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(iii) Bathhouses referred to in 

paragraph (b)(2)(iii)(C) must pay all 

costs associated with connections for 

obtaining such thermal water. 

(iv) Written instruments authorizing 

the use of the thermal water may require 

bathhouses to reimburse the NPS for 

costs incurred from the distribution of 

thermal water and maintenance of the 

distribution system. 

(v) The NPS will readjust the terms 

and amounts of payments required 

under a written instrument authorizing 

the use of thermal water at least every 

five years during its term and upon the 

renewal of a written instrument at end 

of its term. 

* * * * * 

Part 21 [Removed] 

■ 3. Remove part 21, consisting of 

§§ 21.1 through 21.12. 

Shannon Estenoz, 

Assistant Secretary for Fish and Wildlife and 

Parks. 

[FR Doc. 2024–27571 Filed 11–26–24; 8:45 am] 

BILLING CODE 4312–52–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 147 

[EPA–HQ–OW–2024–0357; FRL 12000–01– 

OW] 

West Virginia Underground Injection 

Control (UIC) Program; Class VI 

Primacy 

AGENCY: U.S. Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA or the Agency) 

has received a complete Underground 

Injection Control (UIC) program revision 

package from the State of West Virginia 

(State), requesting approval of a revision 

to the State’s Safe Drinking Water Act 

(SDWA) section 1422 UIC program to 

include Class VI injection well primary 

enforcement responsibility (primacy). 

The proposed revision would allow the 

West Virginia Department of 

Environmental Protection (WVDEP) to 

issue UIC permits for geologic carbon 

sequestration facilities as Class VI wells 

and ensure compliance of Class VI wells 

under the UIC program. The EPA 

proposes to issue a final rule approving 

West Virginia’s application to 

implement the UIC program for Class VI 

injection wells located within the State, 

except those on Indian lands. The EPA 

proposes amendments to reflect this 

proposed approval of West Virginia’s 

Class VI primacy application. 

DATES: Comments must be received on 

or before December 30, 2024. Public 

hearing: The EPA will hold a public 

hearing on December 30, 2024. Please 

refer to the SUPPLEMENTARY INFORMATION

section for additional information on 

the public hearing. 

ADDRESSES: You may send comments, 

identified by Docket ID No. EPA–HQ– 

OW–2024–0357 by any of the following 

methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov/ (our 

preferred method). Follow the online 

instructions for submitting comments. 

• Mail: U.S. Environmental 

Protection Agency, EPA Docket Center, 

Water Docket, Mail Code 28221T, 1200 

Pennsylvania Avenue NW, Washington, 

DC 20460. 

• Hand Delivery or Courier: EPA 

Docket Center, WJC West Building, 

Room 3334, 1301 Constitution Avenue 

NW, Washington, DC 20004. The Docket 

Center’s hours of operations are 8:30 

a.m. to 4:30 p.m., Monday–Friday 

(except Federal Holidays). 

Instructions: All submissions received 

must include the Docket ID No. for this 

rulemaking. Comments received may be 

posted without change to https://

www.regulations.gov/, including 

personal information provided. For 

detailed instructions on sending 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

FOR FURTHER INFORMATION CONTACT: 

Colin Dyroff, Drinking Water 

Infrastructure Development Division, 

Office of Ground Water and Drinking 

Water (4606M), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460; 

telephone number: (202) 564–3149; or 

Himanshu Vyas, Water Division, Source 

Water & UIC Section (3WD22), 

Environmental Protection Agency, 

Region 3, Four Penn Center, 1600 JFK 

Boulevard, Philadelphia, PA 19103; 

telephone number: (215) 814–2112. 

Both can be reached by emailing 

WVClassVI@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Public Participation 

A. Written Comments 

B. Participation in Public Hearing 

C. Public Participation Activities 

Conducted by West Virginia 

II. Introduction 

A. UIC Program and Primary Enforcement 

Authority (Primacy) 

B. Class VI Wells Under the UIC Program 

C. West Virginia UIC Program 

III. Legal Authorities 

IV. The EPA’s Evaluation of West Virginia’s 

Program Revision Application 

A. Background 

B. Environmental Justice in Class VI 

Permitting 

C. Summary of the EPA’s Comprehensive 

Evaluation 

V. The EPA’s Proposed Action 

A. Incorporation by Reference 

B. Class I–V Codification—No Action 

VI. Statutory and Executive Orders Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 14094: Modernizing Regulatory 

Review 

B. Paperwork Reduction Act (PRA) 

C. Regulatory Flexibility Act (RFA) 

D. Unfunded Mandates Reform Act 

(UMRA) 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations and Executive Order 14096: 

Revitalizing Our Nation’s Commitment 

to Environmental Justice for All 

VII. References 

I. Public Participation 

A. Written Comments 

Submit your comments, identified by 

Docket ID No. EPA–HQ–OW–2024– 

0357, at https://www.regulations.gov 

(our preferred method), or the other 

methods identified in the ADDRESSES

section. Once submitted, comments 

cannot be edited or removed from the 

docket. The EPA may publish any 

comment received to its public docket. 

Do not submit to the EPA’s docket at 

https://www.regulations.gov any 

information you consider to be 

Confidential Business Information (CBI), 

Proprietary Business Information (PBI), 

or other information whose disclosure is 

restricted by statute. If you need to 

submit CBI, contact Himanshu Vyas 

with the contact information available 

in the FOR FURTHER INFORMATION

CONTACT section. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 


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submission (i.e., on the web, cloud, or 

other file sharing system). Please visit 

https://www.epa.gov/dockets/ 

commenting-epa-dockets for additional 

submission methods; the full EPA 

public comment policy; information 

about CBI, PBI, or multimedia 

submissions; and general guidance on 

making effective comments. 

B. Participation in Public Hearing 

A public hearing is anticipated to be 

held on December 30, 2024. The EPA 

expects to announce the location, time 

of the hearing, as well as any updates 

made to any aspect of the hearing online 

at https://www.epa.gov/aboutepa/eparegion-3-mid-atlantic#pn. The hearing 

can also be attended virtually at https:// 

www.zoomgov.com/j/1600637199. 

While the EPA expects the hearing to go 

forward as set forth above, please 

monitor our website or contact 

Himanshu Vyas at (215) 814–2112 or 

WVClassVI@epa.gov to determine if 

there are any updates or for additional 

information regarding the public 

hearing. The EPA does not intend to 

publish a document in the Federal 

Register announcing updates. 

The EPA will begin pre-registering 

speakers for the hearing upon 

publication of this document in the 

Federal Register. To register to speak at 

the hearing, please contact Himanshu 

Vyas at (215) 814–2112 or WVClassVI@

epa.gov and indicate whether you will 

be attending in-person or virtually. The 

last day to pre-register to speak at the 

hearing will be December 23, 2024. 

Prior to the hearing, the EPA will post 

a general agenda for the hearing that 

will list pre-registered speakers in 

approximate order at: https://

www.epa.gov/aboutepa/epa-region-3- 

mid-atlantic#pn. 

The EPA will make every effort to 

follow the schedule as closely as 

possible on the day of the hearing; 

however, please plan for the hearings to 

run either ahead of schedule or behind 

schedule. Additionally, requests to 

speak will be taken the day of the 

hearing at the hearing registration desk. 

The EPA will make every effort to 

accommodate all speakers who arrive 

and register, although preferences on 

speaking times may not be able to be 

fulfilled. 

The EPA encourages commenters to 

provide the EPA with a copy of their 

oral testimony electronically by 

emailing it to WVClassVI@epa.gov. The 

EPA also recommends submitting the 

text of your oral comments as written 

comments to the rulemaking docket. 

The EPA may ask clarifying questions 

during the oral presentations but will 

not respond to the presentations at that 

time. Written statements and supporting 

information submitted during the 

comment period will be considered 

with the same weight as oral comments 

and supporting information presented at 

the public hearing. 

The EPA will not provide audiovisual 

equipment for presentations unless we 

receive special requests in advance. 

Commenters should notify Himanshu 

Vyas when they pre-register to speak 

that they will need specific equipment. 

If you require the services of an 

interpreter or special accommodations 

such as audio description, please preregister for the hearing with Himanshu 

Vyas and describe your needs by 

December 23, 2024. The EPA may not be 

able to arrange accommodations without 

advance notice. 

C. Public Participation Activities 

Conducted by West Virginia 

On June 23, 2021, the WVDEP posted 

a notice of public comment period on 

their website for an action to revise 

West Virginia Code of State Rules 

47CSR13 to add new regulations for 

Class VI wells and to update the State’s 

existing Class I–V regulations. The 

WVDEP held a public comment period 

from June 23, 2021 to July 23, 2021 and 

held a virtual public hearing on July 23, 

2021. The WVDEP received 55 

comments, 19 of which commented on 

Class VI wells. These comments did not 

result in changes to the proposed 

regulatory revisions. The effective date 

for this rule revision was March 9, 2022. 

Then, on June 12, 2023, the WVDEP 

posted a notice of public comment 

period on their website for another 

action to make additional updates to the 

State’s Class I–VI regulations in 

47CSR13 of the West Virginia Code of 

State Rules. The WVDEP held a public 

comment period from June 12, 2023 to 

July 18, 2023 and held a public hearing 

on July 18, 2023 in Charleston, WV. The 

WVDEP received five comments, all of 

which related to Class VI wells. These 

comments did not result in changes to 

the proposed updates to the regulations. 

The effective date for this rule revision 

was April 5, 2024. 

Commenters on the WVDEP’s 

proposed rulemakings shared concerns 

on various topics including applicant 

financial burden, fees, the area of review 

radius, post-injection site care, and 

seismic activity reviews. Commenters 

also expressed concern about whether 

the WVDEP has adequate staffing and 

technical expertise to properly manage 

a UIC Class VI program. Environmental 

justice (EJ) also appeared to be a major 

concern, with commenters asking about 

how EJ protections will be integrated 

into the program. The WVDEP 

responded to all public comments, 

provided various clarifications, and 

confirmed to commenters that EJ will be 

an important part of the agency’s Class 

VI program. The WVDEP also added 

that the agency’s Class VI team would 

be composed of technical specialists 

with expertise in geology, well 

construction, and UIC inspections. 

Additionally, the WVDEP stated that the 

rule revisions were adopted to be 

consistent with Federal requirements 

and that the agency’s primary objective 

is to protect underground sources of 

drinking water, groundwater, and 

surface water. Documentation of West 

Virginia’s public participation activities, 

including comments received and 

responses by the WVDEP, can be found 

in the EPA’s Docket ID No. EPA–HQ– 

OW–2024–0357. 

II. Introduction 

A. UIC Program and Primary 

Enforcement Authority (Primacy) 

The SDWA protects public health by 

regulating the nation’s public drinking 

water supply, including both surface 

and groundwater sources. The SDWA 

requires the EPA to develop minimum 

requirements for effective State and 

Tribal UIC programs to prevent 

underground injection of fluids (such as 

water, wastewater, brines from oil and 

gas production, and carbon dioxide) 

from endangering underground sources 

of drinking water (USDWs). In general, 

USDWs are aquifers or parts of aquifers 

that supply a public water system or 

contain enough groundwater to supply 

a public water system. See 40 CFR 

144.3. 

The UIC program regulates various 

aspects of an injection well project. 

These include technical aspects 

throughout the lifetime of the project 

from site characterization, construction, 

operation, and testing and monitoring 

through site closure, as well as 

permitting, site inspections, and 

reporting to ensure well owners and 

operators comply with UIC regulations. 

SDWA section 1421 directs the EPA 

to establish requirements that States, 

territories, and federally recognized 

Tribes (hereafter referred to as 

applicants) must meet to be granted 

primary enforcement responsibility or 

‘‘primacy’’ for implementing a UIC 

program, including a Class VI program. 

An applicant seeking primacy under 

SDWA section 1422 for a Class VI 

program must demonstrate to the EPA 

that the applicant’s Class VI program 

meets the Federal requirements and is 

protective of USDWs. An applicant 

agency must also demonstrate 

jurisdiction over underground injection 


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and the administrative, civil, and 

criminal enforcement authorities 

required by EPA regulation. After the 

EPA approves a State for UIC primacy, 

the State’s UIC program may be revised 

with EPA approval. See 40 CFR 145.32. 

When a State that already has primacy 

under SDWA section 1422 seeks to add 

Class VI primacy to its existing program, 

a subsequent primacy application and 

review process takes the form of a 

program revision. 

The EPA conducts a comprehensive 

technical and legal evaluation of each 

primacy application to assess and 

confirm that the proposed program 

meets Federal regulations and to 

evaluate the effectiveness of the State’s 

proposed program. The EPA likewise 

conducts a comprehensive evaluation of 

a proposed revision to an existing UIC 

program, particularly a revision as 

substantial as adding Class VI primacy. 

B. Class VI Wells Under the UIC 

Program 

Class VI wells are used to inject 

carbon dioxide into deep rock 

formations for the purpose of long-term 

underground storage, also known as 

geologic sequestration. The geologic 

sequestration of carbon dioxide in UIC 

Class VI wells is used in carbon capture 

and storage to prevent carbon dioxide 

emissions from industrial sources from 

reaching the atmosphere. Class VI 

injection wells are regulated under an 

existing, rigorous SDWA permitting 

framework that protects USDWs. 

The UIC Class VI program provides 

multiple safeguards that work together 

to protect USDWs and human health. 

Owners or operators that wish to inject 

carbon dioxide underground for the 

purpose of geologic sequestration must 

demonstrate that their injection well 

and injection activities will meet all 

regulatory requirements and receive a 

Class VI permit for each well. The UIC 

Class VI program requires applicants to 

meet strict technical, financial, and 

managerial requirements to obtain a 

Class VI permit, including: 

• Site characterization to ensure the 

geology in the project area will contain 

the carbon dioxide within the zone 

where it will be injected. 

• Modeling to delineate the predicted 

area influenced by injection activities 

through the lifetime of operation. 

• Evaluation of the delineated area to 

ensure all potential pathways for fluid 

movement have been identified and 

addressed through corrective action. 

• Well construction requirements that 

ensure the Class VI injection well will 

not leak carbon dioxide. 

• Testing and monitoring throughout 

the life of the project, including after 

carbon dioxide injection has ended. 

Requirements include, for example, 

testing to ensure physical integrity of 

the well, monitoring for seismic activity 

near the injection site, monitoring of 

injection pressure and flow, chemical 

analysis of the carbon dioxide stream 

that is being injected, and monitoring 

the extent of the injected carbon dioxide 

plume and the surrounding area (e.g., 

ground water) to ensure the carbon 

dioxide is contained as predicted. 

• Operating requirements (for 

example, injection pressure limitations) 

to ensure the injection activity will not 

endanger USDWs or human health. 

• Financial assurance mechanisms 

sufficient to cover the costs for all 

phases of the geologic sequestration 

project including the post-injection site 

care period and until site closure has 

been approved by the permitting 

authority. 

• Emergency and remedial response 

plans. 

• Reporting of all testing and 

monitoring results to the permitting 

authority to ensure the well is operating 

in compliance with all permit and 

regulatory requirements. 

The permitting authority ensures that 

these protective requirements are 

included in each Class VI permit. A 

draft of each Class VI permit is made 

available to the public for comment 

before the decision is made whether to 

issue a final permit. 

C. West Virginia UIC Program 

The State of West Virginia received 

primacy for Class I, III, IV, and V 

injection wells under SDWA section 

1422 and Class II injection wells under 

SDWA section 1425 on December 9, 

1983 (48 FR 55127). On May 1, 2024, 

West Virginia applied to the EPA under 

section 1422 of SDWA, 42 U.S.C. 300h– 

1, for primacy for Class VI injection 

wells located within the State, except 

those located on Indian lands. 

III. Legal Authorities 

This regulation is proposed under 

authority of SDWA sections 1422 and 

1450, 42 U.S.C. 300h–1 and 300j–9. 

Section 1421 of SDWA requires the 

Administrator of the EPA to promulgate 

Federal requirements for effective State 

UIC programs to prevent underground 

injection activities that endanger 

USDWs. Section 1422 of SDWA 

establishes requirements for States and 

Tribes seeking EPA approval of their 

UIC programs. It also requires that 

States and Tribes seeking approval 

demonstrate how the applicant (after 

public notice) will implement a UIC 

program which meets the requirements 

that the EPA promulgated under section 

1421. 

For States and Tribes that seek 

approval for UIC programs under 

section 1422 of SDWA and those 

seeking EPA approval of revisions to 

existing State and Tribal UIC programs, 

the EPA has promulgated regulations 

setting forth the applicable procedures 

and substantive requirements codified 

in 40 CFR parts 144, 145 and 146. 40 

CFR part 144 outlines general program 

requirements that each State must meet 

to obtain primary enforcement 

authority. 40 CFR part 145 specifies the 

procedures the EPA will follow in 

approving, revising, and withdrawing 

State programs and outlines the 

elements and provisions that a State 

must include in its application for 

primacy. 40 CFR part 145 also includes 

requirements for State permitting 

programs (by reference to certain 

provisions of 40 CFR parts 124 and 144), 

compliance evaluation programs, 

enforcement authority, and sharing of 

information between the EPA and the 

State. 40 CFR part 146 contains the 

technical criteria and standards 

applicable to each well class, including 

Class VI wells. 

IV. The EPA’s Evaluation of West 

Virginia’s Program Revision 

Application 

A. Background 

On May 1, 2024, West Virginia 

submitted to the EPA a program revision 

application to add Class VI wells to the 

State’s SDWA section 1422 UIC 

program. The UIC program revision 

package from West Virginia includes a 

description of the State’s UIC Class VI 

program, copies of all applicable rules 

and forms, a statement of legal 

authority, a summary and results of 

West Virginia’s public participation 

activities, an amended addendum to the 

existing Memorandum of Agreement 

(MOA) between West Virginia and the 

EPA’s Region 3 office, an interagency 

MOA between the WVDEP and the West 

Virginia Geologic and Economic Survey 

(WVGES), and an interagency MOA 

between the WVDEP and the West 

Virginia Department of Health. The EPA 

reviewed the application for 

completeness and performed a technical 

evaluation of the application materials. 

B. Environmental Justice in Class VI 

Permitting 

People across the country have shared 

with the EPA concerns that already 

environmentally overburdened 

communities may bear a 

disproportionate environmental burden 

associated with geologic sequestration. 


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Executive Order 12898 (59 FR 7629, 

February 16, 1994) and Executive Order 

14096 (88 FR 25251, April 21, 2023) 

direct Federal agencies, to the greatest 

extent practicable and permitted by law, 

to identify and address, as appropriate, 

disproportionate and adverse human 

health or environmental impacts on 

communities with EJ concerns. On 

August 17, 2023, the EPA released a 

guidance document titled 

Environmental Justice Guidance for UIC 

Class VI Permitting and Primacy. This 

guidance outlines expectations for the 

EPA to incorporate EJ considerations 

into Class VI activities. It is organized 

into five themes that address various 

aspects of EJ in UIC Class VI permitting, 

and strongly encourages States, Tribes, 

and Territories to implement their Class 

VI programs in a similar fashion. 

As part of developing this proposal, 

the EPA worked with the State of West 

Virginia to adopt the EJ approaches 

encouraged in the August 17, 2023 

guidance document, which West 

Virginia has incorporated in its primacy 

application. The EPA reviewed West 

Virginia’s EJ approach as described in 

the State’s Class VI program description 

and amended MOA addendum and 

compared it to the EJ themes and 

actions in the guidance document. The 

EJ approach in the amended MOA 

addendum corresponds to the five 

themes in the EPA’s August 17, 2023 

guidance document, which include 

identifying communities with potential 

EJ concerns, implementing an 

augmented public participation process, 

conducting additional assessments for 

projects identified as having EJ 

concerns, ensuring the permitting 

process is transparent, and minimizing 

adverse effects to underground sources 

of drinking water and the communities 

they may serve. Furthermore, West 

Virginia’s Class VI program description 

specifies that the WVDEP will require 

well owners or operators to conduct an 

EJ review as part of the Class VI permit 

application process. The EPA supports 

the WVDEP’s agreement in its Class VI 

program description to evaluate project 

sites using the EPA’s EJ Screen and to 

take additional steps if this initial 

screening identifies the presence of an 

EJ community or other risk factors in the 

area of review (AOR). West Virginia’s 

Class VI program, as described in the 

WVDEP’s primacy application, includes 

approaches to ensure equity and EJ will 

be appropriately considered in permit 

reviews, and in the WVDEP’s UIC Class 

VI program as a whole. 

C. Summary of the EPA’s 

Comprehensive Evaluation 

The EPA conducted a comprehensive 

technical and legal evaluation of West 

Virginia’s Class VI primacy application 

to assess and confirm that the State’s 

UIC Class VI program is as stringent as 

the Federal regulations and evaluated 

the effectiveness of the State’s Class VI 

program. To be approved for Class VI 

primacy under SDWA section 1422, a 

State or Tribe must have a UIC program 

that meets Federal requirements (40 

CFR parts 124, 144, 145, and 146). The 

EPA evaluated West Virginia’s Class VI 

UIC statutes and regulations against 

these Federal requirements. The EPA 

worked with West Virginia to address 

any stringency issues with their Class VI 

statutes and regulations prior to 

submittal of the Class VI primacy 

application. The Agency also evaluated 

for stringency and effectiveness West 

Virginia’s Class VI program description, 

the Class VI Attorney General’s 

statement, the amended Class VI 

addendum to the MOA between the 

EPA and West Virginia, the interagency 

MOA between the WVDEP and the West 

Virginia Geologic and Economic Survey, 

and the interagency MOA between the 

WVDEP and the West Virginia 

Department of Health. 

The EPA evaluated West Virginia’s 

Class VI program description against 40 

CFR 145.23, which lists all the 

information to be submitted as part of 

the program description. The EPA’s 

evaluation of the Class VI program 

description included reviewing the 

scope, structure, coverage, processes, 

and organizational structure of the 

permitting authority. The EPA evaluated 

the WVDEP’s permitting, 

administrative, and judicial review 

procedures, as well as the State’s permit 

application, reporting, and manifest 

forms. The EPA also reviewed the 

State’s compliance evaluation and 

enforcement mechanisms. The EPA 

evaluated the WVDEP’s proposed 

schedule for issuing Class VI permits 

within the first two years after program 

approval. The EPA required West 

Virginia to demonstrate that the State’s 

Class VI program will have adequate inhouse staff or access to contractor 

support for technical areas including 

site characterization, modeling, well 

construction and testing, financial 

responsibility, and regulatory and risk 

analysis. 

The EPA evaluated West Virginia’s 

Class VI Attorney General’s statement 

against 40 CFR 145.24 to ensure it met 

Federal requirements. The Attorney 

General’s statement is required to 

ensure that a State’s top legal officer 

affirms that State statutes, regulations, 

and judicial decisions demonstrate 

adequate authority to administer the 

UIC program as described in the Class 

VI program description and consistent 

with the EPA’s regulatory requirements 

for UIC programs. The EPA 

independently evaluates and confirms 

that the Attorney General’s statement 

certifies that the State either does not 

have environmental audit privilege and/ 

or immunity laws, or, if there are 

environmental audit privilege and/or 

immunity laws, that they will not affect 

the ability of the State to meet the 

enforcement and information gathering 

requirements under the SDWA. 

The EPA evaluated West Virginia’s 

amended Class VI MOA addendum 

against 40 CFR 145.25 to ensure it met 

Federal requirements. The MOA is the 

central agreement setting the provisions 

and arrangements between the State and 

the EPA concerning the administration, 

implementation, and enforcement of the 

State UIC program. The EPA’s 

evaluation includes ensuring that the 

MOA contains the necessary provisions 

pertaining to agreements on 

coordination, permitting, compliance 

monitoring, enforcement, and EPA 

oversight. For example, the amended 

MOA addendum specifies that the 

WVDEP and the EPA agree to maintain 

a high level of cooperation and 

coordination to assure successful and 

efficient administration of the UIC Class 

VI program. 

The EPA reviewed the WVDEP’s 

interagency MOA with the West 

Virginia Geological and Economic 

Survey. The WVGES is a West Virginia 

agency with expertise to provide 

information to the WVDEP on local 

geologic characteristics in relation to 

proposed underground injection 

operations. The interagency MOA 

between the WVDEP and the WVGES 

establishes a coordinated relationship 

between the two state agencies to 

properly assess geological 

characteristics in a proposed work area 

to support permit determinations. The 

EPA also reviewed the WVDEP’s 

interagency MOA with the West 

Virginia Department of Health 

(WVDOH). Under this interagency 

MOA, the WVDOH will conduct a 

review of the proposed area of work and 

permit application details and provide 

input to assist in permit determinations, 

among other provisions. 

The EPA is aware that stakeholders 

have raised concern about geologic 

sequestration long term liability transfer 

provisions enacted in West Virginia and 

other States. The EPA reviewed the 

West Virginia statutory provision 

relating to long-term liability transfer 


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1Such requirements include the post closure 

deed notation and record retention requirements at 

40 CFR 146.93 and 47CSR13.13.9, as specifically 

mentioned in the Class VI MOA amended 

addendum. 

2Even if this proposed action were not a revision 

to an existing UIC program, the UIC regulations at 

40 CFR 145.1(i) allow States to apply for primary 

enforcement responsibility for Class VI wells 

independently of other injection well classes. 

(W. Va. Code § 22–11B–12) and 

determined that it does not undermine 

any protections under the Safe Drinking 

Water Act. Under the West Virginia 

long-term liability transfer provision, all 

Class VI regulatory and permit 

requirements must be met before 

liability transfer may occur.1 Consistent 

with EPA regulations, West Virginia 

imposes extensive post-injection 

monitoring—a default of 50 years—and 

site closure requirements at the end of 

a Class VI well’s life cycle to ensure that 

there will be no danger to USDWs. Only 

after all those requirements are met does 

West Virginia’s long-term liability 

transfer provision allow a limited 

transfer of any future liability to a stateadministered and industry-funded trust 

fund. Among other additional 

limitations, the provision is explicit that 

it does not: relieve any owner or 

operator from any liability that arises 

from noncompliance with UIC laws, 

regulations or permits; apply if the 

WVDEP determines that there is fluid 

migration for which the operator is 

responsible that threatens imminent and 

substantial endangerment to a USDW; or 

interfere with the EPA’s emergency 

authority under SDWA section 1431. 

West Virginia has demonstrated that it 

has the legal authority to implement all 

permit requirements found in 40 CFR 

145.11 for Class VI permits. West 

Virginia’s UIC Class VI permitting 

provisions are as stringent as the EPA’s 

regulations in 40 CFR parts 124 and 144. 

The State has incorporated necessary 

procedures, pursuant to 40 CFR 145.12 

to support a robust Class VI compliance 

evaluation program. Additionally, West 

Virginia has the necessary 

administrative, civil, and criminal 

enforcement authorities pursuant to 40 

CFR 145.13. West Virginia’s Class VI 

regulations regarding permitting, 

inspection, operation, and monitoring 

meet Federal requirements found in 40 

CFR parts 145 and 146. West Virginia’s 

reporting and recordkeeping 

requirements meet Federal requirements 

found in 40 CFR 144.54 and 146.91 for 

Class VI wells. 

As a result of this comprehensive 

review, the EPA is proposing to approve 

West Virginia’s application because the 

EPA has determined that the application 

meets all applicable requirements for 

approval under SDWA section 1422 and 

the State is capable of administering a 

UIC Class VI program in a manner 

consistent with the terms and purposes 

of SDWA and all applicable UIC 

regulations. 

V. The EPA’s Proposed Action 

A. Incorporation by Reference 

The EPA is proposing to approve a 

revision to the State of West Virginia’s 

UIC program for primacy for regulating 

Class VI injection wells in the State, 

except for those located on Indian lands. 

West Virginia’s statutes and regulations 

that are proposed to be incorporated by 

reference are publicly available in the 

EPA’s Docket No. EPA–HQ–OW–2024– 

0357. If finalized, this action would 

amend 40 CFR 147.2450 and 

incorporate by reference EPA-approved 

State statutes and regulations that 

contain standards, requirements, and 

procedures applicable to Class VI 

owners or operators. Any provisions 

incorporated by reference, as well as all 

permit conditions or permit denials 

issued pursuant to such provisions, are 

enforceable by the EPA pursuant to 

section 1423 of SDWA and 40 CFR 

147.1(e). The EPA will continue to 

administer the UIC program for Class I, 

II, III, IV, V, and VI injection wells on 

Indian lands. 

The EPA proposes to incorporate by 

reference the West Virginia statutes and 

regulations applicable to owners or 

operators of Class VI wells as a 

compilation titled ‘‘EPA-approved West 

Virginia SDWA section 1422 

Underground Injection Control Program 

Statutes and Regulations for Well Class 

VI,’’ dated [date when the EPA compiles 

the notebook]. This compilation would 

be incorporated by reference into 40 

CFR 147.2450 and is available at 

www.regulations.gov in the docket for 

this proposed rulemaking. The EPA also 

proposes to codify a table in 40 CFR 

147.2450 listing the EPA-approved West 

Virginia Statutes and Regulations for 

Well Class VI included in the 

compilation that EPA would incorporate 

by reference. While the regulations in 

47CSR13 contain requirements for all 

UIC well classes (i.e., Class I–VI), only 

the requirements applicable to owners 

or operators of Class VI wells would be 

incorporated by reference as part of this 

action. 

Upon approval, the EPA would 

oversee West Virginia’s administration 

of its Class VI program and will 

continue to oversee West Virginia’s 

administration of its programs for Class 

I, II, III, IV, and V wells. The EPA will 

require quarterly reports on noncompliance and annual UIC 

performance reports pursuant to 40 CFR 

144.8. The amended MOA addendum 

between the EPA and West Virginia, 

signed by the Regional Administrator on 

October 9, 2024, articulates that the EPA 

will oversee the State’s administration 

of the UIC Class VI program on a 

continuing basis to assure that such 

administration is consistent with the 

program MOAs, UIC grant agreements, 

and all applicable requirements 

embodied in current regulations and 

Federal law. In addition, the amended 

MOA addendum provides that the EPA 

may request specific information 

including permits and the 

accompanying EJ reviews. 

B. Class I–V Codification—No Action 

As referenced in section II.C of this 

preamble, the EPA approved West 

Virginia for Class I–V primacy in 1983. 

After notice and public comment, the 

EPA determined that West Virginia’s 

UIC program met Federal requirements 

and published its decision to approve 

West Virginia’s UIC program in the 

Federal Register (48 FR 55127, 

December 9, 1983). The Code of Federal 

Regulations (CFR) sets forth the 

applicable UIC program for each State 

(40 CFR 147.1) and, upon approving a 

State for UIC primacy, the EPA typically 

updates the CFR to reflect its approval. 

However, for reasons that current EPA 

staff were unable to ascertain, when the 

EPA approved West Virginia’s UIC 

program in 1983, the CFR was not 

revised to reflect the EPA’s approval, 

and the CFR currently does not reflect 

West Virginia’s Class I–V primacy. 

While the EPA is not addressing this 

CFR discrepancy as part of this 

proposed action, the EPA expects to 

address it later as part of a separate 

action. The current proposal is confined 

to approving a revision to West 

Virginia’s existing UIC primacy program 

to grant the State primacy over Class VI 

wells; it is not addressing other well 

classes.2 Separately, the EPA is working 

with West Virginia to assess the State’s 

current Class I–V program elements and 

expects to codify in the CFR the State’s 

Class I–V program in 2025 as part of a 

separate action. An email from the 

WVDEP affirming the State’s intention 

to submit a Class I–V program revision 

package in 2025 following the Class VI 

process can be found in the docket for 

this proposed rulemaking. 

VI. Statutory and Executive Orders 

Reviews 

Additional information about these 

statutes and Executive orders can be 

found at: https://www.epa.gov/lawsregulations/laws-and-executive-orders. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Proposed Rules 93543 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 14094: Modernizing Regulatory 

Review 

This proposed action is exempt from 

review under Executive Order 12866, as 

amended by Executive Order 14094, 

because the Office of Management and 

Budget (OMB) has exempted, as a 

category, the approval of State UIC 

programs. 

B. Paperwork Reduction Act (PRA) 

This proposed action will not impose 

any new information collection burden 

under the PRA. OMB has previously 

approved the information collection 

activities contained in the existing 

regulations and has assigned OMB 

control number 2040–0042. Reporting or 

recordkeeping requirements will be 

based on West Virginia’s Class VI UIC 

Regulations, and the State of West 

Virginia is not subject to the PRA. 

C. Regulatory Flexibility Act (RFA) 

I certify that this proposed action will 

not have a significant economic impact 

on a substantial number of small entities 

under the RFA. This proposed action 

would not impose any new 

requirements on small entities. It simply 

approves and codifies West Virginia’s 

UIC Class VI program, which meets the 

same standard under SDWA section 

1422 as is required for the EPA’s 

regulations governing its direct 

implementation of a UIC Class VI 

program. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This proposed action does not contain 

an unfunded mandate as described in 

UMRA, 2 U.S.C. 1531–1538, and does 

not significantly or uniquely affect small 

governments. The proposed action 

imposes no enforceable duty on any 

state, local, or Tribal governments or the 

private sector. The EPA’s proposed 

approval of West Virginia’s Class VI 

program will not constitute a Federal 

mandate because there is no 

requirement that a state establish UIC 

regulatory programs and because the 

program is a state, rather than a Federal 

program. 

E. Executive Order 13132: Federalism 

This proposed action does not have 

federalism implications. It will not have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This proposed action does not have 

Tribal implications as specified in 

Executive Order 13175. This proposed 

action contains no Federal mandates for 

Tribal governments and does not 

impose any enforceable duties on Tribal 

governments. Thus, Executive Order 

13175 does not apply to this proposed 

action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

The EPA interprets Executive Order 

13045 as applying only to those 

regulatory actions that concern 

environmental health or safety risks that 

the EPA has reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive Order. This proposed action 

is not subject to Executive Order 13045 

because it approves a state program. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This proposed action is not subject to 

Executive Order 13211, because it is not 

a significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This proposed rulemaking does not 

involve technical standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations and Executive 

Order 14096: Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All 

The EPA believes that it is not 

practicable to assess whether the human 

health or environmental conditions that 

exist prior to this proposed action result 

in disproportionate and adverse effects 

on communities with environmental 

justice concerns. There currently are no 

Class VI wells permitted in West 

Virginia and this proposed action would 

be a procedural action. The EPA has 

reviewed West Virginia’s proposed 

approach to environmental justice, as 

outlined in the Class VI Program 

Description and Class VI MOA amended 

addendum, and described in section 

IV.B of this preamble. The EPA 

considers West Virginia’s Class VI 

primacy application to integrate 

environmental justice and equity 

considerations into the State’s UIC Class 

VI program, while ensuring protection 

of USDWs. This proposed action would 

provide West Virginia with primacy 

under SDWA section 1422 for a UIC 

Class VI program, pursuant to which 

West Virginia would implement a 

program that meets the EPA’s 

requirements for UIC Class VI programs. 

VII. References 

Attorney General’s Statement ‘‘Attorney 

General’s Statement to Accompany West 

Virginia’s Underground Injection 

Program Class VI Primacy Application,’’ 

signed by the General Counsel of the 

West Virginia Department of 

Environmental Protection, April 29, 

2024. 

Class VI Underground Injection Control 

Program Description ‘‘WV Class 6 

Program Description’’, June 2024. 

Email from West Virginia to EPA related to 

Class I–V program revision, April 22, 

2024. 

Letter from Governor of West Virginia to 

Regional Administrator, EPA Region III, 

April 25, 2024. 

Memorandum of Agreement Amended 

Addendum 1 between the State of West 

Virginia and the EPA, Region III for the 

UIC Class VI Program, signed by the EPA 

Regional Administrator on October 9, 

2024. 

Federal Register notice ‘‘West Virginia 

Department of Natural Resources; 

Underground Injection Control Program 

Approval’’, EPA, 48 FR 55127–55128 

(December 9, 1983). 

Memorandum of Agreement between the 

State of West Virginia and the EPA, 

Region III, signed by the EPA Regional 

Administrator on August 31, 1983. 

Memorandum of Agreement Between The 

West Virginia Department of 

Environmental Protection and The West 

Virginia Department of Health, signed 

April 26, 2024. 

Memorandum of Agreement Between The 

West Virginia Department of 

Environmental Protection and The West 

Virginia Geological and Economic 

Survey, signed April 29, 2024. 

Program Description ‘‘Program Description 

for the West Virginia Underground 

Injection Control Program’’, December 

1983. 

State of West Virginia. Notice of Action 

Taken by Legislative Rule-Making 

Review Committee, December 9, 2021. 

State of West Virginia. Notice of Action 

Taken by Legislative Rule-Making 

Review Committee, September 13, 2023. 

State of West Virginia. Notice of Public 

Comment Period and Hearing, June 12, 

2023. 

State of West Virginia. Notice of Public 

Comment Period and Hearing, June 23, 

2021. 

State of West Virginia. Public Comments and 

Responses, July 24, 2023. 

State of West Virginia. Public Comments and 

Responses, July 30, 2021. 

State of West Virginia. Public Hearing 

Transcript (Public Hearing Date: July 23, 

2021), July 31, 2021. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
93544 Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Proposed Rules 

State of West Virginia. Public Hearing 

Transcript (Public Hearing Date: July 18, 

2023), August 12, 2023. 

USEPA. 2023b. U.S. Environmental 

Protection Agency. Memorandum to 

Water Division Directors, Regions I–X, 

from Radhika Fox, Office of Water. 

Environmental Justice Guidance for UIC 

Class VI Permitting and Primacy (August 

17, 2023). 

West Virginia Code § 22–11. Water Pollution 

Control Act. May 13, 2024. 

West Virginia Code § 22–11A. Carbon 

Dioxide Sequestration Pilot Program. 

May 20, 2022. 

West Virginia Code § 22–11B. Underground 

Carbon Dioxide Sequestration and 

Storage. May 13, 2024. 

West Virginia Code of State Rules § 47–13. 

Underground Injection Control. April 5, 

2024. 

List of Subjects in 40 CFR Part 147 

Environmental protection, 

Incorporation by reference, Indian 

lands, Intergovernmental relations, 

Reporting and recordkeeping 

requirements, Water supply. 

Michael S. Regan, 

Administrator. 

For the reasons set forth in the 

preamble, the EPA proposes to amend 

40 CFR part 147 as follows: 

PART 147—STATE, TRIBAL, AND 

EPA–ADMINISTERED UNDERGROUND 

INJECTION CONTROL PROGRAMS 

■ 1. The authority citation for part 147 

continues to read as follows: 

Authority: 42 U.S.C. 300f et seq.; and 42 

U.S.C. 6901 et seq. 

■ 2. Add § 147.2450 to read as follows: 

§ 147.2450 State-administered program— 

Class VI Wells 

The UIC program for Class VI wells in 

the State of West Virginia, except those 

on Indian lands, is the program 

administered by the West Virginia 

Department of Environmental 

Protection, approved by the EPA 

pursuant to SDWA section 1422. The 

effective date of this program is [DATE 

30 DAYS AFTER FINAL RULE 

PUBLICATION IN THE FEDERAL 

REGISTER]. The UIC program for Class 

VI wells in the State of West Virginia, 

except those located on Indian lands, 

consists of the following elements, as 

submitted to the EPA in the State’s 

program revision application. 

(a) Incorporation by reference. The 

requirements applicable to owners or 

operators of Class VI wells set forth in 

the State statutes and regulations 

approved by the EPA for including in 

‘‘EPA-approved West Virginia SDWA 

§ 1422 Underground Injection Control 

Program Statutes and Regulations for 

Well Class VI,’’ dated [date when the 

EPA compiles the notebook], and listed 

in table 1 to this paragraph (a), are 

hereby incorporated by reference and 

made a part of the applicable UIC 

program under the SDWA for the State 

of West Virginia. The Director of the 

Federal Register approves this 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. Copies of the State of West 

Virginia’s statutes and regulations that 

are incorporated by reference may be 

inspected at the U.S. Environmental 

Protection Agency, Region 3, Four Penn 

Center, 1600 JFK Blvd., Philadelphia, 

PA 19103 and the U.S. Environmental 

Protection Agency, Water Docket, EPA 

Docket Center (EPA/DC), EPA WJC 

West, Room 3334, 1301 Constitution 

Ave. NW, Washington, DC 20004. If you 

wish to obtain materials from the EPA 

Regional Office, please call (215) 814– 

2816, or from the EPA Headquarters 

Library, please call the Water Docket at 

(202) 566–2426. You may also view this 

material at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, visit 

www.archives.gov/federal-register/cfr/ 

ibr-locations.html or email 

fr.inspections@nara.gov. You may also 

obtain the State of West Virginia’s 

statutes and regulations that are 

incorporated by reference from: Room 

MB–27, Building 1, State Capitol 

Complex, Charleston, West Virginia 

25305; phone: (304) 347–4836; website: 

www.wvlegislature.gov. 

TABLE 1 TO PARAGRAPH (a)—EPA-APPROVED WEST VIRGINIA SDWA SEC. 1422 UNDERGROUND INJECTION CONTROL

PROGRAM STATUTES AND REGULATIONS FOR WELL CLASS VI 

State citation Title/subject State effective date EPA approval date 

West Virginia Code § 22–11 ..... Water Pollution Control Act ...... May 13, 2024 .................. [DATE OF FINAL RULE PUBLICATION IN THE 

FEDERAL REGISTER.] 

West Virginia Code § 22–11A ... Carbon Dioxide Sequestration 

Pilot Program.

May 30, 2022 .................. [DATE OF FINAL RULE PUBLICATION IN THE 

FEDERAL REGISTER.] 

West Virginia Code § 22–11B ... Underground Carbon Dioxide 

Sequestration and Storage.

May 13, 2024 .................. [DATE OF FINAL RULE PUBLICATION IN THE 

FEDERAL REGISTER.] 

West Virginia Code of State 

Rules § 47–13.

Underground Injection Control .. April 5, 2024 ................... [DATE OF FINAL RULE PUBLICATION IN THE 

FEDERAL REGISTER.] 

(b) Memorandum of Agreement 

(MOA). (1) The Memorandum of 

Agreement between the State of West 

Virginia and the EPA, Region III, signed 

by the EPA Regional Administrator on 

August 31, 1983. 

(2) Memorandum of Agreement 

Amended Addendum 1 between the 

State of West Virginia and the EPA, 

Region III for the UIC Class VI Program, 

signed by the EPA Regional 

Administrator on October 9, 2024. 

(c) Letter from Governor. Letter from 

Governor of West Virginia to Regional 

Administrator, EPA Region III, April 25, 

2024. 

(d) West Virginia Memorandums of 

Agreement. (1) Memorandum of 

Agreement Between The West Virginia 

Department of Environmental Protection 

and The West Virginia Geological and 

Economic Survey, effective April 1, 

2024. 

(2) Memorandum of Agreement 

Between The West Virginia Department 

of Environmental Protection and The 

West Virginia Department of Health, 

signed April 26, 2024. 

(e) Statement of legal authority. 

Attorney General’s Statement, ‘‘Attorney 

General’s Statement to Accompany West 

Virginia’s Underground Injection 

Program Class VI Primacy Application’’, 

signed by the Attorney General of West 

Virginia on April 29, 2024. 

(f) Program Description. The Program 

Description, ‘‘Program Description for 

the West Virginia Underground 

Injection Control Program’’, and any 

other materials submitted as part of the 

application or amendment thereto, and 

the Class VI Underground Injection 

Control Program Description, ‘‘WV Class 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024 / Proposed Rules 93545 

1See, e.g., Medicare and State Health Care 

Programs: Fraud and Abuse; Revisions to Safe 

Harbors Under the Anti-Kickback Statute, and Civil 

Monetary Penalty Rules Regarding Beneficiary 

Inducements, 85 FR 77684 (Dec. 2, 2020). 

2Medicare and State Health Care Programs: Fraud 

and Abuse; OIG Anti-Kickback Provisions, 56 FR 

35952, 35958 (July 29, 1991). 

3See, e.g., Special Fraud Alert: OIG Alerts 

Practitioners To Exercise Caution When Entering 

Into Arrangements With Purported Telemedicine 

Companies (July 20, 2022), https://oig.hhs.gov/ 

documents/root/1045/sfa-telefraud.pdf. 

6 Program Description’’, and any other 

materials submitted as part of the 

program revision application or as 

amendment thereto. 

[FR Doc. 2024–27638 Filed 11–25–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1001 

Solicitation of Proposals for New and 

Modified Safe Harbors and Special 

Fraud Alerts 

AGENCY: Office of Inspector General 

(OIG), Department of Health and Human 

Services (HHS or the Department). 

ACTION: Notification of intent to develop 

regulations. 

SUMMARY: In accordance with section 

205 of the Health Insurance Portability 

and Accountability Act of 1996 

(HIPAA), this annual notification 

solicits proposals and recommendations 

for developing new, or modifying 

existing, safe harbor provisions under 

section 1128B(b) of the Social Security 

Act (the Act), the Federal anti-kickback 

statute, as well as developing new OIG 

Special Fraud Alerts. 

DATES: To ensure consideration, public 

comments must be received no later 

than 5 p.m. on January 27, 2025. 

ADDRESSES: You may submit comments 

electronically at https://

www.regulations.gov. Follow the 

‘‘Submit a comment’’ instructions and 

refer to file code OIG–1124–N. 

For information on viewing public 

comments, please see the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin Wallfisch, (202) 339–7980. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: https://

www.regulations.gov. 

I. Background 

A. OIG Safe Harbor Provisions 

Section 1128B(b) of the Act (42 U.S.C. 

1320a–7b(b)), the Federal anti-kickback 

statute, provides for criminal penalties 

for whoever knowingly and willfully 

offers, pays, solicits, or receives 

remuneration to induce or reward, 

among other things, referrals for or 

purchases of items or services 

reimbursable under any of the Federal 

health care programs, as defined in 

section 1128B(f) of the Act (42 U.S.C. 

1320a–7b(f)). The offense is classified as 

a felony and is punishable by a fine of 

up to $100,000 and imprisonment for up 

to 10 years. Violations of the Federal 

anti-kickback statute also may result in 

the imposition of civil monetary 

penalties under section 1128A(a)(7) of 

the Act (42 U.S.C. 1320a–7a(a)(7)), 

program exclusion under section 

1128(b)(7) of the Act (42 U.S.C. 1320a– 

7(b)(7)), and liability under the False 

Claims Act (31 U.S.C. 3729–33). 

Because of the broad reach of the 

statute, stakeholders expressed concern 

that some relatively innocuous business 

arrangements were covered by the 

statute and, therefore, potentially 

subject to criminal prosecution. In 

response, Congress enacted section 14 of 

the Medicare and Medicaid Patient and 

Program Protection Act of 1987, Public 

Law 100–93 (note to section 1128B of 

the Act; 42 U.S.C. 1320a–7b), which 

requires the development and 

promulgation of regulations, the socalled safe harbor provisions, that 

would specify various payment and 

business practices that would not be 

subject to sanctions under the Federal 

anti-kickback statute, even though they 

potentially may be capable of inducing 

referrals of business for which payment 

may be made under a Federal health 

care program. Since July 29, 1991, there 

has been a series of final regulations 

published in the Federal Register 

establishing safe harbors to protect 

various payment and business 

practices.1 These safe harbor provisions 

have been developed ‘‘to limit the reach 

of the statute somewhat by permitting 

certain non-abusive arrangements, while 

encouraging beneficial and innocuous 

arrangements.’’ 2 Health care providers 

and others may voluntarily seek to 

comply with the conditions of an 

applicable safe harbor so that they have 

the assurance that their payment or 

business practice will not be subject to 

sanctions under the Federal antikickback statute. The safe harbor 

regulations promulgated by OIG are 

found at 42 CFR part 1001. 

B. OIG Special Fraud Alerts 

OIG periodically issues Special Fraud 

Alerts to give continuing guidance to 

health care industry stakeholders about 

practices that OIG considers to be 

suspect or of particular concern.3

Special Fraud Alerts encourage industry 

compliance by giving stakeholders 

guidance that can be applied to their 

own practices. OIG Special Fraud Alerts 

are published in the Federal Register, 

on OIG’s website, or both, and are 

intended for extensive distribution. 

In developing Special Fraud Alerts, 

OIG relies on several sources and 

consults directly with experts in the 

subject field, including those within 

OIG, other agencies of HHS, other 

Federal and State agencies, and those in 

the health care industry. 

C. Section 205 of the Health Insurance 

Portability and Accountability Act of 

1996 

Section 205 of HIPAA, Public Law 

104–191, and section 1128D of the Act 

(42 U.S.C. 1320a–7d), requires the 

Department to develop and publish an 

annual notification in the Federal 

Register formally soliciting proposals 

for developing additional or modifying 

existing safe harbors to the Federal antikickback statute and for issuing Special 

Fraud Alerts. 

In developing or modifying safe 

harbors under the Federal anti-kickback 

statute, and in consultation with the 

Department of Justice, OIG thoroughly 

reviews the range of factual 

circumstances that may receive 

protection by the proposed or modified 

safe harbor. In doing so, OIG seeks to 

identify and develop safe harbors that 

protect beneficial and innocuous 

arrangements and safeguard Federal 

health care programs and their 

beneficiaries from the harms caused by 

fraud and abuse. 

II. Solicitation of New and Modified 

Safe Harbor Recommendations and 

Special Fraud Alert Proposals 

OIG seeks recommendations regarding 

the development of additional or 

modified safe harbor regulations and the 

issuance of new Special Fraud Alerts. A 

detailed explanation of justifications for, 

or empirical data supporting, a 

suggestion for a new or modified safe 

harbor or for the issuance of a new 

Special Fraud Alert would be helpful 


ddrumheller on DSK120RN23PROD with PROPOSALS1