SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL)

1. Identification of the Information Collection 1( a) Title of the Information Collection NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL)

1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) for the regulations published at 40 CFR Part 63, Subpart LLL were proposed on March 24, 1998, and promulgated on June 14, 1999. These regulations apply to the following facilities: each new, existing or reconstructed kiln, in line kiln/ raw mill and greenfield raw material dryer at these facilities, except for kilns and in line kiln/ raw mills that burn hazardous waste and are subject to 40 CFR 63, Subpart EEE. In addition, the rule applies to each new, existing or reconstructed clinker cooler; raw mill; finish mill; raw material, clinker or finished product storage bin; conveying system transfer point; bagging system and bulk loading and unloading system at facilities which are major sources; and to each existing, reconstructed or new brownfield raw material dryer at facilities which are major sources. This information is being collected to assure compliance with 40 CFR Part 63, Subpart LLL.

In general, all NESHAP standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NESHAP.

Any owner or 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.

Approximately 107 sources are currently subject to the regulation, and it is estimated that no additional sources will become subject to the regulation over the next three years. 2 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 or 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, hazardous air pollutant ( HAP) emissions from portland cement manufacturing facilities cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, NESHAP were promulgated for this source category at 40 CFR Part 63, Subpart LLL.

2( b) Practical Utility/ Users of the Data The control of emissions of HAPs from portland cement manufacturing facilities requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of HAPs from portland cement manufacturing facilities are the result of operation of the affected facilities. The subject standards are achieved by the capture of particulate HAP emissions using fabric filters or electrostatic precipitators control, temperature control for the reduction of dioxins and furans ( D/ F), and feed selection for reduction of other organic HAP. The notifications required in the applicable regulations 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 and/ or leaks are being detected and repaired and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance 3 determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP continue to operate the control equipment and achieve compliance with the regulation. Adequate monitoring, recordkeeping, and reporting is necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The recordkeeping and reporting requested is required under 40 CFR Part 63, Subpart LLL.

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 their 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 on October 29, 2001. No comments were received on the burden published in the Federal Register.

3( c) Consultations No comments were received on the burden published in the Federal Register.

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. 4 3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.5.

3( f) Confidentiality The required information consists of emissions data and other information that have been determined not to be private. However, 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 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 portland cement manufacturing facilities. The SIC code for the respondents affected by the standards is SIC ( United States Standard Industrial Classification) 3241 which corresponds to the NAICS ( The North American Industry Classification System) 32731 for portland cement manufacturing facilities.

4( b) Information Requested ( i) Data Items All data in this ICR that is recorded and/ or reported is required by NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL). 5 A source must make the following reports:

Reports for 40 CFR Part 63, Subpart LLL Notification of applicability 63.9( b)( 1& 2)

Notification of actual startup 63.9( b)( 4)

Notification of construction/ reconstruction 63.9( b)( 5)

Request for extension of compliance 63.9( c)

Notification of special compliance requirements 63.9( d)

Notification of initial performance test 63.9( e), 63.7( b)

Notification of opacity and visible emission observations 63.9( f)

Notification of the continuous emission monitoring performance evaluation 63.9( g)

Notification of compliance status 63.9( h)

Adjustments to time periods or postmark deadlines for submittal and review of required communications 63.9( i)

Change in information already provided 63.9( j)

Operations and maintenance plan 63.1350( a)

Report of performance test 63.10( d)( 2)

Opacity and visual emission observation 63.10( d)( 3)

Progress reports 63.10( d)( 4)

Periodic startup, shutdown, malfunction reports 63.10( d)( 5)( i)

Immediate startup, shutdown, malfunction reports 63.10( d)( 5)( ii)

Reporting results of continuous monitoring system performance evaluations 63.10( e)( 2)

Excess emissions and continuous monitoring system performance report and summary report 63.10( e)( 3)

Reporting continuous opacity monitoring system data produced during a performance test 63.10( e)( 4)

Waiver of recordkeeping and reporting requirements 63.10( f) 6 A source must maintain the following records:

Recordkeeping for 40 CFR Part 63, Subpart LLL All reports and notifications 63.10( b)

Startups, shutdowns, malfunctions, periods where the continuous monitoring system is inoperative 63.10( b)( 2)

Record of applicability 63.10( b)( 3)

Records for sources with continuous monitoring systems 63.10( c)

Records are required to be retained for five ( 5) Years. The first two ( 2) years of records must be retained at the facility 63.1355( a), 63.10( b)( 1)

( ii) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate CMS for: 1) opacity; 2) to record the temperature of the exhaust gases to monitor D/ F; 3) to record the rate of carbon injection and the carrier gas parameter, if using activated carbon injection to control D/ F; and 4) to measure Total Hydrocarbons ( THC), if applicable.

Perform initial performance test, Reference Method 5 test for Particulates, Method 9 test for Opacity, Method 23 test for dioxin/ furans ( D/ F), and Performance Specification 8A of Appendix B to Part 60 for THC, if applicable. Repeat performance tests, if necessary.

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. 7 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 AIRS ( Aerometric Information Retrieval System) Facility Subsystem ( AFS) database.

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 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 AIRS ( Aerometric Information Retrieval System Facility Subsystem ( AFS) database which is operated and maintained by EPA's Office of Enforcement and Compliance Assurance. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for over 100,000 industrial and government owned facilities. EPA uses 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.

These standards require affected facilities 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 with 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 8 violators due to the destruction or nonexistence of records if records were retained for less than five years.

5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses). However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 2: Annual Burden of Reporting and Recordkeeping Requirements, NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL).

6. Estimating the Burden and Cost of the Collection Table 2 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.

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 53,181 [ Total Labor Hours from Table 2: Annual Burden of Reporting and Recordkeeping Requirements, NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL)]. 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 9 ( i) Estimating Labor Costs This ICR uses the following labor rates: $ 85.81 per hour for Executive, Administrative, and Managerial labor; $ 57.12 per hour for Technical labor, and $ 36.27 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 2001, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The wage rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

Managerial $ 85.81 ($ 40.86 + 110%) Technical $ 57.12 ($ 27.20 + 110%) Clerical $ 36.27 ($ 17.27 + 110%)

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The type of industry costs associated with the information collection activity in the regulations are for labor and continuous emission monitoring ( CEM). 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 monitor 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) Startup Cost ($) for One Affected Facility ( C) Number of New Affected Facilities to Startup ( D) Total Startup ( B X C) ( E) Annual O& M Costs ($) for One Affected Facility ( F) Number of Affected Facilities with O& M ( G) Total O& M ( E X F)

Continuous Emission Monitors $ 190,000 0 0 $ 6,400 107 $ 684,800 There are no capital/ startup costs for this ICR due to the fact that no new facilities are expected to startup over the next three years. This is the total of column D in the above table. These costs are shown in block 14( a), Total annualized capital/ startup costs, on the OMB 83 I form. It should be noted that the numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

The total operation and maintenance ( O& M) costs for this ICR are $ 684,800. These costs are associated with continuous opacity monitors for 50 kilns and 74 clinker coolers located at 10 major sources not subject to the NSPS; data acquisition systems for 48 facilities; temperature monitoring and recording systems for 48 facilities; temperature monitoring and recording systems on 170 kiln air pollution control devices; THC CEMS on 2 new kilns and one new raw material dryer; and particulate matter ( PM) CEMS on 129 kilns. The annual O& M cost for one facility is can be found in column E. The total O& M cost can be found in column G. These costs are shown in block 14( b), Total annual costs ( O& M), on the OMB 83 I form.

The total respondent non labor 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 $ 684,800 . 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.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. Publication and distribution of the information are part of the AFS program. Examination of records to be maintained by the respondents will occur as part of the periodic inspection of sources, which is part of EPA's overall compliance and enforcement program.

The average annual Agency cost during the three years of the ICR is estimated to be $ 185,557 ( See attached Table 1: Average Annual EPA Resource Requirement, NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL)). This cost is based on the following average hourly labor rates:

Managerial $ 51.62 ( GS 13, Step 5, $ 32.26 x 1.6) Technical $ 38.30 ( GS 12, Step 1, $ 23.94 x 1.6) Clerical $ 20.72 ( GS 6, Step 3, $ 12.95 x 1.6)]

These rates are from the Office of Planning and Management ( OPM) " 2002 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 1: Average Annual EPA Resource Requirement, NESHAP for the Portland Cement Industry ( 40 CFR Part 63, Subpart LLL).

6( d) Estimating the Respondent Universe and Total Burden and Costs 11 Respondent Universe and Number of Responses Per Year Regulation Citation ( A) Average Number of New Respondents per Year ( B) Number of Reports for New Sources ( C) Number of Existing Respondents ( D) Number of Reports for Existing Sources ( F) Number of Respondents that keep records but do not submit reports ( E) Total Annual Responses = ( AxB)+( CxD)+ F 40 CFR Part 63, Subpart LLL 0 0 107 2 0 214 The number of total respondents is 107. This number is the sum of column A and column C of the Respondent Universe and Number of Responses Per Year table. This represents the number of existing sources plus the number of new sources averaged over the three year period. It is shown in block 13 ( a), Number of respondents, on the OMB 83 I form.

The number of Total Annual Responses is 214. This is the number in column E of the Respondent Universe and Number of Responses Per Year table. It is shown in block 13 ( b), Total annual responses, on the OMB 83 I form.

The total annual labor costs are $ 3,007,594. This number is not shown on the OMB 83 I form in block 13( c), Total hours requested. Only the burden hours are reflected in block 13( c). Details upon which this estimate is based appear in Table 2. Annual Respondent Burden and Cost, NESHAP for the Portland Cement Manufacturing Industry ( 40 CFR Part 63, Subpart LLL).

The total annual capital and O& M costs to the regulated entity are $ 684,800. This number is shown on the OMB 83 I form in block 14 ( c), Total annualized cost requested. These costs are detailed in section 6( b)( iii), Capital/ Startup vs. Operating and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours Burden Hours And Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents are attached.

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to an adjustment. During the previous ICR, all existing facilities were conducting performance testing to come into compliance with the standard. As a result, the majority of the burden hours from the previous ICR were associated with initial notifications and performance testing and reporting. Since the compliance date has recently past, it is assumed that all existing facilities have completed compliance testing during the previous ICR period. Therefore, all of the burden hours associated with this ICR are related to reporting requirements for facilities that have already demonstrated compliance. No new facilities are expected to startup over the next three years. 12 6( g) Burden Statement Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. The OMB Control Numbers for EPA's standards are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to Ms. Susan Auby, Collection Strategies Division ( Mail Code 2822T), Office of Environmental Information, United States Environmental Protection Agency, 1200 Pennsylvania Avenue, N. W., Washington, D. C. 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N. W., Washington, D. C. 20503, Attention: Desk Officer for EPA. Include the EPA ICR Number and OMB Control Number in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information.


[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Notices]
[Pages 25631-25632]
[FR Doc No: 2017-11422]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2017-0008]

California State Plan; New Operational Status Agreement

AGENCY: Occupational Safety and Health Administration, Department of
Labor.

ACTION: Notice.

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SUMMARY: This document announces a new Operational Status Agreement
between the Occupational Safety and Health Administration (OSHA) and
the California State Plan, which specifies the respective areas of
federal and state authority, and which clarifies California's coverage
over maritime employment and OSHA's coverage over private employers on
military installations and federal parks, and under which OSHA gains
coverage over private and tribal employers on U.S. Government-
recognized Native American reservations and trust lands.

DATES: Effective June 2, 2017.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Francis Meilinger, OSHA Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    For general and technical information: Douglas J. Kalinowski,
Director, OSHA Directorate of Cooperative and State Programs, Room N-
3700, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The California State Plan (Cal/OSHA)
administers an OSHA-approved State Plan to develop and enforce
occupational safety and health standards for private-sector and state
and local government employers pursuant to the provisions of section 18
of the Occupational Safety and Health

Act (the Act), 29 U.S.C. 667. The California State Plan received
initial federal OSHA plan approval on May 1, 1973 (38 FR 10719) and the
Division of Occupational Safety and Health of the California Department
of Industrial Relations is designated as the state agency responsible
for administering the State Plan. On October 3, 1989, an Operational
Status Agreement was entered into between OSHA and Cal/OSHA whereby
concurrent federal enforcement authority was suspended with regard to
federal occupational safety and health standards in issues covered by
the State Plan. Federal OSHA retained its authority over occupational
safety and health with regard to federal government employers and
employees, and employees of the U.S. Postal Service (effective June 9,
2000). OSHA also retained its authority over private-sector maritime
employment on the navigable waters of the United States; private-sector
contractors on federal installations; whistleblower complaints under
Section 11(c) of the Act; emergency temporary standards; and employers
manufacturing explosives for the U.S. Department of Defense. Notice of
this OSA was published in the Federal Register on July 12, 1990 (55 FR
28613), and there were subsequent minor amendments to the OSA. That
1990 Federal Register Notice contained a full history of the California
State Plan.

Notice of New Operational Status Agreement

    OSHA and Cal/OSHA signed a new OSA on April 30, 2014, which
replaced the prior 1989 OSA. This new OSA clarified that concurrent
federal enforcement authority would not be initiated with regard to any
federal occupational safety and health standards in issues covered by
the State Plan. Under the 2014 OSA, Federal OSHA retained coverage over
all Federal employees and sites (including the United States Postal
Service (USPS), USPS contract employees, and contractor-operated
facilities engaged in USPS mail operations). The OSA also clarified
that federal OSHA has enforcement authority over private-sector
employers within the borders of all military installations and within
U.S. National Parks, National Monuments, National Memorials, and
National Recreational Areas in California. Further, OSHA gained
enforcement authority over private-sector and tribal employers within
U.S. Government-recognized Native American reservations and trust
lands. Under the 2014 OSA, Federal OSHA retained authority over
maritime employment (except marine construction on bridges and on
shore) on the navigable waters of the United States and over
whistleblower complaints under Section 11(c) of the Act. The 2014 OSA
also did not contain the language from the 1989 OSA about specific
elements of the Cal/OSHA program that had achieved operational status.
    Federal OSHA and Cal/OSHA will exercise their respective
enforcement authority according to the terms of the 2014 OSA between
OSHA and Cal/OSHA. All terms of the 2014 OSA remain in effect.
Additional information about this OSA is available at https://www.osha.gov/dcsp/osp/stateprogs/california.html.

Authority and Signature

    Dorothy Dougherty, Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor, authorized the preparation
of this notice. OSHA is issuing this notice under the authority
specified by section 18 of the Occupational Safety and Health Act of
1970 (29 U.S.C. 667), Secretary of Labor's Order No. 1-2012 (76 FR
3912), and 29 CFR part 1902 and 1953

    Signed in Washington, DC, on May 25, 2017.
Dorothy Dougherty,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-11422 Filed 6-1-17; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: November 20, 2007 (Volume 72, Number 223)]
[Proposed Rules]
[Page 65283-65285]
[DOCID:fr20no07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2007-0638; FRL-8497-5]

Revisions to the California State Implementation Plan; San
Joaquin Valley Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the San Joaquin
Valley Air Pollution Control District (SJVAPCD) portion of the
California State Implementation Plan (SIP). These revisions concern
volatile organic compound (VOC) emissions from flare operations at
facilities such as oil and chemical refineries. We are proposing to
approve a local rule regulating these emission sources under the Clean
Air Act as amended in 1990 (CAA or the Act). We are taking comments on
this proposal and plan to follow with a final action.

DATES: Any comments must arrive by December 20, 2007.

ADDRESSES: Submit comments, identified by docket number [DOCKET
NUMBER], by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-

line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business

hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Jerald S. Wamsley, EPA Region IX, at
either<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``We'', ``Us'',
and ``Our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rule did the State submit?
    B. Are there other versions of this rule?
    C. What is the purpose of the submitted rule revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rule?
    B. Does the rule meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rule
    D. Public Comment and Final Action

I. The State's Submittal

A. What rule did the State submit?

    Table 1 lists the rule addressed by this proposal with the date it
was adopted by the local air agency and submitted by the California Air
Resources Board (CARB).

                                            Table 1.--Submitted Rules
----------------------------------------------------------------------------------------------------------------
            Local agency                  Rule No.            Rule title            Adopted         Submitted
----------------------------------------------------------------------------------------------------------------
SJVAPCD.............................            4311   Flares.................        06/15/06         12/29/06
----------------------------------------------------------------------------------------------------------------

    On February 13, 2007, EPA found Rule 4311 met the completeness
criteria in 40 CFR Part 51, Appendix V. SJVAPCD must meet these
criteria before formal EPA review.

B. Are there other versions of this rule?

    On February 26, 2003, EPA approved a version of Rule 4311 and
incorporated it within the SIP; please see 68 FR 8835. California has
not made any intervening submittals of the rule.

C. What is the purpose of the submitted rule revisions?

    VOCs and oxides of nitrogen (NOX) help produce ground-
level ozone and smog, which harm human health and the environment.
Section 110(a) of the CAA requires states to submit regulations that
control VOC and NOX emissions.
    SJVAPCD Rule 4311 is designed to decrease VOC and NOX
emissions from industries such as refineries, unrecoverable gases from
oil wells, vented gases from blast furnaces, unused gases from coke
ovens, and gaseous wastes from chemical industries by requiring that
flares be operated in a prescribed manner. The June 15, 2006 revisions
to the rule set the applicability threshold for the rule at ten tons
per year potential to emit VOC or NOX and provide a
compliance schedule for facilities subject to the rule.
    EPA's technical support document (TSD) has more information about
the Rule 4311.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rule?

    Generally, SIP rules must be enforceable (see section 110(a) of the
Act), must require Reasonably Available Control Technology (RACT) for
each category of sources covered by a Control Techniques Guidelines
(CTG) document as well as each major source in nonattainment areas (see
section 182(a)(2)), and must not relax existing requirements (see
sections 110(l) and 193). The SJVAPCD regulates an ozone nonattainment
area (see 40 CFR part 81), so Rule 4311 must fulfill RACT.
    Guidance and policy documents that we used to help evaluate
enforceability and RACT requirements consistently include the
following:
    1. Portions of the proposed post-1987 ozone and carbon monoxide
policy that concern RACT, 52 FR 45044, November 24, 1987.
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' USEPA, May 25, 1988 (the Bluebook).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' USEPA Region 9, August 21, 2001 (the Little Bluebook).

B. Does the rule meet the evaluation criteria?

    We believe Rule 4311 is consistent with the relevant policy and
guidance regarding enforceability, RACT, and SIP relaxations. The TSD
has more information on our evaluation.

C. EPA Recommendations To Further Improve the Rule

    The TSD describes additional rule revisions that do not affect
EPA's current action but are recommended for the next time the local
agency modifies the rules. We recommend that SJVAPCD reconsider the
utility of incorporating provisions such as those in South Coast Air
Quality Management District Rule 1118 and Bay Area Air Quality
Management District Rule 12-12 within Rule 4311 to aid their enforcing
of the rule, developing an accurate emissions inventory for these
sources, and minimizing excess emissions from flare activity to the
maximum extent practicable.

D. Public Comment and Final Action

    Because EPA believes Rule 4311 fulfills all relevant requirements,
we are proposing to fully approve it as described in section 110(k)(3)
of the Act. We will accept comments from the public on this proposal
for the next 30 days. Unless we receive convincing new information
during the comment period sufficient to cause us to reverse our
position, we intend to publish a final approval action that will
incorporate these rules into the federally enforceable SIP.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a ``significant regulatory action'' and
therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This
proposed action merely proposes to approve state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this proposed rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601, et seq.). Because this rule proposes to approve pre-
existing requirements under state law and does not impose any
additional enforceable duty beyond that required by state law, it does
not contain any unfunded mandate or significantly or uniquely affect
small governments, as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4).
    This proposed rule also does not have tribal implications because
it will 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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does 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, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely proposes to approve a
state rule implementing a Federal standard, and does not alter the
relationship or the distribution of power and responsibilities
established in the Clean Air Act. This proposed rule also is not
subject to Executive Order 13045 (Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal
standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does
not impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements, Volatile
organic compound.

    Authority: 42 U.S.C. 7401, et seq.

    Dated: November 2, 2007.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. E7-22656 Filed 11-19-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48794-48796]
[FR Doc No: 2021-18781]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0383; FMCSA-2014-0386; FMCSA-2018-0135]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for four
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions are applicable on September 12, 2021. The
exemptions expire on September 12, 2023. Comments must be received on
or before September 30, 2021.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0383, Docket No. FMCSA-
2014-0386, or Docket No. FMCSA-2018-0135 using any of the following
methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number, FMCSA-2014-0383, FMCSA-2014-0386, or FMCSA-
2018-0135 in the keyword box, and click ``Search.'' Next, sort the
results by ``Posted (Newer-Older),'' choose the first notice listed,
and click on the ``Comment''

button. Follow the online instructions for submitting comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2014-0383, Docket No. FMCSA-2014-0386, or
Docket No. FMCSA-2018-0135), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that FMCSA can contact you if there are questions regarding
your submission.
    To submit your comment online, go to www.regulations.gov/, insert
the docket number, FMCSA-2014-0383, FMCSA-2014-0386, or FMCSA-2018-0135
in the keyword box, and click ``Search.'' Next, sort the results by
``Posted (Newer-Older),'' choose the first notice listed, click the
``Comment'' button, and type your comment into the text box on the
following screen. Choose whether you are submitting your comment as an
individual or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2014-0383, FMCSA-2014-0386, or FMCSA-2018-0135 in the
keyword box, and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click ``Browse
Comments.'' If you do not have access to the internet, you may view the
docket online by visiting Dockets Operations in Room W12-140 on the
ground floor of the DOT West Building, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Dockets Operations.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its regulatory process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).
    The four individuals listed in this notice have requested renewal
of their exemptions from the hearing standard in Sec.  391.41(b)(11),
in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the
four applicants has satisfied the renewal conditions for obtaining an
exemption from the hearing requirement. The four drivers in this notice
remain in good standing with the Agency. In addition, for Commercial
Driver's License (CDL) holders, the Commercial Driver's License
Information System and the Motor Carrier Management Information System
are searched for crash and violation data. For non-CDL holders, the
Agency reviews the driving records from the State Driver's Licensing
Agency. These factors provide an adequate basis for predicting each
driver's ability to continue to safely operate a CMV in interstate
commerce. Therefore, FMCSA concludes that extending the exemption for
each of these drivers for a period of 2 years is likely to achieve a
level of safety equal to that existing without the exemption.
    As of September 12, 2021, and in accordance with 49 U.S.C. 31136(e)
and

31315(b), the following four individuals have satisfied the renewal
conditions for obtaining an exemption from the hearing requirement in
the FMCSRs for interstate CMV drivers:

Daniel Alcozer (TX)
Jason Gensler (OH)
Jay Larson (TX)
Eduwin Pineiro (NJ)

    The drivers were included in docket number FMCSA-2014-0383, FMCSA-
2014-0386, or FMCSA-2018-0135. Their exemptions are applicable as of
September 12, 2021 and will expire on September 12, 2023.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must report any crashes or accidents as defined in
Sec.  390.5; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR 383 and 49 CFR 391 to FMCSA; and
(3) each driver prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements. Each exemption will be valid for 2 years
unless rescinded earlier by FMCSA. The exemption will be rescinded if:
(1) The person fails to comply with the terms and conditions of the
exemption; (2) the exemption has resulted in a lower level of safety
than was maintained before it was granted; or (3) continuation of the
exemption would not be consistent with the goals and objectives of 49
U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the four exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the hearing
requirement in Sec.  391.41(b)(11). In accordance with 49 U.S.C.
31136(e) and 31315(b), each exemption will be valid for two years
unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-18781 Filed 8-30-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Rules and Regulations]
[Pages 50613-50617]
[FR Doc No: 2012-20663]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0950; FRL-9359-5]

Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium
Bicarbonate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues of Didecyl Dimethyl Ammonium Carbonate and
Didecyl Dimethyl Ammonium Bicarbonate, jointly referred to as DDACB on
food contact surfaces when applied or used in public eating places,
dairy processing equipment, and/or food processing equipment and
utensils. Lonza, Inc. submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment which
would provide for an increase in the final use concentration of DDACB
in products eligible for the exemption from the requirement of a
tolerance. As amended, the regulation will exempt solutions from the
requirement of tolerance residues resulting from contact with surfaces
treated with solutions where the end-use concentration of the DDACB
does not exceed 400 parts per million (ppm).

DATES: This regulation is effective August 22, 2012. Objections and
requests for hearings must be received on or before October 22, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.)

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0950, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm.
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Dairy Cattle Milk Production (NAICS code 11212).
     Food manufacturing (NAICS code 311).
     Beverage Manufacturing (NAICS code 3121).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0950 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 22, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0950, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statue.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more

information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of December 8, 2011 (76 FR 76674) (FRL-
9328-8), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0F7758) by Lonza Inc., 90 Boroline Road, Allendale NJ
07401. The petition requested that 40 CFR 180.940(a), be amended by
establishing concentration limits for DDACB in end use solutions
eligible for tolerance exemption. That notice referenced a summary of
the petition prepared by Lonza Inc., the registrant, which is available
in the docket, http://www.regulations.gov. There were no comments
received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for DDACB including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with DDACB follows.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by DDACB,
part of the Aliphatic Alkyl Quaternary group of compounds, are
discussed in this unit. In assessing the proposed toxicity, the
toxicological endpoints were extracted from the DDAC RED (EPA-HQ-2006-
0338).
    The Aliphatic Alkyl Quaternaries are corrosive and highly
irritating to the eye and skin, with moderate acute toxicity by oral,
dermal, and inhalation routes of exposure. These chemicals are
classified as ``not likely'' to be human carcinogens based on negative
carcinogenicity in rat and mouse feeding studies using doses above the
limit dose. There is no evidence of these chemicals being associated
with increased susceptibility of infants and children based on two
developmental toxicity studies and a 2-generation reproductive toxicity
study. Lastly, they are negative for mutagenicity and neurotoxicity.
Specific information on the studies received and the nature of the
toxic effects from the toxicity studies can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2005-0338 Toxicology
Disciplinary Chapter for the Reregistration Eligibility Decision (RED)
for Didecyl Dimethyl Ammonium Chloride (DDAC).
    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(NOAEL) from the toxicology study identified as appropriate for the
risk assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in variations
in sensitivity among members of the human population as well as other
unknowns.
    A detailed discussion of EPA's conclusions regarding the toxic
endpoints for the Aliphatic Alkyl Quaternaries can be found at 73 FR
37852, July 2, 2008.

IV. Aggregate Exposure

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residues in food and all other sources, including drinking
water from ground water or surface water and exposure through pesticide
use in gardens lawns or buildings (residential and other non-
occupational exposures).

A. Dietary Exposure

    1. Food. In evaluating dietary exposure to DDACB, EPA considered
exposure under the petitioned-for exemption as well as all existing
aliphatic alkyl quaternaries exemptions or tolerances in (40 CFR
180.940(a)). EPA assessed dietary exposures from DDACB in food as
follows:
    Aliphatic alkyl quaternaries are to be used as sanitizers on
appliances, beverage bottling, counter tops, food packaging,
refrigerators, tables, and utensils. The use of these actives in
antimicrobial products for use on food or feed-contact surfaces and in
agricultural premises may result in pesticide residues in human food.
Residues from treated surfaces, such as appliances, countertops,
equipment, and utensils can migrate to food coming into contact with
the treated and rinsed surfaces and can be ingested by humans.
    The Agency assessed acute and chronic dietary exposures from the
use of DACB as a disinfectant and food-contact sanitizer on utensils,
countertops, and in food/beverage processing facilities. The assessment
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI) using modified Food and Drug Administration (FDA) methodologies
for utensils and the Indirect Dietary Residential Exposure Model
(IDREAM) for countertops.
    The EDI calculations presented in this assessment for treated
indirect dietary exposures resulting from sanitizing utensils assumed
that food would contact 4,000 cm\2\ (which represents contact with
treated china, glass, and silverware used by an individual who
regularly eats three meals per day at an institutional or public
facility) and that the residual solution remaining on the surface or
pesticide migration fraction is 1 milligram/centimeter (mg/cm\2\) of
treated area. The body weights used for this assessment were 70
kilograms (kg) for an adult male, 60 kg for an adult woman, and 10 kg
for an infant. Based on data provided in a new residue study,
Transferability Equivalence

among Quats and Measured Food Surrogate Transfer Efficiency (Master
Record Identification Number 46870703), a conservative transfer rate of
43% was used to demonstrate the amount of residues on the surface that
will be transferred to food and subsequently ingested. The maximum
application rate for DDACB on utensils is 0.0033 lbs active ingredient
(a.i.) per gallon of treatment solution.
    There are two levels of refinement for assessing dietary exposure
to antimicrobial products used on countertops. The three dimensional
approach, Tier 2, was utilized for this assessment. This conservative
approach uses food consumption and preparation patterns, food-specific
conversion factors that relate the surface area contacting the
countertop with the corresponding weight of the food item, transfer
efficiency, and likelihood of contact with a countertop. Food
ingredients, as presented in the model, are separated into nine
categories and reflect a person's daily diet. Based on the structure of
the model, available countertop residues are estimated and presented as
the amount of residue that is expected to be available for each of the
nine food categories. These calculated available residues are then
combined with the food consumption rate, as extracted from the USDA
Continuing Survey for Food Intake by Individuals (CSFII) consumption
data, and a total daily exposure value is provided as the output. This
value is then compared to the toxicological endpoint to determine risk
to those consuming foods that have come into contact with a freshly
sanitized countertop.
    For the assessment of the food bottling/packaging use, EPA assumed
a 100% transfer rate because the food is potentially in contact with
the treated surfaces for very long periods of time. The maximum
application rate for DDACB for bottling/packing of food is 0.0033 lbs
a.i. per gallon of treatment solution. EDI values were calculated using
an approach similar to that used for treated food utensils. Exposure
was assumed to occur through the ingestion of three food products that
might be packaged with treated material: Beverages (alcoholic and non-
alcoholic), egg products, and milk. A calorie intake modification
factor of 0.64 was applied to the EDI for a child to account for the
differences between intake values among children and adults.
    2. Drinking water exposure. DDACB outdoor uses are as an algaecide
in wood preservative treatment and a slimicide in secondary oil field
uses. The oil field uses are considered to be contained. The other uses
are not expected to significantly contaminate drinking water sources.
Therefore, the DDACB contributions for drinking water exposure are
considered to be negligible and are not quantified.

B. Other Non-Occupational Exposure

    The term ``residential exposure'' is used in this document to refer
to non-occupational, non-dietary exposure (e.g., textiles (clothing and
diapers), carpets, swimming pools, and hard surface disinfection on
walls, floors, tables). DDACB is currently registered for the following
residential non-dietary sites: Homes and day-care nurseries. EPA
assessed residential exposure using the following assumptions:
     Residential exposure may occur during the application as
well as post application of DDACB to indoor hard surfaces (e.g.,
mopping, trigger pump sprays, wiping).
     The residential handler scenarios were assessed to
determine dermal and inhalation exposures.
     Residential post application scenarios such as children's
exposure to treated toys and floors were also assessed to determine
dermal and incidental oral exposures.
     Surrogate dermal, inhalation, and incidental oral unit
exposure values were estimated using Pesticide Handler Exposure
Database (PHED) data and the Chemical Manufactures Association
Antimicrobial Exposure Assessment Study (EPA, 1999). Note that for this
assessment, EPA assumed that residential users complete all elements of
an application (mix/load/apply) without the use of personal protective
equipment.
     The duration for most residential exposures is believed to
be best represented by the short-term duration (1 to 30 days). The
short-term duration was chosen for this assessment because the
residential handler and post-application scenarios are assumed to be
performed on an episodic, not daily basis.
    Specific information on the residential exposure assessment for
DDACB can be found at http://www.regulations.gov. Docket ID Number EPA-
HQ-OPP-2006-1024, Review of Petition to Amend 40 CFR 180.940 to add
Didecyl Dimethyl Ammonium Carbonate/Bicarbonate.

C. Additional Safety Factor for the Protection of Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold (``10X'') margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base on toxicity
and EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) safety factor (SF). In applying this provision, EPA either
retains the default value of 10X when reliable data do not support the
choice of a different factor, or, if reliable data are available, EPA
uses a different additional FQPA safety factor value based on the use
of traditional uncertainty/safety factors and/or special FQPA safety
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence that
Aliphatic Alkyl ammonium chloride quaternaries result in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X except for assessments addressing inhalation exposure. For
inhalation exposure assessments the 10X FQPA safety factor is retained.
Those decisions are based on the following findings:
    i. The toxicity database for Aliphatic Alkyl Quaternaries is
complete except for a 90-day inhalation toxicity study in the rat which
was requested in the Aliphatic Alkyl Quaternary Reregistration
Eligibility Document. Due to the absence of the 90-day inhalation
toxicity study, a FQPA safety factor of 10X has been applied to the
oral endpoint to calculate inhalation risks in order to be protective
of any uncertainties associated with route-to-route extrapolation.
    ii. There is no indication that Aliphatic Alkyl Quaternaries are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
neurotoxicity.
    iii. There is no evidence that Aliphatic Alkyl Quaternaries result
in increased susceptibility in in utero rats or rabbits in the prenatal
developmental toxicity studies or in young rats in the 2-generation
reproductive toxicity study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment was performed based on
10% transfer rate and tolerance-level residues. Similarly conservative
Residential SOPs were used to assess post-application exposure to
children as well as incidental oral exposure of toddlers.

These assessments will not underestimate the exposure and risks posed
by Aliphatic Alkyl Quaternaries.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA's risk assessment for the Group I Cluster is based on an
assessment of the cumulative exposure to all aliphatic alkyl quaternary
compounds. The individual exposure scenarios in the DDAC assessments
(as well as the aggregate assessment in the Aliphatic Alkyl Quaternary
(DDAC) Reregistration Eligibility Decision (RED)) were developed by
assuming that a DDAC compound was used on 100% of the surfaces
authorized on the label that could result in human exposure and summing
the percent active ingredients on the labels for all of the aliphatic
alkyl quaternary compounds when used in combination. Thus, because the
risk assessment for DDAC accounts for exposures to all of the aliphatic
alkyl quaternary compounds, there is no need for a separate cumulative
risk assessment for those compounds. The Agency has not identified any
other substances as sharing a common mode of toxicity with DDACB.

VI. Aggregate Risks and Determination of Safety

    1. Dietary risk from food and feed uses. EPA compares the estimated
dietary exposures to an acute population adjusted dose (aPAD) and a
chronic population adjusted dose (cPAD), 0.1 mg/kg/day, which are the
same value for DDACB. Generally, a dietary exposure estimate that is
less than 100% of the aPAD or the cPAD does not exceed the Agency's
LOC.
    The antimicrobial indirect food use acute and chronic risk
estimates from exposure to treated utensils and countertops are below
the Agency's LOC. For adult males, the acute and chronic dietary
exposure risk estimates are 9.9% for utensils and 0.8% for countertops.
The aPAD and cPAD for adult females (13-69) is 11.5% for utensils. The
aPAD from countertops for adult females is 0.8% and the cPAD is 0.5%.
For children ages 1-2, the most highly exposed population subgroup, the
acute and chronic dietary risk estimates are 68.9% for utensils and
2.6% and 1.8%, respectively for acute and chronic dietary risks for
countertops. Therefore, dietary exposure estimates are below Agency's
LOC for all population subgroups. The antimicrobial indirect food use
chronic risk estimates from exposure to treated food packaging and
beverage bottles are also below the Agency's LOC.
    Specific information on the dietary exposure assessment for DDACB
can be found at http://www.regulations.gov. Docket ID Number EPA-HQ-
2006-1024, Review of Petition to Amend 40 CFR 180.940 to add Didecyl
Dimethyl Ammonium Carbonate/Bicarbonate.
    2. Non-occupational risk. Aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Using the exposure
assumptions described in this unit for other non-occupational
exposures, the MOEs are greater than the target of 1,000 for the
inhalation route of exposure and 10 for dermal exposure, with the
exception of the short term dermal exposures in females which has an
MOE of 9. However, there is no significant concern for the proposed
increase in use concentrations from 240 ppm to 400 ppm, with regard to
dermal exposure, considering the contributing MOEs used to calculate
the MOE of 9 were derived using conservative assumptions for the unit
exposures and quantity handled. Furthermore there is a low likelihood
that all scenarios (mopping, wiping, trigger pump spraying, immersing
items into a solution and wearing treated clothing items) that were
used to derive an MOE of 9 for dermal exposure would occur
simultaneously.
    Based on the toxicological and exposure data discussed in this
preamble, EPA concludes that DDACB will not pose a risk under
reasonably foreseeable circumstances. Accordingly, EPA finds that there
is a reasonable certainty that no harm will result to the general
population or to infants and children from aggregate exposure to DDACB
residues.

VII. Other Considerations

    An analytical method for food is not needed. Food-contact
sanitizers are typically regulated by the State health departments to
ensure that the food industry is using products in compliance with the
regulations in 40 CFR 180.940. The end-use solution that is applied to
the food-contact surface is analyzed not food items that may come into
contact with treated surface. An analytical method is available to
analyze the use dilution that is applied to food-contact surfaces. A
titration method is used to determine the total amount of quaternary
compound. If the use solution is a mixture of ADBAC and DDACB, then
high pressure liquid chromatogram with ultraviolet visible (HPLC-UV) is
used to determine the amount of ADBAC. The amount of DDACB is
determined by calculating the difference between the total amount of
quaternary compounds and ADBAC.

VIII. Conclusion

    This regulation amends the exemption from the requirement of a
tolerance for residues of DDACB under 40 CFR 180.940(a) resulting from
an increase in the final use concentration from 240 ppm to 400 ppm on
food contact surfaces in public eating establishments, on dairy
processing equipment and food processing equipment and utensils.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions

of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Aliphatic alkyl quaternaries, Food-contact
sanitizers, Pesticides and pests, Quaternary ammonium compounds,
Reporting and recordkeeping requirements.

    Dated: August 9, 2012.
Joan Harrigan-Farrelly,
Director, Antimicrobials Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.940(a), the table is amended by revising in its
entirety, the entry for ``Quaternary ammonium compounds, didecyl
dimethyl ammonium carbonate/didecyl dimethyl ammonium bicarbonate''
which immediately preceeds the pesticide chemical which reads in part
``Silver ions resulting * * *'' to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

----------------------------------------------------------------------------------------------------------------
          Pesticide chemical                          CAS Reg. No.                             Limits
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Quaternary ammonium compounds,         148788-55-0/148812-654-1..................  When ready for use, the end-
 didecyl dimethyl ammonium carbonate/                                               use concentration of these
 didecyl dimethyl ammonium                                                          specific ammonium compounds
 bicarbonate.                                                                       is not to exceed 400 ppm of
                                                                                active quaternary ammonium
                                                                                compound.

                                                  * * * * * * *
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* * * * *
[FR Doc. 2012-20663 Filed 8-21-12; 8:45 am]
BILLING CODE 6560-50-P