Order 13211, ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001). In addition, because the agency has made a ``good
cause'' finding that this action is not subject to notice-and-comment
requirements under the Administrative Procedure Act or any other
statute (See Section I. Background Information of this preamble) it is
not subject to sections 202 and 205 of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4). In addition, this action does not
impose any enforceable duty or contain any unfunded mandates as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4),
or require prior consultation with State officials, as specified by
Executive Order 12875 (58 FR 58093, October 28, 1993), or involve
special consideration of environmental justice related issues, as
required by Executive Order 12898 (59 FR 7629, February 16, 1994).
Further, because the agency has made a ``good cause'' (See Section I.
Background Information of this preamble) finding that this action is
not subject to notice-and-comment requirements under the Administrative
Procedure Act or any other statute, it is not subject to the regulatory
flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601,
et seq.). This action also does not have Tribal implications because it
will not have a substantial direct effect on one or more Indian Tribes,
on the relationship between the Federal government and Indian Tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian Tribes, as specified by Executive Order
13175 (65 FR 67249, November 9, 2000). This action also does not have
Federalism implications because it does not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999). This action
also is not subject to Executive Order 13045, ``Protection of Children
from Environmental Health Risks and Safety Risks'' (62 FR 19885, April
23, 1997). The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This action does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et
seq.). EPA's compliance with these statutes and Executive Orders for
the underlying rule is discussed in the November 30, 2010 Federal
Register document.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 808 allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and public procedure is impracticable,
unnecessary or contrary to the public interest. This determination must
be supported by a brief statement. 5 U.S.C. 808(2). As stated
previously, EPA has made such a good cause finding, including the
reasons therefore, and established an effective date of April 30, 2011.
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

III. How Can I Get Copies of This Document and Other Related
Information?

    This Federal Register notice is available in the docket for the
final rule titled ``Mandatory Reporting of Greenhouse Gases: Petroleum
and Natural Gas Systems,'' published on November 30, 2010 at 98 FR
74458, under Docket ID No. EPA-HQ-OAR-2009-0923.
    All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information may not be publicly available, i.e., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the EPA's Docket Center, Docket ID No. EPA-HQ-OAR-2009-0923, Public
Reading Room, EPA West Building, Room 3334, 1301 Constitution Avenue,
Northwest, Washington, DC 20004. This Docket Facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket Center is<PHONE_NUMBER>.
    In addition to being available in the docket, an electronic copy of
this Federal Register notice is also available on the World Wide Web at
http://www.epa.gov/climatechange/emissions/ghgrulemaking.html.

List of Subjects in 40 CFR Part 98

    Environmental Protection, Administrative practice and procedures,
Air pollution control, Monitoring, Reporting and recordkeeping.

    Dated: April 20, 2011.
Lisa P. Jackson,
Administrator.

    For the reasons discussed in the preamble, the EPA amends 40 CFR
parts 98 as follows:

PART 98--[AMENDED]

0
1. The authority citation for part 98 continues to read as follows:

    Authority:  42 U.S.C. 7401-7671q.

0
2. Section 98.234 is amended as follows:
0
a. By revising paragraph (f)(2) introductory text.
0
b. By revising paragraph (f)(3) introductory text.
0
c. By revising paragraphs (f)(5)(i), (f)(5)(ii), (f)(5)(iii)(A),
(f)(5)(iv)(A).
0
d. By revising paragraphs (f)(6) introductory text, (f)(6)(i),
(f)(6)(ii)(D), (f)(6)(iii).
0
e. By revising paragraphs (f)(7) introductory text, (f)(7)(i), and
(f)(7)(iii)
    The revisions read as follows:

Sec.  98.234  Monitoring and QA/QC Requirements.

* * * * *
    (f) * * *
    (2) Best available monitoring methods for well-related emissions.
During January 1, 2011 through September 30, 2011, owners and operators
may use best available monitoring methods for any well-related data
that cannot reasonably be measured according to the monitoring and QA/
QC requirements of this subpart, and only where required measurements
cannot be duplicated due to technical limitations after September 30,
2011. These well-related sources are:
* * * * *
    (3) Best available monitoring methods for specified activity data.
During January 1, 2011 through September 30, 2011, owners or operators
may use best available monitoring methods for activity data as listed
below that cannot reasonably be obtained according to the monitoring
and QA/QC requirements of this subpart, specifically for events that
generate data that can be collected only between January 1, 2011 and
September 30, 2011 and cannot be duplicated after September 30, 2011.
These sources are:
* * * * *
    (5) * * *
    (i) No request or approval by the Administrator is necessary to use
best available monitoring methods between January 1, 2011 and September
30, 2011 for the sources specified in paragraph (f)(2) of this section.
    (ii) No request or approval by the Administrator is necessary to
use best available monitoring methods between January 1, 2011 and
September 30, 2011 for sources specified in paragraph (f)(3) of this
section.
    (iii) * * *
    (A) Timing of Request. The request to use best available monitoring
methods for paragraph (f)(4) of this section must be submitted to EPA
no later than July 31, 2011.
* * * * *
    (iv) * * *
    (A) Timing of Request. The request to use best available monitoring
methods for sources not listed in paragraph (f)(2), (f)(3), and (f)(4)
of this section must be submitted to EPA no later than July 31, 2011.
* * * * *
    (6) Requests for extension of the use of best available monitoring
methods through December 31, 2011 for sources in paragraph (f)(2) of
this section. The owner or operator may submit a request to the
Administrator to use one or more best available monitoring methods
described in paragraph (f)(2) of this section beyond September 30,
2011.
    (i) Timing of Request. The extension request must be submitted to
EPA no later than July 31, 2011.
* * * * *
    (ii) * * *
    (D) If the reason for the extension is that the owner or operator
cannot collect data from a service provider or relevant organization in
order for the owner or operator to meet requirements of this subpart
for the 2011 calendar year, the owner or operator must demonstrate a
good faith effort that it is not possible to obtain the necessary
information, service or hardware which may include providing
correspondence from specific service providers or other relevant
entities to the owner or operator, whereby the service provider states
that it is unable to provide the necessary data or services requested
by the owner or operator that would enable the owner or operator to
comply with subpart W reporting requirements by September 30, 2011.
* * * * *
    (iii) Approval criteria. To obtain approval, the owner or operator
must demonstrate to the Administrator's satisfaction that it is not
reasonably feasible to obtain the data necessary to meet the
requirements of this subpart for the sources specified in paragraph
(f)(2) of this section by September 30, 2011.
    (7) Requests for extension of the use of best available monitoring
methods through December 31, 2011 for sources in paragraph (f)(3) of
this section. The owner or operator may submit a request to the
Administrator to use one or more best available monitoring methods
described in paragraph (f)(3) of this section beyond September 30,
2011.
    (i) Timing of request. The extension request must be submitted to
EPA no later than July 31, 2011.
* * * * *
    (iii) Approval criteria. To obtain approval, the owner or operator
must demonstrate to the Administrator's satisfaction that is not
reasonably feasible to implement the data collection for the sources
described in paragraph (f)(3) of this section for the methods required
in this subpart by September 30, 2011.
* * * * *
[FR Doc. 2011-10026 Filed 4-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Rules and Regulations]
[Pages 56773-56776]
[FR Doc No: 2023-17431]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0235; FRL-10953-01-OCSPP]

Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyraclostrobin in or on stevia, dried leaves and stevia, fresh leaves
and revises the tolerance for residues of pyraclostrobin in or on
coffee, green bean. The Interregional Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective August 21, 2023. Objections and
requests for hearings must be received on or before October 20, 2023,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0235, is available at
https://www.regulations.gov or in-person at the Office of Pesticide
Programs Regulatory Public Docket (OPP Docket) in the Environmental
Protection Agency Docket Center (EPA/DC), West William Jefferson
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room and the OPP Docket is (202) 566-
1744. For the latest status information on EPA/DC services, docket
access, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2022-0235 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 20, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2022-0235, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
12-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3),
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition
(PP1E8981) by IR-4 Project Headquarters, North Carolina State
University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC
27606. The petition requested that 40 CFR 180.582 be amended to
establish tolerances for residues of the fungicide pyraclostrobin,
(carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]
methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite
(methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]
phenylcarbamate), calculated as the stoichiometric equivalent of
pyraclostrobin in or on the following raw agricultural commodities:
stevia, dried leaves at 150 parts per million (ppm) and stevia, fresh
leaves at 40 ppm. The petition also requested the revision of the
tolerance for residues of pyraclostrobin in or on coffee, green bean at
0.3 ppm to support the domestic use on coffee rather than being a
tolerance on coffee imported into the U.S. One comment was received on
the notice of filing. EPA's response to this comment is discussed in
Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for pyraclostrobin including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with pyraclostrobin follows.
    In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings for
pyraclostrobin in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to pyraclostrobin and established
tolerances for residues of that chemical. In this rulemaking, EPA is
incorporating previously published sections from the September 20,
2021, rulemaking (86 FR 52083) (FRL-8857-01-OCSPP) as described further
below, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological
Profile of pyraclostrobin, see Unit III.A. of the September 20, 2021,
rulemaking.
    Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
human risk assessment, see Unit III.B. of the September 20, 2021,
rulemaking and pages 11-13 of the document titled ``Pyraclostrobin.
Human Health Risk Assessment of Proposed Tolerances and Uses on Coffee,
Green Bean; Stevia, Dried Leaves; and Stevia, Fresh Leaves''
(hereinafter ``Pyraclostrobin Human Health Risk Assessment'') in docket
ID number EPA-HQ-OPP-2022-0235.
    Exposure assessment. Much of the exposure assessment remains the
same, although updates have occurred to account for exposures from the
petitioned-for tolerances. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, please reference Unit III.C. of the
September 20, 2021, rulemaking.
    EPA's dietary exposure assessments have been updated to include the
additional exposures from the new uses of pyraclostrobin on coffee and
stevia. In conducting the acute dietary

exposure assessment, EPA used the Dietary Exposure Evaluation Model
software with the Food and Commodity Intake Database (DEEM-FCID)
Version 4.02. This software uses the 2005-2010 food consumption data
from the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA).
The acute dietary exposure assessment is partially refined, assuming
tolerance level residues or highest field trial residues and 100
percent crop treated (PCT) for all crop and livestock commodities.
    The chronic dietary exposure assessment also uses the DEEM-FCID
Version 4.02 software with the 2005-2010 NHANES/WWEIA data. The chronic
dietary exposure assessment is refined and uses the same assumptions as
the Unit III.C.1.ii in the September 20, 2021, rulemaking;
specifically, anticipated residues based on average field trial residue
levels for plant raw agricultural commodities or tolerance-level
residues, PCT information where available, and experimentally
determined processing factors where available. Anticipated residues for
livestock commodities were also calculated and incorporated into the
assessment.
    Anticipated residue and PCT information. For a discussion of the
FFDCA requirements regarding use of anticipated residue and PCT
information and the PCT assumptions used in the chronic dietary
exposure assessment, see Unit III.C.1.iv. of the September 20, 2021,
rulemaking.
    Drinking water exposure. The new uses do not result in an increase
in the estimated residue levels in drinking water, so EPA used the same
estimated drinking water concentrations in the acute and chronic
dietary exposure assessments as identified in Unit III.C.2. of the
September 20, 2021, rulemaking.
    Non-occupational exposure. There are no new proposed residential
(non-occupational) uses expected for pyraclostrobin at this time;
however, pyraclostrobin is currently registered for uses on turf,
ornamental, and residential fruit and nut trees that may result in
residential handler and post-application exposures from commercial and
residential use. For a summary of those exposures, see Unit III.C.3 of
the September 20, 2021, rulemaking as it has not changed since then.
    Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency consider ``available information'' concerning the
cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to pyraclostrobin and any other substances. For
purposes of this tolerance action, therefore, EPA has not assumed that
pyraclostrobin has a common mechanism of toxicity with other
substances.
    Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit
III.D. of the September 20, 2021, rulemaking for a discussion of the
Agency's rationale for that determination as nothing has changed since
the 2021 rulemaking.
    Aggregate risk and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
dietary exposure estimates to the acute population adjusted dose (aPAD)
and the chronic population adjusted dose (cPAD). Short-, intermediate-,
and chronic term aggregate risks are evaluated by comparing the
estimated total food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists.
    Acute dietary risks are below the Agency's level of concern of 100%
of the aPAD; they are 86% of the aPAD for females 13 to 49 years old,
the only population subgroup for which an acute toxic effect was
identified. Chronic dietary risks are below the Agency's level of
concern of 100% of the cPAD; they are 54% of the cPAD for children 1 to
2 years, the most highly exposed population subgroup.
    EPA determined that it is inappropriate to combine the oral route
of exposure with dermal and inhalation exposures because of dissimilar
toxic response observed from exposures to pyraclostrobin via the oral,
dermal and inhalation routes. Therefore, the short-term aggregate
exposure assessment includes dietary (food and drinking water) and
incidental oral hand to mouth exposure from high contact lawn activity
on treated lawns for children 1 to less than 2 years old. The short-
term aggregate MOE is 260 and is not of concern because it is above the
Agency's level of concern of 100.
    Pyraclostrobin is classified as ``Not Likely to Be Carcinogenic to
Humans'' due to an absence of carcinogenicity in the available studies;
therefore, EPA does not expect pyraclostrobin exposures to pose an
aggregate cancer risk.
    Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to pyraclostrobin residues. More detailed
information on this action can be found in the Pyraclostrobin Human
Health Risk Assessment in docket ID EPA-HQ-OPP-2022-0235.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method for
various crops, see Unit IV.A of the September 20, 2021, rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
    The U.S. tolerance for pyraclostrobin in or on coffee, green bean
is harmonized with the Codex MRL at 0.3 ppm. There are no Codex MRLs
for stevia.

C. Response to Comments

    One comment was received in response to the notice of filing, which
opposed EPA establishing the requested tolerances and objected to the
use of pesticides on crops. Although the Agency recognizes that some
individuals believe that pesticides should be banned on agricultural
crops, the existing legal framework provided by section 408 of the
FFDCA authorizes EPA to establish tolerances when it determines that
the tolerance is safe. Upon consideration of the validity,
completeness, and reliability of the available data as well as other
factors the FFDCA requires EPA to consider, EPA has determined that
pyraclostrobin tolerances are safe. The commenter has provided no
information indicating that a safety determination cannot be supported.

V. Conclusion

    Therefore, tolerances are established for residues of
pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

yl]oxy]methyl] phenylcarbamate) in or on stevia, dried leaves at 150
ppm and stevia, fresh leaves at 40 ppm. The established tolerance for
residues of pyraclostrobin in or on coffee, green bean at 0.3 ppm is
revised to remove footnote 1.
    Additionally, EPA is correcting the active ingredient name in the
introductory paragraph from ``pyradostrobin'' to ``pyraclostrobin''.
EPA is also removing the Section 18 emergency exemption tolerance for
residues of pyraclostrobin in or on endive, Belgium at 11.0 ppm as a
housecleaning measure since that tolerance expired on December 31,
2013. These changes have no substantive effect and can be accomplished
without further notice and comment.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 8, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.582:
0
a. In paragraph (a)(1):
0
i. In the introductory text,'';
0
ii. Amend the table by adding the heading ``Table 1 to Paragraph
(a)(1)'';
0
b. In Table 1 to Paragraph (a)(1):
0
i. Revise the entry for ``Coffee, green bean'';
0
ii. Add, in alphabetical order, the entries ``Stevia, dried leaves''
and ``Stevia, fresh leaves'';
0
iii. Remove footnote 1 from the end of the table.
0
c. Remove and reserve paragraph (b).
    The additions and revision read as follows:

Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) * * *
    (1) Tolerances are established for residues of the fungicide
pyraclostrobin, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]
phenylcarbamate), calculated as the stoichiometric equivalent of
pyraclostrobin, in or on the commodity.

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Coffee, green bean......................................             0.3

                                * * * * *
Stevia, dried leaves....................................             150
Stevia, fresh leaves....................................              40

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

* * * * *
    (b) [Reserved]
* * * * *
[FR Doc. 2023-17431 Filed 8-18-23; 8:45 am]
BILLING CODE 6560-50-P