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WVDEP Responds to Comments on 2012 Proposed Voluntary Remediation Rule

In June 2011, the West Virginia Department of Environmental Protection (WVDEP) proposed revisions to the West Virginia Voluntary Remediation & Redevelopment Rule, 60 CSR 3 (the Rule), for the 2012 legislative session.  Following a public hearing and the end of the public comment period on July 12, 2011, the WVDEP filed its agency approved version of the Proposed Rule the end of July 2011.  The agency approved version of the Proposed Rule is currently available on the West Virginia Secretary of State’s website at: http://www.sos.wv.gov/administrative-law/modified/Pages/default.aspx.  The agency approved Proposed Rule should be of interest to landowners, developers, and those involved in remediation activities in West Virginia because it includes the WVDEP’s Response to Comments and offers insight on the WVDEP’s interpretation of various provisions of the Rule.  

In February of this year, the WVDEP solicited input regarding the West Virginia Voluntary Remediation Program (WV VRP) and provided a survey for participants to complete and submit.  In March, the West Virginia Chamber of Commerce (Chamber) submitted its response, noting that generally the Rule has served the WV VRP well but suggesting changes to the Rule.  In its response, the Chamber noted that while additional changes may be needed, such changes required more discussion and a more thorough vetting than the time allowed for response to the survey.  The Proposed Rule that the WVDEP filed in June incorporated many of the changes the Chamber suggested.  

In July, the Chamber followed up on its earlier response to the WVDEP’s survey and suggestion that additional changes may be needed and filed written comments on the WVDEP’s June 2011 Proposed Rule.  The Chamber suggested changes to the regulatory text of the sections concerning Definitions, Licensed Remediation Specialists, Voluntary Remediation Agreements, Remediation Standards, and Certificates of Completion.  The Chamber also urged WVDEP to convene a stakeholder group to consider revisions addressing technical concerns and updates to the Guidance Manual. The Chamber requested an opportunity to comment on the de minimis values “as they are generated” and transparency on the process the WVDEP uses for quality control of those values.  No other comments were submitted.  The WVDEP’s response to the Chamber’s comments and the agency approved proposed revisions to the Rule are discussed below.   

Definition of Risk-based Concentrations:  The existing VRP Rule at Section 60-3-2.53 defines the term “risk-based concentrations” as follows: 

Concentration levels developed by the secretary for individual chemicals that correspond to a specific incremental cancer risk level of l x 10^-6 for residential land use and 1 x 10^-5 for industrial land use or a hazard quotient of 1. These concentrations are to be used with the De Minimis Standard. 

The Chamber suggested that the definition be revised: 

to reflect that any reduction of the hazard quotient to a value less than 1 under this Rule (which would reduce the De Minimis values) will only be considered under situations where site-specific cumulative risks warrant such reduction based on scientific principles consistent with the principles of USEPA risk assessment methodologies (i.e., if multiple constituents exists at elevated concentrations that all target the same organs per the USEPA IRIS database). 

The WVDEP declined to make the suggested change.  According to the WVDEP, “including this discussion under the suggested section [which defines risk-based concentrations in the context of de minimis standards] would be confusing” because, as the WVDEP explained, “a reduction of target concentrations for individual constituents arising from multiple chemicals acting on the same target organ through related modes of action would be related to the suite of chemicals occurring at a specific site.”  Instead, the WVDEP noted that “cumulative site risks are already discussed under CSR§60-3.9.3.g and CSR§60-3.9.4.a and b for uniform and site-specific risk-based standards, respectively.” The WVDEP promised to “consider additional clarification through updates in the guidance document.”  

Licensed Remediation Specialists:  Section 5 of the VRP Rule concerns Licensed Remediation Specialists (LRSs) and requires the applicant to notify the WVDEP within 72 hours if the LRS-client relationship is severed for any reason.  The Chamber suggested that the 72-hour notice requirement at Section 60-3-5.1.b be limited to severance of the relationship only if the LRS believes he is unable to meet his duty to protect the safety, health, and welfare of the public in the performance of his professional duties.  The WVDEP declined to revise Section 60-3-5.1.b, stating that the section “is sufficiently clear as written and the suggested changes are not necessary in the context of the section.” 

Voluntary Remediation Agreements:  Section 6 of the VRP Rule addresses the Voluntary Remediation Agreement (VRA) and requires, among other items, that the VRA provide a listing of the applicable standards to be achieved at the site and where applicable, a description of any engineering or institutional controls and any land-use covenants to be imposed for the property.  The Chamber suggested language changes to Section 60-3-6.1.h and .i that would provide that this information should be required only if the applicable standards, engineering and institutional controls, and land-use covenants have been determined at the time the VRA is executed.  The WVDEP declined to revise Section 60-3-6.1 for the following reasons: 

Section 6.1 pertains to the provisions of the Voluntary Remediation Agreement, cites Appendix 60-3A and Appendix 60-3B as meeting the requirements, and notes that additional modifications may be agreed upon by the applicant and the secretary. Appendix 60-3A is the “No Further Action” agreement, in which the standards and/or controls as required by sections 6.1.h and 6.1.i should be known and therefore stated. Appendix 60-3B is the “standard” agreement used for sites which are often involved in an iterative process as the site progresses through the program in pursuit of a Certificate of Completion. The WVDEP believes that Appendix 60-3B provides the flexibility suggested by the Chamber for modifications subsequent to execution of the initial agreement. 

Remediation Standards:  Section 9 of the VRP Rule pertains to the risk-based remediation standards used in the program.  Section 60-3-9.4 explains how to determine human-health-site-specific risk-based standards.  The Chamber proposed adding language to address those sites where the anticipated future land use is as a “recreational area,” which is an undefined term used in the VRP.  Specifically, the Chamber proposed adding to the end of Section 60-3-9.4 language allowing “reasonable assumptions with respect to frequency and duration of exposure as well as other relevant factors for exposure [to] be made in accordance with division guidance.”  The WVDEP responded it did “not see a need for the added language,” explaining that the Chamber’s addition “is inherent to establishing a site-specific risk-based standard.” 

The Chamber also noted that the WVDEP was proposing to change the word “significant” to “substantial” when describing the risk to human health established under the de minimis standard in Section 9.2 but was not proposing a similar change when defining the de minimis risk-based standard for human health in Section 9.1.a.1. The WVDEP agreed that this inconsistency is confusing and revised the VRP Rule to incorporate the word “substantial” in Section 9.1.a.1. 

Certificates of Completion:  Section 12 of the VRP Rule pertains to the Certificate of Completion (COC) and sets forth the items to be included in the COC.  The Chamber proposed adding the following language regarding amending the COC: 

12.3.b.6. The certificate of completion may be amended only where new information or changed conditions at a site demonstrate that one or more of the restrictions placed upon the site are no longer necessary to meet the applicable standards. A request to amend a certificate of completion may be considered only where it is submitted by or with the written consent of the owner(s) of the site at the time the request is submitted. 

The WVDEP declined to add the suggested language or any language addressing amending the COC and suggested that parties wishing to amend the COC use the “Reopener” provisions of the VRP Rule.  The WVDEP stated that: 

Inasmuch as no Voluntary Remediation Agreement is in place once the Certificate of Completion is issued, WVDEP has no means to conduct an effective review of “the new information or changed conditions” described in the proposed change. Although not specifically articulated in the existing rule, the means to amend the Certificate of Completion would best be accomplished by following the "Reopener" provisions as outlined in 60-3-16.4.a or 60-3-16.4.b. 

Model Documents:  The WVDEP agreed with the Chamber that at the end of the list of statutes found in paragraph 19 of Appendix 60-3B, “West Virginia Voluntary Remediation Agreement for Investigation and Remediation Activities,” the language “any applicable regulation promulgated thereunder” is intended to apply to all of the enumerated statutes and not just the last enumerated statute.   Accordingly, the WVDEP incorporated the formatting change in paragraph 19 of Appendix 60-3B so that the language “any applicable regulation promulgated thereunder” begins a new line as follows: 

(i) Toxic Substances Control Act, 15 U.S.C.A. §§2601, et seq.; and

(j) Any applicable regulation promulgated thereunder. 

Guidance Manual and Technical Revisions to the VRP Rule:  In its comments, the Chamber recognized that “changes to those provisions pertaining to the approach for sampling surface water and sediment may be needed” but stated that “such changes require more discussion and a more thorough vetting than the time allowed for comments on the proposed Rule.”  The Chamber therefore urged the WVDEP to establish a stakeholder group similar to the Technical Standards Subcommittee that drafted the original Guidance Manual for the VRP to consider these and other technical revisions to the VRP Rule, update the current version of the Guidance Manual, and address major technical issues.  Technical issues identified by the Chamber in need of updating include:  the list of guidance documents and references; the approach provided in Appendix J for sampling surface water and sediment; and guidance regarding investigating soil vapor intrusion and the discharge of groundwater to surface water.  The Chamber further commented that if the WVDEP establishes a stakeholder group or approaches the task of updating the Guidance Manual and VRP through other means, the “flexibility of the current Guidance Manual and the West Virginia [VRP] in general to be absolutely necessary to the success of those environmental programs.” 

The WVDEP agreed with the Chamber’s comment on convening a stakeholder group and promised to “strive to establish a stakeholder group in the future.”  The WVDEP acknowledged the Chamber’s comment on the need for the VRP to retain flexibility. 

The Chamber also noted that the Guidance Manual in Section 2.6.6 refers to “USEPA Region III Risk-Based Concentration Tables," which USEPA Region III is no longer using and instead is using Regional Screening Levels (RSLs). The Chamber requested that the WVDEP clarify whether it is using RSLs instead of Risk-Based Concentrations (RBCs) and if so, consider proposing appropriate revisions to the text of the Rule in Sections 2.53, 9.2.0.1, and 9.2.b.2.A.  The WVDEP acknowledged that USEPA Region III no longer provides a set of screening values published as Risk-Based Screening (RBC) Tables, but instead is using a series of tables produced by the Oak Ridge National Laboratory under contract with USEPA, and published on a semiannual basis as Regional Screening Levels. The WVDEP promised to include the updated name in the revised guidance document.  In its Response to Comments, the WVDEP clarified the targeted cleanup levels under the VRP as follows: 

Although the guidance manual citation refers to a specific set of values produced by USEPA Region III for screening purposes, the [VRP R]ule references the concept of cleanup standards calculated to meet specified levels of risk/hazard. Thus, de minimis, uniform, and site-specific standards continue to be based on meeting target excess lifetime cancer risks or hazard quotients and may be characterized as “risk-based concentrations”. 

De Minimis Table:  The 2012 proposed revisions would update the toxicological profiles used in developing the De Minimis risk-based cleanup standards table that is used to determine whether or not environmental contamination at a site exceeds levels that would be protective of human health. In the original briefing document that accompanied the proposed revisions, WVDEP explained that the proposed changes to the De Minimis Table were necessary because the toxicological profiles for many chemicals in the federal IRIS database had been revised.  The Chamber questioned the WVDEP’s stated rationale for the proposed revisions to the De Minimis Table.  In its Response to Comments, the WVDEP acknowledges that the “proposed changes in the de minimis values are not due solely to updated toxicity criteria available on the IRIS database.” According to the WVDEP, the rationale in the original briefing document was prepared “from a document provided with a previous de minimis revision.”  The WVDEP provides a two-page, technical explanation of the bases for the current revisions in its Response to Comments and has also revised the briefing document to reflect a one paragraph summary. 

Regarding the process for revising the De Minimis Table, the Chamber urged the WVDEP to provide an opportunity for public comment on proposed revisions to values in the table “as those values are generated.”  The Chamber noted that “the process that the WVDEP uses for quality control (QC) of proposed revisions to values in the De Minimis Table should be transparent” and requested that the WVDEP “explain the QC process it follows in revising values in the De Minimis Table.”  The WVDEP, in its Response to Comments, “agree[d] that the process…should be transparent” and promised to carefully consider the Chamber’s suggestions for future revisions. 

With regard to the 2012 proposed revisions to the de minimis values, the WVDEP intends to publish its spreadsheets on its webpage at: http://www.dep.wv.gov/dlr/oer/voluntarymain/Pages/default.aspx.  In particular, WVDEP states it “intends to publish the revised calculation algorithms, as well as all of the input terms including physicochemical, toxicological, and exposure data used in their calculation in a suitable format ….”   The WVDEP’s Response to Comments describes the spreadsheet models and input terms used to revise the current de minimis values.  For QC, the WVDEP explains that “a limited distribution to internal DEP and external reviewers” conducted a “final review” of the spreadsheets incorporating updated algorithms, toxicity criteria, and physicochemical data, and “spot checks of toxicity and physiochemical data were also performed.” 

For the text of the WVDEP approved Proposed VRP Rule, including the Chamber’s comments and the WVDEP’s Response to Comments, filed July 29, 2011, click here.  For a summary of WVDEP’s proposed revisions for which no written comments were filed, see article titled “WVDEP Proposes Revisions to Waste Rules” posted on the Jackson Kelly PLLC Energy & Environment Monitoron July 6, 2011. 

This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author, see here.

Personnel Changes at U.S. EPA Region 3 and WV DEP

Ken Ellison, Director of the Division of Land Restoration of the West Virginia Department of Environmental Protection (WV DEP), announced certain personnel changes at U.S. EPA Region 3 and WV DEP to attendees of the 2010 West Virginia Brownfields Conference held at the Charleston Marriott September 8 and 9, 2010. The announcements were made during the session on State and Federal Regulatory Updates.   

 

With respect to changes at U.S. EPA Region 3, Director Ellison told those attending the conference that on July 6, 2010, Ronald Borsellino became the new Director of U.S. EPA Region 3’s Hazardous Site Cleanup Division. The Hazardous Site Cleanup Division oversees all activities regarding the Oil Pollution Act and Comprehensive Environmental Response, Compensation and Liability Act, commonly known as Superfund and is responsible for determining goals, priorities and objectives for the Superfund and oil programs as well as overseeing the work of federal responsible party cleanups. Among other responsibilities, the division develops strategy to reuse Superfund sites and supports the redevelopment of Brownfields. Director Borsellino is a career U.S. EPA professional. Before coming to U.S. EPA Region 3, he served in U.S. EPA Region 2 as the Acting Director of Planning and Protection, Deputy Director of Policy and Management, and Chief of the Air Programs Branch. Director Borsellino replaces Abraham Ferdas who is now Director of U.S. EPA Region 3’s Land and Chemicals Division. The Land and Chemicals Division’s responsibilities include, among other things, the public’s right-to-know about hazardous chemicals in their community, asbestos emissions, recycling and recovery; pesticides, and lead-based paint. It also regulates underground storage tanks containing petroleum or hazardous substances.

 

With respect to personnel changes at the WV DEP, Director Ellison announced that the Division of Land Restoration would be adding two new supervisory positions. By way of background, Director Ellison explained that the statistics indicated that up to fifty percent of the WV DEP staff would be eligible for retirement over the next couple of years and that Governor Manchin and WV DEP Secretary Huffman had directed the WV DEP to look at succession planning. Director Ellison emphasized that it was “extremely important” that the Division of Land Restoration have a “good working relationship” with the regulated community, licensed remediation specialists, developers, and others involved in remediation and redevelopment of sites that are contaminated or perceived to be contaminated in West Virginia. Director Ellison stated that to provide “customer service” the Division of Land Restoration needed to retain its knowledge and history of the “rhyme and reason” associated with the sites issued certificates of completion under the West Virginia Voluntary Remediation Program. He explained that to retain this institutional knowledge, new employees would need additional supervision. He stated that Don Martin would move to Deputy Director and that two new supervisory positions would be added – one supervisor/manager would be responsible for administrative matters, such as grant funds and leaking underground storage tank accounts, and the other supervisor/manager would be responsible for RCRA and Superfund sites. Finally, Director Ellison reported that both he and Don Martin are planning to retire within the next two years. 

 

This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author, see here.

U.S. EPA Region III and WVDEP Sign Memorandum of Agreement for Voluntary Remediation Program

Following more than ten years of negotiations, the United States Environmental Protection Agency (U.S. EPA) Region III and the West Virginia Department of Environmental Protection (WVDEP) finally signed a Memorandum of Agreement (MOA) on February 24, 2010, for the West Virginia Voluntary Remediation Program (VRP). The MOA relates only to the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. §§ 9601 et seq. (CERCLA, also known as Superfund) and applies only prospectively. Nonetheless, the signing of the MOA marks a significant milestone for the WVDEP and the remediation of sites that are contaminated or perceived to be contaminated in West Virginia. Absent exceptional circumstances, the MOA offers liability protection for anyone cleaning up contaminated properties in West Virginia under the VRP from actions brought by U.S. EPA under CERCLA. For a copy of the MOA, click here. 

In the MOA, U.S. EPA agrees generally to refrain from bringing an administrative or judicial enforcement action under CERCLA for sites that are being cleaned up under the VRP subject to four exceptions. The specific forbearance language is found in Section IV.B of the MOA and reads as follows: “U.S. EPA does not anticipate taking an administrative or judicial enforcement action under CERCLA §§ 106(a) or 107(a) against a person regarding a specific release at an eligible response site that is being addressed by that person in compliance with the VRP requirements.” This language -- “does not anticipate taking”-- is similar to language found in U.S. EPA’s MOAs with other states for their voluntary cleanup programs.  

The four exceptions to U.S. EPA’s forbearance are set forth in CERCLA § 128(b). They are: (1) West Virginia requests U.S. EPA’s assistance in the performance of a response action; (2) contamination has migrated or will migrate across a state line or onto federal property; (3) a release or threatened release may present an imminent and substantial endangerment to public health or the environment and additional response actions are likely to be necessary to address, prevent, limit or mitigate the release or threatened release; and (4) information discovered after the approval or completion of a cleanup establishes that the contamination or conditions at the site present a threat requiring further remediation to protect public health or the environment.  

The applicability of the liability protection offered by the MOA is limited temporally and in scope. The MOA does not apply to sites that were cleaned up under the VRP before February 24, 2010, the effective date of the MOA. In addition, the MOA relates only to cleanups that satisfy CERCLA.   It does not affect hazardous waste remediation at facilities subject to the Resource Conservation and Recovery Act (RCRA) Subtitle C cleanup requirements or environmental cleanups pertaining to leaking underground storage tanks under RCRA Subtitle I. Nor does it affect cleanups of polychlorinated biphenyls (PCBs) under the Toxic Substances Control Act.  

While the MOA is not a “one cleanup program” agreement, it does document U.S. EPA’s recognition and approval of the VRP. For example, U.S. EPA Region III acknowledges in Section III.A of the MOA the “comprehensive” nature of the VRP. In particular, U.S. EPA Region III states its support for “the use of the WVDEP’s VRP 60 C.S.R. III comprehensive cleanup rules at properties where this approach is appropriate for achieving timely and protective cleanups.” (Emphasis added). Importantly, West Virginia and U.S. EPA Region III continue to discuss a separate memorandum of understanding for the VRP to address RCRA.  

The MOA applies to contaminated or potentially contaminated properties, commonly called “brownfields,” that are “eligible response sites” as defined in CERCLA and that are cleaned up under the WVDEP’s oversight pursuant to the VRP. Because the MOA offers liability protection from CERCLA, it does not apply to “[a]ny site that is the subject of a federal enforcement or response action under CERCLA.” This includes “an administrative order, a judicial order, a permit, an injunction, a consent decree, a CERCLA general or special notice letter, or an information request letter under CERCLA § 104(e).” Other sites ineligible for the liability protection offered by the MOA include: (1) a facility that is listed or proposed for listing on the NPL; (2) a facility that is subject to a unilateral administrative order, court order, administrative order on consent or judicial consent decree that has been issued to or entered into by the parties, or a facility to which a permit has been issued, under RCRA, the Federal Water Pollution Control Act, 33 U.S.C. § 1321, TSCA, or the Safe Drinking Water Act, 42 U.S.C. § 300f et seq.; (3) a facility that is subject to RCRA corrective action or to which a RCRA corrective action permit or order has been issued; (4) a land disposal unit with respect to which a RCRA Subtitle C closure notification has been submitted and closure requirements have been specified in a closure plan or permit; (5) a federal facility; (6) a portion of a facility at which there has been a release of PCBs; and (7) a portion of a facility, for which portion assistance for response activity has been obtained under RCRA Subtitle I from the Leaking Underground Storage Tank Trust Fund.  

In addition, anyone seeking CERCLA liability protection under this MOA should be careful not to rely on the “deemed” approved language in West Virginia’s Voluntary Remediation and Redevelopment Rule at 60 CSR. § 60-3-10.3.c. Under the Rule, certain work plans or reports required to be submitted under the VRP are “deemed” approved if the WVDEP fails to approve or disaapprove the document within the time period specified in the Rule “unless such work plans or reports are determined to be materially inaccurate.” This language was inserted in West Virginia’s Voluntary Remediation and Redevelopment Rule, and agreed to by the WVDEP, to help achieve cleanups in a timely manner. The MOA, however, does not apply to any plan, report, or other document required to be submitted under the VRP that is “deemed” approved. Entities wishing to obtain CERCLA liability protection will need to have all of their plans, reports, or other documents required to be submitted under the VRP approved by the WVDEP.  

This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author, see here.

Status of WV Voluntary Land Stewardship Program

In previous articles I have discussed the ongoing process by the West Virginia Department of Environmental Protection (WVDEP) to develop a West Virginia Voluntary Land Stewardship Program (VLSP) in West Virginia. The WVDEP envisions that the VLSP would be a “comprehensive integrated system for implementing, monitoring, tracking, and protecting institutional and engineering controls” at formerly environmentally contaminated sites that have been closed under either State or Federal programs in West Virginia. 

In early 2009, the WVDEP established a stakeholders group, which is referred to as the Institutional Controls (IC) Work Group, to assist it in this process. The IC Work Group consists of various stakeholders from trade associations, industry, and government, which has been working with the WVDEP and its contractors. The most recent meeting of the IC Work Group with the WVDEP and its contractors was on January 27, 2010. This was the sixth meeting of the IC Work Group since its inception. As the representative of the WV Coal Association on the IC Work Group, I think it is safe to say that the WVDEP and the IC Working Group have made significant progress in a number of areas, which include: 

·     Developed the overall administrative structure of a VLSP.

·     Developed various draft documents that would be used by a VLSP.

·     Identified the range of services that the VLSP could offer to an entity (public or private) that has entered a site into the VLSP (e.g., operation and maintenance of remediation systems, environmental monitoring, reporting to WVDEP).

·     Evaluated the advantages and disadvantages of creating a 501(C)3 or 501(C)4 non-profit corporation versus a for-profit corporation to operate the fiduciary “Trust” that would be established to manage the dollars paid into the VLSP to perform the operations, maintenance, and tracking functions required under the site closure documents. 

Based on the progress made during 2009, the WVDEP anticipates that the following activities will occur during 2010: 

1)   WVDEP will continue to move forward with implementing a pilot program to further test the concept of a VLSP, most likely during the second half of 2010. At this time, both DOW Chemical and FMC Corporation have reported that they are still planning on entering two of their sites into the pilot program. In addition, the WVDEP intends to enter several former municipal solid waste (MSW) landfills into the pilot program. At the sites, it is anticipated that the VLSP will provide a mix of the following services during the term of the pilot program:

·     Maintaining the landfill cap.

·     Operating the landfill leachate collection system.

·     Implementing the provisions of the Land Use Covenants (LUCs) under the provisions of the Voluntary Remediation Program.

·     Performing groundwater monitoring. 

2)   The IC Focus Group will prepare a report for the public entitled Recommendations for Establishing a Comprehensive State Voluntary Land Stewardship Program. This document will likely address the following topics:

·     Identify the universe of State and Federal risk-based programs that include the option to use institutional and/or engineering controls to achieve site closure.

·     Discuss the challenges and benefits of a VLSP for West Virginia.

·     Survey the approaches to tracking and monitoring long-term institutional controls that are being implemented by other States.

·     Outline the administrative structure of a VLSP, the elements of the fiduciary “Trust,” and overall management issues. 

At this time, it is anticipated that the Recommendations for Establishing a Comprehensive State Voluntary Land Stewardship Program will be completed by mid-2010.  

This article was authored by Greg Tieman, Acacia Environmental Group LLC. For more information on the author see here. 

Status of WV Voluntary Land Stewardship Program

I have discussed in previous articles the ongoing process by the West Virginia Department of Environmental Protection (WVDEP) to develop/implement a West Virginia Voluntary Land Stewardship Program (VLSP) in West Virginia. As discussed previously, the VLSP would be a “comprehensive integrated system for implementing, monitoring, tracking, and protecting institutional and engineering controls” at sites that have been closed in West Virginia. In addition to sites closed under the Voluntary Remediation Program (VRP), the WVDEP envisions that sites closed under a range of regulatory programs, such as the Leaking Underground Storage Tank (LUST), Landfill Closure Assistance Program (LCAP), RCRA Corrective Action, Toxic Substances Control Act (TSCA), and mining programs could eventually be managed under a VLSP.   A “Trust” would be established that would have fiduciary responsibilities for managing funds that would be placed into the Trust by the entity responsible for any long-term institutional and/or engineering controls required to close the site. At present, it is envisioned that the VLSP would be a non-profit charitable trust that would continue into perpetuity.  

As part of the process of developing/implementing a VLSP, the WVDEP early in 2009 established a stakeholders group, which is referred to as the Institutional Controls (IC) Work Group, to assist it in this process.  The IC Work Group consists of various stakeholders from trade associations, industry, and government, which has been working with the WVDEP and its contractors. The most recent meeting of the IC Work Group with the WVDEP and its contractors was on September 23, 2009. This was the fifth meeting of the IC Work Group since its inception earlier this year.  

Although, a number of significant questions still remain, the process is now far enough along that the WVDEP is planning on moving forward with a pilot program to further test the concept of a VLSP during 2010. As of this most recent IC Work Group meeting, it appears that two former industrial sites and three former municipal solid waste (MSW) landfills will be entered into the pilot program in 2010. The former industrial sites are currently owned by private industry and the former MSW landfills are currently managed by the WVDEP under its Landfill Closure Assistance Program (LCAP). To facilitate the pilot program, the WVDEP envisions establishing the charitable trust during the first half of 2010. Each applicant to the VLSP, including the WVDEP, will enter into a contract with the VLSP for the provision of various post-closure activities that will be performed by the VLSP during the pilot program period, which is anticipated to be for one year. The range of post-closure services will likely consist of the following activities: 

·     Annual certification of compliance with any land use covenants.

·     Operation of any treatment or remediation systems (e.g., groundwater remediation or landfill leachate collection).

·     Performance of monitoring and/or maintenance activities (groundwater monitoring, grass cutting, asphalt pavement repair).

·     Preparation of monitoring and/or maintenance reports and submittal to the WVDEP. 

At the end of the pilot program, the results will be evaluated by the IC Work Group and the WVDEP, and recommendations will be prepared regarding the viability of the implementation of a full-scale VLSP.

This article was authored by Greg Tieman, Acacia Environmental Group LLC. For more information on the author see here. 

Uniform Environmental Covenants Act (UECA) Program Moving Forward

The Uniform Environmental Covenants Act (UECA) program in West Virginia came into existence on July 2, 2008, West Virginia Code §22-17. UECA was developed to allow risk-based closure of contaminated sites. These sites are likely to have land use covenants (LUCs) associated with the property following closure of the site by the West Virginia Department of Environmental Protection (WVDEP). LUCs, such as restricting the property to exclude residences or prohibiting groundwater wells are a common practice for contaminated sites using human health and ecological risk-based closure. West Virginia had no standard procedure for attaching LUCs to property deeds. UECA will provide a standard practice (hence-Uniform) for covenants placed upon the property. Additionally, there is a provision for the property owner to conduct inspections of the property on a regular basis to monitor compliance with the LUCs and report those inspections to the WVDEP after site characterization, remedial design and implementation of the remedial measures have been completed. There is a provision to discontinue the inspections, if it is determined that the inspections are no longer necessary to protect human health and ecological receptors.

UECA is very similar to the West Virginia Voluntary Remediation Program (VRP) administered by the WVDEP. The VRP became effective on July 1, 1997. The VRP also allows for closure of contaminated sites using risk-based technology and has been successful in redevelopment of numerous contaminated properties that otherwise would not have been remediated or redeveloped. Below is a comparison of major components of the VRP and UECA requirements. 

VRP

·     Under the VRP, successful closure of the site results in a Certificate of Completion (COC) for all potential historical environmental impacts that can be identified at the site and thus results in screening for an expanded analytical parameter list. The COC is a legal document that limits the ability of the regulatory agencies from re-opening of the site for regulatory enforcement.

·     Requires an application fee and reimbursement costs for DEP employee’s time and expenses associated with the project.

·     Requires a signing of a Voluntary Remediation Agreement (VRA) and use of a Licensed Remediation Specialist to manage the project. Detailed risk assessment in accordance with USEPA protocols must be performed.

·     Requires extensive QA/QC and laboratory data validation. 

UECA

·     Under UECA, successful closure results in a No Further Action at this time (NFA) for specific environmental impacts associated with an identified environmental release such as a Leaking Underground Storage Tank (LUST) site. This generally results in a limited analytical parameter list. The NFA would allow the regulatory agency to re-open the site, if environmental conditions warrant and does not provide the broader protection of the COC.

·     Requires reimbursement costs for DEP employee’s time and expenses associated with the project. There is no initial application fee, as is the case with the VRP.

·     Requires signing of an Agreement For Investigation And Remediation Activities Under W.VA. Code §22-17 & §22-22B (UECA Agreement) and use of a Licensed Remediation Specialist to manage the project. Detailed risk assessment in accordance with USEPA protocols must be performed. (same as VRP)

·     Requires extensive QA/QC and laboratory data validation. (same as VRP)

The UECA program is currently being developed by the WVDEP. The UECA Agreement became available for use in August 2009. The UECA Agreement and the Uniform Environmental Covenant Act are available through the WVDEP website at www.wvdep.org. 

At this time, no site has officially entered the UECA program, with a signed UECA Agreement. This program will provide another tool to effectively remediate contaminated sites. Each contaminated site must be evaluated for its own characteristics to determine if it would be more cost effective or logistical to use UECA, the VRP, or remediate to conventional numerical clean-up standards, which was often the only option, prior to existence of the VRP and UECA. Such factors as spreading costs over time, problems with off-site impacts that may affect neighboring properties, future land use, cost of remedial alternatives and liability issues are just a few of the considerations when determining which program may best fit your situation. 

This article was authored by William Chambers, Acacia Environmental Group LLC. For more information on the author see here.

WV Voluntary Land Stewardship Program (Trust)

Early in 2009, the West Virginia Department of Environmental Protection (WVDEP) brought together a group of stakeholders representing various business interests and trade associations (Dow Chemical Company, Exxon/Mobil, FMC Corporation, WV Coal Association, WV Chamber of Commerce, WV Manufacturers Association), WVDEP, USEPA Region III, and the WV Development Office to form an Institutional Controls (IC) Focus Group. The WVDEP tasked this Group with the following objectives: 

·     Evaluate the current status/best practices of risk-based remediation and related land use controls. 

·     Evaluate the feasibility/framework of the WVDEP developing/implementing a West Virginia Voluntary Land Stewardship Program (VLSP). 

The efforts of the IC Focus Group are supported by an IC Work Group, which consists of representatives from Marshall University, WVDEP, and a consultant who facilitates the meetings. The IC Focus Group and the IC Work Group met during February, April, June, and August 2009, and two additional meetings are scheduled for this year. The goal of this blog article is to summarize the background leading up to this effort and what a VLSP might look like.  

A.)  Background.

For years, the performance of site cleanups in West Virginia was based on achieving an unrestricted future land-use; e.g. residential level. One result of this approach was that federal and state environmental programs developed a backlog of sites that were not being addressed, since the technology to remediate soil, sediment, and groundwater to such pristine levels was often not available or could only be implemented at an unacceptable cost.  

In July 1997, West Virginia implemented the Voluntary Remediation and Redevelopment Rule (VRRR, 60CSR3). A primary goal of the VRRR was to allow the use of risk-based approaches to remediation, so that sites could be remediated to less restrictive levels (e.g., industrial) rather than residential. Any engineering or institutional controls (e.g., future land-use deed restrictions) that must be implemented to meet the level of cleanup desired (residential or industrial) are described in a Land Use Covenant (LUC). Under the VRRR, the LUC must be recorded with the property deed at the respective County Court House for the Certificate of Completion (COC) to become effective. It should be noted that the LUC remains with the property deed for as long as engineering and/or institutional controls are in place (e.g., theoretically, in perpetuity). 

Over the last several years, the WVDEP has come to believe that the COC is an imperfect way to enforce the provisions of the LUCs over time. Therefore, the WVDEP has taken several actions (some legislative, some not) in recent years to address their concern: 

·     First, West Virginia enacted the Uniform Environmental Covenant Act (UECA), which was integrated into the VRRR in July 2008. UECA modified LUCS. However, even with these modifications, the WVDEP believes that UECA still does not address the practical aspect of determining whether the provisions of LUCs are being violated over time.  

·     Second, in addition to incorporating UECA, the VRRR was revised to require regular certification by the applicant or property owner that the site is being used in compliance with the provisions of the LUC. In general, WVDEP anticipates that the inspections should be formed and certifications be submitted to the WVDEP, at a minimum, on an annual basis. 

·     Third, WVDEP recently joined Miss Utility as a participating member and now receives notification of excavation and subsurface disturbance activities at VRP sites, as the utilities do. The WVDEP (Division of Land Restoration Project Managers) is reportedly responding to approximately 300 “tickets” issued by Miss Utility per year.  

·     Fourth, although not originally envisioned when the VRRR was implemented in July 1998, the WVDEP (Division of Land Restoration Project Managers) is now performing an annual inspection at each site that has been issued a Certificate of Completion (COC) under the Voluntary Remediation Program (VRP). 

As a result of the third and fourth actions, WVDEP feels that it now has a practical way of enforcing LUCs, but WVDEP believes that some risk of exposure remains because not all site activities require excavation nor does everyone use the Miss Utility service. The WVDEP is also concerned that the time required by its current staff to implement these actions is causing time-constraints that detracts from their ability to support ongoing sites entered into the VRP. In addition, the WVDEP reports that it has not received, nor is likely to receive funding from the Legislature to perform the activities described in the third and fourth actions. 

WVDEP believes that the issue of monitoring LUCs over time has become a major concern and one that could threaten the long-term viability of risk-based closures in West Virginia, since the potential exists for such sites to be redeveloped in the future in ways that would violate the LUCs and place individuals or the environment at an unacceptable risk. WVDEP feels that this risk is further compounded by the steadily increasing number of sites being closed under the VRP, while payroll and staff available to address this issue are not increasing. WVDEP reports that nearly 50% of the Division of Land Restoration’s Project Managers are eligible for retirement within the next four years, taking their site-specific knowledge of the sites and their LUCs with them. 

Finally, a couple of pertinent facts should be noted relative to this effort to develop a West Virginia Voluntary Land Stewardship Program (VLSP): 

·     Pennsylvania had developed a similar program, referred to as the “Guardian Trust,” earlier in this decade. The program was ultimately not adopted by the State. 

·     The USEPA is hoping that West Virginia will help figure out how to monitor these sites in perpetuity, and has provided West Virginia with a $100,000 grant to assist in the process, which can include implementation of a Voluntary Land Stewardship Program (VLSP). 

B.)    What is a VLSP?

As described in the Meeting Minutes from the June 24, 2009 WVDEP IC Focus Group Meeting, the VLSP would be a “comprehensive integrated system for implementing, monitoring, tracking, and protecting institutional and engineering controls.” A “Trust” would be established that would have fiduciary responsibilities for managing funds that would be placed into the Trust by the holder of the LUC (e.g., the original VRP applicant and/or the property owner). At present, it is envisioned that the VLSP would be a 501(c) non-profit charitable trust that would continue into perpetuity.  

The funds in the Trust would then be used to perform a range of services on behalf of the applicant/property owner. The term of service and specific services would be tailored for each individual site. As currently envisioned, the VLSP might provide the following tier of services, which may expand over time: 

·     Establish or maintain any institutional controls (e.g., environmental covenants, easements, deed notices, restrictions and/or prohibitions on land-use or allowed activities) by filing such documents or updating them when the site is leased, conveyed, subdivided, or when land disturbance activities occur. 

·     Conduct physical inspections. 

·     Monitor and/or operate any treatment systems (e.g., groundwater treatment, soil vapor extraction, or monitored natural attenuation), collect environmental samples, and prepare reports. 

·     Conduct periodic review of county land records to monitor transfers or deed filings. 

·     Develop an administrative record concerning the remediation of the Site in an electronic database, respond to inquiries, and coordinate the sharing of data amongst various stakeholders, such as the WVDEP, other regulatory agencies, economic development agencies, potential purchasers, land owners, and tenants. 

·     Develop and maintain records and information for posting on the WVDEP environmental registry (publicly accessible), which is to be created, to track LUCs. 

·     Coordinate and share data with the WV Miss Utility system. 

This article was authored by Greg Tieman, Acacia Environmental Group LLC. For more information on the author see here. 

U.S EPA Region 3 Discusses Waste Issues At Annual WV Chamber Fly-In

On July 21, 2009, members of the West Virginia Chamber of Commerce (Chamber) met with U.S. Environmental Protection Agency (U.S. EPA) Region 3 staff in Philadelphia as part of the Chamber’s annual fly-in. Present for U.S. EPA Region 3 were, among others, Abraham Ferdas, Director of U.S. EPA Region 3 Land and Chemicals Division, and Kathryn Hodgkiss, Acting Director of U.S. EPA Region 3 Hazardous Site Cleanup Division. Highlights of the waste-related discussion are as follows: 

·        Memorandum of Agreement: The Chamber asked about the status of a possible Memorandum of Agreement (MOA) concerning West Virginia’s Voluntary Remediation Program between West Virginia and U.S. EPA and whether any such MOA would likely cover cleanups under the Resource Conservation and Recovery Act (RCRA) and the Toxic Substances Control Act (TSCA). Director Ferdas reported that U.S. EPA was “close to finalizing” the MOA between West Virginia and U.S. EPA. After more than ten years of negotiations, he promised that the “end is near,” by which he said he meant “before the new fiscal year” or “by September” 2009. He further stated that the MOA would be limited in scope to eligible response sites under Superfund and would not address sites under RCRA or TSCA. With respect to RCRA, he stated that while U.S. EPA had reauthorized West Virginia to administer the RCRA Corrective Action Program, the issue of groundwater leaving sites remains. He explained that PCB contamination was enforceable only under TSCA and therefore would not be covered any MOA. In addition to RCRA and TSCA, he explained that because the leaking underground storage tank (LUST) program is a state program, the MOA would not apply to it. 

·        Regulation of Coal Combustion Residuals: The Chamber inquired about the status of U.S. EPA’s review of the coal combustion fly-ash issues that have arisen since the Kingston, Tennessee spill in December 2008. William C. Earley, Acting Regional Administrator, stated that U.S. EPA is looking at options for regulating coal combustion by products. He stated that the agency wants to protect the beneficial uses of coal combustion by products. He also stated that agency is looking at fly-ash impoundments based on the following three categories: (1) structural integrity (Superfund); (2) enforcement (Clean Water Act); and (3) consequences if the impoundment fails similar to a risk management plan (Federal Emergency Management Act).

·        Definition of Solid Waste: Noting that U.S. EPA recently granted a petition to reconsider the Definition of Solid Waste Rule that was finally published in the Federal Register in October 2008 after twenty 20 years of rulemaking and litigation, the Chamber asked U.S. EPA Region 3 to explain the revisions of the DSW Rule that are anticipated. Director Ferdas responded that U.S. EPA had held a public meeting on June 30, 2009, and said that most of the comments focused on off-site management.  He stated that the issue is when the generator losses control of the wastes. He indicated he believed that the on-site provisions would likely survive the additional review. 

·        CERCLA “Arranger” Liability:   The Chamber asked whether U.S. EPA anticipated revising any formal policy, such as its policy concerning “arranger” liability, for example, in response to the U.S. Supreme Court’s decision in Burlington Northern v. U.S. Director Hodgkiss responded that the regulated community could anticipate “business as usual”. She explained that Burlington Northern involved unusual facts and therefore had limited potential applicability. She stated that the Court affirmed the principle of joint-and-several liability and held that U.S. EPA would have to prove intent to dispose to establish “arranger” liability, explaining that this analysis would be on a case-by-case basis and very fact intensive. She stated that U.S. EPA would continue to assign parties to do cleanups and would continue to pursue cost recovery if the parties did not do so. 

·        RCRA Corrective Action in West Virginia: The Chamber asked if U.S. EPA was focusing on any specific issues in the West Virginia Department of Environmental Protection Agency’s administration of the RCRA Corrective Action Program. Director Ferdas responded that U.S. EPA would continue to provide support to West Virginia. He noted that the WV DEP is organized so that permitting and remediation are handled by two different sections within WV DEP. Further, he noted that West Virginia may regulate only by permits while U.S. EPA may issue orders.  

·        Reopening of the PCB MegaRule: The Chamber indicated it understood that a notice of proposed rulemaking would be published in January 2010, reopening the PCB MegaRule, and that the existing use authorizations would be re-evaluated and possibly eliminated. The Chamber asked what approach U.S. EPA anticipated taking to evaluate the existing authorizations and possible elimination of authorized uses. For example, the Chamber asked whether U.S. EPA anticipates implementing a series of management practices for control, requiring a tiered replacement of equipment using PCBs, or possibly establishing new criteria for “PCB-contaminated” and “PCB-containing” that would mimic the current rule. Director Ferdas responded that in 2008 U.S. EPA had made a decision to transfer the cleanup of PCBs to OSWER. He further explained that under the court decision in Paralyzed Veterans, U.S. EPA is required to reopen the PCB MegaRule, stating that the Paralyzed Veterans’ decision stands for the proposition that if the agency has implemented a program one way then it cannot change how it implements the program without changing the regulations. Paralyzed Veterans of America v. D.C. Arena L.P., 117 F.3d 579, 586, (D.C. Cir.1997) (“Once an agency gives its regulation an interpretation, it can only change that interpretation as it would formally modify the regulation itself: through the process of notice and comment rulemaking”). Director Ferdas added that changing the regulations can take a long time. 

·        Land Stewardship Trust: The Chamber asked whether there were any new developments within U.S. EPA regarding the establishment of Land Stewardship Trusts. In particular, the Chamber asked whether U.S. EPA is monitoring and/or encouraging estate efforts to track, register or inspect risk-based cleanup sites and if U.S. anticipates developing its own Land Stewardship Trust Program. Directors Ferdas and Hodgkiss responded that U.S. EPA has awarded a $100,000 grant to West Virginia to study and evaluate establishing a Land Stewardship Trust Program in connection with the West Virginia Voluntary Remediation Program. They also noted that such programs are very state-specific and that Pennsylvania, for example, has the Guardian Trust. For additional information on the July 21, 2009 meeting between U.S. EPA and the Chamber, contact Gale Lea Rubrecht at galelea@jacksonkelly.com or 304-340-1200. 

This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author see here.

States Privatizing Environmental Remediation

Based on a recent report, New Jersey appears to have become the poster child for a problem facing may state environmental regulatory agencies around the county, a backlog of contaminated sites that these agencies do not have the resources (personnel or financial) to address. For example, New Jersey reportedly has a backlog of more than 19,000 contaminated sites. In response to this problem, several states have recently taken steps to privatize portions of their state remediation programs in an effort to accelerate the site remediation process and reduce their backlogs. Connecticut, Massachusetts, and now New Jersey have all reportedly implemented such privatization programs. Although, the changes to these State remediation programs are reportedly similar, I’ll focus on a few aspects of the New Jersey privatization program that are of general interest. 

The Site Remediation Reform Act (“SRRA,” N.J.S.A. 58:10C-1 et seq) was signed into law on May 7, 2009. In certain cases, primary environmental investigation and cleanup oversight under SRRA will no longer be performed by the New Jersey Department of Environmental Protection (NJDEP), but will now be performed by a new class of environmental professional that has been created under SRRA: “Licensed Site Remediation Professionals (LSRPs). LSRPs will be licensed as such by a 13-member licensing board and will be subject to civil and criminal penalties for violations of SRRA. 

Under SRRA, LSRPs will supervise site remediation activities largely independent of the NJDEP and the LSRPs will certify that the site meets New Jersey’s Technical Requirements for Site Remediation. Notably, the LSRP’s obligations under SRRA will change. Although, the LSRPs will still be hired by the entity responsible for remediation, in the future the LSRP will be responsible for protecting human health and the environment, which must take precedence over client preferences, discretionary sampling decisions, efficient billing, etc. 

It should be noted that New Jersey will no longer issue “No Further Action” (NFA) letters, except for those projects completed before the full phase-in of SRRA. Instead, the LSRP will file a Response Action Outcome (RAO) with the NJDEP. The RAOs are intended to be at least as reliable as NFA letters, and are subject to review and possible revocation for the first three years after issuance, as well as providing for re-openers. 

Under SRRA, the NJDEP will inspect submissions from LSRPs, but only generally at an undefined and likely much lower level of review. However, the NJDEP will be required to perform a higher level of review at those sites that may pose a significant threat to human health and the environment, may affect sensitive populations (i.e., daycare centers), or may involve environmental justice concerns. In addition, NJDEP may also have direct oversight of sites meeting the following criteria: 

·        Chromate contamination.

·        Multiple impacted sensitive natural resources.

·        PCBs, mercury, arsenic, or dioxin impacted surface water bodies.

·        Highest ranking priority in the New Jersey Spill Act. 

Finally, implementation of SRRA raises a number of questions and concerns going forward regarding the remediation of contaminated sites in New Jersey: 

·        Since, the “highest priority” for LSRPs is to protect human health and the environment, will LSRPs become more conservative in their approach and therefore, will remedial actions become more expensive to complete. Anecdotal evidence suggest that this has been the case in Ohio since implementation of their Voluntary Assistance Program (VAP). 

·        LSRPs will have obligations to disclose information and certain data directly to NJDEP about site conditions (even after the LSRP has been discharged). Therefore, how will this requirement affect the traditional relationship between an environmental consultant and their client? 

This article was authored by Greg Tieman, Acacia Environmental Group LLC. For more information on the author see here. 

U.S. EPA Reforms IRIS Process

On May 21, 2009, U.S. EPA Administrator Lisa P. Jackson announced reforms to the agency’s Integrated Risk Information System (IRIS). IRIS is an electronic database that provides information on human health effects that may result from exposure to chemical substances in air, water, and land both from contaminated sites and from products.  

U.S. EPA’s National Center for Environmental Assessment (NCEA) within the Office of Research and Development (ORD) maintains and prepares the database. Government and private entities in the United States and around the world use IRIS to help characterize public health risks of chemical substances in a site-specific situation and support risk-management decisions designed to protect public health. In West Virginia, for example, IRIS is used in risk-management decisions under the West Virginia Voluntary Remediation and Redevelopment Program. Other examples of risk management decisions relying upon IRIS include: deciding how much of a substance a company may discharge into a river, which substances may be stored at a hazardous waste disposal facility, and to what extent a hazardous waste site must be cleaned up; setting permit levels for discharge, storage, or transport; establishing levels for air emissions; and determining allowable levels of contamination in drinking water. 

The reforms announced May 21, 2009, reverse changes to the IRIS process, including procedures formalized by the Bush EPA in an April 10, 2008, memorandum that U.S. EPA Administrator Jackson criticized as “reduc[ing] the transparency, timeliness, and scientific integrity of the IRIS process.” Administrator Jackson promised that the new process would be “more transparent and timely” and would also “ensure the highest level of scientific integrity.” While EPA will consider the scientific input of experts at other agencies and White House offices, EPA will manage the process and have “final responsibility” for the content of all IRIS assessments. The process will include the opportunity for public comment and rely on open and independent external peer review. EPA will provide a response to comments. The assessment development process will be shortened to 23 months and for fiscal year 2010, EPA resources for the IRIS program will be increased. President Obama’s 2010 fiscal year budget includes a request for an additional $5 million and 10 full-time equivalent employees for the IRIS program. 

Before the development of the draft IRIS assessment for each chemical on the proposed agenda, EPA will conduct a scientific literature search and initiate a data call-in. For the scientific literature search, ORD will appoint a chemical manager for each chemical on the proposed agenda, and that chemical manager will then direct an EPA contractor to conduct and complete a comprehensive search of the scientific literature for the chemical. The results of that literature search will be posted on EPA’s web site. After the completion of the literature search for each chemical, EPA will publish a Federal Register notice notifying the public of the availability of the completed literature search on the IRIS web site. The notice will invite the public and other agencies to submit additional scientific information on the chemical and request information on new research that may be planned, underway, or in press.  

After the literature search and data call-in are complete, EPA will begin development of the IRIS human health assessment. All IRIS human health assessments will undergo “rigorous, open, independent external peer review”. IRIS assessments considered being of major importance or high profile may be selected for peer review by panels of experts convened by EPA’s Science Advisory Board or by the National Academy of Sciences. 

IRIS assessments are to be developed under a 7-step process. This seven-step process is expected to be completed within approximately 2 years from the Step 1 start date. Because of their complexity, large scientific literature base, or high profile, some IRIS assessments may take longer than 2 years.  

·        Step 1 – Development of Draft IRIS Toxicological Review: EPA develops and completes a draft IRIS Toxicological Review. An ORD assessment team will assess the data and the scientific literature and any information submitted as a result of the data call-in and develop a draft assessment for the chemical being assessed. The draft assessment will summarize potentially important health effects, information on potential modes of action, and information about potentially susceptible populations. The draft assessment will include a quantitative assessment, including application of certain factors, default approaches, mode of action information, and dose-response modeling. The draft assessment will also identify potential uncertainties that impact the qualitative and quantitative aspects of the assessment. The development and completion of the draft IRIS Toxicological Review is expected to take 345 days. 

·        Step 2 – Internal EPA Review: Once the draft IRIS Toxicological Review has been developed, ORD submits it for internal EPA review. Scientists from EPA programs and regions review the draft Toxicological Review and identify any scientific issues to determine the level of peer review, needed panel member disciplines, and the scope of the review. Internal EPA review is expected to take 60 days. 

·        Step 3 – Interagency Science Consultation: Following the internal EPA review, EPA initiates an Interagency Science Consultation on the draft IRIS Toxicological Review. EPA sends the draft IRIS Toxicological Review and draft external peer review charge to other federal agencies and White House offices for a science consultation. This science consultation is managed and coordinated by EPA. All written comments received during the Interagency Science Consultation become part of the record. Following receipt of written comments, ORD revises the draft assessment documents as appropriate, and science questions that arise may be included as part of a charge question to the peer review panel.  

·        Step 4 – External Peer Review, Public Review and Comment, and Public Listening Session: After the Interagency Science Consultation, EPA initiates an independent external peer review of the draft IRIS Toxicological Review, releases the draft IRIS Toxicological Review for public review and comment, and holds a public listening session. The external peer review, public review and comment, and public listening session are all announced in the Federal Register and are expected to take 105 days. EPA recently announced a listening session for the draft Toxicological Review of Pentachlorophenol (74 Fed. Reg. 27317; June 9, 2009), and a listening session and peer review workshop for the draft Toxicological Review of 1, 4-Dioxan (74 Fed. Reg. 27313; June 9, 2009). 

·        Step 5 – Revisions, IRIS Summary, and Response to Comments: Following the external peer review, public review and comment, and public listening session, ORD evaluates the report of the external peer review panel and all public comments. ORD revises the draft IRIS Toxicological Review, as appropriate, and develops the IRIS Summary. ORD also develops a disposition of peer reviewer and public comments and provides these as an appendix to the IRIS Toxicological Review. The revision process and response to comments is expected to take 60 days but the length of the process may depend on the complexity of the IRIS Toxicological Review and complexity and number of comments. 

·        Step 6 – Final Internal EPA Review and EPA-led Interagency Science Discussion:  After development of the final drafts of the IRIS Toxicological Review and IRIS Summary and response to comments, ORD sends the final drafts of the IRIS Toxicological Review and IRIS Summary for final internal EPA review. This review is intended as a final check-in with Agency program and regions. Concurrent with the internal EPA review, EPA provides other agencies and White House offices with a final draft of the IRIS Summary and Toxicological Review and appendix describing disposition of peer review and public comments. Other agency and White House office scientists may provide written scientific feedback. EPA also hosts a meeting with other agencies and White House offices to discuss any scientific issues related to the final draft of the IRIS Summary and Toxicological Review and appendix. All written comments by other agencies and White House offices are documented in the record. Step 6 is expected to take 45 days. 

·        Step 7 – Completion of IRIS Toxicological Review and IRIS Summary:  EPA completes the IRIS Toxicological Review and IRIS Summary. Step 7 is expected to take 30 days. 

The reforms announced May 21, 2009, respond to criticism of the changes made to the IRIS process by the Bush EPA culminating in the April 10, 2008 memorandum. The 2008 process involved early involvement of other federal agencies and the public. In 2004, the White House directed EPA to begin routinely submitting draft assessments to the White House Office of Management and Budget (OMB) for review. Previously, the need for these reviews had been determined on a case-by-case basis. On April 10, 2008, EPA announced additional changes to the IRIS process which further involved OMB. This upset the scientific community because OMB’s staff is comprised mostly of policy analysts and economists. The 2008 IRIS process included asking other federal agencies whether an industrial chemical was critical to that agency’s mission. OMB then coordinated the agencies’ negotiations over “mission-critical” designations. If OMB and other agencies determined the chemicals in question to be “mission-critical,” then the other agencies had an opportunity to conduct their own research and to fill any identified data gaps or address any uncertainties. This prolonged the process and delayed the completion of IRIS assessments. Further, under the 2008 process, the communications during the consultations with other agencies and OMB were designated as “deliberative” and therefore not subject to a Freedom of Information Act request. The U.S. Government Accountability Office (GAO) was highly critical of an EPA’s 2008 IRIS process. In a May 21, 2008 report, GAO criticized the process as lacking transparency and limiting the credibility of IRIS assessments as well as placing the IRIS database at serious risk of becoming obsolete. GAO stated, “EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years to complete.”  

For additional information on 2009 reforms to the IRIS process, contact Gale Lea Rubrecht at galelea@jacksonkelly.com or 304-340-1200. 

This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author see here.