SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC)

1. Identification of the Information Collection 1( a) Title of the Information Collection NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR part 63, subpart CCC) ( Renewal)

1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) for Steel Pickling, published at 40 CFR part 63, subpart CCC, were proposed on September 18, 1997 ( 62 FR 49051) and promulgated on June 22, 1999 ( 64 FR 33202). This rule applies to all facilities that pickle steel using hydrochloric acid or regenerate hydrochloric acid, and are major sources or are part of a facility that is a major source. This regulation does not apply to any pickling line that uses an acid other than hydrochloric acid or an acid solution containing less than 6 percent HCl or at a temperature less than 100 º F. This rulemaking establishes limits for hydrochloric acid emissions from continuous and batch pickling lines and acid regeneration units and limits for chlorine emissions from acid regeneration units. Also, operational and equipment standards are established for stationary acid storage vessels.

In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/ operators of the affected facilities. Consistent with the NESHAP General Provisions ( 40 CFR part 63, subpart A), respondents submit one time notifications of applicability and a one time report on performance test results for the primary emission control device. Plants also must develop and implement a Startup, Shutdown, and Malfunction Plan ( SSMP) and submit semiannual reports of any event where the procedures in the plan were not followed. Sources are required to submit semiannual reports. NESHAP subpart CCC also requires the owner or operator to submit a written maintenance plan for each emission control device. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to the NESHAP.

Any owner/ operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the United States Environmental Protection Agency ( EPA) regional office. 2 According to EPA's " MACT Tool" database, there are approximately 82 facilities subject to the NESHAP subpart CCC standards. Upon further consultation with the EPA Office of Air Quality Planning and Standards ( OAQPS), we have determined that 72 respondents ( i. e., 64 of 82 existing steel pickling facilities and 8 acid regeneration plants are using hydrochloric acid) are currently subject to the standard. Furthermore, one additional respondent will become subject to the regulation in the next three years.

OMB approved the currently active ICR without any " Terms of Clearance".

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction. In addition, section 114( a) states that the Administrator may require any owner/ operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, hydrochloric acid emissions from continuous and batch pickling lines and acid regeneration units, and chlorine emissions from acid regeneration units cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NESHAP standards were promulgated for this source category at 40 CFR part 63, subpart CCC.

2( b) Practical Utility/ Users of the Data The recordkeeping and reporting requirements in the standard ensure compliance with the applicable regulations which where promulgated in accordance with the Clean Air Act. The 3 collected information is also used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected facility's initial capability to comply with the emission standard. Continuous emission monitors are used to ensure compliance with the standard at all times. During the performance test a record of the operating parameters under which compliance was achieved may be recorded and used to determine compliance in place of a continuous emission monitor.

The notifications required in the standard are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated. The performance test may also be observed.

The required semiannual reports are used to determine periods of excess emissions, identify problems at the facility, verify operation/ maintenance procedures and for compliance determinations.

3. Nonduplication, Consultations, and Other Collection Criteria The requested recordkeeping and reporting are required under 40 CFR part 63, subpart CCC.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register ( 70 FR 24020) on May 6, 2005. No comments were received on the burden published in the Federal Register.

3( c) Consultations After reviewing our internal data sources and discussing the industry growth rate with the Agency industry experts, we have determined that additional consultations with industry are 4 inappropriate for this ICR renewal.

The standard was developed with the participation and/ or consultation with industry representatives. In addition, the Agency has performed additional reviews to determine additional burden reduction opportunities. The Agency currently collects the minimum amount of information necessary to ensure compliance with the standard.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.5.

These standards require the respondents to maintain all records, including reports and notifications for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five year records retention requirement is consistent the Part 70 permit program and the five year statute of limitations on which the permit program is based. Also, the retention of records for five years would allow EPA to establish the compliance history of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years. EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

3( f) Confidentiality Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions 5 None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are facilities that pickle steel using hydrochloric acid or regenerate hydrochloric acid and are major sources or are part of a facility that is a major source. The SIC ( U. S. Standard Industrial Classification) codes for the respondents affected by 40 CFR part 63, subpart CCC and the corresponding NAICS ( The North American Industry Classification System) codes are listed below:

SIC Code and Description Corresponding NAICS Code and Description 3312  Steel Works, Blast Furnaces ( Including Coke Ovens), and Rolling Mills ( except coke ovens not integrated with steel mills 331111 Iron and Steel Mills; 31221 Rolled Steel Shape Manufacturing 3315  Steel Wiredrawing and Steel Nails and Spikes ( steel, wire drawing) 331222  Steel Wire Drawing 3316  Cold Rolled Steel Sheet, Strip and Bars 331221  Rolled Steel Shape Manufacturing 3317  Steel Pipe and Tubes 33121  Iron and Steel Pipe and Tube Manufacturing from Purchased Steel 4( b) Information Requested ( i) Data Items All data in this ICR that are recorded and/ or reported are required by 40 CFR part 63, subpart CCC.

A source must make the following reports: 6 Notification Reports Notification when an area source subsequently becomes subject to the rule requirements. 63.9( b)( 1), 63.1163( a)( 1)

Notification of rule applicability 63.9( a)( 2), 63.1163( a)( 2)

Notification and application of construction or reconstruction 63.9( b)( 3 4), 63.1163( a)( 3 4)

Notification and application of intent to construct a new affected source 63.9( b)( 5), 63.1163( a)( 5)

Request for an extension of compliance 63.1163( b)

Notification that the source is subject to special compliance requirements 63.1163( c)

Notification of performance tests. 63.7( b), 63.9( e), 63.1163( d)

Notification of physical or operational change which may increase the emission rate. N/ A Notification of compliance status 63.9( h), 63.1163( e)

Reports for 40 CFR Part 63, Subpart CCC Report of performance test results 63.10( d)( 2), 63.1164( a)

Demonstration of continuous monitoring system, if applicable 63.9( g)

Progress reports, if applicable 63.6( i), 63.1164( b)

A start up, shutdown, malfunction ( SSM) plan and periodic SSM reports when there is a deviation from the plan 63.10( d)( 5)( I), 63.1164( c)( 1 3) 7 A source must keep the following records:

Recordkeeping Start ups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative 63.10( b)( 2), 63.1165( a)

Emission test results and other data needed to determine emissions 61.13( g), 63.1165( a)( 7)

All reports and notifications 63.9, 63.10( b), 63.1165( a)( 10)

Record of applicability 63.10( b)( 3)

Records for sources with continuous monitoring systems 63.10( 3)

Records are required to be retained for five years. The first two years of records must be retained at the facility. 63.1165( a c)

Electronic Reporting At the present, respondents are using monitoring equipment that automatically records parameter data, e. g., temperature, pressure drop, leaks and spills of mercury, etc. Although personnel at the affected facility must evaluate the data, this internal automation has significantly reduced the burden associated with monitoring and recordkeeping at the plant site.

Also, regulatory agencies in cooperation with the respondents, continue to create reporting systems to transmit data electronically. However, electronic reporting systems are still not widely used. At this time, it is estimated that approximately 10 percent of the respondents use electronic reporting.

( ii) Respondent Activities Respondent Activities Read instructions.

Owners of acid regeneration plants shall install, calibrate, maintain, and operate systems for the measurement of process off gas temperature, excess air proportion, make up water flow, and recirculation flow rate for web scrubbers or other parameters established during the performance test for an alternative control device.

Perform initial performance test, Reference Methods 1, 2, 3, 4 and 26A test or approved alternative method, and repeat performance tests if necessary. 8 Respondent Activities Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of 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.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the EPA's Air Facility System ( AFS) and the MACT Tool databases through the Online Tracking Information System ( OTIS).

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance 9 test reports are used by the Agency to discern a source's initial capability to comply with the emission standard. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS which is operated and maintained by EPA's Office of Compliance. AFS is EPA's database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government owned facilities. EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner/ operator for five years.

5( c) Small Entity Flexibility During the development of the NESHAP for steel pickling, it was determined that there are no small businesses that would be subject to the NESHAP or incur adverse economic impacts. For firms that are not small entities by this definition, the rule provides flexibility to the regulated community in the choice of emission limits or performance standards. Provisions also are included to allow additional time to comply if needed for the installation of capture or control equipment.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 1: Annual Respondent Burden and Cost: NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC).

6. Estimating the Burden and Cost of the Collection Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and major assumptions have been identified. Responses to this information collection are mandatory.

The 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. 10 6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 25,448 ( Total Labor Hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates:

Managerial $ 97.46 ($ 46.41 + 110%) Technical $ 83.71 ($ 39.86 + 110%) Clerical $ 42.55 ($ 20.26 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 19, 2005, " Table 2. Civilian Workers, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The types of industry costs associated with the information collection activity in the regulations are both labor costs which are addressed elsewhere in this ICR and costs associated with continuous monitoring. The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the flow monitors and other costs such as photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Continuous Monitoring Device ( B) Capital/ Star tup Cost for One Respondent ( C) Number of New Respondents ( D) Total Capital/ Star tup Cost, ( B X C) ( E) Annual O& M Costs for One Respondent ( F) Number of Respondents with O& M ( G) Total O& M, ( E X F)

Flowmeters with high/ low alarms $ 830 1 $ 830 $ 106 72.3 $ 7,663.8 11 The total capital/ startup costs for this ICR are $ 830. This cost is associated with the new source buying two recording flow meters with high/ low alarms and its supporting equipment. This is the total of column D in the above table. These costs are shown on the OMB 83 I form in block 14( a), Total annualized capital/ startup costs.

The total operation and maintenance ( O& M) costs for this ICR are $ 7,664 ( rounded). This cost is associated with all sources having O& M costs associated with two recording flowmeters with high/ low alarms which have a lifetime of 15 years. This is the total of column G. These costs are shown on the OMB 83 I form in block 14( b), Total annual costs ( O& M).

The total respondent costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 8,494 ( rounded). This cost is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars. The figures on the OMB 83 I form reflect the rounding up of each cost individually, so the total cost is $ 9,000 ( rounded).

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $ 16,784 ( see Table 2 attached).

This cost is based on the average hourly labor rate as follows:

Managerial $ 56.02 ( GS 13, Step 5, $ 35.01 x 1.6) Technical $ 41.57 ( GS 12, Step 1, $ 25.98 x 1.6) Clerical $ 22.50 ( GS 6, Step 3, $ 14.06 x 1.6)

These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 2: Annual Burden and Cost to the Federal/ State Government: NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC), attached. 12 6( d) Estimating the Respondent Universe and Total Burden and Costs Based on our research for this ICR, on average over the next three years, approximately 72 existing respondents will be subject to the standard. It is estimated that one additional respondent will become subject to this standard over the three year period of this ICR. The overall average number of respondents, as shown in the table below is 72.3 per year.

The number of respondents is calculated using the following table which addresses the three years covered by this ICR.

Number of Respondents Respondents That Submit Reports Respondents That Do Not Submit Any Reports Year ( A) Number of New Respondents 1 ( B) Number of Existing Respondents ( C) Number of Existing Respondents that keep records but do not submit reports ( D) Number of Existing Respondents That Are Also New Respondents ( E) Number of Respondents ( E= A+ B+ C D)

1 0.3 72 0 0 72.3 2 0.3 72 0 0 72.3 3 0.3 72 0 0 72.3 Average 0.3 72 0 0 72.3 1 New respondents include sources with constructed, reconstructed and modified affected facilities. . To avoid double counting respondents, column D is subtracted. As shown above, the average Number of Respondents over the three year period of this ICR is 72 ( rounded). This number appears on the OMB 83 I form in block 13( a), Number of respondents.

The number of Total Annual Responses is 153 ( rounded), as described below. This number is shown on the OMB 83 I form in block 13( b), Total annual responses. 13 Total Annual Responses ( A)

Information Collection Activity ( B)

Number of Respondents ( C)

Number of Responses ( D) Number of Existing Respondents That Keep Records But Do Not Submit Reports ( E) Total Annual Responses E=( BxC)+ D Notification of applicability 0.3 1 N/ A 0.3 Notification of construction/ reconstruction 0.3 1 N/ A 0.3 Notification of actual startup 0.3 1 N/ A 0.3 Notification of special compliance requirements 0.3 1 N/ A 0.3 Notification of initial performance test 0.3 1 N/ A 0.3 Notification of compliance status 0.3 1 N/ A 0.3 Report of monitoring exceedances 14.4 2 N/ A 28.4 Report of no excess emissions 57.6 2 N/ A 115.2 Startup, shutdown, malfunction report 3.6 2 N/ A 7.2 Total 152.6 6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively, and summarized below.

( i) Respondent Tally The total annual labors hours are 25,448 ( rounded). The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 2,054,373 ( rounded). The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1. Annual Respondent Burden and Cost, NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC), attached. Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 166 ( rounded) hours per response. 14 The total annual capital/ startup and O& M costs to the regulated entity are $ 8,494 ( rounded). This number is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The cost calculations are detailed in Section 6( b)( iii), Capital/ Startup vs. Operation and Maintenance ( O& M) Costs.

( ii) The Agency Tally The average annual Agency burden and cost over next three years is estimated to be 418 labor hours at a cost of $ 16,784. See Table 2: Annual Agency Burden and Cost: NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC), attached.

6( f) Reasons for Change in Burden The increase in labor burden from the most recently approved ICR ( from 25,104 to 25,448 hours) is due to an adjustment. The adjustment increase in burden from the most recently approved ICR is due to an increase in the number of new or modified sources. In addition, there was a small increase on the annualized cost associated with continuous emission monitoring for the renewal of the ICR due to the operation and maintenance costs for more existing sources.

However, the Federal/ state burden significantly decreased in this renewal of the ICR ( from $ 99,336 to $ 16,784) since we deleted all costs associated with inspection activities which are exempt under the Paperwork Reduction Act.

6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 166 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; 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 valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided 15 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 OECA 2005 0047, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET 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. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number OECA 2005 0047 and OMB Control Number 2060 0419 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 16 TABLE 1. Annual Respondent Burden and Cost: NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC)

Burden item ( A)

Personhours per occurrence ( B) Number of occurrences per respondent per year ( C)

Personhours per respondent per year ( C= AxB) ( D) Respondents per year ( E) Technical personhours per year ( E= CxD) ( F) Management person hours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Cost, $ a 1. Applications N/ A 2. Survey and Studies N/ A 3. Reporting Requirements A. Read instructions b 4 1 4 0.3 1.20 0.06 0.12 $ 111.41 B. Required activities Initial performance test b, h 125 1 125 0.3 37.50 1.88 3.75 $ 3,481.91 Repeat performance test d 125 1 125 0 0.00 0.00 0.00 $ 0.00 Annual performance test c 125 1 125 72 9,000.00 450.00 900.00 $ 835,542.00 Startup, shutdown and malfunction plan b 40 1 40 0.3 12.00 0.60 1.20 $ 1,114.06 Maintenance plan b 40 1 40 0.3 12.00 0.60 1.20 $ 1,114.06 Maintenance plan revision f 40 1 40 7.2 288.00 14.40 28.80 $ 26,737.34 C. Create information See 3B D. Gather existing information See 3B E. Write report 17 Burden item ( A)

Personhours per occurrence ( B) Number of occurrences per respondent per year ( C)

Personhours per respondent per year ( C= AxB) ( D) Respondents per year ( E) Technical personhours per year ( E= CxD) ( F) Management person hours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Cost, $ a Notification of applicability g 2 1 2 0.3 0.60 0.03 0.06 $ 55.70 Notification of construction/ reconstruction h 2 1 2 0.3 0.60 0.03 0.06 $ 55.70 Notification of actual startup g 2 1 2 0.3 0.60 0.03 0.06 $ 55.70 Notification of special compliance requirements i N/ A Notification of performance test d 2 1 2 0.3 0.60 0.03 0.06 $ 55.70 Notification of compliance status g 4 1 4 0.3 1.20 0.06 0.12 $ 111.41 NESHAP waiver application i N/ A Report of performance test d See 3B Report of monitoring exceedances j 16 2 32 14.4 460.80 23.04 46.08 $ 42,779.75 Report of no excess emissions j 8 2 16 57.6 921.60 46.00 92.16 $ 85,559.50 Startup, shutdown,

malfunction report k 8 2 16 3.6 57.60 2.88 5.76 $ 5,347.47 4. Recordkeeping Requirements 18 Burden item ( A)

Personhours per occurrence ( B) Number of occurrences per respondent per year ( C)

Personhours per respondent per year ( C= AxB) ( D) Respondents per year ( E) Technical personhours per year ( E= CxD) ( F) Management person hours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Cost, $ a A. Read instructions See 3B B. Plan activities N/ A C. Implement activities N/ A D. Develop record system N/ A E. Time to enter information Records of all information required by standards l, m 3 52 156 72.3 11,278.80 563.94 1,127.88 $ 1,047,101.20 F. Time to train personnel 4 1 4 0.3 1.20 0.06 0.12 $ 111.41 G. Time to adjust existing ways to comply with previously applicable requirements N/ A H. Time to transmit or disclose information m 0.25 3 0.75 72.3 54.23 2.71 5.42 $ 5,034.33 I. Time for audits N/ A Subtotal Burden and Cost 22,128.53 1,106.43 2,212.85 $ 2,054,372.60 TOTAL BURDEN AND COST ( Rounded) 25,448 $ 2,054,373 Assumptions: a These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 19, 2005, " Table 2. Civilian Workers, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110% to account for the benefit packages available to those employed by private industry which are technical at $ 83.71, management at $ 97.46, and clerical at $ 42.55.

b We have assumed that there are approximately 72 existing respondents, i. e., 66 of 82 existing steel pickling facilities and 8 acid regeneration plants are using hydrochloric acid, and are currently subject to the standard. We have further assumed that one additional respondent per year will become subject to the regulation in the next three years. We have further assumed that all existing sources are in compliance with the regulation since the compliance date of this 19 rule has passed.

c Estimated hours for performance test and report by EPA Method 26A.

d The new source will be required to conduct an initial performance test and we assume will not have to repeat it.

e All existing sources ( 72) are required to conduct an annual performance test to either measure the HCl mass flows at the control device inlet and outlet or the concentration of HCl exiting the control device and report the results in the semiannual reports.

f Assumes 10% of all existing sources ( or 7.2) must write a revised maintenance plan.

g The new source will be required to meet initial notifications requirements.

h Assumes one reconstructed source at one facility over the 3 yr period, for 0.3 occurrences per respondent ( 1/ 3= 0.3).

i Assumes no respondents will request a NESHAP waiver.

j Assumes 20% of respondents ( or 14.4) report excess emissions semiannually and the remaining 80 % ( or 57.04 sources) report no excess emissions over the 3 year period.

k Assumes 5% of respondents ( or 3.6) will have a startup, shutdown, or malfunction event not managed according to the plan that requires a semiannual report.

l Assumes 3 hours per respondent per week.

m Assumes an average of 3 reports per respondent per year ( e. g., notifications, performance test reports and immediate and periodic reports).

N/ A = Not Applicable. 20 TABLE 2. Annual Burden and Cost to the Federal/ State Government: NESHAP for Steel Pickling, HCl Process Facilities and Hydrochloric Acid Regeneration Plants ( 40 CFR Part 63, Subpart CCC)

Activity ( A)

EPA hours per occurrence ( B) Number of occurrences per respondent per year ( C)

EPA hours per respondent per year ( C= AxB) ( D) Respondents per year a ( E) Technical personhours per year ( E= CxD) ( F) Management person hours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Cost, $ b Report Review: New Sources c Notification of applicability 2 1 2 0.3 0.6 0.03 0.06 $ 27.97 Notification of construction or reconstruction 2 1 2 0.3 0.6 0.03 0.06 $ 27.97 Notification of actual start up 2 1 2 0.3 0.6 0.03 0.06 $ 27.97 Notification of special compliance requirements N/ A Notification of performance test 2 1 2 0.3 0.6 0.03 0.06 $ 27.97 Notification of compliance status 2 1 2 0.3 0.6 0.03 0.06 $ 27.97 Review of performance test report 4 1 4 0.3 0.6 0.03 0.06 $ 27.97 Review of repeat test report 4 1 4 0 0 0 0 $ 0.00 Report Review: Existing Sources d Review of excess emissions report e 4 2 8 14.4 115.2 5.76 11.52 $ 5,370.74 Review of no excess emissions report e 2 2 4 57.6 230.4 11.52 23.04 $ 10,741.48 Review of startup, shutdown,

malfunction report f 2 2 4 3.6 14.40 0.72 1.44 $ 671.47 Review of waiver application g 2 1 0 0 0 0 0 $ 0.00 Subtotal Burden and Cost ( Salary) 363.6 18.18 36.36 $ 16,783.69 21 Activity ( A)

EPA hours per occurrence ( B) Number of occurrences per respondent per year ( C)

EPA hours per respondent per year ( C= AxB) ( D) Respondents per year a ( E) Technical personhours per year ( E= CxD) ( F) Management person hours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Cost, $ b TOTAL BURDEN AND COST ( rounded) 418 $ 16,784 Assumptions:

a We have assumed that there are approximately 72 existing respondents, i. e., 66 of 82 existing steel pickling facilities and 8 acid regeneration plants are using hydrochloric acid, and are currently subject to the standard. We have further assumed that one additional respondent per year will become subject to the regulation in the next three years. We have further assumed that all existing sources are in compliance with the regulation since the compliance date of this rule has passed.

b This cost is based on the average hourly labor rate as follows: Managerial at $ 56.02 ( GS 13, Step 5, $ 35.01 x 1.6), Technical at $ 41.57 ( GS 12, Step 1,

$ 25.98 x 1.6), and Clerical at $ 22.50 ( GS 6, Step 3, $ 14.06 x 1.6). These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule"

which excludes locality rates of pay.

c Assumes one reconstructed source at one facility over the 3 yr period, for 0.3 occurrences per respondent ( 1/ 3= 0.3). The new source will be required to comply with initial notification requirements. We will assumed that the source will not have to repeat the initial performance test.

d All existing sources ( 72) are required to conduct an annual performance test to either measure the HCl mass flows at the control device inlet and outlet or the concentration of HCl exiting the control device and report the results in the semiannual reports.

e Assumes 20% of respondents ( or 14.4) report excess emissions semiannually and the remaining 80 % ( or 57.04 sources) report no excess emissions over the 3

year period.

f Assumes 5% of respondents ( or 3.6) will have a startup, shutdown, or malfunction event not managed according to the plan that requires a semiannual report.

g No waiver application expected.


          Approval of Arizona Air Plan Revision; San Manuel, Arizona
                Second 10-Year Maintenance Plan, 1971 SO2 NAAQS
                      Direct Final Rule and Proposed Rule
                      (Docket No. EPA-R09-OAR-2017-0377)

Docket Index Table of Contents

A. U.S. EPA Guidance Documents, Policies, and Rulemakings
B. State Plans, Rules, Support Documents, Reports, and Correspondence
C. Additional Documents for Proposed Rulemaking
D. Notices of Proposed Rulemaking and Technical Support Document
E. Public Comments and Related Documents
F. Additional Documents Considered for Final Plan Action
G. Notices of Final Rulemaking, Plan Action

A. U.S. EPA Guidance Documents, Policies, and Rulemakings

 43 FR 8962, Title 40  -  Protection of the Environment, Chapter I  -  Environmental Protection Agency, Subpart C  -  Air Programs, Part 81  -  Air Quality Control Regions, Criteria, and Control Techniques, Final rule (March 3, 1978).

 44 FR 21261, Air Quality Control Regions, Criteria, and Control Techniques; Attainment Status Designations, Final rule (April 10, 1979).

 Memorandum dated September 4, 1992, from John Calcagni, Director, Air Quality Management Division, Office of Air Quality Planning and Standards, U.S. EPA, to Air Division Directors, Regions I-X, entitled "Procedures for Processing Requests to Redesignate Areas to Attainment."

 Memorandum dated January 26, 1995, from Sally Shaver, Director, Air Quality Strategies and Standards Division, Office of Air Quality Planning and Standards, U.S. EPA, to Air Division Directors, Regions I-X, entitled "Attainment Demonstration Policy for Sulfur Dioxide Nonattainment Areas."

 64 FR 19916, Approval and Promulgation of Implementation Plans for Arizona and California; General Conformity Rules, Final rule (April 23, 1999).

 73 FR 3396, Approval and Promulgation of Air Quality Implementation Plans; Designation of Areas for Air Quality Planning Purposes; Arizona; San Manuel Sulfur Dioxide State Implementation Plan and Request for Redesignation to Attainment, Direct Final rule (January 18, 2008).

 75 FR 35520, Primary National Ambient Air Quality Standard for Sulfur Dioxide, Final rule (June 22, 2010).

 80 FR 67319, Revisions to Air Plan; Arizona; Stationary Sources; New Source Review, Final rule (November 2, 2015).

B. State Plans, Rules, Support Documents, Reports, and Correspondence

 Arizona State Implementation Plan Revision, San Manuel Sulfur Dioxide Nonattainment Area, Air Quality Division, Arizona Department of Environmental Quality, March 2007.

 San Manuel Sulfur Dioxide Maintenance Plan Renewal, 1971 Sulfur Dioxide National Ambient Air Quality Standards, Air Quality Division, Arizona Department of Environmental Quality, April 20, 2017.

 Email dated July 28, 2017, from Elias Toon, Arizona Department of Environmental Quality, Air Quality Division Planning Unit, to Ashley Graham, U.S. EPA Region 9 Air Planning Office.

C. Additional Documents for Proposed Rulemaking

 Memorandum dated August 8, 2017, from Ashley Graham, U.S. EPA Region 9 Air Planning Office, to docket EPA-R09-OAR-2017-0377, "Technical note regarding emissions inventories in Arizona's San Manuel SO2 2[nd] 10-year maintenance plan."

 Letter dated September 14, 2017, from Elizabeth Adams, U.S. EPA Region 9, Acting Director, Air Division, to Tim S. Franquist, "Completeness Finding for the San Manuel Second 10-Year Maintenance Plan for the 1971 Sulfur Dioxide National Ambient Air Quality Standards."

D. Notices of Proposed Rulemaking and Technical Support Document

D-1.  82 FR 46444, Approval of Arizona Air Plan Revision; San Manuel, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan; proposed rule (October 5, 2017).

E. Public Comments and Related Documents

E-1. Anonymous comment to EPA (October 10, 2017).

F. Notice of Final Rulemaking

F-1.  82 FR 59521, Approval of Arizona Air Plan Revision; San Manuel, Arizona; Second 10-Year Sulfur Dioxide Maintenance Plan; final rule (December 15, 2017).


[Federal Register Volume 88, Number 76 (Thursday, April 20, 2023)]
[Proposed Rules]
[Pages 24375-24377]
[FR Doc No: 2023-08283]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR 165

[USCG--USCG-2023-0229]
1625-AA00

Safety Zone; Illinois River Mile Markers 163.3 to 162.7, Peoria,
IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for all navigable waters in the Illinois River at Mile Marker (MM)
162.7 through 163.3. This action is necessary to provide for the safety
of life on these navigable waters near Peoria, IL, during a drone show
on June 10, 2023. This proposed rulemaking would prohibit persons and
vessels from being in the safety zone unless authorized by the Captain
of the Port Sector Upper Mississippi River or a designated
representative. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 30th, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0229 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email MSTC Nathaniel Dibley, Sector Upper
Mississippi River Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Peoria, IL Parks District notified the Coast Guard that it will
be conducting a drone show from 9 p.m. to 10 p.m. on June 10, 2023. The
drones are to be launched shoreside from Peoria Riverfront Park over
the Illinois River at MM 162.9. Hazards from the displays include
nonresponsive drones falling from the sky and lights associated with
the display interfering with lighted bridge or navigation aids. The
Captain of the Port Sector Upper Mississippi River (COTP) has
determined that potential hazards associated with the drones to be used
in this display would be a safety concern for anyone within a quarter
miles radius on the event.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a quarter mile of MM 162.9 before,
during, and after the scheduled event. The Coast Guard is proposing
this rulemaking under authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from MM 162.7
through 163.3 on June 10, 2023, 8:45 p.m. through June 10, 2023, 10:15
p.m. The safety zone would cover all navigable waters within a quarter
mile MM 162.9 in the Illinois River. The duration of the zone is
intended to ensure the safety of vessels and these navigable waters
before, during, and after the scheduled 9 p.m. to 10 p.m. drone
display. No vessel or person would be permitted to enter the safety
zone without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration of the drone show, and time-of-day of the safety
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting 1 hour that would prohibit entry within a quarter mile of
the drone show. Normally such actions are categorically excluded from
further review under paragraph L60(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0229 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the Dockets tab and then the
proposed rule, you should see a ``Subscribe'' option for email alerts.
The option will notify you when comments are posted, or a final rule is
published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security Measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0229 to read as follows:

Sec.  165.T08-0229  Safety Zone; Illinois River from MM 162.7 through
163.3, Peoria, IL.

    (a) Location. The following area is a safety zone: all navigable
waters within the Illinois Waterway from MM 162.7 through 163.3.
    (b) Effective period. June 10, 2023, 9 p.m. to 10:15 p.m. for the
purposes of enforcement, actual notice will be provided from June 10,
2023, 8:45 p.m.
    (c) Regulations.
    (1) In accordance with the general safety zone regulations in Sec.
165.23, entry of persons or vessels into this safety zone described in
paragraph (a) of this section is prohibited unless authorized by the
COTP or a designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG)
assigned to units under the operational control of USCG Sector Upper
Mississippi River.
    (2) To seek permission to enter, contact the COTP or a designated
representative via VHF-FM channel 16, or through USCG Sector Upper
Mississippi River at<PHONE_NUMBER>. Persons and vessels permitted to
enter the safety zone must comply with all lawful orders or directions
issued by the COTP or designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any

changes in the dates and times of enforcement, as well as reductions in
size or scope of the safety zone, through Local Notice to Mariners
(LNMs), Broadcast Notices to Mariners (BNMs), and/or Safety Marine
Information Broadcast (SMIB) as appropriate.

    Dated: April 14, 2023.
A.R. Bender,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper Mississippi
River.
[FR Doc. 2023-08283 Filed 4-19-23; 8:45 am]
BILLING CODE 9110-04-P


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 30
[EPA-HQ-OA-2018-0259; FRL-XXXX-XX]
RIN 2080-AA14
Strengthening Transparency in Regulatory Science
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes a regulation intended to strengthen the transparency of EPA regulatory science. The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation. In this notice, EPA solicits comment on this proposal and how it can best be promulgated and implemented in light of existing law and prior Federal policies that already require increasing public access to data and influential scientific information used to inform federal regulation.
DATES: Comments must be received on or before [insert date 30 days after date of publication in the Federal Register].
ADDRESSES: Submit your comments, identified by Docket ID No. EPA - HQ - OA-2018-0259, at https:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/ commenting-epa-dockets.
FOR FURTHER INFORMATION, CONTACT: Tom Sinks, Office of the Science Advisor, Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460;<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Submitting CBI. Do not submit information that you consider to be CBI electronically through https://www.regulations.gov or email. Send or deliver information identified as CBI to only the following address using U.S Postal Service: U.S. Environmental Protection Agency, EPA Docket Center, EPA - HQ - OA-2018-0259, Mail Code 28221T, 1200 Pennsylvania Avenue, NW, Washington, DC 20460. For other methods of delivery, see https://www.epa.gov/dockets/where-send-comments-epa-dockets.

      Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. If you submit a CD-ROM or disk that does not contain CBI, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

Organization of This Document. The following outline is provided to aid in locating information in this preamble.

 General Information
 Does this Action Apply to Me?
 What action is the Agency taking?
 What is the Agency's Authority for taking this action?
 Background
 Request for Comment
 Statutory and Executive Orders

 General Information
       A.  Does this action apply to me?
 This proposed regulation does not directly regulate any entity outside the federal government. However, any entity interested in EPA's regulations may be interested in this proposal. This proposal may be of particular interest to entities that conduct research and other scientific activity that is likely to be relevant to EPA's regulatory activity.
      B.  What action is the agency taking?
This notice solicits information and comment from the public on a proposed regulation intended to strengthen the transparency of EPA regulatory science. The proposed regulation provides that, for the science pivotal to its significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available in a manner sufficient for validation and analysis. In this notice, EPA solicits comment on this proposal and how it can best be implemented in light of existing law and prior statements of policy that have called for increasing public access to data and influential scientific information used to inform federal regulation. EPA has not previously implemented these policies and guidance in a robust and consistent manner. This proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.

       C.  What is the agency's authority for taking this action?
The Agency proposes to take this action under authority of  the statutes it administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions, including Clean Air Act sections 103, 301(a), 42 U.S.C. 7403, 7601(a); Clean Water Act sections 104, 501, 33 U.S.C. 1254, 1361; Safe Drinking Water Act sections 1442, 1450(a)(1), 42 U.S.C. 300j-1, 300j-9(a)(1); Resource Conservation and Recovery Act sections 2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; Comprehensive Environmental Response, Compensation, and Liability Act (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660; Emergency Planning and Community Right-To-Know Act section 328, 42 U.S.C. 11048; Federal Insecticide, Fungicide, and Rodenticide Act sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w; and Toxic Substances Control Act, as amended, section 10, 15 U.S.C. 2609. This action is also consistent with requirements in the Administrative Procedure Act to ensure public participation in the rulemaking process.  As noted in Section III below, EPA solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation.

 Background
The best available science must serve as the foundation of EPA's regulatory actions. Enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA's regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions. By better informing the public, the Agency in enhancing the public's ability to understand and meaningfully participate in the regulatory process. In applying the best available science to its regulatory decision-making, EPA must comply with federal transparency and data integrity laws, and must also ensure=that its decision-making is marked by independence, objectivity, transparency, clarity, and reproducibility. Although these standards are important in all scientific endeavors, they are of paramount importance when the government relies on science to inform its significant regulatory decisions that will affect the public. When EPA develops significant regulations using public resources, including regulations for which the public is likely to bear the cost of compliance, EPA should ensure that the data and models underlying scientific studies that are pivotal to the regulatory action are available to the public. This proposed rule is designed to increase transparency in the preparation, identification, and use of science in policymaking.
This proposed rule is consistent with the principles underlying the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.  This proposed rule is also consistent with Executive Orders 13777 and 13783, and the focus on transparency in OMB's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies (the Guidelines) and OMB Memorandum 13-13: Open Data Policy  -  Managing Information as an Asset. It builds upon prior EPA actions in response to government-wide data access and sharing policies, as well as the experience of other federal agencies in this space. In particular, this proposal applies concepts and lessons learned from its ongoing implementation of the 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research to significant regulatory decisions. The proposed rule takes into consideration the policies or recommendations of third party organizations who advocated for open science. These policies are informed by the policies recently adopted by some major scientific journals, spurred in some part by the "replication crisis."
Today, EPA is proposing to establish a clear policy for the transparency of the scientific information used for significant regulations: specifically, the dose response data and models that underlie what we are calling "pivotal regulatory science." "Pivotal regulatory science" is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated.  In other words, they are critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks and other impacts on which a final regulation is based.
With this notice, EPA is soliciting public comment on a proposed regulation designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests. The proposal takes comment on how to ensure that, over time, more of the data and models underlying the science that informs regulatory decisions (over and above the dose response data and models underlying "pivotal regulatory science") is available to the public for validation in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification. As such this proposed regulation is designed to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis.
Regulatory determinations based on science should describe and document any assumptions and methods used, and should address variability and uncertainty. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments. EPA's regulatory science should be consistent with the Office of Management and Budget's Final Information Quality Bulletin for Peer Review. Robust peer review plays a critical role in independently validating key findings and ensuring that the quality of published information meets the standards of the scientific and technical community.

In addition, this proposed regulation is designed to increase transparency of the assumptions underlying dose response models. As a case in point, there is growing empirical evidence of non-linearity in the concentration-response function for specific pollutants and health effects. The use of default models, without consideration of alternatives or model uncertainty, can obscure the scientific justification for EPA actions.  To be even more transparent about these complex relationships, EPA should give appropriate consideration to high quality studies that explore: a broad class of parametric concentration-response models with a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the exposure range; and spatial heterogeneity. EPA should also incorporate the concept of model uncertainty when needed as a default to optimize low dose risk estimation based on major competing models, including linear, threshold, and U-shaped, J-shaped, and bell-shaped models.

Across EPA programs, much of the science that informs regulatory actions is developed outside the Agency. It is the charge of regulators to ensure that key findings are valid and credible, as required by OMB's Guidelines (which apply to "third party" information - e.g., non-government scientific research  -  if the agency use of that information provides the appearance of representing agency views). Using scientific information that can be independently validated will lead to better outcomes, and strengthen public confidence in the health and environmental protections underpinning EPA's regulatory actions.
EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government. Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines. The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that "Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach." More recently, both the National Academies and the Bipartisan Commission on Evidence Based Policy have discussed the challenges and opportunities for facilitating to secure access to confidential data for non-government analysts.
Considering the breadth of dose response data and models used in the development of significant EPA regulations, the requirements for availability may differ. These mechanisms may range from deposition in public data repositories, consistent with requirements for many scientific journals, to, for certain types of information, controlled access in federal research data centers that facilitate secondary research use by the public. EPA should collaborate with other federal agencies to identify strategies to protect confidential and private information in any circumstance in which it is making information publicly available. These strategies should be cost-effective and may also include: requiring applications for access; restricting access to data for the purposes of replication, validation, and sensitivity evaluation; establishing physical controls on data storage; online training for researchers; and nondisclosure agreements.
Implementation of this proposed rule will be consistent with the definition of "research data" in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in P.L. 89-487, and other applicable federal laws.
This proposed regulation is intended to apply prospectively to final regulations that are determined to be "significant regulatory actions" pursuant to E.O. 12866. The Agency's offices should be guided by this policy to the maximum extent practicable during ongoing regulatory action, even where such research has already been generated, solicited, or obtained.

 Request for Comment
EPA solicits comment on all aspects of the proposed regulation and the bases articulated for it above. Specifically, EPA believes that it has identified appropriate sources of statutory authority for this proposed regulation in Section I(c) above, and solicits public comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. EPA further believes that a generally applicable regulatory provision of the type proposed here is the appropriate vehicle to establish and implement the policies articulated in Section II above, in the interests of consistency, predictability, and transparency across the functions that EPA performs.
EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II above.
EPA solicits comment on the effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted or if other requirements would affect implementation. EPA also seeks comments on which criteria the Agency should use to base any exceptions, including whether case-by-case exceptions may be appropriate.
Although the proposed regulatory text would impose requirements specifically on final regulations determined to be "significant regulatory actions" under E.O. 12866, EPA solicits comment on whether and to what extent these requirements, or other provisions and policies, should apply to other stages of the rulemaking process, including proposed rules, as well as to other types of agency actions and promulgations, such as guidance. EPA also solicits comment on whether a narrower scope of coverage would be appropriate, such as only final regulations that are determined to be "major" under the Congressional Review Act, or "economically significant" under EO 12866.  EPA also requests comment on whether certain categories of regulations should be excluded from coverage, such as those that merely reaffirm an existing standard, or some other category. For instance, we request comment on whether the provisions of the proposed rule should apply to individual party adjudications, enforcement activities, or permit proceedings when EPA determines that these provisions are practical and appropriate and that the actions are scientifically or technically novel or likely to have precedent-setting influence on future actions. EPA seeks comment on whether the Agency should apply the provisions of the proposed rule to these actions or to specific types of actions within these categories. The Agency also seeks comment on whether other agency actions, beyond significant final regulatory actions under EO 12866, should be included, such as site-specific permitting actions or non-binding regulatory determinations.
EPA solicits comment on the definitions of "pivotal regulatory science," and "dose response data and models" and how to implement such definitions.
EPA also solicits comment on how to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants. EPA solicits comments on how it can build upon other federal agencies' policies regarding grantee and cooperator requirements for data access and data sharing. EPA also solicits suggestions for a platform that would enable the Agency to implement the provisions of this proposal related to increasing public access to EPA-funded data. EPA also seeks comment on methodologies and technologies designed to provide protected access to identifiable and sensitive data, such as individual health data, and on commenters experience with the use of such methodologies and technologies and their strengths and limitations. Similarly, EPA seeks comment on how to balance appropriate protection for copyrighted or confidential business information, including where protected by law, with requirements for increased transparency of pivotal regulatory science. EPA also requests comment on whether there are other compelling interests besides privacy, confidentiality, national and homeland security that may require special consideration when data is being released.
EPA solicits comment on implementation of the proposed regulation, including which parts of the Agency should be responsible for carrying out these requirements. EPA seeks comment on the effective date of a rule as well as on whether the Agency should seek to phase-in the requirements for certain significant regulatory actions or seek to prioritize specific actions. For regulatory programs, like the National Ambient Air Quality Standards program, in which future significant regulatory actions may be based on the administrative record from previous reviews - particularly where the governing statute requires repeated review on a fixed, date-certain cycle -EPA seeks comment on the manner in which this proposed rule should apply to that previous record. EPA also solicits comments on whether and how the proposed rule should apply to dose response data and models underlying pivotal regulatory science if those data and models were developed prior to the effective date. In addition, EPA seeks comment on how the prospective or retrospective application of the provisions for dose response data and models or pivotal regulatory science could inadvertently introduce bias regarding the timeliness and quality of the scientific information available. EPA seeks comment on how to address a circumstance in which EPA has a statutory requirement to make a determination for which scientific information publicly available in a manner sufficient for independent validation does not exist. EPA also seeks comment on any additional implementation challenges not discussed in this notice that commenters may be aware of as well as suggestions for addressing them.
The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB's Information Quality Bulletin for Peer Review provides for an exemption (Section IX).  The agency requests comment on whether these exemptions are appropriate, and on whether there are other situations in which specific significant regulatory actions, or specific categories of significant regulatory actions should be exempted.

EPA also requests comment on whether the disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as for example economic and environmental impact data and models that are designed to predict the costs, benefits, market impacts and/or environmental effects of specific regulatory interventions on complex economic or environmental systems.
 Statutory and Executive Orders Reviews
A.	Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
EPA believes the benefits of this proposed rule justify the costs. The benefits of EPA  ensuring that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation are that it will improve the data and scientific quality of the Agency's actions and facilitate expanded data sharing and exploration of key data sets; this is consistent with the conclusions of the National Academies This action should be implemented in a cost-effective way and is consistent with recent activities of the scientific community and other federal agencies, which will help to lower costs of implementation. The proposed rule directs EPA to make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making dose response models and data underlying pivotal regulatory science used in significant regulatory decisions available to the public in a manner sufficient for independent validation, consistent with law and protection of privacy, confidentiality, and national and homeland security. However, it does not compel the Agency to make that information available where it concludes after all such reasonable efforts that doing so in way that complies with the law and appropriate protections is not possible.

By limiting the proposed rule to pivotal regulatory science for final significant regulatory actions pursuant to EO 12866, the proposed rule ensures that this standard for transparency affects a smaller subset of regulations which are economically significant, create inconsistency for other federal agencies, alter budgetary impacts, or raise novel legal or policy issues. One recent analysis found that: "Improvements in reproducibility can be thought of as increasing the net benefits of regulation because they would avoid situations in which costs or benefits are wrongly estimated to occur or in which regulatory costs are imposed without corresponding benefits. ..." They concluded that "an increase in existing net benefits from greater reproducibility, which, if it occurred, would cover the costs of obtaining the data and making the data available."
B.	Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs
This action is not expected to be an Executive Order 13771 regulatory action because it relates to "agency organization, management or personnel."
C. Paperwork Reduction Act (PRA)
This action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531 - 1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
G.	Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
This action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
H.	Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of "covered regulatory action" in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
This action is not a "significant energy action" because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards.
K.	Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard.

 List of Subjects in 40 CFR Part 30
 Environmental protection, Administrative practice and procedure, Reporting and recordkeeping requirements

Dated: __________________________________.

________________________________________
E. Scott Pruitt,
Administrator

For the reasons set forth in the preamble, EPA proposes to add 40 CFR part 30 as follows:
PART 30 -- Transparency in Regulatory Decisionmaking
1. Add part 30 to read as follows:

PART 30 -- Transparency in Regulatory Decisionmaking

Sec.

30.1	            What is the purpose of this subpart?
30.2	            What definitions apply to this subpart?
30.3	            How do the provisions of this subpart apply?
30.4	            What requirements apply to EPA's use of studies in taking final action?
30.5	What requirements apply to EPA's use of dose response data and models underlying pivotal regulatory science?
30.6	What additional requirements pertain to the use of dose response data and models underlying pivotal regulatory science?
30.7	           What role does independent peer review play in this section?
30.8	           How is EPA to account for cost under this subpart?
30.9	           May the EPA Administrator grant exemptions to this subpart?
30.10	           What other requirements apply under this subpart?

Authority: Clean Air Act §§ 103, 301(a), 42 U.S.C. §§ 7403, 7601(a); Clean Water Act §§ 104, 501, 33 U.S.C. §§ 1254, 1361; Safe Drinking Water Act §§ 1442, 1450(a)(1), 42 U.S.C. §§ 300j-1, 300j-9(a)(1); Resource Conservation and Recovery Act §§ 2002(a)(1), 7009, 42 U.S.C. §§ 6912(a)(1), 6979; Comprehensive Environmental Response, Compensation, and Liability Act (as delegated to the Administrator via Executive Order 12580) §§ 115, 311, 42 U.S.C. §§ 9616, 9660; Emergency Planning and Community Right-To-Know Act § 328, 42 U.S.C. § 11048; Federal Insecticide, Fungicide, and Rodenticide Act §§ 25(a)(1), 136r(a), 7 U.S.C. §§ 136r(a), 136w; and Toxic Substances Control Act, as amended, § 10, 15 U.S.C. § 2609.

§30.1	What is the purpose of this subpart?

      This subpart directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.

§30.2	What definitions apply to this subpart?

	As used in this subpart, all terms not defined herein shall have the meaning given them in the Act or in subpart A; and the following terms shall have the specific meanings given them.

      Dose response data and models means the data and models used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and the magnitude of a predicted health or environmental impact. Such functions typically underlie pivotal regulatory science that drives the size of benefit-cost calculations, the level of a standard, and/or the points of departure from which reference values (reference doses or reference concentrations) are calculated.

      Pivotal regulatory science means the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions.

      Regulatory decisions mean final regulations determined to be "significant regulatory actions" by the Office of Management and Budget pursuant to Executive Order 12866.

      Regulatory science means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions.

	Research data means "research data" as that term is defined in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

§30.3	How do the provisions of this subpart apply?

	The provisions of this subpart apply to dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions regardless of the source of funding or identity of the party conducting the regulatory science. The provisions of this section do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses. Except where explicitly stated otherwise, the provisions of this subpart do not apply to any other type of agency action, including individual party adjudications, enforcement activities, or permit proceedings.

§30.4	What requirements apply to EPA's use of studies in taking final action?

	EPA shall clearly identify all studies (or other regulatory science) relied upon when it takes any final agency action. EPA should make all such studies available to the public to the extent practicable.

§30.5 What requirements apply to EPA's use of dose response data and models underlying          pivotal regulatory science?

When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation. Where the Agency is making data or models publicly available, it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security.  Information is considered "publicly available in a manner sufficient for independent validation" when it includes the information necessary for the public to understand, assess, and replicate findings. This may include, for example:

 Data (where necessary, data would be made available subject to access and use restrictions).
 Associated protocols necessary to understand, assess, and extend conclusions;
 Computer codes and models involved in the creation and analysis of such information;
 Recorded factual materials; and
 Detailed descriptions of how to access and use such information.

The provisions of this section apply to dose response data and models underlying pivotal regulatory science regardless of who funded or conducted the underlying data, models, or other regulatory science. The agency shall make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national and homeland security is not possible.  Where data is controlled by third parties, EPA shall work with those parties to endeavor to make the data available in a manner that complies with this section.

§30.6 	What additional requirements pertain to the use of dose response data and models underlying pivotal regulatory science?

      EPA shall describe and document any assumptions and methods used, and should describe variability and uncertainty. EPA shall evaluate the appropriateness of using default assumptions, including assumptions of a linear, no-threshold dose response, on a case-by-case basis. EPA shall clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions. When available, EPA shall give explicit consideration to high quality studies that explore: a broad class of parametric dose-response or concentration-response models; a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the dose or exposure range; and models that investigate factors that might account for spatial heterogeneity.

§30.7 What role does independent peer review in this section?

	EPA shall conduct independent peer review on all pivotal regulatory science used to  justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.

      Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results.

§30.8 How is EPA to account for cost under this subpart?

	EPA shall implement the provisions of this subpart in a manner that minimizes costs.

§30.9 May the EPA Administrator grant exemptions to this subpart?

	Yes. The Administrator may grant an exemption to this subpart on a case-by-case basis if he or she determines that compliance is impracticable because:

 It is not feasible to ensure that all dose response data and models underlying          pivotal regulatory science is publicly available in a manner sufficient for independent validation, in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security; or
 It is not feasible to conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions for reasons outlined in OMB Final Information Quality Bulletin for Peer Review (70 FR 2664), Section IX.

§30.10 What other requirements apply under this subpart?

	EPA shall implement the provisions of this section consistent with the definition of "research data" in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in P.L. 89-487, and other applicable federal laws. Where appropriate, data sharing agreements and state-of-the-art data-masking techniques may be employed to facilitate access to information.