[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Page 78849]
[FR Doc No: 2020-26825]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-527-000]

Columbia Gulf Transmission, LLC; Notice of Schedule for the
Preparation of an Environmental Assessment for the East Lateral Xpress
Project

    On September 24, 2020, Columbia Gulf Transmission, LLC (Columbia
Gulf) filed an application in Docket No. CP20-527-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate certain natural
gas pipeline facilities in Louisiana. The proposed project is known as
the East Lateral XPress Project (Project), and would provide a total of
725 million standard cubic feet per day of firm transportation
capacity, on Columbia Gulf's interstate natural gas pipeline system, to
supply feed gas for Venture Global LNG's Plaquemines LNG facility in
Plaquemines Parish, Louisiana.
    On October 8, 2020, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
environmental document for the Project.
    This notice identifies Commission staff's intention to prepare an
environmental assessment (EA) for the Project and the planned schedule
for the completion of the environmental review.\1\
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    \1\ 40 CFR 1501.10 (2020)
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Schedule for Environmental Review

Issuance of EA March 16, 2021
90-day Federal Authorization Decision Deadline June 14, 2021

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The East Lateral XPress Project would consist of the following
facilities:
     8.1 miles of 30-inch-diameter pipeline lateral within
Barataria Bay in Jefferson and Plaquemines Parishes, Louisiana;
     a new 23,470-horsepower compressor station at an existing
Columbia Gulf abandoned compressor station site in St. Mary Parish,
Louisiana (Centerville Compressor Station);
     a new 23,470-horsepower compressor station adjacent to an
existing tie-in facility in Lafourche Parish, Louisiana (Golden Meadow
Compressor Station);
     one new delivery meter station;
     one new tie-in facility in Barataria Bay; and
     two new mainline valves.

Background

    On October 21, 2020, the Commission issued a Notice of Scoping
Period Requesting Comments on Environmental Issues for the Proposed
East Lateral XPress Project (Notice of Scoping). The Notice of Scoping
was sent to affected landowners; federal, state, and local government
agencies; elected officials; environmental and public interest groups;
Native American tribes; other interested parties; and local libraries
and newspapers. In response to the Notice of Scoping, the Commission
received comments from the National Oceanic and Atmospheric
Administration National Marine Fisheries Service, the U.S.
Environmental Protection Agency, and the Teamsters National Pipeline
Labor Management Cooperation Trust. The primary issues raised by the
commenters are essential fish habitat; air quality; environmental
justice populations; and tribal impacts. All substantive comments will
be addressed in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This service
provides automatic notification of filings made to subscribed dockets,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    Additional information about the Project is available from the
Commission's
    Office of External Affairs at (866) 208-FERC or on the FERC website
(www.ferc.gov). Using the eLibrary link, select General Search from the
eLibrary menu, enter the selected date range and Docket Number (i.e.,
CP20-527), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: December 1, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-26825 Filed 12-4-20; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

September 5, 2008

MEMORANDUM

SUBJECT:	Creosote:  Occupational and Residential Exposure and Risk Assessment for the Reregistration Eligibility Decision (RED).  PC Codes 022003, 025003, and 025004.

FROM:	Timothy Leighton, Environmental Scientist

Regulatory Management Branch II

		Antimicrobials Division

THRU:	Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

		Antimicrobials Division

TO:		Jacqueline Campbell-McFarlane  SEQ CHAPTER \h \r 1 , Chemical Review Manager

Antimicrobials Division

And

Timothy F. McMahon, Ph.D., Senior Toxicologist

Antimicrobials Division

 TOC \f Table of Contents	2

Executive Summary	3

1.0  Introduction…………………………………………………… ……………………………5

2.0   Summary of Toxicity Data………………………………………………………... …………5    2.1 Acute Toxicology Categories	7

2.2 Summary of Endpoints of Concern……………………………………………………….. ..8

2.3  FQPAConsideration……………………………………………… ………………………10

3.0 Occupational Exposures and Risks at Pressure Treatment Facilities	10

3.1 Worker Exposure at Pressure Treatment Facilities	13

3.1.1 Pressure Treatment Process	13

3.1.2 Dermal Exposure Monitoring	14

3.1.3 Inhalation Exposure Monitoring…………………………………………………….. .15

3.1.4 Exposure and Risk Characterization……………………………………………… ….16

3.2 Post-Application Exposures and Risks	21

4.0 Summary of Literature Exposure Studies……………………………………………….22

5.0 Uncertainties and Limitations	26

6.0 References	27

EXECUTIVE SUMMARY

Creosote applications are limited to occupational handlers at pressure treatment facilities.  Since it is a restricted-use pesticide that can only be applied by certified applicators or someone under their direct supervision, it is not available for sale to or use by homeowners.  A recent voluntary cancellation of all non pressure treatment uses restricts creosote to commercial and industrial settings.

This chapter is a revision of the earlier draft Human Exposure RED Chapter for Creosote completed in 2003.  Subsequent to the last release of the creosote assessment, additional data were made available to further refine the assessment.  The previous version of the human risk assessment was based on relying on benzo(a)pyrene as an indicator of creosote risk because creosote-specific data were not available.  Data are now available to relate dermal absorption and cancer risks to creosote.  The previous draft risk assessment also included scenarios using data from the Pesticide Handlers Exposure Database (PHED) and the Chemical Manufactures Association (CMA).  These scenarios have been deleted in this current assessment based on the voluntary cancellation of all non pressure treatment uses of creosote.

Toxicological endpoints have been selected for the dermal and inhalation exposure routes to assess the exposure to creosote.  Both non cancer and cancer endpoints are summarized in Table 2 below.  Because the inhalation exposure samples from the Creosote Council’s worker exposure study did not provide reliable air measurements for coal tar pitch volatiles (CTPVs), the naphthalene air samples have been used to indicate the need for inhalation exposure mitigation.  However, the use of the naphthalene inhalation toxicology data is uncertain.  There are notable species differences in the metabolism of naphthalene between rodents and primates as discussed in the toxicology section below.  It is understood that as further research is conducted with regard to the species differences in naphthalene disposition and toxicity, that the occupational inhalation assessment would be modified accordingly.

The results of the Creosote Council’s worker exposure study at pressure treatment facilities indicate that the naphthalene inhalation exposures trigger EPA’s non cancer risk level of concern for 16 of the 19 inhalation MOEs assessed.  The non cancer inhalation MOEs for worker exposure to naphthalene range from 23 to 1,900 (i.e., target MOE of 300).  However, none of the average naphthalene air concentrations for the various job functions exceeded the ACGIH TLV and OSHA PEL of 52 mg/m3.  Furthermore, the published literature for creosote exposure also indicates naphthalene air concentrations in the range of that monitored by the Creosote Council, with some upper ends of the range slightly higher (but those concentrations are for “total vapor”).  The results of the air concentrations reported in the literature support the results of the Creosote Council’s worker exposure study indicating that exposure to creosote should be reduced.

For dermal worker risks, the results indicate the short-term (ST) non cancer dermal MOEs do not trigger a risk concern except for the treatment operator at site C where the dermal MOE is 68 and the target MOE is 100.  The intermediate-term (IT) non cancer dermal MOEs trigger risk concerns for 8 of the 24 scenarios presented.  IT MOEs range from 3 to 2700 and the target MOE is 100.  The long-term (LT) non cancer dermal MOEs trigger risk concerns for 3 of the 24 scenarios.  LT MOEs range from 34 to 34,000 and the target MOE is 300.  IT risks being greater than the LT risks is an anomaly.  However, in the case of creosote it is explainable because the IT toxicity endpoint is based on a dermal study while the LT endpoint is based on an oral study (i.e., there are differences in routes of exposure and dosing levels between the two studies).

All of the cancer risks exceed the Agency’s level of concern of 1 x 10-6 but only 4 of the scenarios had risks exceeding 1 x 10-4 (i.e., risks range from 2.5 x 10-5 to 1.6 x 10-6).

 	The registrants submitted a probabilistic worker risk assessment for creosote in February 2008.  This probabilistic assessment has been included in the public docket.  A thorough EPA review of the probabilistic assessment has not been conducted.  The methodology and data inputs in this recent submission differ from that presented by EPA.  EPA’s assessment herein presents a deterministic risk assessment.  In summary, the Creosote Council’s probabilistic assessment includes cancer risk results with and without the probabilistic analysis of the cancer slope factor.  The mean and 95th percentile cancer risks reported in Table 9 of the Creosote Council’s probabilistic assessment range from  10-4 to 10-5.  These reported risks are within the range of the risks presented by EPA in Table 6 of Section 3.1.4 below.  However, EPA’s assessment reports one cancer risk lower than that reported in the probabilistic assessment (i.e., 1.6 x 10-3 for the treatment operators at a facility built in the 1940s).

1.0	Introduction

An occupational and/or residential exposure risk assessment is required for an active ingredient if (1) certain toxicological criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For creosote, both criteria are met.

On April 1, 1999, the EPA/OPP Health Effects Division's Hazard Identification Assessment Review Committee (HIARC) evaluated the toxicology data base of creosote and selected toxicological endpoints for short-term, intermediate-term, and long-term occupational and residential exposure risk assessments.  On September 3, 2003, the Antimicrobials Division Toxicity Endpoint Selection Committee (ADTC) met to verify the selected endpoints for dermal and inhalation risk assessment.  On December 6, 2007, members of the Antimicrobials Division’s Toxicity Endpoint Selection Committee and members of the Health Effects Division’s Carcinogenicity Assessment Review Committee (CARC) met to discuss the quantitative carcinogenicity analysis performed for creosote by the Pest Management Regulatory Agency, Health Canada and to determine an appropriate potency factor for creosote.

2.0 tc \l2 "4.1 	 Summary of Toxicity Data tc \l1 "Occupational

Dermal tc \l3 "Dermal  Absorption:  Submitted studies on the dermal absorption of creosote have been submitted and consist of an in vivo dermal absorption study in the rat as well as an in vitro dermal absorption study using both rat and human skin (MRIDs 47179501 and 47179502). The results of these studies support the conclusion that dermal absorption in human skin is approximately 8-fold lower than that of rat skin. The results of the submitted studies also support a value for dermal absorption of creosote in rat skin of approximately 34%. Thus, estimated dermal absorption of creosote in human skin is determined to be 5% (34% value divided by 8 and rounded to 5%).  A lower dermal absorption value suggested by the registrant was not used because of the lack of data on solubility limit of the creosote mixture itself in the in vitro test system, and the continued absorption of creosote observed after 8 hours in the in vivo study suggesting the availability of creosote within the skin for absorption.

Short-Term tc \l3 "Short-Term  Dermal (1 day - 1 month): An oral maternal NOAEL of 50 mg/kg/day and a LOAEL of 175 mg/kg/day, based on decreased body weight gain during the study, was chosen for this endpoint (USEPA, 2008).  Although a 90-day dermal toxicity study was available, the developmental toxicity study was chosen because dermal toxicity studies (including the 2-week range-finding studies) did not measure developmental endpoints, which are present in both developmental toxicity studies.  An uncertainty factor (MOE) of 100 is applied to this risk assessment (USEPA, 2008).

Intermediate-Term tc \l3 "Intermediate-Term  Dermal (1 month to 6 months): A dermal NOAEL of 40 mg/kg/day, based on decreased body weight gain in males at 400 mg/kg/day observed in the 90-day dermal toxicity  study (MRID # 43616201).  An uncertainty factor (MOE) of 100 is applied to this risk assessment (USEPA, 2008).

Long-Term tc \l3 "Long-Term  Dermal (greater than 6 months): A parental oral LOAEL of 25 mg/kg/day, based on decreased pre-mating body weight, was selected for this endpoint.  An extra uncertainty factor of 3x is applied for use of a LOAEL in this study for occupational risk assessments (USEPA, 2008).  Based on the results of this study, the Parental Systemic NOAEL is < 25 mg/kg/day, and the Parental Systemic LOAEL is 25 mg/kg/day, based on decreased pre-mating body weight.  The developmental NOAEL in this study is < 25 mg/kg/day, and the developmental LOAEL is 25 mg/kg/day, based on a dose-related decrease in pup body weight for the F0 pups from days 14-21. The reproductive NOAEL is < 25 mg/kg/day, and the reproductive LOAEL is 25 mg/kg/day, based on reduced pregnancy and fertility indices in F1 female parental rats (USEPA, 2008).

Inhalation (any time-period):  An NOAEL of 0.0047 mg/L, based on decreased body weight gain, altered hematology and clinical chemistry, and increased absolute and relative weight of the liver and thyroid and increased incidence of lesions of the nasal cavity observed at 0.048 mg/L in P2 creosote CMT in rats (USEPA, 2008).  In a 13-week inhalation toxicity study (MRID # 43600901), 20 Sprague-Dawley rats/sex/group were treated for 5 days/week, 6 hours/day with P2 Creosote CTM via whole body exposure at doses of 0, 4.7, 48 or 102 mg/m3 (0, 0.005, 0.048 or 0.102 mg/L ) in air measured gravimetrically.  The aerosol size MMAD was between 2.4 and 2.9 microns with a geometric standard deviation between 1.85 and 1.91.

For worker risk, naphthalene was selected as an indicator because of analytical difficulties encountered with the CTPV samples and because all of the naphthalene inhalation samples monitored at the pressure treatment facilities were detectable.  However, the Antimicrobials Division is aware of recent developments regarding potential species differences in toxicity of naphthalene.  “Critical research has been published indicating that metabolic activation is a required step for naphthalene’s respiratory toxicity (unmetabolized naphthalene is not the cause of the cytotoxicity or tumors) and that there are notable species differences in the metabolism of naphthalene between rodents and primates (Buckpitt et al. 1992, 1995, 2002; Bogen et al. 2008).  Available research to date indicates that the metabolism pathway in rodents is more active than in humans (i.e., humans have a slower rate of formation of the active metabolite) (Buckpitt et al. 1992, 1995, 2002; Bogen et al. 2008).”

Recognizing that rodents may be more susceptible to the toxic effects of naphthalene, but that the issue of human relevance is not fully scientifically resolved, the Antimicrobials Division has at this time based its creosote inhalation risk assessments for occupational workers on the LOAEL of 52 mg/m3 selected from the naphthalene 2-year toxicity study in mice (NTP, 1992), as discussed in the Agency’s IRIS Toxicological Review for naphthalene (http://www.epa.gov/ncea/iris/toxreviews/0436-tr.pdf).   Other reasons for using naphthalene at this time are based on several significant deficiencies in the inhalation monitoring study conducted on creosote workers,  including (1) no attempt by the study sponsors to relate inhalation levels found for polynuclear aromatics (PNAs) and coal tar pitch volatiles (CTPVs) to "total creosote" -- a significant weakness with the study; (2) analytical problems encountered with the CTPV samples (all samples were non-detect); (3) the overall inhalation field fortification percent recoveries for the coal tar pitch volatiles (CTPVS) were poor (51-57%).    It is understood that as further research is conducted with regard to the species differences in naphthalene disposition and toxicity, that the occupational inhalation assessment would be modified accordingly.

Carcinogenicity tc \l3 "Carcinogenicity : In conjunction with Health Canada’s Management Regulatory Agency (PMRA), a quantitative risk assessment on carcinogenicity of creosote has been performed using the data of Culp et al. (1998). A dermal carcinogenicity study by Bushmann et al. (1997) was also available, but was determined not suitable for quantitative assessment of carcinogenicity. Ulceration of the skin was significant finding of the study which potentially affected tumor response. In addition, systemic toxicity was not examined, and complete histopathology data were not available. Based upon the analysis of the Culp et al. data, an oral cancer potency factor of 6.28 x 10-6 (µg/kg/day)-1 or 6.28 x 10-3 (mg/kg/day)-1 for the coal tar mixture 1 tested in this study was selected, on the basis of forestomach tumors observed.

2.1 tc \l2 "4.1.4 	Acute tc \l1 "Acute  Toxicology Categories

Table 1 provides the acute toxicity categories for creosote.  It also provides the results of the toxicity tests (USEPA 2008).

 tc \l1 " Table tc \l3 "Table  1. Acute tc \l2 "Acute  Toxicity Categories for Creosote

Test

Results

Toxicity Category

Acute Oral Toxicity

LD50 = 2,451 mg/kg (M); 1,893 mg/kg (F)

III

Acute Dermal Toxicity

LD50 > 2,000 mg/kg

III

Acute Inhalation Toxicity

LC50 > 5 mg/L

IV

Primary Eye Irritation

Irritation clearing in 8-12 days

II

Primary Dermal Irritation

Erythema to day 14

III

Dermal Sensitization

Study unacceptable

NA

NA - Not applicable, no toxicological endpoint.

2.2 tc \l2 "4.1.5 	Summary tc \l1 "Summary  of Endpoints of Concern

Endpoints for assessing occupational and residential risks are presented in Table 2 (USEPA 2008).

Table tc \l3 "Table  2. Summary of Toxicological Endpoints tc \l2 "Endpoints  for Creosote.

EXPOSURE

SCENARIO

DOSE

(mg/kg/day)

ENDPOINT

STUDY

Acute and Chronic Dietary

Acute and Chronic Dietary risk assessment not required

Carcinogenicity

(dermal)

Creosote has been shown to exert positive mutagenic effects in vitro, and has been shown to be positive for carcinogenicity in an initiation/promotion study.  Creosote has been classified as a B1 carcinogen in IRIS. An oral cancer slope factor of 6.28 x 10-3 (mg CTM1/kg/day)-1 was selected for creosote using the data of Culp et al (1998) for the coal tar mixture 1 (CTM1) on the basis of forestomach tumors.

Short-Term  (Dermal)

Oral NOAEL=50

 decreased body weight gain at 175 mg/kg/day

 Developmental Toxicity - Rat

Target MOE = 100 based on 10x interspecies variation and 10x intraspecies extrapolation.  A 5 percent dermal absorption factor is used to correct for use of oral endpoint.

Intermediate-term

(Dermal)

Dermal NOAEL = 40

Decreased body weight gain at 400 mg/kg/day

90-Day Dermal Toxicity Study in the Rat

Target MOE = 100 based on  10x interspecies variation and 10x intraspecies extrapolation

Long-Term (Dermal)

Oral  LOAEL = 25 mg/kg/day

decreased pre-mating body weight

2-generation reproduction study - Rat

Target MOE = 300 based on 10x interspecies, 10x intraspecies, and 3x  for use of a LOAEL.

Inhalation

(any  time period)	Creosote

NOAEL = 0.0047mg/m3

	decreased body  weight, body weight gain, altered hematology

Target MOE = 100 based on  10x interspecies variation and 10x intraspecies extrapolation

90-day Inhalation Study in the Rat

	Naphthalene

LOAEL = 52  mg/m3

[Note:  see Section 2.0 above for a discussion of the uncertainties in the selection of this inhalation endpoint] 	nasal effects: hyperplasia and metaplasia in respiratory and olfactory epithelium respectively

Target MOE = 300 based on 10x interspecies, 10x intraspecies, and 3x  for use of a LOAEL.	Two year inhalation toxicity study - mouse (USEPA, IRIS)

Dermal absorption

5%, determined from the results of in vivo / in vitro testing in rats and in vitro testing using human skin.

2.3 tc \l2 "4.1.3 	FQPA Considerations

	As there are no existing tolerances or other clearances for residues of creosote in food, an FQPA assessment is not necessary.  The available evidence on developmental and reproductive effects of creosote was assessed by the Health Effects Division (HED) Hazard Identification Assessment Review Committee on April 1, 1999.  The committee expressed concern for potential infants and children’s susceptibility of creosote, based on the severity of offspring vs. maternal effects observed with testing of creosote in the P1/P13 blend developmental toxicity study in rats at the 175 mg/kg/day dose level as well as deficiencies observed in the 2-generation reproduction toxicity study in rats.

	Although there are no current Agency guideline neurotoxicity studies available for creosote, the existing studies on creosote indicate no evidence of neurotoxicity for either the P1/P13 or P2 blends of creosote (ATSDR, 2002). Based on the above, and realizing that creosote is currently registered only for non -food use and is a restricted use pesticide, no additional neurotoxicity testing will be required at this time.

3.0 tc \l2 "4.2 	Occupational tc \l1 "Occupational  Exposures and Risks at Pressure Treatment Facilities

	Creosote is used by occupational handlers only.  Since it is a restricted-use pesticide that can only be applied by certified applicators or someone under their direct supervision, it is not available for sale to or use by homeowners.  Furthermore, the non pressure treatments of creosote have been voluntarily cancelled by the registrants.  Creosote applications are now restricted to pressure treatment cylinders.

EPA has determined that there are potential exposures to mixers, loaders, applicators, and other handlers during typical use-patterns associated with creosote pressure treatment uses. Table 3 provides a summary of worker exposure scenarios at pressure treatment facilities.  Although specific job functions have been defined within each exposure scenario, EPA acknowledges the occasional need for workers to cross over into other job functions.  Table 3 also provides the numbers of monitoring events at each of four sites from MRID 453234-01.

Table 3:  Job Descriptions of Workers Exposed at Pressure Treatment Facilities (Creosote Council Study – MRID 453234-01).

Job Function

Description of worker activities

Monitoring Events

Site

Dermal

Inhalation

Treatment Operator TO  (engineer)

Operates and manages the treatment system; may open and close cylinder doors; cleans accumulated creosote from doors and latches; operates valves to transfer creosote solution between holding tanks and treatment cylinders; handles leads and bands.

A

B

C

D

total: 18 4, 1/day

4, 1/day

5, 1/day

5, 1/day

total: 14

0

4, 1/day

5, 1/day

5, 1/day

Treatment Assistant TA (helper)

Performs and assists with tasks of the TO; charge preparation, cylinder cleaning, maintenance, filter cleaning, mixing treatment solution; loader operation and movement of charges.

B

total: 4

4, 1/day

total: 4

4, 1/day

Oil unloader

OU

Operates creosote tank car unloading and transfer system; takes samples from tank cars; inserts siphons into tanks.

(At site C, the tasks for this position were performed by the TO; position was not monitored at Site B)

A

D

total: 9

4, 1/day

5, 1/day

total: 5

0

5, 1/day

Loader Operator

CLO (cylinder area)

LLO (load out area)

Operates self-propelled vehicles for loading wood on and off trams, moving charges in and out of cylinders, and to and from load out areas.  Out-of-cab tasks include tram placement, and handling chains and leads.

CLO

A

B

C

D

total: 18

4, 1/day

4, 1/day

5, 1/day

5, 1/day

total: 14

0

4, 1/day

5, 1/day

5, 1/day

LLO

B

C

D

total: 19

4, 1/day

5, 1/day

10, 2/day

total: 19

4, 1/day

5, 1/day

10, 2/day

Loader helper

CH; LH

Assists the LO in some tasks; works mainly on the drip pad and load out area, placing and removing charge leads, opening and closing cylinder doors, retrieving leads, adjusting track switches, and banding and unbanding charges.

B

C

D

total: 14

4 LH, 1/d

5 CH, 1/d 5 CH, 1/d

total: 14

4 LH, 1/d

5 CH, 1/d

5 CH, 1/d

Checker

CK

Performed tasks of the loader helper as well as inspecting treated lumber.  Worker part time in the treatment area.

C

total: 5

5 CH, 1/d

total: 5

5 CH, 1/d

Test Borer/QC Person

TB

Takes core samples to test for creosote penetration; may test creosote solution concentration (site C); other QC laboratory duties.  (These tasks performed by CLO at site B)

A

C

total: 9

4, 1/day

5, 1/day

total: 5

0

5, 1/day

Water Treatment System Operator

WO

Operates chemical/biological water recovery equipment (At Site C, the tasks associated with this position were performed by the TB; position not monitored at Site D)

A

B

total: 8

4, 1/day

4, 1/day

total: 4

0

4, 1/day

Drip pad cleaner

DP

Steam-cleans drip pad area; disposes of sludge and treated wood waste; other cleanup duties in treatment and drip pad area.

C

total: 4

4, 1/day

total: 4

4, 1/day

Total

108

88

Site A is Florence, SC.  Site B is Delson, Quebec.  Site C is Denver, CO.  Site D is Somerville, Tx.

	The worker exposure study on pressure treatment applications submitted by the Creosote Council II to provide chemical-specific handler dermal and inhalation exposure data in support of the re-registration of pressure treatments of creosote (Creosote Council II, 2001, MRID 453234-01) is presented in Section 3.1.  Other published studies for creosote are presented in Section 4.0.

	Because of the overall variability in the composition of creosote (e.g., over 100 known chemicals are components of creosote), it is difficult to characterize its exact nature. Since neither the characterization of airborne creosote nor the development of inhalation sampling methods is specific for creosote, there exists a high variability in the creosote inhalation data presented in the literature. Most of the studies presented in the literature were conducted by industrial hygienists using methods approved by the National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) for polycyclic aromatic hydrocarbons (PAHs), phenols/creosols, and the individual constituents of the PAHs (i.e., naphthalene, phenanthrene, anthracene, etc).  The Creosote Council study is the most recent study presented on creosote exposure and presents both dermal and inhalation exposure.  This study provides the best available data on worker exposure estimates and encompasses all of the worker activities contributing to exposure.  Nonetheless, other studies available in the literature are also presented below in Section 4.0.

3.1	Worker Exposure at Pressure Treatment Facilities

	The 2001 Creosote Council II study was conducted to determine the dermal and inhalation exposure of workers exposed to creosote while performing routine tasks related to pressure treatment of lumber, utility poles, and railroad ties.  The study was conducted at four typical commercial treatment facilities in the U.S. and Canada, per the requirements of the U.S. Environmental Protection Agency, Canada’s Pesticide Management Regulatory Agency (PMRA), and the California Department of Pesticide Regulation.  The four sites include older facilities from the 1940s as well as more modern facilities with additional engineering controls.  Therefore, the exposure and risk estimates have been presented separately for each site.  The job functions monitored in the study are presented in Table 3 above.

	Previous drafts of the EPA’s creosote assessment have defined the job functions at pressure treatment facilities as either handlers or postapplication.  Since the job functions previously categorized as handlers (treatment operators and assistants) perform many functions, this creosote assessment does not highlight the job functions as being either handler or postapplication.  Workers in the study performed typical tasks related to their job functions and were monitored during a full work cycle beginning at 7 AM and ending at 3 PM.

Pressure tc \l3 "Pressure  Treatment Process

	Pressure treatment is often required because of the resistance of wood to deep penetration by preservatives. The pressure treatment process begins when untreated wood is loaded onto rail/tram cars that are pushed into the treating cylinder using locomotives, forklifts, or similar equipment. The cylinder door is sealed via a pressure-tight door and the operation remains a closed system during the entire treatment process. Treating solutions are then pumped into the cylinder and the inside pressure is raised. At the end of the treatment process, the excess treating solution is pumped out of the treating cylinder and back to storage for reuse. The cylinder is opened, and the rail/tram cars holding the treated wood are pulled out of the cylinder using a locomotive, forklift, or similar equipment.

The amount of creosote handled in a given day among pressure treatment facilities depends on such factors as the size of the facility and the number of treatment cylinders on site. In a given facility, the amount of creosote handled per day varies depending on the wood conditioning techniques used for a given charge, on the type of wood being treated, and the type of product being produced (e.g., marine piling vs utility poles).

According to information provided by industry sources (Krygsman, 1994), wood pressure treatment of railroad ties in a retort may last anywhere from 4 to 24 hours. A typical retort cylinder has a diameter of about 8 feet and a length of about 120 feet. About 16 rail/tram cars can be placed in a retort at one time. The rail/tram cars usually are connected together and are pushed in and out of the retort on railroad tracks using a locomotive. Wood preservative is loaded into the wood pressure treatment retort facilities from rail tank cars using hoses and metered pumps. The wood preservative is stored in two or three holding tanks that may be as large as 60,000 gallons. During the wood treatment process the wood is sprayed under pressure in the enclosed retort. In the retort, a “charge” of liquid preservative is pumped into the trams and then later pumped out. After the wood preservative is pumped out, the wood is dried through a vacuum treatment and the tram cars containing wood (e.g. railroad ties) are then pulled out. Since the wood in the tram cars is pulled by mechanical means there is very little direct human contact with the exposed wood. Likely contact is through dermal contact with equipment that was previously in the retort, removing cables that separated layers of ties, dermal and inhalation contact to vapors inside the retort before and after pressure treatment, cleaning the retort, and inspecting wood pieces by coring the wood.

Dermal tc \l3 "Dermal  Exposure Monitoring

	Since creosote is a complex mixture of over 100 chemicals including phenols, creosol, and aromatic hydrocarbons, it is analytically difficult and cost prohibitive to identify all of the chemicals in the mix. In addition, creosote cannot be measured directly because of its complex mixture.  Dermal exposure to “total creosote” was estimated by measuring the levels of 10 individual polynuclear aromatic hydrocarbon (PNA) compounds.  Each analyte was determined in each whole-body dosimeter (WBD) and glove sample as if it represented total creosote. The goal was to use these marker compounds to represent “total creosote”.

The creosote dermal exposure to each worker was determined using a WBD, consisting of a 100% cotton thermal shirt and long pants.  Each worker at Sites A, C, or D wore his WBD under a fresh work uniform consisting of a cotton long-sleeved work shirt and cotton work trousers (or one-piece cotton coverall) provided by the test site.  The workers at Site B were not provided uniforms therefore; each worker wore a WBD under a fresh lightweight cotton/polyester sweat shirt and pants purchased locally by study personnel.  The workers at all four sites wore a lightweight 100% cotton glove dosimeter on each hand under his chemical-resistant or work gloves, as appropriate. Each of these 10 analytes was determined for each WBD and glove sample as if it represented total creosote.  The average of the analyte concentrations were used to estimate the level of total creosote present in/on the individual sample.

3.1.3	Inhalation tc \l3 "Inhalation  Exposure Monitoring

	Inhalation exposure for each worker was monitored by a personal air sampling train.  Inhalation exposure was estimated for 11 individual PNA compounds as well as for benzene-soluble PNAs and related compounds collectively known as coal tar pitch volatiles (CTPVs).  The Polytetrafluroethylene (PTFE) filter retained the CTPVs, while the PNAs were retained in the XAD-2 resin tubes. Each worker wore a sampling train consisting of a PTFE filter upstream from two in-line XAD-2 resin-filled air sampling tubes.  However, there was no attempt by the study sponsors to relate inhalation levels found for PNAs and CTPVs to "total creosote" -- a significant weakness with the study.  Moreover, there were analytical problems encountered with the CTPV samples and all samples were non detect.  Therefore, EPA did not rely on the CTPV inhalation exposure monitoring results.  Instead, naphthalene was used to indicate inhalation exposure concerns (see Section 2.0 above for a discussion of the uncertainties in the selection of the inhalation toxicological endpoint for naphthalene).

Inhalation exposure monitoring at Site A was unsuccessful because a single XAD-2 tube was used along with a non-solvent-resistant filter cassette.  Therefore, the sampling methodology was changed to include the use of a second XAD-2 resin tube in the sampling train prior to sampling at Sites B, C, and D.  Inhalation exposure monitoring was performed successfully at these sites.  Each worker at Sites B, C, and D was equipped with an air sampling train consisting of a PTFE filter in an opaque, solvent-resistant plastic cassette connected upstream from two in-line XAD-2 resin-filled air sampling tubes.  The intake orifice of the filter was placed in the worker’s breathing zone, directed downward.  Air was pulled through the sampling train by a portable air sampling pump attached to the worker’s belt.  The pump drew air through the sampling tube at approximately 1 L/minute while the worker performed his tasks.  Pumps were calibrated immediately prior to and after each monitoring period using a mass flow meter or bubble calibrator.  The pumps were turned on at the beginning of each work cycle and were left running during restroom, coffee, or other short breaks, but were turned off or set on “hold” during lunch breaks.

The pumps and samplers were removed from the worker during the lunch break.  At the conclusion of the lunch break, the pump and sampling train were reinstalled and the pump restarted.  All start and stop times for breaks were recorded.

During each work cycle, start times and end times of each task performed by the worker were recorded.  Pump parameters during use were also recorded.  At the end of each work cycle, the pumps and sample trains were collected.  Each filter cassette and sampling tube were capped, labeled, bagged, and placed on dry ice for shipment to USX Engineers and Consultants, Inc. (UEC) for extraction and analysis.  After the collection of the air samples, the air sampling pump was re-calibrated.

3.1.4 tc \l2 "4.2.2 	 tc \l1 "Handler Exposure and Risk Characterization

Estimated Dose:  The short-term dermal endpoint is based on a maternal toxicological endpoint; therefore, a female body weight of 60 kg was used for the dose calculation.  The median adult male/female body weight of 70 kg was used for the intermediate-term, long-term, and cancer endpoints.  Short-term, long-term, and cancer endpoints are all based on oral administrations.  Therefore, the 5 percent dermal absorption factor was used to estimate an absorbed dermal dose for comparison to an orally administered dose in the toxicity studies.  The intermediate-term endpoint is based on a dermal toxicity study, and therefore, no absorption factor was necessary.  A route specific inhalation assessment has been developed comparing the air concentrations monitored for workers directly to the human equivalent concentration (HEC) without the need for an extrapolated dose estimate.

	The following equation was used to estimate the dermal dose.  Because EPA traditionally uses an adult body weight of 70 kg and female body weight of 60 kg in its exposure assessments which is slightly different then the 71.8 kg body weight used in the Creosote Council II exposure assessment, the doses used in this assessment had to be normalized back to daily dermal exposures. The normalization was performed by multiplying the exposure dose times the 71.8 kg body weight.  Subsequently, the dermal exposure was converted into an absorbed and/or potential dose using the 60 and 70 kg body weights.

Absorbed Daily Dermal Dose (mg/kg/day) = Dermal Exposure (mg/day) x Dermal Absorption (%) x (1/Body Weight)

	The estimated absorbed dermal lifetime average daily dose (LADD) is based on the following equation:

LADD[absorbed] (mg/kg/day) = Absorbed dermal dose (mg/kg/day) x (250 days worked/365 days) x (35 years worked/70 year lifetime)

Estimated Non Cancer and Cancer Risks:  The calculations of the daily dermal dose of creosote received by workers were used to calculate the non cancer MOEs for the short-term, intermediate-term, and long-term durations.  The dermal MOEs were calculated using (1) a NOAEL of 50 mg/kg/day for short-term exposure with a target MOE of 100: (2) a NOAEL of 40 mg/kg/day for intermediate-term exposures with a target MOE of 100; and, (3) a LOAEL of 25 mg/kg/day for the long-term duration with a target MOE of 300.  Note:  The intermediate-term dermal endpoint was selected from a dermal toxicity study, and therefore, a dermal absorption factor was not necessary to calculate the potential dose.  The dermal and inhalation non cancer MOE equations are as follows:

MOE [dermal] = NOAEL or LOAEL / Potential and/or Absorbed Dermal Dose

MOE [inhalation] = Human Equivalent Concentration (HEC) / Worker’s air concentration

	The cancer risk for creosote is based on the estimated absorbed dermal lifetime average daily dose (LADD) multiplied by the cancer slope factor for creosote dose as follows:

Cancer Risk = LADD[absorbed] (mg/kg/day) x CSF of 6.28 x 10-3 (mg/kg/day)-1

Using these equations, the worker exposure and risk estimates from the Creosote Council’s exposure study are presented in Table 4 (dermal MOEs), Table 5 (inhalation MOEs), and Table 6 (dermal cancer risk).

Dermal MOEs (Table 4):  The results indicate the short-term (ST) non cancer dermal MOEs do not trigger a risk concern except for the treatment operator at site C where the dermal MOE is 68 and the target MOE is 100.  The intermediate-term (IT) non cancer dermal MOEs trigger risk concerns for 8 of the 24 scenarios presented.  IT MOEs range from 3 to 2700 and the target MOE is 100.  The long-term (LT) non cancer dermal MOEs trigger risk concerns for 3 of the 24 scenarios.  LT MOEs range from 34 to 34,000 and the target MOE is 300.  IT risks being greater than the LT risks is an anomaly.  However, in the case of creosote it is explainable because the IT toxicity endpoint is based on a dermal study while the LT endpoint is based on an oral study (i.e., there are differences in routes of exposure and dosing levels between the two studies).

Table 4.  Creosote Dermal MOEs.

Job

Site

n=

Site Description

 	Potential

dermal dose

(mg/kg/day)	Absorbed

Dermal Dose

(mg/kg/day)	Dermal MOEs

ST	IT

LT

TO	A	4	1940s; manual	0.414	0.021	2415	97	1208

 	B	4	1983; Eng. Controls	0.015	0.001	67568	2703	33784

 	C	5	1940s	14.800	0.740	68	3	34

 	D	5	1970s; Automated	0.132	0.007	7576	303	3788

TA	B	4	1983; Eng. Controls	0.025	0.001	40323	1613	20161

OU	A	4	1940s; manual	0.887	0.044	1127	45	564

 	D	5	1970s; Automated	0.938	0.047	1066	43	533

CLO	A	4	1940s; manual	0.212	0.011	4717	189	2358

 	B	4	1983; Eng. Controls	0.089	0.004	11299	452	5650

 	C	5	1940s	2.120	0.106	472	19	236

 	D	5	1970s; Automated	0.117	0.006	8547	342	4274

LLO	B	4	1983; Eng. Controls	0.018	0.001	55249	2210	27624

 	C	5	1940s	0.203	0.010	4926	197	2463

 	D	10	1970s; Automated	0.077	0.004	12953	518	6477

LLO(F)	D	 	1970s; Automated	0.244	0.012	4098	164	2049

LH	B	4	1983; Eng. Controls	0.023	0.001	43860	1754	21930

 	C	5	1940s	1.810	0.091	552	22	276

 	D	5	1970s; Automated	0.383	0.019	2611	104	1305

CK	C	5	1940s	0.822	0.041	1217	49	608

TB	A	4	1940s; manual	0.112	0.006	8929	357	4464

 	C	5	1940s	1.060	0.053	943	38	472

WO	A	4	1940s; manual	0.204	0.010	4902	196	2451

 	B	4	1983; Eng. Controls	0.047	0.002	21322	853	10661

DP	C	4	1940s	0.150	0.008	6667	267	3333

Site A,B,C,D indicate differences in site setup (e.g., eng controls).

Dermal exposures are not normalized to the various amount of wood treated.

Arithmetic mean of the dermal dose from Table 9 of the PMRA worker study review.

Abs Dermal Dose (mg/kg/day) = dermal dose (mg/kg/day) x 5% dermal absorption

 Where ST NOAEL is 50 mg/kg/day (Target MOE = 100) and LT LOAEL is 25 mg/kg/day (Target MOE = 300).

Where IT NOAEL is 40 mg/kg/day (Target MOE = 100) from a dermal study.

Inhalation MOEs (Table 5):  The non cancer inhalation MOEs for worker exposure to naphthalene range from 23 to 1900 with a target MOE of 300.  Sixteen of the 19 inhalation MOEs presented exceed the target MOE of 300, and therefore, are of concern.  None of the average air concentrations for the various job functions exceeded the ACGIH TLV and OSHA PEL of 52 mg/m3.  Additional research is being conducted on the inhalation toxicological endpoint for naphthalene.  Therefore, the risks presented in Table 5 maybe an overestimate of the actual risk as discussed in Section 2.0 above.  Nonetheless, these risks are presented as a conservative estimate to indicate the need for inhalation exposure mitigation.

Table 5.  Inhalation MOEs for Naphthalene.

Job

Site

n=

Site Description	Average

Naphth (ug/m3)	Average

Naphth (mg/m3)

% of TLV	MOE

(Target 300)

TO	A	4	1940s; manual	NA	NA	NA	NA

 	B	4	1983; Eng. Controls	221	0.221	0.4	235

 	C	5	1940s	1320	1.32	2.5	39

 	D	5	1970s; Automated	802	0.802	1.5	65

TA	B	4	1983; Eng. Controls	406	0.406	0.8	128

OU	A	4	1940s; manual	NA	NA	NA	NA

 	D	5	1970s; Automated	925	0.925	1.8	56

CLO	A	4	1940s; manual	NA	NA	NA	NA

 	B	4	1983; Eng. Controls	227	0.227	0.4	229

 	C	5	1940s	2033	2.033	3.9	26

 	D	5	1970s; Automated	574	0.574	1.1	91

LLO	B	4	1983; Eng. Controls	27	0.027	0.1	1926

 	C	5	1940s	694	0.694	1.3	75

 	D	10	1970s; Automated	195	0.195	0.4	267

LLO(F)	D	 	1970s; Automated	679	0.679	1.3	77

LH	B	4	1983; Eng. Controls	43	0.043	0.1	1209

 	C	5	1940s	1870	1.87	3.6	28

 	D	5	1970s; Automated	2251	2.251	4.3	23

CK	C	5	1940s	117	0.117	0.2	444

TB	A	4	1940s; manual	NA	NA	NA	NA

 	C	5	1940s	853	0.853	1.6	61

WO	A	4	1940s; manual	NA	NA	NA	NA

 	B	4	1983; Eng. Controls	917	0.917	1.8	57

DP	C	4	1940s	347	0.347	0.7	150

Site A,B,C,D indicate differences in site setup (e.g., eng controls)

TLV = 10 ppm (52 mg/m3) STEL 15 ppm (79 mg/m3)

mg/m3 = ug/m3 / 1000

% of TLV = (mg/m3 / 52) x 100

MOE = HEC / air conc; Where HEC = 52 mg/m3.

Cancer Risks (Table 6):  All of the cancer risks exceed the Agency’s level of concern of 1 x 10-6 but only 4 of the risks exceed 1 x 10-4 (i.e., risks range from 2.5 x 10-5 to 1.6 x 10-6).

Table 6.  Creosote Dermal Cancer Risks.

Job

Site

n=

Site Description

 	Potential

dermal dose

(mg/kg/day)

Abs Dermal Dose

(mg/kg/day)

Abs LADD

(mg/kg/day)

Creosote

Risk

TO	A	4	1940s; manual	0.414	0.0207	0.0071	4.5E-05

 	B	4	1983; Eng. Controls	0.0148	0.0007	0.0003	1.6E-06

 	C	5	1940s	14.8	0.7400	0.2534	1.6E-03

 	D	5	1970s; Automated	0.132	0.0066	0.0023	1.4E-05

TA	B	4	1983; Eng. Controls	0.0248	0.0012	0.0004	2.7E-06

OU	A	4	1940s; manual	0.887	0.0444	0.0152	9.5E-05

 	D	5	1970s; Automated	0.938	0.0469	0.0161	1.0E-04

CLO	A	4	1940s; manual	0.212	0.0106	0.0036	2.3E-05

 	B	4	1983; Eng. Controls	0.0885	0.0044	0.0015	9.5E-06

 	C	5	1940s	2.12	0.1060	0.0363	2.3E-04

 	D	5	1970s; Automated	0.117	0.0059	0.0020	1.3E-05

LLO	B	4	1983; Eng. Controls	0.0181	0.0009	0.0003	1.9E-06

 	C	5	1940s	0.203	0.0102	0.0035	2.2E-05

 	D	10	1970s; Automated	0.0772	0.0039	0.0013	8.3E-06

LLO(F)	D	 	1970s; Automated	0.244	0.0122	0.0042	2.6E-05

LH	B	4	1983; Eng. Controls	0.0228	0.0011	0.0004	2.5E-06

 	C	5	1940s	1.81	0.0905	0.0310	1.9E-04

 	D	5	1970s; Automated	0.383	0.0192	0.0066	4.1E-05

CK	C	5	1940s	0.822	0.0411	0.0141	8.8E-05

TB	A	4	1940s; manual	0.112	0.0056	0.0019	1.2E-05

 	C	5	1940s	1.06	0.0530	0.0182	1.1E-04

WO	A	4	1940s; manual	0.204	0.0102	0.0035	2.2E-05

 	B	4	1983; Eng. Controls	0.0469	0.0023	0.0008	5.0E-06

DP	C	4	1940s	0.15	0.0075	0.0026	1.6E-05

Site A,B,C,D indicate differences in site setup (e.g., eng controls)

Dermal exposure not normalized to various amounts of wood treated per site

Arithmetic mean from Table 9 of the PMRA review.

Abs Dermal Dose (mg/kg/day) = dermal dose (mg/kg/day) x 5% dermal abs

Creosote Risk = LADD (mg/kg/day) x creosote oral CSF of 6.28E-3 (mg/kg/day)-1

3.2	 tc \l1 "Occupational Post-application Exposures and Risks

	There is the potential for post-application exposures to creosote.  Potential post-application exposure may occur as a result of creosote treated wood in commercial, industrial, and residential settings. There is the potential for contact with creosote treated wood for occupational workers who install railroad ties and poles.  Railroad workers may become exposed during the mechanical and manual installation of pressure treated railroad crossties as well as during inspection procedures (ATSDR, 1990). Pole installers may also contact creosote treated wood while attaching fittings on telephone poles, installing new telephone poles, conducting ground line treatment of telephone poles, and maintaining and repairing existing telephone poles (ATSDR, 1990). No dermal exposure data were available for these scenarios.  Mechanical installation and/or the use of appropriate PPE are recommended to reduce exposure/contact with creosote treated wood.

	There is no creosote product registered for residential uses; however, EPA recognizes that some creosote-treated wood such as railroad ties are used outdoors in home landscaping.  For creosote-treated wood that is recycled into the residential landscaping market, the potential dermal and incidental oral exposures to outdoor landscape timbers are expected to be episodic in nature.  During the public comment period on this risk assessment, EPA received comments recommending wipe studies to assess dermal and incidental oral exposure to children contacting creosote treated landscape ties.  EPA has considered the need for surface residue data on recycled, creosote-treated railroad ties once they are removed from service.  A similar type of assessment was conducted for CCA-treated lumber using the SHEDS model.  The CCA SHEDS assessment was developed for arsenic exposure to treated dimensional lumber.  The CCA SHEDS model assesses children that are exposed to play sets and decks specifically built for contact by children.  Compared to play sets, EPA expects there would be considerably less contact and less frequent contact by children with landscape ties and on wood not used for specific children’s play structures.  Based on this type of comparison and creosote is less potent of a carcinogen then arsenic, EPA does not believe a SHEDS-type of an assessment for creosote treated ties used as landscape timbers is warranted at this time.  However, as a post-RED activity, EPA plans to work with the creosote registrants as well as the rail road industry on the diversion issue of recycled rail ties that are being used in the residential market.

4.0	Summary tc \l3 "Summary  of Literature Exposure Studies

	Additional creosote exposure studies in the literature are summarized below and presented in Table 7.  Some of the air concentrations in Table 7 from these published studies exceed the inhalation level of concern for creosote outlined in this risk assessment as well as the ACGIH TLV and PEL of 0.2 mg/m3 for CTPV.  The results of the air concentrations reported in the literature support the naphthalene air concentration results from the Creosote Council’s worker exposure study indicating that inhalation exposure mitigation measures are needed.

Todd and Timbie (NIOSH 1980) estimated occupational exposures of workers to creosote in a railroad tie treatment plant in Somerville, Texas.  Petroleum oil/creosote solutions of 70/30 and 50/50 were used respectively to treat the cross ties and bridge timbers in the plant. The concentrations of creosote (i.e., coal-tar pitch volatiles; CTPV) in personal air samples over a two-day monitoring period ranged from 0.002 to 1.211 mg/m3.

Another NIOSH study (NIOSH 1981a) of occupational exposure to creosote at a wood-treatment facility in Tacoma, Washington reported CTPV concentrations in personal air samples ranging from less than 0.0004 to 0.112 mg/m3 with the highest concentration found at the end of the treatment process when the cylinder was opened. NIOSH also reported creosote exposures of dock builders ranging from zero to 0.059 mg/m3 based on cyclohexane extractable fraction of CTPV (NIOSH; 1981b).

Studies conducted by Markel et al. (1977) and SRI (1993) indicated that particulate polycyclic organic materials (PPOM) was within 0.1 mg/m3, the NIOSH permissible level for CTPV, when estimating occupational exposure to creosote in wood treatment plants. The concentrations of naphthalene, methylnaphthalene, and acenaphthene (the only components in the vapor-phase fractions that could be reliably measured) ranged from 0.54 to 2.0 mg/m3. Benzene-soluble particulates (PPOM) ranged from 0.02 to 0.10 mg/m3.

Hiekkila et al. (1987) conducted an occupational study in Finland estimating workers’ exposure to creosote in the creosote impregnation plants and when they were handling the impregnated wood. The average vapor concentrations (naphthalene being the major component) ranged from 0.5 to 71 mg/m3 in the impregnation plants; while the vapor concentrations ranged from 0.1 to 11 mg/m3 in the handling of impregnated wood. Most of the airborne contaminants in workers’ breathing zones were in the vapor phase; the proportion of particulate polycyclic aromatic hydrocarbons (PAHs) to total concentration of vapors was less than 0.5 to 3.7 percent.

Rotard and Mailahn (1987) reported high levels of carcinogenic PAHs, such as benzo[a]pyrene, benzo[b]-fluoranthene, and benzo[j]fluoranthene, and cocarcinogenic PAHs in samples of wooden sleepers (railroad cross ties) installed in playgrounds.

Borack et. al. 2002 conducted air sampling and biological monitoring of 36 workers at a wood treatment plant where railroad ties were treated with creosote.  There were 18 low exposure workers who worked as secretaries or clerical staff, 13 moderate exposure workers who transported cured ties to the shipment yard and 3 high exposure workers who worked in the retort building and handled ties immediately after creosote application.   Air sampling was conducted with a filters and adsorbent tubes both of which were analyzed for benzene soluble PAHs.  Six filter samples had detectable levels of particulate PAHs and the highest level was 0.33 ug/m3 for pyrene.  Thirty two of the tube samples had detectable levels of vapor phase PAHs but levels were generally low.   The highest levels were for pyrene and naphthalene measured in the high exposure group and ranged from 1.5 to 2.5 ug/m3 for pyrene and 210 ug/m3 to 330 ug/m3 for naphthalene.   Biomonitoring was performed using urinary 1-hydroxypropene and the results suggested that more than 90% of the measured 1-hydroxypropene could be attributed to dermal exposure.

Elovarra et.al. 1995 conducted air sampling and biological monitoring of six workers (1 impregnator, 2 assistant operators, 1 lorry driver and 2 tie platers) at an impregnation plant in Russia where railroad ties were treated with creosote.  The air sampling was conducted for five consecutive days using filters and adsorbent tubes.  The filters were analyzed for nine PAHS other than naphthalene and the tubes were analyzed for naphthalene.  The results for the filter samples ranged from 1.23 to 13.74 ug/m3 with a GM of 4.77 ug/m3 and an AM of 5.7 ug/m3.   The naphthalene results of the tube samples ranged from 370 to 4200 ug/m3 with a GM of 1536 ug/m3 and an AM of 1254 ug/m3.   Biomonitoring was performed using urinary 1-hydroxypropene and indicated that dermal uptake was much greater than inhalation uptake.

Flickinger and Lawrence, 1982 data was cited in Wong and Harris, 2005 which is an epidemiological study of creosote workers at 11 plants in the United States.  This data indicates that 95 percent of the workers at the woodtreating plants were exposed to no more than 0.14 mg/m3 CTPV-BSF.  In terms of specific jobs, the typical time-weighted average of treating operators at the participating plants ranged from 0.04 to 0.11 mg/m3 CTPV-BSF with most measurements centered on 0.05 or 0.06 mg/m3 CTPV.  Because of the limited nature of the data, however, the epidemiology study was based on job/exposure categories rather than the data.

Heikkila et. al. 1997 conducted air sampling and biological monitoring of six workers at an impregnation plant where railroad ties were treated with creosote.  The air sampling was conducted for one workweek and samples were analyzed for ten PAHs and naphthalene.  The mean exposures were 1.5 mg/m3 for naphthalene vapor, 5.9 ug/m3 for particulate PAHs and 1.4 ug/m3 for PAHs with 4-6 aromatic rings.   Biomonitoring was conducted in conjunction with the air sampling and indicated that airborne naphthalene correlated fairly well with urinary 1-napthol (r = 0.745).  It was also determined, however, that urinary 1-naphthol alone is not a suitable marker for inhalatory or cutaneous exposure to PAH originating from creosote.

Baker and Fannick, 1980 surveyed worker exposures to coal tar pitch volatiles during a NIOSH health hazard evaluation on October 14, 1980 at the New York Port Authority. The evaluation was requested by a union representative on behalf of six workers engaged in pile driving creosote preserved wood logs for a dock underpinning. Personal and area air samples were collected.  Breathing zone CPTV concentrations ranged up to 0.06 mg/m3 and area CPTV concentrations ranged up to 0.02 mg/m3. These concentrations were below the NIOSH recommended limit of 0.1 mg/m3, however weather conditions on the sampling day probably caused substantial reductions in exposure. The authors concluded that on typical days workers may be exposed to significant amounts of CPTV.

Unwin et. al. 2006 conducted air sampling and biological monitoring of eleven workers at a timber impregnation plant as part of a larger study of PAH occupational exposure in the U.K that was funded by the British Health Executive.  The workers included 2 pole fabricators, 2 pole loaders, 1 timber loader, 2 creosote plant operators, 1 unchainer, 2 labourers and 1 QC inspector.  The air sampling was conducted for one day using an IOM fitted with glass fiber filters and followed by an XAD-2 adsorbent tube.  The air samples were analyzed for 17 PAHs including napthalene.  The results expressed as total PAH ranged from 29.9 to 1913 ug/m3 with a mean of 835 ug/m3.   The PAH profile was dominated by naphthalene and the results for total 3-6 ring PAH and BaP were much lower with mean values of 0.05 ug/m3 for 3-6 ring PAH and 0.01 ug/m3 for BaP.   Biomonitoring was performed using urinary 1-hydroxypropene and indicated that the creosote workers had the highest exposure among the 25 workplaces surveyed.

Table tc \l3 "Table  7.  Summary tc \l2 "Summary  of Occupational Inhalation Exposure Studies of Creosote

Study

Setting/Subjects

Components Reported (Analyzed)

Concentration

(mg/m3)

NIOSH; 1980 (Todd & Timbie)

railroad tie treatment plant

coal-tar pitch volatiles (CTPV)

0.002-1.211

NIOSH; 1981a (Todd & Timbie)

wood treatment facility

CTPV

0.0004-0.112

NIOSH; 1981b (Baker & Fannick)

dock builder

CTPV (cyclohexane extractables)

ND-0.059

Markel et al. (1977) and SRI (1993)

wood treatment facility

polycyclic organic materials (PPOM)

<0.1

Hiekkila et al. (1987)

creosote impregnation plant;

average total vapor (naphthalene being the major component)

0.5-71

Hiekkila et al. (1987)

handling impregnated wood

average total vapor (naphthalene being the major component)

 0.1-11

Elovaara et. al., 1995	Railroad Tie impregnation plant in Russia/six workers, 5 days	10 PAHs include Naphthalene	0.40 to 4.2 Naphthalene

Borak,  et.al., 2002	Railroad Tie impregnation plant /34 workers, all jobs including office/1 days	Benzene Soluble Fraction/16 PAHS	0.21 – 0.33 Naphthalene

0.015 to 0.0025 pyrene

Flicker and Lawrence, 1982

Cited in Wong and Harris, 2005	Wood Preserving Industry/Treating Operators	CTPV-BSF	0.04 – 0.11

Heikkila et. al. 1997	Railroad tie impregnation plant/six workers/one week	Naphthalene and 10 PAHs	1.5 Naphthalene (mean)

0.0059 PAH (mean)

Baker and Fannick, 1980	Pile Driving Creosote Dock/New York Port Authority/six workers/one day	CPTV	Up to 0.06 (n=6)

Unwin et. al. 2006	Timber impregnation/UK	Total PAH (Primarily naphthalene)	0.030 – 1.9 (n=11)

5.0	Uncertainties tc \l1 "Uncertainties  and Limitations

	This section summarizes the uncertainties and data limitations in the creosote assessment.

The amount of product applied and the amount of active ingredient handled by each worker was not calculated because the creosote was applied in a closed system which recovered and retained excess treatment solution from the wood and treatment vessel while sealed.  The amount of wood treated at the 4 sites is believed to be representative of the industry.

The number of field fortification samples collected at the sites was less than the required number to satisfy Series 875 guidelines.  According to the guidelines, there should be at least one fortification sample per worker per monitoring period (8 hour shift) per fortification level (three levels) for each matrix and at least one field blank per worker per monitoring period for each matrix.  There were more workers monitored than there were field fortifications and field blank samples collected.

The overall inhalation field fortification percent recoveries for the coal tar pitch volatiles (CTPVS) were poor.  The overall recovery for Site B was 57%.  The overall recoveries for Sites C and D were 51% and 57%, respectively.  The analytical method for quantifying CTPVs in the creosote study was inadequate and only one filter had a detectable level.  Therefore, inhalation exposure to CTPVs was not determined.  Instead, risk concerns are indicated using the results of the naphthalene inhalation samples.  See Section 2.0 above for a discussion of the uncertainties and ongoing research on the inhalation toxicological endpoint for naphthalene.

table low recoveries for gloves.  As an example, for a 60 μg/sample “total creosote” fortification for Site B, the recoveries for the WBD’s were as high as 150% and recoveries for the gloves as low as 52.3%.   There were measurable amounts of total creosote found in each of the control samples prepared at each facility.

The study sponsors made no attempt to relate inhalation levels found for PNAs and CTPVs to "total creosote" -- a significant weakness with the study.

6.0 tc \l2 "4.6 		References tc \l1 "References

Agency for Toxic Substances and Disease Registry (ATSDR, 1990). Toxicological Profile for Creosote. U.S. Public Health Service. February 16, 1990.

Agency for Toxic Substances and Disease Registry (ATSDR, 1995). Toxicological Profile for Creosote. U.S. Public Health Service.

Baker and Fannick, 1980. HHE-80-238-931 New York Port Authority, Brooklyn New York, NIOSH 1980.

Borak et. al. 2002.  Biological Versus Ambient Exposure Monitoring of Creosote Facility Workers, JOEM, Vol. 44, No. 4, April 2002.

Butala J. H. February, 1999. Creosote Council II memorandum with attachment to Nader Elkassabany, U.S. Environmental Protection Agency, Antimicrobial Division.

Creosote Council II, 1998. “Assessment of Potential Creosote Inhalation and Dermal Exposure Associated with Pressure- Treatment of Wood with Creosote.” Submitted by John H. Buttala, Creosote Council II. Field work by George M. Singer, Ph.D, American Agricultural Services Inc. Analytical work by David A. Winkler, EN-CAS Laboratories.

Creosote Council II, 2001. “Assessment of Potential Creosote Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Creosote.” Submitted by John H. Butala, Creosote Council II. Field work by Mark G. Bookbinder, Ph.D, c/o American Agricultural Services Inc. Analytical work by Bert Clayton, EN-CAS Laboratories and Stephanie Guilyard, USX Engineers and Consultants.  MRID 453234-01.

Elovaara et. al. 1995.  Significance of Dermal and Respiratory Uptake in Creosote Workers: Exposure to Polycyclic Aromatic Hydrocarbons and Urinary Excretion of 1-hydroxypyrene, Finnish Institute of Occupational Safety and Health, Occup. Environ Med 1995: 52:196-203.

Flickinger and Lawrence, 1982.  Occupational Health Experience in the Wood Preserving Industry.  Koppers Company, Inc.  MRID 447595-02.

Flickinger and Lawrence, 1982.  Occupational Health Experience in the Wood-Preserving Industry, American Wood-Preservers Association, 1982 (Cited in Wong and Harris).

Heikkila PR, Hameila M, Pyy L, et al. 1987. Exposure to Creosote in the Impregnation and Handling of Impregnated Wood. Scand J Work Environ Health 13:431-437.

Heikkila et.al. 1997. Urinary 1-naphthol Excretion in the Assessment of Exposure to Creosote in an Impregnation Facility, Scand J. Work Environ Health, 1997.

Krygsman, Adrian 1994. “Wood Preservation. An Overview of Biocide Use and Application.”  NIOSH (1980a). Industrial Hygiene Report, Comprehensive Survey of Wood Preservative Treatment Facility at Santa Fe Centralized Tie Plant, Somerville, Texas. National Institute for Occupational Safety and Health, Division of Surveillance, Hazard Evaluations and Field Studies, Cincinnati, OH. (by Todd AS & Timbie CY). NTIS PB83-133892.

Markel, H.L.; Ligo, R.N.; Lucas, J.B.  1977.  Health Hazard Evaluation/Toxicity Determination Report 75-117-372.  Koppers Company, Inc.  North Little Rock, Arkansas.

NIOSH (1980).  Industrial Hygiene Report, Comprehensive Survey of Wood Preservative Treatment Facility at Santa Fe Centralized Tie Plant, Sommerville, Texas.  National Institute of Occupational Safety and Health, Division of Surveillance Hazard Evaluations and Field Studies, Cincinnati, OH.  (by Todd AS and Timbie CY).  NTIS PB83-133892.

NIOSH (1981a). Industrial Hygiene Report, Comprehensive Survey of Wood Preservative Treatment Facility at Cascade Pole Company, McFarland Cascade, Tacoma, Washington. National Institute for Occupational Safety and Health, Division of Surveillance, Hazard Evaluations and Field Studies, Cincinnati, OH. (by Todd AS and Timbie CY). NTIS PB82-174160.

NIOSH (1981b). Health Hazard Evaluation: New York Port Authority, Brooklyn, New 	York. U.S. Department of Health and Human Services, National Institute for Occupational Safety and Health, Cincinnati, OH. (by Baker D & Fannick N). HHE 80-238-931.

Rotard W, Mailahn W (1987). Gas Chromatographic-Mass Spectrometric Analysis of Creosotes Extracted from Wooden Sleepers Installed in Playgrounds. Anal. Chem. 59:65-69.

SRI. 1993. Directory of chemical producers: United States of America. SRI International, Menlo Park, CA.

The Environmental Degradation of Creosote, 1998.

http://inweh1.uwaterloo.ca/biol447new/assignments/creo2.html.

United States Environmental Protection Agency (USEPA), 1984. “Wood Preservative Pesticides: Creosote, Pentachlorophenol, Inorganic Arsenicals. Position Document 4.” Registration Division. Office of Pesticides and Toxic Substances. Washington, DC. July, 1994.

United States Environmental Protection Agency (USEPA), 1997a.  Standard Operating Procedures for Residential Exposure Assessments. December, 1997. Residential Exposure Assessment Work Group, U.S. Environmental Protection Agency.

United States Environmental Protection Agency (USEPA), 1997b. Exposure Factors Handbook.  Volume 1. Office of Research and Development. Washington, DC. EPA/600/P-95/002Fa.

United States Environmental Protection Agency (USEPA), 1998a.  Route to Route Extrapolations.  Memorandum from John E. Whalan EPA/OPP/HED to Margaret Stasikowski, Director EPA/OPP/HED.

United States Environmental Protection Agency (USEPA), 1998b. Creosote LUIS Database. USEPA Report Run Date 3/09/98.

United States Environmental Protection Agency (USEPA), 1998c.  International Harmonization Position Paper. Antimicrobial Exposure Databases. An Overview of the NAFTA Member Agencies Regulatory Authority Over Antimicrobial Pesticides And An Evaluation of Existing Databases Used in Antimicrobial Exposure Assessments. Prepared by Antimicrobial Division. Office of Pesticide Programs.

United States Environmental Protection Agency (USEPA), 1998d.  Inhalation Risk Characterizations and the Aggregate Risk Index (ARI).  Memorandum from John E. Whalan, EPA/OPP/HED, to Margaret Stasikowski, Director, EPA/OPP/HED.

United States Environmental Protection Agency (USEPA), 1998e. Integrated Risk Information System (IRIS) database.

United States Environmental Protection Agency (USEPA), 1999.  Creosote - Report of the Hazard Identification Review Committee, April 1, 1999.

United States Environmental Protection Agency (USEPA), 2001. Assessment of Potential 	Creosote Inhalation and Dermal Exposure Associated with Pressure-Treatment of Wood with Creosote. Office of Pesticides and Toxic Substances, January 30, 2001.

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Wong and Harris, 2005.  Retrospective Cohort Mortality Study and Nested Case Control Study of Workers Exposed to Creosote at 11 Wood-Treating Plants in the United States, JOEM, Vol. 47, no. 7, July 2005.

 PAGE

 PAGE   2


[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46509-46511]
[FR Doc No: 2019-19043]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-28-000]

Commission Information Collection Activities (FERC-555); Comment
Request

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Comment request.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is submitting its information collection FERC-729 (Electric
Transmission Facilities) to the Office of Management and Budget (OMB)
for review of the information collection requirements. Any interested
person may file comments directly with OMB and should address a copy of
those comments to the Commission as explained below. The Commission
previously published a Notice in the Federal Register on June 27, 2019,
requesting public comments. The Commission received no comments and is
making this notation in its submittal to OMB.

DATES: Comments on the collection of information are due by October 4,
2019.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0098, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC19-28-000, by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-555 (Preservation of Records for Public Utilities and
Licensees, Natural Gas and Oil Pipeline Companies).
    OMB Control No.: 1902-0098.
    Abstract: The Commission collects the information under the
requirements of FERC-555 (Records Retention Requirements) to carry out
its responsibilities in implementing the statutory provisions of
Sections 301, 304 and 309 of the Federal Power Act (FPA),\1\ Sections
8, 10 and 16 of the

Natural Gas Act (NGA),\2\ and Section 20 of the Interstate Commerce Act
(ICA).\3\
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 825, 825c and 825h.
    \2\ 15 U.S.C. 717-717w.
    \3\ 49 U.S.C. 20.
---------------------------------------------------------------------------

    The regulations for preservation of records establish retention
periods, necessary guidelines, and requirements for retention of
applicable records. These requirements apply to the regulated public
utilities, natural gas and oil pipeline companies subject to the
Commission's jurisdiction. Regulated entities use these records as the
basis for required rate filings and reports to the Commission.
Additionally, the Commission's audit staff will use the records during
compliance reviews. The Commission's enforcement staff will also use
the information during investigations. Finally, the Commission will use
the records for special analyses when necessary.
    On January 8, 1999 the Commission issued AI99-2-000, an Accounting
Issuance providing guidance on records storage media. More
specifically, the Commission gave each jurisdictional company the
flexibility to select its own storage media. The storage media selected
must have a life expectancy equal to the applicable record period
unless the quality of the data transferred from one media to another
with no loss of data would exceed the record period.
    On January 27, 2000, the Commission issued a final rule amending
its records retention regulations for public utilities and licensees as
well as natural gas and oil pipeline companies. These changes included
revising the general instructions, and shortening various records
retention periods. The objective of the final rule was to reduce or
eliminate burdensome and unnecessary regulatory requirements.
    The Commission is not making any additional changes to the record
retention requirements specified under FERC-555. The Commission
implements these filing requirements in the Code of Federal Regulations
(CFR) under 18 CFR parts 125, 225, and 356.
    Type of Respondent: Electric utilities, natural gas pipelines, and
oil pipelines.
    Estimate of Annual Burden: \4\ The Commission estimates the annual
public reporting burden for the information collection as:
---------------------------------------------------------------------------

    \4\ ``Burden'' is 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. For further
explanation of what is included in the information collection
burden, refer to Title 5 Code of Federal Regulations 1320.3.

   FERC-555--Preservation of Records for Public Utilities and License, Natural Gas and Oil Pipeline Companies
----------------------------------------------------------------------------------------------------------------
                               Annual  number
                                of responses    Total number    Average burden hrs. and    Total annual burden
    Number of respondents            per        of responses     cost per response \5\    hours and total annual
                                 respondent                                                        cost
 (1)                                      (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)
                                                          (3)
----------------------------------------------------------------------------------------------------------------
509..........................               1             509  5,218.14 hrs.; $417,451.  2,656,034 hrs.;
                                                                                $212,482,720.
----------------------------------------------------------------------------------------------------------------

    Additional Background. Based on the data submitted by
jurisdictional filers in 2010, we provide more detail regarding how we
generated burden and cost estimates. We divided the entities into three
size categories based on annual revenue reported on FERC's financial
forms (Form 1, Form 2/2A and Form 6).\6\ As indicated in the appendix,
we only received useful responses from five entities: Three large, one
medium, and one small. Because of this very limited data, it should not
be inferred that the average burden and cost indicated for each entity
size are representative of the burden for all entities in that size
category and industry. We performed the analysis in this way in order
to come up with a better average to apply across all the industries. It
should also be noted that it is difficult to compare across industries
based on entity size. For example, the first table below indicates that
a large electric utility has an annual revenue more than ten times
greater than a large gas pipeline.
---------------------------------------------------------------------------

    \5\ The estimates for cost per response are derived using the
following formula: Average Burden Hours per Response * $80/hour =
Average cost/response. The figure is the 2019 FERC average hourly
cost (for wages and benefits) of $80 (and an average annual salary
of $167,091/year). Commission staff is using the FERC average salary
because we consider any record retention requirements completed in
response to the FERC-555 to be compensated at rates similar to the
work of FERC employees.
    \6\ The size thresholds are estimates based on staff judgment.
---------------------------------------------------------------------------

    The first table shows the estimated size categories by industry,
and the second table shows the burden and cost based on size (combining
the 3 industries).

------------------------------------------------------------------------
      Industry and size
        classification                       Annual revenue
------------------------------------------------------------------------
ELECTRIC:
    Large....................  >$1.15 Billion.
    Medium...................  $310 Million to $1.15 Billion.
    Small....................  <310 Million.
GAS:
    Large....................  >$100 Million.
    Medium...................  $10 Million to $100 Million.
    Small....................  <$10 Million.
OIL:
    Large....................  >$50 Million.
    Medium...................  $5 Million to $50 Million.
    Small....................  <$5 Million.
------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                             Number of      Average hours per     Total burden
                          Size                                entities            entity           hours \7\
                                                                       (1)                (2)          (1) * (2)
----------------------------------------------------------------------------------------------------------------
Large..................................................                174             11,475          1,996,658
Medium.................................................                166              2,371            393,619
Small..................................................                169              1,571            265,572
----------------------------------------------------------------------------------------------------------------

    The total estimated annual cost burden to respondents is
$212,482,720, which includes $127,433,401 for non-labor record storage
costs and $85,049,319 for employee costs. The average cost per
respondent is $417,451, which includes $250,360 for non-labor record
storage costs and $167,091 for employee costs. All of these cost
figures are based on staff analysis of the data we received in 2019.
---------------------------------------------------------------------------

    \7\ Due to rounding during the analysis and calculations, the
total in this column does not sum to the exact figure reported shown
in the summary burden table.
---------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: August 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19043 Filed 9-3-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Proposed Rules]
[Pages 16153-16156]
[FR Doc No: 2021-05154]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2020-0647]
RIN 1625-AA09

Drawbridge Operation Regulation; New Jersey Intracoastal
Waterway, Point Pleasant, NJ

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to modify the operating schedule that
governs the Route 88 (Veterans Memorial) Bridge and Route 13
(Lovelandtown) Bridge across the New Jersey Intracoastal Waterway
(NJICW) at Point Pleasant Canal, mile 3.0 and 3.9, respectively at
Point Pleasant, NJ. This proposed modification will allow the
drawbridges to be maintained in the closed position overnight.

DATES: Comments and related material must reach the Coast Guard on or
before April 26, 2021.

ADDRESSES:  You may submit comments identified by docket number USCG-
2020-0647 using Federal e-Rulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section below for
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Mickey Sanders, Bridge Administration Branch,
Fifth District, U.S. Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code
NJICW New Jersey Intracoastal Waterway

II. Background, Purpose and Legal Basis

    The New Jersey Department of Transportation, which owns and
operates the Route 88 (Veterans Memorial) Bridge and Route 13
(Lovelandtown) Bridge, across the NJICW at Point Pleasant Canal, mile
3.0 and 3.9, respectively, at Point Pleasant, NJ, has requested this
modification to reduce the number of bridge openings during off-peak
hours.
    The Route 88 (Veterans Memorial) Bridge across the NJICW at Point
Pleasant Canal, mile 3.0, at Point Pleasant, NJ, has a vertical
clearance of 10 feet above mean high water in the closed-to-navigation
position. The bridge currently operates under 33 CFR 117.5.
    The Route 13 (Lovelandtown) Bridge across the NJICW at Point
Pleasant Canal, mile 3.9, at Point Pleasant, NJ, has a vertical
clearance of 30 feet above mean high water in the closed-to-navigation
position. The bridge currently operates under 33 CFR 117.5.
    The Point Pleasant Canal is used predominately by recreational
vessels and pleasure craft. The three-year average number of bridge
openings, maximum number of bridge openings, and bridge openings
between 11 p.m. to 7 a.m., by month and overall for August 2017,
through August 2020, as drawn from the data contained in the bridge
tender logs, is presented below. There is a monthly average of two
bridge openings for each bridge, from 11 p.m. to 7 a.m., from August
2017 to August 2020.

----------------------------------------------------------------------------------------------------------------
                                                                                Proposed
                              Month                                   Average         Maximum       openings 11
                                                                     openings        openings      p.m.- 7 a.m.
----------------------------------------------------------------------------------------------------------------
January.........................................................               4              14               0
February........................................................               2               7               0
March...........................................................               7              21               0
April...........................................................              24              72               2
May.............................................................              51             154               6
June............................................................              74             223              18
July............................................................             125             376              20
August..........................................................             101             407              20
September.......................................................              63             190               8
October.........................................................              51             155               6
November........................................................              29              89               7
December........................................................              16              49               1
----------------------------------------------------------------------------------------------------------------

III. Discussion of Proposed Rule

    The bridge owner has requested to modify the operating regulation
for the bridges, due to the limited number of requested openings of the
bridges from 11 p.m. to 7 a.m., over a period of approximately three
years. The data presented in the table above demonstrates that the
requested modification may be implemented with de minimis impact to
navigation. This proposed modification will allow the drawbridges to be
maintained in the closed position from 11:01 p.m. to 6:59 a.m. and
shall open on signal, if at least four hours advance notice is given.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive orders and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB) and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the fact that an
average of only two bridge openings occurred per month from 11 p.m. to
7 a.m., from August 2017 through August 2020.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridges may be small entities, for the reasons stated in section IV.A
above this proposed rule would not have a significant economic impact
on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity

and that this rule would have a significant economic impact on it,
please submit a comment (see ADDRESSES) explaining why you think it
qualifies and how and to what degree this rule would economically
affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, (Consultation and Coordination with Indian
Tribal Governments), because it would not have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes.
If you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule promulgates the
operating regulations or procedures for drawbridges. Normally such
actions are categorically excluded from further review, under paragraph
L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental
Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and
submissions in response to this document, see DHS's eRulemaking System
of Records notice (85 FR 14226, March 11, 2020).
    Documents mentioned in this NPRM as being available in this docket
and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1.

0
2. Amend Sec.  117.733 as follows:
0
a. Remove paragraphs (i) and (k);
0
b. Redesignate paragraphs (b) through (h) and (j) as paragraphs (d)
through (k), respectively; and
0
c. Add new paragraphs (b) and (c).
    The additions read as follows:

Sec.  117.733   New Jersey Intracoastal Waterway.

* * * * *
    (b) The draw of the Route 88 Bridge, mile 3.0, across Point
Pleasant Canal at Point Pleasant, shall operate as follows:
    (1) From 7 a.m. to 11 p.m. the draw shall open on signal.
    (2) From 11:01 p.m. to 6:59 a.m. the draw shall open on signal, if
at least four hours advance notice is given.
    (c) The draw of the Route 13 Bridge, mile 3.9, across Point
Pleasant Canal at Point Pleasant, shall operate as follows:
    (1) From 7 a.m. to 11 p.m. the draw shall open on signal.
    (2) From 11:01 p.m. to 6:59 a.m. the draw shall open on signal, if
at least four hours advance notice is given.
* * * * *

    Dated: March 5, 2021.
L.M. Dickey,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2021-05154 Filed 3-25-21; 8:45 am]
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