                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C. 20460

                                                     OFFICE OF CHEMICAL SAFETY
                                                       AND POLLUTION PREVENTION

MEMORANDUM

DATE:	May 3, 2019

SUBJECT: 	Lipochitooligosaccharide (LCO) MOR116: Summary of Hazard and Science Policy Council (HASPOC) Meeting on May 2, 2019:  Recommendations on the Need for the Following Subchronic Studies: 90-Day Oral Study (OCSPP 870.3000), 90-Day Dermal (OCSPP 870.3250), 90-Day Inhalation (OCSPP 870.3465), Prenatal Developmental Study (OCSPP 870.3700), and Genetic Toxicity Testing (OCSPP 870.5100, 870.5300, 870.5375).

PC Code:  006389

DP Barcode:  N/A
Decision No.:  N/A

Registration No.:  N/A
Petition No.:  N/A

Regulatory Action:  N/A
Risk Assessment Type: N/A

Case No.:  N/A
TXR No.: 0057865

CAS No.: 163181-92-8
MRID No.:  N/A

40 CFR:  N/A

FROM:	Janet Camp, Executive Secretary
HASPOC
Health Effects Division (7509P)

THROUGH:	Hannah Pope-Varsalona, Ph.D., Co-Chair
Kelly Lowe, Co-Chair
HASPOC
Health Effects Division (7509P)

TO:	Elyse Osterweil, Ph.D., Toxicologist
            Catherine Eiden, Senior Advisor
Risk Assessment Branch (RAB)
            Biopesticides and Pollution Prevention Division (7511P)

MEETING ATTENDEES:

HASPOC Members:	Jonathan Chen, Evisabel Craig, Angela Gonzales, Kelly Lowe*, Elizabeth Mendez, Michael Metzger, Hannah Pope-Varsalona*, Elissa Reaves, Kristin Rickard, Brian VanDeusen
	* Co-chair

Presenter: 	Elyse Osterweil, Ph.D., Toxicologist

Other Attendees: 	Janet Camp**, Ruthanne Louden**
	** Secretary

 PURPOSE OF MEETING

The Biochemical Pesticide Branch (BPB) is evaluating a request for the registration of lipochitooligosaccharide (LCO) MOR116, a new active ingredient (a.i.). It is a synthetically derived member of the LCO chemical class and practically identical to the previously registered LCO SP104 (EPA File Symbol No 524-AUN). On October 2, 2017, HASPOC considered it acceptable to bridge data on LCOs and their metabolites (such as chitin, vaccenic acid, and GlcNAC) to LCO SP104. The toxicology database for LCO MOR116 is complete except for a 90-Day Oral Study (OCSPP 870.3000), 90-Day Dermal (OCSPP 870.3250), 90-Day Inhalation (OCSPP 870.3465), Prenatal Developmental Study (OCSPP 870.3700), and Genetic Toxicity Testing (OCSPP 870.5100, 870.5300, 870.5375), which are required in accordance with the current 40 CFR Part 158.2050 Toxicology Data Requirements.  The Hazard and Science Policy Council (HASPOC) met on May 2, 2019 to determine if the required studies are necessary to support the registration for LCO MOR116.

 SUMMARY OF USE PROFILE, EXPOSURE, AND HAZARD CONSIDERATIONS

 Use and Exposure Profile
A new active ingredient (a.i.), LCO MOR116, is intended for use as a plant growth regulator applied as a seed treatment for soybean seeds to facilitate root nodulation and colonization of bacteria on the root and promote mycorrhizal symbiosis. This a.i. is very functionally and structurally similar to other lipochitoosaccharides and the registered a.i. LCO SP104 (PC Code 006388), but differs by one N-acetyl-D-glucosamine (GlcNAC) group (see Figure 1). LCOs are signaling molecules involved in plant-microbe endosymbiotic interactions in an estimated 70-80% of land plants. LCOs and their metabolites (such as chitin, vaccenic acid, and GlcNAC) are ubiquitous in the environment in the roots of food crops and associated endosymbiotic bacteria and fungi, regularly consumed as part of a normal diet, easily digested, and not expected to bioaccumulate. Chitin backbone is composed of linked GlcNAC subunits, which are endogenously present in human tissues and breastmilk.

Figure 1. Structure of (a) LCO MOR116 and (b) LCO SP104

 LCO MOR116

   (b) LCO SP104

Pesticidal use of LCO MOR116 is unlikely to contribute significantly to overall human exposure. Dietary exposure is expected to be negligible as significant residues of the substance are not anticipated on treated commodities at the time of consumption when used as a seed treatment. Moreover, the proposed end-use product (EP) contains 2.66 X 10[-5] % LCO MOR116 and is composed of greater than 99% water. There is potential for occupational exposure; however, no toxicological endpoints were identified from the toxicology database for any routes of exposure and the application rates for the proposed use as a seed treatment are very low. No residential uses have been proposed. An aggregate risk assessment for dietary (food and drinking water) exposures was not conducted as no toxicological endpoints have been identified in the toxicity database.

According to the product labels, the proposed manufacturing-use product (MP) LCO MOR 116 (EPA File Symbol No. 524-ALU) contains 0.013% LCO and the EP LCO Liquid Additive (EPA File Symbol No. 524-ALG) contains 2.66 X 10[-][5] % LCO MOR116. The proposed use is as a plant growth regulator for use as a seed treatment on soybean seeds as a water-based slurry via mixing. The product is to be applied at a maximum application rate of 5.89 X 10[-][11] lb ai/lb seed. The proposed labels require the use of personal protective equipment (PPE; long-sleeved shirt and long pants, shoes and socks, and chemical resistant gloves) for mixers, loaders, applicators, and other handlers.

LCO MOR116 is characterized by the applicant as highly soluble in water and it is expected to degrade relatively rapidly once applied since it can function as a carbon source for microorganisms. Therefore, is not likely to result in significant residues on food or in water and is not likely to bioconcentrate. The physical and chemical properties of LCO MOR116 indicate it is readily biodegradable and will degrade rapidly in the environment through chitinases and soil microbes.

 Toxicity Profile

The Tier 1 acute mammalian toxicology studies were conducted in accordance with the biochemical pesticide data requirements (40 CFR§ 158.2050) and indicate that the proposed MP, LCO MOR116, is unlikely to present a human health hazard. Briefly, the acute Toxicity Categories for LCO MOR116 were determined to be: acute oral toxicity is Category IV (LD50 > 5000 mg/kg); dermal acute toxicity is Category IV (LD50 > 5000 mg/kg); inhalation toxicity is Category IV (LC50 > 5.14 mg/L); minimally irritating for acute eye irritation; minimally irritating for acute dermal irritation; and not a dermal sensitizer. Based on the information presented, LCO MOR116 is expected to have low acute toxicity (MRIDs 50464807 to 50464812).

No subchronic or chronic toxicity studies were submitted for LCO MOR116. In lieu of toxicity data on LCO MOR 116, studies from metabolites and constituents of LCO, such as chitin, GlcNAc, and OAG were used and are considered acceptable surrogates for LCO SP104 and LCO MOR116. Eight repeat dose studies are available for compounds related to LCOs that are adequate for use in risk assessment for LCO MOR116 and indicate a lack of adverse effects. A 90-day oral toxicity rat study performed on OAG indicates a POD value of 641 mg/kg/day, based on decreased weight of salivary glands. All other studies showed no adverse effects at or above the limit dose of 1000 mg/kg/day for structurally similar compounds chitin, GlcNAc, etc.

 LCO MOR116 Mode of Action (Taken from MRID 49819918)

LCOs comprise a class of molecules that act as Nod and Myc factors by promoting plant microbial symbiosis, soil microbial activity, and associated plant growth. When a plant senses the need for a nutrient such as nitrogen and has the capability of entering into Nod factor mediated symbiosis, it releases plant flavonoids that are recognized by rhizobia or other bacteria
capable of nodulation. The bacteria sense the flavonoids and produce LCO molecules that signal
the plant to initiate root nodulation, permitting the bacteria to colonize the plant roots and
provide atmospherically rich nitrogen to the plant. LCOs, acting as either Nod or Myc factors,
activate the DMI (stands for doesn't make infections) pathway by binding to transmembrane receptors that are comprised of extracellular lysine motifs and intracellular kinase domains (Gough and Cullimore, 2011). These receptors and the DMI pathway are not known to be present in humans or other animals and it therefore not considered a mammalian MOA. Furthermore, their presence in plants is not limited to leguminous species.

 History of Safe Use (Taken from MRID 49819919)
Nod and Myc factors are naturally occurring LCOs that have been involved in plant-microbe symbioses for millions of years. The majority of land plants rely on these signaling pathways to regulate effective microbe symbioses. They all belong to the same class of signaling molecules and share the common structural features of a chitin/chitooligomer backbone and fatty acid side chain. Food and feed crops, including corn and soybean, share in these signaling pathways with soil symbionts. LCO SP104 can act as a Nod and/or Myc factor, and act at concentrations similar to other LCOs, namely in the nano- to picomolar concentration range (Tanaka et al., 2015). Since LCOs acting as Nod and Myc factors evolved tens to hundreds of millions of years ago, and today are active signal transducers in the majority of land plants, there is a vast history of safe use/exposure to LCOs present in, or originating from, the rhizosphere.

   STUDY WAIVER REQUESTS

 Quantitative vs. Qualitative Risk Assessment

HASPOC recommends that a qualitative risk assessment is appropriate to support the proposed use of LCO MOR116. The qualitative determination is based on the following: (1) the low overall acute toxicity of LCO MOR116; (2) humans are already exposed to LCOs with structural similarity to LCO MOR116 as they are naturally occurring and have long been part of the normal diet (seafood and plants); and (3) dietary and non-dietary exposure from use as a seed treatment is expected to be negligible based on PPE requirements, very low application rates, and the composition of the proposed end-use product which contains more than 99% water.

 90-day Oral Toxicity (OCSPP 870.3100)

The 90-day oral toxicity study is required to register food uses for a pesticide. In MRID 50738202, data and information were cited from the open scientific literature to satisfy the data requirement. Eight studies (two 28-day, four 90-day, a 1-year, and a 2-year oral toxicity) are available for compounds related to LCOs that are adequate for use in risk assessments and indicate a lack of adverse effects. These structurally-similar compounds are chitooligomers (LCO degradation product), chitosan oligosaccharide (also an LCO degradation product), chitin-glucan, chitin, N-acetylglucosamine, and oligo-N-acetylglucosamine and are considered acceptable surrogates for LCO SP104 and LCO MOR116. Summaries of the eight studies are provided in Table 1 in the Appendix. Based on the results of the available toxicity studies, adverse effects of toxicological concern are not anticipated from exposure to LCO MOR116 as a biopesticide. Therefore, a qualitative assessment will be performed.

Prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of
chitin as food additive, and chitosan and LCO SP104 as plant growth regulators. The rationales for the waivers were based on the low concentration of the active ingredient in pesticide products, the ingredient's low toxicity, and the natural ubiquity of the ingredient in the environment. In addition, the Agency issued a tolerance exemption for chitin and chitosan.

LCOs with structural similarity to LCO MOR116 are present in the roots of food crops, as they are signaling molecules that diffuse into the roots, in addition to being present in bacteria and fungi that are associated with the roots of food crops. Molecules identical to LCO breakdown products are also present in insects, crustaceans, fungi, bacteria, and humans, and are regularly consumed as part of a normal diet.

Based on a WOE approach, considering all the available LCO MOR116 hazard and other
data on similar compounds, the HASPOC recommends that a 90-day oral
study on LCO MOR116 is not required at this time. This approach included the following considerations: (1) several oral toxicity studies conducted on similar compounds to LCO MOR116 showed no adverse effects at the highest dose tested; (2) the acute toxicology studies for the MP LCO MOR116 demonstrate Toxicology Category IV, suggesting that the compound has low toxicity on an acute basis; (3) LCO MOR116 is naturally occurring and has long been part of the normal diet (seafood and plants); (4) prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of chitin and chitosan as food additives and plant growth regulators, respectively; (5) mode of action is not relevant outside the plant kingdom; (6) there is an existing U.S. EPA tolerance exemption for chitin and chitosan; (7) naturally occuring-ubiquity in the environment; (8) due to low toxicity, a qualitative assessment will be performed; and 9) the low application rates of LCO MOR116.

 90-Day Dermal Toxicity

The 90-day dermal study is a conditional data requirement for pesticides with food use registrations.

Based on a WOE approach, considering all the available LCO MOR116 hazard and other data on similar compounds, the HASPOC recommends that a 90-day dermal toxicity study on LCO MOR116 is not required at this time. This approach included the following considerations: (1) several oral toxicity studies conducted on similar compounds to LCO MOR116 showed no adverse effects at the highest dose tested; (2) the acute toxicology studies for the MP LCO MOR116 demonstrate Toxicology Category IV, suggesting that the compound has low toxicity on an acute basis; (3) LCO MOR116 is naturally occurring and has long been part of the normal diet (seafood and plants); (4) prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of chitin and chitosan as food additives and plant growth regulators, respectively; (5) mode of action is not relevant outside the plant kingdom; (6) there is an existing U.S. EPA tolerance exemption for chitin and chitosan; (7) naturally occuring-ubiquity in the environment; (8) due to low toxicity, a qualitative assessment will be performed; and 9) the low application rates of LCO MOR116.

 90-Day Inhalation Toxicity

The 90-day inhalation study is a conditional data requirement for pesticides with food use registrations.

Based on a WOE approach, considering all the available LCO MOR116 hazard and other data on similar compounds, the HASPOC recommends that a 90-day inhalation toxicity study on LCO MOR116 is not required at this time. This approach included the following considerations: (1) several oral toxicity studies conducted on similar compounds to LCO MOR116 showed no adverse effects at the highest dose tested; (2) the acute toxicology studies for the MP LCO MOR116 demonstrate Toxicology Category IV, suggesting that the compound has low toxicity on an acute basis; (3) LCO MOR116 is naturally occurring and has long been part of the normal diet (seafood and plants); (4) prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of chitin and chitosan as food additives and plant growth regulators, respectively; (5) mode of action is not relevant outside the plant kingdom; (6) there is an existing U.S. EPA tolerance exemption for chitin and chitosan; (7) naturally occuring-ubiquity in the environment; (8) due to low toxicity, a qualitative assessment will be performed; and 9) the low application rates of LCO MOR116.

 Prenatal Developmental Toxicity

Prenatal developmental toxicity studies are required in the 2015 CFR Part 158 Toxicology Data Requirement because they provide important scientific information on the potential maternal and developmental toxicity effects from pesticide exposure.

 Evidence for prenatal development toxicity in the LCO MOR116 database: There are no repeated-dose toxicity studies for LCOs. The toxicity profile for LCO MOR116 does not indicate any specific organs that are the primary target organ.

Evidence for prenatal development toxicity in the toxicology database of similar chemicals:  Chemicals with structural similarity to LCO SP104 are present in the roots of food crops as they are signaling molecules which diffuse into the roots, in addition to being present in bacteria and fungi that are associated with the roots of food crops. Molecules identical to LCO breakdown products are also present in insects, crustaceans, fungi, bacteria and humans, and are regularly consumed as part of a normal diet. No toxicity information was provided on prenatal exposure to LCOs.  The use of LCO MOR116 as a plant growth regulator is not expected to increase exposure to women of childbearing age above background levels

Risk assessment considerations: A waiver is requested for the prenatal developmental toxicity data requirement for LCO MOR116 due to low acute oral, dermal, and inhalation toxicity (EPA Toxicity Category IV) and the 90-day oral toxicity of similarly-structured compounds having NOAELs greater than 2000 mg/kg in rats. LCOs are present in the roots of food crops, have long been part of the normal diet (e.g. seafood and plants). A qualitative assessment will be performed on this chemical.

Based on a WOE approach, considering all the available LCO MOR116 hazard and exposure data, the HASPOC recommends that a prenatal developmental study is not required at this time. This approach included the following considerations: (1) LCO MOR116 is naturally occurring and has long been part of the normal diet (seafood and plants); (2) the acute toxicology studies are classified as Toxicity Category IV, indicating low acute toxicity for LCO MOR116, and 90-day oral toxicity studies of similarly-structured compounds (chitin-glucan, chitin, N-acetylglucosamine, and oligo-N-acetylglucosamine) have found NOAELs greater than 2000 mg/kg in rats; (3) prior data waivers for all subchronic toxicity requirements were granted by the Agency for use of chitin and chitosan as food additives and plant growth regulators, respectively; (4) mode of action is not relevant outside the plant kingdom; (5) there is an existing U.S. EPA tolerance exemption for the related compounds, chitin and chitosan; (6) ubiquity in the environment; (7) due to the low toxicity for this chemical, a qualitative assessment will be performed; and (8) the low application rates of LCO MOR116.
 Genetic Toxicity Testing (OSCPP 870.5100, 5300, 5375)

Mutagenicity data are required to support food uses but are unavailable for LCO MOR116. The registrant cited three genotoxicity studies performed on structurally similar compounds to LCO (chitooligomers and N-acetylglucosamine). Fernandes et al. evaluated the genotoxicity of two low molecular weight chitooligosaccharides using fresh peripheral blood lymphocytes both in micronucleus and comet assays. No evidence of genotoxicity was observed in either assay (Fernandes et al., 2011). Qin et al. evaluated the genotoxicity of a chitooligomer preparation derived from shrimp chitosan (85% deacetylated) in Ames, mouse micronucleus, and mouse sperm abnormality assays. When tested up to 5 μg/plate using E. coli strains TA97, TA98, TA100 and TA102, no increase in mutation frequency was noted. Similarly, when tested in a mouse micronucleus assay, the chitooligomer preparation did not cause an increase in the number of micronuclei when tested up to 5,000 mg/kg (Qin et al., 2006). When tested in mice up to 5,000 mg/kg, there was no increase in sperm abnormalities, indicating a lack of mutagenic or genotoxic potential. Jamialahmadi et al. evaluated the potential genotoxicity of GlcNAc in an in vitro comet assay using human peripheral lymphocytes. Cells were exposed to 2.5, 5, 10, 20, or 40 mM GlcNAc and no genotoxic response was observed (Jamialahmadi et al., 2014).

Based on a WOE approach, considering all the available LCO MOR116 hazard and exposure data, the HASPOC recommends that genetic toxicity testing is not required at this time. This approach included the following considerations: 1) available literature studies demonstrated a lack of genotoxicity for LCOs; 2) structure-activity relationships demonstrating a lack of genotoxic potential; 3) prior genotoxicity data waivers granted by the Agency for use of (structurally similar) chitin and chitosan as food additives and plant growth regulators, respectively; 4) U.S. EPA has established a tolerance exemption for chitin and chitosan; 5) ubiquitous nature of LCOs in the environment; and 6) a History of Safe Use (HOSU) of LCOs.

   HASPOC CONCLUSIONS

Based on the summary information presented to HASPOC and a WOE approach, the HASPOC recommends that a qualitative risk assessment is appropriate for the proposed seed treatment use of LCO MOR116.

Based on a WOE approach, considering all the available hazard and exposure data for LCO MOR116, HASPOC recommends that the studies for 90-day oral toxicity, 90-day dermal toxicity, 90-day inhalation toxicity, prenatal developmental toxicity, and genetic toxicity testing for LCO MOR116 are not required at this time.

 APPENDIX A

 Table 1. Oral Toxicity Data from the Open Literature for Structurally Similar Compounds (Taken from MRID 49819918).
Chemical
                                  Study Type
                                    NOAELs
                                  (mg/kg/day)
                                    LOAELs
                                  (mg/kg/day)
                               Effects at LOAEL
                                   Reference
Chitooligomers
28-day rat
3,000 (HDT)
-
No adverse effects at HDT
(Qin et al., 2006)
COS (chitosan oligosachharide)
28-day rat
2,000 (HDT)
-
No adverse effects at HDT
(Kim et al., 2001)
Chitin-glucan
90-day rat
6,600 M (HDT)
7,000 F (HDT)
-
No adverse effects at HDT
(Jonker et al., 2010)
Chitin
90-day rat
3,500 (HDT)
-
No adverse effects at HDT
(Niho et al., 1999)
GlcNAc
90-day rat
2,476 M (HDT)
2,834 F (HDT)
-
No adverse effects at HDT
(Lee et al., 2004)
OAG (oligo-N-acetylglucosamine)
90-day rat
641 M (HDT)
3,640 F (HDT)
5,000 ppm M
None F
M: decreased weight of submaxillary salivary gland
(Tago et al., 2007)
GlcNAc
1 yr rat
2,323 M (HDT)
2,545 F (HDT)
-
No adverse effects at HDT
(Takahashi et al., 2009)

GlcNAc
2 yr rat
2,323 M (HDT)
2,545 F (HDT)

-
No adverse effects at HDT
(not carcinogenic)
(Takahashi et al., 2009)
F = female; M = male; HDT = highest dose tested; LOAEL = lowest-observed-adverse-effect-level; NOAEL = no-observed-adverse-effect-level


[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Page 47487]
[FR Doc No: 2021-18297]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2674-000]

Borderlands Wind, 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
Borderlands Wind, 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 September 8, 2021.
    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_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: August 19, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-18297 Filed 8-24-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 19, 2006 (Volume 71, Number 202)]
[Notices]
[Page 61751]
[DOCID:fr19oc06-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-1407-000; ER06-1408-000; ER06-1409-000; and ER06-
1413-000]

Noble Bliss Windpark, LLC; Noble Ellenburg Windpark, LLC; Noble
Altona Windpark, LLC; Noble Clinton Windpark I, LLC; Notice of Issuance
of Order

October 13, 2006.
    Noble Bliss Windpark, LLC, Noble Ellenburg Windpark, LLC, Noble
Altona Windpark, LLC and Noble Clinton Windpark I, LLC (Applicants)
filed an application for market-based rate authority, with accompanying
rate schedules. The proposed market-based rate schedules provides for
the sale of energy, capacity and ancillary services at market-based
rates. The Applicants also requested waivers of various Commission
regulations. In particular, the Applicants requested that the
Commission grant blanket approval under 18 CFR part 34 of all future
issuances of securities and assumptions of liability by the Applicants.
    On September 28, 2006, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development--West, granted the
requests for blanket approval under part 34. The Director's order also
stated that the Commission would publish a separate notice in the
Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard or to protest
the blanket approvals of issuances of securities or assumptions of
liability by the Applicants should file a motion to intervene or
protest 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,
385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is November 13, 2006.
    Absent a request to be heard in opposition by the deadline above,
the Applicants are authorized to issue securities and assume
obligations or liabilities as a guarantor, indorser, surety, or
otherwise in respect of any security of another person; provided that
such issuance or assumption is for some lawful object within the
corporate purposes of the Applicants, compatible with the public
interest, and is reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of the Applicants' issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also 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
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-17497 Filed 10-18-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: June 5, 2006 (Volume 71, Number 107)]
[Notices]
[Page 32342-32343]
[DOCID:fr05jn06-51]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2002-0059; FRL-8180-1]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Safe Drinking Water Act State Revolving Fund Program;
EPA ICR No. 1803.05, OMB Control No. 2040-0185

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on November 30, 2006. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before August 4, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2002-0059 by one of the following methods: http://www.regulations.gov:

Follow the on-line instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>    Mail: Water Docket, Environmental Protection Agency, Mailcode:
4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    Hand Delivery: Water Docket, EPA Docket Center (EPA/DC), EPA West,
Room B102, 1301 Constitution Ave., NW., EPA West Building, Room B102,
Washington, DC 20004. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2002-
0059. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

FOR FURTHER INFORMATION CONTACT: Howard Rubin, Mail Code 4606M,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-3757; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2002-0059, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in

the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Water Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft

collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What Information Is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number

assigned to this action in the subject line on the first page of your
response. You may also provide the name, date, and Federal Register
citation.

What Information Collection Activity or ICR Does This Apply to?

[Docket ID No. EPA-HQ-OW-2002-0059]

    Affected entities: Entities potentially affected by this action are
the 50 States, Puerto Rico, and the recipients of assistance in each of
these jurisdictions.
    Title: Safe Drinking Water Act State Revolving Fund Program.
    ICR numbers: EPA ICR No. 1803.05, OMB Control No. 2040-0185.
    ICR status: This ICR is currently scheduled to expire on November
30, 2006. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, and are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The Safe Drinking Water Act (SDWA) Amendments of 1996
(Pub. L. 104-182) authorized the creation of the Drinking Water State
Revolving Fund (DWSRF) program in each State and Puerto Rico to assist
public water systems to finance the costs of infrastructure needed to
achieve or maintain compliance with SDWA requirements and to protect
public health. Section 1452 authorizes the Administrator of the U.S.
Environmental Protection Agency (EPA) to award capitalization grants to
the States and Puerto Rico which, in turn, provide low-cost loans and
other types of assistance to eligible drinking water systems. States
can also reserve a portion of their grants to conduct various set-aside
activities. The information collection activities will occur primarily
at the program level through the (1) Capitalization Grant Application
and Agreement/State Intended Use Plan; (2) Biennial Report; (3) Annual
Audit; and (4) Assistance Application Review. Information collected is
needed for input into the DWSRF National Information Management System.
    (1) Capitalization Grant Application and Agreement/State Intended
Use Plan: The State must prepare a Capitalization Grant Application
that includes an Intended Use Plan (IUP) outlining in detail how it
will use all the funds covered by the capitalization grant. The State
may, as an alternative, develop the IUP in a two part process with one
part identifying the distribution and uses of the funds among the
various set-asides in the DWSRF program and the other part dealing with
project assistance from the Fund.
    (2) Biennial Report: The State must agree to complete and submit a
Biennial Report on the uses of the capitalization grant. The scope of
the report must cover assistance provided by the DWSF Fund and all
other set-aside activities included under the Capital Grant Agreement.
States which jointly administer DWSRF and Clean Water State Revolving
Fund (CWSRF) programs, in accordance with section 1452(g)(1), may
submit reports (according to the schedule specified for each program)
which cover both programs.
    (3) Annual Audit: A State must comply with the provisions of the
Single Audit Act Amendments of 1996. Best management practices suggest
and EPA recommends that a State conduct an annual independent audit of
its DWSRF program. The scope of the report must cover the DWSRF Fund
and all other set-aside activities included in the Capitalization Grant
Agreement. States which jointly administer DWSRF and CWSRF programs, in
accordance with section 1452(g)(1), may submit audits that cover both
programs but which report financial information for each program
separately.
    (4) Assistance Application Review: Local applicants seeking
financial assistance must prepare and submit DWSRF loan applications.
States then review completed loan applications and verify that proposed
projects will comply with applicable Federal and State requirements.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to be an average
of 131 hours per response. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimate total number of potential respondents: 1505 respondents
per year.
    Frequency of response: For Capitalization Grants and Audits
responses are annual, for Biennial reports and Loan Applications,
responses are on occasion.
    Estimated total average number of responses for each respondent:
This ICR estimates one annual response per respondent.
    Estimated total annual burden hours per response: Approximately 131
hrs. (196,870 hrs./1505 respondents).
    Estimated total annual burden hours: Respondent burden is estimated
at 196,870 hrs. annually.
    Estimated total annual costs: Respondent total cost is estimated at
$6,862,452 annually.

Are There Changes in the Estimates From the Last Approval?

    There is an increase of 275 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This increase reflects EPA's calculation of burden for biennial
reports. The last ICR assumed 25 respondents in 2003, 26 respondents in
2004, and 25 respondents in 2005. Using this methodology, this ICR
assumes 26 respondents in 2006, 25 respondents in 2007, and 26
respondents in 2008. This results in one additional respondent over the
last ICR.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: May 26, 2006.
Cynthia C. Dougherty,
Director, Office of Ground Water & Drinking Water.
 [FR Doc. E6-8663 Filed 6-2-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 163 (Friday, August 21, 2020)]
[Notices]
[Page 51843]
[FR Doc No: 2020-18313]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0065]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on August 3, 2020, BNSF
Railway Company (BNSF) petitioned the Federal Railroad Administration
(FRA) for a waiver of compliance from certain provisions of the Federal
railroad safety regulations contained at 49 CFR part 218, Railroad
Operating Practices. FRA assigned the petition Docket Number FRA-2020-
0065.
    Specifically, BNSF requests relief from certain blue signal
protection requirements, 49 CFR 218.25, Workers on a Main Track, for
workers engaged in fueling, performing locomotive daily inspections,
and other routine operations on head-end locomotives at fuel pads
situated on main lines. BNSF explains that blue signal protection would
still be required at the rear end of a train if performing fueling,
locomotive daily inspections, and work on locomotives in the
distributed power remote consist.
    BNSF states that adequate safety will be maintained by placing a
blue signal at the head end of the consist in a location readily
visible to the locomotive engineer or whomever may be occupying the
controlling locomotive. Protection at the rear end of the train will be
supplied by railroad signals, which BNSF states will be sufficient, as
there will be no railroad employees performing any inspections on the
rolling equipment beyond the lead locomotive consist to the rear of the
train.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by October 5, 2020 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable. Anyone can search the electronic
form of any written communications and comments received into any of
our dockets by the name of the individual submitting the comment (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its processes. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2020-18313 Filed 8-20-20; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Page 64504]
[FR Doc No: 2022-23141]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4671-DR; Docket ID FEMA-2022-0001]

Puerto Rico; Amendment No. 9 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Puerto Rico (FEMA-4671-DR), dated September 21,
2022, and related determinations.

DATES: This amendment was issued October 2, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Puerto Rico is hereby amended to include
permanent work under the Public Assistance program for those areas
determined to have been adversely affected by the event declared a
major disaster by the President in his declaration of September 21,
2022.

    The municipalities of Bayam[oacute]n, Camuy, Cayey, Ceiba,
Coamo, Corozal, Gu[aacute]nica, Guayama, Guaynabo, Gurabo,
Hormigueros, Juncos, Lajas, Maunabo, Mayag[uuml]ez, Orocovis,
Patillas, Pe[ntilde]uelas, Ponce, Rinc[oacute]n, Sabana Grande,
Villalba, Yabucoa, and Yauco for permanent work [Categories C-G]
(already designated for Individual Assistance and assistance for
debris removal and emergency protective measures [Categories A and
B], including direct federal assistance, under the Public Assistance
program).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-23141 Filed 10-24-22; 8:45 am]
BILLING CODE 9111-23-P