[Federal Register Volume 86, Number 74 (Tuesday, April 20, 2021)]
[Notices]
[Pages 20493-20494]
[FR Doc No: 2021-08107]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10022-69-OP]

White House Environmental Justice Advisory Council; Notification
of Virtual Public Meeting Series

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification for a series of public meetings.

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SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
U.S. Environmental Protection Agency (EPA) hereby provides notice that
the White House Environmental Justice Advisory Council (WHEJAC) will
meet on the dates and times described below. Due to unforeseen
administrative circumstances, EPA is announcing the April 28, 2021
meeting with less than 15 calendar days public notice. The May 13, 2021
meeting will meet the FACA guidance. These meetings are open to the
public. Members of the public are encouraged to provide comments
relevant to the specific issues being considered by the WHEJAC. For
additional information about registering to attend the meetings or to
provide public comment, please see ``REGISTRATION'' under SUPPLEMENTARY
INFORMATION. Pre-registration is required.

DATES: The WHEJAC will hold a series of public virtual public meetings
on Wednesday, April 28, 2021, and Thursday, May 13, 2021, from
approximately 2:00 p.m.-6:00 p.m., Eastern Daylight Time. A public
comment period relevant to the specific issues will be considered by
the WHEJAC at each meeting (see SUPPLEMENTARY INFORMATION). Members of
the public who wish to participate during the public comment period
must pre-register by 11:59 p.m., Eastern Daylight Time, one (1) week
prior to each meeting date.

FOR FURTHER INFORMATION CONTACT: Karen L. Martin, WHEJAC Designated
Federal Officer, U.S. EPA; email<EMAIL_ADDRESS>telephone: (202) 564-
0203. Additional information about the WHEJAC is available at https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council.

SUPPLEMENTARY INFORMATION: The meeting discussion will focus on several
topics including, but not limited to the discussion and deliberation of
draft recommendations to the Chair of the Council on Environmental
Quality and the White House Interagency Council on Environmental
Justice from the Justice40 Work Group, Climate and Economic Justice
Screening Tool Work Group and Executive Order 12898 Work Group.
    The Charter of the WHEJAC states that the advisory committee will
provide independent advice and recommendations to the Chair of the
Council on Environmental Quality (CEQ) and to the White House

Interagency Council on Environmental Justice (Interagency Council). The
WHEJAC will provide advice and recommendations about broad cross-
cutting issues, related but not limited to, issues of environmental
justice and pollution reduction, energy, climate change mitigation and
resiliency, environmental health, and racial inequity. The WHEJAC's
efforts will include a broad range of strategic, scientific,
technological, regulatory, community engagement, and economic issues
related to environmental justice.
    Registration: Individual registration is required for each of the
virtual public meetings. Information on how to register is located at
https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council. Registration for the meetings is available
through the scheduled end time of each meeting day. Registration to
speak during the public comment period will close 11:59 p.m., Eastern
Daylight Time, one (1) week prior to meeting date. When registering,
please provide your name, organization, city and state, and email
address for follow up. Please also indicate whether you would like to
provide public comment during the meetings, and whether you are
submitting written comments at the time of registration.

A. Public Comment

    Every effort will be made to hear from as many registered public
commenters during the time specified on the agenda. Individuals or
groups making remarks during the public comment period will be limited
to three (3) minutes. To accommodate the number of people who want to
address the WHEJAC during the time allotted on the agenda, only one
representative of a particular community, organization, or group will
be allowed to speak. Submission of written comments for the record are
strongly encouraged. The suggested format for individuals providing
public comments is as follows: Name of speaker; name of organization/
community; city and state; and email address; brief description of the
concern, and what you want the WHEJAC to advise CEQ to do. Written
comments received by registration deadline, will be included in the
materials distributed to the WHEJAC prior to the meeting. Written
comments received after that time will be provided to the WHEJAC as
time allows. All written commenters should use the webform at https://www.epa.gov/environmentaljustice/forms/white-house-environmental-justice-advisory-council-whejac-public-comment to submit comments, and
email any additional materials to<EMAIL_ADDRESS>
B. Information About Services for Individuals With Disabilities or
Requiring English Language Translation Assistance

    For information about access or services for individuals requiring
assistance, please contact Karen L. Martin, via email at
<EMAIL_ADDRESS>To request special accommodations for a disability or
other assistance, please submit your request at least seven (7) working
days prior to the meeting, to give EPA sufficient time to process your
request. All requests should be sent to the email listed in the FOR
FURTHER INFORMATION CONTACT section.

Matthew Tejada,
Director for the Office of Environmental Justice.
[FR Doc. 2021-08107 Filed 4-19-21; 8:45 am]
BILLING CODE 6560-50-P


MEMORANDUM
DATE:	September 19th, 2014
TO:	Carbon Power Plan for Existing Power Plants; Docket ID: OAR-2013-0602
FROM:	Neal Fann, EPA
SUBJECT:	Meeting with the New Hampshire Department of Health and Human Services Regarding the Proposed Carbon Power Plan for Existing Power Plants  -  September 19th, 2014

SUMMARY
EPA staff and the attendees listed below met on September 14th, to discuss the proposed Carbon Power Plan for Existing Power Plants. The Carbon Power Plan for Existing Power Plants was proposed on June 2, 2014.
ATTENDEES
EPA
Neal Fann (phone)
Jackie Ashley (phone)
MaryBeth Smuts (phone, EPA R1)
David Conroy (phone, EPA R1)

New Hampshire Department of Health and Human Services
Matt Cahilla (phone)


                           Statement Supporting the
                 Renewal of the Information Collection Request
        for the Community Right-to-Know Reporting Requirements of the
              Emergency Planning and Community Right-to-Know Act

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title of the Information Collection Request

      Community Right-to-Know Reporting Requirements under sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) (Renewal), EPA ICR Number 1352.16, OMB Control Number 2050-0072.

      1(b)	Short Characterization

      EPCRA section 311 requires the owner or operator of any facility that is required to prepare or have available a Safety Data Sheet (SDS) for a hazardous chemical under the Occupational Safety and Health Act (OSHA) of 1970, to submit an SDS for each hazardous chemical stored on-site in a quantity greater than the reporting threshold to their state emergency response commission (SERC) (or Tribal Emergency Response Commission (TERC)), local emergency planning committee (LEPC) (or Tribal Emergency Planning Committee (TEPC)), and local fire department. Alternatively, a list of subject chemicals grouped by hazard type may be submitted. The reporting threshold is 10,000 pounds unless the chemical is an extremely hazardous substance (EHS) under EPCRA section 302, in which case it is the lower of either 500 pounds or the threshold planning quantity (TPQ). The reporting thresholds, all grades combined, are 75,000 gallons for gasoline and 100,000 gallons for diesel fuel. These thresholds apply to chemicals stored entirely underground at retail gas stations in compliance with Underground Storage Tank (UST) regulations. Section 311 of EPCRA allows the public the same access to SDSs that facilities provide their employees. State, tribal and local agencies may have lower reporting thresholds or require facilities to report additional chemicals.

      The deadline for a one-time submittal of a list of chemicals or SDSs under section 311 was October 17, 1987.  Afterwards, if a facility becomes subject to the reporting requirements, it has three months to come into compliance. In addition, facilities must submit updated lists or SDSs within three months when a hazardous chemical above the reporting threshold is brought on-site, and a revised SDS if significant new information becomes available. A facility must provide an SDS if the SERC (or TERC), or LEPC (or TEPC) receives a request, even if the quantity of the hazardous chemical stored is below the reporting threshold.

      Section 312 of EPCRA requires owners and operators of facilities subject to section 311 to report annually the inventories of chemicals reported under section 311. The Environmental Protection Agency EPA or Agency) is required to publish two emergency and hazardous chemical inventory forms, known as "Tier I" and "Tier II," for use by these facilities. The Tier I form provides the minimum amount of information necessary to comply with the section and the Tier II form provides chemical-specific information. The submittal of an inventory form provides local emergency planners/responders and the community access to information regarding the hazards of a chemical at a facility. Facilities do not submit either form to EPA.

      Pursuant to EPCRA section 311, any facility that is required to submit an SDS or list of chemicals under section 311 must submit a Tier I form annually on or before March 1, incorporating the chemicals reported under section 311. The facility submits the Tier I form to the SERC (or TERC), LEPC (or TEPC), and local fire department. The Tier II form, which provides chemical-specific information, must be submitted upon request by the SERC (or TERC) or LEPC (or TEPC). Currently, all states require facilities to submit the federal Tier II form or the state-equivalent, including electronic submission.

      OSHA regulations (29 CFR1910.1200) provide a list of exemptions from the definition of hazardous chemicals. In addition, EPCRA section 311(e) further exempts certain substances from the definition of hazardous chemicals. See Appendix A for the list of exemptions provided under OSHA and EPCRA section 311(e).

2.	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection

      The authority for these requirements is EPCRA sections 311 and 312 (42 U.S.C. §11011 and §11012). EPCRA sections 311 and 312 require covered facilities to submit an inventory of hazardous chemicals stored on-site at or above reporting thresholds established in the regulations at 40 CFR 370.10.

      Currently, some states require facilities to submit the federal Tier II inventory form. Other states developed their own reporting form or format. None of the states accept the Tier I inventory form.

      2(b)	Practical Utility/Users of the Data

      The reports required under sections 311 and 312 are submitted to the state and local officials who use the information to develop or modify emergency response plans for their community. The information also will be accessible to the public. EPA does not collect either Tier I or Tier II forms, nor maintain a national database of facility or chemical inventory information facilities included on the Tier II form.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a)	Non-Duplication

      Many states have laws that require information submittals similar to EPCRA sections 311 and 312. EPA considers state programs that meet EPCRA's minimum reporting requirements to comply with EPCRA. The burden estimate in this ICR also includes burden imposed on facilities that comply with state requirements.

      States have the flexibility to implement the EPCRA program, as appropriate, for their state to meet EPCRA's goals to prepare for and respond to releases of EHSs and to provide the public with information on potential chemical risks in their communities. Many states have used the flexibilities to require reporting of additional chemicals, set lower reporting thresholds and create a reporting form or format, (including electronic reporting formats and certification) which requires more information compared to EPA. Other states use the EPA-developed inventory reporting form or electronic reporting software, Tier2 Submit.

      3(b)	Public Notice

      In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Agency notified the public through the Federal Register notice on the renewal of this ICR on August 20, 2021 (86 FR 17903). EPA received one comment from a private individual, which was supportive of the regulation.

      3(c) 	Consultations

      EPA contacted eight facilities in the following manufacturing industries: chemicals, paper products, agriculture inputs and pharmaceutical ingredients, and one non-manufacturing facility engaged in the marine services industry to obtain estimates on how much time they spent gathering information on hazardous chemicals they have on-site and submitting the form electronically. Facilities of different sizes were selected. All the facilities that were contacted report electronically. Because most states accept on-line reporting of the Tier II form, this reduces the burden for facilities that submit on-line using Tier2 Submit or state-developed or commercial software, which states require facilities to use.

      Two small facilities informed the Agency that they spend between two to four hours to conduct inventory and complete the Tier II form for between two to four chemicals (e.g., between 35 minutes to 80 minutes (1.3 hours) per chemical). Three medium-size facilities that spend between two and 40 hours on Tier II reporting for between 25 to 30 chemicals (e.g., between 5 minutes to 80 minutes (1.3 hours) per chemical). Three large facilities that report more than 80 chemicals reported spending between 15 to 80 hours on their reporting (e.g., between 15 minutes to 3 hours per chemical).

      EPA compared the burden estimates the Agency developed in the previous ICRs to the burden reported in the consultations and decided to maintain the conservative burden assumptions described in this section.

      EPA consulted with the following facilities:

Large Facilities
W. R. Grace
Curtis Bay Works					Baltimore MD

Shintech Freeport Plant				Freeport, TX

Neenah Paper Michigan Inc.              	Munising, MI

Medium Facilities
Genesee Polymers Corporation 			Burton, MI

Nutrien Ag Solutions	Wall Lake, IA

American Pacific	Cedar City, UT

Small Facilities
Billings Diesel & Marine Service 	Stonington, ME

Gerdau Wilton Steel Mill	Wilton, IA

      3(d)	Effects of Less Frequent Collection

      The reporting deadlines for sections 311 and 312 are set by statute. EPA has no authority to allow less frequent collection.

      3(e)	General Guidelines

      The collection activities specified in this renewal ICR adhere to the guidelines specified by OMB.

      3(f)	Confidentiality

      The respondent may claim specific chemical identities as a trade secret under EPCRA sections 322 and 323 (40 CFR Part 350) in reports submitted under section 312 and in the list of chemicals and SDS's submitted under section 311.

      All information submitted under an EPCRA trade secret claim is handled and stored in restricted access areas according to procedures set out in the Manual for Physical Handling, Security, and Protection of Files containing Trade Secret Claims Submitted under Sections 303, 311 and 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA), December 2014. Handling and review of documents containing EPCRA trade secret information is permitted only by persons who have obtained formal clearance to access the information based on a work-related need to engage in these activities. EPA attaches a cover sheet to each trade secret document and otherwise marks the document to clearly identify the document as "confidential."

      3(g)	Sensitive Questions

      The information gathering activities under this renewal ICR do not involve any sensitive questions.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondents

      Sections 311 and 312 are applicable to all facilities that are required to prepare or have available an SDS for a hazardous chemical as required under OSHA and its implementing regulations.

      4(b)	Information Requested

      (i) Data Items

      Facilities that have chemicals subject to section 311 are required to submit either SDSs or a list of regulated chemicals grouped by their hazards. Refer to Table 1 of the Tier II Form Instructions on EPA's website for the list of hazards: https://www.epa.gov/sites/production/files/2017-06/documents/tier_ii_inventory_form_instructions_2017.pdf

      Annually on or before March 1, facilities that have reportable chemicals must submit a Tier I Form; however, EPA is unaware of any states that utilize the Tier I Form. Currently, all states require facilities to submit the federal Tier II form or the state equivalent, including electronic formats, annually by March 1, to the SERC (or TERC), LEPC (or TEPC) or fire department. See Appendix A for the list of mandatory and optional data elements on the Tier II Form. See https://www.govinfo.gov/app/details/CFR-2013-title40-vol29/CFR-2013-title40-vol29-sec370-42 for information on CFR 40 CFR 370.42 - What is Tier II inventory information?

		(ii) Respondent Activities

      Facilities determine whether they are subject to section 311 by reviewing inventory records for all chemicals on-site that are required to have an SDS. The facility also must review the EHS list to determine whether any of its chemicals are subject to a lower reporting threshold and obtain the address of the SERC (or TERC), LEPC (or TEPC) and local fire department. A facility may submit copies of the SDSs for these chemicals or provide a list of the subject chemicals grouped by hazard type.

      To complete the Tier II form, the facility must monitor its inventory records for the chemical, sum the quantities for chemicals with the same hazards, and determine the correct code for the total quantity. A site map may be a convenient way to show locations of hazardous chemicals, or the facility may choose to provide the general location.

      All states now require facilities to submit the federal Tier II or the state-developed inventory reporting format, including electronic submission.

5.	THE INFORMATION COLLECTED:  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities

      The information provided under sections 311 and 312 is submitted to state and local agencies. EPA does not receive any information and incurs no collection burden under this ICR.

      5(b)	Collection Methodology and Management

      The states are responsible for collecting Tier II data. According to the most up-to-date, state-by-state information on the EPA website (www.epa.gov/EPCRA), currently 16 states use Tier2 Submit software as their reporting system, 11 states require their facilities to use E-plan, 21 states use their own software, including some which are coupled with Tier2 Submit, 10 states use Tier2 Manage, and five states allow paper submissions. Three states allow the user to choose between two submission methods (e.g., E-Plan and a state software system).

      5(c)	Small Entity Flexibility

      EPCRA sections 311 and 312 do not include any specific small entity flexibilities.
EPA considers the relative burden for small facilities to be similar to that for large facilities because of the reduced number of chemicals on-site at smaller facilities.

      5(d)	Collection Schedule

      The collection frequency for EPCRA sections 311 and 312 is required by statute. The submittal of a list of chemicals or SDSs under section 311 is a one-time requirement unless significant new information arises concerning a previously submitted SDS or chemical list. A facility must submit a revised SDS or list within three months of having a new hazardous chemical on-site in a quantity above the reporting threshold. The facilities subject to section 312 are required to submit either the Tier II form (or state equivalent) on or before March 1 annually.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      6(a)	Estimating Respondent Burden

      EPA estimated the respondent burden hours and costs associated with all reporting requirements of EPCRA sections 311 and 312. This ICR renewal accounts for reporting updates required under section 311, annual reporting and recordkeeping activities under section 312 which apply to all currently regulated facilities, as well as all initial reporting burdens for new facilities that are expected to become subject to the reporting requirements during the three-year ICR renewal period. The estimated burden to complete each reporting and recordkeeping activity is outlined below.

      The unit burden estimates associated with this collection for facilities are presented in Exhibit 1. For state and local agencies, the unit burden estimates per government agency are presented in Exhibit 2.

      Read and Understand Regulations

      EPA assumes that the initial reporting activity of reading and understanding regulations for currently covered facilities under EPCRA sections 311 and 312 has occurred and therefore, is not included in this ICR renewal. EPA does not receive the information under sections 311 and 312 directly, but is maintaining the conservative assumption from the previous ICR renewals that 140 newly regulated manufacturing facilities will need to read and understand the regulations (40 CFR Part 370) annually. SERCs (or TERCs) and LEPCs (or TEPCs) are assumed to have completed the rule familiarization activities. EPA assumes that facilities spend an average of 10 hours to read and understand the regulations in 40 CFR Part 370.

      Section 311:  SDS Reporting for Facilities (40 CFR 370.30)

      EPA assumes that the initial reporting activity of section 311 submission(s) for currently covered facilities under EPCRA sections 311 and 312 has occurred and therefore, is not included in this ICR renewal. EPA estimates that 140 newly regulated manufacturing facilities will need to determine which chemicals exceed the threshold limits. Of this universe, EPA estimates that 30 percent (42 facilities) will submit SDSs to LEPCs (or TEPCs), SERCs (or TERCs), and local fire departments. Facilities may submit a list of hazardous chemicals grouped by hazard category or a list of the chemical or common names of each hazardous chemical in lieu of submitting an SDS. EPA estimates that 70 percent (98 facilities) will submit such lists. See Exhibit 4.

      In addition, EPA estimates that 23,132 facilities (five percent of the 462,640 facilities reporting under section 312) will need to submit a revised SDS(s) and that the same number of facilities will need to submit a new SDS(s) in accordance with 40 CFR 370.31. This activity represents the incremental burden for a facility that has acquired a new chemical or has otherwise changed its inventory. Because little information is required from facilities after the initial submittal, EPA also estimates that only one percent of the total universe (4,626 facilities) may be requested to submit an SDS to an LEPC (or TEPC) in accordance with 40 CFR 370.32(b). Facility unit burden for each activity under section 311 is in Exhibit 1.

      Section 312:  Inventory Reporting for Facilities (40 CFR 370.40 to 370.42)

	The inventory reporting burden applies to new and currently covered facilities. Although EPA published two inventory forms, Tier I and Tier II, all 50 states accept only the Tier II form or a form developed by the state. All 50 states accept inventory forms electronically, using either Tier2 Submit, the state-developed electronic reporting format or commercial software. Five states accept hard copy submissions of Tier II forms; however, that does not necessarily mean that many facilities submit paper forms.

	Because EPA is not aware of any states that accept the Tier I form, this ICR renewal includes no burden for completing that form.

      EPA assumes small facilities report between one to 15 chemicals, medium facilities report up to 80 chemicals, and large facilities report more than 80 chemicals. Most non-manufacturing sector facilities store few chemicals in amounts that exceed reporting thresholds compared to manufacturing facilities. Therefore, the corresponding burden estimates for completing Tier II inventory forms are lower for non-manufacturing facilities. EPA is maintaining the estimates from the previous ICR renewal for small, medium and large manufacturers and non-manufacturers. Those unit burden estimates are presented in Exhibit 1.

      Most states require facilities to submit electronically (online, CD, or diskette) by using state-developed software, a commercial software or Tier2 Submit. The burden for electronic submission is lower than the burden for submitting in paper form. Five states accept paper submissions of the Tier II form. EPA assumes that those facilities submitting electronically will maintain an electronic copy of their form, which can be revised easily. Most of the information may be unchanged from the previous year and is imported to the new reporting year. Although the burden incurred may be lower for those submitting electronically, EPA applied the same unit burden for both electronic submitters and paper submitters.

      Information Requests for SERCs (or TERCs) and LEPCs (or TEPCs) (40 CFR 370.30)

      SERCs (or TERCs) and LEPCs (or TEPCs) incur a burden from information requests in 40 CFR 370.61. These agencies are required to provide public access to the SDSs and Tier II forms submitted by facilities. EPA estimates that the SERCs (or TERCs) and LEPCs (or TEPCs) will receive requests to provide SDSs to the public for one percent of the total universe of facilities annually (4,626 facilities). SERCs (or TERCs) and LEPCs (or TEPCs) provide Tier II information on an estimated one percent of the same universe of facilities (4,626 facilities) resulting from requests from the public for such information. See Exhibit 3.

      Data Management for SERCs (or TERCs) and LEPCs (or TEPCs)

      SERCs (or TERCs) and LEPCs (or TEPCs) receive annual inventory forms from facilities and must make the forms available to the public on request. The burden hours to manage these forms vary depending on both the number of forms received and how the SERCs (or TERCs) and LEPCs (or TEPCs) uses the data. Smaller LEPCs (or TEPCs) receive few forms each year; SERCs (or TERCs) and LEPCs (or TEPCs) in industrialized areas or areas that cover several counties, may receive many forms. The degree to which the information is used depends on whether the SERCs (or TERCs) and LEPCs (or TEPCs) have the resources to actively handle the data. Based on earlier discussions with LEPCs, EPA determined that small LEPCs (or TEPCs) spend on average five hours a year, updated to 5.8 hours, handling the forms; large LEPCs (or TEPCs) may spend as much as three months processing the forms. SERCs (or TERCs) supported by fees are also likely to spend considerable time on the data. As in the previous ICR renewal, EPA developed a weighted average of 37.6 hours each year, based on the assumption that 120 LEPCs (or TEPCs) and 27 SERCs (or TERCs) devote considerable effort to organizing and checking the data. In addition, a limited number of SERCs (or TERCs) and LEPCs (or TEPCs) have developed databases and input the section 312 data into their CAMEO software systems. Based on previous discussions with LEPCs (or TEPCs) that have databases, EPA estimates that this effort requires two months or 370 hours. See Exhibit 2.

      6(b)	Estimating Respondent Costs

      	(i) Labor Costs

      EPA estimates costs to respondents by multiplying the respondent burden estimates for each labor category by the corresponding labor rate for that category. EPA updated labor rates from the previous ICR using the most recent data available for employer costs for employee compensation tables from the Bureau of Labor Statistics (BLS), Dec. 2020. EPA then multiplied unit costs for each respondent or activity by the number of respondents or activities performed on an annual basis to yield a total cost for each information collection activity in section 6(d). These costs are shown in Exhibit 1.

	Updated hourly respondent labor costs for manufacturing facility respondents are $73.50 for managerial staff, $58.08 for technical staff, and $27.28 for clerical staff, including wages and benefits.  Updated hourly respondent labor costs for non-manufacturing facility respondents are $62.46 for managerial staff, $33.84 for technical staff, and $26.37 for clerical staff.

	EPA then calculated weighted average labor rates for each labor category. Manufacturing facilities comprise 30 percent of all facilities and non-manufacturing facilities comprise 70 percent of all facilities. Therefore, the weighted average wage rate for managerial labor is calculated as ($73.50 * 0.30) + ($62.46 * 0.70) = $65.78. Using the same weights for technical and clerical labor in manufacturing and non-manufacturing facilities results in a technical labor weighted average wage rate of $41.11 and a clerical labor weighted average wage rate of $26.65.

	Updated hourly labor rates, including wages and benefits, for SERCs (or TERCs) and LEPCs (or TEPCs) are $62.46 for managerial staff, $60.85 for technical staff, and $35.99 for clerical staff.

      	(ii) Capital and O&M Costs

      All 50 states allow facilities to submit their inventory reports (Tier II form) electronically using Tier2 Submit, or state-developed or commercial software. Currently, five states allow facilities to submit Tier II forms in hard copy; however, this does not mean that facilities actually submit paper forms vs. use electronic submission methods. In a change from previous ICR renewals, EPA is now assuming that the file cabinets these states use to store the paper forms do not need to be replaced after 15 years, so there is no longer an estimated cost to states to purchase new file cabinets.

      O&M costs consist of mailing costs. Facilities are assumed to incur postage costs for mailing new and revised SDSs to SERCs (or TERCs) and LEPCs (or TEPCs) and fire departments; lists of hazardous chemicals, and the annual inventory reports. Postage costs for facilities and state and local governments are estimated to be $10 per certified package. In the previous ICR renewal, EPA assumed that facilities incurred $5,136,704 annually in mailing costs. Given the prevalence of electronic mail and the availability and use of the internet to request and send information such as new and revised SDSs, EPA is estimating that in this ICR renewal, mailing costs are reduced by two-thirds compared to the previous renewal. Therefore, annual mailing costs are now estimated to be $1,695,000.

	State and local governments are assumed to incur postage costs to provide SDSs upon request to the public and to provide Tier II information upon written request. The annual estimated mailing costs of $60,520 are also assumed to be reduced by approximately two-thirds in this ICR renewal because of the prevalence of electronic communications, and are now estimated to be $20,000.

6(c) Agency Burden and Cost

	EPA incurs no annual Agency recordkeeping burden associated with this ICR. Only state and local government entities incur burden and cost to manage information submitted by facilities.
	EPA updates the electronic reporting software, Tier2 Submit, annually and accommodates state requests by including state-required fields. EPA estimates it spends an average of $70,000 per year to update and maintain Tier2 Submit software, including changes requested by states. This is an increase of $20,000 per year over the previous ICR renewal and is based on consultation with NOAA, which manages the contract EPA uses to maintain the software.

	6(d) Estimating the Respondent Universe and Total Annual Respondent Burden and Costs

	In the previous ICR renewal, EPA estimated that 462,640 facilities may be subject to the requirements covered by this ICR, and that 138,792 facilities (30 percent) are manufacturers and 323,848 (70 percent) are non-manufacturers. EPA Headquarters obtained Tier II form numbers from nine states via the EPA Regions, for 2017, 2018 and 2019. Appendix B shows the nine states and the numbers of facilities those states reported are subject to Tier II reporting, in addition to national totals calculated based on the nine state figures. While the numbers were higher than the current estimate of 462,640 facilities, EPA has decided to keep the estimates from the previous ICR renewal. Three of the states for which EPA obtained data, Texas, New Jersey and Arizona, require reporting for additional chemicals beyond the federal reporting requirements, and have lower reporting thresholds. In addition, EPA did not obtain any information for American Samoa, the District of Columbia, Guam, Puerto Rico or the U.S. Virgin Islands, and they are not included in the 50-state national total extrapolated from the nine states. Because EPA does not collect the Tier II data and does not maintain a national database of the data, we are unable to develop a more complete, national estimate. In fact, EPA believes that there is no better representative set of states because the states vary widely in the numbers of Tier II subject facilities, the stringency of their state regulations and their lists of additional chemicals.

      EPA is maintaining the assumption that 30 percent of facilities (138,792) are manufacturers and 70 percent (323,848 facilities) are non-manufacturers. Also, as in the previous ICR, EPA makes the conservative assumption that a total of 420 new manufacturing facilities (140 annually) will be covered by the requirements under sections 311 and 312 during the three-year ICR renewal period.

	Exhibits 1 and 4 present information collection activities, unit burden and annual burden and costs for facilities. The total annual respondent burden for 462,640 facilities is 6,825,633 hours, for a total annual cost of $305,040,615. Including O&M costs, the total is $306,735,727.

      EPA estimates the 3,000 LEPCs (or TEPCs) and 52 SERCs (or TERCs) that will implement the regulation will remain constant during the period covered by this ICR. Exhibits 2 and 3 present information collection activities, unit burden and annual burden and costs for SERCs and LEPCs to implement the program. The total annual respondent burden for 3,052 SERCs and LEPCs is 137,638 hours, for a total annual labor cost of $5,529,293. Including O&M costs, the total annual cost is $5,549,265.

      6(e)	Bottom Line Burden Hours and Cost

      The estimated annual burden for facilities is 6,825,633 hours at a cost of $306,735,727. The estimated annual burden to SERCs (or TERCs) and LEPCs (or TEPCs) respondents is 137,638 hours at a cost of $5,549,265. Exhibits 5, 6, and 7 present summaries of the bottom line burden and cost estimates for the ICR for facilities and state and local governments, including labor and O&M costs.

      6(f)	Reasons for Change in Burden

      The estimated average annual burden for facilities for reporting and recordkeeping activities under EPCRA sections 311 and 312 is 6,825,633 hours per year, which is unchanged from the previous ICR renewal approved by OMB.

      Changes in labor costs are attributable to higher labor rates updated from March 2018 to December 2020 using BLS data from the Economic News Release. O&M costs were reduced from the previous ICR renewal for two reasons, First, mailing costs were reduced by two-thirds because electronic communications have greatly reduced the reliance on the use of mail services. In addition, EPA no longer assumes that filing cabinets used to store paper forms are replaced every 15 years. Instead, EPA now believes it is more reasonable to assume that the file cabinets are used indefinitely.

      The state and local government annual burden is estimated to be 137,638 hours, which is a small decrease of 4,134 hours from the previous ICR renewal and corrects a previous calculation error.

      6(g)	Burden Statement

      The average burden for SDS reporting (basic and additional reporting) is estimated at 6.75 hours for new facilities. Additional reporting to submit revised and new SDSs for currently covered and new facilities is two hours. The average burden for new and currently covered facilities to submit SDSs upon request is one hour.

      The average burden to comply with Tier II inventory reporting for small, medium and large manufacturers is 14.25, 80.25 and 120.25 hours, respectively. The average burden to comply with Tier II inventory reporting for small, medium and large non-manufacturers is 10.25, 40.25, and 40.25 hours, respectively. There are no recordkeeping requirements for facilities under EPCRA sections 311 and 312, although EPA assumes that they will maintain a copy of annual reports to use for future filings. The recordkeeping for SDSs is mandated under the OSHA HCS.

	The average burden for state and local governments to respond to requests for SDSs or Tier II information under 40 CFR 370.30 is estimated to be 1.2 hours per request. The average burden for managing and maintaining the reports and files is estimated to be 37.6 hours. The average burden for maintaining and updating a section 312 database is estimated to be 370 hours.

	The annual public reporting and recordkeeping burden for this collection of information is estimated to range from 10.25 to 120.25 hours per response, which covers the range from small non-manufacturers to large manufacturers. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-SFUND-2004-0006, which is available for online viewing at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select "search," then key in the Docket ID Number identified above. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room is closed to the public, with limited exceptions, to reduce the risk of transmitting COVID-19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. For further information about the EPA's public docket, Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets. The telephone number for the Docket Center is<PHONE_NUMBER>.
 Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-SFUND-2004-0006 and OMB Control Number 2050-0072 in any correspondence.

                                   Exhibit 1
         Section 311 and 312 Reporting and Recordkeeping Requirements
              Estimated Unit Burden and Labor Costs -- Facilities
Information Collection Activity
                                  Management
                                   Technical
                                   Clerical
Total Hours
Annual Unit Cost
RULE FAMILIARIZATION

  Read and understand regulations
                                      2.5
                                      7.5
                                       0
                                      10
                                                                       $472.76
SDS REPORTING

Basic Reporting

Determine which chemicals meet/exceed the thresholds (new facilities)
                                       1
                                       3
                                       0
                                       4
                                                                       $189.10
Submit SDSs to SERCs (or TERCs), LEPCs (or TEPCs), and fire dept. (new facilities)
                                     0.25
                                       1
                                      0.5
                                     1.75
                                                                         $70.88
Alternative Reporting

Submit list of hazardous chemicals grouped by hazard category (new facilities)
                                       0
                                       1
                                     0.25
                                     1.25
                                                                        $47.77
Submit revised SDSs (new and currently covered facilities)
                                     0.25
                                      0.5
                                     0.25
                                       1
                                                                        $43.66
Submit new SDSs (new and currently covered facilities)
                                     0.25
                                      0.5
                                     0.25
                                       1
                                                                        $43.66
Additional Reporting

Submit SDS upon request (new and currently covered facilities)
                                     0.25
                                      0.5
                                     0.25
                                       1
                                                                        $43.66
INVENTORY REPORTING

Basic Reporting

Develop and submit Tier II (new and currently covered facilities

                                                                  Manufacturers

                                                                         Small
                                       4
                                     10.25
                                       0
                                     14.25
                                                                       $684.48
                                                                         Medium
                                       4
                                     76.25
                                       0
                                     80.25
                                                                     $3,397.73
                                                                          Large
                                       8
                                    112.25
                                       0
                                    120.25
                                                                     $5,140.78
                                                              Non-manufacturers

                                                                          Small
                                       2
                                     8.25
                                       0
                                     10.25
                                                                       $470.71
                                                                         Medium
                                       4
                                     36.25
                                       0
                                     40.25
                                                                     $1,753.33
                                                                          Large
                                       6
                                     34.25
                                       0
                                     40.25
                                                                       $394.65
GRAND TOTAL

                                                                     $12,753.18
                                   Exhibit 2
         Sections 311 and 312 Reporting and Recordkeeping Requirements
                     Estimated Unit Burden and Labor Costs
                         State and Local Governments

                               Management Hours
                                Technical Hours
                                Clerical Hours
                                  Total Hours
                               Annual Unit Cost
INFORMATION REQUESTS

File and maintain annual inventory forms and data
                                       0
                                      5.8
                                     31.8
                                     37.6
                                                                        $1,497
Input data and maintain database of 312 data
                                       0
                                     46.3
                                     323.8
                                     370.1
                                                                       $14,472
Provide SDSs upon written request
                                       0
                                      0.6
                                      0.6
                                      1.2
                                                                           $56
Provide Tier II information upon written request
                                       0
                                      0.6
                                      0.6
                                      1.2
                                                                           $56
                                                                          Total
                                       0
                                     53.2
                                     356.8
                                     410.0
                                                                       $16,081

                                   Exhibit 3
         Sections 311 and 312 Reporting and Recordkeeping Requirements
                    Estimated Annual Burden and Labor Costs
                          State and Local Governments

                             Number of Respondents
                               Management Hours
                                Technical Hours
                                Clerical Hours
                              Total Annual Hours
                                  Annual Cost
INFORMATION REQUESTS

File & maintain annual inventory forms and data
                                     3,052
                                       0
                                    17,650
                                    97,073
                                    114,755
                                  $4,568,062
Input data and maintain database of 312 data
                                      43
                                       0
                                     1,989
                                    13,925
                                    15,914
                                   $622,287
LEPCs (or TEPCs) provide SDS on written request
                                     3,000
                                       0
                                     1,735
                                     1,735
                                     3,470
                                   $168.016
SERCs (or TERCs) and LEPCs (or TEPCs) provide Tier II information upon written request
                                     3,052
                                       0
                                     1,765
                                     1,765
                                     3,530
                                   $170,928
                                    Total

                                      0
                                    23,139
                                    114,499
                                    141,772
                                  $5,529,293
                                   Exhibit 4
       Section 311 and 312 Reporting and Recordkeeping Requirements  -
             Estimated Annual Burden and Labor Costs - Facilities

                             Number of Respondents
                               Management Hours
                                Technical Hours
                                Clerical Hours
                              Total Burden Hours
                                  Annual Cost
RULE FAMILIARIZATION

  Read and understand regulations
                                      140
                                      350
                                     1050
                                       0
                                     1,400
                                                                       $66,187
                                                                       Subtotal

                                     1,400
                                                                       $66,187
SDS REPORTING

Basic Reporting

Determine which chemicals meet/exceed the thresholds (new facilities)
                                      140
                                      140
                                      420
                                       0
                                      560
                                                                       $26,476
Submit SDSs to SERCs (or TERCs), LEPCs (or TEPCs) and fire depts (new facilities)
                                      42
                                     10.5
                                      42
                                      21
                                     73.50
                                                                         $2,977
Alternative Reporting

Submit list of hazardous chemicals grouped by hazard category (new facilities)
                                      98
                                       0
                                      98
                                     24.5
                                     122.5
                                                                         $4,682
Submit revised SDSs (new and currently covered facilities)
                                    23,132
                                     5,783

                                    11,566
                                     5,783
                                    23,132
                                                                     $1,009,984
Submit new SDSs (new and currently covered facilities)
                                    23,132
                                     5,783
                                    11.566
                                     5,783
                                    23,132
                                                                     $1,009,984
Additional Reporting

Submit SDS upon request (new and currently covered facilities)
                                     4,626
                                     1,157
                                     2,313
                                     1,157
                                     4,626
                                                                       $201,997
                                                                       Subtotal

                                    51,646
                                                                     $2,256,099
INVENTORY REPORTING

Basic Reporting

Develop and submit Tier II (new and currently covered facilities

                                                                  Manufacturers

                                                                         Small
                                    124,219
                                    496,875
                                   1,273,243
                                       0
                                   1,770,118
                                                                    $85,024,861
                                                                         Medium
                                    10,409
                                    41,638
                                    793,717
                                       0
                                    835,354
                                                                   $35,368,289
                                                                          Large
                                     4,164
                                    33,310
                                    467,382
                                       0
                                    500,692
                                                                   $21,404,978
                                                              Non-manufacturers

                                                                          Small
                                    312,282
                                    624,564
                                   2,576,327
                                       0
                                   3,200,891
                                                                  $146,993,151
                                                                         Medium
                                     6,940
                                    27,758
                                    251,561
                                       0
                                    279,319
                                                                   $12,167,425
                                                                          Large
                                     4,626
                                    27,758
                                    158,454
                                       0
                                    186,213
                                                                    $1,825,812
                                                                       Subtotal
                                    462,640
                                   1,251,904
                                   5,520,683

                                                                      6,772,587
                                                                  $302,784,517
                           GRAND TOTAL (Facilities)

                                                                      6,825,633
                                                                   $305,040,615

                                   Exhibit 5
                  Summary of Total Burden and Cost Estimates
                                  Facilities

                              Total Burden Hours
                                  Labor Cost
                                 Capital Cost
                                 O&M Cost
                                  Total Cost
                                    Annual
                                   6,825,633
                                 $305,040,615
                                      $0
                                  $1,695,112
                                 $306,735,727
                                  Three-Year
                                  20,476,900
                                 $915,121, 846
                                      $0
                                  $5,085,337
                                 $920,207,182

                                   Exhibit 6
                  Summary of Total Burden and Cost Estimates
                     SERCs (or TERCs) and LEPCs (or TEPCs)

                              Total Burden Hours
                                  Labor Cost
                                 Capital Cost
                                 O&M Cost
                                  Total Cost
Annual
                                    137,638
                                  $5,529,293
                                      $0
                                    $19,972
                                                                     $5,549,265
Three-Year
                                    412,913
                                 $16,587,879
                                       $0
                                    $59,915
                                                                    $16,647,794

                                  Exhibit 7
                              Total Public Burden

                              Total Burden Hours
                                  Labor Cost
                                 Capital Cost
                                 O&M Cost
                                  Total Cost
Facilities
                                                                      6,824,633
                                                                  $305,040,615
                                                                            $0
                                                                   $1,695,112
                                                                   $306,735,727
 SERCs (or TERCs) and LEPCs (or TEPCs)
                                                                        137,638
                                                                     $5,529,293
                                                                            $0
                                                                        $19,972
                                                                     $5,549,265
Annual Total
                                                                      6,961,871
                                                                   $310,569,908
                                                                             $0
                                                                     $1,715,094
                                                                   $312,284,992
Three-Year Total
                                                                     20,885,613
                                                                   $931,709,724
                                                                             $0
                                                                     $5,145,252
                                                                   $936,854,976

                                  APPENDIX A
             Information Included on Tier II Forms and Exemptions

The Tier II form includes the following information as required by statute:

 The chemical name or the common name of the chemical as provided on the SDS;
 An estimate, in ranges, of the maximum quantity of the hazardous chemical present at the facility at any time during the preceding calendar year;
 An estimate, in ranges, of the average daily quantity of hazardous chemical present at the facility during the preceding calendar year;
 A brief description of the manner of storage of the hazardous chemical;
 The location of the hazardous chemical within the facility;
 CAS number to identify more accurately each chemical that is reported;
 The physical state to help identify the type of hazard each chemical presents in an emergency;
 The physical and health hazards associated with the chemical;
 Primary NAICS code and Dun and Bradstreet number of the facility;
 Two emergency contacts (added to give SERCs (or TERCs) and LEPCs (or TEPCs) , and local fire departments a contact at the facility who could clarify information at any time, particularly in the event of an emergency); and,
 Number of days on-site (added to produce a more accurate estimate of the average daily quantity, particularly for those chemicals that are on-site for only a short period of time each year).
 Latitude and longitude of the facility;
 Maximum number of occupants;
 An indication of whether the facility is manned or unmanned;
 Facility identification numbers assigned under the Toxic Chemical Release Inventory and the Risk Management Programs;
 Email address of the owner or operator of the facility;
 Name, title, email address, phone number and 24-hour phone number of the facility emergency coordinator;
 Name, title, email address, phone number of the person knowledgeable about the information reported on the Tier I and Tier II forms;
 Email address of the emergency contact(s);
 An indication of whether the facility is subject to EPCRA section 302; and,
 An indication of whether the facility is subject to Clean Air Act (CAA) section 112(r), also known as the Risk Management Program.

The forms also include the following optional data elements:
 Name, address, phone number, Dun & Bradstreet number and email address of the parent company; and,
 Phone number of the facility.

Section 1910.1200 of the OSHA regulations provides exemptions from the definition of hazardous chemical. In addition, EPCRA section 311(e) excludes the following substances:

     ::		Any food, food additive, color additive, drug, or cosmetic regulated by the Food and Drug Administration;
 Any substance present as a solid in any manufactured item to the extent exposure to the substance does not occur under normal conditions of use;
 Any substance, to the extent it is used:
 For personal, family, or household purposes, or is present in the same form and concentration as a product packaged for distribution and use by the public;
 In a research laboratory, hospital, or other medical facility under the direct supervision of a technically qualified individual; and,
In routine agricultural operations or is a fertilizer held for sale by a retailer to the ultimate customer.

                                  APPENDIX B
                     Tier II Facility Data for Nine States

      EPA obtained the numbers of facilities in nine states via a request to the EPA Regions, for 2017, 2018 and 2019 (plus 2020 for Iowa). The nine states are Maine, New Jersey, Maryland, Florida, Michigan, Texas, Iowa, Utah and Arizona. The data are presented below.

      EPA calculated an annual average for each state, summed those averages and then divided the total by nine, to obtain an annual state average for the set of nine states (13,166 facilities per state). We then multiplied that average by 50, to obtain an estimated national total of 658,307 facilities.

Region 1  -  Maine
Year
Tier II Facilities
2017
                                     2,333
2018
                                     2,536
2019
                                     2,848

Region 2  -  New Jersey
Year
Tier II Facilities
2017
                                     6,074
2018
                                     6,114
2019
                                     6,027

Region 3 - Maryland
Year
Tier II Facilities
2017
                                     2,476
2018
                                     2,489
2019
                                     2,436

Region 4 - Florida
Year
Tier II Facilities
2017
                                    12,369
2018
                                    12,642
2019
                                    12,777

Region 5  -  Michigan
Year
Tier II Facilities
2017
                                     6,325
2018
                                     6,585
2019
                                     6,979

Region 6  -  Texas
Year
Tier II Facilities
2017
                                    76,093
2018
                                    73,354
2019
                                    78,391

Region 7 - Iowa
Year
 Tier II Facilities
2017
                                     4,134
2018
                                     4,580
2019
                                     4,678
Region

Region 8  -  Utah
Year
 Tier II Facilities
2017
                                     3,712
2018
                                     3,414
2019
                                     3,532

Region 9  -  Arizona
Year
Tier II Facilities
2017
                                     4,526
2018
                                     4,607
2019
                                     4,233


[Federal Register: August 16, 2007 (Volume 72, Number 158)]
[Notices]
[Page 46097-46099]
[DOCID:fr16au07-112]

=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0019]

Storage and Handling of Anhydrous Ammonia Standard; Extension of
the Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits comments concerning its proposal to extend OMB
approval of the information collection requirements contained in the
Standard on the Storage and Handling of Anhydrous Ammonia (29 CFR
1910.111). Paragraphs (b)(3) and (b)(4) of the Standard have paperwork
requirements that apply to nonrefrigerated containers and systems, and
refrigerated containers, respectively; employers use these containers
and systems to store and transfer anhydrous ammonia in the workplace.

DATES: Comments must be submitted (postmarked, sent, or received) by
October 15, 2007.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2007-0019,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., EST.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2007-0019). All comments, including any
personal information you provide, are placed in the public docket
without change, and may be made available online at http://www.regulations.gov.
 For further information on submitting comments see

the ``Public Participation'' heading in the section of this notice
titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at

the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;

however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue, NW., Washington, DC 20210; telephone (202)
693-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the Act or for developing information
regarding the causes and prevention of occupational injuries,
illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires
that OSHA obtain such information with minimum burden upon employers,
especially those operating small businesses, and to reduce to the
maximum extent feasible unnecessary duplication of efforts in obtaining
information (29 U.S.C. 657).
    Paragraph (b)(3) of the Standard specifies that containers and
systems have nameplates if required, and that these nameplates ``be
permanently attached to the system (as specified by paragraph
(b)(3)(ii)(j)) so as to be readily accessible for inspection * * * .''
In addition, this paragraph requires that markings on containers and
systems covered by paragraphs (c) (``Systems utilizing stationary,
nonrefrigerated storage containers''), (f) (``Tank motor vehicles for
the transportation of ammonia''), (g) (``Systems mounted on farm
vehicles other than for the application of ammonia''), and (h)
(``Systems mounted on farm vehicles for the application of ammonia'')
provide information regarding nine specific characteristics of the
containers and systems. Similarly, paragraph (b)(4) of the Standard
specifies that refrigerated containers be marked with a nameplate on
the outer covering in an accessible place which provides information
regarding eight specific characteristics of the container.
    The required markings ensure that employers use only properly
designed and tested containers and systems to store anhydrous ammonia,
thereby preventing accidental release of, and exposure of employees to,
this highly toxic and corrosive substance. In addition, these
requirements provide the most efficient means for an OSHA compliance
officer to ensure that the containers and systems are safe.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on the Storage and
Handling of Anhydrous Ammonia (29 CFR 1910.111). The Agency is
requesting to retain its current burden hour estimate associated with
this Standard at 345 hours. The Agency will summarize the comments
submitted in response to this notice and will include this summary in
the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Storage and Handling of Anhydrous Ammonia Standard (29 CFR
1910.111(b)(3) and (b)(4)).
    OMB Number: 1218-0208.
    Affected Public: Farms.
    Number of Respondents: 2,030.
    Frequency: On occasion.
    Average Time Per Response: 10 minutes (.17 hour) for an employee to
replace or revise markings on ammonia containers.
    Estimated Total Burden Hours: 345.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2007-0019).

You may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov.
 Therefore, OSHA cautions commenters about

submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov
 index, some information (e.g., copyrighted

material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit

comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2002 (67 FR
65008).

    Signed at Washington, DC, on August 9, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
 [FR Doc. E7-16043 Filed 8-15-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49247-49248]
[FR Doc No: 2015-20174]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1176]

Compounding Animal Drugs From Bulk Drug Substances; Draft
Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the document that appeared in the Federal Register
of May 19, 2015. In the document, FDA requested comments on draft
guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs
from Bulk Drug Substances.'' FDA is taking this action in response to a
request for an extension to allow interested persons additional time to
submit comments.

DATES: FDA is extending the comment period on the document published
May 19, 2015 (80 FR 28624). Submit either electronic or written
comments on the draft guidance by November 16, 2015.

ADDRESSES: You may submit comments by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-1176. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Division of Compliance, Center for
Veterinary Medicine, Food and Drug Administration (HFV-230), 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 2015, FDA published a document
with a 90-day comment period for draft GFI #230 entitled ``Compounding
Animal Drugs from Bulk Drug Substances.'' The draft guidance describes
FDA's policies with regard to compounding animal drugs from bulk drug
substances. When final, the guidance will reflect FDA's current
thinking on the issues addressed by the guidance.
    FDA has received a request for a 90-day extension of the comment
period. The request conveyed concern that the current 90-day comment
period does not allow sufficient time to respond. FDA has considered
the request and is extending the comment period for 90 days, until
November 16, 2015. FDA believes that a 90-day extension allows adequate
time for interested persons to submit comments without significantly
delaying further FDA action on this guidance document.

II. Specific Topics for Comment

    In addition to comments on the draft guidance as written, we are
specifically requesting comments on the following issues:
     Should the final guidance address the issue of FDA-
approved animal and human drugs that are in shortage or are otherwise
unavailable (e.g., disruptions in the manufacture or supply chain;
business decisions to stop marketing the drug; drug is subject to
Agency action based on safety, effectiveness, or manufacturing
concerns)? If so:
    [cir] How should these situations be addressed in the final
guidance?
    [cir] How should the final guidance define the terms ``shortage''
and ``unavailable''?
    [cir] What criteria should FDA use to determine if an approved
animal or human drug is in shortage or otherwise unavailable?
     Do United States Pharmacopeia and National Formulary (USP-
NF) \1\ chapters 795 and 797 provide suitable standards for animal
drugs compounded by veterinarians, and if not, what standards of
safety, purity, and quality should apply to animal drugs compounded by
veterinarians?
---------------------------------------------------------------------------

    \1\ Chapters <795> ``Pharmaceutical Compounding--Nonsterile
Preparations'' and <797> ``Pharmaceutical Compounding--Sterile
Preparations'' can be found in both the USP Compounding Compendium
and the combined United States Pharmacopeia and National Formulary
(USP-NF). These compendia are available at http://www.usp.org/.
---------------------------------------------------------------------------

     Should licensed veterinarians be able to sell or transfer
an animal drug compounded from bulk drug substances by a State-licensed
pharmacy or an outsourcing facility to owners or caretakers of animals
under the veterinarian's care?
     Should the final guidance include a condition on the
amount or percentage of compounded animal drugs that a pharmacy or
outsourcing facility can ship in interstate commerce? If so, what would
a reasonable amount be?
     Is additional guidance needed to address the repackaging
of drugs for animal use?
    [cir] How widespread is the practice of repackaging drugs for
animal use?
    [cir] What types of drugs are repackaged for animal use, and why
are they repackaged?
    [cir] Have problems been identified with repackaged drugs for
animal use?
     Is additional guidance needed to address the compounding
of animal drugs from approved animal or human drugs under section
512(a)(4) or (a)(5) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360b(a)(4) and (a)(5)) and 21 CFR part 530?
     Is additional guidance needed to address the compounding
of animal drugs from bulk drug substances for food-producing animals?

     As one condition under which FDA does not generally intend
to take action for certain violations of the FD&C Act if this and the
other conditions are followed, FDA is proposing that State-licensed
pharmacies and veterinarians report any product defect or serious
adverse event associated with animal drugs they compound from bulk drug
substances to FDA within 15 days of becoming aware of the product
defect or serious adverse event. Outsourcing facilities are required to
report adverse events associated with the drugs they compound. FDA
believes it is important to receive this information from State-
licensed pharmacies and veterinarians because there are no other State
Departments of Health or Federal Agencies (e.g., the Centers for
Disease Control and Prevention) charged with identifying and tracing
animal injuries or disease associated with an animal drug compounded by
these entities. FDA has the following specific questions with respect
to this proposed condition:
    [cir] How many State-licensed pharmacies and veterinarians compound
animal drugs from bulk drug substances and would potentially be
reporting product defects and serious adverse events to FDA?
    [cir] Are State-licensed pharmacies and veterinarians reporting the
same or similar information to any State regulatory agency (e.g., State
boards of pharmacy, State boards of veterinary medicine)? If so, how
many reports on average does each State-licensed pharmacy and
veterinarian submit to these State agencies each year?
    [cir] For purposes of the guidance, how should FDA define the terms
``product defect'' and ``serious adverse event?''
    [cir] Can FDA achieve the same objective of identifying and tracing
the source of injuries or disease associated with an animal drug
compounded from a bulk drug substance through means other than product
defect and serious adverse event reporting, and if so, what other
means? For example, would reports of product defects alone achieve the
same objective?

III. Request for Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm or
http://www.regulations.gov.

    Dated: August 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20174 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Notices]
[Page 72815-72816]
[DOCID:fr07de05-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 28, 2005.
    Take notice that the Commission received the following electric
rate filings.
    Docket Numbers: ER00-2268-011.
    Applicants: Pinnacle West Capital Corporation.
    Description: Joint motion to expedite consideration of pending
offer of settlement and concurrent filing by Arizona Public Service Co
of notice of cancellation re Pinnacle West Capital Corp, Rate Schedule
FERC No. 127.
    Filed Date: November 14, 2005.
    Accession Number: 20051115-0150.

    Docket Numbers: ER04-961-005.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits proposed revisions to Schedule 2 and Module A of their FERC
Electric Tariff, Third Revised Volume No. 1.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0202.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER05-1047-002.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits the Small Generator Interconnection & Operating Agreement with
East Ridge Transmission, LLC and Great River Energy.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0221.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER05-1048-002.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits the Small Generator Interconnection & Operating Agreement with
Wolf Wind Transmission, LLC and Great River Energy.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0222.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER05-1318-002.
    Applicants: Geneva Energy, LLC.
    Description: Geneva Energy LLC submits a petition for acceptance of
initial rate schedule, waiver and blanket authority in reference to
Geneva's self-certified small power production facility located in Ford
Heights, IL formerly known as New Heights Recovery & Power, LLC.
    Filed Date: November 17, 2005.
    Accession Number: 20051121-0108.
    Comment Date: 5 p.m. eastern time on Thursday, December 8, 2005.

    Docket Numbers: ER05-1534-001.
    Applicants: American Electric Power.
    Description: American Electric Power Service Corp, as agent for its
affiliate Appalachian Power Co submits AEP & Blue Power Agency, Inc
Second Revised Substitute Original Sheet No. 13 of Interconnection &
Local Delivery Service Agreement No. 1252.
    Filed Date: November 14, 2005.
    Accession Number: 20051116-0192.
    Comment Date: 5 p.m. eastern time on Monday, December 5, 2005.

    Docket Numbers: ER05-1361-001.
    Applicants: Calpine Fox LLC.
    Description: Calpine Fox LLC's compliance filing of its revised
Reactive Supply & Voltage Control from generation service rate
schedule, Rate Schedule FERC No. 2.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0203.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-162-000.
    Applicants: Entergy Service, Inc.
    Description: Entergy Operating Companies submits proposed revisions
to their Open Access Transmission Tariff, FERC Electric Tariff, second
Revised Volume No. 3.
    Filed Date: November 4, 2005.
    Accession Number: 20051108-0284.
    Comment Date: 5 p.m. eastern time on Thursday, December 8, 2005.

    Docket Numbers: ER06-214-000.
    Applicants: Power Bidding Strategies, LLC.
    Description: Power Bidding Strategies, LLC submits the petition for
acceptance of initial rate schedule, waiver & blanket authority.
    Filed Date: November 15, 2005.
    Accession Number: 20051118-0204.
    Comment Date: 5 p.m. eastern time on Tuesday, December 6, 2005.

    Docket Numbers: ER06-215-000.
    Applicants: DeGreeffpa, LLC.
    Description: DeGreeffpa, LLC's petition for order accepting market-
based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0201.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-216-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator,
Inc., submits a Large Generator Interconnection Agreement with Ameren
Services Co et al.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0205.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.
    Docket Numbers: ER06-217-000.
    Applicants: Geysers Power Company, LLC.
    Description: Geysers Power Co LLC submits updated rate schedule for
the Reliability Must-Run Service Agreement for Service Year 2006 w/ the
California Independent System Operator Corp et al.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0216.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-218-000.
    Applicants: Liberty Power District of Columbia LLC.
    Description: Liberty Power District of Columbia LLC submits a
Petition for Initial Rate Schedule, Waivers and Blanket Authority.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0214.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-219-000.
    Applicants: Liberty Power New York LLC.
    Description: Liberty Power New York LLC submits a Petition for
Initial Rate Schedule, Waivers and Blanket Authority.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0215.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-220-000.
    Applicants: Bendwind, LLC.
    Description: Petition of Bendwind LLC for order accepting market-
based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.

    Accession Number: 20051118-0218.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-221-000.
    Applicants: Sierra Wind, LLC.
    Description: Petition of Sierra Wind LLC for order accepting
market-based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0217.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-222-000.
    Applicants: Groen Wind, LLC.
    Description: Groen Wind, LLC's petition for order accepting market-
based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0224.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-223-000.
    Applicants: Larswind, LLC.
    Description: Larswind, LLC's petition for order accepting market-
based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0226.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-224-000.
    Applicants: TAIR Windfarm, LLC.
    Description: TAIR Windfarm, LLC's petition for order accepting
market-based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0225.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-225-000.
    Applicants: Hillcrest Wind, LLC.
    Description: Hillcrest Wind, LLC's petition for order accepting
market-based rate tariff for filing and granting waivers and blanket
approvals.
    Filed Date: November 16, 2005.
    Accession Number: 20051118-0223.
    Comment Date: 5 p.m. eastern time on Wednesday, December 7, 2005.

    Docket Numbers: ER06-226-000.
    Applicants: Choctaw Gas Generation, LLC.
    Description: Application of Choctaw Gas Generation, LLC for
approval of rate schedule for sales of electric capacity, energy &
ancillary services at market-based rates & for approval of certain
waivers & blanket authorizations.
    Filed Date: November 17, 2005.
    Accession Number: 20051121-0109.
    Comment Date: 5 p.m. eastern time on Thursday, December 8, 2005.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other and the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6911 Filed 12-6-05; 8:45 am]

BILLING CODE 6717-01-P