#49.	Standard Evaluation Procedure.  Acute Toxicity T4est for Estuarine
and Marine Organisms (Mollusc 96-Hour Flow-Through Shell Deposition
Study).

#50.	Standard Evaluation Procedure.  Fish Early Life-Stage.

#51.  	Technical Guidance Document.  Aquatic Mesocosm Tests to Support
Pesticide Registrations.

#52.	Standard Evaluation Procedure.  Avian Single-Dose Oral LD50.

#53.	Standard Evaluation Procedure.  Avian Dietary LC50 Test.

#54.	Standard Evaluation Procedure. Avian Reproduction Test.

#55.  	Guidance Document for Conducting Terrestrial Field Studies.

#56.	Standard Evaluation Procedure. Honey Bee – Toxicity of Residues
on Foliage.

#57.	Standard Evaluation Procedure. Honey Bee - Acute Contact LD50.

#58.	Standard Evaluation Procedure.  Field Testing for Pollinators.

#59.  	Standard Evaluation Procedure.  Pesticide Spray Drift Evaluation:
Droplet Size Spectrum Test and Drift Field Evaluation Test.

#60.  	Standard Evaluation Procedure.  Anaerobic Soil Metabolism
Studies.

#61.	Standard Evaluation Procedure.  Hydrolysis Studies.

#62.	Standard Evaluation Procedure.  Aqueous Photolysis Studies.

#63.	Standard Evaluation Procedure.  Acute Toxicity Test for Freshwater
Invertebrates.

#64.	Policy Establishing Procedures for Reviewing and Approving New
Science Policy.

#65.	EFED’s Revised Policy Guidance for Section 18's.

#66.	Information on Exposure Modeling Work Group.

#67.   	Atrazine 4L Herbicide Pesticide Label.

#68.	Lorsban - 4E Pesticide Label.

#69.	Use the NOAEC from Aquatic Chronic in Risk Assessment.

#70	Background on the Development of LOCs.

#71b.	Procedure for the Inclusion of Open Literature Searches in
Pesticide Screening Level Risk Assessments for Ecological Effects.
January 21, 2004.

#72. 	Section 1.  Database and Documentation Overview.  MED
ECOTOXICOLOGY DATABASE SOP’s.  September 1997.

#73.	ECOTOX.  ECOTOXicology Database System.  Literature Search and
Citation Identification. MED ECOTOXICOLOGY DATABASE SOP’s.  April
2001.

#74.  	ECOTOX.  ECOTOXicology Database System.  AQUIRE Coding
Guidelines. August 2003.

#75.	ECOTOX Data Entry Procedures (AQUIRE).  MED ECOTOXICOLOGY DATABASE.
 June 2000.

#76.	ECOTOX.  ECOTOXicology Database System.  Chemical Verification and
Database Entry Procedures (EcoChem). April 2001.

#77.	ECOTOX.  ECOTOXicology Database System.  Taxonomic Name
Verification Procedures (CRITTERS). September 2001.

#78.	Draft. SOP for Metabolism Assessment Review Committee.  July 5,
2002.

#79.	Microbial Sample Case Studies.

#80	European Union Directive 91/414/EEC.

#81.	Memorandum and Attached Procedure - “Pesticide Root Zone Model
(PRZM) Field and Orchard Crop Scenarios: Standard Procedures for
Conducting Quality Control and Quality Assurance.  January 21, 2004.

VIII.  References tc \l1 "VIII.  References

Akesson, N.B.  1990.  Drift evaluation field tests.  In Evaluation of
drift exposure and environmental fate of pesticide application, report
prepared in compliance with drift contract WM175 between the Florida
department of Environmental Regulation and the University of Florida,
Gainesville.

Baehr, C.H. and C.  Habig.  2000.  Statistical evaluation of the UTAB
database for use in terrestrial nontarget organism risk assessment.
Presentation at the American Society for testing and Materials (ASTM)
Tenth Symposium on Environmental Toxicology and Risk Assessment, April
2000, Toronto, Canada.

Beacham, W.  1994. The Official World Wildlife Fund Guide to Endangered
Species of North 	America.   Vol 4; Beacham Publishing Company,
Washington D.C.

Dolbeer, K.R., M.L. Avery, M.E. Tobin.  1994.  Assessment of field
hazards to birds from methiocarb applications to fruit crops.  Pesticide
Science 40:147-161.

Driver, C.J., M.W. Ligotke, P. Van Voris, B.D. McVeety, D.B. Brown.
1991.  Routes of uptake and their relative contribution to the
toxicologic response of northern bobwhite (Colinus virginianus) to an
organophosphate pesticide.  Environmental Toxicology and Chemistry
10:21-33.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger. 1994.  Literature
review and evaluation of the 	EPA food-chain (Kenaga) nomogram, an
instrument for estimating pesticide residues on plants.  Environmental
Toxicology and Chemistry 13(9):1383-1391.

Fox, G.A. 1991.  Practical causal inference for epidemiologists. J.
Toxicol. Environ. Health 33:359-373.

Hallam, T.G., R.R. Lasiter.  1994.  Individual-based mathematical
modeling approaches in ecotoxicology: a promising direction for aquatic
population and community ecological risk assessment.  In: Wildlife
Toxicology and Population Modeling R.J. Kendall and T.E. Lacher, Jr.,
eds., Lewis Publishers, Boca Raton, FL.

Hill, A.B.  1965.  The environment and disease: association or
causation?  Proc. R. Soc. Med. 58:295-300.

Hakoyama, H., Y. Iwasa, J.  Nakanishi.  2000.  Comparing Risk factors
for population extinction.  Journal of Theoretical Biology 204:327-336.

Kirkwood, J.K.  1983.  A limit to metabolizable energy intake in mammals
and birds.  Comp.  Biochem.  Physiol.  75A:1-3.

Lowe, D.W., J.R. Matthews, C.J. Moseley.  1990.  The Official World
Wildlife Fund Guide to 	Endangered Species of North America.  Vol 1 and
2. Beacham Publishing Company, Washington D.C.:

Luttik R. and T. Aldenberg.  1997.  Extrapolation factors for small
samples of pesticide toxicity data: specific focus on LD50 values for
birds and mammals.  Environmental Toxicology and Chemistry 16:1785-1788.

Mosely, C.  1992.  The Official World Wildlife Fund Guide to Endangered
Species of North 	America.  Vol 3. Beacham Publishing Company,
Washington D.C.

Nellessen, J.E.,and J.S. Fletcher. 1992.  UTAB: A computer database on
residues of xenobiotic organic chemicals and heavy metals in plants.  J.
 Chem.  Inf.  Comput.  Sci.  32:144-148.

Penman, H.L. 1948.  Natural evaporation from open water, bare soil, and
grass.  Proc.  Royal.  Soc.  London, Series A, 193:120-145.

Pfleeger, T.G., A.  Fong, R.  Hayes, H.  Ratsch, C.  Wickliff.  1996.
Field evaluation of the EPA (Kenaga) nomogram, a method for estimating
wildlife exposure to pesticide residues on plants.  Environmental
Toxicology and Chemistry 15:535-543.

.

Susser, M. 1986a.  Rules of inference in epidemiology.  Regul. Toxicol.
Pharmacol.  6: 116-128.

Susser, M. 1986b.  The logic of Sir Carl Popper and the practice of
epidemiology.  Am. J. Epidemiol.  124:711-718.

Tanner J.T.  1978.  Guide to the Study of Animal Populations.  The
University of Tennessee Press, Knoxville.

U.S. Department of Health Education and Welfare.  1964.  Smoking and
health: Report of the Advisory Committee to the Surgeon General.  Public
Health Service Publication 1103. Washington, DC: U.S. Department of
Health Education and Welfare.

U.S. Environmental Protection Agency. 1990.  Laboratory Test Methods of
Exposure to

Microbial Pest Control Agents by the Respiratory Route to Nontarget
Avian Species.

Environmental Research Laboratory, Corvalis, OR.  EPA/600/3-90/070.

U.S. Environmental Protection Agency.  1993.  Wildlife Exposure Factors
Handbook.  EPA/600/R-13/187a, Office of Research and Development,
Washington, DC.

U.S. Environmental Protection Agency.   2002a.  Biological Evaluation on
the CWA 304(a) Aquatic Life Criteria as Part of the National
Consultations Methods Manual.  Draft 12/20/2002.

U.S. Environmental Protection Agency.  2002b.  Eligibility Checklist for
Results of Acute Lethality Tests with Aquatic Animals.  Draft.

U.S. Environmental Protection Agency. 2003.  Environmental Fate and
Effects Division Guidance for Conducting a New Chemical Screen.
Internal Guidance.  Draft.

Appendix A.	Overview of OPP’s Screening-Level Ecological Risk
Assessment Process for Antimicrobial Pesticides

I.  Background tc \l2 "I.  Background

The Antimicrobials Division (AD) in OPP is responsible for the
registration and reregistration of antimicrobial pesticides.
Antimicrobial pesticides include those that claim mitigation or control
of bacteria, viruses, fungi, protozoa, algae, slime, and most recently
prions.  Antimicrobial products used in or on humans or animals are
considered drugs and are approved and regulated by the Food and Drug
Administration (FDA).  The AD regulates antimicrobial pesticides used on
or in inanimate objects, such as wood, floors, and walls; industrial
processes or systems; on surfaces, in water or other liquids to prevent
or reduce contamination, fouling, or deterioration.

AD reviews data submitted by registrants and conducts screening-level
risk assessments using the basic process outlined for EFED.  These
assessments are conducted  for individual pesticide active ingredients,
formulations, and degradates to evaluate the ecological risk of
antimicrobial pesticides to non-target species, including the potential
impact on listed species.  Formulated product and/or degradate tests are
conditionally required for terrestrial and aquatic animal species, and
aquatic plants using the same approach used by EFED.  Formulated product
tests are always required for terrestrial plant studies, and special
leaching studies.

In addition to the data required under FIFRA, AD uses open literature
data routinely. A great deal of literature is available for both the
pesticide and non-pesticidal uses of these chemicals and is considered
during the assessment process.  Searches are conducted by a contractor.

AD also reviews human health data that can be useful for predictions of
adverse effects to mammalian wildlife, information on pesticide residue
dissipation in food crops and animal feed items, and leach rate data
from treated objects.  These data can be used to estimate dissipation
half-lives for long term exposure scenarios.

II.  Ecological Effects Testing tc \l2 "II.  Ecological Effects Testing

AD’s current practice is similar to EFED’s assessment process
described in Section V and uses a tiered system of ecological effects
testing to assess the potential risks of proposed pesticide uses to
non-target plants (§158.540 of the current regulatory text), aquatic
and terrestrial vertebrates and invertebrates (§158.490), and nontarget
insects (§158.590).  These tests include short-term acute, subacute,
reproduction, and field studies, which progress from the basic
laboratory tests to the applied field tests.  The results of each set of
tests must be evaluated to determine the potential of the pesticide to
cause adverse effects and to determine whether further testing is
required.  These data requirements provide the Agency with ecological
effects information and allow the Agency to determine if registration is
appropriate and if precautionary label statements concerning toxicity or
potential adverse effects to nontarget organisms are necessary.

A.  Antimicrobial Pesticide Categories tc \l3 "A.  Antimicrobial
Pesticide Categories

Antimicrobial pesticides currently fall within one of the following 12
categories:

Agricultural premises and equipment, such as animal houses/pens/milk
houses;

Food handling/storage establishments premises and equipment, such as
food storage areas, processing plants, restaurants, transport vehicles;

Commercial, institutional and industrial premises and equipment, such as
hotels, theaters;

Residential and public access premises, such as homes, shelters, public
buildings;

Medical premises and equipment, such as medical related facilities -
clinics, hospitals;

Human drinking water systems, such as public/private/emergency water
systems;

Materials preservatives, indoor food/feed, indoor non-food/feed,
indoor/outdoor non-food/feed;

Industrial processes and water systems, such as cooling towers,
pulp/paper mills;

Antifoulants, such as boat bottoms, crab/lobster pots, underwater
structures;

Wood preservatives, such as freshly cut logs, utility poles, fence
posts, railroad ties;

Swimming pools, such as swimming pools, jacuzzis, hot tubs; and

Aquatic areas, such as lakes, streams, drainage ditches, ponds.

B.  Use Categories with Minimal Expected Environmental Exposure tc \l3
"B.  Use Categories with Minimal Expected Environmental Exposure

Of the 12 antimicrobial use categories, eight are indoor and related
uses: agricultural premises and equipment; food handling and storage
establishments, premises and equipment; commercial, institutional and
industrial premises and equipment; residential and public access
premises; medical premises and equipment; human drinking water systems;
materials preservatives; and swimming pools.

Movement of antimicrobials from these indoor uses into the general
environment is most likely to occur through water and moves from
rinsates and flushes to effluent water to the aquatic environment.  The
Agency believes that environmental exposures from these uses are likely
to be small for one or more of the following reasons:

These uses are not rapidly or directly connected to aquatic
environments.

Antimicrobials tend to be degraded or bound in the presence of
biological matter.

In some cases effluents are processed in water treatment plants.

Therefore, AD believes these uses pose little prospect of significant
environmental exposure to non-target terrestrial and aquatic organisms

Given the low prospect of significant environmental exposure from this
group of uses, AD requests only a small set of ecological effects and
environmental fate data for these use scenarios.  The data requirements
are avian acute oral LD50 (Guideline 850.2100), an acute freshwater fish
LC50 (Guideline 850.1750), an acute freshwater invertebrates EC50
(Guideline 850.1010), and a hydrolysis study (Guideline 832.2120).
These studies characterize hazard to target species for label hazard
statements and if an unexpected spill were to occur. AD may request the
testing of additional species or higher tier testing based on the
results of this basic set of studies or reports of adverse effects in
the literature or via FIFRA 6(a)(2).

C.  Use Categories with Significant Expected Environmental Exposure tc
\l3 "C.  Use Categories with Significant Expected Environmental Exposure

The remaining four use categories are industrial processes and water
systems (once-through and all others), antifoulants, aquatic areas, and
wood preservatives.  (Only once-through systems directly introduce the
antimicrobial into the environment in effluent.  Recirculating
industrial processes and water systems, in which the antimicrobial is
re-circulated in the treated system or is disposed of as a hazardous
waste, do not result in direct discharge of antimicrobial pesticide into
the environment.)  These uses either occur outdoors, discharge effluent
directly to the outdoors or result in materials treated with
antimicrobials (i.e. wood preservatives and antifoulants) being placed
in the environment, thereby leading to potentially significant
environmental exposure.  AD utilizes the same battery of ecotoxicity and
environmental fate studies requested by the EFED for agricultural sites.
 In addition, AD requests product leach rate tests (antifoulant paints,
wood preservatives), when appropriate.

III.  Ecological Effects Assessment tc \l2 "III.  Ecological Effects
Assessment

A.  Exposure Assessment tc \l3 "A.  Exposure Assessment

Field residue monitoring studies, when available, are used to estimate
EEC’s.  These additional, higher-tiered studies (e.g., avian, fish,
and invertebrate reproduction studies, sediment toxicity studies,
aquatic field studies) may be required when basic data and environmental
conditions suggest possible adverse effects, in order to determine
whether the pesticide meets the requirements for registration and to
determine the need for mitigation. Data from these studies are used to
estimate the potential for chronic effects, taking into account the
measured or estimated residues in the environment.

In some cases, the results of field studies may give rise to the need
for further testing and/or field residue monitoring.  Field residue
monitoring may be requested of the registrant in lieu of higher tier
biological field studies (Support Document # 7 and #25).  The Agency
makes this determination on a case-by-case basis, considering such
information as the pesticide’s intended use, use rates, toxicity,
physical and chemical properties; the parent compound’s environmental
fate characteristics and transformation products (such as metabolites
and degradation products); nontarget organisms likely to be exposed; and
the likelihood of exposure.

When field residue monitoring data are not available, models are used to
estimate EEC’s.  The models account for dosage per unit area,
half-lives of the chemical in soil and water, soil
adsorption/desorption, leaching rate, and other factors.   AD generally
uses the fate models used by the EFED and occasionally uses
Luttik-Johnson for antifoulant paints.  In addition, AD is  assessing
additional models for antifouling and for large scale runoff scenarios.
 AD is currently participating on workgroups formed by the Organization
for Economic Cooperation and Development that are evaluating the various
models available for antifouling paints, wood preservatives, and cooling
towers.

B.  Toxicity Assessment tc \l3 "B.  Toxicity Assessment

AD generally only requires toxicity data for antimicrobial pesticides
expected to have high exposure.  For pesticides with low exposure based
on labeled uses or other information, AD has adopted an approach that
should allow registrants to generate fewer toxicity studies in total
than those required for high exposure uses.  Under this approach,
registrants of low exposure antimicrobials may perform tests in a tiered
fashion.  After initially required tests are conducted, additional
testing may be required for low-exposure uses if the result of the
initial tests trigger the need for additional data.

High exposure uses include human or animal drinking water, fruit and
vegetable rinses, egg washes, metal cutting (metalworking) fluids,
swimming pools, outdoor aquatic uses in lakes, rivers or streams which
have the potential to contaminate potable water, indirect food uses with
residues >200 parts per billion (ppb), and any other uses not already
specified which require a tolerance or exemption from the requirement
for a tolerance. Low exposure uses consist of all other uses, which are
expected to pose little or no exposure.

An antimicrobial use is considered an indirect food use when it is not
applied directly to food, but is used in such a way that food may
reasonably be expected to bear inadvertent residues through contact with
treated surfaces and articles.  Examples of antimicrobial uses which may
result in inadvertent residues in food through normal use are sanitizers
and disinfectants, which may be used in food handling areas.

C.  Risk Assessment Methods and LOCs tc \l3 "C.  Risk Assessment Methods
and LOCs

The risk assessment methods used to evaluate potential risk are similar
to those used by the EFED and are based on the RQ, which is compared to
AD’s LOCs.  The LOCs currently address the following risk presumption
categories:

(1) Acute high - Potential for acute risk is high, and regulatory action
may be warranted in addition to restricted use classification;

(2) Acute Restricted Use - Potential for acute risk is high, but this
may be mitigated through restricted use classification;

(3) Acute Listed Species - Potential for acute risk to listed species is
high, and regulatory action may be warranted, and

(4) Chronic Risk - Potential for chronic risk is high, and regulatory
action may be warranted.

AD does not perform assessments for chronic risk to plants, acute or
chronic risks to nontarget insects, or chronic risk from granular/bait
formulations to mammalian or avian species.

The ecotoxicity test values (i.e., measurement endpoints) used in the
acute and chronic risk quotients are derived from the results of
required studies.  Examples of ecotoxicity values derived from the
results of short-term laboratory studies that assess acute effects are:

LC50 - fish and birds,

LD50 - birds and mammals,

EC50 - aquatic plants and aquatic invertebrates, and

EC25 - terrestrial plants.

Examples of toxicity test effect levels derived from the results of
long-term laboratory studies that assess chronic effects are:

LOEC - birds, fish, and aquatic invertebrates,

NOEC - birds, fish and aquatic invertebrates,  and

MATC - fish and aquatic invertebrates.

For birds and mammals, the NOEC value is used as the ecotoxicity test
value in assessing chronic effects.  Other values may be used when
justified.  Generally, the MATC (defined as the geometric mean of the
NOEC and LOEC) is used as the ecotoxicity test value in assessing
chronic effects to fish and aquatic invertebrates.  However, the NOEC is
used if the measurement endpoint is production of offspring or survival.

Risk presumptions, along with the corresponding RQs and LOCs are
summarized in Table 1.

Table 1.  Risk Presumptions for Terrestrial Species

Risk Presumption

RQ

LOC

Birds and Wild Mammals

Acute High Risk

EEC1/LC50 or LD50/sqft2 or LD50/day3

0.5

Acute Restricted Use

EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)

0.2

Acute Listed Species

EEC/LC50 or LD50/sqft or LD50/day

0.1

Chronic Risk

EEC/NOEC

1

 1  abbreviation for Estimated Environmental Concentration (ppm) on
avian/mammalian food items

 2    mg/ft2             	3  mg of toxicant consumed/day

   LD50 * wt. of bird             	LD50 * wt. of bird

Risk Presumptions for Aquatic Animals

Risk Presumption

RQ

LOC

Acute High Risk

EEC1/LC50 or EC50

0.5

Acute Restricted Use

EEC/LC50 or EC50

0.1

Acute Listed Species

EEC/LC50 or EC50

0.05

Chronic Risk

EEC/MATC or NOEC

1

 1  EEC = (ppm or ppb) in water

Risk Presumptions for Plants

Risk Presumption

RQ

LOC

Terrestrial and Semi-Aquatic Plants

 tc \l2 "Terrestrial and Semi-Aquatic Plants

Acute High Risk

EEC1/EC25

1

Acute Listed Species

EEC/EC05 or NOEC

1

Aquatic Plants

 tc \l2 "Aquatic Plants

Acute High Risk

EEC2/EC50

1

Acute Listed Species

EEC/EC05 or NOEC

1

1  EEC = lbs ai/A

2  EEC = (ppb/ppm) in water

IV.  Assessments for Listed Species tc \l2 "IV.  Assessments for Listed
Species

AD’s registration and reregistration documents contain a section on
listed species.     When LOCs for listed species are exceeded, AD will
note in the document that LOC’s are exceeded.  Listed species
exceeding LOC’ s are tabulated by state/county and assessed for their
proximity to the pesticide.  FEAD is then consulted for further analysis
of the species at risk.   FEAD provides appropriate recommendations for
mitigation/restrictions on use if necessary.

Appendix B.	Overview of OPP’s Screening-Level Ecological Assessment
Process for Biological Pesticides

 tc \l1 "Appendix B.	Overview of OPP’s Screening-Level Ecological
Assessment Process for Biological Pesticides

I.  Background tc \l2 "I.  Background

The Biopesticides and Pollution Prevention Division (BPPD) was created
for the purpose of bringing safer pesticide products into the
marketplace and to encourage the adoption of these safer, reduced risk
products and related integrated pest management (IPM) practices.  The
safer, reduced risk products that are scientifically reviewed and
registered are known as biological pesticides or biopesticides.
Biopesticides are distinguished from conventional chemical pesticides by
their unique modes of action, low use volumes, natural occurrence,
generally low to no persistence in the environment, and, for many
biopesticide active ingredients, target species specificity.

There are three categories of biopesticides:  biochemicals, microbials,
and plant-incorporated protectants (PIPs).  As defined in 40 CFR
§158.65 (a) and (b), Biochemical Pesticides include, but are not
limited to compounds such as semiochemicals, natural plant and insect
hormones and synthetic growth regulators, and enzymes.  Microbial
Pesticides include microorganisms and their toxic metabolites such as
bacteria, fungi, viruses, and protozoans, as well as novel microbes (i.
e. genetically-modified or nonindigenous species).  In 40 CFR §152.3, a
Plant Incorporated Protectant (PIP) is defined as a "pesticidal
substance that is intended to be produced and used in a living plant, or
in the produce thereof, and the genetic material necessary for the
production of such a pesticidal substance.  It also includes any inert
ingredient contained in the plant, or produce thereof."

The Biochemical Pesticide Branch (BPB) is responsible for the
registration of biochemical pesticides.  Microbial pesticides and PIPs
are the responsibility of the Microbial Pesticides Branch (MPB).  Prior
to registration, the potential for any biological pesticide to cause
adverse effects to non-target organisms, including listed species, and
the environment must be thoroughly investigated.  Due to the unique
nature of these pesticides, slightly different, but generally
complimentary and overlapping approaches, are used by BPB and MPB to
assess the potential risks involved with the use of biochemical and
microbial pesticides and PIPs.

Section II of this appendix describes the assessment process for
biochemical pesticides, and Section III addresses microbial pesticides
and PIPs.

II. Non-Target Organism Risk Assessment for Biochemical Pesticides tc
\l2 "II. Non-Target Organism Risk Assessment for Biochemical Pesticides

Before beginning a description of the biochemical pesticide risk
assessment process, it is important to first describe the nature of
biochemical pesticides, how they are distinguished from conventional
chemical pesticides, and their pesticidal  mode of action.

A.  What are Biochemical Pesticides tc \l3 "A.  What are Biochemical
Pesticides

A biochemical pesticide is defined by the following two criteria:

It is a generally naturally-occurring substance (or is structurally
similar and functionally identical to a naturally-occurring substance),
and

It has a non-toxic mode of action.

It is important to note that not all biochemicals are
naturally-occurring.  An example of  synthetic substances that meet the
criteria for classification as a biochemical are synthetic Lepidopteran
pheromones, which are structurally and functionally identical to the
naturally occurring pheromones produced by moths and butterflies.

Additionally, the "natural occurrence" of a substance does not
immediately lead to the presumption that it has a non-toxic mode of
action.  An example of a substance in this category would be pyrethrum,
a natural insecticide obtained from certain chrysanthemum flowers that
is known to be a very potent neurotoxin.  This toxic mode of action
would preclude pyrethrum from being classified as a biochemical.

B.  Non-Toxic Modes of Action: tc \l3 "B.  Non-Toxic Modes of Action:

There are several non-toxic modes of action whereby biochemicals
accomplish their pesticidal activity. These are grouped according to the
following categories:

Plant and insect growth regulators (PGRs and IGRs)

Semiochemicals

Pheromones

Attractants/repellents (including irritants)

Suffocating agents

Desiccants

Coatings

Systemic Acquired Response (SAR)-inducers

Biochemical PGRs and IGRs include those substances that mimic or block
the activity of naturally-occurring growth substances.  Pheromones are
be used as either mating disruptants or as attractants to lure target
pests (usually insects) into traps.  Attractants and repellents
encompass all those substances generally considered to be non-pheromone
semiochemicals.  Suffocating agents (typically oils) act by physically
preventing respiration of the target pest, resulting in death by
asphyxiation.  Desiccants accomplish their activity by solubilizing or
physically perturbing waxy cuticles of plants or insects such that the
organisms succumb to rapid evaporative water loss.  Coatings are
substances commonly found in the environment (e.g. clay particles), and
have a passive mode of action (i.e. there is no biochemical interaction
against the target pest).  When applied to plant foliage, coatings
function as physical barriers to infections by plant pathogens, cause
unpalatable abrasiveness to phytophagous insects, or act as physical
irritants.  Substances that induce the SAR response have no direct
activity against the target pest, but function to enhance the inherent
capacity of plants to resist infection by plant pathogens, or produce
secondary plant metabolites that cause the plant to be unpalatable, or
possibly toxic to a pest (e. g. increase phenolic content).

Although biochemical pesticides, by definition, act via a non-toxic mode
of action, they can still be lethal to the target pest.  Due to the
broad-spectrum, non-species-specific activity of many biochemical
pesticides, all unintentional exposure pathways and potential lethality
to non-targets must be assessed.  Furthermore, a non-toxic mode of
action against the target pest does not presume a lack of toxicity to
non-target organisms.  The following discussion will focus on the
detailed information that are required by reviewers to conduct an risk
assessment.

C.  Characterization of the Risk tc \l3 "C.  Characterization of the
Risk

Risks to non-target organisms are characterized via a preliminary
assessment of toxicity (or lethality) and of all conceivable exposure
pathways to non-targets by application of the biochemical pesticide.
The risk characterization is summarized in the following equation:

Toxicity (or Lethality) x Exposure = Risk

Due to non-toxic modes of action and/or lack of exposure to non-targets
by most biochemical pesticides, a Risk Quotient (RQ) is not typically
calculated since the point estimates of either toxicity and/or exposure
will usually be at or near zero.  A qualitative assessment is conducted,
which is discussed in the next section.

D.  Components of the Risk Assessment tc \l3 "D.  Components of the Risk
Assessment

The preliminary assessment of toxicity is facilitated by a complete
understanding of the product chemistry of the biochemical active
ingredient and by the use pattern of the end-use product.  These
data/information include (but are not limited to):

Mode of action;

Persistence/degradation rate;

Environmental fate (what are the degradation products and where do they
go);

Product formulation (is it a liquid, granular, or dust);

Application method (e.g. foliar, soil, or fog applications; seed
treatments);

Application rate and timing (amount per unit area;, applications/growing
season; early, mid-, and/or late season applications);

Use sites (terrestrial or aquatic; agricultural, natural area, or
urban/homeowner); and

Target pest(s).

Other data/information may be required on a case-by-case basis,
depending on the nature of the active ingredient and the use sites
proposed for the product.  The risk assessor also must have an in-depth
understanding of the chemistry of the formulated product, particularly
of the "other" (formerly known as inert) ingredients (buffers, diluents,
stabilizers, surfactants, etc.) that are applied with the end-use
product.  These intentionally added ingredients may have unanticipated
adverse effects to non-targets and the environment.

E.  Risk Assessment for Listed Species tc \l3 "E.  Risk Assessment for
Listed Species

Potential risks to all non-target organisms are considered when
evaluating a biochemical pesticide and, therefore, specific risk
assessments for listed species are usually not conducted.  As it will be
discussed in more detail below, registrants are required to present
studies, data, and/or information demonstrating a lack of  toxicity
and/or exposure to any non-target species (avian, fish, aquatic
invertebrate, insect, and plant) via the use of a biochemical pesticide
end-use product according to its proposed label directions.  The unique
characteristics of biochemical pesticides, which generally have
non-toxic modes of action, low use volumes, and ready biodegradability
(low to no persistence), usually minimize the risks to all non-targets,
including listed species.

If the BPB risk assessor, upon review of the product label use
directions and use sites, determines that there is a potential for
exposure to non-target organisms, the registrant will be required to
revise the product label language to ensure that the potential exposure
to non-targets will be mitigated.  These revisions may include, but are
not limited to, changes in application timing and/or deletion of
selected use sites.  When the biochemical has a broad spectrum
(non-specific) and lethal (but non-toxic) mode of action, revisions to
product label use directions, use sites, and environmental hazards
statements may also be required.  An example of a lethal, but non-toxic
model of action is a suffocating oil, such as soybean oil.

Most biochemicals are registered for use in agriculture and
horticultural/ornamental sites, and to a lesser extent in public
recreation areas (e.g., golf courses, city/county parks, etc),
railroad/highway/electrical rights-of-way, and homeowner settings.  If a
listed species is expected to be exposed from a pesticide on a labeled
use site, the risk assessor will consult with FEAD to determine whether
the proposed use of a biochemical pesticide will result in exposure to
listed species.  If it is determined that exposure will occur and that
such exposure has the potential for adverse effects, BPPD and FEAD will
arrange for a consultation with the appropriate agency (U.S. Fish and
Wildlife Service and/or U.S. National Marine Fisheries Service).
Potential exposure will be minimized as previously described by
evaluating the product label and requiring revisions to the label
language and, if necessary, restricting and/or deleting certain use
sites.

Similarly, if biochemical pesticides are intended for use in natural
areas (nature preserves, state parks, national forests, etc.) or if
there is a potential for off-site movement to such areas, the products
will be evaluated on a case-by-case basis, as described above, to
determine exposure to listed species and other non-target organisms.
Exposure is not considered to be a problem if the registrant can
unequivocally demonstrate (via EPA-guideline studies or publically
available technical data) that the biochemical pesticide is non-toxic to
all potentially exposed non-target organisms, including listed species,
or that it will not significantly and permanently disrupt the normal
biological activities of potentially exposed non-targets.

It is important to note that most biochemical pesticide active
ingredients are already present in the environment and that non-target
organisms are already regularly exposed to these substances.
Furthermore, the amount of biochemical active ingredient applied is
often less than what is present in the environment.  It should also be
noted that other governmental agencies (state, local, and/or federal)
that have land management responsibilities may provide additional
site-based assessments to determine whether they will use a particular
biochemical pesticide to control pests and protect listed species.

F.  The Biochemical Risk Assessment tc \l3 "F.  The Biochemical Risk
Assessment

Once the components of the risk assessment have been assembled, the risk
assessor uses this information to assess the full range of potential and
actual exposure pathways of a biochemical pesticide to non-target
organisms and the environment.  Toxicity (or lethality) data for the
toxicity component of the risk equation are typically obtained from the
tiered guideline studies conducted and submitted by the registrant to
support a registration.  A list of non-target organism study
requirements for biochemicals, arranged as Tiers I, II, and III, is
presented in a table in 40 CFR §158.690 (d).  The tiered study
guidelines are summarized below:

Tier I

Tier II

Tier III

Avian Acute Oral Toxicity

Volatility

Terrestrial Wildlife Testing

Avian Dietary Toxicity

Leaching

Aquatic Animal Testing

Freshwater Fish LC50

Adsorption/Desorption

Non-Target Plant Studies

Freshwater Invertebrate LC50

Octanol/Water Part. Coeff.

Non-Target Insect Studies

Non-Target Plant Studies

UV Absorption

Non-Target Insect Studies

Aerobic Soil Metabolism

Aerobic Aquatic Metabolism

Soil Photolysis

Aquatic Photolysis

Tier I guideline studies are basically acute toxicity studies designed
to determine acute, short-term effects of pesticide exposure to
non-target organisms.  The need for Tier II and Tier III studies are
triggered only when one or more Tier I studies demonstrate significant
adverse effects to non-targets.  Tier II studies are environmental fate
studies that provide additional information on the degradation and
persistence of biochemical pesticides and the potential for
subchronic/chronic exposure.  Tier III studies are longer term and more
rigorous non-target studies on terrestrial and aquatic organisms and
will be needed especially if the active ingredient is shown to persist
in the environment.

It is important to note that no biochemical active ingredient or product
has yet triggered a requirement for Tier II or Tier III non-target
organism and ecological fate/effects studies.

Once the exposure pathways to non-target organisms have been determined
and the potential for toxicity (or lethality) to non-target organisms is
understood, a risk assessment is conducted that incorporates all
exposure, toxicity, target pest, and use pattern information.

Upon completion of the risk assessment, the biochemical pesticide is
subjected to a risk management analysis.  This is generally conducted by
the Regulatory Action Leader (or RAL) for the product, in close
consultation with the science reviewer(s).  The RAL is the principal
point of contact with the registrant of a particular product and is
responsible for administratively guiding the product through the
registration process.

G.  Risk Assessments for Straight-Chain Lepidopteran Pheromones (SCLPs
tc \l3 "G.  Risk Assessments for Straight-Chain Lepidopteran Pheromones
(SCLPs )

Non-target organism risk assessments are not typically conducted for
products containing straight-chain lepidopteran pheromones (SCLPs).
SCLPs are a group of pheromones consisting of unbranched aliphatics
having a chain of nine to eighteen carbons, containing up to three
double bonds, ending in an alcohol, acetate or aldehyde functional group
(40 CFR ???).  This structural definition encompasses the majority of
known pheromones produced by insects in the order Lepidoptera, which
includes butterflies and moths.  Based on the data available to the
Agency (Federal Register Notice 1/26/94 & OECD, 2000), adverse effects
on nontarget organisms are not expected from the use of SCLPs because
these pheromones are released in very small quantities in the
environment and act on a select group of insects (i.e.,
species-specific).  SCLPs are biodegradable by enzyme systems present in
most living organisms, and should present no problems with their normal
physiology. For example, the known metabolism of long-chain fatty acids
predicts that SCLPs would be metabolized either by (-oxidation yielding
a series of paired carbon losses or by complexing with glucuronide and
excretion by the kidneys (Federal Register v.60, Aug.30/95).

H.  Waiver Requests tc \l3 "H.  Waiver Requests

Submission of guideline studies is the most unambiguous approach to
satisfy the data requirements for registration.  The guideline studies
are designed to provide the BPB risk assessor with the necessary
information to assess the risks posed by a biochemical pesticide when it
is used according to its proposed label directions.  However, there may
be circumstances where the registrant believes that conducting a study
to support a particular data requirement is unnecessary, or may be too
costly to conduct.  The registrant may then request a waiver from the
requirement for conducting one or more guideline studies.

Study waiver requests must be addressed on a guideline-by-guideline
basis for all Tier I data requirements.  Each waiver request must be
accompanied by a scientific rationale, including technical
information/data, that credibly supports the waiver request and will
assure the BPB risk assessor that a guideline study will not be needed
to complete the risk assessment.

Data from non-guideline studies are acceptable on a case-by-case basis
only if they provide information/data that is equivalent to
information/data that would have been generated by guideline studies,
and they are conducted according to generally accepted scientific
principles.  Non-guideline studies obtained from the open technical
literature, which is routinely searched,  must have a reasonably
complete description of the materials and methods to assure the BPB risk
assessor that the submitted data will be useful in completing the risk
assessment.  Journal abstracts and reports from technical meeting
proceedings generally do not contain sufficient information and,
therefore, are typically classified as unacceptable for use in risk
assessments.  Similarly, testimonials found in advertising literature
and anecdotal information unsupported by credible data are also
unacceptable.

Another approach to supporting waiver requests is to demonstrate that
there will be no exposure of non-target organisms (either directly or
indirectly) to the biochemical pesticide following application to the
proposed use site(s) and target pest(s) listed on the product label.
For example, if the registrant request waivers from the study data
requirements for fish toxicity and aquatic invertebrate toxicity, it
must be demonstrated that the product is intended solely for terrestrial
uses and that it is highly unlikely that fish or aquatic invertebrates
would be exposed to the biochemical pesticide directly or indirectly
(via runoff or spray drift).  The product label would also be required
to contain specific language warning the product user to avoid applying
the product on or near aquatic sites and environmental hazards
statements indicating that the product is toxic to fish and aquatic
invertebrates.   Alternatively, the registrant could present data
demonstrating that the active ingredient rapidly degraded to non-toxic
compounds following application, thereby minimizing exposure.  The
"other"  (inert) ingredients in an end-use product must also be
considered when developing a scientific rationale to support a waiver
request.

I.  Risk Management tc \l3 "I.  Risk Management

After the risk assessment is completed, the biochemical pesticide is
subjected to a risk management analysis by the RAL for the product, in
close consultation with the science reviewer(s).  If minor risks
regarding toxicity/lethality of the biochemical pesticide are identified
in the risk assessment, the risks may be mitigated by addition of
precautionary statements and environmental hazards statements (see
discussion above under Waiver Requests) on the product label.

Conversely, if it is determined that risks cannot be mitigated with
restrictive label language, and that severe adverse effects may result
if the product is used as intended, BPPD may recommend that the product
be transferred to the Registration Division where it would be treated as
a conventional chemical pesticide and would receive a higher level of
scrutiny and the reduced data requirements would not apply.  Usually, if
adverse non-target organism and environmental effects are indicated in
the risk assessment it is also likely that there may be analogous
adverse effects to human health.

J.  Guidance for Non-Target Organism, Fate, and Expression Data
Requirements tc \l3 "J.  Guidance for Non-Target Organism, Fate, and
Expression Data Requirements

For biochemical pesticides, guidance for all non-target organism, fate,
and expression data requirements may be found in the following Subpart
D, Data Requirement Tables:  40 CFR §158.202 and in 40 CFR §158.690
(d).  Specific information on individual non-target organism, fate, and
expression testing guidelines is located in the OPPTS Harmonized
Guidelines Series 850 and Series 835, and may be accessed in
downloadable format at the U.S. EPA website at:

www.epa.gov/docs/OPPTS_Harmonized/850_Ecological_Effects_Test_Guidelines
/Series

and

www.epa.gov/OPPTS_Harmonized/835_Fate_Transport_and_Transformation_Test_
Guidelines/Series/

Ideally, biochemical pesticides will have little or no effects on
non-target organisms, degrade rapidly in the environment, have low
application rates and are applied when non-targets are least likely to
be present.

BPPD has registered many products that have broad spectrum effects on
targets and non-targets, that persist in the environment, and/or are
applied at relatively high rates.  These issues are typically managed by
the use of restrictive language (i.e. explicit use directions and
precautionary statements) on the product label.  For example, if a
product has been determined to be a hazard to honey bees or other
pollinators, the registrant will be instructed to have a label statement
that restricts application of the biochemical pesticide at times when
these beneficial non-target insects are present at the use site.

II. Endangered Species  Risk Assessment for Microbial Pesticides tc \l2
"II. Endangered Species  Risk Assessment for Microbial Pesticides

A.  Characterization of the Listed Species Risk tc \l3 "A.
Characterization of the Listed Species Risk

BPPD must identify all biological pesticides whose use may cause
potential adverse impacts on listed species and their habitats by
determining which flora and fauna may be affected by the proposed
product.  This determination is made by examining the information on
non-target species and host range data of the proposed pesticide.
Available information on the biology and toxicity of the microbial pest
control agent (MPCA),  non-target effects data submitted for
registration, and the pre-registration host-range studies are used to
identify the non-target plants and wildlife that may be adversely
affected.  The data examined include avian, wild mammal, freshwater,
estuarine and marine plants and wildlife, terrestrial plants and several
orders of insects.  Because of the relative specificity and limited host
range of MPCAs, the listed species most likely to be affected are
usually related to the target pests.  (Five sample case studies are
provided in Support Document #79.)

1.  Exposure Assessment tc \l4 "1.  Exposure Assessment

The listed species related to the non-target organisms that may be
affected are identified to see if the use patterns of the pesticidal
product will encroach on their habitat.  The U.S. Fish and Wildlife
Service web site (http://endangered.fws.gov/) is consulted for the
identification of listed species and their location by state(s) and
their habitat within the state(s).  Internal EPA documents or search
programs, such as DANGER which identify overlap of  the habitat of
listed species with agricultural crops, may also be used.  If  overlap
of the habitat of listed species and pesticide use sites does not exist,
a “no effect’ finding is made.  (Refer to case study #1, An ES
Assessment for Bacillus thuringiensis Cry 3bb1 Delta Endotoxin in Corn
by Habitat Overlap Evaluation, and case study #2, M.anisopliae for an
example of a case where habitat overlap cannot be determined).

2.  Integration of Exposure and Effects Data Using the RQ tc \l4 "2.
Integration of Exposure and Effects Data Using the RQ

 	When the use pattern of a pesticidal MPCA may overlap with the habitat
of any listed species related to a species susceptible to the pesticide,
a risk characterization is performed.  Risk characterization integrates
the results of exposure and toxicity data to evaluate the likelihood of
adverse effects on non-target species.  In this approach, BPPD uses the
RQ method to compare exposure over toxicity.

For most pesticides, the effects characterization is based on a
deterministic approach using the LC50.  Estimated Environmental
Concentrations (EECs) based on maximum application rates are divided by
acute toxicity (LD50) values.  The methods are based on the procedures
described in Section V and include risk assessment criteria for listed
species.  These species risk endpoints have also been accepted by the
Office of Endangered Species (1980).

A typical risk assessment starts with a determination of the EEC based
on maximum application rates and the LD50 value for a given species.
The ratio of the EEC and LD50 can then be compared to some relative
quotient ranking to indicate possible acute adverse effects to
non-target organisms.  The criteria for a “may effect” determination
for listed species include the following:

Acute Risk: Species may be potentially affected by use when the acute RQ
is >0.05 (20-fold safety factor) for aquatic or when the RQ is >0.1
(10-fold safety factor) for terrestrial species.

Chronic Risk: Species may potentially be affected through chronic
exposure when the chronic RQ > 1 (for all animals).

Plant risk: Potential for effects in plants (RQ > 1).

In OPP a safety factor of 5x is applied to the acute RQ for terrestrial
non-endangered organisms.  The more stringent safety margin criteria for
listed species were developed to accommodate uncertainty of a no-effect
level based on the toxicity data available for related non-endangered
species.  It is impossible to obtain LC50 or LD50 data for listed
species, and thus it must be assumed that the sensitivity of these
species is similar to that of closely related indicator organisms.

A potential “may effect” risk to listed species can be evaluated by
comparing the toxicity value from the most sensitive species tested  to
a conservative estimate of exposure.  The most conservative approach is
to apply the safety factor (10-fold for terrestrial and 20-fold for
aquatic) to the LC50 or LD50 from the most sensitive species tested to
accommodate uncertainty in the risk assessment process. A safety factor
is desirable to ensure protection of species in which even a single
death is of special concern.

When the RQ meets or is higher than the safety margins given above,  a
“no effect” finding is made in cases where there may be an overlap
of  species habitat and pesticide use. (Refer to case studies #3 and #4
as examples for an actual application of the RQ method in BPPD).

If, however, the calculated RQ is less than the level set by the above
criteria, then BPPD presumes that there will be a “may effect” risk
to the  species and BPPD, in cooperation with FEAD, will initiate
consultation with the  FWS.  (Refer to case study #5 for an example of
restrictions placed on B.thuringiensis uses by a FWS consultation.)

 PAGE  124


[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67938-67939]
[FR Doc No: 2019-26764]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10853-022]

Otter Tail Power Company; Notice of Application Tendered for
Filing With the Commission and Establishing Procedural Schedule for
Licensing and Deadline for Submission of Final Amendments

    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.: 10853-022.
    c. Date Filed: November 27, 2019.
    d. Applicant: Otter Tail Power Company.

    e. Name of Project: Otter Tail River Hydroelectric Project.
    f. Location: The Otter Tail River Hydroelectric Project consists of
five developments on the Otter Tail River that starts in the Township
of Friberg, Minnesota and extends downstream (south) of the City of
Fergus Falls, Minnesota. The project does not occupy federal land.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Michael Olson, Natural Gas Turbine Operations
and NERC Compliance, Otter Tail Power Company, 215 South Cascade
Street, Fergus Falls, Minnesota 56537;<PHONE_NUMBER>;
<EMAIL_ADDRESS>    i. FERC Contact: Patrick Ely at<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. The Otter Tail River Project consists of the following five
existing developments listed upstream to downstream: (1) Friberg
development; (2) Hoot development; (3) Central development; (4) Pisgah
development; and (5) Dayton Hollow development.
    The Friberg development consists of: (1) A reservoir with a surface
area of 340 acres, and negligible storage capacity, at a normal water
surface elevation of 1,299 feet mean sea level (msl); (2) a 341-foot-
long dam which contains a 31-foot-high and 61-foot-long spillway with
seven bays, an 80-foot-long and 36-foot-high east earthfill dike, and a
200-foot-long and 36-foot-high west earthfill dike; (3) a power canal;
(4) a 194-foot-long, 9-foot-diameter penstock; (5) a 27-foot-wide and
27-foot-long reinforced concrete powerhouse; (6) a vertical turbine
rated at 900 horsepower (hp) under a head of 35 feet, connected to a
560-kilowatt (kW) generator; (7) a tailrace; (8) a 75-foot-long, 2.4-
kilovolt (kV) transmission line; and (9) appurtenant facilities.
    The Hoot development facilities include: (1) A reservoir with a
negligible surface area and storage capacity (dam diverts river flow)
at a normal water surface elevation of 1,256 feet msl; (2) a 150-foot-
long, 9-foot-high dam which contains a concrete spillway with six
stoplogged openings with the two outer openings 5 feet 4 inches wide
and the other four openings 11 feet 4 inches wide; (3) a 500-foot-long,
90-inch-diameter concrete tunnel (Hoot Lake); (4) a 20-foot-wide, 700-
foot-long channel between Hoot Lake and Wright Lake; (5) a 20-foot-
wide, 300-foot-long channel leading to the intake structure; (6) a
1,050-foot-long, 8-foot-square concrete tube; (7) a surge tank; (8) an
89-foot-long, 6-foot-diameter steel penstock; (9) a reinforced concrete
powerhouse; (10) a horizontal turbine rated at 1,260 hp under a head of
68 feet connected to a 1,000-kw generator; (11) a tailrace; (12) a 200-
foot-long, 2.4-kV transmission line; (13) a nature-like fishway; and
(14) appurtenant facilities.
    The Central development consists of: (1) A reservoir having a
surface area of 15 acres and a storage capacity of 400 acre-feet, at a
normal water surface elevation of 1,181 feet msl; (2) a 107-foot-long
and 25-foot-high dam which contains a 70-foot-long and 25-foot-high
spillway; (3) an intake structure; (4) a 30-foot-wide and 40-foot-long
brick masonry powerhouse; (5) a vertical turbine rated at 720 hp under
a head of 22 feet, connected to a 400-kW generator; (6) a tailrace; (7)
a 40-foot-long, 2.4-kV transmission line; and (8) appurtenant
facilities.
    The Pisgah development consists of: (1) A reservoir having a
surface area of 70 acres and storage capacity of 250 acre-feet at a
normal water surface elevation of 1,156 feet msl; (2) a 493-foot-long
concrete gravity and earthfill dam ranging in height from 21 feet to 38
feet which has (a) an earthfill dike, (b) a 123-foot-long and 38-foot-
high concrete wing wall, (c) six spillway bays, (d) a 150-foot-long and
21-foot-high south earthfill embankment, and (e) a 220-foot-long and
38-foot-high north earthfill embankment; (3) an intake; (4) a 22-foot-
wide and 32-foot-long reinforced concrete and brick masonry powerhouse;
(5) a vertical turbine rated at 850 hp under a head of 25 feet,
connected to a 520-kW generator; (6) a tailrace; (7) a 330-foot-long,
2.4-kV transmission line; and (8) appurtenant facilities.
    The Dayton Hollow development consists of: (1) A reservoir having a
surface area of 230 acres and a storage capacity of 5,000 acre-feet at
a normal water surface elevation of 1,107 feet msl; (2) a 265-foot-long
concrete and earthfill dam varying in height from 11 feet to 40 feet
which contains (a) an 80-foot-long and 40-foot-high concrete spillway
section, (b) a 95-foot-long and 11-foot-high east earthfill embankment,
and (c) a 90-foot-long and 22-foot-high west earthfill embankment; (3)
an intake structure; (4) a 22-foot-wide and 32-foot-long reinforced
concrete and masonry powerhouse; (5) a vertical turbine rated at 800 hp
under a head of 35 feet, connected to a 520-kW generator and a
horizontal 650 hp turbine connected to a 450-kW generator; (6) a
tailrace; (7) an 80-foot-long, 2.4-kV transmission line; and (8)
appurtenant facilities.
    The Otter Tail River Project is operated in a run-of-river mode
with an estimated annual energy production of approximately 22,323
megawatt hours. Otter Tail Power Company proposes to continue operating
the project as a run-of-river facility and does not propose any new
construction or modifications to the project.
    l. 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 website 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>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). A copy is also available for inspection
and reproduction at the address in item h above.
    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Procedural Schedule: The application will be processed according
to the following preliminary schedule. Revisions to the schedule will
be made as appropriate.

------------------------------------------------------------------------
                Milestone                           Target date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready for  April 2020.
 Environmental Analysis.
Filing of recommendations, preliminary    June 2020.
 terms and conditions, and fishway
 prescriptions.
Commission issues Environmental           November 2020.
 Assessment (EA).
Comments on EA..........................  December 2020.
Modified terms and conditions...........  February 2021.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: December 6, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-26764 Filed 12-11-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Pages 19086-19087]
[FR Doc No: 2022-06893]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-1464-000]

EnerSmart Murray BESS LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
EnerSmart Murray BESS LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 18, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: March 28, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-06893 Filed 3-31-22; 8:45 am]
BILLING CODE 6717-01-P