                           SUPPORTING STATEMENT FOR
                 INFORMATION COLLECTION REQUEST NUMBER 2421.04

"HAZARDOUS WASTE MANAGEMENT SYSTEM: CONDITIONAL EXCLUSION FOR CARBON DIOXIDE (CO2) STREAMS IN GEOLOGICAL SEQUESTRATION ACTIVITIES  -  FINAL RULE"

                                August 27, 2013

                               TABLE OF CONTENTS

1.	IDENTIFICATION OF THE INFORMATION COLLECTION	1
1(a)	Title and Number of the Information Collection	1
1(b)	Short Characterization or 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	2
3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA	3
3(a)	Nonduplication	3
3(b)	Public Notice	3
3(c)	Consultations	3
3(d)	Effects of Less Frequent Collection	3
3(e)	General Guidelines	4
3(f)	    Confidentiality	4
3(g)	Sensitive Questions	4
4.	THE RESPONDENTS AND THE INFORMATION REQUESTED	4
4(a)	Respondents and NAICS Codes	4
4(b)	Information Requested	5
5.	THE INFORMATION COLLECTED, AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT	7
5(a)	Agency Activities	7
5(b)	Collection Methodology and Management	7
5(c)	Small Entity Flexibility	7
5(d)	Collection Schedule	7
6.	ESTIMATING THE ANNUAL HOUR AND COST OF THE COLLECTION	8
6(a)	Estimating Respondent Hours	8
6(b)	Estimating Respondent Costs	8
6(c)	Estimating Agency Hours and Costs	10
6(d)	Estimating the Respondent Universe	10
6(e)	Bottom Line Burden Hours and Cost Tables	18
6(f)	    Reasons for Change in Burden	18
6(g)	Burden Statement	18

1.	IDENTIFICATION OF THE INFORMATION COLLECTION
	1(a)	Title and Number of the Information Collection

This ICR is titled, "Hazardous Waste Management System: Conditional Exclusion for Carbon Dioxide (CO2) Streams in Geological Sequestration Activities  -  Final Rule."  ICR Number 2421.04, OMB Number 2050-0207.
	1(b)	Short Characterization or Abstract

      Under the authority of the Resource Conservation and Recovery Act (RCRA), the U.S. Environmental Protection Agency (EPA) is finalizing a conditional exclusion from the definition of hazardous waste for carbon dioxide (CO2) streams that are captured, stored, transported, and injected into a well subject to the requirements for Class VI Underground Injection Control (UIC) wells, including the requirements in 40 CFR Parts 144 and 146 of the Underground Injection Control Program of the Safe Drinking Water Act.  The exclusion will only apply to the CO2 stream itself (as defined in 40 CFR 146.81(d)), and not to hazardous wastes that are mixed with, or are otherwise co-injected with, CO2 streams.  The exclusion will be codified at 40 CFR 261.4(h).

	The conditional exclusion requires that generators and owner/operators of a Class VI UIC well who claim that a CO2 stream is exempt under section 261.4(h), have an authorized representative sign a certification statement worded as specified under (i) or (ii).  The signed certification statement must be kept on site for no less than three years, and posted prominently on the corporate website (if such website exists) as a public notification with the title of "Carbon Doxide Stream Certification."  The signed certification statement, which must be made available within 72 hours of a written request from EPA or a state director (if authorized), must be renewed every year that the generator and Class VI UIC well owner/operator claim the exclusion.

	The EPA is taking this action to encourage the use of carbon capture and sequestration (CCS) technologies in order to help reduce the levels of greenhouse gases emitted to the atmosphere.  In 2010, EPA finalized amendments to the UIC program to establish a new type of well (Class VI) to cover the underground injection of CO2 for the purposes of geological sequestration (December 10, 2010 FR 77230).[1],  These UIC amendments address the unique nature of geological sequestration projects to ensure that the injection of large volumes of CO2 in geological formations for the purposes of long term storage would not endanger underground sources of drinking water.  The UIC amendments prohibit the injection of RCRA hazardous waste into Class VI wells.

      Public comments on the proposed UIC amendments raised questions and concerns about the status of CO2 as a RCRA hazardous waste.  The final RCRA conditional exclusion clarifies that captured CO2 would not be RCRA hazardous provided that the generator and Class VI UIC well owner/operator claim the exclusion and comply with its conditions.  In this respect, the RCRA conditional exclusion is necessary for clarifying the status of the captured CO2 stream under RCRA and encouraging the capture and sequestration of CO2 in Class VI wells in accordance with the final UIC amendments.

	The Agency believes that the risk posed to human health and the environment from the management of CO2 streams is not substantial when these streams are managed for purposes of geological sequestration under the final RCRA conditional exclusion, including compliance with regulations governing the storage, transport and injection into UIC Class VI permitted wells. The EPA believes that the full set of hazardous waste regulations is in many ways inappropriate for these CO2 streams and the conditional exclusion would substantially reduce the uncertainty associated with managing the streams under the hazardous waste regulations.

      This ICR examines the information collections under the final RCRA conditional exclusion at 40 CFR 261.4(h).  Sections 1 through 5 of this document describe the collections (e.g., from the standpoint of need and use/utility of the information collected).  The sections also describe respondent and Agency activities.  In Section 6, we estimate the total annual hour and cost burden to respondents and the Agency under the information collections.
2.	NEED FOR AND USE OF THE COLLECTION
      2(a)	Need and Authority for the Collection

	The conditional exclusion is being finalized under the authority of sections 2002, 3001, 3002, 3003, 3004, and 3007 of RCRA, as amended.  EPA believes that the final rule is an important part of its efforts to establish a regulatory framework that supports the future development and deployment of carbon capture and sequestration (CCS) technology, to help control levels of greenhouse gases (GHGs) in the atmosphere.

	The certification statements required by the conditional exclusion are necessary to hold claimants accountable for knowing and following the conditions of the exclusion.  They also are necessary to demonstrate to regulators that claimants are aware of the conditions applicable to them (e.g., during an onsite inspection).  In addition, the certification statements help to convey the seriousness of the conditions to claimants and likely would encourage employees to make their upper management aware of the conditions and involve them in ensuring that their company remains in compliance.
	2(b)	Practical Utility and Users of the Data

	The certification statements required by the conditional exclusion would be used by regulators to hold generators and Class VI well owner/operators accountable for knowing the conditions applicable to them (e.g., during an onsite inspection).  The certification statements and Web posting requirements would also be used by generators and owner/operators to demonstrate that they are aware of, and complying with, the conditions.

	EPA believes the certifications are a practical way to assure compliance because they hold a single person at each facility accountable for compliance (i.e., the authorized representative).  Because of this, the representative has a personal incentive to make sure that the facility complies with the conditions.  The rule requires that the certification be posted to the company websites (if such exists), and updated annually to ensure that the facilities are reminded regularly of the applicable conditions, and that the person chosen to be the authorized representative is a current employee.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
      3(a)	Nonduplication

      The information collected under this ICR is not available from any source other than respondents.  No other Federal agency or department currently collects or will collect this information.
      3(b)	Public Notice

      In compliance with the Paperwork Reduction Act of 1995, EPA opened a 60-day public comment period at the time that the Proposed Rule was published in the Federal Register.  To assist the public in commenting on the proposal, EPA raised a number of issues in the preamble to the Proposed Rule and asked for public comment.  EPA responses to public comments on the proposed rulemaking are available from the RCRA docket (Docket ID No. EPA-HQ-RCRA-2010-0695).

      The proposed rule was published at 76 FR 48073 on August 8, 2011, and a correction was published at 76 FR 55846 on September 9, 2011.
      3(c)	Consultations

	EPA consulted and collected information from interested parties over the course of several months to support the Final Rule. EPA solicited and received comments on the Proposed Rule and has addressed these comments.  EPA also met and communicated with interested stakeholders and those potentially affected by the rule.
	3(d)	Effects of Less Frequent Collection

	The certification statements must be prepared and posted to the company website (if such exists) when the generator and Class VI well owner/operator claim the exclusion, and renewed every year that the exclusion is claimed.  EPA believes this frequency is essential to ensure that the facilities are reminded regularly of the conditions applicable to them.  If EPA does not require an annual renewal, it is possible that a facility could overlook the conditions, particularly as a result of employee turnover.  In addition, the requirement for an annual renewal helps to ensure that the authorized representative is currently employed by that organization.

	In addition, the signed certification must be made available within 72 hours of a written request from EPA or an authorized state official.  The certification is submitted only when requested (e.g., one-time basis) and therefore is not submitted according to any specified frequency.
	3(e)	General Guidelines

      This ICR adheres to the guidelines established in the Paperwork Reduction Act of 1995, OMB's implementing regulations, EPA's ICR Handbook, and other applicable OMB guidance.

      Information collections performed under this clearance will follow all of OMB's General Guidelines regarding data collection, as relevant.
	3(f)	Confidentiality

      Section 3007(b) of RCRA and 40 CFR Part 2, Subpart B, which defines EPA's general policy on public disclosure of information, contain provisions for confidentiality.  However, the Agency does not anticipate that businesses will assert a claim of confidentiality covering all or part of the Final Rule.  If such a claim is asserted, EPA must and will treat the information in accordance with the regulations cited above.  EPA also will assure that this information collection complies with the Privacy Act of 1974 and OMB Circular 108.
	3(g)	Sensitive Questions

      No questions of a sensitive nature are included in the information collection requirements associated with this Final Rule.
4.	THE RESPONDENTS AND THE INFORMATION REQUESTED
	4(a)	Respondents and NAICS Codes

      Table 1 presents the North American Industrial Classification System (NAICS) codes that may be affected by information collections in this ICR.

    Table 1.  North American Industrial Classification System (NAICS) Codes

                                  NAICS Codes

                                  Description
                                    211111
Crude Petroleum and Natural Gas Extraction
                                      22
Utilities
                                    31-331
Manufacturing
                                     48-49
Transportation
                                      56
Administrative and Support and Waste Management and Remediation Services
                                      92
Public Administration

      4(b)	Information Requested

      This section describes information collection requirements applicable to entities that would be affected by the Final Rule.

	(1)	Private Sector Organizations

      EPA is finalizing a conditional exclusion from the definition of hazardous waste for carbon dioxide (CO2) streams that are captured, stored, transported, and injected into a well subject to the requirements for Class VI Underground Injection Control (UIC) wells, including the requirements in 40 CFR Parts 144 and 146 of the Underground Injection Control Program of the Safe Drinking Water Act.  The exclusion would only apply to the CO2 stream itself (as defined in 40 CFR 146.81(d)), and would not apply to hazardous wastes that are mixed with, or are otherwise co-injected with CO2 streams.  The exclusion is codified at 40 CFR 261.4(h).

	The conditional exclusion requires that any generator (person or persons, by site, who capture the carbon dioxide for eventual injection into a Class VI Underground Injection Control well) and any owner/operator of a Class VI UIC well who claim that a CO2 stream is exempt under section 261.4(h) to have an authorized representative sign a certification statement worded as specified.  The signed certification statement must be posted to the company website (if such is available) and kept on site for no less than three years. The signed certification, which must be made available within 72 hours of a written request from EPA, must be renewed every year by anyone claiming the exclusion.

	(i)	Data Item

      A signed certification statement from the generator and Class VI UIC well owner/operator that is worded as follows:

      *             For any generator of a carbon dioxide stream who claims that a carbon dioxide stream is excluded under this section:

                  I certify under penalty of law that the carbon dioxide stream that I am claiming to be excluded under 40 C.F.R. §261.4(h) has not been mixed with hazardous wastes, and I have transported the carbon dioxide stream in compliance with (or have contracted with a pipeline operator or transporter to transport the carbon dioxide stream in compliance with) Department of Transportation requirements, including the pipeline safety laws (49 U.S.C. § 60101 et seq.) and regulations (49 C.F.R. Parts 190-199) of the U.S. Department of Transportation, and the pipeline safety regulations adopted and administered by a state authority pursuant to a certification under 49 U.S.C. § 60105, as applicable, for injection into a well subject to the requirements for the Class VI Underground Injection Control Program of the Safe Drinking Water Act.

      * For any Class VI Underground Injection Control well owner or operator who 	claims that a carbon dioxide stream is excluded under this section:

                  I certify under penalty of law that the carbon dioxide stream that I am claiming to be excluded under 40 C.F.R. §261.4(h) has not been mixed with, or otherwise co-injected with, hazardous waste at the Underground Injection Control (UIC) Class VI permitted facility, and that injection of the carbon dioxide stream is in compliance with the applicable requirements for UIC Class VI wells, including the applicable requirements in 40 CFR parts 144 and 146.

	(ii)	Respondent Activities

      *       Generators and Class VI UIC well owner/operators claiming the exclusion must perform the following:
            -		Prepare the certification statement and have it signed by the authorized representative;
            -		Keep the signed certification statement onsite for no less than three years;
            -		Post the certification statement to the company website (if such is available);
            -		Renew and report the certification every year the exclusion is claimed; and
            -		Make the certification available to EPA or state, if requested.

	(2)	State Governments

	Authorized states may provide a written request to generators or Class VI UIC well owner/operators asking for a copy of the signed certification.

	(i)	Data Item

      * Written request for a signed certification.

	(ii)	Respondent Activities

      *       Authorized states may perform the following:
            -		Prepare and transmit a written request to generators or Class VI UIC well owner/operators requesting a copy of their signed certification; and
            -		Receive, review and file the signed certifications.
5.	THE INFORMATION COLLECTED, AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
	5(a)	Agency Activities

	EPA may perform the following:

      *       Prepare and transmit a written request to generators or Class VI UIC well owner/operators requesting a copy of their signed certification; and

      *       Receive, review and file the signed certifications.
	5(b)	Collection Methodology and Management

      EPA will review and file the certification statements received from generators and Class VI UIC well owner/operators.
      5(c)	Small Entity Flexibility

	The conditional exclusion is optional and will only be claimed if generators and Class VI UIC well owner/operators find that the exclusion is in their best interest.  EPA believes that the conditional exclusion will reduce the burden for generators and owner/operators, regardless of size, because they would no longer be required to comply with the existing RCRA hazardous waste regulations for the exempted CO2 stream.
	5(d)	Collection Schedule

	Following is the rule's collection schedule:

      *       Generators and Class VI UIC well owner/operators that claim the exclusion must sign a certification statement attesting to their compliance with the conditions and keep it onsite for three years.
      *       Generators and Class VI UIC well owner/operators claiming the exclusion must post the signed certification statement to the company website (if such is available)..
      *       The signed certification must be renewed and reposted each year that the exclusion is claimed.
      *       The signed certification must be made available within 72 hours of a written request from EPA or authorized state officials

6.	ESTIMATING THE ANNUAL HOUR AND COST OF THE COLLECTION
	6(a)	Estimating Respondent Hours

      Exhibit 1 estimates annual burden hours for private sector organizations under the final rule.  Exhibit 2 estimates annual burden hours for state governments under the final rule.  Exhibit 3 presents the total annual burden to the private sector and state governments under the rule.  Exhibit 4 estimates the annual burden hour impacts (i.e., savings) to these respondents under the existing RCRA requirements.
	6(b)	Estimating Respondent Costs

      Exhibit 1 estimates annual costs to private sector organizations under the final rule.  Exhibit 2 estimates annual costs to state governments under the final rule.  Exhibit 3 presents the total annual cost to the private sector and state governments under the rule. Exhibit 4 estimates the annual cost impacts (i.e., savings) to these respondents under the existing RCRA requirements.  Specific cost assumptions are discussed below.

      (i)	Estimating Labor Costs

	Private Sector Organizations

      EPA estimates an average loaded hourly labor rate for private sector organizations of $101.13 for legal staff, $77.67 for management, $110.99 for technical staff, and $25.06 for clerical staff.  To derive these rates, EPA obtained mean (unloaded) average hourly labor rates from the "Occupational Employment Statistics, May 2009 National Occupational Employment and Wage Estimates, United States" of the U.S. Bureau of Labor Statistics (BLS) and from surveys of oil and gas professionals performed by the American Association of Petroleum Geologists (AAPG) and the Society of Petroleum Engineers (SPE).  Table 2 identifies the occupations whose labor rates were used in this ICR for each labor category as well as the source of the rates.  Note that the technical labor rate is an average of petroleum geologists and petroleum engineers.

      EPA updated the non loaded labor rates to 2010 levels using the BLS Employment Cost Index.  Finally, we applied an average loading factor of 1.6 to reflect overhead.

          Table 2. Occupation Labor Category and Wage Rate Source --
                         Private Sector Organizations
                                Labor Category
                                  Occupation
                                    Source
                                     Legal
                                    Lawyers
                          Bureau of Labor Statistics
                                  Managerial
                             Managers, All Others
                          Bureau of Labor Statistics
                                   Technical
                             Petroleum Geologists
                              AAPG Salary Survey

                        Petroleum Engineers, Reservoirs
                               SPE Salary Survey
                                   Clerical
                 Office and Administrative Support, All Others
                          Bureau of Labor Statistics

      State Governments

      EPA estimates an average loaded respondent hourly labor rate for state governments of $64.86 for legal staff, $61.50 for management, $38.53 for technical staff, and $26.74 for clerical staff.  To derive these rates, we obtained mean (unloaded) average hourly labor rates from the "May 2009 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 999200  -  State Government" of the Bureau of Labor Statistics (BLS).  Table 3 identifies the occupations whose labor rates were used in this ICR for each labor category as well as the source of the rates.

      EPA updated the wage rates to June 2010 levels using the BLS Employment Cost Index. Finally, we applied an average loading factor of 1.6 to reflect overhead.

        	Table 3.  Occupation Labor Category and Wage Rate Source  -
                               State Governments
                                Labor Category
                                  Occupation
                                    Source
                                     Legal
                                    Lawyers
                          Bureau of Labor Statistics
                                  Managerial
                             Managers, All Others
                          Bureau of Labor Statistics
                                   Technical
                              Compliance Officers
                          Bureau of Labor Statistics
                                   Clerical
                 Office and Administrative Support, All Others
                          Bureau of Labor Statistics

      (ii)	Estimating Capital and Operations and Maintenance (O&M) Costs

      Operation and maintenance (O&M) costs are those costs associated with a paperwork requirement incurred continually over the life of the ICR. They are defined by the Paperwork Reduction Act of 1995 as the recurring dollar amount of costs associated with O&M or purchasing services.  This ICR includes postage costs for generators and Class VI UIC well owner/operators to mail the certification to EPA or the state (i.e., $0.44/letter).  There are no capital costs associated with the information collections.
      6(c)	Estimating Agency Hours and Costs

      EPA estimates an average loaded hourly labor rate of $76.38 for legal staff, $71.42 for management, $52.37 for technical staff, and $21.02 for clerical staff.  To derive these rates, EPA obtained unloaded federal government hourly rates from the 2010 GS pay schedule available from the Office of Personnel Management.  The labor rates are based on the following GS levels and steps: legal labor rates were based on GS Level 15, Step 1, managerial labor rates were based on GS Level 14, Step 4, technical labor rates were based on GS Level 12, Step 5, and clerical labor rates were based on GS Level 5, Step 1.  We then multiplied the unloaded rates by the standard government loading factor of 1.6 to reflect overhead (loading factor recommended in EPA's ICR Handbook).
      6(d)	Estimating the Respondent Universe

	In this section, we estimate the impacted universe and the annual burden to respondents under the rule's paperwork requirements.  We then estimate the burden impact (i.e., savings) to respondents for no longer complying with the existing RCRA paperwork standards for excluded CO2 streams.  Exhibits 1 through 4 calculate respondent burden.

PAPERWORK REQUIREMENTS

      (1)	Private Sector Organizations

      Table 4 presents that annual number of generators and Class VI UIC well owner/operators that are estimated to claim the exclusion and prepare the certification statement during the three-year period of this ICR.  These estimates reflect the number of generators and Class VI UIC well owner/operators that are expected to begin capture and sequestration activities from 2012 through 2014 as estimated for the final rule economic assessment.

      As shown in the table, EPA estimates that 2 generators and 1 Class VI UIC well owner/operator would prepare the certification statement at 40 CFR 261.4(h) on average annually during the three-year period of this ICR.  In total, this equates to 3 respondents on average annually.

      For purposes of this ICR, EPA expects that legal, managerial, and technical personnel at each generator site and UIC well facility would read the regulations before claiming the exclusion.  We have applied our best professional judgment to estimate that it would take 45 minutes per respondent to read the regulations at section 261.4(h) for purposes of discussing the requirement to prepare the certification statement.

      In addition, EPA believes these personnel would review relevant documentation and discuss the exclusion's paperwork requirements.  A clerical person would type up the certification statement and a manager would sign and keep it onsite.  Again, we have used best professional judgment to estimate that these activities would take 4 hours per respondent.

      Table 4.  Annual Number of Generators and Class VI UIC Well Owner/Operators
             Claiming the Exclusion During Three-Year Period of ICR[a]
                                 Facility Type
                                     Years
                                     Total
                             Three-Year Average[b]

                                       1
                                       2
                                       3

Claiming Exclusion/Preparing Certification
Generators
                                       3
                                       1
                                       0
                                       4
                                   1.33 (2)
Class VI UIC Well Owner/Operators
                                       1
                                       0
                                       0
                                       1
                                   0.33 (1)
Sub-Total
                                       4
                                       1
                                       0
                                       5
                                   1.67 (3)
Renewing Certification Annually
Generators
                                       0
                                       3
                                       4
                                       7
                                   2.33 (3)
Class VI UIC Well Owner/Operators
                                       0
                                       1
                                       1
                                       2
                                   0.67 (1)
Sub-Total
                                       0
                                       4
                                       5
                                       9
                                   3.00 (4)

                                  Grand Total

                                       4

                                       5

                                       5

                                      14

                                   4.67 (7)

[a] For the Final Rule ICR we assume that no more than 10 percent CO2 is hazardous waste.
The annual number for affected facilities is based on the revised high-end number of generators (19) and Class VI well owner/operators (9) that are projected would begin practice over the three-year ICR duration period, as derived from the June 2, 2011 Assessment Exhibits 5 and 10.

[b] Table contains rounding.  Three-year averages rounded up.

      Table 4 also presents that annual number of generators and Class VI UIC well owner/operators that are estimated to renew their certification statement during the three-year period of this ICR.  The number of respondents expected to renew their certification statement each year is equal to the cumulative number of respondents that have claimed the exclusion in all prior years.

      As shown in the table, EPA estimates that 3 generators and 1 Class VI UIC well owner/operator would renew the certification on average annually during the three-year period of this ICR.  In total, this equates to 4 respondents on average annually.   We applied our best professional judgment to estimate that it would take 2 hours for each respondent to renew its certification statement annually.

	Finally, we estimate that there would be 4 generators and Class VI UIC owner/operators under the exclusion by the end of the first year, 5 by the end of the second, and 5 by the end of the third.  Hence, EPA estimates that, on average, there could be as many as 7 (summed from subtotals) respondents on average during the ICR's three-year period.  Based on our best professional judgment, we expect that, each year, 30 percent of affected facilities would be asked to submit their certifications to EPA or state.   We applied our best professional judgment to estimate that 90% of these submissions would be sent to authorized states and 10% to EPA.

	These estimates are incorporated into Exhibit 1.

	(2)	State Governments

	As discussed above, EPA applied best professional judgment to estimate that state governments would prepare and transmit 1 request to generators or Class VI well owner/operators for their signed certifications annually.  State governments would then receive, review and file these statements.  In addition, we estimated, based on our best professional judgment, that state governments would take one hour to prepare a letter requesting a certification statement and 30 minutes (i.e., 50 percent of one hour, as presented in the Exhibit) to receive, review and file the certification after receipt.  These estimates are reflected in Exhibit 2.

	(3)	Total Respondent Burden under Proposed Paperwork Requirements

	Exhibit 3 presents the total annual burden to private sector and state government respondents under the new paperwork requirements.  The Exhibit indicates that these respondents are estimated to incur approximately 38 hours and $3,765 annually.

EXISTING PAPERWORK REQUIREMENTS

      Generators and Class VI UIC well owner/operators claiming the exclusion would not be subject to existing RCRA information collection requirements in handling the exempted CO2 streams.  As a result, these entities would experience some burden savings under the existing RCRA paperwork requirements.

      Exhibit 4 presents the total annual burden under the final rule's paperwork requirements, the annual burden savings under the existing paperwork requirements, and the net savings.  Exhibit 4 presents the savings under the existing requirements according to the approved ICR in which the requirements are addressed.  Below is a brief discussion of these ICRs:

   * Hazardous Waste Generator Standards (EPA ICR Number 820).  EPA estimates that facilities that begin capturing hazardous waste CO2 would change in generator status from conditionally exempt small quantity generators (CESQGs) to large quantity generators (LQGs) under the existing hazardous waste regulations.  As LQGs, they would be subject to RCRA paperwork requirements related to hazardous waste determinations, contingency planning, and personnel training.

      Under the conditional exclusion, EPA estimates that they would remain CESQGs, be exempt from these paperwork requirements, and therefore realize a burden savings.

   * Notification of Regulated Waste Activity and 2009 Hazardous Waste Report (EPA ICR Number 976).  EPA estimates that, under the existing hazardous waste regulations, facilities that capture hazardous waste CO2 would change in generator status from CESQGs to LQGs and be required to submit a new or revised Site Identification (ID) Form to EPA indicating this change.  As LQGs they also must prepare and submit a Hazardous Waste Report biennially, including a Site ID Form and GM Form.  Under the conditional exclusion, they would be relieved of these requirements and therefore see a burden savings.

It is also assumed that, under the existing hazardous waste regulations, UIC wells that receive the CO2 for injection (e.g., a Class I UIC well that also meets Class VI requirements) would need to submit a Site ID Form to notify EPA that they are subject to RCRA.  They also would need to prepare and submit a Hazardous Waste Report biennially, including a Site ID Form and Form WRs.  Under the conditional exclusion, they would be relieved of these requirements and therefore see a burden savings.

         *       Land Disposal Restrictions ICR (EPA ICR Number 1442).  EPA estimates that, under the existing hazardous waste regulations, facilities that capture CO2 would be required to determine if it is RCRA hazardous and keep records of this determination.  Under the conditional exclusion, they would be relieved of these requirements and therefore realize a burden savings.

      6(e)	Bottom Line Burden Hours and Cost Tables

      (1)	Respondent Tally

      As shown in Exhibit 3, EPA estimates the total annual burden to respondents (i.e., the private sector and state governments) under the new paperwork requirements to be 38 hours and $3,765. This includes $1.10 in operations & maintenance costs, of which 66 cents are for private respondents and 44 cents for state government respondents.  There are no capital costs. In addition, Exhibit 4 indicates an annual burden savings under the existing paperwork requirements of 103 hours and $8,497.  This results in a net annual savings of 65 hours and $4,733.  The bottom-line burden savings over three years is estimated to be 195 hours and $14,199.

      (2)	Agency Tally

	As shown in Exhibit 5, EPA estimates the total annual burden to the Federal government under the new paperwork requirements to be less than one hour and about $24.  The bottom-line burden over three years is estimated to be 1.5 hours and $72.
      6(f)	Reasons for Change in Burden

	EPA is taking this action to support its efforts to encourage the use of carbon capture and sequestration technologies to help reduce the levels of greenhouse gases emitted to the atmosphere.  EPA estimates that the minor incremental burden imposed by the new paperwork requirements would be more than offset by savings that respondents would experience under the existing paperwork requirements.  At the same time, the paperwork requirements are necessary to hold generators and Class VI UIC well owner/operators accountable for their actions under the exclusion and increase compliance rates.

      6(g)	Burden Statement

	The annual public reporting and recordkeeping burden (private sector plus states) for this collection of information is estimated to average 4.8 hours per respondent.  For private-sector respondents, the estimate is 5.3 hours per response.  This includes time for reading the regulations, preparing the certification statement, posting the statement to the company website (if such exists), renewing it annually, and submitting it to EPA or authorized state, if requested.  The annual public reporting and recordkeeping burden for this collection of information is estimated to average 1.5 hours per state government respondent.  This includes the time for preparing and mailing a letter requesting the generator or UIC well owner/operator submit the signed certification statement, and then receiving, reviewing, and filing it after receipt.

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

 	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-RCRA-2010-0695, which is available for online viewing at www.regulations.gov, or in person viewing at the RCRA Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 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<PHONE_NUMBER>, and the telephone number for the RCRA Docket is<PHONE_NUMBER>.  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-RCRA-2010-0695 and OMB Control Number 2050-0207 in any correspondence.


[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6009-6011]
[FR Doc No: 2019-03197]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1425]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Focused Mitigation Strategies To Protect Food Against
Intentional Adulteration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on collections of information describing
mitigation strategies to protect food against intentional adulteration.

DATES: Submit either electronic or written comments on the collection
of information by April 26, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 26, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-1425 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Focused Mitigation Strategies to
Protect Food Against Intentional Adulteration.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential

Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Focused Mitigation Strategies To Protect Food Against Intentional
Adulteration--21 CFR Part 121

OMB Control Number 0910-0812--Extension

    This information collection supports FDA regulations. Under the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA
Food Safety Modernization Act (FSMA), certain provisions have been
established to protect against the intentional adulteration of food.
Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional
adulteration in the context of facilities that manufacture, process,
pack, or hold food and are required to register under section 415 of
the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C.
350h) addresses intentional adulteration in the context of fruits and
vegetables that are raw agricultural commodities. Section 420 of the
FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the
context of high risk foods and exempts farms except for farms that
produce milk. These provisions are codified at part 121 (21 CFR part
121), and include requirements that that an owner, operator, or agent
in charge of a facility must:
     Prepare and implement a written food defense plan that
includes a vulnerability assessment to identify significant
vulnerabilities and actionable process steps, mitigation strategies,
and procedures for food defense monitoring, corrective actions, and
verification (Sec.  121.126);
     identify any significant vulnerabilities and actionable
process steps by conducting a vulnerability assessment for each type of
food manufactured, processed, packed, or held at the facility using
appropriate methods to evaluate each point, step, or procedure in a
food operation (Sec.  121.130);
     identify and implement mitigation strategies at each
actionable process step to provide assurances that the significant
vulnerability at each step will be significantly minimized or prevented
and the food manufactured, processed, packed, or held by the facility
will not be adulterated. For each mitigation strategy implemented at
each actionable process step, include a written explanation of how the
mitigation strategy sufficiently minimizes or prevents the significant
vulnerability associated with the actionable process step (Sec.
121.135);
     establish and implement mitigation strategies management
components, as appropriate to ensure the proper implementation of each
such mitigation strategy, taking into account the nature of the
mitigation strategy and its role in the facility's food defense system
(Sec.  121.138);
     establish and implement food defense monitoring
procedures, for monitoring the mitigation strategies, as appropriate to
the nature of the mitigation strategy and its role in the facility's
food defense system (Sec.  121.140);
     establish and implement food defense corrective action
procedures that must be taken if mitigation strategies are not properly
implemented, as appropriate to the nature of the actionable process
step and the nature of the mitigation strategy (Sec.  121.145);
     establish and implement specified food defense
verification activities, as appropriate to the nature of the mitigation
strategy and its role in the facility's food defense system (Sec.
121.150);
     conduct a reanalysis of the food defense plan (Sec.
121.157);
     ensure that all individuals who perform required food
defense activities are qualified to perform their assigned duties
(Sec.  121.4); and
     establish and maintain certain records, including the
written food defense plan (vulnerability assessment,

mitigation strategies and procedures for food defense monitoring,
corrective actions, and verification) and documentation related to
training of personnel. All records are subject to certain general
recordkeeping and record retention requirements (Sec. Sec.  121.301 to
121.330).
    Description of Respondents: The respondents to this information
collection are manufacturers of retail food products marketed in the
United States.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity; 21 CFR section               Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food from very small                     18,080               1          18,080  0.5 (30 minutes).........................           9,040
 businesses; Sec.   121.5.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Certain facilities may qualify for an exemption under the
regulations. Because these facilities must provide documentation upon
request to verify their exempt status, we have characterized this as a
reporting burden. We estimate 18,080 respondents will prepare and
update relevant files an average of 30 minutes annually, for a total
annual burden of 9,040 hours (30 minutes x 18,080 firms).

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity; 21 CFR section               Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Defense Plan; Sec.   121.126............           3,247               1           3,247  23.......................................          74,681
Actionable Process Steps; Sec.   121.130.....           9,759               1           9,759  20.......................................         195,180
Mitigation Strategies; Sec.   121.135(b).....           9,759               1           9,759  20.......................................         195,180
Monitoring Corrective Actions, Verification;            9,759               1           9,759  175......................................       1,707,825
 Sec.   121.140(a), Sec.   121.145(a)(1).
Training; Sec.   121.160.....................         367,203               1         367,203  0.67 (40 minutes)........................         244,802
Records; Sec.   121.305, Sec.   121.310,.....           9,759               1           9,759  10.......................................          97,590
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       2,515,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Under the regulations, an owner, operator, or agent in charge of a
facility must prepare, or have prepared, and implement a written food
defense plan, including written identification of actionable process
steps, written mitigation strategies, written procedures for defense
monitoring, written food defense corrective actions, and written food
defense verification procedures. The estimated recordkeeping burden
associated with these activities totals 2,515,258 annual recordkeeping
burden hours and 409,486 annual recordkeeping responses.
    We estimate an average of 3,247 firms will continue to need to
create a food defense plan under Sec.  121.126, that a one-time burden
of 60 hours will be needed to create a plan, and that a burden of 10
hours will be required to update the plan. We annualize this estimate
by dividing the total number of burden hours (70) over a 3-year period
as reflected in table 2, row 1.
    Under Sec.  121.130, each of the estimated 9,759 food production
facilities will identify and specify actionable process steps for its
food defense plan. We estimate that an individual at the level of an
operations manager incurs a burden of 20 hours for this activity, as
reflected in table 2, row 2.
    Under Sec.  121.135(b), each of the estimated 9,759 food production
facilities must identify and implement mitigation strategies to provide
assurances that any significant vulnerability at each step is
significantly minimized or prevented, ensuring that the food
manufactured, processed, packed, or held by the facility will not be
adulterated. We do not specify a specific number or set of mitigation
strategies to be implemented. Some of the covered facilities are
already implementing mitigation strategies. We estimate that it
requires an average of 20 hours per facility to satisfy the
recordkeeping burden associated with these activities for a total of
195,180 hours, as reflected in table 2, row 3.
    We estimate that the recordkeeping activities associated with
monitoring, documenting mitigation strategies, and implementing
necessary corrective actions require first-line supervisors or others
responsible for quality control an average of 175 hours for each
recordkeeping, and that these provisions apply to each of the 9,759
facilities. This results in a total of 1,707,825 annual burden hours,
as reflected in table 2, row 4.
    We estimate that recordkeeping activities associated with training
under Sec.  121.60 total 244,802 annual burden hours, as reflected in
table 2, row 5. We estimate that there are 1.2 million employees
working at the regulated facilities and that 30 percent of them
(367,203) require training. We estimate that the average burden for the
associated recordkeeping activity is approximately 40 minutes (or .67
hours) per record.
    Finally, we estimate the 9,759 food production facilities will
fulfill the recordkeeping requirements under Sec. Sec.  121.305 and
121.310, and that it will require an average of 10 hours per record, as
reflected in table 2, row 6.
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: February 19, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03197 Filed 2-22-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: February 11, 2008 (Volume 73, Number 28)]
[Notices]
[Page 7747-7748]
[DOCID:fr11fe08-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Hemoglobin Based Oxygen Carriers: Current Status and Future
Directions; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled: Hemoglobin Based Oxygen Carriers: Current Status and
Future Directions. The purpose of the public workshop is to discuss the
safety of hemoglobin-based oxygen carriers (HBOCs) as related to a
variety of potential uses of these investigational products. We are
having this discussion because clinical and nonclinical studies of
HBOCs, as either blood substitutes or as resuscitation fluids, have
raised questions about the safety of these products as a group. The
public workshop will feature presentations and roundtable discussions
led by experts from academic institutions, government, and industry.
    Date and Time: The public workshop will be held on April 29, 2008,
from 8:30 a.m. to 5 p.m. and April 30, 2008, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Lister Hill
Center Auditorium, Building 38A, National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>    Registration: Mail or fax your registration information (including
name, title, firm name, address, and telephone and fax numbers) to the
contact person by April 11, 2008. There

is no registration fee for the public workshop. Early registration is
recommended because seating is limited to 175 attendees. Registration
on the day of the public workshop will be provided on a space available
basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Rhonda Dawson at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: FDA; the National Heart, Lung, and Blood
Institute, National Institutes of Health; and the Department of Health
and Human Services' Office of the Secretary and Office of Public Health
and Science are co-sponsoring this public workshop. The primary goal of
the workshop is to discuss what is known about the safety of HBOCs, and
possible paths forward for development of these products. Topics to be
discussed on April 29, 2008, will include: (1) Introduction to the
issues and unmet needs surrounding HBOC development, (2) overview of
the physiology and chemistry of hemoglobin in HBOCs, (3) nitric oxide
physiology and pathophysiology related to HBOCs, (4) review of
nonclinical studies of HBOCs, (5) risk-benefit considerations in
clinical trials of HBOCs, (6) proposed clinical indications for HBOCs,
and (7) industry's experience with HBOC clinical trials. Panel
deliberations on the safety and efficacy of HBOCs in various clinical
settings and potential mechanisms of effects on organs will be the main
topics of discussion on April 30, 2008. We also will discuss future
development pathways with a focus on the use and development of animal
models, biochemical redesign approaches, and alternative clinical
designs where benefit exceeds risk.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: February 4, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2397 Filed 2-8-08; 8:45 am]

BILLING CODE 4160-01-S


                          NOTICE OF INTENT TO DELETE
                  THE MARTIN-MARIETTA/SODYECO SUPERFUND SITE
                           CHARLOTTE, NORTH CAROLINA

                                  AUGUST 2011

                        ENVIRONMENTAL PROTECTION AGENCY
                                40 CFR Part 300
                              EPA-HQ-QA-2011-0707
       National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List:  Deletion of the Martin-Marietta/Sodyeco Superfund Site
AGENCY: Environmental Protection Agency.
ACTION:  Proposed rule; notice of intent.
SUMMARY: The Environmental Protection Agency (EPA) Region 4 is issuing a Notice of Intent to Delete the Martin-Marietta/Sodyeco Superfund Site (Site), which is a portion of the Clariant Corporation property located at 11701 Mount Holly Road in Charlotte, North Carolina, from the National Priorities List (NPL) and requests comment on this proposed action.  The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP).   EPA, with the concurrence of the State of North Carolina, through the Department of Environment and Natural Resources (DENR), has determined that all appropriate response actions under CERCLA, other than operation, maintenance, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund if deemed necessary by EPA.
DATES:  Comments must be received by (insert 30 days from the date of publication in the Federal Register.
ADDRESSES: Submit your comments, identified by Docket ID no.  EPA-HQ-QA-2011-0707, by one of the following methods:
   * Online: http://www.regulations.gov. Follow instructions for submitting comments.
   * E-mail<EMAIL_ADDRESS>   * Fax:<PHONE_NUMBER> Attention: Michael Townsend
   * Mail:	Michael Townsend
            Remedial Project Manager, Superfund Remedial Section
            Superfund Remedial Branch, Superfund Division
            U.S. Environmental Protection Agency, Region 4
            61 Forsyth Street, SW
            Atlanta, Georgia 30303-8960
   * Hand delivery:  U.S. Environmental Protection Agency, Region 4
            61 Forsyth Street, SW
            Atlanta, Georgia 30303-8960
      Such deliveries are only accepted during the public docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.  The Regional EPA Office is open for business Monday through Friday, 8:30 am to 4:30 pm, excluding Federal holidays.
Instructions:  Direct your comments to Docket ID no. EPA-HQ-QA-2011-0707.  EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless a comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov website is an "anonymous access" system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any electronic files you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
DOCKET: All documents in the docket are listed in the http://www.regulations.gov index.  Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statue. Certain other material, such as copyrighted material, will be publicly available only in hard copy.  Publicly available docket materials are available either electronically at http://www.regulations.gov or in hard copy at:

      Regional Site Information Repository:
      U.S. EPA Record Center, Attn: Ms. Debbie Jourdan
      Atlanta Federal Center
      61 Forsyth Street, SW.
      Atlanta, Georgia 30303-8960
      Hours of Operation (by appointment only):
             8 a.m. to 4 p.m., Monday through Friday

Local Site Information Repository:
      Mt. Holly Public Library
            235 West Catawba Avenue
Mt. Holley, North Carolina 28120-1603
            Hours of operation:
              10:00 a.m.  -  6:00 p.m., Monday, Tuesday, Thursday and Friday
              10:00 a.m.  -  2:00 p.m., Wednesday and Saturday
FOR FURTHER INFORMATION, CONTACT:
            Michael Townsend
            Remedial Project Manager, Superfund Remedial Section
            Superfund Remedial Branch, Superfund Division
            U.S. Environmental Protection Agency, Region 4
            61 Forsyth Street, SW
            Atlanta, Georgia 30303-8960
<PHONE_NUMBER>
      Electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
Table of Contents:
 I. Introduction
 II. NPL Deletion Criteria
 III. Deletion Procedures
 IV. Basis for Site Deletion

I. 	Introduction
EPA Region 4 is announcing its intent to delete the Martin-Marietta/Sodyeco Superfund Site (Site), which is a portion of the Clariant Corporation facility, located at 11701 Mount Holly Road, Charlotte, NC, from the NPL and requests public comment on this proposed action.  The NPL constitutes Appendix B of 40 CFR Part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP)., which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended.  EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare or the environment.  Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund).   As described in 40 CFR Section 300.425(e) (3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if warranted by future conditions.
      EPA will accept comments on the proposal to delete the Site for thirty (30) days after publication of this document in the Federal Register.
      Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Site and demonstrates that the deletion criteria are met.

II. 	NPL Deletion Criteria
	The NCP establishes the criteria that EPA uses to delete sites from the NPL.  In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate.  In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:
	i. 	responsible parties or other persons have implemented all appropriate 				response actions required;
	ii. 	all appropriate Fund-financed  response under CERCLA has been 				implemented, and no further response action by responsible parties is 				appropriate; or
	iii. 	the remedial investigation has shown that the release poses no significant 			threat to public health or the environment and, therefore, the taking of 				remedial measures is not appropriate.
	Pursuant to CERCLA Section 121 (c) and the NCP, EPA conducts five year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure.  EPA conducts such five year reviews even if a site is deleted from the NPL.  EPA may initiate further CERCLA action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate.  Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the Hazard Ranking System.
III. 	Deletion Procedures
	The following procedures apply to deletion of the Site:
   (1) EPA consulted with the State of North Carolina prior to developing this Notice of Intent to Delete.
   (2) The State of North Carolina, through DENR, has concurred on the deletion of the Site from the NPL.
   (3) Concurrently with the publication of this Notice of Intent to Delete in the Federal Register, a notice is being published in a major local newspaper, the Charlotte Observer.  The newspaper notice announces the thirty (30) day comment period for the proposed action to delete the Site from the NPL.
   (4) EPA placed copies of documents supporting the proposed deletion in the deletion docket and has made these items available for public inspection and copying at the Site's information repositories identified above.
      If adverse comments on this deletion notice are received within the thirty (30)day public comment period, EPA will evaluate and respond appropriately to the comments before making a final decision to delete.  If necessary, EPA will prepare a Responsiveness Summary to address any significant public comments received.  After the public comment period, if EPA determines it is still appropriate to delete the Site, the Regional Administrator will publish a final Notice of Deletion in the Federal Register.  Public notices, public submissions and copies of the Responsiveness Summary, if prepared, will be made available to interested parties and added to the Site's information repositories listed above.
	Deletion of a site from the NPL does not itself create, alter or revoke any individual's rights or obligations.  Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate.  The NPL is designed primarily for informational purposes and to assist EPA management.  In addition, 40 CFR Section 300.425(e)(3) states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.
IV. 	Basis for Site Deletion
      The following information provides EPA's rationale for deleting the Site from the NPL.
Site Background and History
	The Martin Marietta/Sodyeco Superfund Site (EPA ID: NCD001810365) is located in Charlotte, Mecklenberg County, North Carolina.  The Site is located within a 492 acre property referred to as the Sandoz Chemical Corporation, Mount Holly Plant, and is located on Highway 27 West in Mecklenburg County, North Carolina. The Site is comprised of five noncontiguous areas located within the facility's boundaries.  Manufacturing, administrative and storage facilities cover about 362 acres. The remaining balance of the land is covered by woodlands and grassed areas.
	The entire 492-acre facility is regulated under RCRA authority.  DyeStuff Company began operations at the facility in 1936.  Initially, the plant produced liquid sulfur dyes from purchased raw materials. American Marietta (which became Martin Marietta in 1961) purchased the facility in 1958.  Martin Marietta's products included vat dyes, disperse dyes and specialty chemical products for the agrochemical, electronic, lithographic, pigment, plastic, rubber and general chemical industries.  Sodyeco Inc. purchased the plant from Martin Marietta in 1983.  Sodyeco Inc.'s early operations produced wastes that consisted of low-volume, aqueous, acidic or alkaline streams containing inorganic salts, which were discharged untreated to the Catawba River.  Later, Sodyeco Inc.'s operations were expanded and included organic solvent wastes.  Among the materials placed in landfills at the Site were residual distillation tars from solvent recovery operations, empty drums and cartons, discarded chemicals, off-specification products, general plant wastes and construction debris.   The first indication of potential groundwater contamination at the Site was the discovery of organic solvents in the Sodyeco's potable water well in September 1980.  Contaminated groundwater was also detected in water supply wells adjacent to the Sodeyco Plant.  In June 1982, a hazardous waste site investigation was conducted by EPA.  Results of surface water, groundwater and sediment samples revealed the presence of organic contaminants in groundwater and small amounts in the surface water.  The Site was proposed to NPL on December 30, 1982 (47 FR 58476) and finalized on the NPL September 8, 1983 (48 FR 40674) due to the presence of potable water wells within a three mile radius and the presence of two municipal surface water intakes on the Catawba River
	The Site contains five contaminated areas designated as A, B, C, D, and E.  Area A is an on-site landfill that operated between the 1930s and 1973.  Area B is an on-site landfill that operated between 1973 and 1978.  Area C consists of three covered pits that contained the remains of laboratory and production samples, distillation tars, and waste solvents. The two northern pits in Area C were excavated in March 1981 and the contents were trucked off site to a landfill in Pinewood, South Carolina. Removal of the remaining pit was conducted in 1983. After excavation activities, Area C was regraded and planted with grass.  Area D formerly contained two wastewater settling ponds. The ponds were taken from service in 1966; one was cleaned out in 1973 and the other between 1976 and 1977. Area E is located down-gradient of the old plant and manufacturing area. No waste is known to have been disposed of in this area.
	The current land use is heavy industrial.  There are two business tenants located within the facility that occupy only a few buildings.  Most of the land surrounding the Site is primarily undeveloped woodland.  The Site is currently fenced and requires security clearance for access.  The ground water aquifer underlying the Site is currently not used as a drinking water source; however, there are no controls preventing that use.  Although the groundwater is not being used for drinking purposes, the aquifer is classified as a Class IIA aquifer, a current source of drinking water.  There are no residential properties that exist above or near the ground water contaminant plume at the Site.
Remedial Investigation and Feasibility Study (RI/FS)
	In February 1986, Sandoz Chemical Corporation, the facility owner, entered into an Administrative Order on Consent with EPA to conduct the RI/FS to evaluate the extent of contamination and identify feasible alternative remedies.
	Results of the RI showed the groundwater in the five identified CERCLA areas A through E were contaminated with toluene, chlorobenzene, ethylbenzene, xylene, o-dichlorobenzene, tetrachloroethylene, and trichloroethylene.  The Site posed an unacceptable carcinogenic risk to human receptors via ingestion of local water fowl and small mammals and the ingestion of ground water. The Site also posed an unacceptable non-carcinogenic risk to human health via inhalation intake from Area D and the ingestion of onsite groundwater.
Selected Remedy
	EPA issued the ROD for the clean-up of the Site in 1987.  The remedial action objectives at the Site were to protect human health and the environment from exposure to contaminated on-site soils through inhalation and direct contact, and to restore contaminated groundwater to levels protective of human health and the environment.   The cleanup consisted of the following elements:
   * Extraction, treatment and discharge of contaminated ground water for all five areas;
   * Excavation and off-site incineration for Area D;
   * Installation of a landfill cap for Area B; and,
   * Implementation of one of the following activities after treatability studies were undertaken for Area C, including:  1) flushing; 2) soil washing; 3) thermal processing; or 4) in-situ steam stripping and excavation and off-site incineration.
	No soil remediation was deemed necessary for CERCLA Areas A and E during the RI/FS.
      The initial cleanup approach for Area C was an interim action. The final cleanup plan for Area C was outlined in a 1994 Explanation of Significant Difference (ESD), and included in-situ soil flushing, with the flushing water being captured and treated by the existing ground water treatment system.  The ESD also included continuation of a vacuum extraction pilot study to treat soil stock-piled on site that was contaminated with VOCs.   The vacuum extraction method eventually proved ineffective and EPA issued a second ESD in November 1998, which required off-site treatment and disposal for the stock-piled soil in Area C.
Response Actions
	Installation of the asphalt cap for Area B was completed in October 1989.  The off-site treatment and disposal of Area C stockpiled soils was completed in March of 1999.  The installation of an in-situ flushing system for the Area C soil was completed during the third week of September of 1999.  Remediation of Area D soil was completed in April 1999.  A total of 397 tons of soils were removed in two phases, and sent off-site for treatment and disposal.
	The groundwater system was designed to removed VOCs from the shallow (Areas C and D), intermediate (Areas A/B, D and E) and deep aquifers (Area D).  The groundwater remediation involved extraction through recovery wells and treatment in the onsite RCRA wastewater treatment facility.  The treated water is discharged to the Catawba River, as regulated by the National Pollutant Discharge Elimination System (NPDES) program.  The groundwater extraction wells for Areas A through E were installed 1990.  The contaminated groundwater continues to be treated in the RCRA-regulated on-site wastewater treatment facility, along with contaminated groundwater from the RCRA-regulated portions of the facility.
	The remedial actions were completed by the responsible party, with oversight by the state RCRA program.  The Preliminary Close-Out Report was issued by EPA on September 29, 1999.
	Since the groundwater remedy was constructed, implementation has been conducted under the facility's RCRA permit and authority.  The facility's permit incorporated the groundwater remediation goals and cleanup levels established in the 1987 ROD and requires ICs for limiting the use of groundwater from aquifers impacted by Site contaminants.  At the time the Site was listed on the NPL, the RCRA Hazardous Solid Waste Amendments (HSWA) provisions had not been promulgated, and it was necessary to use CERCLA response authority to address the contamination at the Site outside of the regulated RCRA units (Areas A  -  E).  Since the facility's RCRA permit and authority have been used to implement the groundwater cleanup and HSWA now provides the legal authority necessary to continue the treatment until cleanup levels are achieved in the CERCLA areas outside of the RCRA regulated units, EPA has concluded that the groundwater risks originally identified in the 1987 ROD no longer need to be addressed by CERCLA authority.
	Institutional controls were also necessary because the selected remedy

resulted in hazardous substances, pollutants, or contaminants remaining at the Site above

levels that would allow for unlimited use and unrestricted exposure in the soils.  More

specifically, the remedy capped soil in place in CERCLA Areas A and B, as well as left

contaminated soils covered by clean soils in place in Area D.  The Declaration of

Perpetual Land Use Restrictions were implemented on 8/10/2011 with the Charlotte,

Mecklenburg County, Register of Deeds.

	The 1987 ROD, as amended by the ESDs, was further amended to select no

further CERCLA action for groundwater and required institutional controls preventing

disturbance of the caps and precluding direct contact with any onsite soils impacted by Site contaminants.  The ROD amendment was signed on July 5, 2011.

Cleanup Goals
	Contaminated soils above industrial cleanup levels were excavated and disposed of off-site or were capped in place in Areas B, C and D.  Post-excavation sampling was conducted and described in the Preliminary Closeout Report issued by EPA on September 29, 1999.
Operation and Maintenance
   For CERCLA Areas A, B, and C, the Clariant Corporation, under the existing RCRA C permit, is conducting the long-term monitoring, and operation and maintenance activities at the Site.  The primary activities associated with O&M, associated with the Site, include:
   * Visual inspection of the cap, assuring that it is stable and sound; and
   * Monitoring of institutional controls
	Operation of the water treatment plant and associated groundwater monitoring is being conducted under the RCRA Subtitle C permit and is not part of the CERCLA response.
Five-Year Reviews
      Three five year review reports for the Site have been issued, in 1996, 2002 and 2007.   The 2007 five year review report concluded that the remedy selected in the ROD is protective in the short term, but recommended follow-up actions to analyze the extraction wells for their effectiveness in addressing ground water contamination, conduct maintenance on the Area B cap, and to evaluate the type of ICs that should be implemented at the Site.  All recommended actions have been addressed.  Additional groundwater studies are being conducted to address issues identified in the 2007 five year review report under RCRA oversight.  These activities included installation of additional groundwater extraction and monitoring wells in Areas D and E.  These activities were completed in 2007 and 2010.  Repairs to surficial cracks on the Area B cap were completed in 2008.  EPA incorporated institutional controls into a decision document in the July 5, 2011 ROD.  The ICs preventing disturbance of the caps and precluding direct contact with any onsite soils impacted by site contaminants were implemented and filed on August 10, 2011 with the Charlotte, Mecklenburg County, Register of Deeds.
Community Involvement
      EPA has conducted a range of community involvement activities at the Site to solicit community input and to ensure that the public remains informed about site-related activities throughout the cleanup process.  Outreach activities have included public notices, interviews and public meetings on cleanup activities.  In addition to publishing notices about its intent to delete the Site and amend the ROD in the Federal Register and in a local newspaper, EPA conducted a public meeting on May 12, 2011 to provide the public with the opportunity to comment on the proposed ROD Amendment.  The ROD Amendment and Responsiveness Summary, addressing comments received during the comment period, have been included in the Administrative Record.
      EPA has also prepared the deletion docket, which includes the documents which EPA relied on for its decision to propose deleting the Site from the NPL.  Therefore, the public participation requirements, required in CERCLA Section 113(k), 42 U.S.C. Section 9613(k), and CERCLA Section 117, 42 U.S.C. Section 9617, have been satisfied.

Determination that the Site Meets the Criteria for Deletion in the NCP
	The NCP specifies that EPA may delete a site from the NPL if "all appropriate responsible parties or other persons have implemented all appropriate response actions required."  EPA, with concurrence of the State of North Carolina, through the Department of the Environment and Natural Resources, by a letter dated July 17, 2011, believes this criteria for deletion have been satisfied.  The contaminated soils have been capped and institutional controls are in place preventing unacceptable exposure.  The contaminated groundwater is being addressed under the facility's RCRA permit and authority, therefore CERCLA response is not warranted.  Therefore, EPA is proposing to delete this Site from the NPL.
List of Subjects in 40 CFR Part 300
Environmental protection; Air pollution control; Chemicals; Hazardous waste, Hazardous substances; Intergovernmental relations; Penalties; Reporting and recordkeeping requirements; Superfund; Water pollution control; Water supply.

__________                                               ___________________________
                                         Dated:                                                                 Gwendolyn Keyes Fleming
                                                                 Regional Administrator, Region 4

For the reasons set out in this document, 40 CFR Part 300 is amended as follows:

1. The authority citation for part 300 continues to read as follows:

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923; 3 CFR, 1987 Comp., p. 193.

2. Table 1 of Appendix B to Part 300 is amended by removing "Martin-Marietta, Sodyeco, Inc.," "Charlotte, North Carolina."