RENEWAL OF INFORMATION COLLECTION REQUEST FOR NOTIFICATION OF EPISODIC RELEASES OF OIL AND HAZARDOUS SUBSTANCES May 13, 2004 OMB Submittal TABLE OF CONTENTS 1. IDENTIFICATION OF THE INFORMATION COLLECTION . . . . . . . . . . . . . . . . . . 1 l( a) Title and Number of the Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . 1 l( b) Short Characterization and Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. NEED FOR AND USE OF THE COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( a) Need and Authority for the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( b) Practical Utility and Users of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( a) Non duplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( b) Public Notice Required Prior to ICR Submission to OMB . . . . . . . . . . . . . . . . . 5 3( c) Consultations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3( d) Effects of Less Frequent Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3( e) General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3( f) Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3( g) Sensitive Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4. THE RESPONDENTS AND THE INFORMATION REQUESTED . . . . . . . . . . . . . . . 6 4( a) Respondents and SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4( b) Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 ( i) Data Items, Including Recordkeeping Requirements . . . . . . . . . . . . . . . . 6 ( ii) Respondent Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5. THE INFORMATION COLLECTED   AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT . . . . . . . . . . . . . . . . . . . 8 5( a) Agency Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5( b) Collection Methodology and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5( c) Small Entity Flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5( d) Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION . . . . . . . . . . . . . 9 6( a) Estimating Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6( b) Estimating Respondent Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6( c) Estimating Agency Burden and Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6( d) Estimating the Respondent Universe and Total Burden and Costs . . . . . . . . . . . 13 6( e) Bottom Line Burden Hours and Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 6( f) Reasons for Change in Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 6( g) Burden Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 APPENDIX A  Phone Log Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 EXHIBITS Exhibit 1 Unit Burden Hours for Reporting a Typical Release to the NRC . . . . . . . . . . . . . . . . . 10 Exhibit 2 Unit Cost for Reporting a Typical Release to the NRC . . . . . . . . . . . . . . . . . . . . . . . . . 12 Exhibit 3 Agency Burden Hours and Costs for Processing a Telephone Notification . . . . . . . . . . 13 Exhibit 4 Estimated Annual Burden Hours and Costs Incurred by Industry . . . . . . . . . . . . . . . . . 14 Exhibit 4a Estimated Annual Burden Hours and Costs Incurred by Industry ( Exhibit 4 from ICR supporting statement 1049.09) . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Exhibit 4b Estimated Annual Burden Hours and Costs Incurred by Industry ( Corrected Exhibit 4 from ICR supporting statement 1049.09) . . . . . . . . . . . . . . . . . . 15 Exhibit 5 Estimated Annual Burden Hours and Costs for Information Collection Under CERCLA Section 103( a) and CWA Section 311 . . . . . . . . . . . . . . . . 15 Exhibit 6 Summary of Total Burden Hour Change Between This ICR and the Previous ICR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 OMB SUBMITTAL*** May 13, 2004 Page 1 1. IDENTIFICATION OF THE INFORMATION COLLECTION l( a) Title and Number of the Information Collection Notification of Episodic Releases of Oil and Hazardous Substances  EPA No. 1049.10.

l( b) Short Characterization and Abstract This information collection request ( ICR) addresses the reporting and recordkeeping activities required to comply with the release notification requirements for hazardous substances and oil specified in section 103( a) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( CERCLA), as amended, and section 311 of the Clean Water Act ( CWA), as amended. These reporting requirements are codified at 40 CFR parts 110, 117, and 302. This ICR renews the collection activity previously approved under OMB No. 2050 0046 and applies to the period September 1, 2003 through August 31, 2006. Estimates of the burden placed on industry and the government to comply with the release notification requirements are presented on an annual basis.

CERCLA section 103( a) and CWA section 311 require the person in charge of a facility or vessel to immediately notify the National Response Center ( NRC) of a hazardous substance release into the environment if the release quantity equals or exceeds the substance's reportable quantity ( RQ) level and an oil discharge into U. S. waters. The regulated community is expected to:

Gather necessary release data, such as the time, quantity, and source of the release;

Notify the facility manager of the release;

Consult with the environmental compliance expert regarding the release;

Report the release to the NRC; and

Keep a log of release data such as the time, date, and circumstances of the release. ( This information is expected, but not required under the regulations.)

There are no recordkeeping requirements specified under CERCLA section 103( a), CWA section 311, or their implementing regulations. The person in charge of the facility or vessel, however, may elect to maintain a log detailing the time, date, and circumstances associated with the reported release. The purpose of maintaining a log of reported releases is to track correspondence with response authorities and to document compliance with release notification requirements under CERCLA and the CWA. Because it is assumed the respondent will maintain a log of reported releases, burden and cost estimates associated with recordkeeping are included in the ICR. 1 The estimate for the number of release notifications received by the NRC per annum is based on the number of notifications received by the NRC in the years 2000, 2001, and 2002. The source of the number of NRC release notifications is, NRC Statistics  Incident Types, and can be found at: http:// www. nrc. uscg. mil/ incident97 02. html. For the purposes of this ICR ( 1049.10), the following incident types are included in the totals for release notifications: fixed, unknown sheen, vessel, storage tank, railroad, aircraft, and unknown. The NRC received 22,817 release notifications in 2000, 25,644 in 2001, and 23,784 in 2002. Therefore, assuming the years 2000, 2001, and 2002 are representative of the period covered by this ICR ( 1049.10), the NRC is estimated to receive, on average, 24,082 release notifications per annum between September 1, 2003 through August 31, 2006. In the previous ICR ( 1049.09) the per annum estimate for the number of release notifications received by the NRC was 23,726.

OMB SUBMITTAL*** May 13, 2004 Page 2 During the three year period covered by this ICR ( 1049.10), it is estimated that the NRC will receive 24,082 release notifications ( i. e., hazardous substance release and oil discharge notifications) per annum. 1 Assuming 24,082 release notifications per annum, the total annual burden to respondents is estimated to be approximately 98,736 hours, at a cost of $ 7,230,537. The total annual burden to the government associated with 24,082 release notifications is estimated to be approximately 24,082 hours, at a cost of $ 950,998.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need and Authority for the Collection The reporting activity required under 40 CFR parts 110, 117, and 302 is authorized under CERCLA sections 103( a) and 104( e), and CWA sections 311 and 308. The regulations implementing CERCLA section 103( a) ( 40 CFR part 302) require the person in charge of a facility or vessel to immediately notify the NRC of a hazardous substance release if the release quantity equals or exceeds the substance's RQ. The specific information provided in the notification required under CERCLA section 103( a) is authorized under CERCLA section 104( e). Section 104( e) authorizes the collection of release information, entry and inspection of the release site, and sampling activities at the release site for the purposes of " determining the need for response, or choosing or taking any response action under [ CERCLA]." The release information collected is the minimum information needed to determine if a Federal response action is required to control or mitigate any potential adverse effects associated with a release.

In addition to the CERCLA notification requirements, the regulations implementing CWA section 311 ( 40 CFR part 110) require immediate notification to the NRC of any release of oil into U. S. navigable waters that causes a sheen, violates applicable water quality standards, or causes a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines. The information required to be provided under CWA section 311 is authorized by CWA section 308, which allows for the collection of release information and entry, monitoring, inspection and sampling activities at the release site for the purpose of ensuring that the objectives of the CWA are satisfied. The Federal government needs to be notified of releases of oil in order to determine if a response action is necessary to mitigate or prevent damage to public health or welfare or the environment. OMB SUBMITTAL*** May 13, 2004 Page 3 2( b) Practical Utility and Users of the Data The hazardous substance and oil release information collected pursuant to CERCLA section 103( a) and CWA section 311 has a variety of different uses. Federal response authorities, such as EPA and United States Coast Guard On Scene Coordinators ( OSCs), use the information to evaluate the environmental and human health risks attributable to a reported release and to determine if a Federal response action is necessary to mitigate or prevent any adverse effects associated with the release. Any reportable hazardous substance release or discharge of oil into the environment warrants a timely evaluation of its source, emission rate, chemical form, media affected, and quantity released to ensure the proper protection of public health and welfare and the environment. Responses to hazardous substance and oil release notifications by Federal authorities may take a variety of forms, including monitoring and overseeing cleanup activities conducted by the responsible party, evacuating surrounding populations, and directing the actual cleanup operation.

The hazardous substance and oil release information collected under CERCLA section 103 and CWA section 311 also is used by EPA program offices and other Federal agencies to evaluate the potential need for additional regulations, new permitting requirements for specific substances or sources, or improved emergency response planning.

In addition, release notification information, which is stored in the national Emergency Response Notification System ( ERNS) data base, is used by State and local government authorities, the regulated community, and the general public. State and local government authorities and the regulated community use release information to help inform local emergency response planning. The public use release information to become aware of the releases that have occurred in their communities and throughout the nation and to learn of actions, if any, that are being taken to protect public health and welfare and the environment. The public has access to release information, statistics, and fact sheets through the Freedom of Information Act and the NRC's website ( http:// www. nrc. uscg. mil/ nrchp. html).

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication The information required to be provided in the telephone call to the NRC is the minimum information necessary to evaluate a hazardous substance release or discharge of oil. Direct notification to the NRC, as opposed to notification to multiple Federal response authorities, helps to ensure a coordinated Federal response effort and that unnecessary delays in requesting assistance do not occur. One call to the NRC fulfills the requirement to report releases of hazardous substances under CERCLA and several other regulatory programs, including the CWA, the Resource Conservation and Recovery Act, and the Hazardous Materials OMB SUBMITTAL*** May 13, 2004 Page 4 Transportation Act. When the NRC receives a notification, the NRC watchstander immediately notifies the appropriate Federal OSC, who evaluates the circumstances surrounding the release and determines the need for a government response action. The Federal government has extensive resources, expertise, and authority under CERCLA to formulate response actions, ensuring a timely and coordinated field response with State, local, and private organizations, if needed.

EPA analyzed possible areas of overlap with other regulations, and concluded that there are limited areas of overlap with reporting requirements under other statutes and provisions. For example, there may be limited duplication with the reporting requirements specified in CERCLA section 103( a) and in certain permitting regulations. Permitting regulations often require reports if the permit level is exceeded. Thus, if a release of a hazardous substance exceeds its permit level and the substance's RQ, the release must be reported to both the applicable Federal or State permitting authority and NRC. However, the purpose and timing of the two reports often differ. Violations of permit regulations are reported to EPA Regional permitting offices or to State permitting authorities in order to maintain proper permit enforcement records or to evaluate ambient conditions over time. In contrast, Federal officials use release information provided to the NRC to evaluate the release situation and determine if a government response is necessary. Thus, the notification in monthly monitoring reports that a permit is exceeded is not timely for response purposes.

In addition to a possible overlap between CERCLA reporting and certain permitting regulations, there may be some overlap with respect to the reporting requirements specified in section 304 of the Emergency Planning and Community Right to Know Act ( EPCRA), which requires immediate reporting of releases of CERCLA hazardous substances equal to or above an RQ to State and local response officials. Reporting to the NRC as well as to the appropriate State Emergency Response Commission ( SERC) and Local Emergency Planning Committee ( LEPC), as required under EPCRA section 304, is appropriate, however, because it ensures that the Federal government is alerted to releases that may require a Federal field response. Although the SERCs and LEPCs are notified of the releases under EPCRA section 304, some SERCs and LEPCs may not possess the resources necessary for a proper response action. Notification to the NRC allows for a timely response in the event of an emergency. Furthermore, reporting to the NRC, SERC, and LEPC provides for a coordinated effort among Federal, State, and local response officials, which helps ensure that an efficient response action is taken. When Congress enacted EPCRA section 304, it was aware that releases of hazardous substances were already reported to the NRC; Congress determined that it was necessary and appropriate for such potentially hazardous releases to be reported immediately to all potentially affected government jurisdictions. The requirements under EPCRA, however, are separate from those under CERCLA, and are outside the scope of this ICR ( 1049.10). The statutory requirements under CERCLA and EPCRA are clear and distinct; the Federal response system, as well as the State and local response systems, must be immediately alerted to potentially dangerous releases of hazardous substances that may pose a threat to public health or welfare or the environment. OMB SUBMITTAL*** May 13, 2004 Page 5 3( b) Public Notice Required Prior to ICR Submission to OMB In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), EPA requested comment from the public through the Federal Register notice on the renewal of this ICR ( 1049.10). The public EDocket Number for the notice is SFUND 2000 0009, and can be accessed at ( http:// www. epa. gov/ edocket/). On December 12, 2003 ( 68 FR 69397), EPA sought comments on this ICR. There were no comments received.

3( c) Consultations EPA consulted with a number of Federal and State government agencies in the development of the information collection activities described in this ICR ( 1049.10). Workgroups were used to develop all RQ adjustment regulations as well as the oil discharge regulation. These Workgroups consisted of representatives from various EPA program offices, the ten EPA Regions, and the NRC. Participation of these parties in the Workgroups was sufficient to address and resolve all outstanding issues. The comments received on the proposed rules were addressed in the relevant Response to Comments Documents and in the preambles to the respective final rules.

In addition to Workgroup activities, EPA sponsored many workshops and training sessions throughout the country for industry and Federal, State, and local government response officials on the release notification requirements under CERCLA and the CWA. The workshops were held to educate the regulated community as well as those Federal and State agencies required to implement the regulations. In addition, the workshops provided an opportunity for the public to ask questions about, and comment on, the implementation of the reporting regulations under CERCLA and the CWA.

For this renewal, several individuals ( fewer than 9) responsible for making notifications to the NRC were consulted regarding the burden this collection imposes. Brief summaries of those consultations are contained in Appendix A to this renewal supporting statement.

3( d) Effects of Less Frequent Collection The information required under the regulations implementing CERCLA section 103( a) and CWA section 311 is not collected at any specified frequency; rather, it is collected when reportable releases occur. The information collected under the regulations, such as the source, quantity, and type of material released and the environmental medium affected, is critical to evaluating the threat posed by the release and the need for a response action. The regulatory requirements evaluated in this ICR ( 1049.10) represent EPA's efforts to ensure that the NRC is notified immediately of those hazardous substance and oil releases for which a Federal response action may be necessary to protect public health and welfare and the environment.

3( e) General Guidelines OMB SUBMITTAL*** May 13, 2004 Page 6 The regulations implementing CERCLA section 103( a) and CWA section 311 adhere fully to OMB's general guidelines concerning the collection of information and the control of paperwork burdens on the public.

3( f) Confidentiality The regulations implementing CERCLA section 103( a) and CWA section 311 do not require the submittal of any proprietary, trade secret, or other confidential information.

3( g) Sensitive Questions The regulations implementing CERCLA section 103( a) and CWA section 311 do not require the submission of any sensitive business information. In addition, the information collection requested under these regulations is in compliance with the Privacy Act of 1974 and OMB Circular A 108.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents and SIC Codes This section is not applicable. The use and release of hazardous substances and oil are pervasive throughout industry. EPA expects a number of different industrial categories to report hazardous substance and oil releases pursuant to the requirements specified in CERCLA section 103( a) and CWA section 311. No one industry sector or group of sectors or size of facility is affected disproportionately by the information collection burden.

4( b) Information Requested ( i) Data Items, Including Recordkeeping Requirements Notification under CERCLA section 103( a) and CWA section 311 is intended to ensure that Federal authorities receive prompt notification of hazardous substance and oil releases for which a timely response may be necessary to protect public health or welfare or the environment. The information provided in the telephone call to the NRC serves to notify government authorities of the release and provides them with a description of the circumstances surrounding the release. The following information is requested from all callers:

The name and location of the individual reporting the release, the name and type of organization ( e. g., general public, industrial facility, or Federal, State, or local government) with which the individual reporting the release is affiliated, and the telephone number of the person reporting the release;

The name and location of the releaser, the type of organization responsible for the OMB SUBMITTAL*** May 13, 2004 Page 7 release, and the telephone number of the releaser;

The location of the release;

The date and time of the release;

The name and type of material involved in the release, and the quantity of the substance released;

The source of the release, the vehicle identification or carrier number, if applicable, and a brief description of the source;

The environmental medium affected by the release ( e. g., air, land, water, or ground water);

The cause of the incident ( e. g., transportation accident, operational error, natural phenomenon), and a brief description of the release scenario denoting any unusual circumstances associated with the release;

Information on damages that occurred as a result of the release, including the number of injuries, number of deaths, and any property damage;

A description of the response actions taken at the release site, if any;

The name( s) and type of organization( s) that the caller has already notified; and

Any additional comments or information regarding the release.

As mentioned previously, there are no recordkeeping requirements specified under CERCLA section 103( a), CWA section 311, or their implementing regulations. The person in charge of the facility or vessel, however, may elect to maintain a log detailing the time, date, and circumstances associated with the reported release. The purpose of maintaining a log of reported releases is to track correspondence with response authorities and to document compliance with release notification requirements under CERCLA and the CWA. Because the respondent will in all likelihood maintain a reported release log, burden and cost estimates associated with recordkeeping are included in this ICR ( 1049.10).

( ii) Respondent Activities To comply with the notification requirements specified in the regulations implementing CERCLA section 103( a) and CWA section 311, the regulated community is expected to perform the following activities:

Gather necessary release data, such as the time, quantity, and source of the release; 2This verification was not repeated for this ICR. It is assumed to remain the same.

OMB SUBMITTAL*** May 13, 2004 Page 8

Notify the facility manager of the release;

Consult with the environmental compliance expert regarding the release;

Report the release by telephone to the NRC; and

Keep a log of release data such as the time, date, and circumstances of the release. ( This information is expected but not required under the regulations.)

These five general steps have been verified through conversations with environmental compliance experts at facilities that reported releases of hazardous substances to the NRC during 1992, 1993, and 19942. Each environmental compliance manager at these facilities was asked about the internal activities that are likely to occur between the time a release of a hazardous substance is discovered and the time a call is made to the NRC. The burden hours associated with reporting a release were in part based upon these findings.

5. THE INFORMATION COLLECTED   AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities Every hazardous substance and oil release reported by the regulated community to the NRC must be evaluated by Federal authorities. The appropriate Federal On Scene Coordinator ( OSC) is notified of a release by a telephone call from the NRC. The NRC conveys all the relevant information regarding the release to the OSC, including whether the release is to air, soil, water, etc., the source of the release, and the type of substance released. The telephone call from the NRC to the OSC must occur within 15 minutes of the original release notification. The OSC is responsible for evaluating the circumstances surrounding the release to determine whether government monitoring and/ or a Federal response action may be necessary.

NRC personnel are also responsible for entering release information into the NRC data base. The release data are stored in the NRC data base, ERNS, a national data base that stores release information by facility. The data can be accessed through the NRC web site: http:// www. nrc. uscg. mil/ foia. html. The primary activity of the Federal government under the regulations implementing CERCLA section 103( a) and CWA section 311 is processing and recording the reported release information, and responding to releases that may pose a significant hazard to public health or welfare or the environment.

With respect to OMB's Terms of Clearance ( ICR 1049.09), EPA was directed to promptly make any necessary adjustments to the ICR if and when any changes are made to the OMB SUBMITTAL*** May 13, 2004 Page 9 definition of " federally permitted releases." No changes to that definition were made by EPA.

5( b) Collection Methodology and Management For purposes of reporting releases under the regulations implementing CERCLA section 103( a) and CWA section 311, a person in charge of a facility or vessel that experiences a reportable release must telephone the NRC. The NRC notifies the appropriate EPA Region or United States Coast Guard Office, the affected State, and any other Federal agency that may be able to lend support to a potential response action.

To manage the hazardous substance and oil release information submitted in accordance with CERCLA section 103( a) and CWA section 311, EPA uses the ERNS data base. When a hazardous substance or oil release is reported to the NRC, it is immediately entered into the NRC data base. The ERNS data base allows EPA to document, analyze, and maintain data gathered under the CERCLA and CWA notification process.

For Federal response authorities, the ERNS data base reduces the cost and time associated with processing and documenting release reports. For other EPA program offices, State and local response officials, and the public, ERNS provides for easy access to release data.

5( c) Small Entity Flexibility The notification requirements apply equally to all facilities or vessels, regardless of size, that have reportable releases of CERCLA hazardous substances or oil. The regulations do not impose any general information collection or recordkeeping requirements on small businesses. EPA believes that the notification requirements specified under these regulations represent the minimum level of information necessary for Federal response officials to determine if a government response action is needed to prevent or mitigate any damage to public health or welfare or the environment. The regulatory requirements are satisfied by a toll free telephone call to the NRC. A reduction in these reporting requirements for small businesses is not possible without jeopardizing the Federal government's ability to evaluate the threat posed by a release and determine if a Federal response is necessary.

5( d) Collection Schedule Information is not collected at any specified frequency; rather, it is collected when reportable releases occur. Under CERCLA section 103( a), a release of a hazardous substance is reportable when it equals or exceeds its RQ. Pursuant to CWA section 311, a discharge of oil into navigable waters is reportable whenever the discharge causes a sheen, violates applicable water quality standards, or causes a sludge or emulsion to be deposited beneath the surface of the water or upon adjoining shorelines.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION OMB SUBMITTAL*** May 13, 2004 Page 10 6( a) Estimating Respondent Burden Under CERCLA section 103( a) and CWA section 311, the person in charge of a facility or vessel that experiences a reportable release is expected to perform the following activities: ( 1) gather necessary release data, such as the time, date, quantity, and source of the release; ( 2) notify the facility manager of the release; ( 3) consult with the environmental compliance expert regarding the release; ( 4) report the release by telephone to the NRC; and ( 5) keep a log of release data such as time, date, and circumstance of the release. ( A respondent is not required to keep a log of release data under the episodic release notification regulation, however EPA assumes respondents will keep a log of release data.) Cost and burden estimates associated with completing these activities assume that respondents will telephone the NRC with 24,082 release notifications per annum between September 1, 2003 through August 31, 2006.

Exhibit 1 presents a summary of the unit burden hours associated with reporting a typical release to the NRC. The burden associated with the first collection activity in Exhibit 1, " Initial Telephone Call to the NRC," includes the burden of gathering of data on the release, notifying the facility manager of the release, and consulting with an environmental compliance expert regarding the release. EPA has estimated that the respondent's burden hours for reporting a typical release is 4.1 hours.

Exhibit 1 Unit Burden Hours for Reporting a Typical Release to the NRC Collection Activity Burden Hours Total Burden Hours Managerial Technical Clerical Initial Telephone Call to the NRC 1.0 1.0 0.0 2.0 Recordkeeping 0.1 1.0 1.0 2.1 Total 1.1 2.0 1.0 4.1 Initial Telephone Notification In estimating the burden to industry that the regulations implementing CERCLA section 103( a) and CWA section 311 may impose, EPA has assumed that the respondent's initial telephone notification to the NRC regarding a release requires approximately one hour of technical personnel time and one hour of managerial time. Therefore, in this ICR ( 1049.10), as in the previous ICR ( 1049.09), EPA assumes two burden hours for the initial telephone notification. This burden hour estimate was confirmed through telephone conversations with facilities that reported releases to the NRC. Facilities generally agreed that the time required to evaluate a release will vary, depending on the nature of the release. Most of the facilities stated that the evaluation was relatively straightforward, requiring well under one hour. One facility stated that evaluating a release and determining if the release should be reported to the NRC could require as many as four hours of a single technical expert's time. Other facilities responded that it would probably take 15 minutes to ½ hour of managerial time to determine whether a call to the NRC 3 Bureau of Labor Statistics' news release dated, August 26, 2003, entitled, " Employer Costs for Employee Compensation  June 2003" listed hourly compensation ( wages and salaries plus fringe benefits) rates for civilian managerial, technical, and clerical workers. Therefore the wage rates used in this ICR ( 1049.10) include salaries, fringe benefits, overhead costs and general and administrative costs as of June 2003.

OMB SUBMITTAL*** May 13, 2004 Page 11 was required. In general, most facilities agreed that, on average, two to three person hours was a reasonable estimate for the time required to determine the need to report the release to the NRC. Therefore, in this ICR ( 1049.10), as in the previous ICR ( 1049.09), the assumption is made that the burden of the telephone call for each reportable release is two hours ( composed of one hour of management's time and one hour of technician's time), regardless of the environmental medium affected and the substance released.

Recordkeeping Although neither CERCLA nor the CWA requires that records of releases be kept, EPA assumes that a facility will keep a log of any calls made to government organizations. Such a log will be useful for managers in establishing that the notification requirements of CERCLA section 103( a) and CWA section 311 have been met. The log may include a description of the incident and its cause, the NRC/ ERNS report number, a brief account of any conversations with Federal officials, and a description of the outcome of the incident, including any cleanup action taken. The burden associated with internal recordkeeping is estimated at one technical hour and one clerical hour per release. Further, a ratio of one tenth managerial hour to each hour of clerical time is also assumed. Therefore, in this ICR ( 1049.10), as in the previous ICR ( 1049.09), EPA assumes 2.1 burden hours per release for recordkeeping.

Response Actions Under section 103( a) of CERCLA and section 311 of CWA facilities and vessels responsible for a release are required to take appropriate action to clean up the release. However, because there is no paperwork burden associated with these response actions, the capital and labor costs associated with response actions are not within the scope of this ICR ( 1049.10).

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs The estimated cost to a respondent for evaluating a release and calling the NRC regarding the release are a function of the time expended by respondent personnel ( i. e., the burden estimates presented in section 6( a)), and the hourly wage rates for the appropriate categories of labor. The hourly wage rates used for industry in this ICR are from June 2003 and were obtained from the Bureau of Labor Statistics. 3 For purposes of this analysis, EPA estimates an average hourly respondent labor cost of $ 43.74 for managerial staff, $ 30.18 for technical staff, and $ 19.22 for clerical staff. OMB SUBMITTAL*** May 13, 2004 Page 12 These rates reflect employer cost for employee compensation in the United States as of June 2003 and include both employer costs for legally required benefits ( e. g., social security, worker's compensation, and unemployment insurance), other important fringe benefit categories ( e. g., insurance, paid leave, retirement and savings), and overhead and general and administrative costs.

( ii) Estimating Capital and Operation & Maintenance Costs Capital costs usually include any produced physical good needed to provide the needed information, such as machinery, computers, and other equipment. EPA does not anticipate that respondents will incur capital costs in carrying out the information collection requirements of this regulation.

Operation and Maintenance ( O& M) costs are those costs associated with paperwork requirements incurred continually over the life of the ICR. EPA does not anticipate that respondents will incur O& M costs in carrying out the information collection requirements of the proposed rule.

Costs associated with the burden hours presented in section 6( a) of this ICR ( 1049.10) are shown in Exhibit 2.

Exhibit 2 Unit Cost for Reporting a Typical Release to the NRC Collection Activity Burden Hours Unit Capital/ Start Up Cost Unit O& M Cost Total Unit Cost Managerial ($ 43.74/ Hour) Technical ($ 30.18/ Hour) Clerical ($ 19.22/ Hour)

Initial Telephone Notification to the NRC 1.0 1.0 0.0 $ 0.00 $ 0.00 $ 73.92 Recordkeeping 0.1 1.0 1.0 $ 0.00 $ 0.00 $ 53.77 Total 1.1 2.0 1.0 $ 0.00 $ 0.00 $ 127.69 For a typical release, EPA has estimated that it costs the respondent $ 127.69 to report the release to the NRC and record the release data in the respondent's log.

6( c) Estimating Agency Burden and Cost Federal government authorities are expected to perform the following activities under the episodic release notification regulation: ( 1) process respondent telephone notifications of a release; ( 2) monitor cleanup activities; and ( 3) conduct field response actions. EPA estimates that only the first Federal government activity listed above, " process telephone notifications," will involve the processing of submitted paperwork. Estimated unit burden hours and costs and total annual burden hours and costs for the " process telephone notifications" activity are presented in 4 This hourly wage estimate was calculated by summing the basic hourly wage rate for a GS 12 step 1 government employee in 2003 ($ 24.68) and the hourly monetary value of the representative employee's fringe benefits ( assumed to be the basic hourly wage rate multiplied by 60 percent).

OMB SUBMITTAL*** May 13, 2004 Page 13 Exhibit 3. For the period covered by this ICR ( 1049.10), EPA has assumed that the Federal government average hourly labor cost is $ 39.49.4 Exhibit 3 Agency Burden Hours and Costs for Processing a Telephone Notification Collection Activity Number of Reportable Releases/ Year Unit Burden Hours Unit Capital/ Start Up Cost Unit O& M Cost Total Unit Cost Total Annual Burden Hours Total Annual Cost Processing Telephone Notification 24,082 1.0 $ 0.00 $ 0.00 $ 39.49 24,082 $ 950,998 Processing Telephone Notification The total burden of processing a telephone notification of a release consists of the time the NRC uses to ( 1) communicate with the respondent, ( 2) record and enter the information provided in the telephone call into the NRC data base, and ( 3) contact the predesignated EPA or Coast Guard OSC or other parties by telephone. EPA has estimated that one hour is needed to complete all the activities associated with processing an initial telephone notification. Therefore, the unit cost associated with processing an initial telephone call is $ 39.49 ( 1 hour x $ 39.49 per hour = $ 39.49).

Response Activities For some percentage of releases, the information provided in the telephone notification will prompt EPA to monitor cleanup activities. Monitoring a cleanup will allow EPA to directly assess and evaluate the circumstances surrounding the release, and the population and environment potentially affected by the release. In a small percentage of cases, the owner/ operator will be unable to respond to the release or cleanup activities will appear unsatisfactory, requiring EPA to conduct its own field response actions to ensure that all potential hazards have been addressed and that the release has been thoroughly cleaned up. However, as these actions are not directly related to the processing of submitted paperwork, the costs and burden hours associated with these actions are not covered under this ICR ( 1049.10).

6( d) Estimating the Respondent Universe and Total Burden and Costs ERNS data from 2000, 2001, and 2002 were used to estimate the number of releases that will be reported to the NRC during the period of September 1, 2003 through August 31, 2006. The exhibits in this section show projected annual release reports, burden hours, and costs. OMB SUBMITTAL*** May 13, 2004 Page 14 The total cost and total burden estimates presented in this ICR ( 1049.10) are the aggregate annual costs and burden hours associated with reporting all hazardous substances and oil releases pursuant to CERCLA section 103( a) and CWA section 311.

Annual respondent burden hours are equal to the number of releases reported to the NRC in a year multiplied by the unit burden hours associated with reporting a release. Annual cost is equal to the number of releases reported to the NRC in a year multiplied by the unit cost of reporting a release. Exhibit 4 presents the annual total annual burden hour and cost estimates for respondents.

Exhibit 4 Estimated Annual Burden Hours and Costs Incurred by Industry Collection Activity Number of Reportable Releases / Year Unit Burden Hours Unit Cost Burden Hours Annual Cost Telephone Notification 24,082 2.0 $ 73.92 48,164 $ 3,560,283 Recordkeeping 24,082 2.1 $ 53.77 50,572 $ 2,719,256 Total 24,082 4.1 $ 127.69 98,736 $ 6,279,539 6( e) Bottom Line Burden Hours and Costs Exhibits 3 and 4 present the annual burden hours and costs incurred by the government and respondents, respectively, for all information collection requirements covered in this ICR ( 1049.10). Exhibit 5 summarizes the bottom line burdens and costs incurred by both respondents and government. The bottom line burden to respondents is approximately 98,736 hours per year, at a cost of $ 6,279,539. The bottom line burden to the government is approximately 24,082 hours per year, at a cost of $ 950,998.

It appears that there is a significant increase in the bottom line cost burden to respondents from the previous ICR ( 1049.09). In that ICR ( 1049.09), the bottom line cost to respondents was estimated at, $ 3,962,005. Unfortunately there was a calculation error in that estimate that was identified and corrected for this ICR ( 1049.10). The following Exhibit 4a is a reprint from the previous ICR ( 1049.09):

Exhibit 4a Estimated Annual Burden Hours and Costs Incurred by Industry ( Exhibit 4 from ICR supporting statement 1049.09)

Collection Activity Number of Reportable Releases / Year Unit Burden Hours Unit Cost Burden Hours Annual Cost Telephone Notification 23,726 2.0 $ 95.39 47,452 $ 2,263,223 Recordkeeping 23,726 2.1 $ 71.60 49,825 $ 1,698,782 OMB SUBMITTAL*** May 13, 2004 Page 15 Total 23,726 4.1 $ 166.99 97,277 $ 3,962,005 Note that the calculation for annual cost multiplied the " Number of Reportable Releases/ Year" by the " Unit Cost" instead of " Unit Cost" by " Burden Hours." The corrected Exhibit 4b appears below:

Exhibit 4b Estimated Annual Burden Hours and Costs Incurred by Industry ( Corrected Exhibit 4 from ICR supporting statement 1049.09)

Collection Activity Number of Reportable Releases / Year Unit Burden Hours Unit Cost Burden Hours Annual Cost Telephone Notification 23,726 2.0 $ 95.39 47,452 $ 4,526,446 Recordkeeping 23,726 2.1 $ 71.60 49,825 $ 3,567,470 Total 23,726 4.1 $ 166.99 97,277 $ 8,093,916 The estimated annual burden cost should have been reported as $ 8,093,916, rather than the $ 3,962,005 actually reported for the previous ICR ( 1049.09).

Exhibit 5 Estimated Annual Burden Hours and Costs for Information Collection Under CERCLA Section 103( a) and CWA Section 311 Economic Sector Burden Hours Cost Industry 98,736 $ 6,279,539 Government 24,082 $ 950,998 Total 122,818 $ 7,230,537 6( f) Reasons for Change in Burden Compared to the previous ICR ( 1049.09), unit burden hours for industry and the government have not changed in this ICR ( 1049.10). However, total annual burden hours for industry and government have increased in this ICR ( 1049.10) because the projected number of release notifications per annum in this ICR ( 1049.10) is higher than the projected number of release notifications per annum in the previous ICR ( 1049.09). The previous ICR ( 1049.09) projected 23,726 releases would be reported to the NRC annually, while this renewal ICR ( 1049.10) projects 24,082 releases will be reported to the NRC annually. Therefore, comparing this ICR ( 1049.10) to the previous ICR ( 1049.09), total annual burden hours for industry increase by 1,459 hours and for EPA by 356 hours.

Although this ICR ( 1049.10) projects an increase in the number of releases reported to the NRC annually, decreases in the unit costs to responders for managerial, technical and clerical labor categories results in an overall reduced cost burden for industry. The previous ICR 5See corrected calculation in Exhibit 4b.

OMB SUBMITTAL*** May 13, 2004 Page 16 ( 1049.09) estimated the cost burden to industry as $ 8,093,9165, this renewal estimates the costburden to industry will be $ 7,230,537 or $ 863,379 less than the previous estimate. The estimated government unit cost increased and therefore the cost burden for government is projected to increase, from $ 854,136 to $ 950,998 an increase of $ 96,862.

Exhibit 6 Summary of Total Burden Hour Change Between This ICR and the Previous ICR This ICR Previous ICR Difference Number of Releases Projected to be Reported to NRC Over Three Year Period 72,246 71,178 1,068 Annual Industry Burden Hours 98,736 97,277 1,459 Annual Government Burden Hours 24,082 23,726 356 6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average approximately 4.1 hours per response, which includes 2.0 hours of reporting and 2.1 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 currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. SFUND 2000 0009, which is available for public viewing at the Office of Solid Waste and Emergency Response Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., 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 Office of Solid Waste and Emergency Response Docket is ( 202) 566 0276. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at OMB SUBMITTAL*** May 13, 2004 Page 17 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. Once 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 Office for EPA. Please include the EPA Docket ID No. ( SFUND 2000 0009) and OMB control number ( 2050 0046) in any correspondence. OMB SUBMITTAL*** May 13, 2004 Page 18 APPENDIX A  Phone Log Summaries The following calls were made between April 27, 2004 and May 12, 2004. The companies were selected from the universe of facilities for which a release of a hazardous substance at or above an RQ to the NRC was reported. Persons responsible for making notifications were queried about the internal process and procedures taken at the facility between the time a release is observed and a call is made to the NRC. Because the reporting party is not public information, the information summarized below is about the suspected responsible party. Additional information about the reported incident can be obtained through the NRC's web site, specifically at: http:// www. nrc. uscg. mil/ wdbcgi/ wdbcgi. exe/ WWWUSER/ WEBDB. foia_ query. show_ parms.

BP Chemicals Private Enterprise Lima, OH Incident Report # 712468 On February 5, 2004, BP Chemicals accidentally released 100 pounds of acrylonitrile. On May 13, 2004, spoke with the person responsible for developing procedures for reporting releases. The facility has procedures in place and believes EPA's burden estimates are reasonable. The company spokesperson did not have any questions about the reporting process.

Wayne Farms LLC Private Enterprise Jack, AL Incident Report # 716028 On March 15, 2004, Wayne Farms, LLC accidentally released an unknown amount of anhydrous ammonia due to equipment failure ( power failure). As soon as the actual amount ( later that day) of the substance was known, that information was sent via written report. On May 11, 2004, spoke with the person responsible for consolidating communications for the company. The company has a crisis action system in place to address regulatory requirements. The company keeps records of who they talk to with regard to submitting reports. The company spokesperson confirmed that EPA's burden estimates were reasonable.

Sarah Lee Bakery Private Enterprise Tarboro, NC Incident Report # 715999 Left message, call returned April 28, 2004 OMB SUBMITTAL*** May 13, 2004 Page 19 On March 15, 2004, Sarah Lee Bakery accidentally released 20 pounds of anhydrous ammonia due to a faulty gasket on a 3 way valve. On April 28, 2004, spoke with the person responsible for making the report to the NRC. Generally, most plants are running as trim as possible. When there is a leak or release, the first priority is to stop it. Having to stop to report the release is an issue. Little nuisance leaks are problematic because they have to report. Responder said that he reports releases within 15 minutes.

Westlake Vinyls, Inc Private Enterprise Calvert City, KY Incident Report # 716614 On March 21, 2004, a release of an unknown amount of ethylene dichloride was reported from the facility. On May 11, 2004, spoke with the individual responsible for making the notification regarding notification procedures and burden estimates. Burden estimates are reasonable. The facility has plans in place to report episodic releases to the NRC with followup reports to the state and local authorities. The individual did not have any questions.


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Registration Division contact: Laura E. Nollen,<PHONE_NUMBER>>

<>

<<Interregional Research Project Number 4 (IR-4)>

>

<Petition Number PP# 0E7820>

<	EPA has received a pesticide petition, PP# 0E7820, from Interregional
Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W
Princeton, NJ 08540, proposing, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.608 by establishing tolerances for residues of
spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl
2,2-dimethylbutanoate, in or on the raw agricultural commodities sugar
apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava,
feijoa, jaboticaba, wax jambu, starfruit, passionfruit, persimmon and
acerola at 0.45 parts per million (ppm) and lychee, longan, Spanish
lime, rambutan and pulasan at 3.5 ppm.  EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.>

<A. Residue Chemistry>

<	1. Plant metabolism. The metabolism of spirodiclofen in plants is
adequately

understood. Studies have been conducted to delineate the metabolism of

radiolabeled spirodiclofen in various crops, all showing similar
results. The residue

of concern is spirodiclofen.>

<	2. Analytical method. Adequate analytical methodology using LC/MS/MS

detection is available for enforcement purposes.>

<	3. Magnitude of residues. Magnitude of the residue data was conducted
on

guava, sugar apple and lychee in accordance with OPPTS Guideline
860.1500. The data supports establishing the requested tolerances.>

<B. Toxicological Profile>

<	1. Acute toxicity.  Oral and dermal LD50 values were >2000 mg/kg bw.>

Inhalation LC50 values were >5030 mg/m3 air. Spirodiclofen was not
irritating to

rabbit skin or eyes but did cause skin sensitization in the
Magnusson/Kligman

maximization test in guinea pigs. Acute toxicity studies for
spirodiclofen support an

overall toxicity Category III. Spirodiclofen did not show any evidence
of neurotoxicity in an acute neurotoxicity study in rats.

<	2. Genotoxicty. Several genotoxicity tests were conducted to test for
point- mutagenic> activity, chromosome aberration in vitro and in vivo,
and for DNA

repair. All tests conducted were negative, indicating no evidence of
mutagenic or

genotoxic potential.

<	3. Reproductive and developmental toxicity. An oral developmental
toxicity>

study in rat did not reveal any evidence of teratogenic potential. The
maternal and

developmental NOELs were 1000 mg/kg bw/day. An oral developmental
toxicity

study in rabbits demonstrated a maternal NOEL of 100 mg/kg bw/day and
did not

reveal any teratogenic potential. A two-generation study in rats, with a
parental

toxicity NOAEL of 5.2 mg/kg bw/day, did not reveal evidence of a primary

reproductive toxicity potential. The reproductive NOAEL was 26.2 mg/kg
bw/day

based on various clinical and histopathological findings at higher dose
levels. The results of a second DNT study demonstrated no changes in
developmental/ functional parameters in offspring at the highest dose
tested.

<	4. Subchronic toxicity. A subchronic toxicity feeding study with rats
over 90

days demonstrated a NOAEL of 32.1 and 8.1 mg/kg bw/day for males and
females,

respectively, based on effects on the lipid metabolism (decrease of
triglycerides and

cholesterol), liver effects (increase in transaminases) and adrenal
effects (vacuolation) at the higher dose levels. A subchronic feeding
study in mice over 13

weeks revealed no clinical toxicological signs. A NOAEL of 30.1 mg/kg
bw/day for

females was observed and a NOAEL of 15 mg/kg bw was established for
males). A 14-week feeding study in dogs demonstrated a NOAEL of 7.7
mg/kg bw/day for males and <8.4 mg/kg bw/day for females based on
adrenal gland effects in 2 out of 4 animals. Spirodiclofen did not show
any evidence of neurotoxicity in a subchronic neurotoxicity study in
rats. A 28 day immunotoxicity investigation in rats in combination with
other guideline studies provide evidence that spirodiclofen does not
adversely affect the immune system.>

<	5. Chronic toxicity. A 24-month combined chronic
feeding/carcinogenicity

study in rats demonstrated a NOAEL of 14.7 mg/kg bw/day. An oncogenicity
study

in the mouse revealed a NOAEL of 4.1 mg/kg bw/day. Uterine and
testicular

oncogenicity was noted in the rat and hepatic neoplasia was observed in
the mouse.

A one-year feeding study with dog demonstrated a NOAEL of 1.38 mg/kg bw
day

based on adrenal effects (vacuolization) as well as changes in
circulating cholesterol

and prostate weight at higher dose levels.>

<	6. Animal metabolism. Metabolism and pharmacokinetic studies in the
rat

demonstrate that spirodiclofen residues are rapidly absorbed,
metabolized and

eliminated. The primary metabolite is the enol, which is formed by
cleavage of the

alkyl ester group, but numerous other metabolites are also formed.>

<	7. Metabolite toxicology. In crop matrices, spirodiclofen is the only
residue of

concern. The residues of concern in livestock tissues are spirodiclofen
and its enol

metabolite. Since the enol is inherently present after administration,
toxicology data

for this metabolite is completely supported by data obtained for
spirodiclofen.>

<	8. Endocrine disruption. The mammalian mode of action for
spirodiclofen

includes that classified as inhibitory to steroid biosynthesis,
resulting in an indirect

and endogenously-mediated toxicological response. Effects do not have an
impact

on fertility, reproduction, developmental or neuropathological
parameters.

Additional mechanistic studies with the chemical indicated that there is
no direct

effect on the endocrine system as there is no interaction with hormone
receptors.>

<C. Aggregate Exposure>

<	1. Dietary exposure. Spirodiclofen has a low acute toxicity via the
oral,

dermal or inhalation route. An endpoint of concern attributable to a
single dose

was not identified in the hazard database; therefore an acute reference
dose was not

established. Chronic dietary analysis was conducted to estimate exposure
to

potential spirodiclofen residues for the proposed use on sugar apple,
cherimoya, atemoya, custard apple, ilama, soursop, briba, guava, fejoa,
jaboticaba, wax jambu, starfruit, passionfruit,  acerola, persimmon,
lychee, longan, Spanish lime, rambutan and pulasan and all registered
and pending uses. DEEM-FCID™ software (Version 2.14) utilizing the
94-96-98 CSFII consumption database was used to estimate exposure.
Average anticipated residues, processing factors (where available) and
average percent crop treated values were used in the chronic assessment.
The chronic reference dose of 0.014 mg/kg bw/day is based on the one
year dog study NOAEL of 1.38 mg/kg bw/day and an applied uncertainty
factor of 100X (10x for interspecies extrapolation and 10x for
intraspecies variations). Spirodiclofen has been classified by EPA as
“likely to be carcinogenic to humans” by the oral route.  The unit
risk, Q1*(mg/kg/day)-1 for spirodiclofen is 1.49 x 10-2 based on male
rat testes Leydig cell adenoma.  Chronic and cancer aggregate risk
estimates include exposure from drinking water and from food sources. >

<	i. Food. Chronic dietary exposure estimates from residues of
spirodiclofen

for the U.S. population is 0.3% of the cPAD. The population with the
highest

exposure is children 1-2 years with 0.9% of the cPAD utilized. The
chronic

cancer dietary exposure estimate for the general population is 5.88 x
10-7.>

<	ii. Drinking water. To assess chronic risk, drinking water estimates
were

incorporated directly into the dietary analysis (DEEM-FCID residue
file). The chronic estimated environmental concentration (EEC) for
drinking water was based on the PRZM/EXAMS model. The water exposure
assessment was done using the latest EPA modeling tool PE5 and the
latest modeling scenarios.  In the assessment, regional percent crop
areas were used.  The chronic (non-cancer) exposure for spirodiclofen
(total residue including its three metabolites: spirodiclofen-enol,
spirodiclofen-ketohydroxy, and spirodiclofen-dihydroxy) in surface water
was estimated to be 0.98 ppb in surface water. The EEC for chronic
(cancer) exposure in surface water was estimated to be 0.67 ppb.
Combined chronic dietary exposure estimates from residues of
spirodiclofen in food and drinking water for the U.S. population is 0.4%
of the cPAD. The populations with the highest potential; exposures are
infants and children 1-2 years with 1.1% of the cPAD utilized. The
chronic cancer dietary exposure estimate for the general population is
8.96 x 10-7. >

<	2. Non-dietary exposure. There are no indoor residential, indoor
commercial

or outdoor residential uses for spirodiclofen.>

<D. Cumulative Effects>

<	Spirodiclofen represents a new class of chemistry, ketoenols. There
are no

data available to indicate that toxic effects produced by spirodiclofen
are a result of

a common mechanism and should be cumulated with those of any other
compound.

EPA has not made a common mechanism of toxicity finding as to
spirodiclofen and

any other substances and spirodiclofen does not appear to product a
toxic

metabolite produced by other substances. Bayer CropScience will submit

information, if necessary, for EPA to consider concerning potential
cumulative

effects of spirodiclofen consistent with the schedule established by EPA
at 62

Federal Register 42020 (Aug. 4, 1997) and other EPA publications
pursuant to the

Food Quality Protection Act. >

<E. Safety Determination>

<	1. U.S. population. Based on the exposure assessments described above
and

on the completeness and reliability of the toxicity data, it can be
concluded that total

aggregate exposure to spirodiclofen residues in food and drinking water
resulting from all label and pending uses as well as the proposed
tropical fruit uses will utilize 0.4 percent of the cPAD for chronic
dietary exposures to the U.S. Population. EPA generally has no concerns
for exposures below 100 percent of the cPAD, because it represents the
level at or below which daily aggregate exposure over a lifetime will
not pose appreciable risks to human health. Cancer aggregate risk was
calculated for the U.S. population only. The cancer risk estimate with
drinking water included is 8.96 x 10 -7. Since EPA considers a cancer
risk to be greater than negligible when it exceeds the range of 1-3 in a
million, the estimated cancer risk for spirodiclofen is not likely to
exceed the Agency’s level of concern. Thus, it can be concluded that
there is a reasonable certainty that no harm will result to the U.S.
population from aggregate exposure to spirodiclofen residues.>

<	2. Infants and children. The Agency has concluded that there is no
evidence of

increased susceptibility following the in utero and/or
prenatal/postnatal exposure in

the developmental toxicity studies in rabbits and 2-generation
reproduction studies

in rats. The results from developmental, reproduction and 2 DNT studies
do not indicate a significant concern for increased susceptibility, and
therefore the FQPA safety factor has not been retained in calculating
the reference dose for chronic risk. The most highly exposed population
subgroups are infants and children 1-2 years with a total aggregate
(food and water) exposure to spirodiclofen from all the registered and
pending uses and the proposed tropical fruit uses being 1.1% of the cPAD
for chronic dietary exposures. EPA generally has no concerns for
exposures below 100 percent of the cPAD, because it represents the level
at or below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health.

>

<F. International Tolerances>

<	At the July 2010 Codex meeting, the Committee decided to advance the
proposed draft MRLs for adoption at Step 5/8 as follows:

Commodity	MRL (mg/kg)

Dried grapes (= currants, sultanas, raisins)	0.3

Tree nuts	0.05

Tomato	0.5

Strawberry	2

Stone fruits	2

Pome fruits	0.8

Papaya	0.03*

Meat (from mammals other than marine mammals)	0.01*

Milks	0.004*

Hops, Dry	40

Gherkins	0.07

Edible offal (mammalian)	0.05*

Currants (red, black, white)	1

Cucumber	0.07

Citrus fruits	0.4

Coffee beans	0.03*

Apple pomace, Dry	4

Almond hulls	15

Peppers, sweet (including pimento, pimiento)	0.2

Grapes	0.2

>

 PAGE

 PAGE   2


[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Notices]
[Pages 82005-82008]
[FR Doc No: 2020-27723]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90642; File No. SR-CBOE-2020-115]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the Fees Schedule With Respect to Certain Fees Related to Qualified
Contingent Cross Transactions the Exchange's LMM Incentive Programs

December 11, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 4, 2020, Cboe Exchange, Inc. (the ``Exchange'' or
``Cboe Options'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend the Fees Schedule with respect to certain fees related to
Qualified Contingent Cross transactions the Exchange's LMM incentive
programs. The text of the proposed rule change is attached [sic] as
Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Fees Schedule with respect to
Qualified Contingent Cross (``QCC'') transaction fees and the
Exchange's Lead Market-Maker (``LMM'') programs.\3\
---------------------------------------------------------------------------

    \3\ The Exchange initially filed the proposed fee changes
December 1, 2020 (SR-CBOE-2020-113). On December 4, 2020, the
Exchange withdrew that filing and submitted this proposal.
---------------------------------------------------------------------------

    The Exchange first notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels at a particular venue to be
excessive or incentives to be insufficient. More specifically, the
Exchange is only one of 16 options venues to which market participants
may direct their order flow. Based on publicly available information,
no single options exchange has more than 15% of the market share.\4\
Thus, in such a low-concentrated and highly competitive market, no
single options exchange possesses significant pricing power in the
execution of option order flow. The Exchange believes that the ever-
shifting market share among the exchanges from month to month

demonstrates that market participants can shift order flow or
discontinue to reduce use of certain categories of products in response
to fee changes. Accordingly, competitive forces constrain the
Exchange's transaction fees, and market participants can readily trade
on competing venues if they deem pricing levels at those other venues
to be more favorable. In response to competitive pricing, the Exchange,
like other options exchanges, offers rebates and assesses fees for
certain order types executed on or routed through the Exchange.
---------------------------------------------------------------------------

    \4\ See Cboe Global Markets U.S. Options Monthly Market Volume
Summary (November 25, 2020), available at https://markets.cboe.com/us/options/market_statistics/.
---------------------------------------------------------------------------

QCC Fees
    By way of background, a QCC order is comprised of an `initiating
order' to buy (sell) at least 1,000 contracts, coupled with a contra-
side order to sell (buy) an equal number of contracts and that for
complex QCC transactions, the 1,000 contracts minimum is applied per
leg. Currently, the Exchange assesses no fee for Customer (``C''
capacity) QCC transactions and $0.17 per contract side for non-Customer
transactions. In addition, the Exchange provides a $0.10 per contract
credit for the initiating order side, regardless of origin code. The
Exchange proposes to eliminate the $0.17 transaction fee for
Professional (``U'' capacity) QCC orders (i.e., such transactions would
be free).\5\ The Exchange similarly proposes to provide that the $0.10
per contract credit for the initiating order side would not apply to
(i) Professional to Professional executions or (ii) Professional to
Customer executions, in light of the fact that the Exchange is
proposing to waive the transaction fee for Professional QCC Orders.
More specifically, since the Exchange is proposing to eliminate the fee
for Professional QCC transactions, and since Customers already aren't
assessed a fee for such transactions, the Exchange does not wish to
provide a credit for transactions that do not generate any fees. The
proposed change is consistent with the current Fees Schedule which
provides that the QCC credit is not applied to Customer to Customer QCC
executions. The purpose of the proposed change to waive fees for
Professional QCC orders is to incentivize the sending of QCC orders to
the Exchange by these market participants and compete with other
Exchanges that similarly do not assess fees to QCC orders from
Professional Customers.\6\
---------------------------------------------------------------------------

    \5\ Pursuant to this proposal, Professional Customer (Capacity
U) QCC orders would receive fee code QC instead of fee code QN.
    \6\ See e.g., BOX Options Fee Schedule, Section 1(D), Qualified
Contingent Cross (``QCC'') Transactions, which provides that no fees
are assessed for Customer and Professional Customer QCC
transactions. See also NYSE American Options Fee Schedule, Section
1(F), QCC Fees and Credits, which also provides that no fees are
assessed for Customer and Professional Customer QCC transactions.
---------------------------------------------------------------------------

LMM Programs
    The Exchange next proposes to amend each of its LMM Programs (i.e.,
the MSCI LMM Incentive Program, the GTH VIX/VIXW LMM Incentive
Programs, the GTH SPX/SPXW LMM Incentive Program and the RTH SPESG LMM
Incentive Programs (collectively ``LMM Programs'')). The LMM Programs
each currently provide a specified rebate where the LMM(s) in the
respective classes meet certain prescribed heightened quoting standards
as specified in the respective LMM Program tables in the Fees Schedule.
The Exchange notes that the LMMs for each program are not currently
obligated to satisfy the respective heightened quoting standards
detailed in the Fees Schedule, but rather, are eligible to receive the
respective rebates if they satisfy the prescribed heightened quoting
standards, which the Exchange believes encourage LMMs to provide
liquidity in their appointed classes. The Exchange also notes that the
notes section for each LMM Program provides that the Exchange may
consider exceptions to the prescribed quoting standards based on
demonstrated legal or regulatory requirements or other mitigating
circumstances. The Exchange proposes to adopt and codify another
exception to the prescribed quoting standards for each LMM Program.
Particularly, the Exchange wishes to provide that for each program, in
calculating whether an LMM meets the heightened quoting standard each
month, the Exchange will exclude from the calculation the LMM's worst
quoting day in that month (i.e., the business day on which the LMM met
or exceeded the heightened quoting standard in the least amount of
series).\7\ The Exchange proposes to adopt this exception to provide
further flexibility for LMMs. For example, the Exchange notes that
there may be certain circumstances, such as a day of extreme volatility
or where the LMM has a system issue, that may impact an LMM's ability
to meet the heightened quoting standards for that day, which could
result in the LMM no longer being able to satisfy the heightened
quoting standard for the remainder of the month. The Exchange believes
this proposed change will further encourage LMMs to continue to quote
aggressively in a class throughout the entire month despite one poor
performing day. For example, absent the proposed rule change, if an LMM
has a poor performing day early in the month, the LMM may no longer
have an incentive to continue to quote at the prescribed heightened
levels for the remainder of the month as it would know it would no
longer be eligible to receive the LMM rebate for that month even if it
continued to meet or exceed the prescribed quoting standards.
Accordingly, the Exchange believes the proposed rule change would
eliminate the potential disincentive that could occur if one poor
performing day prevented an LMM from meeting the heightened quoting
standards.
---------------------------------------------------------------------------

    \7\ An LMM's ``worst'' quoting day will be based on the highest
number of series missed and not the percentage of series missed. As
an example, assume an LMM met the heightened quoting standard for
all series every day of a given month except for two days. On ``day
1'' there were 100 available series and the LMM didn't meet the
heightened quoting standard for 40 of those series (i.e., missed 40%
of the available series) and on ``day 2'' there were 50 available
series and the LMM didn't meet the heightened quoting standard for
25 of those series (i.e., missed 50% of the available series). In
this scenario, the Exchange would omit from its calculation ``day
1'', because it missed a higher number of series (40 vs 25) even
though the LMM missed a lower percentage of available series (40% vs
50%). The Exchange notes that if an LMM misses the same number of
series on more than one day, it will still omit only one day to
eliminate from the calculation.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\8\ in general, and
furthers the objectives of Section 6(b)(4),\9\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Trading Permit Holders (``TPHs'') and
issuers and other persons using its facilities. The Exchange also
believes that the proposed rule change is consistent with the
objectives of Section 6(b)(5) \10\ requirements that the rules of an
exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest,
and, particularly, is not designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ 15 U.S.C. 78f.(b)(5).

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

    The Exchange believes that the proposed amendments to the Fees
Schedule are reasonable, equitable and not unfairly discriminatory. In
particular, the Exchange believes the proposal to not assess a fee for
Professional QCC orders is reasonable because such market participants
would not be subject to a transaction fee for such transactions. The
Exchange notes other Exchanges also waive fees for Professional QCC
transactions.\11\ Additionally, the proposed change would apply to all
Professional alike and the proposed fee changes reflect a competitive
pricing structure designed to compete with other exchanges that
similarly do not assess fees on these market participants. The Exchange
believes the proposed rule change will also incentivize Professionals
to direct their QCC order flow to the Exchange, which the Exchange
believes would enhance market quality to the benefit of all TPHs.
---------------------------------------------------------------------------

    \11\ See e.g., BOX Options Fee Schedule, Section 1(D), Qualified
Contingent Cross (``QCC'') Transactions, which provides that no fees
are assessed for Customer and Professional Customer QCC
transactions. See also NYSE American Options Fee Schedule, Section
1(F), QCC Fees and Credits, which also provides that no fees are
assessed for Customer and Professional Customer QCC transactions.
---------------------------------------------------------------------------

    The Exchange believes it's reasonable to eliminate the credit on
the initiating order side of a QCC transaction for (i) Professional to
Professional and (ii) Professional to Customer QCC executions as the
Exchange will no longer receive any transaction fees for such
transactions in light of its proposal to eliminate a transaction fee
for Professional QCC orders. The Exchange notes another exchange
similarly waives QCC-related credits for similar transactions.\12\ The
Exchange believes the elimination of the proposed credit is equitable
and not unfairly discriminatory because it applies to all Professionals
and because such market participants will no longer be subject to
transaction fees for QCC transactions.
---------------------------------------------------------------------------

    \12\ See NYSE American Options Fee Schedule, Section 1(F), QCC
Fees and Credits, which provides Floor Brokers will not receive a
credit for QCC trades that have a Customer or Professional Customer,
or both, on both sides of the trade.
---------------------------------------------------------------------------

    The Exchange believes the proposed rule change to omit an LMM's
worst quoting day each month is reasonable because it will encourage
LMMs to quote aggressively in a class throughout the entire month
despite one poor performing day. As discussed above, there may be days
on which an LMM cannot quote aggressively (e.g., LMM has a system
issue) and in certain months, one poor performing day can prevent an
LMM from meeting the heightened quoting standard required to receive
the rebate under the LMM Program. Moreover, in such months where an LMM
has a poor performing day, an LMM may be discouraged from quoting
aggressively the remainder of the month if it knows it were no longer
eligible to receive the rebate that month. This can be especially
problematic if a poor performing day occurs early in the month. The
Exchange notes that it adopted each of its LMM programs and
corresponding financial incentives to ensure there was sufficient
incentive for a TPH to undertake an obligation to quote at heightened
levels, without which could result in lower levels of liquidity in the
LMM Program classes. Accordingly, the Exchange believes the proposed
rule change will encourage LMMs to quote aggressively in a class
throughout the entire month (and thereby ensure sufficient liquidity),
notwithstanding a poor performing day. The Exchange also notes that
another exchange similarly omits a Market-Maker's worst quoting day
each month under from one of its financial incentive programs.\13\ The
Exchange believes the proposed change is equitable and not unfairly
discriminatory as it applies equally to all appointed LMMs.
---------------------------------------------------------------------------

    \13\ See Nasdaq ISE LLC, Options 7 Pricing Schedule, Section 3,
Regular Order Fees and Rebates, Footnote 5.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. First, the Exchange notes
that the proposed changes apply uniformly to similarly-situated TPHs.
The Exchange believes the proposed rule change serves to increase
intramarket competition by incentivizing Professionals to direct their
QCC orders to the Exchange, which will bring greater volume and
liquidity, thereby benefitting all market participants by providing
more trading opportunities and tighter spreads. Further, the Exchange
notes that other Exchanges don't assess fees to Professional (or
Customer) QCC transactions. The Exchange does not believe that the
proposed rule change related to LMM Programs will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because it applies uniformly to
any LMM appointed under these programs, which market participants play
a crucial role in providing active and liquid markets in their
respective assigned products.
    Next, the Exchange believes the proposed rule change does not
impose any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. As previously
discussed, the Exchange operates in a highly competitive market. TPHs
have numerous alternative venues they may participate on and direct
their order flow, including 15 other options exchanges. Additionally,
the Exchange represents a small percentage of the overall market. Based
on publicly available information, no single options exchange has more
than 15% of the market share. Therefore, no exchange possesses
significant pricing power in the execution of order flow. Indeed,
participants can readily choose to send their orders to other exchanges
and off-exchange venues if they deem fee levels at those other venues
to be more favorable. As noted above, the Exchange believes that the
proposed QCC transaction fee change is comparable to that of other
exchanges offering similar QCC functionality. Also, while the proposed
change to the LMM Programs applies only to the Exchange, another
exchange provides for a similar exception as proposed for one of its
financial incentive programs. Moreover, the Commission has repeatedly
expressed its preference for competition over regulatory intervention
in determining prices, products, and services in the securities
markets. Specifically, in Regulation NMS, the Commission highlighted
the importance of market forces in determining prices and SRO revenues
and, also, recognized that current regulation of the market system
``has been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' The fact that this market is competitive has also long
been recognized by the courts. In NetCoalition v. Securities and
Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .''. Accordingly, the Exchange does not believe its
proposed fee change imposes any burden on

competition that is not necessary or appropriate in furtherance of the
purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \14\ and paragraph (f) of Rule 19b-4 \15\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2020-115 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2020-115. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2020-115 and should be
submitted on or before January 7, 2021.
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-27723 Filed 12-16-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Page 19063]
[FR Doc No: 2017-08302]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Sentinel Training at the Food and Drug Administration; Public
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Sentinel Training
at FDA.'' The purpose of the public workshop is to provide training to
understand the kinds of questions that can be asked using health care
claims data generally and within the FDA Sentinel System specifically,
allowing an understanding of the capabilities of the Sentinel System.

DATES: The public workshop will be held on July 10, 2017, from 10 a.m.
to 4 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), Silver
Spring, MD 20993. Entrance for the public workshop participants (non-
FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Kayla Garvin, Food and Drug
Administration, 10903 New Hampshire Avenue, Bldg. 51, Rm. 6314, Silver
Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Sentinel Initiative began in 2008 as a multiyear effort to
create a national electronic system for monitoring the performance of
FDA-regulated medical products. The Sentinel Initiative is FDA's
response to the Food and Drug Administration Amendments Act of 2007
(FDAAA) requirement that FDA work with public, academic, and private
entities to develop a system to obtain information from existing
electronic health care data from multiple sources to assess the safety
of FDA approved medical products.
    The Sentinel System uses a distributed data approach in which Data
Partners maintain physical and operational control over electronic
health care data in their existing environments. The distributed
approach is achieved by using a standardized data structure referred to
as the Sentinel Common Data Model. Data Partners transform their data
locally in accordance with the Common Data Model, which enables them to
execute standardized computer programs that run identically at each
Data Partner site. Data Partners are able to review the results of the
queries before sending them back to the Sentinel Operations Center.
Queries are distributed and results are returned through a secure
portal to preserve privacy.

II. Topics for Discussion at the Public Workshop

    This full-day seminar, targeting clinical researchers and others
without direct experience using health care claims data, will provide
an overview of data that are and are not available in the Sentinel
Distributed Database, the Sentinel Common Data Model, and a description
of the distributed tools available to work with the data. This seminar
will help those in attendance understand the kinds of questions that
can be asked using health care claims data generally and within the
Sentinel System specifically. Attendees will leave with an
understanding of the capabilities of the Sentinel System. The Sentinel
System can help the public, academia, and private entities better
understand potential safety issues associated with FDA-approved medical
products. Importantly, users can get responses to their questions in a
matter of weeks, as compared to months, or even longer using
traditional surveillance methods.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following Web site: https://www.eventbrite.com/e/sentinel-training-at-food-and-drug-administration-registration-32503315291. Please provide
required contact information for each attendee, including name, title,
affiliation, and email.
    Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. If time and space permit, onsite registration
on the day of the public workshop will be provided beginning at 9 a.m.
    If you need special accommodations due to a disability, please
contact Kayla Garvin no later than June 30, 2017.
    Streaming Webcast of the public workshop: This public workshop will
also be Webcast at: https://collaboration.fda.gov/sentineltraining2017/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
    Transcripts: Please be advised that transcripts will not be
available.

    Dated: April 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-08302 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P