1 Summary of Summary of EPA Ethics Review EPA Ethics Review McFarlane, P.; Freestone, S. ( 1999) A Randomised Double Blind Ascending Oral Dose Study with Oxamyl: Lab Project No. HLO 1998

01505. Unpublished study prepared by Inveresk Clinical Research. 624 p. MRID 44912301. 2 Oxamyl Oral Study Oxamyl Oral Study

Conducted at ICR in 1999, following earlier Methomyl study

Designed as a 5 level escalating dose protocol,

with no further escalation after   40% ChEI or   25% at two successive time points

After original five dose levels were well tolerated, a sixth higher dose was added. 3 Oxamyl Oxamyl " Framework Framework"

1. Value  Not published or disseminated  Societal value not addressed in reports 2. Scientific Validity: Defer to others 3. Subject Selection  Adult male volunteers from pool at laboratory  No evidence of use of vulnerable groups 4 Oxamyl Oxamyl " Framework Framework"

 2 4. Risk Benefit Ratio  Risks adequately described to subjects  Risk minimization not discussed; narrow margin between planned doses and reported animal NOELs  Societal or other benefits not addressed  Weighing of societal benefits against risks to subjects not addressed  Protocol states no information on incidents available;

sponsor submitted 12 incident reports to EPA before this study 5 Oxamyl Oxamyl " Framework Framework"

 3 5. Independent Ethics Review  Protocol approved by Inveresk Independent Ethics Committee  Committee members named, but independence from investigators and freedom from conflicts of interest not addressed  Committee expressed concern about how little was known about oxamyl, and its " alarming"

toxicity 6 Oxamyl Oxamyl " Framework Framework"

 4 6. Informed Consent  Consent was obtained from all subjects  Volunteer information covered procedure and possible physical effects adequately, but was less complete on other topics, especially the nature and distribution of benefits  potentially confusing references to the " supervising doctor" and " the company", neither of whom was identified 7 Oxamyl Oxamyl " Framework Framework"

 5 7. Respect for Subjects  Subjects' privacy was protected  Subjects were free to withdraw without penalty 8 Oxamyl: Prevailing Standard Oxamyl: Prevailing Standard

Conducted in UK in 1999

Cites and asserts compliance with Declaration of Helsinki ( 1996)

Cites and asserts compliance with   guideline for Good Clinical Practice ( CPMP/ ICH/ 135/ 95)  9 Comparison to Comparison to DoH DoH

Basic Principle # 1:   Biomedical research involving human subjects . . .

should be based . . . on a thorough knowledge of the scientific literature.

EPA Comment: Protocol statement that   no data on accidental or incidental exposure of people to oxamyl is available  is inconsistent with the twelve incident reports previously submitted to EPA. 10 Comparison to Comparison to DoH DoH

 2

Basic Principle # 5:   Every . . .

project . . . should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.

EPA Comment: If a careful assessment was conducted it was not reported. 11 Comparison to Comparison to DoH DoH

 3

Basic Principle # 12:   The research protocol should always contain a statement of the ethical considerations involved . . . .

EPA Comment: There is no such statement in the protocol 12 Oxamyl Summary Oxamyl Summary

There are some gaps in the record, but gaps are not   clear and convincing evidence .

There is no evidence that the research was fundamentally unethical.

Some deficiencies are apparent relative to the cited 1996 Declaration of Helsinki.

We welcome the Board s advice on the significance of those deficiencies. 13 Methomyl Methomyl Charge to the HSRB Charge to the HSRB Methomyl is a member of the N methyl carbamate ( NMC) common mechanism group based on its ability to inhibit acetylcholinesterase via carbamylation. The Agency has previously completed the acute, aggregate ( single chemical,

multi route) risk assessment of methomyl. At the present time, the Agency is considering the use of the methomyl acute oral, human toxicity study to inform the inter species uncertainty factor used in the cumulative risk assessment of the NMCs. 14 Methomyl Methomyl Charge to the HSRB Charge to the HSRB 1. Scientific considerations:

The Agency's WOE document and DER for methomyl describe the study design and results of the methomyl acute oral, human study. The WOE document also discusses the Agency's conclusions regarding the usefulness of the human study in the cumulative risk assessment for the NMCs. For methomyl, the Agency has concluded that the human toxicity study supports a 10X inter species uncertainty factor for methomyl in the cumulative risk assessment of the NMCs.

Please comment on the scientific evidence that supports this conclusion. 15 Methomyl Methomyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations:

a. The Agency requests that the Board provide comment on the following:

 Whether the investigators' decision to administer a dose to additional subjects in session 3, when one subject receiving that dose in session 2 displayed RBC ChEI greater than 40%, a response that triggered the protocol's anti escalation provision, should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; 16 Methomyl Methomyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

a. cont'd. The Agency requests that the Board provide comment on the following:

 Whether the timing of the investigators' report to the ethics committee of the adverse effects observed in one subject during session 2 should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; 17 Methomyl Methomyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

a. cont'd. The Agency requests that the Board provide comment on the following:

 Whether the failure of the investigators to request approval from the ethics committee for certain amendments to the approved protocol, as required by the protocol, when the changes were administrative and had no effect on the safety of the subjects should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; and 18 Methomyl Methomyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

a. cont'd. The Agency requests that the Board provide comment on the following:

 Whether the absence from the protocol of discussion of the potential risks to subjects or benefits to society of conducting the proposed research ( as required by the Declaration of Helsinki, Principle # 5) should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; and 19 Methomyl Methomyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

b. The Agency asks that the Board provide comment on the following, taking into account all that is known about the ethical conduct of this study:

 OPP's conclusion that there is not clear and convincing evidence that the conduct of the research was fundamentally unethical.

 Whether there is clear and convincing evidence that the conduct of the study was significantly deficient relative to the ethical standards prevailing when the study was conducted 20 Oxamyl Oxamyl Charge to the HSRB Charge to the HSRB Similar to aldicarb and methomyl, oxamyl is a member of the N methyl carbamate ( NMC) common mechanism group based on its ability to inhibit acetylcholinesterase via carbamylation and is thus included in the NMC cumulative risk assessment.

The Agency has previously completed the acute,

aggregate ( single chemical, multi route) risk assessment of oxamyl. The Agency is now considering the use of the oxamyl acute oral, human toxicity study to inform the inter species uncertainty factor in the cumulative risk assessment of the NMCs. 21 Oxamyl Oxamyl Charge to the HSRB Charge to the HSRB 1. Scientific considerations:

The Agency's WOE document and DER for oxamyl describe the study design and results of the oxamyl acute oral, human toxicity study. The WOE document also discusses the Agency's conclusions regarding the usefulness of the human study in the cumulative risk assessment for the NMCs. For oxamyl, the Agency has concluded that the human toxicity study is sufficiently robust for reducing the 10X inter species ( ie, animal to human) uncertainty factor in the cumulative risk assessment.

Please comment on the scientific evidence that supports this conclusion. 22 Oxamyl Oxamyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations:

a. The Agency requests that the Board provide comment on the following:

 Whether inclusion in the protocol submitted to the ethics committee of a factually inaccurate statement regarding unavailability of data on accidental or incidental exposure to oxamyl should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; 23 Oxamyl Oxamyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations:

a. cont'd. The Agency requests that the Board provide comment on the following:

 Whether the absence from the protocol of any discussion of the potential risks to subjects or benefits to society of conducting the proposed research ( as required by the Declaration of Helsinki, Principle # 5) should be considered significantly deficient relative to the ethical standards prevailing when the study was conducted; and 24 Oxamyl Oxamyl Charge to the HSRB Charge to the HSRB 2. Ethical considerations, cont'd:

b. The Agency asks that the Board provide comment on the following, taking into account all that is known about the ethical conduct of [ this/ each] study:

 OPP's conclusion that there is not clear and convincing evidence that the conduct of the research was fundamentally unethical.

 Whether there is clear and convincing evidence that the conduct of the study was significantly deficient relative to the ethical standards prevailing when the study was conducted


1 Statement Supporting the Renewal of the Information Collection Procedure for Local Planning Requirements and Facility Emergency Release Notification 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection Emergency Planning and Release Notification Requirements ( EPCRA sections 302, 303, and 304) ( Renewal) B EPA No. 1395.06, OMB Control No. 2050 0092.

1( b) Short Characterization This information collection request ( ICR) was previously approved as OMB No. 2050 0092 through February 28, 2006, for 212,460 hours. The Emergency Planning and Community Right to Know Act of 1986 ( EPCRA) established broad emergency planning and facility reporting requirements. Section 302 ( 40 CFR 355.30) requires any facility where an extremely hazardous substance ( EHS) is present in an amount at or in excess of the threshold planning quantity ( TPQ) to notify the state emergency response commission ( SERC) by May 17, 1987. This activity has been completed; the section 302 costs and burden hours for this ICR, therefore, reflect only the estimate of the cost and burden incurred by those additional facilities who come to have an EHS in excess of the TPQ during the period covered by this ICR. Section 303 ( 40 CFR 355.30) requires local emergency planning committees ( LEPCs) to prepare emergency plans for facilities that have EHSs in excess of the TPQs in their local planning district. Facilities are required to provide local planners with information necessary for the preparation of emergency plans. In addition, the facilities are required to inform LEPCs of any relevant changes in chemical use or production that may effect the emergency plans. Section 303 requires LEPCs to complete their emergency plans by October 17, 1988. This ICR therefore reflects the costs attributable to the requirement of annually updating the local emergency response plans.

Section 304 ( 40 CFR 355.40) requires facilities to report to SERCs and LEPCs releases in excess of quantities established by EPA. Facilities are required to report releases above the reportable quantity ( RQ) of any EHS or other hazardous substance, as identified under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( CERCLA) section 101. Notice of release must be given to both the LEPC and SERC. In addition, facilities must provide a written follow up report providing additional information on the release, its impacts, and any actions taken in response.

EPA estimates that 76,916 facilities ( 19,998 manufacturers and 56,918 non manufacturers) are subject to reporting under EPCRA section 302 and 3,456 SERCs and LEPCs are subject to section 303. EPA estimates that approximately 4,443 release notifications are made annually under section 304. The total burden to facilities over the three year information collection period is estimated to be 229,473 hours ( 76,491 hours annually), at a cost of $ 11.1 million $( 3.7 million annually), with an associated state and local burden of 320,568 hours ( 106,856 hours annually), at a cost of $ 8.1 million ( 2.7 million annually). The combined total annual burden for facilities and state and local agencies is 183,347 hours at a cost of $ 6.4 million. No Agency burden is estimated in association with this ICR. 2 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection The authority for these requirements is EPCRA sections 302, 303, and 304 ( 42 U. S. C. ' 11002, 11003, and 11004).

Section 302 of EPCRA required the EHS list to be " the same list as the list published in November 1985 by the Administrator in Appendix A of the   Chemical Emergency Preparedness Program Interim Guidance'." The section further required EPA to " publish an interim final regulation establishing a threshold planning quantity for each substance on the list..." If EPA failed to publish the interim final rule, " the threshold planning quantity for the substance shall be 2 pounds until such time as the Administrator publishes regulations establishing a threshold for the substance."

The interim final rule was published in the Federal Register on November 17, 1986 ( 51 FR 41570), followed by a final rule published on April 22, 1987 ( 52 FR 13378). The EHS list consisted at that time of 406 chemicals, and the TPQs ranged from one pound to ten thousand pounds. There are currently 355 chemicals on the EHS list.

The EHS list along with the TPQs is used to designate facilities for initial screening for the local emergency planning process. Section 303 of EPCRA requires facilities that have to provide the notification under section 302 to designate a facility coordinator to the LEPC and to " promptly provide information to [ the LEPC] necessary for developing and implementing the emergency plan." In this manner, the LEPC determines the potential scope of a response and, therefore, the amount of effort necessary for emergency planning. The LEPC will review its plan annually and incorporate any changes or additions. These emergency plans increase the local response and preparedness capability by allowing local planners to work with industry in their community, to determine the level of preparedness necessary for a response if a release should occur.

Under section 304, respondents are required to notify the LEPC and SERC of releases of EHSs or hazardous substances ( as identified under CERCLA section 101) above the reportable quantity. The purpose of the reporting is to allow response agencies to determine whether their assistance is needed in handling the response action. The facility must provide a written follow up report.

2( b) Practical Utility/ Users of the Data The information provided by facilities under sections 302, 303, and 304 is provided to the SERCs and LEPCs. Individuals can obtain the information by contacting the SERCs and LEPCs. The information provided under sections 302 and 303 is used to increase the community's level of preparedness to respond to releases of chemicals in their community. The information is also made available to the public to allow individuals to practice their " right to know" about the hazards posed by chemicals in their community.

The information provided under section 304 is the trigger to activate the community's chemical emergency response system. The written follow up report is to update and clarify the information provided in the initial call. It is also made available to the public so that the community can understand what happened during the release. 3 3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non Duplication Currently, there are no federal reporting requirements comparable to sections 302, 303, and 304 of EPCRA. Release reporting under CERCLA section 103 is an emergency notification to the National Response Center ( NRC), while release reporting under section 304 is directly to local and state entities. The follow up report required under section 304 is also unique.

3( b) Consultations EPA talked with the following representatives of SERCs to obtain estimates of the number of facilities subject to the rule:

Ray Dinardo Carole Dougherty Steve Mason EPA Region 1 EPA Region 3 EPA Region 6 Martha Wolfe Ted Mix Dan Roe EPA Region 8 EPA Region 10 AZ SERC 3( c) Public Notice In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq. ), the Agency notified the public through a Federal Register notice on the re submission of this ICR on September 12, 2005 ( 70 FR 53793). EPA received only one comment.

The commenter raised two issues. The first issue raised by the commenter is related to the proposed rule on Administrative Reporting Exemption for Certain Air Releases of Nox ( NO and NO2), October 4, 2005 ( 70 FR 57813). Commenter stated that this ICR should be adjusted to consider the impact of this rule on the regulated community.

EPA recognizes that once the rule is finalized there will be some reduction in burden to those facilities that fall under the exemption. Until the rule is finalized, the Agency cannot account for the reduction in burden in this ICR.

The second issue raised by the commenter was that the Agency did not use updated wage rates for private industries. Note that the Agency revised this ICR by using the wage rates stated in the U. S. Bureau of Labor Statistics, March 2005 edition.

3( d) Effects of Less Frequent Collection The reporting deadlines for sections 302, 303, and 304 are set by statute. EPA has no authority to allow less frequent collection.

3( e) General Guidelines The collection activities specified in this renewal ICR adhere to the guidelines specified by OMB. 4 3( f) Confidentiality The respondent may claim specific chemical identities as trade secret in the notification to LEPC on information for developing and implementing the emergency response plan, under Section 303( d)( 2) and ( d)( 3). Such information must be submitted according to EPCRA sections 322 and 323 ( 40 CFR Part 350). All trade secrecy claims submitted to EPA under EPCRA are handled and stored according to procedures set out in the Manual for Physical Handling, Security, And Protection of Files Containing Trade Secret Claims Submitted under Sections 303, 311, 312 and/ or 313 of the Emergency Planning and Community Right to Know Act ( EPCRA). These procedures were developed expressly for EPCRA trade secrecy claims with the knowledge that these documents are sensitive. Handling and review of documents containing EPCRA trade secret information is permitted only by persons who have obtained formal clearance to access the information based on a work related need to engage in these activities. When not being processed or reviewed by authorized individuals, the claim submissions containing trade secret information are stored in restricted access areas. To ensure that appropriate handling procedures are activated and the confidentiality of EPCRA trade secret submissions is maintained, the Agency attaches a cover sheet to the top of each trade secret document and otherwise marks the document to clearly identify the document as EPCRA confidential.

3( g) Sensitive Questions The information gathering activities under this renewal ICR do not involve any sensitive questions.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS Codes Sections 302, 303, and 304 are applicable to all facilities that either have present or release the regulated substances. These sections apply to facilities in both the manufacturing and non manufacturing sectors. EPCRA, as written, does not apply to federal facilities. However, Executive Order 12856 requires all federal agencies to comply with the law.

Facilities in the following major group of NAICS codes may be subject to either or both implementing regulations under EPCRA section 302 and 304. There may be other facilities covered by these regulations, but not listed. Major group that may be subject are: 11 ( Agriculture, Forestry, Fishing and Hunting), 22 ( Utilities), 31 33 ( Manufacturing), 43 ( Wholesale Trade ), 44 45 ( Retail Trade), 48 49 ( Transportation and Warehousing).

4( b) Information Requested 4( b)( i) Data Items Facilities newly subject to section 302 must notify their SERC and LEPC of their reporting obligation. Under section 303, the facility must designate a coordinator and provide " information to ( the LEPC) necessary for developing and implementing the ( LEPC's) emergency plan." The amount of information necessary to fulfill this requirement is determined by the facility and the LEPC. If a facility 5 has very low likelihood of having a release that would impact the community, the LEPC would probably require very little information for emergency planning. However, if the facility is a large chemical plant or is in close proximity to a populated area, the LEPC most likely will develop extensive planning ( especially if the facility is anticipating an offsite response). Information requested for the plan would likely include:

C Names, hazards, quantities, and storage information for hazardous chemicals on site;

C Methods and procedures to be followed by facility owners and operators to respond to a release;

C Description of emergency equipment;

C Methods for determining the occurrence of a release, and the area or population likely to be affected by the release; and C Procedures to provide reliable, effective, and timely notification.

LEPCs were required to have their plans completed by October 17, 1988. Therefore, only facilities newly subject to these requirements would have to provide this information. Facilities already subject would only have to update the LEPC if the information that they have already provided changes.

Under section 304, respondents are required to notify the LEPC and SERC of releases of EHSs or hazardous substances ( as identified in CERCLA section 101) above the reportable quantity. The notice must include the following information, to the extent that it is known:

C The chemical name or identity of any substance involved in the release;

C An indication of whether the substance is on the list of EHSs;

C An estimate of the quantity of any such substance that was released into the environment;

C The time and duration of the release;

C The medium or media into which the release occurred;

C Any known or anticipated acute or chronic health risks associated with the emergency and, where appropriate, advice regarding medical attention necessary for exposed individuals;

C Proper precautions to take as a result of the release, including evacuation ( unless such information is readily available to the community emergency coordinator pursuant to the emergency plan); and C The name and telephone number of the person or persons to be contacted for further information. 6 The facility must provide a written follow up report that includes the information above and any updates. Also, additional information must be given:

C Actions taken to respond to and contain the release;

C Any known or anticipated acute or chronic health risks associated with the release; and C Where appropriate, advice regarding medical attention necessary for exposed individuals.

4( b)( ii) Respondent Activities To determine if a facility is subject to section 302, the facility would need to review the EHS list to determine if it has any of the 355 chemicals on site. The facility would then need to look at the inventory of any EHSs it may have on site and compare it to the TPQ. If the facility has an EHS above the TPQ, the facility would need to contact ( preferably in writing) their SERC and LEPC to notify them of their reporting obligation.

To comply with section 303, the designated facility coordinator would have to work with the LEPC to ensure that the community has an adequate plan to respond to emergencies that would involve their facility. Facility coordinators may be asked to serve as an industry representative to the LEPC.

To comply with section 304, the facility would need to determine, when an EHS or a CERCLA hazardous substance is being released, if the quantity of the chemical released is greater than the reportable quantity; this information needs to be provided in the initial telephone notification to the SERC and LEPC. The material safety data sheet ( MSDS) or other information that the facility has would provide the health risks and medical information, as well as response information.

The written follow up notice needs to be filed " as soon as practical after a release." This notice documents and updates the information provided in the initial notification. Because the initial notification should be provided immediately after the discovery of the release, the written follow up notice allows the facility more time to determine with greater precision the information provided in the initial notification. The facility may include a copy of their own internal report of the circumstances of the accident.

5. THE INFORMATION COLLECTED: AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities No information provided under sections 302, 303, and 304 is sent to EPA. All of the information is kept at the state or local level.

5( b) Collection Methodology and Management EPA does not receive the data; therefore, EPA does not have any special data collection methodology and management. However, to assist SERCs and LEPCs in their information management practices and emergency planning, EPA and the National Oceanic and Atmospheric Administration have created the Computer Aided Management of Emergency Operations ( CAMEO) database. 7 5( c) Small Entity Flexibility There are no special allowances made for small businesses in the regulations for sections 302, 303, and 304. The burden hours for small businesses are considered to be smaller than those for large facilities because of the reduced number of chemicals and processes present at smaller facilities.

5( d) Collection Schedule The frequency of collection for these sections of EPCRA is required by statute. Facilities are required to report any relevant changes when they occur. Under section 304, releases of EHSs and CERCLA hazardous substances in excess of the reportable quantity must be reported " immediately" after the owner/ operator has knowledge that they occurred. The written follow up notice is required " as soon as practicable after the release."

6. ESTIMATING THE BURDEN AND COST OF COLLECTION 6( a) Estimating Respondent Burden EPA estimated the respondent burden hours and costs associated with all recordkeeping and reporting requirements covered in EPCRA sections 302, 303, and 304. Unit burden and costs were estimated by labor category required for each of the tasks performed by facilities under 40 CFR Part 355, and tasks performed by LEPCs and SERCs under 40 CFR Part 355 and 40 CFR Section 300.215.

The previous ICR estimated that 71,400 facilities were subject to the requirements of EPCRA section 302. In preparing that ICR, EPA contacted seven states listed under 3( b) to obtain data on the actual number of facilities reporting under sections 302 and 303.

In developing this ICR, EPA estimated that 76,916 facilities are subject to EPCRA 302 notification requirements. For purposes of comparison, EPA used a strictly population based extrapolation and found that 80,664 facilities would be subject to such notification requirements. In calculating the facilities number of 76,916 that is employed in this ICR, EPA used reported regional and state level data to determine missing data for EPA regions IV, V, and VII where such information was lacking. The following methodology was used: EPA determined correlating factors that may demonstrate similarities or dissimilarities in the number of facilities in different regions. These included both a measure of manufacturing per capita ( i. e., manufacturing density) and an assessment of agricultural land use ( i. e., agricultural density) for states and regions. Using the reported data for each state and region, EPA gathered population data by state from the 2004 U. S. Census to determine the ratio of EPCRA facilities per capita ( i. e., facilities density) for both states and regions. Due to the limited number of statelevel EPCRA facilities data points, EPA determined that a more accurate conclusion would result by making comparisons at the regional level ( where more data was available). These comparisons were based both on manufacturing density and agricultural density to find regions that were most similar. Finally, the ratio if EPCRA facilities per capita was used to extrapolate the total number of such facilities in the regions lacking data. 8 EPA estimates that approximately 26 percent of these facilities are manufacturers ( 19,998), based on the total estimated number of manufacturers and non manufacturers subject to sections 311 and 312.1 An annual growth factor of . 67 percent is applied to the number of manufacturers to yield an estimated 19,864 manufacturing facilities that are subject to EPCRA section 302 requirements as of the first year of the ICR approval period. 2 In this ICR, the number of non manufacturers is estimated to remain constant, at 56,918 facilities. These estimates are used as the basis for calculating the total annual burden and cost estimates for each of the three years covered by this ICR. It is important to note, however, that initial reporting burdens for these facilities under EPCRA sections 302 are assumed to have occurred and are not included in this ICR. This ICR accounts for periodic reporting activities that apply to all currently regulated facilities. We do not expect any new facilities to be in compliance during this ICR period based on the most recent census data.

The number of notifications under section 304 was based on the number of reports of hazardous substance releases reported to the National Response Center in 2004, approximately 4,443. ( This estimate does not include reports on substances that are not subject to reporting requirements.)

Exhibit 1 presents the estimated unit burden by labor category required for each of the tasks performed by facilities under 40 CFR Part 355, and tasks performed by LEPCs and SERCs under 40 CFR Section 300.215.

Read and Understand Regulations EPA assumes that only newly regulated facilities incur the cost of reading and understanding regulations at 40 CFR Part 355. As explained above, we do not expect any new facilities to come into compliance in the period covered by this ICR based on the most recent census data. Therefore, EPA did not estimate any burden for this activity for new facilities. All currently regulated facilities are already familiar with the regulations and the burden for this activity was estimated in previous ICRs.

Emergency Planning by Facilities ( 40 CFR 355.30)

All newly regulated facilities must first determine whether they have at least a threshold planning quantity of an EHS. All newly regulated facilities are required to notify the SERC and designate a facility representative.

Because few facilities have significant changes that would affect emergency planning, EPA estimates that only ten percent of all subject facilities will be required to inform LEPCs of any changes at the facility. In addition, because little information is required from facilities after the initial submittal, EPA also estimates that only five percent of all subject facilities will provide additional information to LEPCs either to develop or implement emergency plans. The burden associated with providing local governments with updated information for planning purposes is assumed to be a small percentage of the 1 EPA previously estimated that only nine percent of the universe was manufacturers, based on a ratio of manufacturers to nonmanufacturers in the EPCRA section 311/ 312 universe. The number of non manufacturers, however, included a large number of facilities that are subject to 311/ 312 solely because of their production or storage of petroleum products, which are not subject to section 302. With these facilities removed from the non manufacturing universe of 311/ 312, the ratio of manufacturers to the total 311/ 312 universe is 26 percent. 2 To develop this estimate, EPA reviewed the most recent U. S. Census data on the number of manufacturing establishments. The summary data provided by the Census for changes in the number of manufacturers between 1997 and 2002 was then calculated using the formula for compounded annual growth, arriving at an annual growth rate of . 67 percent. This annual growth rate has been used to determine the current number of manufacturing facilities. 9 initial burden for contributing to planning efforts. EPA assumes that a burden of 17.65 hours are incurred per new respondent for emergency planning. ( See Exhibit 1). Emergency Release Notification by Facilities ( 40 CFR 355.40)

The number of annual reportable quantity ( RQ) releases based on the number of CERCLA hazardous substance releases reported in the National Response Center for 2004, approximately 4,443. EPA estimates 90 percent of RQ releases require notifying LEPCs and SERCs, and 10 percent require notifying the 911 operator. All reportable releases require a written follow up report.

For a previous ICR, EPA contacted four industries ( small to large size, see Section 3( b) of this document), to determine the actual burden incurred to comply with initial notification and written followup requirements in Section 304 of EPCRA. The average estimate from facilities closely matched to EPA= s estimate. The burden per respondent for initial notification is approximately 0.50 hours, for written follow up, it is approximately 4.35 hours. 10 Exhibit 1 Section 302, 303, and 304 Reporting and Recordkeeping Requirements Estimated Unit Burden and Cost Annual Hours Burden Total Hours Information Collection Activity Legal Management Technical Clerical Burden Annual Cost EMERGENCY PLANNING ( 355.30) ( Facilities)

Inform LEPC of changes to facility that may affect emergency planning 0.00 0.00 1.00 0.50 1.50 $ 50 Provide information to LEPC, as required 0.00 2.00 8.00 1.00 11.00 $ 527 EMERGENCY RELEASE NOTIFICATION ( 355.40) ( Facilities)

Determine if release is an RQ 0.00 0.10 0.10 0.00 0.20 $ 14 Notify LEPC and SERC of any RQ release 0.00 0.50 0.00 0.00 0.50 $ 48 Develop and submit written follow up notice 0.50 0.65 2.25 0.95 4.35 $ 230 Notify 911 operator of transportation related releases 0.00 0.25 0.00 0.00 0.25 $ 24 EMERGENCY RESPONSE PLANS ( 300.215) ( SERCs, LEPCs, and RRTs)

Update Emergency Response Plans ( LEPCs) 0.00 5.00 15.00 1.00 21.00 $ 822 Review Emergency Response Plans ( SERCs) 0.00 4.00 12.00 0.00 16.00 $ 642 Keep records and make them available to the public 0.00 0.00 0.00 10.00 10.00 $ 199 11 Emergency Response Plan Development by SERCs and LEPCs ( 40 CFR 300.215)

Emergency Response Plans must be reviewed and updated annually. EPA estimates that SERCs review all LEPC plans over a three year period. There are approximately 3,400 LEPCs. Based on information from LEPCs, the time required to update plans varies from 4 hours a year to 40 to 60 hours. To develop an estimate, EPA assumed that the largest 120 LEPCs would spend 40 hours a year and the smaller LEPCs would spend 20 hours a year; a weighted average of 21 hours was obtained for the recordkeeping burden to keep records of all Emergency Response Plans. Similarly, a weighted average was developed for recordkeeping associated with release reports. The LEPC with a large concentration of chemical plants indicated that it spent a month on release notification; the other LEPCs indicated that this activity took five hours a year at most. A weighted average of 10 hours was developed for the annual burden for each of the LEPCs ( 3400) and SERCs ( 56).

6( b) Estimating Respondent Costs Estimating costs to respondents on an annual basis is accomplished by multiplying the respondent burden estimates for each labor category by the corresponding labor rate for that category. Unit costs for each respondent or activity are then multiplied by the number of respondents or activities performed on an annual basis to yield a total cost for each information collection activity in Section 6( d). These costs are shown in Exhibit 1.

EPA estimates an hourly respondent labor cost for manufacturing facility respondents of $ 129.29 for managerial staff, $ 39.97 for technical staff, and $ 23.38 for clerical staff, including wages and benefits. Hourly respondent labor costs for non manufacturing facility respondents are estimated at $ 84.26 for managerial staff, $ 38.78 for technical staff, and $ 22.19 for clerical staff. Legal review is estimated at $ 116.17 and $ 112.49 per hour for manufacturing and non manufacturing facilities respectively. 3 A weighted average was developed based on the percentage of manufacturing and non manufacturing facilities.

EPA estimates an hourly respondent labor cost ( including overhead) for LEPCs and SERCs of $ 40.27 for managerial staff, $ 40.11 for technical staff, and $ 19.89 for clerical staff. 4 Total burden hours and costs for the first year of the ICR are shown in Exhibit 2.

Capital and O& M Costs Capital costs incurred by state and local agencies were estimated in the previous ICR. Capital costs include the cost of space required to store information in filing cabinets. Life expectancy for file cabinets were assumed to be 15 years. Therefore, the Agency did not develop any cost for this.

3 U. S. Bureau of Labor Statistics, Employer Cost for Employee Compensation, Table 12: Private Manufacturing and Nonmanufacturing Industries, March 2005.

4 Fringe rate from U. S. Bureau of Labor Statistics, Employer Cost for Employee Compensation, Table 4: State and local Government By Occupational and Industry Group, March 2005. 12 Operating and maintenance costs are limited to mailing costs. Facilities are assumed to incur postage costs for the following activities:

$ Providing information to the LEPC as required $ submitting written follow up notice ( assume about 4 pages per report)

Facilities are expected to incur long distance charges when notifying SERCs. This estimate affects notification of the SERC of any RQ release. Long distance charges are estimated to be $ 3.50 per fifteen minute call.

State and local governments are assumed to incur postage costs for the following activities:

$ Submitting Emergency Response Plans for review ( SERCs)

$ Submitting Emergency Response Plans as requested by SERCs to federal regional response teams for review Postage is estimated to cost $ 0.37 for a first class letter and $ 3.10 to submit a LEPC plan ( plan is up to 500 pages and weighs up to 5 pounds).

Operation and maintenance costs are shown in Exhibit 3.

6( c) Estimating Agency Burden and Cost EPA estimates no annual Agency burden associated with this ICR. Only state and local government entities are required to comply with sections 302, 303, and 304 of EPCRA.

6( d) Estimating Total Annual Respondent Burden and Costs Exhibit 2 presents the respondent burden for each information collection activity and for the sum of all information collection activities performed by each respondent type. The total average annual burden to facility respondents is 76,491 hours at a cost of $ 3.7 million ( or 229,473 hours at a cost of $ 11.1 million for three years). The total average annual respondent burden for state and local governments is 106,856 hours at a cost of $ 2.7 million ( or 320,568 hours at a cost of $ 8.1 million for three years). These burden estimates are summarized in Exhibit 2.

6( e) Bottom Line Burden Hours and Cost The total burden to facilities over the three year information collection period is estimated to be 229,473 hours ( 76,491 hours annually), at a cost of $ 11.1 million $( 3.7 million annually), with an associated state and local burden of 320,568 hours ( 106,856 hours annually), at a cost of $ 8.1 million ( 2.7 million annually). The combined total annual burden for facilities and state and local agencies is 183,347 hours at a cost of $ 6.4 million.

6( f) Reasons for Change in Burden 13 Based on the information received from SERCs/ LEPC and the most recent data from the census, the number of annual respondents increased slightly from the previous ICR. The estimated average annual burden to facilities decreased from 88,188 hours per year under the previous ICR to 76,491 hours per year under this ICR. The estimated burden to affected facilities has declined from the previous ICR because no new facilities will be subject to the regulations during this ICR period. Therefore, the burden or costs were not calculated for compliance for new facilities. Costs have risen for currently covered facilities because we used the most recent wage rates ( March 2005). The estimated average burden for SERCs and LEPCs decreased from 124,272 hours to 106,856 hours because the number of plans reviewed by SERCs annually has been reduced based on information from states that indicate that the level of review has declined from the early years of the program. The O& M costs in the previous ICR are in error. This ICR reflects the correct costs and an increase is noted due to an increase in the number of respondents.

6( g) Burden Statement As explained in the previous sections of this document, EPA do not expect any new facilities to come into compliance during this ICR period. This ICR only covers periodic reporting or updates of information submitted previously by existing facilities. The average reporting burden for a limited number of existing facilities, to inform the LEPC of any changes at the facility that may affect emergency planning is 1.50 hours. The average reporting burden for facilities reporting releases under 40 CFR 355.40 is estimated to average approximately 5 hours per release, including the time for determining if the release is a reportable quantity, notifying the LEPC and SERC, or the 911 operator, and developing and submitting a written follow up notice. There are no record keeping requirements for facilities under EPCRA Sections 302 304. The total burden to facilities over three years is 229,473 hours at a cost of $ 11.1 million.

The average burden for emergency planning activities is 21 hours per plan for LEPCs, and 16 hours per plan for SERCs. Each SERC and LEPC is also estimated to incur an annual record keeping burden of 10 hours. The total burden to LEPC and SERC over three years is 320,568 hours at a cost of $ 8.1 million.

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. 14 To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA HQ SFUND 2005 0008, which is available for online viewing at www. regulations. gov, or in person viewing at the Superfund Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, D. C. 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 Superfund Docket is ( 202) 566 0276. An electronic version of the public docket is available at www. regulations. gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D. C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA HQ SFUND 2005 0008 and OMB Control Number 2050 0092 in any correspondence. 15 Exhibit 2 Section 302, 303, and 304 Reporting and Recordkeeping Requirements Estimated First Year Total Burden and Cost Number of Annual Hours Burden Total Hours Information Collection Activity Respondents Legal Management Technical Clerical Burden Annual Cost RULE FAMILIARIZATION ( Facilities)

Read and understand regulations at 40 CFR Part 355 0 0 0 0 0 0 Subtotal      0 0 EMERGENCY PLANNING ( 355.30) ( Facilities)

Calculate if chemicals meet/ exceed TPQ 0 0 0 0 0 0 0 Notify SERC that facility is subject to emergency planning 0 0 0 0 0 0 0 Designate facility representative and notify LEPC 0 0 0 0 0 0 0 Inform LEPC of facility changes that may affect emer. Planning 7,692 0 0 7,692 3,846 11,538 $ 387,208 Provide information to LEPC, as required 3,846 7,692 30,768 3,846 42,306 $ 2,027,420 Subtotal 53,844 $ 2,414,628 EMERGENCY RELEASE NOTIFICATION ( 355.40) ( Facilities)

Determine if release is an RQ 4,936 0 494 494 0 987 $ 66,664 Notify LEPC and SERC of any RQ release 4,443 0 2,222 0 0 2,222 $ 213,192 Develop and submit written follow up notice 4,443 2,222 2,888 9,997 4,221 19,327 $ 1,020,955 Notify 911 operator of transportation related releases 444 0 111 0 0 111 $ 10,660 Subtotal 22,647 $ 1,311,472 Total ( Facilities) 76,491 $ 3,726,100 EMERGENCY RESPONSE PLANS ( 300.215) ( SERCs, LEPCs, and RRTs)

Update Emergency Response Plans ( LEPCs) 3,400 0 17,000 51,000 3,400 71,400 $ 2,797,826 Review Emergency Response Plans ( SERCs) 56 0 224 672 0 896 $ 35,974 Keep records and make them available to the public 3,456 0 0 0 34,560 34,560 $ 687,398 Total ( SERCs and LEPCs) 106,856 $ 3,521,199 16 Exhibit 3 Capital/ Start up and O& M Costs ( Annual) Facilities, SERCs and LEPCs Activity Capital/ Start up Costs O & M Costs Provide information to LEPC, as required  $ 1423 Notify LEPC and SERC of any RQ release  $ 13,995 Develop and submit written follow up notice  $ 1,644 Review Emergency Response Plans  $ 10,540 Total  $ 27,602 17 Exhibit 4 Summary of Total Annual Burden and Cost Estimates Burden Hours Labor O & M Facilities 76,491 $ 3,726,100 $ 17,062 SERCs and LEPCs 106,856 $ 2,674,982 $ 10,540 Total 183,347 $ 6,401,082 $ 27,602


[Federal Register Volume 87, Number 137 (Tuesday, July 19, 2022)]
[Proposed Rules]
[Pages 42988-42989]
[FR Doc No: 2022-15402]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 98

[EPA-HQ-OAR-2019-0424; FRL-7230-04-OAR]
RIN 2060-AU35

Revisions and Confidentiality Determinations for Data Elements
Under the Greenhouse Gas Reporting Rule; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of public comment period.

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SUMMARY: On June 21, 2022, the Environmental Protection Agency (EPA)
published a proposed rule titled ``Revisions and Confidentiality
Determinations for Data Elements Under the Greenhouse Gas Reporting
Rule'' (87 FR 36920). The EPA is extending the comment period for this
proposed rule.

DATES: The comment period for the proposed rule published on June 21,
2022, at 87 FR 36920, is extended. Comments must be received on or
before October 6, 2022.

ADDRESSES: You may send your comments, identified by Docket ID No. EPA-
HQ-OAR-2019-0424, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov
(our preferred method) Follow the online instructions for submitting
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Office of Air and Radiation Docket, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
     Hand Delivery: EPA Docket Center, WJC West Building, Room
3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket
Center's hours of operations are 8:30 a.m.-4:30 p.m., Monday-Friday
(except Federal Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. Submit your comments, identified by Docket ID No. EPA-HQ-OAR-
2019-0424, at https://www.regulations.gov (our preferred method), or
the other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Due to public health concerns related to COVID-19, the EPA Docket
Center and Reading Room are open to the public by appointment only. Our
Docket Center staff also continues to provide remote customer service
via email, phone, and webform. Hand deliveries or couriers will be
received by scheduled appointment only. For further information and
updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

FOR FURTHER INFORMATION CONTACT: Jennifer Bohman, Climate Change
Division, Office of Atmospheric

Programs (MC-6207A), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address: [email protected]. For technical information, please go to
the Greenhouse Gas Reporting Program (GHGRP) website, https://www.epa.gov/ghgreporting. To submit a question, select Help Center,
followed by ``Contact Us.''

SUPPLEMENTARY INFORMATION: On June 21, 2022, the Environmental
Protection Agency (EPA) published a proposed rule titled ``Revisions
and Confidentiality Determinations for Data Elements Under the
Greenhouse Gas Reporting Rule'' (87 FR 36920). The public comment for
this proposed rule was scheduled to end on August 22, 2022. The EPA is
extending that deadline to October 6, 2022. This extension will provide
the general public additional time for participation and comment.

List of Subjects

40 CFR Part 9

    Environmental protection, Administrative practice and procedure,
Reporting and recordkeeping requirements.

40 CFR Part 98

    Environmental protection, Administrative practice and procedure,
Greenhouse gases, Incorporation by reference, Reporting and
recordkeeping requirements, Suppliers.

Paul M. Gunning,
Director, Climate Change Division, Office of Atmospheric Programs.
[FR Doc. 2022-15402 Filed 7-18-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 2, 2007 (Volume 72, Number 212)]
[Notices]
[Page 62277]
[DOCID:fr02no07-86]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension: Rule 15Ba2-5; OMB Control No. 3235-0088; SEC File No.
270-91.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in the following rule:
Rule 15Ba2-5 (17 CFR 240.15Ba2-5).
    On July 7, 1975, effective July 16, 1975 (see 41 FR 28948, July 14,
1975), the Commission adopted Rule 15Ba2-5 under the Securities
Exchange Act of 1934 (15 U.S.C. 78a et seq.) to permit a duly-appointed
fiduciary to assume immediate responsibility for the operation of a
municipal securities dealer's business. Without the rule, the fiduciary
would not be able to assume operation until it registered as a
municipal securities dealer. Under the rule, the registration of a
municipal securities dealer is deemed to be the registration of any
executor, administrator, guardian, conservator, assignee for the
benefit of creditors, receiver, trustee in insolvency or bankruptcy, or
other fiduciary, appointed or qualified by order, judgment, or decree
of a court of competent jurisdiction to continue the business of such
municipal securities dealer, provided that such fiduciary files with
the Commission, within 30 days after entering upon the performance of
his duties, a statement setting forth as to such fiduciary
substantially the same information required by Form MSD or Form BD. The
statement is necessary to ensure that the Commission and the public
have adequate information about the fiduciary.
    There is approximately 1 respondent per year that requires an
aggregate total of 4 hours to comply with this rule. This respondent
makes an estimated 1 annual response. Each response takes approximately
4 hours to complete. Thus, the total compliance burden per year is 4
burden hours. The approximate cost per hour is $20, resulting in a
total cost of compliance for the respondent of approximately $80 (i.e.,
4 hours x $20).
    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 control number.
    Comments should be directed to (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted within 30
days of this notice.

     Dated: October 29, 2007.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-21577 Filed 11-1-07; 8:45 am]

BILLING CODE 8011-01-P