UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF CRIMINAL ENFORCEMENT, FORENSICS AND TRAINING
EPA- 330 / 9- 9 7- 002
Compliance-Focused Environmental
Management System -
Enforcement Agreement Guidance
August 1997
Steven W. Sisk
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Diana A. Love, Director
Denver, Colorado
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INTRODUCTION
Since the late 1980s, civil multimedia compliance investigations conducted by
the EPA National Enforcement Investigations Center (NEIC) have increasingly
involved identifying causes of observed noncompliance. In a significant number of
cases, the causes arise from inadequate environmental management systems (EMSs).1
NEIC, in response, developed key elements for a compliance-focused EMS model,
which have been used as the basis for EMS requirements in several settlement
agreements. The purpose of this guidance is to present those key elements and to
show, through the attached example, how they can be incorporated into a settlement
agreement. The compliance-focused EMS model described here is intended to
supplement, not replace, EMS models developed by voluntary consensus standards
bodies, such as the ISO 14001 EMS standard developed by the International
Organization for Standardization.
A settlement agreement that requires an EMS should include a requirement
that the organization conduct an initial review of its current EMS, followed by
development of a comprehensive compliance-focused EMS that must be documented
in a manual. The EMS manual must contain policies, procedures, and standards for
the 12 key elements, at a minimum, and should also identify other, more detailed
procedures and processes (e.g., inspections and self-monitoring) that may be located
elsewhere at the facility. After the organization has had sufficient time to implement
and refine the EMS (usually 2 to 3 years), the agreement should require at least one
EMS audit by an independent third-party auditor, with results reported to both the
The International Organization for Standardization (ISO) defines an EMS as "thatpart
of the overall management system which includes organizational structure, planning
activities, responsibilities, practices, procedures, processes and resources for developing,
implementing, achieving, reviewing, and maintaining [the organization's]
environmental policy." The EMS provides the structure by which specific activities
related to environmental protection and compliance can be effectively and efficiently
carried out.
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organization and EPA. However, additional audits may be required, as individual
circumstances dictate.
The intended result of this approach is twofold: first, to have the organization
develop an EMS that will both improve its compliance with applicable environmental
requirements and, second, to improve its environmental performance by achieving the
organization's environmental goals and objectives.
The 12 key elements of a compliance-focused EMS addressed in this guide were
compiled from a number of sources: EMS assessment protocols developed by Deloitte
and Touche LLP of San Francisco for the Global Environmental Management
Initiative (1992) and an industrial client (1994); ISO 14001 "Environmental
management systems - Specification with guidance for use" (1996); National Sanitation
Foundation EMS standards (NSF 110-1995); a November 14,1986 EPA memorandum
entitled "Final EPA Policy on the Inclusion of Environmental Auditing Provisions in
Enforcement Settlements"; and the "due diligence" definition in the current EPA "audit
policy" (60 FR 66710 published December 22, 1996). Additional input was obtained
through NEIC participation in several EPA EMS-related work groups including the
Environmental Leadership Program (ELP) Pilot Project workgroup tasked with
defining the EMS requirements for the full-scale program. Refinement of the key
elements and the EMS improvement approach continues through settlement
negotiations, and discussions with EPA staff, EMS consultants, and environmental
personnel from several companies with medium-size and large facilities.
A general EMS provision for a settlement agreement and the 12 key elements
are presented in the following sections. The prescriptive style has been retained to
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facilitate future use in settlement agreements.1 Example consent decree language
incorporating the EMS improvement approach described above is presented in
Attachment A. Questions concerning this document should be directed to Steve Sisk
of NEIC at (303) 236-3636 x540.
GENERAL EMS PROVISION
A comprehensive compliance-focused Environmental Management System
(EMS) shall be developed, implemented, and maintained by the organization. The
EMS shall address, at a minimum, the 12 key elements listed below, and shall be
described in an "Environmental Management System Manual."
ENVIRONMENTAL MANAGEMENT SYSTEM MANUAL PROVISIONS
The EMS Manual shall be organized to clearly address the following key
elements.
1. Management Policies and Procedures
a. Organization's Environmental Policy - This policy must clearly
communicate management commitment to environmental
performance, including compliance with applicable federal, state,
and local environmental statutes, regulations, enforceable
agreements, and permits (hereafter, "environmental
requirements").
b. Site-specific Environmental Policies and Standards
The 12 elements are closely inter-related components of an EMS for which subsystems
and procedures must be developed and fully integrated if the entire program is to be
effective. They are usually included in settlement agreements as a complete group;
however, individual elements may need to be modified to reflect site-specific conditions
and circumstances.
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! Compilation of general principles, policies, rules, and
procedures for site-specific environmental practices.
! Includes process for developing, approving, and
communicating standard operating practices for activities
having potentially adverse environmental or regulatory
compliance impacts.
! Clearly identifies organizational responsibilities for
maintaining regulatory compliance, including required
reporting to regulatory agencies.
! Includes ongoing means of communicating environmental
issues and information to all organization personnel, on-site
service providers, and contractors, and for receiving and
addressing their concerns.
! Establishes and describes processes to ensure sustained
interaction with regulatory agencies, and within the
organization (e.g., between the various divisions,
contractors, and the Environmental Control Department)
regarding environmental requirements and regulatory
compliance.
2. Organization, Personnel, and Oversight of EMS
a. Describes, organizationally, how the EMS is implemented and
maintained.
b. Includes organization charts that identify units, line management,
and other individuals having environmental performance and
regulatory compliance responsibilities.
c. Identifies and defines duties, roles, responsibilities, and
authorities of key environmental program personnel in
implementing and sustaining the EMS (e.g., could include position
descriptions and performance standards for all environmental
department personnel, and excerpts from others having specific
environmental program and regulatory compliance
responsibilities).
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3. Accountability and Responsibility
a. Specifies accountability and responsibilities of organization's
management, on-site service providers, and contractors for
environmental protection practices, compliance, required reporting
to regulatory agencies, and corrective actions implemented in their
area(s) of responsibility.
b. Describes potential consequences for departure from specified
operating procedures, including liability for civil/administrative
penalties imposed as a result of noncompliance.
4. Environmental Requirements
a. Describes process for identifying, interpreting, and effectively
communicating environmental requirements to affected
organization personnel, on-site service providers, and contractors,
and ensuring that facility activities conform to those requirements.
Specifies procedures for prospectively identifying and obtaining
information about changes and proposed changes in
environmental requirements, and incorporating those changes into
the EMS.
5. Assessment, Prevention, and Control
a. Identifies an ongoing process for assessing operations, for the
purposes of preventing and controlling releases, ensuring
environmental protection, and maintaining compliance with
statutory and regulatory requirements. This section shall describe
monitoring and measurements, as appropriate, to ensure
sustained compliance. It shall also include identifying operations
and waste streams where equipment malfunctions and
deterioration, operator errors, and discharges or emissions maybe
causing, or may lead to: (1) releases of hazardous waste or other
pollutants to the environment, or (2) a threat to human health or
the environment. Finally, the process shall include performing
root-cause analysis of identified problems in order to develop
remedies and prevent recurring issues.
b. Describes process for identifying operations and activities, which
could result in adverse environmental impacts and/or regulatory
noncompliance, where documented standard operating practices
need to be developed (see element l.b.).
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c. Describes a system for conducting and documenting routine,
objective, self-inspections by department supervisors and trained
staff, especially at locations identified by the process described in
a. above.
d. Describes process for ensuring input of environmental
requirements (or concerns) in planning, design, and operation of
ongoing, new, and/or changing buildings, processes, maintenance
activities, and products.
6. Environmental Incident and Noncompliance Investigations
a. Describes standard procedures and requirements for incident and
noncompliance reporting.
b. Establishes procedures for investigation of potential violations or
noncompliance.
c. Describes a system for development, tracking, and effectiveness
verification of corrective and preventative actions.
d. Each of these procedures shall specify self-testing of such
procedures, where practicable.
7. Environmental Training, Awareness, and Competence
a. Identifies specific education and training required for organization
personnel, as well as process for documenting training provided.
b. Describes program to ensure that organization employees are
aware of its environmental policies and procedures, environmental
requirements, and their roles and responsibilities within the
environmental management system.
c. Describes program for ensuring that personnel responsible for
meeting and maintaining compliance with environmental
requirements are competent on the basis of appropriate education,
training, and/or experience.
8. Planning for Environmental Matters
a. Describes how environmental planning will be integrated into
other plans developed by organizational subunits, as appropriate
(e.g., capital improvements, training, maintenance).
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b. Requires establishing written goals, objectives, and action plans by
at least each operating organizational subunit with environmental
responsibilities, as appropriate, including those for contractor
operations conducted at the facility, and how specified actions will
be tracked and progress reported.
9. Maintenance of Records and Documentation
a. Identifies the types of records developed in support of the EMS
(including audits and reviews), who maintains them and where,
and protocols for responding to inquiries and requests for release
of information.
b. Specifies the data management systems for any internal waste
tracking, environmental data, and hazardous waste
determinations.
10. Pollution Prevention Program
a. Describes an internal program for preventing, reducing, recycling,
reusing, and minimizing waste and emissions, including
procedures to encourage material substitutions. Also includes
mechanisms for identifying candidate materials to be addressedby
program and tracking progress.
11. Continuing Program Evaluation and Improvement
a. Describes program for periodic (at least annually) evaluation of the
EMS, including incorporating the results of the assessment into
program improvements, revisions to the manual, and
communicating findings and action plans to affected employees,
on-site service providers, and contractors.
12. Public Involvement/Community Outreach
a. Describes a program for ongoing community education and
involvement in the environmental aspects of the organization's
operations and general environmental awareness.
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ATTACHMENT A
EXAMPLE CONSENT DECREE LANGUAGE
FOR EMS IMPROVEMENTS
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Attachment A
EXAMPLE CONSENT DECREE LANGUAGE FOR EMS IMPROVEMENTS
A. Environmental Management System
1. Upon the effective date of this Decree, Defendant shall provide to EPA
and the state in writing the name, affiliation and address of the
individual(s) selected by the Defendant to conduct the Initial EMS
Review and Evaluation, how such individual(s) satisfies the proficiency
criteria described in the [reference standard, e.g., ISO 14012
"Guidelines for environmental auditing - Qualification criteria for
environmental auditors" or American Society for Testing of Materials
("ASTM") Provisional Standard 12-95 - Provisional Standard Guide for
Study and Evaluation of An Organizations Environmental Management
Systems], and the schedule, including milestones, for conducting the
Initial EMS Review and Evaluation.
2. The individual identified pursuant to paragraph A. 1 above shall conduct
an initial review and evaluation of the current EMS relating to the
operations of both [the company] and Contractors, as defined in
paragraph A. 17 below. The Defendant shall review and evaluate the
current EMS to identify gaps using the elements set forth in paragraphs
A.4.a(l) through (12) below.
3. Based on the Initial Review and Evaluation results and other
information, Defendant shall prepare a written Comprehensive EMS for
the Facility1 addressing, at a minimum, the twelve key elements pre-
1 "Facility" is a defined term in each settlement agreement.
A-1
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sented in paragraphs A.4.a(l) through (12) below. The purpose of
preparing the Comprehensive EMS is to assist [the company] in its
program to comply with federal, state and local environmental statutes,
regulations, permits, and enforceable agreements (hereinafter in this
Section A (Environmental Management System) referred to as
"environmental requirements").
4. Within two hundred seventy (270) days of the effective date of this
Decree, Defendant shall complete the preparation of an "Environmental
Management System Manual" which shall include the Comprehensive
EMS, an EMS implementation schedule and rationale identifying pro-
posed changes to the current EMS and explaining what the changes are
intended to accomplish. For each of the elements identified in
paragraphs A.4.a(l) through (12) below, as appropriate, the manual shall
provide a detailed blueprint of the EMS, describing how the activity or
program is or will be: (a) established as a formal system, (b) integrated
into ongoing department operations, and (c) continuously evaluated and
improved.
a. Defendant shall develop an Environmental Management System
Manual - The EMS Manual shall address the following elements:
NOTE: The 12 key elements of the compliance-focused EMS (or alternate
standard) are inserted here.
5. Defendant shall submit the complete Environmental Management
System Manual to EPA and the state for review and comment within
thirty (30) days of its completion.
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6. EPA will provide its and the state's comments on the Environmental
Management System Manual within ninety (90) days of EPA's receipt of
such Manual unless EPA or the state notifies the Defendant in writing
that additional time for review and approval is required. The state's
review and EPA's review and comment will not extend beyond one
hundred and fifty (150) days of EPA's receipt of the Environmental
Management System Manual.
7. [The company] shall, within thirty (30) days of receipt of EPA's and the
state's comments on the proposed EMS Manual, submit to EPA and the
state a supplement to the EMS Manual or a written response, as
appropriate, addressing EPA's and the state's comments. The EMS
Manual shall contain an implementation schedule for initiating each
component of the system not already implemented.
8. Within thirty (30) days of completing their reviews, EPA and the state
will return the supplement or written response, and the EMS Manual to
the Defendant.
9. Upon Defendant's receipt of EPA's and the state's comments, Defendant
shall immediately commence implementation of the EMS in accordance
with the schedule contained in the EMS Manual. The Defendant shall
submit status reports regarding the implementation to EPA and the
state, on a quarterly basis, beginning no later than thirty (30) days from
receipt of EPA's and the state's comments on the manual. The status
reports shall be due on the 15th day of the first month of the next quarter
and every quarter thereafter until implementation is complete.
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10. Within twenty (20) months of the effective date of this Decree, the
Defendant shall provide to EPA and the state in writing (1) the name,
affiliation, and address of the independent 3rd party consultant selected
by the defendant to perform a Comprehensive EMS Review and
Evaluation at the Facility; (2) how the selected independent 3rd party
consultant satisfies the independence and proficiency criteria in the
[reference standard, e.g., ISO 14012 "Guidelines for environmental
auditing - Qualification criteria for environmental auditors" American
Society for Testing of Materials (ASTM) Provisional Standard 12-95 -
Provisional Standard Guide for Study and Evaluation of An
Organizations Environmental Management Systems]; and (3) a schedule,
including milestones, for conducting the review. The review shall be
performed in accordance with the [reference standard, e.g., ISO 14011
"Guidelines for environmental auditing - Audit procedures - Auditing of
environmental management systems", or ASTM Provisional Standard 12-
95 - Provisional Standard Guide for Study and Evaluation of An
Organizations Environmental Management Systems]. The Defendant's
contract with the 3rd party consultant shall require such 3rd party
consultant to review and evaluate the implementation of the systems,
policies, and procedures described in the EMS Manual, using the EMS
elements set forth in paragraphs A.4.a(l) through (12) above as criteria
for the evaluation.
11. Within ninety (90) days after submitting the notification required by
Paragraph A. 10, above, the independent 3rd party consultant shall
complete the Comprehensive EMS Review and Evaluation and submit a
Comprehensive EMS Review and Evaluation Report to [the company],
EPA and the state, simultaneously. This report shall include (1) the
results of the auditor's review and evaluation of the facility EMS relating
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to both [the company] and Contractor operations and (2) the auditor's
recommendations for improvements to the Comprehensive EMS.
12. Within thirty (30) days after receipt of the independent 3rd party
consultant Comprehensive EMS Review and Evaluation Report,
Defendant shall provide to EPA and the state for review and comment a
written response to the recommendations presented in that Report
identifying those recommendations it does and does not intend to
implement and/or plans to implement with modification(s). The
Defendant shall include in its response an explanation of its rationale for
not implementing and/or modifying the independent 3rd party consultant
recommendations and a schedule for implementing changes to the EMS
based on the Comprehensive EMS Review and Evaluation.
13. EPA will provide its and the state's comments on the Comprehensive
EMS Review and Evaluation Report within ninety (90) days of EPA's
receipt of such Plan unless EPA or the state notifies the Defendant in
writing that additional time for review and comment is required. The
state's review and EPA's review and comment will not extend beyond one
hundred and fifty (150) days of EPA's receipt of the Comprehensive EMS
Review and Evaluation Report.
14. [The company] shall, within thirty (30) days of receipt of EPA's and the
state's comments on the Comprehensive EMS Review and Evaluation
Report, submit to EPA and the state a written response to such
comments.
15. Within thirty (30) days of completing their review of the Defendant's
response to EPA's and the state's comments, EPA and the state will
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return the Comprehensive EMS Review and Evaluation Report to the
Defendant.
16. Any submissions made to EPA or the state pursuant to this Section A
shall not be interpreted as a waiver or limitation of the United state's or
the state of [state name] authority to enforce any federal, state, or local
statute or regulation including permits.
17. For purposes of this Environmental Management System section, the
term "Contractor" shall mean [contractor one name], any successor to
[contractor one name] located on facility, [contractor two name], any
successor to [contractor two name] located at Defendant's facility and
contractors providing the following services at the facility: [list of specific
services such as asbestos removal; demolition; painting; waste handling,
including vacuum truck operators; and construction].
18. Confidential Business Information ("CBI") - Defendant may, if
appropriate, declare portions of the EMS Manual, rationale or underlying
information, to be confidential pursuant to 40 C.F.R. Part 2.
A-6
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